Ex Parte Yuhas

Patent Trial and Appeal Board

Jan 23, 2017

13655161 (P.T.A.B. Jan. 23, 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.
13/655,161 10/18/2012 Edward Richard Yuhas 1608-004 9371
96056 7590 01/23/2017
Flnrek & F.nHrp.s PT T C EXAMINER
1156 Avenue of the Americas JUSTICE, GINA CHIEUN YU
Suite 600
New York, NY 10036 ART UNIT PAPER NUMBER
1617
MAIL DATE DELIVERY MODE
01/23/2017 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EDWARD RICHARD YUHAS1
Appeal 2015-007369
Application 13/655,161
Technology Center 1600
Before JEFFREY N. FREDMAN, RICHARD J. SMITH,
and TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to methods
of treating psoriasis, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
Appellant’s “invention relates to a method and compositions for
treating psoriasis and other similar skin disorders .... The method
1 Appellant identifies the Real Party in Interest as Anaplasi Pharmaceuticals,
LLC. (App. Br. 3.)
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Application 13/655,161
comprises the topical administration of a composition comprising a sterol
ester.” (Spec. 1:4—6.)
Claims 42—54 are on appeal. Claim 42 is illustrative:
42. A method for treating psoriasis comprising the topical
administration of an unoccluded composition to a psoriatic area
of a patient at least once a day wherein the unoccluded
composition is a mixture consisting of:
(a) about 75 wt% to about 99 wt% of a C10-C30
carboxylic acid cholesterol/lanosterol mixture;
(b) about 0.01 wt% to about 15 wt% of a penetration
enhancer selected from the group consisting of oleyl alcohol,
lauryl alcohol, isopropyl myristate, oleyl oleate, levulinic acid,
glycerol monooleate, methyl laurate, sorbitan monooleate,
triacetin, cetyl alcohol, cetyl lactate, dimethyl isosorbide,
dipropylene glycol, ethyl hexyl lactate, glycolic acid, lauramine
oxide, lauryl betaine, lauryl lactate, lauryl laurate, isopropyl
palmitate, myristyl alcohol, myristal lactate, octyl salicylate,
oleamine oxide, oleic acid, oleyl betaine, salicylic acid, stearyl
alcohol, stearyl lactate, triethanolamine triacetate and
combinations thereof;
(c) about 0.1 wt% to about 10 wt% of a water-insoluble
fdm-forming/polymeric agent selected from the group consisting
of polyalkenes, oleophilic copolymers of vinylpyrrolidone,
acrylic copolymers, polyethylene glycol derivatives, polyolefins,
polyurethanes and mixtures thereof;
(d) about 0 to about 10 wt% of an antioxidant;
(e) about 0 to about 10 wt% of a preservative selected
from the group consisting of propyl paraben, methyl paraben,
benzyl alcohol, benzalkonium chloride, tribasic calcium
phosphate and phenoxyethanol;
(f) about 0 to about 15 wt% of a vitamin; and
(g) optionally a further additive selected from the group
consisting of viscosity increasing agents selected from the group
consisting of natural waxes, synthetic waxes, C12-C60 alcohols,
C12-C60 acids, alpha-hydroxy fatty acids, polyhydroxy fatty acid
esters, polyhydroxy fatty acid amides, metal ester complexes,
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Application 13/655,161
fumed silicas, organoclays, polyol polyesters, glyceryl esters,
polyglyceryl esters, polysiloxanes, gelling agents, hydrogenated
vegetable oils, petroleum based emollients having a chain length
from C10-C100 and mixtures thereof, emulsifiers, humectants, pH
adjusting agents, chelating agents, fragrances and combinations
of the foregoing.
(App. Br. 17 (Claims App’x).)
The claims stand rejected as follows:
Claims 42, 43, 49, and 50—54 under 35 U.S.C. § 103(a) over Mak,2
Zhang,3 and Spann-Wade.4 (“Rejection I”).
Claims 44-48 under 35 U.S.C. § 103(a) over Mak, Zhang, Spann-
Wade, and Szanzer5 (“Rejection II”).
DISCUSSION
Issue
Appellant does not argue the rejection of claims 44-48 (Rejection II)
separately, but rather agrees that the patentability of those claims rises or
falls with claim 42. (App. Br. 9.) We thus address the patentability of
claims 44-48 together with the rejection of claim 42. Appellant also
contends the claims stand or fall together according to the following
additional groupings: claims 49 and 53; claims 43 and 50; claims 51 and 52;
and claim 54. (Id.)
2 Mak et al., US 2002/0182260 Al, published Dec. 5, 2002.
3 Zhang et al., US 2007/0196459 Al, published Aug. 23, 2007.
4 Spann-Wade et al., US 2011/0217248 Al, published Sept. 8, 2011.
5 Szanzer, US 2006/0172022 Al, published Aug. 3, 2006.
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Application 13/655,161
The issue is whether the Examiner established by a preponderance of
the evidence that claims 42—54 would have been obvious over the cited art.
Findings of Fact
FF 1. Mak teaches “methods of treating inflammation of the skin and
mucosal membranes by administering compositions that contain
concentrated inflammation modifiers as active ingredients.” (Mak Abstract.)
Mak teaches “[disorders for which the methods are useful include . . .
psoriasis.” {Id. at 113 and claim 75.) Mak teaches “[t]he formulation will
typically contain the concentrated inflammation modifier, typically in
concentrations in the range from about 0.001% to 100%, preferably, from
about 0.01% to about 50%.” {Id. at 1103.)
FF 2. Mak teaches concentrated inflammation modifiers obtained
from wool fats or lanolin derivatives, including super sterol ester (C10-C30
carboxylic acid cholesterol/lanosterol mixture). (Id. at Fig. 5d and ]Hf 26 and
198—236; see also id. at claims 36 and 37; see also Final Act. 2 and App. Br.
9 n.l.)
FF 3. Mak teaches “[djosage forms for the topical administration of
the concentrated inflammation modifiers . . . including powders, sprays,
ointments, pastes, creams, lotions, [and] gels.” (Mak| 106.) Mak teaches
the topical compositions can be prepared by combining the inflammation
modifier with conventional pharmaceutical diluents and carriers. (Id.) Mak
teaches the composition may include an aqueous or oily base and “suitable
thickening and/or gelling agents” including, among others, “cetostearyl
alcohol, propylene glycol [and] polyethylene glycols.” (Id.) Mak teaches
that various additional ingredients may be included including, inter alia,
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Application 13/655,161
vegetable oils and preservatives such as benzalkonium chlorides. (Id. at
107—110.) Mak further teaches oleic acid may be included as a
penetration enhancer. (Id. at 1167.)
FF 4. Zhang teaches formulations for treating skin disorders such as
psoriasis that “include a drug, a solvent vehicle, and a solidifying agent.”
(Zhang Abstract and 16.) Zhang identifies solidifying agents, including,
among others, polyurethane, acrylic polymers, and polyvinyl pyrrolidone.
(Id. at 157.)
FF 5. Zhang defines the “solvent vehicle” as “compositions that
include both a volatile solvent system and non-volatile solvent system.” (Id.
at 132.) Zhang teaches “the volatile solvent system can including ethanol,
isopropyl alcohol, water, dimethyl ether, butane, [and] propane” among
other compounds. (Id. at 148.) According to Zhang, “[t]oo little of the
volatile solvent system [in the formulation] can make it difficult to spread
the formulation on the skin.” (Id. at 149.)
FF 6. Spann-Wade teaches topical compositions for treating psoriasis
that “comprise[s] a Drug and a solvent system, wherein the solvent system
comprises at least two solvent alcohols .... Exemplary solvent systems are
those for which one of the at least two solvent alcohols is polyethylene
glycol, glycerin,. . . propylene glycol, ethanol, isopropanol, or a derivative
thereof.” (Spann-Wade Abstract; see also id. at || 283—284.) Spann-Wade
discloses embodiments where the compositions are “alkonal-ffee and have at
least one of polyethylene glycol... or a propylene glycol.” (Id. at 1122;
see also id. at H 142—143.)
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FF 7. Spann-Wade teaches compositions including a drug, solvent
system, and other ingredients including, for instance, up to 5% of a
keratolytic agent such as salicylic acid (id. at 1236) and the polymeric film
former tricontanyl PVP (id. at § 253). (Final Act. 5.) Spann-Wade teaches
the “polymeric film former tricontanyl PVP is well known to this art and it
too is available commercially. . . . The concentration of the tricontanyl PVP
polymer formulated into the compositions of the invention advantageously
ranges from about 1% to about 10%.” (Spann-Wade 1253.)
Analysis
We begin with claim construction because it is a necessary
prerequisite to comparing the claims to the prior art.
The claims recite a method of administering an “unoccluded
composition [that] is a mixture consisting of’ certain ingredients. Because
the claims use the closed transitional phrase “consisting of,” which modifies
the “unoccluded mixture,” the claims encompass administering the
unoccluded mixture with the specific ingredients recited — and those
ingredients alone. AFGIndustries, Inc. v. CardinalIG Co., Inc., 239 F.3d
1239, 1245 (Fed. Cir. 2001) (“When a claim uses . . . ‘closed’ transition
phrases such as ‘consisting of [such claims] are understood to exclude any
elements, steps or ingredients not specified in the claim.”). For example,
and as argued by Appellant, ingredients such as “water, ethanol and[/]or
isopropanol [] are excluded from the present claims by the transition phrase
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‘consisting of to describe the claimed unoccluded topical composition.”
(Reply Br. 6.)
The Specification defines “unoccluded” to “refer to a transdermal
formulation that is applied to the skin without the use of a support, backing
member, cover or otherwise associated structure. In other words, the
transdermal formulation is applied to the skin in free form.” (Spec. 5:12—
16.) As examples, the Specification identifies gels, ointments, lotions,
pastes, mousses, aerosols, and creams. {Id. at 18—19.)
Claims 42 and 44-48
Claim 42 is drawn to a method of administering a composition
consisting of three required ingredients, and a number of other ingredients
are optional.6 The first required ingredient is “(a) about 75 wt% to about 99
wt% of a C10-C30 carboxylic acid cholesterol/lanosterol mixture.” The
Specification discloses that this ingredient is commercially available as
“SUPER STEROL ESTER®.” (Spec. 7:7—10.) The remaining two required
ingredients are in elements (b) and (c) of claim 42, which respectively recite
about 0.01 to about 15 wt% of the listed “penetration enhancer[s]” and about
0.1 to about 10 wt% of the listed “film-forming/polymeric agent[s].”
The Examiner rejected claim 42 as obvious over Mak, Zhang, and
Spann Wade. The Examiner finds that Mak teaches topical formulations for
treating psoriasis that include Super Sterol Ester®, and that Mak indicates
the formulations can contain from 0.001 to 100% of the active agent, thus
6 Elements (d), (e), and (f) are optional insofar as the recited range
encompasses 0 wt%. Element (g) expressly states that the listed ingredients
are “optionally” added.
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teaching a mixture having ingredient (a) of claim 42. (Final Act. 2—3.)
According to the Examiner, discovery of the optimum concentration would
have only required routine experimentation of the skilled artisan. (Id. at 4.)
The Examiner further finds that Mak teaches use of auxiliary agents (e.g.,
absorption enhancers, emulsifiers, and thickening agents) in the formulation,
such as cetyl and stearyl alcohol, and oleic acid, thus teaching several of the
penetration enhancers listed in limitation (b) of claim 42. (Id. at 3 4.)
The Examiner finds “[t]he differences between the present method
and the Mak method are that 1) Mak teaches using polyurethane in an
‘occlusive’ dressing formulation; and 2) the composition used in [the
claimed method] has a penetration enhancer and a film forming agent in
defined concentration ranges.” (Id. at 4.) The Examiner thus turns to Zhang
and Spann-Wade. According to the Examiner, Zhang teaches non-occlusive
formulations comprising polymeric agents such as polyurethane (as
solidifying agents) to provide controlled release and desirable flexing and
stretching. (Id. at 4—5.) The Examiner finds Spann-Wade teaches topical
formulations for treating psoriasis that may include, among other
ingredients, a drug and the film-former tricontanyl PVP (an oleophilic
copolymer of vinylpyrrolidone as recited in limitation (c) of claim 42 (Spec.
11:21—22:2)) in a concentration from about 1 to about 10 wt%.7 The
Examiner reasons it would have been obvious to modify the formulation of
Mak to design a composition for anti-inflammatory topical treatment with
7 The Examiner finds that Spann-Wade teaches including up to 5% of
salicylic acid, which is one of the penetration enhancers in the claimed
concentration recited in claim 42.
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the specific additives of Spann-Wade for their known and expected function
and because they are “conventional auxiliary components” known in the art
for use in compositions for treating psoriasis. {Id. at 6.)
Appellant argues “the Examiner’s combination improperly ignores
critical teachings of the cited references.” (App. Br. 10.) According to the
Appellant, “the addition of Zhang and/or Spann-Wade to Mak would not
lead a skilled artisan to the present claimed invention” because the solvent
systems of Zhang and Spann-Wade include ingredients that are excluded
from the scope of claim 42 given its closed format. {Id. at 11 (“the appealed
claims exclude the solvent systems required by Zhang and Spann-Wade”).)
Appellant’s argument is persuasive with respect to Zhang. We agree
that Zhang’s formulation requires a volatile solvent, such as ethanol or
water, which is excluded from the scope of claim 42. (FF 4—5; Reply Br. 6.)
The Examiner responds that claim 42 does not exclude the non-volatile
solvents, such as propylene glycol and polyethylene glycol, of Zhang or
Spann-Wade. (Ans. 2—3.) The Examiner is correct, but the key question is
whether claim 42 encompasses volatile solvents disclosed in Zhang. We are
not persuaded that it does, nor has the Examiner made any findings as to that
question. Instead, the Examiner responds that the volatile solvents are not
critical to Zhang’s formulation and that “the reference clearly teaches that
either volatile or non-volatile solvent can be used.” (Ans. 3 (citing Zhang
Abstract).) We disagree. Upon our reading of Zhang and based on
Appellant’s arguments, the reference appears to clearly require both a non­
volatile and volatile solvent. (FF 4—5; App. Br. 12.) The Examiner has not
shown otherwise and, absent hindsight, we are not persuaded the skilled
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person would have predictably combined Zhang’s solidifying agents with
Mak’s formulation in a mixture that lacked a volatile solvent.
We reach a different conclusion with respect to claim 42 and the
combination of Mak and Spann-Wade.8 Spann-Wade’s solvent system
requires at least two solvent alcohols, and these solvent alcohols may be
polyethylene glycol and propylene glycol. (FF 6—7.) Appellant
acknowledges this teaching in Spann-Wade: “a topical psoriatic composition
would require . . . [options a, b] or c) a combination of polyethylene glycol
and propylene glycol as taught by Spann-Wade.” (App. Br. 12.) Moreover,
“Appellant acknowledges that the viscosity increasing agents [limitation (g)]
recited in the optional Markush grouping of claim 42 could include
polyethylene glycol as taught by Spann-Wade.” (App. Br. 12.) As the
Examiner determined, “humectants of [limitation] (g) include polyols such
as propylene glycol and polyethylene glycols according to appellant’s own
definition in the specification.” (Ans. 2 (citing Spec. 1 54).) Appellant
contends “claim 42 do[es] not include lower alcohols such as propylene
glycol.” (App. Br. 12.) But this is not persuasive as propylene glycol is a
well-known humectant — an optional ingredient recited in claim 42 —
consistent with the Examiner’s finding. Accordingly, even assuming Spann-
Wade required a solvent system that includes polyethylene glycol and
propylene glycol in order to incorporate Spann-Wade’s film-forming
polymer, those ingredients are not excluded from claim 42.
8 See generally, In re Bush, 296 F.2d 491, 496 (CCPA 1961) (the Board may
rely on less than all of the references relied upon by Examiner).
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In Appellant’s Reply Brief, Appellant acknowledges that “Mak
suggests Super Sterol Ester® may be useful in treating psoriasis among
other inflammatory conditions . . . [but Appellant argues Mak] provides no
data confirming” the drug’s efficacy and suggests the condition is not well
understood. (Reply Br. 4.) Appellant also argues “Mak fails to exemplify
any unoccluded topical composition containing more than 50% of a
therapeutic agent and a water-insoluble film-forming polymer as required by
the pending claims.” {Id. at 6.)
These arguments are unpersuasive. Rejections under Section 103 do
not require “data” confirming what is taught or suggested in the references,
nor is the prior art limited to what is “exemplified.” Merck & Co., Inc. v.
Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Insofar as
Appellant is arguing the art exemplified lower concentrations of the active
agent (Super Sterol Ester®) than is recited in the claims and thus supports a
determination of nonobviousness (Reply Br. 5—8), the Examiner found that
the skilled person would have arrived at the claimed ranges through routine
optimization in view of Mak’s teaching that the agent is present in a range of
between 0.001 to 100%. (FF 1; Final Act. 3.) Appellant’s suggestion to the
contrary is untimely new argument, as is Appellant’s argument that Spann-
Wade is deficient because the film-forming polymer is mentioned in a
section related to sunscreens. (Reply Br. 6—7.) 37 C.F.R. § 41.41(a)(2). On
the merits, Appellant fails to provide evidence demonstrating that the
amount of active agent was not a routinely optimizable variable, that the
claimed range supports an unexpected result or other secondary
consideration, because in “cases involving overlapping ranges,. . . [the
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Federal Circuit and its] predecessor court have consistently held that even a
slight overlap in range establishes a prima facie case of obviousness.” In re
Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
For the above reasons, we conclude that the Examiner established by a
preponderance of the evidence that claim 42 would have been obvious over
Mak and Spann-Wade.
Claims 44-489 have not been argued separately and therefore fall with
claim 42. 37 C.F.R. § 41.37(c)(l)(iv).
Claims 49 and 53
Appellant argues the patentability of claims 49 and 53 together. (App.
Br. 14.) Claims 49 and 53 are similar in that limitations (d) and (e) are no
longer optional as in claim 42; at least some antioxidant and preservative
must be included. (App. Br. 18—20 (Claims App’x).) Optional limitation (g)
is also further limited compared to claim 42, and no longer recites a
humectant. Accordingly, Appellant argues “[b]oth claims 49 and 53 exclude
the use of polyethylene glycol which claim 42 includes.” (App. 14.)
The Examiner responds that “the skilled artisan would have had a
reasonable expectation of successfully modifying the Mak invention by
combining Super Sterol Esters with the water-insoluble polymers of Zhang
or Spade-Wade [sic] with non-volatile solvents like polyols.” (Ans. 4.)
We are not persuaded that Mak and Zhang can be properly combined
without Zhang’s volatile solvent as discussed above. On the present record,
we are persuaded that claims 49 and 53 exclude polyethylene glycol and
9 We adopt the Examiner’s findings of fact and reasoning with respect to
Szanzer, which are not disputed on appeal. (Final Act. 6—7; App. Br. 13.)
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propylene glycol — and thus exclude the solvent system of Spann-Wade
discussed above. The Examiner has not provided findings or persuasive
reasoning sufficient to demonstrate that the film-forming polymer of Spann-
Wade would have been predictably included in a mixture with Mak’s active
agent, penetration enhancer, and other ingredients without Spann-Wade’s
solvent system.
For these reasons, we conclude the Examiner did not establish by a
preponderance of the evidence that claims 49 and 53 would have been
obvious over Mak, Zhang, and Spann-Wade.
Claims 43 and 50
Claims 43 and 50 both depend from claim 42 and each requires an
unoccluded mixture where the film-forming polymer of limitation (c) is
polyurethane. (App. Br. 18—20 (Claims App’x).) The Examiner relied on
Zhang for teaching of polyurethane as a film-former in an unoccluded
mixture. (Final Act. 4—5; FF 4.) But because we are not persuaded that
Zhang’s polyurethane film former would have been predictably combined
with Mak’s formulation to produce a composition within the scope of claim
42 (i.e., that excludes Zhang’s volatile solvents), we reverse the Examiner’s
rejection of claims 43 and 50.
Claims 51 and 52
Appellant’s argument that it would not be obvious to use
hydrogenated vegetable oils as in the compositions of claim 51 or 52
because “neither Mak nor a combined reading of Mak, Zhang, and Spann-
Wade teaches the specific use of ‘hydrogenated vegetable oil’ as a viscosity
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increasing agent” (App. Br. 15) is unpersuasive for the reasons explained by
the Examiner. (Ans. 4—5.)
We nevertheless reverse the rejection of claims 51 and 52 based on
the dependency of those claims from claims 49 and 50 respectively.
Claim 54
We reverse the rejection of claim 54 for the reasons above and based
on its dependency from claim 53.
SUMMARY
We affirm the rejection of claim 42 under 35 U.S.C. § 103(a) over
Mak and Spann-Wade.
We affirm the rejection of claims 44^48 under 35 U.S.C. § 103(a)
over Mak, Spann-Wade, and Szanzer.
We reverse the rejection of claims 43 and 49—54.
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).
AFFIRMED-IN-PART
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