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2010 KSR GUIDELINES UPDATES

2010 KSR GUIDELINES UPDATE
by Kelly McKinney, Patent Attorney

Effective September 1, 2010, the USPTO has issued an update (2010 KSR Guidelines Update[1]) to its 2007 KSR Guidelines[2] that highlights case law developments on obviousness under 35 U.S.C. § 103 since the 2007 decision by the United States Supreme Court in KSR Int'l Co. v. Teleflex Inc. The 2010 KSR Guidelines Update is intended to be used in conjunction with the 2007 KSR Guidelines in order to provide a more complete view of the state of the law of obviousness after KSR.

The 2010 KSR Guidelines Update discusses obviousness issues from various post-KSR Federal Circuit cases and provides a "teaching point" for each discussed case.These and corresponding notes are outlined below:

Case

Teaching Point / Notes

Combining Prior Art Elements

In re Omeprazole Patent Litig., 536 F.3d 1361 (Fed. Cir. 2008).

"Even where a general method that could have been applied to make the claimed product was known and 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 Comm'n., 598 F.3d 1294 (Fed. Cir. 2010).

"A claimed combination of prior art elements may be nonobvious where the prior art teaches away from the claimed combination and the combination yields more than predictable results."

Note: "[A] proper rejection based on the rationale that the claimed invention is a combination of prior art elements... includes a finding that results flowing from the combination would have been predictable to a person of ordinary skill in the art."

Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356 (Fed. Cir. 2008).

"A claimed invention is likely to be obvious if it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they have been combined."

Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed. Cir. 2009).

"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."

Note: "When considering the question of obviousness, Office personnel should keep in mind the capabilities of a person of ordinary skill."

Wyers v. Master Lock Co., No. 2009-1412, -F.3d-, 2010 WL 2901839 (Fed. Cir. July 22, 2010).

"The scope of analogous art is to be construed broadly and includes references that are reasonably pertinent to the problem that the inventor was trying to solve. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning."

Note:"Office personnel should continue to provide a reasoned explanation for every obviousness rejection"-even those based on the idea of common sense.

DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314 (Fed. Cir. 2009).

"Predictability as discussed in KSR encompasses the expectation that prior art elements are capable of being combined, as well as the expectation that the combination would have worked for its intended purpose. 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., 496 F.3d 1374 (Fed. Cir. 2007).

"When determining whether a reference in a different field of endeavor may be used to support a case of obviousness (i.e., is analogous), it is necessary to consider the problem to be solved."

Note: "ICON is another useful example for understanding the scope of analogous art....ICON is also informative as to the relationship between the problem to be solved and the existence of a reason to combine....ICON also makes clear that if the reference does not teach that a combination is undesirable, then it cannot be said to teach away."

Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337 (Fed. Cir. 2008).

"Analogous art is not limited to references in the field of endeavor of the invention, but also includes references that would have been recognized by those of ordinary skill in the art as useful for the applicant's purpose."

Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318 (Fed. Cir. 2008).

"Because Internet and Web browser technologies had become commonplace for communicating and displaying information, it would have been obvious to adapt existing processes to incorporate them for those functions."

Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293 (Fed. Cir. 2007).

"A chemical compound would have been obvious over a mixture containing that compound as well as other 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."

Note: "[I]n chemical cases, structural similarity can provide the necessary reason to modify prior art teachings."

Eisai Co. Ltd. v. Dr. Reddy's Labs., Ltd., 533 F.3d 1353 (Fed. Cir. 2008).

"A claimed compound would not have been obvious where there was no reason to modify the closest prior art lead compound to obtain the claimed compound and the prior art taught that modifying the lead compound 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."

Note:"[T]he term 'lead compound' in a particular opinion can have a contextual meaning that may vary from the way a pharmaceutical chemist might use the term."

Proctor & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989 (Fed. Cir. 2009).

"It is not necessary to select a single compound as a 'lead compound' in order to support an obviousness rejection. However, where there was reason to select and modify the lead compound to obtain the claimed compound, but no reasonable expectation of success, the claimed compound would not have been obvious."

Note: "Office personnel should recognize that in certain situations, it may be proper to reject a claimed chemical compound as obvious even without identifying a single lead compound."

Altana Pharma AG v. Teva Pharms. USA, Inc., 566 F.3d 999 (Fed. Cir. 2009).

"Obviousness of a chemical compound in view of its structural similarity to a prior art compound may be shown by identifying some line of reasoning that would have led one of ordinary skill in the art to select 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. Cir. 2009).

"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 'predictable' arts."

Note: There are "two classes of situations where 'obvious to try' is erroneously equated with obviousness under § 103...: (1) When what would have been 'obvious to try' would have been to vary all parameters to try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful; and (2) when what was 'obvious to try' was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it."

Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007).

"A claimed compound would not have been obvious where it was not obvious to try to obtain it from a broad range of compounds, any one of which could have been selected as the lead compound for further 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."

Note: "[T]he obvious to try rationale does not apply when the appropriate factual findings cannot be made."

Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358 (Fed. Cir. 2008).

"Where the claimed anti-convulsant drug had been discovered somewhat serendipitously in the course of research aimed at finding a new anti-diabetic drug, it would not have been obvious to try to obtain a 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."

Note: "Under the Federal Circuit's case law 'finite' means 'small or easily traversed' in the context of the art in question....[I]t is essential that the inquiry be placed in the context of the subject matter at issue, and each case must be decided on its own facts."

Bayer Schering Pharma AG v. Barr Labs., Inc., 575 F.3d 1341 (Fed. Cir. 2009).

"A claimed compound would have been obvious where it was obvious to try to obtain it from a finite and easily traversed number of options that was narrowed down from a larger set of possibilities by the prior art, and the outcome of obtaining the claimed compound was reasonably predictable."

Note: "[T]he mere existence of a large number of options does not in and of itself lead to a conclusion of nonobviousness. Where the prior art teachings lead one of ordinary skill in the art to a narrower set of options, then that reduced set is the one to consider when determining obviousness using an obvious to try rationale."

Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. 2008).

"A claimed isolated stereoisomer would not have been obvious where the claimed stereoisomer exhibits unexpectedly 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."

Note: "[E]ven when only a small number of possible choices exist, the obvious to try line of reasoning is not appropriate when, upon consideration of all of the evidence, the outcome would not have been reasonably predictable and the inventor would not have had a reasonable expectation of success."

Rolls-Royce, PLC v. United Techs. Corp., 603 F.3d 1325 (Fed. Cir. 2010).

"An obvious to try rationale may be proper when the possible options for solving a problem were known and finite. However, if the possible options were not either known or finite, an obvious to try rationale cannot be used to support a conclusion of obviousness."

Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324 (Fed. Cir. 2009).

"Where there were a finite number of identified, predictable solutions and there is no evidence of unexpected results, an obvious to try inquiry may properly lead to a legal conclusion of obviousness. Common sense may be used to support a legal conclusion of obviousness so long as it is explained with sufficient reasoning."

Consideration of Evidence

PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342 (Fed. Cir. 2007).

"Even though all evidence must be considered in an obviousness analysis, evidence of nonobviousness may be outweighed by contradictory evidence in the record or by what is in the specification. Although a 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. Cir. 2007).

"All evidence, including evidence rebutting a prima facie case of obviousness, must be considered when properly presented."

Note:"Nonobviousness can be shown when a person of ordinary skill in the art would not have reasonably predicted the claimed invention based on the prior art, and the resulting invention would not have been expected."

Hearing Components, Inc. v. Shure Inc., 600 F.3d 1357 (Fed. Cir. 2010).

"Evidence that has been properly presented in a timely manner must be considered on the record. Evidence of commercial success is pertinent where a nexus between the success of the product and the claimed invention has been demonstrated."

Note: "The mere presence of some credible rebuttal evidence does not dictate that an obviousness rejection must always be withdrawn....Office personnel must consider the appropriate weight to be accorded to each piece of evidence. An obviousness rejection should be made or maintained only if evidence of obviousness outweighs evidence of nonobviousness."

Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310 (Fed. Cir. 2008).

"Evidence of secondary considerations of [non]obviousness such as commercial success and long-felt need may be insufficient to overcome a prima facie case of obviousness if the prima facie case is strong. An argument for nonobviousness based on commercial success or long-felt need is undermined where there is a failure to link the commercial success or long-felt need to a claimed feature that distinguishes over the prior art."

Note:"Office personnel should carefully weigh any properly presented objective evidence of nonobviousness against the strength of the prima facie case.If the asserted evidence, such as commercial success or satisfaction of long-felt need, is attributable to features already in the prior art, the probative value of the evidence is reduced."


[1] Examination Guidelines Update: Developments in the Obviousness Inquiry after KSR v. Teleflex, 75 FR 53643 (Sept. 1, 2010) (2010 KSR Guidelines Update), available at http://edocket.access.gpo.gov/2010/pdf/2010-21646.pdf.

[2] Examination Guidelines for Determining Obviousness under 35 U.S.C. 103 in View of the Supreme Court Decision in KSR International Co. v. Teleflex Inc., 72 FR 57526 (Oct. 10, 2007), 1324 Off. Gaz. Pat. Office 23 (Nov. 6, 2007) (2007 KSR Guidelines), available at http://www.uspto.gov/web/offices/com/sol/notices/72fr57526.pdf.

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