Wednesday, April 04, 2007

More on the re-exam of the Thomson / WARF patents

Here are a few more points on the coverage of the first Office Action in the re-exam of the WARF patents on stem cells.

I. Milwaukee Journal Sentinel: "nothing new here"

JOHN SCHMID of the Milwaukee Journal Sentinel covered some details which do NOT appear in other newspaper accounts.

The issues raised by the two groups [FTCR and PubPat] already were considered in the original patent process and are not new, said Grady Frenchick, a patent attorney in Madison at the Whyte Hirschboeck Dudek law firm.

Frenchick, who has practiced patent law for 30 years, expects the final ruling to be in WARF's favor.

"There's really nothing new here. The arguments and analysis are in the file history," he said.

The two foundations that filed complaints managed to "reconfigure" the old arguments more forcefully and aggressively this time around, forcing the agency to initiate a process called patent "re-examination," Frenchick said.

Frenchick does not do any stem-cell work for WARF and regards himself as an independent observer of the case.

Past case histories also work in WARF's favor.

According to Frenchick and the Patent and Trademark Office, 70% to 88% of all patents retain their patent status after a patent re-examination process.

"For this re-examination to take out all claims of all three patents would be extremely rare," Frenchick said.

IPBiz had discussed the "nothing new" aspect in the post entitled On the obviousness challenge to WARF's '780 by PubPat:

An interesting aspect is that the Piedrahita 1990 reference was used in an obviousness rejection by the USPTO, basically identical to that posed by PubPat, in an Office Action in the parent case on January 17, 1996 (the '780 patent is a cip derived from Ser. No. 08/376,327 filed Jan. 20, 1995.) The arguments used for obviousness over the Piedrahita 1990 reference are basically the same with the Robertson 1983 and Robertson 1987 references.

According to PubPat, WARF never overcame the rejection over the Piedrahita 1990 reference in the '327 prosecution and the matter did not come up in the prosecution of the later application (08/591,246). Piedrahita 1990 does not appear in the "references cited" section of the '780 patent.

In taking the re-exam, and using the Piedrahita 1990 reference, the USPTO determined that there was a "new" question of patentability. Whether that was entirely true from a simple historical point of view may be questioned, but that's what the USPTO found.

A different point, not in the Journal Sentinel article, is that prior art in the form of US patent references, is presumptively enabled. That presumption can be overcome.

As noted in the IPBiz post First Office Action rejects claims of WARF's patents, this may have direct relevance to the use of the Williams reference, US 5,166,065. Thus, when Williams wrote The embryos used may be isolated from animals including, but not limited to, humans and a number of other animal species such as birds (e.g. chickens), mice, sheep, pigs, cattle, goats and fish, the USPTO ASSUMES that the method for animal embryos will work for humans, EVEN THOUGH there is no evidence in the '065 patent that it did work for humans. It's WARF's burden to show it didn't. Given that about five years elapsed during which the method of the '065 was not used successfully for human stem cells, that should not be difficult.

II. Relevant to post on californiastemcellreport

I attempted to post the following comment on californiastemcellreport, but it didn't show up:

Of --"Discovering human embryonic stem cells, which have been around since man first walked the earth, is more like Isaac Newton discovering gravity than the Wright Brothers building the first airplane,"-- the claim is not for "discovering" human embryonic stem cells, but (in the case of the '780 patent)--A purified preparation of primate embryonic stem cells which (i) is capable of proliferation in an in vitro culture for over one year, (ii) maintains a karyotype in which all the chromosomes characteristic of the primate species are present and not noticeably altered through prolonged culture, (iii) maintains the potential to differentiate into derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, and (iv) will not differentiate when cultured on a fibroblast feeder layer,-- which has NOT been around since man first walked the earth.

There is something in the first Office Action that reminds one of the Wright Brothers. The Williams patent (US 5,166,065) mentions a method to isolate animal stem cells, but the method was never used to isolate human stem cells. In the case of the Wrights, people who arrived in the field later tried to use the Langley machine (which never flew)as prior art against the Wrights.

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