Ex Parte Boghani et al

Patent Trial and Appeal Board

Jun 30, 2016

11913267 (P.T.A.B. Jun. 30, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111913,267 05/09/2008
23413 7590 07/05/2016
CANTOR COLBURN LLP
20 Church Street
22nd Floor
Hartford, CT 06103
FIRST NAMED INVENTOR
Navroz Boghani
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.
CDS0165US30 1707
EXAMINER
LOVE, TREVOR M
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
07/05/2016 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):
usptopatentmail@cantorcolbum.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NA VROZ BOGHANI, PETROS GEBRESELLASIE, and
SHIUH JOHN LUO
Appeal2013-003965
Application 11/913,267 1
Technology Center 1600
Before DEMETRA J. MILLS, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to a delivery system for use in an
edible composition, where the delivery system has a managed release profile
for at least one active ingredient. Appellants appeal from the Examiner's
final rejection of claims 61---67 and 69-73 as obvious under 35 U.S.C. § 103.
We have jurisdiction under 35 U.S.C. § 134. The obviousness rejections are
affirmed.
1 "The '267 Application."
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Application 11/913,267
STATEMENT OF CASE
The claims stand finally rejected by the Examiner as follows:
Claims 61-64, 66, 67, and 69-73 under 35 U.S.C. § 103(a) (pre-AIA)
as obvious in view Cherukuri et al (U.S. Pat No. 4,816,265, issued Mar. 28,
1989). Answer 3.
Claim 65 under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view
Cherukuri and Schobel (U.S. Pat. No. 4,824,681, issued Apr. 25, 1989).
Answer 3.
Claim 61 is the only independent on appeal. Claims 61---67 and 69-73
depend from claim 61. Claim 61 is reproduced below
61. A delivery system for use in an edible composition, said
delivery system having a managed release profile of at least one
active ingredient, said delivery system comprising: an
encapsulating material comprising polyvinyl acetate; and the at
least one active ingredient encapsulated with said encapsulating
material, and a tensile strength modifying agent comprising
hydrogenated vegetable oil;
wherein said delivery system has four managed release
characteristics that modify the release profile of the ingredient
to its desired release profile in said edible composition, wherein
said four managed release characteristics are ( 1) tensile strength
of said delivery system of at least 6500 psi, (2) hydrophobicity
of said encapsulating material of from about 0% to about 15%
as measured according to ASTM D570-98, (3) average particle
size of said delivery system of less than 710 microns, and ( 4)
ratio of said at least one ingredient to said encapsulating
material,
wherein said ratio of said at least one active ingredient to said
encapsulating material is from about 1 to about 99 to from
about 30 to about 70.
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Application 11/913,267
REJECTION BASED ON CHERUKURI
Claim 61 is directed to a delivery system for use in an edible
composition. The delivery system comprises: a) at least one active
ingredient; b) an encapsulating material comprising polyvinyl acetate; and c)
a tensile strength modifying agent comprising hydrogenated vegetable oil.
The active ingredient is encapsulated with the encapsulating material.
The delivery system has "four managed release characteristics that
modify the release profile" of the active ingredient. These characteristics are
recited in the claim as follows:
(1) tensile strength of the delivery system of at least 6500 psi,
(2) hydrophobicity of the encapsulating material of from about 0% to
about 15% as measured according to ASTM D570-98,
(3) average particle size of the delivery system of less than 710
microns, and
( 4) ratio of the active ingredient to said encapsulating material is from
about 1 to about 99 to from about 30 to about 70.
The Examiner found that Cherukuri describes a chewing gum
composition comprising the same components as recited in claim 61: a) an
active ingredient, such as the sweetener aspartame; b) an encapsulating
material comprising polyvinyl acetate; and c) a tensile strength modifying
agent comprising glyceryl monostearate and "hydrogenated fat or wax."
Final Rej. 4.
The Examiner found Cherukuri teaches a particle size between 7 5 and
600 microns, meeting the claimed particle size limitation of (3) less than 710
microns. Id. The Examiner also found that the (4) ratio of the active
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Application 11/913,267
ingredient to the encapsulating material in Examples B and C of Table 1 of
Cherukuri is 16.67 to 63.66 and 15 to 75, respectively, falling with the
claimed ratio. Id. at 4--5.
With respect to the (1) tensile strength and (2) hydrophobicity values,
the Examiner found that Cherukuri' s product is similar to the claimed
composition with overlapping amounts and would be expected to have the
same values as claimed. Id. at 6. The Examiner specifically found that
amounts of tensile strength modifying agent in Cherukuri's examples
overlap with the amounts in Examples 25A and 25C of the '267 Application
and thus, would necessarily meet ( 1) the tensile strength requirement of least
6500 psi. Id.
Appellants contend that Cherukuri "teaches away" from utilizing a
fatty acid or waxy component in its composition, i.e., the tensile modifying
agent of claim 61. Br. 5. Appellants contend that the examples in Cherukuri
"do not teach a single coating layer containing a mixture of a sweetener
active component, polyvinyl acetate, hydrogenated oil and glycerol
monostearate." Id. Appellants also state there is no recognition in
Cherukuri that recited "four managed release characteristics" help control
the desired release profile of the active ingredient. Id. at 6-10.
Discussion
"hydrogenated vegetable oil"
Cherukuri describes a chewing gum composition comprising "a
delivery system comprising a high intensity sweetener encapsulated in a low
molecular weight polyvinyl acetate material and an emulsifier." Cherukuri,
Abstract. As found by the Examiner, the latter disclosure meets the
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Application 11/913,267
limitation of claim 61 of (b) "an encapsulating material comprising
polyvinyl acetate; and the (a) at least one active ingredient encapsulated with
said encapsulating material." Final Rej. 4.
Appellants dispute the Examiner's finding that Cherukuri discloses ( c)
"a tensile strength modifying agent comprising hydrogenated vegetable oil."
We thus first look to Cherukuri's disclosure.
Cherukuri discloses that it "has been discovered that simple mixing of
known coating materials such as fats, with certain other core materials such
as aspartame does not provide adequate protection to keep the core material
in a stabilized state." Cherukuri, col. 3, 11. 1--4. Specifically, Cherukuri
teaches that fats and waxes "require solvents and moisture for application,
which have adverse effects on the stability of hy[ d]rophilic instable
materials such as aspartame." Id. at col. 3, 11. 1-10. Cherukuri concludes:
"The instant invention seeks to provide coating compositions which
eliminate the need for fatty acid or wax components, yet still provides
adequate protection and delayed release of the sweetener or other active
contained therein." Id. at col. 3, 11. 36-40. Based on this disclosure,
Appellants contend that Cherukuri "explicitly teaches away from the use of
fatty acids or wax components." Br. 5.
We have considered this argument, but do not find it supported by a
preponderance of the evidence. Specifically, the examples in Cherukuri
relied upon by the Examiner expressly state that "Hydrogenated fat or wax"
may be included. Cherukuri, cols. 9-10, Table I. Cherukuri also discloses:
A second coating of fat or wax and glycerol monostearate blend
was applied on some of the above compositions using
conventional fluidized bed granulation techniques. This second
coating, although not required, is useful in applications where
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Application 11/913,267
prolonged exposure to acid pH, water or high temperature is
likely. The second coating also assures that rod-like shaped
sweeteners such as aspartame are adequately coated.
Id. at col. 9, 11. 15-22.
Despite this express disclosure of a hydrogenated fat in the examples,
Appellants state in "most likelihood" the examples contain "a wax rather
than hydrogenated fat." Br. 5. However, there is no factual support for this
statement or explanation as to why the express disclosure of "fat" should be
ignored. Br. 5.
The inclusion of a wax or hydrogenated fat is not inconsistent with
Cherukuri. As mentioned, Cherukuri teaches that fats and waxes can cause
aspartame to degrade. Cherukuri, col. 3, 11. 5-15. To address this problem,
Cherukuri teaches, inter alia, the additional of polyvinyl acetate (id. at col. 4,
11. 7-11, 3 3-3 6, and 41--46), the same encapsulating agent which is claimed.
After describing the benefit of polyvinyl acetate, Cherukuri expressly states
that waxes can optionally be used in its compositions (id. at col. 4; 11. 37-
40). In addition to this, Examples B, C, I, and L in Table I of Cherukuri
describe the presence of hydrogenated fat or wax (id. at cols. 9-10). A
second coating of fat or wax is also expressly described (id. at co 1. 9, 11. 15-
20). Based on this explicit disclosure of fat in Cherukuri's compositions, we
find that Appellants' contentions that "it is not even clear that Cherukuri ...
even intended any delivery system with a hydrogenated fat in the outer
layer" to be unpersuasive. Br. 7.
Appellants also contend that there is no teaching of a "hydrogenated
vegetable oil" as recited in claim 61. However, as indicated by the
Examiner (Answer 4), the '267 Application identifies "hydrogenated oil" as
a fat. Appl. 80: 32-33. The Examiner found this disclosure to be consistent
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with the finding that "hydrogenated fat" is well-known term in the art which
would be understand to be inclusive of hydrogenated vegetable oil,
particularly in view of Cherukuri's disclosure of vegetable waxes. Answer
4; Final Rej. 4 (citing claim 13 of Cherukuri). Appellants did not identify a
flaw in the Examiner's facts or reasoning with regard to this specific
limitation of claim 61.
Appellants contend that the examples in Cherukuri "do not teach a
single coating layer containing a mixture of a sweetener active component,
polyvinyl acetate, hydrogenated oil and glycerol monostearate." Br. 5.
However, Appellants appear to be reading a limitation in the claims because
the claims do not require "a single coating layer."
"four managed release characteristics that modifj; the release profile" of the
active ingredient
Claim 61 recites four specific release characteristics, including a
tensile strength value, a hydrophobicity value, a particle size, and a ratio of
active ingredient to encapsulating material. The Examiner found the
characteristics to be met either by Cherukuri' s express disclosure or by
following Cherukuri's guidance. Final Rej. 5--6.
Appellants contend that Cherukuri does not clearly teach or suggest
adding hydrogenated vegetable "to help control the tensile strength of the
delivery system and thereby help control the release profile of the active
components in the core of the delivery system." Br. 6. Appellants also
state that tensile strength is not disclosed in Cherukuri and tensile strength
was not known as a result-effective variable to manage the drug release
profile. Id. at 7.
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Application 11/913,267
Appellants' argument is not persuasive. As found by the Examiner,
Table I of Cherukuri describes amounts of hydrogenated fat or wax of 10%,
8%, 9%, and 9.04% by weight of the composition. Cherukuri, cols. 9-10.
Example 25A and 25C of the '267 Application describe high tensile strength
compositions containing 3.25% of the hydrogenated oil. Appl. 121. The
'267 Application examples do not identify the specific tensile strength, but
Appellants have not pointed to any other disclosure in the '267 Application
that shows what amounts of hydrogenated oil are necessary to achieve a
strength of 6500 psi. Accordingly, the Examiner reasonably found that the
values in Examples 25A and 25C would correspond to amounts within the
scope of the claim. Because the amounts of fat described by Cherukuri are
even greater than the amounts in Examples 25A and 25C, the Examiner had
basis to find that the amounts in Cherukuri' s composition would confer a
tensile strength of at least 6500 psi. Appellants did not provide rebuttal
argument or evidence to demonstrate error in the Examiner's findings.
There is no requirement that Cherukuri explicitly recognized that the tensile
strength value controlled the release profile because Cherukuri meets the
claimed limitation and therefore would necessarily control the drug release
profile in the same way as claimed. Appellants have not explained how
recognizing that the amount of hydrogenated fat controls the release profile
of the active ingredient distinguishes the claimed delivery system from the
delivery system suggested by Cherukuri.
The Examiner found that the examples in Table 1 of Cherukuri
comprising hydrogenated fat would possess a tensile strength of 6500 psi.
No optimization is required to achieve this value is necessary, contrary to
Appellants' contention. Br. 8.
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Appellants also contend that there is "no recognition by" Cherukuri
that the "hydrophobicity of the polyvinyl acetate from about 0% to about
15% as measured according to ASTM D570-98 helps manage the release
profile of the encapsulated active ingredient." Br. 8. Appellants
acknowledge that the particle size and weight ratios recited in the claims are
met by Cherukuri (id. at 9), but Appellants contend that there is "no
recognition" that these factors alone, or together, help "manage the release
profile of the encapsulated active ingredient (id. at 9--10).
As already discussed, Appellants have not distinguished the claim on
the basis of the components in the claim. Rather, Appellants contend what is
missing is the "recognition" that the components with the recited
characteristics modify the release profile of the active ingredient. This
argument is not persuasive.
First, Appellants have overlooked the teachings in Cherukuri that its
compositions are formulated to control the release of the active ingredient.
It has been discovered that a sweetener delivery system can be
made using a coating formed from the combination of an
emulsifier with low molecular weight polyvinyl acetate ...
. When applied to sweeteners such as aspartame, these coatings
effectuate sustained release of the sweetener, thereby extending
the period of sweetener perception and enjoyment of the
chewing gum or confection.
Cherukuri, col. 4, 11. 7-16.
The resultant product of this invention is in powder or
granulated form. The particle size is not critical to the delivery
system and can be adjusted to accommodate a particular desired
release rate and mouthfeel, depending on the vehicle, e.g.,
chewing gum, confection or pharmaceutical in which it is
incorporated.
Id. at col. 5, 11. 11-16.
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As we understand it, the four recited characteristics impart a specific
release profile to the active ingredient. Because Cherukuri discloses or
suggests such characteristics, the skilled worker would have reasonably
expected the delivery system to have the same release profile as claimed.
Appellants have not shown that release profile of the claimed delivery
system would be any different from the delivery system suggested by
Cherukuri or that recognizing that each one of the recited characteristics
modifies the release of the active ingredient distinguishes the delivery
system from the delivery system described or suggested by Cherukuri.
Consequently, we conclude that Appellants did not demonstrate an error in
the rejection. We affirm the rejection of claim 61 and dependent claims 62-
64, 66, 67, and 69-73 which were not argued separately. 37 C.F.R. §
41.37( c )(iv).
REJECTION BASED ON CHERUKURI AND SOBEL
Claim 65 depends from claim 61, and further recites that "at least one
active ingredient is at least partially coated before encapsulating with the
encapsulating material." The Examiner found this limitation met by Sobel.
Final Rej. 6. The Examiner found that it would have been obvious to one of
ordinary skill in the art to have applied Sobel' s teaching to Cherukuri to
"allow for control over the particle size of the agglomerated sweetener." Id.
at 7. Appellants discuss the rejection based on Schobel (Br. 6), but do not
identify an error. Consequently, we affirm the rejection of claim 65.
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TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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