Kouda, Tohru et al.

Patent Trials and Appeals Board

Oct 10, 2019

11165200 - (D) (P.T.A.B. Oct. 10, 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.
11/165,200 06/24/2005 Tohru Kouda 274239US0CIP 2762
22850 7590 10/10/2019
OBLON, MCCLELLAND, MAIER & NEUSTADT, L.L.P.
1940 DUKE STREET
ALEXANDRIA, VA 22314
EXAMINER
WESTERBERG, NISSA M
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
10/10/2019 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):
OBLONPAT@OBLON.COM
iahmadi@oblon.com
patentdocket@oblon.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TOHRU KOUDA, CHIKA MORISHIMA,
KENTARO INAGAWA, and SHINOBU SEKI
Appeal 2019-000284
Application 11/165,200
Technology Center 1600

Before ERIC B. GRIMES, ULRIKE W. JENKS, and
MICHAEL A. VALEK, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.

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 Ajinomoto Co.,
Inc. Appeal Br. 2. We have considered, and herein refer to, the
Specification of June 24, 2005 (“Spec.”); Non-Final Office Action of Nov.
15, 2017 (“Non-Final Act.”); Appeal Brief of May 16, 2018 (“Appeal Br.”);
Examiner’s Answer of July 25, 2018 (“Ans.”); Reply Brief of Sept. 25, 2018
(“Reply Br.”); and prior Board Decision Appeal 2013-007339 of Mar. 23,
2016 (“Dec.”).

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Application 11/165,200

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STATEMENT OF THE CASE
According to the Specification, “present-day life tends to be
sympathetic dominant due to mental stress and the like.” Spec. 11:24–25.
The ingestion of glycine right before bedtime is helpful in order “to induce
shift to slow wave sleep (deep sleep), [which] improves the quality of sleep
during sleep hours, appropriately controls visceral activity during sleep and
encourages natural sleep by allowing dominant action on [the]
parasympathetic [nervous system] that acts opposite to sympathetic
dominant [nervous system].” Id. at 12:1–12:4.
CLAIMED SUBJECT MATTER
Claims 12, 24–26, 28–34, and 36–40 are on appeal, and can be found
in the Claims Appendix of the Appeal Brief. Claim 12 and 24 are
representative of the claims on appeal, and read as follows:
Claim 12: A method of shortening slow wave sleep latency,
comprising administering a composition comprising glycine to
a human subject in need of such shortening, wherein the
composition comprises 5 g or less of amino acids other than
glycine.
Claim 24: A method of extending the duration of slow wave
sleep in early stage sleep, comprising administering a
composition comprising glycine to a human subject in need of
such extension, wherein the composition comprises 5 g or less
of amino acids other than glycine.
Appeal Br. 25 (Claims Appendix).
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Appellant seeks review of the following rejections made by Examiner:
1. Claims 12, 24, 25, 28–31, 33, and 36–39 under 35 U.S.C. § 103(a) as
unpatentable over Komissarova2 and Kryger.3
2. Claims 26 and 34 under 35 U.S.C. § 103(a) as unpatentable over
Komissarova, Kryger, and Blum.4
3. Claims 32 and 40 under 35 U.S.C. § 103(a) as unpatentable over
Komissarova, Kryger, and Choi.5
OPINION
Since all three rejections rely upon the teaching of Komissarova and
Kryger regarding the administration of glycine for the purpose of
“shortening slow wave sleep latency” or “extending the duration of slow
wave sleep in early stage sleep,” the same issue is dispositive for all of these
rejections. Thus, we will consider the rejections together.
Examiner finds that Komissarova teaches pharmaceutical preparations
containing glycine that have anti-stress or stress protective and nootropic
effects, as well as exhibiting sedative qualities. Non-Final Act. 7 (citing
Komissarova 2:38–45, 6:25–29, 12:54–59, 13:1–45); Ans. 4–5. Examiner
acknowledges that Komissarova “does not explicitly teach the
administration of the glycine containing composition to human subjects in
the claimed amounts.” Non-Final Act. 7; Ans. 4. Examiner looks to Kryger
for teaching “that stress is probably the most frequent cause of a transient or

2 Komissarova et al., US 5,643,954, issued July 1, 1997 (“Komissarova”).
3 Principles and Practice of Sleep Medicine, 3rd ed., editors Meir H. Kryger,
Thomas Roth, and William C. Dement, 627–28 (2000) (“Kryger”).
4 Blum et al., Synergy of Ethanol and Putative Neurotransmitters: Glycine
and Serine, SCIENCE 176:2935–94 (1972) (“Blum”).
5 Choi et al., US 6,416,795 B1, issued July 9, 2002 (“Choi”).
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short term insomnia, with the stress arising from positive or negative life
events or cognitive expectancies.” Non-Final Act. 8; Ans. 4. Based on these
combined teachings, Examiner concludes that it would have been obvious to
administer glycine to patients experiencing stress related transient insomnia
because glycine is taught to reduce stress. Non-Final Act. 8; Ans. 4.
Examiner finds that the claims define a patient population to whom
the claimed glycine treatment is administered, namely patients that are in
need of shortened slow wave sleep latency or extended duration of slow
wave sleep. Non-Final Act. 6. According to Examiner, “[t]he difference in
the basis of the definitions does not patentably distinguish the claimed
patient populations from those suffering from insomnia.” Non-Final Act. 6;
Ans. 9. Specifically, Examiner finds that “[t]he patient population
encompassed by the claims is broader than indicated by applicants and can
even be broader than subjects suffering from insomnia.” Non-Final Act. 6;
see also Ans. 10 (“the patient population of the claimed method is quite
broad and substantially overlaps with the patient population to whom
glycine would be administered”).
Appellant contends that “a skilled artisan at the time of present
invention: (i) would not have understood all insomnia patients to be in need
of improved [slow wave sleep (SWS)], and (ii) would not have reasonably
expected that an insomnia treatment would be effective in improving SWS.”
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Appeal. Br. 9 (citing Bannai Declaration,6 AASM,7 Kotorii,8 and Pagel9).
Specifically, Appellant contends that “[a] skilled artisan would have
understood that insomnia is a broader concept than SWS.” Appeal Br. 11
(citing Bannai Decl. ¶ 22).
This is the second time rejected claims based on this application have
come before us for review. In our prior decision, in Appeal 2013-007339
(entered March 23, 2016), we affirmed obviousness rejections over
Komissarova either alone or in conjunction with Blum. See Dec. 1–12. As
explained in that decision, “Examiner has identified a group of patients (a
species), those suffering from stress, that are administered glycine.” Dec. 6
(citing Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293,
1300 (Fed. Cir. 2007) (disclosure of a species in the prior art renders a later
claim to a genus encompassing that species unpatentable)). Since that
decision, the claims have been amended to recite a different patient
population. The present claims no longer recite a broad genus, but instead
recite a narrower species. Specifically, the presently claimed patient
population is directed to those requiring either “shortening slow wave sleep
latency” or “extending the duration of slow wave sleep in early stage sleep.”

6 Declaration under 37 C.F.R. § 1.132 by Makoto Bannai signed Dec. 22,
2016 (“Bannai Decl.”).
7 The international classification of sleep disorders, AMERICAN ACADEMY OF
SLEEP MEDICINE (2001) (“AASM”).
8 Kotorii, Effect of psychoactive drugs on sleep in insomnia, JAPANESE J.
CLIN. PSYCHOPHARM. 14:401–10 (2011) (“Kotorii”).
9 Pagel and Parnes, Medications for the Treatment of Sleep Disorders:
An Overview, PRIMARY CARE COMPANION J. CLIN. PSYCHIATRY 3:118–25
(2001) (“Pagel”).
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The contention lies with the interpretation of the relevant patient
population. The Specification discloses that “[t]he concept represented by
what is called a ‘sleep disorder’ and ‘insomnia’ is also included in the
concept of the aforementioned ‘deep sleep disorder.’” Spec. 11:1–3, see
also 9:23–10:25. The Specification broadly defines “deep sleep disorder” to
include conditions such as insufficient sleep hours due to mental and/or
physical stress, and to also encompass “shallow sleep, difficult shift to slow
wave sleep indicating profound sleep after sleep onset” among others. Id. at
9:23–11:3, see also 24:2–4 (“the time from the lights-out to slow wave sleep
considered to represent deep sleep was shortened and extension of the slow
wave sleep in the early stage of sleep onset was confirmed”). In other
words, “deep sleep disorder” and “insomnia” represent a genus of patients
encompassing different etiologies that manifest in the disruption of sleep.
Id. at 9:23–11:3. Disruption in achieving slow wave sleep or maintaining
slow wave sleep are two species out of a broader genus of conditions leading
to insomnia. Id. at 9:23–11:3, 24:2–4.
Examiner finds that “[t]he definition of slow wave sleep or delta sleep
[is] related to the physiological characteristics of various stages of sleep.
Being in need of shortened slow wave sleep latency or extended duration of
SWS defines the patient population to whom the claimed treatment (glycine)
is administered.” Non-Final Act. 6; Ans. 9 (short wave sleep is known to be
the “most restorative stage of sleep”). Because “[i]nsomnia is defined as
insufficient sleep or not feeling rested or a complaint of the inability to either
initiate or maintain sleep. . . . Therefore patients suffering from insomnia fall
within the scope of the patient population of the instant claims.” Ans. 9.
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On this record, we find that Appellant has the better position. We
agree with Appellant that insomnia is a broad concept encompassing all
complaints about sleep. Appeal Br. 10 (citing Bannai Decl. ¶ 20). We
understand that sleep has many stages. However, not all sleep disruptions
leading to insomnia affect the same stage of sleep. See Bannai Decl. ¶¶ 20–
24 (citing AASM, Kotorii, and Pagel). Appellant explains that patients
presenting with insomnia do not necessarily need improved slow wave sleep,
as evidenced by successfully treating insomnia with sleep aids that either do
not have an effect on slow wave sleep or may even disrupt slow wave sleep.
Reply Br. 210 (citing Bannai Decl. ¶¶ 1–4, 19, 23); Appeal Br. 11. Here,
Appellant has presented a sufficient evidentiary basis from which to
conclude that not all insomnia has the same underlying etiology, therefore,
treatment with glycine would not necessarily have the same effect on all
insomnia patients. Reply Br. 13; Bannai Decl. ¶ 23; see generally AASM.
In other words, administering glycine to treat a patient with stress-induced
insomnia, as taught by the cited prior art, will not necessarily shorten slow
wave sleep latency or extend the duration of slow wave sleep, because the
underlying etiology of the patient’s insomnia may not be associated with
slow wave sleep. Nor is there evidence of record connecting stress-induced
insomnia to slow wave sleep such that it would be obvious that glycine
could also be used to shorten slow wave sleep latency or extend the duration
of slow wave sleep, as claimed.

10 Appellant’s Reply Brief is not paginated; we refer here to the second of
nine pages.
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CONCLUSION
We conclude that the preponderance of the evidence of record does
not support the Examiner’s conclusion that the combination of Komissarova
and Kryger discloses a method having all limitations of independent claims
12 and 24 and dependent claims thereto. We thus reverse the rejections
under 35 U.S.C. § 103(a) that rely on the teachings of Komissarova and
Kryger.
DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Basis  Affirmed Reversed
12, 24, 25,
28–31, 33,
36–39
103 Komissarova, Kryger  12, 24, 25,
28–31, 33,
36–39
26, 34 103 Komissarova, Kryger,
Blum 
26, 34
32, 40 103 Komissarova, Kryger,
Choi
32, 40
Overall
Outcome
12, 24–26,
28–34, 36–
40
REVERSED