Julio A. Chirinos

Patent Trials and Appeals Board

Dec 5, 2019

14765583 - (D) (P.T.A.B. Dec. 5, 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.
14/765,583 08/04/2015 Julio A. CHIRINOS 46483-6090-00-US.604682 2007
10872 7590 12/05/2019
Riverside Law LLP
Glenhardie Corporate Center, Glenhardie Two
1285 Drummers Lane, Suite 202
Wayne, PA 19087
EXAMINER
ARNOLD, ERNST V
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
12/05/2019 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):
dcoccia@riversidelaw.com
dockets@riversidelaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JULIO A. CHIRINOS
__________

Appeal 2018-006907
Application 14/765,583
Technology Center 1600
__________

Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and
MICHAEL A. VALEK, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 3–7, 9, 11, 12, 24, 26, and 27. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 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 The
Trustees of The University of Pennsylvania. Appeal Br. 3.
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STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner’s rejection of
claims 1, 3–7, 9, 11, 12, 24, 26, and 27, under 35 U.5.C. § 103(a) as being
unpatentable over Lundberg,2 Kapil,3 Udelson,4 and Elkayam5 (Final Act.
3–11 (entered May 11, 2017)).
Claim 1 is representative and reads as follows:
1. A method of treating heart failure with preserved ejection
fraction (HFpEF) in a subject in need thereof, the method
comprising administering to the subject a therapeutically
effective amount of a composition comprising at least one
selected from the group consisting of inorganic nitrate or
inorganic nitrite.
Appeal Br. 19.
OBVIOUSNESS
The Examiner’s Prima Facie Case
The Examiner cited Lundberg as disclosing the use of inorganic
nitrates and nitrites for treating congestive heart disease. See Final Act. 4.
The Examiner also noted Lundberg’s teaching that inorganic nitrates and
nitrites could be used in combination with sildenafil. Id. at 5.
The Examiner cited Kapil as disclosing that beetroot juice, which
contains significant amounts of nitrate, lowers blood pressure and also

2 US 2010/0092441 A1 (published Apr. 15, 2010).
3 Vikas Kapil et al., Inorganic Nitrate Supplementation Lowers Blood
Pressure in Humans[:] Role for Nitrite-Derived NO, 56 HYPERTENSION
274–281 (2010).
4 James E. Udelson, MD, Heart Failure with Preserved Ejection Fraction,
124 CIRCULATION e540–e543 (2011).
5 Uri Elkayam et al., The Role of Organic Nitrates in the Treatment of Heart
Failure, 41 PROGRESS IN CARDIOVASCULAR DISEASES 255–264 (1999).
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increases plasma nitrate and nitrite. Id. The Examiner noted in particular
that Kapil “suggest[s] the thesis that dietary (inorganic) nitrate is a potential
preventative measure or treatment for cardiovascular disease (page 280,
perspectives).” Id. at 6.
The Examiner cited Udelson as teaching that approximately half of
heart failure patients have heart failure with preserved ejection fraction
(HFpEF), the treated condition recited in Appellant’s claims. Id. The
Examiner particularly noted Udelson’s teaching that favorable results were
obtained in a study in which HFpEF was treated with sildenafil. Id.
The Examiner cited Elkayam as teaching that organic nitrates (as
opposed to the inorganic nitrates recited in Appellant’s claims) were
associated with a number of positive effects in patients with chronic
congestive heart failure. Id. at 6–7.
The Examiner found that Lundberg differed from Appellant’s claims
in that Lundberg did not “expressly teach that the patient has heart failure
with preserved ejection fraction in the method resulting in improved exercise
tolerance, reduction of large artery stiffness, reducing arterial wave
reflections, improving vasodilator response to exercise, increasing blood
flow during exercise and increasing muscle oxidative capacity.” Id. at 7.
The Examiner determined, however, that “[t]his deficiency in Lundberg et
al. is cured by the teachings of Kapil et al., Elkayam et al., and Udelson.”
Id.
Specifically, the Examiner concluded that it would have been obvious
to
perform the method of Lundberg et al. on a patient that has
heart failure with preserved ejection fraction, as suggested by of
Kapil et al. and Udelson, resulting in improved exercise
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tolerance, reduction of large artery stiffness, reducing arterial
wave reflections, improving vasodilator response to exercise,
increasing blood flow during exercise and increasing muscle
oxidative capacity, as suggested by Elkayam et al., and produce
the instant invention.
Id. at 9.
The Examiner reasoned that a skilled artisan would have been
motivated to administer inorganic nitrates and/or nitrites to patients with
HFpEF as recited in Appellant’s claims because “administration of nitrites
and nitrates, whether organic or inorganic, to treat patients with heart failure,
such as congestive heart disease, is already extremely well known in the art
as taught by Lundberg et al. and Udelson teaches that 50% of those patients
had preserved ejection fraction.” Id.
The Examiner also reasoned that it would have been obvious to
administer inorganic nitrates and/or nitrites to HFpEF patients “because
Udelson teaches that the best treatment of those patients has been with
sildenafil and Lundberg et al. teach combining nitrites and nitrates, with
beetroot as a source of nitrate, with sildenafil to treat heart disease.” Id. at
10.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

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We select claim 1 as representative of the rejected claims. See
37 C.F.R. § 41.37(c)(1)(iv). Having carefully considered the arguments and
evidence advanced by Appellant and the Examiner, Appellant does not
persuade us that the preponderance of the evidence fails to support the
Examiner’s conclusion of obviousness as to claim 1.
Lundberg discloses administering inorganic nitrites and/or nitrates, the
active agents recited in Appellant’s claim 1, in order “to decrease oxygen
consumption.” Lundberg ¶ 6. Lundberg includes “congestive heart disease”
among disorders treatable with inorganic nitrites and/or nitrates. Id. ¶¶ 11,
98.
Lundberg discloses an experiment in which ingesting beetroot juice,
which contains inorganic nitrates, significantly reduced blood pressure in a
hypertensive individual. Id. ¶¶ 129–130.
Lundberg discloses that inorganic nitrites and/or nitrates can be
combined with a variety of additional drugs, including “cardiovascular drugs
(statins, ACE inhibitors, beta-receptor antagonists, diuretics, angiotensin 2
receptor antagonists, organic nitrates, calcium channel blockers)” as well as
“drugs for treatment of pulmonary hypertension including prostacyclin
analogues, endothelin receptor antagonists and sildenafil.” Id. ¶ 58.
Although Lundberg describes treating “congestive heart disease” with
inorganic nitrites and/or nitrates (id. ¶ 11, 98), Lundberg does not expressly
describe using inorganic nitrites and/or nitrates to treat patients with HFpEF,
the treated disorder recited in Appellant’s claim 1.
As the Examiner noted, however, Udelson discloses that it was “well
established that among patients with the clinical syndrome of heart failure
(HF), approximately half have preserved systolic function, known most
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commonly as heart failure with preserved ejection fraction (HFpEF).”
Udelson e540.
Udelson discloses that hypertension is among conditions associated
with HF hospitalization. See id. (“Several factors were associated with an
increased risk of incident HF hospitalization or HF death, including older
age, hypertension, and diabetes mellitus, whereas randomization to
trandolapril reduced risk.”) (Emphasis added).
Udelson notes in particular that “[p]redictors of HFpEF include[]
increased systolic blood pressure, atrial fibrillation, and female sex, whereas
HF with reduced EF was associated with prior myocardial infarction and left
bundle-branch block QRS morphology.” Id. (Emphasis added).
Udelson, noting that studies of therapeutic agents in HFpEF patients
“have generally shown neutral results,” discloses that one study involved
“controlled blood pressure.” Id. at e542. Udelson notes that when
administered sildenafil, “[f]avorable results were . . . seen in a small study
involving an important subgroup of HFpEF patients, those with pulmonary
hypertension.” Id.
Thus, although Udelson (like Lundberg) does not describe treating
HFpEF patients with inorganic nitrites and/or nitrates, Udelson informed the
skilled artisan that hypertension is among the risk factors for HF in general,
and HFpEF in particular. And, as noted above, in addition to its generic
teaching of treating congestive heart disease with inorganic nitrites and/or
nitrates, Udelson teaches that inorganic nitrates reduce blood pressure.
Lundberg ¶¶ 129–130.
Accordingly, to summarize, Udelson teaches that hypertension is
among the risk factors for HFpEF, and Lundberg teaches that inorganic
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nitrates reduce blood pressure. Appellant does not persuade us, therefore,
that the Examiner erred in determining that a skilled artisan, viewing
Lundberg’s generic teaching of treating congestive heart disease with
inorganic nitrites and/or nitrates, had motivation and a reasonable
expectation of success in treating HFpEF patients with inorganic nitrites
and/or nitrates.
Indeed, the Kapil article cited by the Examiner bolsters the
Examiner’s position. Specifically, as the Examiner found, Kapil discloses a
study “demonstrat[ing] dose-dependent decreases in blood pressure and
vasoprotection after inorganic nitrate ingestion in the form of either
supplementation or by dietary elevation” including in the form of beetroot
juice. Kapil 274 (abstract). And, as the Examiner also found, Kapil
suggests administering inorganic nitrates to treat cardiovascular disease. See
id. at 280 (“Although we acknowledge that our studies represent the
responses of a healthy volunteer population, our evidence suggests that a
dietary nitrate approach to CVD [cardiovascular disease] may have
therapeutic use.”).
Given Udelson’s teaching that hypertension is among the risk factors
for HFpEF, and given the teachings in Lundberg and Kapil that inorganic
nitrates reduce blood pressure in a manner suggesting their use in treating
congestive heart and cardio vascular diseases, we are not persuaded that the
Examiner erred in finding that a skilled artisan had motivation and a
reasonable expectation of success in treating HFpEF patients with inorganic
nitrites and/or nitrates, as recited in Appellant’s claim 1.
Elkayam, the last reference cited by the Examiner, further bolsters the
Examiner’s conclusion of obviousness. Elkayam discloses that “[a]lthough
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not approved by the FDA for the treatment of chronic congestive heart
failure (CHF), organic nitrates are widely used in patients with CHF.”
Elkayam 255 (citations omitted). Elkayam notes that, among other desirable
effects of organic nitrates, one desirable result of administering organic
nitrates to CHF patients is a “substantial reduction in . . . systemic blood
pressure.” Id.
Thus, although Elkayam does not specifically describe treating
HFpEF patients as recited in Appellant’s claim 1, Elkayam nonetheless
discloses more generally that it was desirable to treat congestive heart failure
with nitrate-containing compounds that reduce blood pressure. Accordingly,
to summarize, Udelson discloses that hypertension was a known risk factor
for HFpEF, and Lundberg and Kapil teach that inorganic nitrates, like the
organic nitrates used in Elkayam, reduce blood pressure in a manner
suggesting their use in treating congestive heart and cardio vascular diseases.
We are not persuaded, therefore, that the Examiner erred in finding that the
cited references would have provided a skilled artisan with motivation for
and a reasonable expectation of success in treating HFpEF patients with
inorganic nitrites and/or nitrates, as recited in Appellant’s claim 1.
Turning to Appellant’s arguments, Appellant cites twelve documents,
among them three declarations, as evidence that the Examiner erred in
determining that a skilled artisan would have considered it obvious to
administer inorganic nitrites and/or nitrates, as recited in Appellant’s claim
1, to treat HFpEF patients. See Appeal Br. 10 (citing Appendices A–C
(entered on March 2, 2017), Exhibits G, I, N, and O (entered on February
23, 2016), Exhibits S and T (entered on August 15, 2016), the Declaration of
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Dr. Chirinos (entered on August 15, 2016), and the Declarations of Drs.
Sweitzer and Shah (entered on March 2, 2017)).
In particular, Appellant contends, the Declarations of Drs. Chirinos,6
Sweitzer,7 and Shah8 establish that a skilled artisan would not have
considered organic nitrites/nitrates to be equivalent to inorganic
nitrites/nitrates in relation to treating HFpEF, and that a skilled artisan
therefore would not have had a reasonable expectation of success in, or
motivation for, treating HFpEF patients with inorganic nitrates, as recited in
Appellant’s claim 1. See Appeal Br. 11–13. Moreover, Appellant contends,
HFpEF is specific disease with a distinct physiology and response to
treatment, such that a skilled artisan would not have been motivated to apply
teachings regarding other types of heart failure to HFpEF. See id. at 14–16.
We do not find Appellant’s arguments persuasive. We first note that
“[o]bviousness, and expectation of success, are evaluated from the
perspective of a person having ordinary skill in the art at the time of
invention.” Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d
967, 974 (Fed. Cir. 2014) (quoting Velander v. Garner, 348 F.3d 1359, 1377
(Fed. Cir. 2003)).
Thus, in Bristol-Myers Squibb v. Teva the court determined that,
based on prior art teachings, selection of a particular lead compound would
have been obvious, despite the fact that post-invention disclosures

6 Declaration of Julio A. Chirinos, M.D., Ph.D., pursuant to 37 C.F.R.
§ 1.132 (declaration signed August 12, 2016).
7 Declaration of Nancy K. Sweitzer, M.D., Ph.D., pursuant to 37 C.F.R.
§ 1.132 (declaration signed January 17, 2017).
8 Declaration of Sanjiv Shah, M.D., pursuant to 37 C.F.R. § 1.132
(declaration signed January 27, 2017).
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established that the compound later was found to be toxic. See Bristol-
Myers Squibb v. Teva, 752 F.3d at 974 (“As the district court points out, in
October 1990 [(the time of the invention)], 2′–CDG was not yet known to
have high toxicity, and BMS’s expert, Dr. Schneller, agreed that researchers
at the time treated 2′–CDG as a promising compound.”) (Internal quotations
omitted).
In the present case, Appellant’s earliest claimed priority date is
February 7, 2013. See Spec. 1 (as amended August 4, 2015).
In contrast, each of Appendices A9 and B,10 as well as Exhibits G,11
I,12 S,13 and T,14 has a publication date after Appellant’s earliest priority
date, that is, after Appellant’s invention.

9 Payman Zamani et al., Isosorbide Dinitrate, With or Without Hydralazin,
Does Not Reduce Wave Reflections, Left Ventricular Hypertrophy, or
Myocardial Fibrosis in Patients with Heart Failure With Preserved Ejection
Fraction, 6 J. AM. HEART. ASSOC. 1–16 (2017) (Appendix A). The copy of
Appendix A in the record appears to be an uncorrected proof, as evidenced
by markings on each page.
10 Payman Zamani et al., Pharmacokinetics and Pharmacodynamics of
Inorganic Nitrate in Heart Failure with Preserved Ejection Fraction, 120
CIRC. RES. 1–11 (2016) (Appendix B).
11 Payman Zamani et al., Effect of Inorganic Nitrate on Exercise Capacity in
Heart Failure with Preserved Ejection Fraction, 131 CIRCULATION 371–380
(2014) (Exhibit G).
12 Margaret M. Redfield, M.D., et al., Isosorbide Mononitrate in Heart
Failure with Preserved Ejection Fraction, 373 N. ENGL. J. MED. 2314–2324
(2015) (Exhibit I).
13 Joel Eggebeen, MS, et al., One Week of Daily Dosing With Beetroot Juice
Improves Submaximal Endurance and Blood Pressure in Older Patients
With Heart Failure and Preserved Ejection Fraction, 4 JACC: HEART
FAILURE 428–437 (2016) (Exhibit S).
14 Clyde W. Yancy, MD, MSc, FACC, FARA, et al. (Writing Committee
Members), 2013 ACCF/AHA Guideline for the Management of Heart
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As to Exhibit T, each of Drs. Sweitzer and Shah declares that the
information therein is “representative of expert opinion and best practice at
the time of the invention.” Sweitzer Decl. ¶ 3; see also Shah Decl. ¶ 3 (same
statement). Appellant, however, advances no evidence suggesting that,
despite their post-invention publication dates, a skilled artisan would have
been aware of the teachings in Appendices A and B, or Exhibits G, I, and S,
such that the artisan would have been able to consider the information in
those documents when evaluating whether it would have been obvious to
treat HFpEF patients with inorganic nitrates, as recited in Appellant’s claim
1.
Appendix C, cited in each of the Declarations of Drs. Chirinos,
Sweitzer, and Shah (Chirinos Decl. ¶ 13; Sweitzer Decl. ¶ 4; Shah Decl. ¶
4), includes no indicia that the document was ever published, such that a
skilled artisan would have been aware of the teachings therein at the time of
Appellant’s invention. See Appendix C generally (document entered March
2, 2017). Indeed, it is unclear who performed the study described in
Appendix C, or when the study was performed. See id. generally.
Accordingly, to the extent Appellant’s arguments, and the opinions of
Drs. Chirinos, Sweitzer, and Shah rely on the teachings in Appendices A–C,
and Exhibits G, I, and S, as undermining the motivation for, and the
reasonable expectation of success in, treating HFpEF patients with inorganic
nitrites and/or nitrates, we do not find those arguments persuasive. See
Bristol-Myers Squibb v. Teva, 752 F.3d at 974 (“Obviousness, and

Failure, 128 CIRCULATION e240–e327 (2013) (Exhibit T or “the
Guideline”). The even numbered pages of Exhibit T provide an October 15,
2013 publication date.
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expectation of success, are evaluated from the perspective of a person
having ordinary skill in the art at the time of invention.”).
As noted above, despite the post-invention publication date of
Appellant’s Exhibit T (the 2013 ACCF/AHA Guideline for the
Management of Heart Failure or “the Guideline”), both Dr. Sweitzer and Dr.
Shah testify that the information therein is “representative of expert opinion
and best practice at the time of the invention.” Sweitzer Decl. ¶ 3; see also
Shah Decl. ¶ 3 (same statement).
Rather than undermining the Examiner’s conclusion of obviousness,
however, we find that the Guideline bolsters the Examiner’s conclusion of
obviousness. Contrary to Appellant’s contention that HFpEF and HFrEF
(heart failure with reduced ejection fraction) are entirely distinct conditions
requiring entirely distinct therapeutic treatment agents, the Guideline teaches
that one shared treatable symptom of HFpEF and HFrEF is hypertension:
Elevated blood pressure is a major risk factor for the
development of both HFpEF and HFrEF, a risk that extends
across all age ranges. Long-term treatment of both systolic and
diastolic hypertension has been shown to reduce the risk of
incident HF by approximately 50%. Treatment of hypertension
is particularly beneficial in older patients. . . . Given the robust
outcomes with blood pressure reduction, clinicians should
lower both systolic and diastolic blood pressure in accordance
with published guidelines.
Exhibit T e260 (emphasis added; citations omitted).
And, as to HFpEF, the treated condition recited in Appellant’s claims,
the Guideline expressly teaches that it is desirable to administer blood
pressure reducing agents:
Blood pressure control concordant with existing
hypertension guidelines remains the most important
recommendation in patients with HFpEF. Evidence from an
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RCT [randomized controlled trial] has shown that improved
blood pressure control reduces hospitalization for HF, decreases
cardiovascular events, and reduces HF mortality in patients
without prevalent HF. In hypertensive patients with HFpEF,
aggressive treatment (often with several drugs with
complementary mechanisms of action) is recommended. ACE
inhibitors and/or ARBs are often considered as first-line agents.
Specific blood pressure targets in HFpEF have not been firmly
established; thus, the recommended targets are those used for
general hypertensive populations.
Id. at e274 (citations omitted).
Thus, consistent with the Udelson article’s identification of
hypertension as a primary risk factor for HFpEF, the Guideline identifies
reducing blood pressure as a primary therapeutic objective in HFpEF
patients. And as noted above, both Lundberg and Kapil disclose that
inorganic nitrates are effective blood pressure reducing agents. See
Lundberg ¶¶ 129–130; Kapil 274, 280.
Accordingly, to summarize, the Guideline teaches that blood pressure
reducing agents were known to be useful for treating HFpEF, and Lundberg
and Kapil teach that inorganic nitrates were known to be effective blood
pressure reducing agents. Appellant does not persuade us, therefore, that the
Guideline establishes that a skilled artisan, at the time of the invention,
lacked either motivation for, or a reasonable expectation of success in, using
inorganic nitrates to treat HFpEF, as recited in Appellant’s claim 1.
To the contrary, given the Guideline’s teaching that blood pressure
reducing agents were useful for treating HFpEF, viewed alongside the
teachings in Lundberg and Kapil that inorganic nitrates were known to be
effective blood pressure reducing agents, we find that the Guideline actually
supports the Examiner’s conclusion of obviousness.
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We acknowledge the disclosure in Exhibit N15 that “[i]f HFpEF and
HFrEF were part of the same HF disease spectrum, they would be expected
to respond similarly to treatment. However, medications that have been
shown to produce unequivocal improvements in HFrEP have not produced
similar beneficial effects in HFpEF (Figure 2).” Exhibit N 2007 (citations
omitted).
We acknowledge the disclosure in Exhibit O16 that β-blockers
produced inconsistent results in HFrEF and HFpEF patients:
Large clinical trials have convincingly shown that
β-blocker therapy reduces mortality and improves LV function
in [HFrEF] patients. In [HFpEF] patients, favourable effects of
β–blocker therapy on mortality and LV function have not been
convincingly demonstrated. After hospital discharge, [HFpEF]
patients had improved survival when using β-blockers and in a
community-based registry, carvedilol use was accompanied by
similar 1 year mortality in [HFpEF] and [HFrEF] patients but
less reduction in hospitalizations in [HFpEF] patients. In the
SWEDIC trial, carvedilol had no effect on mortality or
hospitalizations, but ameliorated E/A ratio of [HFpEF] patients.
In a similar study, however, 6 months of atenolol use had no
effect on diastolic LV function of [HFpEF] patients with
unchanged pulmonary capillary wedge pressure. Because of
these inconsistent results, the use of β-blockers in [HFpEF]
patients is further evaluated in clinical trials, such as the
Japanese DHF study.
Exhibit O 1864 (citations omitted).

15 Barry A. Borlaug, MD & Margaret M. Redfield, MD, Are Systolic and
Diastolic Heart Failure Overlapping or Distinct Phenotypes Within the
Heart Failure Spectrum ?, 123 CIRCULATION 2006-2014 (2011) (Exhibit N).
16 Nazha Hamdani et al., Distinct myocardial effects of beta-blocker therapy
in heart failure with normal and reduced left ventricular ejection fraction,
30 EUR. HEART J. 2314–2324 (2015) (Exhibit O).
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As noted above, however, the Guideline expressly states that “[b]lood
pressure control concordant with existing hypertension guidelines remains
the most important recommendation in patients with HFpEF.” Exhibit T
e274 (emphasis added). And as also discussed above, inorganic nitrates
were known in the art to be effective blood pressure reducing agents. See
Lundberg ¶¶ 129–130; Kapil 274, 280.
Accordingly, the fact that certain therapeutic agents might not have
been expected to treat HFpEF patients does not negate the fact that blood
pressure reducing agents were known to be useful for treating HFpEF, the
condition treated in Appellant’s claim 1. And, inorganic nitrates, treatment
agents recited in Appellant’s claim 1, were known to be useful for reducing
blood pressure.
In sum, for the reasons discussed, Appellant does not persuade us that,
when viewed as a whole, the prior art of record fails to support the
Examiner’s conclusion that a skilled artisan would have considered it prima
facie obvious to administer inorganic nitrates to treat HFpEF, as recited in
Appellant’s claim 1. Appellant does not advance any specific objective
evidence of nonobviousness to rebut the prior art evidence of obviousness
discussed above. Because a preponderance of the evidence, therefore,
supports the Examiner’s conclusion of obviousness as to Appellant’s claim
1, we affirm the Examiner’s rejection of claim 1.
As to the Examiner’s rejection of claims 3–7, 9, 11, 12, and 24,
Appellant relies on the arguments discussed above in relation to claim 1.
See Appeal Br. 16. Therefore, for the reasons discussed above as to claim 1,
we also affirm the Examiner’s rejection of claims 3–7, 9, 11, 12, and 24.
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As to the Examiner’s rejection of claims 26 and 27, Appellant relies
on the arguments discussed above in relation to claim 1, and also includes a
brief summary reiterating the arguments presented in traversing the rejection
of claim 1. See Appeal Br. 16–17. Therefore, for the reasons discussed
above as to claim 1, we also affirm the Examiner’s rejection of claims 26
and 27.

CONCLUSION
In summary:

Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3–7, 9, 11,
12, 24, 26, 27
103(a) Lundberg, Kapil,
Udelson, Elkayam
1, 3–7, 9, 11,
12, 24, 26, 27

TIME PERIOD
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