NICONOVUM USA, INC.

Patent Trials and Appeals Board

Oct 13, 2020

2020001550 (P.T.A.B. Oct. 13, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/540,754 11/13/2014 Darrell Holton JR. N64138 1020US.D1
(0024.1)
8617
26158 7590 10/13/2020
WOMBLE BOND DICKINSON (US) LLP
ATTN: IP DOCKETING
P.O. BOX 7037
ATLANTA, GA 30357-0037
EXAMINER
AHMED, HASAN SYED
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
10/13/2020 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):
BostonDocket@wbd-us.com
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PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DARRELL HOLTON JR., NELLY FRANSÉN, and
MATT REDDICK
____________

Appeal 2020-001550
Application 14/540,754
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1,2 under 35 U.S.C. § 134(a) involving claims to a
method for preparing nicotine-containing pharmaceutical composition. The
Examiner rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identified the Real Party in Interest as
Niconovum USA, Inc., (see Appeal Br. 1) but has since updated the name of
the applicant to Modoral Brands, Inc. (see Application Data Sheet submitted
May 21, 2020).
2 We have considered and herein refer to the Specification of Nov. 13, 2014
(“Spec.”); Final Office Action of Dec. 31, 2018 (“Final Act.”); Appeal Brief
of July 1, 2019 (“Appeal Br.”); Examiner’s Answer of Oct. 22, 2019
(“Ans.”); and Reply Brief of Dec. 23, 2019 (“Reply Br.”).
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Statement of the Case
Background
“[A]dministration of nicotine has been employed in an effort to help
cigarette smokers quit smoking (i.e., as a smoking cessation aid). For
example, nicotine has been an active ingredient of various types of so-called
‘nicotine replacement therapy’ or ‘NRT’ products” (Spec. 2). One “way that
has been employed to provide oral administration of nicotine has been
through the use of nicotine-containing lozenge or tablet types of products”
(id. at 3). The Specification states that “[i]t would be desirable to provide
alternative compositions capable of delivering or administering nicotine via
an oral route for therapeutic purposes” (id. at 4).
The Claims
Claims 28–39 and 41–47 are on appeal.3 Independent claim 28 is
representative and reads as follows:
28. A method of preparing a nicotine-containing
pharmaceutical composition, comprising:

(i) mixing a non-hygroscopic sugar substitute capable of
forming a glassy matrix in an amount of at least about
80% by weight and a sugar alcohol syrup in a melted
state to form a mixture;

(ii) cooling the mixture and incorporating a nicotinic
compound into the cooled mixture; and

(iii) further cooling the mixture to room temperature to form
a solid nicotine containing pharmaceutical composition,

3 Claims 1–27 and 40 are cancelled (Appeal Br. 13–15). Claims 48–52 are
withdrawn (id. at 16–17).
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wherein the mixture does not comprise a gum component,
and

wherein the solid nicotine-containing pharmaceutical
composition is translucent.

(Appeal Br. 13).

The Issues
A. The Examiner rejected claims 28–30, 33–39, 41–43, 46, and 47 as
unpatentable under 35 U.S.C. § 103 as obvious over Liu4 and Chan5 (Final
Act. 2–4).
B. The Examiner rejected claims 28–39 and 41–47 as unpatentable under
35 U.S.C. § 103 as obvious over Liu, Chan, and Hansson6 (Final Act. 4–5).

35 U.S.C. 103 over Liu, Chan, and Hansson
Because the obviousness rejections all rely on Liu, we discuss the
rejections together. The Examiner finds Liu teaches a method for preparing
a nicotine-containing solid oral dosage form by: (1) mixing and heating a
non-hygroscopic sugar alcohol and a sugar component to form a melt; (2)
cooking the melt; (3) removing excess moisture; (4) cooling the melt; (5)
incorporating a nicotine active; and (5) forming a solid (Final Act. 2–3).
The Examiner finds that the process forms a transparent glassy matrix (see
id. at 3). The Examiner concludes that it would have been obvious to a
person of ordinary skill in the art to modify Liu to perform the claimed

4 Liu et al., US 2004/0101543 A1, published May 27, 2004
5 Chan et al., US 2005/0123502 A1, published June 9, 2005
6 Hansson, US 2004/0191322 A1, published Sept. 30, 2004.
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process to provide a dosage form that dissolves more rapidly than
commercially available compressed nicotine tablets (id. at 3–4).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the combination of Liu, Chan,
and Hansson renders the claims obvious?
Findings of Fact (“FF”)
1. Liu teaches a solid oral dosage form including a glassy matrix formed
from at least one substantially non-hygroscopic sugar substitute and a
nicotine active (Liu ¶¶ 19–21) and that “[l]ozenges are a preferred
dosage form” (Liu ¶ 12).
2. Liu teaches:
The product matrix is in a glassy, i.e., amorphous, physical
state. . . . [I]t is believed that the glassy matrix structure
stabilizes nicotine actives such as nicotine and its derivatives,
and potentially other components that tend to be unstable to
moisture, e.g., by reducing penetration of water into the oral
dosage form. The glassy matrix structure also tends to be more
[a]esthetically appealing to the user, e.g., providing a desirably
smooth, organoleptic feel, which may increase user compliance.
In addition, the glassy matrix structure tends to dissolve more
rapidly than commercially available compressed nicotine tablets
of which the present inventors are aware, thereby providing
potentially faster craving relief than such tablets.

(Liu ¶ 23).
3. Liu teaches:
The formation of a glassy state is also typically characterized by
a transparent appearance. As will be appreciated by those
skilled in the art, the physical state is influenced by the
properties of the components (especially sugar alcohols and
other sugar components), and the process of making the
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product, and those skilled in the art will be able to select
appropriate components and processes.

(Liu ¶ 24).
4. Liu teaches the “[t]he substantially non-hygroscopic sugar
alcohol serves as a carrier . . . for the nicotine actives and optional adjuvants.
The solid, oral dosage form typically comprises at least about 40% of the
sugar alcohol . . . most preferably at least about 85%, based on the weight of
the dosage form” (Liu ¶ 28).
5. Liu teaches:
One or more sugars or-other sugar alcohols may be used, e.g.,
as bulking agents. It has been found that such other sugar
components may reduce the processing temperature required to
form the oral dosage form, thereby tending to maintain stability
of nicotine actives such as nicotine and its derivatives, and to
increase the cost effectiveness of the process. Suitable other
sugar components include sucrose, sorbitol, and xylitol, and in
a preferred embodiment is sorbitol.

(Liu ¶ 37).
6. Liu teaches “the type and amount of optional other sugar
components will preferably be selected such that the oral dosage form is
substantially non-hygroscopic and glassy” (Liu ¶ 38).
7. Liu teaches “[t]ypically the oral dosage form will comprise
from 0% to about 20%, e.g., from about 1 % to about 20% or from about
10% to about 20% of such other sugar components” (Liu ¶ 38).
8. Liu teaches a method of preparing a solid oral dosage form
including the steps of:
(1) with mixing and heating, forming a melt of the
substantially non-hygroscopic sugar alcohol and optionally,
other sugar components and/or a diluent such as water;
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(2) cooking the melt;
(3) removing excess moisture from the melt (e.g., to less than
about 2% moisture);
(4) cooling the melt with mixing until the melt is a plastic-like,
workable mass;
(5) while the melt is a plastic-like mass, incorporating the
nicotine active and any remaining optional ingredients; and
(6) forming the plastic-like mixture into solid, oral dosage
forms having the desired size and shape.

(Liu ¶¶ 54–60).
9. Liu teaches a method in which “the desired quantity of the
substantially non-hygroscopic sugar alcohol and any other sugar components
are dissolved in water by heating them in a kettle until dissolved. Additional
sugar components may be added and cooking continued until a final
temperature of about 145–165° C.” (Liu ¶ 62).
10. Liu teaches a method in which “a film of a mixture of the sugar
components is spread on a heat exchange surface and heated to about 165–
170° C. . . . The composition is then rapidly cooled to about 100–120° C.
and worked as a plastic-like mass, mixing in the nicotine active” (Liu ¶ 64).
11. Liu teaches “the cooking temperature should be sufficiently
high to drive water from the mixture.” Further, “to facilitate formation of a
transparent product, [a] buffer is added as a solution” (Liu ¶ 65).
12. Chan teaches nicotine containing oral compositions that may
include additional excipients, including sodium chloride, and sucralose
(Chan ¶¶ 10, 24, 69).
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13. Hansson teaches nicotine containing oral compositions
including nicotine sorbed onto a porous particulate carrier, viz.,
microcrystalline cellulose (Hansson ¶10).

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’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).

Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 2–5; FF 1–13) and agree that
the claims are obvious over Liu, Chan, and Hansson. We address
Appellant’s arguments below.
Appellant contends that “Liu does not teach or suggest a method of
preparing a nicotine-containing pharmaceutical composition, wherein the
resulting solid nicotine-containing pharmaceutical composition is
translucent” (Appeal Br. 4). Appellant contends that “[t]he inventors of the
present invention have specifically recognized the importance of
incorporating a syrup, e.g., a sugar alcohol syrup, to provide the desired
level of translucency/transparency in the resulting product” (id. at 4–5).
We do not find this argument persuasive because Liu expressly
teaches a glassy matrix characterized by a transparent appearance (FF 3).
Liu teaches the use of sugar alcohols and sugar alcohol syrups where melted
sugar alcohol forms a syrup (FF 5, 8). Moreover, Liu expressly teaches that
the transparent appearance is influenced by the properties of the sugar
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alcohol and other sugar components, and the process of making the product
(id.).
Appellant contends that “[t]he Examiner has pointed to nothing in Liu
that discloses the recited step of mixing the non-hygroscopic sugar substitute
with a sugar alcohol syrup” (Appeal. Br. 5). Appellant contends that the
Specification defines “sugar alcohol syrup” as “a thick solution of sugar
alcohol in water” (id., citing Spec. 15:29–16:8). Appellant further contends
that Liu does not teach mixing a sugar alcohol syrup with a non-hygroscopic
sugar substitute in a melted state to form a mixture (id. at 6–7). Appellant
contends that the claimed process requires previously preparing a sugar
alcohol syrup by heating and cooling to form a viscous composition, then
mixing with a non-hygroscopic sugar substitute (Reply Br. 4).
We are not persuaded by Appellant’s arguments. Liu teaches forming
a melt of a non-hygroscopic sugar substitute, a sugar alcohol (sugar
component), and a diluent such as water (FF 8). Liu teaches that a person of
ordinary skill in the art would have been able to form a transparent lozenge
by selecting the appropriate components, e.g., sugar alcohol and water, and
processes, e.g., combining sugar alcohol and water (FF 3). Accordingly, Liu
teaches the general conditions for forming a sugar alcohol syrup, i.e.,
combining sugar alcohol and water (FF 8), and further suggests optimizing
those conditions to form a transparent lozenge (FF 1, 11). “[W]here 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).
Appellant contends that Liu teaches away from forming a sugar
alcohol syrup (Appeal Br. 6). Specifically, Appellant contends that Liu
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teaches a process that requires adding a sugar alcohol, e.g., xylitol, as a
powder and not a syrup (id., citing Liu ¶ 85 (Example 4)). Appellant further
contends that Liu’s Example 4 teaches adding a sugar alcohol powder during
the “cooling step” and not the “mixing step” (see id. at 6–7). Appellant
contends that the order of addition in Liu’s Example 4 would not have been
expected to produce a translucent product (id. at 7).
We are not persuaded by Appellant’s argument. “The prior art’s mere
disclosure of more than one alternative does not constitute a teaching away
from . . . alternatives because such disclosure does not criticize, discredit, or
otherwise discourage the solution claimed.” In re Fulton, 391 F.3d 1195,
1201 (Fed. Cir. 2004). Liu teaches several alternatives for mixing sugar
alcohol with a sugar substitute. The alternatives include a sugar alcohol
powder as cited by Appellant, and solutions of sugar alcohol and water (see
FF 8–11). Liu does not criticize, discredit, or otherwise discourage
combining a non-hygroscopic sugar substitute with a solution of sugar
alcohol and water (see id.). Accordingly, we are not persuaded that Liu
teaches away from mixing a sugar alcohol syrup with a non-hygroscopic
sugar substitute.
Appellant argues that dependent claims 34 and 46 are independently
patentable over cited art (Appeal Br. 8–10). As to claim 34—reciting an
amount of sugar alcohol “sufficient to slow recrystallization of the sugar
substitute in melted form”—Appellant contends that Liu does not teach the
“use of sugar alcohol syrup in any amount, and further does not disclose or
suggest any specific benefit associate with use of this component.” (Id. at 8).
We are not persuaded by Appellant’s argument. The Specification
discloses that the amount of sugar alcohol syrup may be up to about 20% by
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weight of the product mixture (Spec. 16; see also claim 37). The
Specification explains that “[o]ne of skill in the art would understand the
need to vary the amount of sugar alcohol syrup depending on the
composition of the remaining ingredients to ensure that the recrystallization
is sufficiently slow to provide a material with the desired characteristics
(e.g., a desired level of translucency/transparency)” (id.).
Liu teaches the same amount of sugar alcohol, i.e., up to about 20%,
for the same purpose, i.e., forming a transparent nicotine containing lozenge
(see FF 1, 3, 5–7, 11). Because the Examiner has shown Liu teaches a
substantially identical process for preparing a substantially identical product,
the burden shifts to Appellant to show a difference between the prior art
process and the claimed process. See in re Best, 562 F.2d 1252, 1254–1255
(CCPA 1977) (“[The] fairness [of the burden-shifting] is evidenced by the
PTO’s inability to manufacture products or to obtain and compare prior art
products”). Appellant has not submitted the kind of factual evidence
required to rebut the Examiner’s findings. See In re Geisler, 116 F.3d 1465,
1470 (Fed. Cir. 1997).
As to claim 46, Appellant contends that Liu does not teach “heating a
melted mixture to a temperature above the hard crack stage of the sugar
substitute” (Appeal Br. 9). Appellant contends that Liu teaches dissolving a
non-hygroscopic sugar substitute and sugar alcohol in water, rather than
mixing the components in a melted state (id., citing Liu ¶ 62).
We are not persuaded by Appellant’s argument. The Specification
describes “the temperature at which the hard crack stage is achieved can
vary, depending on the specific makeup of the product mixture but generally
is between about 145 °C and about 170 °C” (Spec. 25). Liu teaches various
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methods for mixing a non-hygroscopic sugar substitute and a sugar alcohol,
including dissolving the components in water (FF 9), and, alternatively,
forming a melt mixture (FF 8, 10). Liu teaches using a cooking temperature
of 145–170° C in both processes, sufficiently high to drive water from the
mix (FF 9–11). Accordingly, Liu teaches heating the melt mixture to a
temperature above the hard crack stage, as required by claim 46.

Conclusion of Law
A preponderance of the evidence of record support the Examiner’s
conclusion that the claims are obvious over the combination of Liu, Chan,
and Hansson.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
28–30, 33–39,
41–47
103 Liu, Chan 28–30, 33–39,
41–47

28–39, 41–47 103 Liu, Chan, Hansson 28–39, 41–47
Overall
Outcome
28–39, 41–47

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