Ex Parte Blye et al

Patent Trials and Appeals Board

Mar 13, 2019

13022391 - (D) (P.T.A.B. Mar. 13, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/022,391 02/07/2011
45733 7590 03/15/2019
LEYDIG, VOIT & MAYER, LTD.
TWO PRUDENTIAL PLAZA, SUITE 4900
180 NORTH STETSON A VENUE
CHICAGO, IL 60601-6731
FIRST NAMED INVENTOR
Richard P. Blye
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.
707658 6599
EXAMINER
BAD IO, BARBARA P
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
03/15/2019 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
Chgpatent@leydig.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RICHRAD P. BLYE and HYUN K. KIM 1
Appeal2018-002088
Application 13/022,391
Technology Center 1600
Before JEFFREY N. FRED MAN, ELIZABETH A. LA VIER, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal2 under 35 U.S.C. § 134 from the Examiner's
rejection of claims to compositions for suppressing fertility in males which
have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 Appellants identify the Real Party in Interest as The United States of
America, as represented by the Secretary of the Department of Health and
Human Services. Appeal Br. 1.
2 We have considered and herein refer to the Specification of Feb. 2, 2011
("Spec."); Final Office Action of Mar. 1, 2017 ("Final Act."); Appeal Brief
of June 29, 2017 ("Br."); Examiner's Answer of Oct. 18, 2017 ("Ans."); and
Reply Brief of Dec. 18, 2017 ("Reply Br.").
Appeal2018-002088
Application 13/022,391
STATEMENT OF THE CASE
When a person is unable to synthesize testosterone,
therapy directed at replacing the missing hormone is commonly
undertaken. In practice, however, this therapy can be
problematic. For example, testosterone exhibits only weak
activity when administered orally. While parenteral
administration is possible, it is impractical because testosterone
remains active in the body for only a short time. Research has
therefore focused on identifying so-called synthetic androgens
that are acceptable substitutes for natural testosterone.
Spec. ,r 4. The Specification discloses a composition for oral administration
comprising a synthetic androgen. ,r,r 10 and 12.
Claims 98-1193 are on appeal. Claim 98 is representative and reads
as follows:
98. A pharmaceutical composition comprising 7a, 11B-
dimethyl-17B-hydroxyestr- 4-en-3-one 17-undecanoate and a
pharmaceutically acceptable carrier, wherein a single dose of
the pharmaceutical composition provides effective fertility
suppression in a male patient in need thereof.
98-119 have been rejected under 35 U.S.C. § 103(a) as unpatentable
over Cook. 4
3 The Examiner has indicated that if allowable subject matter is found, the
Examiner will object to claims 109-119 as being substantially duplicative of
claims 98-108. Final Act. 3. Appellants addressed this objection in the
Appeal Brief. Appeal Br. 2-3. Objections are not the proper subject of an
appeal but should be addressed in a petition. MPEP § 706.01.
4 Cook et al., US 5,952,319, issued Sept. 14, 1999 ("Cook").
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Appeal2018-002088
Application 13/022,391
DISCUSSION
Issue
The issue with respect to this rejection is whether Appellants have
presented sufficient objective evidence of non-obviousness to rebut the
Examiner's prima facie finding of obviousness
The Examiner finds that Cook teaches the preparation of androgenic
steroids including a steroid with the formula
wherein R3 is an acyl group, (CO)-R4 is n-C8H13 as well as R4 which is
C9H19. Ans. 2-3. The Examiner finds that Cook teaches that the
compounds exhibit enhanced activity relative to testosterone. Ans. 2. The
Examiner finds that Cook teaches administration of the compound as a
therapeutic agent. Ans. 3. The Examiner finds that the claimed compound
is structurally similar to that disclosed in Cook, with the key difference
being the number of carbon atoms in the R 4 group, with Cook teaching
analogs having fewer or greater carbon atoms in the R 4 group than the
claimed compound. Ans. 4. The Examiner concludes that it would have
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Appeal2018-002088
Application 13/022,391
been obvious to one of ordinary skill in the art to prepare a structurally
similar compound with similar properties to those recited in Cook. Ans. 4.
Appellants contend that there is sufficient evidence of non-
obviousness to rebut the Examiner's finding of obviousness. Appeal Br. 6.
Appellants contend that the claimed compounds exhibit unexpected
properties when compared to the compounds disclosed in Cook. Id. In
support Appellants point to the Declarations of Dr. Min Lee5 which report
two series of experiments comparing the claimed compound with those
disclosed in the prior art.
In the first set of experiments, Dr. Lee administered 1.25 µmol or 2.5
µmol of the claimed compound, 7a, 11B-dimethyl-17B- hydroxyestr-4-en-3-
one 17-undecanoate ("DMAU" a Cl 1 ester) and 7a,llB-dimethyl-17B-
hydroxyestr-4-en-3-one 17-enanthate ("DMAE" a C7 ester) disclosed in
Cook to castrated rats. Lee Deel. I ,r,r 3--4. Dr. Lee measured the change in
ventral prostate weights over time and found that the administration of
DMAU resulted in a greater increase in prostate weight in rats administer
DMAU than those administered DMAE. Id. ,r 5. Dr. Lee testified that the
increase in average weight demonstrates the androgenic properties of a
compound and that the data showed that DMAU had a higher androgenic
activity than DMAE. Id. Similar results were seen when measurements
were taken of the change in weight for Levator ani. Id. ,r,r 6-7. Dr. Lee
5 Declaration Under 37 C.F.R. § 1.132 From Min S. Lee, Ph.D. filed Apr.
26, 2016 ("Lee Deel. I") and Declaration Under 37 C.F.R. § 1.132 From Min
S. Lee, Ph.D., filed Dec. 5, 2016 ("Lee Deel. II").
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Appeal2018-002088
Application 13/022,391
stated that the results were surprising and unexpected given the slight
differences in structure between the compounds. Id. ,r 7. Dr. Lee states
Id.
One advantage that results from the unexpected improved
and longer acting activity of DMAU is the ability to provide a
patient with a long acting contraceptive, which may result in
improved patient compliance. An additional advantage that
results from the unexpected improved activity of DMAU is the
ability to provide a patient with a lower dose for hormonal
therapy, which typically results in fewer side effects and
improved patient compliance.
In the second series of experiments Dr. Lee tested the plasma stability
ofDMAU, DMAE and 7a, 11B-dimethyl-17B-hydroxyestr-4-en-3-one 17-
pentadecanoate ("DMAP" a C15 ester). Lee Deel. II ,r,r 3--4. Quantities of
the three compounds were added to both human and monkey plasma and
incubated for 24 hours. Id. ,r 4--5. Measurements of the amount of each
compounds in the samples were taken over time. Id. The results showed
that DMAU exhibited greater stability than either DMAE or DMAP. Id. ,r 5.
Dr. Lee states that this result was unexpected in that one skilled in the art
would have expected DMAP to exhibit the greatest stability. Id. ,r 8.
Appellants contend that the Examiner failed to properly consider the
evidence submitted by Appellants.
Principles of Law
[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prima facie
case ofunpatentability. If that burden is met, the burden of
coming forward with evidence or argument shifts to the
applicant.
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Application 13/022,391
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
"One way for a patent applicant to rebut a prima facie case of
obviousness is to make a showing of 'unexpected results,' i.e., to show that
the claimed invention exhibits some superior property or advantage that a
person of ordinary skill in the relevant art would have found surprising or
unexpected." In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995).
Analysis
We have considered the arguments presented by the Examiner and
Appellants as well as the declarations submitted by Dr. Lee and find that
Appellants have the better argument. Appellants have presented persuasive
evidence of unexpected results especially with respect to the stability of the
claimed compounds versus the prior art. We find that this evidence is
sufficient to overcome the Examiner's prima facie case of obviousness. The
Examiner's failure to adequately address the evidence advanced by
Appellants compels us to reverse the rejection.
The Examiner contends that Cook teaches that the claimed class of
compounds have enhanced activity and that it would have been a matter of
routine experimentation to find compounds which exhibit the greatest
enhanced activity. Ans. 6-7. The Examiner also argues that the issue of
unexpected results was addressed in two decisions of the Board in the parent
case. Ans. 8. In the parent case the Board found that there was insufficient
evidence of unexpected results. Id.
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Application 13/022,391
We have considered the Examiner's arguments and are unpersuaded.
While Cook states that the disclosed compounds exhibit superior properties,
the comparison was made with respect to testosterone and not within the
class of compounds. Cook col. 1, 11. 55-57. Here Appellants have
submitted evidence comparing the claimed compound with that disclosed in
Cook as well as another analog. Lee Deel. I ,r 3; Lee Deel. ,r 3. Thus the
unexpected results are not relative to testosterone as suggested by Cook but
are with the class of compounds suggested by Cook and therefore a
comparison with closer prior art.
The Examiner's argument regarding routine experimentation is also
unpersuasive. That one skilled in the art might have found a compound that
exhibited unexpected results, that does not detract from the fact that the
results are unexpected. Dr. Lee not only stated that the results are achieved
were unexpected, but has explained why the results are unexpected. For
example, with respect to the stability of the compounds, Dr. Lee explained
that one skilled in the art would have expected DMAP to have the greatest
stability. Lee Deel. II ,r 8. Thus it was surprising that DMAU had greater
stability than either DMAE or DMAP. Id. The Examiner has not presented
any persuasive arguments or evidence to address the unexpected results
reported by Dr. Lee.
The Examiner's reliance on the Board's prior decision is misplaced.
In Ex parte Blye, the evidence before the Board consisted of data relating to
ventral prostate weight similar to that data reported in Dr. Lee's first
declaration. Ex parte Blye, Appeal No. 2009-002563 at 5 (PTAB June 29,
2009). In finding the evidence of unexpected results to be unpersuasive, the
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Board found that the declarant, Dr. Blye, had failed to adequately explain
why the results achieved were unexpected. Id. at 8.
In the present case, Appellants have presented additional data not
before the prior panel - stability data. Lee Deel. II. Dr. Lee has provided a
clear explanation as to why the results shown in the stability experiments are
unexpected given the teachings of the art. Lee. Deel. ,r 8. The prior panel's
finding that the evidence of unexpected results was unpersuasive is
inapplicable to the present proceeding.
Conclusion of Law
We conclude that Appellants have presented sufficient persuasive
evidence to overcome the Examiner's prima facie case of obviousness.
SUMMARY
We reverse the rejection under 35 U.S.C. § 103(a).
REVERSED
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