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Full text of "USPTO Patents Application 09773351"

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Feb 05-. 03 09:38p * Dorene -Price , 63^744—3594 * p. 5 



19. A method of treating or reducing damage to th skin, wherein the damage ^associated with a reductiOTTor 
loss of skin harrier fimction, which cc^rises.addbg an effective amount of a mixture'to a cosnssicalry or" 
J plianaaceutically acceptable vAicle wbwein smd^mixture comprises cholesterol sulfated salts thoeof in S - 
amount from about 0.05 to ab^lM.percott, and lO.Op^i^of.wanunosui'ralefctedl 
'-. ' Wme &° U P <^si«i°9 of N^-D^uMsarmne, N^ratyigahjctosamine, and a c^matic^thWby" 
_w^ofth*<»imxBM^ . - *_ - - 

. • - Please cancel claim 2. - - - _ - 

. - - , REMARKS 

The Examiner rejects' Claims 1 to J2, and 16 to 20 under section §112, 'second paragraph for " 
indefiniteness. In particular, . Claim 1 is rejected because the phrase "effective amount" is unclear," and Claims 
16 and 19 are rejected because the phrase "and _app!ying said mixture to the skin is unclear, and finally Claim 

- 18 is rejected for lack of antecedent basis. Clahn' 1 has been amended to clarify the meaning ^ reffective 
amount." Claim 18 has bean amended to removethe typographical error, and antecedent basis is*not present. - 

- With respect to Claim 16, Applicants are not sure where the source of confusion lies. The Examiner notes that 
it is not clear what mixture is applied tothe skin, the mixture of cholesterol sulfate and amino sugar- or the 
mixture of the cholesterol sulfete and amino sugar with a vehicle. However, in claims 16 and 19 the "mixture" 
is added directly to a vehicle for application to the skin. Regardless of whether the mixture S applied^ the " 
skin with or without the vehicle, the term "mixture" is quite clear in this claim as being the mixture of the 
cholesterol sulphate and the amino sugar, and the mixture, with or without the vehicle, is applied to the skin in 
. both cases. However, to_addjurmw clarification to ^ - 
. the mixture and the vetode^ - - * ~~ ~~" -"■"..* 

_ ** - - * 

. The Examiner rejectsClaims 1, 3; and 1 1 under 35 US.£.-102(b) as bemg" anticipated^ Ribier et 
aL, US. Patent No. 5,925>4 Ohe«'364 reference"). -The''364 reference discloses an enui«mcsmpc*if^ ~ 
that has a lamellar liquid crystal coating. _ The Deposition as described in me-claims can include materials— 
such as alkali.metal salts of chotesteryl "sulphate as the ionic amphilic lipid as one of the layers coating an" - 
-^.active. Further, "the composition can contain as a fatty substance a keratolytic agent."*' One' of the Thany- 
^ keratorync' agents listed is rrtinol and salicylic acid which the Examiner notes that these materials are T known 
defoliants. Therefore, according to the Examiner, the '364 reference has disclosed the present invertion ~ 
because the Examiner maintains that fcyered "coatings such as the "one described in the '364 reference 

- «*stitutoamixtiw!asd 



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Feb 0£ 03 09:38p DCTPene Price - 63T^744-3594 



. - s '"rnixture." However, Applicants assert that the sa*{of the term is to be interpreted in vie* of hwoneof 

- ordinary skill in the art would make such an bteipretatba. Applicant Juimer assert aWWExaminer has 

. ' ^ - ^tban^the term's ordinary ineanmg, and it is Applicant postepn that one«of onlinary skill in the art would 
^ " ^tonjietllietemmi^ Fimdry 'even if 

tfie interpretation of one of wdmary skill in the art were to be inconsistent with the use of the terifin the 
present mvention, Applicants assert that the claimsof the presertmventionlndtheten^ 
, read m tight of the specitkation- Markman v. Wes^i^Imtrumems r btc.,'S2'VM961;. i ^9. 34 USPQ2d J 
1321, 1329 (Fed. Cir. 1995Xen banc), afFd, 517 U.S..370, 38 USPQ2d 1461 (1996); /„ n Pauk e n y 30 F.3d 
1475,.1480, 31 USPQ2d 1671, 1674 (Fed. Cir. 1994). Therefore, the onlinary meaning of the tern! mixture* 

- should.be applied and as such one of ordinary skiU.in the art would find the mixture of the present invention 
distinguishable over compositions containing components separated by encapsulation or vesicles as disclosed 
in the cited prior. art. . ■"-> 

~ The Examiner rejects Claims 1 to 9~and 13 to 19 under 35 U.S.C.103 as being ahpateniable over 
. . -Ribier et al, U.S.. Patent No. 5,650,166 ("the .'166 reference'-). The/lte references teaches' a moisturizing 
f """^"^hccmpi^ 

lipid vesicles. The first lipid vesicle penetrates, according to the • Preference, into the deep layers of the skin 
- - - % and contains at least one active. This action is, like the two daemons themselves, separate from' the actwo of 
the other dispersion, and therefore, is not a disclosure of the mixture of the present invention where the two . 
r , s components art together. Thus, as previously discussed, the M66 reference fails to teach or suggest a -fnixture- 
of^olesterol sulphate and an exfotiant of the present roventionTa no^ereibre, the^ ; i667efetence also feils~to~" 
teach_or_suggEst-the : pres^-inverrr^ teaching,; suggestion* or motivatiori in the 1 jut or the 

■ knowledge of one of ordhuuy.skUl in the art to support the assertion that "mixing components is broadly" 

equivalent to or includes encapsulatmg^compjmente, or any other ordered arrangement bf-ajparately atfing 
-_ ^components. In the present action, the Examiner adds a broad interpretation of the term "add" to mean any * 
- - variety of mixing steps. Again, there is no basis for such a Broad readmg d£me term. If Such" a broad - 

;meaning,applied to these of any omer.terms, Vocabulary wouH be a limited subject as there would be alwieed 
. Jbr other specific words to describe in me case of the cited prior ^rt processing steps .fbr encapsulation or 
_ ^. creation of two dispersions of vesicles. The *166. reference'iuggesfcs separately acting dispersions cClipid 
yesicJes, and in no way suggests the mixture of the present invention . ■ - ~" \\" 



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Feb 0? 03^ 09:38p D^^ene Price I 6^^744.-3594 p 



^ ^^ande^li^ -'. 

vehicle. This is also not taught or suggested-by the '166 reference which <5rJy-disclos« the use of these - 
_ _ - b ^«^Jo tbrm lipid yesicU», : ^ 

sepa^ by r^g pie^ in different laye^ < Thesis no ir^gtfthe»im^^ 

-T for N^cetylglucosamirfc (NADG) as the '166 reference teaches that the^NADG is'encapsukted within the "' 
^ lipid vesicle. Therefore, even though as the Examiner points-out "the^vesicJe if added to a phase; because the 
7 NADG is inside the .vesicle; it is not possible .for NADG, per se, to be added drectry to the vehicle: The * 

-NADG stays separated from the vehicle by virtue of the encapsulation. . ' * - * 

- The teachings of the '166 reference are contrary.to the present invention because with the'mixture of - * 
NADG and cholesterol sulfate there is no separation between the two components or the vehicle. The NADG 
in the present invention is directly added to the vehicle as a part of the mixture with'cholesterol sulfate.' Tlrus, . " 
since the '166 reference fails to teach ah NADG added direcfly to the' whide, there is no^teaching or 
suggestion of the mixture of cholesterol stilfate and an NADG.^ - 
demcflstrates, therefore also, that the ?166 reference, atone or in combration with Snbbiab, U St-Patent No. 
6,150,381 (IKe '381 referencOjand Ichinose et al., U.S. Patent No. 5",702.691 ^the £91 reference), fails to ~ 
r rena me preset claims^ _as amended, envious.. Neither the '381 reference nor ^ 
c*8x*-<>f the ^166 reference in failing to teach or suggest either jhe iruxture of the amino sugar" and the . 
cholesterol sulfite or the direct addition of tfc, mixture to the vehicle by their teaching of sclareblide and-white " 

- birch extract in a composition. " r "* 

— " » . ~ - ... . . 

FinaUy.eyenif/aprf/y^ 
present mvention. As noted in tte present specification atpage 4, lines 1 toTI2, it is-unexpected to find that " 
^ two opposing components-wodld not cancel each other out when combined~and .added" as a mixture.to a 
, cornposition. The Examiner responds thaf there arejrany ingredients in Example"l of the present invention. " \ 
- Applicants have explamed^that most of these ingredients are part of the vehicleTand the rekainmg 8 as a whole *• 

"t are not central to the invention' The present invention centers around twolngredients. the cJiolesteV^s'ulW 

^ and the amino sugar, that although tbey have opposing activities, when adtiexl admixture to a pharmaceutical- ~ . 
^ - or cosrnetic vehicle, th'eir activity occurs in tandem, and can uin>]^ 

is surprising is that their activity behaves in this manner without keeping'them physically separate as disclosed 



4 

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Feb 0,5 03 09:3£p 



I^^ene Price 



63^*744-3594 



P. 8 



in thVcited prior .art by sqwirate dispersions of vesicles or by^encapsultfian. Tlus~is a apprising and 
ime^ecled fedmgth^ls not taught » «*■ ^ ~ % 



1 n& ? c cited jtrferences alone nor in combin^ion ^oiild lead^orie 6f«ordinary skill in the 
„ _ to 40 compositions and methods of the present invention, a prima/arte case of obwousness has not bin . 
.established. Applicants request^therefor^lhat the Examiner's rejection under "§103 bTw^drawn. ' " " 



^ ' CONCLUSION ! . ^ " - - . 

In view of the arguments presented above~ in the present submission, the claims are believed to be 
" condition for allowance, and issuance of a Notice of Allowance is respectfully solicited 



in 



Respectfully submitted, 



Date DZfoS/m ? 



Dorene M, Price (Reg.No> 43,018) % 
Estee Lauder Companies 
125 Pinelawn Road - ' 
Melville, NY 11 747„ " ^ 
(631)531-1194- „ * 



Received from < 631,744 3554 > at 2/5/03 9:13:50 PM [Eastern Standard Time] 



Feb 0,5 03 09:39p 



Dffrene Price 



'744-3594 



~ ^ ' MARKED AMENDMENTS ; . / " , * * 

* - / Please amend the claims as followsin their marked fonn. .* :r ~* ^ , ^ 

_ 1. ^composition for topical -application to .the- skin' comprising^ mixmre of [effective amounts" of> 
' -cholesterol sulfate or saltethereof prelent in an amount between 0 n s to aboutloo p ^nt, and an exfohant j 

- present in an amount between 0.1 to about 1 P-pern-nt added to^a- cosmetically or pharmaceutically 
.. -acceptable vehicle. " _ ~ * ~. ~ - ~ ~ 

16. A method for improving or maintaining a healthy-skin barrier which comprises adding an effective 
• , amount of a mixture to a cosmetically-or pharmaceutically acceptable vehicle whereuv'said mixfure 
comprises cholesterol sulfate or salts thereof in an amount from about 0'.05 to about 5.00 percent by Wight • 
•of the composition, and from-about 0. 1 to 1 0.O percent by weight of an amino sugar selected from-the group 
. consisting of N-acetyl-D-gliicosarnme, N-acetylgalactosamine, and. a combination thereof, and applying said 
• vehicle co ntaining said m ixture tn th<» tinV, _ -' " ' •• -. . 

. ' • " " • ■ "* • " - 

18. The method of claim 1 in 'which the composition comprises about 0.05[4] to about 1,00' percent 
cholesterol sulfate. * *. ^ - : . '. 

19. A method of treating or reducing damage to the skin, wherein thedamage is associated with a reduction' 
. m or loss of skin barrier' fraction, which comprises adding an effective amount of a mixture to a cosmetically 

or pharmaceutically acceptable vehicle wherein .said mixture compriseslcholesterol sulfate or salts thereof in 
an amount from about 0.05 : to aboutli.OO percent.and about 0.1 to aboutVo.O percent of an amino -sugar ~ 
selected from the group consisting of N-acetyl-D-glucosamine, N-acetylgalactosamine, and a^combination*- 
t thereof by weight of the composition, and applying said vehicle containin.r sairi miv'tT.^ t n th> .n^. " ^- 

Please cancel claim 2?" — ^ ^ - ~T 



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