BAYER PHARMA AKTIENGESELLSCHAFT

Patent Trials and Appeals Board

Oct 12, 2021

2021000781 (P.T.A.B. Oct. 12, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
14/783,839 10/09/2015 Barbara SCHÜTT 2923343-497000 3025
84331 7590 10/12/2021
McBee Moore & Vanik, IP, LLC
510 South Market Street
Frederick, MD 21701
EXAMINER
HUI, SAN MING R
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
10/12/2021 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):
docketing@mmviplaw.com
smcbee@mmviplaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte BARBARA SCHÜTT,
MARCUS-HILLERT SCHULTZE-MOSGAU, and
ANDREAS KAISER
____________

Appeal 2021-000781
Application 14/783,839
Technology Center 1600
____________

Before DONALD E. ADAMS, TAWEN CHANG, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1–5, 7–9, 11, 14, and 19–28 (Final Act.2 2). We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as “Bayer
Pharma Aktiengesellschaft (Appellant’s June 26, 2020, (Appeal Br.) 2).
2 Examiner’s November 29, 2019, Final Office Action.
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Application 14/783,839

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STATEMENT OF THE CASE
Appellant’s disclosure relates to
a pharmaceutical composition comprising a progesterone
receptor antagonist namely (11β,17 β)-17-Hydroxy-11-[4-(
methylsulphonyl)phenyl]-17-(pentafluoroethyl)estra-4,9-dien-
3-one at the dosage of about 0.5 to 5 mg and more particularly
2 mg. Additionally, . . . [Appellant’s disclosure relates] to the
use of the novel pharmaceutical composition for treatment of
and/or prophylaxis of gynaecological diseases, such as fibroids
of the uterus (myomas, uterine leiomyoma), endometriosis or
excessive menstrual bleeds, and method for obtaining such
composition and oral dosage form.
(Spec. 1.) Appellant’s claim 1 is reproduced below:
1. A method of treatment and/or prophylaxis of a
gynaecological disease characterized by excessive uterine
bleeding, endometriosis or excessive menstrual bleeds
comprising administering, to a woman in need thereof, an
effective amount of a pharmaceutical composition comprising 1
to 5 mg of (11β,17β)-17-Hydroxy-11-[4-
(methylsulphonyl)phenyl]-17(pentafluoroethyl)estra-4,9-dien-
3-one of formula

or a salt thereof.
(Appeal Br. 29.)
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Claims 1–5, 7–9, 11, 14, and 19–28 stand rejected under 35 U.S.C.
§ 103 as unpatentable over Schwede.3

ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Schwede “relates to 17-hydroxy-17-pentafluoroethyl-estra-4,9(10)-
dien-11-aryl derivatives . . . for the treatment and/or prophylaxis of diseases,
in particular of fibroids of the uterus (myomas, uterineleiomyoma),
endometriosis, heavy menstrual bleeds, meningiomas, hormone-dependent
breast cancers and complaints associated with the menopause or for fertility
control and emergency contraception” (Schwede, Abstr.; see also Ans.4 3).
FF 2. Schwede identifies Appellant’s claimed compound as a preferred
compound within the scope of its 17-hydroxy-17-pentafluoroethyl-estra-

3 Schwede et al., WO 2011/009531 A2, published Jan. 27, 2011. Examiner
relies on the “English equivalent,” Schwede et al., US 2012/0149670,
published Jun. 14, 2012. In addition, we acknowledge Appellant’s
explanation that Schwede’s US 2012/0149670 published application
issued as two U.S. patents, 9,717,739 and 10,155,004. The
’739 patent claims the compound recited in the claims,
pharmaceutical compositions comprising same, and methods
for treating enumerated gynaecological disorders using an
“effective amount’ of the compound. The ’004 patent claims a
method of treating gynaeocological disorders including heavy
bleeding, uterine fibroids, and endometriosis, or achieving
fertility control by administering the recited compound or
pharmaceutical acceptable salts thereof.
(Appeal Br. 8, n.1.)
4 Examiner’s August 28, 2020, Answer.
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4,9(10)-dien-11-aryl derivatives (see Schwede ¶¶ 47, 115–116; see also Ans.
3).
FF 3. Schwede discloses “a method of treatment and/or prophylaxis of
diseases, in particular the aforementioned diseases, using 0.1-100 mg of the
compounds according to the invention per day per patient in the treatment of
fibroids of the uterus or endometriosis” (Schwede ¶ 65; see also Ans. 3).
FF 4. Examiner finds that Schwede does not “expressly teach . . . [a]
dosage . . .[of] 1-5, 1-4.5, 2mg, or 4mg” (Ans. 3).
ANALYSIS
Based on Schwede, Examiner concludes that, before the effective
filing date of Appellant’s claimed invention, it would have been prima facie
obvious “to adjust the amount of the active to 2mg,” by utilizing routine
experimentation to optimize the dosage, to correspond to a patient and
condition treated (see Ans. 3–4; FF 1–4). We find no error in Examiner’s
conclusion of obviousness.
Where, as here, “the general conditions of a claim are disclosed in the
prior art, it is not inventive to discover the optimum or workable ranges by
routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955); see
also Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed.
Cir. 2004) (“[W]here there is a range disclosed in the prior art, and the
claimed invention falls within that range, there is a presumption of
obviousness.”); Ans. 4–6; cf. Appeal Br. 12–18 (citing Appellant’s Exhibit
A). For the foregoing reasons, we are not persuaded by Appellant’s
contentions regarding In re Stepan Co., 868 F.3d 1342 (Fed. Cir. 2017) and
In re Grose, 592 F.2d 1161 (CCPA 1979) (see Appeal Br. 15–18). For the
same reasons, we are not persuaded by Appellant’s contention that legal
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precedent regarding dosage ranges supports a conclusion of non-obviousness
(see id. at 19).
On this record, Appellant’s claimed method requires the
administration of a composition comprising 1–5 mg of Appellant’s
11β,17β)-17-Hydroxy-11-[4-(methylsulphonyl)phenyl]-
17(pentafluoroethyl)estra-4,9-dien-3-one, to a woman in need thereof (see
Appellant’s claim 1, reproduced above). In order to be persuasive of non-
obviousness, “[e]vidence of secondary considerations must be reasonably
commensurate with the scope of the claims.” In re Huai-Hung Kao, 639
F.3d 1057, 1068 (Fed. Cir. 2011). Therefore, we are not persuaded by
Appellant’s contentions regarding the unexpected result associated with the
administration of its composition at a dosage of 1 mg per day, which is not
commensurate in scope with Appellant’s claimed invention (see Appeal Br.
8–9; cf. Ans. 7–8).
As discussed above, Schwede teaches a method of treating a
gynaecological disease within the scope of Appellant’s claimed method with
Appellant’s claimed compound. “[W]hen unexpected results are used as
evidence of nonobviousness, the results must be shown to be unexpected
compared with the closest prior art.” In re Baxter Travenol Labs., 952 F.2d
388, 392 (Fed. Cir. 1991)). Thus, we are not persuaded by Appellant’s
contentions regarding a comparison of its claimed method against methods
of using structurally distinct compounds (see Appeal Br. 19–27 (citing
Appellant’s Exhibit B); cf. Ans. 7 (Examiner makes clear that Lonaprisan,
Ulipristal, and Asoprisnil are structurally distinct from the closest prior art
(i.e. Schwede) and the compound set forth in Appellant’s claimed method)).
For the foregoing reasons, we are not persuaded by Appellant’s contention
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that “[p]recedent [c]ompels [r]eversal based on . . . [u]nexpected [r]esults”
(see Appeal Br. 27–28).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 1 under 35 U.S.C.
§ 103(a) as unpatentable over Schwede is affirmed. Claims 2–5, 7–9, 11,
14, and 19–28 are not separately argued and fall with claim 1.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–5, 7–9, 11,
14, 19–28
103 Schwede 1–5, 7–9,
11, 14,
19–28

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). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2019).

AFFIRMED