Ex Parte Ebert et al

Patent Trial and Appeal Board

May 23, 2018

11205297 (P.T.A.B. May. 23, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111205,297 08/15/2005
96056 7590
Florek & Endres PLLC
1156 A venue of the Americas
Suite 600
New York, NY 10036
05/24/2018
FIRST NAMED INVENTOR
Charles Ebert
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.
141-728 2225
EXAMINER
BAD IO, BARBARA P
ART UNIT PAPER NUMBER
1628
MAILDATE DELIVERY MODE
05/24/2018 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 CHARLES EBERT, GARY HOEL,
ANGELA ANIGBOGU, and SAMIR ROY 1
Appeal2017-005920
Application 11/205,297
Technology Center 1600
Before RICHARD M. LEBOVITZ, RICHARD J. SMITH, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method of providing progestin-only contraception to a
woman. Claims 77-92, 96, and 97 are on appeal and stand rejected by the
Examiner under 35 U.S.C. § 103. We have jurisdiction under 35 U.S.C.
§ 6(b).
We reverse.
1 The Real Party in Interest is identified as "Actavis Laboratories." Appeal
Br. 3.
Appeal2017-005920
Application 11/205,297
STATEMENT OF THE CASE
The Specification states, "[t]he present invention relates to
formulations and methods for effective contraception while minimizing or
reducing adverse side effects associated with progestin-only contraception,
such as breakthrough bleeding." Spec. 1 :6-8.
Independent claim 77 is representative and is reproduced below:
77. A method of providing progestin-only contraception to a
woman while minimizing adverse side effects associated with
the progestin-only contraception, comprising the steps of:
1) applying a transdermal patch to the outer skin surface
of a woman and allowing the patch to remain applied to the outer
skin surface of the woman for at least seven days; and
2) removing the transdermal patch from the outer skin
surface after about seven days
wherein the transdermal patch comprises norethindrone
and/or norethindrone acetate as the only active hormonal agents
in an amount of from about 1 % w/w to about 15% w/w of the
transdermal formulation and a permeation enhancer comprising
isopropyl myristate and lauryl alcohol in an amount from about
3% w/w to about 15% w/w of the transdermal patch; and
the norethindrone and/ or norethindrone acetate are administered
from the transdermal patch at a rate and amount that provides a
minimum norethindrone serum level of at least 300 pg/ml from
about 24 hours to about 168 hours following application of the
patch to the outer skin surface and a maximum norethindrone
serum level of less than 1200 pg/ml about 24 to 96 hours
following application of the patch to the outer skin surface.
Appeal Br. 15 (Claims App'x; additional paragraphing added for clarity).
2
Appeal2017-005920
Application 11/205,297
The following rejection is appealed:
Claims 77-92, 96, and 97 stand rejected under 35 U.S.C. § 103(a)
over Jain2 and Singh. 3 Answer 2.
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Obviousness criteria includes: 1) scope and content of prior art;
2) differences between prior art and claims at issue; 3) level of ordinary skill
in the art at the time invention was made; and 4) objective evidence of non-
obviousness. Graham v. John Deere Co., 383 U.S. 1 (1966). "The
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results." KSR Int 'l Co.
v. Teleflex Inc., 550 U.S. 398, 416 (2007). "In determining whether the
subject matter of a patent claim is obvious, ... [ w ]hat matters is the
objective reach of the claim. If the claim extends to what is obvious, it is
invalid under§ 103." Id. at 419. When a prima facie case of obviousness
has not been established, the rejection must be reversed. In re Fine, 837
F.2d 1071, 1075 (Fed. Cir. 1988). "[D]ependent claims are nonobvious if
the independent claims from which they depend are nonobvious." In re
Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992).
2 US 5, 780,050 (issued July 14, 1998) ("Jain").
3 Mukul Singh et al., Biodegradable Norethindrone (NET.· Cholesterol)
Contraceptive Implants: Phase II-A: A Clinical Study in Women, 55
CONTRACEPTION 23-33 (1997) ("Singh").
3
Appeal2017-005920
Application 11/205,297
The Examiner determined the rejected claims would have been
obvious over the combination of the Jain and Singh publications. Final
Action 3--4 (citing Jain 6:10-13, 6:60-7:8); Answer 2-8 (citing Jain in its
entirety, but specifically at 1 :49-60, 3:42-53, 3:65--4: 13, 4:56-5:3, 6:50-
7:25, examples 1---6, claims 5, 6, 11, 12, 19-21, 26, and 27; citing Singh in
its entirety, but specifically at abstract, 24). The Examiner also cited
Anigbogu4 and Zieman5 as evidence to support the proposition that "the
skilled artisan in the art as it relates to contraception would know that
administration of a contraceptive agent is done over a period of several days,
inclusive of seven days," as claimed, but did not include the publications in
the statement of the rejection. Answer 5.
Appellants argue that the prior art combination does not teach or
suggest the claimed permeability enhancer combination of isopropyl
myristate ("IPM") and lauryl acid ("LA") and also does not teach or suggest
the claimed 7-day patch application followed by removal thereof. See
Appeal Br. 7, 9-13.
We agree with Appellants that the Examiner has not established that
the prior art combination set forth in the statement of the rejection teaches or
suggests including LA with IPM as a penetration enhancer or a 7-day patch
administration, as claimed.
The Examiner indicates that Jain discloses mono-alcohols as
penetration enhancers and implies that LA is such an alcohol. Answer 6.
4 US 2004/0037873 Al (pub. Feb. 26, 2004) ("Anigbogu").
5 Miriam Zieman, M.D. et al., Contraceptive Efficacy and Cycle Control
with the Ortho Evraâ„¢!Evraâ„¢ Transdermal System: The Analysis of Pooled
Data, 77 FERTILITY & STERILITY, supp. 2, s 13-S 18 (2002) ("Zieman").
4
Appeal2017-005920
Application 11/205,297
The Examiner points to "European Patent Application No. 43,738, published
Jun. 13, 1982," cited and incorporated in Jain (6:65---66) as listing dodecyl
alcohol (i.e., LA) as a "[c]ell-envelope disordering compound[]" (id. 6:60).
Final Action 3. If LA is disclosed in in Jain at all, it is only indirectly by
way of this European patent application and, even therein, only as one of a
list of many such compounds. The Examiner has not provided an adequate
reason to have selected the claimed combination of isopropyl myristate and
lauryl alcohol, when only the former compound is expressly disclosed in
Jain, while the latter compound is found only in the European Patent
Application, which is incorporated by reference. The Examiner's reference
to lauryl alcohol as being a mono-alcohol (Ans. 6) is an apparent reference
to its disclosure in Jain as a "solvent." Jain 7: 11-12. However, this is not
explicitly a teaching of it being a penetration enhancer. The Examiner did
not establish that one of ordinary skill in the art would have selected the two
claimed compounds in combination as a penetration enhancer.
The Examiner indicates that a 7-day application of a contraceptive
patch was a well-known concept. Jain is silent as to any actual application
of norethindrone and/or norethindrone acetate, as opposed to its stability.
Singh discloses various time periods of applying a contraceptive, but only in
relation to an implant, not a patch. The Examiner cites two references as
support for the proposition that a 7-day application of a patch was well-
known, i.e., Anigbogu and Zieman. However, these references were not part
of the statement of the rejection.
As held in Ex parte Raske, 28 USPQ2d 1304, * 1 (BP AI 1993):
We therefore view the reference to [two new references], at
page 4 of the Answer [but not in the statement of the rejection],
5
Appeal2017-005920
Application 11/205,297
as an improper effort to bring these references in the "back
door". Compare In re Hoch, 428 F.2d 1341, 1342 n. 3, 166
USPQ 406, 407 n. 3 (CCPA 1970) (where reference is relied on
to support a rejection, whether or not in a "minor capacity",
there would appear to be no excuse for not positively including
that reference in statement of the rejection). [The two new
references] are not positively included in the statement of
rejection, and we have considered the issue under 35 USC 103
based solely on the evidence contained in [the prior art
affirmatively recited in the rejection].
Here, the rejection may not be based solely on evidence in Anigbogu and
Zieman, but we conclude the rejection relies largely thereupon. We have not
considered Anigbogu nor Zieman, but decide the rejection based on the
references cited in the statement of the rejection.
On the evidence before us, we conclude the Examiner has not set forth
a prima facie case, supported by a preponderance of the evidence from the
publications included in the statement of the rejection, rather than mere
conclusions, that the claims would have been obvious.
SUMMARY
The rejection of the claims as obvious is reversed.
REVERSED
6