Ex Parte Lou et al

Patent Trial and Appeal Board

May 3, 2016

12784046 (P.T.A.B. May. 3, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
121784,046 05/20/2010 AnjingLou
201 7590 05/05/2016
UNILEVER PATENT GROUP
800 SYLVAN A VENUE
AG West S. Wing
ENGLEWOOD CLIFFS, NJ 07632-3100
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
J9140US 8024
EXAMINER
HIRT,ERINE
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
05/05/2016 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):
patentgroupus@unilever.com
pair_unilever@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANJING LOU and QIANG QIU
Appeal2013-010634
Application 12/784,046
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
r-T"I .. • • .. 1 .. ,..... ,_ TT r'1 I'\ l\ -1,..... Al • "1 • "1 • , ims 1s an appear unaer j) u.~.L. s U4 mvo1vmg crnnns to a
chaotrope and active additive, a composition, and a method for treating skin.
The Examiner rejected the claims as failing to comply with the enablement
requirement and as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as Conopco, Inc.
d/b/a ULILEVER (see Br. 3).
Appeal2013-010634
Application 12/784,046
Statement of the Case
Background
"One of the main disadvantages in topical active delivery is low
and/or slow penetration of active via transdermal delivery" (Spec. 1 ). "[T]he
invention is directed to a topical composition comprising a chaotrope and an
active whereby the chaotrope surprisingly results in better transdermal
delivery of the active while at the same time enhancing the efficacy of the
active" (Spec. 2).
The Claims
Claims 1-17 are on appeal. Independent claim 1 is representative and
reads as follows:
1. A chaotrope and active additive comprising:
(a) a chaotrope represented as:
NR.,
""
and optionally a chaotrope represented as:
0
!! I<· ;1
where each R is independently H, C1-10 alkyl or aryl
and A- is a halide; and
(b) an active
wherein the chaotrope of Formula I comprises
guanidinium chloride to enhance transdermal delivery
of the active, the chaotrope of Formula II comprises
urea and the active comprises self-tanning agent
comprising dihydroxyacetone.
2
Appeal2013-010634
Application 12/784,046
The Issues
A. The Examiner rejected claims 15 and 16 under 35 U.S.C. § 112, first
paragraph for failing to satisfy the enablement requirement (Final Act. 2-5).
B. The Examiner rejected claims 1-17 under 35 U.S.C. § 103(a) over
Fares,2 Van Duzee,3 and Elden4 (Final Act. 8-11).
A. 3 5 U.S. C. § 112, first paragraph
The Examiner finds that "[t]he specification, while being enabling for
applying the composition to the skin, does not reasonably provide
enablement for treating skin" (Final Act. 2).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that the claims fail to comply with
the enablement requirement for the full scope of the claimed invention?
Findings of Fact
Breadth of the claims
1. Claim 15 is directed to " [a] method for treating skin comprising
the step of topically applying to the skin the composition of claim 7 to color
the skin."
Presence of Working Examples
2. Example 3 of the Specification teaches that
[t]he ingredients below were added to formulations having
2.5% by weight DHA and the base of Example 1 as a
balance .... The pig skin used was treated as described
below .... The results ... unexpectedly show that skin
darkening was enhanced when DHA was applied to pig skin
2 Fares et al., US 2008/0299156 Al, published Dec. 4, 2008.
3 Van Duzee, US 4,246,285, issued Jan. 20, 1981.
4 Elden, US 5,814,659, issued Sept. 29, 1998.
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Appeal2013-010634
Application 12/784,046
(2mg/cm2) in a formulation comprising the chaotrope of this
invention.
(Spec. 19).
Amount of Direction or Guidance Presented
3. The Specification teaches that "[i]n a preferred embodiment ...
the active used in this invention is a self-tanning agent" (Spec. 4).
4. The Specification teaches "self tanning agents like
dihydroxyacetone [DHA], melanin, mahakanni (eclipta alba), methyl
glyoxal, erythrulose, alloxan and 2,3-dihydroxysuccindialdehyde" (Spec. 6).
State of the Prior Art and Unpredictability of the Art
5. The Examiner finds that "[t]he art however is unpredictable.
As illustrative of the state of the art, the [E]xaminer cites Elden (US
5,814,659)" (Final Act. 4).
Quantity of Experimentation
6. The Examiner finds that "no one skilled in the art would accept
the assertion that the instantly claimed agents could be predictably used as
therapeutic agents as inferred by the claim and contemplated by the
specification" (Final Act. 4--5).
Skill in the Art
7. The Examiner finds that "[t]he relative skill of those in the art is
high, that of an MD or Ph.D." (Final Act. 4).
Principles of Law
Factors to be considered in determining whether a disclosure
would require undue experimentation ... include (1) the
quantity of experimentation necessary, (2) the amount of
direction or guidance presented, (3) the presence or absence
of working examples, (4) the nature of the invention, (5) the
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Appeal2013-010634
Application 12/784,046
state of the prior art, ( 6) the relative skill of those in the art,
(7) the predictability or unpredictability of the art, and (8)
the breadth of the claims.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Analysis
We begin by interpreting claim 15, which requires "treating skin
comprising the step of topically applying to the skin the composition of
claim 7 to color the skin." That is, claim 15 is not broadly open to any
treatment whatsoever, but is narrowly tailored to specific treatments that use
the composition of claim 7 to effect coloration of the skin. We therefore
conclude that the Examiner's interpretation of claim 15 as encompassing
treatments of disease in general and encompass the use of any active agents
whatsoever is unreasonable in light of the specific language of claim 15 and
in light of the specific teachings of the Specification regarding tanning.
"The protocol of giving claims their broadest reasonable interpretation
during examination does not include giving claims a legally incorrect
interpretation. This protocol is solely an examination expedient, not a rule of
claim construction." In re Skvorecz, 580 F.3d 1262, 1267 (Fed. Cir. 2009).
Claim 15 is therefore properly interpreted as limited to treating skin
with the composition of claim 7 in order to color the skin, not to obtain any
other effect whatsoever.
As we balance the Wands factors with a properly interpreted claim 15,
we conclude that the narrow breadth of claim 15 as limited to treatment of
skin in order to color the skin (FF 1 ), working examples demonstrating
tanning of the skin (FF 2), specific guidance on how to tan skin (FF 3--4) and
unpersuasive evidence of unpredictability and quantity of experimentation
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Application 12/784,046
(FF 5---6) combined with a high level of skill (FF 7) supports a finding of
enablement for claims 15 and 16.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that the claims fail to comply with the enablement requirement.
B. 35 U.S.C. § 103(a)
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that Fares, Van Duzee, and Elden
render claims 1 and 15 obvious?
Findings of fact
8. Fares teaches "a skin care composition comprising (a) at least
one high internal phase emollient-in-water emulsion; (b) at least one fatty
compound, capable of forming a liquid crystal; ( c) at least one thickening
agent; (d) at least one active agent; and (e) water" (Fares Abstract).
9. Fares teaches that "[t]he composition of the present invention
may also contain a self-tanning active agent. Suitable self tanning agents
include, but are not limited to ... dihydroxyacetone (DHA)'' (Fares i-f 38).
10. Fares teaches that "[s]uitable anti-wrinkle active agents for use
in the compositions of the present invention include, but are not limited to
... urea" (Fares i-f 32).
11. Van Duzee teaches that "[t]he compositions of this invention
consist essentially of guanidine inorganic salts and a cosmetically acceptable
vehicle capable of delivering the guanidine to the skin .... Examples of
suitable guanidine inorganic salts are ... guanidine hydrochloride" (Van
Duzee, col. 1, 1. 58 to col. 2, 1. 1 ).
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Application 12/784,046
12. Example 1 of Van Duzee teaches that "[t]he following skin
conditioning solution is tested for its effect upon skin:
~py.!ett~ !l~·cc.1 l4%
l'\:il;0 h)·!e.riri~ 5'%
__ w_.sw_• ______ ..:.:ba..:.:;i:.nc;;;;;:)I: __ .,,
(Van Duzee, col. 5, 11. 42-50).
13. Elden teaches "a topical analgesic composition comprising an
analgesic agent, an alcohol, a chaotropic agent and an unsaturated fatty acid"
(Elden, Abstract).
14. Elden teaches that "[a]gents that break up dense
macromolecular and lipid-rich domains are known as chaotropic agents. In
cosmetology, their activity is the basis for improved hydration and
moisturization of otherwise rough, scaly and dry skin" (Elden, col. 3, 11. 45-
50).
15. Elden teaches that "[u]rea, substituted ureas ... are known
chaotropic agents .... A pharmaceutically acceptable chaotropic agent of
this type plays an important role in facilitating penetration of the analgesic
agent into the skin" (Elden, col. 4, 11. 8-16).
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR!nt'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability." Id. at 417.
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Application 12/784,046
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 7-11; FF 8-15) and agree that
the claims are rendered obvious by Fares, Van Duzee, and Elden. We
address Appellants' arguments below.
Appellants contend that "Fares is silent regarding guanidinium salts in
particular and thus cannot render Appellants claims obvious under§ 103(a)"
(Br. 10). Appellants contend that "Van Duzee is silent regarding any
additional role of guanidine beyond a skin conditioning agent and certainly
no role in enhancing the efficacy of any functional ingredient, let alone a
self-tanning active" (Br. 11 ). Appellants contend that "Elden is silent
regarding the influence, if any, on the penetration of an analgesic produced
by a cheotropic [sic] agent used on its own" (Br. 11 ).
We are not persuaded. Fares teaches compositions that may include
self-tanning agents such as dihydroxyacetone (FF 8-9) and adjuvants such
as urea (FF 10), while Van Duzee demonstrates guanidine hydrochloride
was a known chaotrope useful in skin preparations (FF 11-12). These
teachings, when combined with Elden's suggestion to use chaotropic agents
to assist in delivery of active agents to the skin and skin hydration (FF 14--
15) provide specific reasons to form the claimed composition (cf Ans. 6).
That is, the ordinary artisan would have expected, based on the teachings of
Elden, that chaotropes would assist in delivery of active agents such as
dihydroxyacetone into the skin (FF 8-15). "Non-obviousness cannot be
established by attacking references individually where the rejection is based
upon the teachings of a combination of references .... [The reference] must
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Application 12/784,046
be read, not in isolation, but for what it fairly teaches in combination with
the prior art as a whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir.
1986) (citing In re Keller, 642 F.2d 413, 425 (CCPA 1981)).
Appellants "submit that a person of ordinary skill in the art having
Fares, Van Duzee and Elden before him or her, without the benefits of
hindsight, would not have been lead to Appellants' claimed invention" (Br.
12).
We are not persuaded. While we are fully 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, Fares alone expressly suggests the use
of both the chaotrope urea and the self-tanning agent dihydroxyacetone in
skin care compositions (FF 8-10). As already noted, Elden provides specific
reasons for incorporating chaotropes such as urea or guanidine into skin care
compositions (FF 14--15). Thus, the evidence does not indicate hindsight,
but rather a "strong case of obviousness based on the prior art references of
record. [The claim] recites 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).
Appellants contend that the "combination of references thus would
not have provided the skilled person with any inkling that guanidium [sic]
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Appeal2013-010634
Application 12/784,046
salts would have provided the significant potentiation of DHA in self-
tanning which Appellants have discovered" (Br. 12-13).
We are not persuaded because Elden specifically teaches that
"pharmaceutically acceptable chaotropic agent of this type plays an
important role in facilitating penetration of the ... agent into the skin" (FF
15). Thus, rather than unexpected, the finding that the use of a chaotropic
agent increases penetration of the active tanning agent into the skin would
have been expected based upon the teachings of Elden. See In re Skoner,
517 F .2d 94 7, 9 50 ( CCP A 197 5) ("Expected beneficial results are evidence
of obviousness of a claimed invention. Just as unexpected beneficial results
are evidence ofunobviousness.")
Appellants further contend regarding claims 15 and 16 that "[ n ]one of
these references specifically relate to a method of self-tanning and none of
the references alone or in combination teach or suggest any route to enhance
the extent and rate of self-tanning actives in general and DHA in particular"
(Br. 13).
We are not persuaded because Fares teaches that "[t]he composition
of the present invention may also contain a self-tanning active agent.
Suitable self tanning agents include, but are not limited to ...
dihydroxyacetone (DHA)'' (FF 9). Thus, contrary to Appellants' argument,
Fares expressly suggests self-tanning, while Elden teaches methods of
enhancing penetration of actives into skin (FF 15).
Conclusion of Law
The evidence of record supports the Examiner's conclusion that Fares,
Van Duzee, and Elden render claims 1 and 15 obvious.
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Application 12/784,046
SUMMARY
We reverse the rejection of claims 15 and 16 under 35 U.S.C. § 112,
first paragraph for failing to satisfy the enablement requirement.
We affirm the rejection of claims 1and15 under 35 U.S.C. § 103(a)
as obvious over Fares, Van Duzee, and Elden. Claims 2-14, 16, and 17 fall
with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
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
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