In a decision issued in May, the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office reversed the final rejection of claims 35-48 in U.S. Application No. 13/512,585. The claims at issue had been rejected by the Examiner under 35 U.S.C. § 103(a) as being unpatentable over U.S. Patent No. 7,056,690 ("Laskey") in view of Pajor et al., International Society for Analytical, Cytometry Part A. (2008) ("Pajor"), and Stoeber et al., J. Nat. Cancer Inst. 94(14): 1071-79 (2002) ("Stoeber"), and under 35 U.S.C. § 101 as being directed to a judicial exception without significantly more.
The '585 application relates to a screening method for bladder cancer. Representative claim 35 recites:
35. A method of diagnosing a subject with bladder cancer or at risk of developing bladder cancer comprising:
a) providing a urine sample isolated from said subject;
b) isolating cells from said sample and dispersing them on a slide, wherein said slide contains at least 5000 total cells;
c) contacting said cells with a labelled specific binding member capable of binding to a minichromosome maintenance 2 (MCM2) polypeptide to stain cells with that express MCM2; and
d) counting said stained cells to provide a cell count;
wherein if said cell count is at least 50 cells of said 5000 total cells said subject has bladder cancer or is at risk of developing bladder cancer.
In reversing the Examiner's § 103 rejection, the Board began by citing CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003), for the proposition that "[o]bviousness requires a suggestion of all limitations in a claim." The Board noted that the Examiner had determined that Laskey teaches all of the claimed elements except for dispersing 5000 total cells on a slide and then counting MCM2 positive cells, and that Pajor and Stoeber teach those elements. In particular, the Examiner had determined that:
One of ordinary skill in the art at the time the invention was made would have been motivated to . . . count dispersed cells expressing MCM2 by performing the method of Pajor et al using the labeled anti-MCM2 antibodies of Laskey et al wherein the presence of (including 50 or more) MCM2-expressing cells is indicative of bladder cancer.
The Board determined, however, that the Examiner failed to establish that either Stoeber or Pajor teaches the claimed step of counting cells. With respect to Stoeber, the Board noted that this reference teaches the calculation of the fluorescence of batch cell lysate samples labeled with Mcm5 antibody by Dissociation-Enhanced Lanthanide Fluorometric Immunoassay (DELFIA). The Board concluded that "[t]he Examiner points to no evidence or disclosure in Stoeber that individual cells were counted, and makes no supported finding that one of ordinary skill in the art would understand a correlation between a batch fluorescence value of cells and individual cell counts."
As for Pajor, the Board noted that this reference discloses the scanning of CK-7 and hematoxylin stained cell samples on slides from voided urine by examining predefined areas of the slides using immunostain microscopy. The Board concluded that "[t]he Examiner points to no evidence or disclosure in Pajor that individual cells were counted, and makes no supported finding that one of ordinary skill in the art would have understood there to be a correlation between a fluorescent intensity of cells obtaining by immunostain microscopy and individual cell counts."
The Board therefore reversed the Examiner's obviousness rejection, finding that "the Examiner has not provided evidence of each and every method step claimed, in particular the claimed cell counting step."
In reversing the Examiner's § 101 rejection, the Board noted that the Examiner had determined that the judicial exception to which the claims were directed was the natural phenomenon of "elevated numbers of MCM2 expressing cells in urine [that] are indicative of bladder cancer or risk of developing bladder cancer." The Examiner had also determined that "in the instant case, the claims only recite well-understood, routine and conventional limitations in addition to the judicial exception(s)." In particular, the Examiner had determined that:
[D]etection methods encompassed by the instant claims are well[-]known, routine, and conventional. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (common methods of detecting expression and common therapeutic methods) are routinely performed in the art to obtain data regarding expression and treat subjects.
Appellants, however, argued that the Examiner's assertion that the additional claim elements consisted of well-understood, routine, and conventional methods of detecting a known bladder cancer urine biomarker (MCM2 of Laskey) by modifying the generic method of Pajor was "conclusory and fails to consider the claims as a whole." Appellants also argued that "the combination of Laskey and Pajor does not even provide all limitations of the claim and are conflicting technologies, not providing a routine path to practice the claims."
The Board concluded that the Examiner failed to provide evidence to support a prima facie case of patent ineligible subject matter, citing Berkheimer v. HP Inc., 881 F.3d 1360, 1369 (Fed. Cir. 2018), for the proposition that "[w]hether something is well-understood, routine, and conventional to a skilled artisan at the time of the patent is a factual determination." In particular, the Board noted that "the Examiner did not establish with factual evidence, that the cell counting step, as claimed, is conventional or known in the art." The Board therefore reversed the Examiner's rejection of the claims at issue under § 101.
Ex parte Galloway (PTAB 2018)
Panel: Administrative Patent Judges Adams, Mills, and Jenks
Decision on Appeal by Administrative Patent Judge Mills
Hat tip to Warren Woessner of Schwegman Lundberg & Woessner and Patents4Life for bringing the above decision to our attention.
