Ex Parte Duan

Patent Trial and Appeal Board

Mar 6, 2013

12090422 (P.T.A.B. Mar. 6, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte DANIEL C. DUAN
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Appeal 2012-001650
Application 12/090,422
Technology Center 3700
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Before DONALD E. ADAMS, ERIC GRIMES, and ULRIKE W. JENKS,
Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 22-28 and 34-36
(App. Br. 2; Ans. 3). We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to a drug delivery device (claims 22-28) and a
microneedle array (claims 34-36). Claims 22 and 34 are representative and
are reproduced in the Claims Appendix of Appellants’ Brief.
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Claims 22-25, 27, 28, and 34-36 stand rejected under 35 U.S.C.
§ 102(a) as being anticipated by Ameri.1
Claim 26 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Ameri and Tanaami.2
We affirm the rejection of claims 34-36 under 35 U.S.C. § 102(a) as
being anticipated by Ameri and reverse all other grounds of rejection.
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Ameri teaches Appellant’s claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Ameri’s figures 11 and 12 are reproduced below:

“FIG. 11 is a perspective view of a microprojection array that would be used
in conjunction with the present invention” (Ameri 5: ¶ [0057]; see Ans. 5).
“FIG. 12 is a perspective view of a microprojection array showing several
microprojections that have been coated” (id. at ¶ [0058]; see Ans. 5).

1 Ameri et al., US 2004/0265354 A1, published December 30, 2004.
2 Tanaami et al., US 2004/0254559 A1, published December 16, 2004.
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FF 2. Ameri teaches “[i]n one embodiment, the microprojection is
constructed out of stainless steel, titanium, nickel titanium alloys, or similar
biocompatible materials” (id. at ¶ [0043]).
FF 3. Ameri teaches coating the first 100 µm of the tips of
microprojections with formulations containing hPTH(1-34) and evaluating
the amount of peptide coated on the arrays by ultraviolet spectroscopy (id. at
8: ¶ [0192]; see Ans. 5).
FF 4. Examiner finds that
In ultraviolet spectroscopy, the absorption or reflectance in the
visible range directly affects the perceived color of the
chemicals involved. Since the active agent (18) is a chemical
coating the tips (12) of the microneedles only, not the
base/substrate (14) as clearly depicted in Figure 12, then it
follows that the tip (coated with active agent) of the
microneedle would fluoresce a different color than the titanium
base of the microneedle when exposed to UV light; therefore
providing the coated microneedle and the base with different
optical responses … [and] the coated microneedle a greater
fluorescent value than the substrate.

(Ans. 7-8.)
ANALYSIS
The delivery device of Appellant’s claim 22 comprises a plurality of
microneedles arranged on a substrate and requires, inter alia, that (1) the tip
of one or more of the microneedles has a first optical response when probed
with a selected incident light spectrum; (2) the base of the microneedle has a
second optical response differing from the first optical response; and (3) an
active agent formulation covers at least a portion of the tip of one or more of
the microneedles and modulates the first optical response of the
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microneedles when probed with the selected incident light spectrum (Claim
22). Claims 23-25, 27, and 28 depend directly from claim 22.
Appellant contends that since Ameri “teaches that the microneedles
are made of a single material, [e.g.,] titanium … the microneedles of Ameri
do not have tips having a first optical response and a base having a second
different optical response” (App. Br. 4; see FF 2). We agree.
Notwithstanding Examiner’s assertion to the contrary, Appellant’s claim 22
requires that one or more of the microneedles on the array exhibit two
different optical responses, wherein the first optical response is modulated
by a coating that is applied to the tip of the one or more microneedles
(Appellant’s claim 22; Cf. FF 1-5).
Examiner appears to discount the foregoing requirement of
Appellant’s claimed invention, wherein the one or more microneedles
exhibit two different optical responses prior to applying a coating to the tip
of the one or more microneedles that modifies the first of the optical
responses (FF 5; Cf. Appellant’s claim 22).

Claim 34:
The microneedle array of Appellant’s claim 34 comprises a plurality
of tapered microneedles arranged on a substrate, wherein the microneedles
have a fluorescence that is greater than that of the substrate (Claim 34).
Unlike Appellant’s claim 22, claim 34 does not require that the
microneedles have a first optical response that is modulated by a coating. In
addition, the claim is open to include a coating on the tips of the
microneedles. Therefore, notwithstanding Appellant’s contentions to the
contrary, and absent evidence to the contrary, we agree with Examiner’s
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finding that Ameri’s coated microneedle will inherently exhibit a greater
fluorescent value than the uncoated substrate (FF 5; Cf. App. Br. 4).
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner’s
finding that Ameri teaches the invention of Appellant’s claim 34. The
rejection of claim 34 under 35 U.S.C. § 102(a) as being anticipated by
Ameri is affirmed. Claims 35 and 36 are not separately argued and fall with
claim 34.
The preponderance of evidence on this record fails to support
Examiner’s finding that Ameri teaches the invention of Appellant’s claims
22-25, 27, and 28. The rejection of claims 22-25, 27, and 28 under 35
U.S.C. § 102(a) as being anticipated by Ameri is reversed.

Obviousness:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 5. Examiner relies on Ameri as discussed above (Ans. 6).
FF 6. Examiner finds that Ameri fails to suggest that the incident light
spectrum comprises visible wavelengths and relies on Tanaami to suggest
the use of “visible light and ultraviolet light in the detection of molecules
based on spectroscopy” (id. at 6-7).
ANALYSIS
Based on the combination of Ameri and Tanaami, Examiner
concludes that, at the time Appellant’ s invention was made, it would have
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been prima facie obvious to “modify the device of Ameri with the ability
[to] also use visible wavelengths to optimize usage when detecting
molecules with shorter wavelengths” (Ans. 7).
Appellant contends that Tanaami “does not overcome the deficiencies
of the teachings of Ameri” (App. Br. 4). We agree. Examiner failed to
establish that Tanaami makes up for Ameri’s failure to suggest one or more
microneedles that exhibit two different optical responses prior to applying a
coating to the tip of the one or more microneedles that modifies the first of
the optical responses.
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support a
conclusion of obviousness. The rejection of claim 26 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Ameri and Tanaami is
reversed.
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-IN-PART

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