Ex Parte Anderson et al

Patent Trial and Appeal Board

Mar 12, 2019

13867510 (P.T.A.B. Mar. 12, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/867,510 04/22/2013
93726 7590 03/14/2019
EPA - Bozicevic Field & Francis LLP
Bozicevic, Field & Francis
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
FIRST NAMED INVENTOR
Carter R. Anderson
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.
VERDE-001DIV2 7411
EXAMINER
CHANNA V AJJALA, LAKSHMI SARADA
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
03/14/2019 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):
docket@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CARTER R. ANDERSON and RUSSELL L. MORRIS 1
Appeal2018-000474 2
Application 13/867,510
Technology Center 1600
Before DEMETRA J. MILLS, TA WEN CHANG, and RACHEL H.
TOWNSEND, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims 34--46 and 49-51 for obviousness. We have jurisdiction under
35 U.S.C. § 6(b).
We reverse.
1 Appellants state that the real party in interest is Verde Environmental
Technologies, Inc. App. Br. 3.
2 Related Appeals, Application No, 14/827 ,998, Appeal 2018-000621 and
Application No. 14/828005, Appeal No. 2018-000874.
Appeal2018-000474
Application 13/867,510
STATEMENT OF CASE
The following claims are representative ( emphasis added).
34. A method for reducing potential for substance abuse
from a skin-worn transdermal patch device comprising an
abusable substance layer containing residual amounts of an
abusable substance of interest after removal from a user, the
method comprising:
inserting the transdermal patch device into a container
and thereby contacting the abusable substance layer of the
transdermal patch device as removed from a user to an anti-
abuse substance present in an anti-abuse layer that is attached
to an interior wall of the container, wherein the anti-abuse
substance is selected from the group consisting of co-soluble
antagonists, irritants and combinations thereof so that the
potential for abuse is reduced.
39. A system for reducing potential for substance abuse
from a skin-worn transdermal patch device comprising an
abusable substance layer containing residual amounts of
abusable substance after administration to a user, said system
compnsmg:
(a) a disposable container having an opening therein to
receive a skin-worn patch device containing a residual amount
of an abusable substance
therein;
(b) an anti-abuse layer attached to an interior wall of the
container and containing an amount of an anti-abuse substance
selected from the group consisting of co-soluble antagonists,
irritants and combinations thereof, said anti-abuse layer being
disposed in said container in a manner such that a skin-worn
patch device properly inserted into said container causes said
abusable substance of said skin-worn patch device to contact
said anti-abuse substance; and
( c) a closure for closing said container containing a used
skin-worn patch device.
44. A method for reducing potential for substance abuse
from a skin-worn transdermal patch device having an abusable
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Application 13/867,510
substance layer containing a residual amount of an abusable
substance of interest and an anti-abuse layer, the method
compnsmg:
contacting said abusable substance layer with said anti-
abuse layer by removing the transdermal patch from a user and
thereby removing a membrane from between the abusable
substance layer and the anti-abuse layer, wherein said anti-
abuse layer comprises a substance selected from the group
consisting of co-soluble antagonists, irritants and combinations
thereof.
Cited References
Warner et al.
("Warner")
US 2005/0112068 Al May 26, 2005
Shevchuk et al.
("Shevchuck")
US 2004/0126323 Al July 1, 2004
Cubbage et al.
("Cubbage")
US 5,804,215 September 8, 1998
Grounds of Rejection
3-13.
1. Claims 34, 36-40, 42--43 are rejected under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Warner.
2. Claims 35 and 41 are rejected under pre-AIA 35 U.S.C. § I03(a)
as being unpatentable over Warner further in view of Shevchuk.
3. Claims 44--46, 49, and 51 are rejected under pre-AIA 35 U.S.C.
§ I03(a) as being unpatentable over Cubbage in view of Warner.
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Answer at pages
3
Appeal2018-000474
Application 13/867,510
1. The system described by Warner includes a dermal patch
containing an active substance such as fentanyl or other opiates
(see ,r 36 and examples), which reads on the dependent claim
limitations of instant claims 37-38 and 45--46, and further meets
the claimed abusable substance.
2. According to Warner, the active agent (prone to unintended use),
can be present in a first side of the dermal patch or peel and
configured to deliver the active agent to skin or mucosa (i-f 10). In
the method of reducing the unintended use of active agent, a
destructive agent that is chemically reactive with the active
ingredient is employed, which includes chemical substances such
as sodium hypochlorite, oxidants, permanganate; trace metals, etc.
(i-f 36 and ,r,r 42--43).
3. In Warner, the active agent can be chemically reacted with the
destructive agent present in a supporting device or an absorber
(i-fi-f 7-8).
4. Warner describes a device having a glue coated surface that is
configured to adhere to the active containing adhesive side of the
patch, such that the unspent active agent is rendered substantially
inaccessible for unintended use (i-f 10).
5. Further, Warner describes that the device is configured to envelope
and seal the dermal patch, such that the unspent active agent is
rendered substantially inaccessible for unintended use (i-f 12).
6. In one embodiment, Warner teaches that a destructive material can
be impregnated on to an absorber and stored in the container,
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Application 13/867,510
wherein the container is provided with a resalable lid, cap, or plug
to prevent spillage (i1i134--38).
7. Shevchuk teaches a tamper resistant dosage form comprising an
active such as an opioid; an adverse agent such as an opioid
antagonist and a salt thereof (abstract & figure 3A).
8. For the abusive drugs, Shevchuk teaches opioids (i158) including
fentanyl and for the adverse agent, Shevchuk teaches opioid
antagonists such as naloxone (i167). In particular, Shevchuk
teaches combination of fentanyl and naltrexone (i1 78).
9. Shevchuk further teaches that in one embodiment, Fig 3A, wherein
the active agent (opioid), and the adverse agent (antagonist), are
separated by a barrier layer (i1 44).
10. Specification, Fig 1 is reproduced below.
Specification, Fig. 1 shows,
A disposal container or pouch designed to accompany
the skin-worn patch 10 is shown generally by the reference
character 16 and includes a layer of absorbent material 18
attached to one side of the container 16 in the manner such
that insertion of the used skin-worn patch 10 as is shown by
the arrow 20 with the opioid layer 14 facing the adsorptive
material 18, ensures that contact will occur between the
layers 14 and 18, thereby adsorbing and deactivating the
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Application 13/867,510
opioid from layer 14.
Spec. 7; italicized emphasis added.
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007).
Moreover, "obviousness requires a suggestion of all limitations in a
claim." CFMT, Inc. v. Yieldup Int'! Corp., 349 F.3d 1333, 1342 (Fed. Cir.
2003) (citing In re Royka, 490 F.2d 981,985 (CCPA 1974)).
Obviousness Rejections
The Examiner finds that W amer "teaches a system drawn to and a
method of reducing unintended use of an active ingredient, such as residual
active ingredients present in spent dermal patches and peels ( abstract; 0007-
0014 ). " Final Act. 3. The Examiner finds that the:
Instant claims do not require any glue coated anti-abuse layer
and instead only require that the anti-abuse layer is attached to a side
of the container. In other words, one of an ordinary skill in the art
would be motivated to dispose the patch in to the glue-coated
container with or without an absorber, and still be able to attach the
spent patch (with residual active agent) to the glue coated surface of
the disposing container.
Ans. 12.
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Application 13/867,510
Appellants contend that:
the Examiner errs in asserting that the glue-coated surface and
absorber are described in one embodiment. The system of paragraph
[001 OJ fails to disclose any absorber element and the method of
Claims 3 8 and 41 of Warner fails to disclose any glue-coated device.
Nowhere does Warner teach or suggest that the glue-coated device
and a container having an absorber are both components of a single
embodiment. As reviewed above, Warner provides no guidance to a
container where an anti-abuse layer is attached to an interior wall of
a container.
App. Br. 6; italicized emphasis added.
ANALYSIS
Rejection 1- Obviousness Warner
We do not find that the Examiner has provided evidence to support a
prima facie case of obviousness. The dispositive issue for each of the
rejections is whether Warner teaches an "anti-abuse substance present in an
anti-abuse layer that is attached to an interior wall of the container." Claim
34.
Claim 34 requires, "in an anti-abuse layer that is attached to an
interior wall of the container." (emphasis added). "[O]bviousness requires a
suggestion of all limitations in a claim." CFMT, Inc. v. Yieldup Int 'l Corp.,
349 F.3d 1333, 1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d 981,985
(CCPA 1974)). The burden is on the examiner to set forth a prima facie case
ofunpatentability. See In re Glaug, 283 F.3d 1335, 1338 (Fed. Cir. 2002).
We agree with Appellants that "Warner provides no guidance to a
container where an anti-abuse layer is attached to an interior wall of a
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container." App. Br. 6. The Examiner contends that the absorber, which
may be included in a container, "implicit[ly] ... sticks to the interior of the
container ... because a solution or an absorber material in a container
touche[s] the bottom and/or side surfaces of the container." (Ans. 11.) The
Examiner further states that "it would have been obvious for one of an
ordinary skill in the art at the time of the instant invention was made to place
the glue-coated absorber in a suitable position to the sides or the base of the
container and see that the patch with unspent abusive agent is properly
attached/secured to the absorber .... " (Id.) We do not agree with the
Examiner that Warner teaches a glue-coated absorber or that the absorber is
inherently "attached" to a container in Warner.
In particular, Warner teaches separate embodiments, one that involves
the use of a destructive agent that deactivates the active agent of a spent
dermal drug delivery device (i1i1 7-9), and another that involves adhering the
spent dermal drug delivery device to a glue coated surface of a device
(i-fi-fl0-11). The Examiner has not indicated where the prior art discloses a
container where an anti-abuse layer is attached to an interior wall of a
container, as claimed.
Rejections 2 and 3 as set forth in the Grounds of Rejection also rely
on Warner for the claimed feature of a container where an anti-abuse layer is
attached to an interior wall of a container. In addition, Cubbage, Fig. 2,
discloses a transdermal patch disposal system where "the inner surface 21 of
the preferred substrate 20 is coated with an adhesive 22 which is
aggressively self-sticking such that once the facing surface 21 of the disposal
substrate 20 is pressed against itself." Col. 2, 11. 64-68. However, the
Examiner has not provided evidence in the prior art that either Warner or
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Cubbage disclose an "anti-abuse substance present in an anti-abuse layer
that is attached to an interior wall of the container," as claimed. W amer
discloses the inclusion of a destructive agent in a method for reducing the
unintended use of active ingredients in dermal delivery devices i-f3 6, but does
not specifically disclose that the anti-abuse substance/layer is attached to an
interior wall of the container.
Rejections 2-3 are reversed for the same reasons as rejection 1.
CONCLUSION OF LAW
The cited references do not support the Examiner's obviousness
rejections, which are reversed.
REVERSED
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