Ex Parte Pickar et al

Board of Patent Appeals and Interferences

Aug 31, 2009

10264187 (B.P.A.I. Aug. 31, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte JAMES HARRISON PICKAR and BARRY SAMUEL KOMM
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Appeal 2007-004477
Application 10/264,187
Technology Center 1600
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Decided: August 31, 2009
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Before TONI R. SCHEINER, DONALD E. ADAMS, and RICHARD M.
LEBOVITZ, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the Patent Applicants’ appeal from the Patent
Examiner’s rejection of claims 1-7 and 9-16 under 35 U.S.C. § 102(e).
Jurisdiction for this appeal is under 35 U.S.C. § 6(b). We affirm.

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Statement of the Case
The claims are directed to a pharmaceutical composition comprising
an estrogen, such as 17β-estradiol (Spec. 4:1-2; 16:10-11) and a compound
of formula (I) or (II). According to the Specification, the composition is for
“alleviating the symptoms of post-menopausal syndrome in women”, “to
minimize undesirable side effects of estrogen treatment or therapy”, and “to
minimize” amounts of estrogen necessary for a particular regime (Spec. 3:
23-30.) The formula (I) and (II) compounds are stated to be “estrogen
agonists/antagonists useful for the treatment of diseases associated with
estrogen deficiency.” (Spec. 3:31 to 4:2)
Claims 1-7 and 9-16 are pending and stand rejected under 35 U.S.C.
§ 102(e) as anticipated by Miller (U.S. Pat. No. 5,998,402, issued Dec. 7,
1999; filed Apr. 4, 1997; provisional application filed Apr. 19, 1996) (Ans.
3).
The claims were not argued separately and therefore stand or fall
together. 37 C.F.R. § 41.37(c)(1)(vii). Claim 1 is representative and reads
follows:
1. A pharmaceutical composition comprising a
pharmaceutically effective amount of one or more estrogens
and a pharmaceutically effective amount sufficient to achieve
the desired level of antagonism/agonism of said estrogen of a
compound having the structure: [of formula (I) or (II)1] or a
pharmaceutically acceptable salt thereof, and a
pharmaceutically acceptable carrier or excipient.

1 The complete formula (I) and (II) structures are listed on page 16 of the
Appeal Brief dated Nov. 11, 2006 (“App. Br.”).
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Statement of the Issue
The Examiner contends the Miller describes an example of a
pharmaceutical composition administered to rats that meets all the
limitations of claim 1, including comprising an estrogen combined with a
compound having a structure of the claimed formula (I) or (II) (Ans. 3-4).
Appellants contend that Miller does not describe or enable a
“pharmaceutical composition” comprising the “effective amounts” as
claimed (App. Br. 12-15; Reply Br. 2-4).
The issue in this appeal is therefore whether Appellants have
established that the Examiner erred in finding that Miller’s composition is a
“pharmaceutical composition” as recited in claim 1.

Principles of Law
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
In some cases, the inherent property corresponds to a claimed
new benefit or characteristic of an invention otherwise in the
prior art. In those cases, the new realization alone does not
render the old invention patentable. See Atlas Powder, 190
F.3d at 1347 (“[T]he discovery of a previously unappreciated
property of a prior art composition, or of a scientific
explanation for the prior art’s function, does not render the old
composition patentably new to the discoverer.”).
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005).
“[W]hile it is true that claims are to be interpreted in light of the
specification and with a view to ascertaining the invention, it does not follow
that limitations from the specification may be read into the claims.” Sjolund
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v. Musland, 847 F.2d 1573, 1581 (Fed. Cir. 1988). “[L]imitations are not to
be read into the claims from the specification.” In re Van Geuns, 988 F.2d
1181, 1184 (Fed. Cir. 1993).
“The specification shall conclude with one or more claims particularly
pointing out and distinctly claiming the subject matter which the applicant
regards as his invention.” 35 U.S.C. § 112, second paragraph.

Claim Interpretation
Because Appellants dispute that Miller’s composition administered to
rats would be understood by persons of ordinary skill in the art to be a
“pharmaceutical composition” as in claim 1, we begin our analysis with
claim interpretation.
The phrase “pharmaceutical composition” is not defined in the
Specification. However, the Specification characterizes the “invention” as a
“pharmaceutical composition” for “alleviating the symptoms of post-
menopausal syndrome in women” and “to minimize undesirable side effects
of estrogen treatment or therapy.” (Spec. 3: 23-30.) The composition
comprises an estrogen and a compound of formula (I) or (II). On pages 15-
19, the Specification describes the physiological activities of the estrogen
and formula (I) and (II) when administered to subjects. It is therefore
evident that a “pharmaceutical composition” must be suitable for
administration to a subject for it to achieve a physiological effect.
The claims do not recite that the “pharmaceutically effective amount”
is for treating a specific disease, symptom, or condition, or a specific
subject. Thus, we interpret the claims broadly to include amounts to achieve
any discernable physiological effect in a subject produced by administration
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of the estrogen and formula (I) or (II) compound. While the claimed
“pharmaceutical composition” is disclosed in the Specification for treating
post-menopausal syndrome in women, we do not require the “effective
amounts” to be restricted to this utility. Claim limitations are not ordinarily
imported from a specification into the claims. Sjolund v. Musland, 847 F.2d
at 1581; In re Van Geuns, 988 F.2d at 1184. It is the purpose of the claim,
not the specification, to point out the subject matter which is regarded as the
invention. 35 U.S.C. § 112, second paragraph. Thus, absent express
limitations in the claim, we will not interpret “pharmaceutical composition”
more narrowly than the claim language mandates.

Facts2
Miller
1. Miller describes indole compounds which are stated to be “useful as
estrogenic agents, as well as pharmaceutical compositions and methods of
treatment utilizing these compounds.” (Abstract.)
2. The Examiner found that Miller’s indole compounds met the limitations
of the formula (I) or (II) compounds of the instant claims (Ans. 3-4).
Appellants did not dispute this finding.
3. In Method No. 19, Miller describes an assay in which the “estrogenic and
antiestrogenic properties of the compounds were determined in an immature
rat uterotropic assay” (Col. 101, ll. 35-37).
4. Immature rats were injected daily with: 1) 100 µG compound; 2) 100 µG
compound + 1 µG 17β-estradiol; or 3) 1 µG 17β-estradiol. (Col. 101, ll. 38-
60.)

2 Findings and conclusions of fact (“F”).
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5. The compounds used in Method No. 19 were indoles, which Appellants
did not dispute meet the structural requirements of the claimed formula (I) or
(II) compounds.
6. After four days, each animal was sacrificed and the weight of its uterus
determined. (Col. 101, ll. 44-47.)
7. As shown in Miller’s Table 17, 17β-estradiol led to an increase in the
weight of the rat uterus. (Table 17, compare column titled “1 µG 17β
estradiol” to column titled “Vehicle.”)
8. Example Nos. 97 and 98 of Table 17 show compounds which
antagonized the effects of the 17β-estradiol. (Table 17, compare column
titled “100 µG cmpd + 1 µG 17β-estradiol” to column titled “1 µG 17β
estradiol.”) Other examples are also disclosed of compounds which
antagonized estradiol activity. (Table 17, Example Nos. 100 & 101.)

Comparison between claim 1 and Miller
9. Claim 1 is to a “pharmaceutical composition” comprising: (1) a
“pharmaceutically effective amount of one or more estrogens”; and (2) a
“pharmaceutically effective amount sufficient to achieve the desired level of
antagonism/agonism of said estrogen of a compound having the structure”
recited in formula (I) or (II).
10. Miller described an experiment in which a composition (100 µG
compound + 1 µG 17β-estradiol) was administered to rats by injection (F3-
4; Miller, Col. 101, “Method No. 19”; F4).
11. The composition administered to the rats by Miller contained 17β-
estradiol (F4), which is an estrogen as required by claim 1.
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12. The amount of estrogen in the composition was effective in causing an
increase in uterus weight (F7) (a physiological effect) and therefore was
present in a “pharmaceutically effective amount” as required by claim 1.
13. The composition also contained a compound which, Appellants have not
disputed, meets the limitations of a compound having the structure of
formula (I) or (II) as recited in claim 1.
14. The amount of the compound in the composition was effective in
antagonizing the estrogen (F8) (a physiological effect) and therefore was
present in a “pharmaceutically effective amount” as required by claim 1.

Analysis
Claim 1 was rejected by the Examiner under 35 U.S.C. § 102(b) as
anticipated by Miller. A claim is said to be “anticipated” when all its
limitations are described in a prior art reference. An anticipated claim is
directed to an invention which is not novel, and therefore, unpatentable by
statute. Anticipation is a question of fact. In re Gleave, 560 F.3d 1331,
1334-35 (Fed. Cir. 2009).
In this case, the Examiner provided adequate factual findings that all
the limitations of the claimed invention were described in Miller (Ans. 3-4).
As summarized above, we have reviewed these findings and find no fault in
them. Therefore, we turn to Appellants’ arguments.
Appellants contend that Miller does not describe a “pharmaceutical
composition.” Appellants asserted that Miller’s composition – which
undisputedly comprises both the estrogen and formula (I) or (II) compound
of claim 1 – is a “test condition” to determine antiestrogenicity which would
not have been interpreted by one of ordinary skill in the art to be “equivalent
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to the Appellants’ inventive pharmaceutical composition.” (Reply Br. 3).
Appellants’ position appears to be that because Miller was determining
whether its compounds had antiestrogenic activity, Miller was not
administering the composition to prevent or treat a disease, and therefore its
“test condition” was not a “pharmaceutical composition.” See App.
Br. 14-15.
The “test condition” disclosed in Miller is a composition which
contains effective amounts of estrogen and formula (I) or (II) compound as
recited in the claim (F10-14). The composition has a physiological effect in
rats and therefore is a pharmaceutical composition as we have interpreted
the phrase. While the “test condition” composition is not taught as useful
for treating post-menopausal syndrome in a woman, we discern no language
in the claim that would limit the claimed pharmaceutical composition to this
use. As stated above, it is the purpose of the claims, not the specification, to
point out the subject matter which is regarded as the invention. 35 U.S.C.
§ 112, second paragraph.
Appellants have not provided any evidence or testimony that a
“pharmaceutical composition” would exclude the composition utilized in
Miller’s Method No. 19, which as shown in Table 17, contains an estrogen
in an amount which causes the uterus to gain weight and the formula (I) or
(II) compound in an amount which antagonizes the estrogen activity (F12,
14). Therefore, contrary to Appellants’ argument, the evidence establishes
that composition is an appropriate form to be provided to a subject and to
produce discernable physiological effects when so provided. It is therefore a
pharmaceutical composition as we have interpreted the phrase.
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Appellants argue the “reference does not teach that any effect in
treating or preventing a disease, disorder, or symptom (a requirement of a
pharmaceutical composition containing effective amounts of compounds as
claimed) would be obtained by administering a compound of formula (I) or
(II) in conjunction with an estrogen.” (Reply Br. 3-4.)
Appellants have interpreted the scope of claim 1 too narrowly. As
discussed above, there is no limitation in the claim that would restrict it to a
composition to treat or prevent “a disease, disorder, or symptom.” Once
again, factual evidence is lacking from the record to establish Appellants’
alternative claim interpretation. It is well-established that during
prosecution claims are given their broadest interpretation as they would be
understood by a person of ordinary skill in the art having read the
Specification. Having read the Specification, it is evident the claimed
pharmaceutical composition must be in a form suitable for administration
and capable of achieving a physiological effect, but there is no express
definition that would limit it to one which must have been used to treat or
prevent a disease as asserted by Appellants. Appellants appear to be reading
limitations into the claim from the Specification.
Appellants also contend that Miller does not disclose an effective
amount of the compound of formula (I) or (II) “to achieve the desired level
of antagonism/agonism of said estrogen” as recited in claim 1 (Reply Br. 4.)
We do not interpret this limitation to demand an appreciation that a specific
level of effect was achieved. Rather, we interpret the claim to simply
require that a “level of antagonism/agonism” was achieved, i.e., that it be a
statement of effect. See Ex parte Batteux, Appeal No. 2007-0622 (BPAI,
Mar. 27, 2007, Informative Opinion).
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Conclusion of Law and Summary
Appellants have not established that the Examiner erred in finding that
Miller’s composition is a “pharmaceutical composition” as recited in claim
1. The anticipation rejection of claim 1 is affirmed. Claims 2-7 and 9-16
fall with claim 1 because separate reasons for their patentability were not
provided. 37 C.F.R. § 41.37(c)(1)(vii).

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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