Ex Parte Clarke et al

Patent Trial and Appeal Board

May 29, 2018

11149100 (P.T.A.B. May. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111149,100 0610912005 Allan J. Clarke
56457 7590 05/29/2018
OHLANDT, GREELEY, RUGGIERO & PERLE, L.L.P.
(GLAXOSMITH KLINE)
ONE LANDMARK SQUARE
IOTHFLOOR
STAMFORD, CT 06901
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.
0001534USU2/2241 9763
EXAMINER
WESTERBERG, NISSA M
ART UNIT PAPER NUMBER
1618
MAILDATE DELIVERY MODE
05/29/2018 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALLAN J. CLARKE, DAVID
GEORGE DOUGHTY, and FREDERICK H. FIESSER
Appeal2017-007664
Application 11/149, 100 1
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and RYAN H. FLAX,
Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 9, 12, 13, 15-
22, 33--42, 46, and 47 (App. Br. 2). Examiner entered rejections under 35
§ 102(b) and 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C.
§ 6(b).
We REVERSE.
1 Appellants identify "Glaxosmithkline LLC" as the real party in interest
(Appellants' October 24, 2016 Appeal Brief (App. Br. 2)).
Appeal2017-007664
Application 11/149,100
STATEMENT OF THE CASE
Appellants' disclosure "relates to [a] pharmaceutical and
pharmaceutical-like product" and "[m]ore particularly, ... to the delivery of
an active agent in a pharmaceutical and pharmaceutical-like product" (Spec.
2). Appellants' independent claim 9 and 40 are representative and
reproduced below:
9. A pharmaceutical product comprising:
an active agent; and
a tablet carrier substrate for holding said active agent,
said tablet carrier substrate having a first outer substrate surface
with a single, first recess formed therein, wherein said active
agent is positioned in said first recess, and
wherein said active agent is formed into a film so that
said film partially defines an outer surface of the
pharmaceutical product,
wherein said first recess has a smooth concave shape.
(Claims App'x2 4.)
40. A pharmaceutical product comprising:
a first active agent;
a second active agent; and
a tablet carrier substrate having a first outer substrate
surface and a second outer substrate surface that are on opposite
sides of said tablet carrier substrate from each other,
wherein said first substrate outer surface has a first,
single recess formed therein, and said second outer substrate
surface has a second, single recess formed therein,
wherein said first active agent is in said first recess and
wherein said second active agent is in said second recess, so
2 Appellants' January 23, 2017 Supplemental Response to Notice ofNon-
Compliant Appeal Brief.
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Application 11/149,100
that said first active agent and said second active agent partially
define an outer surface of the pharmaceutical product,
wherein said first active agent is formed into a film on
said first outer substrate surface of said tablet carrier substrate,
and
wherein each of said first and second recesses has a
smooth concave shape.
(Claims App'x 7.)
The claims stand rejected as follows:
Claims 9, 13, 15, 33-36, 46, and 47 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Payumo. 3
Claims 9, 12, 13, 15-22, 33-36, 38--42, 46, and 47 stand rejected
under 35 U.S.C. § 103(a) as unpatentable over the combination of Payumo
and Vromans. 4
Claim 37 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Payumo, Vromans, and Errigo. 5
Claims 9, 33-35, and 46 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Bunick. 6
Claims 9, 13, 15, 16, 33-35, 40, 42, 46, and 47 stand rejected under
35 U.S.C. § 103(a) as unpatentable over the combination of Bunick and
Pather. 7
3 Payumo et al., WO 01/87272 A2, published Nov. 22, 2001.
4 Vromans et al., US 6,054,145, issued Apr. 25, 2000.
5 Errigo, US 5,683,718, issued Nov. 4, 1997.
6 Bunick et al., WO 03/026627 Al, published Apr. 3, 2002.
7 Pather et al., US 6,350,470 Bl, issued Feb. 26, 2002.
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Application 11/149,100
Claim 12 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Bunick, Pather, and Conte. 8
Claims 17-22, 38, and 39 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Bunick, Pather, and Vromans.
Claim 37 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Bunick, Pather, and Errigo.
Claims 9, 13, 15, 16, 33-36, 40-42, 46, and 47 stand rejected under
35 U.S.C. § 103(a) as unpatentable over Lee. 9
Claim 12 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Lee and Conte.
Claims 17-22, 38, and 39 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Lee and Vromans.
Claim 37 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Lee and Errigo.
Claims 9, 13, 15, 33-35, and 46 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Pather and Plachetka. 10
Claims 17-22, 38, and 39 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Pather, Plachetka, and Vromans.
Claim 37 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Pather, Plachetka, and Errigo.
8 Conte et al., US 6,294,200 B 1, issued Sept. 25, 2001.
9 Lee et al., WO 03/026628 A2, published Apr. 3, 2003.
10 Plachetka, US 6,926,907 B2, issued Aug. 9, 2005.
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Application 11/149,100
The rejections over Payumo, alone or in combination with Vromans and
Errigo:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that Payumo teaches or that Payumo in combination
with Vromans with or without Errigo makes obvious Appellants' claimed
invention?
FACTUAL FINDINGS (FF)
FF 1. Appellants' Figure 3 is reproduced below:
p '3000
/~--1000 _,,.
FlG. 3
Appellants' "FIG. 3 is a plan view of a pharmaceutical product" and
illustrates a "pharmaceutical product 3000, which is a combination of a
carrier tablet or other substrate 1000 and a liquid dose 2000" (Spec. i-fi-1 40
and 79).
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Application 11/149,100
FF 2. Appellants' Figure 12 is reproduced below:
p-3000
1200 FIG.12
Appellants' "FIG. 12 is a cross-sectional view of [Appellants'] carrier tablet
... with a dose droplet" that "preferably forms a film 2200 upon the outer
surface 1100 or substantially along the outer surface of the carrier tablet
1000" (Spec. i-fi-1 73 and 82; see also id. i1 82 ("the liquid dose 2000 is
preferably heated so that excess amounts of liquid are evaporated and the
active agent becomes captured in the film 2200"); id. i1 204 ("carrier tablet
1000 preferably has a recess or reservoir 1150 disposed centrally along outer
surface 1100," wherein "reservoir 1150 has a volume that is sufficient to
hold the liquid dose 2000") ).
FF 3. Payumo discloses:
A drug delivery device ... in the form of an oral dosage
form (ODF) with a toxic or potent drug encapsulated by a non-
toxic region wherein the non-toxic region may be a
pharmacologically inert substance. The non-toxic region
provides an isolation barrier or buffer zone protecting the toxic
or potent core from damage during handling or from early
release of the drug.
(Payuma 4: 18-23; see Ans. 2 (Payumo "discloses an oral dosage form in
which an active agent ... is encapsulated by a non-toxic region, which reads
on a carrier substance"); see generally Ans. 2-3.)
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Application 11/149,100
FF 4. Paymno's Figure 7D is reproduced below:
744 ~ --------,-....
:~~~~;?r-140
Copsule design ~ZI@ I
~742
................... -..... -....._.._.._.._ ... ~---..,.--""-.,.,.-.
R' ... Jg. 7D
Paymno' s Fig. 7D illustrates a pharmaceutical form that "includ[ es]
individual regions for two different drugs" (Payumo 4: 15-16).
FF 5. Examiner does not identify and we do not find a disclosure in
Payumo that defines or identifies the precise location of elements 740, 742,
744 of Payumo's "Capsule design" illustrated in Payumo's Fig. 7D.
Payumo does, however, disclose "[i]n the capsule geometry, the length is the
longest dimension of the dosage form, and so the preferred geometric
arrangement of the two individual drug regions is for them to be stacked on
top of each other and both enclosed inside a pharmacologically inert shell"
(Payumo 17: 30-18: 3 (emphasis added)).
FF 6. Payumo' s Figure 7E is reproduced below:
154-
752;~-:=~-7:=:-~·-750
T. i..! t 0 ·-· ( ,-~~~1t~~- ; 0$.11e e{>rgn l ··t~1~~~:-"'f"_.....t
l.~:=~~~~-::~~~.:~~: __ )
Fig. 7E
Payumo' s Fig. 7E illustrates a pharmaceutical form that "includ[ es]
individual regions for two different drugs" (Payumo 4: 15-16).
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Application 11/149,100
FF 7. Examiner does not identify and we do not find a disclosure in
Payumo that defines or identifies the precise location of elements 750, 752,
754 of Payumo's "Tablet Design" illustrated in Payumo's Fig. 7E. Payumo
does, however, disclose:
For the tablet geometry, the diameter is the largest dimension of
the dosage form, and again all the active would have to be
surrounded by an inert shell, but it might be preferable to locate
one drug region concentrically inside the other drug region,
with both of them further being surrounded by the
pharmacologically insert shell.
(Payumo 18: 3-7 (emphasis added).)
FF 8. Examiner finds that Payumo "does not discuss a coating of [a]
dosage form as in [Appellants'] claim 35 or[] the relative standard deviation
(RSD) of the content uniformity of the dosage form" and relies on Vromans
to make up for this deficiency in Payumo (Ans. 5---6).
FF 9. Examiner finds that the combination of Payumo and Vromans fails
to suggest "the inclusion of an identification marker applied to the carrier
substrate" and relies on Errigo to make up for this deficiency in the
combination of Payumo and Vromans (Ans. 7).
ANALYSIS
Examiner finds that Payumo anticipates the subject matter of
Appellants' claims 9, 13, 15, 33-36, 46, and 47 (see Ans. 2-3). We are not
persuaded.
Initially, we note that Appellants' claim 4 7 depends from Appellants'
independent claim 40 (see Claims App'x 7). Examiner's statement of the
rejection and analysis do not account for Appellants' claim 40 (see Ans. 2-
3). Thus, because Examiner failed to establish that Payumo anticipates the
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Application 11/149,100
subject matter of Appellants' claim 40, Examiner failed to establish that
Payumo anticipates the subject matter of Appellants' claim 47.
In addition, we are not persuaded by Examiner's finding that
Payumo 's "Figure 7E show[ s] the active ingredient (darkest shaded portion
in [F]igure 7E) forming a portion of the outer surface" (Ans. 3). As
Appellants explain, Payumo does not support Examiner's interpretation of
Payumo's Figure 7E (see App. Br. 5---6). To the contrary, as Appellants
explain, Payumo discloses that the active agent "is 'encapsulated by a non-
toxic region"' (App. Br. 5 (emphasis omitted); see FF 3-7). Therefore, we
agree with Appellants' contention that "[i]f the non-toxic core encapsulates,
isolates, or protects the toxic core from exposure or damage, then the toxic
core clearly cannot be on the outer surface of the product, as required in
claim 9," from which Appellants' claims 13, 15, 33-36, and 46 directly or
indirectly depend (App. Br. 5 (emphasis omitted); see also FF 3).
For the foregoing reasons, we find that Examiner failed to establish an
evidentiary basis on this record to support a finding that Payumo anticipates
Appellants' claims 9, 13, 15, 33-36, 46, and 47.
Examiner also failed to establish that Vromans alone or in
combination with Errigo makes up for the foregoing deficiency in Payumo
(see Ans. 4--7; see also FF 8-9). Therefore, Examiner failed to establish an
evidentiary basis on this record to support a conclusion that the combination
of Payumo and Vromans with or without Errigo makes obvious the subject
matter of Appellants' claims 9, 12, 13, 15-22, 33--42, 46, and 47.
CONCLUSION
The preponderance of evidence on this record fails to support
Examiner's finding that Payumo teaches or that Payumo in combination
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Application 11/149,100
with Vromans with or without Errigo makes obvious Appellants' claimed
invention.
The rejection of claims 9, 13, 15, 33-36, 46, and 47 under 35 U.S.C.
§ 102(b) as anticipated by Payumo is reversed.
The rejection of claims 9, 12, 13, 15-22, 33-36, 38--42, 46, and 47
under 35 U.S.C. § 103(a) as unpatentable over the combination of Payumo
and Vromans is reversed.
The rejection of claim 37 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Payumo, Vromans, and Errigo is reversed.
The rejections over Bunick alone or in combination with Pather, with or
without Conte, Vromans, or Errigo:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that Bunick teaches or that Bunick in combination with
Pather, with or without Conte, Vromans, or Errigo makes obvious
Appellants' claimed invention?
ANALYSIS
Examiner finds that
Bunick et al. discloses composite dosage forms that comprise at
least one active ingredient, a first portion comprising a molded
material and a second portion comprising a second material that
is compositionally different from the first and either or both of
the two portions can contain active ingredient (whole
document, e.g., abstract). A portion of [Bunick's] active
ingredient may be optionally coated with a release modifying
coating as is known in the art . . . . The first portion can be in
any shape which can be molded and the second portion
prepared by any suitable method . . . . Illustrative shapes of the
first and second portions are set forth in [Bunick' s] figures ....
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Application 11/149,100
For example, [Bunick's] figure 2A and B show a dosage form
with a first portion [] made from two different molded materials
... that form substantially smoothly concave recesses that hold
the second portion [] made from material [], which anticipate a
dosage form as required by [Appellants'] claim 9. [Bunick's]
[ fJigure 1 also anticipates as the second portion [] of
compressed material [] resides within a substantially smoothly
concave recess in the first portion [] made of compressed
molded material [].
Claims such as 33, 34 and 36 are product-by-process
claims. "[E]ven though product-by-process claims are limited
by and defined by the process, determination of patentability is
based on the product itself. The patentability of a product does
not depend on its method of production. If the product in the
product-by-process claim is the same as or obvious from a
product of the prior art, the claim is unpatentable even though
the prior product was made by a different process." In re
Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir.
1985) (citations omitted)[;] MPEP 2113.
(Ans. 3--4 (citing Bunick Abstract, i1i196, 98-99, and 150) (reference
numbers omitted).) We are not persuaded.
As Appellants explain, "Bunick discloses dosage forms that are
prepared by molding of compressed powder," wherein "a first portion of the
dosage in Bunick is prepared by molding, and the second portion by any
suitable method, such as compression or molding" (App. Br. 8 (citing
Bunick i1i1 23 and 98-99 (emphasis omitted)). Appellants' independent
claim 9, however, requires an active agentformed into afilm (see Claims
App'x. 4). Appellants' claims 33-35 and 46 depend directly or indirectly
from Appellants' claim 9. Examiner failed to identify a disclosure in Bunick
of an active agent formed into a film or, otherwise, provide an evidentiary
basis on this record to support a finding that Bunick necessarily teaches an
active agent film (cf Ans. 3--4). Therefore, because Examiner failed to
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Application 11/149,100
establish that Bunick discloses an active agent formed into a film or would
necessarily comprise an active agent film, we are not persuaded by
Examiner's assertion that Bunick teaches a different method of producing
Appellants' claimed invention (see Ans. 26).
For the foregoing reasons, we find that Examiner failed to establish an
evidentiary basis on this record to support a finding that Bunick anticipates
Appellants' claims 9, 33-35, and 46.
Examiner also failed to establish that Bunick alone or in combination
with Pather, with or without Conte, Vromans or Errigo makes up for the
foregoing deficiency in Bunick (see Ans. 16-21 ). Therefore, Examiner
failed to establish an evidentiary basis on this record to support a conclusion
that the combination of Bunick and Pather with or without Conte, Vromans,
or Errigo makes obvious the subject matter of Appellants' claims 9, 12, 13,
15-22, 33-35, 37--40, 42, 46, and 47.
CONCLUSION
The preponderance of evidence on this record fails to support
Examiner's finding that Bunick teaches or that Bunick in combination with
Pather, with or without Conte, Vromans, or Errigo makes obvious
Appellants' claimed invention.
The rejection of claims 9, 33-35, and 46 under 35 U.S.C. § 102(b) as
anticipated by Bunick is reversed.
The rejection of claims 9, 13, 15, 16, 33-35, 40, 42, 46, and 47 under
35 U.S.C. § 103(a) as unpatentable over the combination of Bunick and
Pather is reversed.
The rejection of claim 12 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Bunick, Pather, and Conte is reversed.
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The rejection of claims 17-22, 38, and 39 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Bunick, Pather, and Vromans is
reversed.
The rejection of claim 37 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Bunick, Pather, and Errigo is reversed.
The rejections over Lee alone or in combination with any of Conte,
Vromans, or Errigo:
ISSUE
Does the preponderance of evidence on this record support
Examiner's conclusion that Lee alone or in combination with any of Conte,
Vromans, or Errigo makes obvious Appellants' claimed invention?
ANALYSIS
Examiner finds that Lee "discloses a dosage form with a first portion
comprising an exterior surface [comprising cavities] and [a] second molded
portion inlaid into the cavities" of the first portion (Ans. 7-8). In this regard,
Examiner finds that Lee's "second molded portion can comprise at least one
active ingredient ... and [is] made of any material which can [be] molded,
including film formers or gelling polymers" (id. at 8). Thus, Examiner
concludes, inter alia, that because Lee discloses a second molded portion
that may be made of film formers, at the time of Appellants' claimed
invention, it would have been prima facie obvious to a person of ordinary
skill in this "art to apply the film-forming solution in a solvent, that will
allow for partial[] absorption of the active agent into the matric or first part
of the dosage form" (id. at 9). We are not persuaded.
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Examiner established that Lee discloses that "[t]he inlaid portion of
... [Lee's] invention may comprise any material which can be molded,
including for example, film formers" (see Lee i-f 128; see also id. i-f 22; Ans.
7-9). Examiner, however, failed to establish an evidentiary basis on this
record to support a conclusion that Lee necessarily molds the inlaid portion
of the dosage form into a film or that the use of film forming materials to
manufacture Lee's molded portion necessarily result in the production of a
film (see App. Br. 9 ("Lee fails to disclose or suggest an active agent that is
formed into a film")) (emphasis omitted).
Examiner further failed to establish that Conte, Vromans, or Errigo
make up for the foregoing deficiency in Lee (see Ans. 10-12).
CONCLUSION
The preponderance of evidence on this record fails to support
Examiner's conclusion that Lee alone or in combination with any of Conte,
Vromans, or Errigo makes obvious Appellants' claimed invention.
The rejection of claims 9, 13, 15, 16, 33-36, 40-42, 46, and 47 under
35 U.S.C. § 103(a) as unpatentable over Lee is reversed.
The rejection of claim 12 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Lee and Conte is reversed.
The rejection of claims 17-22, 38, and 39 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Lee and Vromans is reversed.
The rejection of claim 37 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Lee and Errigo is reversed.
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The rejections over the combination of Pather and Plachetka with or without
Vromans or Errigo:
ISSUE
Does the preponderance of evidence on this record support
Examiner's conclusion that the combination of Pather and Plachetka with or
without Vromans or Errigo makes obvious Appellants' claimed invention?
ANALYSIS
Examiner finds that Pather discloses "an orally administrable dosage
form that ... [comprises] recesses," but fails to discloses "[t ]he presence of
drug filling in the recess on the surface of the tablet" (Ans. 12-13).
Examiner further finds that Plachetka discloses "a multilayer tablet with an
outer layer comprising [an] acid inhibitor and an inner core which comprises
[a] NSAID" (id. at 13). Based on the combination of Pather and Plachetka,
Examiner concludes that, at the time Appellants' invention was made, it
would have been prima facie obvious "to fill in the recess of the dosage
forms of Pather ... with a layer or film that contains an acid inhibitor" (Ans.
13; see also id. at 13-14). Examiner, however, fails to establish an
evidentiary basis on this record to support this conclusion (see App. Br. 9-
10 (Pather fails to disclose "forming the active agents into a film")).
Examiner further failed to establish that Plachetka, Vromans or Errigo
make up for the foregoing deficiency in Pather (see Ans. 13-16).
CONCLUSION
The preponderance of evidence on this record fails to support
Examiner's conclusion that the combination of Pather and Plachetka with or
without Vromans or Errigo makes obvious Appellants' claimed invention.
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The rejection of claims 9, 13, 15, 33-35, and 4 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Pather and Plachetka is
reversed.
The rejection of claims 17-22, 38, and 39 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Pather, Plachetka, and Vromans is
reversed.
The rejection of claim 37 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Pather, Plachetka, and Errigo is reversed.
REVERSED
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