Ex Parte Laermer et al

Patent Trial and Appeal Board

Jan 28, 2015

11821994 (P.T.A.B. Jan. 28, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte FRANZ LAERMER, MICHAEL STUMBER, DICK SCHOLTEN,
CHRISTIAN MAEURER, JULIA CASSEMEYER1
__________

Appeal 2012-005517
Application 11/821,994
Technology Center 3700
__________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to a device
for delivering an active substance, which have been rejected as obvious. We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 According to Appellants, the Real Party in Interest is ROBERT BOSCH
GMBH (Appeal Br. 1).
Appeal 2012-005517
Application 11/821,994

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STATEMENT OF THE CASE
Claims 1 and 3–7 are on appeal. Claim 1 is illustrative and reads as
follows:
1. A device for storing, transporting, and delivering an
active substance, comprising:
a plurality of microneedles; and
a package forming a reservoir, the reservoir containing
the plurality of microneedles and the active substance for
delivery by the microneedles;
wherein the microneedles are mounted on a substrate
permeable to the active substance.

DISCUSSION
Issue
The Examiner has rejected claims 1 and 3–7 under 35 U.S.C. § 103(a)
as obvious based on Fleming2 and Marsoner3 (Ans. 4). The Examiner finds
that Fleming discloses a device comprising a package forming a reservoir
and microneedles mounted on a substrate (Ans. 4, citing Fleming’s Fig. 13).
The Examiner finds that Fleming implies that the substrate is permeable to
the active substance because it states that “the substrate may be selected for
its hydrophilic properties to facilitate fluid transport” (id. at 5, citing
Fleming ¶ 48) and that “Marsoner discloses a substrate (penetrable
protective layer, 4) permeable to the active substance” (id.). The Examiner
concludes that it would have been obvious to make Fleming’s substrate
permeable to the active substance in order to ensure optimum wetting of the
microneedles, as taught by Marsoner (id.).

2 US 2005/0187521 Al; pub. Aug. 25, 2005
3 US 2002/0042589 Al; pub. Apr. 11,2002
Appeal 2012-005517
Application 11/821,994

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Appellants contend that “Fleming does not imply a permeable
substrate” (Appeal Br. 3); that “there is no disclosure in Marsoner of an
active substance permeating across a protective layer” (id.); and that
“[a]ccordingly, the combination of Fleming and Marsoner does not disclose,
or even suggest, all of the features of claim 1” (id. at 4).
The issue presented is whether the cited references would have made
obvious a drug-delivery device having microneedles “mounted on a
substrate permeable to the active substance,” as recited in claim 1.
Findings of Fact
1. The Specification states that “[i]n [an] exemplary embodiment,
microneedles 1a, 1b are applied to a substrate 2 that is permeable to the
active substance. Substrate 2 may be implemented as a thin film having
small openings.” (Spec. 2:32–34.)
2. Fleming discloses “microneedle devices [that] include
microneedles protruding from a substrate” (Fleming 1, ¶ 6).
3. Fleming’s Figure 13 is reproduced below:

Figure 13 shows a microneedle device that “includes a substrate 620
with microneedles 630 and a cover 640 that form a capillary volume” (id. at
5, ¶ 75). “In addition, the device 610 includes a reservoir volume 681
located on the opposite side of the substrate 620” (id.). “The volume 681 is
defined by a housing 680 “ (id.). “The reservoir volume 681 may be filled
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Application 11/821,994

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with a fluid including, e.g., a medicament or other pharmacological agent to
deliver” (id.).
4. Fleming states that “[t]he substrate 620 preferably includes one or
more voids 628 formed therethrough, such that any fluids contained within
the reservoir volume 681 can be communicated to the capillary volume
formed between the substrate 620 and the cover 640” (id. at 6, ¶ 76).
Analysis
Claim 1 requires, among other things, a plurality of microneedles
“mounted on a substrate permeable to the active substance” (claim 1). The
Specification describes one example of a permeable substrate as “a thin film
having small openings” (FF 1). Thus, the broadest reasonable interpretation
of “a substrate permeable to the active substance,” as recited in claim 1,
includes a substrate that has small openings in it.
Fleming discloses a device that includes a plurality of microneedles
630, substrate 620, and a package formed by cover 640 and housing 680 that
defines a reservoir 681 containing an active substance (FF 3). Fleming
states that “[t]he substrate 620 preferably includes one or more voids 628
formed therethrough, such that any fluids contained within the reservoir
volume 681 can be communicated to the capillary volume formed between
the substrate 620 and the cover 640” (FF 4). That is, Fleming describes its
substrate as preferably including small openings (“voids”) that allow the
active substance to permeate through it to reach the capillary volume
between substrate 620 and cover 640. We agree with the Examiner that it
would have been obvious to make Fleming’s substrate permeable to the
active substance, because Fleming describes that as a preferred feature of its
invention. We do not find it necessary to rely on Marsoner support a prima
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Application 11/821,994

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facie conclusion of obviousness. See In re Kronig, 539 F.2d 1300 (CCPA
1976) (Board may rely upon less than all cited references in affirming an
obviousness rejection).
Appellants argue that Fleming’s paragraph 48 “does not imply a
permeable substrate. . . . [but] simply refers to the movement of fluid from
one end of a capillary volume to another” (Appeal Br. 3). Whether or not
paragraph 48 implies that the substrate is permeable, however, Fleming
expressly describes its Figure 13 as showing a substrate that “preferably
includes one or more voids 628 formed therethrough” (FF 4), which is one
example of a permeable substrate, according to the Specification.
Appellants also argue that “there is no disclosure in Marsoner of an
active substance permeating across a protective layer” (Appeal Br. 3). For
the reasons discussed above, however, we do not find it necessary to rely on
Marsoner in order to conclude that the invention of claim 1 would have been
obvious in view of the prior art.
Conclusion of Law
The cited references would have made obvious a drug-delivery device
having microneedles “mounted on a substrate permeable to the active
substance,” as recited in claim 1.
Claims 3–7 have not been argued separately and therefore fall with
claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
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Application 11/821,994

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SUMMARY
We affirm the rejection of claims 1 and 3–7 under 35 U.S.C. § 103(a)
based on Fleming and Marsoner.
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

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