First Office Action rejects claims of WARF's patents
The United States Patent and Trademark Office has made a preliminary decision to revoke fundamental patents on human embryonic stem cells that some scientists and consumer groups say have impeded research into a promising new field.
After a re-examination, patent examiners rejected all claims of the three patents already issued, which are based on the work of James A. Thomson of the University of Wisconsin.
In an ex parte re-examination, all 11 claims of US 5,843,780 were rejected in a first Office Action in 90/008,102.
A Bongso reference, 9 Human Reproduction 2110 (1984) was presented/viewed in a new light and used in the rejection of claim 11.
Claims 9-10 were rejected under 102(b) over Williams, US 5,166,065. The examiner asserted column 2 lines 30-32 teach a method for isolating stem cells from a human blastocyst. Under the law, a reference is presumptively enabled. That presumption can be challenged. Williams did not isolate stem cells from a human blastocyst.
It should be noted that column 2 lines 30-32 of the '065 patent state: Accordingly, a first aspect of the present invention relates to a method for the isolation of embryonic stem (ES) cells from animal embryos in vitro which method ... One does not find mention of the word "human." Lines 37-40 include 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. Later, one has the text: A second aspect of the present invention, contemplates a process for maintaining animal embryonic stem (ES) cells in vitro while retaining their pluripotential phenotype, which process comprises culturing said cells in a culture medium containing an effective amount of leukaemia inhibitory factor (LIF) under conditions sufficient to maintain said cells. The ES cells in accordance with this aspect of the invention include cells from humans, mice, birds (e.g. chickens), sheep, pigs, cattle, goats and fish.
The problem here is that the text of the '065 patent never discloses actually ISOLATING or MAINTAINING human ES cells.
Claims 1-8 and 11 were rejected as anticipated under 102(b) and/or obvious over Williams 5,166,065. Column 2, lines 30-35 were cited. Here we are dealing with animal embyros (blastocyst). The USPTO argues inherency for certain claim elements.
The USPTO notes that the USPTO can require patentee to prove that the prior art composition does NOT possess properties of the claimed composition, citing In re Ludtke, 441 F.2d 660. The USPTO stated: "This office does not have the facilities and resources to provide the factual evidence needed ..." The USPTO also cites In re Best, 562 F.2d 1262 and Ex parte Grey, 10 USPQ2d 1922. Thus, procedurally, the ball is in WARF's court to provide evidence of differences. If WARF does so, these rejections go away.
Claims 1-8 are rejected as anticipated under 102(e) and or obvious over Hogan, 5,690,926.
Claim 11 is rejected as anticipated under 102(a) and/or obvious over Bongso.
Claims 1-11 are rejected as obvious over Williams-I, Williams-II, Piedrahita, taken individually or together.
Of the anticipation rejections, the ball is in WARF's court to prove "not anticipated." Of the obviousness rejections, WARF can attack the prima facie case and/or introduce evidence of secondary considerations.
Of the '065 patent, the patent cites 3 1990 publications, but cites to NO patents at all. The publications are:
Piedrahita et al. (1990); Influence of feeder layer type on the efficiency of isolation of porcine embryo derived cell lines; Theriogenology 34:865-877. .
Piedrahita et al. (1990); On the isolation of embtryonic stem cells: Comparative behaviour or murine, porcine and ovine embryos; Theriogenology 34:879-901. .
Strojek et al. (1990); A method for cultivating morphologenically undifferentiated embryonic stem cells from porcine blastocysts; Theriogenology 33:901-913. .
Thomson's '780 patent (a cip of an app filed Jan. 20, 1995) cites:
Bongso, et al., "Isolation and culture of inner cell mass cells from human blastocysts", Human Reproduction, 9:2110-2117, 1994. .
Brown, et al., "Criteria that optimize the potential of murine embryonic stem cells for in vitro and in vivo developmental studies", In Vitro Cell. Dev. Biol. 284:773-778, Dec. 1992. .
Damjanov, et al., "Retinoic acid-induced differentiation of the developmentally pluripotent human germ cell tumor-dervied cell line, NCCIT", Laboratory Investigation, 68:220-232, 1993. .
Nation/World, "Embryonic monkey cells isolated". -Nov. 4, 1994. .
Bongso, A., et al., "The Growth of Inner Cell Mass Cells from Human Blastocysts," Theriogenology, 41:167 (1994). .
Thomson, James A., et al., "Pluripotent Cell Lines Derived from Common Marmoset (Callithrix jacchus) Blastocysts," Biology of Reproduction, 55:254-259 (1996)..
***Of relevant law
A claimed invention cannot be anticipated by a prior art reference if the allegedly anticipatory disclosures cited as prior art are not enabled. Long ago our predecessor court recognized that a non-enabled disclosure cannot be anticipatory (because it is not truly prior art) if that disclosure fails to “enable one of skill in the art to reduce the disclosed invention to practice.” In re Borst, 345 F.2d 851, 855, 145 USPQ 554, 557 (C.C.P.A. 1962); accord In re Donohue, 766 F.2d at 533, 226 USPQ at 621. Thus, the critical issue here is not whether Sugimoto must be enabled, but rather whether it is the plaintiff or the defendant who bears the burden of proof with respect to that question.
relying on our precedent, we hold a presumption arises that both the claimed and unclaimed disclosures in a prior art patent are enabled.
In patent prosecution the examiner is entitled to reject application claims as anticipated by a prior art patent without conducting an inquiry into whether or not that patent is enabled or whether or not it is the claimed material (as opposed to the unclaimed disclosures) in that patent that are at issue. In re Sasse, 629 F.2d 675, 681, 207 USPQ 107, 111 (C.C.P.A. 1980) (“[W]hen the PTO cited a disclosure which expressly anticipated the present invention . . . the burden was shifted to the applicant. He had to rebut the presumption of the operability of [the prior art patent] by a preponderance of the evidence.” (citation omitted)). The applicant, however, can then overcome that rejection by proving that the relevant disclosures of the prior art patent are not enabled. Id. We hold that an accused infringer should be similarly entitled to have the district court presume the enablement of unclaimed (and claimed) material in a prior art patent defendant asserts against a plaintiff. Thus, a court cannot ignore an asserted prior art patent in evaluating a defense of invalidity for anticipation, just because the accused infringer has not proven it enabled. Like the applicant in ex parte prosecution, however, the patentee may argue that the relevant claimed or unclaimed disclosures of a prior art patent are not enabled and therefore are not pertinent prior art. If a patentee presents evidence of nonenablement that a trial court finds persuasive, the trial court must then exclude that particular prior art patent in any anticipation inquiry, for then the presumption has been overcome. Therefore, it was Amgen who bore the burden of proving the nonenablement of Sugimoto before the district court. TKT did not bear a bear burden of proving enablement.
**In the WARF matter, WARF bears the burden of showing Williams is NOT enabled as to human stem cells. Given that the Williams method was never used to isolate human ES cells, this might not be too difficult. Of the initial Office Action, the USPTO had to presume Williams WAS ENABLED. If Williams is shown to be NOT ENABLED, it ceases to be an anticipatory reference.