Ex Parte SHAH et al

Patent Trials and Appeals Board

Jul 9, 2019

13727739 - (D) (P.T.A.B. Jul. 9, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/727,739 12/27/2012
144293 7590 07/09/2019
McNees Wallace & Nurick, LLC/L'OREAL
100 Pine Street
P.O. Box 1166
Harrisburg, PA 17108-1166
FIRST NAMED INVENTOR
AnilSHAH
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.
OA12522/3 l 710-0008-0l 9791
EXAMINER
BABSON, NICOLE PLOURDE
ART UNIT PAPER NUMBER
1619
MAIL DATE DELIVERY MODE
07/09/2019 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, and KEVIN NIKITCZUK
Appeal2018-007996
Application 13/727,739 1
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 for obviousness and for
obviousness-type double patenting. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We affirm.
STATEMENT OF THE CASE
The invention seeks to provide an improved sunscreen composition
that is an oil-in-water emulsion that "quickly inverts to a water-in-oil
1 Appellants identify the real party in interest as L' Oreal, as well as the
inventors. (Appeal Br. 1.)
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Application 13/727,739
emulsion ... upon rubbing into the skin" and is "pleasing to consumers."
(Spec. ,r 5.)
Claims 1-12 and 14--21 are on appeal. Claims 1 and 19 are
representative 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 0.3, and
wherein the composition does not include any film
forming polymers, 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 0.3
to 0.5, and
wherein the combination of the at least one water-in-oil
emulsifier, the at least one non-ionic oil-in-water emulsifier,
and the at least one ionic surfactant is present in the
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composition in an amount from about 0.9% to about 2.5%, by
weight, based on the total weight of the composition, and
wherein the composition does not include any film
forming polymers, and
wherein the composition is an oil-in-water emulsion that
inverts to a water-in-oil emulsion upon rubbing.
(Appeal Br. 14, 16.)
The following grounds of rejection by the Examiner are before us on
review:
Claims 1, 2, 5-12, and 14--21 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
Claims 1-12 and 14--21 on the ground of non-statutory obviousness-
type double patenting as being unpatentable over claims 1-21 of U.S. Patent
Application 14/655,216, now U.S. Patent 9,918,911. 6
2 Ribier et al., US 5,925,364, issued on July 20, 1999 ("Ribier").
3 Amela Conesa et al., WO 2008/043470 Al, 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, Vol. 7,218
(1999), available at http://app.knovel.
com/hotlink/toc/id:kpCTFVE062/ cosmetic-toiletry-formulations-3.
6 We note that the rejection is no longer considered provisional because the
Application has issued as a US Patent.
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Application 13/727,739
DISCUSSION
This Application has been before us in a prior appeal, Appeal No.
2014-007953, mailed June 13, 2016 (the "Prior Appeal"). The present
claims on appeal differ in two respects from the claims that were previously
on appeal. The first difference goes to the claimed weight ratio of the at
least one non-ionic oil-in-water emulsifier to the at least one water-in-oil
emulsifier. Claim 1 in the prior appeal, identified that weight ratio as being
about 0.2 to about 2.0. (Prior Appeal 2.) Claim 1 presently on appeal
requires the ratio to be about 0.3. Claim 19 presently on appeal requires the
ratio to be about 0.3 to 0.5. The second difference is that the claims on
appeal require that the composition "does not include any film forming
polymers," which was not a limitation at issue with respect to the claims in
the Prior Appeal. The prior art relied upon to reject the pending claims is
the same as that in the Prior Appeal.
I. Obviousness
Claim 1
Claims 1, 19, and 20 have been argued together by Appellants without
comment as to the different limitations of those independent claims.
(Appeal Br. 5-10.) We address Appellants' arguments with respect to
representative claim 1.
Regarding the now claimed weight ratio of water-in-oil emulsifier to
non-ionic oil-in-water emulsifier, the Examiner explains that Ribier provides
example compositions that are not literally within the range of claim 19 or at
about 0.3 as required by claim 1 (see Final Action 13), but Ribier teaches a
"range of 0.45-1.14, which overlaps the range of 0.3---0.5 as called for in
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Claim 19 and is slightly above the range of above 0.3 as called for in claim[]
1" (Final Action 4). The Examiner contends that while "[t]his range is
slightly above the claimed values, ... [it] is understood to satisfy the
limitation of 'about 0.3. '" (Final Action 4.) The Examiner alternatively
finds that "it would have been obvious to one of ordinary skill in the art at
the time of the instant invention to vary the emulsifier concentrations
through routine experimentation to arrive at the concentration of about 0.3 in
order to optimize the resulting product." (Id.) The Examiner explains that
"it is not inventive to discover the optimum or workable ranges by routine
experimentation" where the general conditions of a claim are disclosed in
the prior art. (Final Action 13 (quoting In re Aller, 220 F.2d 454,456
(CCP A 1955).)
Regarding the newly added negative limitation, i.e., that the
composition does not include a film-forming polymer, the Examiner finds
that Ribier does "not teach or require the inclusion of film-forming
polymers, and exemplif[ies] compositions which comprise no film-formers
(e.g. Example 1, 7, 8, among others)." (Id. at 5, 12 ("Ribier et al. do not
require film-formers and exemplify compositions which exclude them.").)
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 5.) The Examiner finds that Amela Conesa teaches oil-in-
water (0/W) emulsions that invert to water-in-oil (W/0) emulsions that have
similar compositional elements to the compositions taught by Ribier. (Id.
(noting that the compositions of Amela Conesa include "an oil component,
w/o emulsifiers, ionic surfactants, and UV filters.").) The Examiner notes
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that Amela Conesa does not teach inclusion of film-formers, though it does
include polymeric stabilizers that are thickeners and rheology modifiers (id.
at 12), but those stabilizers are not taught as "critical to the inversion of the
composition from and 0/W emulsion to a W /0 emulsion" (Ans. 5). The
Examiner explains that Amela Conesa states that "[t]he nature of the anionic
surfactants is more critical ... with respect to stability [ of the emulsion] and
the power to induce a spontaneous phase inversion of the emulsion when
applied to skin" and that acyl glutamates are particularly preferred anionic
surfactants for use. ( Ans. 5 ( quoting Amela Conesa 5: 1-8).) The Examiner
further notes that there is no indication in Amela Conesa that a film forming
polymer is required to achieve a formulation that will invert from an 0/W
emulsion to a W/0 emulsion upon rubbing. (Final Action 12.) The
Examiner further finds that Ribier exemplifies compositions that include
acyl glutamate. (Ans. 5 (citing Ribier Examples 1, 3, 4, 5, 7, and 8).) The
Examiner contends that "[a]s the inversion [of Amela Conesa] appears to be
dependent on the ionic surfactant chosen and Ribier . . . and Amela Conesa
... teach overlapping ionic surfactants, 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." (Ans. 5; see also Final Action 5, 13-14.) The
Examiner explains that one of ordinary skill in the art would have been
motivated in such a formulation "to obtain an emulsion which is stable under
normal storage conditions with improved absorption, reduced tackiness and
improved smoothness," which are properties that Amela Conesa indicate are
achieved by the inversion compositions it teaches. (Final Action 5.)
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We agree with the Examiner's factual findings and conclusion that
claim 1 would have been obvious. "In determining whether the subject
matter of a patent claim is obvious ... [ w ]hat matters is the objective reach
of the claim. If the claim extends to what is obvious, it is invalid under
§ 103." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,419 (2007). We
conclude that the Examiner has adequately established a prima facie case of
obviousness.
As the Examiner indicated, Ribier exemplifies compositions with the
claimed components (see, e.g., Ribier Example 4), including where the ionic
surfactant acyl glutamate is present. Amela Conesa indicates acyl glutamate
is a preferred compound that is critical for stability of a similar emulsion to
Ribier and its power to induce spontaneous phase inversion when applied to
skin. (Amela Conesa 5:1---6).
Ribier also indicates that the relative amounts of lipophilic surfactant,
hydrophilic surfactant, and nonionic amphiphilic lipid can vary "within the
following respective ranges: 35-55%/25--40%/15-35% by weight relative to
their total weight." (Ribier 4: 15-19.) That range includes a ratio of
hydrophilic surfactant to lipophilic surfactant ( or in the terms of the claims
on appeal the ratio of "the at least one non-ionic oil-in-water emulsifier to
the at least one water-in-oil emulsifier") of0.45-1.14. We agree with the
Examiner that the lower limit of 0.45 is about 0.3 as recited in claim 1.
Moreover, we agree with the Examiner that it would have been
obvious to one of ordinary skill in the art to formulate a composition of
Ribier such as the one disclosed in Example 4 that includes the claimed
ingredients with no film former to include a ratio of hydrophilic surfactant to
lipophilic surfactant of 0.45 instead of the demonstrated 0.667 in Example 4
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(a composition which includes the sunscreen agents "PARSOL MCX" AND
"P ARSOL 1789") as a matter of routine optimization in light of Ribier' s
teaching that such a variation is within the skill in the art. "[T]he discovery
of an optimum value of a variable in a known process is normally obvious."
In re Antonie, 559 F .2d 618, 620 (CCP A 1977). Exceptions to this rule
include (1) the results of optimizing a variable were unexpectedly good and
(2) the parameter optimized was not recognized in the prior art as one that
would affect the results. Id. Ribier clearly indicates that the ratio of
hydrophilic surfactant to lipophilic surfactant is an optimizable parameter by
teaching that there is a range for this ratio. And Appellants have not
established with any comparative evidence that optimizing this variable
provides unexpectedly good results.
Rather than provide any comparative testing to demonstrate
unexpected results between Ribier and what is claimed, Appellants argue
instead that one of ordinary skill in the art would not seek to achieve
inversion of Ribier's composition by modifying it according to Amela
Conesa because the principal of operation of Ribier is to have nano scale
fatty phase droplets that are able to penetrate into the intercomeocytic spaces
to deliver the active ingredient. (Appeal Br. 5; Reply Br. 2-3.) According
to Appellants, Ribier teaches away from a formulation such as described
by Amela Conesa. (Appeal Br. 5---6; Reply Br. 3--4.) We do not find
Appellants' argument persuasive because the only modification necessary of
the teachings of Ribier to achieve the claimed composition is to adjust the
weight ratio of the at least one non-ionic oil-in-water emulsifier to the at
least one water-in-oil emulsifier to the low end point taught by Ribier, i.e.,
0.45. According to the Examiner, such an adjustment would render the
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modified composition to have a ratio of about 0.3 of the at least one non-
ionic oil-in-water emulsifier to the at least one water-in-oil emulsifier. 7 The
Examiner relies on Amela Conesa only to indicate that in adjusting the
composition according to Ribier, which composition would include an acyl
glutamate, one of ordinary skill in the art would have reasonably expected
the composition to invert from an 0/W to a W /0 emulsion, irrespective of
Ribier's mode of operation. As will be discussed below, we agree with the
Examiner that one of ordinary skill in the art would have reasonably
expected the composition so formulated with acyl glutamate to invert to a
water-in-oil emulsion upon rubbing.
Appellants' argument that one would not have been motivated to
change Ribier's mode of operation does not address the fact that the
teachings of Ribier suggest a composition whose constitution would,
nevertheless, convert to a W /0 emulsion. That such a property would be
extant is supported by the teachings of Amela Conesa, where it is indicated
that an acyl glutamate as an ionic surfactant in similar composition as that
described by Ribier provides the "critical" component giving stability to the
0/W emulsion but also the "power to induce a spontaneous phase inversion
of the emulsion when applied to the skin." (Amela Conesa 5:3-8.) In light
of this teaching in Amela Conesa, and the Examiner's reliance thereon (Ans.
5), we disagree with Appellants that the Examiner "has not offered any
explanation nor identified any specific ingredients in [Amela] Conesa that
would enable the inversion of Ribier' s composition" (Appeal Br. 6).
7 We note further, that with respect to claim 19, 0.45 is within the range of
about 0.3 to 0.5.
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We also agree with the Examiner that Amela Conesa provides an
incentive for the desire to have a formulation that starts out as an 0/W
emulsion (a positive sensory profile that is also a stable composition) and
inverts to a W /0 emulsion ( obtaining a lipophilic film on the skin surface
much faster than the normal inversion process to provide a water resistance
effect without including waterproof ingredients). (Amela Conesa 2-3.) This
provides a further incentive to modify the ratio of hydrophilic surfactant to
lipophilic surfactant to the lower end point of Ribier.
Appellants argue that modifying Ribier to achieve a composition that
would invert as described in Amela Conesa, however, would go against the
essential teaching of Ribier of requiring small size oily globules. (Appeal
Br. 5, 9-10; Reply Br. 2--4.)8 It is true that Ribier does discuss that the small
size of the fatty phase droplets "greatly facilitate[]" the penetration of the
oily globules into the intercomeocytic spaces. (Ribier 2:52---63, Appeal Br.
5-6.) However, it is also important to Ribier that the active agent be
"transported and delivered to the skin or hair." (Ribier 2:64---66.) We note
that sunscreens are an active agent taught by Ribier, and that sunscreens are
undisputedly effective at providing sun protection whether or not they
achieve penetration into the intercomeocytic space, and instead sit on the
surface of the skin or hair. Ribier indicates that inclusion of nanotitaniums
in the composition "made it possible to obtain sun protection compositions
8 We agree with Appellants scientific argument that if conversion from the
0/W emulsion to W /0 emulsion by rubbing were to occur, then the oil
globules of Ribier would necessarily have to become a continuous phase
thereby eliminating the nanoscale oil globules taught by Ribier. (Appeal Br.
10.)
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which have a higher protection factor." (Ribier 5: 16-20 ( emphasis added).)
Ribier does not, however, teach that if the sunscreen particles do not
penetrate into the intercomeocytic space they will not provide sun
protection. Moreover, Example 4 of Ribier includes parsol, and there is no
evidence of record that parsol is delivered to the intercomeocytic space, or
even that if delivered to the surface of the skin rather than to
intercomeocytic spaces it would not be capable of providing sunblock
protection. Even if nanoscale titanium would provide improved sunblock
protection, Ribier does not teach (Appeal Br. 9) that non-inverted oil-in-
water emulsions in which the oil globules are large would be ineffective at
providing SPF protection when sunscreen active agents are provided in an
oil-in-water emulsion to the surface of the skin.
Appellants argue that the ionic surfactant may not be sufficient to
result in an inversion. (Appeal Br. at 7.) According to Appellants Amela
Conesa teaches inclusion of polymeric stabilizer is required in the
composition and Ribier does not teach inclusion of such a component. (Id.)
We do not find Appellants' argument persuasive to establish non-
obviousness. Amela Conesa does not teach the polymeric stabilizer is
necessary for the inversion. Amela Conesa states that the anionic surfactant
is critical and that acyl glutamate is preferred for an 0/W emulsion to have
the inversion property disclosed in Amela Conesa. (Amela Conesa 5:3-8.)
Furthermore, regarding the stabilizer, Amela Conesa teaches that it is added
after the o/w emulsion is prepared (Amela Conesa 12), thus one of ordinary
skill in the art would expect it to stabilize the 0/W emulsion to prevent
inversion until mechanical energy was applied not that it was critical to
achieve inversion. Moreover, Ribier teaches inclusion of acyl glutamate in
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its composition without including the stabilizer of Amela Conesa and
indicates that such a formulation is a "particularly stable emulsion[]."
Consequently, we conclude that one of ordinary skill in the art taking into
consideration the teachings of both Ribier and Amela Conesa would not
have determined a polymeric stabilizer was a necessary component to
achieve an 0/W emulsion that is stable on application but that would convert
to a W /0 emulsion on rubbing the 0/W emulsion after application.
"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). We
conclude that the teachings of Amela Conesa regarding the preference for
acyl glutamate as the anionic component that is critical for the spontaneous
phase inversion criticality provides evidence of a reasonable expectation of
success that the composition of Ribier with a ratio of hydrophilic surfactant
to lipophilic surfactant of 0.45, which is about 0.3, and including acyl
glutamate would have the property of inverting to a W /0 emulsion upon
rubbing. Appellants' contrary assertion that the acyl glutamate "may" not be
sufficient is attorney argument, which is not evidence, and thus is
insufficient to rebut the Examiner's prima facie case. Icon Health & Fitness
v. Strava, 849 F.3d 1034, 1043 (Fed. Cir. 2017).
Even if "[l]oss of the fatty-phase droplets is the phenomenon that
Ribier is trying to prevent" (Reply Br. 6), Appellants have not established by
scientific reasoning or with other rebuttal evidence that the teachings of
Ribier of a formulation that would fall within the scope of the claim if made,
and which Amela Conesa' s teachings indicate would reasonably be expected
to be a composition that would convert to a W /0 emulsion on rubbing, do
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not render obvious the composition recited by claim 1. Thus, as in the Prior
Appeal, we again affirm the Examiner's rejection of claim 1 for
obviousness.
Claims 2, 5-12, 14--18 and 21 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
Claims 3 and 4
Appellants argue that Flick does not remedy the defect in the
Examiner's rejection of claim 1. (Appeal Br. 11.) We do not find this
argument persuasive as we do not agree with Appellants' that the Examiner
failed to make out a prima facie case of obviousness of claim 1 as set for the
above.
In addition, Appellants argue that Amela Conesa teaches an emulsion
showing a "viscosity according to Brookfield of less than 3,000 mPas
(20 °C, spindle 5, 10 rpm) which allows them to be applied as a spray." (Id.)
( emphasis omitted) Thus, Appellants contend that "it is based on
impermissible hindsight reasoning to rely on Flick to have a viscosity of less
than 450 cps or 100 cps." (Id. 11-12.) The Examiner contends that the
viscosity teaching in Flick for an 0/W lotion for spray application ( e.g., 100
mPas, which is 100 cps) with Amela Conesa's teaching of less than 3,000
mPas for an 0/W emulsion for spray application supports a prima facie case
of obviousness. (Ans. 6-7.) As the Examiner stated, "[o]ne of ordinary skill
in the art would have been motivated to seek out a teaching of an appropriate
viscosity for a sprayable emulsion, and would have predicted success as the
composition of Flick is also an oil-in-water sprayable lotion." (Ans. 7)
Appellants do not respond to the Examiner's position. We agree with the
Examiner for the reasons stated.
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II. Nonstatutory Obviousness-Type Double Patenting
Appellants do not contest the provisional obviousness-type double
patenting rejection. (Appeal Br. 12). Therefore, we summarily affirm the
obviousness-type double patenting rejection. Hyatt v. Dudas, 551 F.3d
1307, 1314 (Fed. Cir. 2008) ("When the appellant fails to contest a ground
of rejection to the Board, ... the Board may treat any argument with respect
to that ground of rejection as waived.").
SUMMARY
We affirm the rejection of claims 1, 2, 5-12, and 14--21 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.
We affirm the rejection of claims 1-12 and 14--21 on the ground of
non-statutory obviousness-type double patenting as being unpatentable over
claims 1-21 of U.S. Patent 9,918,911.
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
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