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Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
(8) Narrow woven ribbons comprised Countervailing Duty Order
merchandise in an amount equal to the at least 85 percent by weight of threads According to section 706(b)(2) of the net countervailable subsidy rates noted having a denier of 225 or higher; Act, duties shall be assessed on subject (9) Narrow woven ribbons constructed merchandise entered, or withdrawn from pile fabrics (i.e., fabrics with a from warehouse, for consumption on or Exporter/manufacturer surface effect formed by tufts or loops of after the date of publication of the ITC's yarn that stand up from the body of the notice of final determination if that Yama Ribbons and Bows Co., determination is based upon the threat (10) Narrow woven ribbon affixed of material injury. Section 706(b)(1) of Changtai Rongshu Textile Co., (including by tying) as a decorative the Act states, ‘‘If the Commission, in its detail to non-subject merchandise, such final determination under section All Others .
as a gift bag, gift box, gift tin, greeting 705(b), finds material injury or threat of card or plush toy, or affixed (including material injury which, but for the Termination of the Suspension of
by tying) as a decorative detail to suspension of liquidation under section Liquidation
packaging containing non-subject 703(d)(2), would have led to a finding The Department will also instruct of material injury, then entries of the CBP to terminate the suspension of (11) Narrow woven ribbon that is (a) merchandise subject to the liquidation for entries of narrow woven affixed to non-subject merchandise as a countervailing duty order, the ribbons from the PRC entered, or working component of such non-subject liquidation of which has been withdrawn from warehouse, for merchandise, such as where narrow suspended under section 703(d)(2), consumption prior to the publication of woven ribbon comprises an apparel shall be subject to the imposition of the ITC's notice of final determination, trimming, book marker, bag cinch, or countervailing duties under section and refund any cash deposits made and part of an identity card holder, or (b) 701(a).'' In addition, section 706(b)(2) of release any bonds posted between affixed (including by tying) to non- the Act requires CBP to refund any cash December 14, 2009 (i.e., the date of subject merchandise as a working deposits or bonds of estimated publication of the Department's component that holds or packages such countervailing duties posted since the Preliminary Determination) and the date non-subject merchandise or attaches Department's preliminary of publication of the ITC's final packaging or labeling to such non- countervailing duty determination, if determination in the Federal Register.
subject merchandise, such as a ‘‘belly the ITC's final determination is threat- This notice constitutes the band'' around a pair of pajamas, a pair based. Because the ITC's final countervailing duty order with respect of socks or a blanket; determination in this case is based on to narrow woven ribbons from the PRC, (12) Narrow woven ribbon(s) the threat of material injury and is not pursuant to section 706(a) of the Act. comprising a belt attached to and accompanied by a finding that injury Interested parties may contact the imported with an item of wearing would have resulted but for the Department's Central Records Unit, apparel, whether or not such belt is imposition of suspension of liquidation Room 1117 of the main Commerce removable from such item of wearing of entries since the Department's Building, for copies of an updated list Preliminary Determination 1 was of countervailing duty orders currently (13) Narrow woven ribbon(s) included published in the Federal Register,
with non-subject merchandise in kits, section 706(b)(2) of the Act is This order is issued and published in such as a holiday ornament craft kit or accordance with section 706(a) of the a scrapbook kit, in which the individual As a result of the ITC's determination, Act and 19 CFR 351.211(b). lengths of narrow woven ribbon(s) and in accordance with section 706(a)(1) Dated: August 30, 2010. included in the kit are each no greater of the Act, the Department will direct than eight inches, the aggregate amount Ronald K. Lorentzen,
U.S. Customs and Border Protection of narrow woven ribbon(s) included in Deputy Assistant Secretary for Import (‘‘CBP'') to assess, upon further the kit does not exceed 48 linear inches, Administration. instruction by the Department, none of the narrow woven ribbon(s) [FR Doc. 2010–21978 Filed 8–31–10; 8:45 am] countervailing duties equal to the included in the kit is on a spool, and the amount of the net countervailable BILLING CODE 3510–DS–P
narrow woven ribbon(s) is only one of subsidy for all relevant entries of narrow multiple items included in the kit. woven ribbons from the PRC. In DEPARTMENT OF COMMERCE
The merchandise subject to this order accordance with section 706 of the Act, is classifiable under the HTSUS the Department will direct CBP to Patent and Trademark Office
statistical categories 5806.32.1020; reinstitute suspension of liquidation 2 5806.32.1030; 5806.32.1050 and effective on the date of publication of [Docket No.: PTO–P–2010–0055]
5806.32.1060. Subject merchandise also the ITC's notice of final determination may enter under subheadings Examination Guidelines Update:
in the Federal Register, and to require
5806.31.00; 5806.32.20; 5806.39.20; Developments in the Obviousness
a cash deposit for each entry of subject 5806.39.30; 5808.90.00; 5810.91.00; Inquiry After KSR v.Teleflex
5810.99.90; 5903.90.10; 5903.90.25; Narrow Woven Ribbons With Woven Selvedge AGENCY: United States Patent and
5907.00.60; and 5907.00.80 and under From the People's Republic of China: Preliminary Trademark Office, Commerce. Affirmative Countervailing Duty Determination and statistical categories 5806.32.1080; Alignment of Final Countervailing Duty ACTION: Notice.
5810.92.9080; 5903.90.3090; and Determination With Final Antidumping Duty 6307.90.9889. The HTSUS statistical Determination, 74 FR 66090 (December 14, 2009). SUMMARY: The United States Patent and
categories and subheadings are provided The Department instructed CBP to discontinue Trademark Office (USPTO or Office) is the suspension of liquidation on April 13, 2010, in for convenience and customs purposes; issuing an update (2010 KSR Guidelines accordance with section 703(d) of the Act. Section however, the written description of the Update) to its obviousness guidelines 703(d) states that the suspension of liquidation merchandise under the order is pursuant to a preliminary determination may not for its personnel to be used when remain in effect for more than four months. applying the law of obviousness under VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
35 U.S.C. 103. This 2010 KSR This 2010 KSR Guidelines Update by patent applicants in response to Guidelines Update highlights case law does not constitute substantive rule obviousness rejections. developments on obviousness under 35 making and hence does not have the The 2007 KSR Guidelines pointed out, U.S.C. 103 since the 2007 decision by force and effect of law. It has been as had the Supreme Court in KSR, that the United States Supreme Court developed as a matter of internal Office the factual inquiries announced in (Supreme Court) in KSR Int'l Co. v. management and is not intended to Graham v. John Deere, 383 U.S. 1, 17– Teleflex Inc. These guidelines are create any right or benefit, substantive 18 (1966) (scope and content of the prior intended to be used by Office personnel or procedural, enforceable by any party art; differences between the claimed in conjunction with the guidance in the against the Office. Rejections will invention and the prior art; level of Manual of Patent Examining Procedure continue to be based upon the ordinary skill in the art; and secondary when applying the law of obviousness substantive law, and it is these indicia of nonobviousness), remain the under 35 U.S.C. 103. Members of the rejections that are appealable. foundation of any determination of public are invited to provide comments Consequently, any failure by Office obviousness. It remains true that ‘‘[t]he on the 2010 KSR Guidelines Update. personnel to follow this 2010 KSR determination of obviousness is The Office is especially interested in Guidelines Update is neither appealable dependent on the facts of each case.'' receiving suggestions of recent nor petitionable. Sanofi-Synthelabo v. Apotex, Inc., 550 decisional law in the field of After a review of the principles of F.3d 1075, 1089 (Fed. Cir. 2008) (citing obviousness that would have particular obviousness and Office policy as Graham, 383 U.S. at 17–18 (1966)). As value as teaching tools. reflected in the Manual of Patent for the reasoning required to support an DATES: Effective Date: This 2010 KSR
Examining Procedure (MPEP), this 2010 obviousness determination, the 2007 Guidelines Update is effective KSR Guidelines Update addresses a KSR Guidelines noted that the teaching- September 1, 2010. number of issues that arise when Office suggestion-motivation (TSM) test was but one possible approach. The 2007 ADDRESSES: Comments concerning this
personnel consider whether or not a 2010 KSR Guidelines Update may be claimed invention is obvious. The KSR Guidelines identified six other sent by electronic mail message over the concepts discussed are grounded in rationales gleaned from the KSR Internet addressed to Federal Circuit cases, and correlated decision as examples of appropriate or submitted with existing Office policy as lines of reasoning that could also be by mail addressed to: Mail Stop appropriate. A number of cases which used. The six other rationales identified Comments—Patents, Commissioner for have been selected for their in the 2007 KSR Guidelines are: (1) Patents, P.O. Box 1450, Alexandria, VA instructional value on the issue of Combining prior art elements according 22313–1450. Although comments may obviousness will be discussed in detail. to known methods to yield predictable be submitted by mail, the Office prefers results; (2) simple substitution of one The law of obviousness will continue to receive comments via the Internet. known element for another to obtain to be refined, and Office personnel are predictable results; (3) use of a known FOR FURTHER INFORMATION CONTACT:
encouraged to maintain an awareness of technique to improve similar devices, Kathleen Kahler Fonda or Pinchus M. precedential case law from the Federal methods, or products in the same way; Laufer, Legal Advisors, Office of Patent Circuit and precedential decisions of the (4) applying a known technique to a Legal Administration, Office of the Board of Patent Appeals and known device, method, or product Associate Commissioner for Patent Interferences (Board) in this area. The ready for improvement to yield Examination Policy, by telephone at Office will train Office personnel and predictable results; (5) obvious to try— (571) 272–7754 or (571) 272–7726; by update the MPEP as necessary to reflect choosing from a finite number of mail addressed to: Mail Stop Comments the current state of the law. identified, predictable solutions, with a Patents, Commissioner for Patents, P.O. 2. Principles of Obviousness and the reasonable expectation of success; and Box 1450, Alexandria, VA 22313–1450; Guidelines. In response to the Supreme (6) known work in one field of endeavor or by facsimile transmission to (571) Court's April 2007 decision in KSR, the may prompt variations of it for use in 273–7754, marked to the attention of Office developed guidelines for patent either the same field or a different one Kathleen Kahler Fonda. examiners to follow when determining based on design incentives or other SUPPLEMENTARY INFORMATION:
obviousness of a claimed invention and market forces if the variations are 1. Introduction. The purpose of this published these guidelines in the predictable to one of ordinary skill in 2010 KSR Guidelines Update is to Federal Register and Official Gazette.
the art. Any rationale employed must remind Office personnel of the See Examination Guidelines for provide a link between the factual principles of obviousness explained by Determining Obviousness Under 35 findings and the legal conclusion of the Supreme Court in KSR Int'l Co. v. U.S.C. 103 in View of the Supreme Teleflex Inc., 550 U.S 398 (2007) (KSR), Court Decision in KSR International Co. It is important for Office personnel to and to provide additional guidance in v. Teleflex Inc., 72 FR 57526 (Oct. 10, recognize that when they do choose to view of decisions by the United States 2007), 1324 Off. Gaz. Pat. Office 23 formulate an obviousness rejection Court of Appeals for the Federal Circuit (Nov. 6, 2007) (2007 KSR Guidelines). using one of the rationales suggested by (Federal Circuit) since KSR. This body The 2007 KSR Guidelines have been the Supreme Court in KSR and of case law developed over the past incorporated in the MPEP. See MPEP discussed in the 2007 KSR Guidelines, three years provides additional § 2141 (8th ed. 2001) (Rev. 6, Sept. they are to adhere to the instructions examples that will be useful to Office 2007). The purpose of the 2007 KSR provided in the MPEP regarding the personnel as well as practitioners Guidelines was to give Office personnel necessary factual findings. However, the during the examination process. practical guidance on how to evaluate 2007 KSR Guidelines also stressed that Although every question of obviousness obviousness issues under 35 U.S.C. while the Graham inquiries and the must be decided on its own facts, these 103(a) in accordance with the Supreme associated reasoning are crucial to a cases begin to clarify the contours of the Court's instruction in KSR. The 2007 proper obviousness determination, the obviousness inquiry after KSR, and help KSR Guidelines also alerted Office Supreme Court in KSR did not place any to show when a rejection on this basis personnel to the importance of limit on the particular approach to be is proper and when it is not. considering rebuttal evidence submitted taken to formulate the line of reasoning. VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
In other words, the KSR decision is not The Supreme Court's flexible approach and the requirement for to be seen as replacing a single test for approach to the obviousness inquiry is explanation, Office personnel may obviousness—the TSM test—with the reflected in numerous pre-KSR invoke legal precedent as a source of seven rationales listed in the 2007 KSR decisions, as can be seen in a review of supporting rationale when warranted Guidelines. See MPEP §§ 2141 and 2143 MPEP § 2144. This section provides and appropriately supported. See MPEP (8th ed. 2001) (Rev. 8, July 2010) many lines of reasoning to support a § 2144.04. So, for example, automating a (references to the MPEP are to Revision determination of obviousness based manual activity, making portable, 8 of the 8th Edition of the MPEP unless upon earlier legal precedent that had making separable, reversal or otherwise indicated). It remains Office condoned the use of particular examples duplication of parts, or purifying an old policy that appropriate factual findings of what may be considered common product may form the basis of a are required in order to apply the sense or ordinary routine practice (e.g., rejection. However, such rationales enumerated rationales properly. If a making integral, changes in shape, should not be treated as per se rules, but rejection has been made that omits one making adjustable). Thus, the type of rather must be explained and shown to of the required factual findings, and in reasoning sanctioned by the opinion in apply to the facts at hand. A similar response to the rejection a practitioner KSR has long been a part of the patent caveat applies to any obviousness or inventor points out the omission, examination process. See MPEP § 2144. analysis. Simply stating the principle Office personnel must either withdraw Although the KSR approach is flexible (e.g., ‘‘art recognized equivalent,'' the rejection, or repeat the rejection with regard to the line of reasoning to ‘‘structural similarity'') without including all required factual findings. be applied, the 2007 KSR Guidelines providing an explanation of its 3. The Impact of the KSR Decision. and MPEP § 2143 state: ‘‘The Supreme applicability to the facts of the case at KSR's renewed emphasis on the Court in KSR noted that the analysis hand is generally not sufficient to foundational principles of Graham supporting a rejection under 35 U.S.C. establish a prima facie case of coupled with its abrogation of the strict 103 should be made explicit.'' MPEP TSM test have clearly impacted the § 2143. In Ball Aerosol v. Limited Many basic approaches that a manner in which Office personnel and Brands, 555 F.3d 984 (Fed. Cir. 2009), practitioner may use to demonstrate practitioners carry out the business of the Federal Circuit offered additional nonobviousness also continue to apply prosecuting patent applications with instruction as to the need for an explicit in the post-KSR era. Since it is now regard to issues of obviousness. analysis. The Federal Circuit explained, clear that a strict TSM approach is not However, Office personnel as well as as is consistent with the 2007 KSR the only way to establish a prima facie practitioners should also recognize the Guidelines, that the Supreme Court's case of obviousness, it is true that significant extent to which the requirement for an explicit analysis practitioners have been required to shift obviousness inquiry has remained does not require record evidence of an the emphasis of their nonobviousness constant in the aftermath of KSR. explicit teaching of a motivation to arguments to a certain degree. However, In footnote 2 of the 2007 KSR combine in the prior art. familiar lines of argument still apply, Guidelines, the Office acknowledged including teaching away from the that ongoing developments in the law of [T]he analysis that ‘‘should be made claimed invention by the prior art, lack obviousness were to be expected in the explicit'' refers not to the teachings in the prior art of a motivation to combine, but to of a reasonable expectation of success, wake of the KSR decision. That footnote the court's analysis * * *. Under the flexible and unexpected results. Indeed, they also stated that it was ‘‘not clear which inquiry set forth by the Supreme Court, the may have even taken on added Federal Circuit decisions will retain district court therefore erred by failing to take importance in view of the recognition in their viability'' after KSR. See 2007 KSR account of ‘‘the inferences and creative KSR of a variety of possible rationales. Guidelines, 72 FR at 57,528 n.2. The steps,'' or even routine steps, that an inventor At the time the KSR decision was edition of the MPEP that was current would employ and by failing to find a handed down, some observers when the KSR decision was handed motivation to combine related pieces from questioned whether the principles down had made the following statement discussed were intended by the Ball Aerosol, 555 F.3d at 993. The Supreme Court to apply to all fields of Federal Circuit's directive in Ball The rationale to modify or combine the inventive endeavor. Arguments were prior art does not have to be expressly stated Aerosol was addressed to a lower court, made that because the technology at in the prior art; the rationale may be but it applies to Office personnel as issue in KSR involved the relatively expressly or impliedly contained in the prior well. When setting forth a rejection, well-developed and predictable field of art or it may be reasoned from knowledge Office personnel are to continue to make vehicle pedal assemblies, the decision generally available to one of ordinary skill in appropriate findings of fact as explained was relevant only to such fields. The the art, established scientific principles, or in MPEP §§ 2141 and 2143, and must Federal Circuit has soundly repudiated legal precedent established by prior case law. provide a reasoned explanation as to such a notion, stating that KSR applies MPEP § 2144 (8th ed. 2001) (Rev. 5, why the invention as claimed would across technologies: Aug. 2006) (citing five pre-KSR Federal have been obvious to a person of This court also declines to cabin KSR to the Circuit opinions and two decisions of ordinary skill in the art at the time of ‘‘predictable arts'' (as opposed to the the Board). The KSR decision has the invention. This requirement for ‘‘unpredictable art'' of biotechnology). In fact, reinforced those earlier decisions that explanation remains even in situations this record shows that one of skill in this validated a more flexible approach to in which Office personnel may properly advanced art would find these claimed providing reasons for obviousness. rely on intangible realities such as ‘‘results'' profoundly ‘‘predictable.'' However, the Supreme Court's common sense and ordinary ingenuity. In re Kubin, 561 F.3d 1351, 1360 (Fed. pronouncement in KSR has at the same When considering obviousness, Office Cir. 2009). Thus, Office personnel time clearly undermined the continued personnel are cautioned against treating should not withdraw any rejection viability of cases such as In re Lee, 277 any line of reasoning as a per se rule. solely on the basis that the invention F.3d 1338 (Fed. Cir. 2002), insofar as MPEP § 2144 discusses supporting a lies in a technological area ordinarily Lee appears to require a strict basis in rejection under 35 U.S.C. 103 by considered to be unpredictable. record evidence as a reason to modify reliance on scientific theory and legal The decisions of the Federal Circuit precedent. In keeping with the flexible discussed in this 2010 KSR Guidelines VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
Update provide Office personnel as well are not the focus of separate discussions problem which had suggested use of the as practitioners with additional in this 2010 KSR Guidelines Update, it method had been previously unknown. examples of the law of obviousness. The will be noted that obviousness concepts The case of In re Omeprazole Patent purpose of the 2007 KSR Guidelines such as applying known techniques, Litigation is one in which the claims in was, as stated above, to help Office design choice, and market forces are question were found to be nonobvious personnel to determine when a claimed addressed when they arise in the in the context of an argument to invention is not obvious, and to provide selected cases. The cases included in combine prior art elements. The an appropriate supporting rationale this 2010 KSR Guidelines Update invention involved applying enteric when an obviousness rejection is reinforce the idea, presented in the 2007 coatings to a drug in pill form for the appropriate. Now that a body of case KSR Guidelines, that there may be more purpose of ensuring that the drug did law is available to guide Office than one line of reasoning that can not disintegrate before reaching its personnel and practitioners as to the properly be applied to a particular intended site of action. The drug at boundaries between obviousness and factual scenario. The selected decisions issue was omeprazole, the generic name nonobviousness, it is possible in this also illustrate the overlapping nature of for gastric acid inhibitor marketed as 2010 KSR Guidelines Update to contrast the lines of reasoning that may be Prilosec®. The claimed formulation situations in which the subject matter employed to establish a prima facie case included two layers of coatings over the was found to have been obvious with of obviousness. Although the 2007 KSR active ingredient. those in which it was determined not to Guidelines presented the rationales as The district court found that Astra's have been obvious. Thus, Office discrete, self-contained lines of patent in suit was infringed by personnel may use this 2010 KSR reasoning, and they may indeed be defendants Apotex and Impax. The Guidelines Update in conjunction with employed that way, it is useful to district court rejected Apotex's defense the 2007 KSR Guidelines (incorporated recognize that real-world situations may that the patents were invalid for into MPEP §§ 2141 and 2143) to provide require analyses that may not be so obviousness. Apotex had argued that the a more complete view of the state of the readily pigeon-holed into distinct claimed invention was obvious because law of obviousness. coated omeprazole tablets were known This 2010 KSR Guidelines Update A. Combining Prior Art Elements. In from a prior art reference, and because provides a ‘‘teaching point'' for each discussing the obviousness rationale secondary subcoatings in discussed case. The ‘‘teaching point'' concerning combining prior art pharmaceutical preparations generally may be used to quickly determine the elements, identified as Rationale A, the were also known. There was no relevance of the discussed case, but 2007 KSR Guidelines quoted KSR and evidence of unpredictability associated should not be used as a substitute for noted that ‘‘it can be important to with applying two different enteric reading the remainder of the discussion identify a reason that would have coatings to omeprazole. However, of the case in this 2010 KSR Guidelines prompted a person of ordinary skill in Astra's reason for applying an Update. Nor should any case in this the relevant field to combine the intervening subcoating between the 2010 KSR Guidelines Update be applied elements in the way the claimed new prior art coating and omeprazole had or cited in an Office action solely on the invention does.'' KSR, 550 U.S. at 401. been that the prior art coating was basis of what is stated in the ‘‘teaching In view of the cases decided since KSR, actually interacting with omeprazole, point'' for the case. one situation when it is important to thereby contributing to undesirable 4. Obviousness Examples from identify a reason to combine known degradation of the active ingredient. Federal Circuit Cases. The impact of the elements in a known manner to obtain This degradation of omeprazole by Supreme Court's decision in KSR can be predictable results is when the interaction with the prior art coating more readily understood in the context combination requires a greater had not been recognized in the prior art. of factual scenarios. The cases in this expenditure of time, effort, or resources Therefore, the district court reasoned 2010 KSR Guidelines Update are than the prior art teachings. Even that based on the evidence available, a broadly grouped according to though the components are known, the person of ordinary skill in the art would obviousness concepts in order to combining step is technically feasible, have had no reason to include a provide persons involved with patent and the result is predictable, the subcoating in an omeprazole pill prosecution with ready access to the claimed invention may nevertheless be examples that are most pertinent to the nonobvious when the combining step The Federal Circuit affirmed the issue at hand. The first three groups involves such additional effort that no district court's decision that the claimed correspond directly with three of the one of ordinary skill would have invention was not obvious. Even though rationales identified in the 2007 KSR undertaken it without a recognized subcoatings for enteric drug formulation Guidelines. These rationales— reason to do so. When a combination were known, and there was no evidence combining prior art elements, invention involves additional of undue technical hurdles or lack of a substituting one known element for complexity as compared with the prior reasonable expectation of success, the another, and obvious to try—have each art, the invention may be nonobvious formulation was nevertheless not been the subject of a significant number unless an examiner can articulate a obvious because the flaws in the prior of post-KSR obviousness decisions. The reason for including the added features art formulation that had prompted the fourth group focuses on issues or steps. This is so even when the modification had not been recognized. concerning consideration of evidence claimed invention could have been Thus there would have been no reason during prosecution. Office personnel as readily implemented. to modify the initial formulation, even well as practitioners are reminded of the Example 4.1. In re Omeprazole Patent though the modification could have technology-specific obviousness Litigation, 536 F.3d 1361 (Fed. Cir. been done. Moreover, a person of skill examples previously posted on the 2008). Teaching point: Even where a in the art likely would have chosen a general method that could have been different modification even if he or she applied to make the claimed product had recognized the problem. was known and within the level of skill Office personnel should note that in Although the other rationales of the ordinary artisan, the claim may this case the modification of the prior discussed in the 2007 KSR Guidelines nevertheless be nonobvious if the art that had been presented as an VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
argument for obviousness was an extra base section. Because both the base the Federal Circuit stated that even if all process step that added an additional portion and the strap were made of elements of the claimed invention had component to a known, successfully foam, friction between the strap and the been taught by the prior art, the claims marketed formulation. The proposed base section allowed the strap to would not have been obvious because modification thus amounted to extra maintain its position after pivoting. In the combination yielded more than work and greater expense for no other words, the foam strap did not fall predictable results. apparent reason. This is not the same as under the force of gravity to a position The Federal Circuit's discussion in combining known prior art elements A adjacent to the heel of the base section. Crocs serves as a reminder to Office and B when each would have been The International Trade Commission personnel that merely pointing to the expected to contribute its own known (ITC) determined that the claims were presence of all claim elements in the properties to the final product. In the obvious over the combination of two prior art is not a complete statement of Omeprazole case, in view of the pieces of prior art. The first was the a rejection for obviousness. In expectations of those of ordinary skill in Aqua Clog, which was a shoe that accordance with MPEP § 2143 A(3), a the art, adding the subcoating would not corresponded to the base section of the proper rejection based on the rationale have been expected to confer any footwear of the ‘858 patent. The second that the claimed invention is a particular desirable property on the was the Aguerre patent, which taught combination of prior art elements also final product. Rather, the final product heel straps made of elastic or another includes a finding that results flowing obtained according to the proposed flexible material. In the ITC's view, the from the combination would have been modifications would merely have been claimed invention was obvious because predictable to a person of ordinary skill expected to have the same functional the prior art Aqua Clog differed from the in the art. MPEP § 2143 A(3). If results properties as the prior art product. claimed invention only as to the would not have been predictable, Office The Omeprazole case can also be presence of the strap, and a suitable personnel should not enter an analyzed in view of the discovery of a strap was taught by Aguerre. obviousness rejection using the previously unknown problem by the The Federal Circuit disagreed. The combination of prior art elements patentee. If the adverse interaction Federal Circuit stated that the prior art rationale, and should withdraw such a between active agent and coating had did not teach foam heel straps, or that rejection if it has been made. been known, it might well have been a foam heel strap should be placed in Example 4.3. Sundance, Inc. v. obvious to use a subcoating. However, contact with a foam base. The Federal DeMonte Fabricating Ltd., 550 F.3d since the problem had not been Circuit pointed out that the prior art 1356 (Fed. Cir. 2008). Teaching point: A previously known, there would have actually counseled against using foam as claimed invention is likely to be been no reason to incur additional time a material for the heel strap of a shoe. obvious if it is a combination of known and expense to add another layer, even The record shows that the prior art would prior art elements that would reasonably though the addition would have been actually discourage and teach away from the have been expected to maintain their technologically possible. This is true use of foam straps. An ordinary artisan in respective properties or functions after because the prior art of record failed to this field would not add a foam strap to the they have been combined. mention any stability problem, despite foam Aqua Clog because foam was likely to Sundance involved a segmented and the acknowledgment during testimony stretch and deform, in addition to causing mechanized cover for trucks, swimming at trial that there was a known discomfort for a wearer. The prior art depicts pools, or other structures. The claim foam as unsuitable for straps. theoretical reason that omeprazole was found to be obvious over the prior might be subject to degradation in the Id. at 1309. presence of the known coating material. The Federal Circuit continued, stating A first prior art reference taught that Example 4.2. Crocs, Inc. v. U.S. that even if—contrary to fact—the a reason for making a segmented cover International Trade Commission, 598 claimed invention had been a was ease of repair, in that a single F.3d 1294 (Fed. Cir. 2010). Teaching combination of elements that were damaged segment could be readily point: A claimed combination of prior known in the prior art, the claims still removed and replaced when necessary. art elements may be nonobvious where would have been nonobvious. There A second prior art reference taught the the prior art teaches away from the was testimony in the record that the advantages of a mechanized cover for claimed combination and the loose fit of the heel strap made the shoe ease of opening. The Federal Circuit combination yields more than more comfortable for the wearer than noted that the segmentation aspect of predictable results. prior art shoes in which the heel strap the first reference and the The case of Crocs, Inc. v. U.S. was constantly in contact with the mechanization function of the second International Trade Commission is a wearer's foot. In the claimed footwear, perform in the same way after decision in which the claimed foam the foam heel strap contacted the combination as they had before. The footwear was held by the Federal Circuit wearer's foot only when needed to help Federal Circuit further observed that a to be nonobvious over a combination of reposition the foot properly in the shoe, person of ordinary skill in the art would prior art references. thus reducing wearer discomfort that have expected that adding replaceable The claims involved in the could arise from constant contact. This segments as taught by the first reference obviousness issue were from Crocs' U.S. desirable feature was a result of the to the mechanized cover of the other Patent No. 6,993,858, and were drawn to friction between the base section and would result in a cover that maintained footwear in which a one-piece molded the strap that kept the strap in place the advantageous properties of both of foam base section formed the top of the behind the Achilles portion of the the prior art covers. shoe (the upper) and the sole. A strap wearer's foot. The Federal Circuit Thus, the Sundance case points out also made of foam was attached to the pointed out that this combination that a hallmark of a proper obviousness foot opening of the upper, such that the ‘‘yielded more than predictable results.'' rejection based on combining known strap could provide support to the Id. at 1310. Aguerre had taught that prior art elements is that one of ordinary Achilles portion of the wearer's foot. friction between the base section and skill in the art would reasonably have The strap was attached via connectors the strap was a problem rather than an expected the elements to maintain their that allowed it to be in contact with the advantage, and had suggested the use of respective properties or functions after base section, and to pivot relative to the nylon washers to reduce friction. Thus they have been combined. VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
Example 4.4. Ecolab, Inc. v. FMC parameter disclosed in the Bender patent for tow hitches. The court explained Corp., 569 F.3d 1335 (Fed Cir. 2009). with the PAA methods disclosed in FMC's that the Supreme Court's decision in Teaching point: A combination of ‘676 patent. The answer is yes. KSR ‘‘directs [it] to construe the scope of known elements would have been Id. If optimization of the application analogous art broadly.'' Wyers, slip. op. prima facie obvious if an ordinarily parameters had not been within the at 12. For these reasons, the court found skilled artisan would have recognized level of ordinary skill in the art, the that Master Lock's asserted references an apparent reason to combine those outcome of the Ecolab case may well were analogous prior art, and therefore elements and would have known how to have been different. relevant to the obviousness inquiry. Example 4.5. Wyers v. Master Lock The court then turned to the question In the case of Ecolab, Inc. v. FMC Co., No. 2009–1412, —F.3d—, 2010 WL of whether there would have been Corp., an ‘‘apparent reason to combine'' 2901839 (Fed. Cir. July 22, 2010). adequate motivation to combine the in conjunction with the technical ability Teaching point: The scope of analogous prior art elements as had been urged by to optimize led to the conclusion that art is to be construed broadly and Master Lock. The court recalled the the claimed invention would have been includes references that are reasonably Graham inquiries, and also emphasized pertinent to the problem that the the ‘‘expansive and flexible'' post-KSR The invention in question was a inventor was trying to solve. Common approach to obviousness that must not method of treating meat to reduce the sense may be used to support a legal ‘‘deny factfinders recourse to common incidence of pathogens, by spraying the conclusion of obviousness so long as it sense.'' Wyers, slip op. at 13 (quoting meat with an antibacterial solution is explained with sufficient reasoning. KSR, 550 U.S. at 415 and 421). The under specified conditions. The parties In the case of Wyers v. Master Lock did not dispute that a single prior art Co., the Federal Circuit held that the KSR and our later cases establish that the reference had taught all of the elements claimed barbell-shaped hitch pin locks legal determination of obviousness may of the claimed invention, except for the used to secure trailers to vehicles were include recourse to logic, judgment, and pressure limitation of ‘‘at least 50 psi.'' common sense, in lieu of expert testimony FMC had argued at the district court The court discussed two different sets * * *. that the claimed invention would have of claims in Wyers, both drawn to Thus, in appropriate cases, the ultimate been obvious in view of the first prior improvements over the prior art hitch inference as to the existence of a motivation art reference mentioned above in view pin locks. The first improvement was a to combine references may boil down to a question of ‘‘common sense,'' appropriate for of a second reference that had taught the removable sleeve that could be placed resolution on summary judgment or JMOL. advantages of spray-treating at pressures over the shank of the hitch pin lock so of 20 to 150 psi when treating meat with that the same lock could be used with Id. at 15 (citing Perfect Web Techs., Inc. a different antibacterial agent. The towing apertures of varying sizes. The v. InfoUSA, Inc., 587 F.3d 1324, 1329 district court did not find FMC's second improvement was an external (Fed. Cir. 2009); Ball Aerosol, 555 F.3d argument to be convincing, and denied flat flange seal adapted to protect the the motion for judgment as a matter of internal lock mechanism from After reviewing these principles, the law that the claim was obvious. contaminants. Wyers had admitted that court proceeded to explain why Disagreeing with the district court, the each of several prior art references adequate motivation to combine had Federal Circuit stated that ‘‘there was an taught every element of the claimed been established in this case. With apparent reason to combine these inventions except for the removable regard to the sleeve improvement, it known elements—namely to increase sleeve and the external covering. Master pointed out that the need for different contact between the [antibacterial Lock had argued that these references, sizes of hitch pins was well known in solution] and the bacteria on the meat in combination with additional the art, and that this was a known surface and to use the pressure to wash references teaching the missing source of inconvenience and expense additional bacteria off the meat surface.'' elements, would have rendered the for users. The court also mentioned the Id. at 1350. The Federal Circuit marketplace aspect of the issue, noting explained that because the second The court first addressed the question that space on store shelves was at a reference had taught ‘‘using high of whether the additional references premium, and that removable sleeves pressure to improve the effectiveness of relied on by Master Lock were addressed this economic concern. As to an antimicrobial solution when sprayed analogous prior art. As to the reference the sealing improvement, the court onto meat, and because an ordinarily teaching the sleeve improvement, the pointed out that both internal and skilled artisan would have recognized court concluded that it dealt specifically external seals were well-known means the reasons for applying [the claimed with using a vehicle to tow a trailer, and to protect locks from contaminants. The antibacterial solution] using high was therefore in the same field of court concluded that the constituent pressure and would have known how to endeavor as Wyers' sleeve elements were being employed in do so, Ecolab's claims combining high improvement. The reference teaching accordance with their recognized pressure with other limitations the sealing improvement dealt with a functions, and would have predictably disclosed in FMC's patent are invalid as padlock rather than a lock for a tow retained their respective functions when obvious.'' Id. hitch. The court noted that Wyers' combined as suggested by Master Lock. When considering the question of specification had characterized the The court cited In re O'Farrell, 853 F.2d obviousness, Office personnel should claimed invention as being in the field 894, 904 (Fed. Cir. 1988) for the keep in mind the capabilities of a of locking devices, thus at least proposition that a reasonable person of ordinary skill. In Ecolab, the suggesting that the sealed padlock expectation of success is a requirement Federal Circuit stated: reference was in the same field of for a proper determination of endeavor. However, the court also Ecolab's expert admitted that one skilled in observed that even if sealed padlocks Office personnel should note that the art would know how to adjust application parameters to determine the optimum were not in the same field of endeavor, although the Federal Circuit invoked the parameters for a particular solution. The they were nevertheless reasonably idea of common sense in support of a question then is whether it would have been pertinent to the problem of avoiding conclusion of obviousness, it did not obvious to combine the high pressure contamination of a locking mechanism end its explanation there. Rather, the VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
court explained why a person of result'' discussed in KSR refers not only examiner rejected the claims as obvious ordinary skill in the art at the time of to the expectation that prior art based on a combination of references the invention, in view of the facts elements are capable of being physically including an advertisement (Damark) for relevant to the case, would have found combined, but also that the combination a folding treadmill demonstrating all of the claimed inventions to have been would have worked for its intended the claim elements other than the gas obvious. As stated in the MPEP: purpose. In this case, it was successfully spring, and a patent (Teague) with a gas The key to supporting any rejection under argued that Puno ‘‘teaches away'' from a spring. Teague was directed to a bed 35 U.S.C. 103 is the clear articulation of the rigid screw because Puno warned that that folds into a cabinet using a novel reason(s) why the claimed invention would rigidity increases the likelihood that the dual-action spring that reverses force as have been obvious. The Supreme Court in screw will fail within the human body, the mechanism passes a neutral KSR noted that the analysis supporting a rendering the device inoperative for its position, rather than a single-action rejection under 35 U.S.C. 103 should be intended purpose. In fact, the reference spring that would provide a force made explicit. The Court quoting In re Kahn, did not merely express a general pushing the bed closed at all times. The 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 preference for pedicle screws having a dual-action spring reduced the force (Fed. Cir. 2006), stated that ‘‘[R]ejections on ‘‘shock absorber'' effect, but rather required to open the bed from the closed obviousness cannot be sustained by mere expressed concern for failure and stated position, while reducing the force conclusory statements; instead, there must be some articulated reasoning with some that the shock absorber feature required to lift the bed from the open rational underpinning to support the legal ‘‘decrease[s] the chance of failure of the conclusion of obviousness.'' screw of the bone-screw interface'' The Federal Circuit addressed the because ‘‘it prevent[s] direct transfer of propriety of making the combination MPEP § 2141 III. Office personnel load from the rod to the bone-screw since Teague comes from a different should continue to provide a reasoned interface.'' Thus, the alleged reason to field than the application. Teague was explanation for every obviousness combine the prior art elements of Puno found to be reasonably pertinent to the and Anderson—increasing the rigidity problem addressed in the application Example 4.6. DePuy Spine, Inc. v. of the screw—ran contrary to the prior because the folding mechanism did not Medtronic Sofamor Danek, Inc., 567 art that taught that increasing rigidity require any particular focus on F.3d 1314 (Fed. Cir. 2009). Teaching would result in a greater likelihood of treadmills, but rather generally point: Predictability as discussed in KSR failure. In view of this teaching and the addressed problems of supporting the encompasses the expectation that prior backdrop of collective teachings of the weight of such a mechanism and art elements are capable of being prior art, the Federal Circuit determined providing a stable resting position. combined, as well as the expectation that Puno teaches away from the Other evidence was considered that the combination would have proposed combination such that a concerning whether one skilled in the worked for its intended purpose. An person of ordinary skill would have art would have been led to combine the inference that a claimed combination been deterred from combining the teachings of Damark and Teague. would not have been obvious is references as proposed. Secondary Appellant argued that Teague teaches especially strong where the prior art's considerations evaluated by the Federal away from the invention because it teachings undermine the very reason Circuit relating to failure by others and directs one skilled in the art not to use being proffered as to why a person of copying also supported the view that single-action springs and does not ordinary skill would have combined the the combination would not have been satisfy the claim limitations as the dual- obvious at the time of the invention. action springs would render the The claim in DePuy Spine was B. Substituting One Known Element invention inoperable. The Federal directed to a polyaxial pedicle screw for Another. As explained in the 2007 Circuit considered the arguments and used in spinal surgeries that included a KSR Guidelines, the substitution found that while Teague at most teaches compression member for pressing a rationale applies when the claimed away from using single-action springs to screw head against a receiver member. invention can be viewed as resulting decrease the opening force, it actually A prior art reference (Puno) disclosed from substituting a known element for instructed that single-action springs all of the elements of the claim except an element of a prior art invention. The provide the result desired by the for the compression member. Instead, rationale applies when one of ordinary inventors, which was to increase the the screw head in Puno was separated skill in the art would have been opening force provided by gravity. As to from the receiver member to achieve a technologically capable of making the inoperability, the claims were not shock absorber effect, allowing some substitution, and the result obtained limited to single-action springs and motion between receiver member and would have been predictable. See MPEP were so broad as to encompass anything the vertebrae. The missing compression that assists in stably retaining the tread member was readily found in another Example 4.7. In re ICON Health & base, which is the function that Teague prior art reference (Anderson), which Fitness, Inc., 496 F.3d 1374 (Fed. Cir. accomplished. Additionally, the fact disclosed an external fracture 2007). Teaching point: When that the counterweight mechanism from immobilization splint for immobilizing determining whether a reference in a Teague used a large spring, which long bones with a swivel clamp capable different field of endeavor may be used appellant argued would overpower the of polyaxial movement until rigidly to support a case of obviousness (i.e., is treadmill mechanism, ignores the secured by a compression member. It analogous), it is necessary to consider modifications that one skilled in the art was asserted during trial that a person the problem to be solved. would make to a device borrowed from of ordinary skill would have recognized The claimed invention in ICON was the prior art. One skilled in the art that the addition of Anderson's directed to a treadmill with a folding would size the components from Teague compression member to Puno's device tread base that swivels into an upright appropriately for the application. would have achieved a rigidly locked storage position, including a gas spring ICON is another useful example for polyaxial pedicle screw covered by the connected between the tread base and understanding the scope of analogous the upright structure to assist in stably art. The art applied concerned retaining In conducting its analysis, the Federal retaining the tread base in the storage mechanisms for folding beds, not Circuit noted that the ‘‘predictable position. On reexamination, the treadmills. When determining whether a VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
reference may properly be applied to an In determining that the claimed The only difference between the prior invention in a different field of invention was obvious, the Federal art bidding system and the claimed endeavor, it is necessary to consider the Circuit noted that ‘‘[t]he asserted claims invention was the use of a conventional problem to be solved. It is certainly simply substitute a resistive electrical Web browser. At trial, the district court possible that a reference may be drawn switch for the mechanical pressure had determined that Muniauction's in such a way that its usefulness as a switch'' employed in the prior art claims were not obvious. Thomson teaching is narrowly restricted. device. Id. at 1344. In this case, the prior argued that the claimed invention However, in ICON, the ‘‘treadmill'' art concerning the hand-held devices amounted to incorporating a Web concept was too narrow a lens through revealed that the function of the browser into a prior art auction system, which to view the art in light of the substituted resistive electrical switch and was therefore obvious in light of prior art teachings concerning the was well known and predictable, and KSR. Muniauction rebutted the problem to be solved. The Teague that it could be used in a pest control argument by offering evidence of reference was analogous art because device. According to the Federal Circuit, skepticism by experts, copying, praise, ‘‘Teague and the current application the references that taught the hand-held and commercial success. Although the both address the need to stably retain a devices showed that ‘‘the use of an district court found the evidence to be folding mechanism,'' id. at 1378, and animal body as a resistive switch to persuasive of nonobviousness, the because ‘‘nothing about ICON's folding complete a circuit for the generation of Federal Circuit disagreed. It noted that mechanism requires any particular an electric charge was already well a nexus between the claimed invention focus on treadmills,'' id. at 1380. known in the prior art.'' Id. Finally, the and the proffered evidence was lacking ICON is also informative as to the Federal Circuit noted that the problem because the evidence was not relationship between the problem to be solved by using the resistive electrical coextensive with the claims at issue. For solved and existence of a reason to switch in the prior art hand-held this reason, the Federal Circuit combine. ‘‘Indeed, while perhaps not devices—malfunction of mechanical determined that Muniauction's evidence dispositive of the issue, the finding that switches due to dirt and dampness— of secondary considerations was not Teague, by addressing a similar also pertained to the prior art stationary entitled to substantial weight. problem, provides analogous art to pest control device. The Federal Circuit analogized this ICON's application goes a long way The Federal Circuit recognized case to Leapfrog Enterprises, Inc. v. towards demonstrating a reason to Agrizap as ‘‘a textbook case of when the Fisher-Price, Inc., 485 F.3d 1157 (Fed. combine the two references. Because asserted claims involve a combination Cir. 2007), cited in the 2007 KSR ICON's broad claims read on of familiar elements according to known Guidelines. The Leapfrog case involved embodiments addressing that problem methods that does no more than yield a determination of obviousness based on as described by Teague, the prior art predictable results.'' Id. Agrizap application of modern electronics to a here indicates a reason to incorporate its exemplifies a strong case of obviousness prior art mechanical children's learning teachings.'' Id. at 1380–81. based on simple substitution that was device. In Leapfrog, the court had noted The Federal Circuit's discussion in that market pressures would have ICON also makes clear that if the not overcome by the objective evidence reference does not teach that a of nonobviousness offered. It also prompted a person of ordinary skill to combination is undesirable, then it demonstrates that analogous art is not use modern electronics in the prior art cannot be said to teach away. An limited to the field of applicant's device. Similarly in Muniauction, assessment of whether a combination endeavor, in that one of the references market pressures would have prompted would render the device inoperable that used an animal body as a resistive a person of ordinary skill to use a must not ‘‘ignore the modifications that switch to complete a circuit for the conventional Web browser in a method one skilled in the art would make to a generation of an electric charge was not of auctioning municipal bonds. device borrowed from the prior art.'' Id. in the field of pest control. Example 4.10. Aventis Pharma Example 4.9. Muniauction, Inc. v. Deutschland v. Lupin Ltd., 499 F.3d Example 4.8. Agrizap, Inc. v. Thomson Corp., 532 F.3d 1318 (Fed. 1293 (Fed. Cir. 2007). Teaching point: A Woodstream Corp., 520 F.3d 1337 (Fed. Cir. 2008). Teaching point: Because chemical compound would have been Cir. 2008). Teaching point: Analogous Internet and Web browser technologies obvious over a mixture containing that art is not limited to references in the had become commonplace for compound as well as other compounds field of endeavor of the invention, but communicating and displaying where it was known or the skilled also includes references that would information, it would have been obvious artisan had reason to believe that some have been recognized by those of to adapt existing processes to desirable property of the mixture was ordinary skill in the art as useful for incorporate them for those functions. derived in whole or in part from the applicant's purpose. The invention at issue in Muniauction claimed compound, and separating the Agrizap involved a stationary pest was a method for auctioning municipal claimed compound from the mixture control device for electrocution of pests bonds over the Internet. A municipality was routine in the art. such as rats and gophers, in which the could offer a package of bond In Aventis, the claims were drawn to device is set in an area where the pest instruments of varying principal the 5(S) stereoisomer of the blood is likely to encounter it. The only amounts and maturity dates, and an pressure drug ramipril in difference between the claimed device interested buyer would then submit a stereochemically pure form, and to and the prior art stationary pest control bid comprising a price and interest rate compositions and methods requiring device was that the claimed device for each maturity date. It was also 5(S) ramipril. The 5(S) stereoisomer is employed a resistive electrical switch, possible for the interested buyer to bid one in which all five stereocenters in while the prior art device used a on a portion of the offering. The claimed the ramipril molecule are in the S rather mechanical pressure switch. A resistive invention considered all of the noted than the R configuration. A mixture of electrical switch was taught in two prior parameters to determine the best bid. It various stereoisomers including 5(S) art patents, in the contexts of a hand- operated on conventional Web browsers ramipril had been taught by the prior held pest control device and a cattle and allowed participants to monitor the art. The question before the court was course of the auction. whether the purified single stereoisomer VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
would have been obvious over the compound and the prior art taught that substituent was known to increase known mixture of stereoisomers. modifying the lead compound would lipophilicity, so a skilled artisan would The record showed that the presence destroy its advantageous property. Any have expected that replacing the of multiple S stereocenters in drugs known compound may serve as a lead trifluoroethoxy substituent with a similar to ramipril was known to be compound when there is some reason methoxypropoxy substituent would associated with enhanced therapeutic for starting with that lead compound have reduced the lipophilicity of the efficacy. For example, when all of the and modifying it to obtain the claimed compound. Thus, the prior art created stereocenters were in the S form in the the expectation that rabeprazole would related drug enalapril (SSS enalapril) as Eisai concerns the pharmaceutical be less useful than lansoprazole as a compared with only two stereocenters compound rabeprazole. Rabeprazole is a drug for treating stomach ulcers and in the S form (SSR enalapril), the proton pump inhibitor for treating related disorders because the proposed therapeutic potency was 700 times as stomach ulcers and related disorders. modification would have destroyed an great. There was also evidence to The Federal Circuit affirmed the district advantageous property of the prior art indicate that conventional methods court's summary judgment of compound. The compound was not could be used to separate the various nonobviousness, stating that no reason obvious as argued by Teva because, stereoisomers of ramipril. had been advanced to modify the prior upon consideration of all of the facts of The district court saw the issue as a art compound in a way that would the case, a person of ordinary skill in close case, because, in its view, there destroy an advantageous property. the art at the time of the invention was no clear motivation in the prior art Co-defendant Teva based its would not have had a reason to modify to isolate 5(S) ramipril. However, the obviousness argument on the structural lansoprazole so as to form rabeprazole. Federal Circuit disagreed, and found similarity between rabeprazole and Office personnel are cautioned that that the claims would have been lansoprazole. The compounds were the term ‘‘lead compound'' in a obvious. The Federal Circuit cautioned recognized as sharing a common core, particular opinion can have a contextual that requiring such a clearly stated and the Federal Circuit characterized meaning that may vary from the way a motivation in the prior art to isolate 5(S) lansoprazole as a ‘‘lead compound.'' The pharmaceutical chemist might use the ramipril ran counter to the Supreme prior art compound lansoprazole was term. In the field of pharmaceutical Court's decision in KSR. The court useful for the same indications as chemistry, the term ‘‘lead compound'' rabeprazole, and differed from has been defined variously as ‘‘a rabeprazole only in that lansoprazole chemical compound that has Requiring an explicit teaching to purify the pharmacological or biological activity 5(S) stereoisomer from a mixture in which it has a trifluoroethoxy substituent at the and whose chemical structure is used as is the active ingredient is precisely the sort 4-position of the pyridine ring, while of rigid application of the TSM test that was rabeprazole has a methoxypropoxy a starting point for chemical criticized in KSR. substituent. The trifluoro substituent of modifications in order to improve potency, selectivity, or pharmacokinetic Id. at 1301. The Aventis court also lansoprazole was known to be a parameters;'' ‘‘[a] compound that relied on the settled principle that in beneficial feature because it conferred exhibits pharmacological properties chemical cases, structural similarity can lipophilicity to the compound. The which suggest its development;'' and ‘‘a provide the necessary reason to modify ability of a person of ordinary skill to potential drug being tested for safety prior art teachings. The Federal Circuit carry out the modification to introduce also addressed the kind of teaching that the methoxypropoxy substituent, and would be sufficient in the absence of an the predictability of the result were not explicitly stated prior art-based Despite the significant similarity motivation, explaining that an between the structures, the Federal accessed January 13, expectation of similar properties in light Circuit did not find any sufficient of the prior art can be sufficient, even reason to modify the lead compound. without an explicit teaching that the According to the Federal Circuit: accessed January 13, 2010. compound will have a particular utility. The Federal Circuit in Eisai makes it In the chemical arts, the cases Obviousness based on structural similarity clear that from the perspective of the involving so-called ‘‘lead compounds'' thus can be proved by identification of some law of obviousness, any known form an important subgroup of the motivation that would have led one of ordinary skill in the art to select and then compound might possibly serve as a obviousness cases that are based on modify a known compound (i.e. a lead lead compound: ‘‘Obviousness based on substitution. The Federal Circuit has compound) in a particular way to achieve the structural similarity thus can be proved had a number of opportunities since the claimed compound. * * * In keeping with by identification of some motivation KSR decision to discuss the the flexible nature of the obviousness that would have led one of ordinary circumstances under which it would inquiry, KSR Int'l Co. v. Teleflex Inc., 550 skill in the art to select and then modify have been obvious to modify a known U.S. 398, 127 S.Ct. 1727, 1739, 167 L.Ed.2d a known compound (i.e. a lead compound to arrive at a claimed 705 (2007), the requisite motivation can come compound) in a particular way to compound. The following cases explore from any number of sources and need not achieve the claimed compound.'' Eisai, the selection of a lead compound, the necessarily be explicit in the art. See Aventis 533 F.3d at 1357. Thus, Office personnel Pharma Deutschland GmbH v. Lupin, Ltd., need to provide a reason for any 499 F.3d 1293, 1301 (Fed. Cir. 2007). Rather should recognize that a proper proposed modification, and the ‘‘it is sufficient to show that the claimed and obviousness rejection of a claimed predictability of the result. prior art compounds possess a ‘sufficiently compound that is useful as a drug might Example 4.11. Eisai Co. Ltd. v. Dr. close relationship * * * to create an be made beginning with an inactive Reddy's Labs., Ltd., 533 F.3d 1353 (Fed. expectation,' in light of the totality of the compound, if, for example, the reasons Cir. 2008). Teaching point: A claimed prior art, that the new compound will have for modifying a prior art compound to compound would not have been ‘similar properties' to the old.'' Id. (quoting arrive at the claimed compound have obvious where there was no reason to Dillon, 919 F.2d at 692). nothing to do with pharmaceutical modify the closest prior art lead Eisai, 533 F.3d at 1357. The prior art activity. The inactive compound would compound to obtain the claimed taught that introducing a fluorinated not be considered to be a lead VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
compound by pharmaceutical chemists, case to consider the question of whether emphasized that whether there was a but could potentially be used as such 2-pyr EHDP had been appropriately long-felt unsatisfied need is to be when considering obviousness. Office selected as a lead compound. Rather, evaluated based on the circumstances as personnel might also base an the Federal Circuit stated that if 2-pyr of the filing date of the challenged obviousness rejection on a known EHDP is presumed to be an appropriate invention—not as of the date that the compound that pharmaceutical lead compound, there must be both a invention is brought to market. chemists would not select as a lead reason to modify it so as to make It should be noted that the lead compound due to expense, handling risedronate, and a reasonable compound cases do not stand for the issues, or other business considerations. expectation of success. Here there was proposition that identification of a However, there must be some reason for no evidence that the necessary single lead compound is necessary in starting with that lead compound other modifications would have been routine, every obviousness rejection of a than the mere fact that the ‘‘lead so there would have been no reasonable chemical compound. For example, one compound'' merely exists. See Altana expectation of success. might envision a suggestion in the prior Pharma AG v. Teva Pharmaceuticals Procter & Gamble is also informative art to formulate a compound having USA, Inc., 566 F.3d 999, 1007 (Fed. Cir. in its discussion of the treatment of certain structurally defined moieties, or 2009) (holding that there must be some secondary considerations of non- moieties with certain properties. If a reason ‘‘to select and modify a known obviousness. Although the court found person of ordinary skill would have compound''); Ortho-McNeil that no prima facie case of obviousness known how to synthesize such a Pharmaceutical, Inc. v. Mylan Labs, had been presented, it proceeded to compound, and the structural and/or Inc., 520 F.3d 1358, 1364 (Fed. Cir. analyze Procter & Gamble's proffered functional result could reasonably have evidence countering the alleged prima been predicted, then a prima facie case Example 4.12. Procter & Gamble Co. facie case in some detail, thus shedding of obviousness of the claimed chemical v. Teva Pharmaceuticals USA, Inc., 566 light on the proper treatment of such compound might exist even without F.3d 989 (Fed. Cir. 2009). Teaching identification of a particular lead point: It is not necessary to select a The Federal Circuit noted in dicta that compound. As a second example, it single compound as a ‘‘lead compound'' even if a prima facie case of obviousness could be possible to view a claimed in order to support an obviousness had been established, sufficient compound as consisting of two known rejection. However, where there was evidence of unexpected results was compounds attached via a chemical reason to select and modify the lead introduced to rebut such a showing. At linker. The claimed compound might compound to obtain the claimed trial, the witnesses consistently testified properly be found to have been obvious compound, but no reasonable that the properties of risedronate were if there would have been a reason to expectation of success, the claimed not expected, offering evidence that link the two, if one of ordinary skill compound would not have been researchers did not predict either the would have known how to do so, and potency or the low dose at which the if the resulting compound would have A chemical compound was also found compound was effective, and that the been the predictable result of the to be nonobvious in Procter & Gamble. superior properties were unexpected linkage procedure. Thus, Office The compound at issue was and could not be predicted. Tests personnel should recognize that in risedronate—the active ingredient of comparing risedronate to a compound certain situations, it may be proper to Procter & Gamble's osteoporosis drug in the prior art reference showed that reject a claimed chemical compound as Actonel®. Risedronate is an example of risedronate outperformed the other obvious even without identifying a a bisphosphonate, which is a class of compound by a substantial margin, single lead compound. compounds known to inhibit bone could be administered in a greater Example 4.13. Altana Pharma AG v. amount without an observable toxic Teva Pharmaceuticals USA, Inc., 566 When Procter & Gamble sued Teva for effect, and was not lethal at the same F.3d 999 (Fed. Cir. 2009). Teaching infringement, Teva defended by arguing levels as the other compound. The point: Obviousness of a chemical invalidity for obviousness over one of weight of the evidence and the compound in view of its structural Procter & Gamble's earlier patents. The credibility of the witnesses were similarity to a prior art compound may prior art patent did not teach sufficient to show unexpected results be shown by identifying some line of risedronate, but instead taught thirty-six that would have rebutted an reasoning that would have led one of other similar compounds including 2- obviousness determination. Thus, ordinary skill in the art to select and pyr EHDP that were potentially useful nonobviousness can be shown when a modify a prior art lead compound in a with regard to osteoporosis. Teva argued claimed invention is shown to have particular way to produce the claimed obviousness on the basis of structural unexpectedly superior properties when compound. It is not necessary for the similarity to 2-pyr EHDP, which is a compared to the prior art. reasoning to be explicitly found in the positional isomer of risedronate. The court then addressed the prior art of record, nor is it necessary for The district court found no reason to evidence of commercial success of the prior art to point to only a single select 2-pyr EHDP as a lead compound risedronate and the evidence that in light of the unpredictable nature of risedronate met a long-felt need. The Although the decision reached by the the art, and no reason to modify it so as court pointed out that little weight was Federal Circuit in Altana involved a to obtain risedronate. In addition, there to be afforded to the commercial success motion for preliminary injunction and were unexpected results as to potency because the competing product was also did not include a final determination of and toxicity. Therefore the district court assigned to Procter & Gamble. However, obviousness, the case is nevertheless found that Teva had not made a prima the Federal Circuit affirmed the district instructive as to the issue of selecting a facie case, and even if it had, it was court's conclusion that risedronate met rebutted by evidence of unexpected a long-felt, unsatisfied need. The court The technology involved in Altana rejected Teva's contention that because was the compound pantoprazole, which The Federal Circuit affirmed the the competing drug was available before is the active ingredient in Altana's district court's decision. The Federal Actonel®, there was no unmet need that antiulcer drug Protonix®. Pantoprazole Circuit did not deem it necessary in this the invention satisfied. The court belongs to a class of compounds known VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
as proton pump inhibitors that are used starting point from which to pursue that it encodes where the skilled artisan to treat gastric acid disorders in the further development efforts. That would have had a reasonable finding was not clearly erroneous.'' Id. at expectation of success in deriving the Altana accused Teva of infringement. claimed polynucleotide using standard The district court denied Altana's C. The ‘‘Obvious to Try'' Rationale. biochemical techniques, and the skilled motion for preliminary injunction for The question of whether a claimed artisan would have had a reason to try failure to establish a likelihood of invention can be shown to be obvious to isolate the claimed polynucleotide. success on the merits, determining that based on an ‘‘obvious to try'' line of KSR applies to all technologies, rather Teva had demonstrated a substantial reasoning has been explored extensively than just the ‘‘predictable'' arts. question of invalidity for obviousness in by the Federal Circuit in several cases The Federal Circuit's decision in In re light of one of Altana's prior patents. since the KSR decision. The 2007 KSR Kubin was an affirmance of the Board's Altana's patent discussed a compound Guidelines explain, in view of the decision in Ex parte Kubin, 83 USPQ2d referred to as compound 12, which was Supreme Court's instruction, that this 1410 (Bd. Pat. App. & Interf. 2007), and one of eighteen compounds disclosed. rationale is only appropriate when there the Board in turn had affirmed the The claimed compound pantoprazole is a recognized problem or need in the examiner's determination that the was structurally similar to compound art; there are a finite number of claims in question would have been 12. The district court found that one of identified, predictable solutions to the obvious over the prior art applied. A ordinary skill in the art would have recognized need or problem; and one of discussion of Ex parte Kubin was selected compound 12 as a lead ordinary skill in the art could have included in the 2007 KSR Guidelines. compound for modification, and the pursued these known potential See 2007 KSR Guidelines, 72 FR at Federal Circuit affirmed. solutions with a reasonable expectation 57532. The claimed invention in Kubin Obviousness of a chemical compound of success. The case law in this area is was an isolated nucleic acid molecule. in view of its structural similarity to a developing quickly in the chemical arts, The claim stated that the nucleic acid prior art compound may be shown by although the rationale has been applied encoded a particular polypeptide. The identifying some line of reasoning that in other art areas as well. encoded polypeptide was identified in would have led one of ordinary skill in Some commentators on the KSR the claim by its partially specified the art to select and modify the prior art decision have expressed a concern that sequence, and by its ability to bind to compound in a particular way to because inventive activities are always a specified protein. A prior art patent to produce the claimed compound. The carried out in the context of what has Valiante taught the polypeptide necessary line of reasoning can be come before and not in a vacuum, few encoded by the claimed nucleic acid, drawn from any number of sources and inventions will survive scrutiny under but did not disclose either the sequence need not necessarily be explicitly found an obvious to try standard. The cases of the polypeptide, or the claimed in the prior art of record. The Federal decided since KSR have proved this fear isolated nucleic acid molecule. Circuit determined that ample evidence to have been unfounded. Courts appear However, Valiante did disclose that by supported the district court's finding to be applying the KSR requirement for employing conventional methods, such that compound 12 was a natural choice ‘‘a finite number of identified as those disclosed by a prior art for further development. For example, predictable solutions'' in a manner that laboratory manual by Sambrook, the Altana's prior art patent claimed that its places particular emphasis on sequence of the polypeptide could be compounds, including compound 12, predictability and the reasonable determined, and the nucleic acid were improvements over the prior art; expectations of those of ordinary skill in molecule could be isolated. In view of compound 12 was disclosed as one of Valiante's disclosure of the polypeptide, the more potent of the eighteen In a recent Federal Circuit decision, and of routine prior art methods for compounds disclosed; the patent the court pointed out the challenging sequencing the polypeptide and examiner had considered the nature of the task faced by the courts— isolating the nucleic acid molecule, the compounds of Altana's prior art patent and likewise by Office personnel—when Board found that a person of ordinary to be relevant during the prosecution of considering the viability of an obvious skill in the art would have had a the patent in suit; and experts had to try argument: ‘‘The evaluation of the reasonable expectation that a nucleic opined that one of ordinary skill in the choices made by a skilled scientist, acid molecule within the claimed scope art would have selected the eighteen when such choices lead to the desired could have been successfully obtained. compounds to pursue further result, is a challenge to judicial Relying on In re Deuel, 51 F.3d 1552 investigation into their potential as understanding of how technical advance (Fed. Cir. 1995), Appellant argued that proton pump inhibitors. is achieved in the particular field of it was improper for the Office to use the In response to Altana's argument that science or technology.'' Abbott Labs. v. polypeptide of the Valiante patent the prior art must point to only a single Sandoz, Inc., 544 F.3d 1341, 1352 (Fed. together with the methods described in lead compound for further Cir. 2008). The Federal Circuit Sambrook to reject a claim drawn to a development, the Federal Circuit stated cautioned that an obviousness inquiry specific nucleic acid molecule without that a ‘‘restrictive view of the lead based on an obvious to try rationale providing a reference showing or compound test would present a rigid must always be undertaken in the suggesting a structurally similar nucleic test similar to the teaching-suggestion- context of the subject matter in acid molecule. Citing KSR, the Board motivation test that the Supreme Court question, ‘‘including the characteristics stated that ‘‘when there is motivation to explicitly rejected in KSR * * *. The of the science or technology, its state of solve a problem and there are a finite district court in this case employed a advance, the nature of the known number of identified, predictable flexible approach—one that was choices, the specificity or generality of solutions, a person of ordinary skill has admittedly preliminary—and found that the prior art, and the predictability of good reason to pursue the known the defendants had raised a substantial results in the area of interest.'' Id. options within his or her technical question that one of skill in the art Example 4.14. In re Kubin, 561 F.3d grasp. If this leads to anticipated would have used the more potent 1351 (Fed. Cir. 2009). Teaching point: A success, it is likely the product not of compounds of [Altana's prior art] claimed polynucleotide would have innovation but of ordinary skill and patent, including compound 12, as a been obvious over the known protein common sense.'' The Board noted that VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
the problem facing those in the art was claimed compound was pioglitazone, a case fails to present the type of situation to isolate a specific nucleic acid, and member of a class of drugs known as contemplated by the Court when it stated there were a limited number of methods thiazolidinediones (TZDs) marketed by that an invention may be deemed obvious if available to do so. The Board concluded Takeda as a treatment for Type 2 it was ‘‘obvious to try.'' The evidence showed that it was not obvious to try. that the skilled artisan would have had diabetes. The Takeda case brings reason to try these methods with the together the concept of a ‘‘lead Takeda, 492 F.3d at 1359. reasonable expectation that at least one compound'' and the obvious-to-try Accordingly, Office personnel should would be successful. Thus, isolating the recognize that the obvious to try specific nucleic acid molecule claimed Alphapharm had filed an Abbreviated rationale does not apply when the was ‘‘the product not of innovation but New Drug Application with the Food appropriate factual findings cannot be of ordinary skill and common sense.'' and Drug Administration, which was a made. In Takeda, there was a The Board's reasoning was substantially technical act of infringement of recognized need for treatment of adopted by the Federal Circuit. Takeda's patent. When Takeda brought diabetes. However, there was no finite However, it is important to note that in suit, Alphapharm's defense was that number of identified, predictable the Kubin decision, the Federal Circuit Takeda's patent was invalid due to solutions to the recognized need, and no held that ‘‘the Supreme Court in KSR obviousness. Alphapharm argued that a reasonable expectation of success. There unambiguously discredited'' the Federal two-step modification—involving were numerous known TZD Circuit's decision in Deuel, insofar as it homologation and ring-walking—of a compounds, and although one clearly ‘‘implies the obviousness inquiry cannot known compound identified as represented the closest prior art, its consider that the combination of the ‘‘compound b'' would have produced known disadvantages rendered it claim's constituent elements was pioglitazone, and that it was therefore unsuitable as a starting point for further ‘obvious to try.' '' Kubin, 561 F.3d at research, and taught the skilled artisan 1358. Instead, Kubin stated that KSR The district court found that there away from its use. Furthermore, even if ‘‘resurrects'' the Federal Circuit's own would have been no reason to select there had been reason to select wisdom in O'Farrell, in which ‘‘to compound b as a lead compound. There compound b, there had been no differentiate between proper and were a large number of similar prior art predictability or reasonable expectation improper applications of ‘obvious to TZD compounds; fifty-four were of success associated with the particular try,' '' the Federal Circuit ‘‘outlined two specifically identified in Takeda's prior modifications necessary to transform classes of situations where ‘obvious to patent, and the district court observed compound b into the claimed try' is erroneously equated with that ‘‘hundreds of millions'' were more compound pioglitazone. Thus, an obviousness under § 103.'' Kubin, 561 generally disclosed. Although the obviousness rejection based on an F.3d at 1359. These two classes of parties agreed that compound b obvious to try rationale was not situations are: (1) When what would represented the closest prior art, one appropriate in this situation. have been ‘‘obvious to try'' would have Example 4.16. Ortho-McNeil reference had taught certain been to vary all parameters or try each Pharmaceutical, Inc. v. Mylan Labs, disadvantageous properties associated of numerous possible choices until one Inc., 520 F.3d 1358 (Fed. Cir. 2008). with compound b, which according to possibly arrived at a successful result, Teaching point: Where the claimed anti- the district court would have taught the where the prior art gave either no convulsant drug had been discovered skilled artisan not to select that indication of which parameters were somewhat serendipitously in the course compound as a lead compound. The critical or no direction as to which of of research aimed at finding a new anti- district court found no prima facie case many possible choices is likely to be diabetic drug, it would not have been of obviousness, and stated that even if successful; and (2) when what was obvious to try to obtain a claimed a prima facie case had been established, ‘‘obvious to try'' was to explore a new compound where the prior art did not it would have been overcome in this technology or general approach that present a finite and easily traversed case in view of the unexpected lack of seemed to be a promising field of number of potential starting toxicity of pioglitazone. experimentation, where the prior art The Federal Circuit affirmed the compounds, and there was no apparent gave only general guidance as to the decision of the district court, citing the reason for selecting a particular starting particular form of the claimed invention need for a reason to modify a prior art compound from among a number of or how to achieve it. Id. (citing compound. The Federal Circuit quoted unpredictable alternatives. O'Farrell, 853 F.2d at 903). The Ortho-McNeil case provides KSR, stating: Example 4.15. Takeda Chemical another example in which a chemical Industries, Ltd. v. Alphapharm Pty., The KSR Court recognized that ‘‘[w]hen compound was determined not to be Ltd., 492 F.3d 1350 (Fed. Cir. 2007). there is a design need or market pressure to obvious. The claimed subject matter was solve a problem and there are a finite number Teaching point: A claimed compound topiramate, which is used as an anti- of identified, predictable solutions, a person would not have been obvious where it convulsant. As in DePuy Spine, whether of ordinary skill has good reason to pursue was not obvious to try to obtain it from the known options within his or her the combination would predictably be a broad range of compounds, any one of technical grasp.'' KSR, 127 S.Ct. at 1732. In effective for its intended purpose is part which could have been selected as the such circumstances, ‘‘the fact that a of the obviousness analysis. lead compound for further investigation, combination was obvious to try might show In the course of working toward a new and the prior art taught away from using that it was obvious under § 103.'' Id. That is anti-diabetic drug, Ortho-McNeil's a particular lead compound, and there not the case here. Rather than identify scientist had unexpectedly discovered was no predictability or reasonable predictable solutions for antidiabetic that a reaction intermediate had anti- expectation of success in making the treatment, the prior art disclosed a broad convulsant properties. Mylan's defense selection of compounds any one of which particular modifications necessary to of invalidity due to obviousness rested could have been selected as a lead compound transform the lead compound into the on an obvious to try argument. for further investigation. Significantly, the claimed compound. closest prior art compound (compound b, the However, Mylan did not explain why it Takeda is an example of a chemical 6-methyl) exhibited negative properties that would have been obvious to begin with case in which the Federal Circuit found would have directed one of ordinary skill in an anti-diabetic drug precursor, that the claim was not obvious. The the art away from that compound. Thus, this especially the specific one that led to VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
topiramate, if one had been seeking an the solubility of poorly water soluble that reduced set is the appropriate one anti-convulsant drug. The district court to consider when determining ruled on summary judgment that Ortho- Based on the known acid sensitivity, obviousness using an obvious to try McNeil's patent was not invalid for Bayer had studied how effectively an enteric-coated drospirenone tablet Example 4.18. Sanofi-Synthelabo v. The Federal Circuit affirmed. The delivered a formulation as compared to Apotex, Inc., 550 F.3d 1075 (Fed. Cir. Federal Circuit pointed out that there an intravenous injection of the same 2008). Teaching point: A claimed was no apparent reason why a person of formulation to measure the ‘‘absolute isolated stereoisomer would not have ordinary skill would have chosen the bioavailability'' of the drug. Bayer added been obvious where the claimed particular starting compound or the an unprotected (normal) drospirenone stereoisomer exhibits unexpectedly particular synthetic pathway that led to tablet and compared its bioavailability strong therapeutic advantages over the topiramate as an intermediate. to that of the enteric-coated formulation prior art racemic mixture without the Furthermore, there would have been no and the intravenous delivery. Bayer correspondingly expected toxicity, and reason to test that intermediate for expected to find that the enteric-coated the resulting properties of the anticonvulsant properties if treating tablet would produce a lower enantiomers separated from the racemic diabetes had been the goal. The Federal bioavailability than an intravenous mixture were unpredictable. Circuit recognized an element of injection, while the normal pill would The case of Sanofi also sheds light on serendipity in this case, which runs produce an even lower bioavailability the obvious to try line of reasoning. The counter to the requirement for than the enteric-coated tablet. However, claimed compound was clopidogrel, which is the dextrorotatory isomer of predictability. Summarizing their they found that despite observations methyl alpha-5(4,5,6,7-tetrahydro(3,2- conclusion with regard to Mylan's that drospirenone would quickly obvious to try argument, the Federal isomerize in a highly acidic acetate. Clopidogrel is an anti- environment (supporting the belief that an enteric coating would be necessary to thrombotic compound used to treat or [T]his invention, contrary to Mylan's preserve bioavailability), the normal pill prevent heart attack or stroke. The characterization, does not present a finite and the enteric-coated pill resulted in racemate, or mixture of dextrorotatory (and small in the context of the art) number the same bioavailability. Following this and levorotatory (D- and L-) isomers of of options easily traversed to show the compound, was known in the prior obviousness * * *. KSR posits a situation study, Bayer developed micronized with a finite, and in the context of the art, drospirenone in a normal pill, the basis art. The two forms had not previously small or easily traversed, number of options for the disputed patent. been separated, and although the that would convince an ordinarily skilled The district court found that a person mixture was known to have anti- artisan of obviousness* * * . [T]his clearly is having ordinary skill in the art would thrombotic properties, the extent to not the easily traversed, small and finite have considered the prior art result that which each of the individual isomers number of alternatives that KSR suggested a structurally related compound, contributed to the observed properties might support an inference of obviousness. spirorenone, though acid-sensitive, of the racemate was not known and was Id. at 1364. Thus, Ortho-McNeil helps would nevertheless absorb in vivo, not predictable. to clarify the Supreme Court's would have suggested the same result The district court assumed that in the requirement in KSR for ‘‘a finite for drospirenone. It also found that absence of any additional information, number'' of predictable solutions when while another reference taught that the D-isomer would have been prima an obvious to try rationale is applied: drospirenone isomerizes in vitro when facie obvious over the known racemate. However, in view of the evidence of Under the Federal Circuit's case law exposed to acid simulating the human unpredicted therapeutic advantages of ‘‘finite'' means ‘‘small or easily stomach, a person of ordinary skill the D-isomer presented in the case, the traversed'' in the context of the art in would have been aware of the study's district court found that any prima facie question. As taught in Abbott, discussed shortcomings, and would have verified case of obviousness had been overcome. above, it is essential that the inquiry be the findings as suggested by a treatise on At trial, the experts for both parties placed in the context of the subject the science of dosage form design, testified that persons of ordinary skill in matter at issue, and each case must be which would have then showed that no enteric coating was necessary. the art could not have predicted the decided on its own facts. The Federal Circuit held that the degree to which the isomers would have Example 4.17. Bayer Schering Pharma patent was invalid because the claimed exhibited different levels of therapeutic A.G. v. Barr Labs., Inc., 575 F.3d 1341 formulation was obvious. The Federal activity and toxicity. Both parties' (Fed. Cir. 2009). Teaching point: A Circuit reasoned that the prior art would experts also agreed that the isomer with claimed compound would have been have funneled the formulator toward greater therapeutic activity would most obvious where it was obvious to try to two options. Thus, the formulator likely have had greater toxicity. Sanofi obtain it from a finite and easily would not have been required to try all witnesses testified that Sanofi's own traversed number of options that was possibilities in a field unreduced by the researchers had believed that the narrowed down from a larger set of prior art. The prior art was not vague in separation of the isomers was unlikely possibilities by the prior art, and the pointing toward a general approach or to have been productive, and experts for outcome of obtaining the claimed area of exploration, but rather guided both parties agreed that it was difficult compound was reasonably predictable. the formulator precisely to the use of to separate isomers at the time of the In Bayer the claimed invention was an either a normal pill or an enteric-coated invention. Nevertheless, when Sanofi oral contraceptive containing ultimately undertook the task of micronized drospirenone marketed as It is important for Office personnel to separating the isomers, it found that recognize that the mere existence of a they had the ‘‘rare characteristic of The prior art compound drospirenone large number of options does not in and ‘absolute stereoselectivity,' '' whereby was known to be a poorly water-soluble, of itself lead to a conclusion of the D-isomer provided all of the acid-sensitive compound with nonobviousness. Where the prior art favorable therapeutic activity but no contraceptive effects. It was also known teachings lead one of ordinary skill in significant toxicity, while the L-isomer in the art that micronization improves the art to a narrower set of options, then produced no therapeutic activity but VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
virtually all of the toxicity. Based on United had argued that it would have art had also recognized three potential this record, the district court concluded been obvious for a person of ordinary solutions: Increasing the size of the that Apotex had not met its burden of skill in the art to try a fan blade design initial recipient list; resending e-mails proving by clear and convincing in which the sweep angle in the outer to recipients who did not receive them evidence that Sanofi's patent was region was reversed as compared with on the first attempt; and selecting a new invalid for obviousness. The Federal prior art fan blades from rearward to recipient list and sending e-mails to Circuit affirmed the district court's forward sweep, in order to reduce them. The last option corresponded to endwall shock. The Federal Circuit the fourth step of the invention as Office personnel should recognize disagreed with United's assessment that that even when only a small number of the claimed fan blade would have been The Federal Circuit noted that based possible choices exist, the obvious to try obvious based on an obvious to try on ‘‘simple logic,'' selecting a new list of line of reasoning is not appropriate rationale. The Federal Circuit pointed recipients was more likely to result in when, upon consideration of all of the out that in a proper obvious to try the desired outcome than resending to evidence, the outcome would not have approach to obviousness, the possible those who had not received the e-mail been reasonably predictable and the options for solving a problem must have on the first attempt. There had been no inventor would not have had a been ‘‘known and finite.'' Id. at 1339, evidence of any unexpected result reasonable expectation of success. In citing Abbott, 544 F.3d at 1351. In this associated with selecting a new Bayer, there were art-based reasons to case, there had been no suggestion in recipient list, and no evidence that the expect that both the normal pill and the the prior art that would have suggested method would not have had a enteric-coated pill would be that changing the sweep angle as Rolls- reasonable likelihood of success. Thus, therapeutically suitable, even though Royce had done would have addressed the Federal Circuit concluded that, as not all prior art studies were in the issue of endwall shock. Thus, the required by KSR, there were a ‘‘finite complete agreement. Thus, the result Federal Circuit concluded that changing number of identified, predictable obtained was not unexpected. In Sanofi, the sweep angle ‘‘would not have solutions,'' and that the obvious to try on the other hand, there was strong presented itself as an option at all, let inquiry properly led to the legal evidence that persons of ordinary skill alone an option that would have been conclusion of obviousness. in the art, prior to the separation of the obvious to try.'' Rolls-Royce, 603 F.3d at The Federal Circuit in Perfect Web isomers, would have had no reason to 1339. The decision in Rolls-Royce is a also discussed the role of common sense expect that the D-isomer would have reminder to Office personnel that the in the determination of obviousness. such strong therapeutic advantages as obvious to try rationale can properly be The district court had cited KSR for the compared with the L-isomer. In other used to support a conclusion of proposition that ‘‘[a] person of ordinary words, the result in Sanofi was obviousness only when the claimed skill is also a person of ordinary solution would have been selected from creativity, not an automaton,'' and found a finite number of potential solutions Example 4.19. Rolls-Royce, PLC v. that ‘‘the final step [of the claimed known to persons of ordinary skill in United Technologies Corp., 603 F.3d invention] is merely the logical result of 1325 (Fed. Cir. 2010). Teaching point: Example 4.20. Perfect Web common sense application of the maxim An obvious to try rationale may be Technologies, Inc. v. InfoUSA, Inc., 587 ‘try, try again.' '' In affirming the district proper when the possible options for F.3d 1324, 1328–29 (Fed. Cir. 2009). court, the Federal Circuit undertook an solving a problem were known and Teaching point: Where there were a extended discussion of common sense finite. However, if the possible options finite number of identified, predictable as it has been applied to the were not either known or finite, then an solutions and there is no evidence of obviousness inquiry, both before and obvious to try rationale cannot be used unexpected results, an obvious to try since the KSR decision. to support a conclusion of obviousness. inquiry may properly lead to a legal The Federal Circuit pointed out that In Rolls-Royce the Federal Circuit conclusion of obviousness. Common application of common sense is not addressed the obvious to try rationale in sense may be used to support a legal really an innovation in the law of the context of a fan blade for jet engines. conclusion of obviousness so long as it obviousness when it stated, ‘‘Common The case had arisen out of an is explained with sufficient reasoning. sense has long been recognized to interference proceeding. Finding that The Perfect Web case provides an inform the analysis of obviousness if
the district court had correctly example in which the Federal Circuit explained with sufficient reasoning.''
determined that there was no held that a claimed method for Perfect Web, 587 F.3d at 1328 (emphasis interference-in-fact because Rolls- managing bulk e-mail distribution was added). The Federal Circuit then Royce's claims would not have been obvious on the basis of an obvious to try provided a review of a number of obvious in light of United's application, argument. In Perfect Web, the method precedential cases that inform the the Federal Circuit affirmed. required selecting the intended understanding of common sense, The Federal Circuit described the fan recipients, transmitting the e-mails, including In re Bozek, 416 F.2d 1385, blade of the count as follows: determining how many of the e-mails 1390 (CCPA 1969) (explaining that a had been successfully received, and patent examiner may rely on ‘‘common Each fan blade has three regions—an inner, knowledge and common sense of the an intermediate, and an outer region. The repeating the first three steps if a pre- area closest to the axis of rotation at the hub determined minimum number of person of ordinary skill in the art is the inner region. The area farthest from the intended recipients had not received the without any specific hint or suggestion center of the engine and closest to the casing in a particular reference'') and In re surrounding the engine is the outer region. The Federal Circuit affirmed the Zurko, 258 F.3d 1379, 1383, 1385 (Fed. The intermediate region falls in between. The district court's determination on Cir. 2001) (clarifying that a factual count defines a fan blade with a swept- summary judgment that the claimed foundation is needed in order for an forward inner region, a swept-rearward invention would have been obvious. examiner to invoke ‘‘good common intermediate region, and forward-leaning Failure to meet a desired quota of e-mail sense'' in a case in which ‘‘basic recipients was a recognized problem in knowledge and common sense was not Id. at 1328. the field of e-mail marketing. The prior based on any evidence in the record''). VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
The Federal Circuit implicitly rebut the prima facie case of obviousness, testimony was contrary to the inventors' acknowledged in Perfect Web that the Office personnel should specifically set forth admissions in the specification, as well kind of strict evidence-based teaching, the facts and reasoning that justify this as prior art teachings that disclosed suggestion, or motivation required in In stem cells in cord blood. In this case, re Lee, 277 F.3d 1338, 1344 (Fed. Cir. MPEP § 2145. The following cases PharmaStem's evidence of 2002), is not an absolute requirement for exemplify the continued application of nonobviousness was outweighed by an obviousness rejection in light of the these principles both at the Federal contradictory evidence. teachings of KSR. The Federal Circuit Circuit and within the Office. Note that Despite PharmaStem's useful explained that ‘‘[a]t the time [of the Lee these principles were at issue in some experimental validation of decision], we required the PTO to of the cases previously discussed, and hematopoietic reconstitution using identify record evidence of a teaching, have been addressed there in a more hematopoietic stem cells from umbilical suggestion, or motivation to combine cursory fashion. cord and placental blood, the Federal references.'' However, Perfect Web went Example 5.1. PharmaStem Circuit found that the claims at issue on to state that even under Lee, common Therapeutics, Inc. v. Viacell, Inc., 491 would have been obvious. There had sense could properly be applied when F.3d 1342 (Fed. Cir. 2007). Teaching been ample suggestion in the prior art analyzing evidence relevant to point: Even though all evidence must be that the claimed method would have obviousness. Citing DyStar Textilfarben considered in an obviousness analysis, worked. Absolute predictability is not a GmbH v. C.H. Patrick Co., 464 F.3d evidence of nonobviousness may be necessary prerequisite to a case of 1356 (Fed. Cir. 2006), and In re Kahn, outweighed by contradictory evidence obviousness. Rather, a degree of 441 F.3d 977 (Fed. Cir. 2006), two cases in the record or by what is in the predictability that one of ordinary skill decided shortly before the Supreme specification. Although a reasonable would have found to be reasonable is Court's decision in KSR, the Federal expectation of success is needed to sufficient. The Federal Circuit Circuit noted that although ‘‘a reasoned support a case of obviousness, absolute concluded that ‘‘[g]ood science and explanation that avoids conclusory predictability is not required. useful contributions do not necessarily The claims at issue in PharmaStem generalizations'' is required to use result in patentability.'' Id. at 1364. were directed to compositions common sense, identification of a Example 5.2. In re Sullivan, 498 F.3d comprising hematopoietic stem cells ‘‘specific hint or suggestion in a 1345 (Fed. Cir. 2007). Teaching point: from umbilical cord or placental blood, particular reference'' is not. All evidence, including evidence 5. Federal Circuit Cases Discussing and to methods of using such rebutting a prima facie case of Consideration of Evidence. Office compositions for treatment of blood and obviousness, must be considered when immune system disorders. The personnel should consider all rebuttal properly presented. composition claims required that the evidence that is timely presented by the It was found to be an error in Sullivan stem cells be present in an amount for the Board to fail to consider applicants when reevaluating any sufficient to effect hematopoietic evidence submitted to rebut a prima obviousness determination. In the case reconstitution when administered to a facie case of obviousness. of a claim rendered obvious by a human adult. The trial court had found The claimed invention was directed combination of prior art references, that PharmaStem's patents were to an antivenom composition applicants may submit evidence or infringed and not invalid on comprising F(ab) fragments used to treat argument to demonstrate that the results obviousness or other grounds. On venomous rattlesnake bites. The of the claimed combination were appeal, the Federal Circuit reversed the composition was created from antibody district court, determining that the molecules that include three fragments, Another area that has thus far claims were invalid for obviousness. remained consistent with pre-KSR 2, F(ab) and F(c), which have The Federal Circuit discussed the separate properties and utilities. There precedent is the consideration of evidence presented at trial. It pointed have been commercially available rebuttal evidence and secondary out that the patentee, PharmaStem, had antivenom products that consisted of considerations in the determination of not invented an entirely new procedure whole antibodies and F(ab) obviousness. As reflected in the MPEP, or new composition. Rather, but researchers had not experimented such evidence should not be considered PharmaStem's own specification with antivenoms containing only F(ab) simply for its ‘‘knockdown'' value; acknowledged that it was already fragments because it was believed that rather, all evidence must be reweighed known in the prior art that umbilical their unique properties would prevent to determine whether the claims are cord and placental blood-based them from decreasing the toxicity of compositions contained hematopoietic snake venom. The inventor, Sullivan, Once the applicant has presented rebuttal stem cells, and that hematopoietic stem discovered that F(ab) fragments are evidence, Office personnel should reconsider cells were useful for the purpose of effective at neutralizing the lethality of any initial obviousness determination in hematopoietic reconstitution. rattlesnake venom, while reducing the view of the entire record. See, e.g., In re PharmaStem's contribution was to occurrence of adverse immune reactions Piasecki, 745 F.2d 1468, 1472, 223 USPQ 785, 788 (Fed. Cir. 1984); In re Eli Lilly & Co., provide experimental proof that in humans. On appeal of the examiner's 90 F.2d 943, 945, 14 USPQ2d 1741, 1743 umbilical cord and placental blood rejection, the Board held that the claim (Fed. Cir. 1990). All the rejections of record could be used to effect hematopoietic was obvious because all the elements of and proposed rejections and their bases reconstitution in mice. By extrapolation, the claimed composition were should be reviewed to confirm their one of ordinary skill in the art would accounted for in the prior art, and that continued viability. have expected this reconstitution the composition taught by that prior art method to work in humans as well. would have been expected by a person The court rejected PharmaStem's of ordinary skill in the art at the time Office personnel should not evaluate expert testimony that hematopoietic rebuttal evidence for its ‘‘knockdown'' value the invention was made to neutralize against the prima facie case, Piasecki, 745 stem cells had not been proved to exist the lethality of the venom of a F.2d at 1473, 223 USPQ at 788, or summarily in cord blood prior to the experiments dismiss it as not compelling or insufficient. described in PharmaStem's patents. The Rebuttal evidence had not been If the evidence is deemed insufficient to court explained that the expert considered by the Board because it VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
considered the evidence to relate to the nonobvious. The district court upheld rejection should be made or maintained intended use of the claimed the jury verdict, stating that in view of only if evidence of obviousness composition as an antivenom, rather the conflicting evidence presented by outweighs evidence of nonobviousness. than the composition itself. Appellant the parties as to the teachings of the See MPEP § 706(I) (‘‘The standard to be successfully argued that even if the references, motivation to combine, and applied in all cases is the Board had shown a prima facie case of secondary considerations, the ‘preponderance of the evidence' test. In obviousness, the extensive rebuttal nonobviousness verdict was sufficiently other words, an examiner should reject evidence must be considered. The grounded in the evidence. a claim if, in view of the prior art and evidence included three expert Shure appealed to the Federal Circuit, evidence of record, it is more likely than declarations submitted to show that the but the Federal Circuit agreed with the not that the claim is unpatentable.''). prior art taught away from the claimed district court that the jury's MPEP § 716.01(d) provides further invention, an unexpected property or nonobviousness verdict had been guidance on weighing evidence in result from the use of F(ab) fragment supported by substantial evidence. making a determination of patentability. antivenom, and why those having Although Shure had argued before the Example 5.4. Asyst Techs., Inc. v. ordinary skill in the art expected jury that the Carlisle reference taught an Emtrak, Inc., 544 F.3d 1310 (Fed. Cir. antivenoms comprising F(ab) fragments ear piece positioned inside the ear 2008). Teaching point: Evidence of to fail. The declarations related to more canal, Hearing Components' credible secondary considerations of than the use of the claimed witness countered that only the molded obviousness such as commercial success composition. While a statement of duct and not the ear piece itself was and long-felt need may be insufficient to intended use may not render a known taught by Carlisle as being inside the ear overcome a prima facie case of composition patentable, the claimed canal. On the issue of combining obviousness if the prima facie case is composition was not known, and references, Shure's witness had given strong. An argument for nonobviousness whether it would have been obvious testimony described as ‘‘rather sparse, based on commercial success or long- depends upon consideration of the and lacking in specific details.'' Id. at felt need is undermined when there is rebuttal evidence. Appellant did not 1364. In contradistinction, Hearing a failure to link the commercial success concede that the only distinguishing Components' witness ‘‘described or long-felt need to a claimed feature factor of its composition is the statement particular reasons why one skilled in that distinguishes over the prior art. of intended use and extensively argued the art would not have been motivated The claims at issue in Asyst that its claimed composition exhibits to combine the references.'' Id. Finally, concerned a processing system for the unexpected property of neutralizing as to secondary considerations, the tracking articles such as silicon wafers the lethality of rattlesnake venom while Federal Circuit determined that Hearing which move from one processing station reducing the occurrence of adverse Components had shown a nexus to the next in a manufacturing facility. immune reactions in humans. The between the commercial success of its The claims required that each Federal Circuit found that such a use product and the patent by providing processing station be in communication and unexpected property cannot be evidence that ‘‘the licensing fee for a with a central control unit. The Federal ignored—the unexpected property is covered product was more than cut in Circuit agreed with the district court relevant and thus the declarations half immediately upon expiration'' of that the only difference between the describing it should have been claimed invention and the prior art to Although the Hearing Components Hesser was that the prior art had taught Nonobviousness can be shown when case involves substantial evidence of the use of a bus for this communication, a person of ordinary skill in the art nonobviousness in a jury verdict, it is while the claims required a multiplexer. would not have reasonably predicted nevertheless instructive for Office At trial, the jury had concluded that the claimed invention based on the personnel on the matter of weighing Hesser was not relevant prior art, but prior art, and the resulting invention evidence. Office personnel routinely the district court overturned that would not have been expected. All must consider evidence in the form of conclusion and issued a judgment as a evidence must be considered when prior art references, statements in the matter of law (JMOL) that the claims properly presented. specification, or declarations under 37 would have been obvious in view of Example 5.3. Hearing Components, CFR 1.131 or 1.132. Other forms of Hesser. Because the evidence showed Inc. v. Shure Inc., 600 F.3d 1357 (Fed. evidence may also be presented during that persons of ordinary skill in the art Cir. 2010). Teaching point: Evidence prosecution. Office personnel are would have been familiar with both the that has been properly presented in a reminded that evidence that has been bus and the multiplexer, and that they timely manner must be considered on presented in a timely manner should could have readily selected and the record. Evidence of commercial not be ignored, but rather should be employed one or the other based on success is pertinent where a nexus considered on the record. However, not known considerations, the Federal between the success of the product and all evidence need be accorded the same Circuit affirmed the district court's the claimed invention has been weight. In determining the relative conclusion that the claims were invalid weight to accord to rebuttal evidence, for obviousness. The case of Hearing Components considerations such as whether a nexus The Federal Circuit also discussed involved a disposable protective exists between the claimed invention arguments that the district court had covering for the portion of a hearing aid and the proffered evidence, and whether failed to consider the objective evidence that is inserted into the ear canal. The the evidence is commensurate in scope of nonobviousness presented by Asyst. covering was such that it could be with the claimed invention, are Asyst had offered evidence of readily replaced by a user as needed. appropriate. The mere presence of some commercial success of its invention. At the district court, Shure had credible rebuttal evidence does not However, the Federal Circuit pointed argued that Hearing Components' dictate that an obviousness rejection out that Asyst had not provided the patents were obvious over one or more must always be withdrawn. See MPEP required nexus between the commercial of three different combinations of prior § 2145. Office personnel must consider success and the claimed invention, art references. The jury disagreed, and the appropriate weight to be accorded to emphasizing that ‘‘Asyst's failure to link determined that the claims were each piece of evidence. An obviousness that commercial success to the features VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
of its invention that were not disclosed Pfizer, Inc. v. Apotex, Inc., 480 F.3d addresses a number of issues that arise in Hesser undermines the probative 1348, 1372 (Fed. Cir. 2007); Ryko Mfg. when Office personnel consider force of the evidence * * *.'' Id. at 1316. Co. v. Nu-Star, Inc., 950 F.2d 714, 719– whether or not a claimed invention is Asyst had also offered evidence from 20 (Fed. Cir. 1991); Newell Cos. v. obvious. While Office personnel are others in the field praising the invention Kenney Mfg. Co., 864 F.2d 757, 768 encouraged to make use of these tools, as addressing a long-felt need. Once (Fed. Cir. 1988)). they are reminded that every question of again, the Federal Circuit found the When considering obviousness, Office obviousness must be decided on its own argument to be unavailing in view of the personnel should carefully weigh any facts. The Office will continue to properly presented objective evidence of prior art, stating that ‘‘[w]hile the monitor the developing law of nonobviousness against the strength of evidence shows that the overall system obviousness, and will provide the prima facie case. If the asserted drew praise as a solution to a felt need, additional guidance and updates as evidence, such as commercial success or there was no evidence that the success satisfaction of a long-felt need, is * * * was attributable to the attributable to features already in the Dated: August 20, 2010. substitution of a multiplexer for a bus, prior art, the probative value of the David J. Kappos,
which was the only material difference evidence is reduced. Under Secretary of Commerce for Intellectual between Hesser and the patented 6. Conclusion. This 2010 KSR Property and Director of the United States invention.'' Id. The Federal Circuit also Guidelines Update is intended to be Patent and Trademark Office. reiterated, citing pre-KSR decisions, that used by Office personnel in conjunction ‘‘as we have often held, evidence of with the guidance provided in MPEP Appendix
secondary considerations does not §§ 2141 and 2143 (which incorporates The following table contains the cases set always overcome a strong prima facie the 2007 KSR Guidelines) to clarify the out as examples in this 2010 KSR Guidelines showing of obviousness.'' Id. (citing contours of obviousness after KSR. It Update and the teaching points of the case. Combining Prior Art Elements
In re Omeprazole Patent Litigation, Even where a general method that could have been applied to make the claimed product was known and 536 F.3d 1361 (Fed. Cir. 2008).
within the level of skill of the ordinary artisan, the claim may nevertheless be nonobvious if the problem which had suggested use of the method had been previously unknown. Crocs, Inc. v. U.S. Int'l Trade A claimed combination of prior art elements may be nonobvious where the prior art teaches away from the Comm'n., 598 F.3d 1294 (Fed. claimed combination and the combination yields more than predictable results. Sundance, Inc. v. DeMonte Fabri- A claimed invention is likely to be obvious if it is a combination of known prior art elements that would rea- cating Ltd., 550 F.3d 1356 (Fed. sonably have been expected to maintain their respective properties or functions after they have been Ecolab, Inc. v. FMC Corp., 569 A combination of known elements would have been prima facie obvious if an ordinarily skilled artisan F.3d 1335 (Fed. Cir. 2009).
would have recognized an apparent reason to combine those elements and would have known how to do so. Wyers v. Master Lock Co., No. The scope of analogous art is to be construed broadly and includes references that are reasonably perti- 2009–1412, —F.3d—, 2010 WL nent to the problem that the inventor was trying to solve. Common sense may be used to support a 2901839 (Fed. Cir. July 22, legal conclusion of obviousness so long as it is explained with sufficient reasoning. DePuy Spine, Inc. v. Medtronic Predictability as discussed in KSR encompasses the expectation that prior art elements are capable of Sofamor Danek, Inc., 567 F.3d being combined, as well as the expectation that the combination would have worked for its intended pur- 1314 (Fed. Cir. 2009).
pose. An inference that a claimed combination would not have been obvious is especially strong where the prior art's teachings undermine the very reason being proffered as to why a person of ordinary skill would have combined the known elements. Substituting One Known Element for Another
In re ICON Health & Fitness, Inc., When determining whether a reference in a different field of endeavor may be used to support a case of 496 F.3d 1374 (Fed. Cir. 2007).
obviousness (i.e., is analogous), it is necessary to consider the problem to be solved. Agrizap, Inc. v. Woodstream Corp., Analogous art is not limited to references in the field of endeavor of the invention, but also includes ref- 520 F.3d 1337 (Fed. Cir. 2008).
erences that would have been recognized by those of ordinary skill in the art as useful for applicant's purpose. Muniauction, Inc. v. Thomson Because Internet and Web browser technologies had become commonplace for communicating and dis- Corp., 532 F.3d 1318 (Fed. Cir. playing information, it would have been obvious to adapt existing processes to incorporate them for those functions. Aventis Pharma Deutschland v. A chemical compound would have been obvious over a mixture containing that compound as well as other Lupin, Ltd., 499 F.3d 1293 (Fed. compounds where it was known or the skilled artisan had reason to believe that some desirable property of the mixture was derived in whole or in part from the claimed compound, and separating the claimed compound from the mixture was routine in the art. Eisai Co. Ltd. v. Dr. Reddy's Labs., A claimed compound would not have been obvious where there was no reason to modify the closest prior Ltd., 533 F.3d 1353 (Fed. Cir. art lead compound to obtain the claimed compound and the prior art taught that modifying the lead com- pound would destroy its advantageous property. Any known compound may serve as a lead compound when there is some reason for starting with that lead compound and modifying it to obtain the claimed compound. Procter & Gamble Co. v. Teva It is not necessary to select a single compound as a ‘‘lead compound'' in order to support an obviousness Pharmaceuticals USA, Inc., 566 rejection. However, where there was reason to select and modify the lead compound to obtain the F.3d 989 (Fed. Cir. 2009).
claimed compound, but no reasonable expectation of success, the claimed compound would not have been obvious. VerDate Mar<15>2010 18:24 Aug 31, 2010 E: FR FM 01SEN1.SGM hsrobinson on DSK69SOYB1PROD with NOTICES Federal Register / Vol. 75, No. 169 / Wednesday, September 1, 2010 / Notices
Altana Pharma AG v. Teva Obviousness of a chemical compound in view of its structural similarity to a prior art compound may be Pharms. USA, Inc., 566 F.3d 999 shown by identifying some line of reasoning that would have led one of ordinary skill in the art to select (Fed. Cir. 2009).
and modify a prior art lead compound in a particular way to produce the claimed compound. It is not necessary for the reasoning to be explicitly found in the prior art of record, nor is it necessary for the prior art to point to only a single lead compound. The Obvious To Try Rationale
In re Kubin, 561 F.3d 1351 (Fed. A claimed polynucleotide would have been obvious over the known protein that it encodes where the skilled artisan would have had a reasonable expectation of success in deriving the claimed polynucleotide using standard biochemical techniques, and the skilled artisan would have had a reason to try to isolate the claimed polynucleotide. KSR applies to all technologies, rather than just the ‘‘predict-able'' arts. Takeda Chem. Indus. v. A claimed compound would not have been obvious where it was not obvious to try to obtain it from a Alphapharm Pty., Ltd., 492 F.3d broad range of compounds, any one of which could have been selected as the lead compound for fur- 1350 (Fed. Cir. 2007).
ther investigation, and the prior art taught away from using a particular lead compound, and there was no predictability or reasonable expectation of success in making the particular modifications necessary to transform the lead compound into the claimed compound. Ortho-McNeil Pharmaceutical, Inc. Where the claimed anti-convulsant drug had been discovered somewhat serendipitously in the course of v. Mylan Labs, Inc., 520 F.3d research aimed at finding a new anti-diabetic drug, it would not have been obvious to try to obtain a 1358 (Fed. Cir. 2008).
claimed compound where the prior art did not present a finite and easily traversed number of potential starting compounds, and there was no apparent reason for selecting a particular starting compound from among a number of unpredictable alternatives. Bayer Schering Pharma A.G. v. A claimed compound would have been obvious where it was obvious to try to obtain it from a finite and Barr Labs., Inc., 575 F.3d 1341 easily traversed number of options that was narrowed down from a larger set of possibilities by the prior (Fed. Cir. 2009).
art, and the outcome of obtaining the claimed compound was reasonably predictable. Sanofi-Synthelabo v. Apotex, Inc., A claimed isolated stereoisomer would not have been obvious where the claimed stereoisomer exhibits un- 550 F.3d 1075 (Fed. Cir. 2008).
expectedly strong therapeutic advantages over the prior art racemic mixture without the correspondingly expected toxicity, and the resulting properties of the enantiomers separated from the racemic mixture were unpredictable. Rolls-Royce, PLC v. United Tech- An obvious to try rationale may be proper when the possible options for solving a problem were known nologies Corp., 603 F.3d 1325 and finite. However, if the possible options were not either known or finite, then an obvious to try ration- (Fed. Cir. 2010).
ale cannot be used to support a conclusion of obviousness. Perfect Web Techs., Inc. v. Where there were a finite number of identified, predictable solutions and there is no evidence of unex- InfoUSA, Inc., 587 F.3d 1324 pected results, an obvious to try inquiry may properly lead to a legal conclusion of obviousness. Com- (Fed. Cir. 2009).
mon sense may be used to support a legal conclusion of obviousness so long as it is explained with suf-ficient reasoning. Consideration of Evidence
PharmaStem Therapeutics, Inc. v. Even though all evidence must be considered in an obviousness analysis, evidence of nonobviousness ViaCell, Inc., 491 F.3d 1342 may be outweighed by contradictory evidence in the record or by what is in the specification. Although a (Fed. Cir. 2007).
reasonable expectation of success is needed to support a case of obviousness, absolute predictability is not required. In re Sullivan, 498 F.3d 1345 (Fed. All evidence, including evidence rebutting a prima facie case of obviousness, must be considered when properly presented. Hearing Components, Inc. v. Shure Evidence that has been properly presented in a timely manner must be considered on the record. Evi- Inc., 600 F.3d 1357 (Fed. Cir. dence of commercial success is pertinent where a nexus between the success of the product and the claimed invention has been demonstrated. Asyst Techs., Inc. v. Emtrak, Inc., Evidence of secondary considerations of obviousness such as commercial success and long-felt need may 544 F.3d 1310 (Fed. Cir. 2008).
be insufficient to overcome a prima facie case of obviousness if the prima facie case is strong. An argu-ment for nonobviousness based on commercial success or long-felt need is undermined when there is a failure to link the commercial success or long-felt need to a claimed feature that distinguishes over the prior art. [FR Doc. 2010–21646 Filed 8–31–10; 8:45 am] BILLING CODE P
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