Ex Parte Mok et alDownload PDFBoard of Patent Appeals and InterferencesNov 13, 200810869027 (B.P.A.I. Nov. 13, 2008) Copy Citation 1 UNITED STATES PATENT AND TRADEMARK OFFICE _________________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES _________________ Ex parte SAMUEL C. MOK, BIN YE, and DANIEL W. CRAMER _________________ Appeal 2008-2127 Application 10/869,027 Technology Center 1600 _________________ 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. Appeal 2008-2127 Application 10/869,027 2 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). Appeal 2008-2127 Application 10/869,027 3 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 Appeal 2008-2127 Application 10/869,027 4 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). Appeal 2008-2127 Application 10/869,027 5 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 Appeal 2008-2127 Application 10/869,027 6 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 cc: Michael A. Sanzo 15400 Calhoun Drive Suite 125 Rockville, Md. 20855 Copy with citationCopy as parenthetical citation