Ex Parte Galloway et al

Patent Trial and Appeal Board

May 22, 2018

13512585 (P.T.A.B. May. 22, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/512,585 1112112012 David Galloway
22798 7590 05/24/2018
QUINE INTELLECTUAL PROPERTY LAW GROUP, P.C.
2033 CLEMENT A VENUE
SUITE 200
ALAMEDA, CA 94501
UNITED ST A TES OF AMERICA
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
177-001210US 7605
EXAMINER
AEDER, SEAN E
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
05/24/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
info@quinelaw.com
gbaker@quinelaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID GALLOWAY and NICK COLEMAN
Appeal2017-004696
Application 13/512,585
Technology Center 1600
Before DONALD E. ADAMS, DEMETRA J. MILLS, and
ULRIKE W. JENKS, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF CASE
This is an appeal under 35 U.S.C. § 134(a). The Examiner has rejected
claims 35--48 for obviousness, and as directed to patent ineligible subject
matter. Claims 1-34 have been cancelled. We have jurisdiction under 3 5
U.S.C. § 6(b ).
We reverse.
Appeal2017-004696
Application 13/512,585
CLAIMED SUBJECT MATTER
The following claim is representative.
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.
Cited References
Laskey et al. ("Laskey") US 7 ,056,690 B2 June 6, 2006
Laszlo Pajor et al., Increased Efficiency of Detecting Genetically
Aberrant Cells by UroVysion Test on Voided Urine Specimens Using
Automated lmmunophenotypical Preselection of Uroepithelial Cells,
International Society for Analytical, Cytometry Part A. (2008). ("Pajor")
Kai Stoeber et al., Diagnosis of Genito-Urinary Tract Cancer by
Detection of Minichromosome Maintenance 5 Protein in Urine
Sediments, J. Nat. Cancer Inst., Vol. 94, No. 14, 1071-1079 (2002).
("Stoeber")
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Application 13/512,585
Grounds of Rejection
1. Claims 35--48 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Laskey in view of Stoeber and Pajor.
2. Claims 35--48 are rejected under 35 U.S.C. § 101 because the
claimed invention is directed to judicial exception(s) (i.e., a law of
nature, a natural phenomenon, and/ or an abstract idea) without
significantly more.
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Final Action at
pages 2-8, Answer pages 2-16.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
"Obviousness requires a suggestion of all limitations in a claim."
CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
(citing In re Royka, 490 F .2d 981, 985 ( CCP A 197 4) ).
Obviousness Rejection
The Examiner finds that Laskey teaches each element claimed except
Laskey does not specifically teach dispersing the cells on a slide containing
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Application 13/512,585
at least 5000 total cells, or" 'counting' dispersed cells which bind anti-
MCM2 antibodies." Final Act. 3. The Examiner relies on Stoeber and Pajor
for this teaching. Final Act. 4. The Examiner concludes that,
One of ordinary skill in the art at the time the invention was
made would have been motivated to non-invasively diagnose
and treat bladder cancer comprising dispersing cells isolated by
centrifugation from 30-120 ml of a urine sample from a subject
on a slide and using an automated counter 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, wherein the
subject is just any suspect suspected of having bladder cancer
(including a subject with a previous occurrence of bladder
cancer and those with hematuria) and administering a treatment
regimen to a subject diagnosed with bladder cancer based on
the presence of MCM2 expressing cells because subjects that
have previously had bladder cancer are at high risk for
recurrence, MCM2 is a biomarker for bladder cancer, and
administering a treatment regimen specific for a cancer to a
subject diagnosed with cancer would predictably result in a
therapeutic benefit. As evidenced by the instant specification
(see Example 2), 5000 cells would predictably be present in the
30-120 ml urine sample.
Final Act. 4--5.
Appellants contend, among other things, that
The Examiner brings in the Pajor feature of using dispersed cells on a
slide from a 30-120 ml urine sample and counting labeled cancer
cells. However, this feature specifically incorporated does not
provide the feature of a threshold of 50 positive cells per 5000 on a
urine sediment slide. And, it is notable that Pajor does not actually
count positive cells.
App. Br. 4.
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Application 13/512,585
The dispositive issue in the case is whether the Examiner has provided
sufficient evidence on this record that the combination of cited references
discloses a step of "d) counting said stained cells to provide a cell count, as
in claim 3 5."
ANALYSIS
We do not find that the Examiner has provided evidence to support a
prima facie case of obviousness.
The Examiner relies on Stoeber and Pajor for teaching counting of
cells an element missing from Laskey. See Final Act. 3, Ans. 3.
Specifically, the Examiner finds that
Stoeber et al teaches a diagnostic method of detecting a subject
suffering from bladder cancer comprising providing 50---80 ml of urine
from a subject, isolating cells from said urine by centrifugation to
provide a cell sample, contacting the sample with antibodies that
specifically bind a biomarker on cancer cells, determining binding of
said antibodies to the cell sample by measuring fluorescence,
providing a cell count by comparing fluorescence of the sample to a
threshold fluorescence obtained from 1500---6000 of Hela cells, and
determining that the subject has bladder cancer when the fluorescence
is elevated as compared to controls (Table 5, in particular).
Pajor et al teaches methods of diagnosing bladder cancer by
detecting the expression of a bladder cancer biomarker on cells
isolated by centrifugation of 30-120ml of urine from subjects
followed by dispersing the cells on a slide, contacting the dispersed
cells with antibodies, and using an automated counter to count
dispersed cells which bind the antibodies (see pages 260---261).
Ans. 3--4.
We are not persuaded that the Examiner has established that either
Stoeber or Pajor teaches a step of counting cells, as claimed. Stoeber
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teaches calculating the fluorescence values of clinical tumor, batch cell
lysate samples labeled with Mcm5 antibody. Stoeber, p. 1073, col. 2, to
107 4, col. 1. In Stoeber, fluorescence of the batch of cells was calculated by
the Dissociation-Enhanced Lanthanide Fluorometric Immunoassay
(DELFIA) method. Id. at p. 1073, col. 2. The 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.
Similarly, Pajor placed a urine sediment on a slide (p. 260, col. 2), and
positive cells of interest were identified by first identifying uroepithelial
cells, followed by counting chromosomes in the intact cells to positively
identify individual neoplastic cells using a scanning microscope (p. 262-
263). Pajor discloses that the scanning of CK-7 and hematoxylin stained
cell samples on slides from voided urine was done automatically on a
predefined area of the slides using 20X objective at transmitted light mode.
P. 260, col. 2. Pajor used immunostain microscopy with automated scanning
to measure sample intensity. P. 260-261. The 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.
Therefore, neither Stoeber nor Pajor make up for the deficiencies of
Laskey. Because the Examiner has not provided evidence of each and every
method step claimed, in particular the claimed cell counting step, we reverse
the obviousness rejection of record.
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Application 13/512,585
101 Rejection-Patent Ineligible Law of Nature,
Natural Phenomenon
The Examiner finds that
The "natural phenomenon" is: elevated numbers of MCM2
expressing cells in urine are indicative of bladder cancer or
risk of developing bladder cancer. A claim that focuses on
judicial exception(s) can be shown to recite something
"significantly more" than the judicial exception(s) by reciting a
meaningful limitation. However, in the instant case, the claims
only recite well-understood, routine and conventional
limitations in addition to the judicial exception(s). Such
limitations are not meaningful limitations and are not enough to
qualify the claimed method as reciting something "significantly
more" than the judicial exception(s) (see Part LB.I of the
interim Guidance). Here, the claims do not contain any
significant additional elements or steps beyond the observation
of judicial exception( s) present when performing routine and
conventional methods. Further, just as PCR was identified in
Ariosa v. Sequenom as "well-known, routine, and
conventional" (see first paragraph on page 13 of Ariosa
Diagnostics, Inc. v. Sequenom Inc. (Fed. Cir. 2015)), detection
methods encompassed by the instant claims are wellknown,
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. The claims do not recite
something "significantly more" than the judicial exception( s );
rather, the claims "simply inform" the natural phenomenon to
one performing routine active method steps and do not amount
to significantly more than the judicial exception(s). See the
2014 Interim Guidance on Patent Subject Matter Eligibility (79
FR 7 4618) ("the interim Guidance'').
Final Act. 6-7; bold italicized emphasis added.
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Appellants contend that,
The examiner maintains that the claims are not patent eligible
because the claims are directed to a natural phenomenon and do
not recite something "significantly more" than the natural
phenomenon by reciting a meaningful limitation because the
additional elements (when considered both individually and as an
ordered combination) are limited to well understood, routine and
conventional methods of detecting a known bladder cancer urine
biomarker (MCM2 of Laskey) by modifying the generic method
of Pajor et al of detecting bladder cancer biomarkers in urine.
Emphasis added. The allegation is conclusory and fails to consider the
claims as a whole. The facts above, in the inventiveness analysis, show
that the additional steps of the claimed methods were not routine in
the art. In fact 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.
Reply Br. 4--5; italicized emphasis added.
PRINCIPLES OF LAW
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992)
(emphasis added); see e.g., Hyatt v. Dudas, 492 F.3d 1365, 1369-71 (Fed.
Cir. 2007) (once the examiner presents a prima facie case for
unpatentability, e.g., under§ 112, the burden is properly shifted to
applicant).
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Application 13/512,585
ANALYSIS
We do not find that the Examiner has provided evidence to support a
prima facie case of patent ineligible subject matter. "Whether something is
well-understood, routine, and conventional to a skilled artisan at the time of
the patent is a factual determination." Berkheimer v. HP Inc., 881 F.3d
1360, 1369 (Fed. Cir. 2018).
The Examiner has not established with appropriate factual evidence
that the claimed method uses conventional cell counting methods. In
particular, as noted in the obviousness rejection discussed above, the
Examiner did not establish with factual evidence, that the cell counting step,
as claimed, is conventional or known in the art.
Therefore, we do not find that the Examiner has provided a prima
facie case of patent ineligibility supported by factual evidence, and reverse
the rejection of the claims as directed to an abstract idea or natural
phenomenon.
CONCLUSION OF LAW
The cited references do not support the Examiner's obviousness
rejection and lack of patentable subject matter rejection. These rejections
are reversed.
REVERSED
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