Ex Parte LASKEY

Patent Trial and Appeal Board

Nov 21, 2018

14489207 (P.T.A.B. Nov. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/489,207 09/17/2014
22798 7590 11/26/2018
Quine IP Law Group
Gary Baker
Suite 210
2033 Clement A venue
Alameda, CA 94501
UNITED ST A TES OF AMERICA
FIRST NAMED INVENTOR
Ronald Alfred LASKEY
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.
177-001411US 2142
EXAMINER
REDDIG, PETER J
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
11/26/2018 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):
gbaker@quinelaw.com
info@quinelaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RONALD ALFRED LASKEY1
Appeal2017-010120
Application 14/489,207
Technology Center 1600
Before DONALD E. ADAMS, RY ANH. FLAX, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a diagnostic or prognostic assay for the detection of
prostate cancer cells in a urine sample. Claims 1-5, 7-10, 13, 14, and 17-21
are on appeal as rejected under 35 U.S.C. § 101. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.
1 Appellant identifies the Real Party in Interest as "Cytosystems Limited."
Br. 1.
Appeal2017-010120
Application 14/489,207
STATEMENT OF THE CASE
Claims 1 is representative and is reproduced below:
1. A diagnostic or prognostic assay for the detection of prostate
cancer cells in a urine sample, the assay comprising the steps of:
i) obtaining an isolated cell sample from said urine sample
and contacting the isolated cell sample with a binding agent that
specifically binds a minichromosome maintenance (MCM)
polypeptide;
ii) contacting the isolated cell sample with a further
binding agent that specifically binds an androgen receptor
polypeptide [AR];
iii) contacting the isolated cell sample with a still further
binding agent that specifically binds prostate specific antigen
[PSA];
iv) detecting the binding of two or more of the binding
agents having different specificities; and
v) determining the number of cells in said isolated cell
sample that positively bind the two or more binding agents,
wherein the number of positive cells is an indicator of the
presence of prostate cancer cells in the urine sample;
wherein the binding agents are antibodies.
Supp. Br. 3 (Claims Appendix). Claim 14, the other independent claim, is
similar, but differs in requiring detecting PSA in serum. Id. at 4--5.
The following rejections are appealed:
Claims 1-5, 7-10, 13, 14, and 17-21 stand rejected under 35 U.S.C.
§ 101 as directed to patent-ineligible subject matter. Final Action 2.
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability. If
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Application 14/489,207
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).
"Phenomena of nature, though just discovered, mental processes, and
abstract intellectual concepts are not patentable, as they are the basic tools of
scientific and technological work." Mayo Collaborative Servs. v.
Prometheus Labs, Inc., 566 U.S. 66, 71 (2012) (quoting Gottschalkv.
Benson, 409 U.S. 63, 67 (1972)). Claims directed to nothing more than
abstract ideas (such as mathematical algorithms), natural phenomena, and
laws of nature are not eligible for patent protection. Diamond v. Diehr, 450
U.S. 175, 185 (1981); accordMPEP § 2106 (II) (discussingDiehr); see also
Parker v. Flook, 437 U.S. 584, 592-94 (1978) (if, once the mathematical
algorithm is removed from consideration, nothing patentable remains, the
claims are not patent-eligible).
In analyzing patent-eligibility questions under 35 U.S.C. § 101, the
Supreme Court instructs us to "first determine whether the claims at issue
are directed to a patent-ineligible concept." Alice Corp. Pty. Ltd. v. CLS
Bankint'l, 134 S. Ct. 2347, 2355 (2014). If the claims are so-directed, we
then move to a second step and "consider the elements of each claim both
individually and 'as an ordered combination' to determine whether the
additional elements 'transform the nature of the claim' into a patent-eligible
application." Id. (quoting Mayo, 566 U.S. at 78-79).
Here, under Alice's step one, the Examiner determined, "[ c ]laim(s) 1-
5, 7-10, 13, 14 and 17-21 is/are directed to the natural phenomena of
expression of MCM, AR, and PSA expression [sic] in prostate cancer cells
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Application 14/489,207
in urine or serum." Final Action 2. Under Alice's step two, the Examiner
determined that "[t ]he claim(s) does/do not include additional elements that
are sufficient to amount to significantly more than the judicial exceptions
because beyond the judicial exception the claimed method steps recite
routine steps of detecting MCM, AR, and/or PSA, e.g. antibody binding,
which does not amount to significantly more than the judicial exception,"
noting specifically:
Given that the claims 1-5, 7-10, 13, 14 and 17-21 simply
describe and correlate natural processes, i.e. the MCM, AR, and
PSA expression and cell number in urine or serum and their
correlation with prostate cancer cells by routine methods known
in the art. See teachings of Watkins et al. (Amer. Assoc. Cancer
Res. 96th Annual Meeting April 16-20, 2005, Abstract# 3163,
IDS) "Watkins[,"] US Pat No. 7,459,157 (Laskey et al. Dec. 2,
2009, IDS), "Laskey", US 2005/0079576 (French et al. Apr. 14,
2005, IDS), "French", Diallo et al. (Investigative Urology Feb.
2008, 101:1302-1309, IDS), "Diallo", and US Pat. No. 6,566,130
(Srivastava et al. May 20, 2003, IDS), "Srivastava" of record, the
claimed invention is not directed to patent eligible subject matter.
Id. at 3; see also Answer 11-16.
Appellant argues that "the methods taken as a whole employ a non-
routine (even taught away) series of narrowly focused steps." Br. 3, 6-7.
It is without question that "[t]he line between a patentable 'process'
and an unpatentable 'principle' is not always clear." Flook, 437 U.S. at 589;
see also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1150
(Fed. Cir. 2016) ("defining the precise abstract idea of patent claims in many
cases is far from a 'straightforward' exercise") (quoting DDR Holdings, LLC
v. Hotels.com, L.P., 773 F.3d 1245, 1257 (Fed. Cir. 2014)). Here, a
reasonable case could be made that the Examiner's determination under
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Application 14/489,207
Alice 's step one is without error on the basis that the claims are directed to a
natural correlation between the body's expression of certain proteins' and
the existence of prostate cancer. See, e.g., Mayo, 566 U.S. 66; Genetic
Technologies, Ltd. v. Merial L.L.C., 818 F.3d 1369 (Fed. Cir. 2016); Ariosa
Diagnostics, Inc. v. Seqenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015); and In
re. BRCAJ- and BRCA2-based Hereditary Cancer Test Patent Litigations,
744 F.3d 755 (Fed. Cir. 2014). As noted by the Supreme Court, however,
"all inventions at some level embody, use, reflect, rest upon, or apply laws
of nature, natural phenomena, or abstract ideas" and "a process is not
unpatentable simply because it contains a law of nature or a mathematical
algorithm." Mayo, 566 U.S. at 71 (quoting Diehr, 450 U.S. at 187).
Even if the claims on appeal are "directed to" a natural phenomenon
under the first step of the Alice framework as determined by the Examiner,
we conclude that the Examiner has not established that the additional
elements recited in the claims, considered individually and as an ordered
combination, were well-understood, routine, and conventional as required
under the second step of Alice. Regarding a determination that, e.g., non-
natural-phenomenon, claim elements are merely routine and conventional,
the Federal Circuit has explained that
Whether something is well-understood, routine, and con-
ventional to a skilled artisan at the time of the patent is a factual
determination. Whether a particular technology is well-
understood, routine, and conventional goes beyond what was
simply known in the prior art. The mere fact that something is
disclosed in a piece of prior art, for example, does not mean it
was well-understood, routine, and conventional.
Berkheimer v. HP Inc., 881 F.3d 1360, 1369 (Fed. Cir. 2018).
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Application 14/489,207
Here, after we strip away the Examiner-identified natural
phenomenon ( expression of MCM, AR, and PSA in prostate cancer cells in
urine or serum), we are left with the claims' required coordinated steps of
isolating cells from a urine ( or serum) sample, performing a multi-marker
immunoassay for MCM, AR, and PSA ( or a 3-step assay therefor), and
determining the number of cells binding at least two of the antibody agents
for the MCM, AR, and PSA to then, thereby, determine the presence of
prostate cancer. The Examiner concluded that the prior art references -
Watkins, Laskey, French, Diallo, and Srivastava- evidenced that such
additional steps beyond the natural correlation of such proteins to prostate
cancer was no more than routine (and conventional). Final Action 3-11.
Although we agree with the Examiner that these cited prior art
references may disclose using detected MCM, AR, and/or PSA to diagnose
cancer, even based on urine samples in some instances, and sometimes using
antibodies, we conclude that these references do not indicate that the
claimed individual steps, much less the ordered combination thereof, were
necessarily routine in the art. To the contrary, the references describe the
relevant techniques individually as inventive or experimental.
For example, we note Watkins is directed to an investigation of
"MCMs (Mini-chromosomal maintenance proteins), as alternative markers
of prostate disease," because, Watkins notes, " [ c ]urrent diagnosis [ using]
Prostate Specific Antigen (PSA) and digital rectal examination," i.e., the
conventional and routine ways of diagnosing prostate cancer, was
questionable with respect to sensitivity and specificity because "PSA is not
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Application 14/489,207
prostate specific." Watkins 1. Thus, Watkins is not evidence that the
claimed ordered combination of steps was routine or conventional.
Laskey is directed to an invention where target polypeptides,
including MCM, are detected in cells spun from urine to detect cancer using
immunoassay. Laskey Abstract, 5:27-50. Regarding immunoassay cancer
screening prior to its invention, Laskey indicates that such techniques had
been attempted, but only with limited success. Id. at 4:53-56. As with
Watkins, this does not indicate that the claimed ordered combination of steps
was routine or conventional.
French discloses that prior to its invention, which was directed to a
DNA sequence coding for a protein similar to AR, studies suggested a
positive correlation may exist between AR in cancer cells and the cancer's
growth. French ,r 5. French indicated that assays for AR were based on
tritium-labeled androgen, which binds to AR (not immunoassays). Id.
Again, this does not indicate the claimed ordered combination of steps was
routine or conventional.
Diallo is directed to the question of whether or not (nuclear) AR
expression might be a precursor to prostate cancer. Diallo 1302. Thus,
Diallo suggests it was not established that AR was known to have been a
good marker to indicate prostate cancer. Thus, Diallo does not evidence that
AR detection using an immunoassay, individually or with MCM and PSA,
followed by a cell count, was routine or conventional.
Srivastava is directed to using androgen-regulated nucleic acids for
cancer diagnosis. Srivastava Abstract. Srivastava indicates that, prior to its
invention, PSA tests were the customary way of detecting prostate cancer,
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Application 14/489,207
but that these tests had a very high false positive rate. Id. at 1 :30-35.
Srivastava indicated that AR had been reported in advanced prostate cancer,
but that its role was poorly understood. Id. at 1 :57---64. However, Srivastava
does not indicate that an immunoassay for AR, alone or with MCM and
PSA, followed by a cell count, was routine and customary.
Thus, while the prior art might teach or suggest the individual steps
recited by the appealed claims, or components thereof, the evidence on
appeal does not support the conclusion that the claimed steps, as an ordered
combination, constitute mere routine and customary techniques that do not
provide the "something more" than the natural phenomenon upon which
they rely so as to provide an inventive concept.
For these reasons, we find the rejection insufficient.
SUMMARY
The rejection of the claims as directed to patent-ineligible subject
matter is reversed.
REVERSED
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