SEBELA INTERNATIONAL LIMITED

Patent Trials and Appeals Board

Aug 18, 2020

2020000025 (P.T.A.B. Aug. 18, 2020)

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.
15/785,769 10/17/2017 Patricia Allison Tewes RICHARDS P51773 5460
7055 7590 08/18/2020
GREENBLUM & BERNSTEIN, P.L.C.
1950 ROLAND CLARKE PLACE
RESTON, VA 20191
EXAMINER
KANTAMNENI, SHOBHA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
08/18/2020 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):
gbpatent@gbpatent.com
greenblum.bernsteinplc@gmail.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte PATRICIA ALLISON TEWES RICHARDS
____________

Appeal 2020-000025
Application 15/785,769
Technology Center 1600
____________

Before DONALD E. ADAMS, ERIC B. GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals2 from Examiner’s
decision to reject claims 1–5 and 7–12. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM the obviousness-type double patenting rejections.

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 “SEBELA
INTERNATIONAL LIMITED” (Appellant’s April 1, 2019 Appeal Brief
(Appeal Br.) 1).
2 This Appeal is related to Appeal 2012-004394 (Application 15/408,924).
Decision reversing the rejections under 35 U.S.C. § 103(a) entered October
21, 2013 (see Appeal Br. 2).
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STATEMENT OF THE CASE
Appellant’s disclosure “relates to a method for treating a patient
suffering from a thermoregulatory dysfunction, especially hot flashes and
flushes associated with hormonal changes due to naturally occurring
menopause (whether male or female) or due to chemically or surgically
induced menopause” (Spec. ¶ 3). Appellant’s only independent claim, claim
1, is reproduced below:
1. A method for treating a patient suffering from a
thermoregulatory dysfunction comprising:
administering to said patient a compound selected from
paroxetine, paroxetine mesylate, paroxetine hydrochloride,
paroxetine hydrochloride anhydrous, paroxetine hydrochloride
hemihydrate, and paroxetine hydrochloride monohydrate; said
compound being in an amount, based on the paroxetine moiety,
which is at least about 0.1 mg/day up to 9.5 mg/day.
(Appeal Br. A-1.)

Grounds of rejection before this Panel for review:
Claims 1–5 and 7–12 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Stearns ’003 and Jenkins.4
Claims 1–5 and 7–12 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Stearns ’05.5

3 V. Stearns, et al., A pilot trial assessing the efficacy of paroxetine
hydrochloride (Paxil®) in controlling hot flashes in breast cancer survivors,
11 ANNALS OF ONCOLOGY 17–22 (2000).
4 Jenkins, US 6,369,051 B1, issued April 9, 2002.
5 V. Stearns, et al., Paroxetine Is an Effective Treatment for Hot Flashes:
Results from a Prospective Randomized Clinical Trial, 23(28) J. CLIN.
ONCOL. 6919-6930 (2005).
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Claims 1–5 and 7–12 stand rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1–5 of Richards ’663.6
Claims 1–5 and 7–12 stand rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1–12 of Richards ’251.7
Claims 1–5 and 7–12 stand rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1–5 of Richards ’576.8
Claims 1–5 and 7–12 stand rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1–14 of Richards ’237.9

Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Stearns ’00 discloses a method of treating hot flashes associated with
dysfunction of thermoregulation comprising administering the selective
serotonin-reuptake inhibitor (SSRI) paroxetine hydrochloride at a dosage of
10 mg daily for one week, followed by four weeks of paroxetine

6 Richards, US 8,658,663 B2, issued Feb. 25, 2014.
7 Richards, US 8,946,251 B2, issued Feb. 3, 2015.
8 Richards, US 8,859,576 B2, issued Oct. 14, 2014.
9 Richards, US 9,393,237 B2, issued July 19, 2016.
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hydrochloride at a dosage of 20 mg daily (see Stearns ’00 17: Summary; id.
at 18: right column, ll. 28–32; see also Final Act.10 4).
FF 2. Stearns ’00 discloses:
Adverse effects were minimal and included mostly somnolence
(Table 2). Two patients discontinued drug therapy due to
excessive somnolence following three days, and seventeen
days, respectively, of drug therapy. One patient discontinued
the drug following twenty-three days of therapy due to anxiety.
Two patients decreased their paroxetine dose to 10 mg due to
somnolence encountered on the higher dose.
(Stearns ’00 19: right column, ll. 17–24; see Ans.11 4 (Examiner finds that
Stearns ’00 discloses “that [a] lower dose of paroxetine ha[s] fewer side
effects”).)
FF 3. Stearns ’00 discloses that its
This pilot trial cannot answer questions related to the optimal
dose of treatment. For example, many of the study participants
noted an almost immediate reduction in the frequency and
severity of their hot flashes. It is therefore possible that a dose
of paroxetine 10 mg daily might be sufficient in alleviating hot
flashes. Also, it is possible that women who did not respond to
the standard antidepressant dose of 20 mg might benefit from
an increased paroxetine dose. The pilot study was not
sufficiently powered to detect differences in benefit between
various subgroups, such as women who suffered long versus
short duration of hot flashes, younger or older women.
(Stearns ’00 21: left column, ll. 31–43; see generally Ans. 7).
FF 4. Examiner finds that Stearns ’00 does not disclose the administration
of paroxetine hydrochloride at a concentration below 10 mg/day (Final Act.
4).

10 Examiner’s June 25, 2018 Final Office Action.
11 Examiner’s July 29, 2019 Answer.
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FF 5. Jenkins’ “invention relates to methods of using substituted indole
compounds in the combination with a . . . (SSRI) for the treatment [of, inter
alia,] . . . hot flush” (Jenkins 1:6–10; see generally Final Act. 4).
FF 6. Jenkins discloses that its
invention includes acceptable salt forms of the substituted
indoles formed from the addition reaction with either inorganic
or organic acids . . . [and] [a]dditionally . . . includes quaternary
ammonium salts of the compounds herein. . . . It is understood
that the dosage, regimen and mode of administration of these
compounds will vary according to the extent of the malady and
the individual being treated and will be subject to the
judgement [sic] of the medical practitioner involved. It is
preferred that the administration of one or more of the SSRIs
and substituted indole compounds herein begin at a low dose
and be increased until the desired effects are achieved.
Effective administration of these compounds may be
given at an effective dose of from about 0.1 mg/day to about
500 mg/day.
(Jenkins 15:49–59; see id. at 16:48–49 (Jenkins discloses that “[t]he SSRI
compounds . . . may be administered in regimens and at dosages known in
the art”); id. at 17: 1–4 (Jenkins discloses that “[t]he joint administration of
the two groups of compounds in . . . [its] methods will be determined by a
medical professional based upon the condition of the recipient and the
malady for which the prophylaxis or treatment is provided”); id. at 17: 21–
24 (Jenkins discloses that “[w]hen optimum dosages for the indole
compounds and the SSRI of these formulations have been determined, it
may [be] preferable to incorporate both into a single formulation for ease of
administration”); see generally Final Act. 4; Ans. 4.)
FF 7. Jenkins discloses that “SSRI agents useful with the present methods
of treatment include . . . paroxetine . . . or a pharmaceutically acceptable salt
thereof” (Jenkins 7:44–47; see id. at 16:48–60 (Jenkins discloses that “[t]he
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SSRI compounds of [its] methods may be administered in regimens and at
dosages known in the art” and, specifically discloses that “[p]aroxetine
hydrochloride . . . has a recommended daily dosage of from 20 to 50 mg”);
see Final Act. 4).
FF 8. Stearns ’05 “report[s] results of a prospective, double-blind,
randomized cross-over clinical trial designed to evaluate the efficacy of two
doses of paroxetine [hydrochloride] versus placebo” (Stearns ’05 6920: left
column, ll. 17–20; see also id. at right column, ll. 16–18; see generally Final
Act. 7).
FF 9. Stearns ’05 discloses that an “objective [of its study] was to compare
the effectiveness of the standard starting dose of paroxetine for depression
and other psychiatric illnesses (20 mg) and low-dose (10 mg) for the
treatment of hot flashes” (Stearns ’05 6920: left column, ll. 22–26).
FF 10. Stearns ’05 reports that the “[e]fficacy was similar between the two
doses, but women were less likely to discontinue low-dose paroxetine”
treatment (id. at 6919: Abstract; see generally Final Act. 7).
FF 11. Examiner finds that Stearns ’05 does not disclose the administration
of paroxetine hydrochloride at a concentration below 10 mg/day (Final Act.
7).
ANALYSIS
The rejection over the combination of Stearns ’00 and Jenkins:
Based on the combination of Stearns ’00 and Jenkins, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious “to administer paroxetine in an amount of up to 9.0
mg/day, not more than 8.5 mg/day, or not more than 8.0 mg/day to treat hot
flashes because Jenkins teaches that paroxetine can be administered at an
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effective dose of from 0.1 mg/day to about 500 mg/day” (Final Act. 4). In
this regard, Examiner finds that
one of ordinary skill in the art would have been motivated to
determine the effective amounts of paroxetine such as not more
than about 9.5 mg/day, not more than about 9.0 mg/day, not
more than 8.5 mg/day, or not more than 8.0 mg/day as in instant
claims, with [a] reasonable expectation of success of treating
hot flashes, since the optimization of effective amounts of
known agents to be administered, is considered well in the
competence level of an ordinary skilled artisan in
pharmaceutical science, involving merely routine skill in the
art.
(Id. at 4–5; see also Ans. 4–6.) We are not persuaded.
Although Stearns ’00 discloses the use of a daily paroxetine dose of
10 mg, or more, for the treatment of hot flashes, Stearns ’00 makes clear that
its “pilot trial cannot answer questions related to the optimal dose of
treatment” (FF 3; see also FF 1–2). In addition, Examiner recognizes that
Stearns ’00 does not “disclose the administration of paroxetine
hydrochloride at a concentration below 10 mg/day” (FF 4). Examiner,
therefore, relies on Jenkins to make up for this deficiency in Stearns ’00 (see
e.g., FF 5–7). We are, however, not persuaded that Jenkins makes up for the
deficiency in Stearns ’00.
As Appellant explains, notwithstanding Examiner’s assertion to the
contrary, a “skilled artisan reading Jenkins would not understand Jenkins to
teach or suggest that every dose of every SSRI within the range of 0.1
mg/day to 500 mg/day is useful against every condition mentioned in
Jenkins” (Appeal Br. 7; see FF 6; see generally Reply Br. 1–4; cf. Final Act.
4–5). To the contrary, Jenkins discloses that “[t]he SSRI compounds of [its]
methods may be administered in regimens and at dosages known in the art”
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and, specifically discloses that “[p]aroxetine hydrochloride . . . has a
recommended daily dosage of from 20 to 50 mg” (FF 7; see also Appeal Br.
7).
Thus, although the combination of Stearns ’00 and Jenkins may
provide a reasonable expectation that a lower dose of paroxetine, i.e.
paroxetine hydrochloride, would have fewer side effects, the combination of
Stearns ’00 and Jenkins provides no expectation that a dose below 10
mg/day would exhibit a therapeutic effect in the treatment of a patient
suffering from a thermoregulatory dysfunction as required by Appellant’s
claimed invention (see Appeal Br. 7–9). In sum, Examiner failed to
establish an evidentiary basis to support a conclusion that a person of
ordinary skill in this art, at the time of Appellant’s claimed invention, would
have reasonably expected a dose of less than 10 mg/day of paroxetine, i.e.,
paroxetine hydrochloride, would be effective in treating a patient suffering
from a thermoregulatory dysfunction as is required by Appellant’s claimed
invention.

The rejection over Stearns ’05:
Based on Stearns ’05, Examiner concludes that, at the time
Appellant’s invention was made, it would have been prima facie obvious “to
administer paroxetine in an amount of up to 9.5 mg/day, not more than about
9.0 mg/day, not more than 8.5 mg/day, or not more than 8.0 mg/day to treat
hot flashes because Stearns et al. teach that lower dose of paroxetine have
fewer side effects” (Final Act. 7–8; see also Ans. 12). In this regard,
Examiner finds that “one of ordinary skill in the art would have been
motivated to administer lower doses of paroxetine with reasonable
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expectation of success of treating hot flashes with fewer side effects” (id. 8).
We are not persuaded.
Examiner recognizes that Stearns ’05 does not disclose the
administration of paroxetine hydrochloride at a concentration below 10
mg/day (FF 11; see also Appeal Br. 10). Thus, Examiner failed to establish
an evidentiary basis on this record to support a conclusion that a person of
ordinary skill in this art, at the time of Appellant’s claimed invention, would
have reasonably expected a dose of less than 10 mg/day of paroxetine, i.e.,
paroxetine hydrochloride, would be effective in treating a patient suffering
from a thermoregulatory dysfunction as is required by Appellant’s claimed
invention (see Appeal Br. 10; see also Reply Br. 4–5).
CONCLUSION
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
The rejection of claims 1–5 and 7–12 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Stearns ’00 and Jenkins is reversed.
The rejection of claims 1–5 and 7–12 under 35 U.S.C. § 103(a) as
unpatentable over Stearns ’05 is reversed.

Obviousness-type Double Patenting:
ANALYSIS
Appellant’s claim 1, reproduced above, is representative.
On this record, Appellant does not contest the rejections of claim 1
under the judicially created doctrine of obviousness-type double patenting.
Appellant also did not file a terminal disclaimer to moot these rejections (see
Final Act. 12 (Examiner acknowledges Appellant’s “remarks that ‘a
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Terminal Disclaimer over each cited patent is being simultaneously filed’,”
but “did not find any Terminal Disclaimers” on this record, and suggested
that Appellant “file the Terminal Disclaimers”)).
“If a ground of rejection stated by the examiner is not addressed in the
appellant’s brief, appellant has waived any challenge to that ground of
rejection and the Board may summarily sustain it.” MPEP § 1205.02 (9th
Ed., Rev. 08.2017 (Jan. 2018)).
Accordingly, the obviousness-type double patenting rejections are
summarily affirmed.
CONCLUSION
The rejection of claim 1 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1–5 of
Richards ’663 is affirmed. Claims 2–5 and 7–12 are not separately argued
and fall with claim 1.
The rejection of claim 1 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1–12
of Richards ’251 is affirmed. Claims 2–5 and 7–12 are not separately
argued and fall with claim 1.
The rejection of claim 1 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1–5 of
Richards ’576 is affirmed. Claims 2–5 and 7–12 are not separately argued
and fall with claim 1.
The rejection of claim 1 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1–14
of Richards ’237 is affirmed. Claims 2–5 and 7–12 are not separately
argued and fall with claim 1.
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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–5, 7–12 103(a) Stearns ’00, Jenkins 1–5, 7–12
1–5, 7–12 103(a) Stearns ’05 1–5, 7–12
1–5, 7–12 Nonstatutory
Double Patenting,
Richards ’663
1–5, 7–12
1–5, 7–12 Nonstatutory
Double Patenting,
Richards ’251
1–5, 7–12
1–5, 7–12 Nonstatutory
Double Patenting,
Richards ’576
1–5, 7–12
1–5, 7–12 Nonstatutory
Double Patenting,
Richards ’237
1–5, 7–12
Overall
Outcome
1–5, 7–12

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