Ex Parte Zerbe et al

Patent Trial and Appeal Board

Jun 11, 2013

11647033 (P.T.A.B. Jun. 11, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte HORST G. ZERBE, NADINE PAIEMENT,
and POMPILIA ISPAS-SZABO
__________

Appeal 2011-010573
Application 11/647,033
Technology Center 1600
__________

Before FRANCISCO C. PRATS, MELANIE L. McCOLLUM, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

SNEDDEN, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1-3, 5 and 9-13. The
Examiner rejected the claims as anticipated and obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.

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STATEMENT OF THE CASE
Appellants‟ invention relates to “[a] multilayer oral dosage form that
provides controlled release of an active compound [that] includes a non-
erodible core containing a pharmaceutically active compound”
(Specification, Abstract). The Specification discloses that “[t]he polymers
comprising the non-erodible core may consist exclusively of one or more
insoluble polymers defining a porous matrix, or a combination of one or
more non-swellable insoluble polymers and one or more swellable insoluble
polymers” (id. at 4, ¶ [0024]).
Independent claims 1 and 5 are representative of the appealed subject
matter and read as follows (emphasis added):
1. A trilayer tablet, comprising:
a non-erodible core layer containing at least one
pharmaceutically active compound and/or at least one
nutritionally active compound; and
at least one erodible layer laminated to each side of the
non-erodible core layer, wherein the non-erodible layer
comprises an insoluble polymer or insoluble polymers defining
a porous matrix.

5. A trilayer tablet comprising:
a non-erodible core layer containing at least one
pharmaceutically active compound and/or at least one
nutritionally active compound; and
at least one erodible layer laminated to each side of the
non-erodible layer,
wherein the non-erodible core layer comprises a
combination of a polymer matrix, and a granulation distributed
in the matrix, the granulation comprising at least one active
compound and a swellable polymer.

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The claims stand rejected as follows:
I. Claims 1, 2 and 9-11 under 35 U.S.C. § 102(b) as anticipated by
Qiu
1
and as evidenced by Hamel.
2

II. Claims 12 and 133 under 35 U.S.C. § 103(a) based on Qiu.
III. Claim 54 under 35 U.S.C. § 103(a) as obvious over the
combination of Qiu and Bastin.
5

IV. Claim 3 under 35 U.S.C. § 103(a) as obvious over the combination
of Qiu and Bartholomaeus.
6

ANTICIPATION
Issue Presented
The Examiner finds that claim 1 requires “that the non-erodible layer
comprises either an insoluble polymer or insoluble polymers defining a
porous matrix” (Ans. 17; emphasis omitted). Regarding the former, the
Examiner finds that Qiu discloses “a core layer comprising an active agent
embedded in a non-swelling, non-erodible hydrophobic matrix (which is
insoluble) [and thus the] limitation of an insoluble polymer is clearly met”
(id.; emphasis omitted).

1
Qiu, WO 98/30208, published Jul. 16, 1998.
2
Hamel et al., US 4,662,880, issued May 5, 1987.
3
The Answer lists claim 8 as rejected on this basis (Ans. 8). However, the
record reflects that claim 8 has been cancelled (App. Br. 2).
4
The Answer lists claim 7 as rejected on this basis (Ans. 10). However, the
record reflects that claim 7 has been cancelled (App. Br. 2).
5
Bastin et al., US 6,309,668 B1, issued Oct. 30, 2001.
6
Bartholomaeus, US 5,601,842, issued Feb. 11, 1997.
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Regarding the alternative recitation of “insoluble polymers defining a
porous matrix,” the Examiner finds that Qiu discloses that the core layer
may be made of carnauba wax, which is inherently porous. In reaching this
conclusion, the Examiner reasons as follows:
Qui discloses that an especially preferred material for the core
layer is carnauba wax (page 4, lines 23-24). Nonswellable
waxes include at least one member selected from the fatty acids
or glycerides (page 4, lines 19-20). Then regarding the
lipophilic barrier layer Qui discloses that preferred material for
the lipophilic barrier is nonswellable wax selected from the
fatty acids or glycerides (page 6, lines 1-2). The most preferred
wax for use in the lipophilic barrier layer is carnauba wax (page
6, line 2). As clearly seen from the above teachings by Qui that
an especially preferred material for the non- erodible
nonswellable hydrophobic core layer is carnauba wax (page 4,
lines 23-24) and also the most preferred wax for use in the
lipophilic barrier layer is carnauba wax (page 6, line 2).
Therefore, the examiner is describing about exactly the same
material. Under such circumstances if the carnauba wax used
for making the lipophilic barrier layer makes pores it must
necessarily make pores also while being used to make non-
erodible nonswellable hydrophobic core layer since it is the
same material.
(Id. at 18; emphasis omitted.)
Appellants contend that Qiu does not “teach or suggest the
requirement that the non-erodible core layer is comprised of at least one
insoluble polymer defining a porous matrix” (Reply Br. 1). Appellants
further contend that:
The Examiner‟s reasoning is inconsistent with the
teaching of Qiu et al. Qiu et al. disclose, at page 2, lines 22-25,
that “as soluble ingredients in the non-erodible coating
dissolve” pores are formed in the barrier layers. This teaching is
repeated at page 2, lines 32-35 and at page 3, lines 4-5. Qiu et
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al. do not teach that carnauba wax causes pores to form, but
rather teach that soluble materials cause pores to form. Thus,
the fact that carnauba wax can be included in the core is of no
relevance to the claimed invention. Carnauba wax is not water
soluble, and cannot dissolve in the presence of gastrointestinal
fluids.
(Id. at 3.)
The issue presented is:
Does the evidence of record support the Examiner‟s finding that Qiu
discloses a tablet having a non-erodible layer comprising “an insoluble
polymer or insoluble polymers defining a porous matrix” as set forth in
claim 1.
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
FF1. Example 1 of the Specification provides that “[t]he preparation
of core layer formulations consists of dry mixing insoluble polymers
together with a granulation containing the active compound(s)” (id. at
[0039]).
FF2. “Preferred pore-forming materials including sugars such as
lactose, dextrose, fructose, glucose; polysaccharides such as dextran; and
polyols such as sorbitol, propylene glycol, and glycerin” (id. at [0024]).
FF3. Qui disclose a multilayer tablet “comprising (a) a core layer
comprising an active agent embedded in a non-swelling, non-erodible
hydrophobic matrix; (b) a first barrier layer applied to and coating a single
face of the core layer; and (c) an optional second barrier layer applied to and
coating the opposite face of the core layer” (Qiu 3, ll. 31-34).
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FF4. Qui disclose that “[a]n especially preferred material for the core
layer is carnauba wax” (id. at 4, ll. 23-24).
FF5. Qui disclose that “[t]he most preferred wax for use in the
lipophilic barrier layer is carnauba wax” (id. at 6, ll. 1-2).
FF6. “The routes of diffusion are through the uncoated side wall of
the tablet and through the hydrophilic barrier layer as it swells and erodes.
Drug diffusion also occurs through the lipophilic barrier layer as soluble
ingredients in the non-erodible coating dissolve and form pores.” (Id. at 2,
ll. 22-25; emphasis added.)
Principles of Law
The Board gives pending claims “their broadest reasonable
interpretation consistent with the specification” and “in light of the
specification as it would be interpreted by one of ordinary skill in the art.” In
re Am. Acad. Of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004)
(internal citations omitted). This broader claim construction standard is
justified because, during prosecution, the applicant has the opportunity to
amend the claims, and the Federal Circuit has held that an applicant has the
opportunity and the obligation to define his or her invention precisely during
proceedings before the USPTO. See In re Morris, 127 F.3d 1048, 1056-57
(Fed. Cir. 1997).
Unless a more limited construction is indicated by the specification or
prosecution history, the indefinite article “a” or “an” is construed in a claim
to mean “one or more.” KCJ Corp. v. Kinetic Concepts Inc., 223 F.3d 1351,
1356 (Fed. Cir. 2000).
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Analysis
We begin with claim interpretation, since until a claim is properly
interpreted, its scope cannot be compared to the prior art. The Examiner
interprets the phrase in claim 1 “wherein the non-erodible layer comprises an
insoluble polymer or insoluble polymers defining a porous matrix” to
include two distinct classes of polymers: (a) an insoluble polymer and (b)
insoluble polymers defining a porous matrix (see e.g., Ans. 17). We find the
Examiner‟s interpretation of “an insoluble polymer” as a distinct limitation
from “insoluble polymers defining a porous matrix” reasonable in light of
the Specification. For example, the Examples set forth in the Specification
describe core layers consisting of insoluble polymers, such as swellable
insoluble polymers (FF1), that are absent pore-forming materials disclosed
elsewhere in the Specification (FF2).
Appellants do not dispute that Qiu discloses a non-erodible core layer
comprising an insoluble polymer. Rather, Appellants contend that Qiu does
not disclose a non-erodible layer comprising insoluble polymers defining a
porous matrix. While the evidence of record (see e.g., FF3-FF6) supports
Appellants‟ argument that Qiu does not disclose a porous core for the
reasons set forth in the Reply Brief (Reply Br. 3), claim 1 is not so limited.
Conclusion of Law
The preponderance of evidence on this record supports the
Examiner‟s finding that Qiu anticipates claim 1. Claims 2 and 9-11 fall with
claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

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OBVIOUSNESS
Issue Presented
Regarding the obviousness rejections involving claims 3, 12 and 13,
Appellants rely on their arguments responding to the Examiner‟s
anticipation rejection (App. Br. 6). Thus, for the same reasons discussed in
the section above, Appellants‟ arguments do not persuade us that the
Examiner has erred in concluding that claims 3, 12 and 13 are obvious over
Qiu, alone or in view of Bartholomaeus.
The Examiner also rejected claim 5 under 35 U.S.C. § 103(a) as
obvious over the combination of Qiu and Bastin. The Examiner finds that
“Qiu does not explicitly teach the polymers recited in the claim as swellable
insoluble polymer core layer” but that “[t]hese deficiencies are cured by the
teachings of Bastin et al.” (Ans. 10). In reaching the conclusion of
obviousness, the Examiner finds that
It would have been prima facie obvious to a person of
ordinary skill in the art at the time of the instant invention was
made to modify the teachings of Qiu via incorporating
swellable insoluble polymer in the core layer because Bastin et
al. teach in a trilayer tablet such polymers can be used to
prepare the core layer. The skilled artisan would have been
motivated to use the polymers in the core layer because these
polymers are conventionally known in the tablet making art.
The skilled artisan would have had a reasonable expectation of
success in combining the teachings of Qiu and Bastin et al.
because both Qiu and Bastin et al. teaches a similar trilayer
tablets comprising a core and layers. “It is prima facie obvious
to combine two compositions each of which is taught by the
prior art to be useful for the same purpose, in order to form a
third composition to be used for the very same purpose ....
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[T]he idea of combining them flows logically from their having
been individually taught in the prior art.”
(Ans. 12, quoting In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).)
Appellants contend that “Bastin et al. expressly teaches that „[t]he
drug(s) and gelling agent(s) are in separate layers of the tablet‟” and not in
the same core layer as required by claim 5 (App. Br. 7; citing Bastin,
Abstract). “Accordingly, there is not any motivation for, or expectation of
success by, adding the gelling agents of Bastin et al. to the drug-containing
core of Qiu et al. Rather, the addition of gelling agent to the core of Qiu et
al. would be expected to change the fundamental character of the Qiu et al.
core layer so that it is no longer non-erodible.” (Reply Br. 4.)
The issue presented with regard to this rejection is:
Does the preponderance of evidence on this record support the
Examiner‟s conclusion that the combination of references suggests a tablet
having a core layer comprising at least one active compound and a swellable
polymer?
Additional Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
FF7. Bastin discloses an abuse restraint tablet where “the drug(s) and
gelling agent(s) are in separate layers of the tablet” (Bastin, Abstract).
FF8. Bastin discloses that “it should be appreciated that the tablet
may comprise separate layers one stacked on top of the other in a sandwich
arrangement, or may comprise a core layer of gelling agent surrounded by
one or more layers comprising one or more drugs” (id. at col. 1, 36-40; Ans.
23).
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Principles of Law
In rejecting claims under 35 U.S.C. § 103, the Examiner bears the
initial burden of presenting a prima facie case of obviousness. See In re
Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). When determining whether a
claim is obvious, an examiner must make “a searching comparison of the
claimed invention — including all its limitations — with the teachings of the
prior art.” In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995). As the
Supreme Court pointed out in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007), “a patent composed of several elements is not proved obvious
merely by demonstrating that each of its elements was, independently,
known in the prior art.” Rather, the Court stated:
[I]t can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention
does … because inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed
discoveries almost of necessity will be combinations of what, in
some sense, is already known.

Id. at 418-419 (emphasis added). While the analysis under 35 U.S.C. § 103
allows flexibility in determining whether a claimed invention would have
been obvious, it still requires showing that “there was an apparent reason to
combine the known elements in the fashion claimed by the patent at issue.”
(Id. at 418.)
Analysis
We are not persuaded by the Examiner‟s rationale that a person of
ordinary skill in the art would have modified Qiu‟s drug-containing core
with Bastin simply because swellable insoluble polymers were known in the
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tablet making art. This rationale fails to adequately explain why a person of
ordinary skill in the art would have made such a modification especially
where Bastin clearly discloses tablets with the drug and gelling (swellable)
agents in separate layers (FF7, FF8).
Conclusion of Law
The preponderance of evidence fails to support the Examiner‟s
conclusion that the combination of Qiu and Bastin renders claim 5 obvious.

SUMMARY
We affirm the rejection of claims 1, 2 and 9-11 under 35 U.S.C. §
102(b) as anticipated by Qiu and as evidenced by Hamel.
We affirm the rejection of claims 12 and 13 under 35 U.S.C. § 103(a)
based on Qiu.
We reverse the rejection of claim 5 under 35 U.S.C. § 103(a) as
obvious over the combination of Qiu and Bastin.
We affirm the rejection of claim 3 under 35 U.S.C. § 103(a) as
obvious over the combination of Qiu and Bartholomaeus.
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-IN-PART

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