contain all the essential elements of the anticipated claim. Lindemann Maschinenfabrik v. American
Hoist and Derrick , 730 F.2d 1452, 1458, 221 USPQ 481, 485-86 (Fed. Cir. 1984); Shanklin Corp, v.
Springfield Photo Mount Co., 521 F.2d 609, 187 USPQ 129 (1st Cir. 1975). However, Applicants believe
that a careful review of the '742 reference reveals that it fails to disclose salicylic acid, and therefore,
fails to disclose an exfoliant. The present invention is the surprising discovery that cholesterol sulfate
and an exfoliant, two agents having contra-activities, can be simply mixed together in a composition to
enhance the protective barrier of the skin and/or repair the barrier if it has been damaged. This beneficial
effect can be advantageously exploited on skin of all ages, and it is not disclosed by the '742 reference.
The '742 reference discloses a lipid vesicle which contains at least one salicylic acid derivative
in a lipid phase forming the membrane of the vesicle. The salicylic acid derivative, according to the '742
reference, at column 3, lines 34 to 63, fortifies the lipid bilayer of the lipid vesicles and provides anti-
acne activity. The Examiner points out that salicylic acid is a known exfoliant. However, the '742
reference discloses only derivatives of salicylic acid and not salicylic acid itself. There is no support in
the '742 reference to indicate that the derivatives disclosed therein have any exfoliant activity at all,
either alone or in combination with other actives. In fact, the '742 reference suggests that salicylic acid
derivatives do not behave similarly, and therefore, provides reason for one of ordinary skill in the art to
believe that salicylic acid derivatives would not behave like salicylic acid. At column 3, lines 44 to 54,
the '742 reference discloses two salicylic acid derivatives that do not improve the physiochemical
stability of vesicles and the encapsulation level. But, the particular salicylic acid derivative disclosed by
the '742 reference allegedly achieves these benefits. Therefore, the '742 reference establishes that
different salicylic acid derivatives behave differently, and therefore, there is no reason for one of
ordinary skill in the art to believe that the particular salicylic acid derivatives of the '742 reference have
exfoliant activity or any activity similar with that of salicylic acid. Thus, it can be seen that the '742
reference not only fails to disclose an exfoliant, but it also fails to inherently disclose an exfoliant.
Therefore, the '742 reference fails to disclose the present invention, and Applicants respectfully request
that the rejection under 35 U.S.C. § 102(b) be withdrawn.
Further, the Examiner rejects Claims 1 to 4, 6 to 10, and 18 under §103 over the '742 reference
in view of Subbiah, U.S. Patent No. 6,150,381 ("the '381 reference"). Obviousness is not found if the
prior art fails to teach or suggest to one of ordinary skill in the art that the claimed invention should be
carried out and if one of ordinary skill in the art would have no reasonable expectation of success making
the claimed invention, as viewed in light of the prior art. Amgen Inc. v. Chugai Pharmaceutical Co. Ltd.,
18 USPQ2d 1016, 1022 (CAFC 1991); see In re Dow Chemical Co., 837 F.2d 469 473, 5 USPQ2d 1529,
1531 (Fed. Cir. 1988). Although it is known that compounds having structural similarity without more
can give rise to prima facie obviousness, see, e.g., In re Dillon, 919 F.2d 688, 692-94, 16 USPQ2d 1897,
1900-02 (Fed. Cir. 1990) (tri-orthoesters and tetra-orthoesters), cert, denied, U.S. , 111 S. Ct.
1682 (1991); In re May, 51 A F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers); In re Wilder, 563
F.2d 457, 195 USPQ 426 (CCPA 1977) (adjacent homologs and structural isomers); In re Hoch, 428 F.2d
1341, 166 USPQ 406 (CCPA 1970) (acid and ethyl ester), generalization is to be avoided insofar as
specific structures are alleged to be prima facie obvious. In re Jones, 21 USPQ2d 1941, 1943 (CAFC
1992); In re Grabiak , 769 F.2d 729, 731, 226 USPQ 870, 872 (Fed. Cir. 1985).
The present invention is a simple mixture of an effective amount of an exfoliant and cholesterol
sulfate. The combination of these two components has surprisingly been found to improve and/or protect
the barrier of the stratum corneum even though the two components have opposite acting activities with
respect to exfoliation. The present invention is not taught or suggested by the cited references nor would
one of ordinary skill in the art reasonably expect to achieve the present invention based on the
combination of the '742 reference and the '381 reference as discussed in further detail below.
The '742 reference teaches a lipid vesicle, and therefore, in addition to its failure to teach or
suggest an exfoliant, as discussed above with respect to the novelty rejection, the '742 reference fails to
teach or suggest the present invention of topically applying a simple mixture of two components, namely
the cholesterol sulphate and the exfoliant. Lipid vesicles are formed, as disclosed at column 1, lines 46 to
54, of the '742 reference, by lipid membranes consisting essentially of concentric sheets of
multimolecular lipid bilayers. The concentric layers are similar to the layers of an onion, and each layer
is separated by an aqueous phase because the lipid layers swell in the presence of the aqueous solution
and encapsulate the aqueous phase within the lipid layers. Therefore, within each of the layers there is a
space wherein aqueous actives can be encapsulated. As a result of the ability to encapsulate actives, the
vesicles act as a delivery system for the active, protecting and transmitting the active to a target.
Materials used to make the lipid membrane of the lipid vesicles are not simply mixed together.
As presented in the '742 reference, at column 1, lines 33 to 37, there is a difference between the use of
salicylic acid derivatives in emulsions, gels or lotions and the use of salicylic acid derivatives in lipid
vesicles where the derivatives are part of the lipid membrane. The '742 reference specifically discloses,
at column 1, lines 51 to 54, that amphiphilic lipids capable of forming vesicles are known to be ionic
amphiphilic lipids and/or non-ionic amphiphilic lipids. In particular at column 2, lines 33 to 35, the '742
reference discloses that the role of charged lipids, of which cholesterol sulphate is included as an ionic
amphiphilic lipid, is to improve the stability of the vesicles by preventing their flocculation, as a
consequent of their melting, even in the presence of an electrolyte. The presence of charged lipids also
contributes to an increase in the encapsulation capacity of water-soluble substances by increasing the
thickness of the aqueous layers separating the lipid sheets of the membranes of the vesicle, according to
the '742 reference. The lipid vesicle requires specific processing steps to form the lipid bilayers and the
internal cavity for encapsulation of the active. Therefore, the '742 reference establishes that lipid
vesicles are distinct and separate entities from simple admixtures of components. The lipid vesicle is not
a simple admixture of ingredients.
Unlike the compositions disclosed in the '742 reference, the cholesterol sulfate of the present
invention is not in the context of a lipid vesicle but is part of a simple mixture with an exfoliant in a
composition. Further, the '742 reference fails to disclose that a simple mixture of cholesterol sulfate and
an exfoliant in a cosmetic composition has any benefit at all. The '742 reference fails to disclose that the
derivatives would exhibit activity other than as an anti-acne agent. The lipid phase of the lipid vesicle
forms many concentric layers of cavities each of which holds the aqueous phase similar to an apple
filling held in the pastry dough of an apple turnover. A recipe for apple turnover containing a flour-
derived substitute to fortify the pastry does not teach a simple combination of flour and apples nor does it
teach any of the beneficial results that such a combination might have, presumably because it is not
expected to have any. The present invention, however, has surprisingly found that by simply combining
these two components, despite the fact that their activities are opposing with respect to exfoliation, a
beneficial effect is achieved with respect to protecting the skin barrier. This is not recognized by the
'742 reference, either alone or in combination with the '381 reference.
The '381 reference teaches sclareolide-like compounds for treating disorders caused by
microbials such as, for example, bacteria, and one specific disorder is acne. As disclosed in the '381
reference, topical formulations containing sclareolide are generally prepared by admixing sclareolide in
water and at least one organic solvent. Therefore, the '381 reference teaches that sclareolide is an
aqueous active. Since the '742 reference teaches lipid vesicles encapsulating water soluble actives, the
combination of these references at most suggests that sclareolide could be incorporated within the
aqueous phase of the '742 lipid vesicles (i.e., sclareolide could be encapsulated). Because lipid vesicles
are not simple admixtures, the combination of the '742 reference and the '381 reference fails to teach or
suggest the compositions of the present invention.
In addition, the Examiner finds that a combination of the '381 reference with U.S. Patent No.
5,650,166 issued to Ribier et al. ("the '166 reference") also renders the present invention obvious.
However, the combination of these references likewise fails to teach or suggest the present invention
because one of ordinary skill in the art would expect the sclareolide disclosed in the '381 reference, as
with the previous combination of references, to merely be incorporated within the aqueous cavity of the
lipid vesicles disclosed by the '166 reference, and therefore, be encapsulated.
The '166 references teaches a moisturizing composition which comprises a first and a second
dispersion of lipid vesicles. The first lipid vesicle penetrates, according to the '166 reference into the
deep layers of the skin and contains at least one active. The '166 reference discloses at column 3, lines
66 to 67, that the lipid phase of the vesicles is an alkali metal salt of cholesterol sulphate. Therefore, the
alkali metal salt of cholesterol sulphate is, similar to the '742 reference, disclosed as part of the lipid
bilayer which forms the cavity within which an aqueous active is encapsulated. This, however as
previously discussed, is not an admixture of cholesterol sulphate and an exfoliant as is the subject of the
present invention, and therefore, the '166 reference also fails to teach or suggest the present invention. In
addition to this, the combination of the '166 teachings with that of the '742 reference, similarly fails to
teach or suggest the present invention because this combination only, at best, teaches that the aqueous
phase can contain an aqueous active agent such as sclareolide in the cavity formed by the lipid bilayers of
the lipid vesicle. Therefore, the combination of these two references fails to teach a mixture of the two
components of the present invention, namely, the cholesterol sulphate and the exfoliant.
The lipid vesicle is not a mixture of components. Lipid vesicles are made of alternating layers of
a lipid phase and an aqueous phase. The lipid phase encapsulating the aqueous phase carries and protects
aqueous actives held by the aqueous phase within the cavity formed between the lipid phases. This is not
the mixture of cholesterol sulphate and an exfoliant as described in the present invention for enhancing
and protecting the protective barrier of the skin. A mixture of components is a random solution of
components unlike a vesicle which is a discrete arrangement of its components. Because none of the
cited references alone nor in combination would lead one of ordinary skill in the art to the compositions
and methods of the present invention, a prima facie case of obviousness has not been established.
Applicants request therefore, that the Examiner's rejection under §103 be withdrawn.
In view of the arguments presented above in the present submission, the claims are believed to be
in condition for allowance, and issuance of a Notice of Allowance is respectfully solicited.
Dorene M. Price (Reg. No. 43,018)
Estee Lauder Companies
125 Pinelawn Road
Melville, NY 11747
5? MARKED AMENDMENTS
12 (Amended). The composition of claim 1 further comprising both sclareolide and white birch extract.
20 (Amended). The method of claim 19 further comprising cholesterol sulfate or salts thereof in an
amount of about 0.1 to 2.0 percent, about 0.5 to 8.0 percent of N-acetyl-D-glucosamine, cholesterol in an
amount of about 0.2 to 1.0 percent, linoleic acid in an amount of about 0.2 to 1.0 percent by weight of the
[of the] composition, sclareolide in an amount of about 0.001 to about 1.000 percent, and white birch
extract in an amount of about 0.001 to about 1.000 percent.