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06/23/2034 17:47 



6315311340 



ESTEE LAUDER 



PAGE 05/12 



Attorney Docket No. : 00.22US 



PATENT 



IN THE UNITED STATES PATENT AND TRADEMARK OFFICE 



In re Application of; Maes, ct al. 



Serial No.: 09/773,351 



Group Art Unit: 1617 



Filed: January 31, 2001 



Examiner: Jiang, Shaojia A. 



For: Cholesterol Sulfate and Amino Sugar Compositions for Enhancement of Stratum. Corneum Function 

RESPONSE PURSUANT TO 37 CFR 1.111 
REMARKS 

§112 Rejections 

The Examiner hag rejected Claims 1 and 3 to 20 for failing to reasonably convey to one skilled in 
the art that the inventor(s) possessed the claimed invention under § 1 12, first paragraph. In particular, the 
phrase "integral with" is, according to the Examiner, new matter. Therefore, one of ordinary skill in the 
art could not ascertain and interpret what is encompassed by this phrase. However, Applicants 
respectfully traverse this rejection because the term is one which one of ordinary skill in the art. would 
familiar. The term "integral with" has an ordinary meaning that is accessible in any dictionary, and the 
term is commonly used in the art. Further, the words used in the claims do not need to be found ipxis 
verbis in the specification to satisfy the written description requirement of § 1 12. Rather, what is required 
is a reasonable conveyance to one of ordinary skill in the art that Applicants possessed the subject matter 
at issue. In re Edwards , 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). Thus, what is to he 
questioned is whether the specification provides adequate direction which, reasonably would lead one of 
ordinary skill in the art to the phrase "integral with." Fujikawa y. Waitanasin, 39 USPQ2d \ 895 (CAFC 
1996); Id. at 1352, 196 USPQ at 467. 

The Examiner admits that "IX)he recitation 'integral with' could be interpreted as 'mixed with' or 
'a mixture of according [sic] its plain and ordinary meaning. Applicants fully agree with this 
interpretation and therefore assert that support for the amendment to the claims is found in the present 
specification which repeatedly refers to the present invention as a mixture. In the present specification, 
support is found for the amendments made in Applicants' Response of January 5, 2004 at page 4, lines 1 1 
to 12, 21 to 29, and page 5, lines 26 to 28 for the phrase "integral with." The first is at page 4, lines 1 1 to 
12 wherein the discovery of the present invention is described. Basically, the present invention finds that 
two opposing components do not cancel each other out in a composition even when the two components 



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arc mixed together. Another reference in the specification is at page 4, lines 2 1 to 29 including lines 22 to 
24 which were noted in Applicants' Response of January 5, 2004 as providing support for the 
amendment. The two components are noted therein as being in combination, with one another. Further, 
the compositions containing this combination are referred to as a mixture. 

The common definition of " mixture" i s a combination of different elements ( or c omponcnts.) 
Thus, these two words arc used interchangeably. The present invention is a mixture, and therefore, the 
whole composition of the present invention contains the two components, one integral with the other as 
based on the basic definition of "integral" which is to be of, pertaining to, or belonging as a part of the 
whole. The components of the mixture in the present invention are noted as being a part of a whole in 
the specification at page 5, lines 26 to 28. The components of the present invention are described as 
belonging to a whole. Specifically, at this point in the specification, formulations of the present 
invention are described as having a mixture of cholesterol sulfate and the exfoliant combined with other 
components. The present invention is described as a mixture throughout the specification. Thus, as the 
Examiner admits that one of ordinary skill in the art would understand that integral with can be 
interpreted as mixture according to its plain and ordinary meaning, Applicants assert that there is ample 
support in the specification for the amendments made in the Response of January 5, 2004. No new 
matter is added, and Applicants request that the rejection for new matter be withdrawn. 

The § 1 12 rejection is based on a failure, according to the Examiner, to particularly point out and 
distinctly claim the subject matter of the present invention. As indicated above, "integral with" is clearly 
defined in the specification. Therefore, contrary to the Examiner's assertion, one of ordinary skill in the 
art would know what the metes and bounds of the claims are. The phrase "integral with" merely 
describes a quality of what it means to be a mixture or a combination. Therefore, there is no broadening 
beyond the combination and mixture described by the claims, and indeed, the phrase provides further 
clarification to the mixture and combination of the present invention. The phrase "integral with" is a 
clarification to quell the Examiner's concern that there is any commonality between two components in a 
mixture, a s i n t he p resent i nvention, and t wo c omponcnts i n a 1 ipid v esicle, a s in the cited prior art. 
There is no such connection between the two. Thus, the fact that the phrase "integral with" can be 
interpreted as "mixed with" or a "mixture" according to its plain and ordinary meaning does not render 
the claims indefinite. Rather, based on this factual situation it renders the claims more definite because 
the present invention is a mixture and the phrase "integral with" offers more clarification of what it 
means to be a mixture. This fact is being disregarded in the present rejection under §11.2 and in the 
rejections which are discussed further below. With respect to the rejection under §112, second 
paragraph, Applicants request that it be withdrawn. 



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II, Novelty and Obviousness Rejections 

The Examiner has rejected Claims 1 and 3 to 20 provisionally under the judicially created 
doctrine of obviousness-type double patenting as being unpatentable over Claims 1-21 of copending 
Application. No. 10/424,616. The claims of the copending Application are believed to be still pending. 
Applicants acknowledge the provisional double patent rejection made by the Examiner. H owever, in 
light of the arguments set forth below, Applicants will make a terminal disclaimer, if necessary, in the 
event that allowable subject matter is indicated. 

A. U.S. Patent No. 3.650.166 ("the '166 Ribier reference") 

Tti the present office action, the Examiner fmdsi that Claims 1 and 3 to 9 are anticipated by the 
'166 Ribier reference. The Examiner asserts that the '166 Ribier reference discloses a composition 
comprising cholesterol sulfate and N-acetylglucosamine. However, Applicants have argued repeatedly, 
without comment from the Examiner on this point, that the elements in the 4 1 66 Ribier reference are not 
arranged as they arc in the present invention. The arrangement in the ' 1 66 R ibier r eference i s n ot a 
"mixture" as one of ordinary skill in the art would understand it. Two ingredien ts that are separated from 
one another, as they are in the '166 Ribier by virtue of the vesicle formation, cannot be a mixture or be 
integral w ith o ne a nother b ecause t hey are n ot a ctually c ombined. T he E xarniner h as a dmitted i n t he 
present office action that a mixture can be interpreted by one of ordinary skill in the art as being integral 
with. There is no integration where there is separation. To anticipate under § 102(b), a single prior 
source must contain all the essential elements of the anticipated claim. Lindemann Maschinenfabrik v. 
American Hoist and Derrick, 730 F.2d 1452, 1458, 221 USFQ 481, 485-86 (Fed. Cir. 1984); Shanklin 
Corp, v. Springfield Photo Mown Co., 521 F.2d 609, 187 USFQ 129 (1st Cir. 1975). Therefore, the '166 
Ribier reference does not anticipate the claims of tbc present invention because it fails to contain the 
essential element of the present invention of being a mixture or, in other words, integral with. Applicants 
request that the rejection of the claims based on anticipation be withdrawn. 

The Examiner notes in the office action that the present claims are not limited to specific steps in 
a method. However, this is not necessary as the limitations of the claims sufficiently describe an integral 
mixture of components which one of ordinary skill in the art would recognize as being distinct and 
separate from the same components physically located in separate bilayers of a liposome (or vesicle). 
This has not been addressed by the Examiner. "A proper analysis under §103 requires, inter alia, 
consideration of two factors: (1) whether the prior art would have suggested to those of ordinary skill in 
the art that they should make the claimed composition or device, or carry out the claimed process; and (2) 



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whether the prior art would also have revealed that in so making or carrying out [the claimed process], 
those of ordinary skill would have a reasonable expectation of success." In re Vaeck, 20 USPQ2d 1438, 
1442 (CAFC 1991); see fit re Dow Chemical Co., 5 USPQ2d 1529, 1531 (Fed. Cir. 1988). These two 
factors have not been met in the present case. First, there is no teaching or suggestion in the prior to 
make a mixture ofthe pertinent components in the '166 Ribicr reference. The teaching in the '166 Ribier 
reference of the components physically located in separate bilaycrs of a liposome is contrary and 
opposite to the mixture of the same components of the present invention. In a mixture, the components 
are not separated; but rather, are integrated. Since the 4 166 Ribier reference only teaches the components 
in a state of separation, the mixture of the present invention is not taught or suggested by the '166 Ribier 
reference. 

The second factor of an obviousness analysis is likewise not met because the '166 Ribier 
reference fails to reveal that malting the composition of the present invention, namely the mixture of the 
components, would be expected by one of ordinary skill in the art to have reasonable success. T his 
factor is linked to the first factor because as long as there is no teaching or suggestion in the ' 166 Ribier 
reference to make the mixture of the present invention, there likewise, cannot be a reasonable expectation 
of success to do what is not taught or suggested. But beyond this, the teachings of the "166 Ribier 
reference are aimed at treating two different layers of the skin at the same time. Thus, the components of 
the ' 166 Ribier compositions start out separated in the composition and the components remain separated 
as they are directed to two different areas of the skin. There is never a mixing or integration of the 
components of the '166 Ribier compositions. This is illustrated by the teaching at column 1, lines 11 to 
14, where the '166 Ribier compositions are described as comprising at least one active agent conveyed 
via at least two distinct types of lipid vesicles. Additional support is found at column 2, lines 19 to 21, of 
the ' 166 Ribicr reference wherein it is taught that the alleged invention involves two different agents to 
act in different areas of the skin. The d ifferent agents act in different areas due to the different lipid 
vesicles containing them- The different vesicles are classified based on the different types of action (sec 
column 2, lines 34 to 41.) Every aspect of the '166 Ribier compositions relates to being separate and 
distinct. 

Not only do the components of the ' 1 66 Ribicr compositions exist separately in the composition; 
but, they are further targeted to act in separate and distinct areas of the skin transported by separately 
classified lipid vesicles. The two components of the ' 1 66 Ribier reference are intended to be separate 
and distinct at all times (i.e., not mixed, combined, nor integrated at any time.) Thus, the '166 Ribier 
reference does not teach, suggest, nor motivate one of ordinary skill in the art to make the compositions 



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of the present invention having mixed components. Accordingly, the present invention is not obvious in 
view of the '166 Ribier reference and Applicants request that this rejection be withdrawn. 

B U.S. Patent Nos. 5.925,364 and 5.41 1.742 

In the present office action, the Examiner rejects Claims 1. and 3 to 20 because both cited 
references, U.S. Patent Nos. 5,925,364 ("the '364 reference") and 5,41 1,742 ("the '742 reference"), teach 
an integral mixture in a stabilized oil-in-water emulsion without discrete layers of a lipid vesicle. The 
Examiner notes that the preparation of the vesicles involves a mixing step in which the final, product, an 
oil-in-water emutsion is formed without discrete layers of a lipid vesicle. However, the Examiner's 
description of the preparation at column 6 to 7 of the '364 reference is not accurate because indeed what 
is formed are discrete layers of a lipid vesicle. This is supported by the teachings of another cited 
reference, the '742 reference. Specifically, it is indicated in the '742 reference at column 1, lines 38 to 
54, that ionic lipids arc capable of swelling in an aqueous solution to form a lamellar phase, and after 
stirring, ta form vesicles dispersed in the aqueous solution. Thus, the formation, of discrete layers of a 
lipid vesicle is precisely what occurs when the ionic lipid is mixed in the '364 preparation. The '364 
preparation does not produce a mixture because the ionic lipids swell under the action of mixing to form 
discrete layers of a lipid vesicle which separates its contents from the other ingredients in the 
composition, namely the outside media (e.g., the aqueous phase). 

There is a stark contrast between the act of mixing and the act of producing a mixture. In none of 
the cited references does the act of mixing produce a mixture. To the contrary, the act of mixing causes 
the ionic lipid to swell and arrange itself in an. orderly manner to form discrete layers of a vesicle 
dispersed in the aqueous phase. Thus, the ionic lipid used with other materials to make the vesicle is not 
mixed with the content of the aqueous phase; but, rather is used to form a discrete entities present in the 
outside media (i.e., the aqueous phase). They are not mixed. As previously discussed, the vesicle holds 
active agents within and keeps the actives separate from media outside of its walls. Creating a vesicle is 
akin to encapsulation where the actives inside and the materials used to encapsulate are not mixed with 
the outside media. Therefore, the combination of the '364 Ribier reference and the '742 reference fails 
to teach or suggest the mixture of the present invention. 

Applicants also point out teachings in each of the cited references indicating that the 
compositions contain vesicles. First, Applicants direct the Examiner's attention to the abstract of the 
'364 reference wherein it is stated "[oily globules are] provided with a lamellar liquid crystal coating and 
are dispersed in an aqueous phase." This is reiterated at column 2, lines 24 to 33., providing further detail 
about the coating. Specifically, it is noted therein that each oily globule is obtained from a lipophilic 



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surfactant, a hydrophilic surfactant, and an ionic amphophilic lipid (the ionic lipid previously noted as 
swelling and forming vesicles). Further, the "coated oily globutes" have a diameter less than 500 
nanometers. Thus, as Applicants have asserted the oil globules in the '364 reference are coated and as 
such they resemble lipid vesicles because the active inside the oil globules is separated from the aqueous 
phase and the contents of the aqueous phase. 

The lipid vesicle type component of the '364 reference is also described at column 2, lines 52 to 
63. The '364 emulsions are described as having fatty phase droplets that are extremely small in size and 
most importantly, that are coated with an extremely fine oligolamellar layer. Thug the contents of the 
coated oily droplets are separated from the contents of the aqueous phase. One of ordinary skill in the art 
would also understand that the coated oily globules of the '364 reference are similar to lipid vesicles 
because at column 2, lines 64 to 67 ? the ability to transport and deliver active agents contained in the 
coated oily globule is taught. Previously, Applicants asserted that the oily globules coated with a 
lamellar liquid crystal coating in the '364 Ribier reference are similar to the lipid vesicles of the 1 166 
Ribier reference. Specifically, the '364 Ribier reference discloses an emulsion composition that has oily 
globules with a 1 amcllar 1 iquid crystal coating dispersed in an aqueous phase. Like that of the ' 166 
Ribier reference, the '364 compositions can include materials such as alkali metal salts of cholesteryl 
sulphate as the ionic amphophilic lipid, taught as one of components of the coating (i.e., similar to the 
membrane layers of the '166 Ribier vesicles)- However, the teaching of the '364 reference to include an 
alkali metal salt of cholesteryl sulfate as part of the coating of an oily globule is not a teaching or 
suggestion to make a mixture of cholesterol sulfate with any other component as it is described in the 
present invention. Therefore, the '364 Ribier reference, like that of the '166 Ribier reference, fails to 
teach or suggest the integral mixture of the exfoliant and cholesterol sulfate in the present invention. 

According to the Examiner, the '364 Ribier reference in combination with the '742 reference is 
obvious to one of ordinary skill in the art. Both the '364 Ribier reference, as shown above, and the '742 
reference disclose lipid vesicle/lamellar systems. Specifically, it is indicated in the ' 742 reference at 
column 1, lines 38 to 54, that ionic lipids are capable of swelling in an aqueous solution to form a 
lamellar phase, and after stirring, to form vesicles dispersed in the aqueous solution. The amphiphilic 
lipids capable of forming vesicles noted in the '742 reference include, inter alia, ionic amphiphilic lipids 
(note these are the same ionic amphiphilic lipids disclosed in the '364 Ribier reference at column 3, line 
43, and the '166 Ribier reference at column 3, lines 45 to 47, both of which discloses vesicles.) Thus it 
can clearly be seen from the descriptions in both the '364 Ribier reference and the '742 reference that 
these t he a lleged i nventions b oth r elate t o 1 ipid v esicles/lamellar s ystems 1 ike t hat o f the '166 Ribier 



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reference. Therefore, the combination of these references for reasons stated above, fail to teach or 
suggest an integral mixture of exfoliant and cholesterol sulfate as in the present invention. 

Finally, even if the interpretation of one of ordinary skill in the art were that a lipid vesicle 
containing cholesterol sulfate in the membrane layer and NADG encapsulated therein was equivalent to 
the integral mixture of the present, invention, Applicants assert that it would be rebutted by the surpris ing 
results of the present invention. The Examiner previously noted in the Advisory Action and the Final 
Office Action that the Example in the present specification does not provide clear and convincing 
evidence of nonobviougness or unexpected results over the cited prior art because there is no direct 
comparison of the same. However, as Applicants have pointed out in the present response, the two 
systems are not the same and there is no reason to believe that the integral mixture of the ingredients of 
the present invention directly in a vehicle would necessitate a comparison with a lipid vesicle as these are 
two completely different systems and different arrangements of the components. To support this fact, 
Applicants submit herewith a copy of an article, Bouwstra et a!., "Cholesterol sulfate and calcium affect 
stratum corneum lipid organization over a wide temperature range" Journal of Lipid Research, vol. 40, 
2303-3212 (Dec. 1999). In the article, the authors note that reduced levels of cholesterol sulfate 
contribute to desquamation, thus indicating that the presence of cholesterol sulfate would maintain the 
integrity of the stratum comeum and prevent desquamation. This has not been addressed. Therefore, 
Applicants maintain that one of ordinary skill in the art would expect a combination of cholesterol sulfate 
and an exfoliant to have no effect on the surface on the skin because while the exfoliant would contribute 
to desquamation, the cholesterol sulfate would act to prevent desquamation. 

The present invention is based on the finding that two ingredients, the cholesterol sulfate and the 
exfoliant, although they have opposing activities , when added as a mixture to a pharmaceutical or 
cosmetic vehicle, do not neutralize one another's activities, but rather their activity occurs in tandem, and 
can improve or maintain a healthy skin barrier. This benefit cannot even be addressed with the cited 
references because these two materials form lipid vesicles, and therefore, are not in fact mixed. Rather, 
they are separated such that one, the cholesterol sulfate, is part of a protective membrane that encases the 
other, the NADG. The whole point of the lipid vesicles/lamellar systems of the cited references is to 
protect and prevent the active inside from integrating with anything else. Thus, a comparison of this kind 
would be futile. Finally, Applicants point out that the burden to provide evidence of unexpected results 
does not pass from the Examiner to Applicants until a prima facte case of obviousness has been made. 



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CONCLUSION 



The present invention, as amended, is an integral mixture of an exfoliant and a cholesterol sulfate 
that is not taught or suggested fay the cited references describing lipid vesicles having one bilayer 
containing N-acetyl D-glucosamine, and another bilayer containing cholesterol sulfate as the component 
arc arranged differently. 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 arc 
believed to be in condition for allowance, and issuance of a Notice o f Allowance is respectfully solicited. 



Respectfully submitted, 





Dorene M. Price (Reg. No. 43,018) 
Estee Lauder Companies 
125 Pinclawn Road 
Melville, NY 11747 
(631) 531-1194 



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