Ex Parte Singh et al

Patent Trial and Appeal Board

Dec 19, 2016

13101071 (P.T.A.B. Dec. 19, 2016)

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.
13/101,071 05/04/2011 Parminder Singh 091500-0376 4238
108547 7590 12/21/2016
McDermott Will & Emery LLP
500 North Capitol Street NW
Washington, DC 20001
EXAMINER
HALL, DEANNA K
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
12/21/2016 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
mweipdocket @ mwe. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PARMINDER SINGH, DANIR BAIRAMOV,
GUOHUA CHEN, and ROBERT WADE WORSHAM
Appeal 2015-002793
Application 13/101,0711
Technology Center 3700
Before JENNIFER D. BAHR, WILLIAM A. CAPP, and
FREDERICK C. LANEY, Administrative Patent Judges.
LANEY, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Parminder Singh et al. (Appellants) appeal under 35 U.S.C. § 134(a)
from the Examiner’s final decision rejecting claims 1—14 under 35 U.S.C.
§ 103(a) as unpatentable over Andrianov (US 2009/0017210 Al, pub. Jan.
15, 2009).2 We have jurisdiction over this appeal under 35 U.S.C. § 6(b).
We REVERSE.
1 According to Appellants, the real party in interest is Corium International,
Incorporated. Br. 1 (filed July 23, 2014).
2 Claims 15—18 have been withdrawn. Final Act. 2.
Appeal 2015-002793
Application 13/101,071
INVENTION
Appellants’ invention “relates generally to a method and drug delivery
system for transdermally administering parathyroid hormone (PTH) using an
array of microprojections.” Spec. 2.
Claim 1, reproduced below, is independent and representative of the
claimed invention.
1. A method of transdermally administering a dose of PTH
to a mammalian subject, comprising:
applying to a skin site of a subject a microprotrusion array
comprising a plurality of microprotrusions extending from an
approximately planar base, each microprotrusion comprising an
end portion distal to the base and an upper portion proximal to
the base, the end portion comprising a tip of the microprotrusion,
at least the end portion comprising parathyroid hormone (PTH)
in a water-soluble polymer matrix,
inserting all or a portion of the plurality of
microprotrusions into the skin, and
maintaining the array on the skin site for 15 minutes or
less, whereby at least a portion of the end portions including the
tip of the plurality of microprotrusions detach from the
microprotrusion array,
whereby the method achieves an average time to
maximum PTH plasma concentration (T max) of about ten
minutes or less.
Appeal Br. 6 (Claims App.) (emphasis added).
ANALYSIS
Claim 1 is the only independent claim from which claims 2—14
depend, either directly or indirectly. Appeal Br. 7—8 (Claims App.).
Appellants argue the Examiner’s finding that Andrianov anticipates claim 1
is mistaken because Andrianov fails to disclose “any portion of the
microneedles being formed of a water-soluble polymer matrix comprising
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Appeal 2015-002793
Application 13/101,071
any drug much less PTH as in the presently claimed method.” Id. at 3, 4.
The “Examiner maintains that the coating is part of the end portion of the
microprotrusion. The coating comprises the PTH and the portion of the end
portion that detaches from the microprotrusion array is the coating.” Final
Act. 4 (citing Andrianov, H 51, 100, 107). Appellants do not dispute
Andrianov discloses a coating including PTH applied onto the microneedles,
but assert this fact is not fatal because it fails to disclose the microprotrusion
itself being the carrier of the PTH, “[a]s the coating and microneedles of
Andrianov el al.are separate.” Appeal Br. 2—5.
Whether the Examiner’s rejection is proper, therefore, depends on the
reasonableness of the Examiner interpreting the claimed microprotrusion to
broadly cover the coating, which carries the PTH and is applied to the
microneedle. For the following reasons, Appellants have persuasively
shown the Examiner’s interpretation is unreasonable.
During examination of a patent application, pending claims are given
their broadest reasonable construction consistent with the specification. In
re American Acad. ofSci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
Under the broadest reasonable interpretation standard, claim terms are given
their ordinary and customary meaning as would be understood by one of
ordinary skill in the art in the context of the entire disclosure. In re
Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Federal
Circuit cases “on [broadest reasonable construction] make clear that the
proper [broadest reasonable construction] is not just the broadest
construction, but rather the broadest reasonable construction in light of the
specification.'1'’ In re Man Machine Interface Techs. LLC, 822 F.3d 1282,
1287 (Fed. Cir. 2016). “The broadest reasonable interpretation of a claim
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Appeal 2015-002793
Application 13/101,071
term cannot be so broad as to include a configuration expressly disclaimed
in the specification.” Id. at 1286. A construction that is “unreasonably
broad” and which does not “reasonably reflect the plain language and
disclosure” will not pass muster. Microsoft Corp. v. Proxiconn, Inc., 789
F.3d 1292, 1298 (Fed. Cir. 2015).
In the Specification, paragraph 56, Appellants expressly define
“microprotrusion” to mean the “elements adapted to penetrate or pierce the
stratum comeum or other biological membranes.” The Specification teaches
a microprotrusion array,
is prepared by (a) providing a mold with cavities corresponding
to the negative of the microprotrusions, (b) filling the mold with
a casting solution comprising a biocompatible polymer and a
solvent, (c) removing the solvent, and (d) demolding the
resulting array from the mold. The solution preferably contains
an active ingredient such as PTH . . . the microprojections
themselves comprise PTH in a water-soluble polymer matrix, as
opposed to having the PTH present as a coating on a
microprotrusion or microneedle made of a different,
biocompatible material such as a metal.
Spec. 1 65 (emphasis added). “The desirability of placing a higher amount
of active such as PTH in the projections themselves is particularly high when
the active is costly.” Id. 178 (emphasis added). Based on the above
disclosure, the proper understanding of the claim language reciting a
microprotrusion as “comprising an end portion ... at least the end portion
comprising parathyroid hormone (PTH) in a water-soluble polymer matrix ”
would not include a microprotrusion that is capable of existing
independently of the water-soluble polymer matrix having PTH.
Appellants’ Specification expressly distinguishes the invention from
structures in which the PTH is present as a coating on the microprotrusion.
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Appeal 2015-002793
Application 13/101,071
As such, the proper construction requires the PTH to be incorporated into the
water-soluble polymer matrix that is used to form the end portion of the
microprotrusion itself, not merely into a coating applied to the
microprotrusion. In other words, the claimed microprotrusion alone serves
two functions: (1) penetrate or pierce the stratum comeum or other
biological membranes; and (2) administer the PTH to a recipient. Therefore,
the Examiner’s interpretation is unreasonably broad because it covers
microprotrusions that do not themselves have any PTH integrated into the
material forming them.
Andrianov describes the array of microneedles as the structure
adapted to penetrate or piece a biological membrane — “[t]he array of
microneedles are attached to the skin of a recipient for penetration of the
skin by the microneedles.” Andrianov, 1 51 (emphasis added). Andrianov
describes the coating as being applied to the exterior surface of the
microneedle and as a means for “dispers[ing] the biological active
compound into the flesh or dermis, or epidermis of the recipient to
administer the biologically active compound.” Id. As such, the only
function the Andrianov microneedles themselves serve is to penetrate or
pierce the biological membrane. They alone cannot administer any PTH to a
recipient. Because the Examiner’s rejection of claim 1 was based on an
erroneous claim construction and because the rejection is not supported
under the proper construction, we do not sustain the Examiner rejection of
claim 1 or, as a result, claims 2—14 depending therefrom.
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Appeal 2015-002793
Application 13/101,071
DECISION
The Examiner’s rejection of claims 1—14 is reversed.
REVERSED
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