John Bondo. Hansen et al.

Patent Trials and Appeals Board

Aug 6, 2019

14395134 - (D) (P.T.A.B. Aug. 6, 2019)

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.
14/395,134 10/17/2014 John Bondo Hansen HAN-10102/16 4554
25006 7590 08/06/2019
DINSMORE & SHOHL LLP
900 Wilshire Drive
Suite 300
TROY, MI 48084
EXAMINER
SONG, JIANFENG
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
08/06/2019 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):
MichiganPatTM@dinsmore.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JOHN BONDO HANSEN, MIKAEL S. THOMSEN,
JENS D. MIKKELSEN, PETER GUDMUND NIELSEN,
and MADS KREILGAARD
____________

Appeal 2018-0034001
Application 14/395,1342
Technology Center 1600
____________

Before ULRIKE W. JENKS, JOHN G. NEW, and JAMES A. WORTH,
Administrative Patent Judges.

WORTH, Administrative Patent Judge.

DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the Examiner’s final
rejection of claims 1, 7–14, 16, 18–29, and 31–47, which are all pending
claims. We have jurisdiction under 35 U.S.C. §§ 134 and 6(b).
We reverse.

1 Our Decision refers to Appellants’ Appeal Brief (“Appeal Br.,” filed Nov.
15, 2017) and Reply Brief (“Reply Br.,” filed Feb. 8, 2018), and the
Examiner’s Final Office Action (“Final Act.,” mailed May 22, 2017) and
Answer (“Ans.,” mailed Dec. 12, 2017).
2 According to Appellants, the real parties in interest for this Appeal is
Contera Pharma ApS. Appeal Br. 1.
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Application 14/395,134

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Statement of the Case
Background
Appellants’ application relates to “a pharmaceutical formulation
comprising an agonist of two or more of the 5-HT1B, 5-HT1D and 5-HT1F
receptors, such as a triptan, e.g. zolmitriptan, in a matrix constituent having
extended release characteristics, and further comprising a 5-HT1A-R
agonist, such as buspirone, in a constituent having immediate release
characteristics.” Spec. 1:5–9. According to the Specification, “[t]he present
formulation is particularly well-suited for use in the treatment of movement
disorders and is suitable for oral administration.” See id. at 1:9–10.
The Specification states that high doses of 5-HT1A agonists can cause
serotonin syndrome or serotonin toxicity, and that it is important to limit the
exposure to 5-HT1A agonists. Id. at 2:24–27. According to the
Specification, the inventors previously discovered synergistic effects of two
or more of the 5-HT1B, 5-HT1D, and 5-HT1F receptors, exemplified by
zolmitriptan, with a 5-HT1A agonist, exemplified by buspirone, e.g., in
animal models by inhibiting L-DOPA Induced Dyskinesia (LID). Id. at
1:28–29, 2:29–3:2. The Specification states that the administering
zolmitriptan separately, before buspirone, created additional beneficial
effects, but such administration is undesirable for long-term treatment and
bolus injection may cause safety concerns. Id. at 3:4–10.
The Claims
Claim 1, reproduced below, is the sole independent claim on appeal
and is representative of the subject matter on appeal:
1. A pharmaceutical formulation comprising
a. a matrix constituent comprising zolmitriptan, and
pharmaceutically acceptable derivatives thereof, said matrix
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constituent providing for extended release of said zolmitriptan,
and
b. a constituent comprising buspirone, and
pharmaceutically acceptable derivatives thereof, said
constituent providing for immediate release of said buspirone.
Appeal Br. 6 (Claims App.).
The Issues
A. The Examiner rejected claims 1, 7–14, 16, 18–29, and 31–47
under 35 U.S.C. § 103(a) as being unpatentable over Barlow,3 Hall,4
Burgey,5 Shalaby,6 Nurnberg,7 Cao,8 Dixit,9 and Nagaraju.10
B. The Examiner rejected claims 1, 7–14, 16, 18–29, and 31–47 on
the ground of nonstatutory double patenting as being unpatentable over
claims 1–13 of U.S. Patent No. US 9,186,359 in view of Hall.
C. The Examiner rejected claims 1, 7–14, 16, 18–29, and 31–47 on
the ground of nonstatutory double patenting as being unpatentable over
claims 54–71 of copending Application No. 14/937,286 in view of Hall.
Analysis
A. 35 U.S.C. § 103 Over Barlow, Hall, Burgey, Shalaby, Nürnberg, Cao,
Dixit, and Nagaraju
We are persuaded by Appellants’ argument that the Examiner has not
made a prima facie case of obviousness (see Appeal Br. 2) because the

3 Barlow, US 2007/0270449 A1, pub. Nov. 22, 2007.
4 Hall, US 2008/0069874 A1, pub. Mar. 20, 2008.
5 Burgey, US 2008/0125413 A1, pub. May 29, 2008.
6 Shalaby, US 2008/0166407 A1, pub. July 10, 2008.
7 Nürnberg, US 5,288,501, pub. Feb. 22, 1994.
8 Cao, US 2006/0003005 A1, pub. Jan. 5, 2006.
9 Dixit, US 7,470,435 B2, pub. Dec. 30, 2008.
10 Nagaraju, WO 2007/129329 A2, pub. Nov. 15, 2007.
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Application 14/395,134

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Examiner has not identified a prior art teaching to use zolmitriptan in an
extended release formulation and buspirone in an immediate release
formulation.
The Examiner relies on Barlow for a combination of buspirone and
sumatriptan. Final Act. 3–4 (citing Barlow ¶ 21). However, the Examiner
concedes that Barlow does “not expressly teach a formulation comprising
zolmitriptan in extended release unit and buspirone in immediate release
unit.” Id. at 7.
The Examiner finds that the deficiency in Barlow is cured by the
teachings of the remaining references. Id. We review the remaining
references relied on as follows.
The Examiner finds that Hall discloses the use of buspirone, gepirone,
sumatriptan, zolmitriptan, and combination thereof. Final Act. 5 (citing Hall
¶ 50). The Examiner finds that Hall also discloses dosage forms including
immediate, sustained, modified, delayed, or pulsed release systems or
combinations thereof, including an immediate release dosage unit coated
with delayed release dosage unit. Id. at 5–6 (citing Hall, Abstract, ¶¶ 78, 83,
98). However, the Examiner does not rely on Hall for a disclosure of
partitioning zolmitriptan in the extended release unit and buspirone in the
immediate release unit.
Similarly, the Examiner finds that Shalaby discloses a bilayer tablet
with a slow-releasing layer and a fast-releasing layer (citing Shalaby ¶ 19);
finds that Cao discloses an immediate release layer (citing Cao ¶ 89); and
finds that Dixit and Nagaraju disclose extended release layers (citing Dixit,
7:40–45; Nagaraju, Abstract). Final Act. 6. However, the Examiner does
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Application 14/395,134

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not rely on Shalaby, Cao, Dixit, or Nagaraju for partitioning zolmitriptan in
the extended release unit and buspirone in the immediate release unit.
The Examiner also relies on Burgey for teaching the
interchangeability of sumatriptan and zolmitriptan (citing Burgey ¶ 436) and
on Nürnberg for a tablet hardness (citing Nürnberg, 3:40–46) but does not
rely on these references for the location of zolmitriptan and buspirone. Final
Act. 6, 7.
The Examiner also provides reasoning in an attempt to cure the
deficiency. As above, the Examiner finds that Hall teaches a tablet
containing an immediate release dosage and a delayed release dosage, and
that Hall discloses buspirone and zolmitriptan. The Examiner reasons that
[s]ince buspirone is either in immediate release unit or in
extended release unit, with this limit[ed] choice, it is obvious
for one of ordinary skill in the art to prepare a formulation
comprising zolmitriptan in extended release unit and buspirone
in immediate release unit and produce the instant claimed
invention with reasonable expectation of success.
Final Act. 8. We do not agree with the Examiner that this is a situation with
a limited number of choices because the Examiner has selected buspirone
and zolmitriptan as two species out of a lengthy list of over 200 items in
paragraph 50 of Hall (i.e., a list that occupies nearly a column of text, all
told, in the printed patent application publication). We note that Barlow also
discloses a list of 11 agents to be used in combination, including buspirone
and sumatriptan (Barlow ¶ 21; Final Act. 14). Whether or not the
combination of buspirone and zolmitriptan would have been obvious in view
of the aforementioned prior art, we determine that the Examiner has not
provided adequate reasoning to select buspirone for the immediate release
unit and zolmitriptan for the extended release unit.
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Accordingly, we reverse the Examiner’s rejection of claims 1, 7–14,
16, 18–29, and 31–47 under 35 U.S.C. § 103(a) as being unpatentable over
Barlow, Hall, Burgey, Shalaby, Nürnberg, Cao, Dixit, and Nagaraju.

B and C. Nonstatutory Double Patenting Over Claims 1–13 of U.S.
Patent No. 9,186,359, or Claims 54–71 of copending Application No.
14/937,286, in view of Hall
The Examiner’s nonstatutory double patenting rejections exhibit a
similar deficiency as the Examiner’s rejection under 35 U.S.C. § 103(a) over
Barlow, Hall, Burgey, Shalaby, Nürnberg, Cao, Dixit, and Nagaraju. Instead
of relying on Barlow, the Examiner relies on claims 1–13 of U.S. Patent No.
9,186,359, and in the alternative on claims 54–71 of copending Application
No. 14/937,286, for the disclosure of a combination of buspirone and
zolmitriptan. As with the rejection under 35 U.S.C. § 103(a), the Examiner
relies on Hall for the teaching of a formulation with extended release and
immediate release. However, the Examiner has not provided adequate
evidence or reasoning to select buspirone for the immediate release unit and
zolmitriptan for the extended release unit.
Accordingly, we reverse the Examiner’s rejection of claims 1, 7–14,
16, 18–29, and 31–47 for nonstatutory double patenting over claims 1–13 of
U.S. Patent No. 9,186,359, or claims 54–71 of copending Application No.
14/937,286, in view of Hall.

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Application 14/395,134

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DECISION
The Examiner’s decision to reject claims 1, 7–14, 16, 18–29, and 31–
47 is reversed.

REVERSED