Ex Parte Galloway

Patent Trial and Appeal Board

May 11, 2018

13000942 (P.T.A.B. May. 11, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/000,942 03/31/2011 David Brian Galloway
22798 7590 05/15/2018
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.
177-001310US 7612
EXAMINER
XIAO, YAN
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
05/15/2018 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 BRIAN GALLOW A Y 1
Appeal2017-005972
Application 13/000,942
Technology Center 1600
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of detecting prostate cancer cells, which have been rejected as obvious and
as directed to patent ineligible subject matter. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.
1 Appellant identifies the Real Party in Interest as Cytosystems, Ltd. Appeal
Br. 1.
Appeal2017-005972
Application 13/000,942
STATEMENT OF THE CASE
"MCMs [ minichromosome maintenance proteins] were identified as
useful biomarkers of 'cell cycle state', i.e. whether a cell is capable of
proliferating rather than being quiescent or senescent." Spec. 1.
Although MCMs can be used as targets in the detection of
malignant cells in a body fluid such as urine, they are not tissue
specific. There is, therefore, a need for a means of specifically
detecting prostate cancer cells in urine. The present invention
is based on the determination that prostate epithelial cells can
be detected in urine which can in tum be analysed for
malignancy.
Id. at 2. The Specification states that prostate epithelial cells can be detected
based on their expression of "Prostate Specific Antigen (PSA)," among other
antigens. Id.
Claims 29-35, 39--42, and 49 are on appeal. Claim 40 is the only
independent claim and reads as follows:
40. A method of detecting or determining the presence of prostate cancer
cells in a sample of body fluid from a subject,
(i) isolating cells from said sample to provide a cell sample;
(ii) contacting said cell sample first with a monoclonal antibody or
fragment thereof, having an antigen binding domain specific fora [sic, for a]
prostate antigen;
(iii) washing said cell sample;
(iv) contacting said cell sample from step (iii) with a monoclonal
antibody or fragment thereof, having an antigen binding domain specific for
a minichromosome maintenance MCM-2 polypeptide; and
(iv) determining the binding of both of said monoclonal antibodies or
fragments thereof, to the cell sample to detect prostate cancer cells in said
subject.
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Application 13/000,942
The claims stand rejected as follows: 2
Claims 29-35, 39--42, and 49 under 35 U.S.C. § 103(a) as obvious
based on Meng, 3 Bolduc, 4 Oesterling, 5 and Reeves6 (Ans. 4) and
Claims 29-35, 39--42, and 49 under 35 U.S.C. § 101 as directed to
patent ineligible subject matter (Ans. 2).
I
The Examiner has rejected all of the claims on appeal as obvious
based on Meng, Bolduc, Oesterling, and Reeves. The Examiner finds that
"Meng teaches detecting prostate cancer cells in tissue samples of prostate
cancer patients using monoclonal anti-MCM2 antibody" and suggests that
"'biochemical analysis of prostate epithelial cells shed into the seminal fluid
2 The Final Action also included a rejection under 35 U.S.C. § 112, second
paragraph, and two rejections under 35 U.S.C. § 103(a) based on Laskey
(US 6,303,323 Bl, issued Oct. 16, 2001), among other references. Office
Action mailed Sept. 17, 2015, pages 4--8. However, after Appellant
amended the claims, the Examiner stated that "[t]he amendment and
response does NOT place the application in condition for allowance
because" of the§ 101 rejection and§ 103 rejection based on Meng, Bolduc,
Oesterling, and Reeves. Adv. Action mailed Dec. 30, 2015. We therefore
understand the rejections under 35 U.S.C. § 112, second paragraph, and the
rejections under 35 U.S.C. § 103(a) based on Laskey to be withdrawn.
3 Maxwell V. Meng et al., Minichromosome Maintenance Protein 2
Expression in Prostate: Characterization and Association with Outcome
after Therapy for Cancer, 7 Clinical Cancer Research 2712-2718 (2001).
4 Stephane Bolduc et al., Urinary PSA: A Potential Useful Marker When
Serum PSA is Between 2.5ng/ml and 10/ng/ml, 1CUAJ377-381 (2007).
5 Joseph E. Oesterling, Prostate Specific Antigen: A Critical Assessment of
the Most Useful Tumor Marker For Adenocarcinoma of the Prostate, 145
Journal of Urology 907-923 (1991).
6 Reeves et al., WO 2006/133560 Al, Dec. 21, 2006.
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Application 13/000,942
could provide an early, noninvasive assay for prostate cancer detection.'"
Ans. 4.
The Examiner finds that Bolduc teaches "urinary (body fluid) PSA as
a useful marker in diagnosis of prostate cancer" and teaches "determining
urinary PSA with ELISA using a monoclonal anti-PSA antibody." Id. at 5.
The Examiner finds that Oesterling and Reeves disclose the limitations of
dependent claims 32-34. Id.
The Examiner concludes that it would have been obvious "[t]o
detect[] prostate cancer cells in body fluid (e.g. urine) of prostate cancer
patients using PSA and MCM2 as biomarkers" because Meng suggests that
detection of MCM2 in prostate cells in seminal fluid could provide an early,
noninvasive assay for prostate cancer and Bolduc teaches that urinary PSA is
a useful marker for diagnosing prostate cancer. Id. The Examiner reasons
that it would have been obvious to assay for both proteins because "using a
panel of biomarkers will increase accuracy for diagnosis." Id. at 6.
Appellant argues that Meng teaches detection in tissue samples, not a
body fluid sample, and Bolduc teaches that "reduced urine PSA is correlated
to prostate cancer." Appeal Br. 3. Appellant also argues that, "[e]ven if
Meng did refer to cells in seminal fluid, this would conflict with the
teachings of the secondary Bolduc reference which expressly avoids semen
in his urine PSA assays. That is, Bolduc prohibits urine samples within 24
hours post ejaculation." Id. at 4. Appellant argues that "Li]ust because the
markers were correlated in two different samples does not motivate one to
use the markers together in a third type of sample, particularly since one
marker is taught as correlating negatively to the disease state." Reply Br. 5.
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Application 13/000,942
We agree with Appellant that the Examiner has not established that
the method of claim 40 would have been obvious to a person of ordinary
skill in the art based on the cited references. Meng states that "[t]umors
from 92 patients who underwent radical prostatectomy for prostate cancer
... were examined for Mcm 2 expression by immunohistochemistry using a
monoclonal antibody." Meng 2712, Abstract. "Patients with high Mcm 2
expression exhibited shorter disease-free survival." Id. Meng states that
"Mcm 2 expression is an independent predictor of disease-free survival after
definitive local therapy and has potential as a molecular marker for clinical
outcome in prostate cancer." Id. Meng suggests that "biochemical analysis
of prostate epithelial cells shed into the seminal fluid could provide an early,
noninvasive assay for prostate cancer." Id. at 2718, left col.
Bolduc discloses a study "to evaluate the usefulness of urinary prostate
specific antigen (PSA) in the differential diagnosis of benign prostatic
hyperplasia (BPH) and prostate cancer." Bolduc 3 77, Abstract. Bolduc
states that the "study supports urinary PSA as a useful marker in the
differential diagnosis of prostate cancer and BPH. . . . Low urinary PSA and
PSA ratios [urinary PSA:serum PSA] point toward prostate cancer." Id. In
Bolduc's study, patients "provided blood samples to measure serum PSA ....
[P]atients also provided a 50-ml sample of first-voided urine, any time during
the day, but after at least 1 hour of continence, no sexual intercourse within
24 hours." Id. at 378, left col. Urinary PSA was measured "using a
polyclonal antibody, 'Poly PSA,' and a monoclonal antibody, '4Dl."' Id. at
378, right col.
Thus, Meng suggests that detection of MCM2 in or on prostate cells
shed into seminal fluid might provide a useful assay for prostate cancer, and
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Application 13/000,942
Bolduc discloses that the level of PSA in urine is useful in distinguishing
prostate cancer from BPH. The claims specifically require binding of the
antibody to prostate cancer cells in the sample. However, Bolduc does not
describe the PSA in urine as being found in or on prostate cells, as opposed
to being secreted into the urine by such cells. Nor does Bolduc state that
detecting PSA in or on prostate cells in the urine provides a useful result in
distinguishing prostate cancer from BPH.
The Examiner has not pointed to evidence showing that those skilled
in the art would have expected to find prostate cells in urine or would have
expected that the level of PSA in seminal fluid would be useful in either
diagnosing prostate cancer or distinguishing between prostate cancer and
BPH. In summary, the evidence does not support the conclusion that a
person of ordinary skill in the art would have considered it obvious to test
the same sample of body fluid for both a prostate antigen (e.g., PSA) and
MCM2. We therefore reverse the rejection under 35 U.S.C. § 103(a).
II
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 101 on the basis that they "are directed to detecting the judicial exception
of naturally occurring levels of a prostate antigen and MCM-2 in a bodily
fluid sample from prostate cancer patient." Ans. 2. The Examiner finds that
"[t]he steps of measuring levels of a prostate antigen and MCM-2 including
using antibodies, are considered known, routine steps and are typically taken
by those in the field." Id. at 2-3 (citing Meng and Bolduc). The Examiner
concludes that
the additional steps in the claims are considered as routine data
gathering steps in order to test for the correlation between the
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Application 13/000,942
two marker levels and prostate disease state. These routine
laboratory steps do not add a meaningful limitation to the
method as they would be routinely used by those of ordinary
skill in the art in order to apply the correlation.
Id. at 3.
Appellant argues that "[t]he claims recite elements and non-routine
steps in addition to the natural product." Appeal Br. 6. That is, "[t]he steps
focus the [claimed] method to address a single problem in a specific way
requiring an unusual combination of components and specific steps." Id. at
7. Appellant argues that
the rejection is wrong in suggesting, e.g., that it was routine to
detect the well known PSA protein in urine cell sample much
less in combination with MCM2 detection in urine cells. The
invention is not stealing the detection of well known antigens,
but inventively contributing an odd combination of two
antigens with specific cells and sequential method steps to solve
an old problem.
Id. at 8.
We agree with Appellant that the claimed method is eligible for
patenting. The Supreme Court has set out a two-step test for
distinguishing patents that claim laws of nature, natural
phenomena, and abstract ideas from those that claim patent-
eligible applications of those concepts. First, we determine
whether the claims at issue are directed to one of those patent-
ineligible concepts. If so, we then ask, "[ w ]hat else is there in
the claims before us?" To answer that question, we 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. We have described step two of this analysis as a
search for an "'inventive concept'"-i.e., an element or
combination of elements that is "sufficient to ensure that the
patent in practice amounts to significantly more than a patent
upon the [ineligible concept] itself."
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Application 13/000,942
Alice Corp. Pty. Ltd. v. CLS Banklnt'l, 134 S. Ct 2347, 2355 (2014)
(citations omitted, alterations in original).
With regard to the second step of the test, the Court has held that
"well-understood, routine, conventional activity previously engaged in by
scientists who work in the field ... is normally not sufficient to transform an
unpatentable law of nature into a patent-eligible application of such a law."
Mayo Collaborative Services v. Prometheus Labs., Inc., 566 U.S. 66, 79
(2012).
Here, we agree with the Examiner that the claims are directed to a
patent-ineligible concept; specifically, the correlation between MCM2 and a
prostate-specific antigen, in or on prostate cells, and the presence of prostate
cancer. However, when the steps of the claimed method are considered "as
an ordered combination," id., we conclude that they amount to a patent-
eligible application of the natural phenomenon rather than an attempt to
claim the natural phenomenon itself.
Specifically, the claims require testing a body fluid sample for the
presence of prostate cells, using a monoclonal antibody (or fragment of one)
specific for a prostate antigen, and then testing the same sample for the
presence of MCM2 using a second monoclonal antibody. Assuming for the
sake of discussion that it was routine and conventional to test urine for the
presence of PSA (Bolduc) and to test seminal fluid for the presence of
MCM2 (Meng), the evidence does not show that it was routine and
conventional to sequentially test the same sample of body fluid for the
presence of both antigens, as required by the claims.
We therefore conclude that the claimed method "has additional
features that provide practical assurance that the process is more than a
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Application 13/000,942
drafting effort designed to monopolize the law of nature itself." Mayo, 566
U.S. at 77. Because the claimed method includes more than routine and
conventional activity in addition to the natural phenomenon on which it is
based, it is eligible for patenting under 35 U.S.C. § 101.
SUMMARY
We reverse both of the rejections on appeal.
REVERSED
9