Ex Parte Sowden

Patent Trial and Appeal Board

Mar 3, 2016

11043634 (P.T.A.B. Mar. 3, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111043,634 01/26/2005
27777 7590 03/07/2016
BERNARD F. PLANTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
FIRST NAMED INVENTOR
Harry S. Sowden
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.
MCP0242DIV2 8269
EXAMINER
LOVE, TREVOR M
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
03/07/2016 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):
jnjuspatent@corus.jnj.com
lhowd@its.jnj.com
pairjnj@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HARRY S. SOWDEN
Appeal2013-007045
Application 11/043,634
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
RICHARD J. SMITH, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to methods
of making dosage forms. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b ). We affirm.
1 Appellant identifies the Real Party in Interest as McNeil-PPC,
Inc. (see Br. 1 ).
Appeal2013-007045
Application 11/043,634
Statement of the Case
Background
Capsules are typically manufactured using a two-
piece gelatin shell formed by dipping a steel rod into
gelatin so that the gelatin coats the end of the rod.
The gelatin is hardened into two half-shells and the
rod extracted. The hardened half-shells are then filled
with a powder and the two halves joined together to
form the capsule
(Spec. i-f 2). The Specification teaches that "these processes have certain
drawbacks. For example, because these systems are batch processes, each of
the various apparatuses employed is housed in a separate clean room that
must meet FDA standards" (Spec. i-f 4).
The Claims
Claims 28-36 and 40-46 are on appeal. Claim 28 is representative
and is reproduced below:
28. A method of making dosage forms, comprising the
steps of:
a) compressing a powder into a compressed dosage
form in a compression module;
b) transferring said compressed dosage form to an
injection molding module;
c) injecting gelatin under pressure around said
compressed dosage form in said injection molding module,
wherein said injection molding module and said gelatin are
heated prior to said injecting; and
d) cooling said gelatin so as to form a hard coating
over said compressed dosage form;
wherein steps (a) through (d) are linked together such
that essentially no interruption occurs between said steps.
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Application 11/043,634
The Issues
A. The Examiner rejected claims 28-33 and 43--46 under 35 U.S.C.
§ 103(a) as obvious over GB '081,2 Lehmann, 3 Alt, 4 Conte, 5 and Angell, Jr. 6
(Final Act. 3-11 ).
B. The Examiner rejected claims 34--36, 40 and 41under35 U.S.C.
§ 103(a) as obvious over GB '081, Lehmann, Alt, Conte, Angell, Jr., and
Bar-Shalom7 (Final Act. 11-14).
A. 35 US.C. § 103(a) over GB '081, Lehmann, Alt, Conte, and Angell, Jr.
The Examiner finds it obvious to "utilize the injection molded coating
of Lehmann on the composition of [GB] '081. ... Lehmann teaches the
clear advantage of utilizing the injection molding coating in order to allow
for individual dosages of active to be released in desired sections of the
gastrointestinal tract" (Final Act. 6). The Examiner further finds it obvious
to "utilize gelatin (a thermoplastic polymer) in combination with the acrylic
and/or methacrylic acid coating of Lehmann ... since Alt teaches that
gelatin and methacrylic acid are both known in the art as useful coating
materials for controlled release compositions" (Final Act. 7).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that GB '081, Lehmann, Alt,
Conte, Angell, Jr., render claim 28 obvious?
2 Stott, F., GB 759,081, published Oct. 10, 1956.
3 Lehmann et al., US 5,705,189, issued Jan. 6, 1998.
4 Alt et al., US 5,788,979, issued Aug. 4, 1998.
5 Conte et al., WO 94/06416 Al, published Mar. 31, 1994.
6 Angell, Jr. et al., US 3,988,403, issued Oct. 26, 1976.
7 Bar-Shalom et al., US 5,213,808, issued May 25, 1993.
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Appeal2013-007045
Application 11/043,634
Findings of Fact
1. GB '081 teaches "machines for the production of coated
tablets" (GB '081 1, 11. 13-14) including:
a stationary cam 10 employed to raise and lower the punches
7 which are also acted on by a roller (not shown) serving to
force the punches 7 into the dies 3 at the appropriate time in
order to compress powder fed by means of a stationary
hopper 22 to the dies into core tablets. A stationary cam 11
acts on the punches 8 to raise them sufficiently to force the
made core tablets out of the dies.
(GB '081 2, 1. 130 to 3, 1. 8).
2. Lehmann teaches "thermoplastic materials useful for drug
coatings and which dissolve in intestinal juices. There also remains a need
for pharmaceutical compositions in which an active agent or drug is coated
with such a material" (Lehmann, col. 1, 11. 55-59).
3. Lehmann teaches that an "injection molding method can also be
used to coat preshaped drug cores with a polymer sheath. The cores are
thereby held centered by means of auxiliary dies, which are withdrawn
before the final filling of the mold cavity and before the solidification of the
molding composition" (Lehmann, col. 3, 11. 2-7).
4. Lehmann teaches that "[t]ogether with acrylic and/or
methacrylic acid and methyl acrylate, other alkyl esters of acrylic and/or
methacrylic acid, if desired, can also be used ... The present thermoplastic
material copolymer can be mixed with auxiliaries in the melt, which are
common in drug coating compositions" (Lehmann, col. 3, 11. 51-64).
5. Alt teaches that "[ s Jome materials suitable for the coating are
presently in clinical use for the slow release of drugs, for example, from
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Appeal2013-007045
Application 11/043,634
capsules, tablets, powders, or other galenic preparations after internal
application into the gastrointestinal tract, such as gelatin, cellulose and
methacrylic acid" (Alt, col. 3, 11. 47-51 ).
6. Conte teaches that the "availability of pharmaceutical
compositions capable of liberating different drugs at successive times would
solve a therapeutic problem also involving a serious social impact" (Conte 5,
11. 20-23).
7. Conte teaches "tablet as per the present invention consists of
three layers ... a first layer containing one or more drugs with immediate or
controlled release formulation ... a second layer containing one or more
drugs ... a low-permeability barrier type layer coating ... consisting of
polymeric materials ... and if necessary, a drug" (Conte 6, 11. 11-25).
8. Angell, Jr. teaches that the "thermoplastic material immediately
adjacent to the inner surface of the mold neither slips or slides along the
surface nor does it fracture, as the thermoplastic material flows in the mold
cavity" (Angell, Jr., col. 3, 11. 44--47).
Principles of Law
"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). "If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability." Id. at 417.
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 3-11; FF 1-8) and agree that
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Appeal2013-007045
Application 11/043,634
claim 28 is rendered obvious by GB '081, Lehmann, Alt, Conte, and Angell
Jr. We address Appellants' arguments below.
Appellant contends that "GB759081 does not disclose or suggest a
method that employs use of a compression module and an injection molding
module as claimed" (Br. 7) and
Lehman[ n] et al., which discloses the use of specified
amounts of specified thermoplastic materials in dosage
forms, Alt et al, which discloses that gelatin is suitable as a
coating for a biomaterial, Conte et al., which discloses
dosage forms having three layers, and Angell et al., which
discloses a process for molding a foamed thermoplastic
article, do not disclose injecting gelatin around a compressed
dosage form.
(Br. 8). Appellant contends that "the references alone or combined would
not lead one skilled in the art to a method for injecting gelatin around dosage
forms as claimed" (Br. 9).
We find these arguments unpersuasive because they fail to combine
the teachings of the references. "The test for obviousness is not whether the
features of a secondary reference may be bodily incorporated into the
structure of the primary reference ... Rather, the test is what the combined
teachings of the references would have suggested to those of ordinary skill
in the art." In re Keller, 642 F.2d 413, 425 (CCPA 1981).
Here, Appellant's arguments do not address the combined teachings
of GB '081, Lehmann, Alt, Conte, and Angell, Jr., but instead dissects the
references into their separate teachings. As the Examiner explains, Conte
motivates coating drugs with polymers for controlled drug release (FF 6-7;
cf Final Act. 6), which provides a reason for coating the compressed pills of
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Appeal2013-007045
Application 11/043,634
GB '081 (FF 1) with thermoplastic coatings such as the methacrylic
polymers of Lehmann or the equivalent gelatin polymers of Alt (FF 2, 5; cf
Final Act. 6-7). The Examiner reasonably relies upon Lehmann to teach
injection molding as a known process for coating the compressed pills (FF
3). Appellant provides no reason or evidence explaining why the prior art
does not render injection molding of gelatin around drug cores unobvious in
view of these teachings.
Conclusion of Law
The evidence of record supports the Examiner's conclusion that GB
'081, Lehmann, Alt, Conte, and Angell, Jr., render claim 28 obvious.
B. 35 USC§ 103(a) over GB '081, Lehmann, Alt, Conte, Angell, Jr.,
and Bar-Shalom
The Examiner finds it obvious "utilize the dual injection molded
coating method of Bar-Shalom in the invention '081 in view of Lehmann,
Alt, Conte, and Angell ... since Bar-Shalom teaches that the layers allow for
variation which enables one of ordinary skill to 'prepare compositions
having different release profiles"' (Final Act. 13).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that GB '081, Lehmann, Alt,
Conte, Angell, Jr., and Bar-Shalom render claim 34 obvious?
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Appeal2013-007045
Application 11/043,634
Findings of Fact
9. Figures 1 la-1 le of Bar-Shalom are reproduced below:
FtG. ffb FIG.Uc FIG. lld
FIG. 11 shows a method for producing a composition ... In
step a) a layer comprising an active substance 1 dispersed in,
e.g., a molten polyethylene glycol with a molecular weight
of about 1.000-10.000, is injected into a central cavity
formed by two pistons 3 and 4, after which the molten
polyethylene glycol is allowed to solidify. In step b) the two
pistons 3 and 4 have moved an equal distance away from the
active substance 1 in the central cavity. Two layers 2, each
of which comprises a crystalline polymer matrix and a
surface active agent, are then injected into the two new
cavities which are formed on either side of the active
substance 1 by the movement of the two pistons 3 and 4. In
step c) the two layers 2 have solidified and the two pistons 3
and 4 have moved forward, thereby pushing a central
composite rod comprising the two matrix layers 2 and the
active substance 1 into a new cavity into which a coating 5
is injected. In step d) the mold is opened by moving one
part 6 of the mold from the other part 7. In step e) the
finished composition 8 is ejected from the mold 7 by the
movement of piston 4.
(Bar-Shalom, col. 21, 11. 24--53).
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Appeal2013-007045
Application 11/043,634
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 11-14; FF 1-9) and agree that
claim 34 is rendered obvious by Bar-Shalom in combination with GB '081,
Lehmann, Alt, Conte, and Angell, Jr.
Appellant contends that "Bar-Shalom does not disclose embedding an
insert in powder prior to compressing the powder into a compressed dosage
form as claimed" (Br. 10).
The Examiner responds that "Bar Shalom clearly teaches an insert
which is embedded prior to compression" (Ans. 6). The Examiner finds that
"Bar-Shalom teaches an injection mold as shown in figures 11 a-11 e which
forms a first injection molded coating 11 b, which is around component
number '1' which comprises the active and an insert made of polyethylene
glycol" (Ans. 6).
We find that the Examiner has the better position. Bar-Shalom
teaches that layer 1 comprising an active substance is placed between two
layers 2 composed of a "crystalline matrix" which is reasonably interpreted
as a powder (FF 9). The layers 2 are compressed by pistons around layer 1
and so layer 1 is reasonably interpreted as "embedded" within the layers 2
after the compression (FF 9). Appellant does not provide any reasoning to
distinguish these teachings of Bar-Shalom.
Conclusion of Law
The evidence of record support the Examiner's conclusion that GB
'081, Lehmann, Alt, Conte, Angell, Jr., and Bar-Shalom render claim 34
obvious.
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Appeal2013-007045
Application 11/043,634
SUMMARY
In summary, we affirm the rejection of claim 28 under 35 U.S.C.
§ 103(a) as obvious over GB '081, Lehmann, Alt, Conte, and Angell, Jr.
Claims 29--33 and 43--46 fall with claim 28. 37 C.F.R. § 41.37(c)(l)(iv).
We affirm the rejection of claim 34 under 35 U.S.C. § 103(a) as
obvious over GB '081, Lehmann, Alt, Conte, Angell, Jr., and Bar-Shalom.
Claims 35, 36, 40 and 41 fall with claim 34. 37 C.F.R. § 41.37(c)(l)(iv).
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
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