Ex Parte Wu et al

Board of Patent Appeals and Interferences

Sep 8, 2010

11113890 (B.P.A.I. Sep. 8, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte JEFFREY M. WU, JUE-CHEN LIU,
YING SUN, JUSTIN MCDONOUGH,
DANILO LAMBINO, and MARIAM MAGHRIBI
____________________

Appeal 2009-012838
Application 11/113,890
Technology Center 3700
____________________

Before JOHN C. KERINS, KEN B. BARRETT, and FRED A.
SILVERBERG, Administrative Patent Judges.

BARRETT, Administrative Patent Judge.

DECISION ON APPEAL1

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.
Appeal 2009-012838
Application 11/113,890

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STATEMENT OF THE CASE
Jeffrey M. Wu et al. (Appellants) seek our review under 35 U.S.C.
§ 134 of the final rejection of claims 1-24. We have jurisdiction under 35
U.S.C. § 6(b).
The Examiner entered a new ground of rejection of claim 3 under 35
U.S.C. § 103(a) in the Examiner’s Answer. Ans. 3. The Examiner informed
Appellants that they must, within two months from the date of the Answer,
exercise one of two options to avoid sua sponte dismissal of the appeal:
(1) file a reply under 37 C.F.R. § 1.111 to reopen prosecution; or (2) file a
reply brief under 37 C.F.R. § 41.41 addressing the new ground of rejection
to maintain the appeal as to the claim subject to the new ground. Ans. 7-8.
Appellants failed to exercise either option. As such, we dismiss the appeal
as to claim 3. The remainder of this decision addresses only the rejections
pertaining to claims 1, 2, and 4-24.
We AFFIRM.

THE INVENTION
Appellants’ claimed invention pertains to the treatment of skin
disorders with devices for penetrating the skin and delivering active
substances. Spec. 1-2. Claim 1, the sole independent claim on appeal, is
reproduced below and is representative of the subject matter on appeal.
1. A method of treating a skin disorder with a device, said
device comprising (i) a microprotrusion member having a skin-
contacting surface and plurality of stratum corneum-piercing
microprotrusions thereon and (ii) a composition for treatment of
said skin disorder, wherein said method comprises piercing the
stratum corneum of said skin with said microprotrusion
member and applying said composition from said device to said
Appeal 2009-012838
Application 11/113,890

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skin, wherein said device provides an impact pressure when
applied to said skin of from about 0.5 lbs/cm2 to about 7
lbs/cm2.

THE REJECTIONS
The Examiner relies upon the following as evidence of
unpatentability:
Cormier US 2002/0128599 A1 Sept. 12, 2002
Skover US 2003/0078518 A1 Apr. 24, 2003
Connelly US 6,689,100 B2 Feb. 10, 2004
Lastovich US 2004/0064087 Apr. 1, 2004

The following Examiner’s rejections are before us for review:
1. Claims 1, 2, 7, 9, 152, 17, and 19 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Skover and Lastovich; and
2. Claims 4-6, 8, 10-14, 16, 18, and 20-24 are rejected under 35
U.S.C. § 103(a) as being unpatentable over Skover, Lastovich, and
Connelly.
In the Answer, the Examiner withdrew the rejection of claim 3 as
unpatentable over Skover and Lastovich, in favor of a new rejection of claim
3 as unpatentable over Skover, Lastovich, and Cormier. Ans. 3. As
mentioned above, Appellants did not reply to the new rejection and the
appeal as to claim 3 is dismissed.

2 Claim 15 is not listed in the heading of the ground of rejection, but is listed
in the body of the rejection. See Final Rej. 2-3; Ans. 3-4.
Appeal 2009-012838
Application 11/113,890

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OPINION
The rejection of claims 1, 2, 7, 9, 15, 17, and 19 under 35 U.S.C. § 103(a)
as being unpatentable over Skover and Lastovich
Appellants argue the rejected claims as a group. App. Br. 3-4. We
select claim 1 as the representative claim, and claims 2, 7, 9, 15, 17, and 19
stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii) (2009).
Appellants contend that the rejection is in error because neither
reference discloses the recited pressure range, and that the claimed range is
not an obvious modification. App. Br. 3-4. Appellants argue that the cited
references are not concerned with treatment of skin on a particular part of
the body, such as facial skin, and that they “have experimentally identified
an optimum pressure range for use in their method, so that the method may
be used on facial skin.” Id. at 4.
Appellants’ reference to facial skin is not persuasive of error. As the
Examiner correctly noted (Ans. 7), claim 1 is not limited to facial skin or to
the skin on any other particular body part.
Appellants’ argument that they identified the optimum pressure range
is also not persuasive. “[D]iscovery of an optimum value of a result
effective variable in a known process is ordinarily within the skill of the art.”
In re Boesch, 617 F.2d 272, 276 (CCPA 1980) (citing In re Antonie, 559
F.2d 618 (CCPA 1977) and In re Aller, 220 F.2d 454 (CCPA 1955)). “[A]
prima facie case of obviousness may be rebutted ‘where the results of
optimizing a variable, which was known to be result effective, (are)
unexpectedly good.’” Id. (quoting In re Antonie, 559 F.2d at 620).
The Examiner found that the method of treating a skin disorder by the
use of a stratum corneum-piercing device for the application of compositions
was known in the art. Final Rej. 2-3; Ans. 3-4. The Examiner additionally
Appeal 2009-012838
Application 11/113,890

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found that the modified Skover device would be capable of providing the
recited impact pressure, that the claimed pressure “is well within the range
of pressure applications of a normal user,” and that there is no indication in
the Specification that the recited range is critical (and pointing to the data in
Table 1 (Spec. 51-52) indicating that there was no difference in the results at
pressures of 6 lb/cm2 and 8 lb/cm2, which fall on either side of the recited
maximum of 7 lb/cm2). Final Rej. 3, 6; Ans. 6-7. The Examiner maintains
that “[o]ne of ordinary skill in the art would recognize the impact pressure to
be a result effective variable which would be obvious to optimize during
treatment to achieve the best drug delivery rate with the least amount of
patient discomfort.” Id. at 7. Appellants do not contest the Examiner’s
particular findings, and present no persuasive argument or evidence that
impact pressures within the recited range yield unexpectedly good results.
As such, we are not persuaded that the Examiner erred in concluding that the
combination of Skover and Lastovich renders obvious the method of claim
1. Claims 2, 7, 9, 15, 17, and 19 fall with claim 1.

The rejection of claims 4-6, 8, 10-14, 16, 18, and 20-24 under 35 U.S.C.
§ 103(a) as being unpatentable over Skover, Lastovich, and Connelly
Appellants do not present separate arguments regarding the
obviousness rejection based on Skover, Lastovich, and Connelly. Rather,
Appellants assert that the Connelly reference fails to cure the alleged error in
the underlying rejection discussed above. We have not been persuaded that
there is an error to be cured in that underlying rejection. Therefore, we are
not persuaded that the Examiner erred in concluding that the subject matter
of claims 4-6, 8, 10-14, 16, 18, and 20-24 would have been obvious in light
of Skover, Lastovich, and Connelly.
Appeal 2009-012838
Application 11/113,890

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DECISION
The appeal is dismissed as to claim 3.
The decision of the Examiner to reject claims 1, 2, and 4-24 is
affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2007).

AFFIRMED

mls

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