Ex Parte Woeller et al

Patent Trial and Appeal Board

Apr 20, 2017

13499861 (P.T.A.B. Apr. 20, 2017)

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.
13/499,861 06/25/2012 Karl-Heinz Woeller 3321-P50004 1065
13897 7590 (
Abel Law Group, LLP
8911 N. Capital of Texas Hwy
Bldg 4, Suite 4200
Austin, TX 78759
EXAMINER
ZHANG, YANZHI
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
04/24/2017 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):
mail @ Abel-IP.com
hmuensterer @ 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 WOLBER1
Appeal 2016-004051
Application 13/499,861
Technology Center 1600
Before RICHARD M. LEBOVITZ, RICHARD J. SMITH, 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 self-
adhesive transdermal therapeutic system, which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm. However, as to claims 50 and 51, because our affirmance
relies on somewhat different reasoning from the Examiner’s, we designate
our affirmance of the rejection of claims 50 and 51 as New Grounds of
Rejection.
1 Appellants identify the Real Party in Interest as Beiersdorf AG. (Appeal
Br. 3.)
Appeal 2016-004051
Application 13/499,861
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
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.) Appellants’ invention is directed to a
system to deliver 4-n-butylresorcinol transdermally and “provide remedies
for the disadvantages of the prior art.” (Id.)
Claims 28—30, 32—35, 37-45, and 49—51 are on appeal. Claim 28 is
representative and reads as follows:
28. A transdermal therapeutic system, wherein the system
comprises 4-n-butylresorcinol as an active ingredient in an
amount from 0.001 % to 10 % by weight based on a total
weight of the system and is present in a form of a matrix system
comprising a self-adhesive matrix that comprises the 4-n-
butylresorcinol and is selected from nonpolar polyisobutylene
matrices and polar water gel matrices based on agar
agar/polyacrylic acid.
(Appeal Br. 22.)
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The following grounds of rejection by the Examiner are before us on
review:
1. Claims 28, 38, 39, 48, 49, and 51 under 35 U.S.C. § 103(a) as
unpatentable over Woeller2 and Torihara.3
2. Claims 28-30, 32-344, 41, 44, and 50 under 35 U.S.C. § 103(a)
as unpatentable over Wang5 and Torihara.
3. Claims 35, 37, 42, and 43 under 35 U.S.C. § 103(a) as
unpatentable over Wang, Torihara, and Panigrahi.6
4. Claim 40 under 35 U.S.C. § 103(a) as unpatentable over
Woeller, Torihara, and Panigrahi.
5. Claim 45 under 35 U.S.C. § 103(a) as unpatentable over
Woeller, Torihara, and Wang.
2 Woeller et al., US 7,829,099 B2, issued Nov. 9, 2010. The application that
issued as Woeller ’099 was filed June 22, 2005, and published Dec. 22,
2005.
3 Torihara et al., US 4,959,393, issued Sept. 25, 1990.
4 The Examiner’s rejection refers to claims “28—34.” (Final Action 5; Ans.
6.) However, the Examiner acknowledges in the Advisory Action dated
May 6, 2015, that claim 31 is not rejected (Advisory Action 1), and
Appellants’ claim Appendix does not include claim 31 as one of the claims
on appeal.
5 Wang et al., US 5,508,038, issued Apr. 16, 1996.
6 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).
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DISCUSSION
I. Claims 28, 38, 39, 48, 49, and 51 are obvious from Woeller and Torihara
The Examiner finds that, like the claimed transdermal therapeutic
system, Woeller discloses a self-adhesive polymer matrix that can include a
pharmaceutical active ingredient up to 15% by weight of the matrix and can
be used to topically or buccally administer the active substance. (Final
Action 3—4.) The matrix “comprises from 2% to 55% by weight of (a) at
least one polymer which forms a gel in water (interpreted as water gel) and
the polymer matrix comprises at least one polyacrylic acid polymer, at least
one of agar-agar and carrageenan and glycerin,” meeting one of the recited
self-adhesive matrix composition of claim 28. (Ans. 5; Final Action 3.) The
Examiner further finds that Woeller discloses the gel matrix is applied on a
flexible cover layer constructed from a backing material that can be, among
other things, a film, non woven or woven. (Final Action 3.) The Examiner
notes that in a preferred embodiment the backing materials of Woeller
“available for selection include polyethylene, polypropylene, polyether-ester
copolymers and polyurethane or else natural fibers.” (Id. at 3—4; Ans. 6.)
Woeller is also said to disclose the use of penetration enhancers in the
polymer matrix. (Final Action 4.) The Examiner finds that the difference
between Woeller and the claimed transdermal therapeutic system is that
Woeller does not disclose the matrix contains 4-n-butylresorcinol as the
active ingredient. (Id. at 4.)
The Examiner finds that Torihara discloses 4-n-butylresorcinol is a
skin depigmental agent and that it can be used along with any cosmetic base
ordinarily used for skin depigmental agents. (Id.) The Examiner concludes
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that it would have been obvious to one of ordinary skill in the art to use 4-n-
butylresorcinol with the Woeller matrix thereby providing “a constant level
of active substance to be maintained in the body over a long period of time,”
and that there would have been a reasonable expectation of success in
combining that active ingredient with the Woeller matrix. (Id.)
We agree with the Examiner’s factual findings concerning the prior
art teachings and conclusion of obviousness. Appellants’ arguments that
Woeller does not address substance release characteristics at all (Appeal Br.
7—8), that the presence of an active ingredient is optional in Woeller (Appeal
Br. 8; Reply Br. 3), that “none of the examples of pharmaceutical active
substances which are mentioned in . . . WOELLER shows any structural or
other resemblance with 4-n-butyl resorcinol” (Appeal Br. 8), and that
Torihara does not “suggest[] that any of the skin depigmental agents
mentioned therein can or should be applied in the form of a matrix system”
(Appeal Br. 9; Reply Br. 2), are not persuasive to rebut the Examiner’s
prima facie case of obviousness.
In particular, “[n]on-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. Furthermore, “[i]t is well settled
that a prior art reference is relevant for all that it teaches to those of ordinary
skill in the art.” In reFritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992).
Regardless of the fact that Woeller does not provide any examples
where the matrix includes an active pharmaceutical substance, Woeller
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teaches the gel 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
8:4—9.) 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. And, thus, even if true, it is not dipositive that “none of
the examples of pharmaceutical active substances which are mentioned in
col. 5, lines 24-30 of WOELLER shows any structural or other resemblance
with 4-n-butyl resorcinol” (Appeal Br. 8).
Torihara teaches that 4-n-butyl resorcinol is a skin care active
substance, i.e., a depigmental agent to restore age spots or freckles to a
“normal skin color.” (Torihara 1: 9—16.) That Torihara does not teach 4-n-
butyl resorcinol provided in a matrix for transdermal delivery is not of
import. The rejection is not an anticipation rejection based on Torihara, but
rather an obviousness rejection based on the combined teachings of Woeller
and Torihara. “As long as some [reason,] motivation or suggestion to
combine the references is provided by the prior art taken as a whole, the law
does not require that the references be combined for the reasons
contemplated by the inventor.” In re Beattie, 974 E.2d 1309, 1312 (Led. Cir.
1992.)
As the Examiner noted, Woeller teaches that “transdermal therapeutic
systems for delivering active substances into and/or through the skin have
been known for a long time and constitute patch-like systems which in
particular are doped with drugs” (Final Action 3; Woeller 1:29—32). Such
systems provide “time-dependent release” of the drug and amount released
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per unit time and the duration of activity of the drug is influenced directly by
the composition of the matrix. (Woeller 1:47—54.) Woeller further 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
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 2:4—15.) In light of the foregoing, the Examiner’s findings and
conclusions are supported by a preponderance of the evidence that it would
have been obvious to one of ordinary skill in the art to use the Woeller
transdermal therapeutic system, which employs a simple self-adhesive
polymer matrix with 4-n-buytl resorcinol as the active ingredient to achieve
the advantages of improved user compliance, due to the rapid administration
and the long-lasting efficacy of the transdermal therapeutic system. That is
so regardless of whether Woeller specifically addresses particular release
characteristics, as Woeller generally teaches that transdermal therapeutic
systems are beneficial because they provide “time-dependent” drug release,
and none of claims 28, 38, 39, 48, 49, or 51 recite a specific release rate.
Appellants did not provide evidence that 4-n-butyl resorcinol would not
have been reasonably expected to be released from the matrix described in
Woeller. Appellants argue that it could not be predicted what the release
characteristics would be, but did not establish that it would not be expected
to be released at all. (Appeal Br. 8.)
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Appellants argue that “WOELLER and TORIHARA are unable to
suggest to one of ordinary skill in the art that any of the matrix materials
disclosed in WOELLER is far superior to other matrix materials in terms of
release of active substance, let alone in terms of release of 4-n-
butylresorcinol,” and that this unexpected result renders the claimed
invention non-obvious. (Appeal Br. 7.) We are not persuaded that
Appellants have provided sufficient evidence of unexpected results. First,
that Woeller does not mention release rates of the matrix material does not
mean Woeller’s matrix does not have a release rate. “[A] compound and all
of its properties are inseparable; they are one and the same thing.” In re
Papesch, 315 F.2d 381, 391 (CCPA 1963). And, as discussed above,
Woeller teaches that matrices used in transdermal therapeutic systems have
time-dependent release that is “determined by the composition of the
matrix.” (Woeller 1:46—51) Second, the mere fact that Woeller does not
report the release rate of its matrix does not render the release rates of the
claimed polar water gel—a property that results from the composition of the
matrix—unexpectedly far superior. “Mere recognition of latent properties in
the prior art does not render nonob vious an otherwise known invention.” In
re Baxter TravenolLabs., 952 F.2d 388, 392 (Fed. Cir. 1991). As the
Examiner noted (Ans. 5), the fact demonstrated by Appellants’ Specification
that a “polar water gel matrix based on agar/agar polyacrylic acid” results in
34% release of active ingredient present in the matrix at 1% after 24 hours
(Spec. 5) would appear to be an inherent property of the polar water gel
matrix disclosed by Woeller, (see, e.g., Woeller 4:20-65), which Appellants
did not dispute falls within the scope of the claim.
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Second, to the extent there is a difference between the matrix
described in the examples in Appellants’ Specification and Woeller, we note
that “when unexpected results are used as evidence of nonobviousness, the
results must be shown to be unexpected compared with the closest prior art.”
Baxter., 952 F.2d at 392. Appellants’ Specification provides a comparison
of ingredient release of different matrix systems as follows:
A nonpolar matrix based on synthetic and natural rubber (KA)
A polar wet adhesive film based on polyacrylic acid/polyvinyl
alcohol (FKF)
A nonpolar matrix based on a polyacrylic acid copolymer
(PAC)
A polar anhydrous gel matrix based on polyacrylic
acid/polyvinylpyrrolidone (WFG)
A nonpolar polyisobutylene matrix (PIB)
A polar water gel matrix based on agar agar/poly acrylic acid
(WG)
(Spec. 5.) The active ingredient release results after 24 hours when these
matrices included 1% of 4-n-butylresorcinol were reported as follows:
Results of the active ingredient release of different matrix systems:
(KA) (FKF) (PAC) (WFG) (PIB) (WG)
7.4% 17.8% 18.1% 20.6% 22.2% 34.0%
(Id.) Appellants have simply demonstrated that a WG matrix described by
Woeller has better release characteristics than other matrices known in the
prior art. However, such prior art matrixes as KA, FKF, PAC, and WFG,
were not identified as the closest prior art. In the rejection based on
Woeller, WG was identified as the prior art matrix; Appellants have not
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provided evidence that the result with WG is attributable to anything other
than the inherent properties of the WG matrix which is disclosed by Woeller.
Third, Appellants’ argument in the brief on Appeal that the 34%
release reported in the Specification “is an unexpected result” (Appeal Br. 7)
is merely attorney argument, and the Specification does not identify the
release result with WG as unexpected in light of Woeller’s teaching of using
the same matrix material with an active ingredient in a transdermal
therapeutic system (see Spec. 5). The Specification indicates that “[a]
disadvantage of TTS is that usually only ca. 10% to 20% of the active
ingredient content of the plaster are released during the application time” but
that using WG and 1% 4-n-butylresoricnol provided a greater release than
about 10—20%. (Spec. 4—5.) The Specification does not establish that this
greater that about 10-20% release would not have been achieved with any of
the other active ingredients disclosed in Woeller. Thus, Appellants’
argument of “unexpectedness” over the prior art teaching is unsupported by
relevant objective evidence, and thus, is insufficient to establish unexpected
results. In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995) (“‘[i]t 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. 1984); see also In re Wood,
582 F.2d 638, 642 (CCPA 1978) (‘Mere lawyer’s arguments and conclusory
statements in the specification, unsupported by objective evidence, are
insufficient to establish unexpected results.’).”).
Furthermore, as the Examiner noted, Appellants’ evidence provides a
single data point for an active ingredient present in an amount of 1%. (Ans.
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6.) Appellants do not provide any indication that the 34% release rate over
24 hours would be the same across the claimed range of from 0.001 % to
10 % by weight based on a total weight of the system. Contrary to
Appellants argument (Reply Br. 3), it is not the Examiner’s burden to
explain why it cannot reasonably be assumed that the result would be the
same across the entire range. “An examiner bears the initial burden of
presenting a prima facie case of obviousness. Once the examiner establishes
a prima facie case of obviousness, the burden shifts to the applicant to rebut
that case.” In re Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011). When
unexpected results are proffered by Appellants, Appellants must “provide []
an adequate basis to support the conclusion that other embodiments falling
within the claim will behave in the same manner” in order to “establish that
the evidence is commensurate with [the] scope of the claims.” Id. at 1068.
One data point is insufficient to “to ascertain a trend in the exemplified data
which would allow [one having ordinary skill in the art] to reasonably
extend the probative value thereof.” In re Kollman, 595 F.2d 48, 56 (Fed.
Cir. 1979). And Appellants have not offered any reasoning by which one of
ordinary skill in the art could reasonably conclude that other embodiments
falling within the claimed range, such as the inclusion of a much smaller or
much larger percentage of 4-n-butylresorcinol, will release in similar
percentages to the 1% exemplified data point. Thus, even were unexpected
results established for this one data point, it is not commensurate with the
full scope of the claim.
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For the foregoing reasons, we are not persuaded that the Examiner
erred in rejecting claims 28, 38, 39, 48, and 49 as obvious over Woeller and
Torihara.
Claim 51
We agree with Appellants that the Examiner does not explain why the
subject matter of claim 51, which depends from claim 50 and requires the
thickness of a carrier layer to be “below 100 pm,” is obvious just because
Woeller teaches that polyurethane is a possible selection for a backing
material. However, we agree with the Examiner that claim 51 would have
been obvious to one having ordinary skill in the art based on the art cited by
the Examiner. As the Examiner noted, Woeller teaches that polyurethane is
a known backing material for transdermal delivery systems. (Final Action
3—4.) Moreover, the Examiner apparently presumed that polyurethane with
the claimed thickness was known in the art, and we note that the Examiner is
correct; polyurethane backings with a thickness below 100 pm were known
in the prior art.7 “The combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results.” KSR Inti Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). In light of
the fact that backing materials having the claimed thickness were known in
7 See, e.g., S. Kandavilli et al., Polymers in Transdermal Drug Delivery
Systems, Pharm. Tech., 62—80, 76 (2002) (disclosing that CoTran 9701 is a
known prior art polyurethane film for use in transdermal drug delivery)).
See also 3M™ CoTran™ 9701 Backing Specification Sheet, available at
http://solutions.3m.com/3MContentRetrievalAPI/BlobServlet?lmd=1219086
353000&locale=en_WW&assetType=MMM_Image&assetId=l 1142796955
53&blobAttribute=ImageFile (describing the thickness without a carrier of
CoTran 9701 as being 51.8 pm)).
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the prior art, and Appellants have not argued that the backing having a
thickness below 100 pm provides more than predictable results, we agree
with the Examiner that claim 51, is obvious.
Because our rationale differs from the Examiner’s, we designate our
affirmance a new ground of rejection under 37 C.F.R. § 41.50(b).
II. Claims 28—30, 32—34, 41, 44, and 50 are obvious from Wang and
Torihara
Claim 28 is also directed to transdermal therapeutic system that
comprises a matrix system of “nonpolar polyisobutylene” rather than polar
water gel matrices based on agar agar/poly acrylic acid. The Examiner finds
that Wang discloses polyisobutylene adhesives useful in transdermal drug
delivery systems, and that the thickness of the adhesive is generally
“between about 1 mil (0.0254 mm) and about 15 mil (0.381 mm) when used
with a rate-controlling membrane, which overlaps with the range of claim
29” (Final Action 5—6.) Wang teaches that any beneficial agent or
compound that can be delivered to produce a beneficial and useful result can
be incorporated into the adhesive. (Final Action 6; Ans. 7 (noting that Wang
teaches “[i]n its broadest application, the adhesives of this invention can be
used in monolithic transdermal delivery devices which comprise a thin film
of the agent dispersed in the adhesive which is normally provided with a
protective, agent-impermeable backing layer (col. 3 lines 18—27.”) The
Examiner further finds that Wang teaches that the adhesive layer thickness is
a result effective parameter. (Final Action 6; Ans. 8 “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
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the device, particularly in rate-controlled delivery devices (col. 4 lines 33 44
of Wang).”) While Wang does not disclose 4-n-butylresorcinol, the
Examiner found that this deficiency is met by Torihara.
The Examiner finds that Torihara discloses 4-n-butylresorcinol is a
skin depigmental agent and that it can be used along with any cosmetic base
ordinarily used for skin depigmental agents. (Final Action 7.) The
Examiner concludes that it would have been obvious to one of ordinary skill
in the art to use 4-n-butylresorcinol in the transdermal drug delivery system
of Wang in light of the fact that Wang “comprises topical contact of a drug
on the skin” and Torihara teaches topical application of 4-n-butylresorcinol”
and the combination “would have been no more than the combination of
prior art elements to yield predictable results.” (Final Action 7—8.)
We agree with the Examiner’s factual findings regarding the teachings
of Wang and Torihara and conclusion of obviousness.
Appellants’ argument that the rejection is in error because “the entire
disclosure of WANG relates to devices in which the polyisobutylene is used
exclusively as an adhesive, whereas the reservoir material is separate and
completely different from the polyisobutylene” (Appeal Br. 11; Reply Br. 4)
is not persuasive. Appellants concede that Wang mentions “that the
adhesive may function as both the agent reservoir and the adhesive.”
(Appeal Br. 11; see also Wang 3:18—27.) There is no disagreement,
therefore, that Wang teaches a matrix as claimed, i.e., that the adhesive is a
release rate-controlling adhesive that includes an active ingredient to be
released transdermally. That the teaching may be “in passing,” does not
detract from the fact that it is a relevant teaching to one of ordinary skill in
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the art. In re Inland Steel Co., 265 F.3d 1354, 1360 (Fed. Cir. 2001) (“The
fact that Irie teaches that annealing in addition to adding antimony produces
optimal results does not negate Irie’s additional teaching that adding
antimony is effective even in non-annealed steel.”).
Appellants’ argument that Wang is concerned “primarily, if not
exclusively . . . with the transdermal delivery of oily, non-polar agents such
as nicotine, benztropine, secoverine, dexsecoverine, and arecoline . . .
substances which are structurally and chemically completely different from
4-n-butylresorcinol” (Appeal Br. 12) is also unavailing. Wang does not
teach that the polyisobutylene adhesive can only be used with oily, non­
polar agents; rather, Wang indicates that, unlike some prior art adhesives,
the disclosed adhesive is capable of being used with such agents. (Wang
2:6—13, 30-36; 3:8—13.) 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.) Thus, that Wang teaches that the matrix can be used with
oily, non-polar agents does not detract from the combination of Wang with
active ingredients that are not oily, non-polar agents, e.g., active agents
disclosed in Torihara. 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 considered”). Appellants’
argument has thus not established that there would not have been a
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reasonable expectation of success of including 4-n-butylresorcinol as the
active agent in the Wang polyisobutylene adhesive. “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).
Appellants argue that the claims concerning a particular thickness
range recited for the matrix (claims 29, 30, 41, and 44) are not rendered
obvious by Wang and Torihara because Wang does not disclose a thickness
value or range for the “reservoir” that contains the active ingredient for
transdermal delivery. (Appeal Br. 12.) This argument is not persuasive
because Wang teaches the adhesive can be the reservoir, and discloses that
the adhesive layer is generally between about 1 mil (0.0254 mm) and about
15 mil (0.381 mm). (Ans. 8; Wang 4:33—35.) This range is within both the
broadly claimed range of 0.15 mm to 1.00 mm of dependent claim 29 and
the narrower range of 0.20 mm to 0.50 mm that Appellants argue achieves
“a particularly high release” (Appeal Br. 13). Moreover, Wang teaches that
the thickness of the layer, as well as its composition, is a result effective
variable that is “adjusted such that the adhesive layer does not constitute a
significant permeation barrier to the passage of the agent.” (Wang 4:35—39.)
Appellants further argue that the thickness range disclosed by Wang is
in conjunction with a rate controlling membrane. (Reply Br. 5.) We do not
disagree with Appellants. But we note that the relevant claims of Appellants
with respect to this rejection do not preclude the presence of such a
membrane. Furthermore, Wang teaches the thickness of the adhesive is a
results effective variable, and it would have been obvious to vary the
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thickness of the matrix layer within the claimed range to optimize “the
passage of the agent.” (Wang 4:37—39.) “[Discovery of an optimum value
of a result effective variable in a known process is ordinarily within the skill
of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). And, ‘“it is not
inventive to discover the optimum or workable ranges by routine
experimentation.’ In re Aller, 220 F.2d 454, 456 (CCPA 1955). Only if the
‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be
obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620
(CCPA 1977).” In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997).
Appellants have not argued or provided evidence of the criticality of the
claimed thickness range or that the range provides unexpected results
compared with the closest prior art, i.e., the adhesive matrix of Wang, and in
light of the teachings of Wang that indicates that thickness of the adhesive
will have an effect on the release/passage of the agent. While Appellants
have demonstrated a higher release percentage for a polyisobutylene matrix
that is thinner than 0.50, the thickness of Wang’s adhesive material is taught
to be within this range. Thus, it is also not pertinent to the obviousness
analysis that “[njothing in WANG teaches or suggests that the relationship
between release rate and thickness of the matrix (even if different from
polyisobutylene) is not approximately linear” (Reply Br. 5).
Appellants’ arguments concerning unexpected results regarding the
matrix material (Appeal Br. 10—11) are unpersuasive as to the rejection
relying on Wang, just as they were with respect to the rejection relying on
Woeller. That Wang mentions a nonpolar matrix based on synthetic and
natural rubber is a suitable reservoir is immaterial in light of the fact that
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Wang also teaches and exemplifies using a polyisobutylene matrix.
Appellants’ comparative data (set forth in the Specification) regarding
different matrices and their release rates when they include 1% active
ingredient is insufficient to establish unexpected results. Appellants have
simply demonstrated that a PIB matrix described by Wang has better release
characteristics than other matrices known in the prior art. However, such
prior art matrixes as KA, FKF, PAC, and WFG, were not identified as the
closest prior art. In the rejection based on Wang, PIB was identified as the
prior art matrix; Appellants have not provided evidence that the result with
PIB is attributable to anything other than the inherent properties of the PIB
matrix which is the same matrix disclosed by Wang. The recognition of an
inherent latent property “does not render nonobvious an otherwise known
invention.” Baxter, 952 F.3d at 392.
Nor do Appellants even provide objective evidence that the observed
results are unexpected to one having ordinary skill in the art. Attorney
argument is not objective evidence. See Soni, 54 F.3d at 750. And the
Specification does not identify the release result with PIB is unexpected in
light of Wang’s teaching of using the same matrix material with an active
ingredient in a transdermal therapeutic system (see Spec. 5).
For the reasons discussed, we are not persuaded that the Examiner
erred in rejecting claims 28—30, 32—34, 41, and 44 as obvious over Wand
and Torihara.
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Claim 50
Regarding claim 50, Appellants argue that the claimed “carrier
material” is “completely different” from the strippable release liner disclosed
in Wang to have a thickness of 0.076 mm and that the structure in Example
2 demonstrates that the system of Wang does not “consist of’ matrix and
carrier material for the matrix. (Appeal Br. 13—14.) The Examiner appears
to have agreed that the strippable release liner is not equivalent to the
claimed carrier, but the Examiner notes in the Answer that the backing
material is (Ans. 8), and Appellants apparently concede the point. (Reply
Br. 6 (arguing issues with respect to the backing material).) The Examiner
also appears to assert that while Wang is silent about the physical properties
of the backing material, suitable materials are well known in the art and at
least one of those materials would inherently have the qualities claimed, i.e.,
transparent to translucent, and having a thickness below 100 pm (0.1 mm).
(Ans. 8-9.)
To be inherent, the claimed properties of the carrier must necessarily
and inevitably be present in the prior art suitable backing materials. See,
e.g., In re Montgomery, 677 F.3d 1375, 1379—80 (Fed. Cir. 2012). While
the Examiner has not cited references reciting these characteristics for
backing materials used in transdermal delivery systems, we agree with the
Examiner that such materials were known in the prior art.8 “The
8 See, e.g., US 3,731,683 (Ex. I and II (noting the use of cellophane and
mylar sheets as backing material for a transdermal delivery system)); US
4,915,950 (4:37-40 (noting the use of sheet or film of flexible elastomeric
material with a thickness between 0.0005 inches (0.0127 mm) to 0.003
inches (0.0762 mm) as backing layer for a transdermal delivery system)).
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combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results.” KSR Int 7 Co.
v. Teleflex Inc., 550 U.S. 398, 416 (2007). In light of the fact that backing
materials having the claimed properties were indeed known in the art as
asserted by the Examiner, and Appellants have not argued that the backing
provides more than predictable results, we agree with the Examiner that
claim 50 is also obvious.
We are not persuaded by Appellants’ argument that claim 50 is not
obvious because Example 2 of Wang does not describe a transdermal
therapeutic delivery system that “consists of’ the matrix and carrier material,
i.e., the limitation of claim 48, from which claim 50 depends. Wang teaches
that a backing layer is useful in a transdermal therapeutic system to prevent
passage of the agent through to the skin and provides support for the system
if needed. While Example 2 of Wang describes the use of a backing layer
with a release rate-controlling membrane, Wang teaches that the adhesive
itself could serve as the release rate-control. (Wang 3:28—29.) Thus, Wang
teaches a delivery system that “consists of’ the matrix, which serves as a
release rate control, and a carrier material as required. In light of this, we
agree with the Examiner that claim 50 is obvious from the teachings of
Wang and Torihara.
However, because our rationale differs somewhat from the
Examiner’s, we designate our affirmance a new ground of rejection under 37
C.F.R. §41.50(b).
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III. Claims 35, 37, 40, 42, and 43 are obvious
The Examiner finds that, while neither Woeller nor Wang teach the
addition of penetration enhancers generally or isopropyl myristate
specifically, the addition of such a known penetration enhancer in the
transdermal system of Woeller and Torihara or Wang and Torihara would
have been obvious in light of the teachings of Panigrahi. (Final Action 8—
11). In particular, the Examiner finds that Panigrahi discloses a transdermal
drug delivery system and demonstrates that the addition of a penetration
enhancer (which it denotes as “permeation enhancer”) assists permeation
kinetics, and that isopropyl myristate at 2% provides the greatest benefit of
the three ester type enhancers tested. (Final Action 9, 11.) The Examiner
concludes that it would be obvious to select isopropyl myristate from this
finite number of described penetration enhancers with a reasonable
expectation of success. (Id. ) We agree with the Examiner’s factual findings
and conclusion of obviousness.
Appellants’ argue that the Examiner’s rejections of the claims is in
error because “the system with which PANIGRAHI is concerned differs
significantly from the instant transdermal system” and thus there would be
no reasonable expectation of success. (Appeal Br. 15—19.) In particular,
Appellants note that (1) the compound to be transdermally delivered is
terbutaline sulfate—a salt with a bulky amino substituent and an aliphatic
hydroxyl group rather than a nonpolar aliphatic group and (2) the matrix “is
completely different,” being highly polar salts. (Id.) This argument is
unpersuasive.
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Obviousness exists if there is a reasonable expectation of success, In
re O’Farrell, 853 F.2d at 903-04, and as discussed above, “[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, 550 U.S.
at 416. Appellants have not argued that the addition of penetration
enhancers generally, or isopropyl myristate in particular, are unpredictable
with the two different claimed matrices. Moreover, Woeller teaches that the
use of enhancers in transdermal systems to affect the amount of drug
released and duration of activity of a drug from a transdermal drug delivery
system was known. (Woeller 1:50-57.) While it may be true that
Panigrahi’s matrix and compound for delivery are different than what is
disclosed by Wang, Woeller, and Torihara—Panigrabi, nevertheless, teaches
isopropyl myristate is an effective penetration enhancer for an active
ingredient in a transdermal delivery system. In light of the foregoing, we
find the Examiner has established that one of ordinary skill in the art would
have had a reasonable expectation of success in using isopropyl myristate as
a penetration enhancer in the transdermal therapeutic system
Thus, for the reasons discussed, we are not persuaded that the
Examiner erred in rejecting claims 35, 37, 40, 42, and 43 for obviousness
over Woeller or Wang, Torihara and Panigrahi.
IV. Claim 45 is obvious
In addition to the arguments Appellants raised regarding the
deficiency of the combination of Woeller, Torihara, and Panigrahi,
Appellants add that the thickness ranges disclosed in Wang are not of the
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matrix because Wang is overall concerned with the active being present in
the reservoir and not in the matrix. (Appeal Br. 20.) We do not find this
argument persuasive for the reasons discussed above, namely that Wang
teaches that the adhesive polymer matrix can include the active ingredient
(Wang 3:18—27), a point which Appellants concede (Appeal Br. 11).
Consequently, the teachings regarding the adhesive thickness are applicable
to an adhesive that includes the active.
Thus, we are not persuaded that the Examiner erred in maintaining the
rejection of claim 45 as unpatentable over Woeller, Torihara, Panigrahi, and
Wang.
SUMMARY
We affirm the rejection of claims 28, 38, 39, 48, 49, and 51 under 35
U.S.C. § 103(a) as unpatentable over Woeller and Torihara. Because our
reasoning regarding the rejection of claim 51 differs from the Examiner’s,
we designate our affirmance of the rejection of this claim as a New Grounds
of Rejection.
We affirm the rejection of claims 28—30, 32—34, 41, 44, and 50 under
35 U.S.C. § 103(a) as unpatentable over Wang and Torihara. Because our
reasoning regarding the rejection of claim 50 differs from the Examiner’s,
we designate our affirmance of the rejection of this claim as a New Grounds
of Rejection.
We affirm the rejection of claims 35, 37, 42, and 43 under 35 U.S.C.
§ 103(a) as unpatentable over Wang, Torihara, and Panigrahi.
We affirm the rejection of claim 40 under 35 U.S.C. § 103(a) as
unpatentable over Woeller, Torihara, and Panigrahi.
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We affirm the rejection of claim 45 under 35 U.S.C. § 103(a) as
unpatentable over Woeller, Torihara, and Wang.
TIME PERIOD FOR RESPONSE
37 C.F.R. § 41.50(b) also provides that the Appellants, WITHIN
TWO MONTHS FROM THE DATE OF THE DECISION, must exercise
one of the following two options with respect to the new grounds of
rejection to avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate amendment of the
claims so rejected or new Evidence relating to the claims so rejected,
or both, and have the matter reconsidered by the examiner, in which
event the prosecution will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be reheard under
§ 41.52 by the Board upon the same Record. . . .
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. 37 C.F.R, $ 41,501b)
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