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United States Bvtent and IkADEMARK Qftice 



UNITED STATES DEPARTMENT OF COMMERCE 

United States Patent and Trademark OCGce 

Addresa: COMMISSIONER OF PATENTS AND TRAITEMARKS 

Washington. D.C. 20231 

H'ww.uspto.gov 



APPLICATION NO. 



FILING DATE 



FIRST NAMED INVENTOR 



ATTORNEY DOCKET NO. 



CONHRMATION NO. 



09/773.351 



01/31/2001 



Daniel H. Maes 



00.22US 



5974 



7590 



05/01/2002 



Karen A. Lowney, Esq. 
Estee Lauder Companies 
125 Pinelawn Road 
Melville, NY 11747 



EXAMINER 



WILLIS, MICHAEL A 



ART UNIT 



PAPER NUMBER 



1617 

DATE MAILED: 05/01/2002 



Please find below and/or attached an Office communication concerning this application or proceeding. 



PTO-90C (Rev. 07-01) 



Office Action Summary 



Applicati n N 

09/773,351 



Examiner 

Michael A. Willis 



Applicant(s) 

MAES ETAL 



Art Unit 

1617 



- The MAILING DATE of this communication appears n the cover sheet with th correspondence address 
Period for Reply 

A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) FROM 
THE MAILING DATE OF THIS COMMUNICATION. 

- Extensions of time may t>e available under the provisions of 37 CFR 1 .136(a). In no event, however, may a reply be timely filed 
after SIX (6) MONTHS from the mailing date of this communication. 

- If the period for reply specified above is less than thirty (30) days, a reply within the statutory minimum of thirty (30) days will be considered timely. 

- If NO period for reply Is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication. 

- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 1 33). 

- Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any 
earned patent term adjustment. See 37 CFR 1.704(b). 

Status 

1 )^ Responsive to communication(s) filed on 12 April 2002 , 
2a)^ This action is FINAL. 2b)n This action is non-final. 

3) n Since this application is in condition for allowance except for fomrial matters, prosecution as to the merits is 

closed in accordance with the practice under Ex parte Quayle, 1935 CD. 1 1 , 453 O.G. 213. 
Disposition of Claims 

4) ^ Claim(s) 1-20 is/are pending in the application. 

4a) Of the above claim(s) is/are withdrawn from consideration. 

5) 0 Claim{s) is/are allowed. 

6) ^ Claim(s) 1-20 is/are rejected. 
?)□ Claim(s) is/are objected to. 

8) n Claim(s) are subject to restriction and/or election requirement. 

Application Papers 

9) n The specification is objected to by the Examiner. 

10)n The drawing(s) filed on is/are: a)n accepted or b)^ objected to by the Examiner. 

Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1 .85(a). 
1 1 )0 The proposed drawing correction filed on is: a)D approved b)0 disapproved by the Examiner. 

If approved, corrected drawings are required in reply to this Office action. 

12) D The oath or declaration is objected to by the Examiner. 
Priority under 35 U.S.C. §§ 119 and 120 

13) 0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f). 

a)nAII b)n Some*c)n None of: 

1 .□ Certified copies of the priority documents have been received. 

20 Certified copies of the priority documents have been received in Application No. . 



3.n Copies of the certified copies of the priority documents have been received in this National Stage 
application from the International Bureau (PCT Rule 17.2(a)). 
* See the attached detailed Office action for a list of the certified copies not received. 

14) 0 Acknowledgment is made of a claim for domestic priority under 35 U.S.C. § 1 19(e) (to a provisional application). 

a) □ The translation of the foreign language provisional application has been received. 

15) 0 Acknowledgment is made of a claim for domestic priority under 35 U.S.C. §§ 120 and/or 121. 
Attachment(s) 

4) n Interview Summary (PTO-41 3) Paper No(s). . 



1) □ Notice of References Cited (PTO-892) 

2) d Notice of Draflsperson's Patent Drawing Review (PTO-948) 

3) CH Information Disclosure Statement(s) (PTO-1449) Paper No(s). 



5) n Notice of Informal Patent Application (PTO-1 52) 

6) n Other: 



U.S, Patent and Tradeirark Office 
PTO-326 (Rev. 04-01) 



Office Action Summary 



Part of Paper No. 13 



Application/Control Number: 09/773,351 Page 2 

Art Unit: 1617 

DETAILED ACTION 

Applicant's Request for Continued Examination of 12 April 2002 is entered. Claims 1-20 
are pending. Any previous rejections that are not restated in this Office Action are 
hereby withdrawn. The text of those sections of Title 35, U.S. Code not included in this 
action can be found in a prior Office action. 



Response to Arguments 

Claim 19 is rejected under 35 USC 1 12, 1®* paragraph, for lack of enablement 
due to the phrase "or preventing". 

Applicant argues that, while damage to the skin cannot be predicted in its 
entirety, there are specific types of damage that the skin may experience that are 
predictable. For example, applicant cites from US Patent Re. 36,068 that a decreased 
sensitivity to pain is a predictable characteristic of sun-damaged skin. Further, applicant 
argues that damage that is "associated" with a reduction or loss of skin barrier function 
includes UV-damage, degradation of collagen, and wrinkling and skin atrophy. Applicant 
argues that there is an ability to predict with great accuracy the damage associated with 
a reduction or loss of skin barrier function. 

In response, applicant's assertion that there is an ability to predict with great 
accuracy the damage associated with a reduction or loss of skin barrier function is 
completely without merit. To the examiner's knowledge, there is no data to allow such a 
prediction. For example, there is no data in the specification or the prior art that would 
allow one of ordinary skill in the art to predict the exact number of skin wrinkles on a 




Application/Control Number: 09/773.351 Page 3 

Art Unit: 1617 

particular individual's face given a measurement of 32% reduction of skin barrier 
function for that individual. While the examiner concedes that broad correlations may 
exist between the loss or reduction of skin barrier function and various trends in the 
pathology of skin, such correlations neither prove causality nor allow for accurate 
predictions in any particular individual. Simply put, the prediction of the exact amount of 
skin pathology such as the level of collagen degradation or skin atrophy in an individual 
based on the measurement of skin barrier function is beyond the current state of the art. 
Without such predictive capability, a claim to the prevention of such symptoms lacks 
enablement. 

With respect to the definition of "prevention", applicant provides a dictionary 
definition as "to keep from occurring". Applicant argues that to reduce a condition that 
already exists inherently prevents that condition. This is incorrect. Treatment of a 
condition after the fact is quite different from prevention. For example, a vaccine to 
prevent an infection is different from antibiotic treatment after infection has occurred. 

Claims 1-20 are rejected under 35 USC 103(a) as being unpatentable over Ribier 
et al (US Pat. 5,650,166) in view of Subbiah (US Pat. 6,150,381) for reasons as stated 
previously. 

Applicant argues that the example of vesicle formation by simple stirring as 
pointed out previously by the Examiner "does not teach or suggest a simple mixture of 
an exfoliant and cholesterol sulfate which are the actives of the present invention". 



Application/Control Number: 09/773.351 Page 4 

Art Unit: 1617 

In response to applicant's argument, the test for obviousness is not that the 
claimed invention must be expressly suggested in any one or all of the references. 
Rather, the test is what the combined teachings of the references would have 
suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 
USPQ 871 (CCPA 1981). In the instant case, the teachings of Ribier and Subbiah 
suggest a mixture of exfoliant and cholesterol sulfate. Applicant's argument that Ribier 
does not teach N-acetyl glucosamine as being a surface diffusing active is moot, 
because such a teaching is not required to suggest the mixture of N-acetyl glucosamine 
and cholesterol sulfate. As stated previously, the term "mixture" is not limited to random 
solutions, but includes ordered compositions such as vesicles. 

Applicant argues that the '166 reference teaches away from the instant invention 
of a "simple mixture" because of the use of vesicles in the '166 reference. However, as 
stated previously, applicant's reliance on the features of a "simple mixture" is not 
supported by the claims or the specification. The specification clearly states that "the 
combination of these two components can be applied in any type of cosmetically or 
pharmaceutically acceptable vehicle for topical application with which the active 
component is compatible" (page 5, lines 12-13 of the specification). The term "mixture" 
as claimed is broadly interpreted by the examiner to include both random and ordered 
compositions. 



Application/Control Number: 09/773,351 Page 5 

Art Unit: 1617 

Conclusion 

This is an RCE. All claims are drawn to the same invention claimed in the earlier 
application and could have been finally rejected on the grounds and art of record in the 
next Office action if they had been entered in the earlier application. Accordingly, THIS 
ACTION IS MADE FINAL even though it is a first action of the RCE. See MPEP 
§ 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 
CFR 1.136(a). 

A shortened statutory period for reply to this final action is set to expire THREE 
MONTHS from the mailing date of this action. In the event a first reply is filed within 
TWO MONTHS of the mailing date of this final action and the advisory action is not 
mailed until after the end of the THREE-MONTH shortened statutory period, then the 
shortened statutory period will expire on the date the advisory action is mailed, and any 
extension fee pursuant to 37 CFR 1 .136(a) will be calculated from the mailing date of 
the advisory action. In no, however, event will the statutory period for reply expire later 
than SIX MONTHS from the mailing date of this final action. 

Any inquiry concerning this communication or earlier communications from the 
examiner should be directed to Michael A. Willis whose telephone number is (703) 305- 
1679. The examiner can normally be reached on Mon. to Fri. from 9 a.m. to 5:30 p.m. 

If attempts to reach the examiner by telephone are unsuccessful, the examiner's 
supervisor, Minna Moezie can be reached on (703) 308-4612. The fax phone numbers 
for the organization where this application or proceeding is assigned are (703) 872-9306 
for regular communications and (703) 872-9307 for After Final communications. 



Application/Control Number: 09/773,351 Page 6 

Art Unit: 1617 

Any inquiry of a general nature or relating to the status of this application or 
proceeding should be directed to the receptionist whose telephone number is (703) 308- 




Examiner 
Art Unit 1617 

April 25, 2002