Ex Parte Dharmadhikari et al

Patent Trial and Appeal Board

Sep 24, 2018

13608782 (P.T.A.B. Sep. 24, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/608,782 09/10/2012 Nitin Bhalachandra Dharmadhikari
21186 7590 09/26/2018
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.
2867.013US1 9699
EXAMINER
YOUNG, MICAH PAUL
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
09/26/2018 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
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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
Appeal2016-008432
Application 13/608, 782 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-in-part.
1 Appellants identify Sun Pharma Advanced Research Company, Ltd. as the
real party in interest. Br. 3.
Appeal 2016-008432
Application 13/608,782
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 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 1:22-2:24.
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: 17-19.
2 Specification filed September 10, 2012 ("Spec.").
2
Appeal 2016-008432
Application 13/608,782
Claims 1-12 are on appeal. 3 Sole independent claim 1 is illustrative
and reads as follows:
1. An orally administerable drug delivery system in the
form of a coated tablet, having one or more surfaces, the coated
tablet further comprising:
( 1) a core comprising one or more active ingredient
composition layers and one or more separate swellable
composition layers wherein;
(i) the one or more active ingredient composition layers
comprising a 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 swellable composition layer comprising a
swellable composition; and
(2) a water insoluble polymer coating surrounding the
core wherein at least one preselected portion of the coating
comprises a defect, and wherein said defect is not a passageway
through the preselected portion of the coating
wherein one or more of the swellable composition layers
is located in an immediate vicinity of one or more preselected
portions of the containing the defect 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 portion of
the coating containing the defect that is in immediate vicinity of
the swellable composition layer is removed after contact with
3 Claims 1-10 are rejected by the Final Action dated May 22, 2015.
However, claims 1-12 are pending as identified by Appellants. Br. 5.
Accordingly, we include claims 11 and 12 in our analysis as both claims
depend from rejected claim 1 and are not argued separately.
3
Appeal 2016-008432
Application 13/608,782
an aqueous environment and wherein the remaining portion of
the coating is not removed.
Br. 16 (Claims Appendix).
Appellants seek our review of the Examiner's rejections as follows:
I. Claims 1-3 and 8 are provisionally rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 1-5 of
co-pending Application No. 13/608,712.4 Ans. 3.
II. Claims 1-10 are rejected on the ground of nonstatutory double patenting
as being unpatentable over claims 1-16 ofU.S. Patent No. 8,470,367. 5
Id.
I-REJECTION OVER '712 APPLICATION
The Examiner finds that the claimed subject matter and claims 1-5 of
the co-pending '712 application are not identical, but are
not patentably distinct from each other because both sets of
claims 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. The
claims differ in that the instant claims further comprise a defect
in the coating allowing the coating to rupture. However, the
disposition and function of the components within the dosage
form are the same, such that the claims would obviate each
other.
Ans. 3.
4 Co-pending Application No. 13/608,712 ("the '712 application") is the
subject of concurrently decided Appeal No. 2016-008239.
5 Nitin Bhalachandra Dharmadhikari et al., U.S. Patent No. 8,470,367 B2,
issued June 25, 2013 ("Bhalachandra").
4
Appeal 2016-008432
Application 13/608,782
The issue with respect to this rejection is whether the Examiner erred
in rejecting the claimed subject matter over claims 1-5 of the '712
application. We select appealed claim 1 as representative of the claims
subject to this ground of rejection. 37 C.F.R. § 4I.37(c)(l)(iv).
Findings of Fact
1. Appellants' claim chart(s) below, wherein Appellants have
emphasized alleged differences between the respective
independent claims, accurately recites claim 1 of the '782
application and, in comparison thereto, claim 1 of the '712
application:
L An nrnl!y ,3dministerable drug delivery
,y'ile.m in tlw form oLi co~tkd tablet, having
nne or rnon) sm·l;:i:(Yk the coated Labkt fi.1rLh,)r
comprising:
. q) u core cc,mprising one or more act iv:::
itH;J~dknt COrt1m,~itkm !av\:crs -ilin n · krve r
c,miprising a swellahle rnmpo.;;ition; m1d
12) a water insoluble polymer coating
,mnnmding thc con.'. whtrein n:Lkl'\'.-lD!!f
pre:s.ekcte,-itli ·~·ai~l p!'csckt ! cd j){;tt i,)!l;.
nfllK! ('.O(llit1g, and the (IHC or rnor';' .•• . .. •. ..
(he rapctttfC i'd l y HCt ivc ln$ffCd ir:nt fompfr;i!io O.
·iajterS aiti.itl.{ht \;kfoit)of ,mbtJicr flOttioh·of
the coating: ani:l
wherein the al. lca,;t one or more
pre$ekcted portion of the coarinf! containing
the _ddt:x:t__that_i<;_in _immediaie. vie init'( o(lbe
s,y~'l l,1[)l.o;.\:r11JApii~Aliq11. Jw,{~r.i?.ft:J11t,iy1~(1 after
,~on.tad ·,vilh an uquernl<; environment and
wherein tbc rcimtining JKHtion of !he cnathig is
not rcinonxL [Emphasis Suppfo:'.d._l
Br. 9--10.
,,:vherdn ()IW M more ,1f th:c 1t,acth,e
cm11pnsitfon tavcr-s i~ lnc.iucd jd an irhmedfofe
vidnitv of one or nmre rre~ekcted portions of
the crrnthm in order to be in co1nmunjca,Ei{Jft
.,,------,----,,,--- ,-----,,-----------,,,-----------,,,----,-----,,,----,,-----,,,---,,
with ,mid prc.~ckctcd nortions of the coating,
and Uw znw or tnor1:.: th1:.:rnpcnticaHy m.~11ve
ingredient C()m.position layers arc in :th<.'
vi~inity of ,witlwr ponion. d tlw .:;oatit1g; .,tnd
\Vhcrein the at. 1c,i<-t one or more
presckc!ed p011ion<; of the coa1inf! that i,;;, ln
cnrnrnuniration. with.tbe.1,e.1e1ive .layer.b
r~1.t : t· .. ·t.. •. ,.J .. 1:.:,;:. \., :" H. f'-"··~:
rmupt·i,;ing_a swelfabJe cmnposition;m1d
(1) a \Valer insoluhk polytncr coaling
::;urrounding tbe con.:: \.Vlwn:in at kia:c,t one
p:n::sclccll::dpc,rtirn\ d the, coaling rn mpri,;c:e., .i.
dd'<.!cL and wlwrchl said defoct is nm a
pas:s.appsay thrm1gh the pres,dtcted !Kirt ion of
ihe coating
wk1dn one of'morcofthe ,wc:lbhk
C()ffl_l)f!Sfriot1,J:,Nerk,i,; !o/at,Xi ii, iln ,ll:n!,'IC,'linl\:!
yi<::irt~1yn{_(1nc (}(. tiylt(~_ pn:}:-l:l0ct~·dpcw~io)1s9f
H,;;;,stmtflinin~ th(~Jkfoctjn or<.kr to he: in
bJ.frnnm1kation wilh said prc~ck:dcd p1)1tinn1, of
the coallrig .. allition .layer. i:( retlH)ved .after. conta{:(.vdfh
an_aqnenu,_cnvi:wmm)nt and whcrdn the
ntrnaining portion of the c1:1ating i~ noi renioved.
[EmplKtsi~ si..1ppiie