Daniel Cantrell et al.

Patent Trials and Appeals Board

Aug 3, 2020

2019005862 (P.T.A.B. Aug. 3, 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.
12/854,342 08/11/2010 Daniel Verdin Cantrell R60999 1690.1 (0148.7) 7604
26158 7590 08/03/2020
WOMBLE BOND DICKINSON (US) LLP
ATTN: IP DOCKETING
P.O. BOX 7037
ATLANTA, GA 30357-0037
EXAMINER
KRINKER, YANA B
ART UNIT PAPER NUMBER
1747
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08/03/2020 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DANIEL VERDIN CANTRELL and GONG CHEN
Appeal 2019-005862
Application 12/854,342
Technology Center 1700

Before CATHERINE Q. TIMM, MONTÉ T. SQUIRE, and
JANE E. INGLESE, Administrative Patent Judges.

TIMM, Administrative Patent Judge.

DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–6, 8–10, 22, and 24–34 under 35
U.S.C. § 103(a) as obvious over Regrut.2 See Final Act. 2. This is the second
appeal in this application. See Decision in Appeal 2017-003567 dated March
14, 2018 (Prior Decision). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM IN PART.

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 R. J. Reynolds
Tobacco Company. Appeal Br. 1.
2 Regrut et al., WO 2009/068279 A1, published June 4, 2009.
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CLAIMED SUBJECT MATTER
The claims are directed to a meltable smokeless tobacco composition.
The composition is a mixture of tobacco material, at least about 20 dry
weight percent sugar alcohol, and greater than about 30 dry weight percent
of a lipid having a melting point within a particular range. Claim 1,
reproduced below, is illustrative of the claimed subject matter:
1. A meltable smokeless tobacco composition configured
for insertion into the mouth of a user, the tobacco composition
comprising a tobacco material, a sugar alcohol present in an
amount of at least about 20 dry weight percent, and a lipid
having a melting point of about 29°C to about 49°C,
wherein the tobacco material, the sugar alcohol, and the
lipid are in the form of a mixture, and
wherein the lipid in the mixture is present in an amount
of greater than about 30 dry weight percent.
Appeal Br. 20 (Claims Appendix).
OPINION
Appellant confines the arguments to claims 1 and 26. Appeal
Br. 4–17. We select claim 1 as representative for those claims not argued
separately. We consider claim 26 separately.
Claim 1
There is no dispute that Regrut teaches a meltable smokeless tobacco
composition including tobacco material, a sugar alcohol, and a lipid having a
melting point of about 29°C to about 49°C. Compare Appeal Br. 4–17, with
Final Act. 3. Appellant’s arguments call into question the Examiner’s
finding that Regrut’s composition is in the form of a mixture and the
Examiner’s findings and determinations regarding the concentrations of
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sugar alcohol and lipid. Appeal Br. 4–17. We determine that a
preponderance of the evidence supports the Examiner’s findings and
determinations.
In the Form of a Mixture
Claim 1 requires that the tobacco material, sugar alcohol, and lipid be
“in the form of a mixture.” The Examiner finds that Regrut teaches those
components in a mixture. Final Act. 3; Ans. 3–4. Appellant contends that the
Examiner’s interpretation of “mixture” is too broad and neither Regrut’s
infused tablet form, nor Regrut’s tobacco/lipid mixture are mixtures of
tobacco material, sugar alcohol, and lipid as required by claim 1. Appeal
Br. 4–6.
First, we agree with the Examiner’s interpretation of “mixture.” Ans.
3–4. As pointed out by the Examiner, the Specification does not define or
limit “mixture” to any particular processed form and, in fact, conveys that
“[t]he manner by which the various components of the smokeless tobacco
composition are combined may vary.” Spec. 13, ll. 25–26. Although the
Specification discloses methods of mixing in blenders, mixing drums, and
mixers (Spec. 13, ll. 26–28), the claims are not so limited. See In re Van
Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993) (“[L]imitations are not to be
read into the claims from the specification.”). “Mixture” encompasses
heterogeneous mixtures as well as homogeneous mixtures as well as any
other aggregate or combination of tobacco material, sugar alcohol, and lipid
that remains unreacted. See, e.g., the Chemistry, Physics definition of
“mixture” at Dicitonary.com (“an aggregate of two or more substances that
are not chemically united and that exist in no fixed proportion to each
other.”).
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Second, we agree with the Examiner, that Regrut teaches or suggests a
product with tobacco material, sugar alcohol as a binder, and lipid “in the
form of a mixture.” Regrut discloses two combinations that are mixtures
within the meaning of the claim, an infused tablet that does not contain lipid
as an initial ingredient and one that does. Regrut 11, l. 29–12, l. 31.
The initial mixture may include lipid. Regrut teaches forming a
tobacco blend, grinding the blend to particles of less than about 1 mm
average particle size, and cooking. Regrut 11, l. 34–12, l. 16. Lipid infusion
may be achieved by forming a mixture comprising powdered tobacco
laminae and lipid before cooking. Regrut 11, l. 34–12, l. 21. This cooked
mixture is used in the initial formulation Regrut describes “hereinbelow.” Id.
In the “hereinbelow” process, the tobacco component is dry blended with
“an initial formulation of components, including at least one filler-binder
[e.g., sugar alcohol], at least one flavorant, at least one lubricant and at least
one glidant.” Regrut 12, ll. 22–24. Thus, the final formulation that is placed
into the tablet press may include lipid. Regrut 14, ll. 3–4. Thus, Regrut, by
this process, forms a mixture of tobacco material, binder (sugar alcohol), and
lipid.
Regrut also teaches compressing a tablet containing tobacco and
binder that does not contain lipid and then infusing the tablet with lipid. It is
reasonable to believe that the resulting infused tablet contains a mixture
within the meaning of the claim. Lipid is infused into the tablet by placing
the tablet in an oil bath containing a hot lipid mixture. Regrut 15, ll. 3–4.
“The hot liquid lipid fills the interstitial spaces of the tablet, extracting oil
soluble materials from the tobacco matrix and incorporating them into the
lipid.” Regrut 15, ll. 4–6. The lipid impregnates or infuses the compressed
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tobacco matrix. Regrut 15, ll. 6–7. The result is at least a heterogeneous
mixture of tobacco, binder, and lipid.
Appellant has not persuaded us of a reversible error in the Examiner’s
finding that Regrut suggests a meltable tobacco composition containing
tobacco material, sugar alcohol, and lipid in the form of a mixture.
Lipid Concentration
Claim 1 further requires lipid be present in the mixture in an amount
of greater than about 30 dry weight percent. Regrut does not disclose a
concentration for lipid. But Regrut discloses concentrations for the other
required ingredients and based on those disclosures the Examiner determines
that the amount of lipid the ordinary artisan would use overlaps the greater
than about 30 dry weight percent range of claim 1. Final Act. 3. The
Examiner also determines that the concentration is a result effective variable
the ordinary artisan would have routinely optimized. Final Act. 4.
As a first matter, we agree with Appellant that the issue is somewhat
different than that presented in the prior appeal (Appeal 2017-003567)
because the claims now require the concentration of lipid be the
concentration of lipid in the mixture. Appeal Br. 6–7. We had considered
Regrut’s lipid coating as providing “further evidence that workable or
optimal concentrations of lipid would include amounts greater than about 30
dry weight percent.” Prior Decision 4–5. That finding does not apply in this
appeal due to the mixture limitation, which excludes the coating.
Our analysis proceeding the discussion of the coating, however, still
applies. Decision 3–4. We reproduce that reasoning below.
Regrut’s dissolvable compressed tobacco product may include about
30% to 50% by weight tobacco component, about 5% to 35% by weight
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filler-binder and less than about 1% by weight of lubricants and glidants.
Regrut 11, ll. 11–18. In another form, the filler-binder may be as little as
about 3%. Id. Sweeteners may be present in an amount of about 1% to about
3% by weight and flavorant in an amount to provide desired flavoring, such
as about 1% to about 15% by weight. Id. Regrut further discloses that the
amounts of tobacco, binder, glidant, and optional flavorants, are at levels
that “provide a balance between [the] desired mechanical properties (such as
compressibility) and desired organoleptic properties (such as its taste,
dissolvability, mouthfeel).” Regrut 11, ll. 7–10.
The compressed tobacco product is infused with lipid. Regrut 5,
ll. 1–2. The Examiner finds that Regrut teaches that the lipid provides the
tobacco product with various properties. Final Act. 3–4. Regrut supports the
Examiner’s finding. Specifically, Regrut teaches:
Once in the mouth, the lipids melt, allowing the dissolved
flavors to exit the compressed tobacco product still in the liquid
lipid which then coats the tongue and oral mucosa, providing a
pleasant and smooth mouth feel. The hydrophobic lipid also
inhibits migration of saliva into the interior of the tablet,
smoothing dissolution and reducing the spalling of the tobacco
matrix and resulting muddy texture of a conventional
compressed tobacco product. Additionally, many flavors and
aromas are hydrophobic and thus difficult to liberate from a
conventional compressed tobacco product using only aqueous
saliva dissolution. Instead, the oils allow these flavors and
aromas to be spread easily within the mouth and retronasal
olfactory environment.
Regrut 16, ll. 2–10. Regrut further teaches that “it has been observed that the
porosity of the compressed tobacco product tablet and, thus, lipid inclusion
level, may be controlled by compression pressure or tablet composition or a
combination of both approaches.” Regrut 23, ll. 28–30.
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A preponderance of the evidence supports the Examiner’s
determination that the concentration of lipid is a result effective variable.
See In re Applied Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012) (“A
recognition in the prior art that a property is affected by the variable is
sufficient to find the variable result-effective.”). “Thus, it would have been
obvious to one of ordinary skill in the art at the time of the invention to
have[,] given these benefits, optimized the amount of the lipid in the Regrut
composition to achieve these benefits, with a reasonable expectation of
success,” as determined by the Examiner. Final Act. 3–4. One would have
used the concentration of lipid that would accomplish the desired benefits
and would have arrived at the workable or optimal concentration through
controlling the compression pressure and tablet composition using routine
experimentation. Performing such routine experimentation is within the
ordinary skill of the artisan and supports a conclusion of obviousness when
the results are predictable rather than unexpected. See In re Aller, 220 F.2d
454, 456 (CCPA 1955) (“Normally, it is to be expected that a change in
temperature, or in concentration, or in both, would be an unpatentable
modification.”); In re Kulling, 897 F.2d 1147, 1149 (Fed. Cir. 1990) (finding
no clear error in the Board’s finding that the amount of eluent to be used in
the washing sequence was a matter of routine optimization in the pertinent
art where the reference fails to provide any numerical quantities.).
Although we agree with Appellant that one must consider the
concentration of lipid together with the concentrations of the other
components to be incorporated within the product, with the knowledge that
those amounts must be selected so as to reasonably form a product
consistent with the remainder of the reference teachings, Appellant has not
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presented the kind of evidence that persuades us that such selections would
lead away from amounts of lipid greater than about 30 dry weight percent.
Appeal Br. 8–15. Appellant’s assertions are mostly based on attorney
argument rather than evidence. On its face, the concentrations of the other
components are such that what is left over is an amount of lipid that overlaps
with the range of the claim. This is enough to support a prima facie case of
obviousness in the absence of evidence that the blending of lipid with
tobacco and infusion into the compressed tablet with sugar alcohol binder to
achieve lipid levels of greater than about 30 dry weight percent would not
have been achievable in Regrut’s tableting process or that an unexpected
result is achieved.
Sugar Alcohol Concentration
Appellant further contends, as they did in the prior appeal, that Regrut
would not have led the ordinary artisan to include a filler in the form of a
sugar alcohol in an amount of at least about 20 dry weight percent. Compare
Appeal Br. 15–17, with Prior Appeal Br. 20–22. We reproduce our reasons
for determining the argument unpersuasive of reversible error below.
Appellant points to a teaching in Regrut regarding sweeteners. Id.
According to Regrut:
Sweeteners are employed for their impact on the
consumer use and enjoyment mode. Sucrasweet® and
sucralose have been found to benefit consumer use and
enjoyment. Although sugar alcohols have been found to provide
adequate sweetness, they also serve as a quick release agent
with respect to extractables and, as such, serve to negatively
impact consumer use and enjoyment. Additionally, sugar
alcohols have been found to negatively affect product hardness,
thus also affecting the tablet mode.
Regrut 23, ll. 5–10.
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As rightly pointed out by Appellant (Appeal Br. 15), the above
teaching must be read in the context of Regrut as a whole. Regrut
specifically discloses using sugar alcohols as a binder and further discloses
that the binder may be present in the amount of about 5% to about 35%.
Regrut 2, ll. 19–21, 6, ll. 33–34. Specific sugar alcohols mentioned include
sorbitol, mannitol, xylitol or mixtures thereof. Regrut 11, ll. 4–6. These
sugar alcohols can serve the dual purposes of a sweetener and a binder. Id.
The teaching with regard to sugar alcohols as having a negative impact on
consumer use and enjoyment, product hardness, and affecting tablet mode
on page 23 is disclosed in the context of a list of positive and negative
effects on three distinct modes: (1) production mode; (2) a tablet mode; and
(3) a consumer use and enjoyment mode. Regrut 22, ll. 11–16. Regrut
discloses a number of different positive and negative effects for different
selections of tobacco, binders, sweeteners, lubricants, and flavor/aroma
agents in this portion of the reference. Regrut 22, l. 17–23, l. 21. The
disclosure of positive and negative effects does not negate the disclosure of
using sugar alcohol as a binder and binder in the amount of 5–35 wt%. The
specific amount used would have been a matter of routine optimization for
the specific sugar alcohol selected and a preponderance of the evidence
indicates that useful amounts would have included the amounts of about 20
wt% to 35 wt% that would overlap the range of the claim.
Appellant has not identified a reversible error in the Examiner’s
conclusion of obviousness nor met their burden in establishing that the
ordinary artisan would have been led away from concentrations within the
ranges of claim 1. See In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997)
(quoting In re Malagari, 499 F.2d 1297, 1303 (CCPA 1974)) (“a prima facie
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case of obviousness can be rebutted if the applicant (1) can establish ‘the
existence of unexpected properties in the range claimed’ or (2) can show
‘that the art in any material respect taught away’ from the claimed
invention.”).
Claim 26
Claim 26 requires the sugar alcohol be present in an amount of at least
about 40 dry weight percent. Appellant has persuaded us of reversible error
in the Examiner’s finding that Regrut suggests using sugar alcohol in
concentrations of at least about 40 dry weight percent.
Contrary to the finding of the Examiner, Regrut would not have
suggested using sugar alcohol in concentrations of about 38%. This finding
is based on Regrut’s teaching that sugar alcohols can serve the dual purpose
of a sweetener and a binder-filler. Final Act. 5; Regrut 11, ll. 4–6. Because
Regrut teaches using about 3% to about 35% by weight binder-filler (Regrut
11, l. 15) and about 1% to about 3% by weight sweetener (Regrut 11, l. 16),
the Examiner concludes that the sugar alcohol would be present in a
concentration of about 4% to about 38% and that “about 38%” falls within
the range of “about 40%.” Final Act. 5. But the fact that the sugar alcohol
can serve a dual purpose does not mean the concentrations are additive.
There is no persuasive evidence that the ordinary artisan would have used
more than about 35 weight percent of sugar alcohol. Thus, we do not sustain
the Examiner’s rejection of claim 26.
CONCLUSION
The Examiner’s decision to reject claims 1–6, 8–10, 22, 24, 25, and
27–34 is affirmed, but the Examiner’s decision to reject claim 26 is reversed.
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DECISION SUMMARY
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–6, 8–10,
22, 24–34
103(a) Regrut 1–6, 8–10,
22, 24, 25,
27–34
26

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). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2018).
AFFIRMED IN PART