Skip to main content

Full text of "USPTO Patents Application 09773351"

See other formats


REMARKS 



In the outstanding Office Action, the Examiner withdrew finality of the previous Office 
Action as well as the obviousness-type double patenting rejections of claims 1, 6, 8 and 9 of the 
present application. However, the Examiner upheld the previously raised §103 rejections against 
pending claims of the present application and stated that the arguments presented by Applicants in 
support of non-obviousness of such claims over the cited prior art references are not persuasive. 

Specifically, the Examiner asserted that the Howard reference, which was submitted 
previously by the Applicants to show the mechanism of exfoliants, does not qualify as prior art 
because it was published after the filing date of the present application. Further, the Examiner 
asserted that the Madison reference, which was submitted previously by the Applicants to show the 
desquamation inhibitory effect of cholesterol sulfate, is not reliable because it only showed inhibition 
of desquamation at excess amounts of cholesterol sulfate and it stated that the mechanism by which 
such desquamation inhibition takes effect is still under investigation. 

In response to the Examiner's dismissal of the previously submitted references, i.e., Howard 
and Madison, Applicants hereby submit two new references, both of which were published before 
the filing date of the present application, to support the previously presented arguments for non- 
obviousness of the pending claims of the present application over the cited prior art references. The 
first reference, Sato et al., "Cholesterol Sulfate Inhibits Proteases that are Involved in Desquamation 
of Stratum Corneum" The Journal of Investigative Dermatology, Vol. 1 11 , No. 2 Aug. 1 998 
(hereinafter "Sato"), is provided herein to show the known inhibitory effect of cholesterol sulfate on 
desquamation or cell dissociation from the stratum corneum sheet at various concentrations ranging 
from 0.01 mM to 10 mM. The second reference, International Patent Application No. WO 00/67722 
published on November 16, 2000 (hereinafter "WO 00/67722"), is provided herein to show the 
known use of amino sugar as exfoliant to accelerate the natural desquamation process. Further, 
Applicants hereby submit English translations of the two prior art references cited by the Examiner in 
the outstanding Office Action. 

Based on the newly submitted supporting references, Applicants respectfully traverse the 
Examiner's §103 rejections of claims 1 and 3-20 of the present application, as follows: 

Non-Obviousness of Claims 1, 3, 5, 13 and 16-19 Over Abe '911 and Shimada 



Page 2 of 10 



The Examiner has based her §103 rejections of claims 1, 3, 5, 13, and 16-19 on the reasoning 
that such claims are unpatentable over the combination of Abe et ah, Japanese Patent Application 
No. 60-16191 1 (hereinafter "Abe 6 911") with Shimada et al., Japanese Patent Application No. 59- 
013708 (hereinafter "Shimada") and that it would be obvious to combine the teaching of Abe '911 
on using cosmetic compositions containing cholesterol sulfate for "improving dried skin, preventing 
aging skin, providing skin with wetting characteristics, softness and luster by promoting the water 
retention function of the skin" (see outstanding Office Action, page 5) with the teaching of Shimada 
on using cosmetic compositions containing N-acetylamino sugars or their salts to "give smoothness 
and moist feeling to the 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 outstanding Office 
Action, page 6). The Examiner concludes that it would have been obvious to combine these two 
distinct compositions since they are taught by the prior art to be useful for the same purpose urging 
that the idea to combine them flows logically from their having been individually taught in the prior 
art, citing In re Kerkhoven (see outstanding Office Action, page 7). 

However, in doing so, the Examiner has chosen to read the Abe '911 and Shimada references 
in vacuum while ignoring the underlying knowledge that one of ordinary skill in the art would have 
been expected to be aware of Applicants hereby submit that this is not the appropriate approach in 
evaluating the obviousness of a claimed invention. 

It has been well established that when challenge is made on the ground that the claimed 
invention would have been obvious, all evidence relevant to the obviousness-nonobviousness issue 
must be considered . In re Sernaker, 217 USPQ 1, 7 (Fed. Cir. 1983). Because virtually all 
inventions are combinations of old elements known in the art, it is insufficient for the Examiner to 
merely establish that the separate elements of the invention existed in the prior art. The Examiner 
must consider what the prior art as a whole would have suggested to one skilled in the art. 
Environmental Designs, Ltd v. Union Oil Company of California, 218 USPQ 865, 870 (Fed. Cir. 
1983), citing In re McLaughlin, 170 USPQ 209, 212 (CCPA 1971). Specifically, the Examiner must 
view the beliefs of those in the field at the time of the invention. Arlde Lures Inc. v. Gene Larew 
Tackle Inc., 43 USPQ2d 1294, 1297 (Fed. Cir. 1997). 

In other words, the obviousness-nonobviousness issue should be determined on what one of 
ordinary skill in the art would have considered at the time of the invention, while viewing the prior 
art as a whole, hi so doing, the skilled artisan would have been expected to ascertain what is already 



Page 3 of 10 



known in the art about the ingredients individually disclosed by separate references, prior to 
combining such ingredients. 

In the present case, although the Abe '911 and Shimada references separately disclose the 
cosmetic use of cholesterol sulfate or a salt thereof and N-acetylamino sugars for improving skin 
appearance and feel, evidence also indicates that prior to the present invention, it was known in the 
art that cholesterol sulfate and N-acetylamino sugars achieve their respective skin care benefits 
through opposite mechanisms or modes of action on the stratum corneum layer of the skin . 

Specifically, the Sato reference submitted herewith proves that prior to the present invention, 
cholesterol sulfate is known to inhibit or retard desquamation . Through various in vivo and in 
vitro tests, Sato clearly demonstrates that cholesterol sulfate has an inhibitory effect on desquamation 
or cell dissociation from the stratum corneum sheet , and that topical application of cholesterol sulfate 
functions to increase stratum corneum thickness . Further, the English translation of the Abe 6 911 
reference, which was cited by the Examiner to support the §103 rejections of the pending claims of 
the present application, confirms such desquamation inhibitory effect of cholesterol sulfate 
demonstrated by Sato, In Table 3 on page 66, the Abe '91 1 reference clearly shows that the skin of 
test subjects treated with compositions containing cholesterol sulfate has a lower exfoliation index 
value in comparison with skin treated with compositions without cholesterol sulfate, indicating that 
cholesterol sulfate retards or inhibits exfoliation or desquamation of corneal cells from the skin . 

In the outstanding Office Action, the Examiner dismissed the previously submitted Madison 
reference on the basis that Madison only discloses inhibition of desquamation at excess amounts of 
cholesterol sulfate (see outstanding Office Action, page 24). However, the term "excess amounts" in 
Madison is not clearly defined, and it is incorrect for the Examiner to immediately jump into the 
conclusion that the amounts of cholesterol sulfate as used by the Abe '91 1 reference are not "excess" 
and are therefore insufficient to achieve the desquamation inhibitory effect. The newly submitted 
Sato reference clearly demonstrates that cholesterol sulfate is capable of retarding or inhibiting 
desquamation at various concentrations ranging from as low as 1 mM (equivalent to about 0.0488 
wt%) to as high as 10 mM (equivalent to about 0.488 wt%), while the Abe £ 91 1 reference teaches 
use of cholesterol sulfate at concentrations ranging from about 0.01 to about 5 wt%. Therefore, the 
cholesterol sulfate concentrations as taught by the Abe '911 reference are sufficient to have an 
inhibitory effect on skin desquamation. This is further confirmed by the Abe 6 91 1 reference itself, 
which discloses in Table 3 that topically application of compositions containing 0.5 wt% of 



Page 4 of 10 



cholesterol sulfate is sufficient to cause retardation or inhibition of exfoliation or desquamation of 
corneal cells from the skin. 

In the outstanding Office Action, the Examiner also alleged that the previously submitted 
Madison reference is not reliable because it fails to disclose the mechanism by which cholesterol 
sulfate inhibits desquamation (see outstanding Office Action, page 24). However, one can learn to 
use an ingredient without having to understand the exact mechanism by which such ingredient takes 
effect. For example, our ancestors have long ago learned to use certain herbs for treating certain 
disease without understanding the biological mechanisms by which such herbal medicines take 
effect. In the present case, the mere lack of understanding of the underlying biological mechanism 
would not have prevented one ordinarily skilled in the art from appreciating the fact that cholesterol 
sulfate has an inhibitory effect on skin desquamation. 

Therefore, a person ordinarily skilled in the art would have readily taken into consideration of 
the desquamation inhibitory effect of cholesterol sulfate after reading Sato and Abe '911. 

On the other hand, the newly submitted WO 00/67722 reference discloses the use of N- 
acetylamino sugars as exfoliants for aiding skin desquamation or sloughing . Specifically, WO 
00/67722 states that exfoliation is a technique whereby dead skin cells are removed or sloughed from 
the skin surface to promote a healthier and more youthful appearance to the skin and that exfoliants 
function to break the bond holding individual squames together and allow them to detach and shed 
(see WO 00/67722, page 1, last paragraph). WO 00/67722 demonstrates that at the time of the 
invention, amino sugars such as N-acetyl-D-glucosamine and N-acetyl-D-galactosamine were known 
exfoliants which enhance or accelerate the natural desquamation process when applied to the skin. 

The references as cited hereinabove, i.e., Sato, Abe '911 and WO 00/67722 clearly reveal 
prior art knowledge about the opposite mechanisms of action through which cholesterol sulfate and 
N-acetylamino sugars achieve their respective skin care benefits. Thus, while both of the noted 
compositions as disclosed by Abe '911 and Shimada were known to enhance the feel and 
appearance of the skin if applied individually, a person ordinarily skilled in the art would have 
known that such compositions act based on totally different and opposite mechanisms , and it is 
unlikely that one skilled in the art would have chosen to combine a compound known to retard or 
inhibit skin desquamation (i.e., cholesterol sulfate) with a compound known to enhance or accelerate 
skin desquamation (i.e., amino sugars). At best, one would have expected these two compounds not 
to yield a beneficial result, but to cancel each other out. 



PageS of 10 



This alone would have led one of ordinary skill in the art NOT to combine such ingredients 
in the manner suggested by the Examiner. The totality of the prior art disclosure as described 
hereinabove not only fails to teach or suggest, but actually leads away from, combination of 
cholesterol sulfate or a salt thereof and exfoliants such as N-acetylamino sugars . In other words, a 
person ordinarily skilled in the art, i.e., a person who would have been aware of the opposite 
mechanisms of action by cholesterol sulfate and amino sugars, would not be motivated toward, but 
would be motivated against, combining cholesterol sulfate or a salt thereof with exfoliants such as N- 
acetylamino sugars, due to the likelihood that the effects of these two ingredients would cancel each 
other out and thereby defeat the very purposes of the Abe '911 and Shimada references. In fact, not 
until Applicants' invention was it realized that the combination of these two types of active 
ingredients into a single composition would provide a beneficial result. 

Based on the foregoing, Applicants submit that contrary to the Examiner's assertions in the 
outstanding Office Action, it would not have been obvious for a person ordinarily skilled in the art to 
combine the cholesterol sulfate or a salt thereof disclosed by the Abe '911 reference and the N- 
acetylamino sugars disclosed by the Shimada reference. Consequently, claims 1, 3, 5, 13, and 16-19 
of the present application are patentable over Abe '911 and Shimada. 

Non-Obviousness of Claim 4 Over Abe '911, Shimada, and Abe '314 

In the outstanding Office Action, the Examiner finalized the previous rejection of claim 4 
under 35 U.S.C. § 103(a) as allegedly obvious over Abe '911 in view of Shimada, as applied to 
claims 1, 3, 5, 13, and 16-19 above, and further in view of Japanese Patent Application Publication 
No. 05-05 13 14 to Abe et al. (hereinafter "Abe '314"). 

Claim 4 depends directly from claim 3, which in turn depends from claim 1 . Therefore, 
claim 4 incorporates all the limitations recited by claim 1 , including the combination of cholesterol 
sulfate or a salt thereof and an exfoliant. 

As discussed in the above section pertaining to claim 1, it would not have been obvious for 
one of ordinary skill in the art to combine the cholesterol sulfate or a salt thereof disclosed by Abe 
'911 and the exfoliant (i.e., N-acetylamino sugar) disclosed by Shimada, and claim 1 is thereby 
patentably distinguished over Abe '911 and Shimada by reciting a combination of cholesterol 
sulfate or a salt thereof and an exfoliant. Abe '314 was filed after Abe '911 by the same applicant, 
i.e., Kanebo Ltd. Specifically, Abe '314 discloses uses of specific cholesterol sulfate salts, such as 



Page 6 of 10 



calcium, magnesium, sodium, and potassium salts, for promoting the water retention function of skin, 
consistent with the teachings of Abe '911 (see the English translation of Abe 6 314, paragraph 
[0007]), Nothing in Abe 6 314 teaches or suggests use of the cholesterol sulfate salts in a manner 
different from that taught by Abe '911. 

Therefore, Abe 6 314 does not remedy the above-described deficiency of Abe 6 911 and 
Shimada and thus cannot support the rejection against claim 4 of the present application. 

Non-Obviousness of Claims 6-9 and 14-15 Over Abe '911, Shimada, and Bernstein 

Claims 6-9 and 14-15 were rejected by the Examiner in the outstanding Office Action under 
35 U.SC §1 03(a) as allegedly obvious over Abe 6 911 in view of Shimada, as applied to claims 1, 3, 
5,13, and 16-19 above, and further in view of International Patent Application Publication No. 
WO90/01323 to Bernstein (hereinafter "Bernstein"). 

Claims 6-9 and 14-15 depend from claims 1 and 13, respectively, and therefore incorporate 
all the limitations recited by claims 1 and 13, including the combination of cholesterol sulfate or a 
salt thereof with an exfoliant or an amino sugar. 

As discussed in the above section pertaining to claims 1 and 13, it would not have been 
obvious for one of ordinary skill in the art to combine the cholesterol sulfate or a salt thereof 
disclosed by Abe 6 911 and the exfoliant or amino sugar (i.e., N-acetylamino sugar) disclosed by 
Shimada, and claims 1 and 13 are therefore patentably distinguished over Abe 6 911 and Shimada 
by reciting a combination of cholesterol sulfate or a salt thereof and an exfoliant or amino sugar. 
Bernstein only discloses uses of fatty acids, such as arachidonic, linoleic, linolenic, palmitic, stearic, 
oleic and docosanoic acids, and sterols, such as cholesterol and cholesterol sulfate, for improving the 
protective water barrier of the stratum corneum layer of the skin and treating dry skin. Nothing in 
Bernstein teaches or suggests combination of cholesterol sulfate or a salt thereof with an exfoliant or 
amino sugar. 

Therefore, Bernstein does not remedy the above-described deficiency of Abe '911 and 
Shimada and thus cannot support the rejections against claims 6-9 and 14-15 of the present 
application. 

Non-Obviousness of Claim 10 Over Abe '911, Shimada, and Kitada 



Page 7 of 10 



The Examiner rejected claim 10 under 35 U.S.C. § 103(a) as allegedly obvious over Abe '911 
in view of Shimada, as applied to claims 1, 3, 5, 13, and 16-19 above, and further in view of 
Japanese Patent Application Publication No. 10-017458 to Kitada (hereinafter "Kitada"). 

Claim 10 directly depends from claim 1 and therefore incorporates all the limitations recited 
by claim 1, including the combination of cholesterol sulfate or a salt thereof with ah exfoliant. 

As discussed in the above section pertaining to claim 1, it would not have been obvious for 
one of ordinary skill in the art to combine the cholesterol sulfate or a salt thereof disclosed by Abe 
'911 and the exfoliant (i.e., N-acetylamino sugar) disclosed by Shimada, and claim 1 is thereby 
patentably distinguished over Abe '911 and Shimada by reciting a combination of cholesterol 
sulfate or a salt thereof and an exfoliant. Kitada only discloses use of a plant extract from Salvia 
officinalis L, which contains sclareolide, for improving the uniformity of skin and preventing skin 
darkness caused by aging. Nothing in Kitada teaches or suggests combination of cholesterol sulfate 
or a salt thereof with an exfoliant. 

Therefore, Kitada does not remedy the above-described deficiency of Abe '911 and 
Shimada and thus cannot support the rejection against claim 10 of the present application. 

Non-Obviousness of Claim 11 Over Abe '911, Shimada, and Takahashi 

The Examiner further rejected claim 1 1 under 35 U.S.C. § 103(a) as allegedly obvious over 
Abe '911 in view of Shimada, as applied to claims 1, 3, 5, 13, and 16-19 above, and further in view 
of Japanese Patent Application Publication No. 06-263627 to Takahashi et al. (hereinafter 
"Takahashi"). 

Claim 1 1 directly depends from claim 1 and therefore incorporates all the limitations recited 
by claim 1 , including the combination of cholesterol sulfate or a salt thereof with an exfoliant. 

As discussed in the above section pertaining to claim 1, it would not have been obvious for 
one of ordinary skill in the art to combine the cholesterol sulfate or a salt thereof disclosed by Abe 
'911 and the exfoliant (i.e., N-acetylamino sugar) disclosed by Shimada, and claim 1 is thereby 
patentably distinguished over Abe '911 and Shimada by reciting a combination of cholesterol 
sulfate or a salt thereof and an exfoliant. Takahashi only discloses use of a plant extract from white 
birch, which contains protease inhibitors, for preventing skin aging, improving the stratum corneum, 
and imparting skin-beautifying effects. Nothing in Takahashi teaches or suggests combination of 
cholesterol sulfate or a salt thereof with an exfoliant. 



Page 8 of 10 



Therefore, Takahashi does not remedy the above-described deficiency of Abe '911 and 
Shimada and thus cannot support the rejection against claim 1 1 of the present application. 

Non-Obviousness of Claim 12 Over Abe '911, Shimada, Kitada, and Takahashi 

The Examiner rejected claim 12 under 35 U.S.C. § 103(a) as allegedly obvious over Abe '911 
in view of Shimada, as applied to claims 1, 3, 5, 13, and 16-19 above, and further in view of Kitada 
and Takahashi. 

Claim 12 directly depends from claim 1 and therefore incorporates all the limitations recited 
by claim 1, including the combination of cholesterol sulfate or a salt thereof with an exfoliant 

As discussed in the above section pertaining to claim 1 , it would not have been obvious for 
one of ordinary skill in the art to combine the cholesterol sulfate or a salt thereof disclosed by Abe 
'911 and the exfoliant (i.e., N-acetylamino sugar) disclosed by Shimada, and claim 1 is thereby 
patentably distinguished over Abe '911 and Shimada by reciting a combination of cholesterol 
sulfate or a salt thereof and an exfoliant. 

Further, as discussed hereinabove in sections pertaining to claims 1 0 and 1 1 , nothing in the 
Kitada and Takahashi reference teaches or suggests combination of cholesterol sulfate or a salt 
thereof with an exfoliant. In other words, Kitada and Takahashi do not remedy the above-described 
deficiency of Abe '911 and Shimada and thus cannot support the rejection against claim 12 of the 
present application. 

Non-Obviousness of Claim 20 Over Abe '911, Shimada, Bernstein, Kitada and Takahashi 

The Examiner rejected claim 20 under 35 U.S.C §103(a) as allegedly obvious over Abe '911 
in view of Shimada, as applied to claims 1,3,5, 13, and 16-19 above, and further in view of 
Bernstein, as applied to claims 6-9 and 14-15 above, and further in view of Kitada and Takahashi. 

Claim 20 directly depends from claim 19 and therefore incorporates all the limitations recited 
by claim 19, including the combination of cholesterol sulfate or a salt thereof with an amino sugar. 

As discussed in the above section pertaining to claim 19, it would not have been obvious for 
one of ordinary skill in the art to combine the cholesterol sulfate or a salt thereof disclosed by Abe 
'911 and the amino sugar disclosed by Shimada, and claim 19 is thereby patentably distinguished 
over Abe '91 1 and Shimada by reciting a combination of cholesterol sulfate or a salt thereof and an 
amino sugar. 



Page 9 of 10 



Further, as discussed hereinabove in the section pertaining to claims 6-9 and 14-15 and the 
sections pertaining to claims 10 and 1 1, nothing in the Bernstein, Kitada, and Shimada references 
teaches or suggests combination of cholesterol sulfate or a salt thereof with an amino sugar. In other 
words, the secondary references Bernstein, Kitada, and Shimada do not remedy the above- 
described deficiency of Abe '911 and Shimada and thus cannot support the rejection against claim 
20 of the present application. 



Based on the foregoing, Applicants submit that claims 1-20 as currently pending in the 
present application are in condition for allowance. Accordingly, Applicants respectfully request the 
Examiner to issue a Notice of Allowance in favor of the Applicants. 



Conclusion 



Respectfully submitted, 




Yongzhi Yang (Reg. No. 56,310) 
Estee Lauder Companies 
155 Pinelawn Road 
Suite 345 South 
Melville, NY 11747 



Telephone No.: 631-414-6089 
Facsimile No.: 631-531-1340 



Page 10 of 10