Ex Parte SHAH et al

Patent Trial and Appeal Board

Jun 13, 2016

13727739 (P.T.A.B. Jun. 13, 2016)

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.
13/727,739 12/27/2012 Anil SHAH OA12522/31710-0008-01 9791
26587 7590 06/13/2016
MCNEES WALLACE & NURICK LLC
100 PINE STREET
P.O. BOX 1166
HARRISBURG, PA 17108-1166
EXAMINER
BABSON, NICOLE PLOURDE
ART UNIT PAPER NUMBER
1619
MAIL DATE DELIVERY MODE
06/13/2016 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 ANIL SHAH, JEAN-THIERRY SIMONNET,
CARLOS CRISSIEN, SUSAN HALPERN, KEVIN NIKITCZUK1
__________

Appeal 2014-007593
Application 13/727,739
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, JACQUELINE T. HARLOW, 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
sunscreen composition, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
In conventional sunscreen compositions, film formers are
incorporated to add water-resistance properties to the composition. (Spec.

1 Appellants identify the Real Party in Interest as L’Oreal, as well as the
inventors. (Appeal Br. 1.)
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¶ 3). These film-forming ingredients, however, make “the compositions feel
tacky to the user.” (Id.) Water-in-oil emulsion systems are known to enable
active ingredients to reach the stratum corneum and provide water-
resistance, however, they are tacky, greasy, and slow spreading. (Id. ¶ 4.)
The invention seeks to provide an improved sunscreen composition that is an
oil-in-water emulsion that “quickly inverts to a water-in-oil emulsion . . .
upon rubbing into the skin” and is “pleasing to consumers.” (Id. ¶ 5.)
Claims 1–12 and 14–19 are on appeal. Claims 1 and 19, the two
independent claims on appeal, are illustrative and read as follows:
1. A meta-stable photoprotective composition comprising:
at least one water-in-oil emulsifier having a hydrophilic-
lipophilic balance (HLB) of less than 6;
at least one non-ionic oil-in-water emulsifier having an
HLB of greater than 9;
at least one ionic surfactant; and
at least one sunscreen active ingredient;
wherein the weight ratio of the at least one non-ionic oil-
in-water emulsifier to the at least one water-in-oil emulsifier is
about 0.2 to about 2.0, and
wherein the composition is an oil-in-water emulsion that
inverts to a water-in-oil emulsion upon rubbing.
19. A product formed from a meta-stable photoprotective
composition comprising:
at least one water-in-oil emulsifier having a hydrophilic-
lipophilic balance (HLB) of less than 6;
at least one non-ionic oil-in-water emulsifier having an
HLB of greater than 9;
at least one ionic surfactant; and
at least one sunscreen active ingredient;
wherein the ratio of the at least one non-ionic oil-in-water
emulsifier to the at least one water-in-oil emulsifier is about 0.2
to about 2.0, and
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wherein the composition is an oil-in-water emulsion that
inverts to a water-in-oil emulsion upon rubbing.
(Appeal Br. 11, 13.)

The following grounds of rejection by the Examiner are before us on
review:
Claims 1, 2, 5–12, and 14–19 under 35 U.S.C. § 103 as unpatentable
over Ribier2 and Amela Conesa.3
Claims 3 and 44 under 35 U.S.C. § 103 as unpatentable over Ribier,
Amela Conesa, and Flick.5
DISCUSSION
The Examiner finds that Ribier teaches an oil-in water photoprotective
composition as claimed, including the weight ratio of the at least one water-
in-oil emulsifier and the non-ionic oil-in water emulsifier. (Final Action 3–
4.) The Examiner further finds that Ribier, in fact, exemplifies a water-in-oil
emulsifier, a non-ionic oil-in-water emulsifier and an ionic surfactant recited
in the group of such components set forth in claims 9–11, respectively.

2 Ribier et al., US 5,925,364, issued on July 20, 1999 (“Ribier”).
3 Amela Conesa et al., WO 2008/043470 A1, published Apr. 17, 2008
(“Amela Conesa”).
4 The Examiner stated the rejection as claims 1–12 and 14–19 being
unpatentable over Ribier, Amela Conesa, and Flick. However, as
Appellants’ noted (Appeal Br. 8), it is evident that this rejection simply
addressed the additional limitations of dependent claims 3 and 4 that were
not addressed in the discussion of the obviousness of claims 1, 2, 5–12, and
14–19 over Ribier and Amela Conesa. (Final Action 6–7.)
5 Flick, E.W. Cosmetic and Toiletry Formulations, 2nd Edition, Volume 7,
218 (1999), available at http://app.knovel.
com/hotlink/toc/id:kpCTFVE062/cosmetic-toiletry-formulations-3.
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(Ans. 3.) The Examiner notes that while disclosing and exemplifying
compositions including each of the claimed elements, Ribier does not
specify that the compositions invert to a water-in-oil emulsion upon rubbing.
(Final Action 4; see also Adv. Act. 2; Ans. 3.) The Examiner observes with
regard to this inversion function that
the instant Specification does not provide guidance as to what is
necessary for an oil-in-water emulsion which inverts to a water-
in-oil emulsion upon rubbing, other than the statement in
paragraph 0048 “The nature of the ionic surfactants is more
important with respect to stability and the power to induce a
spontaneous phase inversion of the emulsion when applied to
skin.”
(Ans. 3.)
The Examiner finds that Amela Conesa teaches oil-in-water emulsions
that invert to water-in-oil emulsions upon rubbing are not novel. (Final
Action 4; Ans. 4.) The Examiner explains that Amela Conesa teaches the
inversion of such emulsion improves the compositions absorption when
applied but prior to inversion the oil-in-water emulsion is less tacky and is
smoother than a water-in-oil composition would be. (Ans. 4.)
The Examiner finds that the compositions taught by Amela Conesa
that have the inversion capability include an oil component, water-in-oil
emulsifiers, ionic surfactants and UV filters, “much like those of Ribier . . .
and the instant claims.” (Id.) The Examiner further finds that Amela
Conesa teaches “inversion [is] dependent on the ionic surfactant chosen,”
noting that “[t]he nature of the anionic surfactants is more critical . . . with
respect to stability [of the emulsion] and the power to induce spontaneous
phase inversion of the emulsion when applied to skin.” (Ans. 5 (citing
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Amela Conesa 5:1–8).) The Examiner points out that Amela Conesa teaches
that acyl glutamates are particularly preferred anionic surfactants to achieve
the stability and provide for the inversion function. (Ans. 5.)
The Examiner concludes it would have been obvious to formulate the
Ribier composition such that it would “invert to a water-in-oil emulsion as
taught by Amela Conesa.” (Final Action 4; Adv. Act. 2; Ans. 4–5.) The
Examiner explains that “[a]s the composition of Ribier et al. meets the
claimed ingredients in the claimed concentrations it would be expected to
behave similarly to the claimed invention.” (Adv. Act. 2.) According to the
Examiner, one of ordinary skill in the art would have had a reasonable
expectation of success in so formulating the composition of Ribier since “the
[two] formulations [of Ribier and Amela Conesa] are both dermatological
formulations comprising substantially similar ingredients.” (Final Action 5;
Ans. 4–5.) We agree with the Examiner’s factual findings and conclusion
that the claimed meta-stable photoprotective composition would have been
obvious from Ribier and Amela Conesa.
We disagree with Appellants that Ribier teaches away from a meta-
stable composition because Ribier’s compositions are stable on application,
not just shelf stable as the Examiner contends. (Appeal Br. 4–5.) According
to Appellants, Ribier “is clearly describing stabilization in terms of behavior
upon application” because Ribier notes that (a) the prior art describes
emulsions that broke “as soon as they are applied to the skin” and resulted in
deposit of lipophilic active agents that were poorly absorbed, and (b) the
prior art oil-in-water emulsions stabilized “by a lamellar liquid crystal three-
dimensional network” had the problem of the “oil [being] more sequestered
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by the three-dimensional network than genuinely dispersed in the form of
individualized oil microdroplets.” (Appeal Br. 4.) Appellants further
contend that it is evident that Ribier’s formulations are concerned with
stability on application because Ribier teaches that the coated oily globules
are designed to be able to “directly penetrate into the intercorneocytic
spaces,” and thus, “are clearly stabilized through application.” (Appeal Br.
4–5.)
Irrespective of Ribier’s discussion of the problems with the prior art,
we agree with the Examiner that Ribier does not teach away from an oil-in-
water composition that will invert to a water-in-oil composition when
mechanical energy is applied during application of the formulation to the
skin. (Adv. Act. 2; Ans. 3–4.) While it may be true that Ribier describes its
formulations as “particularly stable,” Ribier describes the improvement over
the prior art oil-in-water emulsions to be the formation of an emulsion
having fatty phase droplets, i.e., oily globules, that have an “extremely small
size” that can be transported to the “site [on the skin] where its action will be
the most effective” and that “[o]n account of the small size of the oily
globules, their penetration into the intercorneocytic spaces, which are of
comparable size, is greatly facilitated.” (Ribier 2:20–32, 52–67.) Nothing in
Ribier indicates that if the oil-in-water emulsion formulations taught and
exemplified in Ribier were to invert to water-in-oil formulations by the
application of mechanical energy, such as rubbing the formulation, such
would inhibit either the transportation of the active ingredient to the active
site on the skin where its action will be most effective or the penetration of
the active ingredient into the intercorneocytic spaces. The small size of the
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globules of Ribier facilitates the penetration of the active ingredient into the
intercorneocytic spaces. (Ribier 2:60–63.) Appellants have not argued, nor
do we discern, that the size of the particles would get larger due to the
change in state of the emulsion. Thus, the small size of the globule will exist
whether the coating changes from an oil-in-water coating to a water-in-oil
formulation on application of mechanical energy. Moreover, we do not
discern that the stability of Ribier’s formulation so as to transport the active
ingredient where its action will be most effective would be disturbed by the
formulations ability to invert to a water-in-oil emulsion upon application of
mechanical energy such as rubbing.
As the Examiner explained, “the composition of Ribier [] meets the
claimed ingredients in the claimed concentrations” and indeed exemplifies
“the species recited in claims 9–11 (i.e. sucrose distearate, polysorbate-61,
and sodium stearoyl glutamate).” (Adv. Act. 2; Ans. 3.)6 And, like
Appellants’ Specification (Spec. ¶¶ 48, 63–64), Amela Conesa suggests
inversion would occur with formulations including anionic surfactants such
as acyl glutamates, which Ribier indicates is a preferred anionic surfactant
included in its formulations (and exemplifies in the sunscreen composition).
(Amela Conesa 5:3–7; Ribier 3:47–60, Ex. 7; Ans. 5.) We disagree with
Appellants’ argument that Amela Conesa’s compositions are not equivalent
to Ribier’s such that modifying Ribier in view of Amela Conesa would

6 While the Examiner does not identify where in particular Ribier
exemplifies the use of sucrose distearate, polysorbate-61, and sodium
stearoyl glutamate, we note that Example 7 provides such a composition,
and also includes as part of that composition, a sunscreen active ingredient.
(Ribier 12:1–41.)
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change the composition of Ribier or the principle of operation of Ribier
(Appeal Br. 5–6). In particular, as the Examiner noted, the meta-stable
compositions of Amela Conesa include an oil component. (See, e.g., Ans.
4.) Whether Amela Conesa denominates the oil component as an oil-in-
water emulsifier (Appeal Br. 6) is irrelevant; that is because the list of
suitable oils in Amela Conesa demonstrates the oil component is what
Appellants identify as oil-in-water emulsifiers. (Compare Amela Conesa
3:5–4:2 with Spec. ¶¶ 25–46.) Furthermore, we also disagree that the
formulation of Amela Conesa includes additional polymeric stabilizers that
are not present in Ribier (Appeal Br. 6). Ribier Example 7 includes a
polyacrylate polymer (Carbopol 940) and Amela Conesa discloses that
suitable stabilizers include polyacrylates. (Ribier 12:39; Amela Conesa
11:11–12.) And in any event, even if it were true that Amela Conesa
includes additional polymeric stabilizers not present in Ribier, “[t]he test for
obviousness is not whether the features of a secondary reference may be
bodily incorporated into the structure of the primary reference . . . . Rather,
the test is what the combined teachings of those references would have
suggested to those of ordinary skill in the art.” In re Keller, 642 F.2d 413,
425 (CCPA 1981).
We conclude that the Examiner has established a reasonable
belief that Ribier’s oil-in-water compositions, and particularly the sunscreen
composition disclosed, would be expected to invert upon rubbing. (Adv.
Act. 2; Ans. 2–3.) The Examiner has established, and Appellants do not
disagree, that compositions disclosed and exemplified in Ribier have the
same ingredients as the composition recited in claims 1 and 19, as well as
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being within the ratio of oil-in-water to water-in-oil emulsifier claimed.
Moreover, there is no dispute that Amela Conesa teaches acyl glutamates
have the power to induce a spontaneous phase inversion of an oil-in-water
emulsion of similar composition.
Where . . . the claimed and prior art products are identical or
substantially identical . . . the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product. . . . [The]
fairness [of the burden-shifting] is evidenced by the PTO’s
inability to manufacture products or to obtain and compare
prior art products.

In re Best, 562 F.2d 1252, 1255 (CCPA 1977). We disagree with
Appellants’ argument that the declaration of Jean-Thierry Simonnet7
countermands the Examiner’s prima facie case of obviousness (Appeal Br.
7).
Opinion evidence in declarations has little value without factual
support In re Beattie, 974 F.2d 1309, 1313 (Fed. Cir. 1992). The Simonnet
Declaration fails to provide any experimental or other support for
Simonnet’s opinion (Simonnet Decl. ¶¶ 12, 15) that “the oil-in-water
emulsions” taught by Ribier remain as oil-in-water emulsions, even upon
rubbing. The Declaration does not demonstrate that the opinion as to non-
inversion of the “oil-in-water emulsions in Ribier” or “the compositions
disclosed in Ribier” (Simonnet Decl. ¶¶ 12–13) is commensurate in scope
with the broadly claimed subject matter. In particular, Simonnet does not

7 Declaration of Jean-Thierry Simonnet, dated July 29, 2013.
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address the exemplified sunscreen composition in Ribier, which is
encompassed by the broad claims on appeal here.
Moreover, Simonnet’s opinion which is unsupported by experimental
evidence is undermined by the express teaching of Amela Conesa (relied
upon by the Examiner (Final Action 4; Ans. 5)) that acyl glutamates (ionic
surfactants) have the power to induce a spontaneous inversion of oil-in-
water emulsions that include oil component having the hydrophilic-
lipophilic balance (“HLB”) claimed, a water-in-oil emulsifier having the
HLB claimed, and at least one sunscreen active agent (Amela Conesa 1:11–
13, 2:20–24, 5:1–8, 8:24–10:36), such as described and exemplified in
Ribier. In the absence of experimental evidence supporting Simonnet’s
opinion, we are unable to conclude that actual differences between the
compositions disclosed and exemplified in Ribier and the claimed
composition are established by the declarant’s opinion alone. Thus, we
conclude that the Simonnet Declaration falls short of establishing a
patentable difference between the claims and the compositions taught and
exemplified by Ribier. Cf. In re Wilder, 429 F.2d 447, 451–52 (CCPA
1970) (finding a declaration purporting to show claimed compositions
possess a particular property not disclosed by the prior art was inapposite to
establish the prior art did not describe the claimed composition).
Appellants also contend the Examiner’s rejection was in error because
the “Examiner has failed to provide any discussion or rationale for how
Ribier would be modified in view of Amela Conesa to formulate an
inverting emulsion.” (Appeal Br. 6.) We disagree. The Examiner noted,
“[i]t is obvious to apply a known technique to a known product ready for
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improvement to yield predictable results (see MPEP 2143),” and that “[a]s
the composition of Ribier et al. meets the claimed ingredients in the claimed
concentrations it would be expected to behave similarly to the claimed
invention.” (Adv. Act 2; Ans. 4.) The Examiner concluded “one of ordinary
skill in the art would expect to be able to formulate the composition of
Ribier . . . such that ‘the composition is an oil-in-water emulsion that inverts
to a water-in-oil emulsion upon rubbing’” and is stable under normal
conditions as Amela Conesa teaches. (Final Action 4–5; Ans. 4–5.) For the
reasons discussed, we are not persuaded of Examiner error, and accordingly,
we affirm the Examiner’s rejection of independent claims 1 and 19.
Claims 2, 5–12, and 14–18 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
Claims 3 and 4
Appellants argue the Examiner’s rejection of dependent claims 3 and
4 is improper because Flick does not “correct the deficiencies of Ribier and
Amela Conesa [as to claim 1].” (Appeal. Br. 8.) Because we found
Appellants’ arguments unpersuasive as to claim 1, we affirm the Examiner’s
rejection of claims 3 and 4.
SUMMARY
We affirm the rejection of claims 1, 2, 5–12, and 14–19 under
35 U.S.C. § 103 as unpatentable over Ribier and Amela Conesa.
We affirm the rejection of claims 3 and 4 under 35 U.S.C. § 103 as
unpatentable over Ribier, Amela Conesa, and Flick.
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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).

AFFIRMED