Ex Parte Richardson et al

Patent Trial and Appeal Board

Nov 30, 2018

13737823 (P.T.A.B. Nov. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/737,823 01/09/2013 Peter Richardson
45200 7590 12/04/2018
K&L Gates LLP-Orange County
1 Park Plaza
Twelfth Floor
IRVINE, CA 92614
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.
1951300.00254CON(090) 1069
EXAMINER
LIU, SAMUEL W
ART UNIT PAPER NUMBER
1656
NOTIFICATION DATE DELIVERY MODE
12/04/2018 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):
uspatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER RICHARDSON, ROBERT A. BAUGHMAN,
ANDREA LEONE-BAY, and DONALD COSTELL0 1
Appeal2017-000785
Application 13/737,823
Technology Center 1600
Before RICHARD M. LEBOVITZ, JOHN G. NEW, and
RICHARD J. SMITH, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state that the real party-in-interest MannKind Corporation.
App. Br. 3.
Appeal2017-000785
Application 13/737,823
SUMMARY
Appellants file this appeal under 35 U.S.C. § I34(a) from the
Examiner's Non-Final Rejection of claims 1-10 and 12-21. Specifically,
claims 1-9, 13-19, and 21 stand rejected as unpatentable under 35 U.S.C.
§ 103 (a) as being obvious over the combination of Steiner et al. (US
6,428,771, August 6, 2002) ("Steiner '771"), Roy et al. (WO 2007/100535
A2, September 7, 2007) ("Roy"), and Steiner et al. (US 6,652,885 B 1,
November 25, 2003) ("Steiner '885").
Claims 12 and 20 stand rejected as unpatentable under 35 U.S.C.
§ I03(a) as being obvious over the combination of Steiner '771, Roy, Steiner
'885, and DeFelippis et al. (US 2005/0043228 Al, February 24, 2005)
("DeF elippis").
Claim 10 stands rejected as unpatentable under 35 U.S.C. § I03(a) as
being obvious over the combination of Steiner '771, Roy, Steiner '885, and
Schuckmann (US 2007/0240708 Al, October 18, 2007) ("Schuckmann").
Claims 1-9, 12, and 14--20 stand rejected as unpatentable under the
nonstatutory doctrine of obviousness-type double patenting as being obvious
over claims 1-7 of Richardson et al. (US 8,377,869 B2, February 19, 2013)
(the "' 869 patent").
Claims 1-10 and 13-19 stand rejected under the nonstatutory doctrine
of obviousness-type double patenting as being obvious over claims 1-8, 13,
and 20 of Richardson et al. (US 8,372,804 B2, February 12, 2013) (the "'804
patent").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART and enter a NEW GROUND OF
REJECTION.
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NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to a method of introducing a
physiologically-active labile agent into the circulatory system of a mammal.
Abstr.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A method of administering a labile active agent to a
patient in need thereof comprising:
administering to said patient by inhalation a
pharmaceutical composition comprising the labile active agent
associated with a diketopiperazine microparticle wherein about
35% to about 75% of the microparticles have an aerodynamic
diameter of less than 5. 8 µm, wherein the active agent is subject
to degradation in a patient as a result of exposure to peripheral
tissue, vascular venous tissue, or liver metabolism, and wherein
the effectiveness of said active agent is reduced by said
degradation prior to reaching the agent's site of action, and
further wherein insulin is not a labile active agent.
App. Br. 24.
ISSUES AND ANALYSES
We are persuaded by, and expressly adopt, the Examiner's findings,
reasoning, and conclusion that Appellants' claims are prima facie obvious
over the combined cited prior art, with the exception of claim 10, which we
reverse. We also enter a new ground of rejection for claim 10. We address
the arguments raised by Appellants below.
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A. Rejection of claims 1-9, 13-19, and 21 under 35 U.S.C. § 103(a)
Issue 1
Appellants argue the Examiner erred because there would have been
no reason for a skilled artisan to combine the prior art elements in the
manner claimed. App. Br. 10.
Analysis
The Examiner finds that Steiner '885 teaches administering a
composition of an active agent ( active peptide) in the form of microparticles
in a dry powder form for pulmonary (inhalation) administration. Final Act.
2 (citing Steiner '885 col. 3, 11. 7-13, 42--46; col. 10, 11. 37--42). The
Examiner finds that Steiner '885 teaches that the active agent is formulated
into microparticles with diketopiperazine ("DKP"), the most preferred
embodiment of which includes fumaryl diketopiperazine ("FDKP"), and is
suitable for pulmonary administration. Id. (citing Steiner '885 Abst.; col. 3,
11. 12-13, 29-33; col. 7, 11. 16-17). The Examiner finds that Steiner '885's
preferred active agent is glucagon, which, though unstable, can be stabilized
when formulated with (DKP) to form microparticles. Id. (citing Steiner '885
col. 5, 11. 20-21; col. 11, 11. 16-19).
The Examiner finds that Steiner '885 further teaches that DKP serves
to stabilize and enhance delivery of the active agent, and defines the term
"enhance" as meaning "to enhance transport of the active agent across
biological membrane, thereby rapid increase in the concentration of active
agent in the blood circulation after administration of the FDKP/DKP
formulated active agent." Final Act. 3 ( emphasis omitted) ( citing Steiner
col. 4, 1. 12-22). The Examiner finds that these teachings suggest that
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FDKP-fornmlated, stabilized glucagon microparticles are suitable for
pulmonary delivery. Id.
The Examiner further finds that Steiner '885 teaches that it is
desirable to apply the DKP-based delivery composition to other biologically
active agents, including glucagon (but not insulin). Final Act. 3 (citing
Steiner '885 col. 3, 11. 4---6; col. 6, 11. 9-10; col. 5, 11. 20-21). The Examiner
finds that Steiner '885 teaches that pulmonary administration of the FDKP-
formulated active peptides enhances delivery efficiency via rapid adsorption
of said active peptides into blood circulation ( col. 4, 11. 43--48).
The Examiner finds that Roy teaches the peptide hormone
oxyntomodulin ("OXM," also known as "glucagon-37"), a preproglucagon.
Final Act. 5 ( citing Roy 1 ). The Examiner finds that OXM has a very short
half-life and is rapidly inactivated (degraded) by cellular peptidases. Id.
The Examiner finds that Roy also teaches that OXM is useful in treating
both obesity and diabetes. Id. ( citing Roy 18).
The Examiner concludes that it would have been obvious to a skilled
artisan to combine the teachings of the references and substitute OXM, as
taught by Roy, for the similar peptidergic active agents, including glucagon,
taught by Steiner '885. Final Act. 5. The Examiner concludes that a person
of ordinary skill would have been motivated to combine the references in
this way so as to increase the efficiency of OXM administration in the
treatment of obesity and diabetes. Id.
Appellants argue that the Examiner has provided no reasoning as to
why a person of ordinary skill in the art would have selected the various
elements from the prior art and combine them in the claimed manner. App.
Br. 11.
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We disagree. The Examiner concludes that a person of ordinary skill
in the art would have been motivated to combine the teachings of the cited
prior art references and substitute OXM, as taught by Roy, for the similar
peptidergic active agents, including glucagon, taught by Steiner '885 so as to
increase the efficiency of OXM administration in the treatment of obesity
and diabetes. Final Act. 5. Appellants adduce no evidence or argument to
rebut the Examiner's conclusion in this respect beyond an unsupported
conclusory statement that the Examiner has articulated no reasoning as to
why a person of ordinary skill in the art would combine the teachings of the
references. We accord such attorney argument little probative value and are
not persuaded by Appellants in this regard. See In re Geisler, 116 F.3d
1465, 1470 (Fed. Cir. 1997) (holding that attorney arguments and conclusory
statements that are unsupported by factual evidence are entitled to little
probative value). We are consequently not persuaded by Appellants'
contention.
Issue 2
Appellants argue that the references relied upon by the Examiner do
not teach or suggest each claim element. App. Br. 11.
Analysis
Appellants contend that, whereas Steiner '885 discloses some
advantages associated with pulmonary administration for certain active
agents, the reference is focused on storage or shelf stability prior to
administration. Id. at 12 ( citing Steiner '885 col. 2, 11. 42-54; Ex. 2).
According to Appellants, Steiner '885 mentions "degradation" twice, in the
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context of a storage stability test, and teaches overcoming this shelf stability
problem by complexing the active agent with a diketopiperazine. Id.
In contrast, Appellants argue, the instant claims address the problem
of in vivo degradation by using diketopiperazine microparticles for
administration specifically by the pulmonary route, thus minimizing
degradation of the active agent in venous blood circulation, in a peripheral
tissue, or in the liver, associated with administration of active agent. App.
Br. 12. Appellants therefore assert that, because the reference does not
address these disadvantages associated with certain modes of active agent
administration as compared to other modes, Steiner '885 would not have
suggested to a skilled artisan that active agents can be administered to better
effect using specific modes of administration. Id. at 12-13.
Appellants also argue that, with respect to dependent claims 12 and
20, Steiner '885 does not teach the claimed glucagon-like protein ("GLP-
1"), but, rather, teaches glucagon. 2 App. Br. 13. Appellants further point
out that Steiner '885 explicitly states that its glucagon compositions are
intended for subcutaneous administration, rather than by inhalation. Id. at
14 (citing Steiner '885 col. 15, 11. 8-18).
Appellants contend that Roy does not remedy the alleged deficiencies
of Steiner '885. App. Br. 14. According to Appellants, Roy relates to
oxyntomodulin derivatives and discloses "pulmonary" a single time amidst
an alleged laundry list of prospective administration methods. Id. ( citing
Roy 19). Appellants assert these teachings of Roy would not provide a
2 Appellants also point out that dependent claim 13 expressly excludes GLP-
1. App. Br. 13. Steiner '885 teaches the use of other peptides, including
glucagon. See Steiner '885 col. 3, 11. 4---6; col. 6, 11. 9-1 O; col. 5, 11. 20-21.
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person of skill in the art any reason to select pulmonary administration from
the disclosed options. Id. Furthermore, Appellants argue, even if one of
ordinary skill were motivated to combine Steiner '885 with Roy, the
combination would not suggest the claimed methods, because, Appellants
contend, Steiner '885 does not teach or suggest the claimed administration
of a labile active agent by inhalation. Id. at 14--15. Furthermore, Appellants
argue, Roy teaches that pulmonary administration can more efficiently
deliver certain active agents to particular target organs when compared to
other routes, thereby requiring lower doses of active agent and preventing or
reducing these unwanted side effects. Id. at 15.
We are not persuaded. As an initial matter, we observe that: "[O]ne
cannot show non-obviousness by attacking references individually where ...
the rejections are based on combinations of references." In re Keller, 642
F.2d 413,426 (C.C.P.A. 1981). We thus look to the combined teachings of
the references.
We also note that the claimed advantages of Appellants' invention,
i.e., that administration via inhalation of an active agent: "minimiz[ es]
degradation of the active agent in venous blood circulation, in a peripheral
tissue, or in the liver" (App. Br. 15), although recited in the claims, is an
inherent property of inhaling the claimed active agents. Administering the
active agent combined with DKP as described in Steiner '885 would have
reasonably been expected to achieve the same results recited in the claims
because the same agents are administered through the same route, thus
presumptively having the same properties and results. See In re Best, 562
F.2d 1252, 1255 (CCPA 1977) ("Where, as here, the claimed and prior art
products are identical or substantially identical, or are produced by identical
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or substantially identical processes, the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently possess the
characteristics of his claimed product"). The burden therefore shifts to
Appellants to show that, following the explicit guidance in the cited prior
art, the results recited in the limitation (i.e., avoiding degradation of the
activation via inhalation) would not have been achieved. In response to the
rejection, Appellants did not provide adequate evidence to show that the
result would not been routinely achieved by following the guidance in the
prior art.
Steiner '885 teaches that:
Encapsulation or entrapment of large polymers, such as
proteins and peptides, in diketopiperazines can be used to remove
impurities or contaminants such as metal ions or other small
molecules. The diketopiperazines also serve both to stabilize and
enhance delivery of the entrapped materials. Formulations also
have been developed for the enhanced transport of active agents
across biological membranes. These formulations include
microparticles formed of (i) the active agent, which may be
charged or neutral, and (ii) a transport enhancer that masks the
charge of the agent and/or that forms hydrogen bonds with the
membrane. The formulations can provide rapid increases in the
concentration of active agent in the blood following
administration of the formulations.
Steiner '885 col. 4, 11. 8-22. Steiner '885 teaches that preferred active
agents include: "[H]ormones, cytokines and other immunomodulatory
peptides, and antigens/vaccines .... In another preferred embodiment, the
active agent is glucagon." Id. at col. 5, 11. 16-21. Steiner '885 also teaches
that other peptides can be delivered with fumaryl diketopiperazine to
achieve rapid absorption. Id. at col. 4, 11. 43--48. Steiner '885 further
teaches that:
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The compositions of active agent described herein can be
administered to patients in need of the active agent. The
compositions preferably are administered in the form of
microparticles, which can be in a dry powder form for pulmonary
administration or suspended in an appropriate pharmaceutical
carrier, such as saline.
The microparticles preferably are stored in dry or
lyophilized form until immediately before administration. The
microparticles then can be administered directly as a dry powder,
such as by inhalation using, for example, dry powder inhalers
known in the art. Alternatively, the microparticles can be
suspended in a sufficient volume of pharmaceutical carrier, for
example, as an aqueous solution for administration as an aerosol.
Id. at col. 10, 11. 38-51.
We acknowledge that Steiner '885 additionally teaches that its
disclosed formulations are useful in preventing degradation of the active
agent during storage. See Steiner '885, col. 2, 11. 42-54. Nevertheless, as
the passages quoted supra liberally illustrate, Steiner '885 also expressly
teaches: "administering ... by inhalation a pharmaceutical composition
comprising the labile active agent associated with a diketopiperazine
microparticle," as recited in claim 1.
With respect to claims 12 and 20, which recite that the active agent is
GLP-1, we note that the Examiner has rejected these claims as obvious over
the combination of Steiner '885, Roy, Steiner '771, and DeFelippis. See
Final Act. 8. The Examiner finds that DeFelippis teaches that GLP-1 can be
formulated into particles in dry powder form for inhalation or pulmonary
administration. Id. (citing DeFelippis ,r,r 9, 57, 178). The Examiner finds
that GLP-1, which is useful for treating Type 2 diabetes, is a labile peptide
with an extremely short in vivo half-life. Id. (citing DeFelippis ,r,r 1, 5).
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The Examiner further finds that DeFelippis teaches an "enhancer,"
i.e., diketopiperazine (DKP), that can be added to the formulation to increase
bioavailability after pulmonary administration. Final Act. 8 ( citing
DeFelippis ,r 201).
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to formulate GLP-1 with DKP for pulmonary
administration, because the Steiner '885 teaches the usefulness of
formulating a peptide active agent with DKP for administration by
inhalation to increase the active agent concentration in blood stream. Final
Act. 8. The Examiner concludes that a person of ordinary skill would have
understood from the teachings of the references that the peptidergic active
agent of Steiner '885 could include GLP-1, as taught by DeFelippis, using
DKP to enhance the bioavailability of the active agent when administered
via pulmonary administration, for the treatment of Type 2 diabetes.
We agree with the Examiner. DeFelippis expressly teaches:
Doses of the compositions of the present invention depend
on the potency and bioavailability of the GLP-1 compound in the
particular composition. Generally, when delivered by the
pulmonary route, the compositions of the present invention will
have a bioavailability that is approximately 10% to 50% that of
the compound delivered subcutaneously. However, an enhancer
such as diketopiperazine [i.e., DKP] may be added to further
increase bioavailability after pulmonary administration.
DeFelippis ,r 201. We agree that the teachings ofDeFelippis, combined with
the teachings of Steiner '885, Steiner '771, and Roy, as explained supra,
teach the limitation of claims 12 and 20 reciting: "The method of claim 10
wherein said composition comprises GLP-1." Furthermore, with respect to
claim 13, which recites: "The method of claim 1 wherein the labile active
agent is not GLP-1," Steiner '885 teaches the use of other peptidergic active
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agents, particularly glucagon, which, as Appellants point out, is not GLP-1.
See, e.g., Steiner '885 col. 11, 11. 13-24. We consequently do not find
Appellants' arguments persuasive with respect to this issue.
Issue 3
Appellants argue that the Examiner erred because a person of ordinary
skill in the art would have had no reasonable expectation of success in
combining the teachings of the cited prior art to arrive at Appellants'
claimed invention. App. Br. 16.
Analysis
Appellants argue that, as with Steiner '885, neither Roy nor Steiner
'771 recognizes that pulmonary administration can more efficiently deliver
certain active agents to particular target organs (such as the brain and the
liver) as compared to other routes, thereby requiring lower doses of active
agent and preventing or reducing these unwanted side effects. App. Br. 16.
Therefore, Appellants argue, the references fail to provide any reasonable
expectation that the claimed methods would provide any benefit over the
prior art. Id.
Appellants further argue that Steiner '771 provides no teaching or
suggestion that the claimed inhaled administration provides any benefit over
subcutaneous administration. App. Br. 15. Appellants point to Steiner
'771 's teaching that, with respect to administration of salmon calcitonin
("SCt"): "The bioavailability of the pulmonary route in this preliminary
analysis was 17% versus the subcutaneous administration." Id. ( quoting
Steiner '771 col. 12, 11. 21-28; also citing Steiner '771, Fig. 2A).
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We are not persuaded by Appellants' arguments. As we have
explained supra, both Steiner '885 and Steiner '771 expressly teach
administration of a peptidergic active agent and DKP microparticles via
inhalation, as recited in the claims. Steiner '885 col. 10, 11. 38-51; Steiner
'771 Abstr., ,r 3. Roy similarly teaches that its OXM peptide prohormone
can be administered via pulmonary methods (i.e., inhalation). Roy 19.
Similarly, DeFelippis teaches administration of GLP-1 and DKP
microparticles via inhalation (i.e., pulmonary administration). DeFelippis
,r 201. We agree with the Examiner that the combined teachings of the prior
art would have revealed to a person of ordinary skill that pulmonary
administration was routine in this field of endeavor, and that there would
therefore have been a reasonable expectation of success in administering the
claimed composition via this method. We consequently affirm the
Examiner's rejection of the claims.
B. Rejection of claims 12 and 20 under 35 U.S.C. § 103(a)
Appellants argue these claims separately. App. Br. 17-20. However,
Appellants raised these same issues supra, viz., that neither Steiner '885.
Steiner '771, nor Roy teach the use of GLP-1. We have already explained
our reasoning as to why we affirm the Examiner's rejection of these claims,
viz., that the Examiner relies upon DeFelippis as teaching this limitation.
See App. Br. 13.
Appellants additionally argue that DeFelippis teaches GLP-1
complexed with a basic polypeptide, in contrast to the claimed labile active
agent associated with a diketopiperazine microparticle. App. Br. 20.
Appellants further note that DeFelippis mentions diketopiperazine a single
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time as an optional component, and not in the context of administering a
diketopiperazine-containing microparticle. Id.
We disagree. As we have pointed out supra, DeFelippis expressly
teaches combining GLP-1 and DKP and administering them via inhalation.
DeFelippis ,r 201. We agree with the Examiner that a person of ordinary
skill in the art would understand this teaching of DeFelippis, especially
when combined with the teachings of the other cited references, would
understand that GLP-1 could be administered in this manner with a
reasonable expectation of success. The fact, as Appellants argue, that
DeFelippis teaches this but a single time is of little moment, particularly
given the express manner of DeFelippis' teaching. See supra; see also
Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989)
(holding that all disclosures of the prior art, including unpreferred
embodiments, must be considered). We consequently affirm the Examiner's
rejection of the claims.
C. Rejection of claim 10 under 35 U.S.C. § 103(a)
Claim 10 depends ultimately from claim 1, and recites: "[W]herein
the step of administering said composition to said patient comprises
administration of said composition using a breath-powered dry powder
inhaler comprising a cartridge." App. Br. 25.
Appellants essentially repeat their arguments presented supra,
contending that Schuckmann does not cure the alleged deficiencies of
Steiner '885 and '771 and Roy. App. Br. 22. As we have explained supra,
we do not find Appellants' arguments persuasive.
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Furthermore, Appellants argue that Schuckmann relates to inhalers
comprising a pressurized cartridge. App. Br. 22 ( citing Schuckmann ,r 3).
Appellants contend that because claim 10 recites "a breath-powered ...
inhaler," Schuckmann neither teaches nor suggests the limitation of claim
10.
The Examiner responds that Steiner '885 that the: "dry powder inhaler
has been known in the art," and that Schuckmann teaches that a hand-held
inhaler that comprises a cartridge for delivery of inhaler medicaments. Ans.
19 (citing Steiner col. 10, 11. 47--48; Schuckmann (claims 10 and 17)). The
Examiner thus relies upon Schuckmann as teaching the structural limitation
"cartridge" and concludes that the breath-powered dry-powder inhaler taught
in the prior art is an obvious variation of the claimed breath-powered dry
power inhaler. Id.
We are not persuaded by the Examiner's reasoning. In addition to the
teachings of Steiner '885, Appellants' Specification discloses that dry-
powder inhalers are known in the prior art:
In one embodiment, the formulation comprising the active
ingredient can be administered to the patient in a dry powder
formulation by inhalation using a dry powder inhaler such as the
inhaler disclosed, for example, in U.S. Patent No. 7,305,986 and
U.S. Patent Application Serial No. 10/655,153 (US
2004/01823 87), which disclosures are incorporated herein by
reference.
Spec. 22. Appellants' Specification is otherwise silent with respect to
"breath-powered inhalers."
Steiner '885 similarly teaches that dry-powder inhalers are known in
the art. Steiner '771 also teaches a "breath-activated" inhaler. Steiner '771,
col 2, 11. 22-25. However, we are not persuaded, nor can we discern, based
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upon the evidence of record, that any of these references teaching the use of
a "breath-activated inhaler" can be unambiguously said to teach or suggest a
"breath-powered" inhaler. We consequently reverse the Examiner's
rejection of claim 10.
NEW GROUND OF REJECTION
We hereby enter a new ground of rejection. Claim 10 is rejected as
unpatentable under 35 U.S.C. § I03(a) as being obvious over the
combination of Steiner '885, Steiner '771, Roy, Schuckmann, and Volgyesi
(US 6,325,063 Bl, December 4, 2001) ("Volgyesi").
Volgyesi teaches a "breath-powered inhalation device" that "provides
advantages over conventional inhalation devices using compressed gases as
propellants since it is more compact, simpler and does not require
synchronization of activation of the device and inhalation by the user.
Volgyesi Abstr.
We conclude that it would have been obvious for a person of ordinary
skill in the art to substitute the breath-powered inhaler of Volgyesi for the
pressurized cartridge inhaler of Schuckmann. See KSR Int 'l Co. v. Teleflex
Inc., 550 U.S. 398, 421 (2007) (holding that, here a skilled artisan merely
pursues "known options" from a "finite number of identified, predictable
solutions," obviousness under § 103 arises); see also id. at 416 ("The
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results"). We conclude
that a person of ordinary skill in the art would have been motivated to
substitute the breath-powered inhaler of Volgyesi to obtain the advantages
expressly taught by the Volgyesi Abstract, as quoted supra.
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For the same reason, we agree with the Examiner that a person of
ordinary skill in the art would have had a reasonable expectation of success
in substituting a breath-powered inhaler for a pressurized dry-powder
inhaler, not least because Appellants adduce no evidence, beyond mere
attorney argument, that a person of ordinary skill in the art, making such a
substitution, would have had no reasonable expectation of success. See App.
Br. 23. We consequently affirm the Examiner's rejection of the claim.
D. Rejection of claims 1-10 and 13-20 under the nonstatutory doctrine
of obviousness type double patenting
Appellants make no argument in their Brief addressing the
Examiner's rejections upon this ground. We consequently summarily affirm
the Examiner's rejections of the claims upon this ground.
DECISION
The Examiner's rejection of claims 1-9 and 12-21 under 35 U.S.C.
§ 103(a) is affirmed.
The Examiner's rejection of claims 10 under 35 U.S.C. § 103(a) is
reversed.
The Examiner's rejection of claims 1-10 and 13-20 under the
nonstatutory doctrine of obviousness-type double patenting is affirmed.
We also enter a new ground of rejection under 37 C.F.R.
§ 4I.50(b) for claim 10.
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 4I.50(b). 37 C.F.R. § 4I.50(b) provides that "[a] new ground of
rejection ... shall not be considered final for judicial review."
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37 C.F.R. § 4I.50(b) also provides that the Appellants, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new ground of rejection
to avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new evidence relating to the claims so
rejected, or both, and have the matter reconsidered by the
examiner, in which event the proceeding will be remanded to
the examiner ....
(2) Request rehearing. Request that the proceeding be reheard
under § 41.52 by the Board upon the same record ....
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l). See 37 C.F.R.
§ 1.136(a)(l)(iv) (2010).
AFFIRMED-IN-PART
37 C.F.R. § 4I.50(b)
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