Ex Parte Blom et al

Patent Trial and Appeal Board

Jul 6, 2016

12837292 (P.T.A.B. Jul. 6, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/837,292
757 7590
BGL
P.O. BOX 10395
CHICAGO, IL 60610
07/15/2010
07/07/2016
FIRST NAMED INVENTOR
TaruBlom
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.
13601-416 3916
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)
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
Appeal2013-010100
Application 12/837,292
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, 2016. 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.
Appeal2013-010100
Application 12/837,292
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-121-23.
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, 143
2 The Office Action dated August 27, 2012 ("Final Act.") and the
Examiner's Answer lists claims 1--4, 6, 8-11 and 16-26 as rejected and the
Examiner's statement of the rejection identifies claims 1-11 and 19-24 as
rejected. Final Act. 2; Ans. 3 and 5---6. A review of the prosecution history
reveals that claims 5, 7, 12-15 and 18-23 were cancelled. Amendment filed
August 29, 2011; see also Amendment filed May 21, 2012; Final Act dated
August 27, 2012 1. 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
Appeal2013-010100
Application 12/837,292
ENDOCRINOLOGY 809 (2000) ("Qu") and Degregorio, et al., W0967402 Al
(published Mar. 14, 1996) ("Degregorio"). Final Act. 3.
DISCUSSION
Issue
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 12 71 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
Appeal2013-010100
Application 12/837,292
and also teach that FC127a has selective estrogenic effect on
reproductive tissue.
Id. at 4--5.
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 - not
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
references3 cited by the Appellants demonstrate that at the time of the
invention, the effects of SERMs was considered unpredictable. Id. at 13-16.
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.
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-281 - III-288 (2000) ("Yue") and
Albertazzi, et al., Urogenital effects of selective estrogen receptor
modulators: a systematic review, 8 CLIMACTERIC 214--20 (2005)
("Albertazzi") as part of Appellants' evidence showing that the effects of
SERMs were deemed unpredictable at the time of the invention.
4
Appeal2013-010100
Application 12/837,292
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, 11. 19-23.
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 2004. 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
Appeal2013-010100
Application 12/837,292
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 12 71 a for Raloxifene in the method of
Cullinan would have been successful in treating dyspameunia in woman.
Appeal Br. 10-17. 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
Appeal2013-010100
Application 12/837,292
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 15-18. While Albertazzi
was published in 2005, it is based on a review of clinical trials stemming
back to 1995. 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
Appeal2013-010100
Application 12/837,292
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