Please find below and/or attached an Office communication concerning this application or proceeding.

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1 UNITED STA TES p A TENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 12/837,292 07/15/2010 TaruBlom BGL P.O. BOX CHICAGO, IL /07/2016 EXAMINER CORNET, JEAN P ART UNIT PAPER NUMBER 1628 MAILDATE DELIVERY MODE 07/07/2016 PAPER 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. PTOL-90A (Rev. 04/07)

2 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TARU BLOM, PAULA GRONROOS, KAIJA HALONEN, and PIRKKO HARKONEN 1 Appeal Technology Center 1600 Before DONALD E. ADAMS, RICHARD J. SMITH, and JOHN E. SCHNEIDER, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. 134(a) involving claims to a method for treating dyspareunia in women, which have been rejected as obvious. A hearing was held on June 2, We have jurisdiction under 35 U.S.C. 6(b). We reverse. 1 Appellants identify the Real Party in Interest as Hormos Medical Corporation. Appeal Br. 2.

3 STATEMENT OF THE CASE The invention relates to a method for treating dyspareunia in women by the administration of the selective estrogen replacement modulator ospemifene ("FC1271a"). Spec. i-fi Claims 1--4, 6, 8-11, 16, 17, and 24 are on appeal. 2 Claim 1 is illustrative and reads as follows: 1. A method for alleviating dyspareunia in women during or after menopause, said method comprising administering to a woman in need of treatment to treat dyspareunia an effective amount of ( deaminohydroxy)toremifene or a pharmaceutically acceptable salt thereof. Appeal Br. 24 The claims stand rejected as follows: Claims 1--4, 6, 8-11, 16, 17, and 24 stand rejected under 35 U.S.C. 103(a) as obvious over Cullinan U.S. 5,461,064 (issued Oct. 24, 1995) ("Cullinan") in view of Qu, et al., Selective Estrogenic Effect of a Novel Triphenylethylene Compound, FCJ 271 a, on Bone, Cholesterol Level and Reproductive Tissues in Intact and Ovariectomized Rats, The Office Action dated August 27, 2012 ("Final Act.") and the Examiner's Answer lists claims 1--4, 6, 8-11 and as rejected and the Examiner's statement of the rejection identifies claims 1-11 and as rejected. Final Act. 2; Ans. 3 and A review of the prosecution history reveals that claims 5, 7, and were cancelled. Amendment filed August 29, 2011; see also Amendment filed May 21, 2012; Final Act dated August 27, Claims 25 and 26 were never offered. Id. Appellants correctly identify the pending and rejected claims as claims 1--4, 6, 8-11, 16, 17, and 24. Appeal Br. 4, Reply Br. 2. 2

4 ENDOCRINOLOGY 809 (2000) ("Qu") and Degregorio, et al., W Al (published Mar. 14, 1996) ("Degregorio"). Final Act. 3. Issue DISCUSSION In rejecting the claims as obvious, the Examiner finds that Cullinan teaches the use of the Selective Estrogen Receptor Modulator ("SERM") Raloxifene to inhibit atrophy of the skin or vagina in post-menopausal women. Final Act. 3. The Examiner finds that vaginal atrophy can lead to dyspareunia. Id. The Examiner finds that while Cullinan is silent as to the use of ( deaminohydroxy )tormifene ("FC a"), Qu discloses the use of FC 1271a on bone, cholesterol level and reproductive tissues. Id. The Examiner goes on to find that Qu teaches that FC 1271a is a SERM that does not cause unwanted side effects. Id. at 4. With respect to Degregorio, the Examiner finds that FC1271a may enhance the useful properties of estrogen without the hormonal side effects of estrogen. Id. In conclusion the Examiner finds that It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to modify the method taught by Cullinan by replacing raloxifene with FC127a taught by Qu et al and Degregorio et al to achieve Applicant's claimed method. One would have been motivated to make such modification with the expectation of treating vaginal atrophy and symptoms associated with vaginal atrophy including dyspareunia because Degregorio et al teach FC127a has enhanced estrogenic properties lacking significant hormonal sided effects and also because Qu et al teach raloxifene is ineffective against or may even increase climacteric symptoms 3

5 Id. at and also teach that FC127a has selective estrogenic effect on reproductive tissue. Appellants contend that a person or ordinary skill in the art would not have a reasonable expectation that using FC1271a would result in relieving dyspareunia in woman. Appeal Br. 10. Appellants contend that Qu teaches that the SERM used in Cullinan, raloxifene, may actually increase - alleviate - climacteric symptoms. Id. at 11. Appellants contend that Degregorio teaches that FC1271a may enhance useful properties of estrogen when used in combination, not used by itself. Id. at 12. Appellants go on to argue that the references cited by the Examiner as well as the additional references 3 cited by the Appellants demonstrate that at the time of the invention, the effects of SERMs was considered unpredictable. Id. at Appellants go on to argue that "[b ]ecause it is widely accepted and known in this art that SERM activities are unpredictable absent tissue-specific clinical investigation, one of skill in the art would not have a reasonable expectation that (deaminohydroxy)toremifene would successfully alleviate dyspareunia without clinical, empirical study as was undertaken by applicant and disclosed in the pending application." Id. at 15. not 3 Appellants cite Yue, et al., Selective Estrogen Receptor Modulator Idoxifene Inhibits Smooth Muscle Cell Proliferation, Enhances Reendothelialization, and Inhibits Neointimal Formation in Vivo after Vascular Injury, 200 CIRCULATION III III-288 (2000) ("Yue") and Albertazzi, et al., Urogenital effects of selective estrogen receptor modulators: a systematic review, 8 CLIMACTERIC (2005) ("Albertazzi") as part of Appellants' evidence showing that the effects of SERMs were deemed unpredictable at the time of the invention. 4

6 The issue with respect to this rejection is whether the Examiner has established by a preponderance of the evidence that the rejected claims would have been obvious in view of Cullinan combined with Qu and Degregorio as defined by 35 U.S.C. 103(a). Findings of Fact FF 1. Cullinan teaches the use of Raloxifene for the treatment of vaginal atrophy. Cullinan, col. 3, FF2. Raloxifene is a SERM. Qu 809. FF3. Qu teaches the use offc1271a to treat bone loss and high cholesterol. Qu 816. FF4. With respect to treating bone loss and lowering cholesterol, FCl 721a is comparable to Raloxifene. Qu 819. FF5 Qu teaches that Raloxifene is "not effective against or may increase climacteric symptoms." Id. FF6. Yue teaches that in 2000 the "tissue-specific effects of each SERM [was] still unpredictable and was based mainly on animal and clinical studies. Yue III-286. FF7. Albertazzi reports a review of studies of SERMs on the urogenital tract from 1988 to Albertazzi 215. FF8. Albertazzi teaches that "[a]ll SERMS that have so far undergone clinical trials appear to be equally ineffective in relieving vasomotor symptoms, but their effects on vaginal lubrication appear to differ with each specific compound." Id. FF9. Abertazzi goes on to teach that Raloxifene "has no effect on vaginal lubrication." Id. 5

7 FF 10. Albertazzi teaches that "[b] ecause the effect of SERMs in the genito-urinary tract is not class-specific, it is important to evaluate them individually." Id. Principles of Law Expectation of success is assessed from the perspective of a person of ordinary skill in the art, at the time the invention was made. See Life Techs. Inc. v. Clontech Labs. Inc., 224 F.3d 1320, 1326 (Fed. Cir. 2000). ("Reasonable expectation of success is assessed from the perspective of the person of ordinary skill in the art. That the inventors were ultimately successful is irrelevant to whether one of ordinary skill in the art, at the time the invention was made, would have reasonably expected success." (citation omitted)). Later publications may be used "as evidence of the state of the art existing on the filing date of an application." In re Hogan, 559 F.2d 595, 605 (CCP A 1977). Analysis We agree with Appellants' contention that one of ordinary skill in the art at the time the invention was made would not have has a reasonable expectation that the substitution of FC 1271 a for Raloxifene in the method of Cullinan would have been successful in treating dyspameunia in woman. Appeal Br While Cullinan teaches that Raloxifene can be used to treat vaginal atrophy, subsequent literature demonstrates that it is ineffective in treating dyspameunia. FF 1, 8, and 9. In addition, one skilled in the art at the time the invention was made would have also understood that the effects 6

8 of SERMs on different tissues are unpredictable. FF 6, 8. Thus, while Raloxifene and FC1271a have similar effects on bone tissue, FF 4, one skilled in the art would not conclude that they would have the same effect on other tissues including vaginal tissues. The Examiner found that Appellants' evidence of unpredictability consists of articles published after the filing date of the instant application and are therefore irrelevant. Ans. 9. We disagree with the Examiner's conclusion. While the Yue and Albertazzi references were published after the filing date of Appellants' application, they discuss the state of the art at the time the invention was made. For example, the conclusion drawn by Yue regarding the unpredictability of the effects of SERMs was based on a review of work done in 1997 through 1999, all before the filing date of the present application. Yue III-286 and footnotes While Albertazzi was published in 2005, it is based on a review of clinical trials stemming back to FF 5. We agree with Appellants that the references are relevant to showing the state of the art at the time the application was filed. In re Hogan, 559 F.2d at 605. We agree with Appellants that the secondary references cited by the Examiner do not support the combination asserted by the Examiner. Qu teaches that Raloxifene is "not effective against or may increase climacteric symptoms." FF 5. Thus, the teaching of Qu would lead one skilled in the art not to use a similar compound, such as FC1271a, as a treatment for climacteric symptoms such as dyspameunia. 7

9 Conclusion of Law We conclude that the Examiner failed to establish by a preponderance of the evidence that the instant claims are obvious in view of Cullinan in combination with Qu and Degregorio as defined by 35 U.S.C. 103(a). SUMMARY We reverse the rejection claims 1--4, 6, 8-11, 16, 17, and 24. REVERSED 8