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United States Patent and Trademark Office 



UNITED STATES DEPARTIMENT OF COMMERCE 
United States Patent and Trademark Office 

Address: COMMISSIONER FOR PATENTS 
P.O. Box 1450 

Alexandria, Virginia 223 13-1450 
www.uspto.gov 



APPLICATION NO. 



FILING DATE 



FIRST NAMED INVENTOR 



ATTORNEY DOCKET NO. 



CONFIRMATION NO. 



' 09/773,351 



01/31/2001 



Daniel H, Maes 



7590 

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



09/14/2007 



00.22US 



5974 



EXAMINER 



CARTER, KENDRA D 



ART UNIT 



1617 



PAPER NUMBER 



MAIL DATE 



DELIVERY MODE 



09/14/2007 PAPER 

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

The time period for reply, if any, is set in the attached communication. 



PTOL-90A (Rev. 04/07) 



Office Action Summary 


Application No. 

09/773,351 


Applicant(s) 

MAES ET AL 


Examiner 

Kendra D. Carter 


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)^ Responsive to communication(s) filed on 25 June 2007 , 
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4a) Of the above claim(s) is/are withdrawn from consideration. 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) S 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 Thei drawing(s) filed on is/are: a)n 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) 0 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) 0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f). 
a)n All b)n Some * c)^ None of: 

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

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

3. n Copies of the certified copies of the priority documents have been received in this National Stage 

application from the International Bureau (PCT Rule 17.2(a)). 
* See the attached detailed Office action for a list of the certified copies not received. 



Attach ment(s) 

1) O 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) □ Infomnation Disclosure Statement(s) (PTO/SB/08) 5) □ Notice of Infonrial 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 NoVMail Date 20070905 



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

Art Unit: 1617 

DETAILED ACTION 

The Examiner acknowledges the applicant's remarks and arguments of June 25, 
2007 made to the office action filed December 27, 2006. Claims 1 and 3-20 are 
pending. Claims 1, 13, 16 and 19 are amended. 

In light of the amendments, the 35 U.S.C. 112, first paragraph rejection of claims 
1 and 3-20 is withdrawn. 

For the reasons in the previous office action and below, the Applicant's 
arguments of the 35 U.S.C. 103(a) of claims 1, 3, 5, 13 and 16-19 as being 
unpatentable over JP Publication No. 60-161911 to Abe et a! (English abstract), in view 
of JP Publication No. 59-013708 to Shimada et al., was found not persuasive, and thus 
upheld. 

For the reasons in the previous office action and below, the Applicant's 
arguments of the 35 U.S.C. 103(a) of claim 4 as being unpatentable over JP Publication 
No. 60-161911 to Abe et al (English abstract), in view of JP Publication No. 59-013708 
to Shimada et al. as applied to claims 1, 3, 5, 13 and 16-19 above, and further in view of 
JP 05-051314 to Abe et al., was found not persuasive, and thus upheld. 



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

Art Unit: 1617 

For the reasons in the previous office action and below, the Applicant's 
arguments of the 35 U.S.C. 103(a) of claims 6-9 and 14-15 as being unpatentable over 
JP Publication No. 60-161911 to Abe et a! (English abstract), in view of JP Publication 
No. 59-013708 to Shimada et al. as applied to claims 1, 3, 5, 13 and 16-19 above, and 
further in view of WO 90/01323 to Joel E. Bernstein, was found not persuasive, and 
thus upheld. 

For the reasons in the previous office action and below, the Applicant's 
arguments of the 35 U.S.C. 103(a) of claim 10 as being unpatentable over JP 
Publication No. 60-16191 1 to Abe et al (English abstract), in view of JP Publication No. 
59-013708 to Shimada et al. as applied to claims 1, 3, 5, 13 and 16-19 above, and 
further in view of JP Publication No. 10-017458 to Kitada et al., was found not 
persuasive, and thus upheld. 

For the reasons in the previous office action and below, the Applicant's 
arguments of the 35 U.S.C. 103(a) of claim 11 as being unpatentable over JP 
Publication No. 60-16191 1 to Abe et al (English abstract), in view of JP Publication No. 
59-013708 to Shimada et al. as applied to claims 1, 3, 5, 13 and 16-19 above, and 
further in view of JP 06-263627 to Takahashi et a!., was found not persuasive, and thus 
upheld. 



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

Art Unit: 1617 

For the reasons in the previous office action and below, the Applicant's 
arguments of the 35 U.S.C. 103(a) of claim 20 as being unpatentable over JP 
Publication No. 60-16191 1 to Abe et al (English abstract), in view of JP Publication No. 
59-013708 to Shimada et al. as applied to claims 1, 3, 5, 13 and 16-19 above, and 
further in view of WO 90/01323 to Joel E. Bernstein, as applied to claims 6-9 and 14-15 
above, and further in view of JP Publication No. 10-017458 to Kitada et al, and JP 06- 
263627 to Takahashi et al, was found not persuasive, and thus upheld. 

The Applicant's arguments of the obviousness-type double patenting of claims 1 
and 3-20 as being unpatentable over claims 1-21 of copending Application No. 
10/424,616, was found persuasive, and thus the rejection has been modified. 

Due to the amendment to the claims, the modified 35 U.S.C. 103(a) and 
obviousness-type double patenting rejections are made below. 

Applicant's arguments are addressed below. 

Claim Rejections - 35 USC § 103 

The following is a quotation of 35 U.S.C. 103(a) which fonns 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 



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



Page 5 



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. 

(1) Claims 1, 3, 5, 13 and 16-19 are rejected under 35 U.S.C. 103(a) as being 
unpatentable over JP Publication No. 60-161911 to Abe et a! (English abstract), 
published August 23, 1985, in view of JP Publication No. 59-013708 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 pharmaceutically acceptable 
vehicle, as recited in claims 1 and 13. 

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. 



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

Art Unit: 1617 

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, 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 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 
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 



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

Art Unit: 1617 

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 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 



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

Art Unit: 1617 

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 2112.01. The burden is shifted to Applicant to show that the prior art product 
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 "[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, 1 05 USPQ 233, 235 (CCPA 1 955.) 

(2) Claim 4 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 



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

Art Unit: 1617 

Shimada etal, published January 24, 1984, as applied to claims 1, 3, 5, 13 and IB- 
IS above, and further in view of JP 05-051314 to Abe et al (hereinafter Abe et al. 
'314) (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 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. '911 and Shimada teach that the cosmetic 



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

Art Unit: 1617 

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. '91 1 and Shimada et al, with 
the expectation of success in providing a suitable salt form for the cosmetic 
composition. 

(3) 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 (liereinafter 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. '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. 

Abe et al. '911 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. '911 and 



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

Art Unit: 1617 

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 
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 



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

Art Unit: 1617 

skin dryness. Thus, one of ordinary sl^ill 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 
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 



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

Art Unit: 1617 

provided in the composition, according to the guidance provided by Abe et al. '911, 
Shimada et al. and Bernstein, to provide a composition having desired properties, such 
as desired moisturization and dry sl^in 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 
the optimum or workable ranges by routine experimentation." In re Aller, 220 F 2d 454, 
456, 105 USPQ 233, 235 (CCPA 1955.) 

(4) 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. 10-017458 to Kitada et al, 
published January 20, 1998 (machine translation.) 

Abe et al. '91 1 and Shimada et al. are applied as discussed aboye, 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. 



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

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. 
'911 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 arf 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 15 



(5) Claim 11 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 06-263627 to Takahashi et al, published 
September 20, 1994 (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 sl^in 
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.) 



Application/Control Number: 09/773,351 Page 16 

Art Unit: 1617 

Accordingly, it is considered that one of ordinary sl<ill 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 and Shimada et al, 
because Abe et al. '911 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 
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 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. 

(6) Claim 12 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. 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. '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 



Application/Control Number: 09/773,351 Page 17 

Art Unit: 1617 

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. 

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, '911 and Shimada et al, because Abe et al. 
'911 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 



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Art Unit: 1617 

Salvia officinalis L, whicli 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. 

Abe et al. '911, 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 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. '911, Shimada et al. and 
Kitada et al, because Abe et al. '911, 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 



Application/Control Number: 09/773,351 Page 19 

Art Unit: 1617 

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. 

(7) 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, 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, 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. 



Application/Control Number: 09/773,351 Page 20 

Art Unit: 1617 

The references do not speoifically 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 unifonnity 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. '911, 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 



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

Art Unit: 1617 

have been motivated to provide the sclareolide in the composition of Abe et al. '911, 
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. '911, Shimada et al, Bernstein 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 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 , Shimada et al, Bernstein 
and Kitada et al, because Abe et al. '911, 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, 



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

Art Unit: 1617 

Shimada et al, Bernstein and Kitada et al, with the expectation of providing a 
component capable of imparting sl<in 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. 

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 



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

Art Unit: 1617 

was made would have found it obvious to vary and/or optimize tlie amount of 
ctiolesteroi 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. '911, 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 
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 Longi, 759 F.2d 887. 225 USPQ 645 (Fed. Cir. 
1985); In re Van Omum, 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. 



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



Page 24 



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, 6, 8, and 9 are provisionally rejected under the judicially created 
doctrine of obviousness-type double patenting as being unpatentable over claims 1-8 
and 17-20 of copending Application No. 10/424,616 for the reasons of record stated in 
the Office Action mailed August 18, 2005. 

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, 
ceramides (i.e. a type of exfoliant), 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. 



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



Page 25 



Response to Arguments 



Applicant's arguments with respect to the rejection of the claims have been 
considered and are not found persuasive. 



Claims 1. 3. 5. 13 and 16-19 are rejected under 35 U.S.C. 103(a) as being 
unpatentable over JP Publication No. 60-161911 to Abe et al. in view of JP Publication 
No. 59-013708 to Shimada et al. 



The Applicant argues that Abe '911 expressly teaches that skin wetting 
agent and skin softener conventionally used in cosmetic composition may 
cause inhibition of normal physiological functions of skin. Abe '911 lies in 
its capability of promoting water retention function of skin through 
normalizing functions between stratum corneum cells and through making 
structure of such cells dense, so that this cosmetic does not require a 
large amount of the conventional skin wetting agent and skin softener, and 
there is therefore no fear that it may inhibit normal physiological functions 
of skin. In contrast, Shimada teaches that amino sugars, such and N- 
acetyl-D-glucosamine and salts thereof, function to moisturize and soften 
the skin. Therefore, the amino sugars disclosed by Shimada can be 
considered skin wetting agents or skin softeners, the use of which is 
expressly taught away by Abe '911 due to concerns described 
hereinabove. Therefore, a person ordinarily skilled in the art, after reading 
Abe '911 and Shimada, would not have been motivated to use the skin- 
moisturizing/softening amino sugars disclosed by Shimada in the 
cholesterol sulfate-containing composition disclosed by Abe '911, in light 
of the express teaching away by Abe '911. 



The Examiner disagrees because Abe '911 teaches that the cosmetic for 
improving dried skin "does not require a large amount of the wetting agent and a 
softener as it is required conventionally" (see abstract). Thus, by using cholesterol 



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



Page 26 



sulfate and/or its salts, large amounts of the wetting agent and softener are not needed, 
and therefore "no fear of inhibition of normal physiological functions of skin [is] caused 
by the compounding agents". Therefore, Abe'911 does not teach away from combining 
cholesterol sulfate, wetting agent and softener, but instead teaches the possibility of 
combining the elements to provide skin with wetting characteristics, softness and luster 
by promoting water retention function of skin (see abstract). 



The Applicant argues that the present invention, by combining cholesterol 
sulfate and an exfoilant, such as an amino sugar, achieves an unexpected 
and surprising result. . Particularly, cholesterol sulfate retards 
desquamation, while amino sugars desquamate the skin. A person 
ordinarily skilled in the art would expect the impacts of these two 
components of opposite functions to cancel each other out when they are 
combined. However, surprisingly the unexpectedly, the combination of 
these two components of opposite functions in the cosmetic composition 
of the present invention achieves a balanced result in nurturing the skin 
and improving/protecting the barrier of the stratum corneum. 



The Examiner disagrees because the present invention is rendered obvious by 
the combined teachings of Abe'911 and Shimada, which teaches the same result (i.e. 
maintaining healthy skin barrier and reducing damage to the skin). As discussed above, 
Abe *911 teaches that by combining cholesterol sulfate, wetting agents and softeners 
are added at less amounts then is required conventionally without fear of inhibition of 
normal physiological functions. Therefore the surprising results that the combination of 
these elements to the above elements to maintain healthy skin barrier or reduce 
damage to the skin (i.e. improving dried skin, preventing aging of skin, providing skin 



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

Art Unit: 1617 

with wetting cliaracteristics, softness and luster by promoting water retention function of 
skin) is taught by the combined teachings of Abe'91 1 and Shimada. 

Claim 4 is rejected under 35 U.S.C. 103(a) as being unpatentable over JP Publication 
No. 60-161911 to Abe et, in view ofJP Publication No. 59-013708 to Shimada et a.l. as 
applied to claims 1. 3. 5, 13 and 16-19 above, and further in view of JP 05-0.51314 to 
Abe et al. 

The Applicant argues that as mention hereinabove the combination of Abe 
'91 1 and Shimada as proposed by the Examiner is not obvious and cannot 
be used to support rejections of claims of the present application. Nothing 
in Abe '314 teaches or suggests use of the cholesterol sulfate salts in a 
manner different from that taught by Abe'91 1 . More specifically, nothing in 
Abe '314 contradicts or modifies the teaching-away by Abe '911 from 
using skin wetting agents or skin softeners in the cholesterol sulfate- 
containing cosmetic coniposition. 

The Examiner disagrees because the reasons given above in regard to the 
teaching-away by Abe '911. Abe '314 provides teaching that suitable salts of the 
cholesterol sulfate can include the sodium and potassium salts (see paragraphs 0017 
and 0023 of machine translation, in particular) are suitable for cosmetic use. 

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 ef ai. in view of JP Publication No. 59-013708 to 
Shimada e t al, as applied to claims 1. 3. 5. 13 and 16-19 above, and further in view of 
WO 90/01323 to Bernstein. Japanese Patent Application Publication No. 10-017458 to 



Application/Control Number: 09/773,351 Page 28 

Art Unit: 1617 

Kitada et al.. and/or Japanese Patent Application Publication No. 06-263627 to 
Takahashi et al.. 



The Applicant argues tfiat as mentioned hereinabove the combination of 
Abe '911 and Shimada as proposed by the Examiner is not obvious and 
cannot be used to support rejections of claims of the present application. 
The secondary references, i.e. Bernstein, Kitada, and Takahashi, cannot 
remedy the above-explained deficiency of Abe'91 1 and Shimada, and thus 
cannot support the rejections against claims 6-12, 14-15 and 20 of the 
present application. 



The Examiner disagrees because the reasons given above in regard to the 
teaching-away by Abe '911. 



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. 2005. 



The Applicant argues that claims 1 and 3-20 of the present application are 
drawn to a composition comprising a mixture of: (1) cholesterol sulfate or 
salts thereof and (2) an exfoliant or an amino sugar and methods of using 
the same. In contrast, claims 1-21 of the '616 Application are drawn to a 
composition coniprising: (1) cholesterol sulfate and (2) optionally, a 
sunscreen, a self-tanning agent or a combination of a' fatty acid, a 
ceraminde, and a sterol and methods of using the same. Thus both are 
drawn to a cosmetic composition containing cholesterol sulfate, fatty 
acids, and a sterol (such as cholesterol) and methods employing the 
compositions. The present application clearly and unequivocally recite an 
exfoliant or amino sugar, which is entirely absent from claims 1-21 of the 
'616 Application. 



Application/Control Number: 09/773,351 Page 29 

Art Unit: 1617 

The Examiner agrees that '616 does not comprise an amino sugar, but does 
comprises ceramide, which is a l<nown exfoliant. Thus, the rejection has been modified 
to only address the claims that require the limitation of an exfoliant and not an amino 
sugar. 

Conclusion 

THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time 
policy as set forth in 37 CFR 1 .1 36(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. 



No claims allowed. 



Application/Control Number: 09/773,351 Page 30 

Art Unit: 1617 

Any inquiry concerning this communication or earlier communications from the 
examiner should be directed to Kendra D. Carter whose telephone number is (571) 272- 
9034. The examiner can normally be reached on 8:30 am - 5:00 pm. 

If attempts to reach the examiner by telephone are unsuccessful, the examiner's 
supervisor, Sreeni 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. 

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KDC 




SREENI PADMANABHAN 
SUPERVISORY PATENT EXAMINER