Kolbe, Ludger et al.

Patent Trials and Appeals Board

Dec 16, 2019

12933231 - (D) (P.T.A.B. Dec. 16, 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.
12/933,231 12/13/2010 Ludger Kolbe 3321-P38625 7233
13897 7590 12/16/2019
Abel Schillinger, LLP
8911 N. Capital of Texas Hwy
Bldg 4, Suite 4200
Austin, TX 78759
EXAMINER
FISHER, MELISSA L
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
12/16/2019 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):
hmuensterer@abel-ip.com
mail@Abel-IP.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte LUDGER KOLBE, JULIA ECKERT, GITTA NEUFANG,
STEFANIE KNAUPMEIER, and NILS PETERS
__________

Appeal 2018-009052
Application 12/933,231
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1,2 under 35 U.S.C. § 134 involving claims to a
method of reducing itching or paraesthesias using various compounds. 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
BEIERSDORF AG of Hamburg Germany (see App. Br. 3).
2 We have considered and refer to the Specification of Sept. 17, 2010
(“Spec.”); Final Action of Nov. 24, 2017 (“Final Act.”); Appeal Brief of
June 18, 2018 (“Appeal Br.”); Examiner’s Answer of July 27, 2018
(“Ans.”); and Reply Brief of Sept. 26, 2018 (“Reply Br.”). We also note our
previous Decision on Nov. 16, 2016 (“Dec.”).
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Statement of the Case
Background
“Itching is an independent sensation of the skin and occurs
independently of pain sensation. . . . The different sensations of itching such
as pure itch, stabbing or burning itch, painful tingling, etc. are explained by
the different neurotransmitters” (Spec. 1:13–17). “One object of the present
invention was to remedy the drawbacks of the prior art and to reduce the
itching and other problems that can occur with aged skin or due to sunburn
by means of preparations that are easy to produce, are tolerated well and are
odorless” (Spec. 2:15–18).
The Claims
Claims 30–49 are on appeal. Claim 30 is representative and reads as
follows:
30. A method of at least one of reducing itching, reducing
paraesthesias with dry skin or aged skin, and reducing
dermatological paraesthesias caused by sunburn, wherein the
method comprises applying to skin of a subject in need thereof
a cosmetic or dermatological preparation that comprises
(1R,2S,5R)-2-isopropyl-5-methyl-N-(2-(pyridin-2-
yl)ethyl)cyclohexane-carboxamide in an amount that is
effective for at least one of reducing itching, reducing
paraesthesias with dry skin and aged skin, and reducing
dermatological paraesthesias caused by sunburn.

The issues
A. The Examiner rejected claims 30–35 under 35 U.S.C. § 103(a) as
obvious over Wei3 and Bell4 (Final Act. 2–8).

3 Wei, US 2005/0187211 A1, published Aug. 25, 2005.
4 Bell et al., WO 2007/019719 A1, published Feb. 22, 2007.
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B. The Examiner rejected claims 30–39 under 35 U.S.C. § 103(a) as
obvious over Wei, Bell, and De Rijk5 (Final Act. 11–12).
C. The Examiner rejected claims 40–43 and 45 under 35 U.S.C. § 103(a)
as obvious over Wei and Rovner6 (Final Act. 13–16).
D. The Examiner rejected claims 40–45 under 35 U.S.C. § 103(a) as
obvious over Wei, Rovner, and Galopin7 (Final Act. 17–18).
E. The Examiner rejected claims 40–49 under 35 U.S.C. § 103(a) as
obvious over Wei, Rovner, and De Rijk (Final Act. 19–21).

A. 35 U.S.C. § 103(a) over Wei and Bell
The Examiner finds
Wei teaches a method of reducing itching (para. [0003] and
[0047]) and reducing paraesthesia with dry skin or aged skin
(pruritus caused by xerosis in the elderly (para. [0038] and
[0047]), and reducing dermatological paraesthesia caused by
sunburn (sunburn (para. [0047]), comprising applying
composition comprising an N-(Substituted-heterocyclyl-alkyl)-
cycloalkyl carboxamide compositions to the skin (para. [0045]-
[0046] and claim 7), wherein the heterocyclyl can be a
pyridinyl group (para. [0017]) and the alkyl can be a C1-C3
alkyl (claim [0015]), and the cycloalkyl carboxamide moiety
can be 1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (para.
[0014]).
(Final Act. 3). The Examiner acknowledges that in Wei, “the main moiety
does not have the same position as in the claimed compound (3 v. 2). Hence,

5 De Rijk, WO 2007/099398 A2, published Sept. 7, 2007.
6 Rovner, Better than mint, 85 CHEMICAL ENGINEERING NEWS 95 (2007).
We number the pages of this reference sequentially from the first page.
7 Galopin et al., US 2006/0276667 A1, published Dec. 7, 2006.
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Wei fails to suggest (1R,2S,5R)- 2-isopropyl-5-methyl-N-(2-(pyridin-2-
yl)ethyl)cyclohexane carboxamide))” (Final Act. 4).
The Examiner finds that Bell teaches “methods for providing a
cooling effect to a skin composition such as a skin cream or ointment” that
may use “1R,2S,5R)- 2-isopropyl-5-methyl-N-(2-(pyridin-2-yl)ethyl)
cyclohexanecarboxamide (FEMA 4549) as a particular example of a
compound that is effective for providing a surprisingly strong and long-
lasting cooling effect” (Final Act. 4).
The Examiner finds it obvious to use Bell’s compound either in
combination with, or in place of, the compound of Wei because Bell’s
compound resulted in a “significantly longer perception of cooling than
other known cooling agents” and “because the perception of cooling
suppresses the perception of itch and pain, as taught by Wei” (Final Act. 6).
The Examiner finds that the combination of the compounds of Wei and Bell
would have been obvious because Bell teaches “using the newly identified
cooling compounds with cooling compounds known in the prior art” (Final
Act. 6).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s finding that Wei and Bell render the claims
obvious?
Findings of Fact
1. Wei teaches “compositions that are useful in sensory
refreshment and alleviation of skin irritation, itch and pain” and that these
compounds activate “TRP-M8 and TRP-A1 receptors that are present in
sensory nerves” (Wei ¶ 3). Wei specifically teaches “[t]herapeutic
indications for which a topical formulation may be beneficial include
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irritation, itch and pain from various forms of dermatitis (atopic, contact and
irritant); pain from burned, traumatized or irritated skin . . . itch and
discomfort from skin infections . . . sunburn” (Wei ¶ 47).
2. Wei teaches compounds of Formula 1 that comprise
(1R,2S,5R)-2-Isopropyl-5-methyl-cyclohexyl linked by a CO-NH group to a
C1–C3 n-alkyl that is linked to a pyridinyl group (see Wei ¶¶ 12–17).
3. Wei teaches that the disclosed compounds “act on specific
receptors to stimulate ion channels of peripheral sensory neurons” to “relay
signals to the spinal cord and brain. These signals generate sensations of
coolness and refreshment. If pathological conditions are present, these
signals also suppress perception of signals for tissue irritation” (Wei ¶ 24).
4. Wei explains that “[f]or topical uses, either as a cosmetic or as a
therapeutic, it is desirable to have more coolness than cold, more cold than
intense cold, and to have a duration of action that permits a practical
application” (Wei ¶ 38).
5. Bell teaches “[c]ooling compounds, that is, chemical
compounds that impart a cooling sensation to the skin or the mucous
membranes of the body, are well known to the art and are widely used in a
variety of products” including “skin creams and ointments, both cosmetic
and medicinal” (Bell 1:2–4, 4:3–4).
6. Bell teaches, in Example 2, the preparation of “[(1R,2S,SR)-2-
isopropyl-5-methyl-N-(2-(pyridin-2-yl)ethyl)cyclohexanecarboxamide”
(Bell 5:3–15).
7. Table 2 of Bell teaches that at a concentration of 0.02 ppm, the
compound of Example 2 has a longevity of 60 minutes, and Bell further
teaches that compounds in Table 2 are “up to 100 times stronger and last
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longer than menthol, the reference cooling compound” and are “also much
stronger than WS-3, the best cooling compound of the prior art” (Bell 6:1–
20).
Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of
ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 2–8; FF 1–7) and agree that the
claims are rendered obvious by Wei and Bell. We address Appellant’s
arguments below.
Appellant contends “it is clear from Tables 2 and 3 thereof that the
compound with the by far highest cooling effect is (1R,2S,5R)-2-isopropyl-
5-methyl-N-(2-(pyridin-3-yl)ethyl)cyclohexane-carboxamide, not
(1R,2S,5R)-2-isopropyl-5-meth y 1-N-(2-(pyridin-2-yl)ethyl)cyclohexane-
carboxamide” (Appeal Br. 7–8). Appellant contends “the question arises
why one of ordinary skill in the art would allegedly have selected a
compound . . . which is a by far less effective cooling compound (by a factor
of 5) than another compound also disclosed in BELL . . . for inclusion in a
composition according to WEI” (Reply Br. 3). Appellant contends
therefore, that “one of ordinary skill in the art would not be motivated to
replace any of the compounds for use in the method of WEI by (1R,2S,5R)-
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2-isopropyl-5-methyl-N-(2-(pyridin-2-yl)ethyl)cyclohexane-carboxamide”
(Appeal Br. 9).
We are not persuaded. As the Examiner pointed out (Ans. 3), Gurley
found that a “known or obvious composition does not become patentable
simply because it has been described as somewhat inferior to some other
product for the same use.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
Even if we agree with Appellant that Bell teaches the 3-yl cooling
compound is superior to the 2-yl cooling compound disclosed in Bell and
claimed here, Appellant does not identify any teaching in Bell that criticizes,
discredits, or otherwise discourages the use of the 2-yl cooling compound as
useful as a cooling agent in anti-itch or sunburn creams. See In re Fulton,
391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art’s mere disclosure of
more than one alternative does not constitute a teaching away from any of
these alternatives because such disclosure does not criticize, discredit, or
otherwise discourage the solution claimed.”)
Indeed, Bell teaches that compounds of Formula I are “also much
stronger than WS-3, the best cooling compound of the prior art” (FF 7).
Thus, Bell provides a specific reason to incorporate any of the disclosed
cooling compounds into a cream such as Wei’s where cooling is desired (see
FF 3). All of Bell’s compounds would have been obvious equivalent
cooling compounds and all were superior to the prior art, and thus when “the
combination of references results in a product or process that is more
desirable . . . there exists in these situations a motivation to combine prior art
references even absent any hint of suggestion in the references themselves.”
DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464
F.3d 1356, 1368 (Fed. Cir. 2006).
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Appellant contends that “there is no disclosure in BELL or WEI that
would cause one of ordinary skill in the art to assume that even the
compounds with the highest cooling activity which are covered by formula I
of BELL are better in this respect than any of the compounds disclosed in
WEI” (Appeal Br. 9). Appellant contends that Bell’s results “relate to the
cooling effect of the tested compounds in the mouth (in the form of aqueous
solutions), not on the skin” and therefore “there is no reason for one of
ordinary skill in the art to assume that the tested compounds according to
BELL are superior to WS-3 in the case of the application thereof to the skin”
(Appeal Br. 8–9).
We find these arguments unpersuasive. First, as to the issue of
whether the compounds are better, the evidence of Bell expressly teaches
that these compounds have superior cooling effect (FF 7). However, even if
Bell’s compounds only had roughly equivalent cooling effects, their
substitution or use in Wei’s composition, where Wei desires cooling
compounds (FF 3), would have been obvious because the claims “recite[] a
combination of elements that were all known in the prior art, and all that was
required to obtain that combination was to substitute one well-known . . .
agent for another.” Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683
F.3d 1356, 1364 (Fed. Cir. 2012). Indeed, Wrigley deals with the
obviousness of cooling compositions including WS-23 and finds “it is fair to
say that there were “a finite number of identified, predictable solutions” to
the problem of finding physiological cooling agents.” Id. at 1364.
Second, as to the issue of administration orally or topically, both Wei
and Bell suggest topical use (FF 4–5). Bell specifically suggests using the
compounds in “skin creams and ointments, both cosmetic and medicinal”
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(FF 5). Thus, the ordinary artisan would have had reason to incorporate
Bell’s cooling compositions into Wei’s topical anti-itch composition in order
to get the cooling activity desired by Wei (FF 3) in a medicinal skin cream
(FF 5).
Third, Appellant lacks any evidence in rebuttal. “[A]ttorney argument
[is] not the kind of factual evidence that is required to rebut a prima facie
case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
Appellant contends “it is only with the benefit of hindsight that one
can arrive at the conclusion that because of the disclosure of BELL one of
ordinary skill in the art would have replaced the compounds of WEI in the
method disclosed in WEI by the compounds according to BELL” (Appeal
Br. 11).
We are not persuaded. While we are aware that hindsight bias may
plague determinations of obviousness, Graham v. John Deere Co., 383 U.S.
1, 36 (1966), we are also mindful that the Supreme Court has clearly stated
that the “combination of familiar elements according to known methods is
likely to be obvious when it does no more than yield predictable results.”
KSR, 550 U.S. at 416. Here, selection of known cooling agents such as the
compounds of Bell (FF 5–6), demonstrated to be superior, would have been
obvious equivalent cooling compounds for use in the composition of Wei,
where Wei expressly teaches a need for cooling compounds (FF 4).
Conclusion of Law
The evidence of record supports the Examiner’s finding that Wei and
Bell render the claims obvious.

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B. 35 U.S.C. § 103(a) over Wei, Bell, and De Rijk
Appellant does not separately argue this obviousness rejection, instead
relying upon their arguments to overcome the combination of Wei and Bell
(see Appeal Br. 11–12). Having affirmed the obviousness of claims 30–35
for the reasons given above, we also find that the further combination with
De Rijk renders the rejected claims obvious for the reasons given by the
Examiner (see Final Act. 11–12).

C. 35 U.S.C. § 103(a) over Wei and Rovner
The Examiner relies on Wei as discussed above and further notes that
“Wei teaches that compounds capable of activating TRP-M8 receptors
generate sensations of coolness and refreshment” (Final Act. 13). The
Examiner acknowledges that “Wei does not teach a compound having the
cyanomethyl substitution of the aryl group i.e., (1R,2S,5R)-N-(4-
(cyanomethyl)-phenyl)-2-isopropyl-5-methylcyclohexane carboxamide”
(Final Act. 13).
The Examiner finds that Rovner teaches a compound that falls within
the scope of claim 40, EVERCOOL 180, and that “EVERCOOL 180 was
developed using a TRPM8 bioassay evaluating cooling activity in vitro”
(Final Act. 14). The Examiner finds “Rovner teaches that EVERCOOL 180
has a three hour duration” (Final Act. 14).
The Examiner finds it obvious “to modify the method of Wei by using
the cyanomethyl substitution of N-arylssalkyl-cCarboxamide shown above
(i.e. EVERCOOL 180) to improve the duration of alleviation of itching,
pain, and inflammation” (Final Act. 14). The Examiner finds the “skilled
artisan would have reasonably expected EVERCOOL 180 to inhibit the
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perception of itch and paraesthesia in the skin because the compound
modulates TRPM8 activity . . . because modulation of ion fluxes via TRPM8
inhibits the perception of itch and discomfort in skin” (Final Act. 14).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s finding that Wei and Rovner render the
claims obvious?
Findings of Fact
8. Rovner teaches “[m]arket demands continue to evolve,
prompting . . . flavor producers to look for compounds that provide even
more intense and longer lasting cooling effects than the current ingredients”
(Rovner 2).
9. Rovner teaches the
TRPM8 receptor, which is expressed in tissues including the
oral mucosa, tongue, and skin, is activated by temperatures
around 25 ºC or below. The receptor can also be activated by
menthol and certain other chemical agents. In either case,
activation triggers a biochemical cascade of events that is
translated by the brain into a perception of cooling.
(Rovner 2).
10. Rovner teaches that menthol “shortcomings have led to the
development of substitutes, including WS-3 and Givaudan’s new Evercool
180” (Rovner 2). The structure of Evercool 180 is reproduced below:

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The image shows the chemical structure of Evercool 180, a menthane
carboxamide compound (see Rovner 4).
11. Rovner teaches “long-lasting and potent new compounds. ‘If
you use a toothpaste with some of our cooling agents, you'll feel a cool
sensation for three hours’” (Rovner 4).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 13–16; FF 1–4, 8–11) and
agree that the claims are rendered obvious by Wei and Rovner. We address
Appellant’s arguments below.
Appellant contends
according to ROVNER only some (but not all) of the new
agents provide a cool sensation for three hours. It is not clear
from ROVNER whether Evercool 180 is one of the agents
which when incorporated into a toothpaste would provide a
cool sensation (in the mouth) for three hours. . . . Accordingly,
even if one were to assume, merely for the sake of argument,
that ROVNER discloses that EVERCOOL 180 has a three hour
duration of cooling effect, it is not seen what could have
motivated one of ordinary skill in the art to replace the
compounds of WEI by a compound whose duration of cooling
effect is not longer, and likely shorter, than that of the
compounds disclosed in WEI.
(Appeal Br. 13).
We find this argument unpersuasive for similar reasons to those
already discussed. First, Rovner provides a specific teaching that the
ordinary artisan was interested in new cooling compounds (FF 8) and a
teaching that Evercool 180 is a known and improved cooling compound
substitute (FF 10). Wrigley finds substitution of one cooling agent for
another obvious when the evidence shows “a combination of elements that
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were all known in the prior art, and all that was required to obtain that
combination was to substitute one well-known . . . agent for another.”
Wrigley, 683 F.3d at 1364. The same situation applies here, where Evercool
180 is known and superior equivalent cooling agent. Appellant provides no
evidence of any secondary consideration.
Appellant contends “ROVNER is not even concerned with topical
compositions for alleviating itch, pain, and discomfort of the skin, but relates
to flavoring compounds having a cooling effect in the mouth” (Appeal Br.
14).
We find this argument unpersuasive because Rovner expressly teaches
that cooling is based on activation of the TRPM8 receptor and that this effect
operates on skin (FF 9). Moreover, Wei teaches that the same TRPM8
receptor is a target for skin itch and pain (FF 1). Thus, the ordinary artisan
would reasonably have expected that the cooling effect disclosed by Rovner
would be applicable to both oral and skin indications. Appellant provides no
evidence to the contrary.
Conclusion of Law
The evidence of record supports the Examiner’s finding that Wei and
Rovner render the claims obvious.

D. & E. 35 U.S.C. § 103(a) over Wei, Rovner and either Galopin or De Rijk
Appellant does not separately argue these obviousness rejections,
instead relying upon their arguments to overcome the combination of Wei
and Rovner (see Appeal Br. 15–16). Having affirmed the obviousness of
claims 40–43 and 45 for the reasons given above over Wei and Rovner, we
also find that the further combinations with Galopin or De Rijk renders the
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rejected claims obvious for the reasons given by the Examiner (see Final
Act. 17–21).

DECISION
In summary:

Claims
Rejected
35 U.S.C. §  Basis/Reference(s) Affirmed Reversed
30–35 103(a)  Wei, Bell 30–35
30–39 103(a)  Wei, Bell, De
Rijk
30–39
40–43, 45 103(a) Wei, Rovner 40–43, 45
40–45 103(a) Wei, Rovner,
Galopin
40–45
40–49 103(a) Wei, Rovner, De
Rijk
40–49
Overall
Outcome
30–49

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