Ex Parte Fares et al

Patent Trial and Appeal Board

Jun 11, 2013

11404148 (P.T.A.B. Jun. 11, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte HANI FARES, ISABELLE HANSENNE, MICHAEL RUSSELL,
and RITA-MARIE GUERRERO
__________

Appeal 2011-011588
Application 11/404,148
Technology Center 1600
__________

Before TONI R. SCHEINER, ERIC GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
topical composition. The Examiner has rejected the claims as anticipated
and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Acids such as salicylic acid are used for treating various skin
conditions (Spec. 1, ¶ 0001). The Specification discloses that formulating
compositions of such acids is problematic “since they occur in crystalline
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form and are poorly soluble in water or in the oils traditionally used in the
cosmetics field” (id.). The Specification discloses that certain organic
compounds improve the solubility of these acids and “allow for the
formulation of cosmetic compositions” (id. at 3, ¶ 0007).
Claims 1, 2, 4, 11, and 30 are on appeal. Claims 1 and 11 are
representative and read as follows:
1. A topical composition comprising:
(a) from about 0.5% to about 15% by weight of at least one acid
having a solubility, in water, at room temperature, of less than about 0.002
g/ml; and
(b) from about 10% to about 99% by weight of at least one organic
compound, liquid at room temperature, having at least one fatty group with a
carbon chain length of from about 12 to about 24 carbon atoms, all weights
being based on the weight of the composition.

11. The topical composition of Claim 1, wherein the organic
compound, liquid at room temperature, is chosen from propylene glycol
isostearate, glyceryl isostearate, and mixtures thereof.

The claims stand rejected as follows:
• Claims 1, 2, 4, and 30 under 35 U.S.C. § 102(b) in view of Griat,1
with evidence provided by the Handbook of Pharmaceutical Excipients2
(“Handbook”); and
• Claims 1, 2, 4, 11, and 30 under 35 U.S.C. § 103(a) in view of
Griat, Guiramand,3 and Massaro.4

1 Griat et al., US 5,558,871, Sept. 24, 1996.
2 Handbook of Pharmaceutical Excipients, 5th ed., Raymond C. Rowe et al.
(eds.), pp. 760-761 (2005).
3 Guiramand et al., US 2003/0027864 A1, Feb. 6, 2003.
4 Massaro et al., US 6,924,256 B2, Aug. 2, 2005.
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I.
Issue
The Examiner has rejected claims 1, 2, 4, and 30 under 35 U.S.C.
§ 102(b) as anticipated by Griat, with evidence provided by the Handbook.
The Examiner finds that Griat discloses “a topical composition comprised
of: 0.5-15% of a salicylic acid derivative, such as 5-n-octanoylsalicylic acid
…; [and] vegetable oils (see abstract) such as 15% of sunflower oil”
(Answer 6). The Examiner finds that the Handbook provides evidence that
“sunflower oil has 66% linoleic acid and 21.3% oleic acid … which are
organic compounds that are liquid at room temperature and having at least
one fatty group with carbon chain of 12-24 carbon atoms” (id. at 6-7). The
Examiner reasons that, therefore, “15% of sunflower [oil] would inherently
have at least a total of 13% of linoleic acid and oleic acid by weight in
GRIAT’s composition” (id. at 7).
Appellants note that the elected species of solvent (organic
compound) is propylene glycol isostearate (Appeal Br. 7), and contend that
the “anticipation rejection is based on the mistaken belief that vegetable oil
is synonymous with propylene glycol isostearate because vegetable oil is
stated in Griat, as containing an oleic acid fraction” (Appeal Br. 4).
Appellants contend that “the recitation of a synthetic oil in Griat does not
qualify as a literal disclosure of the claimed element ‘propylene glycol
isostearate’” (id. at 5).
The issue presented is: Does the evidence of record support the
Examiner’s finding that Griat discloses a topical composition encompassed
by claims 1, 2, 4 and 30?
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Findings of Fact
1. Griat discloses a “process for the solubilization of a salicylic acid
derivative … [which] comprises mixing a vegetable oil with a salicylic acid
derivative” (Griat, col. 2, ll. 27-30).
2. Griat discloses that, in addition to vegetable oil, the fatty phase of
its composition can include “mineral oils …, synthetic oils, silicone oils …,
perfluorinated oils …, fatty alcohols … and fatty acids” (id. at col. 4, ll. 17-
22).
3. Griat exemplifies an oil-in-water emulsion comprising 5-n-
octanoylsalicylic acid (1%) and sunflower oil (15%) (id. at col. 6, ll. 28-45).
4. The Handbook discloses that “[s]unflower oil is classified as an
oleic-linoleic acid oil. Its composition includes linoleic acid (66%) [and]
oleic acid (21.3%)” (Handbook 760, ¶ 5).
5. The Specification discloses that acids suitable for use in the
claimed composition include salicylic acid (Spec. 3, ¶ 0011) and 5-n-
octanoylsalicylic acid (id. at 5, ¶ 0025).
6. The Specification discloses that “[o]rganic compounds which are
suitable for use in the present invention include … oleic acid, isostearic acid,
[and] linoleic acid” (id. at 6, ¶¶ 0032-0033).
Analysis
Claim 1 is directed to a topical composition comprising (a) about 0.5-
15% by weight of an acid such as salicylic acid or 5-n-octanoylsalicylic acid
and (b) about 10%-99% by weight of at least one organic compound which
can be oleic acid or linoleic acid.
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Griat discloses an oil-in-water emulsion comprising 5-n-
octanoylsalicylic acid (1%) and sunflower oil (15%). The Specification
provides evidence that 5-n-octanoylsalicylic acid is an acid meeting the
requirements recited in claim 1. The Handbook provides evidence that
sunflower oil comprises linoleic acid (66%) and oleic acid (21.3%), which
meets the requirements of the organic compound of claim 1. Thus, Griat’s
composition comprises the required organic components in an amount of
about 13%,5 which is within the range recited in claim 1. Thus, Griat’s
composition meets the limitations of claim 1.
Appellants argue that Griat’s vegetable oil is not “synonymous with
propylene glycol isostearate” (Appeal Br. 4), the elected species of organic
compound. Appellants also argue that “the recitation of a synthetic oil in
Griat does not qualify as a literal disclosure of the claimed element
‘propylene glycol isostearate’” (id. at 5).
Appellants’ arguments are not persuasive. As recognized by the
Examiner (Answer 9), only claim 11 is limited to the elected species of
“propylene glycol isostearate,” but claim 11 is not rejected for anticipation.
Appellants have not alleged that Griat’s composition is not encompassed by
the full scope of claims 1, 2, 4, and 30.
Appellants also argue that “the Examiner has not even attempted to
show where the claimed range of the claimed organic compound is literally
disclosed within the Griat reference” (Appeal Br. 5).

5 Griat’s composition comprises 15% sunflower oil, which itself includes
66% linoleic acid and 21.3% oleic acid; 66 + 21.3 = 87.3, and 87.3% of 15%
is 13.1%.
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This argument is also unpersuasive. The Examiner has provided
persuasive evidence to support his finding that “15% of sunflower [oil]
would inherently have at least a total of 13% of linoleic acid and oleic acid
by weight” (Answer 7), and Appellants have not provided evidence or sound
technical reasoning to support a contrary conclusion.
Conclusion of Law
The evidence of record supports the Examiner’s finding that Griat
discloses a topical composition encompassed by claims 1, 2, 4, and 30.
II.
Issue
The Examiner has rejected claims 1, 2, 4, 11, and 30 as obvious in
view of Griat, Guiramand, and Massaro. Since, as discussed above, Griat
anticipates claims 1, 2, 4, and 30, we affirm the obviousness rejection of
these claims. “It is well settled that ‘anticipation is the epitome of
obviousness.’” In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002).
With respect to claim 11, the Examiner relies on Griat as discussed
above, but finds that Griat “does not specifically teach using a fatty acid [sic,
fatty acid ester], such as propylene glycol isostearate” (Answer 8). The
Examiner finds that Guiramand discloses a topical composition that includes
a salicylic acid derivative and up to 80% of a fatty phase that can include
vegetable oils and fatty acids esters, such as polyol esters (id.). The
Examiner finds that Massaro discloses that “fatty acid esters include
propylene glycol isostearate” (id.).
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The Examiner concludes that it “would have been obvious to the
person of ordinary skill in the art … to incorporate fatty acids [sic, fatty acid
esters], such as propylene glycol isostearate into GRIAT’s composition” (id.
at 9) because “fatty acid esters are commonly incorporated up to 80% in
emulsion compositions and [a skilled artisan] reasonably would have
expected success because propylene glycol isostearate is a functional
equivalent of fatty acids” (id.).
Appellants contend that “Guiramand does not teach/suggest/nor
motivate the use of polyol esters to solubilize the acid. Rather, they are
merely mentioned in a listing of numerous oils and esters that MAY be used
in Guiramand’s composition for some [other] purpose” (Appeal Br. 8).
Appellants also contend that Massaro “utilizes propylene glycol isostearate
as a lamellar phase structurant in a cleansing composition which has nothing
whatsoever to do with the … present invention” (id.).
The issue presented is: Does the evidence of record support the
Examiner’s conclusion that the cited references would have made obvious
the use of propylene glycol isostearate in Griat’s composition?
Findings of Fact
7. Guiramand discloses a “dermatological composition comprising, in
a physiologically acceptable medium, at least one compound of low
solubility and at least one lipophilic amino acid derivative” (Guiramand,
abstract).
8. Guiramand discloses that the compound of low solubility can be a
salicylic acid derivative (id.).
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9. Guiramand discloses that the composition can be an emulsion (id.
at 7, ¶ 0134), and “the proportion of the fatty phase can range from 0.5% to
80% by weight” (id. at 7, ¶ 0138).
10. Guiramand discloses that the “fatty phase or oily phase usually
contains at least one oil, examples that may be mentioned include: …
hydrocarbon-based oils of plant origin, such as … sunflower oil, … [and]
synthetic esters and synthetic ethers, especially of fatty acids, for instance …
polyol esters” (id. at 7, ¶ 0139-0142).
11. Massaro discloses “a liquid cleansing composition suitable for
topical application” (Massaro, col. 1, ll. 9-11).
12. Massaro discloses that the compositions “utilize lamellar
structurants … for forming a lamellar phase” (id. at col. 12, ll. 7-9), where
the structurant is “preferably a fatty acid or ester derivative thereof, a fatty
alcohol, or a hydroxystearin” (id. at col. 12, ll. 16-22).
13. Massaro discloses that “[e]ster derivatives include propylene
glycol isostearate, propylene glycol oleate, glyceryl isostearate, glyceryl
oleate and polyglyceryl diisostearate” (id. at col. 12, ll. 29-31).
Analysis
Claim 11 depends from claim 1 and further requires that the organic
compound is propylene glycol isostearate or glyceryl isostearate.
As discussed above, Griat discloses a process for solubilizing salicylic
acid derivatives that comprises mixing a vegetable oil, and optionally also a
synthetic oil, with a salicylic acid derivative. Guiramand discloses emulsion
compositions useful for solubilizing low solubility compounds, including
salicylic acid derivatives, in which the fatty phase can be up to 80% of the
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emulsion and can comprise polyol esters and/or plant oils such as sunflower
oil. Massaro discloses that fatty acids and ester derivatives thereof,
including propylene glycol isostearate, are useful in a topical composition.
Thus, both Griat and Guiramand disclose that vegetable oils and
synthetic oils are useful for solubilizing salicylic derivatives. Guiramand
discloses that the fatty phase of an emulsion can include oils, including
sunflower oil and/or a synthetic ester such as a polyol ester. Massaro
discloses that polyol esters of fatty acids include propylene glycol
isostearate, and its use in topical compositions. Thus, it would have been
obvious for one of ordinary skill in the art to use Massaro’s polyethylene
glycol isostearate in Griat’s vegetable oil-based composition since
Guiramand discloses that synthetic fatty acid polyol esters are useful for this
purpose.
Appellants argue that “Guiramand does not teach/suggest/nor
motivate the use of polyol esters to solubilize the acid. Rather, they are
merely mentioned in a listing of numerous oils and esters that MAY be used
in Guiramand’s composition” (Appeal Br. 8).
This argument is not persuasive. Guiramand discloses compositions
having a low-solubility compound and a fatty phase that can contain
sunflower oil and/or synthetic polyol esters of fatty acids. Guiramand
therefore supports the Examiner’s conclusion that one of skill in the art
would have recognized that polyol esters are functionally equivalent to fatty
acids (e.g., linoleic acid and oleic acid) in Griat’s composition.
Appellants argue that Massaro discloses “propylene glycol isostearate
as a lamellar phase structurant in a cleansing composition” (Appeal Br. 8).
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Appellants argue that “Massaro’s composition is completely devoid of any
teaching/suggestion/motivation to employ the claimed solvent in associated
[sic] with the claimed acid to form the claimed topical composition” (id.).
This argument is also not persuasive. Massaro demonstrates that the
polyol ester propylene glycol isostearate is a known ingredient for use in
topical compositions. Massaro thus provides a reason for a skilled artisan in
the cosmetic arts to choose propylene glycol isostearate as a polyol ester to
be combined with vegetable oil in Griat’s composition.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
cited references would have made obvious the use of propylene glycol
isostearate in Griat’s composition.
SUMMARY
We affirm the rejection of claims 1, 2, 4, and 30 under 35 U.S.C.
§ 102(b). We affirm the rejection of claims 1, 2, 4, 11, and 30 under 35
U.S.C. § 103(a)
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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