Ex Parte Jackson et al

Patent Trials and Appeals Board

Feb 13, 2019

14713283 - (D) (P.T.A.B. Feb. 13, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/713,283 05/15/2015
26158 7590 02/15/2019
WOMBLE BOND DICKINSON (US) LLP
ATTN: IP DOCKETING
P.O. BOX 7037
ATLANTA, GA 30357-0037
FIRST NAMED INVENTOR
ThaddeusJ.Jackson
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.
R60999 2650US.D1
(0970.4)
CONFIRMATION NO.
1471
EXAMINER
MAEWALL, SNIGDHA
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
02/15/2019 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):
IPDocketing@wbd-us.com
BostonPatents@wbd-us.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THADDEUS J. JACKSON and FRANK KELLEY ST. CHARLES
Appeal2018-000725
Application 14/713,283
Technology Center 1600
Before JEFFREY N. FREDMAN, TA WEN CHANG, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1, 2 under 35 U.S.C. § 134 involving claims to an
orally ingestible hard-boiled product. The Examiner rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
1 Appellants identify the Real Party in Interest as the R. J. Reynolds Tobacco
Company (App. Br. 1 ).
2 We have considered and herein refer to the Specification of May 15, 2015
("Spec."); Final Office Action ofNov. 3, 2016 ("Final Act."); Appeal Brief
of Apr. 3, 2017 ("App. Br."); Examiner's Answer of Aug. 24, 2017
("Ans."); and Reply Brief of Oct. 24, 2017 ("Reply Br.").
Appeal2018-000725
Application 14/713,283
Statement of the Case
Background
"Orally ingestible hard boiled products can serve various purposes ...
[and] are found in the food industry (e.g., hard confectionary products of
various forms and flavors), in the pharmaceutical industry ( e.g., cough drops
and nicotine-containing lozenges), and in the tobacco industry ( e.g.,
smokeless tobacco lozenges)" (Spec. 1:12-16). "To ensure that all
ingredients are thoroughly mixed throughout the final product, the
ingredients are typically added to the mixture at a somewhat elevated
temperature in the manufacturing process ... However, certain ingredients
are volatile components that can evaporate when added at an elevated
temperature" (id. at 2:3-7).
The Claims
Claims 63-83 are on appeal. Claim 63 is representative and reads as
follows:
63. An orally ingestible hard boiled product comprising: a) a
buffered portion comprising a first sugar material and a
buffering agent; and b) an unbuffered portion comprising a
second sugar material, which may be the same as or different
than the first sugar material.
The Rejection
The Examiner rejected claims 63-83 under 35 U.S.C. § I03(a) as
obvious over Holton3 (Final Act. 2-7).
The Examiner finds Holton teaches "a composition intended to be
3 Holton, Jr. et al., US 2013/0078307 Al, published Mar. 28, 2013.
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Application 14/713,283
employed for therapeutic purposes and incorporates a nicotinic compound, a
sugar substitute, and sugar alcohol syrup" (Final Act. 2). The Examiner
finds Holton teaches "[b ]uffering agents such as sodium bicarbonates and
carbonates are added" (id. at 3). The Examiner finds that Holton teaches a
method
comprising mixing a non-hygroscopic sugar substitute (isomalt,
first sugar material) capable of forming a glassy matrix in an
amount of at least about 80% by weight and a sugar alcohol
syrup (second sugar material), in a melted state to form a
mixture; cooling the mixture and incorporating a nicotinic
compound into the cooled mixture; and further cooling the
mixture to room temperature to form a solid nicotine-containing
pharmaceutical composition.
(id. at 4).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner's conclusion that Holton
renders the claims obvious?
Findings of Fact ("FF")
1. Holton teaches "nicotine-containing pharmaceutical
compositions intended to be administered to provide a pharmacological
effect" (Holton ,r 1 ).
2. Holton teaches "the composition according to the invention
further comprises one or more buffering agents and/or pH adjusters (e.g.,
acids or bases)" (Holton ,r 48).
3. Holton teaches "mixtures of component ingredients can be
formulated and manufactured into core/shell types of configurations ( e.g.,
lozenge types of products that have an inner region and at least one
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Application 14/713,283
additional overlayer), with the various regions of such products having
differing overall compositions or properties" (Holton ,r 57).
4. Holton explains that "[t]hus, for example, the nicotinic
compound can have a relatively high concentration towards the inner region
of the product, or a relatively high concentration towards the outer region of
the product" (Holton ,r 57).
5. Holton teaches "[ c ]ompositions can be co-extruded, laminated
or formed so as to have sandwich-type forms; and hence the location of
nicotine and other ingredients can be controlled in order to provide the
desired features such as performance" (Holton ,r 57).
6. Holton teaches:
In one exemplary embodiment, the first mixture of ingredients
comprises a high percentage of isomalt and the mixture is
heated past the hard crack stage (e.g., to about 165° C.). The
mixture is heated to this temperature and then removed from the
heat to allow the mixture to cool. At one or more predetermined
temperatures, certain additional components are added. For
example, in certain embodiments, various components are
added when the melt has cooled to about 143° C. For example,
certain components that may be added at this point include, but
are not limited to, buffers, water, and/or the nicotinic
compound. In some embodiments, various components are
added when the melt has cooled to about 120° C. For example,
certain components that may be added at this point include, but
are not limited to, flavorants, the nicotinic compound, water,
and/or sweeteners. Certain flavorants are volatile and are thus
preferably added after the mixture has cooled somewhat.
Further, in some embodiments, it is desirable to add the tobacco
component at a somewhat cooled temperature. As noted above,
in certain embodiments, various components are added at
different stages in the cooling process. However, it is also
possible to combine these components and add them together at
a single stage in the cooling process.
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Application 14/713,283
(Holton ,r 69).
7. Holton teaches an exemplary process where
[i]somalt and maltitol syrup ( or xylitol syrup) are heated to
melting without stirring, to hard crack temperature ( e.g., 165°
C.). The melt is cooled to approximately 143° C., with very
slight, discontinuous stirring. Other components ( e.g., buffer,
nicotine, sweetener, and/or flavorants) are added to the mixture
and folded in carefully with a spatula without introducing much
air into the melt.
(Holton ,r 75).
8. Holton teaches "[i]n certain embodiments, the composition is
translucent. In certain embodiments, the composition is transparent" (Holton
i1 15).
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results"
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007).
Analysis
Claim 63
We adopt the Examiner's findings of fact and conclusions of law
except in regard to claim 67 (see Final Act. 2-7; FF 1-8) and agree that
Holton renders claim 63 obvious. We address Appellant's arguments below.
Appellants contend "the claims are directed to hard boiled products,
which products each comprise two 'portions"' (App. Br. 4). Appellants
contend
that nothing in the Holton reference describes or suggests such
a two-portioned product. What is demonstrated in the Holton
reference, and what is relied upon in the Holton reference as
purportedly rendering obvious the pending product claims, is a
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Application 14/713,283
product prepared using two "portions," rather than a final
product comprising two "portions" as claimed. This is an
important distinction, as the claims specifically recite a hard
boiled product comprising these portions.
(id. at 5).
We find this argument unpersuasive because Holton teaches multi-
portion products, specifically "core/shell types of configurations ( e.g.,
lozenge types of products that have an inner region and at least one
additional overlayer)" (FF 3). We agree with the Examiner that the ordinary
artisan would understand a product with a core/shell configuration as being
composed of two portions, a core portion and a shell portion.
Holton suggests "various regions of such products" may have
"differing overall compositions or properties" (FF 3). Holton uses nicotine
as an example, teaching "the nicotinic compound can have a relatively high
concentration towards the inner region of the product, or a relatively high
concentration towards the outer region of the product" (FF 4 ).
Holton also teaches that one component that may be added at different
times is buffer (FF 2), and exemplifies such a different order of addition by
teaching that"[ o ]ther components ( e.g., buffer, nicotine, sweetener, and/or
flavorants) are added to the mixture and folded in carefully with a spatula
without introducing much air into the melt" (FF 7).
Thus, we also agree with the Examiner that Holton reasonably
suggests an orally ingestible boiled product with two portions that may be
composed of different components (FF 3, 4), that buffering agents and
sweeteners may be among these different components (FF 2, 7), and that
these components may be separately placed into different portions of the
product (FF 3-5).
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Application 14/713,283
We also recognize Appellants' position that the two portions in the
examples "referred to by the Examiner are portions only in the context of the
method used to prepare the final product, and do not result in 'two portions'
within the final product itself' (App. Br. 6). Indeed, if Holton exemplified
two portions, Holton might anticipate the claims. Instead, Holton directly
suggests products with two portions in a final product with "core/shell types
of configurations ( e.g., lozenge types of products that have an inner region
and at least one additional overlayer)" (FF 3).
Appellants also contend "[ a ]lthough various components of the final
hard boiled product of the Holton reference are, in some embodiments,
provided in separate purported 'portions' during production of the product,
the resulting hard-boiled product does not maintain such components in
separate portions, as recited in the pending claims" (App. Br. 7).
We find this argument unpersuasive because Holton specifically
suggests final products with different amounts of components in different
portions, explaining that "[ c ]ompositions can be co-extruded, laminated or
formed so as to have sandwich-type forms; and hence the location of
nicotine and other ingredients can be controlled in order to provide the
desired features such as performance" (FF 5) and "with the various regions
of such products having differing overall compositions or properties" (FF3).
That is, Holton suggests sandwich or layered forms with particular
ingredients in particular locations within the final product (FF 5).
Claim 64
Appellants contend:
The Holton reference not only does not teach or suggest a
product with two portions, but further does not teach or suggest
a product with two portions positioned with respect to each
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other within the product in the manner recited in claim 64 (i.e.,
with one portion fully encapsulated by the other portion).
(App. Br. 9).
We find this argument unpersuasive because Holton suggests
"core/shell types of configurations ( e.g., lozenge types of products that have
an inner region and at least one additional overlayer)" (FF 3). Such a
core/shell configuration reasonably renders obvious a portion fully
encapsulated by a different portion.
Claim 65
Appellants contend Holton "does not teach or suggest a product with
two portions positioned with respect to each other within the product in the
manner recited in claim 65 (i.e., with both portions exposed on the surface of
the product)" (App. Br. 9-10).
We find this argument unpersuasive because Holton teaches
"sandwich-type forms" (FF 5) which reasonably suggests portions with an
upper layer with a first portion and a lower layer with a second portion with
both layers having outer facing surfaces and thus both layers being exposed
to the product surface.
Claim 66
Appellants contend that Holton "does not teach or suggest a product
with two portions visually distinguished with respect to each other within the
product in the manner recited in claim 66 (i.e., with one portion transparent
and one portion nontransparent)" (App. Br. 10).
We find this argument unpersuasive because Holton teaches "[i]n
certain embodiments, the composition is translucent. In certain
embodiments, the composition is transparent" (FF 8). Thus, Holton suggests
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that a portion may be transparent (FF 8). Because Holton also suggests the
two portions may be formed in a core/shell (FF 3) or sandwich (FF 5)
orientation, we agree with the Examiner that "it would have been obvious to
one of ordinary skill to have made a hard boiled product with buffered and
unbuffered portions ... [with] the buffered portion being transparent or non-
transparent" (Ans. 11 ).
Claim 67
Appellants contend that Holton "does not teach or suggest a product
with two portions positioned with respect to each other within the product in
the manner recited in claim 67 (i.e., with one portion in particulate form,
dispersed within the other portion)" (App. Br. 10-11).
The Examiner finds "Nicotine can be sorbed on to particulate
material" (Ans. 6).
While we agree with Appellants that the Examiner's rejection is in
error, we agree on a more limited basis, not simply because claim 67
requires one portion in particulate form that is dispersed within another
portion. As the Examiner correctly notes, Holton teaches "the nicotinic
compound is sorbed onto a porous particulate carrier" (Holton ,r 12).
However, claim 67 requires the buffered portion to be in particulate form.
The Examiner has provided no evidence to establish that the particulate
nicotinic compound that is on a particulate carrier is or should be in buffered
form. In the absence of such evidence, the Examiner has not established a
prima facie case of obviousness that is the Examiner's initial burden under
35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
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Claim 81 4
Appellants contend that Holton "does not teach or suggest a product
with two portions with the relative volume percentages of each portions (i.e.,
with one portion, particularly the buffered portion, comprising less than
about 20% by volume of the product)" (App. Br. 11).
We find this argument unpersuasive because the relative volumes of
the core/shell or sandwich layers in Holton's compositions (FF 3, 5), are
reasonably understood as routinely optimizable variables. "Where the
general conditions of a claim are disclosed in the prior art, it is not inventive
to discover the optimum or workable ranges by routine experimentation."
In re Aller, 220 F.2d 454,456 (CCPA 1955). Appellants have provided no
evidence that the particular relative volumes of the two portions represents
anything other than routine optimization.
Conclusion of Law
A preponderance of the evidence of record support the Examiner's
conclusion that Holton renders claims 63---66 and 81 obvious.
A preponderance of the evidence of record does not support the
Examiner's conclusion that Holton renders claim 67 obvious.
4 Appellants inadvertently identify claim 68 as reciting a specific
configuration concerning volume of a buffered portion (Appeal Br. 10).
However, these limitations are in claim 81, not claim 68. Supporting the
inadvertence of this error, we note that after presenting its arguments with
respect to "claim 68," Appellants summarily note that the additional reasons
argued support independent patentability of "claims 64---67 and 81" (Appeal
Br. 10-11).
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Application 14/713,283
SUMMARY
In summary, we affirm the rejection of claims 63-66 and 81 under 3 5
U.S.C. § 103(a) as obvious over Holton. Claims 69-80 and 82 fall with
claim 63.
We reverse the rejection of claim 67 under 35 U.S.C. § 103(a) as
obvious over Holton.
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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