Ex Parte Anderson et al

Patent Trial and Appeal Board

Mar 12, 2019

14827998 (P.T.A.B. Mar. 12, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/827,998 08/17/2015
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-001DIV2CON 3392
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
Appeal 2018-000621 1
Application 14/827 ,998 2
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--54 for obviousness. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We reverse.
1 Related Appeals, Application No. 13/867,510 (Appeal No. 2018-000474);
and and Application No. 14/828005, (Appeal No. 2018-000874).
2 Appellants state that the real party in interest is Verde Environmental
Technologies, Inc.
Appeal2018-000621
Application 14/827 ,998
STATEMENT OF CASE
The following claim is representative.
34. A method for reducing potential for abuse of a substance, the
method comprising:
(a) introducing the substance into a container comprising an anti-abuse
layer attached to a side of the container; and
(b) sealing the container.
Cited References
Warner et al.
("Warner")
US 2005/0112068 Al May 26, 2005
Boettger US 5,259,499
Schoendorfer et al. US 5,899,856
("Schoendorfer")
Grounds of Rejection
Nov. 9, 1993
May 4, 1999
1. Claims 34--35, 37-39, 41--45, and 48-53 are rejected under pre-AIA 35
U.S.C. § I03(a) as being unpatentable over Warner.
2. Claim 36 is rejected under pre-AIA 35 U.S.C. § I03(a) as being
unpatentable over Warner in view of Schoendorfer.
3. Claims 40, 46, and 48-53 are rejected under pre-AIA 35 U.S.C. § I03(a)
as being unpatentable over Warner in view of Schoendorfer and Boettger.
4. Claims 47 and 54 are rejected under pre-AIA 35 U.S.C. § I03(a) as being
unpatentable over Warner in view of Schoendorfer and Boettger.
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Application 14/827 ,998
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Answer at pages
3-22. The following facts are highlighted.
1. 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
opioid from layer 14.
Spec. 7; italicized emphasis added.
2. The system described by Warner includes a dermal patch
containing an active substance such as fentanyl or other opiates
(see ,r 36 and examples).
3. 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
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Application 14/827 ,998
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.
(iT 36 and iTiT 42--43).
4. In Warner, the active agent can be chemically reacted with the
destructive agent present in a supporting device or an absorber
(iTiT 7-8).
5. 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 (iT 10).
6. 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 (iT 12).
7. In one embodiment, Warner teaches that a destructive material can
be impregnated on to an absorber and stored in the container,
wherein the container is provided with a resalable lid, cap, or plug
to prevent spillage (iTiT 34--38).
8. Schoendorfer teaches that activated carbon has been widely used in
wound dressings, dermal patches as a binder for active agents and
is known to selectively adsorb substances ( col. 3, 1. 6-42).
9. Boettger teaches a method and apparatus designed to facilitate the
dispensing and inventory control of abusive medications, wherein
the apparatus is provided in the form of a book or transparent bags
(abstract & col. 1-2). For the claimed sealing or closure system,
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Application 14/827 ,998
Boettger teaches a releasable locking mechanism to open and close
the bag, in particular, zip lock bags ( col. 2 & col. 3).
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).
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
Each of the four rejections tum on the issue of whether Warner
discloses step a) "introducing the substance into a container comprising an
anti-abuse layer attached to a side of the container." Claim 34 ( emphasis
added).
The Examiner argues that, "While Warner does not explicitly teach
that an anti-abuse layer is attached to the side of the container, Warner
teaches that the container in one embodiment is glue coated and the
container comprises an absorber." Final Act. 3. 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
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Application 14/827 ,998
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.)
Appellants argue that, "Contrary to the position of the Office, Warner
fails to provide any details regarding the asserted container configuration,
and certainly fails to disclose or suggest a container having an anti-abuse
layer attached to a side of the container." App. Br. 6.
ANALYSIS
We find that the Examiner has not 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 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
of unpatentability. 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
container. App. Br. 6-7. The Examiner finds this to be an implicit teaching
based on the fact that Warner teaches in one embodiment a glue coated-
surface to which the dermal patch can be adhered and that in a different
embodiment Warner teaches that a destructive material can be impregnated
on to an absorber which is placed in a container. (Final Action 3, 8.)
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We do not agree that such is an "implicit" teaching of 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 (i1i17-9), and another that involves adhering the spent
dermal drug delivery device to a glue coated surface of a device (i1i1 10-11 ).
In both, Warner discloses a disposal container for an opiate or other drug.
And in both, the drug patch is accompanied by a container device which is
configured to envelop and seal the spent drug containing dermal patch or
peel therein, such that the active ingredient is rendered substantially
inaccessible for unintended use. ,r 12. We agree with the Examiner that
"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 (0010)." Final Act. 3. However, this portion of Warner fails to disclose
that an anti-abuse layer is attached to an interior wall of a container, as
claimed. The use of an anti-abuse layer to deactivate the spent dermal patch
is a separate and distinct teaching in Warner from the embodiment in which
the spent dermal patch is adhered to the side of a container in order to
deactivate it. The deactivation occurs by different means in these different
embodiments, and, thus, we cannot conclude from them that disposing the
absorber into a glue-coated container would be an implicit teaching of
Warner. Moreover, the Examiner has not provided a reason that one of
ordinary skill in the art would have found it obvious to combine these
separate embodiments of Warner, such that the container includes an anti-
abuse layer attached to an interior wall of the container, as claimed. Thus,
we conclude that the Examiner has failed to meet the requisite burden of
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establishing a prima facie case of obviousness. In re Glaug, 283 F.3d at
1338.
Rejections 2--4 as set forth in the Grounds of Rejection above are
reversed for the same reasons as rejection 1. We do not find that the
secondary references cited in these rejections overcome the deficiencies of
Warner.
CONCLUSION OF LAW
The cited references do not support the Examiner's obviousness
rejections, which are reversed.
REVERSED
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