Ex Parte Dharmadhikari et al

Patent Trial and Appeal Board

Sep 17, 2018

13608712 (P.T.A.B. Sep. 17, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/608,712 09/10/2012 Nitin Bhalachandra Dharmadhikari
21186 7590 09/19/2018
SCHWEGMAN LUNDBERG & WOESSNER, P.A.
P.O. BOX 2938
MINNEAPOLIS, MN 55402
UNITED ST A TES OF AMERICA
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.
2867.012US1 5023
EXAMINER
YOUNG, MICAH PAUL
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
09/19/2018 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):
uspto@slwip.com
SLW@blackhillsip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NITIN BHALACHANDRA DHARMADHIKARI,
Y ASHORAJ RUPSINH ZALA, and AMARJIT SINGH
Appeal2016-008239
Application 13/608,712 1
Technology Center 1600
Before RICHARD M. LEBOVITZ, RYAN H. FLAX, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to an orally
administrable drug delivery system. The Examiner entered final rejections
for obviousness-type double patenting.
We have jurisdiction under 35 U.S.C. § 6(b ). We affirm.
1 Appellants identify "the assignee, Sun Pharma Advanced Research
Company Ltd." as the real party in interest. Br. 3.
Appeal2016-008239
Application 13/608,712
STATEMENT OF THE CASE
Background
Oral administration of a drug provides a plasma level
time profile of a drug or its active or inactive metabolite, which
can be modulated by the design of the drug delivery system or
dosage form.
Drug delivery system or dosage forms have been
designed in various ways, depending on the requirements of the
therapy or the needs of the patient.
Drug delivery systems are also designed to release the
drug at [a] specific site in the gastrointestinal tract by use of
pH-dependent coatings that dissolve in the pH environment at
the specific gastrointestinal site. There is a need for designing
cores for such coated systems wherein the cores provide rapid
release without substantial delay over the specific site or region,
for example a release initiated over a period of 1 minute to 30
minutes after encountering the particular site or pH. There is
also a need for designing cores for such site-specific coated
systems wherein the cores are designed to provide controlled
release over the specific region, for example from the colon to
the rectum.
Spec. 2 1: 17-2:24.
The Specification discloses "an oral drug delivery system comprising
a coating that is reliably removed fully or partially from one or more
preselected surfaces of the system upon contact of the system with an
aqueous environment." Id. at 1: 1 7-19.
2 Specification filed October 18, 2012 ("Spec.").
2
Appeal2016-008239
Application 13/608,712
Claims 1-5 are on appeal. Sole independent claim 1 is illustrative and
reads as follows:
1. An orally administ[]rable drug delivery system in the
form of a coated tablet, comprising:
( 1) a core comprising one or more active ingredient
composition layers and one or more separate reactive
composition layers,
(i) the one or more active ingredient composition layers
comprising at least one therapeutically active ingredient and at
least one pharmaceutically acceptable excipient, wherein in at
least one active ingredient composition layer, at least one
pharmaceutically acceptable excipient is a rate controlling
excipient and
(ii) the reactive composition layer comprising a reactive
ingredient; and
(2) a water insoluble polymer coating surrounding the
core and capable of being dissolved, disintegrated, or weakened
in the presence of the reactive ingredient released from the
reactive composition,
wherein one or more of the reactive composition layers is
located in an immediate vicinity of one or more preselected
portions of the coating in order to be in communication with
said preselected portions of the coating, and the one or more
therapeutically active ingredient composition layers are in the
vicinity of another portion of the coating; and
wherein the at least one or more preselected portions of
the coating that is in communication with the reactive layer is
removed after contact with an aqueous environment and
wherein the remaining portion of the coating is not removed.
Br. 16 (Claims Appendix).
3
Appeal2016-008239
Application 13/608,712
Appellants seek our review of the Examiner's rejections as follows:
I. Claims 1-5 are provisionally rejected on the ground of nonstatutory
double patenting as being unpatentable over claims 1-3, and 8 of co-
pending Application No. 13/608,782. 3
II. Claims 1-5 are rejected on the ground of nonstatutory double patenting
as being unpatentable over claims 1-16 of U.S. Patent No. 8,470,367. 4
I-REJECTION OVER '782 APPLICATION
The Examiner finds that both the claimed subject matter and claims
1-3 and 8 of the '782 application are drawn to "an oral coated tablet
comprising a layered core and a coating that surrounds the core. The core
comprises welling agents and the coating is water-insoluble yet allows fluid
from the surrounding environment into the core until a predetermined side of
the coating swells and ruptures." Ans. 3. The Examiner finds that the
claims of the '782 application are different because the coating comprises a
defect "allowing the coating to rupture." Id. The Examiner concludes that,
despite the defect in the coating, "the disposition and function of the
components within the dosage form are the same, such that the claims would
obviate each other." Id.
The issue in this case is whether the Examiner erred in rejecting the
claimed subject matter over claims 1-3 and 8 of the '782 application. We
3 Co-pending Application No. 13/608,782 ("the '782 application") is the
subject of concurrently heard Appeal No. 2016-008432.
4 Nitin Bhalachandra Dharmadhikari et al., U.S. Patent No. 8,470,367 B2,
issued June 25, 2013 ("Bhalachandra").
4
Appeal2016-008239
Application 13/608,712
select claim 1 as representative of the claims subject to this ground of
rejection/on appeal. 37 C.F.R. § 4I.37(c)(l)(iv).
Findings of Fact (FF)
1. Appellants' claim chart below, wherein Appellants have
emphasized alleged differences between the respective
independent claims, accurately recites claim 1 of the '712
5
Appeal2016-008239
Application 13/608,712
application and, in comparison thereto, claim 1 of the '782
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ihcrtby r,·mnving ,)nly the ,:oating !Im~ i~
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rek~a~e of the fo,::tivc ingrcdkl1t for con!rolkxl
rek.'.ase of active ingredient.
18
Appeal2016-008239
Application 13/608,712
6. Bhalachandra discloses:
The coating surrounding the core of the oral drug
delivery system of the present invention is preferably
impermeable to the active ingredient, and has a passageway
therein. In one preferred embodiment of the coating with a
passageway, the coating is made up of water-insoluble
polymers that may be selected from ethyl cellulose,
hydrophobic methacrylic acid derivatives and the like, and
mixtures thereof. Preselected one or more surfaces of the
coating are then provided with a mechanically or laser-drilled
passageway, and cause the core to partially remove the coating,
thereby exposing a portion of the core for the release of the
active ingredient contained therein. In more preferred
embodiments of the present invention wherein the coating has a
passageway, the oral drug delivery system is in the form of a
tablet. The passageways in the coating may be provided on one
or more preselected surfaces of the tablet, such that when water
from the surrounding environment enters the tablet through the
passageway, the core causes partial removal of the coating from
the preselected surfaces, thereby exposing a defined surface
area for release of the active ingredient. In preferred
embodiments the core has components that are swellable or
reactive to the coating.
Bhalachandra 14:31-15: 13.
7. Bhalachandra discloses:
In one embodiment of the present invention, the active
ingredient composition is a swellable composition comprising
at least one active ingredient and a swelling agent. In another
embodiment of the present invention, the core comprises active
ingredient composition and swellable composition, which may
be present as one or more layers. The active ingredient present
in these layers may be the same or different.
Bhalachandra 16:1---64.
8. Bhalachandra discloses that the "swellable composition may
comprise a mixture of swellable excipients and gas generating agents,
the mixture being designed with types and amounts of components
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Appeal2016-008239
Application 13/608,712
selected so as to cause the removal of the coating and initiation of
release without a substantial delay or to cause a predetermined period
of delay." Id. at 9: 16-22. In addition, the "swellable composition
used in oral drug delivery system of the present invention comprises a
swellable agent that may be selected from a group comprising a
swellable excipient, a gas generating agent and mixtures thereof." Id.
at 9:23-26.
Analysis
Appellants argue that the double patenting rejection should be
reversed because the respective claims are structurally and functionally
different. Br. 12-14. According to Appellants, the '712 application
( appealed) claims have preselected portions of the coating that are removed
once contacted by water through the activity of the reactive composition
layer, whereas the claims of Bhalachandra are directed to "an improved
method for the 'swelling' step," which is a coating (containing leachable
components) that facilitates entry of water into the tablet interior to initiate
swelling. Id. at 13-14. Appellants argue the skilled artisan "would not be
motivated to modify the coated tablet of Bhalachandra to arrive at the
instantly claimed coated tablet" and that the Examiner has failed to state any
such motivation. Id. at 14.
The Examiner finds both claims recite a water insoluble coating and
"respond the same way when exposed to an aqueous environment,
specifically when the water-insoluble polymer that surrounds the core is
exposed to an aqueous environment, water is allowed to enter and a
swellable portion of the core is activated." Id.
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Appeal2016-008239
Application 13/608,712
Once again, we begin with an interpretation of the claim terms at issue
"reactive composition layer" and "swellable composition." We adopt the
interpretation of "reactive composition layer" discussed above.
Bhalachandra does not expressly define "swellable composition," but
its claim 1 recites that it is a component of a second layer of the core, and
that, after contact with an aqueous environment, the coating surrounding the
core is removed "in the immediate vicinity of the swellable composition but
not the remaining portion." See claim chart at FF5. Bhalachandra also
teaches that preferred embodiments of the tablet comprise a core with
"components that are swellable or reactive to the coating." FF6. The
swellable composition and a reactive composition may co-exist in the core
as separate components, in layers, or the swellable composition may
comprise a mixture of components, such as swellable excipients and gas
generating agents or mixtures thereof. FF7, FF8. The swellable
composition is designed "to cause the removal of the coating and initiation
of release without a substantial delay or to cause a predetermined period of
delay." FF8. Consistent with the Specification, therefore, a "swellable
composition" of Bhalachandra is interpreted as a component of the core that,
upon contact with an aqueous environment, swells and exerts pressure on the
coating such that coating in its immediate vicinity is removed to permit
release of the active ingredient. FF6-8.
In view of these interpretations of the claim language, we now assess
whether the claimed "one or more separate reactive composition layers"
would have been obvious in light of Bhalachandra's claims, which recite "a
second layer comprising a swellable composition." In re Langi, 7 59 F .2d at
893. We agree with the Examiner that the rejection of the pending claims
over Bhalachandra' s claims for statutory obviousness-type double patenting
21
Appeal2016-008239
Application 13/608,712
is proper. Bhalachandra's "swellable composition," as interpreted in view of
its specification, has the same properties as the "reactive composition layer."
Both the reactive composition layer of the claims on appeal and the
swellable composition of Bhalachandra' s claims are "in an immediate
vicinity" of the coating and, when the "water-insoluble polymer that
surrounds the core is exposed to an aqueous environment, water is allowed
to enter and a swellable portion of the core is activated." Ans. 7; FF5-8.
Bhalachandra teaches that the swellable composition may contain
"swellable excipients and gas generating agents, the mixture being designed
with types and amounts of components selected so as to cause the removal
of the coating," which discloses a mechanism claimed by the '712
application, wherein the coating is "dissolved, disintegrated, or weakened in
the presence of the reactive ingredient released from the reactive
composition." Thus, claim 1 of Bhalachandra is broad enough to read on
and render obvious appealed claim 1. And, although claim 1 of
Bhalachandra application recites the additional feature of a leachable
components, because claim 1 of the '712 application uses the open ended
transition term "comprising," the claim does not preclude use of such
components. Ans. 7. For these reasons, we are not persuaded by
Appellants' arguments (Br. 13-14) that the claims of Bhalachandra are
sufficiently structurally and functionally different to render the claims of the
'782 application patentably distinct.
In particular, we are not persuaded by Appellants' argument that "the
instant claims rely on a reactive composition layer located in an immediate
vicinity of the preselected portion of the coating to remove the coating by
chemical action so that the active ingredient is released." Br. 14. Claim 1 of
Bhalachandra states that contact with an aqueous environment removes
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Appeal2016-008239
Application 13/608,712
"only the coating that is in the immediate vicinity of the swellable
composition but not the remaining portion" (FF5), making this a difference
without distinction. Appellants provide only attorney argument, without
persuasive supporting evidence, to explain how the purported difference
renders the claims patentably distinct. Likewise, we are not persuaded by
attorney argument that the mechanism of action provides a patentable
difference (see, e.g., Tr. 38:5-39: 10), particularly because neither of the
claims requires that the coating be dissolved, disintegrated or weakened
from a specific direction; thus, this purported difference cannot be used to
establish patentability. See In re Self, 671 F.2d at 1348.
Finally, we are not persuaded by Appellants' argument that the
ordinarily skilled artisan "would not be motivated to modify Bhalachandra's
[claimed] coated tablet to arrive at the instantly claimed coated tablet," (Br.
14). The Examiner has shown that claim 1 of the '712 application is obvious
over claim 1 of Bhalachandra, for the reasons discussed above. See In re
Langi, 759 F.2d at 893. We agree. The rejection is affirmed. Claims 2--4
have not been argued separately and therefore fall with claim 1.
SUMMARY
We affirm the provisional rejection of claims 1-5 on the ground of
nonstatutory double patenting as being unpatentable over claims 1-3, and 8
of co-pending Application No. 13/608,782.
We affirm the rejection of claims 1-5 on the ground of nonstatutory
double patenting as being unpatentable over claims 1-16 of U.S. Patent No.
8,470,367.
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Appeal2016-008239
Application 13/608,712
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
24