Ex Parte Mok et al

Board of Patent Appeals and Interferences

Nov 13, 2008

10869027 (B.P.A.I. Nov. 13, 2008)

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UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte SAMUEL C. MOK, BIN YE, and DANIEL W. CRAMER
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Appeal 2008-2127
Application 10/869,027
Technology Center 1600
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Decided: November 13, 2008
Before RICHARD TORCZON, SALLY GARDNER LANE, and
MICHAEL P. TIERNEY Administrative Patent Judges.

LANE, Administrative Patent Judge.

DECISION ON REHEARING

I. STATEMENT OF THE CASE
Appellants have requested rehearing under 37 C.F.R. § 41.52 of that
portion of our Decision on Appeal that entered a new grounds of rejection
for claims 1, 2, and 4-11 under 35 U.S.C. § 103 over Monahan and for
claim 3 under 35 U.S.C. § 103 over Monahan and Paulse.
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We do not modify our opinion.
II. FINDINGS OF FACT
The record supports the following findings of fact as well as any other
findings of fact set forth in this opinion, by at least a preponderance of the
evidence.
1. Appellants’ claim 1 recites:
A method of diagnostically evaluating a woman for the
presence of ovarian cancer, comprising:
(a) obtaining a urine sample from said woman;
(b) assaying said urine sample for the concentration of
osteopontin present;
(c) comparing the results obtained from the assay of step (b)
with results obtained from the assay of one or more control samples;
and
(d) concluding that said woman is at increased risk of having
ovarian cancer if the concentration of osteopontin in said urine sample
is higher than the concentration in said control sample or samples.

2. Table 1 of U.S. Patent Application Publication 2003/0087250
(“Monahan”) “lists all of the markers of the invention, which are over-
expressed in ovarian cancer cells compared to normal (i.e., non-cancerous)
ovarian cells . . . .” (Monahan at ¶ [0068]).
3. Table 1 of Monahan includes the following:
OV48 OPN-a: secreted phosphoprotein-1 (osteopontin,
bone sialoprotein)
OV49 OPN-b: secreted phosphoprotein-1 (osteopontin,
bone sialoprotein)
OV50 OPN-c: secreted phosphoprotein-1 (osteopontin,
bone sialoprotein)

(Monahan at p. 9).
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4. Monahan teaches that the overexpression of a marker can be
determined in “a patient sample.” (Monahan at ¶ [0015]).
5. Monahan teaches that a patient sample can be an “ovary-
associated body fluid.” (Monahan at ¶ [0054]).
6. Monahan includes urine in a list of “ovary-associated body
fluids.” (Monahan at ¶ [0128]).
7. Monahan teaches “the cancerous state of human ovarian cells is
correlated with changes in the levels of expression of the markers of the
invention.” (Monahan at ¶ [0149]).
III. ISSUE
Appellants contend that the Board improperly “held that experimental
results indicating that a gene is elevated in ovarian cancer cells is sufficient
to make it reasonable to expect that assays for the gene product in any
biological fluid can be used diagnostically” (Req. 2). Did the Board
prejudicially misapprehend or overlook any points when it entered a new
ground of rejection against claim 3?
V. ANALYSIS
“When there is a design need or market pressure to solve a problem
and there are a finite number of identified, predictable solutions, a person of
ordinary skill has good reason to pursue the known options within his or her
technical grasp.” KSR Int’l. Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742
(2007). Monahan teaches that osteopontin, among other genes, is a known
marker overexpressed in ovarian cancer cells (FFs 2 and 3) and that urine,
among other fluids, is an “ovary-associated fluid” known to be assayed for
ovarian cancer (FFs 4-6). Thus, from reading Monahan, those of skill in the
art would have had a finite number of identified solutions from which to
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develop a screening test for ovarian cancer. See KSR Int’l. Co., 127 S.Ct. at
1742; Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir.
1989) (“That the [prior art] patent discloses a multitude of effective
combinations does not render any particular formulation less obvious. This
is especially true because the claimed composition is used for the identical
purpose taught by the prior art.”). Monahan also teaches that ovarian cancer
is correlated with the level of expression of markers (FF 7), allowing those
of skill in the art to predict that osteopontin would be a useful diagnostic
screen. Thus, Monahan renders Appellants’ claimed method obvious.
Appellants argue that those of skill in the art would not have thought
there was a likelihood of success in the claimed method because of a number
of factors, which Appellants assert Monahan does not address. (See Req. 2).
Specifically, Appellants argue that in order for the amount of osteopontin in
urine to be diagnostically useful
a) the ovarian tumor cells must lyse and release osteopontin at a
rate high enough to exceed the rate at which the osteopontin is
degraded in, and cleared from, the bloodstream; b) the
osteopontin, or a detectable breakdown product of osteopontin,
must be filtered into the urine; c) the osteopontin entering the
urine must be in a form that can be detected (a largely degraded
product probably could not be);3 and d) the urine must not
contain other factors that interfere with the ability to detect
osteopontin.

(Req. 2-3). Appellants further assert, in footnote 3, that “[u]rine presents a
special problem in this regard. Because of its highly acidic nature, proteins
in urine will tend to lose structural features that would allow for recognition
by antibodies used in imunoassays.” (Req., 2, n.3).
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As explained above, on its face, Monahan teaches screening urine for
osteopontin to diagnose ovarian cancer, among other methods of screening.
Monahan itself provides the expectation of success by reciting the elements
of Appellants’ claim 1 to be used for the same purpose as the claimed
method. Thus, Monahan “is prior art for all that it teaches." Beckman
Instruments v. LKB Produkter AB, 892 F.2d 1547, 1551, (Fed. Cir. 1989).
Appellants have not directed us to evidence showing that those of skill in the
art would have expected otherwise or that Appellants’ own studies produced
unexpected results. See In re Piasecki, 745 F2d 1468, 1472 (Fed. Cir. 1984)
(“After a prima facie case of obviousness has been established, the burden of
going forward shifts to the applicant. Rebuttal is merely ‘a showing of facts
supporting the opposite conclusion’ . . . .” (citation omitted) (emphasis in
original)). Mere attorney argument does not overcome the express teachings
of Monahan. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (“An
assertion of what seems to follow from common experience is just attorney
argument and not the kind of factual evidence that is required to rebut a
prima facie case of obviousness.”). Accordingly, we disagree that
Appellants have shown that Monahan does not provide a prima facie case
for obviousness.
Appellants argued further that “the position of the Board is also
inconsistent with the position that the PTO generally takes with respect to
the predictability of biological [systems] in situations [where] an applicant is
attempting to [justify] the patenting of broad claims based on only one, or a
few, examples.” (Req. 2, n.2). According to Appellants,
it is not clear . . . how, given the unpredictability of this art and
the complicating factors described above, a disclosure can
render an assay for diagnosing ovarian cancer by determining
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the amount of osteopontin in urine obvious in the absence of
some reasonable evidence that at least one urine based assay
can be successfully used. [footnote omitted]

(Req. 3). Appellants have not directed us to evidence that the art is
unpredictable. Nor have Appellants directed us to evidence sufficient to
show that those of skill in the art would have considered Monahan to lack an
enabling disclosure. Accordingly, we see no error or inconsistency in our
new grounds of rejection.
VI. ORDER
Upon consideration of the Request for Rehearing and for reasons
given, it is ORDERED that the decision entering new grounds of rejection
for claims 1, 2, and 4-11 under 35 U.S.C. § 103(a) over Monahan and for
claim 3 under 35 U.S.C. § 103(a) over Monahan and Paulse shall not be
modified.

REHEARING DENIED
ack

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