Ex Parte Vishnupad et al

Board of Patent Appeals and Interferences

Nov 29, 2010

11198613 (B.P.A.I. Nov. 29, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte MOHAN VISHNUPAD
and
NAOMI VISHNUPAD,
Appellants1
____________________

Appeal 2010-009337
Application 11/198,613
Technology Center 1600
____________________

Before CAROL A. SPIEGEL, TONI R. SCHEINER, and
LORA M. GREEN, Administrative Patent Judges.

SPIEGEL, Administrative Patent Judge.

DECISION ON APPEAL2

1 The real party in interest is IMAGINATIVE RESEARCH ASSOCIATES,
INC. (Brief on Appeal filed 21 December 2009 ("Br.") at 2). This decision
also cites to the Office action mailed 21 July 2009 ("FR") and the
Examiner's Answer mailed 19 March 2010 ("Ans.").
2 The two-month period for filing an appeal or commencing a civil action, as
recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited
in 37 C.F.R. § 41.52, begins to run from the "MAIL DATE" (paper delivery
mode) or the "NOTIFICATION DATE" (electronic delivery mode) shown
on the PTOL-90A cover letter attached to this decision.
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2
Appellants appeal under 35 U.S.C. § 134(a) from an Examiner's final
rejection of claims 1, 3, 4, 6-10, 12, and 21 (Br. 2; Ans. 2). Claims 5, 11,
13-20, and 22, the only other pending claims, have been withdrawn from
consideration (id.). We have jurisdiction under 35 U.S.C. § 134. We
AFFIRM.
I. Statement of the Case
The subject matter on appeal is directed to an apparatus and an
emulsion comprising a first composition containing a retinoid, an anhydrous
alcohol, and an ester and a second composition containing benzoyl peroxide.
Claims 1 and 7, the only independent claims on appeal, are illustrative and
read (Br. 18-19):
1. An apparatus comprising: a first chamber
containing a first composition, the first
composition comprising a retinoid selected from
retinoic acid, retinyl palmitate, retinyl propionate,
retinyl acetate, tretinoin, isotretinoin, motretinide,
adapalene, tazarotene, azelaic acid and synthetic
retinoid mimetics, an anhydrous alcohol selected
from anhydrous ethanol, anhydrous isopropanol
and mixtures thereof, and an ester, wherein the
amount of anhydrous alcohol is insufficient alone
to solubilize the retinoid; a second chamber
containing a second composition comprising
benzoyl peroxide; means for selectively
interconnecting the first and second chambers to
allow mixing of the first and second compositions;
and at least one outlet for dispensing a mixture of
the first and second compositions.

7. An emulsion comprising: an aqueous phase
containing benzoyl peroxide; and a non-aqueous
phase containing a solution containing a retinoid,
an anhydrous alcohol and an ester, wherein the
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amount of anhydrous alcohol is insufficient alone
to solubilize the retinoid.

In response to an election of species requirement in the Office action
of September 21, 2007, Appellants elected tretinoic acid as the retinoid,
anhydrous ethanol as the anhydrous alcohol, and alkyl benzoate as the ester.
Thus, apparatuses and emulsions including these three species are before us.
The Examiner finally rejected
I. claims 1, 3, 4, 6-10, 12, and 21 as unpatentable under 35 U.S.C.
§ 103(a) over Vishnupad3 in view of Dascalu,4
II. provisionally rejected claim 1 on the ground of nonstatutory
obviousness-type double patenting over claims 1, 7, 9, and 11 of application
10/151,417 in view of Dascalu, and
III. provisionally rejected claim 1 on the ground of nonstatutory
obviousness-type double patenting over claims 1-3 and 7 of application
11/339,650 in view of Dascalu (FR 2-5).
The Examiner withdrew provisional rejection II in view of the
abandonment of application 10/151,417 (Ans. 3). We summarily affirm
provisional rejection III since Appellants have not appealed the rejection (Br.
4; Ans. 6-85). We also affirm rejection I for the reasons discussed below.

3 US 2002/0193321 A1, Dual Dispenser for Aesthitically [sic] Acceptable
Delivery of Anhydrous Skin Treatment Compositions, published 19
December 2002, by Vishnupad et al. ("Vishnupad").
4 US 2004/0202725 A1, Compositions for the Treatment of Pilosebaceous
Gland Inflammations Comprising Aluminum Fluoride, published 14 October
2004, based on Application 10/490,600, filed 2 October 2002, by Avi
Dascalu ("Dascalu").
5 We note that the Examiner restated this rejection as "Claim 1 is
provisionally rejected on the ground of nonstatutory obviousness-type
double patenting as being unpatentable over claims 7 of copending
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The Examiner found that Vishnupad teaches a substantially anhydrous
first composition comprising a retinoid, a polar solvent, a thickening agent
which may be alkyl benzoate, and a cosolvent such as ethanol and an
aqueous second composition containing a benzoyl peroxide-containing
cream, lotion, gel, or suspension (Ans. 4). The Examiner found that
Vishnupad also teaches a dual dispenser containing the first and second
compositions in separate first and second chambers and having one or more
outlets for simultaneously dispensing the first and second compositions (id.).
The Examiner reasoned that when one outlet simultaneously dispensed the
first and second compositions, there must be a space for the compositions to
mix and, therefore, the limitation of a "means for selectively interconnecting
the first and second chambers to allow mixing of the first and second
compositions" is met by a device with one outlet (id.). The Examiner further
found that Vishnupad's second composition, which may be an emulsion,
"provides the hydration necessary to release the active ingredients in the
anhydrous composition and make the active ingredient readily available to
the skin …" (id. at 5). Thus, the Examiner determined that Vishnupad
differed from the claimed invention in failing to teach tretinoic acid as the
active retinoid ingredient (id.).
The Examiner relied on Dascalu solely to show that tretinoic acid is a
topical retinoid and concluded that it would have been obvious to use
tretinoic acid as the retinoid in the first composition of Vishnupad (id.). The
Examiner further concluded that it would have been obvious to use
anhydrous ethanol as the ethanol co-solvent in the first composition of

Application Vishnupad et al. (11/339,650) in view of Dascalu (US
2004/0202725)" on page 6 of his Answer.
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Vishnupad in view of Vishnupad's teaching that the first composition is
anhydrous or substantially anhydrous (id. at 6). According to the Examiner,
"[a] co-solvent, also referred to as an indirect solvent or latent solvent, is
generally added in small amounts to enhance the solvent power of a mixture.
As such, the artisan would reasonably expect it to be insufficient alone as a
solvent. Polyethylene glycol, for example, is the solvent for the first
composition of Vishnupad …" (id. at 8).
Appellants argue that there is no disclosure of the recited anhydrous
alcohols as a solvent for retinoid in Vishnupad (Br. 7, 13) or of combining
anhydrous ethanol with an ester (id. at 8, 14). Appellants point out that the
aqueous compositions of Examples 11-14 of Vishnupad contain an alcohol
but not ester (id. at 8, 14). Appellants reiterate that Vishnupad never
mentions anhydrous ethanol or gives any amounts for the optional co-
solvents or provides any discussion of the solubility of retinoid in ethanol (id.
at 9, 14-15). Thus, Appellants contend that the Examiner used improper
hindsight to arrive at the claimed invention (id. at 10-11).
As to claim 7 specifically, Appellants further argue that, while
Vishnupad discloses that one of its two compositions can be an emulsion,
the Examiner has not established that Vishnupad discloses a single emulsion
composition containing both retinoid and benzoyl peroxide (id. at 12). To
wit, "the Examiner has pointed to no specific disclosure in Vishnupad
regarding mixing or formation of an emulsion" (id. at 13).
Finally, Appellants argue that Dascalu fails to remedy the deficiencies
of Vishnupad (id. at 9, 12, 15).
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Since Appellants have not separately argued any of the dependent
claims, we decide this appeal on the basis of independent claims 1 and 7.6
37 C.F.R. § 41.37(c)(1)(vii). At issue is whether the record supports the
Examiner's conclusion that the combined references would have made the
claimed apparatus and emulsion of claims 1 and 7 prima facie obvious.
II. Findings of Fact
The following findings of fact ("FF") are supported by a
preponderance of the evidence of record.
[1] Vishnupad discloses, "[i]n one … embodiment, a dual dispenser
contain[ing] i) multiple doses of an anhydrous first composition that
includes a polar solvent, a water-sensitive active ingredient and a
thickening agent; and ii) multiple doses of a second composition
selected from the group consisting of aqueous solutions, aqueous
suspensions, oil-in-water emulsions and water-in-oil emulsions"
(Vishnupad ¶ 9).
[2] Vishnupad's dual dispensers include first and second chambers
containing the first and second compositions, respectively, and "one
or more outlets for simultaneously dispensing the first and second
compositions" (id. at ¶ 18).
[3] Vishnupad defines "the term 'substantially anhydrous' … [to mean]
that, other than water of hydration contained in the various
components used to formulate the composition, no free water is added
to the composition. … [M]ost preferably, [the water content of the

6 We note in passing that dependent claim 12 recites "An apparatus as in
claim 7 …." However, claim 7 recites "An emulsion …." Therefore, for
purposes of this decision we group dependent claim 12 with independent
claim 1.
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composition is] less than about 1% by weight of the composition" (id.
at ¶ 20).
[4] Suitable active ingredients for the first composition include retinoids
(id. at ¶ 21).
[5] Useful polar solvents include polyols, such as propylene glycol (id. at
¶ 24).
[6] "The second composition provides the hydration necessary to release
the active ingredients in the anhydrous composition and make the
active ingredient readily available to the skin. Secondly the end
product aesthetics can be easily controlled by the formulation of the
aqueous emulsions and gel" (id. at ¶ 30).
[7] Benzoyl peroxide may be incorporated into the second composition as
to provide effective anti-acne treatment (id. at ¶ 32).
[8] "The first and second compositions preferably have viscosities that are
similar to provide a cosmetically elegant product when the first and
second compositions are simultaneously dispensed" (id. at ¶ 33).
[9] "Depending on the design of the dosing head, the compounds can be
dosed … in just one stream" (id. at ¶ 38).
[10] In addition, either of the first or second compositions "may contain
one or more co-solvents, such as ethanol …" (id. at ¶ 34).
[11] Examples 1-10 of Vishnupad are exemplary of substantially
anhydrous compositions suitable for use as the first composition (id.
at ¶ 41).
[12] The Examiner explicitly found that "Example 5 contains propylene
glycol (solvent), vitamin A (retinoid), and C Alkyl Benzoate (ester)"
(Ans. 4).
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[13] Examples 11-14 of Vishnupad are exemplary benzoyl peroxide-
containing formulations suitable for use as the second composition to
be dispensed simultaneously with any of the anhydrous formulations
of Examples 1-10 (Vishnupad ¶ 42).
[14] According to Vishnupad, blending sticky anhydrous polar gels with
aqueous compositions at the time of use overcomes aesthetic
negatives and provides consumer-acceptable cosmetic skin treatment
products (id. at ¶ 13).
[15] Dascalu discloses exemplary compositions useful for treating acne
vulgaris and folliculits, including topical retinoids, such as tretinoic
acid (Dascalu ¶¶ 38, 42).
III. Discussion
A. Legal principles
"The combination of familiar elements according to known methods is
likely to be obvious when it does no more than yield predictable results."
KSR Int'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. Moreover, the obviousness analysis is not limited
to the explicit disclosures in prior art publications, but must also take
account of what an ordinary artisan would reasonably infer from those
disclosures. Id. at 418. Thus, a reference disclosure is not limited only to its
preferred embodiments, but is available for all that it discloses and suggests
to one of ordinary skill in the art. In re Lamberti, 545 F.2d 747, 750 (CCPA
1976). Furthermore, skill in the art is presumed. In re Sovish, 769 F.2d 738,
743 (Fed. Cir. 1985). "A person of ordinary skill is also a person of ordinary
creativity, not an automaton." KSR, 550 U.S. at 421. Finally,
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[a]ny judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level
of ordinary skill at the time the claimed invention was made
and does not include knowledge gleaned only from applicant's
disclosure, such a reconstruction is proper.

In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971).
B. Analysis
Appellants argue that neither Vishnupad nor Dascalu teach or suggest
the first composition recited in claims 1 and 7, i.e., a non-aqueous
composition comprising (1) a retinoid, (2) an ester, and (3) an anhydrous
alcohol in an amount insufficient alone to solubilize the retinoid.
However, Vishnupad expressly discloses an anhydrous first composition
containing a water-sensitive agent, such as a retinoid, a polar solvent, a
thickening agent, and an optional ethanol cosolvent (FF 1, 4, 10). While
illustrative Example 5 of Vishnupad does not contain an optional cosolvent,
the Examiner found that it does disclose a composition containing a retinoid,
a polar solvent, and an alkyl benzoate ester (FF 12). Thus, we agree with the
Examiner that since Vishnupad teaches that its first composition, such as
exemplified in Example 5, is substantially anhydrous and may contain a
cosolvent such as ethanol (FF 1, 3, 10), it would have been obvious to one of
ordinary skill in the art to add an anhydrous ethanol cosolvent to the first
composition because "[a] co-solvent … is generally added in small amounts
to enhance the solvent power of a mixture" (Ans. 8).
We also agree with the Examiner that one of ordinary skill in the art
would have reasonably expected that an anhydrous ethanol cosolvent present
in Vishnupad's first composition would be reasonably be expected to be
present in an amount insufficient alone to solubilize the retinoid. Vishnupad
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clearly teaches using a polar solvent, e.g., a polyol, as the primary and, in
some embodiments, the only solvent for the water-sensitive active ingredient
(FF 5, 10). Thus, based not only Vishnupad's disclosure, but also the
uncontested definition of a "co-solvent" provided by the Examiner, an
ordinary artisan would have reasonably inferred that anhydrous ethanol
present in the first composition of Vishnupad as a co-solvent would be
present in an amount insufficient alone to solubilize the active ingredient.
KSR, 550 U.S. at 418.
Therefore, Appellants' argument that the applied prior art fails to teach
or suggest the first composition recited in claims 1 and 7 is unpersuasive.
Appellants further argue that neither Vishnupad nor Dascalu relate to
an emulsion containing retinoid and benzoyl peroxide or to an emulsion
comprising the nonaqueous phase recited in claim 7 (Br. 12). In particular,
Appellants contend that Vishnupad's dual dispenser does not provide a
mixing of the first and second compositions (id. at 13).
However, the Examiner has provided a rational basis for concluding
that Vishnupad's dispenser does provide for mixing of the first and second
compositions. Specifically, Vishnupad's dual dispensers include first and
second chambers containing the first and second compositions, respectively,
and one or more outlets for simultaneously dispensing the first and second
compositions (FF 2), e.g., "in just one stream" (FF 9). Thus, the Examiner
reasoned that when one outlet simultaneously dispensed the first and second
compositions there must be a space for the two compositions to mix (Ans. 4).
Appellants have not proffered evidence to the contrary. Rather, Vishnupad's
disclosure of "simultaneous" dispensing the two compositions "in just one
stream" lends support to the Examiner's conclusion. We note that the
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apparatus of claim 1 simply requires a "means … to allow mixing of the first
and second compositions."
Claim 7, on the other hand, recites "an emulsion" comprising an
aqueous phase containing benzoyl peroxide and a nonaqueous phase
containing a solution containing a (tretinoic acid) retinoid, an anhydrous
(ethanol) alcohol, and an (alkyl benzoate) ester, wherein the amount of
anhydrous ethanol is insufficient alone to solubilize the retinoid. For the
reasons given above, the combined disclosures of Vishnupad and Dascalu
teach or suggest each of these two phases as well as dispensing them
together in a single stream. Furthermore, as noted by the Examiner (Ans. 9-
10), Vishnupad teaches that blending an anhydrous polar composition with
an aqueous composition at the time of use overcomes negatives, e.g.,
stickiness, associated with the anhydrous composition, provides hydration
necessary to release the active ingredients in the anhydrous composition, and
makes the active ingredient readily available to the skin (FF 6, 14). In
Vashnupad's words, "the end product aesthetics can be easily controlled by
the formulation of the aqueous emulsions and gel" (FF 6). Thus, we agree
with the Examiner that Vishnupad fairly teaches providing an emulsion (end
product or blend) comprising its first and second compositions in order to
obtain an aesthetically pleasing skin treatment product wherein the active
ingredients in the anhydrous composition are readily available to the skin.
Therefore, this argument is not persuasive of patentability.
Finally, Appellants argue that the Examiner has engaged in
impermissible hindsight to arrive at the claimed invention (Br. 10-11, 16).
While any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, such a reconstruction is
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proper if it only takes into account knowledge which was within the level of
ordinary skill at time the claimed invention was made and does not include
knowledge gleaned only from applicant's disclosure. In our opinion, the
Examiner has not engaged in improper hindsight in reaching his conclusion
of prima facie obviousness for the reasons discussed above. McLaughlin,
443 F.2d at 1395.
C. Conclusion
We will sustain the rejection of independent claims 1 and 7 under
§ 103(a) over the combined disclosures of Vishnupad and Dascalu. The
record supports the Examiner's conclusion that the combined references
would have made the claimed apparatus and emulsion of claims 1 and 7
prima facie obvious.
IV. Order
Upon consideration of the record, and for the reasons given, it is
ORDERED that the decision of the Examiner to reject claims 1, 3, 4,
6-10, 12, and 21 as unpatentable under 35 U.S.C. § 103(a) over Vishnupad
in view of Dascalu is AFFIRMED;
FURTHER ORDERED that the decision of the Examiner to
provisionally reject claim 1 on the ground of nonstatutory obviousness-type
double patenting over claims 1-3 and 7 of copending application 11/339,650
in view of Dascalu is AFFIRMED; and,
FURTHER ORDERED that no time period for taking any subsequent
action in connection with this appeal may be extended under 37 C.F.R.
§ 1.136(a)(1)(vi).
AFFIRMED

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