Ex Parte Hochberg

Patent Trial and Appeal Board

Dec 7, 2015

10676287 (P.T.A.B. Dec. 7, 2015)

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.
10/676,287 10/01/2003 Richard Hochberg Y03-076US 7077
7590 12/07/2015
Henry D. Coleman
714 Colorado Avenue
Bridgeport, CT 06605-1601
EXAMINER
BADIO, BARBARA P
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
12/07/2015 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 RICHARD HOCHBERG1
__________

Appeal 2013-006456
Application 10/676,287
Technology Center 1600
__________

Before MELANIE L. MCCOLLUM, JEFFREY N. FREDMAN, and
ROBERT A. POLLOCK, Administrative Patent Judges.

POLLOCK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant appeals under 35 U.S.C. § 134(a) from the final rejection of
claims 39–56 and 65–75. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification teaches that estrogen antagonists are important
therapeutic agents for the treatment of menopausal symptoms (e.g.,
osteoporosis, cardiovascular risk factors) and for the treatment of estrogen
sensitive cancers, including breast cancer. Spec. 1–3. Moreover, there are
two major types of estrogen antagonists, pure antiestrogens, which are
typified by analogs of estradiol, and Selective Estrogen Receptor Modulators

1 Appellant identifies the Real Party in Interest as Yale University. Br. 3.
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(SERMS), which “are antiestrogenic in specific tissues, such as the uterus,
breast, vagina as well as the brain, while they are estrogenic in other
estrogen target organs, such as bone, liver and blood vessels.” Id. at 1. The
present invention relates to the latter category, in particular, “11-β estradiol
ester compounds and their use as locally active estrogens in the treatment of
the symptomology of menopause and to treat estrogen sensitive cancers,
including breast cancer.” Spec. Abstract.
Independent claims 39 and 48 are representative and set forth in full in
Appellant’s Claims Appendix. Claim 39 is generally directed to a method of
treating a patient suffering from an estrogen-sensitive cancer by
administering to the patient an effective amount of a selective estrogen
receptor modulator (SERM) having the general formula

Claim 48 is generally directed to a method of treating a patient suffering
from an estrogen-sensitive cancer by administering a SERM compound of
the same chemical genus.
The Examiner rejects claims 39–56 and 65–75 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of van den Broek,2 Cameron,3
Palkowitz,4 and Bodor.5 Ans. 3.6

2 van den Broek and de Winter, US 3,972,906, issued Aug. 3, 1976 (“van
den Broek”).
3 Cameron et al., US 2001/0025051 Al, published Sept. 27, 2001
(“Cameron”).
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ANALYSIS
Van den Broek discloses a genus of 11-substituted steroids of the
estrange series having the general formula

, which exhibit estrogenic (estrogen agonist) properties and are useful in the
treatment of estrogen-deficiency syndromes. Van den Broek, Abstract,
1:19–2:53; Ans. 3–4. The Examiner finds, and Appellant does not contest,
that the compounds recited in the instant claims overlap those of van den
Broek. Ans. 3–4, 8–9; Final Rejection 6, 8. The Examiner does not contest
Appellant’s argument that van den Broek neither exemplifies any of the
compounds claimed, nor recognizes that they have SERM activity, but relies
on the estrogenic properties of van den Broek’s compounds in sustaining the
rejection. See Ans. 7–14.
In particular, the Examiner contends that the instant claims would
have been prima facie obvious because van den Broek teaches estrogenic
compounds and their use in treating estrogen deficiency syndromes, whereas
Cameron, Palkowitz, and Bodor, collectively, teach the use of estrogenic

4 Palkowitz, US 6,268,361 B1, issued July 31, 2001.
5 Bodor and Simpkins, US 4,617,298, issued Oct. 14, 1986 (“Bodor”).
6 The Examiner has withdrawn the obviousness rejection in view of van den
Broek alone and the rejection under 35 U.S.C. § 112, second paragraph. Id.;
Final Rejection 4.
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compounds in the treatment of menopausal symptoms such as osteoporosis,
and their use in treating estrogen-dependent breast cancer.7 Ans. 5.
In order to determine whether the Examiner has established a prima
facie case of obviousness, we consider the factors set forth in Graham v.
John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content of the prior
art; (2) the differences between the prior art and the claims at issue; (3) the
level of ordinary skill in the relevant art; and (4) objective evidence of
nonobviousness, if present. Here, supported by the Declarations of Dr.
Richard Hochberg,8,9 Appellant contends that the sub-genus of van den
Broek’s compounds encompassed by the appealed claims exhibit
unexpected, and previously-unrecognized SERM activity, which render
them particularly useful in the treatment of both menopausal symptoms (via
their estrogenic activity) and estrogenic cancers, particularly breast cancers
(via their antiestrogenic activity). Br. 15–16; see Hochberg I ¶¶ 19–22;
Hochberg II ¶¶ 4–7, 11.
Accordingly, we consider anew the issue of obviousness under
35 U.S.C. § 103, carefully evaluating and weighing the evidence relied upon
by the Examiner, any other evidence of obviousness, including the objective
evidence of nonobviousness provided by Appellant. See In re Eli Lily &
Co., 902 F.2d 943, 945 (Fed. Cir. 1990) (holding that “[a]fter a prima facie
case of obviousness has been made and rebuttal evidence submitted, all the

7 Although Appellant argues that one of ordinary skill in the art at the time
of the invention would not have used estrogen agonists as taught by van den
Broek in the treatment of estrogen sensitive cancers, we need not reach that
issue here. See, e.g., Br. 18, 22–26.
8 Declaration of Dr. Richard Hochberg dated May 2, 2007. (“Hochberg I”).
9 Declaration of Dr. Richard Hochberg dated June 10, 2010. (“Hochberg
II”).
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evidence must be considered anew.”). Although “evidence of unexpected
results and other secondary considerations will not necessarily overcome a
strong prima facie showing of obviousness” (Süd-Chemie, Inc. v. Multisorb
Technologies, Inc., 554 F.3d 1001, 1009 (Fed. Cir. 2009)), in the present
case, we find that Appellant’s evidence of unexpected results, weighs in
favor of nonobviousness by a preponderance of the evidence.
Dr. Hochberg points, for example, to the Zhang10 Figures 5a and 5b as
evidence that a compound within the scope of the claims,

, is a SERM because it exhibits both estrogenic activity (reducing plasma
cholesterol) and antiestrogenic activity (reducing uterine weight).
Hochberg I ¶ 22. Dr. Hochberg testifies that E11-2,2ether and the other
SERM compounds encompassed by the claims are unlike the estrogenic
compounds described in van den Broek and are “therapeutic in menopausal
women because they reduce the risk of breast cancer (inhibiting estrogenic
effects in breast) while stimulating bone and reduc[ing] circulating lipids.”
Id.
Although we find Appellant’s evidence of unexpected results
persuasive, our analysis does not end here because “‘objective evidence of
non-obviousness must be commensurate in scope with the claims which the
evidence is offered to support.” In re Clemens, 622 F.2d 1029, 1035 (CCPA

10 Zhang et al., Nonpolar and Short Side Chain Groups at C-11β of Estradiol
Result in Antiestrogens, 48 J. Med. Chem. 1428 (2005).
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1980). The claims on appeal are directed to a class of 11-β-substituted
estradiol derivatives “where R is a sidechain group of at least 5 non-
hydrogen atoms in length.” Zhang as a whole reasonably suggests that, in
addition to E11-2,2ether, other compounds within the scope of the claims,
e.g., E11-2,2, exhibit SERM properties. See, e.g., Zhang, Abstract, Figure 1.
The Examiner implicitly finds, however, that the compound

(reproduced here from Zhang Figure 1) has a sidechain group, R, “of at least
5 non-hydrogen atoms in length,” as required by the claims, yet is taught by
the Specification as having “high agonistic activity but no antiestrogenic
activity” (Ans. 10 (citing Spec. 22)) and is thus not a SERM.
Accordingly, whether Appellant’s evidence of unexpected results is
commensurate with the claims as a whole turns on the construction of
“where R is a sidechain group of at least 5 non-hydrogen atoms in length,”
and, accordingly, whether E11-2,1 is within the genus claimed.
The Board “determines the scope of claims in patent applications not
solely on the basis of the claim language, but upon giving claims their
broadest reasonable construction ‘in light of the specification as it would be
interpreted by one of ordinary skill in the art.’” Phillips v. AWH Corp., 415
F.3d 1303, 1316 (Fed. Cir. 2005) (quoting In re Am. Acad. of Sci. Tech. Ctr.,
367 F.3d 1359, 1364 (Fed. Cir. 2004). In the present case, the Examiner
indicates that the R group sidechain of E11-2,1 comprises “5 non-hydrogen
atoms.” Ans. 9. Although technically correct, the claim language requires
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“a sidechain group of at least 5 non-hydrogen atoms in length,” suggesting
that a branched side chain may have at least 5 non-hydrogen atoms, but
insufficient length to satisfy the claim language. This reading is confirmed
by the Specification which expressly teaches that the structural difference
between
and

involves “lengthening the side-chain from 4 to 5 atoms (non-hydrogen).”
Spec. 22 (E11-2,1 and E11-2,2 reproduced here from Zhang Figure 1). The
branched R group of E11-2,1, thus, has 5 non-hydrogen atoms, but is not “at
least 5 non-hydrogen atoms in length” as required by the claims.
Because E11-2,1, and for the same reason E11-1,2Rev, are not within
the scope of the claimed compounds,11 we are unaware of any evidence that
Appellant’s evidence of unexpected results is not commensurate with the
claim scope sought. Considering the record as a whole, including
Appellant’s evidence of unexpected results, the rejection of record is not
supported by a preponderance of evidence.

11 In addition, we note that E11-2,2Rev, which is also noted by the Examiner
to be an agonist (Ans. 9), is specifically excluded by representative
claims 39 and 48, as well as additional independent claim 65.
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SUMMARY
We reverse the rejection of claims 39–56 and 65–75 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of van den Broek, Cameron,
Palkowitz, and Bodor.

REVERSED

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