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United States Patent and Trademark Office 



UNITED STATES DEPARTMENT OF COMMERCE 
United States Patent and Trademark Office 

Address: COMMISSIONER FOR PATENTS 
P.O. Box 1450 

Alexandria, Virginia 22313-1450 
www.uspto.gov 



APPLICATION NO. 


FILING DATE 


FIRST NAMED INVENTOR 


ATTORNEY DOCKET NO. 


CONFIRMATION NO. 


09/773,351 


01/31/2001 


Daniel H. Macs 


00.22US 


5974 



7590 

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



09/10/2004 



EXAMINER 



JIANG, SHAOJIA A 



ART UNIT 



PAPER NUMBER 



1617 

DATE MAILED: 09/10/2004 



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



PTO-90C (Rev. 10/03) 



Office Action Summary 



Application No. 

09/773,351 



Examiner 

Shaojia A. Jiang 



Applicant(s) 

MAES ET AL 



Art Unit 

1617 



The MAILING DATE of this communication appears on the cover sheet with the 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 be 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 

- 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 § 133) 
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 

Responsive to communication(s) filed on 23 June 2004 . 
2a)M This action is FINAL. 2b)Q This action is non-final. 

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

closed in accordance with the practice under Ex parte Quayle, 1935 CD. 11, 453 O.G. 213. 

Disposition of Claims 

4) KI Claim(s) 1 and 3-20 is/are pending in the application. 

4a) Of the above claim(s) is/are withdrawn from consideration. 

5) D Claim(s) is/are allowed. 

6) [X] Claim(s) 1 and 3-20 is/are rejected. 

7) \3 Claim(s) ■ is/are objected to. 

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

Application Papers 

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

10) D The drawing(s) filed on is/are: a)D accepted or b)D 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). 
Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1 121(d). 

11) D The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152. 

Priority under 35 U.S.C. § 119 

12) Q Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f). 
a)D All b)Q Some * c)D None of: 

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

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

3. Q 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. 



Attachment(s) 

1 ) □ Notice of References Cited (PTO-892) 4) Q | nte rview Summary (PTO-41 3) 

2) |_| Notice of Draftsperson's Patent Drawing Review (PTO-948) Paper No(s)/Mail Date. . 

3) □ Information Disclosure Statement(s) (PTO-1449 or PTO/SB/08) 5) □ Notice of Informal Patent Application (PTO-152) 
Paper No(s)/Mail Date . 6) □ Other: 



U.S. Patent and Trademark Office 



PTOL-326 (Rev. 1 -04) Office Action Summary Part of Paper No./Mail Date 20040825 



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

Art Unit: 1617 

DETAILED ACTION 

This Office Action is a response to Applicant's response (remarks/Arguments) 
filed June 23, 2004 wherein no amendment is filed, i.e., no claims are amended, 
cancelled, or newly submitted. 

Currently, claims 1 and 3-20 are pending in this application. 

Claims 1 and 3-20 are examined on the merits herein. 

Applicant's remarks filed June 23, 2004 with respect to the rejection of claims 1 
and 3-20 made under 35 U.S.C. 1 12 first paragraph for containing new subject matter 
which was not described in the original specification and claims, i.e., the recitation 
"integral with" of record stated in the Office Action dated March 23, 2004 have been fully 
considered and found persuasive to remove the rejection since the recitation "integral 
with" herein would be interpreted as "mixed with" or "a mixture of or "combination with" 
according its plain and ordinary meaning. Therefore, the specification as originally filed 
does provide support for the recitations "mixed with" or "a mixture of or "combination 
with". Therefore, the said rejection is withdrawn. 

For the same reasons as discussed above, Applicant's remarks filed June 23, 
2004 with respect to the rejection of claims 1 and 3-20 made under 35 U.S.C. 112 
second paragraph for the use of the indefinite recitation, i.e., "integral with" of record 
stated in the Office Action dated March 23, 2004 have been fully considered and found 
persuasive to remove the rejection since the recitation "integral with" herein would be 



Application/Control Number: 09/773,351 Page 3 

Art Unit: 1617 

interpreted as "mixed with" or "a mixture of or "combination with" according its plain and 
ordinary meaning. Therefore, the said rejection is withdrawn. 

Claim Rejections - 35 USC § 103 

The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all 
obviousness rejections set forth in this Office action: 

(a) A patent may not be obtained though the invention is not identically disclosed or described as set 
forth in section 1 02 of this title, if the differences between the subject matter sought to be patented and 
the prior art are such that the subject matter as a whole would have been obvious at the time the 
invention was made to a person having ordinary skill in the art to which said subject matter pertains. 
Patentability shall not be negatived by the manner in which the invention was made. 

Claims 1 , 3-4, 6-9, 1 1 and 18 are rejected under 35 U.S.C. 103(a) as being 
unpatentable over Ribier et al. (5,925,364, of record) in view of Sebag et al.(5,41 1 ,742, 
of record) for the same reasons of record in the previous Office Action March 23, 2004. 

Ribier et al. discloses a cosmetic or dermatological composition comprising the 
ionic amphiphilic lipid such as the alkali metal salts of cholesterol sulphate in particular 
the sodium salt in amount of 2-6% by weight preferably 3-4% by weight (see col.3 lines 
43-48 and 54-55, col.4 lines 12-15), salicylic acid (a known exfoliant) (see claim 18 at 
col. 15 line 6), keratolytic agents (known exfoliants) (see col.5 line 36, claim 15 at col. 14 
line 49), fatty acids broadly (see col.4 line 60, claim 18 at col. 15 line 5), and Centella 
asiatica extract (see col.4 line 64, claim 18 at col. 15 line 8). The cosmetic or 
dermatological composition Ribier et al. is known to topically apply to skin. 



Application/Control Number: 09/773,351 Page 4 

Art Unit: 1617 

Ribier et al. does not expressly disclose the employment of the particular fatty 
acid, linoleic acid, and cholesterol in the composition herein. The prior art does also not 
expressly disclose the amounts of an exfoliant in the composition herein. 

Sebag et al. discloses a cosmetic or dermatological composition comprising the 
salts of cholesterol (see col .2 line 34), salicylic acid or its derivatives (known exfoliants) 
in amounts of 3-10% by weight (see abstract, col .3 lines 26-36), keratolytic agents 
(known exfoliants) (see col.6 line 66), the particular fatty acid, linoleic acid (see claim 10 
at col. 17 line 17), and cholesterol (see claim 8 at col. 17 lines 5-6). 

It would have been obvious to a person of ordinary skill in the art at the time the 
invention was made to employ the particular fatty acid, linoleic acid, and cholesterol in 
the composition of Ribier and to optimize the effective amounts of an exfoliant in the 
composition herein to about 10% by weight. 

One having ordinary skill in the art at the time the invention was made would 
have been motivated to employ the particular fatty acid, linoleic acid, and cholesterol in 
the composition of Ribier since fatty acids broadly and the particular fatty acid, linoleic 
acid, are known to be useful in a cosmetic or dermatological for of treating skin based 
on the prior art. Moreover, cholesterol is well known to be used a cosmetic or 
dermatological for of treating skin according Sebag. Therefore, one of ordinary skill in 
the art would have reasonably expected that combining the composition of Ribier and 
the composition of Sebag known useful for the same purpose, treating skin, in a 
composition to be administered would improve the therapeutic effect for treating skin. 



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

Art Unit: 1617 

Since all active composition components herein are known to useful to treat skin, 
it is considered prima facie obvious to combine them into a single composition to form a 
third composition useful for the very same purpose. At least additive therapeutic effects 
would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 
1980). 

Additionally, one of ordinary skill in the art would have been motivated to 
optimize the effective amounts of the alkali metal salts of cholesterol sulphate and an 
exfoliant in the composition because their amounts are known in the art and the 
optimization of known amounts of active agents to be administered is considered well 
within the skill of artisan. It has been held that it is within the skill in the art to select 
optimal parameters, such as amounts of ingredients, in a composition in order to 
achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980). 

Thus the claimed invention as a whole is clearly prima facie obvious over the 
combined teachings of the prior art. 

Response to Argument 

Applicant's remarks filed June 23, 2004 with respect to this rejection made under 
35 U.S.C. 103(a) as being unpatentable over Ribier et al. (5,925,364) in view of Sebag 
et al.(5,41 1 ,742) in the previous Office Action March 23, 2004 have been fully 
considered but are not deemed persuasive as to the nonobviousness of the claimed 
invention over the prior art as further discussed below. 

Applicants assert that "the formation of discrete layers of a lipid vesicle is 
precisely what occurs when the ionic lipid is mixed in the '364 preparation." and "The 



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

Art Unit: 1617 

'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 composition, namely the outside media (e.g., the aqueous 
phase). Applicants also argue that "There is a stark contrast between the act of mixing 
and the act of producing a mixture" and "In none of the cited references does the act of 
mixing produce a mixture". 

Applicants' assertion and argument are not found convincing. Again, Applicant is 
requested to note that that the instant claims are not limited to "the act of mixing 
produce a mixture" and in what orderly manner to form discrete layers of a vesicle 
dispersed in the aqueous phase. The instant claims merely recite a composition 
comprising a mixture of effective amounts of cholesterol sulfate or salts thereof, integral 
with or mixed with an exfoliant in a cosmetically or pharmaceutical^ acceptable vehicle. 
However, the features upon which applicant argue and assert, are not recited in the 
rejected claim(s). Although the claims are interpreted in light of the specification, 
limitations from the specification are not read into the claims. See In re Van Geuns, 988 
F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, it is irrelevant whether the 
reference includes those features or not. 

For the above stated reasons, said claims are properly rejected under 35 U.S.C. 
103(a). Therefore, said rejection is adhered to. 

Claim Rejections - 35 USC § 102 

The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that 
form the basis for the rejections under this section made in this Office action: 



Application/Control Number: 09/773,351 Page 7 

Art Unit: 1617 

A person shall be entitled to a patent unless - 

(b) the invention was patented or described in a printed publication in this or a foreign country or in public 
use or on sale in this country, more than one year prior to the date of application for patent in the United 
States. 

Claims 1 and 3-9 are rejected under 35 U.S.C. 102(b) as being anticipated by 
Ribier et al. (5,650,166) for the same reasons of record in the previous Office Action 
March 23, 2004. 

Ribier et al. discloses a moisturizing composition for the treatment of surface and 
deep layers of the skin clear comprising the instant ingredients such as cholesterol 
sulfate in the salt of alkali metal (including potassium) (see col.3 lines 64-67), N- 
acetylglucosamine (see col. 5, lines 59-67), the particular sterol, cholesterol (see col.3 
line 60 and col. 6, lines 47-49), fatty acids, including linoleic acid (see col. 6, lines 44- 
46). Ribier' 1 66 further teaches the use of plant extracts (see col. 7, lines 5-8). The 
compositions of Ribier et al. may be emulsion, gel, lotion, and ointment forms (see col.7 
lines 10-14). 

Thus, the disclosure of Ribier et al. anticipates Claims 1 and 3-9. 

Response to Argument 

Applicant's remarks filed June 23, 2004 with respect to this rejection made under 
35 U.S.C. 102(b) as being anticipated by Ribier et al. (5,650,166) in the previous Office 
Action March 23, 2004 have been fully considered but are not deemed persuasive as to 
the nonobviousness of the claimed invention over the prior art as further discussed 
below. 

Applicants ague that the arrangement in the '166 Ribier reference is not a. 
mixture" as one of ordinary skill in the art would understand it" and "Two ingredients that 



Application/Control Number: 09/773,351 Page 8 

Art Unit: 1617 

are separated from one another, as they are in the '166 Ribier by virtue of the vesicle 
formations cannot be a mixture or be integral with one another because they arc not 
actually combined". 

Again, Applicants' assertion and argument are not found convincing. As pointed 
out above, that the instant claims are not limited to what is the way or manner the 
ingredients of prior art combine or mix" and "the act of mixing produce a mixture" or in 
what orderly manner to form discrete layers of a vesicle dispersed in the aqueous 
phase. The instant claims merely recite a composition comprising a mixture of effective 
amounts of cholesterol sulfate or salts thereof, integral with or mixed with an exfoliant in 
a cosmetically or pharmaceutical^ acceptable vehicle. However, the features upon 
which applicant argue and assert, are not recited in the rejected claim(s). Although the 
claims are interpreted in light of the specification, limitations from the specification are 
not read into the claims. See In re Van Geuns, 988 F.2d 1 181, 26 USPQ2d 1057 (Fed. 
Cir. 1993). Therefore, it is irrelevant whether the reference includes those features or 
not, so long as the prior art discloses a composition comprising the same ingredients. 

Claim Rejections - 35 USC § 103 

The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all 

obviousness rejections set forth in this Office action: 

(a) A patent may not be obtained though the invention is not identically disclosed or described as set 
forth in section 1 02 of this title, if the differences between the subject matter sought to be patented and 
the prior art are such that the subject matter as a whole would have been obvious at the time the 
invention was made to a person having ordinary skill in the art to which said subject matter pertains. 
Patentability shall not be negatived by the manner in which the invention was made. 



Application/Control Number: 09/773,351 Page 9 

Art Unit: 1617 

Claims 13-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over 
Ribier et al. (5,650,1 66) for the same reasons of record in the previous Office Action 
March 23, 2004. 

The same disclosure of Ribier et al. (5,650,166) has been discussed in the 
102(b) rejection set forth above. 

The cited prior art does not expressly disclose that the amount of the each 
instant ingredient. 

It would have been obvious to a person of ordinary skill in the art at the time the 
invention was made to employ the amount of the known particular agents taught in 
Ribier et al. 

One having ordinary skill in the art at the time the invention was made would 
have been motivated to employ the amount of the known particular agents taught in 
Ribier et al. since the determination or optimization of amounts of known cosmetic 
agents, is considered well within conventional skills in pharmaceutical science, involving 
merely routine skill in the art. 

It has been held that it is within the skill in the art to select optimal parameters, 
such as amounts of ingredients, in a composition in order to achieve a beneficial effect. 
See In re Boesch, 205 USPQ 215 (CCPA 1980). 

Claims 10-12 and 20 are rejected under 35 U.S.C. 103(a) as being unpatentable 
over Ribier et al. (5,650,1 66) further in view of Subbiah (6,150,381) and Ichinose etal. 
(5,702,691 ) for reasons of record stated in the Office Action dated March 23, 2004. 



Application/Control Number: 09/773,351 Page 10 

Art Unit: 1617 

The claims are directed to compositions further comprising sclareolide and white 
birch extract. 

The same disclosure of Ribier et al. (5,650,166) has been discussed in the 
102(b) rejection set forth above. 

The cited prior art does not expressly disclose the employment of sclareolide and 
white birch extract. 

It would have been obvious to a person of ordinary skill in the art at the time the 
invention was made to add or employ sclareolide and white birch extract in the 
composition of Ribier et al. 

Subbiah teaches the use of sclareolide in topical formulations, padicularly for cne 
(see abstract). Sclareolide is taught in combination with other ingredients (see col. 5, 
line 6 through col. 7, line 12). Subbiah teaches that sclareolide has antimicrobial activity 
that is useful in the treatment of acne (see col. 4, lines 45-65). 

Ichinose teaches that white birch extracts are known anti-inflammatory agents 
(see col . 5, lines 4-13). 

It would have been obvious to one of ordinary skill in the art at the time the 
invention was made to have modified the compositions of Ribier '166 by the addition of 
sclareolide for its anti-acne properties as taught by Subbiah and by the addition of white 
birch extract for its anti-inflammatory properties as taught by Ichinose. The motivation 
for the modification comes from the benefit of such propedies in formulating cosmetic 
compositions. The missing ingredients have art-recognized suitability for the intended 
purpose of formulating cosmetic compositions. The selection of a known material based 



Application/Control Number: 09/773,351 Page 1 1 

Art Unit: 1617 

on its suitability for its intended use has been determined to be prima facie obvious. See 
Sinclair & Carroll Co. F. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)., In re 
Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960); and MPEP 2144.07. 

Response to Argument 

Applicant's remarks filed June 23, 2004 with respect to the rejection of Claims 
13-20 made under 35 U.S.C. 103(a) over Ribier et al. (5,650,166) have been fully 
considered but are not deemed persuasive as to the nonobviousness of the claimed 
invention over the prior art as discussed above. 

In particular, note that the instant claims are not limited to the particular form of 
mixture, and moreover, Ribier et al. teaches the compositions therein for topical use in 
emulsion, gel, lotion, and ointment forms. 

Applicant's argument that the cited Ribier et al. (5,650,166) does not teach 
NADG directly added to a vehicle, is not found convincing. The instant claims are not 
limited to specific method in a specific method steps for the preparation of the instant 
composition. Therefore, it is irrelevant whether the reference includes those features or 
not. 

Further, Applicant's one Example shown in the specification at pages 8-10 herein 
have been fully considered but are not deemed persuasive as to the nonobviousness 
and/or unexpected results of the claimed invention over the prior art for the reasons 
below. Example 1 provides no clear and convincing evidence of nonobviousness or 
unexpected results over the cited prior art since there is no comparison to the same 
present. Therefore, the evidence presented in specification herein is not seen to be 



Application/Control Number: 09/773,351 



Page 12 



Art Unit: 1617 

clear and convincing in support the nonobviousness of the instant claimed invention 
over the prior art. 

For the above stated reasons, said claims are properly rejected under 35 U.S.C. 
103(a). Therefore, said rejection is adhered to. 



Double Patenting 

The nonstatutory double patenting rejection is based on a judicially created 
doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the 
unjustified or improper timewise extension of the "right to exclude" granted by a patent 
and to prevent possible harassment by multiple assignees. See In re Goodman, 11 
F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 
USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 
1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970);and, In re Thorington, 
418 F.2d 528, 163 USPQ 644 (CCPA 1969). 

A timely filed terminal disclaimer in compliance with 37 CFR 1 .321(c) may be 
used to overcome an actual or provisional rejection based on a nonstatutory double 
patenting ground provided the conflicting application or patent is shown to be commonly 
owned with this application. See 37 CFR 1 .130(b). 

Effective January 1 , 1 994, a registered attorney or agent of record may sign a 
terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 
37 CFR 3.73(b). 



Claims 1 and 3-20 are provisionally rejected under the judicially created doctrine 
of obviousness-type double patenting as being unpatentable over claims 1-21 of 
copending Application No. 10/424,616 for reasons of record stated in the Office Action 
dated March 23, 2004. 

Although the conflicting claims are not identical, they are not patentably distinct 
from each other because both the copending application and the instant application are 
drawn to a skin/cosmetic composition containing cholesterol sulfate, fatty acids, and a 



sterol (such as cholesterol) and methods employing the compositions. 



Application/Control Number: 09/773,351 Page 13 

Art Unit: 1617 

Thus, the copending Application No. 10/424,616 and the instant claims are seen 
to substantially overlap. 

Thus, the instant claims are seen to be obvious over the all claims of copending 
Application No. 10/424,616. 

This is a provisional obviousness-type double patenting rejection because the 
conflicting claims have not in fact been patented. 

Note that Applicants did not argue this provisional obviousness-type double 
patenting rejection in the remarks filed June 23, 2004. 

In view of the rejections to the pending claims set forth above, no claims are 
allowed. 

THIS ACTION IS MADE FINAL. 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 event, however, will the statutory period for reply expire later 
than SIX MONTHS from the mailing date of this final action. 



Application/Control Number: 09/773,351 



Page 14 



Art Unit: 1617 

Any inquiry concerning this communication or earlier communications from the 
examiner should be directed to Examiner Jiang, whose telephone number is (571)272- 
0627. The examiner can normally be reached on Monday-Friday from 9:00 to 5:00. 

If attempts to reach the examiner by telephone are unsuccessful, the examiner's 
supervisor, Sreenivasan Padmanabhan, Ph.D., can be reached on (571)272-0629, The 
fax phone number for the organization where this application or proceeding is assigned 
is 703.872.9307. 

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