Ex Parte Sun

Patent Trial and Appeal Board

Jun 9, 2017

13656395 (P.T.A.B. Jun. 9, 2017)

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.
13/656,395 10/19/2012 Thomas Sun 7946-87599-03 2851
74839 7590
Klarquist Sparkman, LLP
121 SW Salmon St
Suite 1600
Portland, OR 97204
06/13/2017 EXAMINER
PAGONAKIS, ANNA
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
06/13/2017 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):
docketing @klarquist.com
AS CChair @klarquist. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THOMAS SUN1
Appeal 2016-008564
Application 13/656,395
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN E. SCHNEIDER,
and RACHEL H. TOWNSEND, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a device
for administering a drug composition, which have been rejected as
anticipated and as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The Specification describes a device for delivering a xinafoate salt.
Spec. 8. The device may be an inhaler such as a dry powder inhaler. Id.
Claims 1, 4, and 16—18 are on appeal. Claim 1 is representative of the
rejected claims and reads as follows:
1 Appellant identifies the Real Party in Interest as Rigel Pharmaceuticals,
Incorporated. Appeal Br. 2.
Appeal 2016-008564
Application 13/656,395
1. A device, comprising:
a housing defining a chamber that houses an excipient-
free, dry powder xinafoate salt-of N4-[(2,2-difluoro-4H-
benzo[l,4]oxazin-3-one)-6-yl]-5-fluoro-N2-[3-
(methylaminocarbonylmethyleneoxy)phenyl]-2,4-
pyrimidinediamine, wherein the xinafoate salt is formulated for
administration to the patient via inhalation using the device
through a patient interface; and
an advancement mechanism capable of distributing the
xinafoate salt to the chamber.
The claims stand rejected as follows:
Clams 1,4, and 16—18 have been rejected under 35 U.S.C. § 102(b) as
anticipated by Taylor2 as evidenced by Islam.3
Claims 1, 4, and 16—18 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Taylor in view of Hodson.4
ANTICIPATION
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that the claims are
anticipated by Taylor.
The Examiner finds that Taylor teaches a drug formulation
comprising the recited xinafoate salt as a dry powder with or without an
excipient. Final Act. 3. The Examiner finds that the drug formulation can
2 Taylor at al., WO 2009/031011 A2 (publ. Mar. 12, 2009) (“Taylor”).
3 Nazrul Islam & Ellen Gladki, Dry powder inhalers (DPIs)—A review of
device reliability and innovation, 360 Inf 1 J. Pharm. 1—11 (2008) (“Islam”).
4 Hodson et al., US 5,619,984 (iss. Apr. 15, 1997) (“Hodson”).
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Application 13/656,395
be administered intranasally or by inhalation using a dry powder inhaler. Id.
The Examiner finds that Islam evidences the structure of the inhalers
referenced in Taylor and that inhalers shown in Islam consist of a housing
chamber and an advancement mechanism capable of distributing the drug to
the chamber. Final Act. 3^4.
Appellant contends that Tylor does not disclose a housing defining a
chamber that houses the xinafoate salt. Appeal Br. 3^4. Appellant also
argues that Taylor does not teach using a xinafoate salt that is free of
excipients. Appeal Br. 4.
Principles of Law
“Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference.” In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009).
A gap in an otherwise anticipating reference may be closed by
reference to extrinsic evidence. The evidence must make clear though that
the missing descriptive matter is necessarily present in the other reference.
Schering Corp. v. Geneva Pharms., 339 F.3d 1373, 1377 (Fed. Cir. 2003).
Analysis
We find that Appellant has the better argument. Taylor broadly
mentions the use of a dry powder inhaler (Taylor p. 16,11. 26—35), Taylor is
silent as to the structure of the inhaler. Thus, Taylor does not anticipate the
pending claims.
The Examiner points to Islam as evidencing the structure of the
standard dry powder inhalers referenced in Taylor. Ans. 6. While this may
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Application 13/656,395
be true, Islam does not teach that all “standard dry powder inhalers” taught
in Taylor to be devices for use with the disclosed xinafoate salt necessarily
have a chamber that houses an active as an excipient free, dry powder, and
an advancement mechanism capable of distributing the active ingredient to
the chamber as required by the claim. Thus, the Examiner has failed to
show that the claimed structure is “necessarily present.” Id.
Conclusion of Law
We conclude that a preponderance of the evidence does not support
the Examiner’s conclusion that the present claims are anticipated by Taylor
as evidenced by Islam.
OBVIOUSNESS
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence support the Examiner’s conclusion that the rejected claims
would have been obvious over Taylor combined with Hodson.
The Examiner finds that Taylor teaches a drug formulation
comprising the recited xinafoate salt as a dry powder with or without an
excipient. Final Act. 4—5. The Examiner finds that Taylor teaches the drug
formulation can be administered intranasally or by inhalation using a dry
powder inhaler. Final Act. 5. While the Examiner finds that Taylor does not
teach “a housing defining chamber that houses the xinafoate salt and an
advancement mechanism capable of distributing the xinafoate salt to the
chamber and is loaded on an elongate carrier,” Hodson teaches such a
structure. Id. The Examiner concludes that
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Application 13/656,395
One of ordinary skill in the art would have found it prima
facie obvious at the time of the invention to administer the dry
powder formulation comprising the claimed xinafoate salt of
Taylor et al. ion [sic] the dry powder inhalation device of Hodson
et al. One would have been motivated to do so as the device of
Taylor et al. is a known effective dry powder inhalation [device]
and the formulation of Taylor et al. is intended for administration
via a dry powder inhaler. As such, one would have a reasonable
expectation of success that the formulation of Taylor et al. would
be therapeutically effective when administered in the dry powder
inhalation device of Hodson et al.
Final Act. 6.
Appellant contends that the Examiner has failed to establish a prima
facie case of obviousness in that neither of the references teaches the use of
the xinafoate salt without an excipient. Appeal Br. 8. Appellant argues that
Taylor mandates the use of an excipient thereby teaching away from the
present invention. Id. Appellant also argues that the present invention
provides superior results. Appeal Br. 7.
Analysis
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Office Action
and Answer regarding this rejection. We find the Examiner has established
that the claims would have been obvious to one of ordinary skill in the art
over Taylor combined with Hodson. Appellant has not produced evidence
showing, or persuasively argued, that the Examiner’s determinations on
obviousness are incorrect. Only those arguments made by Appellant in the
Briefs have been considered in this Decision. Arguments not presented in
the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). We have
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Application 13/656,395
identified claim 1 as representative; therefore, all claims fall with claim 1.
We address Appellant’s arguments below.
Appellant contends that Taylor does not teach the use of the xinafoate
salt without an excipient. Appeal Br. 6. We are unpersuaded. Taylor
specifically teaches that the xinafoate salt can be used alone. Taylor p. 12,
11. 15-19, p. 16,11. 26-35.
Appellant argues that Taylor teaches away from using the xinafoate
salt without excipients. Appeal Br. 8. Again we are unpersuaded. We have
reviewed the sections of Taylor cited by Appellant and find that they do not
rise to the level of a teaching away in that they do not “criticize, discredit, or
otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195,
1201 (Fed. Cir. 2004). For example, Appellant cites to Taylor where it
states that “[compatibility with conventional excipients such as lactose and
starch is a further mandatory requirement” (emphasis omitted) as mandating
the use of excipients. Appeal Br. 4. We do not agree. The cited passage
relates to the properties of the xinafoate salt and does not mandate the
inclusion of excipients. Similarly, while the other cited passages teach the
use of the xinafoate salt with an excipient, they do not mandate the use of
excipients. Moreover, as discussed above, Taylor specifically teaches that
the salt can be used without an excipient.
Appellant argues that the claimed invention exhibits superior results
and that this shows nonobviousness. Appeal Br. 7. We are unpersuaded.
“To be particularly probative, evidence of unexpected results must establish
that there is a difference between the results obtained and those of the closest
prior art, and that the difference would not have been expected by one of
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Application 13/656,395
ordinary skill in the art at the time of the invention.” Bristol-Myers Squibb
Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014). “[I]t is
well settled that unexpected results must be established by factual evidence.
‘Mere argument or conclusory statements in the specification does not
suffice.’” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (quoting In re
De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)).
Appellant has pointed to nothing in the record which supports the
conclusion that the results achieved by the claimed invention are
unexpected. Appellant has only offered arguments that the results are
superior not that they are unexpected. Appeal Br. 7, Reply Br. 7—8. The
superiority is asserted to be related to the advantage of administration
without an excipient: for example, “such as ameliorating concomitant lung
irritation associated with inhaling compositions comprising excipient.”
Reply Br. 8. However, there is no evidence that this benefit is “unexpected”
in light of Taylor’s specific teaching that the xinafoate salt can be used
alone, Taylor p. 12,11. 15—19, p. 16,11. 26—35, i.e., without excipients.
In addition, Appellant’s arguments regarding the alleged superior
results are premised on Appellant’s contention that Taylor mandates the use
of an excipient. Appeal Br. 7. As discussed above, we do not read Taylor as
mandating the use of excipients.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claim 1 would have been obvious over Taylor
combined with Hodson under 35 U.S.C. § 103(a).
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Claims 4 and 16—18 have not been argued separately and, therefore,
fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We reverse the rejection of claims 1,4, and 16—18 under 35 U.S.C. §
102(b).
We affirm the rejection of claims 1, 4, and 16—18 under 35 U.S.C. §
103(a).
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).
AFFIRMED
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