Archive for May, 2010

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.

Chisum On Patents – Live in Seattle!

Friday, May 21st, 2010

The Chisum Patent Academy will offer its second annual Intensive Patent Law Training Workshop at its offices in Seattle, Washington, on July 29-31, 2010.  See http://www.chisum-patent-academy.com/.  The workshop will focus on substantive patent law (patentability and enforcement) through analysis of critical Federal Circuit and Supreme Court decisions.  The 2009 syllabus is at http://www.chisum-patent-academy.com/?page_id=90; new material for the 2010 class will likely include business method patentability post-Bilski, written description requirement compliance post-Ariad, and the evolving landscape of inequitable conduct as reflected by the Federal Circuit’s recent grant of rehearing en banc in Therasense.  The workshop is team-taught in seminar style (maximum of 10 students) by Donald Chisum, author of the treatise Chisum on Patents (LexisNexis), and Professor Janice Mueller, author of Patent Law, 3d Edition (Aspen 2009).  Chisum and Mueller have a combined total of over 40 years experience teaching patent law.  The workshop’s coverage is geared for junior patent attorneys, summer associates, engineers, scientists, paralegals, information specialists, and attorneys experienced in non-patent fields who desire an intensive introduction to patent law.  Eighteen hours of CLE credit have been applied for.  For registration details, see http://www.chisum-patent-academy.com/.

A “Myriad” Of Questions To Resolve? Back To The Basics Of 101

Tuesday, May 18th, 2010

Thinking about Judge Sweet’s recent decision in Ass’n of Molecular Pathologists v. USPTO et al. (The “Myriad Decision”), I am again struck by the wide path the good judge slashed through the field (or is it the jungle now) of patentable subject matter – that is, the type of “invention” that an inventor can apply to patent. Too many of my colleagues, I fear, are simply saying something like “Of course DNA is patentable,” and let’s move on. But I think that the numerous amici planning on weighing in on this decision had better be ready to split some legal hairs. Oh, and we do need a Bilski decision that does away with the M or T test, and here is why.

A claim to an isolated DNA coding for a BRCA1 peptide of SEQ ID NO: X is patentable subject matter as a new and useful composition of matter, and that’s that (note that the statute says “new” – probably to prevent filings on natural products “plucked from nature”—it is not a reference to 102 novelty). We can debate what is and is not a natural product, but the isolated DNA sequences claimed by Myriad are as every bit as much new and useful compositions of matter as the biologically pure cultures of microorganisms claimed In re Bergy, 596 F.2d. 592 (CCPA 1979). In Bergy, the PTO tried to duck the examiner’s “product of nature” rejection but the CCPA specifically ruled on it as a question of law. Of course the CCPA found that the microorganisms were patentable subject matter. (The Court also decided that the transformed microorganisms claimed by Chakrabarty were patentable subject matter. When the decisions were appealed to the Supreme Court, Bergy was noted as moot, leaving Chakrabarty as the only appeal to be heard, and we all know how that came out.)

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Director Kappos Comments on Ariad v. Lilly

Thursday, May 6th, 2010

USPTO David Kappos recently posted a comment on the Fed. Cir. decision in Ariad v. Lilly in which he noted that the Fed. Cir. held that broad functional claims (presumably mechanism-of-action claims) must be supported by sufficient species (read “working examples”). While Director Kappos clearly approves of this holding, he does no more to provide guidance to Examiners attempting to decide how many examples will support such claims and, more importantly, are there generic claims for which no number of working examples would provide sufficient support (like the Ariad claims at issue)?