Eva Millqvist

Patent Trials and Appeals Board

Jul 12, 2021

2020006117 (P.T.A.B. Jul. 12, 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.
14/130,718 02/06/2014 Eva Millqvist 9737-18TS 9328
20792 7590 07/12/2021
MYERS BIGEL, P.A.
PO BOX 37428
RALEIGH, NC 27627
EXAMINER
SIMMONS, CHRIS E
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
07/12/2021 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):
myersbigel_pair@firsttofile.com
uspto@myersbigel.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD

Ex parte EVA MILLQVIST

Appeal 2020-006117
Application 14/130,718
Technology Center 1600
Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, 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 11, 13–15, and 27–36. 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(a). Appellant identifies the real party in interest as Eva
Millqvist. Appeal Br. 2.
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CLAIMED SUBJECT MATTER
Appellant’s claim 11, the sole independent claim on appeal, is
representative and reads as follows:
11. A method of treating cough hypersensitivity syndrome in
a human subject in need thereof, comprising administering to
the human subject a formulation comprising capsaicin and/or a
capsaicinoid, wherein administration is by oral ingestion of a
capsule or tablet, and wherein cough hypersensitivity syndrome
is a non-allergic chronic persistent unexplained cough lasting
eight weeks or more.
Appeal Br. 16 (Claims App.).
REJECTION(S)
The sole rejection before us for review is the Examiner’s rejection of
claims 11, 13–15, and 27–36 under 35 U.S.C. § 103(a) as being unpatentable
over Bessac,2 Novakova-Tousova,3 Morice,4 Ing,5 and Jamieson.6 Ans. 3–8.

2 Bret F. Bessac & Sven-Eric Jordt, Breathtaking TRP Channels: TRPA 1
and TRPV1 in Airway Chemosensation and Reflex Control, 23 PHYSIOLOGY
360–370 (2008) (“Bessac”).
3 L. Vyklický et al., Calcium-Dependent Desensitization of Vanilloid
Receptor TRPV1: A Mechanism Possibly Involved in Analgesia Induced by
Topical Application of Capsaicin, 57 Physiol. Res. S59–S68 (Suppl. 3)
(2008) (“Novakova-Tousova”). Appellant and the Examiner cite to this
reference using the second author’s name. We do the same for consistency.
4 Alyn H. Morice, The Cough Hypersensitivity Syndrome: A Novel
Paradigm for Understanding Cough, 188 LUNG S87–S90 (Suppl. 1) (2010)
(“Morice”).
5 A.J. Ing et al., Chronic persistent cough and gastro-oesophageal reflux, 46
THORAX 479–483 (1991) (“Ing”).
6 US 2006/0240097 A1 (published Oct. 26, 2006) (“Jamieson”).
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DISCUSSION
The Examiner’s Prima Facie Case
The Examiner cited Bessac as teaching that the capsaicin receptor
TRPV1 was a promising target for anti-tussive drugs, and that capsaicin
administration had been shown in animal models to desensitize acute and
inflammatory airway responses to a number of different noxious chemical
stimuli. Ans. 3–5. The Examiner conceded, however, that Bessac differs
from Appellant’s claimed process in that Bessac does not describe treating
the specific cough syndrome recited in Appellant’s claims. Id. at 5.
The Examiner cited Novakova-Tousova as teaching that capsaicin
“selectively excite[s] and subsequently desensitize[s] neurons by the
activation of vanilloid receptors (TRPV1), which leads to an elevation in
intracellular free Ca2+ levels.” Ans. 5.
The Examiner cited Morice as evidence that “the overwhelming
majority of patients with chronic cough have a single diagnosis: cough
hypersensitivity syndrome” and “[i]n the case of capsaicin hypersensitivity,
this is mediated through the TRPV1.” Ans. 5. The Examiner cited Ing as
further evidence that chronic persistent unexplained cough lasting eight
weeks or more, as recited in Appellant’s claims, was a known condition that
a skilled artisan would have considered obvious to treat. Id. at 6.
The Examiner reasoned that a skilled artisan would have had a
reasonable expectation of success in administering capsaicin to the cough
sufferers recited in Appellant’s claims because Bessac and Novakova-
Tousova teach that “capsaicin desensitize[s] TRPV1 receptors while Bessac
further teaches that TRPV1 contribute[s] to, inter alia, chronic cough and
chemical hypersensitivity. Morice teaches TRP receptor upregulation is
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involved in the pathophysiological basis of hypersensitivity in chronic cough
and suggests potential therapeutic strategies could be developed to combat
TRP hypersensitivity.” Ans. 6.
Therefore, the Examiner concluded, a skilled artisan “would have
found it prima facie obvious to treat the claimed cough hypersensitivity
syndrome by administering capsaicin. The artisan would have done so to
provide desensitizing activity on the TRPV1 receptor by capsaicin to reduce
the upregulation of TRPV1 associated with chronic cough.” Ans. 6.
The Examiner cited Jamieson as evidence that, to desensitize the
TRPV1 receptor and thereby treat chronic cough, it would have been
obvious to administer capsaicin in the form of orally ingested capsules or
tablets, as recited in Appellant’s claims, using dosages and administration
regimens encompassed by Appellant’s claims. See Ans. 6–8.
As to the dosage amounts and administration regimens recited in
Appellant’s dependent claims 13–15 and 27–35, the Examiner cited
Jamieson as teaching general dosage amounts encompassed by the claims,
and noted that the “dosage of active ingredient in the compositions may be
varied depending on the dosage form used. The selected dosage depends
upon the desired therapeutic effect, on the route of administration, and on
the duration of the treatment desired.” Ans. 7 (citing Jamieson ¶¶ 23, 108).
Based on the teachings in Jamieson, the Examiner reasoned as follows:
Therefore, it is clearly suggested that the treatment regimen
should be adjusted according to several factors (i.e., dosage
form, desired effect, route of administration, treatment duration,
weight of subject). Accordingly, one of ordinary skill in the art
would have found it obvious to adjust the dose of the drug and
the frequency of its administration in order to optimize its
desensitizing function in treating cough. Therefore, while the
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specific dose regimen is not expressly taught by the prior art,
one of ordinary skill in the art would have found the claimed
doses and administration regimens to be obvious.
Ans. 7.
As to Appellant’s dependent claim 36, the Examiner determined that,
when given its broadest reasonable interpretation, claim “36 does not require
a capsaicinoid given that it is an option in Claim 11 that may or may not be
selected. Therefore, the art need not teach a specific capsaicinoid where one
choses capsaicin as the option instead of a capsaicinoid as provided by
Claim 11.” Ans. 8.
Analysis—Claim 1
[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.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992); see also In re Jung, 637
F.3d 1356, 1365 (Fed. Cir. 2011) (holding that requiring an applicant to
identify “reversible error” in an examiner’s rejection is consistent with long
standing Board practice).
Having carefully considered all of the evidence and argument
presented by Appellant and the Examiner, we are not persuaded that
Appellant has shown reversible error in the Examiner’s conclusion of
obviousness as to Appellant’s claim 1.
As the Examiner found, Bessac discloses that, because of its
involvement in cough hypersensitivity, the TRPV1 receptor is a “promising
target” for developing drugs for cough treatment. See Bessac 367 (“Due to
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their central role, TRPV1 and TRPA1 are considered as promising targets
for the development of novel anti-inflammatory and anti-tussive drugs. This
idea is supported by the recent proof of efficacy of a TRPV1 antagonist in an
animal model of allergen-induced chronic cough.”) (citations omitted).
As the Examiner found, Bessac discloses that although capsaicin is a
respiratory irritant that induces cough, “[s]tudies in animal models found
that capsaicin effectively desensitizes acute and inflammatory airway
responses to many different noxious chemical stimuli.” Bessac 361; see also
id. (disclosing that “intraperitoneal injection of capsaicin prevented chlorine-
induced respiratory depression in mice and reduced ozone-induced airway
inflammation and hyperreactivity in guinea pigs and rats;” disclosing that
capsaicin injections “also diminished airway responses to acrolein in guinea
pigs and mice and to formaldehyde and cigarette smoke in rats;” also
disclosing that capsaicin “abated sulfur dioxide-provoked
bronchoconstriction” in guinea pigs).
Bessac discloses that the results of animal experiments suggest that
“capsaicin receptors are either directly involved in irritant sensing or that
capsaicin desensitizes chemical detection mechanisms. This hypothesis was
further supported by the observation that capsazepine, a specific antagonist
of capsaicin-induced C-fiber activation, effectively blocked acid-induced
bronchoconstriction and cough in guinea pigs.” Bessac 361 (citations
omitted).
As the Examiner found, Novakova-Tousova teaches that the rationale
for using capsaicin to treat pain is that capsaicin ultimately desensitizes
TRPV1 receptors:
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The rationale for the topical application of capsaicin and
other vanilloids in the treatment of pain is that such compounds
selectively excite and subsequently desensitize nociceptive
neurons. This desensitization is triggered by the activation of
vanilloid receptors (TRPV1), which leads to an elevation in
intracellular free Ca2+ levels. Depending on the vanilloid
concentration and duration of exposure, the Ca2+ influx via
TRPV1 desensitizes the channels themselves, which may
represent not only a feedback mechanism protecting the cell
from toxic Ca2+ overload, but also likely contributes to the
analgesic effects of capsaicin.
Novakova-Tousova S59.
As the Examiner found, Morice teaches that “the overwhelming
majority of patients with chronic cough have a single diagnosis: cough
hypersensitivity syndrome.” Morice S87. Similar to Bessac, Morice teaches
that the TRPV1 receptor is involved in hypersensitivity-related cough. See
id. at S88 (“The pathophysiological basis of this hypersensitivity appears to
be upregulation of the TRP nociceptors. In the case of capsaicin
hypersensitivity this is mediated through the TRPV1. Some studies show
increased TRPV1 immunofluorescence in neurones from biopsies in chronic
coughers.”) (citations omitted). And, as the Examiner found, Ing teaches
that chronic cough lasting for over two months, a duration encompassed by
Appellant’s claims “is a common clinical problem.” Ing. 479.
Thus, to summarize, Bessac teaches that because of its involvement in
cough hypersensitivity, the TRPV1 receptor is a promising target for
developing drugs for cough treatment. Bessac 367. In addition, Bessac
teaches that capsaicin desensitizes acute and inflammatory airway responses
to noxious chemical stimuli in animal models, and also that TRPV1
antagonists reduced cough in animal models. Bessac 361, 367. Novakova-
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Tousova similarly teaches that capsaicin desensitizes TRPV1 receptors.
Novakova-Tousova S59.
Given the teachings that the TRPV1 receptor is a promising target for
developing drugs for cough treatment based on animal models using TRPV1
antagonists, and given that capsaicin desensitizes the TRPV1 receptor, we
agree with the Examiner that a skilled artisan seeking to treat chronic cough
lasting for eight weeks or more would have had a good reason for, and a
reasonable expectation of success in, administering capsaicin for the purpose
of desensitizing the TRPV1 receptors and thereby treating the cough, as
recited in Appellant’s claim 1.
We acknowledge that none of the publications discussed above
discloses administering the capsaicin in the form a capsule or tablet that is
orally ingested, as required by Appellant’s claim 1. Jamieson, however,
discloses that, for the purpose of treating TRVP1-mediated disorders,
capsaicin and capsaicinoids can be formulated in orally ingested capsules or
tablets. See Jamieson, Abstr. (“Described here are TRPV1 agonist
compounds and their methods of synthesis and use. In addition to
specifically identified compounds, capsaicin prodrugs, gemini dimers, and
mutual prodrugs are also described. Formulations of the TRPV1 agonist
compounds may be in the form of a liquid, tablets, [or] capsules.”); see also
id. ¶ 4 (“Capsaicin, capsaicinoids and TRPV1 agonists may be useful for
amelioration of a plurality of diseases.”); id. ¶ 23 (“[O]ral dose levels of up
to 2 mg/kg of capsaicin have been administered to humans without reported
adverse effects.”).
While Jamieson does not teach administering capsaicin or
capsaicinoids to treat cough, Jamieson nonetheless teaches that the rationale
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for administering those compounds is to desensitize the TRPV1 receptor:
The initial effect of the activation of TRPV1-expressing
(capsaicin-sensitive) nociceptors are burning sensations,
hyperalgesia, allodynia, and erythema. However, after
prolonged exposure to low-concentration capsaicin or single
exposures to high-concentration capsaicin or other TRPV1
agonist, the small-diameter sensory axons become less sensitive
to a variety of stimuli, including capsaicin or thermal stimuli.
This prolonged exposure is also characterized by reduced pain
responses. These later-stage effects of capsaicin are frequently
referred to as “desensitization” and are the rationale for the
development of capsaicin formulations for the treatment of
various pain syndromes and other conditions.
Jamieson ¶ 3 (emphasis added).
As discussed above, we agree with the Examiner that a skilled artisan
had a good reason for, and a reasonable expectation of success in,
administering capsaicin for the purpose of desensitizing the TRPV1
receptor, and thereby treating a chronic cough lasting eight weeks, as recited
in Appellant’s claim 1. Given Jamieson’s teachings that capsaicin and
capsaicinoids administered orally via tablet or capsule are useful for
desensitizing the TRPV1 receptor, we agree with the Examiner that a skilled
artisan, seeking to desensitize the TRPV1 receptor to treat chronic cough,
would have considered it obvious to administer the capsaicin or
capsaicinoids in the form of a table or capsule, to treat the cough. We
therefore agree with the Examiner that the process recited in Appellant’s
claim 1 would have been prima facie obvious to skilled artisan.
Appellant’s arguments do not persuade us to the contrary. In
particular, given the prior art’s teaching that the TRPV1 receptor was a
promising target for cough treatment (Bessac), and given the prior art’s
teachings that capsaicin can desensitize the TRPV1 receptor (Novakova-
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Tousova), including when ingested orally (Jamieson), Appellant does not
persuade us that a skilled artisan lacked motivation or a reasonable
expectation of success in treating cough with orally ingested capsaicin.
We acknowledge, as Appellant contends, that the teachings in Bessac
relied upon by the Examiner relate to animal models, and that Bessac
identifies the TRPA1 receptor as a target for treating cough in addition to the
TRPV1 receptor. See Bessac 361, 362, 367.
As noted above, however, Bessac expressly teaches that the TRPV1
receptor is a “promising target[] for the development of novel . . . anti-
tussive drugs,” which “is supported by the recent proof of efficacy of a
TRPV1 antagonist in an animal model of allergen-induced chronic cough.”
Bessac 367. We therefore discern no error in the Examiner’s determination
that a skilled artisan would have reasoned that, because capsaicin can
desensitize the TRPV1 receptor when administered appropriately, capsaicin
would be useful in treating chronic cough when administered in a manner
that desensitizes the TRPV1, such as the oral administration described in
Jamieson, discussed above.
We acknowledge, as Appellant contends, that Dr. Morice states that
“there would have been no reason to think that oral capsaicin, even if it did
desensitise TRPV1 expressing nerves, would have an effect on clinical
cough. Research in this area has been abandoned.” Morice Decl. ¶ 5.7 The
sole specific evidentiary basis for this statement, however, is the Belvisi

7 Declaration of Alyn Morice, Ph.D., Pursuant to 37 C.F.R. § 1.132 (signed
Apr. 30, 2019).
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article,8 which has a publication date of 2017, well after the earliest priority
date claimed by Appellant for the present application. See id. (citing Belvisi
article); see also id. at p. 3 (providing full citation for Belvisi article); see
also Spec. 1 (preliminary amendment claiming priority to provisional
application filed July 7, 2011). Appellant points to no persuasive evidence
suggesting that, at the time the present application was filed, despite the
teachings discussed above in the references relied upon in the Examiner’s
rejection, a skilled artisan lacked motivation or a reasonable expectation of
success in orally administering capsaicin to treat chronic cough, as recited in
Appellant’s claim 1.
We also acknowledge Dr. Morice’s statement that capsaicin
concentrations capable of desensitizing sensory C fibers “cannot be given to
man.” Morice Decl. ¶ 6. Dr. Morice does not provide the evidentiary basis
for this statement, however, nor does Dr. Morice explain specifically how
desensitizing sensory C fibers relates to desensitizing the TRPV1 receptor.
In contrast, as noted above, Jamieson expressly discloses that capsaicinoids
can be administered at concentrations that desensitize the TRPV1 receptor to
treat a variety of TRPV1-mediated diseases (see Jamieson ¶¶ 3–4), and
neither Appellant nor Dr. Morice identify any specific evidence
controverting those disclosures.
We acknowledge Dr. Morice’s statement that Ebihara9 discloses that
oral capsaicin is an effective agent in provoking cough, rather than

8 Maria G. Belvisi et al., XEN-D0501, a Novel Transient Receptor Potential
Vanilloid 1 Antagonist, Does Not Reduce Cough in Patients with
Refractory Cough, 199 AM. J. RESPIR. CRIT. CARE MED. 1255–1263 (2017).
9 Takae Ebihara et al., Capsaicin Troche for Swallowing Dysfunction in
Older People, 53 J. AM. GERIATR. SOC. 824–828 (2010).
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suppressing it. Morice Decl. ¶ 6. Ebihara, however, describes administering
the capsaicin in the form of a troche (lozenge) to the throat, rather than by
oral ingestion, as recited in Appellant’s claim 1. See Ebihara 824 (disclosing
that capsaicin was “administered to the throat”); id. at 825 (disclosing that
“[i]t took approximate[ly] 5 minutes for participants to dissolve a troche in
the mouth”). Because Ebihara does not describe administering capsaicin in
the manner required by Appellant’s claim 1, we are not persuaded that
Ebihara suggests that skilled artisan lacked a reasonable expectation of
success in treating cough in the claimed manner, particularly given the
teachings in the references cited by the Examiner, suggesting that
desensitizing the TRPV1 receptor would be useful for treating cough.
We acknowledge Appellant’s contentions regarding the alleged
individual shortcomings of Novakova-Tousova, Morice, Ing, and Jamieson,
in relation to the process recited in Appellant’s claim 1. See Appeal Br. 8–
10; Reply Br. 4–5. It is well settled, however, that “[n]on-obviousness
cannot be established by attacking references individually where the
rejection is based upon the teachings of a combination of references. . . .
[The reference] must be read, not in isolation, but for what it fairly teaches
in combination with the prior art as a whole.” See In re Merck & Co., Inc.,
800 F.2d 1091, 1097 (Fed. Cir. 1986). In the present case, for the reasons
discussed above, when references cited in the rejection are properly viewed
in combination, we agree with the Examiner that a skilled artisan had
motivation for, and a reasonable expectation of success in, treating chronic
cough with orally ingested capsaicin as recited in Appellant’s claim 1.
We are also unpersuaded by Appellant’s contention that, subsequent
to (and despite) the teachings in Bessac, TRPV1-targeting cough therapies
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had been unsuccessful in humans. See Appeal Br. 10–11 (citing
Trevisiani,10 Planells-Cases,11 and Kaneko). In particular, Appellant
identifies no teaching in any of the cited publications suggesting that
TRPV1-targeting cough therapies had been unsuccessful in humans. See id.
Indeed, each of the cited publications suggests that TRPV1 was a promising
target for therapeutic intervention, including for cough treatment as taught in
Bessac. See Trevisiani 769 (“I-RTX is a novel and potent antitussive drug
which inhibits cough mediated by agents possibly acting via TRPV1
activation.”); Planells-Cases 491 (“We propose that the complex regulation
of TRPV1 may be exploited for therapeutic purposes, with the ultimate goal
being the development of novel, innovative agents that target TRPV1 in
diseased, but not healthy, tissues.”); Kaneko 2474 (“TRP channels are also
promising targets for drug discovery. The initial focus of research was on
TRP channels that are expressed on nociceptive neurons. Indeed, a number
of potent, small-molecule TRPV1, TRPV3 and TRPA1 antagonists have
already entered clinical trials as novel analgesic agents.”).
We are also unpersuaded that because capsaicin is a TRPV1 agonist
that induces cough, a skilled artisan would have been led away from treating
cough by orally administering capsaicin as recited in Appellant’s claim 1.
See Appeal Br. 11–12; Reply Br. 4–5. As discussed above, despite the fact
that capsaicin induces cough, capsaicin also desensitizes acute and
inflammatory airway responses, and also desensitizes TRPV1 receptors

10 M Trevisani et al., Antitussive activity of iodo-resiniferatoxin in guinea
pigs, 59 THORAX, 769–772 (2004).
11 Rosa Planells-Cases et al., Complex Regulation of TRPV1 and Related
Thermo-TRPs: Implications for Therapeutic Intervention, 704 ADV. EXP.
MED. BIOL. 491–515 (Chapter 27) (2011).
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when administered appropriately, to treat a variety of TRPV1-mediated
diosrders. See Bessac 361; Novakova-Tousova S59, Jamieson ¶¶ 3–4.
Given these teachings, we are not persuaded that the cited references would
have led a skilled artisan away from the cough treatment recited in
Appellant’s claim 1.
In sum, for the reasons discussed, Appellant does not persuade us that
the Examiner erred in determining that the combined teachings of Bessac,
Novakova-Tousova, Morice, Ing, and Jamieson would have suggested
treating patients suffering from the cough disorder recited in Appellant’s
claim 1, by oral administration of capsaicin or a capsaicinoid as recited in
Appellant’s claim 1. We therefore affirm the Examiner’s rejection of
Appellant’s claim 1 over Bessac, Novakova-Tousova, Morice, Ing, and
Jamieson.
Analysis—Claims 13–15
Appellant states that “[i]n the interest of brevity, Appellant argues
these claims [13–15] in the same paragraph, but submits that each claim is
separately patentable for at least the reasons discussed below.” Appeal Br.
12. Because Appellant thus presents the same patentability arguments as to
claims 13–15, we consider them as a single group, and designate claim 13 as
representative of that claim grouping. See 37 C.F.R. 41.37(c)(1)(iv) (noting
that claims argued separately must be presented under a separate heading
with distinct arguments).
Appellant’s claim 13 recites “[t]he method of claim 11, wherein the
capsaicin and/or capsaicinoid is administered to the human subject in a dose
from 0.05 mg to 100 mg.” Appeal Br. 16.
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In rejecting claim 13, as noted above, the Examiner determined based
on the teachings in Jamieson, that a skilled artisan “would have found it
obvious to adjust the dose of the drug and the frequency of its administration
in order to optimize its desensitizing function in treating cough.” Ans. 7.
Appellant contends that Jamieson fails to direct a skilled artisan “to
the particular claimed dose of capsaicin and/or a capsaicinoid for the method
of treating cough hypersensitivity syndrome as claimed” and notes, “[a]gain,
Jamison fails to teach or suggest treating coughing, let alone to treating
cough hypersensitivity syndrome in the manner claimed.” Appeal Br. 12.
We find that the Examiner has the better position. As our reviewing
court’s predecessor has explained, “where the general conditions of a claim
are disclosed in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456
(CCPA 1955)); see also In re Woodruff, 919 F .2d 1575, 1579 (Fed. Cir.
1990) (In cases where “the difference between the claimed invention and the
prior art is some range or other variable within the claims . . ., the applicant
must show that the particular range is critical, generally by showing that the
claimed range achieves unexpected results relative to the prior art range.”)).
In the present case, as noted above, Jamieson discloses administering
capsaicinoids for the purpose of desensitizing the TRPV1 receptor to treat
TRPV1-mediated disorders such as pain, rhinitis, or sinusitis. See Jamieson
¶ 107. As the Examiner noted, Jamieson discloses that, when administering
capsaicinoids to treat TRPV1-mediated, the dosage can be varied, depending
on a variety of factors, including the desired effect and route of
administration:
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The dosage of active ingredient in the compositions of
this invention may be varied depending on the dosage form
used. However, in all instances, the amount of the active
ingredient shall be such that a suitable dosage form is obtained.
The selected dosage depends upon the desired therapeutic
effect, on the route of administration, and on the duration of the
treatment desired. Generally, dosage levels of between 0.001 to
30 mg/kg of body weight daily are administered to mammals.
Jamieson ¶ 108. As the Examiner noted, moreover, Jamieson discloses that
“oral dose levels of up to 2 mg/kg of capsaicin have been administered to
humans without reported adverse effects.” Jamieson ¶ 23.
Given these teachings, Appellant does not persuade us that the
Examiner erred in determining that a skilled artisan would have considered
the cough-treating dosage of capsaicin and/or a capsaicinoid to be a
routinely optimized result-effective variable. Again, although Jamieson by
itself does not disclose treating cough, the combined teachings of Bessac,
Novakova-Tousova, Morice, Ing, and Jamieson suggest administering a
TRPV1-desensitizing amount of capsaicin by oral ingestion to treat cough,
and we discern no error in the Examiner’s determination that a skilled
artisan would have considered it an obvious matter of routine optimization to
determine a dosage useful for that purpose, based on the references’
combined teachings. Because Appellant does not identify any unexpected or
other critical result coming from the claimed dosage amounts, we affirm the
Examiner’s rejection of Appellant’s claim 13 for obviousness over Bessac,
Novakova-Tousova, Morice, Ing, and Jamieson. Claims 14 and 15 fall with
claim 13. See 37 C.F.R. 41.37(c)(1)(iv).
Analysis—Claims 27–35
Appellant states that “[i]n the interest of brevity, Appellant argues
these claims [27–35] in the same paragraph, but submits that each claim is
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separately patentable for at least the reasons discussed below.” Appeal Br.
13. Because Appellant thus presents the same patentability arguments as to
claims 27–35 we consider them as a single group, and designate claim 27 as
representative of that claim grouping. See 37 C.F.R. 41.37(c)(1)(iv).
Appellant’s claim 27 recites “[t]he method of claim 13, wherein the
dose is administered to the human subject from 1 to 5 times a day.” Appeal
Br. 16.
In rejecting claim 27, as noted above, the Examiner determined based
on the teachings in Jamieson, that a skilled artisan “would have found it
obvious to adjust the dose of the drug and the frequency of its administration
in order to optimize its desensitizing function in treating cough.” Ans. 7.
Appellant contends that “Jamison fails to teach or suggest treating
coughing, let alone to treating cough hypersensitivity syndrome in the
manner claimed.” Appeal Br. 13.
We again find that the Examiner has the better position. Given the
teachings discussed above in Jamieson, Appellant does not persuade us that
the Examiner erred in determining that a skilled artisan would have
considered the daily frequency of administering a cough-treating dosage of
capsaicin to be a routinely optimized result-effective variable. Although
Jamieson by itself does not disclose treating cough, the combined teachings
of Bessac, Novakova-Tousova, Morice, Ing, and Jamieson suggest
administering a TRPV1-desensitizing amount of capsaicin by oral ingestion
to treat cough, and we discern no error in the Examiner’s determination that
a skilled artisan would have considered it an obvious matter of routine
optimization to determine a useful daily dosage regimen useful for that
purpose, based on the cited references’ combined teachings. Because
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Appellant does not identify any unexpected or other critical result coming
from the claimed daily dosage regimen and dosage amounts, we affirm the
Examiner’s rejection of Appellant’s claim 27 for obviousness over Bessac,
Novakova-Tousova, Morice, Ing, and Jamieson. Claims 28–35 fall with
claim 27. See 37 C.F.R. 41.37(c)(1)(iv).
Analysis—Claim 36
Appellant’s claim 36 recites “[t]he method of claim 11, wherein the
capsaicinoid comprises dihydrocapsaicin, nordihydrocapsaicin,
homodihydrocapsaicin, and/or homocapsaicin.” Appeal Br. 17.
As noted above, the Examiner determined that claim 36 “does not
require a capsaicinoid given that it is an option in Claim 11 that may or may
not be selected.” Ans. 8.
Appellant argues that the combined teachings of the references cited
by the Examiner fail to render the process of claim 36 obvious because the
references “fail[] to teach or suggest a method of treating cough
hypersensitivity syndrome in the manner claimed in which the capsaicinoid
comprises dihydrocapsaicin, nordihydrocapsaicin, homodihydrocapsaicin,
and/or homocapsaicin.” Appeal Br. 14.
We again find that the Examiner has the better position. As the
Examiner notes, independent claim 11 recites administering “a formulation
comprising capsaicin and/or a capsaicinoid.” Appeal Br. 16 (emphasis
added). Claim 36 thus recites a process that encompasses several options:
administering capsaicin, administering a capsaicinoid, or administering both.
As seen above, claim 36 does not recite that the administered active
agent is a capsaicinoid, but merely lists certain capsaicinoids to be
administered if a capsaicinoid, rather than capsaicin, is the administered
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active agent. That is, Appellant’s claim 36 does not require the option of
administering a capsaicinoid to be exercised. In such instances, the optional
additional limitations recited in claim 36 are properly interpreted as not
being required by the claim. See Ex parte Schulhauser, Appeal 2013-
007847, 2016 WL 6277792, *5–*6 (PTAB Apr. 28, 2016) (precedential)
(dependent claims held to not further limit where those claims did not
require exercising contingent option recited in independent claim); see also
In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989) (“[D]uring patent prosecution
when claims can be amended, ambiguities should be recognized, scope and
breadth of language explored, and clarification imposed.”).
In sum, claim 36 does not require the administered active agent to be
capsaicinoid, but merely lists certain capsaicinoids to be administered if a
capsaicinoid, rather than capsaicin, is the administered active agent. We
therefore agree with the Examiner that the cited prior art need not teach or
suggest administering the specific capsaicinoids recited in claim 36 to render
the process recited in claim 36 obvious. Accordingly, we affirm the
Examiner’s rejection of claim 36 over Bessac, Novakova-Tousova, Morice,
Ing, and Jamieson.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
11, 13–15,
27–36
103(a) Bessac, Novakova-
Tousova, Morice,
Ing, Jamieson
11, 13–15,
27–36

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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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED