Ex Parte Klose et al

Patent Trial and Appeal Board

Nov 25, 2014

11009361 (P.T.A.B. Nov. 25, 2014)

UNITED STATES PATENT AND TRADEMARKOFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/009,361 12/10/2004 Janine Klose GR-022 3285
12495 7590 11/25/2014
Jason D. Voight
5100A MacArthur Boulevard, NW
Second Floor
Washington, DC 20016
EXAMINER
CHONG, YONG SOO
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
11/25/2014 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 JANINE KLOE, JOHANNES BARTHOLOMAUS,
KLAUS-MICHAEL WILSMANN, and GEORG SCHRAMM
____________

Appeal 2012-009927
Application 11/009,361
Technology Center 1600
____________

Before DONALD E. ADAMS, ULRIKE W. JENKS, and CHRISTOPHER
G. PAULRAJ, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal2 under 35 U.S.C. § 134 involves claims 15, 17, 18, and
21–41 (App. Br. 23). Examiner entered a rejection under 35 U.S.C. § 103(a).
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 The Real Party in Interest is Grünenthal GmbH (App. Br. 2).
2 Notwithstanding Appellants’ contention to the contrary (App. Br. 2; Cf. id.
at 7), this Appeal is related to Appeal 2012-000518 (Application
11/009,938), decision affirming the rejection of all claims on appeal under
35 U.S.C. § 103(a) as obvious over Kulmann (US 2004/0219174 A1 (2004))
entered August 27, 2013.
3 All reference to the Appeal Brief refers to Appellants’ Supplemental
Appeal Brief, received February, 7, 2012. Further, our reference to page
numbers refers to the Supplemental Appeal Brief as if it was numbered
consecutively beginning with the first page.
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Application 11/009,361

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STATEMENT OF THE CASE
The claims are directed to a method for producing a contraceptive
effect. Claims 15 and 36 are representative and are reproduced in the
Claims Appendix of Appellants’ Brief.4
Claims 15, 17, 18, and 21–41 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Kulmann5 and Schramm.6
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Kulman suggests a method of producing a contraceptive effect,
comprising the administration of 0.5–3 mg chlormadinone acetate and 10–50
μg ethinylestradiol (Ans. 5; Kulman Abstract; ¶ 39; 3: col. 1, l. 50–4: col. 1,
l. 14 (Claim 1); 4: col. 2, ll. 5–18 (Claim 19).)
FF 2. Kulman’s method of hormonal contraception lasts several years and
comprises the daily administration of a hormone-containing component
comprising chlormadione acetate and ethinylestradiol for at least 22 days
followed by the daily administration of a hormone-free component for 4–10
days (Ans. 5; FF 1; Kulman 4: 24–26).
FF 3. Examiner finds that Kulmann fails to suggest that Kulmann’s
method treats, inter alia, dysmenorrhoea (see generally Ans. 5–7).

4 We note that Appellants’ Claims Appendix identifies two claims as “Claim
28.” For clarity, we refer to the second appearance of “Claim 28” as claim
38.
5 Kulmann, US 2004/0219174 A1, published Nov. 4, 2004.
6 G. Schramm and D. Steffens, Contraceptive Efficacy and Tolerability of
Chlormadinone Acetate 2mg/Ethinylestradiol 0.03mg (Belara®), 22(4) Clin.
Drug Invest. 221–231 (2002).
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Application 11/009,361

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FF 4. Schramm suggests that the administration of a combination of 2 mg
of chlormadione acetate and 30 μg of ethinylestradiol “had excellent
contraceptive efficacy . . . with beneficial reductions in . . . dysmenorrhoea”
(Schramm Abstract; Ans. 6).
FF 5. Schramm suggests the administration of a combination of 2 mg of
chlormadione acetate and 30 μg of ethinylestradiol to a population ranging
from less than 19 to greater than 38 years of age (Schramm 224: Fig. 1; see
generally Ans. 5–6).
ANALYSIS
Based on the combination of Kulmann and Schramm, Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious to treat, inter alia, dysmenorrhea and produce “a
contraceptive effect by administering [a combination of] ethinyloestradiol
and chlormadione acetate” to “pre- or perimenopausal women” (Ans. 6–7).

Claim 15:
Schramm specifically directs a person of ordinary skill in this art to a
combination of chlormadione acetate and ethinyloestradiol (FF 4).
Therefore, we are not persuaded by Appellants’ contention that a person of
ordinary skill in this art would have to pick chlormadione acetate and
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Application 11/009,361

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ethinyloestradiol out of Kulmann’s list of effective agents (App. Br. 5; Reply
Br. 3–4; see FF 1–2).7
Schramm specifically suggests that the administration of a
combination of 2 mg of chlormadione acetate and 30 μg of ethinylestradiol
“had excellent contraceptive efficacy . . . with beneficial reductions in . . .
dysmenorrhoea” (FF 4). Therefore, we are not persuaded by Appellants’
contention that Kulmann failed to recognize that Kulmann’s method had the
additional benefit of treating, inter alia, dysmenorrhoea (see App. Br. 5;
Reply Br. 3–4; FF 3).
Kulmann suggests that the effective dosage range of ethinylestradiol
is in the range of 10–50 μg (FF 1). Therefore, we are not persuaded by
Appellants’ contention that “there is nothing in Schramm’s disclosure that
would suggest to a skilled artisan that the level of ethinylestradiol could be
reduced. Rather, a skilled artisan, after reading Schramm, is led to believe
that 30 μg of ethinylestradiol are necessary to achieve a contraceptive result”
(App. Br. 5; Reply Br. 4–5; Cf. Ans. 9–10).
We recognize that Appellants’ claim 15 requires the administration of
the composition to pre- or perimenopausal women (see Appellants’ claim
15). Nevertheless, we also recognize that Appellants’ claim 17 depends

7 See also Appeal 2012-000518:
Making the claimed invention would have required no more
than choosing two of the seventeen specific hormones
suggested in . . . [Kulmann], where the reference expressly
suggests using hormones in combination . . ., and choosing a
dosage for those hormones from within the ranges set out in the
prior art. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417
(2007).
(Decision 5.)
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from and further limits the age of the woman to over 35 years old. Taken
together, the age range encompassed by the term pre- or perimenopausal
women, as set forth in Appellants’ claim 15, encompasses more than women
over 35 years of age and necessarily includes women less than 35 years of
age. See Free Motion Fitness, Inc. v. Cybex Int’l, Inc., 423 F.3d 1343, 1351
(Fed. Cir. 2005) (“The doctrine of claim differentiation creates a
presumption that each claim in a patent has a different scope).
Schramm suggests the administration of a combination of 2 mg of
chlormadione acetate and 30 μg of ethinylestradiol to a population ranging
from less than 19 to greater than 38 years of age (FF 5). Therefore, we are
not persuaded by Appellants’ contention that “a person of ordinary skill in
the art would not have taken . . . [Schramm] into account when looking to
treat conditions in women older than 35 years” (App. Br. 6; Cf. Ans. 10–11).
We recognize, but are not persuaded by, Appellants’ contention, with
reference to “‘enclosure 2’ and ‘enclosure 3’ submitted on December 3,
2010,” that “[p]eri- and premenopause are terms used to describe the
menopause transition years[, which] . . . typically begins in the mid to late
40s” (Reply Br. 5). For the reasons discussed above, this contention
attempts to construe the terms peri- and premenopause in a manner that is
inconsistent with the way these terms are used in Appellants’ claims.
Therefore, we are not persuaded by Appellants’ evidence and contention.
For the foregoing reasons we find no error in Examiner’s prima facie
case of obviousness.

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Appellants’ Secondary Evidence:
Appellants present the Schramm Declaration8 to establish that
Appellants’ “claimed method is suitable for treating cycle instabilities and
increased bleeding, although the inventively used combination comprises
ethinyloestradiol only in an amount of 20 μg . . . instead of 30 μg, as taught
by the cited Schramm document” (Reply Br. 6). This evidence, however, is
consistent with Kulmann’s suggestion that the effective dosage range of
ethinyloestradiol is in the range of 10–50 μg (FF 1). Schramm emphasizes
this point by concluding that the administration of a composition comprising
chlormadione acetate and 20 μg ethinyloestradiol “is comparable” to a
composition comprising chlormadione acetate and 30 μg of ethinyloestradiol
(Schramm Dec. ¶ 7). Therefore, we are not persuaded by Appellants’
contention that “[i]t was surprisingly and unexpectedly found that the
incidence of intermenstrual bleeding is virtually the same between
combinations as used in the presently claimed method and the combination
according to Schramm” (Reply Br. 6; App. Br. 6).
We recognize, but decline, Appellants’ invitation to consider a
“Supplemental Declaration Schramm II,”9 which, according to Appellants,
“was supposed to be filed with the appeal brief” (Reply Br. 6 (emphasis
removed)). 37 C.F.R. § 41.33(d)(1); see also Ex parte Borden,
http://www.uspto.gov/ip/boards/bpai/ decisions/inform/fd08004312.pdf
(informative) (Appellant fails to “explain what ‘good cause’ there might be
to consider the new argument. On this record, Appellant’s new argument is
belated.”).

8 Declaration of Dr. Georg Schramm, executed August 27, 2009.
9 Supplemental Declaration of Dr. Georg Schramm, executed July 17, 2009.
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We do, however, recognize Appellants’ contentions in relation to a
publication in “The European Journal of Contraception and Reproductive
Health Care” and a Declaration “filed in support of patentability in a related
application, USSN 11/009,938” (App. Br. 6–8). The subject matter of
Application 11/009,938 was addressed in Appeal 2012-000518. We are not
persuaded by Appellants’ contentions regarding the publication in “The
European Journal of Contraception and Reproductive Health Care” and the
Declaration filed in Application 11/009,938, Appeal 2012-000518 for the
reasons set forth on pages 6–8 of Appeal 2012-000518, which we
incorporate herein by reference.

Claim 36:
For the foregoing reasons, we are not persuaded by Appellants’
contention that (a) “Kulmann fails to teach the specifically claimed
combination of ethinylestradiol and chlormadinone acetate” and that this
alleged deficiency cannot be remedied by Schramm (App. Br. 9); (b) the
August 27, 2009 Schramm Declaration establishes unexpected results (id. at
10); (c) Schramm fails to suggest treating women over the age of 35 (id.);
and (d) a report in the “The European Journal of Contraception and
Reproductive Health Care” and a Declaration “filed in support of
patentability in a related application, USSN 11/009,938” establish
unexpected results (id. at 10–11).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claims 15 and 36 under 35
U.S.C. § 103(a) as unpatentable over the combination of Kulmann and
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Application 11/009,361

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Schramm is affirmed. Claims 17, 18, 21–35, and 37–41 are not separately
argued and fall with claim 15.

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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