Ex Parte Tobinaga et al

Board of Patent Appeals and Interferences

Jun 22, 2012

10666581 (B.P.A.I. Jun. 22, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte YOSHIKAZU TOBINAGA and SUSUMU SUGIYAMA
____________________

Appeal 2010-002856
Application 10/666,581
Technology Center 3700
____________________

Before EDWARD A. BROWN, MICHAEL L. HOELTER, and
BENJAMIN D.M. WOOD, Administrative Patent Judges.

BROWN, Administrative Patent Judge.

DECISION ON APPEAL
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Application 10/666,581

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STATEMENT OF THE CASE
Appellants appeal under 35 U.S.C. § 134(a) from the rejection of
claims 1-10 and 12-35. We have jurisdiction over this appeal under 35
U.S.C. § 6(b).
We reverse.
THE CLAIMED SUBJECT MATTER
Independent claim 1, reproduced below, is representative of the
appealed claims.
1. An applicator for applying functional
substances into human skin, comprising:
(a) a base,
(b) a plurality of microneedles fixed to said
base and projecting therefrom a distance sufficient
to penetrate into the skin, said microneedles being
made of a material that is substantially sugars that
dissolve within the human body and capable of
disintegration and dispersion into the skin, and
(c) a functional substance carried by said
microneedles for delivery by said microneedles
into the skin.
THE REJECTIONS
The following rejections under 35 U.S.C. § 103(a) are before us for
review.
1. Claims 1-10, 14-16, 19-31, and 33-35 over Park (US
2002/0082543 A1, pub. Jun. 27, 2002) and D'Ussel (US 2004/0010237 A1,
pub. Jan. 15, 2004).1

1 The group of claims (i.e., “claims 1-10, 14-16, 10-30 and 33-35”) listed as
being rejected under this ground of rejection is incorrect. (Ans. 4).
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2. Claims 12, 13, and 32 over Park, D'Ussel, and Arias (US
2002/0133129 A1, pub. Sep. 19, 2002). (3, Ans. 7-8).
3. Claims 17 and 18 over Park, D'Ussel, and Sherman (US
6,821,281, iss. Nov. 23, 2004). (Ans. 3, 8).
ANALYSIS
Claims 1-10, 14-16, 19-31, and 33-35 – Park and D'Ussel
The Examiner found Park discloses an applicator that comprises a
plurality of microneedles (12) made of a material capable of disintegration
and dispersion into the skin, and a functional substance carried by the
microneedles for delivery into the skin. (Ans. 4, citing Park para. [0047],
Fig. 5). The Examiner found Park does not disclose the needle material is
substantially sugars. (Ans. 6). The Examiner found D'Ussel discloses "a
needle made substantially of sugars that dissolves within the human body,"
and concluded that it would have been obvious to one of ordinary skill in the
art to modify Park's applicator with the "sugar needles" of D'Ussel to make a
more soluble delivery device of the type disclosed by D'Ussel. (Ans. 6,
citing D'Ussel paras. [0009], [0014]) (emphasis added).
Appellants contend that D'Ussel does not disclose "'a needle made
substantially of sugar,'" but discloses "no more than a sharp tip that can be
made of a sugar or other material that serves as a closure at the tip of a metal
needle." (App. Br. 16). Appellants refer to the Declaration of Dr. Ajay K.
Banga ("Declaration") to support these contentions. Dr. Banga states that
Park and D'Ussel do not disclose or suggest "microneedles made
substantially of sugar that dissolves within the human body and disintegrates
and disperses into the skin for depositing of functional substances into the
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skin." (Decl. para. 7). Dr. Banga states that D'Ussel teaches applying tips to
conventional needles (Decl. para. 11), and these tips made of sugar serve as
a seal to temporarily retain injection liquids in the needles (Decl. para. 9).
Dr. Banga also states that D'Ussel's technique for forming a tip on needles
cannot be used to make an entire microneedle because there must be a
substantial portion of the microneedle formed of metal or rigid material on
which to form the tip. (Decl. para. 9).
D'Ussel discloses a needle that has a rounded end with a sharp tip
made of an inert material soluble in body fluids, such as sugar. (See D'Ussel
paras. [0008]-[0009]). D'Ussel discloses the needle body is generally of
metal. (See D'Ussel para. [0012]). D'Ussel further discloses that a drop of
the inert material is placed on the rounded end to form a sharp tip. (See
D'Ussel para. [0016]). D'Ussel discloses that during puncture, the sharp tip
dissolves in body fluids so that the duct in the needle is open at the end and a
substance can be injected. (See D'Ussel para. [0019]).
We understand the Examiner's position to be that it would have been
obvious to make Park's microneedles "substantially of sugars" in view of
D'Ussel. However, D'Ussel does not disclose or suggest a needle "made
substantially of sugars," but rather discloses a needle including a metal body
and only a tip of sugar formed on the body. In addition, D'Ussel does not
disclose that the sugar material carries a functional substance for delivery
into the skin, but functions as a dissolvable tip that closes the needle duct to
contain the substance to be injected. We also agree with Appellants that
D'Ussel's technique of forming a tip of sugar on a metal needle body by a
dipping technique does not appear to be suitable to form an array of
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microneedles made of a material that is substantially sugars, as claimed. In
view of the above, the Examiner did not articulate an adequate reason to
combine the teachings of Park and D'Ussel to result in the claimed
applicator. Hence, we do not sustain the rejection of claim 1, and claims 2-
10, 14-16, and 19-31 which depend from claim 1.
Independent claim 33 is directed to an applicator for applying
functional substances into the human skin comprising, inter alia, "(d) . . .
microneedles having relatively thick inner portions and relatively thick outer
portions with constricted intermediate portions therebetween to facilitate
separation of said outer portions from said inner portions with the outer
portions remaining in the skin." Appellants correctly point out that the
Examiner did not make any finding that Park or D'Ussel discloses limitation
"(d)", or provide any reason why the claimed subject matter would have
been obvious to one of ordinary skill in the art over these references. (App.
Br. 19).2 Hence, we do not sustain the rejection of claim 33.
Independent claim 34 is directed to an applicator for applying
functional substances into the human skin comprising, inter alia, "(c)
microcontainers containing said functional substance, said microcontainers
being contained within said microneedles for delivery into the skin." The
Examiner found "Park discloses that the microneedles contain
microcontainers containing a functional substance, and the microcontainer is
contained within the microneedle." (Ans. 5, citing Park Fig. 3).

2 In fact, regarding the rejection of claim 12 discussed infra, the Examiner
found that Park and D'Ussel "fail to disclose microneedles with constricted
intermediate ends." (Ans. 7).
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Appellants contend that Park does not disclose microcontainers, but
discloses layers of materials forming the microneedle, and none of the layers
are microcontainers contained within microneedles, but rather the layers
form the microneedles. (App. Br. 21). We agree.
Figure 3 of Park shows microneedles that have a stacked, multilayer
polymer structure, with each of the layers being formed of a different
material. (See Park para. [0143]). The Examiner did not make a finding
supported by a preponderance of the evidence that Park's microneedles
include microcontainers containing a functional substance, or articulate any
reason why the claimed subject matter would have been obvious over Park
and D'Ussel. Hence, we do not sustain the rejection of claim 34, and claim
35 which depends from claim 34.
Claims 12, 13, and 32 – Park, D'Ussel, and Arias
Claim 12 depends from claim 1 and recites "said microneedles are
constricted intermediate their ends to facilitate breaking off the portions of
the needles beyond the narrow portions to leave those portions in the skin."
The Examiner found Park and D'Ussel fail to disclose microneedles with
constricted intermediate ends. (Ans. 7). The Examiner's application of
Arias for claim 12 (Ans. 8) does not cure the deficiencies of the Examiner's
reliance on Park and D'Ussel for the rejection of claim 1 discussed supra.
Hence, we do not sustain the rejection of claim 12.
Claim 13 depends from claim 1 and recites "said microneedles have
relatively thin outer portions and relatively thick inner portions adjacent said
base with a step between said portions to facilitate separation of said outer
portions from said inner portions with the outer portions remaining in the
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skin." The Examiner's application of Arias for claim 13 does not cure the
deficiencies of the Examiner's reliance on Park and D'Ussel for the rejection
of claim 1 discussed supra. Hence, we do not sustain the rejection of claim
13. Claim 32 depends from claim 1 and recites similar limitations as claim
13. For claim 32, the Examiner's findings (Ans. 8) are the same as those for
claim 13, and Appellants' arguments for patentability (App. Br. 24) are
similar to those discussed supra for claim 13. Hence, we do not sustain the
rejection of claim 32.
Claims 17 and 18 – Park, D'Ussel, and Sherman
Claim 17 depends from claim 1 and recites "said microneedles have
capillary recesses in outer portions thereof for retaining said functional
substances for delivery into the skin." The Examiner relied on Sherman for
disclosure with respect to this limitation. (Ans. 9). The Examiner's
application of Sherman to the rejection of claim 17 does not cure the
deficiencies of the Examiner's reliance on Park and D'Ussel with respect to
the rejection of claim 1 as discussed supra. Hence, we do not sustain the
rejection of claim 17, and claim 18 which depends from claim 17.
DECISION
The rejection of claims 1-10 and 12-35 is REVERSED.

REVERSED

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