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12/10/2004 19:25 6315311340 



ESTEE LAUDER 



PAGE 06/12 



Attorney Docket No.: 00.22US PATENT 
IN THE UNITED STATES PATENT AND TRADEMARK OFFICE 

In rc Application of: Maes, et al. 

Serial No.: 09/773,351 ^ro^ Art Urrit: 1617 

Filed: January 31, 2001 Examiner: Jiang, Shaojia A. 

For: Cholesterol Sulfete and Amino Sugar Compositions for Enhancemcixt of Stratum Comeum Function 

RESPONSE PURSUANT TO 37 CFR 1.116 
REMARKS 

The Examiner previously 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 ate believed to be still pending. 
Applicants acknowledge the provisional double patent rejection niade by the Examiner, H owever, in 
light of the arguments set forth belovr, Applicants will make a terminal disclaimer, if necessaty, in the 
event that allowable subject matter is indicated. 

A. The Present Invention is Novel QverU-g. Patent No. 5,650. 166_r"the UeglUbier reference;:) 

In the present office action, the Examiner responds to Applicants arguments that the arrangement 
of the components in the '166 Ribier reference are not as a mixture, and therefore, tlic '166 Ribicr 
reference fails to disclose an element of the present claims. Anticipation requires identity' of invention: 
the claimed invention, as described in appropriately constmed claims, must be the same as that of the 
reference, in order to anticipate. Continental Can Co, USA, Inc. v. Monsanto Co, , 948 F.2d 1264, 1267, 
20 USPQ2d 1746, 1748 (Fed. Cir. 1991). See also In re Spada , 911 F,2d 705, 708, 15 USPQ2d 1655, 
1657 (Fed. Cir. 1990) ("the reference must describe the applicanfs claimed invention sufficiently to have 
placed a person of ordinary skill in the field of the invention in possession of it"). Therefore, Applicants 
assert that it is relevant whether features set forth in the present claims are present in the cited reference. 
This is because the preset invention is based on the arrangement of the ingredients. That the elements 
in the * 166 Ribier reference are not arranged as they are in the present invention has not been addressed. 

The anrangement in the * 1 66 Ribier reference is not a '^mixture'' as one of ordinary skill in the art 
would understand it. Two ingredients 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 with one another because they are 
not actually combined. Hie Examiner has admitted in the present office action that a mixture can be 



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interpreted by one of ordinary skill in the art as being integral with. Therefore, Applicants assert that the 
claims are limited in a way that one of ordinary skill in the art would understand that the present 
invention is a mixture separate and distinct from the separate lipid bilayers of the '166 Ribier reference. 
There is no integration where there is separation. Therefore, the ' 166 Ribier reference does not anticipate 
the claims of the present invention because it fails to disclose a mubcture or, in other words, mtcgral with. 
In deciding the issue of anticipation, two steps must be taken: first, the elements of the claims must be 
identified to determine their meaning in light of the specification; and second, the corresponding 
elements disclosed in the allegedly anticipating reference must be identified. Lindemann 
Maschinenfabrik GMBG v. Am. Hoist and Derrick Co, et al, 221 USPQ 481, 485; Cf, Slimfold Mfg. Co. 
V. Kinkead Indus., Inc., 810 R2d 1113, 1116, 1 USPQ2d 1563, 1566 (Fed. Cir. 1987), As the second step 
has not been taken and cannot be taken because a mixture is not found in the ' 166 Ribier reference, 
Applicants request that the rejection of the claims based on anticipation be withdrawn. 

The Present Invention is Non-obvious in View ot the Cited References 
1 , The * 1 66 Ribier Reference 

The Examiner notes in the final office action that notwithstanding the fact that the '166 Ribier 
reference fails to disclose the amount of each of the ingredient components of the present invention, one 
of ordinaiy skill in the art would know to use the amounts of the ingredients taught in the 466 Ribier 
reference. Therefore, according to the Examiner Claims 13 to 20 of the present invention are obvious. 
Applicants respectfully traverse this line of reasoning because the *166 Ribier reference, as discussed 
above with respect to the novelty rejection, fails to teach or suggest a mixture of the ingredients such that 
they are integral with one another. 

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) as they are in the * 166 Ribier reference. 
Applicants have not found that this point has been addressed. "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) whether the prior art would also have revealed that in so making or carrying out [the 
claimed pfocess], those of ordinary skill would have a reasonable expectation of success/' In re Vaeck, 
20 USPQ2d 1438, 1442 (CAFC 1991); see In re Daw 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 of the pertinent components in the '166 Ribier reference. Tlie teaching in 

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the '166 Ribier reference of the components physically located m separate bilayers of a liposome is 
contrary and opposite to the mixture of flie same components of the present invention, to a mixture, the 
components are not separated; but rather, are integrated. Since the ' 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 fector of an obviousness analysis is likewise not met because the '166 Ribier 
reference fails to reveal that makmg the composition of the present invention, namely ihe mixture of the 
components, wouldbe expected by one of ordinary skill in the art to have reasonable success. This 
factor is linked to Ae first factor because as long as there is no teaching or suggestion in the '166 Ribier 
reference to make Ihe 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 fhey are directed to two different areas of the skin. There is never a mixing or integration of the 
components of the '166 Ribier con^iositions. This is illustrated by the teaching at column I, lines 11 to 
14, where the '166 Ribier conipositions 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 Ribier reference wherein it is taught that the alleged favention involves two diffcrent agents to 
act in differ^t areas of the skin. The different agents act in different areas due to ihe different lipid 
vesicles containing them. The different vesicles are classified based on fte different types of action (see 
colunon 2, lines 34 to 41.) Every aspect of the '166 Ribier compositions relates to being separate and 
distinct. Thus, the '166 Ribier reference does not teach, suggest, nor motivate one of ordinary skill in the 
art to make the compositions of the present invention having mixed components. Accordingly, the 
present invention is not obvious in view of the '166 Ribier reference and AppUcants request that this 
rejection be wididrawn. 

2. U.S. Patent Nos. 5.925.364 and 5.41 1.742 

In the final ofSce action, the &taminer states Applicants assertion. and asserts that the present 
claims are not limited to flie act of mixing to produce a mixhire and in what orderly manner to form 
discrete layers of a vesicle dispersed in the aqueous lAasc. It is not clear what is intended by the latter 
part of this assertion. As the Examiner noted, AppUcants assert that the act of mixing can produce two 
different results, namely, one being a mixture and the other being a vesicle with discrete layers. The 
process is irrelevant. What is at issue in the present application is that the results of mixing are different, 



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and that the claims are dirtctcd to features that are not present in vesicle. The Examiner maintains the 
rejection of Claims 1 and 3 to 20 because both cited references, U.S. Patent Nos. 5,925,364 ("the '364 
reference") and 5,411.742 ("the '742 reference"), teach an integral mixttire in a stabilized oil-in-water 
emulsion without discrete layers of a lipid vesicle. 

Applicants pointed out in their last response that the cited references teach Aat discrete layers of 
a lipid vesicle arc formed by mixing. If an inventor takes steps that the prior art suggests cannot be 
made, it is probative of nonobviousncss. Yamanouchi Pharm. Co. v. Danhury Pharmacal Inc., 21 F. 
Supp. 2d 366, 374 n. 15, 48 USPQ2d 1741, 1748 n. 15 (S.D. N.Y. 1998), aff-d, 231 F.3d 1339, 56 
USPQ2d 1641 (Fed. Cir. 2000). Thus, based on the cited references, orw of ordinary skill in the art would 
expecttomakevesiclcswithdiscrctelayersbymixingandnot the mixture of the present invention. 
Because the result of the present invention is different than the result taught by the cited references, the 
claims are adequately directed to limitations that distinguish these results. It is not permissible to pick 
and choose only so much of any given reference as will support a given position and ignore the reference 
in its totflUty." Lubrizol Corp. V. Exxon Corp., 986 F. supp. 302. 322, 7 USPQ2d 1513, 1527 (NJ). Ohio 
1988). 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 '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). Therefore, there is no teaching or suggestion of a mixture like that of the present invention in 
these cited references. 

As previously discussed in Applicants last response, none of the cited references teaches or 
suggests that the act of mixing produces a mixture. To the contrary, the act of mixing causes the ionic 
lipid to swell and arrange itself in an orderly manner to fonn discr««e layers of a vesicle dispersed in the 
aqueous phase. Thus, the ionic lipid used wlfli other materials to make the vesicle is not mixed with the 
content of the aqueous phase; but. rather is used to fonn 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 waUs. Creating a vesicle is akin to 
encapsulation where the actives inside and the materials used to encapsulate are not mixed with the 
oulHide media. Therefon;, the combination of the '364 Ribicr reference and the '742 reference fails to 
teach or suggest the mixture of the present invention. 

-K. IT S. Patent Nos. S.6SQ.166. 6.150.3 81- and 5.702.691 



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Aocordiixg to the Examiner, the ' 166 Ribier inference in combination wjlh the ' 38 1 reference and 
in further view of U.S. Patent No. 5,702.691 issued to Ichinose et al. ("the '691 reference") tenders 
Claims 10 to 12 and 20 obvious. In aclcnowledging Applicants renoaiks in their last response regarding 
the «166 reference, the Examiner notes that the present claims are not limited to a particular form of a 
mixture. However, Applicants assert that the present claims are in feet limited to a mixture wherein the 
ingredients arc integral with one another. Specifically, Qaim 1 of the present invention states the 
following. 

A composition for topical application to the skin comprising a mixture of effective 
amounts of cholesterol sulfate or sahs thereof, mteffal witi^ an exfoliant m a 
cosmetically or pharmaceutically acceptable vehicle. 

Thus, the present claims as previously amended specify that the mixture is one where cholesterol sulfate 
is integral with an exfoliant. This is not taught or suggested by any of the cited references, and no fitrther 
limitations seem to be necessary to distinguish the present invention from the cited references. 

The '381 reference teaches sclarcolide-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. However, this does not remedy the defect of the ' 166 reference. 
Since the '166 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 
•166 lipid vesicles (i.e., sclareolide could be encapsulated). Because lipid vesicles are not simple 
admixtures, the combination of the '166 reference and the '381 reference fails to teach or suggest the 
compositions of the present invention. Finally, the '691 reference teaches flavanonol derivatives in hair 
nourishing and hair growth products and is cited by the Examiner for its teaching of the anti- 
inflammatoiy properties of white birch exiract. However, like that of the '381 reference, the teachings of 
the '691 reference do nothing to remedy the defect of the '166 reference. Essentially, none of the cited 
references alone or in combination teach or suggest a mixture of cholesterol sulfate and an exfoliant such 
that the two are integral with one another. In order to make out a prima facie case of obviousness, it 
must be shown that there is a suggestion to one of ordinary sMU m the art to make the combination of 
cited references or a teaching to o ne skilled in the art of a reasonable expectation of success. In re 
Vaeck, 20USPQ2d 1438 (Fed. Cir. 1991). 

Finally, Applicants point out that the burden to provide evidence of unexpected results does not 
pass from the Examiner to Applicants until a prima facie case of obviousness has been made. In rejecting 
claims under 35 U.S.C. §103, the Examiner bears the initial burden of presenting z prima facie case of 



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Obviousness. In re Rifckaert, 28 USPQ2d 1955, 1956 (CAFC 1993) (citing In re Oetiker, 977 F.2d 1443, 
1445, 24 USPQZd 1443, 1444 (Fed. Cir. 1992), Only if that burden is met, does the burden of coming 
forward with evidence or argument shift to the appUcant. Id, "A prima facie case of obviousness is 
estabhshed when the teachings from the prior art itself would appear to have suggested the claimed 
subject matter to a person of ordinary skill in the art." M, (citing In re Belt , 991 F,2d 781, 782, 26 
USPQ2d 1529, 1531 (Fed. Cir. 1993) (quoting /« reRinehari, 531 F.2d 1048, 1051, 189 USPQ 143. 147 
(CCPA 1976)), Since a prima facie case of obviousness has not been made, for reasons which are 
discussed above, the burden of coming forward with evidence or data regarding inherent properties has 
not shifted to Applicants. 

Even if the interpretation of one of ordinary skill in the art were that a lipid vesicle containmg 
cholesterol sulfate in the membrane layer and NADG encapsulated therein was equivalent to the mtcgral 
mixture of the present invention, Applicants assert that it would be rebutted by the surprising results of 
the present invention. The Examiner asserts in the final office action that the Example in the present 
specification provides no clear and convincing evidence of nonobviousness or unexpected results since it 
is not a direct comparison between the present invention and the cited prior art references. However, 
Applicants note that all evidence of nonobviousness must be considered. In re Soni^ 44 USPQ2d 1684, 
1687 (1995). As Applicants have pointed out in previous responses, the two systems are not the same 
and there is no reason tobelievc thattheintcgral mixturcoftheingrcdientsofthepresentinvention 
directly in a vehicle would necessitate a comparison with a lipid vesicle as these are two c omplctcly 
different systems and different arrangements of the components. To support this fact, Applicants 
previously submitted a copy of an article, Bouwstra et al., "Cholesterol sulfate and calcium affect stratum 
comeum lipid organization over a wide temperature range" Joximal of Lipid Research, vol. 40, 2303- 
3212 (Dec, 1999). In the article, the authors note that reduced levels of cholesterol sulfete contribute to 
desquamation, thus indicatmg that the presence of cholesterol sulfate would maintain the integrity of the 
stratum comeum and prevent desquamation. 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 skm because while the exfoliant would contribute to desquamation, the cholesterol sulfate would 
act to prevent desquamation. 

To recapitulate, the present invention is based on the finding that two ingredients, the cholesterol 
sulfate and the exfoliant, although they have opnosing activi.ti_es, when added ^ ft 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. As previously mentioned, this 
benefit cannot even be addressed with the cited references because these two materials form lipid 



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vesicles, and therefore, arc not in fact mixed. Rather, they are separated such that one, the cholesterol 
sulfate, is part of a protective membrane that encases Hie other, the NADG. The whole point of the lipid 
vesiclesnamellar systems of the cited references is to protect and prevent the active inside from 
integiatmg with anything else. Thus, a comparison of this kind would be futile. 



The present invention, as amended, is an integral mixture of an exfoliatJt and a cholesterol sulfate 
that is not taught or suggested by the cited references describing lipid vesicles having one bilayer 
containing N-acetyl D-glucosamine, and another bilayer containing cholesterol sulfate as the component 
are airanged dificrently. 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, & 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 respectfiilly solicited. 



CONCLUSION 



Respectfully submitted. 





Dorene M. Price (Reg. No. 43,018) 
Estee Lauder Companies 



155 PinelawnRoad 
Suite No, 345 South 
Melville, NY U747 
(631)414-6087 



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