Ex Parte Ream et al

Board of Patent Appeals and Interferences

Jul 17, 2009

09990628 (B.P.A.I. Jul. 17, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RONALD L. REAM, MICHAEL J. GREENBERG,
WILLIAM J. WOKAS, and CHRISTINE L. CORRIVEAU
__________

Appeal 2009-001864
Application 09/990,628
Technology Center 1600
__________

Decided:1July 17, 2009
__________

Before DEMETRA J. MILLS, LORA M. GREEN, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date
shown on this page of the decision. The time period does not run from the
Mail Date (paper delivery) or Notification Date (electronic delivery).

Appeal 2009-001864
Application 09/990,628

STATEMENT OF CASE

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).

According to Appellants,
[t]he present claims provide improved products for delivering a
medicament or agent to an individual. To this end, chewing gum,
specifically a coated chewing gum product, is provided including a
medicament or agent. The medicament or agent is present within the
coating. The coating substantially encloses a gum center (the water
soluble portion and insoluble base portion) and comprises at least 50%
by weight of the product. In other words, the coating comprising the
medicament must have a weight equal to or greater than that of the
gum center.

(App. Br. 11.)

By having a coating comprising at least 50% by weight of the entire
chewing gum product, a larger amount of medicament or agent can be
placed in the coating. As a result, chewing the gum releases more
medicament or agent into the saliva in higher concentrations. See,
specification, page 12, lines 22-24. A higher concentration of
medicament or agent in the saliva results in a higher concentration
gradient in the oral cavity. This improves absorption of the
medicament or agent through the oral mucosa. See, specification,
page 9, lines 5-20.

(App. Br. 11.)

The following claims are representative.
9. A chewing gum comprising:

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a gum center; and

a coating comprising a medicament that surrounds the gum center, the
coating comprising at least 50% by weight of the chewing gum product, the
medicament being designed to be delivered into the systemic system of a
patient.

18. A product including a medicament that is designed to function by
being delivered through the systemic system of an individual comprising:

a chewing gum center; and

a coating that at least substantially surrounds the chewing gum center
and comprises a medicament and a high-intensity sweetener, the coating
comprising at least 50% by weight of the product.

Cited References
Cherukuri US 4,317,838 Mar. 2, 1982

Stahl WO 99/44436 Sept. 10, 1999

Grounds of Rejection
Claims 9-26 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Cherukuri in view of Stahl. Appellants did not provide
separate arguments with respect to any claims other than claims 9 and 18.
Consequently, these remaining claims fall together with representative
claims 9 and 18. 37 C.F.R. § 41.37(c)(1)(vii).

ISSUE
The Examiner argues that one of ordinary skill in the art would have
found it obvious at the time the invention was made to prepare gum base
(gum center) and coat the gum base using taste masking agent and high
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intensity sweetener taught by Cherukuri and include in the coating
medicament taught by Stahl in analogous coated chewing gum preparations.
Appellants argue that the Examiner has failed to establish a prima
facie case of obviousness because the cited references fail to show a gum
coating comprising at least 50% by weight of the chewing gum product.
The issue is: Have Appellants demonstrated that the Examiner erred
concluding that a gum coating comprising at least 50% by weight of the
chewing gum product would have been obvious?

FINDINGS OF FACT
1. The Examiner finds that “[Cherukuri] teaches method for applying
coating to chewing gum. See the abstract, see co1. 2, lines 35-68,
wherein the patent teaches coating syrup using sweeteners or
bulking agents. This is same as claimed taste masking agent.
[Cherukuri] at co1. 2, lines 40-55 teaches that sweeteners to be
coated using various ingredients.” (Ans. 3.)
2. According to the Examiner, “[t]his range disclosed in the patent for
coating meets the claimed requirement of ‘coating comprising at
least 50% of the chewing gum product’.” [Cherukuri], at co1. 5,
lines 10-19 teaches claimed high-intensity sweeteners. [Cherukuri],
at co1. 5, lines 6-8 teaches that the high-intensity sweetener can be
present in the gum base or in the coating. [Cherukuri], at co1. 5,
lines 29-31 teaches gum base and the amount present by weight.
[Cherukuri], co1. 5, ll. 55-60 suggests, ‘in addition to chewing
gum, the comestibles to be coated may include . . . other dosage
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forms for medicinal or therapeutic use’. Medicinal are same as
medicaments.” (Ans. 3.)
3. The Examiner finds that“[Stahl] teaches coated chewing gum
comprising a core of chewing gum and a coating comprising a
coating material and one or more active substances. See the
abstract, see page 1 under ‘technical field’, see also page 2. [Stahl]
at page 3, last paragraph teaches active ingredients, which can be
sweeteners. [Stahl] at page 8, lines 15- 17 teaches claimed high-
intensity sweeteners. See also page 8, lines 20-24 wherein [Stahl]
teaches that along with active substances other functional groups
can also be incorporated. These functional groups include
vitamins and nutrients along with various pharmaceuticals, which
are described at paragraph bridging pages 9-10. [Stahl] at page 12
first paragraph teaches that the coating suspension comprise
aqueous solution of xylitol, maltitol, isomalt, aspartame,
acesulfame K and saccharin. These ingredients are claimed as taste
masking agent.” (Ans. 3-4.)
4. Stahl discloses that the core is coated with a coating suspension in
approx. 2 to 90 increments to achieve a uniform coating with a
suitable thickness. (Stahl, 12.) Stahl discloses that the coating
process can be repeated as many times as needed in order to obtain
the desired thickness of the coating. (Stahl, 3.)
5. Stahl discloses that using active substance in the coating provides a
faster onset of the effect. (Stahl, 2.)
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6. The Examiner finds that “it would have been obvious to one of
ordinary skill in the art at the time the invention was made to make
to prepare gum base (gum center) and coat the gum base using
taste masking agent and high intensity sweetener taught by
[Cherukuri] and include in the coating medicament taught by
[Stahl] in analogous coated chewing gum preparations.” (Ans. 4.)
7. The Examiner finds that “[t]he idea of adding medicament into the
coating flows logically from the art since one prior art teaches
chewing gum coating using taste masking agent and high intensity
sweetener and another prior art teaches chewing gum coating using
active substances (high intensity sweetener), functional substances
(medicaments) or sugar or sugar alcohols (taste masking agent).”
(Ans. 4.)
8. The Examiner finds that “[o]ne of ordinary skill in the art would
be motivated to coat the gum center with a medicament along with
taste masking agent with the reasonable expectation of success that
having medicament in the coating provides a better stability of the
active substance (medicament) and increased effect there of in all
chewing phases.” (Ans. 4.)
9. The Specification, page 4, states that the coated chewing gum of
the invention enhances the absorption of the drug into the systemic
system as well as the bioavailability of the drug within the system.
10. Plasma caffeine delivered in a gum according to the invention
provides a larger plasma absorbtion rate than for beverages
containing caffeine. (Spec. 31.)
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PRINCIPLES OF LAW
“[W]hen the question is whether a patent claiming the combination of
elements of prior art is obvious” the relevant inquiry is “whether the
improvement is more than the predictable use of prior art elements according
to their established functions.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
417 (2007).
“[D]iscovery of an optimum value of a result effective variable in a
known process is ordinarily within the skill of the art.” In re Boesch,
617 F.2d 272, 276 (CCPA 1980). “[T]he discovery of an optimum value of
a variable in a known process is normally obvious.” Exceptions to this rule
include (1) the results of optimizing a variable were unexpectedly good and
(2) the parameter optimized was not recognized in the prior art as one which
would affect the results. In re Antonie, 559 F.2d 618, 620 (CCPA 1977). “It
is well settled that mere duplication of parts has no patentable significance
unless a new and unexpected result is produced.” In re Harza, 274 F.2d
669, 671 (CCPA 1960).

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ANALYSIS
Claims 9 and 18 are essentially similar in claim scope and we address
them together.
Appellants argue that:
Cherukuri is directed to a … “one step” or “one syrup”
method for providing a sugarless coating on a solid center,
which includes applying alternating layers of coating syrup and
dusting mix. See, Cherukuri, column 2, lines 14-30. As a
result, rather than teaching overall coating levels, Cherukuri
emphasizes the components of the coating syrup and dusting
mix as well as specific ingredient percentages within the
coating syrup and dusting mix. See, Cherukuri, column 2, lines
40-55 and column 3, line 51 to column 4, line 4.

(App. Br. 11). Appellants argue that:
[N]one of the weight percentages disclosed [in Cherukuri] teach
a coating comprising at least 50% by weight of the overall
product. Instead, the highest, and only, coating level disclosed
in Cherukuri is 35 weight percent of the coated chewing gum
tablet. See, Cherukuri, column 4, lines 29-34 and column 7,
lines 13- 19. Therefore . . . Cherukuri fails to disclose or
suggest a coating comprising at least 50% by weight of the
chewing gum product as required, in part, by Claims 9 and 18.

(App. Br. 11.) “Appellants . . . submit that one having skill in the art would
have no reason, in view of Cherukuri, to increase the coating level from a
typical level of 35% to the presently claimed coating level of at least 50%.”
(App. Br. 8.)
We are not persuaded by Appellants’ arguments. Stahl discloses that
the gum core is coated with a coating suspension in approximately 2 to 90
increments to achieve a uniform coating with a suitable thickness. (Stahl,
12.) Stahl also discloses that the coating process can be repeated as many
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times as needed in order to obtain the desired thickness of the coating.
(Stahl, 3.) Stahl discloses that using active substance in the coating provides
a faster onset of the desired effect. (Stahl, 2.) Stahl discloses that active
substances may be in the same or different layers and that combinations of
active substances may include a medicament together with a substance that
decreases the undesirable taste of the medicament, as in a taste masking
agent. (Stahl, 3.)
Cherukuri teaches a method for applying coating to chewing gum.
See the abstract, see co1. 2, ll. 35-68, wherein the patent teaches coating
syrup using sweeteners or bulking agents. This is a taste masking agent.
Cherukuri, co1. 2, ll. 40-55, teaches sweeteners present in gum coatings and
other coating ingredients. Appellants further acknowledge that the coating
level disclosed in Cherukuri is 35 weight percent of the coated chewing gum
tablet. (Cherukuri, col. 4, ll. 29-34 and col. 7, ll. 13- 19.)
We agree with the Examiner that it would have been obvious to one of
ordinary skill in the art at the time the invention was made to coat a gum
base (gum center) with a gum coating comprising at least 50% by weight of
the chewing gum product. We also agree with the Examiner that it would
have been obvious to use a taste masking agent and high intensity sweetener
as taught by Cherukuri and include in the coating a medicament taught by
Stahl in analogous coated chewing gum preparations. Stahl teaches that one
of ordinary skill in the art would have known to coat a chewing gum core
with a coating containing a medicament to the desired coating thickness.
Stahl discloses that the coating process can be repeated as many times as
needed in order to obtain the desired thickness of the coating. (Stahl, 3.)
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Thus, Stahl teaches that it is known to those of skill in the art to vary the
coating thickness on a gum center when the coating contains a medicament
and that the coating process can be repeated as many times as needed.
Because it is an object of the invention of Stahl to use an active substance in
the coating to provide a faster onset of the effect (Stahl, 2), and, in Stahl, the
coating desirably contains a masking or flavoring agent to mask the taste of
the medicament, one of ordinary skill in the art would have chosen a suitable
coating thickness based on the amount of medicament to be delivered and
the amount of flavoring agent required to mask the flavor of the
medicament. Stahl teaches the incremental coating of the gum base up to 90
increments of coating.
Appellants have merely discovered an optimum value of coating
depth of a result effective variable (coating depth to mask taste and deliver
medicament at a faster onset of effect) in a known process of coating a gum
center with a medicament. Thus, we further agree with the Examiner that
one of ordinary skill in the art would modify the coating level from 35% of
Cherukuri to at least 50% by weight of coating, since Stahl clearly teaches
that coating process may be repeated to obtain the desired thickness. Stahl
also teaches that the presence of the active substance in the coating of the
coated chewing gum provides a fast on set of the effect, better stability of the
active substance, and increased effect thereof in all chewing phases. (Ans.
4.)
We find that Appellants have not demonstrated that their additional
gum coating is more than the predictable use of prior art coating elements
according to their established functions.
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CONCLUSION OF LAW
Appellants have not demonstrated that the Examiner erred in
concluding that a coating comprising at least 50% by weight of the chewing
gum product would have been obvious. The obviousness rejection 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).

AFFIRMED

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