John Couvaras

Patent Trials and Appeals Board

Dec 24, 2021

2022001037 (P.T.A.B. Dec. 24, 2021)

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.
15/131,442 04/18/2016 John L. Couvaras 82044.0002-00 7130
85944 7590 12/24/2021
Lei Mei
Mei & Mark LLP
P.O. Box 65981
Washington, DC 20035-5981
EXAMINER
SZNAIDMAN, MARCOS L
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
12/24/2021 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 JOHN L. COUVARAS
__________

Appeal 2022-001037
Application 15/131,442
Technology Center 1600
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
JOHN G. NEW, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
of increasing prostacyclin release in systemic blood vessels to improve
vasodilation. The Examiner rejected the claims as obvious. 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 inventor,
John L. Couvaras (see Appeal Br. 3). We have considered the Specification
of Apr. 18, 2016 (“Spec.”); Non-Final Office Action of Apr. 14, 2021
(“Non-Final Action”); Appeal Brief of July 23, 2021 (“Appeal Br.”);
Examiner’s Answer of Oct. 19, 2021 (“Ans.”); and Reply Brief of Dec. 7,
2021 (“Reply Br.”).
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“Hypertension . . . can be due to various causes, such as constriction
of the blood vessels. Angiotensin II is a potent vasoconstrictor in the human
body” (Spec. 1:21 to 2:1). “Angiotensin II receptor blockers (ARBs) are
substances that block the action of angiotensin II by preventing angiotensin
II from binding to angiotensin II receptors on blood vessels. As a result, the
blood vessels are less constricted and blood pressure is reduced” (id. at
2:11–16). “GABA receptors are activated through the action of the GABA
or GABA-a analog during the period of time to promote production and
release of smooth muscle relaxing substances by the activation of the
GABA-a receptors” (id. at 5:11–15). “[S]ince the GABA-a receptors were
found to be present in substantially any smooth muscle and endothelium, the
composition of the present invention can be used to effect any of the various
vascular circuits such as pulmonary, coronary, cutaneous, splanchnic and the
like” (id. at 11:16–20).
The Specification teaches:
The present invention is a combination of an existing
class of anti-hypertensive drugs, Angiotensin Converting
Enzyme Inhibitors (ACE-I) and/or Angiotensin Receptor
Blockers (ARBs), with the amino acid GABA or GABA-a
analog, to improve the smooth muscle relaxation response,
improved vasodilation and improved blood pressure reducing
response, or reducing the dose of current ACE inhibitor and/or
ARBs with GABA or GABA-a analogue and achieve the same
response.
(Spec. 6:3–10).
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Claims 11, 12, 15, 16, 24, 25, 27, 29, 30, and 32 are on appeal.2
Claim 11 is an independent claim, is representative and reads as follows:
11. A method of increasing prostacyclin release in systemic
blood vessels of a human individual with essential hypertension
to improve vasodilation, the method comprising the steps of:
providing a human individual expressing GABA-a
receptors in systemic blood vessels due to essential
hypertension;
providing a composition of a dosage of a GABA-a
agonist and a dosage of an ARB combined into a deliverable
form, the ARB being an Angiotensin II, type 1 receptor
antagonist;
delivering the composition to the human individual’s
circulatory system by co-administering the dosage of a
GABA-a agonist and the dosage of the ARB to the human
individual orally or via IV;
synergistically promoting increased release of
prostacyclin by blockading angiotensin II in the human
individual through the action of the dosage of the ARB to
reduce GABA-a receptor inhibition due to angiotensin II
presence during a period of time, and
activating the uninhibited GABA-a receptors through the
action of the GABA-a agonist during the period of time; and
relaxing smooth muscle of the systemic blood vessels as
a result of increased prostacyclin release.

The Examiner rejected claims 11, 12, 15, 16, 24, 25, 27, 29, 30, and
32 under 35 U.S.C. § 103(a) as obvious over Thomson,3 Cheng,4 Kaufman,5

2 The Examiner withdrew claims 17, 18, 21–23, 26, 28, 31, and 33 from
consideration (see Non-Final Act. 3).
3 Thomson et al., US 2010/0104728 A1, published Apr. 29, 2010.
4 Cheng et al., US 2012/0164120 A1, published June 28, 2012.
5 Kaufman et al., US 2013/0251671 A1, published Sept. 26, 2013.
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Kimura,6 Hayakawa,7 Elliot,8 Inoue,9 See,10 Kjeldsen,11 and Emala12 (Non-
Final Act. 4–15).
The Examiner finds that Thomson, Cheng, Kaufman, Kimura,
Hayakawa, Elliott, and Inoue evidence that “GABA agonists are effective in
treating hypertension in both animals and humans” (Non-Final Act. 5). The
Examiner finds that Hayakawa teaches a “single oral dose of GABA (0.05
mg/kg or 0.5 mg/kg or 5.0 mg/kg . . . significantly decreases blood pressure
from 4 to 8 hours after administration” (Non-Final Act. 6).
The Examiner also finds “See and [Kjeldsen] teach that the oral
administration of ARBs are known to treat hypertension” (Non-Final Act.
7). The Examiner finds it would have been obvious

6 Kimura et al., Involvement of -Aminobutyric Acid (GABA) B Receptors
in the Hypotensive Effect of Systemically Administered GABA in
Spontaneously Hypertensive Rats, 89 Japanese J. Pharmacol. 388–94 (2002).
7 Hayakawa et al., Effect of a -aminobutyric acid-enriched dairy product on
the blood pressure of spontaneously hypertensive and normotensive Wistar-
Kyoto rats, 92 British J. Nutrition 411–7 (2004).
8 Elliott et al., GAMMA AMINOBUTYRIC ACID: CIRCULATORY AND
RESPIRATORY EFFECTS IN DIFFERENT SPECIES; RE-
INVESTIGATION OF THE ANTI-STRYCHNINE ACTION IN MICE, 146 J.
Physiology 70–84 (1959).
9 Inoue et al., Blood-pressure-lowering effect of a novel fermented milk
containing -aminobutyric acid (GABA) in mild hypertensives, 57 European
J. Clinical Nutrition 490–5 (2003).
10 See, S., Angiotensin II receptor blockers for the treatment of hypertension,
2 Expert Opinion Pharmacol. 1795–1804 (2001).
11 Kjeldsen et al., Targeting the renin-angiotensin system for the reduction of
cardiovascular outcomes in hypertension: angiotensin-converting enzyme
inhibitors and angiotensin receptor blockers, 10 Expert Opinion Pharmacol.
729–45 (2005).
12 Emala, SR., US 2010/0048732 A1, published Feb. 25, 2010.
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to treat hypertension in a human suffering from hypertension
comprising the orally or i.v. co-administration of a composition
comprising a dosage of GABA or a GABA agonist and a
dosage of ARB, each of which is taught by the prior art to be
useful for the same purpose (treating hypertension), in order to
form a third composition to be used for the very same purpose.
(Non-Final Act. 7). The Examiner finds “[d]ose regimen optimization is
clearly a result effective parameter that a person of ordinary skill in the art
would routinely optimize given the guidance of the prior art. Optimization
of parameters is a routine practice” (id. at 13).
Appellant responds
objected indicia of non-obviousness both compel and confirm
that the claimed invention is not obvious. First, the fact that the
prior art in the old, crowded, and lucrative art of hypertension
treatment never referenced, taught, or suggested the co-
administration of a GABA-a agonist (or any GABA-related
compound) and an ARB strongly suggests non-obviousness.
Second, despite the Examiner’s touting that some effective
treatments for hypertension exist, the treatment of essential
hypertension remains a long felt, but unresolved need. Third,
the prior art taught away from the claimed co-administration by
(a) suggesting that GABA is unrelated to the release of
vasodilators (like PGI2) and (b) by indicating that combining
GABA with an ACE Inhibitor (with a known effect similar to,
but distinct from, ARBs) yielded less of a blood pressure
decrease that an ACE Inhibitor alone. Fourth, as confirmed by
the silence in the prior art and the Inventor’s laboratory data,
the resulting synergistic release of PGI2 was an unexpected
result. Fifth, the claimed invention directly flows from the
Inventor’s recognition of a problem, namely “the conflicting
paradigm that ARBs lower blood pressure in eHTN humans
despite that many eHTN humans have negligible to low normal
levels of Angiotensin II in circulation.” Finally, failure of
others is shown by at least the prior art previously cited by the
Examiner.
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(Appeal Br. 13–14).
We find the Examiner has the better position and address Appellant’s
arguments in turn. Appellant first argues that “despite their decades-long
separate prevalence in the prior art relating to hypertension treatment, the
prior art has no record of a GABA-related compound and an ARB being
coadministered or otherwise combined” (Appeal Br. 13).
The Examiner’s cited art is not limited to showing that
antihypertensive agents should be administered singly, but rather Kjeldsen
teaches “[u]se of ARBs alone or in combination with other classes of
antihypertensive agents to lower blood pressure . . . reduces risk of
cardiovascular disease outcomes” (Kjeldsen 729, abstract). Kjeldsen also
notes guidelines that “acknowledge the need for multiple-drug therapy in
many patients to adequately lower blood pressure” (Kjeldsen 729).
Therefore, the prior art itself provided a direct suggestion to combine
different known antihypertensive agents, a teaching that ARBs and GABA
are known hypertensive agents, and a reason to combine different
hypertensive agents because “[m]ost patients require multiple-drug therapy
to reach blood pressure goals. Blood pressure treatment guidelines
recognise the desirability of initiating treatment with multiple-drug therapy”
(Kjeldsen 738, col. 2). See In re Kerkhoven, 626 F.2d 846, 850 (CCPA
1980) (“It is prima facie obvious to combine two compositions each of
which is taught by the prior art to be useful for the same purpose, in order to
form a third composition which is to be used for the very same purpose.”)
Appellant next contends the “law prohibits reliance on inherency in
obviousness for unknown properties . . . . The use of inherency in
obvious[ness] is clearly not appropriate here because, as the Examiner
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repeatedly admitted, ‘the prior art was not aware of’ ‘increasing prostacyclin
release in systemic blood vessels of a human individual’” (Appeal Br. 22).
We find this argument unpersuasive because the Federal Circuit has
“recognized that inherency may supply a missing claim limitation in an
obviousness analysis.” PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d
1186, 1194–5 (Fed. Cir. 2014). The court’s “early precedent, and that of
[its] predecessor court, established that the concept of inherency must be
limited when applied to obviousness, and is present only when the limitation
at issue is the ‘natural result’ of the combination of prior art elements.” Id.
at 1195.
As applied to the current facts, the natural result of treating a patient
with the obvious combination of an ARB and a GABA agonist at optimized
dosages would have necessarily resulted in increasing prostacyclin release in
the absence of rebuttal evidence. As the Examiner noted, “[n]ewly
discovered results of known processes directed to the same purpose are not
patentable because such results are inherent.” In re Montgomery, 677 F.3d
1375, 1381 (Fed. Cir. 2012); cf. Ans. 9–11. This is also analogous to Kao,
where a limitation to a “food effect” was found obvious because the effect
was an inherent property of the composition being used for treatment itself.
In re Huai-Hung Kao, 639 F.3d 1057, 1071 (Fed. Cir. 2011).
We are not persuaded by Appellant’s contention that “the Examiner
may be relying (or may rely) on the similar obviousness rationale of
‘[c]ombining prior art elements according to known methods to yield
predictable results’” (Appeal Br. 22) because to the extent that the Examiner
relies on this as a secondary rationale, the Examiner notes that the prior art
and legal precedent would have suggested combining different
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antihypertensive compounds such as GABA and ARBs for the benefit of
treating hypertension (see Ans. 13). The Examiner finds the reason to
combine in treating hypertension, not in “increasing prostacyclin release in
systemic blood vessels of a human individual” (see id.). The Examiner finds
that result inherent in the obvious combination of GABA and an ARB used
for hypertension treatment.
Appellant contends
the objective indicia of (i) length of intervening time between
the prior art and invention; (ii) long felt, but unresolved needs;
(iii) teaching away by others; (iv) unexpected results; (v)
recognition of a problem; and (v[i]) failure of others all
forcefully counsel towards reversal of the obviousness
rejection. There is a nexus between all of these objective
indicia and claim 11 because, as discussed below, each
secondary condition directly corresponds to the claimed (i) co-
administration of compounds and/or (ii) subsequent steps taken
to arrive at the desired result.
(Appeal Br. 25).
Length of time
Appellant first argues that “the ‘components’ at issue here have been
known as essential hypertension treatments for many, many decades . . .
Nonetheless, there was no teaching or suggestion in the prior art to co-
administer or combine these ‘components’” (Appeal Br. 26). Appellant cites
Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1358 (Fed. Cir. 2013) for the
proposition that “the substantial ‘elapsed time between the prior art and the
[the patent application’s] filing date evinces that the . . . claimed invention
was not obvious to try” (id. at 27 (citing Leo Pharm., 726 F.3d at 1356.)).
We find this argument unpersuasive because the panel decision in Leo
Pharm. cannot overrule the en banc CCPA precedent that the “mere age of
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the references is not persuasive of the unobviousness of the combination of
their teachings, absent evidence that, notwithstanding knowledge of the
references, the art tried and failed to solve the problem.” In re Wright, 569
F.2d 1124, 1127 (CCPA 1977). Appellants have provided no evidence that
the prior art tried to combine GABA and ARBs and failed to obtain an anti-
hypertensive composition. We also note the Examiner pointed out that “Leo
Pharm. presented several medical research articles discouraging the
combination” while here “there is nothing in the prior art teaching away
from mixing GABA a agonists with ARBs” (Ans. 15).
Long-felt need
Appellant next argues that:
The treatment of essential hypertension is a “long felt, but
unresolved need.” It affects millions of Americans; the
pharmaceutical industry generates billions of dollars annually
through related treatments-and the industry spends billions of
dollars in new treatment development. (Affidavit ¶5.) The
claimed invention is squarely directed at this long felt, but
unresolved need.
(Appeal Br. 28; citing Declaration of Dr. John Couvaras ¶5, dated Apr. 30,
2020).
We are not persuaded. To establish a long-felt need, three elements
must be proven: First, the need must have been a persistent one that was
recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538
(CCPA 1967). Second, the long-felt need must not have been satisfied by
another before Appellant’s invention. See Newell Companies, Inc. v.
Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another
supplied the key element, there was no long-felt need or, indeed, a problem
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to be solved . . . .”). Third, the invention must, in fact, satisfy the long-felt
need. In re Cavanagh, 436 F.2d 491, 496 (CCPA 1971).
In this case, Appellant has provided no evidence supporting the first
two of these three elements. While Dr. Couvaras states “there is a long-felt,
but unresolved need,” Dr. Couvaras’ own statements support a finding that
there was no long-felt need as currently available marketed ARBs were
selling billions of dollars of compound to patients (Couvaras Decl. ¶5). That
the ARBs are selling very well does not suggest a need, but rather the
absence of a need. And while Dr. Couvaras states that pharmaceutical
companies “are incentivized to and expend substantial resources toward new
and improved eHTN treatments,” no evidence is presented of expenditures
by a pharmaceutical company on hypertensive treatments after the 2005
publication dates of See and Kjeldsen (Couvaras Decl. ¶5). Even if such
expenditures were demonstrated, there is no evidence that the current
compounds are insufficient. The Examiner pointed out, regarding long-felt
need, that it may be that “there were already so many drugs and
combinations of drugs for the efficacious treatment of hypertension that
there might have been no need to find or explore a new combination that
will require substantial financial commitment” (Ans. 17).
And we agree with the Couvaras Declaration that “[v]arious eHTN
treatments have been used for many, many decades. For example, GABA
has been known about for over 65 years, and the use of ARB’s has been
known over 30 years” (Couvaras Decl. ¶5). The Examiner also finds “there
are already several solutions for the treatment of hypertension” (Ans. 18).
Appellant provides no persuasive evidence that the current antihypertensive
compounds were unsatisfactory or that there was a need or problem with
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these current compounds that was then solved by the combination of GABA
and ARBs.
Teaching away
Appellant argues the prior art teaches away, specifically noting that
Liu,13 a reference previously identified in prosecution, “discloses co-
administering both GABA-related and Angiotensin II-related compound—
and more specifically, GABA and an ACE Inhibitor (as opposed to an
ARB). Liu, however, ultimately found that this combination of yielded less
of a blood pressure decrease that an ACE Inhibitor alone” (Appeal Br. 30).
Appellant also argues that
the Examiner’s apparent proposition that a valid teach-away
must be so narrow and precise as to substantially disclose the
claimed invention makes no sense. If a reference taught the
claimed invention, it would anticipate the claims—even if the
invention was simultaneously denigrated. Accordingly, this
novel dismissal or [sic] a teach away has no merit. The co-
administration of similar compounds in Liu—and their
failure—is unquestionably relevant.
(id. at 32).
In Medichem, the court explained that “[w]here the prior art contains
‘apparently conflicting’ teachings (i.e., where some references teach the
combination and others teach away from it) each reference must be
considered ‘for its power to suggest solutions to an artisan of ordinary skill .
. . consider[ing] the degree to which one reference might accurately discredit

13 Liu et al., Antihypertensive Effects of Lactobacillus-Fermented Milk
Orally Administered to Spontaneously Hypertensive Rats, 59 J. Agricultural
Food Chem. 4537–43 (2011).
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another.’” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir.
2006).
Appellant’s argument that the Examiner’s test would limit teaching
away to anticipation situations is incorrect, as teachings in the instant case
that the ARB or GABA compounds were toxic, were unable to function in
combination with other anti-hypertensive agents, or were previously
incapable of synthesis represent examples of the types of teachings that
might cause an ordinary artisan to “be discouraged from following the path
set out in the reference, or . . . be led in a direction divergent from the path
that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir.
1994). However, no such teaching has been presented on these facts.14
The asserted teaching away, that an entirely different chemical entity
of ACE inhibitor compounds does not show improved anti-hypertensive
effect when combined with GABA compounds, is not a teaching away from
the obvious combination of ARBs and GABA compounds “because such
disclosure does not criticize, discredit, or otherwise discourage the solution
claimed.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
This is particularly the case when the cited prior art teaches “[u]se of
ARBs alone or in combination with other classes of antihypertensive agents
to lower blood pressure . . . reduces risk of cardiovascular disease outcomes”
(Kjeldsen 729, abstract). Kjeldsen also notes guidelines that “acknowledge

14 Indeed, arguably Liu’s teaching does not even teach away from the
combination of ACE inhibitor compounds and GABA compounds because
an “obvious composition does not become patentable simply because it has
been described as somewhat inferior to some other product for the same
use.” Gurley, 27 F.3d at 553.
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the need for multiple-drug therapy in many patients to adequately lower
blood pressure” (Kjeldsen 729). Kjeldsen teaches “[m]ost patients require
multiple-drug therapy to reach blood pressure goals. Blood pressure
treatment guidelines recognise the desirability of initiating treatment with
multiple-drug therapy” (Kjeldsen 738, col. 2).
Thus, to the extent that Liu provides a suggestion regarding
combinations with ACE inhibitor compounds, Kjeldsen directly teaches that
ARBs, one of the claimed antihypertensive class of compounds, should be
combined with other classes of antihypertensive agents as discussed above.
Therefore, the closer evidence of Kjeldsen better evidences a desire and
teaching to combine ARBs with other antihypertensive agents in treatment
of humans than the more remote evidence in Liu that a combination of
unclaimed ACE inhibitor compounds with GABA did not clearly improve
hypertension in a tested animal model.
Unexpected results
Appellant contends:
It was unexpected that systemic vessels released prostacyclin-
and further was unexpected that such release occurs only when
ATI receptor was blocked and GABA-a receptor was
stimulated. (Affidavit ¶9.b.) And, it was unexpected that
release of prostacyclin due to a combined/cooperative action of
GABA-a and Ang II would be highly dependent on the vascular
circuit (and vascular compartment)-and claim 11 recites
“GABA-a receptors in systemic blood vessels.”
(Appeal Br. 33). Appellant further contends “the trend of scientific thinking
for treatment of essential Hypertension has moved towards Nitric Oxide
(EDRF) promotion and away from promotion of ‘release of prostacyclin’”
(id. at 34).
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We do not find any showing of unexpected results here. That is,
Appellant does not demonstrate that the combination of ARBs with GABA
results in unexpectedly better control of hypertension, less toxicity to
patients, the ability to use reduced dosages, or some other unexpected
advantage. Instead, Dr. Couvaras has established that the “main, beneficial
medical result of my claimed invention- ‘increasing prostacyclin release in
systemic blood vessels of a human individual with essential hypertension’-is
unexpected” (Couvaras Decl. ¶9).
However, “increased prostacyclin release” is simply a recitation of an
inherent, but unknown, property of an otherwise obvious formulation and
“an obvious formulation cannot become nonobvious simply by
administering it to a patient and claiming the resulting serum
concentrations.” Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1354
(Fed. Cir. 2012). That is, identifying an inherent result of the combination
of GABA and ARB compounds does not constitute an patentable invention
unless there is also a showing that the newly discovered inherent result also
provides an unexpected benefit of some sort. See also In re Kao, 639 F.3d
1057, 1070 (Fed. Cir. 2011) (The prior art’s “express teachings render the
claimed . . . formulation obvious, and the claimed ‘food effect’ adds nothing
of patentable consequence.”).
Appellant states that this may allow reduced dosages in the
Specification (see Spec. 10:4–10), but no evidence is adduced to show this
benefit. It 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 De Blauwe, 736 F.2d 699, 705 (Fed.
Cir. 1994). Here, neither the Specification nor the Couvaras Declaration
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demonstrate that reduced dosages of ARBs or GABA treat hypertension
when these compounds are combined and used in patients or animal models.
Recognition of a problem
Appellant contends the “claimed invention stems from the Inventor’s
recognition of a problem, namely ‘the conflicting paradigm that ARBs lower
blood pressure in eHTN humans despite that many eHTN humans have
negligible to low normal levels of Angiotensin II in circulation’ and the
breakthrough scientific discoveries made pursuant to such recognition”
(Appeal Br. 35).
We are not persuaded. “The discovery of the cause of a problem . . .
does not always result in a patentable invention” In re Wiseman, 596 F.2d
1019 (CCPA 1979).
Appellants . . . are, in effect, arguing that a structure suggested
by the prior art, and, hence, potentially in the possession of the
public, is patentable to them because it also possesses an
inherent, but hitherto unknown, function which they claim to
have discovered. This is not the law. A patent on such a
structure would remove from the public that which is in the
public domain by virtue of its inclusion in, or obviousness
from, the prior art.
Id. at 1023.
Applying Wiseman to the instant facts, we do agree with Appellant
that Dr. Couvaras appears to have identified a receptor complex that may be
involved in hypertension (see, e.g., Couvaras ¶9), but what is missing from
that recognition is any nonobvious impact on treatment using anti-
hypertensive agents. Simply identifying an inherent result of an obvious
combination is not a persuasive secondary consideration. Santarus, 694
F.3d at 1354.
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Failure of others
Appellant contends the “pharmaceutical industry has failed to solve
the large, continuing, and growing problem of essential hypertension”; that
“the closest prior art of record, Liu, was a failure”; and that “Bird and
Magness, tried and failed to increase the release of PGI2 in systemic vessels
by experimenting with Angiotensin II levels” (Appeal Br. 36).
To show a failure of others, the evidence must establish that others
skilled in the art tried and failed to find a solution for the problem solved by
the applicant. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1540 (Fed.
Cir. 1983). One must also show that the others who failed had knowledge of
the critical prior art. In re Caveney, 386 F.2d 917, 923 (CCPA 1967).
In this case, Appellant does not show that others tried to use the
inventive product, a combination of an ARB and GABA, and failed to treat
hypertension.
Conclusion of Law
Appellant has not provided evidence of secondary considerations that,
when considered as a whole with the evidence supporting the prima facie
case, supports a finding of non-obviousness.

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DECISION SUMMARY
In summary:
Claim(s)
Rejected
35
U.S.C. § 
References/Basis Affirmed Reversed
11, 12, 15,
16, 24, 25,
27, 29, 30,
32
103 Thomson, Cheng,
Kaufman, Kimura,
Hayakawa, Elliot, Inoue,
See, Kjeldsen, Emala
11, 12,
15, 16,
24, 25,
27, 29,
30, 32

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED