Karl-Heinz WOELLER et al.

Patent Trials and Appeals Board

Jun 17, 2020

15641451 - (D) (P.T.A.B. Jun. 17, 2020)

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.
15/641,451 07/05/2017 Karl-Heinz WOELLER 3321-P50390 2932
13897 7590 06/17/2020
Abel Schillinger, LLP
5929 Balcones Drive
Suite 300
Austin, TX 78731
EXAMINER
ZHANG, YANZHI
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
06/17/2020 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 KARL-HEINZ WOELLER, LUDGER KOLBE,
CATHRIN SCHERNER, and RAINER WOLBER
__________

Appeal 2020-000492
Application115/641,451
Technology Center 1600
__________

Before DONALD E. ADAMS, JOHN E. SCHNEIDER, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

TOWNSEND, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating a local pigmentation disorder by applying a self-adhesive
transdermal therapeutic system to affected skin, which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Melanin “brings about a more or less pronounced brownish to brown-
black skin color.” (Spec. 1.) “Problems with hyperpigmentation of the skin

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. (Appeal Br. 3.)
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have a wide variety of causes and/or are accompanying phenomena of many
biological processes.” (Id. at 2.) Active ingredients and preparations which
counteract skin pigmentation are known. (Id. at 3.) 4-n-Butylresorcinol is
known to inhibit the production of melanin. However, the compound itself
“has a tendency to discolor - and to discolor cosmetic or dermatological
preparations comprising it.” (Id. at 4.) Appellant’s invention is directed to a
system to deliver 4-n-butylresorcinol transdermally and “provide remedies
for the disadvantages of the prior art.” (Id.)

Claims 21 and 26–40 are on appeal. Claim 21 is representative and
reads as follows:
21. A method for the treatment of a local pigmentation
disorder, wherein the method comprises applying to skin
affected by the disorder a transdermal therapeutic system,
which comprises 4-n-butylresorcinol as an active ingredient, the
transdermal therapeutic system being employed in the form of a
matrix system selected from nonpolar matrices based on
synthetic and natural rubber, polar wet adhesive films based on
polyacrylic acid/polyvinyl alcohol, nonpolar matrices based on
polyacrylic acid copolymers, polar anhydrous gel matrices
based on polyacrylic acid/polyvinylpyrrolidone, nonpolar
polyisobutylene matrices and polar water gel matrices based on
agar agar/polyacrylic acid.
(Appeal Br. 17.)

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The prior art relied upon by the Examiner is:
Name Reference Date
Torihara et al. US 4,959,393 Sept. 25, 1990
Wang et al. US 5,508,038 Apr. 16, 1996
Woeller et al. US 2005/0281881 A1 Dec. 22, 2005
L. Panigrahi et al., The Effect of pH and Organic Ester Penetration
Enhancers on Skin Permeation Kinetics of Terbutaline Sulfate From
Pseudolatex-Type Transdermal Delivery Systems Through Mouse and
Human Cadaver Skins, 6(2) AAPS PharmSciTech E167–173 (2005)

The following grounds of rejection by the Examiner are before us on
review:
Claims 21, 26, 28–35, and 38–40 under 35 U.S.C. § 103(a) as
unpatentable over Torihara and Wang.
Claims 21, 27, 28, and 29 under 35 U.S.C. § 103(a) as unpatentable
over Torihara and Woeller.
Claims 36 and 37 under 35 U.S.C. § 103(a) as unpatentable over
Torihara, Woeller, and Panigrahi.
Claims 29–40 on the ground of non-statutory obviousness-type double
patenting as being unpatentable over claims 1–19 of U.S. Patent No.
9,801,971.2

2 Appellant argues that “[t]his rejection is not presented for review” and
does not otherwise respond to the merits of the rejection. (Appeal Br. 15.)
We note that the rejection has not been withdrawn by the Examiner in the
Answer and conclude that Appellant has waived any argument as to the
merits of the rejection. Consequently, we summarily affirm the Examiner’s
obviousness-type double patenting rejection. MPEP § 1205.02 (“If a ground
of rejection stated by the examiner is not addressed in the appellant’s brief,
appellant has waived any challenge to that ground of rejection and the Board
may summarily sustain it, unless the examiner subsequently withdrew the
rejection in the examiner’s answer.”)
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DISCUSSION
Obviousness: Torihara and Wang
The Examiner notes that Torihara states “there is a strong demand for
agents which enable acquired deposition sites, such as spots or freckles, to
be restored to a normal skin color.” (Final Action 4 (emphasis omitted).)
The Examiner finds that Torihara discloses 4-n-butylresorcinol is a skin
depigmental agent for topical application and that it can be used along with
any cosmetic base ordinarily used for skin depigmental agents. (Id.) The
Examiner further finds that Torihara teaches “that the amount of the
resorcinol derivative is in the range of from 0.01 wt% to 15 wt% of the total
amount of a cosmetic composition.” (Id.) The Examiner recognizes that
Torihara does not expressly teach that the resorcinol derivative is placed in a
matrix as claimed for topical application. (Id.) However, the Examiner
finds that such would have been obvious in light of the teachings of Wang.
The Examiner finds that Wang teaches polyisobutylene (PIB)
adhesives useful in transdermal drug delivery systems, and that the thickness
of the adhesive layer will generally be between 0.0254 mm and 0.381 mm
when used with a rate-controlling membrane. (Id. at 5.) The Examiner
further finds that Wang teaches “that the composition and thickness of the
adhesive layer will be adjusted so that the adhesive layer does not constitute
a significant permeation barrier to the passage of the agent to be delivered as
compared to that of the rate-controlling membrane.” (Id.)
The Examiner concludes that one of ordinary skill in the art to would
have been motivated to combine Wang with Torihara to take advantage of
transdermal active agent delivery. (Id.) The Examiner also concludes that
there would have been a reasonable expectation that the PIB based system of
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Wang could be used with 4-n-butylresorcinol given that the “LogP, a
parameter measuring polarity data of active agents” of 4-n-butylresorcinol is
between the LogP of nicotine and benztropine, two of the active ingredients
that Wang specifically identifies as active agents that can be used with the
PIB adhesives described. (Ans. 6–7.) The Examiner explains that nicotine
has a lower logP than 4-n-butylresorcinol and is thus more polar and
hydrophilic than 4-n-butylresorcinol, while benztropine has a higher logP
than both 4-n-butylresorcinol and nicotine and is more non-polar and
hydrophobic than either of those two compounds. (Id. at 7.) Given the large
difference between the logP of nicotine and benztropine, the Examiner finds
that it would have been understood “that the transdermal matrix of Wang
can accommodate a variety of active ingredients.” (Id.)
We agree with the Examiner’s factual findings and conclusion of
obviousness. Wang teaches that “[t]he characteristics of the adhesives of
this invention . . . make them particularly useful as in-line adhesives in rate
controlled transdermal delivery devices” (Wang 3:34–36) and that
transdermal delivery devices can be applied by a patient anywhere “from
several hours up to a week depending upon the agent being delivered and the
condition being treated” (id. at 3:42–46). Torihara, as the Examiner
explains, teaches 4-n-butylresorcinol is a skin depigmental agent that can be
applied topically. (See, e.g., Torihara cols. 1–2.)
We agree that these teachings provide sufficient reasoning to establish
a motivation to combine. “[I]nterrelated teachings of multiple patents; the
effects of demands known to the design community or present in the
marketplace; and the background knowledge possessed by a person having
ordinary skill in the art, all [can provide] an apparent reason to combine the
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known elements in the fashion claimed.” KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 418 (2007). Indeed, the obviousness analysis “can take account of
the inferences and creative steps that a person of ordinary skill in the art
would employ.” Id. And we note “[t]he combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
416 (2007).
Contrary to Appellant’s argument, Wang does not “recommend” the
PIB adhesive “for use in combination with only non-polar active agents”
(Appeal Br. 7 (emphasis omitted)). Rather, we conclude that Wang simply
discloses that there is an advantage to use with such ingredients. It is true, as
Appellant indicates, that Wang teaches that the disclosed PIB adhesive
“finds particular use” (id.) for delivering oily nonpolar agents such as
nicotine, benztropine, secoverine, dexsecoverine, and arecoline. (Wang
5:12–29.) Regarding those agents, Wang notes that they have a low
solubility in the PIB adhesives disclosed and thus the concentration of those
agents “is significantly reduced as compared to that observed in prior art
non-PIB adhesives” and thus the degradation of adhesive is reduced where
such oily, non-polar oily agents were known to degrade the typical non-PIB
adhesives in which they were highly soluble. (Id.)
However, Wang does not teach that the PIB adhesive can only be used
with oily, non-polar agents, just because a particular benefit is obtained with
certain oily, non-polar agents. Accord Merck & Co., Inc. v. Biocraft Labs.,
Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (“the fact that a specific
[embodiment] is taught to be preferred is not controlling, since all
disclosures of the prior art, including unpreferred embodiments, must be
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considered” (citation omitted) (alteration in original)). Wang specifically
does not limit the agents that can be included with the matrix noting that
they can be:
any beneficial agent or compound that can be delivered by a
device herein to produce a beneficial and useful result. The
term includes medicines, organic and inorganic drugs,
hormones, nutrients, vitamins, food supplements, and other
agents that benefit an animal or human.
(Wang 3:48–53.) For this reason, we also do not find persuasive of non-
obviousness Appellant’s argument that 4-n-butylresorcinol is “structurally
and chemically completely different” (Appeal Br. 7–8) from the non-polar
agents nicotine, benztropine, secoverine, dexsecoverine, and arecoline.
“Obviousness does not require absolute predictability of success. . . . For
obviousness under § 103, all that is required is a reasonable expectation of
success.” In re O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988). That
Wang suggests its transdermal system can be used with a variety of
beneficial agents without restricting such agents to oily non-polar agents
provides a reasonable expectation of success that 4-n-butylresorcinol could
be delivered with a transdermal system that used the disclosed PIB adhesive.
Appellant separately argues claims 38–40. (Appeal Br. 9–11.) These
claims recite different release rates for 4-n-butylresorcinal from the
therapeutic system. Appellant argues that Wang teaches adhesive layer
thickness ranges when used with a rate controlling membrane and argues
that Wang “makes it clear that when a rate-controlling membrane is present,
the release rate of the drug is controlled by the rate-controlling membrane,
not by the (thickness of the) adhesive layer.” (Id. at 10.) According to
Appellant, “it is impossible to draw any conclusions regarding the release
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rate of a drug in the device of WANG based on the thickness of the adhesive
layer, at least when a rate-controlling membrane is present.” (Id.) We do
not find this argument persuasive of non-obviousness because the claims do
not exclude the presence of a rate-controlling membrane and Wang makes it
clear that the composition and thickness of the adhesive layer is a result-
effective variable with respect to passage of the agent to be delivered.
(Wang 4:33–45 (“The composition and thickness of the adhesive layer will
be adjusted such that the adhesive layer does not constitute a significant
permeation barrier to the passage of the agent to be delivered as compared to
that of the rate-controlling membrane. . . . the thickness is also preferably
selected so that the adhesive does not contain a substantial amount and
preferably less than about 15% of the total amount of agent in the device,
particularly in rate-controlled delivery devices.”) (emphasis added).)
Claim 21, from which claims 38–40 depend, recites that the
transdermal therapeutic system “comprises” a particular active ingredient
and that the system is “employed in the form of a matrix system selected
from” a number of types of materials types matrices. “‘Comprising’ is a
term of art used in claim language which means that the named elements are
essential, but other elements may be added and still form a construct within
the scope of the claim.” Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501
(Fed. Cir. 1997). Thus, we do not consider that the therapeutic system is in
the “form of a matrix system” to limit the composition of the elements that
make up that system to only the active ingredient recited and the group of
matrix materials identified from which to select. Consequently, that Wang
teaches release rate can be controlled in part by a rate-controlling membrane
does not establish non-obviousness of the claimed invention.
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Furthermore, “[w]here 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 Applied Materials, Inc., 692 F.3d
1289, 1295 (Fed. Cir. 2012). The motivation to optimize comes from the
natural desire of those skilled in the art to experiment with, and improve
upon, known conditions taught in the prior art. In re Peterson, 315 F.3d
1325, 1330 (Fed. Cir. 2003). That a number of elements may need to be
adjusted to arrive at the claimed rate of release does not establish non-
obviousness.
In addition, we note that Wang is also not limited to a transdermal
delivery device that has a release rate-controlling membrane. (See generally
Wang 4:46–51; 5:2–8.) Moreover, claims 38–40 are not limited to a
particular concentration range of active to achieve the claimed rate of
release.
In light of the foregoing, we affirm the Examiner’s rejection of claims
21, 26, 28–35, and 38–40 as being obvious over Torihara and Wang.

Obviousness: Torihara and Woeller
The Examiner’s findings regarding Torihara are discussed above. The
Examiner finds that Woeller discloses a self-adhesive polymer matrix that
can be a medical patch or bandage. (Final Action 7.) The Examiner further
finds Woeller teaches:
[T]he . . . polymer matrix comprises (a) at least one polymer
which forms a gel in water, (b) water, (c) a sea algae extract,
and (d) at least one alcohol which is a monohydric or
polyhydric alcohol and, in one aspect of the polymer matrix,
component (a) may comprise a polyacrylic acid polymer or
copolymer.
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(Id. at 7–8 (emphasis omitted).) The Examiner also finds that Woeller
teaches “component (c) may comprise agar-agar and/or carrageenan.” (Id.
at 8.)
The Examiner further finds that Woeller teaches topical
administration of drugs provides the following two advantages:
(1) first-order release kinetics of the active substance, thereby
allowing a constant level of active substance to be maintained in the body
over a very long period of time;
(2) the path of uptake through the skin avoids the gastrointestinal tract
and also the first pass through the liver. (Id.) Thus, the Examiner concludes
that it would have been obvious to one having ordinary skill in the art to
“choose self-adhesive polymer matrix taught by Woeller as the particular
drug delivery system to be incorporated into the invention of Torihara.”
(Id.)
We agree with the Examiner’s factual findings and conclusion of
obviousness.
Appellant’s argument that “none of the examples of pharmaceutical
active substances which are mentioned in col. 5, lines 24–30 and claim 6 of
WOELLER shows any structural or other resemblance with 4-n-
butylresorcinol”3 and that “[t]he same applies to the active ingredients which
are employed in Examples VII-IX of WOELLER” (Appeal Br. 12 (emphasis
omitted)) is not persuasive of non-obviousness. Woeller teaches the gel

3 We note that Woeller, US 2005/0281881 A1, relied on in the Examiner’s
rejection does not have column and line numbers. Moreover, claim 6 of
Woeller does not recite any particular active components, though claims 18
and 27 do.
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matrix taught can be doped “with hydrophilic active substances, or else, in
the case of an appropriate solubilizer, with hydrophobic active substances
for wound healing or skin care.” (Woeller ¶ 75.) Woeller essentially
teaches that any active substance for topical application for wound healing
or skin care is capable of being added to the disclosed matrix. Furthermore,
the actives recited in claims 18 and 27 include menthol and ketoprofen both
of which include cyclic carbon structures and OH substituents, which 4-n-
butyl resorcinol also includes. Even if it were true, it is not dipositive that
none of the examples of pharmaceutical active substances which are
specifically mentioned in Woeller shows any structural or other resemblance
with 4-n-butyl resorcinol. “It is well settled that a prior art reference is
relevant for all that it teaches to those of ordinary skill in the art.” In re
Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992).
Appellant’s argument that “it would be impossible for one of ordinary
skill in the art to predict whether the matrix materials disclosed in
WOELLER can successfully be used in combination with 4-n-
butylresorcinol as active agent” (Appeal Br. 13; see also id. at 14) is
similarly unavailing. Woeller provides a reasonable expectation of success
with any hydrophilic or hydrophobic active substance. And Appellant has
not provide any scientific reasoning or evidence as to why certain active
substances would not reasonably be expected to work. “Attorney argument
is not evidence.” Icon Health & Fitness v. Strava, 849 F.3d 1034, 1043
(Fed. Cir. 2017) Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir.
1989) (“Attorneys’ argument is no substitute for evidence.”)
Woeller teaches that “transdermal therapeutic systems for delivering
active substances into and/or through the skin have been known for a long
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time and constitute patch-like systems which in particular are doped with
drugs” (Woeller ¶ 6.) Such systems provide “time-dependent release” of
the drug and amount released per unit time and the duration of activity of the
drug is influenced directly by the composition of the matrix. (Woeller ¶¶ 8,
10–11.) Whether or not Woeller specifically addresses particular release
rates (Appeal Br. 13) is immaterial as none of the rejected claims requires
any particular release characteristics. Woeller generally teaches that
transdermal therapeutic systems are beneficial because they provide “time-
dependent” drug release and that the amount of drug release per unit time
and the duration of activity is “influenced directly” by the composition of
the matrix. (Woeller ¶ 11.)
Finally, that “[n]othing is mentioned in [paragraph 217] of
WOELLER regarding the treatment of (local) pigmentation disorders”
(Appeal Br. 13) is not persuasive of nonobviousness. “Non-obviousness
cannot be established by attacking references individually where the
rejection is based upon the teachings of a combination of references.” In re
Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). The references must be
read, not in isolation, but in combination for what they fairly teach as a
whole. Id. The Examiner relied on Torihara for the fact that the active agent
4-n-butyl resorcinol is a skin depigmental agent that can be applied topically
to restore age spots or freckles to a “normal skin color.” (Torihara 1:9–16.)
Woeller provides a reason to apply 4-n-butyl resorcinol with an adhesive
transdermal patch system. In particular, Woeller teaches the benefits of
transdermal therapeutic systems, stating that they
avoid the need for frequently repeated administration and avoid
burdening the skin with high concentrations of active
substances, and so reduce irritation to the skin, which is
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unavoidable in the event of repeated administration of liquid
and semisolid administration forms. . . .
In summary, the advantages . . . lie in a distinctly improved
compliance on the part of users, which is attributable to the
simple and rapid administration and to the long-lasting efficacy
of transdermal therapeutic systems.
(Woeller ¶¶ 14–15).
Thus, we affirm the Examiner’s rejection of claims 21, 27, 28, and 29
as being obvious over Torihara and Woeller.
Appellant does not separately argue the rejection of claims 36 and 37
other than to say that “PANIGRAHI is unable to cure the noted deficiencies
of TORIHARA and WOELLER.” (Appeal Br.15.) Because we do not find
any deficiency in the Examiner’s obviousness rejection of the claims over
Torihara and Woeller, we affirm the rejection of claims 36 and 37 as being
obvious over Torihara, Woeller, and Panigrahi.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
21, 26, 28–
35, 38–40
103 Torihara, Wang 21, 26, 28–
35, 38–40

21, 27, 28
29
103 Torihara, Woeller 21, 27, 28,
29

36, 37 103 Torihara, Woeller,
Panigrahi
36, 37
29–40 Obviousness-Type
Double Patenting
29–40
Overall
Outcome
21, 26–40

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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