Omoidesouzou Co., Ltd. et al.

Patent Trials and Appeals Board

Dec 18, 2020

2020001069 (P.T.A.B. Dec. 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.
15/305,114 10/19/2016 Hideyasu Takata HRTA:1019US 4404
34725 7590 12/18/2020
CHALKER FLORES, LLP
14951 NORTH DALLAS PARKWAY
SUITE 400
DALLAS, TX 75254
EXAMINER
PIHONAK, SARAH
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
12/18/2020 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte HIDEYASU TAKATA
____________

Appeal 2020-001069
Application 15/305,114
Technology Center 1600
____________

Before ANTON W. FETTING, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

FETTING, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE1
Hideyasu Takata (Appellant2) seeks review under 35 U.S.C. § 134 of
a non-final rejection of claims 12, 14, 15, 17, 18, 22, and 24–26, the only

1 Our decision will make reference to the Appellant’s Appeal Brief (“App.
Br.,” filed May 1, 2019) and Reply Brief (“Reply Br.,” filed November 20,
2019), and the Examiner’s Answer (“Ans.,” mailed September 25, 2019),
and Non-Final Action (“Non-Final Act.,” mailed December 20, 2018).
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Application 15/305,114

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claims pending in the application on appeal. We have jurisdiction over the
appeal pursuant to 35 U.S.C. § 6(b).
The Specification describes a formulation for suppressing or
inhibiting an amyloid fibril formation with the effect of dissolving or
eliminating (discharging) amyloid fibrils, comprising tranilast or a
pharmacologically acceptable salt thereof as an active ingredient.
Specification para. 1. According to the Specificiation the formulation can be
used inan agent for preventing or treating an amyloid plaque as well as for
preventing or treating amyloidosis. Specification para. 1.
An understanding of the invention can be derived from a reading of
exemplary claim 12, which is reproduced below (some paragraphing added).
12. A method for suppressing or inhibiting an amyloid
fibril formation comprising
orally administering an agent for suppressing or inhibiting an
amyloid fibril formation to a patient in need of suppressing or
inhibiting an amyloid fibril formation,
wherein the agent comprises tranilast or a
pharmacologically acceptable salt thereof as an active
ingredient.

2 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
Omoidesouzou Co., Ltd., Hideyasu Takata and Tsukasa Takemura (Appeal
Br. 2).

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The Examiner relies upon the following prior art:
Name Reference Date
Schneider WO 2009/024543 A1 Feb. 26, 2009
Hamley, I W. “The amyloid beta peptide: a chemist's perspective. Role
in Alzheimer's and fibrillization.” Chemical reviews vol. 112, 10
(2012): 5147–92.

Claims 12, 14, 15, 17, 18, 22, and 24–26 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Schneider and Hamley.
ISSUES
The issues of obviousness turn primarily on whether the art describes
orally administering tranilast to a patient in need of suppressing or inhibiting
an amyloid fibril formation.
FACTS PERTINENT TO THE ISSUES
The following enumerated Findings of Fact (FF) are believed to be
supported by a preponderance of the evidence.
Facts Related to Appellant’s Disclosure
01. The Specification describes a dosage range of 1 mg to 30 g/day,
preferably in a dosage range of 10 to 3000 mg/day, more
preferably in a dosage range of 50 to 2000 mg/day, still preferably
in a dosage range of 100 to 1000 mg/day, still more preferably in
a dosage range of 200 to 600 mg/day, once or more than once
(e.g., two to four times) in divided doses per day, however, the
dosage may be adjusted depending on the state of symptom
improvement. Spec. para. 27.
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02. Examples of . . . cerebral amyloidosis can include,
specifically, cerebral amyloid angiopathy, hereditary cerebral
hemorrhage (Dutch type or Icelandic type) arising from amyloid
fibril deposition in the brain, and dementia arising from amyloid
fibril deposition in the brain, and among these dementia arising
from amyloid fibril deposition in the brain can be preferably
exemplified. Said "dementia" can be exemplified by
Alzheimer's type dementia. Spec. para. 31.
03. A patient with Alzheimer's disease (88 years of age, male)
was administered orally with a 100 mg capsule of tranilast
(brand name: Rizaben, Kissei Pharmaceutical Co., Ltd.) three
times a day. About 5 months after the start of administration of
tranilast on October 11, 2014, clear ameliorating effect on the
symptoms of Alzheimer's type dementia was observed. Spec.
para. 42.
04. Tranilast acted such that it would effectively reduce the
deposited amyloid fibrils in the skin or brain tissues in the
hippocampus upon the systemic administration of tranilast to a
patient with cutaneous lichen amyloidosis or a patient with
dementia such as Alzheimer's type dementia with no improvement
of symptoms observed with conventional treatments. Spec. para.
45.
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Facts Related to the Prior Art
Schneider
05. Schneider is directed to the use of tranilast and derivatives
thereof for the manufacture of a medicament for the treatment
and/or prophylaxis of neurological and/or psychiatric conditions.
Schneider 1:top paragraph.
06. Schneider describes neurological and/or psychiatric conditions
as including Alzheimer's disease (AD). Schneider 1:bottom
paragraph.
07. Schneider describes treating a patient being in need of
neurogenesis comprising administering in a therapeutically
effective amount of tranilast. Schneider 19:bottom paragraph –
20:top paragraph.
08. Schneider describes administering tranilast orally. Schneider
31: last paragraph.
09. Schneider describes using a therapeutically effective amount of
the compound for treating a neurological condition in an amount
that results in a neuroprotective and/or neuroregenerative effect,
the amount preferably range from about 10 mg to 1000 mg per
compound or as a combination and can be determined based on
age, race, sex, mode of administration and other factors based on
the individual patient. Schneider 33:top paragraph.
Hamley
10. Hamley is directed to describing the role of the amyloid beta
peptide in Alzheimer’s and fibrilization. Hamley Title.
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11. Hamley describes the aggregation of the amyloid β-peptide
into oligomers or fibrils as being implicated as a key process
associated with progression of Alzheimer’s. Hamley
5147:Right column, Introduction.
12. Hamley describes Alzheimer's disease (AD) as the most
common cause of dementia. Hamley 5148, left col., 1st full para.
13. Hamley describes the aggregation of the amyloid beta-peptide
into oligomers or fibrils being implicated as a key pathway
associated with Alzheimer's disease (AD) causation. Hamley
5149, left col., 1st para.
14. Hamley describes the two major variants of amyloid beta-
peptide that exist in humans, Aβ40 and Aβ42, and that it is
thought oligomers of these peptides are toxic agents leading to
neurodegeneration. Hamley 5149, right col., next to last para-p.
5150, right col., top 2 lines).
15. Hamley describes Aβ42 as the variant implicated in AD
pathogenesis, and that Aβ42 is the major component of diffuse Aβ
plaques Hamley 5152, left col., 1st para.
16. Hamley describes how, although the production of Aβ40 and
Aβ42 in the central nervous system does not appear to differ for
AD patients compared to controls, the rate of clearance of these
peptides is markedly reduced in AD patients. Hamley 5153, left
col., 1st full para.
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17. Hamley describes the formation of oligomers or fibrils of
amyloid beta peptides, Aβ40 and Aβ42 in humans, is thought to
be the causative agent in AD, leading to progressive cognitive
decline and neurodegeneration. Hamley 5178, right col., 1st full
para.
ANALYSIS
There is only a single prior art rejection and only claim 12 is argued.
This claim is considered representative. Appellant’s argument, though
voluminous in extent, comes down to contending that one of ordinary skill
would not have thought to use tranilast for suppressing or inhibiting an
amyloid fibril formation to a patient in need of suppressing or inhibiting an
amyloid fibril formation.
The difficulty for Appellant is that sole step in the claims, orally
administering tranilast, is described in the art with the same substance in the
same manner, and is applied to the same patient population, patients with
AD3, and with similar dosages. Therefore, the limitation that tranilast
suppresses or inhibits amyloid fibril formation is an inherent result of the art
disclosed oral administration of tranilast to patients with Alzheimer’s.
The Examiner makes a determination as to such inherency, citing
King. “Under the principles of inherency, if a structure in the prior art
necessarily functions in accordance with the limitations of a process or
method claim of an application, the claim is anticipated.” In re King, 801
F.2d 1324, 1326 (Fed. Cir. 1986). From this, the Examiner determines:

3 Appellant withdrew claims directed to a patient population having amyloid
fibrils in skin. Species Election filed Aug. 2, 2017.
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[i]t is unclear how tranilast, administered orally to
patients with Alzheimer's disease as taught by Schneider,
would have not provided the same treatment results as
recited in the instant claims, since the instant claims
recite treatment of the same patient population,
administration of the same agent, and the same route of
administration.
Non-Final Act. 7–8.
According to the Application Disclosure itself, suppressing or
inhibiting an amyloid fibril formation is the natural result of administering
tranilast. Thus, this result is inherent to the administration of the same
compound to the same patient population. The disclosure itself may provide
the admission of what is an inherent property.
In King Pharmaceuticals, Inc. v. Eon Labs, Inc., 616
F.3d 1267, 1270 (Fed.Cir. 2010), one of the claims
covered “a method of increasing the oral bioavailability
of metaxalone” by “administering to the patient a
therapeutically effective amount of metaxalone in a
pharmaceutical composition with food.” We noted that
according to the patent itself, “the natural result of
taking metaxalone with food is an increase in the
bioavailability of the drug,” and that “[t]he prior art
discloses taking metaxalone with food,” so the preamble
was “inherently anticipated.”
In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012)(emphasis added);
also see Persion Pharms. LLC v. Alvogen Malta Operations Ltd., 945 F.3d
1184, 1191 (Fed. Cir. 2019) (“If ... the disclosure is sufficient to show that
the natural result flowing from the operation as taught would result in the
performance of the questioned function, it seems to be well settled that the
disclosure should be regarded as sufficient to render the function
inherent.”)(citing In re Oelrich, 666 F.2d 578, 581 (C.C.P.A. 1981) (quoting
Hansgirg v. Kemmer, 102 F.2d 212, 214 (C.C.P.A. 1939)).
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Because Schneider describes administering the same substance to the
same patient population in the same oral manner and in similar dosage
amounts, the recited claim is not a new and nonobvious method of using an
existing composition. Hamley further describes the purpose as recited, that
the aggregation of the amyloid beta-peptide into oligomers or fibrils being
implicated as a key pathway associated with Alzheimer's disease (AD)
causation and progression. Appellant has not even established a narrow
range of effectiveness different from what the art teaches to administer.
At best, Appellant has possibly described a result or property
associated with administering tranilast to an AD patient population as
practiced in the prior art. But this would not be sufficient for obtaining a
patent. “While a new and nonobvious method of using an existing (or
obvious) composition may itself be patentable, a newly-discovered result or
property of an existing (or obvious) method of use is not patentable.”
Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286 (Fed. Cir. 2013) (citations
omitted) (Dyk, concurring). See also Bristol–Myers Squibb Co. v. Ben Venue
Labs., Inc., 246 F.3d 1368, 1376 (Fed.Cir.2001) (“Newly discovered results
of known processes directed to the same purpose are not patentable because
such results are inherent”); Persion Pharms
Inherency may supply a missing claim limitation in an
obviousness analysis. An inherent characteristic of a
formulation can be part of the prior art in an obviousness
analysis even if the inherent characteristic was
unrecognized or unappreciated by a skilled artisan. It is
long settled that in the context of obviousness, the mere
recitation of a newly discovered function or property,
inherently possessed by things in the prior art, does not
distinguish a claim drawn to those things from the prior
art. The Supreme Court explained long ago that it is not
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invention to perceive that the product which others had
discovered had qualities they failed to detect.
Persion Pharms., 945 F.3d at 1189 (citations omitted).
Therefore, simply reciting a result or property of the process already
described by Schneider is insufficient to confer patentability over the prior
art.
CONCLUSIONS OF LAW
The rejection of claims 12, 14, 15, 17, 18, 22, and 24–26 under
35 U.S.C. § 103(a) as unpatentable over Schneider and Hamley is proper.
CONCLUSION
The rejection of claims 12, 14, 15, 17, 18, 22, and 24–26 is affirmed.
In summary:
Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
12, 14, 15, 17,
18, 22, 24–26
103 Schneider
Hamley
12, 14, 15, 17,
18, 22, 24–26

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) (2011).

AFFIRMED