On March 2nd, I will be presenting with Jeffrey Lewis of Patterson, Belknap, Webb & Tyler in an AIPLA live online seminar entitled, “KSR and the Ripple Effect: Examining the Broad and Increasing Impact of KSR on Patent Litigation and Practice.”
Click here for further information.
Thanks to all of you who attended (or tried to attend) the panel presentations on KSR Tuesday morning at the AIPLA Annual Meeting. We apologize, but were pleasantly surprised, that the room was too small to accommodate all who wished to attend. Although it is available at the AIPLA website, I have attached the paper I submitted: “Adjusting the Rearview Mirror – Blocking Impermissible Hindsight Rejections.” It also touches on the state of “non-analogous art” and “picking and choosing.” I think that KSR unleashed/freed/encouraged Examiners to make obvious to try rejections which involve blatant picking and choosing from laundry lists of known elements, and that are only supported by the “common sense” or “ordinary creativity” of the POSA (read “the Examiner”). If I felt that anything was lacking in the panel, it might be the lack of a speaker on the importance of identifying prior art disclosures teaching away from the claimed invention.
On September 1st, the Office of Patent Legal Administration (I didn’t know there was one) issued 17 pages in the Fed. Reg. (Vol. 75, 53643) updating its obviousness guidelines. (A copy of the guidelines is found at the end of this post.) The Update is mostly a meaty analysis of 22 post-KSR Fed. Cir. decisions, 12 of which are in the pharma/biotech area and nine of which deal with the principles of “structural obviousness.” The Guidelines state that apart from using the TSM test as a rationale “to support an obviousness determination,” the 2007 KSR Guidelines identified six other rationales that can also be used: (1) Combining prior art elements according to known methods to yield predictable results; (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”; and (6) known work in one field of endeavor may prompt variation 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 POSA.
The structural obviousness decisions are either used to illustrate “substituting one known element for another” or “obvious to try.” All the decisions are summarized by “teaching points,” some of which are simply put too broadly. For example, the teaching point for Aventis Pharma v Lupin, 499 F.3d 1293 (Fed. Cir. 2007) is: “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.”
By Paul Cole
Visiting Professor, Intellectual Property Law, Bournemouth University, UK
On Tuesday 24 November, David Kappos made a posting on the Director’s Forum including the following statement:
Some have suggested that the Office is determining obviousness in a way that stifles innovation by refusing patents for truly inventive subject matter. They’ve asked us to provide examples of non-obvious claims in view of KSR. Such examples would serve as a complement to the examples of obvious claims already in the guidelines.
Mr. Kappos gave a presentation at the AIPLA Annual Meeting in Washington in October, and in a question and answer session that followed there were three questions which concerned KSR, more than any other topic. The two questioners who preceded me expressed dissatisfaction with seemingly unjust and arbitrary rejections for lack of inventive step. I asked whether the US examination guidelines on inventive step could be brought into line with those of the EPO, where positive and negative examples are carefully balanced, and the suggestion created a burst of applause from the audience. More detained comments on the suggestion are found in a paper on KSR that was published in the John Marshall Review of Intellectual Property Law in 2008 (a copy is attached at the end of this posting).
It now seems that there is at least a chance that the suggestion that I and others have made may be acted on, and that the possibility is under active consideration in the USPTO. For the most to be made of this opportunity, we as students and users of the patent system can help by suggesting additional positive decisions which it would be good for the USPTO to include in the revised inventive step Guidelines.
For the avoidance of doubt, what we are looking at here is the Manual of Patent Examining Procedure at 2143 – Examples of Basic Requirements of a Prima Facie Case of Obviousness. There are various headings giving examples and the opportunity here is to submit counter-examples. Here are the various headings:
A. Combining prior art elements according to known methods to yield predictable results. Anderson’s Black Rock is one example and US v Adams is a counter-example but mentioned only for teaching away which is not really in point here. Do we have any more recent examples which could usefully go into the MPEP? The Adams case itself provides a good example of persuasive new function, and the nineteenth century examples of Winans and the Washburn & Moen Manufacturing (Glidden barbed wire) case are also instructive. But good recent examples should also be included e.g. compositions exhibiting surprising synergistic properties.
B. Simple substitution. Are there any decisions which could usefully be contrasted with In re Fout, In re O’Farrell, Ruiz v AB Chance and Ex parte Smith?
C. Use of known techniques to improve similar devices. Are there any decisions which it would be good to include in MPEP and which can be contrasted with In re Nilssen and Ruiz v Chance?
D. Applying known techniques to a known device. What decisions might be included to contrast with Dann v Johnson and In re Nilssen?
E. Obvious to try. What decisions should be included to contrast with Pfizer v Apotex, Alza v Mylan Laboratories and Ex parte Kubin? See also the MPEP at 2143.02.
F. Variations prompted by design incentives or other market forces. The examples here are Dann v Johnson, Leapfrog v Fisher Price, KSR itself and Ex parte Catan. Can we provide instructive and hopefully easily comprehended counter-examples?
G. The TSM test. Here Graham and DyStar are mentioned. Do we have any post-KSR examples where it was appropriate to continue to apply the TSM test and a positive finding of patentability was made?
Readers of this blog will obviously be looking for cases which emphasize the empirical nature of research in the chemical, biochemical and pharmaceutical arts. One suitable candidate might be the recent CAFC decision in Sanofi Synthelabo v Apotex which concerned the drug Plavix used for the treatment of heart attacks and strokes. It turned out that the enantiomers had the property of “absolute specificity’ with one isomer providing all of the anti-platelet activity, but no significant neurotoxicity whereas the other had no anti-platelet activity and all the neurotoxicity. Evidence was adduced that there was no scientific principle which allowed prediction of which isomer would be more active, and that weak stereospecificity was more common than strong stereospecificity; also that activity and toxicity were correlated so that the more active isomer would be expected to be the more toxic. Furthermore, in compounds where biological effectiveness is delivered through metabolism in the body, the acid environment of the stomach or other metabolic processes may restore the racemic state. On this basis the CAFC held that the biological activity of the claimed isomer could not reasonably have been predicted
Hopefully readers will respond with references to instructive Board of Appeals, District Court and CAFC cases where patents were held to have inventive character.
The commentary presented herein represents the opinions of the author and not of Schwegman Lundberg & Woessner, P.A. or any other employee thereof. This commentary is provided for general informational and discussion purposes and should not be considered to be, or used as, legal advice to address any particular situation.
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