Ex Parte Bhagwat et al

Board of Patent Appeals and Interferences

Jan 21, 2004

09961623 (B.P.A.I. Jan. 21, 2004)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

Paper No. 20

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DILEEP BHAGWAT, BRADLEY P. GLASSMAN
and DANIEL GLASSMAN
__________

Appeal No. 2003-1424
Application No. 09/961,623
__________

HEARD January 6, 2004
__________

Before WILLIAM F. SMITH, GRIMES, and GREEN, Administrative Patent
Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL

This is a decision on appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 1-13, all of the claims remaining. Claims 12 and 13 are
representative and read as follows:
12. A topical composition comprising:
(a) about 0.5 to about 20 weight % benzoyl peroxide;
(b) about 0.1 to about 40 weight % urea; and
(c) a dermatologically acceptable carrier.

13. The composition of claim 12, wherein the pH of the composition is
below about 9.

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Application No. 09/961,623

The examiner relies on the following references:
Klein et al. (Klein) 4,497,794 Feb 05, 1985
Gennaro et al. (Gennaro), “Remington’s Pharmaceutical Sciences”, 18th edition,
pp. 767-768 and 1329 (1990)

Dipiro et al. (Dipiro), “Pharmacotherapy: A Pathophysiologic Approach”,
pp. 23-26 (1998)

Claims 1-13 stand rejected under 35 U.S.C. § 103 as obvious in view of
Klein and Gennaro.
We reverse.
Background
“Benzoyl peroxide and urea are pharmacological agents useful for the
treatment of dermatological disorders.” Specification, page 2. A composition
comprising both urea and benzoyl peroxide could be expected to provide greater
keratolytic and antibacterial effects than benzoyl peroxide alone, “because urea
has keratolytic activity and has the property of denaturing and solubilizing
proteins in addition to antimicrobial activity.” Id., page 1. “However, benzoyl
peroxide and urea have generally been considered incompatible. . . . Benzoyl
peroxide formulations are generally most stable under acidic conditions.
However, urea containing formulations generally tend to be neutral or slightly
alkaline.” Id., page 2.
The specification discloses compositions comprising benzoyl peroxide,
urea, and a dermatologically acceptable carrier, for use in treating dermatological
disorders such as acne. See, e.g., page 9. The compositions are disclosed to
Appeal No. 2003-1424 Page 3
Application No. 09/961,623

combine the benefits of urea and benzoyl peroxide and yet achieve a stable
formulation. See page 1.
Discussion
Claim 12, the broadest claim on appeal, is directed to a composition
comprising benzoyl peroxide (0.5 to 20 weight percent), urea (0.1 to 40 weight
percent), and a dermatologically acceptable carrier. The examiner rejected all of
the claims as obvious in view of Klein and Gennaro. The examiner cited Klein as
teaching an anti-acne composition comprising, among other things, 5% benzoyl
peroxide, and cited Gennaro for its teaching that urea is a mild keratolytic agent
used in a concentration of 2-20%. See the Examiner’s Answer, page 4. The
examiner acknowledged that, as the basis of an obviousness rejection, Klein and
Gennaro leave something to be desired:
The references do not expressly teach that urea is useful in treating
acne. The references do not expressly teach that the pH of the
composition is in a range of about 4 to about 9. The references do
not expressly teach that the topical composition comprises an
additional keratolytic agent.

Examiner’s Answer, page 5.1
In the examiner’s view, however, a person of ordinary skill in the art would
have been motivated to add urea to Klein’s anti-acne composition, because urea
is a keratolytic agent and “keratolytic agents are known to be useful in treating
acne.” The examiner concluded that “[c]ombining two agents, which are known

1 The examiner’s last point—regarding an additional keratolytic agent—is implicated only by
dependent claim 6 and need not concern us here.
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Application No. 09/961,623

to be useful to treat acne individually, into a single composition and method
useful for the very same purpose is prima facie obvious.” Id.
Appellants dispute the examiner’s basis for combining the references.
See the Reply Brief, pages 2-3:
[T]he Examiner makes a general statement that all keratolytic
agents are known to be useful in treating acne. However, in the
first full paragraph describing keratolytic agents in general,
Gennaro does not mention acne as a specific primary treatment for
such an agent. Although benzoyl peroxide . . . [is] stated to be
possibly useful for treating acne, the Examiner has not
demonstrated that all keratolytic agents are useful for treating acne.
In fact, there is no indication in Gennaro that urea can be used for
treating acne. Notably, it is stated to be used to treat dry skin.

Appellants also argue that the references do not provide a reasonable
expectation of success. See the Appeal Brief, page 8:
The success to be expected here is whether a single stable
combination providing compatibility for the two active ingredients
benzoyl peroxide and urea could actually have been made
providing treatment of dermatological disorders. There is no
expectation of success that a single composition could be made
which would be stable with these two ingredients. In fact, Klein et
al. would teach away from such a single stable composition.

The examiner bears the initial burden of showing unpatentability. See,
e.g., In re Rijckaert, 9 F.3d 1531, 1532, 28 USPQ2d 1955, 1956 (Fed. Cir. 1993).
A prima facie case of obviousness requires evidence that the prior art disclosed
or suggested all of the elements of the claimed invention, and that those skilled in
the art would have been motivated to combine those elements with a reasonable
expectation of success. See In re Wilson, 424 F.2d 1382, 1385, 165 USPQ 494,
496 (CCPA 1970) (“All words in a claim must be considered in judging the
patentability of the claim against the prior art.”); In re Vaeck, 947 F.2d 488, 493,
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Application No. 09/961,623

20 USPQ2d 1438, 1443 (Fed. Cir. 1991) (prima facie obviousness requires, inter
alia, motivation to combine and reasonable expectation of success, both founded
on the prior art).
We agree with Appellants that the examiner’s references do not support a
prima facie case of obviousness. The examiner has not adequately explained
why those skilled in the art would have been led to combine Gennaro’s urea with
Klein’s anti-acne composition. Neither Klein nor Gennaro expressly suggest that
urea would be effective in treating acne, or that it would impart any other
desirable quality to Klein’s composition.
While Gennaro discloses that urea is a mild keratolytic agent, and
discloses that some other keratolytic agents are useful in treating acne, these
disclosures do not support the examiner’s position that it would have been
obvious to combine urea with Klein’s anti-acne composition. First, Gennaro does
not disclose that all keratolytic agents are useful in treating acne. See pages 767-
768: in the general discussion of keratolytics, Gennaro states only that they are
useful for “treatment of epidermophytosis [i.e., fungal infections] . . . [and] to thin
hyperkeratotic areas.” The examiner has not explained how this disclosure would
have suggested treatment of acne to those of ordinary skill in the art.
In addition, Klein teaches away from combining other active agents with its
disclosed benzoyl peroxide-containing composition. See column 2, lines 7-12:
“[B]ecause of the powerful oxidizing properties of the peroxide component, the
inclusion of this substance . . . with other active ingredients results in unstable
compositions that soon display an unacceptable loss in keratolytic potency.”
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Application No. 09/961,623

Klein’s solution to this problem is to store the second active agent (erythromycin)
separately from the benzoyl peroxide-containing composition.
Thus, Klein would have led those skilled in the art to expect that
combining urea with Klein’s benzoyl peroxide composition would have produced
an unstable composition that would soon display an unacceptable loss of
keratolytic potency. It would seem, therefore, that Klein would have discouraged
those of skill in the art from making the combination required by the instant
claims. Such a disclosure is evidence of unobviousness. See Arkie Lures Inc. v.
Gene Larew Tackle Inc., 119 F.3d 953, 957-58, 43 USPQ2d 1294, 1297 (Fed.
Cir. 1997) (“It is insufficient to establish obviousness that the separate elements
of the invention existed in the prior art, absent some teaching or suggestion, in
the prior art, to combine the elements. . . . The evidence that the combination
was not viewed as technically feasible must be considered, for conventional
wisdom that a combination should not be made is evidence of unobviousness.”).
Other Issues
According to the “Search Notes” section of the file wrapper, the examiner’s
search of the patent and non-patent literature consisted of the keywords “benzoyl
peroxide”, “urea”, and “keratolytic”. Notable by its absence is the keyword
“acne”. We recommend that, upon return of this case and before issuing a
Notice of Allowability, the examiner re-search the relevant databases and include
“acne” as a search term. Such a search may well turn up more relevant prior art
than is currently in the record.
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Application No. 09/961,623

For example, a search of the publicly accessible PubMed database
(http://www.ncbi.nlm.nih.gov/entrez/query.fcgi), using the keywords “benzoyl
peroxide”, “urea”, and “acne” turned up a reference entitled “Comparative trial of
benzoyl peroxide versus benzoyl peroxide with urea in inflammatory acne.”2 The
most relevant passage from the reference’s abstract states:
A clinical trial was performed to evaluate an improved vehicle for
topical benzoyl peroxide. Thirty-nine subjects participated in a split-
face, double-blind trial of topical benzoyl peroxide 5 percent versus
benzoyl peroxide 5 percent in 8 percent urea.

The study found “[n]o overall differences” between the effects of the two
compositions (that is, no added efficacy due to the addition of urea). However,
that makes no difference with respect to patentability if the disclosed composition
meets the limitations of Appellants’ claims. See Celeritas Techs. Ltd. v. Rockwell
Int’l Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522 (Fed. Cir. 1998) (“A
reference is no less anticipatory if, after disclosing the invention, the reference
then disparages it.”).
Upon return of this case, the examiner should consider the patentability of
the instant claims over the reference discussed above and any other references
discovered using “acne” as a search term along with other relevant keywords.

2 The reference citation is Prince et al., Cutis, Vol. 29, No. 6, pp. 638-40 and 644-45 (1982). A
copy of the abstract from the PubMed database is attached to this opinion.
Appeal No. 2003-1424 Page 8
Application No. 09/961,623

Summary
The references relied upon by the examiner do not support a prima facie
case of obviousness. The rejection under 35 U.S.C. § 103 is reversed.

REVERSED

William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Eric Grimes )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Green )
Administrative Patent Judge )

EG/dym

Appeal No. 2003-1424 Page 9
Application No. 09/961,623

Andrea G. Reister, Esq.
Covington & Burling
1201 Pennsylvania Avenue, NW
Washington, DC 20004-2401