Ex Parte Krivulka et al

Board of Patent Appeals and Interferences

Sep 28, 2010

11418514 (B.P.A.I. Sep. 28, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOSEPH J. KRIVULKA and LEONARD L. MAZUR
__________

Appeal 2010-003098
Application 11/418,514
Technology Center 1600
__________

Before ERIC GRIMES, TONI R. SCHEINER, and LORA M. GREEN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a kit for
the treatment of acne. The Examiner has rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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STATEMENT OF THE CASE
Claims 1-7 are on appeal. Claims 1 and 3 are representative and read
as follows:
1. A kit for treatment of acne vulgaris, the kit comprising:
a. tretinoin in a formulation acceptable for topical use, the formulation
containing an amount of tretinoin effective for topical use to treat acne
vulgaris;
b. a non-soap skin cleanser having a formulation which avoids
exacerbating tretinoin-associated skin irritation with tretinoin; and
c. a non-greasy skin moisturizer having a formulation which avoids
exacerbating tretinoin-associated skin irritation with tretinoin; and
d. packaging presenting said tretinoin, said skin cleanser and said skin
moisturizer to a user for use together.

3. The kit of claim 1, wherein said non-soap skin cleanser includes
green tea (Camellia sinensis) extract.

The claims stand rejected under 35 U.S.C. § 103(a) as follows:2
• Claims 1, 2, 4 and 5 in view of PsychCentral,3 Goodman,4 and
Puglia.5
• Claims 3, 6 and 7 in view of PsychCentral, Goodman, Puglia, and
Hahn.6

2 Although the Examiner cited the same references with respect to both
rejections, he made clear (Answer 7) that Hahn was applied only with
respect to claims 3, 6, and 7.
3 Archived web page PsychCentral-About Renova (Tretinoin), obtained from
the Internet Archive Wayback Machine, http://web.archive.org/web/
20030728223325/http://www.psychcentral.com/meds/renova.htm
(July 28, 2003).
4 Goodman, US 2002/0155180 A1, Oct. 24, 2002.
5 Puglia, US 2004/0081668 A1, Apr. 29, 2004.
6 Hahn et al., US 5,716,625, Feb. 10, 1998.
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I.
Issue
The Examiner has rejected claims 1, 2, 4 and 5 as obvious based on
PsychCentral, Goodman, and Puglia. The claims have not been argued
separately and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner finds that PsychCentral discloses “topical tretinoin
cream and gel formulations … for treating acne” (Answer 5). The Examiner
also finds that PsychCentral “instructs the user to wash the face with a mild
soap or cleanser (which would reasonably imply to the skilled artisan … a
non-soap cleanser)” and “instructs users to apply creams, lotions, or
moisturizers often” to reduce skin irritation or dryness caused by tretinoin
(id. at 5-6).
The Examiner finds that Goodman discloses acne treatment “which
includes washing the affected area with a mild soap prior to applying a
topical preparation that includes, or may include, tretinoin … but before
applying a moisturizer” (id. at 6). The Examiner finds that Puglia discloses
a treatment method in which patients “apply the tretinoin medication each
night after first washing their face with a mild soapless cleanser. The
patients were also provided a mild moisturizer” (id.). The Examiner
concludes that it would “have been obvious to one of ordinary skill in the art
… to provide a packaged kit containing a topical anti-irritating tretinoin skin
formulation…, a non-soap cleaner, and a non-greasy moisturizer based upon
… the instructions given to users undergoing tretinoin treatment” (id. at 7).
Appellants contend that the PsychCentral reference is not prior art
(Appeal Br. 16-17; Reply Br. 3-9), that Goodman teaches away from the
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claimed kit (Reply Br. 18), and that secondary evidence has overcome any
prima facie case of obviousness (Appeal Br. 21-25; Reply Br. 10-15, 20-23).
The issues with respect to this rejection are:
Does the PsychCentral reference qualify as prior art?,
Do the prior art references of record support the Examiner’s
conclusion that the kit of claim 1 would have been obvious to a person of
ordinary skill in the art? and, if so,
Have Appellants provided evidence of secondary considerations that
outweighs the evidence supporting the prima facie case of obviousness?
Findings of Fact
1. PsychCentral discloses that tretinoin “is used to treat acne”
(PsychCentral 1).
2. PsychCentral discloses: “Before applying tretinoin, wash the skin
with a mild soap or cleanser and warm water…. Wait 20 to 30 minutes
before applying this medicine to make sure the skin is completely dry.
Applying tretinoin to wet skin can irritate the skin.” (Id. at 3.)
3. PsychCentral discloses that “it is especially important to avoid
using the following skin products on the same area as tretinoin: … Skin
products that are too drying or abrasive, such as some cosmetics, soaps, or
skin cleansers[.] Using these products along with tretinoin may cause mild
to severe irritation of the skin” (id. at 5).
4. PsychCentral discloses that “[d]uring the first 6 months of use, …
skin will be more prone to sunburn, dryness, or irritation…. [W]ear
protective clothing and hats, and apply creams, lotions, or moisturizers
often.” (Id. at 5-6.)
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5. PsychCentral discloses that “[r]egular use of water-based creams
or lotions helps to reduce skin irritation or dryness that may be caused by the
use of tretinoin” (id. at 6).
6. Goodman discloses a “method and preparation for the treatment of
acne and hirsutism [that] comprises topically applying an effective amount
of a saw palmetto berry extract, and preferably one or more low irritability
constituents that enhance penetration of the extract into hair follicle
sebaceous glands” (Goodman, abstract).
7. Goodman discloses that preferred penetration enhancers include
tretinoin (id. at 2, ¶ 25).
8. Goodman discloses that its “formulations should be applied after
washing with a mild soap, but before the use of moisturizers, sunscreens or
makeups” (id. at 3, ¶ 33).
9. Puglia discloses “a cream base for the topical application of skin
care therapeutics” (Puglia 1, ¶ 0011).
10. Puglia discloses that, in some embodiments, “the cream is a
carrier that contains as an active ingredient fluocinolone acetonide,
hydroquinone, tretinoin and combinations thereof” (id. at 1-2, ¶ 0013).
11. Puglia discloses that the “patients were instructed to apply their
study medication each night, after washing their face with a mild soapless
cleanser” (id. at 3, ¶ 0034).
12. Puglia discloses that the “patients were provided a mild
moisturizer for use as needed” (id.).
13. Appellants have provided a declaration under 37 C.F.R. § 1.132
of Zoe Diana Draelos (filed March 5, 2008).
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14. Dr. Draelos declares that a study was carried out on acne patients
to compare the effects of tretinoin combined with “a specially selected skin
cleanser and a specially selected skin moisturizer, each commercially
available in the Tretin-XTM Kit, Triax Pharmaceuticals” (Draelos Decl. 19-
20, ¶ 48) with tretinoin combined with “a Dove® brand bar (combining a
skin cleanser and a skin moisturizer” (id.).
15. Dr. Draelos declares that the patients using the Tretin-XTM Kit
also applied a once-weekly facial mask of “a skin moisturizer containing
glycerin and algae humectant” (id.) “to decrease skin dehydration” (id. at 22,
¶ 52).
16. Dr. Draelos declares that the Tretin-XTM kit showed “a
statistically-significant reduction in inflammation (p=0.039) and dryness
(p=0.005) with the claimed skin care system, when compared to the prior art
topical tretinoin and Dove® bar cleanser alone” (id. at 23, ¶ 55.)
17. Appellants have provided a declaration under 37 C.F.R. § 1.132
of Peter Volk (filed May 14, 2008).
18. Mr. Volk declares that Triax Pharmaceuticals began selling the
claimed kit under the trade name Tretin-X® in April 2006 and began selling
a similar kit containing minocycline (the Professional Acne CareTM kit) in
September 2006 (Volk Declaration 2-3, ¶¶ 7-9).
19. Mr. Volk declares that the “claimed kit is the first kit I am aware
of which packages a prescription-strength dermatology drug together with a
non-prescription cosmetic product” (id. at 2, ¶ 6).
20. Mr. Volk declares that “since Triax began offering its
Professional Acne CareTM kits for sale, a large number of competitors have
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begun to copy this concept, offering for sale a variety of new dermatology
care kits which package a prescription-strength dermatology drug together
with appurtenant cosmetic products apparently selected to reduce the
incidence of adverse drug side effects” (id. at 3-4, ¶ 11)
21. Mr. Volk declares: “I know of no competitor who now offers for
sale in The United States a kit which includes each and every one of these
three components [of claim 1]. Rather, each of the above-discussed new kits
by design omits one of the three elements recited by the instant claims.” (Id.
at 4-5, ¶ 14.)
Analysis
Claim 1 is directed to a kit for treating acne comprising a topical
tretinoin formulation, a non-soap skin cleanser and non-greasy skin
moisturizer, each of which does not exacerbate tretinoin-associated skin
irritation, and packaging.
PsychCentral and Goodman both disclose the use of topical tretinoin
to treat acne. PsychCentral discloses that tretinoin can cause skin irritation,
and suggests avoiding the use of skin cleansers that are drying or abrasive in
order to reduce skin irritation. PsychCentral, Goodman, and Puglia all teach
washing the skin with a mild soap or cleanser before applying tretinoin.
PsychCentral also discloses that the regular use of moisturizers helps to
reduce skin irritation or dryness that may be caused by the use of tretinoin,
and Puglia discloses providing patients using a topical tretinoin formulation
with a mild moisturizer to use as needed.
In view of these disclosures, it would have been obvious to one of
ordinary skill in the art to package a tretinoin composition for treating acne
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with a non-drying non-soap cleanser and a moisturizer, each of which does
not exacerbate the skin irritation that was known in the art to be caused by
tretinoin. The claimed kit merely combines known products for their known
functions.
Appellants argue that the PsychCentral reference does not qualify as
prior art (Appeal Br. 16-17) but the Examiner has provided evidence from an
Internet archive (the WayBackMachine) to show that the relevant
disclosures of PsychCentral were available to those skilled in the art as of
July 28, 2003, before the effective filing date of the application on appeal.
Appellants also argue that the evidence provided by the WayBackMachine is
not reliable enough to establish a publication date for a reference (Reply Br.
8-9). This argument is also not persuasive. The Examiner’s evidence
reasonably establishes that the PsychCentral document was publicly
available as of July 28, 2003, and Appellants have not provided any
evidence to the contrary.
Appellants argue that the evidence from the WayBackMachine was
not filed until after they had filed an appeal and therefore is inadmissible
under 37 C.F.R. § 41.33 (Reply Br. 5-6). Rule 41.33, however, applies only
to new evidence submitted by an applicant, not evidence newly cited by an
examiner. See 37 C.F.R. § 41.33 (“An affidavit or other evidence filed after
the date of filing an appeal … may be admitted if the Examiner determines”
that the relevant criteria are met (emphasis added)). If Appellants believed
that the new evidence changed the basis of the rejection so as to make, in
effect, a new ground of rejection, they could have filed a petition to that
effect. See MPEP § 1207.03 (IV) (8th ed., rev. 7, July 2008). Whether a
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rejection on appeal constitutes a new ground of rejection is reviewed by way
of petition, not appeal.
Appellants argue that Goodman teaches away from the claimed
combination (Reply Br. 18) but have pointed to nothing in Goodman that
would have led a skilled worker to expect that tretinoin would not be
effective to treat acne if combined with a cleanser or moisturizer that does
not exacerbate skin irritation. Goodman therefore does not teach away from
the claimed combination. See In re Gurley, 27 F.3d 551, 553 (Fed. Cir.
1994) (“[I]n general, a reference will teach away if it suggests that the line of
development flowing from the reference’s disclosure is unlikely to be
productive of the result sought by the applicant.”).
Appellants argue that “Goodman, Puglia and PsychCentral … teach to
use a skin cleanser which is not too drying or abrasive, and which is mild”
(Reply Br. 11). Appellants assert that a Dove® cleansing bar is just such a
skin cleanser, but the Draelos Declaration showed that a Dove® cleansing
bar “was associated with significantly more skin irritation” than the claimed
kit (id. at 11-12).
This argument is not persuasive. The evidence presented in the
Draelos Declaration does not outweigh the evidence showing obviousness
for several reasons. First, the claims only require a skin cleanser and
moisturizer that “avoid[ ] exacerbating tretinoin-associated skin irritation
with tretinoin” (claim 1). The Draelos Declaration does not present any
comparison of the skin irritation caused by tretinoin alone with skin irritation
caused by tretinoin and Dove® cleanser; i.e., the declaration does not show
that Dove® cleanser exacerbates the skin irritation caused by tretinoin so as
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to be excluded from the scope of the claims. Therefore, the evidence in the
Draelos Declaration does not show that Dove® cleanser is not encompassed
by the claims, even if there are other cleansers and moisturizers that cause
less skin irritation when used with tretinoin.
Second, the course of treatment found to be less irritating in the
Draelos Declaration also included a weekly facial mask to decrease skin
dehydration. The data therefore cannot be relied on to show that the
observed difference in skin irritation was the result of the different cleansers
used, rather than the result of including a facial mask along with the cleanser
and moisturizer in the Tretin-XTM kit.
Finally, the less-irritating course of treatment does not correspond to
the claimed kit because it includes a facial mask that is not a part of the
claims. “Although it is well settled that comparative test data showing an
unexpected result will rebut a prima facie case of obviousness, the
comparative testing must be between the claimed invention and the closest
prior art.” In re Fenn, 639 F.2d 762, 765 (CCPA 1981) (emphasis added).
Appellants argue that the claimed invention has been widely copied,
providing evidence that the claimed invention was not obvious (Appeal Br.
23-24; Reply Br. 20-21; citing the Volk Declaration).
This argument is not persuasive. The Volk Declaration does not
provide evidence that the claimed kit has been copied. Mr. Volk actually
declares that no one has copied the claimed kit, although he asserts that
several companies copied the concept of packaging a prescription
medication with non-prescription cosmetic products. The claims on appeal,
however, are not directed to a kit that generically comprises a prescription
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medication and non-prescription cosmetics, but one that specifically
comprises tretinoin, a non-soap cleanser, and a non-greasy moisturizer.
Thus, no evidence has been provided the claimed kit has been copied.
Conclusion of Law
The PsychCentral reference qualifies as prior art. The prior art
references of record support the Examiner’s conclusion that the kit of claim
1 would have been obvious to a person of ordinary skill in the art.
Appellants have not provided evidence of secondary considerations that
outweighs the evidence supporting the prima facie case of obviousness.
II.
Issue
The Examiner has rejected claims 3, 6 and 7 under 35 U.S.C. § 103(a)
as being obvious in view of PsychCentral, Goodman, Puglia, and Hahn. The
claims have not been argued separately and therefore stand or fall together.
37 C.F.R. § 41.37(c)(1)(vii).
The Examiner relies on PsychCentral, Goodman, and Puglia as
discussed above. The Examiner finds that Hahn discloses topical
compositions designed to reduce skin irritation that “may beneficially
comprise anti-inflammatory agents such as green tea” (Answer 8). The
Examiner concludes that it would “have been obvious to one of ordinary
skill in the art … to include one or more art-accepted anti-inflammatory
agents such as green tea … within a skin cleanser (such as a non-soap
cleaner) and/or moisturizer including those employed by the cited primary
references” (id.).
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Appellants contend that one of skill in the art would not have
considered it obvious to combine Hahn with PsychCentral, Goodman, and
Puglia because the combination would be inoperable (Reply Br. 18).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that one of ordinary skill in the art
would have been motivated to include green tea extract in the non-soap skin
cleanser of the kit suggested by PsychCentral, Goodman, and Puglia?
Additional Findings of Fact
22. Hahn discloses “the use of the divalent cation strontium (Sr2+) and
salts thereof as ingredients to provide fast-acting, efficient and safe topical
skin anti-irritant effects” (Hahn, col. 9, ll. 59-62).
23. Hahn discloses that its formulations are
particularly useful for preventing, reducing or eliminating the
potential irritation caused by topical application of products
containing other irritating ingredients, including … topical drug
products containing irritating active ingredients or vehicles, and
other products such as soaps, detergents, solvents and the like
which are either applied topically or are topically exposed to the
body during use.
(Id. at col. 9, l. 66 to col. 10, l. 10.)
24. Hahn discloses that “the cation of the present invention may be
combined in a formulation with other anti-irritants, such as steroidal or non-
steroidal anti-inflammatory agents or other materials such as aloe vera,
chamomile, α-bisabolol, cola nitida extract, green tea extract,” etc. (id. at
col. 10, l. 65 to col. 11, l. 2).
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Analysis
Claim 3 depends from claim 1and further requires that the non-soap
skin cleanser includes green tea extract.
As discussed above, the combination of PsychCentral, Goodman,
Puglia would have made obvious the kit of claim 1 for the treatment of acne.
Hahn discloses that green tea extract is art-recognized as an anti-irritant for
use in topical compositions. In view of these disclosures, it would have been
obvious to include a green tea extract in the non-soap cleanser of the kit
suggested by the prior art because PsychCentral discloses that tretinoin can
irritate the skin and Hahn discloses that green tea extract is an anti-irritant.
Appellants argue that the combination would not have been obvious
because “Hahn’s strontium ion would oxidize the tretinoin and destroy it”
(Reply Br. 19). Appellants further argue that “strontium is highly reactive
with water, decomposing on contact.… The skilled artisan would recognize
that adding Hahn’s strontium ion to a water-based cream or gel would
degrade the strontium ion” (id.).
This argument is not persuasive. The Examiner’s rejection is based
on including green tea extract, not strontium, in a non-soap cleanser (Answer
8) because Hahn discloses that green tea extract is an art-accepted anti-
irritant for topical applications. Thus, irrespective of Hahn’s disclosure with
regard to strontium ion, one of ordinary skill in the art would have been
motivated to combine green tea extract with the kit components to optimize
the treatment of acne.
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Conclusion of Law
The evidence of record supports the Examiner’s conclusion that one
of ordinary skill in the art would have been motivated to include green tea
extract in the non-soap skin cleanser of the kit suggested by PsychCentral,
Goodman, and Puglia.
SUMMARY
We affirm the rejection of claims 1-7 under 35 U.S.C. § 103(a).
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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