Ex Parte Schnall

Patent Trial and Appeal Board

Mar 21, 2013

11658650 (P.T.A.B. Mar. 21, 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.
11/658,650 01/26/2007 INV001Robert P. Schnall 33259 8367
67801 7590 03/21/2013
MARTIN D. MOYNIHAN d/b/a PRTSI, INC.
P.O. BOX 16446
ARLINGTON, VA 22215
EXAMINER
BOSWORTH, KAMI A
ART UNIT PAPER NUMBER
3767
MAIL DATE DELIVERY MODE
03/21/2013 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 ROBERT P. SCHNALL
__________

Appeal 2011-013048
Application 11/658,650
Technology Center 3700
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a drug
delivery device. The Patent Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

STATEMENT OF THE CASE
Claims 1-20, 24-29 and 31-37 are on appeal. Claims 1, 3 and 9 are
representative and read as follows:

Appeal 2011-013048
Application 11/658,650

2
1. A drug delivery device for delivering a drug to a preselected treatment
site, comprising:
a capsule having a rupturable film enclosing a quantity of the drug to
be delivered;
an array of micro-needles mounted on a supporting matrix carried by
said device, said micro-needles being formed with inlet ends facing the
capsule, outlet ends to face the treatment site when the device is located with
the micro-needles facing the treatment site, and passageways connecting
said inlet and outlet ends, whereby the application of pressure to the device
causes the outlet ends of the micro-needles to penetrate the treatment site,
the capsule to rupture, and the inlet ends of the micro-needles to deliver
the drug via said passageways to the treatment site;
and a porous mesh layer between the capsule and the complete
surface of the inlet ends of the micro-needles effective to space the inlet ends
of the micro-needles from said capsule, to uniformly distribute the drug to
the inlet ends of the micro-needles by a wick action, and, upon the rupture of
the capsule film, to reduce the possibility of clogging of the passageways as
the drug is delivered therethrough from the capsule to the treatment site.

3. The device according to Claim 1, wherein the device further
comprises an outer deformable fluid-tight layer overlaying said capsule and
having an outer peripheral edge hermetically secured to the outer peripheral
edge of the array of micro-needles so as to enclose said capsule between said
array of micro-needles and deformable fluid-tight layer, said deformable
fluid-tight outer layer being deformable by pressure to permit rupturing said
capsule by the application of pressure thereto.

9. The device according to Claim 3, wherein said outer deformable fluid-
tight layer is of an elastic material which is pre-tensioned such as to enhance
the flow of the drug into said passageways upon rupture of said capsule film.

(App. Br. 14-15, Claims App‟x.)(emphasis added).

Appeal 2011-013048
Application 11/658,650

3
The Examiner rejected the claims as follows:
• claims 1-4, 9, 10, and 16 under 35 U.S.C. § 103(a) as unpatentable
over Gertsek,
1
Gyory,
2
and Turnbull;
3

• claim 5 under 35 U.S.C. § 103(a) as unpatentable over Gertsek,
Gyory, Turnbull, and Fleming;
4

• claim 6 under 35 U.S.C. § 103(a) as unpatentable over Gertsek,
Gyory, Turnbull, and Kwiatkowski;
5

• claims 7 and 8 under 35 U.S.C. § 103(a) as unpatentable over
Gertsek, Gyory, Turnbull, Kwiatkowski, and Fox;
6

• claims 11 and 12 under 35 U.S.C. § 103(a) as unpatentable over
Gertsek, Gyory, Turnbull, and Angel;
7

• claims 13-15 under 35 U.S.C. § 103(a) as unpatentable over
Gertsek, Gyory, Turnbull, and Kwon;
8

• claim 17 under 35 U.S.C. § 103(a) as unpatentable over Gertsek,
Gyory, Turnbull, and Chang;
9

1
Patent No. US 6,656,147 B1 issued to Marina Gertsek et al., Dec. 2, 2003.
2
US Patent No. 5,533,972 issued to J. Richard Gyory et al., Jul. 9, 1996.
3
US Patent No. 2,434,875 issued to Frederick M. Turnbull et al., Jan. 20,
1948.
4
Patent Application Publication No. US 2003/0135161 A1 by Patrick R.
Fleming et al., published Jul. 17, 2003.
5
Patent No. US 7,315,758 B2 issued to Krzysztof C. Kwiatkowski et al.,
Jan. 1, 2008.
6
US Patent No. 5,405,366 issued to Adrian S. Fox et al., Apr. 11, 1995.
7
Patent Application Publication No. US 2003/0083645 A1 by Aimee B.
Angel et al., published May 1, 2003.
8
Patent Application Publication No. US 2004/0199103 A1 by Sung-Yun
Kwon, published Oct. 7, 2004.
9
Patent Application Publication No. US 2004/0260251 A1 by Kai-Cheng
Chang et al., published Dec. 23, 2004.
Appeal 2011-013048
Application 11/658,650

4
• claim 18 under 35 U.S.C. § 103(a) as unpatentable over Gertsek,
Gyory, Turnbull, Chang, and Fleming;
• claim 19 under 35 U.S.C. § 103(a) as unpatentable over Gertsek,
Gyory, Turnbull, Kwon, and Angel;

• claim 20 under 35 U.S.C. § 103(a) as unpatentable over Gertsek,
Gyory, Turnbull, and Martin;
10

• claim 24 under 35 U.S.C. § 103(a) as unpatentable over Gertsek,
Gyory, Turnbull, and Krulevitch;
11

• claims 25-28 under 35 U.S.C. § 103(a) as unpatentable over
Gertsek, Gyory, Turnbull, Krulevitch, and Ray;
12

• claim 29 under 35 U.S.C. § 103(a) as unpatentable over Gertsek,
Gyory, Turnbull, Krulevitch, Ray, and Angel;
• claim 31 under 35 U.S.C. § 103(a) as unpatentable over Gertsek,
Gyory, Turnbull, and Trop;
13

• claims 32 and 33 under 35 U.S.C. § 103(a) as unpatentable over
Gertsek, Gyory, Turnbull, Trop, and Guenst;
14

• claim 34 under 35 U.S.C. § 103(a) as unpatentable over Gertsek,
Gyory, Turnbull, Trop, Guenst, and Fitzgerald;
15

10
US Patent No. 7,186,235 B2 by Frank E. Martin et al., issued Mar. 6,
2007.
11
Patent Application Publication No. US 2005/0273049 A1 by Peter
Krulevitch et al., published Dec. 8, 2005.
12
Patent Application Publication No. US 2003/0040712 A1 by Pinaki Ray et
al., published Feb. 27, 2003.
13
US Patent No. 6,030,213 issued to Ayelet Trop, Feb. 29, 2000.
14
US Patent No. 7,063,693 B2 issued to Gary w. Guenst, Jun. 20, 2006.
15
Patent Application Publication No. US 2005/0165355 A1 by Lisa M.
Fitzgerald, published Jul. 28, 2005.
Appeal 2011-013048
Application 11/658,650

5
• claims 35 and 36 under 35 U.S.C. § 103(a) as unpatentable over
Gertsek, Gyory, Turnbull, Trop, Guenst, and Funt;
16
and
• claim 37 under 35 U.S.C. § 103(a) as unpatentable over Gertsek,
Gyory, Turnbull, Trop, Guenst, Funt and Angel.

OBVIOUSNESS
I. Independent Claim 1
The Examiner‟s position is that Gertsek disclosed a drug delivery
device for delivering a drug to a treatment site, the device comprising, a
capsule having a rupturable film enclosing a quantity of drug to be delivered,
an array of micro-needles mounted on a supporting matrix, the micro-
needles being formed with inlet ends facing the capsule and outlet ends
facing the treatment site, with passageways connecting the inlet and outlet
ends. (Ans. 5-6.) The Examiner also found that Gertsek taught that “the
application of pressure to the device causes the outlet ends of the micro-
needles to penetrate the treatment site, the capsule to rupture, and the inlet
ends of the micro-needles to deliver drug via the passageways to the
treatment site.” (Id. at 6.) However, the Examiner found that Gertsek did
not teach that its device comprised a porous mesh layer adjacent to the
micro-needles. (Id.)
The Examiner found that Gyory taught a drug delivery device
comprising a capsule having a rupturable film enclosing a drug, a delivery
means, e.g., a metal screen, having inlet and outlet ends, with passageways
formed therebetween, and a porous layer between the capsule and the

16
US Patent No. 6,276,935 B1 issued to Lawrence A. Funt, Aug. 21, 2001.

Appeal 2011-013048
Application 11/658,650

6
complete surface of the inlet end of the delivery means effective to space the
inlet ends from the capsule and to uniformly distribute the drug to the inlet
ends of the delivery means by a wick action to ensure that the drug is evenly
distributed for delivery to the body. (Id.) According to the Examiner, it
would have been obvious to a person of ordinary skill in the art at the time
the invention was made to have modified Gertsek to include a layer between
the capsule and the inlet ends to uniformly distribute the drug by a wick
action, as taught by Gyory, to ensure that the drug is evenly distributed for
delivery to the body. (Id. at 6-7.)
Further, according to the Examiner, Gyory‟s porous layer reduces the
possibility of clogging of the passageways as drug is delivered therethrough
from the capsule to the treatment site because the porous layer inherently
hinders the movement of the ruptured capsule film. (Id. at 7.) Moreover,
the Examiner found that Turnbull taught a porous mesh layer placed
between a capsule enclosing a quantity of drug and a passageway having an
inlet end and an outlet end, wherein the porous mesh layer is of a size that
reduces the possibility of clogging of the passageway as the drug is
delivered therethrough from the capsule to the treatment site. (Id.)
According to the Examiner, it would therefore have been obvious to a person
of ordinary skill in the art at the time the invention was made to have
modified Gertsek to include a mesh layer as taught by Turnbull to ensure
only the desired materials are delivered to the treatment site. (Id.)
Appellant contends that neither the recited porous mesh layer, nor the
recited functions performed by such a structure, were “disclosed in or
rendered obvious from any of the three cited references, whether taken
singly or in any reasonable combination.” (App. Br. 6.) According to
Appeal 2011-013048
Application 11/658,650

7
Appellant, one of skill in the art would not have been motivated to modify
Gertsek to include a porous mesh layer because neither Gyory nor Turnbull
relates to a drug delivery device including an array of micro-needles having
passageways which deliver drug from a ruptured capsule to a treatment site
as Gertsek and the claimed invention do. (Id. at 7.)
Regarding Gyory, Appellant asserts that the reference instead relates
to an iontophoretic device comprising two spaced electrodes defining a
passageway wherein the drug entry portal is the overall interface between
the patient‟s body surface and the external face of the active electrode‟s
hydrophilic matrix within which the ionic drug is dispersed, and wherein
drug delivery is by repulsive electromotive force of charged drug ions. (Id.)
Further, Appellant asserts that the wicking material in Gyory “is not
effective for avoiding the clogging of discrete conducting channels since
there simply are no such open passageways for fluid bulk flow in the
electrode matrix.” (Id. at 9.) Additionally, Appellant asserts that “Gyory
does not deliver a drug from a capsule, but rather delivers a hydrating fluid
(e.g., water) to a drug formed in a matrix 15 distal from both the wicking
layer 17 and the electrodes 11, 12….” (Id.)
Regarding Turnbull, Appellant asserts that the reference is non-
analogous art as it relates to a nasal spray device comprising a bottle having
an applicator or head axially movable with respect to a collar of the bottle to
discharge a needle-like stream of medicament through an orifice in the head
into the nasal passage of a user. (Id.) According to Appellant, the bottle of
Turnbull “is not the same or equivalent” to a rupturable capsule; its
applicator “is not equivalent to an array of micro-needles”; and the orifice
“is not equivalent to passageways through the micro-needles.” (Id. at 9-10.)
Appeal 2011-013048
Application 11/658,650

8
After considering all the evidence and arguments, we conclude that
the record supports a conclusion of prima facie obviousness for independent
claim 1. We are not persuaded of nonobviousness by Appellant‟s assertions
that Gyory and Turnbull are non-analogous art such that a skilled artisan
would not have been motivated to combine their teachings with Gertsek.
According to Appellant, “the relevant field of endeavor is not a drug
delivery device broadly, but rather a micro-needle type of drug delivery
device having small passageways for the delivery of the drug from a
rupturable capsule to the patient‟s body.” (App. Br. 10.) We disagree.
Indeed, the Specification states in the “Field and Background of the Present
Invention” section that the “invention relates to drug delivery devices, and
particularly to such devices which deliver the drug via micro-needles and/or
iontophoretically.” (Spec. 1, ll. 3-4 (emphasis omitted).) As the
Specification acknowledges, the field of endeavor is broadly drug delivery
devices, including, but not limited to, micro-needle type drug delivery.
Thus, regardless of the problem addressed, Gyory and Turnbull are broadly
from the same field of endeavor as the claimed invention. See In re Clay,
966 F.2d 656, 658-659 (Fed. Cir. 1992).
We are also not persuaded that the combined teachings of Gertsek,
Gyory, and Turnbull did not render obvious the claimed drug delivery
device comprising a porous mesh layer effective to (a) space the inlet ends of
the Gertsek‟s micro-needles from its capsule, (b) uniformly distribute the
drug to the inlet ends of the micro-needles by a wick action, and (c) upon the
rupture of the capsule film, reduce the possibility of clogging of the
passageways as the drug is delivered therethrough from the capsule to the
treatment site, as required by the claim. Contrary to Appellant‟s assertion
Appeal 2011-013048
Application 11/658,650

9
(App. Br. 9) the Examiner correctly found (Ans. 6) that Gyory taught a drug
delivery device comprising a capsule having a rupturable film enclosing a
drug (see Gyory col. 10, ll. 25-39). The Examiner also correctly found that
Gyory disclosed that its device also comprised a delivery means, e.g., a
metal screen, having inlet and outlet ends, with passageways formed
therebetween, and a porous layer between the capsule and the complete
surface of the inlet end of the delivery means. (Ans. 6.) We also find that
the Examiner provided sound reasoning supported by the evidence that
modifying Gertsek‟s device to include Gyory‟s porous layer would have
been effective to (a) space the inlet ends of the micro-needles from the
capsule, and (b) uniformly distribute the drug to the inlet ends of the
delivery means by a wick action to ensure that the drug is evenly distributed
for delivery to the body, as taught by Gyory. (Id.) Further, we agree with
the Examiner that these advantages of the porous mesh layer taught by
Gyory would have motivated a skilled artisan to add the porous mesh layer
to Gertsek‟s device.
Appellant contends, however, that the wicking material in Gyory “is
not effective for [(c)] avoiding the clogging of discrete conducting channels
since there simply are no such open passageways for fluid bulk flow in the
electrode matrix.” (App. Br. 9.) This argument is not persuasive as it
misses the point. The issue is not whether Gyory‟s device satisfied this
element of the claim. Rather, the issue is whether the combined teachings of
the prior art provided a device that satisfied this claim element. In other
words, the issue is whether Gertsek‟s drug delivery device, comprising a
porous mesh layer, as taught by Gyory, incorporated between Gertsek‟s
capsule and the complete surface of the inlet ends of its micro-needles,
Appeal 2011-013048
Application 11/658,650

10
would have been effective to reduce the possibility of clogging of the
passageways, as recited in the claim. The Examiner provided sound
reasoning, supported by the evidence (Ans. 7)(citing Turnbull) that adding
Gyory‟s porous mesh layer to Gertsek‟s device would have inherently
reduced the possibility of clogging of the passageways as drug is delivered
therethrough from the capsule to the treatment site, and Appellant has not
established otherwise with persuasive evidence.
Accordingly, we affirm the rejection of independent claim 1 over
Gertsek, Gyory and Turnbull.
Claims 2-4, 10, and 16 have not been argued separately (see App. Br.
6, 10) and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). In
addition, Appellant has waived arguments directed to the cited references
other than Gertsek, Gyory and Turnbull (see App. Br. 5-6), and therefore we
also affirm the rejections of claims 5-8, 11-15, 17-20, 24-29, and 31-37.
Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“When the appellant
fails to contest a ground of rejection to the Board, . . . the Board may treat
any argument with respect to that ground of rejection as waived. In the
event of such a waiver, the PTO may affirm the rejection of the group of
claims that the examiner rejected on that ground without considering the
merits of those rejections.”). See also MPEP § 1205.02 (“If a ground of
rejection stated by the examiner is not addressed in the appellant‟s brief, that
ground of rejection will be summarily sustained by the Board.”).

II. Claim 9
The Examiner‟s position is that Gertsek disclosed that its device
further comprised an outer deformable fluid-tight layer overlaying the
Appeal 2011-013048
Application 11/658,650

11
capsule made of an elastic material pre-tensioned such as to enhance the
flow of the drug into the passageways upon rupture of the capsule film.
(Ans. 8.)
Appellant contends that “the plastic sheet material of Gertsek is not an
„elastic material which is pre-tensioned‟ to perform the function of
enhancing the flow of the drug.” (App. Br. 11.) Appellant asserts that the
Examiner has failed to appreciate the difference between a monostable
material, i.e., one that “has only one stable condition, and when deformed by
a force to another condition, it tends to return to recover to its initial
monostable condition,” and a bistable material, i.e., one that is stable in “its
original state, and its deformed state.” (Id.) According to Appellant, unlike
pre-tensioned elastic material, e.g., latex, which is a monostable material, the
plastic material cover in Gertsek is a bistable material. In support, Appellant
quotes Gertsek‟s disclosure that the cover member “is made of material that
has sufficient memory to return to its domed shape and can be depressed to
snap to an inverted concave shape.” (Id.)(quoting Gertsek col. 6, ll. 8-
11)(emphasis added by Appellant). We agree.
Accordingly, we reverse the rejection of dependent claim 9 under 35
U.S.C. § 103(a) as unpatentable over Gertsek, Gyory, and Turnbull.

SUMMARY
We affirm the rejections of claims 1-8, 10-20, 24-29 and 31-37;
we reverse the rejection of claim 9.

Appeal 2011-013048
Application 11/658,650

12
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

cdc