Ex Parte Popp

Board of Patent Appeals and Interferences

Mar 2, 2010

10617191 (B.P.A.I. Mar. 2, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
10/617,191 07/11/2003 Karl F. Popp 24948 3528
90434 7590 03/03/2010
Glaxo Smith Kline
c/o The Nath Law Group
112 South West St.
Alexandria, VA 22314-2825
EXAMINER
CHANNAVAJJALA, LAKSHMI SARADA
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
03/03/2010 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)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte KARL F. POPP
__________

Appeal 2009-010010
Application 10/617,191
Technology Center 1600
__________

Decided: March 3, 2010
__________

Before DEMETRA J. MILLS, ERIC GRIMES, and STEPHEN WALSH,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of making a topical composition, which the Examiner has rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification discloses a topical composition for treating skin
disorders or conditions (Spec. 2). The composition is made by combining
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a benzoyl peroxide dispersion and a clindamycin solution (id. at 8-9), and
producing a composition having a viscosity lower than the viscosity of the
benzoyl peroxide dispersion (id. at 8).
Claims 26-31 are on appeal. The claims have not been argued
separately and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii).
Claim 26 is representative and reads as follows:
26. A process for preparing a storage-stable topical composition for
treating a skin disorder or condition, which comprises the steps of:
a) forming at a temperature of about 15 to about 25 °C a benzoyl
peroxide intermediate dispersion having a viscosity of about 60,000 to about
250,000 centipoises sufficient to yield a composition which contains
between about 2.25% and about 12.5% by weight benzoyl peroxide in the
final product;
b) forming at a temperature of about 15 to about 25 °C a clindamycin
intermediate solution sufficient to yield a composition which contains
between about 0.5% and about 1.5% by weight clindamycin active in the
final product; and
c) mixing said benzoyl peroxide intermediate dispersion and said
clindamycin intermediate solution under conditions sufficient to yield a
benzoyl peroxide and clindamycin mixture having final pH of between about
4.5 to about 5.0,
wherein said mixture has a viscosity lower than the viscosity of the
benzoyl peroxide intermediate dispersion, wherein the viscosity of the
mixture is of about 50,000 to about 200,000 centipoises, and wherein said
composition comprises sufficient inactive ingredients to provide storage
stability and effectiveness for a treatment period.

Issue
The Examiner has rejected claims 26-31 under 35 U.S.C. § 103(a) as
obvious in view of Baroody1 (Ans. 3). The Examiner finds that Baroody
discloses a storage-stable composition made by mixing clindamycin and

1 Baroody et al., U.S. Patent 6,117,843, issued Sept. 12, 2000.
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benzoyl peroxide (id.) with viscosities overlapping those recited in claim 26
(id. at 4-5) but “does not teach that the final viscosity is lower than the
viscosity of benzoyl peroxide dispersion” (id. at 4). The Examiner
concludes that the claimed process nonetheless would have been obvious
because Appellant has not shown that the relative viscosities are critical to
the stability of the composition and “a skilled artisan would have been able
to adjust the initial viscosity of benzoyl peroxide in the claimed range . . .
with an expectation to achieve a composition of an appropriate viscosity that
is stable for long periods of time” (id. at 6).
Appellant contends that Baroody emphasizes that a lower-viscosity
benzoyl peroxide dispersion provides the advantage of easier mixing and
therefore would not have suggested using a higher-viscosity benzoyl
peroxide dispersion, as recited in claim 26 (Appeal Br. 15-25). Appellant
also contends that the claimed process provides unexpected results and
advantages compared to Baroody’s process (id. at 25-29).
The issues presented are:
Does the evidence of record support the Examiner’s position that it
would have been obvious to modify Baroody’s process by using a benzoyl
peroxide composition with a viscosity higher than that of the final
composition?,
and
If so, has Appellant provided evidence of unexpected results that
outweighs the evidence in favor of obviousness?
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Findings of Fact
1. Baroody discloses acne treatment compositions comprising 1% to
20% by weight benzoyl peroxide and 0.2% to 4% by weight clindamycin
(Baroody, col. 2, ll. 39-49).
2. Baroody discloses that “the topical compositions are prepared by
combining or admixing an aqueous gel suspension of benzoyl peroxide with
an aqueous solution of a clindamycin salt or ester” (id. at col. 2, ll. 61-64).
3. Baroody discloses that the clindamycin solution has a pH “within a
range of 3.5 to 7, preferably within a range of 6 to 6.5” (id. at col. 5, ll. 31-
32).
4. Baroody discloses that the benzoyl peroxide composition has “a
pH in the range from 3.5 to 7.0, preferably in the range from 4.0 to 5.0” (id.
at col. 5, l. 66 to col. 6, l. 1).
5. Baroody discloses that “[b]y combining preselected amounts of the
two components, the pH of the combination will be below 7 and the
combination will remain stable for several months after admixture at room
temperature” (id. at col. 3, ll. 9-13).
6. Baroody discloses that the “aqueous suspension of benzoyl
peroxide is stored at a pH from 3.5 to 7.0, typically with a gelling agent
which has a relatively low viscosity at the storage pH” (id. at col. 3, ll. 4-9).
7. Baroody discloses that
[b]y properly selecting the nature of the gelling agent and the
pH of the benzoyl peroxide component, the benzoyl peroxide
component itself may be maintained at a relatively low
viscosity while the final topical composition (which is at a
different pH) will have a relatively higher viscosity. In this
way, mixing of the two components to form the topical
composition is facilitated . . . while the final topical
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composition can still possess the desired higher viscosity, gel
consistency.
(Id. at col. 5, ll. 46-57.)
8. Baroody discloses that “[p]referably, the viscosity of the benzoyl
peroxide . . . component will be below about 9x104 cp, usually being in the
range from 5x104 cp to 9x104 cp . . . while the viscosity of the final topical
composition product will be in the range from 7x104 cp to 12x104 cp, more
preferably being in the range from 8x104 cp to 10x104 cp” (id. at col. 5, ll.
58-64).
9. Baroody discloses that “[b]y maintaining the compositions at a pH
below 7, the tendency of benzoyl peroxide to oxidize and degrade
clindamycin is largely overcome and the product remains stable during
storage at room temperature for extended periods, typically several months
or longer” (id. at col. 2, ll. 49-54).
10. The Specification states that “[b]y maintaining the compositions
at the present specific pH, the tendency of benzoyl peroxide to oxidize and
degrade clindamycin is largely overcome and the product remains stable
during storage at room temperature for extended periods, typically several
months or longer” (Spec. 34:17 to 35:3).
Principles of Law
“If a person of ordinary skill can implement a predictable variation [of
a known work], § 103 likely bars its patentability.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 417 (2007)
“Under 35 U.S.C. § 103, a reference must be considered not only for
what it expressly teaches, but also for what it fairly suggests. . . . [W]e
reiterate that ‘all disclosures of the prior art, including unpreferred
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embodiments, must be considered’ in determining obviousness.” In re
Burckel, 592 F.2d 1175, 1179 (CCPA 1979).
“[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.” In re Gurley, 27 F.3d 551,
553 (Fed. Cir. 1994).
“[W]hen unexpected results are used as evidence of nonobviousness,
the results must be shown to be unexpected compared with the closest prior
art.” In re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).
Analysis
Baroody discloses a method of making a topical composition by
mixing separate benzoyl peroxide and clindamycin compositions. Baroody
discloses ranges for the concentrations of the compositions, the viscosities of
the benzoyl peroxide and final compositions, and the pH of the final
composition that overlap the ranges recited in claim 26. Overlapping ranges
typically show a prima facie case of obviousness. See In re Peterson,
315 F.3d 1325, 1329 (Fed. Cir. 2003).
Appellant does not argue that the claimed process is distinguished
from the process taught by Baroody by the concentrations, viscosities, or pH
range recited in the claim. Nor does Appellant argue that mixing at room
temperature, as recited in claim 26, would not have been obvious to a skilled
worker.
Rather, Appellant argues that the claimed process would not have
been obvious based on Baroody because the claimed process requires the
benzoyl peroxide dispersion to have a higher viscosity than the final
composition, and Baroody teaches that a benzoyl peroxide dispersion with a
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lower viscosity than the final composition facilitates mixing. Appellant
argues that this teaching would not have led a skilled worker to modify
Baroody’s method in the manner required by the claims (Appeal Br. 16) and
in fact would have taught away from doing so because that would have been
expected to make the mixing process more difficult (id. at 18-20). Along the
same line, Appellant argues that Baroody’s teaching shows that the claimed
process proceeds in a direction contrary to the generally accepted wisdom,
supporting the nonobviousness of the claims (id. at 22-25, citing In re
Hedges, 783 F.2d 1038 (Fed. Cir. 1986)).
These arguments do not persuade us that the Examiner’s rejection
should be reversed. It is true that Baroody points out that starting with a
benzoyl peroxide composition with a lower viscosity than the final
composition facilitates mixing of the benzoyl peroxide and clindamycin
compositions. A skilled worker would therefore expect that a benzoyl
peroxide composition with a higher viscosity than the final composition
would require more effort to mix with a clindamycin composition.
Baroody, however, does not disclose or suggest that an acceptable
clindamycin/benzoyl peroxide composition cannot be made using a benzoyl
peroxide composition with a higher viscosity than the final composition.
Baroody therefore does not teach away from the claimed process, because it
does not teach that modifying the method as required by the claims would
make it unusable. Baroody merely discloses that using a higher-viscosity
benzoyl peroxide composition is a non-preferred embodiment of its method.
A person of ordinary skill in the art would expect, based on Baroody,
that practicing its method using a benzoyl peroxide composition with a
higher viscosity than the final composition would also produce an acceptable
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final product, even if the mixing process was more difficult. “If a person of
ordinary skill can implement a predictable variation [of a known work],
§ 103 likely bars its patentability.” KSR, 550 U.S. at 417. A non-preferred
embodiment of a disclosed method is a predictable variation of that method,
and therefore obvious to those of ordinary skill in the art.
We do not agree that In re Hedges, 783 F.2d 1038 (Fed. Cir. 1986),
supports the nonobviousness of the claimed process. In Hedges, the claimed
invention was “the reaction of diphenyl sulfone, at a temperature above its
melting point of 127°C, with liquid or gaseous sulfur trioxide in the absence
of water or a solvent.” Id. at 1039. The reference relied on for obviousness
taught carrying out the reaction at a much lower temperature, id., but the
PTO took the position that “determining the optimum temperature is a
matter of ‘routine experimentation.’” Id. at 1040.
The inventor pointed to prior art that showed that similar reactions
either led to charring and decomposition, or required the presence of solvent,
at high temperatures. Id. The court concluded that “the references all
suggest[ed] that lower temperatures of reaction are preferable. No reference
suggests that diphenyl sulfone may advantageously be reacted in the molten
state with sulfur trioxide. The data provided by Hedges show significant
advantages of the claimed invention.” Id. at 1041. Based on all of the
evidence, the court held that the PTO had not shown the claimed method to
be obvious. Id.
Thus, in Hedges, the evidence showed that those skilled in the art
would have expected that the claimed reaction either would not have
proceeded, because a solvent was required at high temperatures, or would
have led to charring and decomposition of the product. In contrast, the
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evidence of record in this case only shows that those skilled in the art would
have expected that Baroody’s composition would have required more effort
to mix if the benzoyl peroxide composition had a higher viscosity, not that it
could not have been mixed or would have produced an unacceptable
product.
The Hedges court did not hold that the claimed reaction conditions
were nonobvious merely because they would have slowed the rate of the
reaction or would have required an additional purification step, factors that
would be similar to the added mixing suggested by Baroody. On these facts,
therefore, Hedges does not require reversal of the Examiner’s rejection.
Appellant also argues that Baroody “would predict the inability to
prepare a storage stable topical composition due to the difficulty of mixing
the various components” (Appeal Br. 16). This argument is not persuasive,
because Appellant has pointed to nothing in Baroody that states that its
components could not be adequately mixed if the benzoyl peroxide
composition had a higher viscosity than the final composition.
Finally, Appellant argues that the claimed process provides
unexpected results compared to Baroody’s, in that the claimed process
“provides compositions that are easier to mix together, contain less
degradates, and have a greater degree of uniformity than those compositions
previously known in the art, including the Baroody et al. composition”
(Appeal Br. 26-27). Appellant also argues that the claimed process provides
compositions that are more storage-stable than Baroody’s (id. at 27-28) and
does not require the composition to be compounded at the time of dispensing
(id. at 28).
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This argument is also unpersuasive, because Appellant has not pointed
to evidence in the record showing a comparison of the claimed process to
that of Baroody, which differs from the claims only in the relative viscosity
of the benzoyl peroxide and final compositions. Appellant has not provided
evidence, for example, to support the assertion that the claimed process
provides compositions that are easier to mix and have greater uniformity
than the composition resulting from Baroody’s process. See In re
Hoeschele, 406 F.2d 1403, 1406 (CCPA 1969) (“[A]n arguable difference
where comparative evidence is clearly needed is not convincing.”).
The other properties that are asserted to be unexpected are all aspects
of storage stability – greater storage stability results in less degradates and
allows mixing in a production facility rather than at the time of dispensing.
Both Baroody and the instant Specification provide evidence, however, that
storage stability is a result of the pH of the final composition, not the
viscosity of the benzoyl peroxide composition (FFs 9, 10). Appellant has
not provided comparative evidence to show that the pH range recited in the
claims (pH 4.5 – 5.0) provides unexpectedly improved storage stability
compared to the pH ranges disclosed by Baroody.
Conclusion of Law
The evidence of record supports the Examiner’s position that it would
have been obvious to modify Baroody’s process by using a benzoyl peroxide
composition with a viscosity higher than that of the final composition. And
Appellant has not provided evidence of unexpected results that outweighs
the evidence in favor of obviousness.
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SUMMARY
We affirm the rejection of claims 26-31 under 35 U.S.C. § 103(a) as
obvious in view of Baroody.
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

lp

GLAXO SMITH KLINE
C/O THE NATH LAW GROUP
112 SOUTH WEST ST.
ALEXANDRIA VA 22314-2825