Saturday, June 02, 2007

WARF responds in the re-examination of the Thomson patents

WARF has apparently filed its response in re-examination 90/008,102 of US 5,843,780, and a response with the other two patents. A copy of the response as to the '780 patent may be found at the WARF website.

Of some interest in the '780 matter, WARF has amended claim 1 to include the phrase "derived from a pre-implantation embryo" after the words "embryonic stem cells." Additionally, WARF has added new claims 12-14.

In the response, WARF first worked to differentiate Thomson's cells from Hogan's cells. The amendment to claim 1 is related to this distinction, because Hogan worked with post-implantation embryos. On page 5 of the WARF response, one has a key legal phrase, "no reasonable expectation of successs," which derives from In re Deuel and In re O'Farrell. Did this standard survive KSR v. Teleflex? Did this standard survive KSR v. Teleflex for unpredictable arts? The USPTO can address the matter in this re-examination. Page 6 of the WARF response includes awards given to Thomson.

At pages 7-8, WARF challenges the examiner's interpretation of In re Best on inherent anticipation, citing to Swinehart.

The WARF response gets around to Williams at page 9, and disputes that Williams teaches all elements, so that an anticipation rejection is improper. At page 10, one has the text: "Williams simply does not disclose what the Examiner says Williams discloses."

At page 11, one has the argument already predicted by IPBiz: "anticipation requires enablement." There is a cite to Impax v. Aventis, 468 F.3d 1366. In re Donohue is indeed cited on page 12, and In re Best shows up again on page 12. Page 13 cites Wands on predictability/unpredictability.

Bongso shows up on page 15, for failure to isolate long term cultures, and In re Donohue is cited again.

Obviousness over Williams shows up at page 17 of the WARF response, and KSR v. Teleflex shows up at page 18. WARF takes the position that predictable arts and unpredictable arts are treated differently in the analysis of obviousness. Stem cells are unpredictable, as distinct from the mechanical art gas pedal of KSR v. Teleflex. "Reasonable expectation of success" shows up on page 20.

At page 22, WARF deals with obviousness over Hogan. Bongso shows up at page 23, and is dealt with in two devastating manners: #1. a concession by the USPTO on March 17, 1998 about Bongso (recall the Bongso reference is literally discussed within the '780 patent) and #2. text within a later paper (co-authored by Bongso, in Nature Biotechnology) which acknowledges the differences between Thomson's work and Bongso's. It's likely bedtime for Bongso as far as the '780 patent goes.

At page 29 one has the signature of Kathryn Doyle of Drinker Biddle and the date, May 30, 2007. Attachments begin at page 30.

Within the attachments, paragraph 11 of the Stewart declaration will be a problem for the PubPat/FTCR position. It includes the text [Thomson] "had managed to accomplish what others had for years tried and failed to do (...) he achieved the seemingly impossible." Paragraph 12 of the Stewart declaration flat out contradicts the Loring declaration (which, in any event, was not considered by the USPTO in the re-exam): "methods used to isolate mouse ES cells ... are not universally applicable" Paragraph 16 of the Stewart declaration deals with LIF. Bongso is discussed at paragraphs 30 ff. The declaration of Stewart is signed May, 29, 2007.

DAVID WAHLBERG of the Wisconsin State Journal included a quote:
"Were the invention obvious, others would not have repeatedly failed to accomplish it, and such scientific and professional acclaim would not have been ascribed to (Thomson)." Wahlberg tried to track down some of the players, and wrote: The Wisconsin State Journal has been unable to locate Williams. Hogan did not respond this week to an interview request, and Bongso declined an interview. Thomson did not respond Thursday to an interview request. Last year, in an e-mail interview, he said, "Some very good, simple ideas only seem obvious afterwards."

Bizjournals reported: In its 113-page filing released Thursday [May 31], WARF described the various differences in the human embryonic stem cells isolated by Thomson and the previously discovered mouse embryonic stem cells that forms the basis of the challenge. It stated that Thomson's research required a unique approach.

"It was long recognized that the techniques used to isolate mouse (embryonic stem) cells were unpredictable and were not universally applicable to the isolation of (embryonic stem) cells from other species, or even from different strains of mice," the filing states. "Further, for nearly two decades from the discovery of mouse (embryonic stem) cells, others repeatedly tried and failed to isolate (other types of embryonic stem) cells, particularly primate/human (embryonic stem) cell lines."

[One can enter PAIR here.]

One notes the word "unpredictable." Will the presence of "unpredictable" science immunize WARF (and others) from KSR v. Teleflex? It shall be most interesting to see how (if?) the USPTO uses the Supreme Court's KSR v. Teleflex in its decision on the Thomson patents.

Joe Vanden Plas of wistechnology reports that the Wisconsin Alumni Research Foundation [WARF] has filed a response refuting the assertions made by PubPat/FTCR in re-examination requests of three Thomson patents.

Dr. Colin Stewart, a stem cell researcher at the Institute of Medical Biology in Singapore, submitted a declaration in support of the patents, emphasizing the differences between mouse stem cells, which were prominent in the PTO's rejections, and the human embryonic stem cells that were isolated and characterized by University of Wisconsin-Madison researcher Jamie Thomson.

Vanden Plas also reported: Simpson said the FTCR is still studying WARF's arguments, but they appear to be a rehash of what already was before the PTO. "We think right now that this is about what we expected at this stage, and we're optimistic," he said.

Some previous IPBiz posts:

KSR v. Teleflex: it's not bedtime for Bongso


Blogger Lawrence B. Ebert said...

Note the August 31 article by Kathleen Gallagher entitled
Stem cell patent fight gets personal
Challenge is 'demeaning,' foundation head declares.

The article includes the text:

"On one hand, they [FTCR and PubPat] say he deserves all these accolades. On the other hand, they say anyone could have done it. That's demeaning to him - that's what really gets my dander up," Gulbrandsen said. "These guys ought to be embarrassed - no, ashamed - about the way they've dealt with Thomson."

IPBiz does believe that John Simpson of FTCR should be embarrassed for promoting a declaration of Jeanne Loring criticizing Thomson for claiming aspects of stem cells when in fact Loring had a broader patent claim. Simpson is not "walking like he is talking" on stem cell patents, and Simpson's credibility is on the line.

Gallagher quoted Simpson: "I don't see where there's any reason for embarrassment whatsoever in raising a question about the validity of a patent that was being asserted in a way that virtually everyone else in the field believed was detrimental to stem-cell research," Simpson said. "I have no embarrassment we raised the issue. In fact, I'm proud we did it."

9:25 AM  

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