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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 
155 Pinelawn Road 
Melville, NY 11747 



04/12/2006 



EXAMINER 



COTTON, ABIGAIL MANDA 



ART UNIT 



PAPER NUMBER 



I6I7 

DATE MAILED: 04/12/2006 



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



PTO-90C (Rev. 10/03) 



Office Action SummBrv 


Application No. 

09/773,351 


Applicant(s) 

MAES ET AL. 


Examiner 

Abigail M. Cotton 


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) OR THIRTY (30) DAYS. 
WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION. 

- Extensions of time may be available under the provisions of 37 CFR 1 . 1 36(a). In no event, however, may a reply be timely filed 
after SIX (6) MONTHS from the mailing date of this communication. 

- 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 13 January 2006 . 
2a)K This action is FINAL. 2b)n This action is non-final. 

3) n 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) ^ Claim(s) 1 and 3-20 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4a) Of the above claim(s) is/are withdrawn from consideration. 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 and 3-20 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)0 The drawing(s) filed on is/are: ajD accepted or b)n 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). 
1 1 )□ The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-1 52. 

Priority under 35 U.S.C. § 119 

12)n Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 1 19(a)-(d) or (f). 
a)D All b)n Some * c)^ None of: 

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

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

3. D 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) □ Inten/iew Summary (PTO-413) 

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

3) T2vInformation Disclosure StateMenl(s) CPTO-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. 7-05) Office Action Summary Part of Paper No./Mail Date 14 



Application/Control Number: 09/773,351 
Art Unit: 1617 



Page 2 



DETAILED ACTION 

This office action is in response to the amendment submitted January 13. 2006. 
Claims 1 and 3-20 are pending in the application, and are being examined on the merits 
herein. 

The Examiner acknowledges Applicant's indication that, if a necessary, a 
terminal disclaimer will be filed to obviate the provisional obviousness-type double 
patenting rejection over co-pending Application No. 10/424,616, in the event that 
allowable subject matter is indicated. However, as no terminal disclaimer has as-yet 
been filed, the provisional obviousness-type double patenting rejection is being 
maintained. 

Applicant's arguments regarding the rejections of the claims over the prior art 
have been fully considered but they are not persuasive. The rejections of record are 
being maintained. 

The claims are rejected as follows. 



Application/Control Number: 09/773,351 
Art Unit: 1617 



Page 3 



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: 
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 as in the previous action dated 
August 18, 2005. 

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- 
acetyglucosamine (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 et al. further teaches the use of plant extracts (see col. 7, lines 5-8.) The 
compositions of Ribier et al. may be an emulsion, gel, lotion, and ointment form (see 
col. 7, lines 10-14.) 

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



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

Art Unit: 1617 

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 102 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, 11 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 as stated in the previous Office Action mailed 

on August 18, 2005. 

Ribier et al. discloses a cosmetic or dermatological composition comprising the 
ionic amphiphilic lipids such as the alkali metal salts of cholesterol sulphate, in particular 
the sodium salt, in an amount of 2-6% by weight, and preferably 3-4% by weight (see 
col. , 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, lines 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 1 at col. 15 line 8.) The cosmetic 
or dermatological composition of Ribier et al. is known to be topically applicable to skin. 



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

Art Unit: 1617 

Ribier et al. does not expressly disclose the employment of the particular fatty 
aid, linoleic acid, and cholesterol in the composition herein. The prior art also does not 
expressly disclose the amount 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 3), salicylic acid or its derivatives (known exfoliants) 
in amount 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 et al and to optimize the effective amounts of 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 et al, since fatty acids broadly and the particular fatty acid, 
linoleic acid, and known to be useful in a cosmetic or dermatological composition for 
treating skin based on the prior art. Moreover, cholesterol is well known to be used as a 
cosmetic or dermatological composition for treating skin according to Sebag. Therefore, 
one of ordinary skill in the art would have reasonably expected that combining the 



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

Art Unit: 1617 

composition of Ribier et al and the composition of Sebag known to be useful for the 
same purpose, treating skin, in a composition to be administered would improve the 
therapeutic effect for treating skin. 

Since all active composition components herein are known to be used to treat 
skin it is considered prima facie obvious to combine then into a single composition to 
form a third composition useful for the very same purpose. At least additive therapeutic 
effects would have been reasonable 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 consider well 
within the skill of the 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 USPW 215 (CCPA 1980.) 

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



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

Art Unit: 1617 

Claims 13-20 are rejected under 35 U.S.C. 103(a) as begin unpatentable over 
Ribier et al. (5,650,166) for the same reasons of record in the previous Office Action 
mailed August 18, 2005. 

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 amount of 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. 



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

Art Unit: 1617 

It has been held that is it 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 USQ 215 (CCPA 1980.) 

Claims 10-12 and 20 are rejected under 35 U.S.C. 103(a) as begin unpatentable 
over Ribier et al. (5,650,166) and further in view of Subbiah (6,150,381) and Ichinose et 
al. (5,702,691) for the reasons of record stated in the Office Action mailed on August 18, 
2005. 

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 nor 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. 



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

Art Unit: 1617 

Subbiah teaches the use of sclareolide in topical formulations, particularly for 
acne (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 composition of Ribier et al. 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 modification comes from the benefit of such properties in formulating cosmetic 
compositions. The missing ingredients have art-recognized suitability for the intended 
purpose of formulation cosmetic compositions. The selection of a known material 
based on its suitability for its intended use has been determined to be prima facie 
obvious. See Sinclair and Carroll Co. F. Interchemical Corp., 325 U.S. 327, 65 USPQ 
297 (1945), In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPS 1960); and MPEP 
2144.07. 



Application/Control Number: 09/773,351 
Art Unit: 1617 



Page 10 



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. A nonstatutory 
obviousness-type double patenting rejection is appropriate where the conflicting claims 
are not identical, but at least one examined application claim is not patentably distinct 
from the reference claim(s) because the examined application claim is either anticipated 
by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 
F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046. 29 
USPQ2d 2010 (Fed. Cir. 1993); In re Long!, 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) or 1 .321 (d) 
may be used to overcome an actual or provisional rejection based on a nonstatutory 
double patenting ground provided the conflicting application or patent either is shown to 
be commonly owned with this application, or claims an invention made as a result of 
activities undertaken within the scope of a joint research agreement. 

Effective January 1 , 1994, 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 overclaims 1-21 of 
copending Application No. 10/424,616 for the reasons of record stated in the Office 
Action mailed August 18, 2006. 



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 



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

Art Unit: 1617 

drawn to a skin/cosmetic composition containing cholesterol sulfate, fatty acids, and a 
sterol (such as cholesterol) and methods employing the compositions. 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 all the 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. 

Response to Arguments 

Applicant's arguments filed January 13, 2006 have been fully considered but they 
are not persuasive. 

In particular. Applicant's argue that the cited references do not teach a 
composition comprising an "integral mixture" of cholesterol sulfate with the exfoliant, as 
recited in the claims. Applicants argue that the cited references (Ribier et al. 
references) teach the formation of a composition having discrete layers or vesicles, and 
thus do not teach an "integral mixture." 



Application/Control Number: 09/773,351 Page 12 

Art Unit: 1617 

The Examiner respectfully notes that the claims are given their broadest possible 
reasonable interpretation during examination. 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). The broadest 
reasonable interpretation of the composition having an "integral mixture" of the 
cholesterol sulfate with the exfoliant is that the composition comprises a mixture of the 
cholesterol sulfate that is formed as a unit with another part of the mixture, which is 
consistent with the dictionary definition of integral as disclosed in the Merriam-Webster 
Online Dictionary (formed as a unit with another part <a seat with integral headrest.) 
The prior art teaches and/or suggests such a composition, because the prior art teaches 
or suggests combining the cholesterol sulfate with the exfoliant in a single cosmetic 
composition (an single unit), and thus the components form an integral mixture in the 
composition because each part forms a unit (the composition) with another part. 

Applicants argue that an integral mixture is not a lipid vesicle, and thus that the 
Ribier et al. references do not teach or suggest the claimed invention. Applicants argue 
that the vesicles in these references are not integrally mixed, but rather are used to form 
separate and discrete entities present in the aqueous phase. However, the Examiner 
respectfully notes that the claims recite an "integral mixture," which given its broadest 
possible reasonable interpretation means a mixture that has components that form a 
unit (i.e. a composition) with one another, which is taught by the Ribier et al. references, 



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

Art Unit: 1617 

and includes even compositions having distinct phases and vesicles, as these phases 
and vesicles nonetheless make up parts of a single unit (the composition.) 

The Examiner furthermore notes that, in rebutting a prior new matter rejection of 
the phrase "integral with" under 35 U.S.C. 112, Applicants argued in the response 
submitted June 23, 2004 that: 

"The Examiner admits that "[t]he recitation 'integral with' could be interpreted as 
'mixed with' or 'a mixture of according [sic] its plain and ordinary meaning. 
Applicants fully agree with this interpretation ..." (page 2 of Amendment 
Arguments Submitted June 23, 2004.) 

Thus, Applicants appear to have already accepted the plain meaning of "integral 
with" as being "mixed with" or "a mixture of," according to their own admission. An 
"integral mixture" as instantly claimed thus clearly encompasses a mixture having the 
components combined together that makes up a single unit, such as a single 
composition, as is taught and/or suggested by the references cited above. 

It is furthermore noted that the instant Specification does not provide support 
under 35 U.S.C. 112, first paragraph, for a definition of "integral mixture" that excludes 
compositions having vesicles or two or more phases. Instead, the specification teaches 
that the composition provides "integrated results" because the two components 



Application/Control Number: 09/773,351 Page 14 

Art Unit: 1617 

(exfoliant and cholesterol sulfate) do not cancel out each other's effects (see page 4, 
lines 21-29.) Thus, the specification specifically refers to "integrated" in the sense that 
effects provided by each component are not canceled out by one another. The 
specification does not disclose that such compositions are required to be absent 
vesicles or multiple phases, and does not otherwise explicitly define "integral" or 
"integral mixture" to mean anything other than its ordinary plain meaning. 

Applicants furthermore provide a declaration signed by Philip Wesley Wertz, 
which was originally provided in Application No. 08/865,821, to show that providing 
cholesterol sulfate in a composition is not obvious or inherent over a teaching of 
providing a cholesterol in general, in a composition. The Examiner notes that the Ribier 
et al. references teach providing cholesterol sulfates in topical compositions, and thus 
provide sufficient motivation for the preparation of a composition comprising such a 
compound. 

Conclusion 

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). 



Application/Control Number: 09/773,351 Page 15 

Art Unit: 1617 

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. 

Any inquiry concerning this communication or earlier communications from the 
examiner should be directed to Abigail M. Cotton whose telephone number is (571) 272- 
8779. The examiner can normally be reached on 9:30-6:00, M-F. 

If attempts to reach the examiner by telephone are unsuccessful, the examiner's 
supervisor, Sreenivasan Padmanabhan can be reached on (571) 272-0629. The fax 
phone number for the organization where this application or proceeding is assigned is 
571-273-8300. 



Application/Control Number: 09/773,351 



Page 16 



Art Unit: 1617 

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AMC 




SREENI RMJMANABHAN 
SUPERVISOflY WTENT EXAMINER