Ex Parte Levine et al

Patent Trial and Appeal Board

Feb 1, 2017

11849862 (P.T.A.B. Feb. 1, 2017)

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.
11/849,862 09/04/2007 Howard L. Levine CL028x-US 6447
20529 7590 02/03/2017
NATH, GOLDBERG & MEYER
Joshua Goldberg
112 South West Street
Alexandria, VA 22314
EXAMINER
CABRAL, ROBERT S
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
02/03/2017 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):
USPTO@nathlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HOWARD L. LEVINE,
WILLIAM J. BOLOGNA, and DOMINIQUE DE ZEIGLER
Appeal 2014-005216
Application 11/849,862
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JOHN G. NEW, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134(a) involves claims 3—7, 10, 11, 26,
27, 45, and 46 (App. Br. 7; Final Act. 22). Examiner entered rejections
under 35 U.S.C. § 102(b) and 35 U.S.C. § 103(a). We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the real party in interest as “Columbia Laboratories,
Inc.” (App. Br. 3).
2 Examiner’s January 17, 2013 Final Office Action. We note Examiner’s
reference to Examiner’s June 27, 2012 Non-Final Office Action (Non-Final
Act.) for the statement of, and rationale for, the anticipation and obviousness
rejections before this Panel for review {see Final Act. 2).
Appeal 2014-005216
Application 11/849,862
STATEMENT OF THE CASE
Appellants disclose “a pharmaceutical composition for treating or
preventing pelvic pain associated with uterine dysrhythmia, as well as to a
method for treating or preventing such pain” (Spec. 1:11—13). In this regard,
Appellants disclose that their
method focus[es] in part on local, topical use of treating agents
for absorption into local tissue to prevent or treat the underlying
abnormal or undesireable [sic] muscle contractions that are
causing the pain or discomfort rather than merely relieving or
masking the resulting pain or discomfort without affecting the
cause.
{Id. at 13—17). Claim 26 is representative and reproduced below:
26. A method of pre-treating or preventing pelvic pain
associated with uterine dysrhythmia, comprising vaginally
administering, to a patient in need thereof, a composition that
includes a therapeutically effective amount of lidocaine, which
normalizes abnormal uterine contractions, and a bioadhesive,
water-swellable, water-insoluble, cross-linked polycarboxylic
acid polymer that releases the lidocaine over an extended period
of time after administration, wherein the treatment is
administered prior to anticipated onset ofpelvic pain associated
with uterine dysrhythmia so as to prevent pelvic pain associated
with uterine dysrhythmia, wherein the pelvic pain is also
associated with secondary dysmenorrhea.
(App. Br. 22 (emphasis added).)
The claims stand rejected as follows:
Claims 3—7, 10, 11, 26, 27, 45, and 46 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Harrison.3
3 Harrison et al., WO 98/56323 A1 (publ. Dec. 17, 1998).
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Application 11/849,862
Claims 3—7, 10, 11, 26, 27, 45, and 46 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Harrison and Edelstam.4
Anticipation'.
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Harrison teaches Appellants’ claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Appellants disclose:
Dysmenorrhea is associated with pain typically related to
the menstrual cycle and can be primary or secondary. . . .
[PJrimary dysmenorrhea . . . pain is cramping or sharp and lasts
the first few days of the menstrual period. It may radiate to the
back, thighs, or deep pelvis. Occasionally, nausea or vomiting
occurs. Secondary dysmenorrhea may be due to endometriosis
or cervical stenosis or, if associated with heavy menstrual flow,
to fibroids, adenomyosis, or large endometrial polyps.
(Spec. 2:29 — 3:2; see also Harrison 1:8—11 (Harrison discloses that
“[djysmenorrhea, which may be primary or secondary, is the occurrence of
painful uterine cramps during menstruation. In secondary dysmenorrhea,
there is a visible pelvic lesion to account for the pain, whereas only a
biochemical imbalance is responsible for primary dysmenorrhea”);
Bettendorf5 599:col. 1,11. 8—13 (“In primary dysmenorrhea, pain is
associated with the onset of menstrual flow with a typical duration of 2—3
4 Edelstam, US 2003/0004213 A1 (publ. Jan. 2, 2003).
5 Brittany Bettendorf et al., Dysmenorrhea: Contemporary Perspectives, 63
Obstetrical & Gynecological Survey 597-603 (2008). We recognize
Appellants’ reliance on Bettendorf as an evidentiary document (see App. Br.
11).
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Application 11/849,862
days. In secondary dysmenorrhea, pain onset occurs 1—2 weeks before
menstrual flow and persists beyond the cessation of bleeding”).)
FF 2. Appellants disclose
a pharmaceutical composition that includes an effective amount
of a treating agent[, such as a local anesthetic], intended to reduce
or relieve uterine dysrhythmia by normalizing propagation of the
nerve impulses and/or nerve impulses or cell to cell
communication (i.e., faster, slower, or more consistent) causing
the abnormal or undesireable [sic] contractions, together with a
pharmaceutically acceptable bioadhesive carrier[, such as
polycarbophil],
(Spec. 4:21—25; see id. at 6:19-22 (Appellants disclosure “relates to a
method for treating or preventing pelvic pain that includes administering [a]
composition vaginally,” wherein “[s]uch administration demonstrates a
therapeutic benefit for treating or preventing pelvic pain associated with
uterine dysrhythmia”); id. at 15—16 (disclosing polycarbophil as
bioadhesive, water-swellable, water-insoluble, cross-linked polycarboxylic
acid polymer); App. Br. 22 (Claim 27: The method of claim 26, wherein the
polymer comprises polycarbophil); see Harrison 2:15—24 (Harrison discloses
“a method for treating a human female suffering from dysmenorrhea
comprising contacting the vaginal epithelium of the female with a
pharmaceutical agent[, such as a local anesthetic,]... in combination with a
biocompatible excipient[, such as polycarbophil,] acceptable for application
of the agent to the vaginal epithelium”]); Harrison 4:21—22 (“the
biocompatible excipient can include . . . polycarbophil”); see generally Non-
Final Act. 3 4.)
FF 3. Appellants define a “[l]ocal anesthetic[]... as a drug which may be
used to provide local numbness or pain relief, by preventing the propagation
of nerve impulses that relay or report the sensation of pain” (Spec. 4:31—33;
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see generally Harrison 2:15—24 and 3:7—8; see also; see generally Non-Final
Act. 3—4).
FF 4. Appellants disclose “[ljidocaine [as] a preferred anesthetic for use
with [Appellants’] invention” (Spec. 5:1—2; id. at 7:15 (“a preferred local
anesthetic for use with the present invention is lidocaine. Lidocaine is an
antidysrhythmic agent”); see Harrison 12:16 (“[preferred local anesthetics
include Lidocaine”); see also Harrison 3:7—8; see generally Non-Final Act.
3—4).
FF 5. Appellants’ composition, when administered, “diffuses through the
vaginal mucosal into the target tissue,” wherein “[r]elief from pain is
provided by treatment or prevention of the cause or source of the pain, e.g.,
increased or dysrhythmic contractility” (Spec. 6:32; id. at 34 — 7:1; see id. at
9:27—29 (Appellants disclose that their “invention . . . may be used to treat
the underlying cause of the pain by delivering sufficient quantity of the
treating agent to the affected tissue for an extended period of time”); see also
id. at 6:6—9 (“The bioadhesive carrier includes a bioadhesive, water-
swellable, water-insoluble, cross-linked polycarboxylic polymer. A
preferred carrier, which may be in a gel formulation, contains a
polycarbophil base designed to give controlled, extended release of the local
anesthetic through the vaginal mucosa”); see generally Harrison 2:15—24;
see generally Non-Final Act. 3—4).
FF 6. Appellants define the term “[prevention” as “includ[ing] pre­
treatment of pelvic pain, such as by administration of compounds in
accordance with [Appellants’] invention, preferably prior to onset of
symptoms, to a patient who is likely to experience pelvic pain, such as that
due to uterine dysrhythmia,” wherein, “[prevention, or pre-treatment, can
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be accomplished by administration of the compounds of the present
invention about 2 to 3 days prior to the expected onset of symptoms” (Spec.
7:1—7 (emphasis added); see Harrison 24:12—16 (Harrison discloses the
application of Harrison’s composition “several hours before or just after
onset of menstruation in order to treat or prevent dysmenorrhea. The
treatment would continue for a few hours up to 2 to 3 days, as needed, to
alleviate and prevent painful menstruation and symptoms”) (emphasis
added); see generally Non-Final Act. 3 4).
FF 7. Harrison discloses an “Ibuprofen Containing Gel for Intravaginal
Application,” wherein the “gel [is] comprised of the following ingredients:
glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil,
glyceride, sodium hydroxide, sorbic acid, and purified water” (Harrison
30:15—19 (Example 7) (emphasis added)); see also id. at 32:1 and 10—13
(“Each of the drugs listed in this example [9, which includes lidocaine (100
mg),] are substituted in Example 4, 5, 6 or 7, unless previously described,
and repetition of the procedures there detailed affords other compositions
according to [Harrison’s] invention” (emphasis added)); see generally Non-
Final Act. 3 4).
ANALYSIS
Examiner finds that Harrison anticipated Appellants’ claimed
invention (Non-Final Act. 3—5).
“Dysmenorrhea is associated with pain typically related to the
menstrual cycle and can be primary or secondary” (FF 1). “[P]rimary
dysmenorrhea . . . pain is cramping or sharp and lasts the first few days of
the menstrual period” (id.). “In secondary dysmenorrhea, pain onset occurs
1—2 weeks before menstrual flow and persists beyond the cessation of
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bleeding” (id.). Appellants’ claim 26 is drawn to “[a] method of pre-treating
or preventing pelvic pain associated with uterine dysrhythmia . . . , wherein
the pelvic pain is also associated with secondary dysmenorrhea” (see App.
Br. 22 (Appellants’ claim 26)). We interpret the method of Appellants’
claim 26 to require the pre-treatment or prevention of pelvic pain associated
with uterine dysrhythmia, i.e., primary dysmenorrhea; wherein the pre­
treatment or prevention of pelvic pain associated with uterine dysrhythmia,
also treats pelvic pain associated with secondary dysmenorrhea (cf. Reply
Br. 4 (Appellants’ “claim terms make it clear that the claims address pelvic
pain from dysrhythmia that is associated at least with secondary
dysmenorrhea, regardless of whether or not any other cause also may be
present, such as primary dysmenorrhea”); see also id. at 7).
Notwithstanding Appellants’ contention to the contrary, Appellants’
claim 26 requires the pre-treatment or prevention of pelvic pain associated
with uterine dysrhythmia, wherein the pelvic pain is also associated with
secondary dysmenorrhea (App. Br. 22 (Appellants’ claim 26); cf. Reply Br.
7). There is no requirement in Appellants’ claim 26 that the uterine
dysrhythmia is associated with secondary dysmenorrhea. To the contrary,
Appellants’ claim 26 draws a clear distinction between pelvic pain
associated with uterine dysrhythmia, i.e., primary dysrhythmia, and pelvic
pain associated with secondary dysmenorrhea (see App. Br. 22 (Appellants’
claim 26)). Thus, by pre-treating pelvic pain associated with dysrhythmia,
i.e., primary dysmenorrhea, pelvic pain associated with secondary
dysmenorrhea, which may occur prior to primary dysmenorrhea, is also
treated.
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Appellants and Harrison both disclose a method of pre-treating or
preventing pelvic pain associated with uterine dysrhythmia, which comprises
vaginally administering, to a patient in need thereof, a composition that
includes a therapeutically effective amount of lidocaine and a bioadhesive,
water-swellable, water-insoluble, cross-linked polycarboxylic acid polymer
(i.e., polycarbophil), wherein the treatment is administered prior to
anticipated onset of pelvic pain associated with uterine dysrhythmia so as to
prevent pelvic pain associated with uterine dysrhythmia (FF 1—7; cf. App.
Br. 22 (Appellants’ claim 26)). Absent evidence to the contrary: (1) the
administration of lidocaine according to Harrison’s method will normalize
abnormal uterine contractions (see, e.g., FF 2—\\ cf. App. Br. 22 (Appellants’
claim 26); see Reply Br. 4) and Harrison’s “a biocompatible excipient[, i.e.,
polycarbophil,]” will release lidocaine over an extended period of time after
administration (see, e.g., FF 2 and 5—7; cf. App. Br. 22 (Appellants’ claim
26)). Further, absent evidence to the contrary, Harrison’s method of
pretreating or preventing pelvic pain associated with uterine dysrhythmia
will necessarily treat pelvic pain associated with secondary dysmenorrhea
(see FF 1—7; cf. App. Br. 22 (Appellants’ claim 26); App. Br. 12 (“Examiner
notes that ‘Harrison does not distinguish between primary and secondary
dysmenorrhea,’ and .. . ‘Harrison does not expressly teach pelvic pain
associated with secondary dysmenorrhea’”); see generally App. Br. 12—13).
Therefore, we are not persuaded by Appellants’ contention that Harrison
“effectively teach[es] away from [Appellants’] claim[ 26]” (Reply Br. 7).
We also note that the Federal Circuit has determined that “[Reaching away is
irrelevant to anticipation.” Seachange Int’l, Inc., v. C-COR, Inc., 413 F.3d
1361, 1380 (Fed. Cir. 2005).
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Harrison discloses the application of Harrison’s composition “several
hours before . . . onset of menstruation in order to treat or prevent
dysmenorrhea” (FF 6) (emphasis added). Absent evidence to the contrary,
Harrison’s method, wherein Harrison’s composition is administered prior to
onset of menstruation, will necessarily pre-treat and/or prevent uterine
dysthymia and, thereby, remove the cause of the pain (see id.; see also FF 1
(“primary dysmenorrhea[] pain is associated with the onset of menstrual
flow”); cf. FF 6 (Appellants define the term “[prevention” as “include[ing]
pre-treatment of pelvic pain, such as by administration of compounds in
accordance with [Appellants’] invention, preferably prior to onset of
symptoms, to a patient who is likely to experience pelvic pain, such as that
due to uterine dysrhythmia”); see Reply Br. 5—6).
Therefore, we are not persuaded by Appellants’ contentions that
“Harrison does not seek, teach, disclose, or otherwise acknowledge
treatment of dysmenorrhea other than by successfully treating the resulting
pain and discomfort” or that “[t]here is absolutely no recognition or teaching
that a treatment could actually remove the cause of the pain, rather than just
treat the resulting pain” (App. Br. 10). For the foregoing reasons, we are not
persuaded by Appellants’ contention that the timing of Harrison’s
administration, i.e., prior to the onset of menstruation, “focuses on treating
the pain and discomfort of primary dysmenorrhea, and not pre-treating by
normalizing the underlying dysrhythmic cause” (App. Br. 10; cf FF 6). In
this regard, Appellants fail to provide persuasive evidence or argument to
support a finding that the vaginal administration of Harrisons’ composition,
which comprises lidocaine and polycarbophil prior to the onset of
menstruation (i.e., primary dysmenorrhea), will result in a different result
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than the vaginal administration of Appellants’ composition, which comprises
lidocaine and polycarbophil, prior to the anticipated onset of pelvic pain
associated with uterine dysrhythmia (i.e., primary dysmenorrhea) (see FF 2—
7; cf. App. Br. 22 (Appellants’ claim 26); Reply Br. 4—6).
“Attorney’s argument in a brief cannot take the place of evidence.” In
re Pearson, 494 F.2d 1399, 1405 (CCPA 1974)). Therefore, we are not
persuaded by Appellants’ unsupported contentions regarding the timing of
menstruation or assertion that Harrison’s disclosure of “prevent[ing] painful
menstruation and symptoms” is inaccurate (App. Br. 10-12; cf. FF 6).
Appellants’ claim 26 does not require administration of Appellants’
composition at any specific time prior to the anticipated onset of pelvic pain
associated with uterine dysrhythmia (see App. Br. 22 (Appellants’ claim 26);
cf. Reply Br. 4 (“Harrison does not administer lidocaine early enough to
‘pretreat or prevent’ symptoms — even for primary dysmenorrhea”)).
Therefore, we are not persuaded by Appellants’ contention that “preventing
and pre-treating the discomfort by pre-treating the dysrhythmia itself — as
contemplated by the instant invention — requires administration as much as
about 2-3 days before the next-anticipated menstruation for primary
dysmenorrhea, and even much earlier for secondary dysmenorrhea,” which
is not commensurate in scope with Appellants’ claimed invention (App. Br.
11; cf. FF 6 (Appellants’ “[prevention, or pre-treatment, can be
accomplished by administration of the compounds of the present invention
about 2 to 3 days prior to the expected onset of symptoms”)). “[WJhile 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 v. Musland, 847 F.2d
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1573, 1581 (Fed. Cir. 1988). Moreover, “during patent prosecution when
claims can be amended, ambiguities should be recognized, scope and
breadth of language explored, and clarification imposed.” In re Zletz, 893
F.2d 319, 322 (Fed. Cir. 1989).
For the foregoing reasons, we are not persuaded by Appellants’
contention that Harrison’s method will not also treat pelvic pain associated
with secondary dysmenorrhea as required by Appellants’ claim 26 (see App.
Br. 12; see generally Reply Br. 7—8).
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner’s
finding that Harrison teaches Appellants’ claimed invention. The rejection
of claim 26 under 35 U.S.C. § 102(b) as being anticipated by Harrison is
affirmed. Claims 3—7, 10, 11, 27, 45, and 46 are not separately argued and
fall with claim 26.
Obviousness'.
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 8. Examiner finds that Harrison does not disclose the administration of
Harrison’s “composition more than 3 days before onset of any symptom(s)”
and relies on Edelstam to make up for this deficiency in Harrison (Non-Final
Act. 6-7).
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ANALYSIS
Based on the combination of Harrison and Edelstam, Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious “to combine the teachings of Harrison and
Edelstam because both references teach compositions comprising lidocaine
that are useful in treating pain associated with dysmenorrhea by vaginally
administering]” Harrison’s composition according to Harrison’s method
(Non-Final Act. 7; see FF 1—7).
Appellants do not separately argue the claims on Appeal, therefore,
Appellants’ claim 26 is representative. In this regard, we recognize
Examiner’s assertion that “Harrison does not expressly teach pelvic pain
associated with secondary dysmenorrhea” (Non-Final Act. 6). For the
reasons discussed above, however, we find that Harrison’s method
inherently teaches the treatment of pelvic pain associated with secondary
dysmenorrhea. Therefore, having found Appellants’ claim 26 anticipated by
Harrison, we find Appellants’ claim 26 obvious over Harrison.6 Connell v.
Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983) (“anticipation
is the epitome of obviousness”).
Therefore, for the reasons set forth above, we are not persuaded by
Appellants’ contentions that Appellants’ claim 26 is non-obvious in view of
Harrison (see App. Br. 14—20; Reply Br. 8—13).
6 The Board may rely upon less than all the references cited by the
Examiner. See In re May, 574 F.2d 1082, 1090 (CCPA 1978); In re Kronig,
539 F.2d 1300, 1304 (CCPA 1976).
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CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 26 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Harrison and Edelstam is
affirmed. Claims 3—7, 10, 11, 27, 45, and 46 are not separately argued and
fall with claim 26.
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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