JSRNTI, LLC

Patent Trials and Appeals Board

Jun 5, 2020

2019006294 (P.T.A.B. Jun. 5, 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.
14/172,604 02/04/2014 Tommy L. CHAU 6296.350 DIV 7160
28410 7590 06/05/2020
BERENATO & WHITE, LLC
6550 ROCK SPRING DRIVE
SUITE 240
BETHESDA, MD 20817
EXAMINER
MILLIGAN, ADAM C
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
06/05/2020 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):
uspto.filings@bw-iplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte TOMMY L. CHAU, JOHN M. PINNEY,
JACK E. HENNINGFIELD, EDWARD J. CONE,
SAUL M. SHIFFMAN, and JOSEPH G. GITCHELL
____________

Appeal 2019-006294
Application 14/172,604
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, ELIZABETH A. LAVIER, and
MICHAEL A. VALEK, Administrative Patent Judges.

VALEK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 submits this appeal under 35 U.S.C. § 134(a) involving
claims to methods of making an orally administrable medicinal delivery
system comprising a nicotine compound. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies JSRNTI, LLC as the real party in
interest. Appeal Br. 2.
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STATEMENT OF THE CASE
Claims 43–62 are on appeal and can be found in the Claims Appendix
of the Appeal Brief. Claim 43 is representative of the claims on appeal. It
reads as follows:
43. A method of making an orally administrable medicinal
delivery system, comprising:
at least partially dissolving a nicotine compound in a bulk
sweetener solution comprising a solvent and a first bulk
sweetener;
subsequent to said at least partially dissolving, coating
the nicotine compound and the first bulk sweetener on a saliva-
soluble bulk sweetener powder comprising a second bulk
sweetener to establish a coated powder premix; and
subsequent to establishing the coated powder premix,
combining the coated powder premix with a chewing gum base
and a buffer.
Appeal. Br. 25. The only other independent claim, claim 53, recites the
same steps “to establish a coated powder premix,” which is then combined
“with a lozenge base and a buffer.” Id. at 27.
Appellant seeks review of the following rejections:
I. Claims 43–62 under 35 U.S.C. § 103 as obvious over
Lindell;2
II. Claims 43–62 for obviousness-type double patenting
(“ODP”) over claims 13–20 of the ’654 patent3 in view of
Lindell; and
III. Claims 43–62 for ODP over claims 28–35 and 43–56 of

2 WO 02/102357 A1, published Dec. 27, 2002 (“Lindell”).
3 US 6,893,654 B2, issued May 17, 2005 (“’654 patent”).
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the ’060 patent4 in view of Lindell.
Appeal Br. 5.
Analysis
I. 103 Rejection:
The issue for this rejection is whether the preponderance of the
evidence supports Examiner’s conclusion that the methods in claims 43–62
are obvious over Lindell.
Relying on Lindell Example 5, Examiner finds that Lindell discloses a
nicotine gum comprising all of the ingredients in claim 43. See Final Act.
3–4. Examiner acknowledges that “Lindell does not teach that the gum base
and buffer are added subsequent to the liquid and powder” ingredients. Id.
at 4. However, Examiner concludes that:
[i]n making the formulation, one of ordinary skill in the art
would have found it obvious to add the components in any
order given that no order is specified (see p. 34, lines 5–15).
Thus it would have been obvious to add the sorbitol nicotine
and xylitol together first in order to dissolve the nicotine.
Given the recited active steps are met, it is reasonably expected
that the nicotine would be partially dissolved in the sorbitol and
the sorbitol liquid would act as a paste, sticking to and coating
the xylitol powder. Further, it would have been obvious to
include the nicotine with coating components, which are only
combined with the chewing gum base and buffer when the gum
base and buffer are coated with the nicotine coating in a final
step (see Lindell at p. 5, lines 21–24).
Ans. 4.
Appellant contends that Examiner’s conclusion of obviousness is
flawed because Lindell does not teach the steps recited “to establish a coated
powder premix” in the independent claims. See Appeal Br. 5–17, 20. In

4 US 6,358,060 B2, issued Mar. 19, 2002 (“’060 patent”).
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particular, Appellant urges that “Lindell teaches adding the liquid and solid
powder mixture components directly to the softened gum base, not
premixing liquid and solid components, such as nicotine, a solvent, and a
first bulk sweetener” to form a solution that is then used to coat a second
bulk sweetener powder to form the recited premix. Id. at 7. Appellant
contends that “[r]ather than coat, Lindell grinds and mixes” its powder
ingredients “to assure good distribution,” whereas the “nicotine [produced in
Appellant’s process] is concentrated in the coating on the second bulk
sweetener to establish the premix.” Id. at 8–9. According to Appellant, the
claimed process results in a more soluble form of nicotine and “disperses the
nicotine over a relatively large surface area, making the nicotine more
available for delivery and absorption by a user’s oral mucosa to promote a
high initial nicotine release rate.” Id. at 4 (citing Spec. 12:5–14; 28:14–19).
On this record, we are persuaded by Appellant’s arguments and
determine Examiner’s rejection is not supported by the preponderance of the
evidence. While it is true that Lindell discloses gums comprising two bulk
sweeteners (i.e., sorbitol and xylitol), nicotine, chewing gum base, and a
buffer (see Lindell 32 (Ex. 5)), it does not teach that those ingredients are
combined according to the steps recited “to establish a coated powder
premix” in Appellant’s independent claims. In particular, there is no
disclosure of: 1) dissolving nicotine in a bulk sweetener solution comprising
a first bulk sweetener and a solvent; and 2) using that nicotine solution to
coat a saliva-soluble powder comprising a second bulk sweetener. Instead,
Lindell suggests that the solid ingredients are first ground up and the
resulting mixture is combined with the gum base concurrently with any
liquid ingredients. See Lindell 34:5–15; see also id. at 24:28–30 (“Before
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adding any solid component, except for the gum base, it is desirable to grind
and size the solid component first, to ensure good distribution.”).
According to Examiner, “the only substantial difference between
[Lindell] and the instant claims is the order of ingredient addition.” Ans. 7–
8. We disagree. Claims 43 and 53 require the formation of a “coated
powder premix.” The claims specify that this premix is established by
performing a specific set of steps that requires first mixing a particular solid
ingredient (nicotine) with a liquid (solvent/first bulk sweetener) and then
coating that liquid onto a different solid ingredient (saliva-soluble powder).
Thus, even if as Examiner found, it would have been obvious to add either
Lindell’s solid or liquid ingredients first before combining them with the
gum base, Examiner has not shown that the particular sequence of steps
required to establish the recited “premix” would have been obvious.
In addition, Examiner has not articulated a sufficient rationale to
explain why one of ordinary skill in the art would have been motivated to
change the process taught in Lindell. Lindell Example 5 states that the
mixing is performed according to a “conventional procedure.” Appellant
submits the declaration of K. Warrant Clark, a chemist with “a detailed
understanding as to the procedures used to make” chewing gum, who
explains that “the conventional procedure at the time . . . did not involve the
formation of a coated powder premix.” Declaration of K. Warren Clark
dated Nov. 15, 2012 (“Clark Decl.”) ¶ 6, 29. Examiner has not identified
any evidence to the contrary, nor otherwise articulated a reason why one of
ordinary skill in the art would have found it obvious to deviate from the
conventional procedures employed at the time by performing the recited
steps “to establish a coated powder premix,” as claimed.
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These facts also differ from the reasoning of In re Burhans, 154 F.2d
690 (CCPA 1946), relied upon in MPEP § 2144.04(IV)(C), where the MPEP
summarizes Burhans as teaching the selection of any order of performing
process steps is prima facie obvious in the absence of new or unexpected
results. A necessary prerequisite for applying this reasoning is evidence that
the process steps themselves were known and used in the cited prior art. As
discussed above, the Examiner’s rejection provides no evidence that the
steps recited to “establish a coated powder premix” were taught in the prior
art. Without a teaching of the steps in the prior art, there is no original order
of steps for the artisan to rearrange into the claimed order of steps, and
consequently nothing obvious about the claimed order of steps.
For these reasons, Examiner has not met the burden “of presenting a
prima facie case of unpatentability” for claims 43 and 53. See In re Oetiker,
977 F.2d 1443, 1445 (Fed. Cir. 1992). Because Examiner’s rejection of the
dependent claims is premised on the same underlying findings as the
independent claims, we reverse the rejection of those claims for the same
reasons.
II. ODP Rejections
The issue for these rejections is whether the preponderance of the
evidence supports Examiner’s conclusion that the methods in claims 43–62
are obvious over the cited claims of the ’654 and ’060 patents each in view
of Lindell and are therefore properly rejected for ODP.
Examiner groups the two ODP rejections together. Final Act. 6. For
each rejection, Examiner finds that the present claims “are not patentably
distinct from” the identified claims of the ’654 and ’060 patents “because a
skilled artisan would have found it obvious to add bulk sweeteners as taught
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by Lindell.” Final Act. 6. Moreover, Examiner determines that “Lindell
suggests forming a coated powder premix,” relying on the “same reasons”
Examiner offers for the obviousness rejection. Id.
Appellant argues that “neither the ’654 patent [claims] nor the ’060
patent [claims] discloses the order of ingredient addition or forming a coated
powder premix.” Appeal Br. 23. Thus, Appellant urges that the claims of
the ’654 patent and ’060 patent “do not overcome Lindell’s deficiencies, and
the Examiner has not pointed to any teaching [in those claims] that
overcomes the deficiencies.” Id.
We agree with Appellant for the reasons articulated above in our
analysis of the obviousness rejection. In the Answer, Examiner states that
the ’654 and ’060 patents “teach mixing a loading compound into the base
material so that said loading compound remains releasable and rapidly
transmucosally absorbable.” Ans. 8–9. While this may be so, the cited
claims of those patents do not refer to a “coated powder premix,” nor has
Examiner otherwise articulated how any of the claims of the ’654 and ’060
patents, alone or in combination with Lindell, teach the steps for establishing
the coated powder premix in Appellant’s present claims. Accordingly,
Examiner’s ODP rejections are not supported by the preponderance of the
evidence.
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
43–62 103 Lindell 43–62
43–62 Nonstatutory
Double Patenting:
’654 patent
43–62
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Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
43–62 Nonstatutory
Double Patenting:
’060 patent
43–62
Overall
Outcome
43–62

REVERSED