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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. Maes 


00.22US 


5974 



7590 

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



12/27/2006 



EXAMINER 



COTTON, ABIGAIL MANDA 



ART UNIT 



PAPER NUMBER 



1617 



SHORTENED STATUTORY PERIOD OF RESPONSE 



MAIL DATE 



DELIVERY MODE 



3 MONTHS 



12/27/2006 



PAPER 



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



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



PTOL-90A (Rev. 10/06) 



Offline* Articin 


Application No. 

09/773,351 


Applicant(s) 
MAES ETAL. 


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 1.136(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. § 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 

1)S Responsive to cornmunication(s) filed on 10 October 2006 . 
2a)D This action is FINAL. 2b)[3 This action is non-final. 

3) D 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) [>3 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) [El Claim(s) 1 and 3-20 is/are rejected. 

7) D 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)Q 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). 

1 1) 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. § 1 19 

12) D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f). 
a)Q All b)D 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) [3 Notice of References Cited (PTO-892) 4) □ Interview Summary (PTO-413) 

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

3) □ Information Disclosure Statement(s) (PTO/SB/08) 5 ) D Not 'ce of Informal Patent Application 

Paper No(s)/Mail Date . 6) □ Other: . 



U.S. Patent and Trademark Office 
PTOL-326 (Rev. 08-06) 



Office Action Summary 



Part of Paper No./Mail Date 20061212 



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



Page 2 



DETAILED ACTION 



This office action is in response to the arguments filed in the Appeal Brief 
submitted on October 10, 2006. Applicant's arguments regarding the rejections of the 
claims over the prior art of record have been fully considered and are persuasive. 
Accordingly, the rejections of the claims are being withdrawn. 

In particular, the Examiner finds that U.S. Patent No. 5,650,166 to Ribier et al 
does not specifically exemplify a composition having cholesterol sulfate and an exfoliant 
present in the amount as claimed, and thus does not properly anticipate claims 1 and 3- 
9. Furthermore, the combination of U.S. Patent No. 5,925,364 to Ribier et al. in view of 
U.S. Patent No. 5,41 1 ,742 to Sebag et al. does not render claims 1 , 3-4, 6-9, 1 1 and 1 8 
obvious, because the references do not provide adequate motivation to combine an 
exfoliant (i.e. salicylic acid) as taught by Sebag et al. into the composition of Ribier et al. 
U.S. Patent No. 5,650,166 to Ribier et al. also does not specifically teach or render 
obvious a composition having the cholesterol sulfate and amino sugar exfoliant in the 
amounts as claimed, and thus does not render claims 13-20 obvious. Accordingly, 
these rejections and the rejections of claims 10-12 and 20 over Ribier in view of U.S. 
Patent No. 6,150,381 to Subbiah and U.S. Patent No. 5,702,691 to Ichinose et al, are 
being withdrawn. 



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Art Unit: 1617 



Page 3 



Claims 1 and 3-20 are pending in the application and are being examined on the 
merits herein. 

The claims are being rejected as follows. 

Claim Rejections - 35 USC §112 

The following is a quotation of the first paragraph of 35 U.S.C. 1 1 2: 

The specification shall contain a written description of the invention, and of the manner and process of 
making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the 
art to which it pertains, or with which it is most nearly connected, to make and use the same and shall 
set forth the best mode contemplated by the inventor of carrying out his invention. 

Claims 1 and 3-20 are rejected under 35 U.S.C. 112, first paragraph, as failing to 
comply with the written description requirement. The claims contains subject matter 
which was not described in the specification in such a way as to reasonably convey to 
one skilled in the relevant art that the inventors, at the time the application was filed, 
had possession of the claimed invention. In particular, the specification as originally 
filed does not provide adequate support for the recitation that the composition is "an 
integral mixture" of the cholesterol sulfate and exfoliant/amino sugar, as recited in 
claims 1, 13, 16 and 19. 

The Examiner notes that the claims were previously rejected for reciting the 
phrase "integral with" in the Office Action mailed on March 23, 2004. In rebutting the 



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Art Unit: 1617 



Page 4 



new matter rejection of this phrase, 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.) 

Accordingly, the Examiner withdrew the new matter rejection on September 10, 
2004, on the grounds that the phrase "integral with" could be understood as meaning 
"mixed with" or "a mixture of," as argued by Applicants, and thus was understood to 
encompass any mixture having the components combined together that makes up a 
single unit, such as a single composition. 

However, contrary to this plain meaning of the phrase, Applicants have argued in 
the response of July 12, 2006 and the appeal brief filed on October 10, 2006, that such 
"integral mixtures" exclude compositions that have, for example, vesicles, as described 
by the previously applied Ribier references. 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. Accordingly, Applicants have indicated that the 
phrase "integral mixture" can be interpreted to mean a mixture that is without separate 
and discrete entities, such as vesicles or discrete phases. 



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



Page 5 



The Examiner notes that 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, as argued by Applicants, 
instead, the specification teaches that the composition provides "integrated results" 
because the two components (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 that the composition is without discrete 
phases. 

Accordingly, as Applicants have pointed out that the phrase "integral mixture" 
could be construed as having a meaning that is not fully supported by the specification 
as originally filed, the claims are being rejected under 35 U.S.C. 112 first paragraph for 
reciting impermissible new matter, as the specification does not provide support for 
compositions that are "integral mixtures" in the sense that they do not contain discrete 
entities or phases. 



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Art Unit: 1617 



Page 6 



Claim Rejections - 35 USC § 103 

The following is a quotation of 35 U.S.C. 1 03(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, 5, 13 and 16-19 are rejected under 35 U.S.C. 1 03(a) as being 
unpatentable over JP Publication No. 60-16191 1 to Abe et al (English abstract), 
published August 23, 1 985, in view of JP Publication No. 59-01 3708 to Shimada et al, 
published January 24, 1984. 

Abe et al. teaches a cosmetic for improving dried skin, preventing aging of skin, 
providing skin with wetting characteristics, softness and luster by promoting the water 
retention function of skin, the composition containing cholesteryl sulfate (cholesterol 
sulfate) and/or its salt (see abstract, in particular.) Abe et al. teaches the cholesterol 
sulfate or salt thereof can be provided in an amount of from 0.1 to 5 wt% (see abstract, 
in particular), and thus teaches an amount that meets the range limitation of claims 1 
and 13. As Abe et al. teaches the composition is a cosmetic, it is considered that Abe 
et al. teaches the composition having a cosmetically or pharmaceutical^ acceptable 
vehicle, as recited in claims 1 and 13. 



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

Art Unit: 1617 

Abe et al. does not specifically teach that the composition contains an exfoliant 
as in claim 1 , such as an amino sugar as in claim 5 or 1 3. 

Shimada et al. teaches that cosmetic compositions can containing N-acetylamino 
sugars or their salts to give smoothness and moist feeling to skin, the amino sugars 
having an emollient effect, a skin activating effect, and being capable of giving smooth 
feeling, springiness and luster to the skin (see abstract, in particular.) Shimada et al. 
teaches that the amino sugars can be N-acetyl-D-glucosamine, N-acetyl-D- 
galactosamine, and others (see abstract, in particular), and thus teaches the "exfoliant" 
as recited in claims 1 and 5, and the amino sugar as in claim 13. Shimada et al. also 
teaches that the N-acetyl amino sugars can be provided in an amount of from 0.1 to 5% 
by weight of the composition (see abstract, in particular), which is an amount that meets 
the range limitation as recited in claims 1 and 13. 

Accordingly, tit is considered that one of ordinary skill in the art at the time the 
invention was made would have found it obvious to provide the N-acetylamino sugars of 
Shimada et al. in the cholesterol sulfate-containing composition of Abe et al, because 
Abe et al. teaches that the cholesterol sulfate composition improves dry skin and wets 
skin to promote softness and luster of skin, whereas Shimada et al. teaches that the N- 
acetylamino sugars give smoothness and moistness to skin to improve the feeling and 
luster of skin. Thus, one of ordinary skill in the art would have found it obvious to 
provide the N-acetylamino sugars in the composition of Abe et al. with the expectation 



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

Art Unit: 1617 

of providing an ingredient suitable for moisturizing an improving the luster of skin. Note 
it is considered that "[l]t is prima facie obvious to combine two compositions each of 
which is taught by the prior art to be useful for the same purpose, in order to form a third 
composition to be used for the very same purpose.... [T]he idea of combining them 
flows logically from their having been individually taught in the prior art." In re 
Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980.) Accordingly, 
claims 1 and 13 are considered to be obvious over the teachings of Abe et al. and 
Shimada et al. 

Regarding the recitation that the composition has an "integral mixture" as recited 
in claims 1 and 13, it is noted that 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.) Thus, 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. 



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

Art Unit: 1617 

Regarding claim 3, Abe et al. teaches that cholesterol sulfate and salts thereof 
can be suitably provided (see abstract, in particular), as discussed above. Regarding 
claim 5; Abe et al. teaches that the N-acetyl amino sugars as claimed can be provided 
(see abstract, in particular), as discussed above. 

Regarding the methods of claims 16 and 19, as Abe et al. and Shimada et al. 
teach applying the composition containing cholesterol sulfate and the amino sugar to 
skin, and teach that the composition is capable of improving the condition of skin, 
including enhancing water retention, preventing aging, and promoting softness and 
luster of skin, it is considered that the method of Abe et al. and Shimada et al. 
necessarily also improves or maintains a healthy skin barrier, as recited in claim 16, and 
necessarily also treats or reduces damage to the skin, where the damage is associated 
with a reduction or loss of skin barrier function, as recited in claim 19. Since the 
combined teachings of Abe et al. and Shimada et al. renders the claimed composition 
obvious, the property of such a claimed composition will also be rendered obvious by 
the prior art teachings, since the properties, namely the improvement or maintenance of 
a healthy skin barrier, or the treatment of reduction of damage to skin, are inseparable 
from its composition. Therefore, if the prior art teaches the composition or renders the 
composition obvious, then the properties are also taught or rendered obvious by the 
prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) See 
MPEP 21 12.01. The burden is shifted to Applicant to show that the prior art product 



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



Page 10 



does not possess or render obvious the same properties as the instantly claimed 
product. 

Regarding claims 17-18, Abe et al. teaches that the cholesterol sulfate can be 
provided in an amount of from 0.01 to 5%, preferably 0.05% to 3% (see abstract, in 
particular), and thus teaches a range that closely overlaps with those claimed. 
Furthermore, it is considered that one of ordinary skill in the art at the time the invention 
was made would have found it obvious to vary and/or optimize the amount of the 
cholesterol sulfate provided in the composition, according to the guidance provided by 
Abe et al, to provide a composition having desired properties. It is noted that M [W]here 
the general conditions of a claim are disclosed in the prior art, it is not inventive to 
discover the optimum or workable ranges by routine experimentation." In re Aller, 220 
F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955.) 

Claim 4 is rejected under 35 U.S.C. 103(a) as being unpatentable over JP 
Publication No. 60-161911 to Abe etal (hereinafter Abe et al. '911) (English abstract), 
published August 23, 1 985, in view of JP Publication No. 59-01 3708 to Shimada et al, 
published January 24, 1984, as applied to claims 1, 3, 5, 13 and 16-19 above, and 
further in view of JP 05-051314 to Abe etal (hereinafter Abe et al. '314) (machine 
translation.) 



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

Art Unit: 1617 

Abe et al. '91 1 and Shimada et al. are applied as discussed above, and teach a 
cosmetic composition and method for improving skin by providing cholesterol sulfate or 
a salt thereof and an N-acetyl amino sugar. 

The references do not specifically teach that the salt of the cholesterol sulfate is 
potassium. 

Abe et al. '314 teaches a cosmetic composition containing ginseng essence and 
a cholesterol sulfate derivative, such as cholesterol sulfate or its salt (see abstract, in 
particular.) Abe et al. '314 teaches that suitable salts of the cholesterol sulfate can 
include the sodium and potassium salts (see paragraphs 0017 and 0023 of machine 
translation, in particular.) Accordingly, Abe et al. '314 teaches that the potassium salt of 
cholesterol sulfate is suitable for cosmetic use. 

Accordingly, it is considered that one of ordinary skill in the art at the time the 
invention was made would have found it obvious to provide the potassium salt of 
cholesterol sulfate, as taught by Abe et al. '314 in the composition of Abe et al. '911 and 
Shimada et al, because Abe et al. '91 1 and Shimada teach that the cosmetic 
composition can contain cholesterol sulfate and salts thereof, whereas Abe et al. '314 
teaches that the potassium salt is a cosmetically acceptable salt form of cholesterol 
sulfate. Thus, one of ordinary skill in the art would have been motivated to provide the 
potassium salt form of the cholesterol sulfate of Abe et al. '911 and Shimada et al, with 



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

Art Unit: 1617 

the expectation of success in providing a suitable salt form for the cosmetic 
composition. 

Claims 6-9 and 14-15 are rejected under 35 U.S.C. 103(a) as being unpatentable 
over JP Publication No. 60-161911 to Abe et al (hereinafter Abe et al. '911) (English 
abstract), published August 23, 1985, in view of JP Publication No. 59-013708 to 
Shimada et al, published January 24, 1984, as applied to claims 1, 3, 5, 13 and 16-19 
above, and further in view of WO 90/01323 to Joel E. Bernstein, published February 22, 
1990. 

Abe et al. '91 1 and Shimada et al. are applied as discussed above, and teach a 
cosmetic composition and method for improving skin, including reducing aging of skin 
and enhancing the moisture retention and luster of skin, by providing cholesterol sulfate 
or a salt thereof and an N-acetyl amino sugar. 

Abe et al. '91 1 and Shimada et al. do not specifically teach that the composition 
contains a fatty acid, as recited for example in claims 6-7 and 14. Abe et al. '91 1 and 
Shimada et al. also do not specifically teach that the composition contains cholesterol, 
as recited for example in claim 8. 

Bernstein teaches a composition for treating dry skin that contains a lipid 
concentrate blended from a combination of three naturally-occurring lipid groups found 



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

Art Unit: 1617 

in the stratum corneum (see abstract, in particular.) Bernstein teaches that the stratum 
corneum of the skin contains certain lipids that form a protective "water barrier", and that 
formulations composed of components of this water barrier can provide treatment of dry 
skin (see page 1, lines 19-30, in particular.) Bernstein teaches that the lipids can 
contain one or more of a fatty acids, such as arachidonic/linoleic, linolenic, palmitic, 
stearic, oleic and docosanoic acids, and sterols such as cholesterol and cholesterol 
sulfate (see page 2, lines 15-25 and claims 1-4, in particular), and thus teaches topically 
providing the fatty acids as recited in claims 6-7 and 14, and the cholesterol as recited 
in claim 8. 

Accordingly, it is considered that one of ordinary skill in the art at the time the 
invention was made would have found it obvious to provide the fatty acids and/or 
cholesterol of Bernstein in the composition of Abe et al. '911 and Shimada et al, 
because Abe et al. '91 1 and Shimada et al. teach a composition for improving skin, 
including reducing aging of skin and enhancing the moisture retention and luster of skin, 
whereas Bernstein teaches that lipids such as fatty acids and cholesterol can be 
provided in a topical composition to improve the water barrier function of skin and treat 
skin dryness. Thus, one of ordinary skill in the art would have been motivated to 
provide the fatty acids and/or cholesterol in the skin improving/moisturizing composition 
of Abe et al. '911 and Shimada et al, with the expectation of providing ingredients 
suitable for relieving dry skin and enhancing the moisture retention of skin. Note it is 
considered that "[l]t is prima facie obvious to combine two compositions each of which is 



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Art Unit: 1617 

taught by the prior art to be useful for the same purpose, in order to form a third 
composition to be used for the very same purpose.... [T]he idea of combining them 
flows logically from their having been individually taught in the prior art." In re 
Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980.) 

Regarding claim 9, Bernstein teaches that suitable lipids can be selected from 
one or more of fatty acids such a linoleic acid and cholesterol, as discussed above, and 
thus renders the claim obvious. 

Regarding claim 15, Bernstein teaches that a concentrate of the lipids can 
contain from 25 to 75% of fatty acids, such as linoleic acid, and 10 to 40% of sterols and 
sterol esters, such as cholesterol (see page 2, lines 15-35, in particular), and teaches 
that the concentrate can be formulated into topical compositions in a concentration 
ranging from about 1% to about 50% (see page 2, lines 30-35), and thus teaches a 
range that overlaps with that in the claims. Furthermore, it is considered that one of 
ordinary skill in the art at the time the invention was made would have found it obvious 
to vary and/or optimize the amount of fatty acids such as linoleic acid and/ or cholesterol 
provided in the composition, according to the guidance provided by Abe et al. '91 1 , 
Shimada et al. and Bernstein, to provide a composition having desired properties, such 
as desired moisturization and dry skin treatment properties. It is noted that "[W]here the 
general conditions of a claim are disclosed in the prior art, it is not inventive to discover 



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the optimum or workable ranges by routine experimentation." In re Alter, 220 F.2d 454, 
456, 105 USPQ 233, 235 (CCPA 1955.) 

Claim 10 is rejected under 35 U.S.C. 103(a) as being unpatentable over JP 
Publication No. 60-161911 to Abe et al (hereinafter Abe et al. '911) (English abstract), 
published August 23, 1985, in view of JP Publication No. 59-013708 to Shimada et al, 
published January 24, 1984, as applied to claims 1, 3, 5, 13 and 16-19 above, and 
further in view of JP Publication No. 1 0-01 7458 to Kitada et al, published January 20, 
1998 (machine translation.) 

Abe et al. '91 1 and Shimada et al. are applied as discussed above, and teach a 
cosmetic composition and method for improving skin, including reducing aging of skin 
and enhancing the moisture retention and luster of skin, by providing cholesterol sulfate 
or a salt thereof and an N-acetyl amino sugar. 

The references do not specifically teach providing sclareolide in the composition. 

Kitada et al. teaches that an essence of plant can be added to a cosmetic 
composition to provide a composition that improves the uniformity of skin and prevent 
skin darkness caused by aging (see abstract, in particular.) Kitada et al. teaches that 
the plant essence may be from Salvia officinalis L, and may include the plant itself, its 
processed product and/or solvent extract, or solvent-removed extract from drying, 



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grinding, finely cutting, etc, a part or all parts of the plant (see abstract, in particular.) 
The Examiner notes that Applicants disclose in their specification that Salvia officinalis 
L. is a source of sclareolide (see page 6, final full paragraph), and thus it is considered 
that Kitada et al. teaches providing sclareolide in the form of a plant essence into a 
cosmetic composition. 

Accordingly, it is considered that one of ordinary skill in the art at the time the 
invention was made would have found it obvious to provide the sclareolide of Kitada et 
al. in the cosmetic composition of Abe et al. '911 and Shimada et al, because Abe et al. 
'91 1 and Shimada et al. teach the composition is suitable for improving the condition of 
skin, such as reducing aging of skin, and Kitada et al. teaches that plant essences such 
Salvia officinalis L, which contains sclareolide, can be provided in cosmetic 
compositions to provide skin benefits such as improved skin uniformity and reduced 
appearance of aging. Thus, one of ordinary skill in the art would have been motivated 
to provide the sclareolide in the composition of Abe et al. '91 1 and Shimada et al, with 
the expectation of providing a component capable of imparting skin benefit effects to the 
composition, such as skin uniformity and anti-aging effects. 

Claim 1 1 is rejected under 35 U.S.C. 1 03(a) as being unpatentable over JP 
Publication No. 60-161911 to Abe et al (hereinafter Abe et al. '911) (English abstract), 
published August 23, 1 985, in view of JP Publication No. 59-01 3708 to Shimada et al, 
published January 24, 1 984, as applied to claims 1,3,5,13 and 1 6-1 9 above, and 



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Art Unit: 1617 

further in view of JP 06-263627 to Takahashi et al, published September 20, 1 994 
(machine translation.) 

Abe et al. '91 1 and Shimada et al. are applied as discussed above, and teach a 
cosmetic composition and method for improving skin, including reducing aging of skin 
and enhancing the moisture retention and luster of skin, by providing cholesterol sulfate 
or a salt thereof and an N-acetyl amino sugar. 

The references do not specifically teach providing the protease inhibitors such as 
white birch extract in the composition, as recited in claim 11. 

Takahashi et al. teaches that a cosmetic for preventing the aging of skin, and that 
can improve the corneum and impart skin-beautifying effects, among other benefits, 
contains an extract of a plant belonging to the genus Betula or AInus of Betulaceae, 
such as Betula platyphylla (white birch) (see abstract, in particular.) 

Accordingly, it is considered that one of ordinary skill in the art at the time the 
invention was made would have found it obvious to provide the white birch extract of 
Takahashi et al. in the cosmetic composition of Abe et al. '91 1 and Shimada et al, 
because Abe et al. '91 1 and Shimada et al. teach the composition is suitable for 
improving the condition of skin, such as reducing aging of skin, and Takahashi et al. 
teaches that white birch extract, can be provided in cosmetic compositions to provide 



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skin benefits such as reduced appearance of aging and skin beautifying effects. Thus, 
one of ordinary skill in the art would have been motivated to provide the white birch 
extract in the composition of Abe et al. '911 and Shimada et al, with the expectation of 
providing a component capable of imparting skin benefit effects to the composition, 
such as anti-aging effects and skin-beautifying effects. 

Claim 12 is rejected under 35 U.S.C. 103(a) as being unpatentable over JP 
Publication No. 60-16191 1 to Abe et al (hereinafter Abe et al. ( 91 1) (English abstract), 
published August 23, 1985, in view of JP Publication No. 59-013708 to Shimada et al, 
published January 24, 1 984, as applied to claims 1,3,5,13 and 1 6-1 9 above, and 
further in view of JP Publication No. 10-017458 to Kitada et al, published January 20, 
1998 (machine translation) and JP 06-263627 to Takahashi et al, published September 
20, 1994 (machine translation.) 

Abe et al. '911 and Shimada et al. are applied as discussed above, and teach a 
cosmetic composition and method for improving skin, including reducing aging of skin 
and enhancing the moisture retention and luster of skin, by providing cholesterol sulfate 
or a salt thereof and an N-acetyl amino sugar. 

The references do not specifically teach providing sclareolide and white birch 
extract in the composition, as recited in claim 12. 



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Art Unit: 1617 

Kitada et al. teaches that an essence of plant can be added to a cosmetic 
composition to provide a composition that improves the uniformity of skin and prevent 
skin darkness caused by aging (see abstract, in particular.) Kitada et al. teaches that 
the plant essence may be from Salvia officinalis L, and may include the plant itself, its 
processed product and/or solvent extract, or solvent-removed extract from drying, 
grinding, finely cutting, etc, a part or all parts of the plant (see abstract, in particular.) 
The Examiner notes that Applicants disclose in their specification that Salvia officinalis 
L. is a source of sclareolide (see page 6, final full paragraph), and thus it is considered 
that Kitada et al. teaches providing sclareolide in the form of a plant essence into a 
cosmetic composition. 

Accordingly, it is considered that one of ordinary skill in the art at the time the 
invention was made would have found it obvious to provide the sclareolide of Kitada et 
al. in the cosmetic composition of Abe et al. '91 1 and Shimada et al, because Abe et al. 
'91 1 and Shimada et al. teach the composition is suitable for improving the condition of 
skin, such as reducing aging of skin, and Kitada et al. teaches that plant essences such 
Salvia officinalis L, which contains sclareolide, can be provided in cosmetic 
compositions to provide skin benefits such as improved skin uniformity and reduced 
appearance of aging. Thus, one of ordinary skill in the art would have been motivated 
to provide the sclareolide in the composition of Abe et al. '911 and Shimada et al, with 
the expectation of providing a component capable of imparting skin benefit effects to the 
composition, such as skin uniformity and anti-aging effects. 



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



Page 20 



Abe et al. '91 1 , Shimada et al. and Kitada et al. do not specifically teach 
providing white birch extract in the composition. 

Takahashi et al. teaches that a cosmetic for preventing the aging of skin, and that 
can improve the corneum and impart skin-beautifying effects, among other benefits, 
contains an extract of a plant belonging to the genus Betula or Alnus of Betulaceae, 
such as Betula platyphylla (white birch) (see abstract, in particular.) 

Accordingly, it is considered that one of ordinary skill in the art at the time the 
invention was made would have found it obvious to provide the white birch extract of 
Takahashi et al. in the cosmetic composition of Abe et al. '91 1, Shimada et al. and 
Kitada et al, because Abe et al. '91 1 , Shimada et al. and Kitada et al. teach the 
composition is suitable for improving the condition of skin, such as reducing aging of 
skin, and Takahashi et al. teaches that white birch extract, can be provided in cosmetic 
compositions to provide skin benefits such as reduced appearance of aging and skin 
beautifying effects. Thus, one of ordinary skill in the art would have been motivated to 
provide the white birch extract in the composition of Abe et al. '91 1, Shimada et al. and 
Kitada et al, with the expectation of providing a component capable of imparting skin 
benefit effects to the composition, such as anti-aging effects and skin-beautifying 
effects. Accordingly, claim 12 is obvious over the teachings of the references. 



Application/Control Number: 09/773,351 Page 21 

Art Unit: 1617 

Claim 20 is rejected under 35 U.S.C. 103(a) as being unpatentable over JP 
Publication No. 60-161911 to Abe et al (hereinafter Abe et al. '911) (English abstract), 
published August 23, 1 985, in view of JP Publication No. 59-01 3708 to Shimada et al, 
published January 24, 1984, as applied to claims 1, 3, 5, 13 and 16-19 above, further in 
view of WO 90/01323 to Joel E. Bernstein, published February 22, 1990, as applied to 
claims 6-9 and 14-15 above, and further in view of JP Publication No. 10-017458 to 
Kitada et al, published January 20, 1998 (machine translation) and JP 06-263627 to 
Takahashi et al, published September 20, 1994 (machine translation.) 

Abe et al. '911, Shimada et al. and Bernstein are applied as discussed above, 
and teach a cosmetic composition and method for improving skin, including reducing 
aging of skin and enhancing the moisture retention and luster of skin, by providing 
cholesterol sulfate or a salt thereof and an N-acetyl amino sugar. The references also 
teach that the composition can contain cholesterol and linoleic acid. 

The references do not specifically teach providing sclareolide and white birch 
extract in the composition, as recited in claim 20. 



Kitada et al. teaches that an essence of plant can be added to a cosmetic 
composition to provide a composition that improves the uniformity of skin and prevent 
skin darkness caused by aging (see abstract, in particular.) Kitada et al. teaches that 
the plant essence may be from Salvia officinalis L, and may include the plant itself, its 



Application/Control Number: 09/773,351 Page 22 

Art Unit: 1617 

processed product and/or solvent extract, or solvent-removed extract from drying, 
grinding, finely cutting, etc, a part or all parts of the plant (see abstract, in particular.) 
The Examiner notes that Applicants disclose in their specification that Salvia officinalis 
L. is a source of sclareolide (see page 6, final full paragraph), and thus it is considered 
that Kitada et al. teaches providing sclareolide in the form of a plant essence into a 
cosmetic composition. 

Accordingly, it is considered that one of ordinary skill in the art at the time the 
invention was made would have found it obvious to provide the sclareolide of Kitada et 
al. in the cosmetic composition of Abe et al. '91 1 , Shimada et al. and Bernstein, 
because Abe et al. '911, Shimada et al. and Bernstein teach the composition is suitable 
for improving the condition of skin, such as reducing aging of skin, and Kitada et al. 
teaches that plant essences such Salvia officinalis L, which contains sclareolide, can be 
provided in cosmetic compositions to provide skin benefits such as improved skin 
uniformity and reduced appearance of aging. Thus, one of ordinary skill in the art would 
have been motivated to provide the sclareolide in the composition of Abe et al. '91 1, 
Shimada et al. and Bernstein, with the expectation of providing a component capable of 
imparting skin benefit effects to the composition, such as skin uniformity and anti-aging 
effects. 

Abe et al. '91 1 , Shimada et al, Bernstein and Kitada et al. do not specifically 
teach providing white birch extract in the composition. 



Application/Control Number: 09/773,351 Page 23 

Art Unit: 1617 

Takahashi et al. teaches that a cosmetic for preventing the aging of skin, and that 
can improve the corneum and impart skin-beautifying effects, among other benefits, 
contains an extract of a plant belonging to the genus Betula or Alnus of Betulaceae, 
such as Betula platyphylla (white birch) (see abstract, in particular.) 

Accordingly, it is considered that one of ordinary skill in the art at the time the 
invention was made would have found it obvious to provide the white birch extract of 
Takahashi et al. in the cosmetic composition of Abe et al. '911, Shimada et al, Bernstein 
and Kitada et al, because Abe et al. '91 1 , Shimada et al, Bernstein and Kitada et al. 
teach the composition is suitable for improving the condition of skin, such as reducing 
aging of skin, and Takahashi et al. teaches that white birch extract, can be provided in 
cosmetic compositions to provide skin benefits such as reduced appearance of aging 
and skin beautifying effects. Thus, one of ordinary skill in the art would have been 
motivated to provide the white birch extract in the composition of Abe et al. '911, 
Shimada et al, Bernstein and Kitada et al, with the expectation of providing a 
component capable of imparting skin benefit effects to the composition, such as anti- 
aging effects and skin-beautifying effects. Accordingly, the combination of these 
ingredients as recited in claim 20 is considered to be obvious over the teachings of the 
references. 



Application/Control Number: 09/773,351 Page 24 

Art Unit: 1617 

Regarding the specific amount of each component, as recited in claim 20, it is 
noted that Abe et al. '91 1 teaches that the cholesterol sulfate or salt thereof can be 
provided in an amount of from 0.1 to 5 wt% (see abstract, in particular), and Shimada et 
al. teaches that the N-acetyl amino sugars can be provided in an amount of from 0.1 to 
5% by weight of the composition (see abstract, in particular), which are amounts that 
closely overlap with the range limitations of claim 20. Bernstein teaches that a 
concentrate of the lipids can contain from 25 to 75% of fatty acids, such as linoleic acid, 
and 10 to 40% of sterols and sterol esters, such as cholesterol (see page 2, lines 15-35, 
in particular), and teaches that the concentrate can be formulated into topical 
compositions in a concentration ranging from about 1% to about 50% (see page 2, lines 
30-35), and thus teaches a range that overlaps with that in the claims. Kitada et al. 
teaches that the Salvia officinalis L. essence can be provided in a cosmetic in an 
amount of from 0.001-10 wt% (see abstract, in particular), and Takahashi et al. teaches 
that the white birch extract can be provided in an amount of fro 0.001 to 2 wt% (see 
abstract, in particular), and thus teach ranges that closely overlap with those claimed. 
Furthermore, it is considered that one of ordinary skill in the art at the time the invention 
was made would have found it obvious to vary and/or optimize the amount of 
cholesterol sulfate and/or salt thereof, N-acetyl-D-glucosamine, cholesterol, linoleic 
acid, sclareolide and white birch extract provided in the composition, according to the 
guidance provided by Abe et al. '91 1 , Shimada et al, Bernstein, Kitada et al. and 
Takahashi et al, to provide a composition having desired properties, such as desired 
skin moisturizing, anti-aging, and skin benefit effects. It is noted that "[W]here the 



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



Page 25 



general conditions of a claim are disclosed in the prior art, it is not inventive to discover 
the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 
456, 105 USPQ 233, 235 (CCPA 1955.) 



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



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



Page 26 



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. 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 with respect to the rejection of the claims have been 
considered but are moot in view of the new grounds of rejection. 

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 



Application/Control Number: 09/773,351 Page 27 

Art Unit: 1617 

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. 

Conclusion 

No claims are allowed. 

The prior art made of record and not relied upon that is considered pertinent to 
applicant's disclosure is cited on the accompanying PTO-892 form. 

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 28 



Art Unit: 1617 

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published applications may be obtained from either Private PAIR or Public PAIR. 
Status information for unpublished applications is available through Private PAIR only. 
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AMC