John-Paul Mua et al.

Patent Trials and Appeals Board

Oct 8, 2019

14965069 - (D) (P.T.A.B. Oct. 8, 2019)

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.
14/965,069 12/10/2015 John-Paul Mua N64138 1090US.1 (0038.1) 4177
26158 7590 10/08/2019
WOMBLE BOND DICKINSON (US) LLP
ATTN: IP DOCKETING
P.O. BOX 7037
ATLANTA, GA 30357-0037
EXAMINER
NGUYEN, JOHN P
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
10/08/2019 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):
BostonPatents@wbd-us.com
IPDocketing@wbd-us.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JOHN-PAUL MUA, GONG CHEN,
THADDEUS JUDE JACKSON, ANTHONY RICHARD GERARDI,
KYLE FORD, BARRY SMITH FAGG, and MELISSA ANN CLARK
____________

Appeal 2018-008606
Application 14/965,069
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1–23.2 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 identifies the real party in interest as
“Niconovum USA” (Appellant’s March 29, 2018 Appeal Brief (Br.) 1).
2 Pending claims 24–29 stand withdrawn from consideration (Examiner’s
October 27, 2017 Final Office Action (Final Act.) 2).
Appeal 2018-008606
Application 14/965,069

2
STATEMENT OF THE CASE
Appellant’s disclosure “relates to compositions and products that
contain active ingredients and, in particular, to nicotine-containing
compositions and products characterized as having a pharmacological effect
and that can be considered to be useful for therapeutic purposes” (Spec. 1:1–
4). Claims 1, 14, and 15 are representative and reproduced below:
1. A protein-enriched pharmaceutical product comprising:
a nicotinic compound;
a protein-enriched, tobacco-derived material in an
amount of about 2 percent to about 10 percent by dry weight;
and
one or more sugar alcohols in an amount of at least 10
percent by dry weight,
wherein the protein-enriched, tobacco-derived material
comprises at least 60 percent tobacco-derived protein by dry
weight.
(Br. 16 (Claims App’x).)
14. The protein-enriched pharmaceutical product of claim 1,
further comprising a binder in an amount of between 2 percent
and 10 percent by dry weight.
(Id. at 17.)
15. The protein-enriched pharmaceutical product of claim 14,
wherein the binder comprises pregelatinized rice starch.
(Id.)

Appeal 2018-008606
Application 14/965,069

3
Grounds of rejection before this Panel for review:
Claims 1–14 and 16–23 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Duggins,3 Wildman,4 and Lo.5
Claim 15 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Duggins, Wildman, Lo, and Hsu.6

ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Duggins “relates to compositions that contain nicotine, and in
particular, to nicotine-containing pharmaceutical compositions intended to
be administered to provide a pharmacological effect, or otherwise used for
therapeutic purposes” (Duggins ¶ 1; see id. ¶ 24 (“The shape of . . .
[Duggins’] composition can, in certain embodiments, resemble a wide
variety of pill, tablet, lozenge, capsule, and caplet types of products”); see
generally Final Act. 5).
FF 2. Duggins discloses:
[A] process for preparing a multi-layered pharmaceutical
composition, comprising: preparing a first formulation by
combining a nicotinic compound with one or more components
selected from the group consisting of[, inter alia,] binders, . . .
sugar alcohol syrups, . . . humectants, . . . and mixtures thereof

3 Duggins et al., US 2013/0209540 A1, published Aug. 15, 2013.
4 Samuel Wildman, An alternate use for tobacco agriculture: Proteins for
food plus a safer smoking material, PRINCETON UNIV. 63–77 (1996),
https://www.princeton.edu/~ota/disk3/1983/8315/831507.PDF.
5 Lo et al., US 2010/0093054 A1, published Apr. 15, 2010.
6 Hsu et al., US 2005/0147670 A1, published July 7, 2005.
Appeal 2018-008606
Application 14/965,069

4
to form a first nicotinic compound-containing mixture and
forming the first nicotinic compound-containing mixture into a
desired form; preparing a second formulation by combining a
nicotinic compound with one or more components selected
from the group consisting of[, inter alia,] binders, . . . sugar
alcohol syrups, . . . humectants, . . . and mixtures thereof to
form a second nicotinic compound-containing mixture . . . into
a desired form; and applying the second formulation to the first
formulation, wherein the formulations are selected from[, inter
alia,] formulations . . . iv), as described . . . [by Duggins].
(Duggins ¶ 20; see Final Act. 5.)
FF 3. Duggins discloses that “[a] binder (or combination of binders) may
be employed in amounts sufficient to provide the desired physical attributes
and physical integrity to the pharmaceutical composition,” wherein “a
representative amount of binder may make up at least about 5 percent, at
least about 10 percent, at least about 15 percent, at least about 20 percent, or
at least about 25 percent of the total dry weight of the composition”
(Duggins ¶ 58; see id. (Duggins discloses that “the binder material includes
a natural gum,” “a natural gum refers to polysaccharide materials of natural
origin that are useful as thickening or gelling agents,” and provides
examples of natural gum binders); see Final Act. 5).
FF 4. Duggins discloses that formulation “iv) comprises a nicotinic
compound; humectant in an amount of about 0.5% by weight or greater;
sugar alcohol filler in an amount of about 20% by weight or greater; and a
natural gum binder in an amount of about 10% or greater” (Duggins ¶ 15).
FF 5. Examiner finds that “Duggins does not specifically disclose [a] . . .
composition comprises a protein-enriched and tobacco-derived material”
(Final Act. 8).
Appeal 2018-008606
Application 14/965,069

5
FF 6. Wildman discloses “[a] simple method . . . for extracting the proteins
from the aerial portions of fresh tobacco and other plants,” wherein “[t]he
water soluble proteins have unique nutritional and functional properties that
could make them valuable for the package food industry and for medical
use. The insoluble proteins have properties similar to soy protein”
(Wildman, Abstract; see Final Act. 8).
FF 7. Lo discloses “methods for obtaining proteins from plant leaves for
use in food and industrial products” (Lo ¶ 3; see generally Final Act. 8).
FF 8. Lo discloses that “[a]pproximately half of the soluble protein in plant
leaves is made up of ‘rubisco’ (ribulose-1,5-bisphosphate (RUBP)
carboxylase/oxygenase or ‘RuBisCO’) . . . , which is found in all known
green plants, appears to be the most abundant leaf protein, and it may be the
most abundant protein on earth” (id. ¶ 6; see Final Act. 8).
FF 9. Lo discloses that rubisco “has excellent binding, gelling, foaming,
whipping and emulsifying characteristics . . . [and] is colorless, tasteless and
odorless, which makes it attractive for incorporation into food or industrial
products.” (id. ¶ 8; see Final Act. 8).
FF 10. Lo “obtained crude protein yields of approximately 13% of total leaf
dry weight from tobacco variety MD 609 LA, a variety of Maryland tobacco
which contains low alkaloids” (id. ¶ 10; see generally Final Act. 8
(Examiner finds that “Lo discloses proteins from tobacco leaf”)).
FF 11. Lo discloses a method of preparing “leaf protein powder containing
97.5% purity” and “[m]ore preferably, . . . 99% purity” (id. ¶ 64; see Final
Act. 9).
FF 12. Examiner finds that although Duggins discloses “binders [that]
include starched-based binders,” the combination of “Duggins, Wildman and
Appeal 2018-008606
Application 14/965,069

6
Lo do not specifically teach that the binder comprises pregelatinized rich
starch” (Final Act. 10 (citing Duggins ¶ 44)).
FF 13. Hsu discloses “pharmaceutical dosage forms having immediate
release via rapid oral disintegration” (Hsu, Abstract; see Final Act. 10).
FF 14. Hsu discloses that “[b]inders are one or more ingredients that are
added [to orally-disintegrating tablets] to form granules and/or promote
cohesive compacts during compression” (Hsu ¶ 46).
FF 15. Hsu discloses that “binder will typically be present in about one
percent to about 80 percent by weight of the total tablet weight,” wherein
“[w]hen the binder comprises starch, any pharmaceutically acceptable starch
may be used in the present invention, including potato starch, rice starch,
com starch and pregelatinized starch,” (Hsu ¶ 47; see Final Act. 11).
ANALYSIS
Obviousness over the combination of Duggins, Wildman, and Lo:
“Duggins discloses a pharmaceutical composition comprising
nicotinic compound and components including binders, fillers and sugar
alcohol syrups” (Final Act. 9; see FF 2–4). According to Duggins, natural
gum binders are useful as thickening or gelling agents (FF 3). Lo also
discloses a binder, rubisco, a protein obtained from tobacco leave, “has
excellent binding, gelling, foaming, whipping and emulsifying
characteristics . . . [and] is colorless, tasteless and odorless, which makes it
attractive for incorporation into food or industrial products” (FF 8–9; see
also Final Act. 9–10 (Examiner finds that “proteins from tobacco leaf are
natural, suitable for pharmaceuticals, have excellent binding characteristics,
is colorless, odorless and tasteless”). Examiner further finds that “Lo
Appeal 2018-008606
Application 14/965,069

7
teaches a [tobacco leave] protein powder with a 99% purity (e.g. at least
about 80 percent tobacco)” (Final Act. 10; see FF 11).
Based on the combination of Duggins, Wildman, and Lo, Examiner
concludes that, at the time Appellant’s invention was made, it would have
been prima facie obvious
to produce a nicotinic compound containing composition
comprising one or more nicotinic compounds, a combination of
binders including [protein-enriched, tobacco-derived
material] . . . (e.g. RuBisCO) . . . at least one filler including a
sugar alcohol and humectants; wherein the amount
of . . . binder[] includes up to at least about 5 percent; wherein
the amount of the at least one filler is about 20% by weight or
greater; and wherein the amount of the humectants is at least
about 1 percent by weight.
(Final Act. 9; see FF 1–11.)
Appellant contends that Duggins discloses a variety of formulations
and one of ordinary skill in this art “would be led to the more focused
disclosures in the Duggins reference on various formulations (i.e.,
dissolvable, pastille, meltable, chewable, or hard coating)” (Br. 5; see also
id. at 6 (Appellant contends that “[o]ne of skill in the art would readily
appreciate that each such formulation is different, both compositionally and
physically, and that certain components and amounts relevant and useful in
one such formulation are not necessarily relevant and useful in another such
formulation”); id. at 6–7). In this regard, we note that Duggins discloses that
formulation “iv) comprises a nicotinic compound; humectant in an amount
of about 0.5% by weight or greater; sugar alcohol filler in an amount of
about 20% by weight or greater; and a natural gum binder in an amount of
about 10% or greater” (FF 4). Thus, Duggins discloses a nicotinic
Appeal 2018-008606
Application 14/965,069

8
compound and sugar alcohol, as required by claim 1, in the same
formulation.
With respect to the amount of tobacco derived material recited in
claim 1, Duggins discloses that “a representative amount of binder may
make up at least about 5 percent, at least about 10 percent, at least about 15
percent, at least about 20 percent, or at least about 25 percent of the total dry
weight of the composition” (FF 3). Therefore, we are not persuaded by
Appellant’s contention that the binder concentration, of about 10% or
greater, in Duggins’ formulation iv) “is inconsistent with the binder content
referenced in [Duggins’] paragraph [0058]” (App. Br. 7–8).
Further, on this record, Examiner finds that rubisco, a protein obtained
from tobacco leaf, has excellent binding and gelling characteristics in
addition to being “colorless, tasteless and odorless, which makes it attractive
for incorporation into food or industrial products” (FF 9). Thus, we find no
error in Examiner’s conclusion that a person of ordinary skill in this art
would have found it prima facie obvious to substitute rubisco for Duggins’
natural gum binder because both have gelling properties (see generally Ans.
6 (Examiner finds that a person of ordinary skill in this art would have found
it prima facie obvious to substitute rubisco for Duggins’ natural gum
binder); Br. 9 (Appellant appreciates Examiner’s rationale that the binder
“component of the Duggins reference . . . would purportedly be replaced
with . . . the purported protein-enriched, tobacco-derived material of the
Wildman and Lo references”)). Therefore, we are not persuaded by
Appellant’s contention that Duggins’ formulation iv), as modified by
Wildman and Lo to include at least about 10% rubisco binder, is
“inconsistent with the [protein] amount [of about 2 percent to about 10
Appeal 2018-008606
Application 14/965,069

9
percent by dry weight] recited in [Appellant’s] . . . pending claim[] [1]”
(App. Br. 7–8). See In re Geisler, 116 F.3d 1465, 1468 (Fed. Cir. 1997)
(Overlapping ranges support a prima facie case of obviousness.).
In addition, a sugar alcohol concentration of at least 10 percent by dry
weight, overlaps Duggins’ formula iv) sugar alcohol concentration of about
20% by weight or greater of Duggins. See id. Therefore, we are not
persuaded by Appellant’s contention that Examiner
has pointed to nothing in the cited reference[s] that would lead
one specifically to a product containing both a protein-enriched,
tobacco-derived material in an amount of about 2 percent to
about 10 percent by dry weight; and one or more sugar alcohols
in an amount of at least 10 percent by dry weight
(Br. 8).
For the foregoing reasons we are not persuaded by Appellant’s
contention that Examiner’s conclusion of obviousness is based “on
impermissible hindsight, using the present application as a guide” (id.).
Appellant contends that a natural gum binder has “fundamentally
different properties than a protein-enriched [binder] material” (Br. 10; see
also id. at 11 (Appellant contends that protein binders such as rubisco cannot
be equated with starch-based binders as described in Duggins)). Appellant,
however, fails to identify an evidentiary basis on this record to support
Appellant’s contention. In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974)
(“Attorney’s argument in a brief cannot take the place of evidence.”). In
contrast, the evidence of record establishes that rubisco, a protein obtained
from tobacco leaf, has excellent binding characteristics in addition to being
“colorless, tasteless and odorless, which makes it attractive for incorporation
into food or industrial products” (FF 9). Thus, absent evidence to the
contrary, we find no error in Examiner’s conclusion that a person of ordinary
Appeal 2018-008606
Application 14/965,069

10
skill in this art would have found it prima facie obvious to have substituted
rubisco for Duggins’ natural gum binder. See In re Fout, 675 F.2d 297, 301
(CCPA 1982) (“Express suggestion to substitute one equivalent for another
need not be present to render such substitution obvious.”). As mentioned
above, Lo expressly discloses that rubisco has, inter alia, excellent gelling
properties (FF9), making it an obvious alternative to a natural gum which
Duggins ascribes having the same properties (FF3). Therefore, we are not
persuaded by Appellant’s unsupported contention that Examiner “has
pointed to nothing to teach or suggest that the protein-enriched materials
purportedly disclosed in the Wildman/Lo references can be reasonably
equated with such gum-based [binder] materials and/or that such protein-
enriched [binder] materials would be expected to serve a comparable
function within the purported composition of the Duggins reference” (Br.
10; see also id. at 11 (Appellant contends “that one of skill in the art would
have no reasonable expectation in replacing the ‘starch-based binder’ or the
‘natural gum binder’ of the Duggins reference with a protein-based
material”); id. at 12 (Appellant contends that “the Lo reference does not
quantify the ‘binding’ characteristics of leaf-derived proteins, much less the
‘binding’ characteristics purportedly exhibited by tobacco-derived
proteins”)).
For the foregoing reasons, we are not persuaded by Appellant’s
unsupported contention that “one of skill in the art would have no reasonable
expectation of success in making the proposed modification to the purported
composition of the Duggins reference (i.e., incorporating a protein-enriched,
tobacco-derived material in the recited amount therein)” (Br. 11).
Appeal 2018-008606
Application 14/965,069

11
To be complete, because claims 24–26 stand withdrawn from
consideration, we do not address Appellant’s contentions regarding these
claims (see Final Act. 2; cf. Br. 12–13).

Obviousness over the combination of Duggins, Wildman, Lo, and Hsu:
As discussed above, the combination of Duggins, Wildman, and Lo
suggests a composition, within the scope of Appellant’s claimed invention,
that is also in the form of a tablet (see FF 1; see also FF 2–11). Hsu
discloses compositions in the form of tablets (FF 14). Hsu, as well as, the
combination of Duggins, Wildman, and Lo also discloses compositions in
the form of a tablet that comprise more than one binder (FF 3 and 14).
Based on the combination of Duggins, Wildman, Lo, and Hsu,
Examiner concludes that, at the time Appellant’s invention was made, it
would have been prima facie obvious
to produce a nicotinic compound containing composition
comprising one or more nicotinic compounds, a combination of
binders including pregelatinized rice starch, . . . [and rubisco],
at least one filler including a sugar alcohol and humectants;
wherein the amount of the combination of binders includes up
to at least about [10] percent; wherein the amount of the at least
one filler is about 20% by weight or greater.
(Final Act. 11.)
Having found no deficiency in the combination of Duggins, Wildman,
and Lo, we are not persuaded by Appellant’s contention that Hsu “does not
remedy the deficiencies of the Duggins, Wildman, and Lo references” (App.
Br. 14). Because the rejection is based on the combination of Duggins,
Wildman, Lo, and Hsu, we are also not persuaded by Appellant’s contention
that Hsu alone “does not disclose a pharmaceutical composition with the
recited components in the recited amounts” (id.).
Appeal 2018-008606
Application 14/965,069

12
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Duggins, Wildman, and Lo (Rejection I) is
affirmed. Claims 2–14 and 16–23 are not separately argued and fall with
claim 1.
The rejection of claim 15 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Duggins, Wildman, Lo, and Hsu is affirmed.
In summary:
Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
1–14, 16–23 103 Duggins, Wildman, Lo 1–14, 16–23
15 103 Duggins, Wildman, Lo, Hsu 15
Overall
Outcome
1–23

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).

AFFIRMED