Ex Parte Ward

Patent Trial and Appeal BoardOct 22, 2012

12120322 (P.T.A.B. Oct. 22, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte KENNETH WARD __________ Appeal 2011-012653 Application 12/120,322 Technology Center 1600 __________ Before DONALD E. ADAMS, FRANCISCO C. PRATS, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON REQUEST FOR REHEARING Appellant has requested rehearing of the decision entered July 24, 2012. That decision affirmed the Examiner‟s rejection of claims 1-5, 8-14, 17-52, 55-62, and 65-77 under 35 U.S.C. § 103(a). Appellant‟s request has been granted to the extent that the decision has been reconsidered, but such request is denied with respect to making any modifications to the decision affirming the Examiner‟s rejection under 35 U.S.C. § 103(a). Appeal 2011-012653 Application 12/120,322 2 DISCUSSION We begin by noting that Appellant‟s arguments were already addressed by both the Examiner and our Decision. However, in the interests of clarity, we further specifically address the arguments. Argument 1 Appellant first argues that Antor represents a change in law and that “appellant rebutted the presumption of enablement” for Treloar 1 and Viganò 2 (Req. Reh‟g 2). Appellant contends that “the prior art is not enabled for a test to „assess a predisposition for endometriosis in a subject that does not exhibit an endometriosis symptom‟” (id. at 3). We have reviewed our Decision in light of this argument. However, we are not persuaded that our Decision was in error. In Antor, the Court held that as “long as an examiner makes a proper prima facie case of anticipation by giving adequate notice under § 132, the burden shifts to the applicant to submit rebuttal evidence of nonenablement.” In re Antor Media Corp., 689 F.3d 1282, 1289 (Fed. Cir. 2012). Antor explains that “[e]nablement of prior art requires that the reference teach a skilled artisan to make or carry out what it discloses in relation to the claimed invention.” Id. at 1290. Antor further teaches that the Appellant must show “that undue experimentation would be required to 1 Treloar et al., Genomewide Linkage Study in 1,176 Affected Sister Pair Families Identifies a Significant Susceptibility Locus for Endometriosis, 77 AM. J. HUM. GENET. 365-376 (2005). 2 Viganò et al., Intercellular adhesion molecule-1 (ICAM-1) gene polymorphisms in endometriosis, 9 MOL. HUM. REPRODUCTION 47-52 (2003). Appeal 2011-012653 Application 12/120,322 3 perform the claimed invention based on the teaching” in the prior art. Id. at 1289. Appellant has made no clear or specific evidentiary showing as to undue experimentation. In particular, Appellant has provided no specific evidence that undue experimentation would have been required to replicate the genotyping methods of either Treloar or Viganò, or to apply these genotyping methods for identification of genomic regions associated with increased risk of endometriosis to the method of claim 13 of Foster, 3 “A method of preventing endometriosis in a woman at higher than normal risk of developing endometriosis, comprising: administering to the woman at higher than normal risk of developing endometriosis a pharmaceutically acceptable composition . . . to inhibit the growth or thickening of endometriotic tissue in the woman” (FF 5, Dec. 5). We also note that absolute predictability is not required to demonstrate enablement of the prior art. As Kubin commented, “[r]esponding to concerns about uncertainty in the prior art influencing the purported success of the claimed combination, this court [in O’Farrell] stated: „[o]bviousness does not require absolute predictability of success … all that is required is a reasonable expectation of success.”‟ In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009) (citing In re O’Farrell, 853 F.2d 894, 903-904 (Fed. Cir. 1988)). Appellant‟s additional arguments relating to the applicability of Treloar and Viganò to Foster‟s method were already addressed by the Decision, which found that “both Treloar and Vigano disclose genetic markers that correlate with endometriosis” (Dec. 12). 3 Foster et al. US 2002/0147155 A1, issued Oct. 10, 2002. Appeal 2011-012653 Application 12/120,322 4 We continue to conclude that there would have been a “reasonable expectation of success” to modify Foster‟s method using known risk factors to treat and prevent endometriosis and to incorporate the newly identified genetic risk factors of Treloar and Viganò for endometriosis since these present additional information for the ordinary artisan in the identification of patients for whom Foster‟s therapy would have been appropriate. Argument 2 Appellant contends that “FF #10 does not render the rejected claims obvious and that FF #10 cannot be used for instance in „assessing a predisposition for endometriosis in a subject that does not exhibit an endometriosis symptom‟” (Req. Reh‟g 3). Appellant then creates a hypothetical analogy which fundamentally results in an argument requiring Treloar alone to anticipate the invention. Appellant contends that “Treolar [sic] does not render the rejected claims obvious” (id. at 4). We have reviewed our Decision in light of this argument. However, we are not persuaded that our Decision was in error. We can agree with Appellant that Treloar alone does not render the claimed invention obvious. It is the combination of Treloar with Foster (as well as Viganò and De Koning 4 ), which renders claim 2 obvious. 5 Foster teaches “[a] method of preventing endometriosis in a woman at higher than normal risk of developing endometriosis, comprising: administering to the woman at higher 4 De Koning, WO 00/21511, published Apr. 20, 2000. 5 As we noted in the decision, Treloar and Viganò were not required for the obviousness of claim 1 (see Dec. 8). Appeal 2011-012653 Application 12/120,322 5 than normal risk of developing endometriosis a pharmaceutically acceptable composition ... to inhibit the growth or thickening of endometriotic tissue in the woman” (Foster 9, claim 13; Dec. 5; FF 5). As extensively discussed in the Decision, it is Foster who teaches the “assessing” step, that is, the association of a higher than normal risk of endometriosis in an asymptomatic woman with treatment for that increased risk (Dec. 5-6, FF 2-9). Treloar is solely relied upon in the Decision and by the Examiner to demonstrate that the prior art was aware of genetic markers that were correlated with endometriosis related conditions, as required by claim 2 (see, e.g., Dec. 8). In that vein, FF10 of the Decision simply established the fact that Treloar teaches the linkage of some alleles in a specific genetic locus, 10q26, with endometriosis. Treloar‟s title demonstrates that a “Genomewide Linkage Study in 1,176 Affected Sister Pair Families Identifies a Significant Susceptibility Locus for Endometriosis on Chromosome 10q26” (Treloar 365, title). The Examiner‟s obviousness determination then, combines Foster and Treloar, finding it obvious to detect if a woman, that does not show any symptoms of endometriosis, and has genetic markers correlated with increase susceptibility to endometriosis as taught by Treolar [sic] . . . to further assess, based on those genetic markers, the predisposition for that woman to be susceptible to endometriosis . . . and administer a pharmaceutical composition known to treat or reduce the conditions associated with endometriosis as taught by Foster . . . in order to reduce the risk of these women of developing endometriosis. (Ans. 7-8.) Similarly, we noted in the decision that Foster teaches certain risk factors for endometriosis (Dec. 5; FF 4, 6), and that Treloar teaches Appeal 2011-012653 Application 12/120,322 6 another risk factor (Dec. 6; FF 10) and agreed with the Examiner that “selection of other known risk factors simply represents the „mere substitution of one element for another known in the field‟ to yield a predictable result” (Dec. 8). We continue to conclude that it is the combination of all of the references, including not only Treloar, but Foster, Viganò, and De Koning that renders the claimed invention obvious, and Appellant‟s focus solely on Treloar fails to properly capture the obviousness analysis. Argument 3 Appellant contends that “FF #11 is in-fact factually incorrect” (Req. Reh‟g 4). Appellant contends that “Vigano does not teach „two polymorphisms (or any polymorphisms) corresponding to an increased risk of endometriosis‟, but rather what Vigano teaches is perhaps a singular polymorphism (R241) corresponding to an increased risk of severe endometriosis but only in those subjects that are otherwise predisposed to endometriosis” (id. at 5). Appellant then creates another hypothetical analogy which results in the contention that “Vigano merely disclosed a biomarker (R241) which is just as common in women who are not predisposed to endometriosis as it is in women who are predisposed to endometriosis” (id. at 6). Appellant also contends that “there is no disease-associated chromosomal location disclosed - only a potential location and markers that are indeterminate for an association with endometriosis” (id. at 7). Appeal 2011-012653 Application 12/120,322 7 We have reviewed our Decision in light of these arguments. We cannot agree, however, that Viganò is solely interested in increased risk of severe endometriosis and not endometriosis itself. As the Examiner noted “Vigano clearly states that, „While the functional correlate of the G/R241 polymorphism remains unclear, this finding indicates that a genetic polymorphism in the ICAM-1 gene domain may contribute to the susceptibility to endometriosis‟ (see Vigano abstract)” (Ans. 19). Thus, consistent with the Examiner‟s position and the Decision, Viganò directly associates the susceptibility, i.e., risk, of endometriosis itself with the presence or absence of the G/R241 polymorphism (see Viganò abstract, Ans. 19). In order to respond to Appellant‟s hypothetical and resulting conclusion, we need to unpack what Viganò actually did as compared to Appellant‟s hypothetical. In Appellant‟s hypothetical, two inventors perform a linkage study without using any controls and, as a result, obtain data lacking value. However, in contrast, the Examiner finds that: Vigano teaches: “we have studied two polymorphic sites located in codons 241 (G/R241) and 469 (E/K469) of the ICAM-1 gene. Three hundred and sixty three Italian Caucasian women of reproductive age who underwent laparoscopy for benign pelvic conditions were enrolled in the study. Endometriosis was documented and staged in 188 women while 175 subjects, in whom endometriosis was laparoscopically ruled out, served as the control group. The frequency of the R241 allele was only marginally higher in endometriosis patients than in controls. However, a strikingly high frequency of this allele was found in patients with stage IV endometriosis vs. controls.” Appeal 2011-012653 Application 12/120,322 8 (Ans. 20.) Thus, unlike Appellant‟s inventor alpha, Viganò studied two sets of women, a group with endometriosis and a control group without endometriosis. Viganò looked at a particular allele, the G/R241 allele, and found that an R at position 241 in ICAM was found more frequently in women with endometriosis, and particularly women with severe endometriosis relative to controls i.e., women without endometriosis than was the alternate possibility of a G at position 241 in ICAM (see Ans. 20). This is significantly different than Appellant‟s hypothetical in which neither hypothetical inventor includes a proper control group, and due to that scientific failure, cannot obtain a meaningful conclusion. Consequently, Viganò finds that a woman who has an R241 allele, that is an R at position 241 of her ICAM gene, has an increased likelihood of endometriosis relative to a woman who has the G241 allele, and further has an increased risk of severe endometriosis (see Ans. 20). This R241 allele is therefore reasonably interpreted in light of Foster‟s definition as a risk factor, where Foster teaches “[a] woman at higher than normal risk of developing endometriosis is a woman at greater risk than the general population of women of developing endometriosis for the first time” (Foster 4 ¶ 0034; Dec. 5; FF 2). Viganò‟s results are not indeterminate, but instead teaches that the R241 allele is more frequent in endometriosis patients than in control patients who did not have endometriosis, and in patients with severe endometriosis more than control patients, would have reasonably been understood as a risk factor for endometriosis by the ordinary artisan familiar with Foster (Dec. 5; FF 2). Appeal 2011-012653 Application 12/120,322 9 We continue to conclude that the combination of all of the references, including Treloar, Foster, Viganò, and De Koning renders the claimed invention obvious, and that “Vigano teaches that „genotyping of the patients could be useful to select subgroups that could develop a more severe form of the disease,‟” addressing the limitation of claim 2 (Viganò 52; Dec. 6; FF 12). Argument 4 Appellant contends that “FF #12 does not render the rejected claims obvious and that FF #12 cannot be used for instance in „assessing a predisposition for endometriosis in a subject that does not exhibit an endometriosis symptom‟” (Req. Reh‟g 7). Appellant contends that “such genotyping is as likely to identify a predisposition in a woman to severe endometriosis when in fact the woman isn‟t predisposed to endometriosis at all (i.e. a false positive), as it is to identify a predisposition in a woman to severe endometriosis wherein the woman is predisposed to developing endometriosis” (id. at 7-8). We have reviewed our Decision in light of these arguments. However, we are not persuaded that our Decision was in error. Appellant again fails to address the combination of all of the references, focusing only on the teaching of Viganò alone that “‟genotyping of the patients could be useful to select subgroups that could develop a more severe form of the disease (Viganò 52)‟” (Dec. 6; FF 12). It is Foster who teaches the “assessing” step, that is, the association of a higher than normal risk of endometriosis in an asymptomatic woman with treatment for that increased risk (Dec. 5-6, FF 2- Appeal 2011-012653 Application 12/120,322 10 9). Foster teaches “[a] method of preventing endometriosis in a woman at higher than normal risk of developing endometriosis, comprising: administering to the woman at higher than normal risk of developing endometriosis a pharmaceutically acceptable composition ... to inhibit the growth or thickening of endometriotic tissue in the woman” (Foster 9, claim 13; Dec. 5; FF 5). Viganò (along with Treloar) is relied upon by the Examiner in the obviousness analysis to establish that the prior art recognized genetic markers that were correlated with an endometriosis related condition as required by claim 2 and established at least a small “higher than normal risk” in the language of Foster (FF 2, 5). To the extent that the obvious method over Foster, De Koning, Treloar, and Viganò would have resulted in the treatment false-positives, the same risk always exists and was evident in Foster, as the Examiner finds that “Foster teaches the administration of a pharmaceutical composition, which is known to be effective in the treatment of endometriosis, to women with no symptoms of endometriosis that have a higher risk to acquire endometriosis, like for example a women with a close relative (mother, sibling, aunt, etc) that has already being diagnosed with endometriosis” (Ans. 25). There is no reasonable expectation that every woman at higher risk will necessarily develop endometriosis, only that they are at higher risk of endometriosis than other equivalent women lacking the same risk factors. We continue to conclude that the combination of all of the references, including Treloar, Foster, Viganò, and De Koning renders the claimed invention obvious. Appeal 2011-012653 Application 12/120,322 11 SUMMARY We have carefully reviewed the original opinion in light of Appellant‟s request, but we find no point of law or fact which we overlooked or misapprehended in arriving at our decision. To the extent relevant, Appellant‟s request amounts to a reargument of points already considered by the Board and the Examiner. Therefore, Appellant‟s request has been granted to the extent that the decision has been reconsidered, but such request is denied with respect to making any modifications to the decision affirming the Examiner's rejection under 35 U.S.C. § 103(a). DENIED cdc