2010 KSR Guidelines Update, 75 FR (September 1, 2010) Updated PTO guidelines on obviousness determinations in a post KSR World

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1 2010 KSR Guidelines Update, 75 FR (September 1, 2010) Updated PTO guidelines on obviousness determinations in a post KSR World ROY D. GROSS Associate St. Onge Steward Johnston & Reens LLC Stamford, Connecticut This Article examines relevant caselaw discussing the obviousness doctrine, outlined in the 2010 KSR Guidelines Update, 75 FR , and the effect of this recent caselaw on patent practitioners. INTRODUCTION In order for a patent to issue, one of the requirements is that the patent must satisfy 35 U.S.C This statute sets forth that a patent may not be obtained if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Whether a patent is obvious over the prior art has always been and continues to be a difficult question that is decided on a case-by-case basis. In 2007, the U.S. Supreme Court, in KSR Int l Co. v. Teleflex Inc., 550 U.S. 398 (2007), analyzed the factual inquiries for a determination of obviousness and established a framework on how the obviousness determination should be made. Recent Federal Circuit cases have since analyzed the KSR v. Teleflex opinion and have provided further instruction for patent practitioners on the doctrine of obviousness. Part I of this Article examines the KSR v. Teleflex decision. Part II provides a brief discussion of relevant post-ksr decisions that further expand upon the obviousness doctrine. Part III sets forth suggestions for patent practitioners in a post-ksr landscape. I. KSR V. TELEFLEX Prior to the 2007 U.S. Supreme Court decision in KSR v. Teleflex, patent examiners were instructed to apply the teaching-suggestion-motivation test (TSM) when making a determination on whether a patent claim was obvious over the prior art. The TSM test involved analyzing whether the prior art suggests or teaches to combine elements in the prior art in order to find a patent obvious and whether the prior art suggests the desirability, and thus the obvious nature, of the combination of previously known elements. The KSR opinion, however, changed the landscape for patent examiners and practitioners, as it explained that the TSM test is just but one possible approach, and is not the sole approach to be followed when making an obviousness determination. Id., 550 U.S. at 415. Instead, KSR outlined a more flexible approach for determining obviousness, and set forth six different rationales for this determination. These rationales, identified in the initial 2007 KSR Guidelines from the USPTO include: (1) combining prior art elements according to known methods to yield predictable results; (2) 1

2 simple substitution of one known element for another to obtain predictable results; (3) use of a known technique to improve similar devices, methods, or products in the same way; (4) applying a known technique to a known device, method, or product ready for improvement to yield predictable results; (5) obvious to try choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; and (6) known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. 72 Fed. Reg (2007 KSR Guidelines). When considering obviousness, the flexible post-ksr approach allows patent examiners to support a rejection under 35 U.S.C. 103 by reliance on scientific theory and legal precedent, while employing one of the above six mentioned rationales. However, such rationales are not per se rules, and patent examiners are required to clearly identify and explain the bases for their rejections and how to apply the facts at hand for each rationale to support an obviousness rejection. On September 1, 2010, the USPTO issued new KSR guidelines ( the 2010 KSR Guidelines ) to provide a more complete view of developments in the law of obviousness for patent examiners and practitioners, as the body of case law regarding obviousness has developed following the 2007 KSR opinion. Such guidelines, following key Federal Circuit decisions, provide further analysis on three groups of rationales identified by the 2007 KSR Guidelines combining prior art elements, substituting one known element for another and obvious to try. Significant cases in these rationales are discussed below. II. RATIONALES FROM POST-KSR CASES a. COMBINING PRIOR ART ELEMENTS TO YIELD PREDICTABLE RESULTS Post-KSR, one of the rationales for establishing an obviousness rejection is when components are known in the prior art, and when it would be foreseeable for persons of ordinary skill in the art to combine these prior art components to yield predictable results. However, when the step of combining prior art references involves additional effort that no one of ordinary skill in the art would have undertaken without a recognized reason, then the combination invention is beyond what is a predictable result and may be unobvious over the prior art. Two cases discuss this principle, and arrive at different outcomes. i. ECOLAB. V. FMC (CLAIMS FOUND OBVIOUS) The Federal Circuit, in Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed. Cir. 2009), found that a combination of known elements would have been prima facie obvious if an ordinarily skilled artisan would have recognized an apparent reason to combine those elements and would have known how to do so. In Ecolab, the claimed invention was directed to a method for sanitizing meat by spraying the meat with an antibacterial solution under specified conditions. A prior art reference asserted for invalidity of the claimed method was found to disclose all elements 2

3 of the method, except for the pressure limitation of spraying the meat at a pressure of at least 50 psi (pounds per square inch). Id., 569 F.3d at The Federal Circuit found the method to be obvious because there was an apparent reason to combine known elements namely to increase the contact between the antibacterial solution and the bacteria on the meat surface by spraying the meat at a high pressure of at least 50 psi to wash additional bacteria off the meat surface. Id., 569 F.3d at The Federal Circuit explained that a person of skill in the art would have recognized the reason to use high pressure to spray the antibacterial solution onto meat and thus, found the method claims to be obvious over the primary prior art reference and a secondary reference, which taught using pressure of 20 to 150 psi to vigorously wash a meat surface. Thus, the Ecolab decision supports the principle that if a claimed invention is merely the combination of familiar elements which yield predictable results, then the claimed invention is obvious. ii. IN RE OMEPRAZOLE PATENT LITIGATION (CLAIMS FOUND UNOBVIOUS) The Federal Circuit reached a contrary conclusion in In re Omeprazole Pat. Lit., 536 F.3d 1361 (Fed. Cir. 2008). In Omeprazole, the claimed invention was directed to an enteric coating for an omeprazole pill for the purpose of ensuring that the active omeprazole drug did not disintegrate before reaching its intended site of action. The Defendant argued that coated omeprazole tablets were known from a prior art reference and that subcoatings for enteric drug formulation were generally known. The Defendant also argued that there was no evidence of undue technical hurdles or lack of a reasonable expectation of success to create an omeprazole pill with an enteric coating, and therefore, the enteric coating of the claimed invention was obvious over the prior art. The Federal Circuit, however, disagreed and found that the problem of degradation of omeprazole by interaction with an enteric coating had not been recognized in the prior art. Therefore, a person of skill in the art would have had no reason to include an additional subcoating in an omeprazole pill formulation, even though the addition of a subcoating could have been done by a person of skill in the art. Thus, the Omeprazole decision explains that even where the modifications necessary to arrive at the claimed invention were known, a claimed invention may be unobvious, if the problem which would have motivated a person of skill in the art to make these modifications was previously unknown. b. SUBSTITUTING ONE KNOWN ELEMENT FOR ANOTHER A second rationale described in the KSR opinion for an obviousness rejection is the substitution rationale. The substitution rationale involves an Examiner substituting a known element from one prior art reference for another prior art reference to render the claimed invention obvious. This rationale may be applied when one of ordinary skill in the art would have been technologically capable of making the substitution, and the result obtained would have been predictable. Two cases discuss this principle, and arrive at different results. 3

4 i. IN RE ICON HEALTH & FITNESS (CLAIMS FOUND OBVIOUS) The Federal Circuit, in In re ICON Health & Fitness, Inc., 496 F.3d 1374 (Fed. Cir. 2007), analyzed when a prior art reference is proper to support a case of obviousness via the substitution rationale. The claimed invention in ICON was directed to a treadmill with a folding base that swivels via a gas spring. The Federal Circuit evaluated whether a secondary prior reference that taught gas springs could be used as a substitution in an obviousness analysis with a reference for a treadmill, even though the secondary reference did not have any particular focus on treadmills. The ICON Court held that this secondary reference was properly applied in connection with a rejection of claims directed to a treadmill invention because the reference considered the problem to be solved (i.e. supporting the weight of a folding mechanism and providing a stable resting position via a spring). The secondary reference was considered to be analogous art for solving the problem of the claimed invention and the ICON Court held that the secondary reference, by addressing a similar problem, was proper for a substitution analysis for obviousness, as it indicated a reason to incorporate its teaching into the primary reference. Id., at Thus, the ICON decision supports the principle that when determining whether a reference in a different field of endeavor may be used in a substitution to support a case of obviousness, it is necessary to consider the problem to be solved by the claimed invention. ii. EISAI V. DR. REDDY S LABS (CLAIMS FOUND UNOBVIOUS) The Federal Circuit reached a contrary conclusion regarding the substitution rationale in Eisai Co. Ltd. v. Dr. Reddy s Labs., Ltd., 533 F.3d 1353 (Fed. Cir. 2008). In Eisai, the Federal Circuit analyzed the claimed invention for the pharmaceutical compound rabeprazole. The Defendant based its obviousness argument on the structural similarity of rabeprazole and lansoprazole, a compound discussed in a prior art reference. The Defendant argued that starting with lansoprazole, it was obvious for a person of skill in the art to arrive at rabeprazole. However, despite the significant similarity between the structures of lansoprazole and rabeprazole, the Federal Circuit did not find any sufficient reason to modify the rabeprazole compound based upon the prior art lansoprazole compound. The Court said that there must be a reason for starting with a lead compound (lansoprazole) and modifying it to arrive at the claimed compound (rabeprazole) in order to support an obvious rejection. Thus, without a reasonable expectation of success, the Court found that it would not have been obvious to arrive at the claimed compound where there was no reason to modify the closest prior art lead compound, as this was not an identifiable predictable solution. Eisai is an example where a substitution would not have been obvious. c. OBVIOUS TO TRY A third rationale recognized by the KSR opinion is the obvious to try rationale. The obvious to try rationale is only appropriate when there are a finite number of 4

5 identified, predictable solutions to the recognized need or problem, and one of ordinary skill in the art could have pursued these known potential solutions with a reasonable expectation of success. Two cases discuss this principle, and arrive at different results. i. ROLLS-ROYCE V. UNITED TECHS. (CLAIMS FOUND UNOBVIOUS) The Federal Circuit, in Rolls-Royce, PLC v. United Techs. Corp., 603 F.3d 1325 (Fed. Cir. 2010), found that a claimed invention may be found obvious when the possible options for solving a problem were known and finite. In Rolls-Royce, the invention was directed to a fan blade for jet engines. The claimed invention was a fan blade design where the asserted novelty of the new design was directed to the sweep angle of the blade. The sweep angle in the outer region of the claimed invention was reversed compared with prior art fan blades in order to reduce endwall shock in the jet engine. The Federal Circuit, in its analysis, acknowledged that there was no suggestion in the prior art that changing the sweep angle would have addressed the issue of endwall shock. Thus, changing the sweep angle would not have presented itself as an option at all, let alone an option that would have been obvious to try. Id., 603 F.3d at The decision in Rolls-Royce supports the conclusion that the obvious to try rationale can properly be used for a finding of obviousness only when the claimed solution would have been selected from a finite number of potential solutions known to persons of ordinary skill in the art. ii. PERFECT WEB TECHS., INC. V. INFOUSA (CLAIMS FOUND OBVIOUS) The Federal Circuit reached a contrary conclusion regarding obvious to try in Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324 (Fed. Cir. 2009). In Perfect Web, the claimed invention was directed to a method for managing bulk distribution involving selecting intended recipients, transmitting s, determining how many of the s had been successfully received, and repeating the previous steps if a predetermined minimum number of intended recipients had not received the . The Federal Circuit held that there was no evidence of any unexpected results associated with selecting a new recipient list and no evidence that the method would not have had a reasonable likelihood of success. Thus, as there were a finite number of identified predictable solutions, the obvious to try inquiry properly led to the legal conclusion of obviousness as it was common sense, and the claim as a whole, simply recites repetition of a known procedure until success is achieved. Id., 587 F.3d at Thus, Perfect Web reaches a contrary conclusion to Rolls-Royce because common sense would allow a person of skill in the art to select from a finite number of potential solutions known to persons of ordinary skill in the art to arrive at the claimed invention. III. SUGGESTIONS FOR PATENT PRACTITIONERS As discussed above, recent Federal Circuit caselaw outlined in the 2010 KSR Guidelines sheds additional light on rationales for obviousness determinations. Patent practitioners need to be aware of and consider these obviousness rationales combining 5

6 prior art elements to yield predictable results, substituting one known element for another, and the obvious to try rationale when drafting patent applications. The good news for patent practitioners is that familiar lines of argument still apply, including teaching away from the claimed invention by prior art, lack of a reasonable expectation of success, and unexpected results, which can help show that claims are unobvious. With regard to the rationale of combining prior art elements to yield predictable results, patent practitioners may now consider, during the patent drafting process, working with inventors to identify the unknown problems and needs that the claimed invention solves and highlighting the existence of these problems in a patent specification. Working with inventors to add disclosure to the specification on why the claimed invention does not achieve a predictable result of elements may reduce the likelihood of receiving an obviousness rejection and/or may provide a basis of arguing against such a rejection when received. To overcome the obvious to try rationale, practitioners should be vigilant in discussing with their clients to include discussion of unexpected results in the patent specification on how the claimed invention has advantages over the prior art that a person of skill the art would not have considered. Thus, considering the new 2010 KSR guidelines, patent practitioners should take additional care when drafting patent applications and should consider the new obviousness rationales set forth by KSR to anticipate potential obviousness rejections that may arise during patent prosecution. 6