Ex Parte Chu et al

Board of Patent Appeals and Interferences

Jun 18, 2010

10191979 (B.P.A.I. Jun. 18, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte JAMES SHUNNAN CHU, YISONG YANG, and JOSEPH A. FIX,

Appellants.
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Appeal 2009-011791
Application 10/191,979
Technology Center 1600
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Decided: June 18, 2010
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Before SALLY GARDNER LANE, JAMESON LEE, and SALLY C.
MEDLEY, Administrative Patent Judges.

LANE, Administrative Patent Judge.

DECISION ON APPEAL
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I. STATEMENT OF THE CASE
The appeal, under 35 U.S.C. § 134(a), is from a Final Rejection of
Appellants’ claims 33, 62-65, and 67-72. Appellants cancelled claims 1-32,
34-61, and 66. (App. Br. 3). We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
Appellants’ application is directed to tablets made of a gel-forming
material. (Spec. p. 2, ll. 16-19).
The real party-in-interest is said to be Astellas Pharmaceuticals, Inc.
(App. Br. 3).
The Examiner relied on the following patent documents:
Sako (‘045) EP 0 661 045 July 5, 1995
Myers (‘552) 5,851,552 December 22, 1998
Kettelhoit (‘201) 6,294,201 September 25, 2001

The Examiner rejected claims 33, 62-65, 67, 69, and 70 under
35 U.S.C. § 102(b) as being anticipated by ‘552. (Ans. 3).
The Examiner also rejected claims 33 and 68 under 35 U.S.C.
§ 103(a) as being rendered obvious by ‘552 and ‘201 (Ans. 4-5) and claims
33, 71, and 72 under 35 U.S.C. § 103(a) as being rendered obvious by ‘522
and ‘045 (Ans. 5-6).
Appellants do not argue for the separate patentability of any of the
claims. Thus, we focus on claim 33 in our analysis. See 37 C.F.R.
§ 41.37(c)(1)(vii).
II. FINDINGS OF FACT
1. Appellants’ claim 33 recites:
A method for producing a pharmaceutical tablet, the
method comprising:
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(1) mixing a formulation comprising:
(a) at least one particle comprising: a hydrophilic
active agent in contact with a coating
material to modify release of the active
agent;
(b) a gel-forming material, wherein the gel-
forming material comprises a polymer, and a
gelation facilitator agent, wherein at least
one particle is blended with said gel-forming
material; and
(2) compressing the formulation to produce the tablet,
wherein the gel-forming material forms a matrix around said
particle in the tablet.

(App. Br. 12, Claims App’x).
2. ‘552 teaches particles that modify the release of a dose of
medication. (‘552 col. 4, ll. 6-20). The controlled release system of ‘552 is
mixed with a “shearform matrix,” which allows a tablet comprising the
particles to dissolve quickly when taken by the patient. (id. col. 3, l. 66,
through col. 4, l. 5).
3. ‘552 teaches numerous active agents for the controlled release
system, including ranitidine hydrochloride (‘552 col. 13, ll. 25-27), which is
also provided in Appellants’ specification as useful in the claimed tablet
(Spec. p. 16, l. 4).
4. ‘552 teaches that it was known in the art to modify the release
of a pharmaceutical agent in a host or patient. (‘552 col. 2, ll. 52-60).
5. Appellants’ specification provides that “[a]ny suitable coating
material may be used with the embodiments of the invention.” (Spec. p. 19,
ll. 21-22).
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6. ‘552 teaches that water-swellable hydrogel matrices, which
achieve slow surface-to-center swelling of the matrix and subsequent release
of the active agent from the water-swollen part of the matrix, were known in
the art. (‘552 col. 2, ll. 29-35).
7. Appellants’ specification provides that the polymer of the “gel-
forming matrix” has characteristics that allow it to retain its shape as it
moves through the lower digestive tract. (Spec. 23, ll. 6-10). Appellants’
specification provides multiple examples of polymers for the gel-forming
material, including polyethylene oxide (“PEO”). (Id. p. 23, l. 21, through
p. 24, l. 7).
8. ‘552 teaches that non-saccharide hydrophilic organic materials
having PEO linkages could be added to the mixture to enhance formation of
a crystalline framework in a shearform matrix. (‘552 col. 11, ll. 29-54).
9. Appellants’ specification provides that the “gelation facilitator
agent” is a hydrophilic base that draws water into the core of the gel-forming
matrix, allowing gelation of the entire tablet. (Spec. p. 22, l. 33, through p.
23, l. 1). Appellants’ specification provides multiple examples of gelation
facilitator agents, including polyethylene glycol (“PEG”). (Id. p. 24, l. 21,
through p. 25, l. 4).
10. ‘552 teaches that PEG can be added to the mixture to accelerate
crystallization in the shearform matrix. (‘552 col. 11, ll. 21-28).
11. ‘552 teaches “compacting” or compressing ingredients to
produce a tablet. (‘552 col. 15, ll. 18-30).
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III. ISSUE
Does ‘552 teach the claimed method steps, even though it also teaches
making a “shearform matrix?”
IV. ANALYSIS
Appellants’ claimed method comprises (1) mixing (a) a particle and
(b) a gel-forming material, and (2) compressing the formulation into a tablet
so that the gel-forming material forms a matrix around the particle in the
tablet. (FF 1). The particle (a) of Appellants’ claimed method comprises a
hydrophilic active agent and a coating material, which modifies release of
the active agent, while the gel-forming material (b) comprises a polymer and
a gelation facilitator agent. (FF 1).
‘552 teaches a controlled-release formulation of an active agent
combined with a “shearform matrix,” that is, a matrix that allows the tablet
to dissolve quickly. (FF 2; ‘552 col. 3, l. 66, through col. 4, l. 5 and col. 4,
ll. 6-20). ‘552 teaches active agents that Appellants disclose as being useful
in the claimed method. (FF 3; ‘552 col. 13, ll. 25-27 and Spec. p. 16, l. 4).
‘552 teaches that controlling the release of active agents was known in the
art. (FF 4; ‘552 col. 2, ll. 52-60). Appellants do not limit the claimed
coating materials that control release of the active agent (FF 5; Spec. p. 19,
ll. 21-22). Thus, ‘552 teaches the particles of element (a) of the claimed
method.
Myers teaches that water-swellable hydrogel matrices were known in
the art for regulating the release of active agents in patients. (FF 6; ‘552
col. 2, ll. 29-35). In addition, ‘552 teaches that materials with PEO linkages
(FF 8; ‘552 col. 11, ll. 29-54) and PEG (FF 10; ‘552 col. 11, ll. 21-28),
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which Appellants’ specification provide as the polymer (FF 7; Spec. p. 23,
l. 21, through p. 24, l. 7) and gelation facilitator agent (FF 9, Spec. p. 24,
l. 21, through p. 25, l. 4), respectively, can be added to tablets. Thus, ‘552
teaches mixing materials that can be the gel-forming material, as in element
(b) of the claimed method, with a particle comprising an active agent and a
coating for its controlled release, as in element (a) of Appellants’ claimed
method.
Finally, ‘552 teaches compressing the components to form a tablet.
(FF 11; ‘552 col. 15, ll. 18-30).
Appellants argue that they do not claim a shearform matrix or a “flash
flow process,” as taught in ‘552, but only a method to make a gel-forming
material. (App. Br. 6 and 10; Reply Br. 8). The method of claim 33
“compris[es]” mixing and compressing, but does not exclude other steps.
See Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997)
("‛Comprising’ is a term of art used in claim language which means that the
named elements are essential, but other elements may be added and still
form a construct within the scope of the claim.”). That ‘552 teaches a more
involved process than what is recited in Appellants’ claim does not mean it
does not anticipate the steps that are recited in the claim. Appellants’
arguments that ‘552 teaches additional steps (such as crystallization and
curing) are not persuasive.
Appellants note that ‘552 teaches using PEO and PEG to enhance
crystallization and curing of the shearform matrix, not to make a gel-forming
material, as claimed. (App. Br. 6; see ‘552 col. 11, ll. 21-54). According to
the Examiner (Ans. 7), PEG inherently draws water into a structure, the
function that Appellants assign to the claimed gelation facilitator agent.
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(FF 9; Spec. p. 22, l. 33, through p. 23, l. 1, and App. Br. 6). Whether or not
‘552 acknowledges the activity of PEG or the ability of PEO to act as a
polymer in a gel-forming material, ‘552 teaches adding these two
components to a tablet and therefore meets the requirement of step (b) of
Appellants’ claimed method. “Where . . . the result is a necessary
consequence of what was deliberately intended, it is of no import that the
article’s authors did not appreciate the results.” MEHL/Biophile Int’l Corp.
v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999).
Appellants characterize their method as requiring the active agent to
be coated with coating material and argue that ‘552 does not teach this
element. (App. Br. 5-6; Reply Br. 7-8). Appellants’ claim 33 recites only
that the “hydrophilic active agent [is] in contact with a coating material”
(FF 1; emphasis added), not that it must coat the material. Claim 33 requires
the coating material to “modify release of the active agent” (FF 1), which is
taught in ‘552 (FFs 2 and 4). Thus, ‘552 teaches a particle comprising an
“active agent in contact with a coating material,” even if it does not describe
the active agent as being coated.
Appellants also characterize the claimed method as making at least
three layers: an inner core of the active agent, a layer of coating material that
makes a particle with the active agent, and a layer of gel-forming material
that forms a matrix around the particle. (App. Br. 4 and 8; Reply Br. 12).
Appellants’ claim 33, though, does not limit the method to forming specific
layers. Instead, claim 33 provides for mixing the recited components and
compressing them into tablets. We find no language in the claim that limits
the structure of the resulting tablet, beyond having “the gel-forming material
form[] a matrix around said particle in the tablet.” (FF 1). Thus, we are not
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persuaded that the formation of three layers is a feature that distinguishes the
method of claim 33 from the teachings of ‘552.
The Examiner also rejected claims 33 and 68 under 35 U.S.C.
§ 103(a) as being rendered obvious by ‘552 and ‘201 and claims 33, 71, and
72 under 35 U.S.C. § 103(a) as being rendered obvious by ‘552 and ‘045.
“It is well settled that ‘anticipation is the epitome of obviousness.’” In re
McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002) (citation omitted). Thus,
the Examiner did not err in making these rejections. While Appellants argue
that the teaching of ‘201 amounts to a teaching way (see App. Br. 8-9), we
note that the Examiner only relied upon the reference to show that a
dependent claim limitation, i.e., the addition of xathan gum to a tablet, was
known in the art as a component of drug release systems (see Ans. 5 and 10).
Though Appellants note that ‘201 teaches that hydrophilic active agents,
PEO, and PEG are not useful with the type of drug delivery system used in
that reference (see ‘201 col. 4, ll. 43-46, and col. 5, ll. 54-58), it does not
teach that xanthan gum is not useful in other delivery systems, such as that
taught in ‘522. Appellants do not provide argument or evidence to refute the
Examiner’s finding that xanthan gum was known to be used in tablet
formulations as a stabilizing agent, regardless of the type of delivery system
employed. (Ans. 10). Thus, we are not persuaded that ‘201 would have
discouraged one skilled in the art from using the method taught in ‘522,
which, as we found above, anticipates the claim 33 method.
V. ORDER
Upon consideration of the record and for the reasons given,
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the rejection of claims 33, 62-65, 67, 69, and 70 under 35 U.S.C.
§ 102(b) as being anticipated by ‘552 is AFFIRMED;
the rejection of claims 33 and 68 under 35 U.S.C. § 103(a) as being
rendered obvious by ‘552 and ‘201 is AFFIRMED; and
the rejection of claims 33, 71, and 72 under 35 U.S.C. § 103(a) as
being rendered obvious by ‘552 and ‘045 is AFFIRMED.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2007).

AFFIRMED
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