Archive for the ‘Obviousness’ Category

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USPTO Issues “2010 KSR Guidelines Update”

Tuesday, September 7th, 2010

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.”

(more…)

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CANCELLATION OF WARF STEM CELL CLAIMS: THE “DR. HYDE” SIDE OF KSR

Tuesday, May 25th, 2010

Recently, in a notably unremarked decision, the Board reversed the Examiner, effectively canceling all of the claims to pluripotent human embryonic stem cells (ES) in Thomson (U.S. Pat. No. 7029913): The Foundation for Taxpayer & Consumer Rights v. Patent of Wisconsin Alumni Research Foundation (WARF), App. No. 2010-001854 (April 28 2010). The Examiner had reversed his original rejections on the basis that there would not have been a reasonable expectation of success that the mouse techniques disclosed in the prior art for producing mourse stem cells would work to yield stable cultures of humna stem cells. The Board reversed the Examiner.

The re-entry of an anticipation rejection based on Williams et al. (US 5166065) deserves a law review article, but it is the obviousness rejection that got my goat (or my murine species, to be more exact). While the Fed. Cir. has recently been reasonably temperate in its application of the somewhat fuzzy KSR standards to chemical composition claims, The Board latched onto one of the most poorly-reasoned early post-KSR decisions, Bayer v. Barr, 575 F.3d 1341 (Fed. Cir. 2009).

In the WARF reexamination, it was established that the art was using two basic techniques to try to isolate animal and human ES. One involving physically disassembling blasocysts (or very early-stage embryos) to get at the inner stem cells, and one involved using antibodies to remove the outer cell layers. Neither technique had been successfully used to produce human ES. In fact they had only worked in rodents (mice, rats, guinea pigs) and perhaps, in pigs. At least ten references were of record to this effect, and were quoted from by the Board. WARF had argued and the Examiner had found that there was no reasonable expectation of success that these techniques would lead to human ES. So what made the claimed cultured human ES obvious?

The Board relied on Bayer to find that “while a requirement that there be a ‘reasonable expectation of success’ …may be one useful standard in assessing the obviousness of an invention, it is not the only standard to be applied when [resolving the obviousness question]…..The Supreme Court has held that an invention may be proved obvious by showing that a combination of elements was ‘obvious to try.’…. A solution which had been known to work when applied to one system might, in some circumstances, be obvious to try in another. If the solution succeeded, the invention likely would have been obvious too persons of ordinary skill in the art…..[WARF] has not established that the protocol followed by Dr. Thomson necessitated him to ‘try all possibilities in a field unreduced by direction,’ but rather the evidence….points to significant guideposts that would have led the skilled worker in the right direction to successful isolation of human ES.”

But wait a minute. Those “significant guideposts” had only directed the art to mouse, rat and guinea pig stem cells (and maybe, pig), not even to dog, or horse, or cow. This reasoning is like saying, “Well there were signs to the base camp at 15000′ so the person of ordinary skill in mountaineering would have been successful in reaching the summit of Everest.” This is using the fact of the pioneer’s success against him/her, essentially as part of the prior art. In effect, the Board is saying, “Even if there was no reasonable expectation of success based on the prior art, the facts that there were techniques that were obvious to try AND that human ES were isolated using these techniques makes the invention unpatentably obvious.” As the Board concluded:

“Because it would have been obvious to have tried the known mouse protocols on human embryos [ed.: of course], and because such protocols would have resulted in human ES, we conclude that the claimed human ES would have been obvious to persons of ordinary skill in the art.”

This is an obviousness standard lifted from its context in KSR, a simple mechanical case, and dropped into a much more uncertain art area. I think what the Supreme Court could have said more clearly was that if the routes to try are available to the art and, if they are tried, the outcome of performing them is manifest (e.g., would be clear to the art worker), then the invention is obvious. The “guideposts alone” standard of KSR and Bayer has no real legal foundation in KSR, was applied improperly in Bayer, and endorses hindsight reconstruction. The Fed. Cir. should clearly disavow this “verdict now, trial later” standard as soon as possible.

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David Kappos and The Impact of KSR – A Unique Opportunity For Our Profession

Monday, December 7th, 2009

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.

Cole Paper

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Federal Circuit Mows Down Bean Patent – Reading Between the Rows

Wednesday, July 15th, 2009

On July 10, 2009, the Court of Appeals for the Federal Circuit in In re Pod-Ners, Appeal No. 2008-1492, affirmed the Board’s rejection of all of the claims of U.S. Pat. No. 5,894,079. The Board had rejected as obvious claims to, inter alia, a pinto bean plant producing yellow beans of a certain color, as well as claims to the beans themselves, which had been deposited in the ATTC. The claims were rejected over a publication argued to disclose the same yellow bean, in view of another non-prior art publication relied upon as demonstrating that the claimed bean and the “well known” yellow bean are gentically identical.

While only six pages long, and eminently predictable given the fact that the Mexican government had alleged theft of their biological heritage, the decision feels muddled. To begin with, the panel clearly would have preferred to invalidate the patent as anticipated by the “well-known” yellow bean, “Azufrado Peruano 87.” The law is well-settled that non-prior art publications can be relied upon to show that a prior art reference is, in fact, anticipatory. But whether anticipated by, or obvious in view of, the prior art publication, it seems that the panel should have acknowledged that the prior art publication which, after all, disclosed a plant variety, was enabling. Historically, a printed publication could not per se place a plant variety in the possession of the public; the public was believed to, in fact, need to have access to the plant. This gap was simply filled by the panel by noting that the older variety was “well known.” This is getting pretty exotic, but I seem to recall a decision which held that evidence of the commercial sale of a plant described in a printed publication was sufficient to render the publication enabling. This decision validated the PTO’s examination policy then in effect. Does anyone but me remember that decision?

Finally, the decision has an odd anti-biotech air about it that I don’t think I am imagining. In April, the Fed. Cir. overturned In re Dueul and In re Bell finding a previously unisolated and unexpressed cDNA sequence obvious, primarily because it would have been obvious to use known techniques to isolate the “gene” and to express it as a protein that was known to exist, but had not itself been isolated. In re Pod-Ners, the panel concluded:

“The Board correctly held that the subject matter of the ’079 patent – yellow beans, the plants they produced and a method for reproducing such plants by cross-breeding – would have been obvious to one [of] ordinary skill in what POD-NERS identifies as the “breeder-grower” art. … [Appelant] does not contend that he devised or applied new or unexpected techniques in reproducing the beans.”

Now substitute “cDNA encoding the NAIL protein, the NAIL protein produced thereby and a method for cloning the DNA” for the description of the holding of the Board given above, and you have the Kubin decision. The patentee in fact had isolated yellow beans (the DNA sequence) from a bag of beans of various colors (the genome) and bred (“cloned”) them so that they became a unique cultivar.

The panel affirmed the invalidity of the claims to the cultivar, which was recited to have a “yellow coat described as within a narrow range of shades of yellow on a particular color chart” without ever stating that the “prior art” bean was the same color. In fact, the panel conceded that the beans may only have been “substantially the same”. If patentee had obtained a Plant Patent instead of a utility patent, the opponents and the court would have had to find that the cultivars were indistinguishable in appearance in order to invalidate the patent. However, Plant Patents are not available for plants that reproduce via seed. My comment is becoming as long as the decision, as I try to turn it into a fable, but it is adamantly not “Jack and the Beanstalk.” These beans did not bring their owner a pot of gold. In the end, the patent wasn’t worth a hill o’ beans.

Pod-Ners Decision
ETCGroup

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