Novartis AG

Patent Trials and Appeals Board

Oct 14, 2021

2021000876 (P.T.A.B. Oct. 14, 2021)

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.
15/686,919 08/25/2017 Markus FENDT VAND-0149-US-CON 9193
23550 7590 10/14/2021
HOFFMAN WARNICK LLC
540 Broadway
4th Floor
Albany, NY 12207
EXAMINER
CORNET, JEAN P
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
10/14/2021 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):
PTOCommunications@hoffmanwarnick.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte MARKUS FENDT, DOMINIK FEUERBACH,
SJOERD JEHANNES FINNEMA, BALTAZAR GOMEZ-MANCILLA,
CHRISTER HALLDIN, DONALD JOHNS, CRISTINA LOPEZ-LOPEZ,
KEVIN HALL MCALLISTER, JUDIT SOVAGO, and MARKUS WEISS
____________

Appeal 2021-000876
Application 15/686,919
Technology Center 1600
____________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TAWEN CHANG, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 49 and 51–68 (Non-Final Act.2 2).3 We have
jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART.

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 “Novartis
AG, Vanda Pharmaceuticals Inc.” (Appellant’s June 1, 2020, Appeal Brief
(Appeal Br.) 1).
2 Examiner’s January 9, 2020, Non-Final Office Action.
3 Pending claims 64–68 stand withdrawn from consideration (Non-Final Act.
2).
Appeal 2021-000876
Application 15/686,919

2
STATEMENT OF THE CASE
Appellant’s disclosure “to medical uses of alpha 7 nicotinic
acetylcholine receptor (α7 nAChR) agonists” (Spec.4 1). Appellant’s claims
49 and 51 are reproduced below:
49. A method comprising:
increasing wakefulness in a subject by administering to the
subject a therapeutically effective amount of (R)-3-(6-p-tolyl-
pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane in free base form
or acid addition salt form.

51. A method of facilitating emergence from general
anesthesia, comprising:
administering to a subject who has previously been treated with
a general anesthetic agent, a therapeutically effective amount of
(R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane in
free base form or acid addition salt form.
(Appeal Br. 25.)
Examiner limited the scope of examination “to the elected species, i.e.
(R)-2-(-p-toyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane,” a general
anesthesia that is a “combination of ketamine and sevoflurane,” and treating
a symptom of narcolepsy (see Non-Final Act. 2; Restriction Requirement5
2–5; Response to Restriction Requirement6 6–10). We, therefore, limit our
deliberations to Appellant’s elected invention and take no position
respecting the patentability of the non-elected species. See Ex parte Ohsaka,
2 USPQ2d 1460, 1461 (BPAI 1987).

4 Appellant’s August 25, 2017, Specification.
5 Examiner’s December 1, 2017, Restriction Requirement.
6 Appellant’s February 1, 2018, Response to Restriction Requirement.
Appeal 2021-000876
Application 15/686,919

3
Grounds of rejection before this Panel for review:
Claim 49 stand rejected under 35 U.S.C. § 102(b) as anticipated by
Feuerbach.7
Claims 51–63 stand rejected under 35 U.S.C. § 103 as unpatentable
over the combination of Feuerbach, Brown,8 and El-Feky.9

Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Feuerbach teaches Appellant’s claimed invention?
ANALYSIS
Feuerbach discloses 1-aza-bicycloalkyl derivatives, their process of
production and use as pharmaceuticals (Feuerbach ¶ 1; see generally Ans.10
4). Feuerbach discloses “[a] method for treating or preventing a disease or
condition . . . to a subject in need of such treatment, which comprises
administering to such subject a therapeutically effective amount of an aza-
bicycloalkyl derivative . . . in free base or pharmaceutically acceptable acid
addition salt form (see Feuerbach 13: Claim 14; see Ans. 4). Feuerbach
disclose that (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane is
an aza-bicycloalkyl derivative within the scope of its disclosure (see

7 Feuerbach et al., US 2007/0249617 A1, published Oct. 25, 2007.
8 Brown et al., US 2013/0310422 A1, published Nov. 21, 2013.
9 El-Feky et al., Comparison Between Sevoflurane Inhalation Anesthesia and
Ketamine or Propofol Infusion for Strabismus Surgery in Pediatrics, 10
AAMJ 94–111 (2012). Examiner refers to this document as “Menoufiya”
(see Appeal Br. 8, n. 38 (Appellant discusses Examiner’s citation of this
document and the potential source of Examiner’s naming convention)).
10 Examiner’s September 17, 2020, Answer.
Appeal 2021-000876
Application 15/686,919

4
Feuerbach ¶ 57: Example 58; see Ans. 4). Feuerbach further discloses that
narcolepsy is a disease or condition that may be treated with the aza-
bicycloalkyl derivatives within the scope of its disclosure (Feuerbach ¶ 36;
see Ans. 4).
Examiner finds that although Feuerbach does not exemplify the
treatment of narcolepsy with (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-
bicyclo[2.2.2]octane, “a person of ordinary skill in the art reading Feuerbach
. . . would clearly ‘at once envisage’” the treatment of narcolepsy with (R)-
3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane (Ans. 4). We
agree. Absent evidence to the contrary, we find that those of ordinary skill
in this art recognize would have recognized that narcolepsy is a sleep
disorder and that treatment of narcolepsy comprises increasing wakefulness
(see Ans. 4 (Examiner finds that the prior art discloses the same method step
as required by Appellant’s claimed method and, thus, “the intended outcome
is necessarily present absent evidence to the contrary”)). See Perricone v.
Medicis Pharmaceutical Corp., 432 F.3d 1368, 1380 (Fed. Cir. 2005)
(“Using the same composition claimed by Dr. Perricone in the same manner
claimed by Dr. Perricone naturally results in the same
claimed . . . benefits”).
For the foregoing reasons, we find no error in Examiner’s finding that
Feuerbach teaches Appellant’s claimed invention.
For the foregoing reasons, we are not persuaded by Appellant’s
contentions regarding Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780
F.3d 1376, 1381 (Fed. Cir. 2015) and Nidec Motor Corp. v. Zhongshan
Broad Ocean Motor Co., 851 F.3d 1270 (Fed. Cir. 2017).
Appeal 2021-000876
Application 15/686,919

5
For the foregoing reasons, we are not persuaded by Appellant’s
contention that “[t]he recitation of ‘increasing wakefulness in a subject’ is
absent from Feuerbach,” Appellant’s “claim 49 recites a method comprising
‘increasing wakefulness in a subject by administering’ the compound,” and
“[t]his is not the same as any step disclosed in Feuerbach, and does indeed
require treatment” (Appeal Br. 7 (footnote omitted)).
As discussed above, Feuerbach discloses that the 1-aza-bicycloalkyl
derivatives within the scope of its invention, which includes (R)-3-(6-p-
tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane are useful in a method of
treating, inter alia, narcolepsy. Absent evidence to the contrary, which we
find none, we find that administering (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-
aza-bicyclo[2.2.2]octane to treat a subject suffering from narcolepsy, as
taught by Feuerbach, will inherently increase wakefulness in the subject.
Therefore, we are not persuaded by Appellant’s contentions regarding
Feuerbach’s alleged failure to disclose a method of increasing wakefulness
in a subject by administering (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-
bicyclo[2.2.2]octane (see Reply Br. 1–3).
CONCLUSION
The preponderance of evidence on this record supports Examiner’s
finding that Feuerbach teaches Appellant’s claimed invention. The rejection
of claim 49 under 35 U.S.C. § 102(b) as being anticipated by Feuerbach is
affirmed.

Appeal 2021-000876
Application 15/686,919

6
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
Examiner relies on Feuerbach as discussed above with respect to the
anticipation rejection (see Ans. 6). In addition, Feuerbach discloses that
compounds within the scope of its disclosure can be administered in as “an
indicated daily dosage . . . in the range of from about 0.7 to about 1400
mg/day p.o . . ., conveniently administered once or in divided doses up to 4x
per day or in sustained release form” (Feuerbach ¶ 37; see generally Ans. 6).
Feuerbach makes clear, however, that “the appropriate dosage of the agents
of the invention will, of course, vary depending upon, for example, the host,
the mode of administration and the nature and severity of the condition
being treated as well as the relative potency of the particular agent of the
invention employed” (Feuerbach ¶ 37; see Ans. 7). Feuerbach discloses that
compounds within the scope of its disclosure may be administered orally or
parenterally (Feuerbach ¶ 40; see Ans. 6 (Examiner finds that parenteral
administration encompasses intravenous administration)).
Examiner finds that Feuerbach does not disclose “administration of a
general anesthetic agent” and relies on the combination of Brown and El-
Feky to make up for this deficiency (Ans. 7–8). Examiner finds that Brown
discloses that “a patient suffering from narcolepsy underwent 3 different
operations between 1979 and 1995, and required 8-10 hours to emerge from
general anesthesia each time,” “general anesthetic includes ketamine and
seveflurane,” and “[n]arcolepsy is a sleep disorder” (Ans. 7 (citing Brown
Appeal 2021-000876
Application 15/686,919

7
¶¶ 16, 90, 250). Examiner relies on El-Feky to disclose that “sevoflurane
and ketamine are general anesthetic agents used for induction and
maintenance” (Ans. 7 (citing El-Feky 96)).
Based on the combination of Feuerbach, Brown, and El-Feky,
Examiner concludes that, before the effective filing date of Appellant’s
claimed invention, it would have been prima facie obvious
to modify the method taught by Feuerbach . . . to include
subject who has been treated/administered with a general
anesthesia (e.g. sevoflurane for a maintenance period and
ketamine for an induction period) to give . . . [Appellant’s]
claimed method. One would have been motivated by the fact
that the compound taught by Feuerbach . . . is known to treat
narcolepsy (a sleep disorder) and also by the fact that the
emergence time increases in patient suffering from narcolepsy
who were under general anesthesia and lastly by the fact that
both ketamine and sevoflurane are general anesthetic agents
used for both induction and maintenance period as taught by
[El-Feky] . . . . Therefore, the skilled artisan would reasonably
expect the method taught by Feuerbach . . . to be effective for
subject who has been administered general anesthesia, resulting
in the instant method.
(Ans. 7–8.)

Claims 60–63:
Appellant’s claim 49 is reproduced above.
Appellant’s claim 60 depends from and limits the method of
Appellant’s claim 49 to “treating or delaying progression of narcolepsy”
(Appeal Br. 26). As discussed above, Feuerbach discloses a method of
treating narcolepsy and, thus, increasing wakefulness, in a subject by
administering to the subject a therapeutically effective amount of (R)-3-(6-p-
tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane in free base form or acid
Appeal 2021-000876
Application 15/686,919

8
addition salt form. Thus, we find no error in Examiner’s conclusion that the
combination of Feuerbach makes obvious Appellant’s claimed invention
(see Ans. 6–8). See Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548
(Fed. Cir. 1983) (“[A]nticipation is the epitome of obviousness.”).
Appellant’s claim 61 depends from and limits the narcolepsy of
Appellant’s claim 60 to “one of: narcolepsy with cataplexy, narcolepsy
without cataplexy, or narcolepsy due to a medical condition” (Appeal Br.
26). Appellant’s claim 62 depends from and limits the method of
Appellant’s claim 49 to “treating, preventing, or delaying progression of a
symptom of narcolepsy selected from: excessive daytime sleepiness,
nocturnal sleep disruption, cataplexy, abnormal REM sleep, paralysis during
sleep onset or during awakening, and hypnagogic hallucinations” (id.).
Examiner finds that Feuerbach’s disclosure of treating narcolepsy
“encompasses the narcolepsy recited in claims 61 and 62” (Ans. 6). Absent
evidence to the contrary, we find no error in Examiner’s conclusion of
obviousness.
Appellant’s claim 63 depends from and limits Appellant’s claim 60 to
requires that “the therapeutically effective amount of the (R)-3-(6-p-tolyl-
pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane is from 1 to 100 mg/day”
(Appeal Br. 26). As discussed above, Feuerbach discloses the
administration of compounds within the scope of its disclosure, which
includes (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane, to a
subject in need thereof in a therapeutically effective amount of from about
0.7 to about 1400 mg/day (see Feuerbach ¶ 37). In addition, Feuerbach
discloses that the therapeutically effective amount may be optimized based
on a number of factors (id.). Thus, we find no error in Examiner’s
Appeal 2021-000876
Application 15/686,919

9
conclusion of obviousness (see Ans. 6–8). See Iron Grip Barbell Co. v. USA
Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (“[W]here there is a range
disclosed in the prior art, and the claimed invention falls within that range,
there is a presumption of obviousness.”); see also In re Aller, 220 F.2d 454,
456 (CCPA 1955) (“[W]here the general conditions of a claim are disclosed
in the prior art, it is not inventive to discover the optimum or workable
ranges by routine experimentation.”).
For the reasons discussed above, we find that Feuerbach discloses that
any of its 1-aza-bicycloalkyl derivatives, which includes (R)-3-(6-p-tolyl-
pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane, would be useful in a method of
treating narcolepsy and, thus, increasing wakefulness. Thus, we are not
persuaded by Appellant’s contention that Feuerbach does not identify (R)-3-
(6-p-tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane as a preferred
compound (see Appeal Br. 10). In re Lamberti, 545 F.2d 747, 750 (CCPA
1976) (“[A]ll disclosures of the prior art, including unpreferred
embodiments, must be considered.”).
For the foregoing reasons, we are not persuaded by Appellant’s
contentions regarding Feuerbach’s disclosure of “eighty-five compounds”
(see. e.g. Appeal Br. 10). See Sinclair & Carroll Co. v. Interchemical Corp.,
325 U.S. 327, 335 (1945) (“Reading a list and selecting a known compound
to meet known requirements is no more ingenious than selecting the last
piece to put into the last opening in a jig-saw puzzle. It is not invention.”);
see also Merck & Co. Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804, 807
(Fed. Cir. 1989) (“Disclos[ure of] a multitude of effective combinations does
not render any particular formulation less obvious.”).
Appeal 2021-000876
Application 15/686,919

10
For the foregoing reasons, we are not persuaded by Appellant’s
contentions regarding the results of compounds outside of the scope of
Feuerbach’s disclosure (see Appeal Br. 11–14). For the same reasons, we
are not persuaded by Appellant’s contention that Examiner’s conclusion of
obviousness is based in improper hindsight or that those of ordinary skill in
this art “would harbor no reasonable expectation of success with any given
combination, for example, treating or delaying progression of narcolepsy in
a subject by administering (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-
bicyclo[2.2.2]octane” (id. at 14).

Claims 51–59:
Appellant’s claim 51 is reproduced above. Appellant’s claims 52–59
depend directly or indirectly from Appellant’s claim 51 (see Appeal Br. 25–
26). Appellant’s claim 51 is directed to a method of facilitating emergence
from general anesthesia by administering a therapeutically effective amount
of (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane in free base
form or acid addition salt form to a subject who has previously been treated
with a general anesthetic agent (see Appeal Br. 25).
As discussed above, Examiner finds that Feuerbach does not disclose
the administration of a general anesthetic agent (Ans. 7). Examiner also
fails to establish an evidentiary basis on this record to support a conclusion
that Feuerbach makes obvious the administration of (R)-3-(6-p-tolyl-pyridin-
3-yloxy)-1-aza-bicyclo[2.2.2]octane to a subject who received treatment
with a general anesthetic agent (cf. Appeal Br. 25).
Examiner’s reliance on Brown and El-Feky to disclose known general
anesthetics fails to make up for the foregoing deficiency in Feuerbach. In
Appeal 2021-000876
Application 15/686,919

11
addition Brown’s disclosure of the time required for a patient with
narcolepsy “to emerge from general anesthesia” also fails to make up for
Feuerbach’s failure to disclose the administration of (R)-3-(6-p-tolyl-
pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane to facilitate a patient’s
emergence from general anesthesia, as is required by the method of
Appellant’s claim 51 (see Ans. 7; cf. Appeal Br. 25). To the contrary,
Examiner failed to establish that Brown or El-Feky, alone or in combination,
disclose the use of 1-aza-bicycloalkyl derivatives generally, or more
specifically (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane.
Examiner also failed to establish that Brown or El-Feky, alone or in
combination, suggest any compound that has pharmacological properties
that those of ordinary skill in this art would recognize as similar to 1-aza-
bicycloalkyl derivatives generally or (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-
aza-bicyclo[2.2.2]octane specifically (see Appeal Br. 19–20). To the
contrary, Brown discloses:
Because the molecular mechanisms underlying the actions of
general anesthetics are poorly understood, it has not been
possible to design antagonists of general anesthetics. However,
the inventors demonstrate that methylphenidate actively
induces emergence from isoflurane anesthesia by stimulating
monoaminergic arousal pathways. These results demonstrate a
novel approach for identifying clinically useful antagonists of
general anesthetics at the level of neural circuits.
(Brown ¶ 255; see also Appeal Br. 18 (citing Brown ¶ 6).) As Appellant
explains, “even if . . . the (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-
bicyclo[2.2.2]octane of Feuerbach were understood by the skilled person to
treat narcolepsy . . ., this would not suggest its use for a different indication,
namely, facilitating emergence from general anesthesia” (Appeal Br. 21).
Appeal 2021-000876
Application 15/686,919

12
For the foregoing reasons, we find that Examiner failed to establish an
evidentiary basis on this record to support a conclusion that the combination
of Feuerbach, Brown and El-Feky makes obvious the subject matter of
Appellant’s claim 51 and its dependent claims 52–59 (see Appeal Br. 21
(Appellant contends that “the record is devoid of any evidence that (R)-3-(6-
p-tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane is active in a pathway
demonstrated or even hypothesized by Brown to be related to emergence
from general anesthesia”)).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to Appellant’s claims 61–63. The
rejection of claims 61–63 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Feuerbach, Brown, and El-Feky is affirmed.
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness with respect to Appellant’s claims 51–
59. The rejection of claims 51–59 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Feuerbach, Brown, and El-Feky is reversed.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
49 102(b) Feuerbach 49
51–63 103 Feuerbach, Brown,
El-Feky
60–63 51–59
Overall
Outcome
49, 60–63 51–59

Appeal 2021-000876
Application 15/686,919

13
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). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2019).

AFFIRMED-IN-PART