Ex Parte Dormady et al

Patent Trial and Appeal Board

Sep 12, 2016

12767468 (P.T.A.B. Sep. 12, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
121767,468 04/26/2010
20462 7590 09/14/2016
GlaxoSmithKline
GLOBAL PATENTS -US, UW2220
P. 0. BOX 1539
KING OF PRUSSIA, PA 19406-0939
FIRST NAMED INVENTOR
Daniel Dormady
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
CN54175 3724
EXAMINER
WESTERBERG, NISSA M
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
09/14/2016 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):
US_cipkop@gsk.com
arlene.e.cannon@gsk.com
laura.m.mccullen@gsk.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DANIEL DORMADY and STEVE JURGENS 1
Appeal2015-003823
Application 12/767,468
Technology Center 1600
Before ULRIKE W. JENKS, JOHN G. NEW, and DAVID COTTA,
Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a layered
drug delivery device. The Examiner rejected the claims on appeal as
obvious under 35 U.S.C. § 103(a).
We reverse.
STATEMENT OF THE CASE
Claims 1---6, 8-18, 40, and 43 are on appeal. Claim 1, the only
independent claim, is illustrative and reads as follows:
1. A layered drug delivery device having an outer side
and an inner side, the device comprising in order from
the outer side to the inner side:
1 Appellants identify the Real Party in Interest as Novartis Consumer Health,
Inc. Br. 1.
Appeal2015-003823
Application 12/767,468
a first layer wherein the first layer is homogenous,
water insoluble, water swellable, and water permeable
when swelled, and
a second layer comprising a therapeutic amount of a
water soluble drug and a water soluble mucoadhesive
film, said second layer disposed such that water passing
through said first layer hydrates the second layer and
solubilizes the drug, wherein said solubilized drug can
permeate through a mucosal membrane when the inner
side is in contact with the mucosal membrane,
wherein the drug delivery device is in sheet form, and
wherein the first layer and the second layer are in
direct contact.
The claims stand rejected as follows:
Claims 1, 5, 6, 8, 9, 12-14, 40, and 43 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Moro2 and Crowley. 3
Claims 2--4 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Moro, Crowley, and Widder. 4
Claim 11under35 U.S.C. § 103(a) as unpatentable over the
combination of Moro, Crowley, Widder, and Edgren. 5
Claims 15-18 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Moro, Crowley, Widder, Edgren, and Yu. 6
2 Moro et al., U.S. Patent No. 6,585,997 B2, issued July 1, 2003 ("Moro").
3 Crowley et al., WO 2007 /112286 A2, published Oct. 4, 2007 ("Crowley").
4 Widder et al., U.S. Patent Publication No. 2004/0006111 Al, published
Jan. 8, 2004 ("Widder").
5 Edgren et al., U.S. Patent No. 6,797,283 Bl, issued Sept. 28, 2004
("Edgren").
6 Yu et al., U.S. Patent Publication No. 2005/0079220 Al, published Apr.
14, 2005 ("Yu").
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Appeal2015-003823
Application 12/767,468
Claim 10 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Moro, Crowley, and Chen.7
The Examiner found that Moro disclosed a layered drug delivery
device comprising a drug containing adhesive layer ("adhesive layer") and a
water-insoluble, water-swellable, water-permeable-when-swelled layer
("coating"). Ans. 2-3. The Examiner found that the adhesive layer and the
coating in Moro were not in "direct contact" as required by claim 1, but that
Crowley disclosed a bilayer bioadhesive composition in which an adhesive
layer was in direct contact with a backing layer. Id. at 4. The Examiner
concluded that it would have been obvious to modify the multilayer device
of Moro so that the adhesive layer and coating were in "direct contact,"
explaining:
It would have been obvious to the person of ordinary
skill in the art at the time the invention was made to prepare a
multi-layered device in which the adhesive and nonadhesive are
in direct contact. The person of ordinary skill in the art would
have been motivated to make those modifications and
reasonably would have expected success because Crowley et al.
discloses that adhesive drug containing layers and nonadhesive
layers can be placed in direct contact with each other and
intervening layers are not required. This reduces the number of
layers that must be prepared and joined together by methods
such as lamination. Moro et al. teaches that the non-adhesive
backing layer is a precast film alone or in combination with
other layers (col 4, ln 9 - 10) and that layer can contain
combinations of polymers (col 4, ln 15 - 16). The water
permeability of this layer allows for prolonged drug release and
controls the rate of residence time and time of drug delivery
7 Chen et al., U.S. Patent Publication No. 2003/0219479 Al, published Nov.
27, 2003 ("Chen").
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Appeal2015-003823
Application 12/767,468
while also providing support for to additional layers are not
required (col 9, ln 57 - 60; col 10, ln 37 - 43). Crowley et al.
discloses that a layer of varying permeability can be applied as
a single layer of uniform (homogenous) composition that is in
direct contact with the adhesive layer. The various materials
taught by Moro et al. as being required for the preparation of
the backing layer that are applied as two portions of this layer
need not be applied as separate layers, but as a homogenous
mixture that can be applied to the adhesive layer directly,
resulting in the homogenous layers in direct contact as required
by the instant claims. The properties of the polymers are not
destroyed when mixed together into one layer rather than being
provided as two distinct layers.
Id. at 4--5.
Appellants contend that "the proposed modification of Moro ignores
and is contrary to the actual teachings and requirements of Moro." Br. 7.
Appellants argue that "Moro describes throughout the specification the
importance, benefit, and requirement that the hydrophobic coating layer be
separate from the water soluble middle layer and hence teaches away from
the modification proposed by the Examiner." Id.
ANALYSIS
Moro discloses a three-layer pharmaceutical carrier device comprising
an adhesive layer, a non-adhesive backing layer, and a coating applied to the
non-adhesive backing layer. Each of the Examiner's five rejections relies on
the conclusion that it would have been obvious to merge Moro's non-
adhesive backing layer and the coating applied to the non-adhesive backing
layer to produce a single homogenous layer. Because the same
determinative facts and arguments apply to each of the Examiner's five
obviousness rejections, we address all five rejections together.
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Appeal2015-003823
Application 12/767,468
Moro describes the disadvantages of existing bilayer devices at length.
Moro explains that while it is claimed that residence time in bilayer devices
can be controlled by modifying the backing layer, these alterations "do not
provide a consistent, controllable and reproducible residence time for the
final device." Moro, col. 3, 11. 28--40. Moro further explains that in order to
produce bilayer devices, "it is required to cast the mucoadhesive layer and/or
backing layer onto a hard and non-porous surface." Id. at col. 3, 11. 40--43.
"The associated manufacturing processes to produce such a device are
complicated and therefore are not commercially viable or cost effective. Id.
at col. 3, 11. 47--49.
Moro teaches that its three-layered device solves these problems. The
non-adhesive backing layer "acts as the substrate or support layer." Id. at
col. 12, 11. 59---60. The application of an erodible coating to the backing
layer:
allows the backing layer to act as the support layer on which the
adhesive solution can be cast without dissolution of the backing
layer during the manufacture of the layered device of the
present invention. The elimination of polyethylene or other
rigid, non-erodible non-porous surface results, and therefore the
device no longer represents a potential threat of user injury and
can be manufactured on a cost effective and reproducible basis.
Id. at col. 9, 11. 57---65. "The hydrophobic coating layer renders the backing
layer water-erodible instead of water soluble, allows the precast backing
layer to be the support layer and provides a wide range of predictable and
controlled residence times." Id. at col. 8, 11. 34--37. Unlike the bilayer
devices described in Moro, in the multi-layered device of Moro, "[t]he
residence time is easily controlled, from minutes to hours, by the amount of
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Appeal2015-003823
Application 12/767,468
coating solution applied to the backing layer and the specific composition of
the coating solution." Id. at col. 10, 11. 40-44.
The Examiner concludes that it would have been obvious to merge
the non-adhesive backing layer and the coating of Moro "because Crowley
et al. discloses that adhesive drug containing layers and nonadhesive layers
can be placed in direct contact with each other and intervening layers are not
required." Ans. 4. Appellants contend that this is contrary to the teachings
of Moro. We find that Appellants have the better position because, as
discussed above, Moro discloses that a multi-layered device has a non-
adhesive backing layer between the hydrophobic coating and the adhesive
layer provides advantages over bilayer devices, including e.g., allowing the
non-adhesive backing to act as a substrate thus reducing manufacturing costs
and providing for controllable residence times. See, e.g., Moro, col. 9, 11.
57----65 and col. 10, 11. 40-44.
The Examiner finds:
The various materials taught by Moro et al. as being required
for the preparation of the backing layer that are applied as two
separate layers need not be applied as separate layers since
Crowley et al. discloses that a layer of varying permeability
comprised of hydrophilic and hydrophobic polymers can be
applied as a single layer of uniform (homogenous) composition
in direct contact with the adhesive layer as required by the
instant claims. The properties of the polymers are not
destroyed when mixed together into one layer.
Ans. 10-11. Even accepting as true the Examiner's finding that the
materials taught by Moro can be merged to form a single layer without
destroying the properties of the polymers, the Examiner does not articulate
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Appeal2015-003823
Application 12/767,468
sufficient reason to merge such materials into single layer. This is
particularly true given that Moro describes its multi-layer device as being
advantageous as compared to bilayer devices like that disclosed in Crowley.
See, e.g., Moro, col. 3, 11. 10-49, col. 9, 11. 57----65, and col. 10, 11. 37----63. In
the absence of sufficient reason to merge the adhesive backing and the
coating layers of Moro into a single layer, we reverse each of the Examiner's
five rejections.
SUMMARY
For the set forth herein, the Examiner's final decision to reject claims
1----6, 8-18, 40, and 43 is reversed.
REVERSED
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