Monday, May 09, 2005

Re-exam request denied in cord blood case

from a press release on businesswire:

PharmaStem Therapeutics, Inc. announced today that the United States Patent Office has confirmed key patent claims in two of its pioneering patents. In Office communications, the Patent Office stated that the prior art cited by third parties did not raise a new question of patentability of these claims. These Office communications were prompted by reexamination requests that had been filed with the Patent Office.


"I am gratified that the Patent Office reached an early and positive conclusion regarding the key claims in Patents 6,461,645 and 6,569,427," said Nicholas Didier, CEO and President of PharmaStem. "I am confident that the Patent Office will also confirm all additional claims in these and other PharmaStem patents in the near future."

PharmaStem is the successor to Biocyte Corporation, and the pioneer in the development of umbilical cord blood preservation and its therapeutic use. Umbilical cord and placental blood are rich in stem cells that can reconstitute human blood and immune systems. The Company provided the roadmap for the creation of today's rapidly growing field of cord blood storage for therapeutic use.

US 6,569,427 is to Edward A. Boyse et al. and is entitled "Isolation and preservation of fetal and neonatal hematopoietic stem and progenitor cells of the blood." The case was written by the [now-defunct] firm of Pennie & Edmonds and the case represents a continuing application. Specifically, the application leading to the '427 is a continuation of application Ser. No. 07/950,356, filed Sep. 24, 1992, now abandoned, which is a continuation of application Ser. No. 07/269,926 filed Nov. 10, 1988 now U.S. Pat. No. 5,192,553, which is a continuation-in-part of application Ser. No. 07/119,746, filed Nov. 12, 1987, now U.S. Pat. No. 5,804,601, each of which is incorporated by reference herein in its entirety. In passing, one notes that this patent family is one that would NOT be treated properly by the approach of Quillen and Webster.

The first claim of the '427 recites:

1. A method for treating a human patient in need of hematopoietic reconstitution comprising introducing into the human patient a composition comprising a cryoprotective agent and human neonatal or fetal hematopoietic stem cells derived from the umbilical cord blood or placental blood of a human collected at birth of said human so as to provide hematopoietic reconstitution.

US 6,461,645 also to Boyse is entitled "Isolation and preservation of fetal and neonatal hematopoietic stem and progenitor cells of the blood." The '645 patent also arose from continuing applications, the application leading to the '645 is a continuation-in-part of U.S. application Ser. No. 07/269,926 filed Nov. 10, 1988, U.S. Pat. No. 5,192,553 which is a continuation-in-part of U.S. application Ser. No. 07/119,746, filed Nov. 12, 1987, U.S. Pat. No. 5,004,631 which are incorporated by reference herein in their entireties.

Of relevance to the use by Quillen and Webster of the Lemley survey data, note that the '645 and the '427 patents BOTH claim priority back to U.S. application Ser. No. 07/119,746, filed Nov. 12, 1987, leading to U.S. Pat. No. 5,004,631. HOWEVER, note also that the '645 does not reference the '427 parent, the application leading to the '427, or the grandparent application (application Ser. No. 07/950,356, filed Sep. 24, 1992). SEPARATELY, the '427 does NOT reference the '645 patent or the application leading to the '645. The survey approach taken by Lemley will be UNDERINCLUSIVE of patent family members and therefore, the reliance upon it by Quillen and Webster will lead to undercompensation for multiple patent families, and a correlative overestimation of patent grant rate. We had previously identified problems in the Quillen and Webster patent grant estimation, and the reliance by Lemley and Moore thereon, and had published the analysis in the July 2004 issue of JPTOS, and within the Kent Journal of Intellectual Property. All papers are now available on LEXIS.

The first claim of the '645 recites:

A cryopreserved pharmaceutical composition comprising:

(a) viable human neonatal or fetal hematopoietic stem cells derived from the umbilical cord blood or placental blood of a single human collected at the birth of said human, in which said cells are present in an amount sufficient to effect hematopoietic reconstitution of a human adult;

(b) an amount of cryopreservative sufficient for cryopreservation of said cells; and

(c) a pharmaceutically acceptable carrier.

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