Skip to main content

Full text of "USPTO Patents Application 09773351"

See other formats


( 1 w 

□CT-01-2002 17:54 H^STEE LAUDER LEGAL DEPT v 631 531 1340 P. 07 



6 



^ . < 

amount of a mixture to a cosmetically--or^Srrnaceutica]ly acceptable vehicle wherein said mixture 

comprises cholesterol sylfetg*orsalts thereof in an amount from about 0.05 to about 5.00 percent by weight 

of the composttiefCaad fr° m about 0.1 to 10.0 percent by weight of an amino sugar selected from the group 

consisting^N-acetyl-D'glucosamine, N-acctylgalactosamine, and a combination thereof, and applying said 

mixtdre to the skin. 



19. A method of treating or reducing damage to the skin, wherein the damage is associated with a reduction 
or loss of skin barrier function, which comprises adding an effective amount of a mixture to a cosmetically 
or pharmaceutical ly acceptable vehicle wherein said mixture comprises cholesterol sulfate or salts thereof in 
an amount from about 0.05 to about 5.00 percent, and about 0.1 to about 10.0 percent of an amino sugar 
selected from the group consisting of N-acclyND-glucosamine, N-acetylgalactosamine, and a combination 
thereof by weight of the composition, and applying said mixture to the skin. 



REMARKS 

The Examiner maintained the rejection of claim 19 under section 1 12, first paragraph for failing to 
describe subject matter such thai one of ordinary skill in the art would be enabled to make and/or use the 
present invention. Specifically, the Examiner asserts that the specification lacks enablement for 
"preventing" damage to the skin. The Examiner's position is based on the reasoning that damage to the skin 
cannot be adequately predicted such that it is not possible to determine if damage has been prevented. In 
addition, in response to the submission of other patents using die term preventing", the Examiner points out 
that each application is examined on its own merits. While Applicants maintain their position as provided in 
previous responses, Applicants amend claim 19 according to the Examiner's suggestion. Thus, Applicants 
respectfully request that the Examiner's rejections based on lack of enablement under 35 U.S.C. §112 ? first 
paragraph be withdrawn. 

The Examiner maintains in the Final Office Action and comments on the rejection in the Advisory 
Action that Ribier et al. (U.S. Patent No. 5,650,166; "the '166 reference") in view of Subbiah (U.S. Patent 
No. 6,150,381; "the '381 reference") renders claims 1 to 20 of the present invention obvious under 35 
U.S.C. § 103(a) because a mixture includes ordered compositions like the lipid vesicles taught in the '166 
reference. However, there is no support provided to indicate why or how one of ordinary skill in the art 
would understand that a mixture of the present invention is taught or suggested by a lipid vesicle described 
in the '166 reference. There is no teaching, suggestion or motivation in the art or the knowledge of one of 
ordinary skill in the art to support the assertion that mixing components is equivalent to or includes 
encapsulating components. As previously mentioned by Applicants, lipid vesicles are a discrete arrangement 
of its components. However, assuming arguendo, that one of ordinary skill in the art could find a that a 



2 

Received from < 631 531 13-10 > at 10)1/02 5:48:15 [Eastern Daylight Time] 



^OCT-01-2002 17:54 




BTEE LAUDER LEGAL DEPT 



G 



631 531 1340 



P. 08 



lipid vesicle is a subset of a mixture, the disclosure of this subset of a mixture is not a disclosure of the other 
subset of a randomly oriented combination. Thus, Applicants assert that the other subset of the term 
"mixture/' namely the random solution of components achieved by addition of the components to a 
pharmaceutical or cosmetic vehicle is not taught or suggested by the "166 reference. As the Examiner has 
admitted and described the term "mixture" in the Advisory Action as being a broad term including as a 
subset, lipid vesicles, it is logical to conclude that the term "mixture" also includes a random solution of 
components, and is generally disclosed in the present invention. 

The claims of the present invention are amended such that the mixture of cholesterol sulfate and 
exfoliant, N-acetyl glucosamine are added to a pharmaceutical or cosmetically acceptable vehicle. Support 
for this amendment is found in the present specification at page 5, lines 12 to 25, and no new matter is 
added. Specifically, in this section of the present specification, it is disclosed that the mixture of cholesterol 
sulfate and amino sugar are added to the vehicle of both therapeutic products and color cosmetic products, 
alike. This is not taught or suggested by the ' 166 reference which only discloses the use of these ingredients 
to form lipid vesicles. As taught at column 3, lines 57 to 67, the lipid membrane of the 6 166 vesicles can 
contain, inter alia, the cholesterol sulfate, and as taught at column 5, lines 59 to 67, the deep down acting 
active agent encapsulated inside of the vesicle can be N-acetylglueosamine. But, these two ingredients are 
not mixed. Their only relationship is that N-acetylglueosaime can be an active agent contained inside of the 
lipid vesicle formed by among other ingredients, cholesterol sulfate. There is no mixing of these 
ingredients, and the vesicles, not the ingredients themselves, are contained in a medium as taught at column 
8, lines 32 to 35. This is especially true for N-acctylglucosamine as the '166 reference fails to teach or 
suggest adding the N-acetylglucosamine directly to a vehicle because it leaches that the N- 
acctylglucosamine is encapsulated within the lipid vesicle. Thus, since the 466 reference fails to teach an 
amino sugar added directly to the vehicle, there is no teaching or suggestion of the mixture of cholesterol 
sulfate and an amino sugar added to the vehicle by the 1 166 reference. This demonstrates, therefore, that the 
M66 reference, alone or in combination with the '381 reference, fails to render the present claims, as 
amended, obvious. 

Finally, even if, a prima facie case could be made, it would be rebutted by the surprising results of 
the present invention. As noted in the present specification at page 4, lines 1 to 12, it is unexpected to find 
that two opposing components would not cancel each other out when combined and added as a mixture to a 
composition. The Examiner notes in the Advisory Action that the composition in Example 1 contains 29 
ingredients, and its activity on the skin is compared to skin that is untreated. From this the Examiner finds 
that meaningful conclusions about the combined activity of 2 out of 29 ingredients in the comparison cannot 
be made. The fact that there are 27 additional ingredients is not of primary importance in comparison to 
what those other 27 ingredients are. Most of those additional ingredients, about two-thirds, arc those 



3 

Received from < 631 531 1340 > at 10/1/02 5:48:15 FM [Eastern Daylight Time] 



.□CT-01-2002 17:55 



[STEE LAUDER LEGAL DEPT 



631 531 1340 



P. 09 



commonly found in a pharmaceutical or cosmetic vehicle, e.g., surfactant, propylene glycol, squalane, BHT, 
butylene glycol, water, carbowax PEG 3350, dimethicone copolyol, glyeereth-26, glucam-E20, 
methylparaben, trisodium EDI A, allantoin, keltrol, carbopol 981, triethanolamine, phcnoxyethanol, benzyl 
alcohol, and pigments, some of which are described al page 7, lines 16 to 30. The remaining 8 ingredients 
are sclareolide, white birch, chamomile, bisabolol, wheat bran extract, olive extract, and linolcic acid and 
they represent examples of the naturally occurring skin barrier component described in the present invention 
as the preferred embodiment at page 5, line 26 to page 7, line 15. However, the present invention begins 
with the finding that two ingredients, the cholesterol sulfate and the amino sugar, 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 is a surprising and unexpected finding that is not taught or suggested by the cited references, 
alone or combined. 

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 §1 03 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 respectfidly solicited. 



CONCLUSION 



Respectfully submitted, 





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



4 

Received rrom < 631 531 1340 > at 1G/1/02 5:48:15 PM [Eastern Daylight Time] 



OCT-01-2002 17:55 ^STEE LAUDER LEGAL DEPT 631 531 1340 P. 10 

MARKED AMENDMENTS 

Please amend the claims as follows in then- marked form. 

1. A composition for topical application to the skin comprising a mixture of effective amounts of 
cholesterol sulfate or salts thereof, and an cxfoliant added to a co s metically or pharmaceuticallv acceptable 
vehicle . 

13. A cosmetic or pharmaceutical formulation for topical application of a composition to the skin, the 
formulation containing a mixture comprising cholesterol sulfate or salts thereof in an amount from about 
0.05 to about 5.00 percent, and from about 0.1 to about 10.0 percent by weight of an amino sugar selected 
from the group consisting of N-aceryl-D-glucb$amine, N-acetylgalactosamine, and a combination thereof by 
weight of the ^impositio n added to a cosmetically or pharmace uticallv acceptable vehicle- 

16. A method for improving or maintaining a healthy skin barrier which comprises[ applying to the skin ] 
adding a n effective amount of a mixture to a cosmetically or pharmaceutical lv acceptable vehicle wherein 
said mixture [comprising 1 comprises cholesterol sulfate or salts thereof in an amount from about 0.05 to 
about 5.00 percent by weight of the composition, and from about 0.1 to 10.0 percent by weight of an amino 
sugar selected from the group consisting of N-acetyl-D-glucosamine, N-acetylgalactosamine, and a 
combination thereo f, and applying sai d mixture to the skin. 

19. A method of treating or [preventing] reducing damage to the skin, wherein the damage is associated 
with a reduction or loss of skin barrier function, which comprises [applying to the skin ] adding an effective 
amount of a mixture to a cosmetically or phar m aceuticals acceptable vehicle wherein said mixture 
[comprising 1 comprise s cholesterol sulfate or salts thereof in an amount from about 0.05 to about 5.00 
percent, and about 0.1 to about 10.0 percent of an amino sugar selected from the group consisting of N- 
acctyl-D-glucosamine, N-acetylgalactosamine, and a combination thereof by weight of the compOSition i fflid 
applying said mixture to the skin . 



5 

Received from < 631 531 1340 > at 10/1/02 5:48:15 PM [Eastern Qaylight Time] 



TOTAL P. 10