USPTO Updates Obviousness Examination Guidelines

By Donald Zuhn --

Last week, the U.S. Patent and Trademark Office issued an update to its obviousness guidelines, publishing a notice in the Federal Register (75 Fed. Reg. 53644) that highlights case law developments on obviousness since the Supreme Court's 2007 decision in KSR Int'l Co. v. Teleflex Inc.  The update supplements the Office's 2007 guidelines, in which the Office identified seven rationales gleaned from the KSR decision (see "Patent Office Issues Examination Guidelines Regarding Obviousness after KSR").

The Office indicates that the update to the obviousness examination guidelines is intended to remind Office personnel of the principles of obviousness explained by the Supreme Court in KSR, as well as provide additional guidance on obviousness in view of several post-KSR Federal Circuit decsions.  The Office's focus on decisional law in the update is reminiscent of the implementation of the 2007 obviousness examination guidelines by Technology Center 1600 almost three years ago (see "USPTO's Bruce Kisliuk Addresses ACI Conference").  Bruce Kisliuk -- at the time a TC 1600 Director -- noted that examiners in the Group were being given "high-level" obviousness training in which they were taught to analyze the issue of obviousness using eleven key cases as tools.  Seven of these cases were Federal Circuit decisions:

• Pharmastem Therapeutics, Inc. v. Viacell, Inc. (Fed. Cir. 2007) -- Patent Docs summary
•  Pfizer, Inc. v. Apotex, Inc. (Fed. Cir. 2007) -- Patent Docs summary
• Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd. (Fed. Cir. 2007) -- Patent Docs summary
• In re Sullivan (Fed. Cir. 2007) -- Patent Docs summary
• Daiichi Sankyo Co. v. Apotex, Inc. (Fed. Cir. 2007) -- Patent Docs summary
• Aventis Pharma Deutschland GmbH v. Lupin, Ltd. (Fed. Cir. 2007) -- Patent Docs summary
• Forest Labs., Inc. v. Ivax Pharm., Inc. (Fed. Cir. 2007) -- Patent Docs summary

Mr. Kisliuk stated that Group 1600 examiners were being asked to focus on the facts of the eleven cases since the issue of obviousness is very fact specific.  In the update to the obviousness examination guidelines, the Office echoes Mr. Kisliuk's comments concerning the instructional value of obviousness case law, stating that "[t]he impact of the Supreme Court's decision in KSR can be more readily understood in the context of factual scenarios."  While the notice emphasizes that "every question of obviousness must be decided on its own facts," the Office explains that case law can help "clarify the contours of the obviousness inquiry after KSR."

To that end, the notice lists two-dozen Federal Circuit cases that "have been selected for their instructional value on the issue of obviousness."  For each of these cases, the update provides a "teaching point," which may be used to quickly determine the relevance of each discussed case, but which the Office explains should not be used as a substitute for reading the remainder of the update's discussion of the case.  The notice divides the 24 cases into four groups, the first three groups corresponding to three of the rationales identified in the 2007 guidelines -- combining prior art elements (cases 4.1 to 4.6), substituting one known element for another (cases 4.7 to 4.13), and obvious to try (cases 4.14 to 4.20) -- and the fourth group focusing on issues concerning the consideration of evidence during prosecution (cases 5.1 to 5.4).

Whether it amounts to a point of pride or a source of frustration (or both), half of the cases discussed in the update are biotech/pharma cases.  Of the twelve biotech/pharma cases, four (Pharmastem Therapeutics, Inc., Takeda Chem. Indus., Ltd., In re Sullivan, and Aventis Pharma Deutschland GmbH) were part of Group 1600's seven CAFC decisions (Ex parte Kubin and the Southern District of New York's decision in In re Omeprazole Patent Litigation -- neither of which had reached the Federal Circuit in the Fall of 2007 -- were included on Group 1600's list, and their CAFC counterparts are included in the update).  The biotech/pharma cases discussed in the update (with links to the Federal Circuit opinion, Patent Docs summary of the case, and the "teaching point" provided in the notice) are:

• Example 4.1.  In re Omeprazole Patent Litigation, 536 F.3d 1361 (Fed. Cir. 2008) -- Patent Docs summary
Teaching point:  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.

• Example 4.10.  Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293 (Fed. Cir. 2007) -- Patent Docs summary
Teaching point:  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.

• Example 4.11.  Eisai Co. Ltd. v. Dr. Reddy’s Labs., Ltd., 533 F.3d 1353 (Fed. Cir. 2008) -- Patent Docs summary
Teaching point:  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.

• Example 4.12.  Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc., 566 F.3d 989 (Fed. Cir. 2009) -- Patent Docs summary
Teaching point:  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.

• Example 4.13.  Altana Pharma AG v. Teva Pharmaceuticals USA, Inc., 566 F.3d 999 (Fed. Cir. 2009) -- Patent Docs summary
Teaching point:  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.

• Example 4.14.  In re Kubin, 561 F.3d 1351 (Fed. Cir. 2009) -- Patent Docs summary
Teaching point:  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.

• Example 4.15.  Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (Fed. Cir. 2007) -- Patent Docs summary
Teaching point:  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.

• Example 4.16.  Ortho-McNeil Pharmaceutical, Inc. v. Mylan Labs, Inc., 520 F.3d 1358 (Fed. Cir. 2008) -- Patent Docs summary
Teaching point:  Where the claimed anticonvulsant drug had been discovered somewhat serendipitously in the course of research aimed at finding a new antidiabetic 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.

• Example 4.17.  Bayer Schering Pharma A.G. v. Barr Labs., Inc., 575 F.3d 1341 (Fed. Cir. 2009) -- Patent Docs summary
Teaching point:  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.

• Example 4.18.  Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. 2008) -- Patent Docs summary
Teaching point:  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.

• Example 5.1.  PharmaStem Therapeutics, Inc. v. Viacell, Inc., 491 F.3d 1342 (Fed. Cir. 2007) -- Patent Docs summary
Teaching point:  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.

• Example 5.2.  In re Sullivan, 498 F.3d 1345 (Fed. Cir. 2007) -- Patent Docs summary
Teaching point:  All evidence, including evidence rebutting a prima facie case of obviousness, must be considered when properly presented.

The remaining cases discussed in the update (with links to the Federal Circuit opinion) are:

• Example 4.2.  Crocs, Inc. v. U.S. International Trade Commission, 598 F.3d 1294 (Fed. Cir. 2010).

• Example 4.3.  Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356 (Fed. Cir. 2008).

• Example 4.4.  Ecolab, Inc. v. FMC Corp., 569 F.3d 1335 (Fed Cir. 2009).

• Example 4.5.  Wyers v. Master Lock Co., No. 2009–1412, —F.3d—, 2010 WL2901839 (Fed. Cir. July 22, 2010).

• Example 4.6.  DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314 (Fed. Cir. 2009).

• Example 4.7.  In re ICON Health & Fitness, Inc., 496 F.3d 1374 (Fed. Cir. 2007).

• Example 4.8.  Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337 (Fed. Cir. 2008).

• Example 4.9.  Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318 (Fed. Cir. 2008).

• Example 4.19.  Rolls-Royce, PLC v. United Technologies Corp., 603 F.3d 1325 (Fed. Cir. 2010).

• Example 4.20.  Perfect Web Technologies, Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328–29 (Fed. Cir. 2009).

• Example 5.3.  Hearing Components, Inc. v. Shure Inc., 600 F.3d 1357 (Fed. Cir. 2010).

• Example 5.4.  Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310 (Fed. Cir. 2008).

The notice also points out that technology-specific obviousness examples can be found on the PTO website.  Included among the materials is a PowerPoint presentation entitled "Obviousness in view of KSR:  TC1600-Specific Examples."

The Office is seeking public comment regarding the update to the guidelines, and is particularly interested in receiving suggestions regarding recent decisions concerning obviousness that would have value as teaching tools.  Comments may be submitted by e-mail to [email protected] or by regular mail: Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 22313–1450.

Comments

[6]

Man the docs are so slow here lately.

[6]

BTW, Don, Kev, do either of you have any feelings on the new weight loss drug that is coming out? Will it get approved in your opinion? Maybe you guys aren't familiar with it and I've forgotten the name, so if that be the case nm.

[Kevin E. Noonan]

Dear 6:

"Slow?" What do you mean?

A drug that would truly control weight would be a boon.

Thanks for the comment.

[6]

Slow man, PO and the rest had you beat on this article by like a week.

But yeah man, there's 3 drugs that were for weight control going through testing, my buddy was investing in the "safest" of them through their companies stock. The first drug already failed to get approval. We'll see about the next 2. 2nd one is due out on the 15th. Might want to look into it.

[Anonymous]

The "teaching points" on the lead compound cases are totally divorced from what the cases actually hold, and attempt to avoid the rule established in those cases prima facie obviousness for compound cases starts with the reasoned identification of the lead compound based on what the reference says followed by showing why it would have been obvious to modify the obvious lead to get the obvious compound. Nowhere in Eisai does it say that "ANY known compound may serve as a lead compound", neither does Procter and Gamble say anywhere that "it is not necessary to select a single compound as a 'lead compound'". Neither do any of the cases say (as do the new guidelines) that even a totally inactive compound is fine as a lead compound.

It seems that the twisting of the holding in these cases is to make it easier for examiners to carry on rejecting compound claims for obviousness using nonsense hindsight reasoning. Typical rejections are those where examiner searches the structure and finds an insignificant compound in a reference (its only significance is that it is structurally similar to the claimed compounds, not anything the reference teaches), and then asserts the claimed compounds would have been obvious because they include a homolog/positional isomer (or whatever) of the compound the examiner has found by searching for similar compounds. The rejection is often accompanied by a string cite of cases per se obviousness cases (Henze and the like), about half of which were decided even before the Patent Act was passed and all of were completely discredited by Ochiai in 1995 (stating that "reliance on per se rules of obviousness is legally incorrect and must cease.")

Fifteen years later, it has not ceased, but is alive and well, and the Patent Office is still encouraging the same kinds of nonsense rejections with twisted "teaching points" that ignore what the cases actually say - that the prior art has to make both the selection of the lead compound and its modification to the claimed compound obvious. Instead, the Patent Office is telling examiners not to worry that the reference would not have made the particular compound obvious ("any compound" is OK as a lead), or that that the compound the examiner found as being similar to the claimed compounds would not have been an obvious lead based on the reference (it is OK to have as many leads as you like in a reference - they don't even need to be active - did we mention that ANY compound can be a lead?). It will be business as usual, and examiners should go ahead and keep making the same per se obviousness rejections, ignoring Takeda, Eisai, and P&G in the same way that Ochiai has been ignored.

[Dan Feigelson]

Anonymous, I hear you, but I'm not surprised. I think it's just business as usual for the USPTO, which as often as not seems to reinterpret court decisions in a manner it finds convenient, then records that (incorrect) reinterpretation in the MPEP as gospel for all examiners to follow.

[6]

"which as often as not seems to reinterpret court decisions in a manner it finds convenient, then records that (incorrect) reinterpretation in the MPEP as gospel for all examiners to follow. "

What is the problem with that? Is the executive branch not free to interpret their judicial brethern's proclamations how they please?

[Anonymous]

Seeing nothing wrong in disregarding the law is about par for USPTO rejections.