Ex Parte MATSUNAGA et al

Patent Trials and Appeals Board

May 16, 2019

14579102 - (D) (P.T.A.B. May. 16, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/579,102 12/22/2014 Yugo MATSUNAGA
22850 7590 05/20/2019
OBLON, MCCLELLAND, MAIER & NEUSTADT, L.L.P.
1940 DUKE STREET
ALEXANDRIA, VA 22314
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
445783US99CONT 1299
EXAMINER
STOCKTON, LAURAL YNNE
ART UNIT PAPER NUMBER
1626
NOTIFICATION DATE DELIVERY MODE
05/20/2019 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):
patentdocket@oblon.com
OBLONPAT@OBLON.COM
iahmadi@oblon.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte YUGO MATSUNAGA, SHIGERU UEKI,
HIROKI KATO, and SHIRO KOBAYASHI
Appeal2018-000721
Application 14/579,102
Technology Center 1600
Before DEBORAH KATZ, JOHN G. NEW, and DAVID COTTA,
Administrative Patent Judges.
KATZ, Administrative Patent Judge.
DECISION ON APPEAL
Appeal2018-000721
Application 14/579,102
Appellants 1 seeks our review, under 35 U.S.C. § 134(a), of the
Examiner's decision to reject claims 13-32. (Appeal Brief filed July 11,
2017 ("App. Br.") 1.) We have jurisdiction under 35 U.S.C. § 6(b). An oral
argument was held on May 2, 2019. We AFFIRM.
Appellants claim methods of relaxing the gastric fundus - the upper
portion of the stomach- by administering a recited compound. (See App.
Br. 16-19, Claims App'x.)
Inventor Shigeru Ueki, testifies that when a "normally functioning"
person eats food,
the stomach expands in a process known as "gastric
accommodation." This accommodation of the stomach to food
involves relaxation of the proximal stomach, in particular the
fundus, providing the food with a reservoir and enabling an
increase in stomach volume without an increase in pressure
within the stomach.
(Ueki Deel, ,r 13) Appellants assert that the claimed compound relaxes the
gastric fundus and alleviates impaired gastric accommodation to improve
feelings of early satiety and bloating. (See Spec. 2:20-26; see App. Br. 5.)
Appellants' claim 13, the only independent claim on appeal, recites2 :
A method for relaxing the gastric fundus in a subject
having impaired gastric accommodation, comprising
administering to a subject having impaired gastric
accommodation an effective amount of 2-[N-( 4,5-dimethoxy-2-
hydroxybenzoyl)amino ]-4-[ (2-
1 Appellants report that the real party in interest is Zeria Pharmaceutical Co.,
LTD. (App. Br. 2.)
2 The Examiner has objected to claim 13 because of the misspelling of the
word "accommodation." (See Final Act. 2-3.)
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Application 14/579,102
diisopropylaminoethyl)aminocarbonyl] -1,3-thiazole or an acid
addition salt thereof to achieve relaxation of the gastric fundus.
(App. Br. 16.)
The Examiner rejected claims 13-32 as being anticipated under
35 U.S.C. § 102(b) over Furuta (Furuta et al., "LC determination of Z-338,
novel gastroprokinetic agent in dog plasma by SCX solid phase extraction,"
25 JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS 599-603
(2001)). (Examiner's Answer, issued August 31, 2017 ("Ans.") 5-9.)
Because we do not agree with Appellants that the Examiner erred and, thus,
sustain this rejection, we decline to reach the Examiner's other rejections. 3
Appellants do not argue for the separate patentability of any of the
rejected claims. We focus on independent claim 13 in our review. See
37 C.F.R. § 4I.37(c)(l)(iv).
35 U.S. C. § 102(b)
"Anticipation requires a showing that each limitation of a claim is
found in a single reference, either expressly or inherently." Atofina v. Great
Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). Appellants agree
that compound Z-338 taught in Furuta is the same thiazole compound recited
in claim 13. (See App. Br. 7-8.) Accordingly, the nature of the recited
compound is not at issue on appeal. Appellants' argument is that Furuta
3 The Examiner also rejected claims 13-32 over U.S. patent 5,981,557,
issued to Nagasawa et al. on November 9, 1999, both as anticipating the
claims under 35 U.S.C. § 102(b) and as rendering them obvious under
35 U.S.C. § 103(a). (Ans. 4 and 9-17.) In addition, the Examiner rejected
claims 13-3 2 as being obvious over Japanese patent application 102122 71,
filed by Nagasawa et al. and published August 11, 1998, either alone or in
combination with U.S. patent 5,981,557. (See Ans. 9-17.)
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Application 14/579,102
does not teach treating subjects with impaired gastric accommodation. (See
App. Br. 8-11.)
As the Examiner finds, Furuta teaches using the claimed compound to
treat functional dyspepsia and gastroesophageal reflux disease. (See Ans. 5,
citing Furuta 599; see App. Br. 7-8.) The Examiner finds that when the
claimed compound is used to treat functional dyspepsia, it inherently relaxes
the gastric fundus. (See Ans. 9.) According to the Examiner: "The instant
claimed invention is anticipated by ... Furuta et al. since the same thiazole
compound is being administered to treat the same disorder such as epigastric
pain, vomiting, etc." (Id.)
"Under the principles of inherency, if the prior art necessarily
functions in accordance with, or includes, the claims limitations, it
anticipates." In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir.
2002). According to Appellants' Specification, administration of the
compound "improves relaxation of gastric fundus and impaired gastric
accommodation and thus clearly alleviates symptoms caused by said
disorders, including early satiety and bloating." (Spec. 12: 19-13 :2.) Thus
administration of the claimed compound inherently relaxes the gastric
fundus.
The Examiner cites references that support the finding that
administration of the claimed compound in Furuta to treat functional
dyspepsia and gastroesophageal reflux disease would inherently treat
subjects having impaired gastric accommodation. (See Ans. 7-8.) For
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Application 14/579,102
example, the Examiner cites to Tack4, which teaches that "[i]mpaired
relaxation of the proximal stomach to a meal is present in a high proportion
of patients with functional dyspepsia." (See Ans. 8, citing Tack abstract.)
Thus, the dyspepsia patients that Furuta teaches to treat by administering the
claimed compound include patients having impaired relaxation of the
proximal stomach. When the claimed compound is administered to these
patients, relaxation of the gastric fundus would inherently occur. As
explained by Mr. Ueki, relaxation of the gastric fundus would allow for
gastric accommodation. (See Ueki Deel. ,r 13.)
Similarly, the Examiner cites Van Emelen5 for its teaching that "it is
believed that compounds which are able to normalize an impaired fundic
relaxation are useful to relieve patients suffering from said dyspeptic
symptoms." (See Ans. 8, citing Van Emelen 2: 17-19.) Cuomo6 and Bayati7
teach that functional dyspepsia causes symptoms such as of early satiety,
postprandial fullness, bloating, belching, anorexia, nausea, vomiting and
epigastric pain or burning. (See Cuomo 130; see Bayati ,r 23.) Thus, when
the claimed compound is used to treat the symptoms of functional dyspepsia,
such as early satiety and bloating, as taught in Furuta, relaxation of the
4 Tack et al., "Role of Impaired Gastric Accommodation to a Meal in
Functional Dyspepsia," GASTROENTEROLOGY 115:1346-52 (1998).
5 Van Emelen, et al., International Patent Application WO 00/75136 Al,
published December 14, 2000.
6 Cuomo et al., "Functional Dyspepsia Symptoms, Gastric Emptying and
Satiety Provocative Test: Analysis of Relationships," SCAND. J.
GASTROENTEROL., 36:1030-36 (2001).
7 Bayati, U.S. Patent Application Publication 2003/0135133 Al, published
July 17, 2003.
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Application 14/579,102
gastric fundus and treatment of impaired gastric accommodation would also
be achieved. Accordingly, we agree with the Examiner that Furuta
inherently anticipates the claimed methods.
Appellants' arguments do not persuade us otherwise. Appellants
argue that the Examiner erred in reasoning that some of the symptoms of
impaired gastric accommodation are the same as the symptoms of functional
dyspepsia. (See App. Br. 8.) Appellants cite to Mr. Ueki's declaration, but
he states the same argument as Appellants, without any additional
explanation. (See Ueki Deel. ,r 26.)
Appellants and Mr. Ueki fail to explain why the Examiner's reasoning
is in error. If treatment of the symptoms of functional dyspepsia necessarily
results in treatment of impaired gastric accommodation, the Examiner's
reasoning is correct. The Examiner cites to Tack as evidence that impaired
relaxation of the proximal stomach is present in a high proportion of patients
with functional dyspepsia, which is evidence of the inherency of the
treatment taught in Furuta. Appellants argue that Furuta does not describe
treating subjects having impaired gastric accommodation, but do not address
the basis of the Examiner's findings of inherency. (See App. Br. 8.)
Appellants also argue that Furuta teaches only treating healthy dogs,
but does not teach treating any subjects having impaired gastric
accommodation. (See App. Br. 8-10, citing Ueki Deel. ,r,r 28 and 29.)
According to Appellants, even though Furuta expressly teaches using the
claimed compound to treat functional dyspepsia (see Furuta 599), the
Examiner erred because the fact that some of the symptoms of impaired
gastric accommodation are the same as the symptoms of functional
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Application 14/579,102
dyspepsia does not overcome the lack of a teaching to treat impaired gastric
accommodation. (See App. Br. 8, citing Ueki Deel. ,r,r 26 and 27.)
We are not persuaded by Appellants' argument because even though
there was no express teaching that the claimed compound would improve
gastric accommodation in the prior art, prior recognition of an inherent
property is not required for anticipation. See Schering Corp. v. Geneva
Pharm., Inc., 339 F.3d 1373-77 (Fed. Cir. 2003) ("this court rejects the
contention that inherent anticipation requires recognition in the prior art.").
Tack, Bayati, Cuomo, and Van Emelen show that a high proportion of
patients with functional dyspepsia have impaired gastric relaxation and that
the symptoms of functional dyspepsia overlap with those of impaired
relaxation of the gastric frundus and gastric relaxation. Thus, the Examiner
has provided sufficient evidence to show that treatment of functional
dyspepsia taught in Furuta by administering the claimed compound would
inherently be relaxation of the gastric fundus and treatment of impaired
gastric accommodation. Where a claimed process is the same use with the
same steps taught in the prior art, newly discovered results directed to the
same purpose do not make it patentable. See Bristol-Myers Squibb Co. v.
Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) ("the claimed
process here is not directed to a new use; it is the same use, and it consists of
the same steps as described by Kris. Newly discovered results of known
processes directed to the same purpose are not patentable because such
results are inherent.").
Appellants do not direct us to evidence that the gastric fundus is not
relaxed by the claimed compound in patients treated for functional dyspepsia
as taught in Furuta.
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Application 14/579,102
[W]here the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the claimed
subject matter may, in fact, be an inherent characteristic of the prior
art, it possesses the authority to require the applicant to prove that the
subject matter shown to be in the prior art does not possess the
characteristic relied on.
In re Swinehart, 439 F.2d 210, 212-13 (CCPA 1971). Accordingly, we
have no reason to find that Appellants' claimed method is not inherently
anticipated by Furuta.
We are not persuaded that the Examiner erred in rejecting Appellants'
claims as being anticipated by Furuta.
Because an affirmance of the rejection under 35 U.S.C. § 102(b) over
Furuta is dispositive of all of Appellants' pending claims, we need not reach
the Examiner's other rejections.
Conclusion
Upon consideration of the record and for the reasons given, the
rejection of claims 13-32 under 35 U.S.C. § 102(b) over Furuta is sustained.
Therefore, we affirm the decision of the Examiner to reject claims 13-
32.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.
AFFIRMED
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