The decision affects the patent for primate and human embryonic stem cells known as "913" (U.S. Pat. 7,029,913). The decision to uphold the patent is the first in a review process that began in October 2006, when the patent office agreed to re-examine the patents following challenges brought by the New York-based Public Patent Foundation and the California-based Foundation for Taxpayer and Consumer Rights. This patent follows a different process than the other two patents, known as "780" and "806" (U.S. Pats. 5,843,780 and 6,200,806), which are still pending.
IPBiz notes that this was the "inter partes" re-exam, wherein declarations were made by Trounson (now head of CIRM) and Loring [among others]. It is "obvious" that these declarations did NOT carry the day. The decisions in the "ex parte" re-exams remain to be made. HOWEVER, the factual and legal positions taken by the USPTO as to the '913 patent STRONGLY SUGGEST the challenges to the '780 and '806 patents will fail.
In the (nonfinal) "action closing prosecution" (85 pages) mailed to Ravicher on 25 Feb. 08 in 95/000154, the USPTO noted that claims 1-3 of the '913 patent are patentable.
Page 6 of the action explicitly notes that the grounds put forth by Dr. Jeanne Loring were NOT adopted.
Page 8 of the action finds that the Williams '065 patent is not an enabling reference, EXACTLY as earlier predicted by IPBiz. This is more fully developed in later parts of the action, including a strong statement repudiating the position of PubPat/FTCR/Loring at page 14.
Page 9 of the action conceded the inapplicability of In re Best.
Page 14 of the action acknowledges that Williams does not teach an all purpose recipe for isolating and culturing embryonic stem cells from all species. The examiner concludes strongly at page 16: "Consequently, the disclosure of Williams '065 cannot be viewed as enabling the isolation of any domestic animal, much less a preparation of human/primate ES cells."
Page 18 of the action states: "Cherny '94 establishes that the Willaims [sic: Williams] '065 patent is not enabling for isolating and maintaining primate/human ES cells in culture."
Page 20 of the action acknowledges undue experimentation was required. The word "hindsight" appears on page 20.
At page 22 of the action, the examiner accepts the patentee's "failure of others" argument.
At page 25, the examiner takes a position different from that either of the requester or the patentee.
The now famous 1994 Bongso reference shows up at page 33 of the action. At page 34, the examiner finds that Bongo failed to isolate and maintain a long term stem cell line without LiF. At page 35, the examiner notes: "Bongso did not achieve the critical element of the claimed invention," so now it is finally "Bedtime for Bongso" as to the 1994 reference applied to these claims.
Page 41 acknowledges that Williams does not support a prima facie case of obviousnesss.
At page 45, the examiner acknowledges that "public acclaim" is a secondary consideration.
At page 47, the examiner touches on the "interested" quality of some of the declarants, and specifically acknowledges that some of the declarants had their own applications with claims that read on ES cells.
At page 53, Justice Kennedy and the KSR decision are mentioned.
Pages 78-79 summarize the reasons for patentability.
See also various IPBiz posts, including
See also a write-up by Jacob Goldstein at Health Blog.