Ex Parte Ream et al

Board of Patent Appeals and Interferences

Oct 29, 2009

10206492 (B.P.A.I. Oct. 29, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RONALD L. REAM,
LEONARD MATULEWICZ, and WILLIAM J. WOKAS
__________

Appeal1 2009-003636
Application 10/206,492
Technology Center 1600
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Decided: October 29, 2009
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Before DONALD E. ADAMS, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s final rejection of claims 8-15 and 36-48.2 We have jurisdiction
under 35 U.S.C. § 6(b).

1 The Oral Hearing scheduled for October 7, 2009, was waived.
2 Claims 1-7 and 21-35 have been cancelled, and claims 16-20 stand
withdrawn from consideration (App. Br. 4).
Appeal 2009-003636
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2
STATEMENT OF THE CASE
Claims 8, 36, and 44 are the independent claims on appeal, and read
as follows:
8. A product comprising a medicament comprising:
a tableted center comprising at least one compressible saccharide or
sugar alcohol; and
a coating comprising a medicament that surrounds the tableted center,
the coating comprising at least 50% by weight of the product.

36. A product comprising a medicament comprising:
a tableted center comprising at least one saccharide or sugar alcohol;
and
a coating comprising a medicament that surrounds the center, the
coating comprising at least 50% by weight of the product.

44. A product including a medicament that has acceptable
organoleptic properties comprising:
a tableted center that is defined by at least one excipient; and
a coating that at least substantially surrounds the center and
comprising a medicament, the coating comprising at least 50% of the
product by weight.

The Examiner relies on the following evidence:
Monte 5,578,336 Nov. 26, 1996
We affirm.

ISSUES
The Examiner concludes that claims 8-15 and 36-48 are rendered
obvious by Monte.
Appellants assert that Monte does not teach a tableted center, that
Monte fails to disclose or suggest a coating comprising at least 50% by
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weight of the product, and that the unobviousness of the claimed
composition is supported by unexpected results.
Thus, the issues on appeal are:
1) Have Appellants demonstrated that the Examiner erred in finding
that Monte teaches a tableted center?
2) Have Appellants demonstrated that the Examiner erred in
concluding that Monte suggests a coating comprising at least 50% by weight
of the product? and,
3) Have Appellants demonstrated that the Examiner erred in
concluding that Appellants have not demonstrated unexpected results
sufficient to demonstrate the unobviousness of the claimed composition?

FINDINGS OF FACT
FF1 The Specification states that the “present invention relates to the
delivery of medicaments and agents using chewing gum formulations and
methods for producing such products.” (Spec. 1.)
FF2 The Specification defines “tableted” as meaning “that a center is
provided that has a precise size (within an acceptable range) depending on
the medicament or agent and shape.” (Id. at 9.)
FF3 The Specification teaches that a variety of different tableting
processes may be used to produce the tableted center, but “[w]hat is
important is that a process is used that allows one to create a uniform
center.” (Id. at 10.)
FF4 The Specification teaches that “[a]s the product is chewed, the
medicament or agent is released into the saliva. . . . [and is] then forced
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through the oral mucosa in the buccal cavity due to the pressure created by
the chewing.” (Id. at 9.)
FF5 The Specification provides an example of a tableted gum as a tableted
center (id. at 17).
FF6 The Examiner rejects claims 8-15 and 36-48 under 35 U.S.C. § 103(a)
as being rendered obvious by Monte (Ans. 3). As Appellants do not argue
the claims separately, we focus our analysis on claim 8, and claims 9-15 and
36-48 stand or fall with that claim. 37 C.F.R. § 41.37(c)(1)(vii).
FF7 The Examiner finds that Monte teaches a chewing gum composition
having a gum center and layers of coatings, in which one layer includes a
vitamin, which the Examiner finds reads on the claimed medicament (id.).
FF8 The Examiner further cites Monte for teaching applying the coating in
layers (Ans. 3).
FF9 Monte teaches a composition comprising a chewing gum composition,
in which there is a first outer coating on the chewing gum, and a second
outer coating containing at least one vitamin, enzyme, phytochemical, and/or
alimentary vegetable composition (Monte, col. 1, ll. 54-67).
FF10 Monte teaches that each of the outer coatings can comprise one or
more layers (id. at col. 2, ll. 62-64).
FF11 In an alternate embodiment, Monte teaches that the center can
comprise a soft candy center (id. at col. 2, ll. 16-25). Specifically, Monte
teaches:
As used herein, the term soft candy center or soft candy
composition refers to a center comprised of soft, chewable,
ingestable candy selected from the group consisting of
chocolate, caramels, toffees, jellies, gums (like the chewable
sugar gum in the center of a jelly bean), creams, fudges, and
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marshmallows. Chewing gum is not ingestable and is not
considered to comprise a soft candy center. Hard candies like
fruit drops, mint, and brittle can not comprise a soft candy
center.

(Id. at col. 2, ll. 29-37.)
FF12 Monte teaches that “pan” coatings of the soft confection core or the
gum pellet may be formed by traveling along a tray or conveyer, or tumbled
with other gum pellets or confection cores (id. at col. 3, ll. 10-16). In that
way, the “coating can be built up layer by layer to the desired thickness.”
(Id. at col. 3, ll. 22-23.)
FF13 According to Monte, the chewing gum composition “is formulated
from standard ingredients and by known methods in the art,” wherein the
gum base may comprise 5 to 50% by weight of the chewing gum
composition (Id. at col. 5, ll. 43-49).
FF14 The Examiner notes that “Monte does not teach either the particular
amounts of the coating or the amounts of the taste masking agent,” but notes
that those amount may be optimized by routine experimentation (Ans. 3).

PRINCIPLES OF LAW
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000).
[T]he PTO applies to the verbiage of the proposed claims the
broadest reasonable meaning of the words in their ordinary
usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of
definitions or otherwise that may be afforded by the written
description contained in the applicant’s specification.
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In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
In KSR Int’l v. Teleflex Inc., 550 U.S. 398, 415 (2007), the Supreme Court
rejected a rigid application of a teaching-suggestion-motivation test in the
obviousness determination. The Court emphasized that “the [obviousness]
analysis need not seek out precise teachings directed to the specific subject
matter of the challenged claim, for a court can take account of the inferences
and creative steps that a person of ordinary skill in the art would employ.”
Id. at 418. Thus, [i]f a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability.” Id. at 417. Moreover,
determining the optimum values of result effective variables is ordinarily
within the skill of the art. In re Boesch, 617 F.2d 272, 276 (CCPA 1980).
Finally, [i]t is well settled that unexpected results must be established by
factual evidence. Mere argument or conclusory statements in the
specification does not suffice.” In re DeBlauwe, 736 F.2d 699, 704 (Fed.
Cir. 1984).

ANALYSIS
Appellants argue that Monte fails to disclose or suggest a tableted
center (App. Br. 10). According to Appellants, Monte “is entirely directed
to a confection having a soft candy center, which teaches away from the
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present claims.” (Id. at 11 (citing Monte, col. 1, ll. 29-37).) Appellants
argue further that Monte does not teach a tableted center that is a gum
center, as Monte “fails to teach or suggest anywhere a product that is
tableted or made by any tableting processes. . . . [and] is entirely directed to
candy products that have soft structures as previously discussed.” (App. Br.
12.)
Appellants’ arguments have been considered, but are not found to be
persuasive. We agree with the Examiner that, as defined by the
Specification, all that is required by the term “tableted” is that the center has
a precise size, within an acceptable range. That limitation appears to be met
by the gum pellets used as a center as taught by Monte, and Appellants have
provided no scientific reasoning or evidence that the gum pellet center of
Monte does not meet that limitation. Moreover, we do not agree that Monte
is limited to a soft structure, as Monte specifically teaches the use of a gum
pellet as the center.
Appellants argue further that Monte “fails to disclose or suggest a
coating comprising at least 50% by weight of the product.” (App. Br. 13.)
Monte, Appellants assert, “only discloses that its product has coating
layers,” and that “there is no need for the coating layers in [Monte] to be a
majority of the composition.” (Id.)
Appellants argue that they have also demonstrated unexpected results,
as they “have surprisingly found that administering medicament through
chewing, as opposed to swallowing, results in faster drug absorption through
the oral mucosa.” (Id.) Appellants assert that by “using such a high coating
level, the level of medicament or agent in the coating can be selected so as to
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create, when the product is chewed, a sufficiently high concentration of the
medicament or agent in the saliva.” (Id. at 13-14.)
Again, Appellants’ arguments are not found to be convincing. First,
as Monte teaches that the active ingredient, such as the vitamin, is in the
coating surrounding the gum center, it would have been obvious to optimize
the coating, including wherein the coating comprises 50% by weight of the
product. In addition, while Appellants assert that the claimed product
demonstrates unexpected results, they have pointed to no factual evidence
that is commensurate in scope with the claims to support that assertion.

CONCLUSIONS OF LAW
We conclude:
1) Appellants have not demonstrated that the Examiner erred in
finding that Monte teaches a tableted center;
2) Appellants have not demonstrated that the Examiner erred in
concluding that Monte suggests a coating comprising at least 50% by weight
of the product; and
3) Appellants have not demonstrated that the Examiner erred in
concluding that Appellants have not demonstrated unexpected results
sufficient to demonstrate the unobviousness of the claimed composition.
We thus affirm the rejection of claims 8-15 and 36-48 under 35
U.S.C. § 103(a) as being rendered obvious by Monte.

Appeal 2009-003636
Application 10/206,492

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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)(1)(iv)(2006).

AFFIRMED

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