Ex Parte Laermer et al

Patent Trial and Appeal Board

Jan 30, 2013

11897299 (P.T.A.B. Jan. 30, 2013)

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.
11/897,299 08/29/2007 Franz Laermer 10191/5241 4095
26646 7590 01/31/2013
KENYON & KENYON LLP
ONE BROADWAY
NEW YORK, NY 10004
EXAMINER
WILSON, LARRY ROSS
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
01/31/2013 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 PATENT TRIAL AND APPEAL BOARD
__________

Ex parte FRANZ LAERMER, MICHAEL STUMBER, DICK SCHOLTEN,
and CHRISTIAN MAEURER
__________

Appeal 2011-004602
Application 11/897,299
Technology Center 3700
__________

Before ERIC GRIMES, MELANIE L. McCOLLUM, and SHERIDAN K.
SNEDDEN, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a drug
delivery device, which have been rejected for anticipation and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The Specification discloses a carrier substrate having on it an array of
microneedles with preset breaking points, so that the microneedles can be
broken off after being placed into the skin (Spec. 4:17-30). “The
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introduction of [ ] active agents can be managed either through active agents
already held in reserve in the porous needle material or through active agent
preparations applied from the outside, via the needles” (id. at 4:30 to 5:3).
The microneedles can be made so that they “will dissolve after a pre-
determined time, so that they do not have to be actively removed” (id. at
5:12-14).
Claims 1-8 and 15-22 are on appeal. Claim 1 is representative and
reads as follows:
1. An array to be placed on the skin of a human patient or an animal
patient for transdermally applying pharmaceuticals, toxins or active agents,
comprising:
a carrier substrate; and
microneedles situated on the carrier substrate, the microneedles
having a present breaking point in an area of a transition to the carrier
substrate, the present breaking point including one of (a) a material tapering
and (b) a constriction.

Claim 8, the only other independent claim, is directed to an array kit
comprising the same array recited in claim 1, and a cover material.
The Examiner has rejected claims 1-6, 8, and 15-20 under 35 U.S.C.
§ 102(b) as anticipated by Prausnitz1 (Answer 4). The Examiner has
rejected claims 7, 21, and 22 under 35 U.S.C. § 103(a) as obvious based on
Prausnitz combined with Kingsford,2 Golubovic-Liakopoulos,3 or Delmore,4
respectively (Answer 6-7). The same issue is dispositive for all of the
rejections.

1 Prausnitz et al., US 2005/0137531 A1, June 23, 2005
2 Kingsford, US 2005/0118388 A1, June 2, 2005
3 Golubovic-Liakopoulos et al., US 2006/0030812 A1, Feb. 9, 2006
4 Delmore et al., US 2003/0045837 A1, Mar. 6, 2003
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The Examiner finds that Prausnitz discloses an array comprising “a
carrier substrate (Fig. 9, #11), and microneedles situated on the carrier
substrate (Fig. 9, #12), the microneedles having a preset breaking point in an
area of a transition to the carrier substrate (para. 190, lines 1-3), the preset
breaking point including one of (a) a material tapering and (b) a constriction
(para. 191, lines 2-5)” (id. at 4).
Appellants argue that “[t]he cited sections of Prausnitz merely
describe that the microneedles may be sheared off from the substrate, and
that the microneedles may include a notch to control breakage of the
microneedles” (Appeal Br. 4). Appellants argue that “although Prausnitz
refers to a notch to control breakage, . . . Prausnitz does not disclose any
location for its notch, and does not further describe the structure of its notch
as constituting a material tapering or a constriction” (id.).
We agree with Appellants that the Examiner has not shown that
Prausnitz discloses a microneedle array meeting all the limitations of claim
1. Prausnitz discloses a microneedle device for drug delivery (Prausnitz 13,
¶¶ 179, 184). In one embodiment, “these microneedles may be purposefully
sheared off from the substrate after penetrating the biological barrier. In this
way, a portion of the microneedles would remain within or on the other side
of the biological barrier and a portion of the microneedles and their substrate
would be removed.” (Id. at 14, ¶ 190.) Prausnitz discloses that the
“[m]icroneedle shape and content can be designed to control the breakage of
microneedles. For example, a notch can be introduced into microneedles
either at the time of fabrication or as a subsequent step. In this way,
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microneedles would preferentially break at the site of the notch.” (Id. at 14,
¶ 191.)
The Examiner reasons that the notch disclosed by Prausnitz is a type
of constriction in a surface and therefore meets the “preset breaking point”
limitation of the claims (Answer 8). Appellants argue that Prausnitz does
not describe “its notch as constituting a material tapering or a constriction”
(Appeal Br. 4).
Regardless of whether or not the notch described by Prausnitz would
be considered a “constriction,” however, we agree with Appellants (Appeal
Br. 4) that Prausnitz does not disclose a specific location for its notch;
specifically, an embodiment in which the notch is located “in an area of a
transition to the carrier substrate,” as required by the claims on appeal.
Instead, Prausnitz describes shearing off the microneedle tip, for example by
introducing a notch, and then removing “a portion of the microneedles and
their substrate” (Prausnitz 14, ¶ 190). The Examiner has not shown that a
skilled worker would recognize this disclosure as expressly or inherently
describing microneedles having a preset breaking point in an area of
transition to the carrier substrate.
Although Prausnitz states that microneedles “may break at the
juncture of the microneedle and substrate due to mechanical stresses at the
sharp angle formed there” (id. at 13, ¶ 178), that disclosure relates to a
different embodiment than the one described as having a preset breaking
point. In addition, Prausnitz describes breakage at the base of the
microneedles as undesirable and states that it can be avoided by reinforcing
the base of the microneedles (id.). The Examiner has not established that a
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skilled worker reading Prausnitz’s ¶¶ 178, 190, and 191 would have
recognized an express or inherent description of the preset breaking point
required by the claims on appeal.
The rejections for obviousness rely on the Examiner’s finding that
Prausnitz identically discloses the products of claims 1 and 8, and therefore
suffer from the same deficiency.
SUMMARY
We reverse all of the rejections on appeal.

REVERSED

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