West Virginia University

Patent Trials and Appeals Board

Aug 3, 2021

2021001422 (P.T.A.B. Aug. 3, 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.
14/644,608 03/11/2015 Scott Pollard 0074539-000049 8199
23464 7590 08/03/2021
BUCHANAN INGERSOLL & ROONEY PC
1737 King Street
Suite 500
ALEXANDRIA, VA 22314-2727
EXAMINER
LEE, ANDREW P
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
08/03/2021 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):
ADIPDOC1@BIPC.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SCOTT POLLARD, PATRICK MARSHALEK, and
RAE MATSUMOTO
Appeal 2021-001422
Application 14/644,608
Technology Center 1600
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
ULRIKE W. JENKS, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision2 to reject claims directed to a method of treating depression in a

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies the real party in interest as West
Virginia University. Appeal Br. 1.
2 We have considered, and herein refer to, the Specification of March 11,
2015 (“Spec.”); Final Office Action of December 19, 2019 (“Final Act.”);
Appeal Brief of July 10, 2020 (“Appeal Br.”); Examiner's Answer of
October 28, 2020 (“Answer”); and Reply Brief of December 22, 2020
(“Reply Br.”).

Appeal 2021-001422
Application 14/644,608
2
patient population that is treatment resistant. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.
CLAIMED SUBJECT MATTER
The claims are directed to a method of treating depression in a patient
population that is treatment resistant. Claims 1 and 24, reproduced below,
are illustrative of the claimed subject matter:
1. A method of treating depression disease in a treatment
resistant patient consisting of:
administering to a mucosal membrane of a patient an
effective amount of a composition consisting of an effective
amount of ketamine and dextromethorphan, wherein said
mucosal administration of said composition allows for the
transmucosal absorption of said ketamine and said
dextromethorphan into the patient’s systemic blood stream and
avoiding the first pass elimination of ketamine and
dextromethorphan from the patient’s digestive tract and liver
for providing a rapid acting antidepressant effect for treating
depression in a treatment resistant patient, wherein said
effective amount of said ketamine is 0.5 mg/kg of said patient’s
body mass to cause antidepressant effects within twenty-four
hours of said administration of said composition and an efficacy
sustained for up to about two weeks.
Appeal Br. 15 (Claims Appendix).
24. A method of treating depression disease in a treatment
resistant patient consisting of:
administering to a treatment resistant patient an effective
amount of a composition consisting of an effective amount of
dextromethorphan to a mucosal membrane of a buccal cavity of
said patient, said composition provides transmucosal absorption
of said dextromethorphan into the patient’s systemic blood
stream thereby avoiding the first-pass elimination of said
dextromethorphan from the patient’s digestive tract and liver
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for providing a twenty-four hour rapid acting antidepressant
effect for treating depression in a treatment resistant patient.
Id. at 16.
REFERENCES
The prior art relied upon by Examiner is:
Name Patent Document Date
Berg US 2009/0111846 Al April 30, 2009
Papalos US 2012/0225949 A1 Sept. 6, 2012

Name Non-Patent Literature Document
Lauterbach Dextromethorphan as a potential rapid-acting
antidepressant, 76 MEDICAL HYPOTHESES
717-19 (2011)
REJECTION
Appellant appeals from Examiner’s rejection of claims 1–6, 8–10, and
24 under 35 U.S.C. § 103(a) as unpatentable over Papalos, Berg, and
Lauterbach.
OPINION
The issue is whether the preponderance of evidence of record supports
Examiner’s conclusion that methods of treating treatment resistant
depression and bipolar depression are interchangeable.
[T]he examiner bears the initial burden, on review of the prior
art or on any other ground, of presenting a prima facie case of
unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant.
After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
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Papalos teaches “treating symptoms associated with bipolar disorder”
using ketamine. Papalos, Abstr. “[T]he therapeutically-effective amount of
ketamine is about 0.01 to about 1 mg/kg of body weight.” Id. ¶ 52. Papalos
also discloses it is understood that “[t]he dose of ketamine that is
administered generally will depend on the size of the subject being treated. .
. . [and can range] between about 0.1 mg/kg per day to about 3.0
mg/kg/day.” Id. ¶ 53. Papalos teaches that “ketamine is administered orally,
parenterally (e.g., intravenous, subcutaneous, intramuscular), intranasally,
buccally, topically, rectally, or transdermally.” Id. ¶ 41. If formulated for
buccal administration, Papalos states that ketamine can take the form of
tablets, lozenges, and gels. Id. ¶ 73. Papalos explains that “[b]uccal drug
delivery avoids the disadvantages encountered with oral drug administration,
e.g., slow absorption, degradation of the agent by fluids present in the
gastrointestinal tract and/or first-pass inactivation in the liver.” Id. ¶ 73.
Berg teaches treating depression, anxiety, and neurodegenerative
diseases with a composition comprising “dextromethorphan in combination
with quinidine.” Berg, Abstr. Berg acknowledges that there is a need for
treatments for patients that suffer from treatment-resistant depression. Id.
¶ 15. Berg teaches “that dextromethorphan has significant neuroprotective
properties.” Id. ¶ 86. Berg explains:
Enhancing the central bioavailability of
dextromethorphan may increase its therapeutic potential as a
neuroprotectant. . . . [T]he brain concentration of
dextromethorphan is believed to be route dependent, parenteral
administration (e.g., intravenous) has been used to avoid the
first-pass effect. . . . The most promising strategy for increasing
systemically available dextromethorphan therefore appears to
be the coadministration of the specific and reversible CYP2D6
inhibitor quinidine. . . . increasing the drug’s likelihood of
reaching neuronal targets.
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Id. ¶ 126.
Lauterbach discloses “that dextromethorphan has antidepressant
activities, [and therefore] is efficacious in the treatment of depressive
disorders (including bipolar, unipolar, and treatment-resistant depressive
disorders), and produces a rapid antidepressant response.” Lauterbach 717.
Lauterback further states that “[l]ike ketamine, dextromethorphan is a
noncompetitive NMDA receptor antagonist and an agonist at mu (μ) opioid
and sigma-1 receptors.” Id. Based on these shared properties, Lauterbach
discloses that dextromethorphan may have antidepressant effects in patients
with treatment-resistant depression. Id. at 718.
Based on the teachings of Papalos, Berg, and Lauterbach, Examiner
concludes that the buccal administration of ketamine and dextromethorphan
to depressed patients is obvious. Specifically, Examiner articulates that
[b]y Applicant’s own admission in the instant
specification, pg. 3, Applicants define depression to include
unipolar depression disease, bipolar depression disease, and
depression treatment resistant disease, and thus, . . . the
treatment of bipolar disorder as disclosed in Papalos would
meet the instant claims of depression as cited in instant claim 1.
Additionally, Berg discloses that “The American Psychiatric
Association recognizes several types of clinical depression,
including mild depression (dysthymia), major depression, and
bipolar disorder (manic-depression).” (Paragraph 0010).
Therefore, one of ordinary skill in the art would have been
motivated to do so since ketamine is known to treat bipolar
disorder and can be administered buccally as taught by Papalos
with a reasonable expectation of success absent evidence of
criticality of the particular steps.
Ans. 4–5 (emphasis added). Examiner further explains that “[o]ne of
ordinary skill in the art would thus recognize bipolar disorder as a type of
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depression and would be motivated to combine the teachings of Papalos and
Berg for the treatment of treatment resistant depression.” Ans. 6.
We begin with claim interpretation because before a claim is properly
interpreted, its scope cannot be compared to the prior art. In this case, the
dispute centers on whether the phrase “treating depression disease in a
treatment resistant patient” as recited in the claim encompasses treating
depression generally. We are not persuaded by Examiner’s position that
depressive disorders are interchangeable or that the Specification admits that
they are interchangeable. The Specification recites that “[t]he methods of
this invention include wherein the depression is selected from the group of
unipolar depression disease, bipolar depression disease, and depression
treatment resistant disease.” Spec. 3; see also id. at 18. Here, the use of the
phrase “selected from the group” would indicate that each of the recited
disorders is a different type of depression. The problem with the Examiner’s
interpretation, as explained below, is that the claims are not directed to
treating “depression” generally; instead the claims are directed to treating a
specific patient population, namely those that have “treatment resistant
depression.”
The preamble of claim 1 recites “treating depression disease in a
treatment resistant patient.” This would indicate that the patient population is
limited to those patients that have treatment resistant depression. In addition
to reciting the patient population in the preamble, the claim body also
requires that the composition is administered in a manner that provides an
“antidepressant effect for treating depression in a treatment resistant
patient.” Thus, the preamble, as well as the body of the claim, identify that
the particular patient population encompasses only those patients that have
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been shown to be treatment resistant. Claim 24, the only other independent
claim, similarly limits the patient population to a treatment resistant patient.
Examiner’s articulated rationale, however, is that it would have been
obvious to combine the cited references because each reference discusses
some form of depression, and therefore it would obvious to combine their
teachings to arrive at the present invention of mucosal or buccal
administration of the recited compounds. Examiner relies on the
Specification that recites “depression to include unipolar depression disease,
bipolar depression disease, and depression treatment resistant disease” (Final
Act. 5; Ans. 4–5) in order to arrive at the conclusion the recited depressions
are interchangeable. See Ans. 4–5. We are not persuaded by Examiner’s
interpretation that the Specification equates the listed depressions.
We agree with Appellant’s contention that the evidence supports the
finding that different types of depression have different etiologies and,
therefore, methods applicable to one type of depression are not necessarily
interchangeable with treatments for another type of depression. See Appeal
Br. 10 (citing Dr. Patrick J. Marshalek Declaration signed February 5, 2020
(“Marshalek Decl.”)). According to Appellant, “[t]reatment-resistant
depression is a term [of art] used in clinical psychiatry to describe a
condition that affects people with major depressive disorder who do not
respond adequately to a course of antidepressant medication.” Reply Br. 5;
see Appeal Br. 7, 11. Appellant’s declarant Dr. Marshalek explains that
“bipolar affective disorder and major depressive disorder are considered
affective disorders and they also have different etiologies, presentations, and
treatments.” Marshalek Decl. 2. Treatment resistant depression (TRD)
“shows specific and significant change with lower functional connectivity
between DMN [(Default Mode Network)] and the Hippocampus as well as
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hippocampal shrinkage. This is a presentation not seen in Bipolar studies not
in MDD [(Major Depression)] studies and can be considered related to the
TRD natural history.” Marshalek Dec. 3. Based on these disclosures, we
determine that Appellant has presented sufficient evidence to support the
position that different types of depression have different etiologies and
therefore their treatment methods are not interchangeable.
We are also not persuaded by Examiner’s rationale that “it is prima
facie obvious to combine components known for the same purpose for their
combined additive effects.” See Ans. 5 (citing In re Kerkhoven, 626 F.2d
846, 850 (CCPA 1980)). As discussed above, the problem is that the
references do not teach treating the same patient population via the same
route for the same purpose; therefore, without more, the Kerkhoven rationale
does not apply to the facts before us.
As the Examiner has failed to adequately articulate any other rationale
explaining how the combination of Papalos, Berg, and Lauterbach teaches a
method of treating depression in a treatment resistant patient population, we
are constrained to reverse this rejection.
CONCLUSION
We conclude that the preponderance of the evidence of record does
not support the Examiner’s conclusion that the combination of Papalos,
Berg, and Lauterbach discloses a method having all limitations of both
independent claims and their dependents.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–6, 8–10,
24
103 Papalos, Berg,
Lauterbach
1–6, 8–10,
24
REVERSED