Joseph PANDOLFINO

Patent Trials and Appeals Board

Mar 10, 2021

2020004844 (P.T.A.B. Mar. 10, 2021)

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.
16/047,948 07/27/2018 Joseph PANDOLFINO A240439 1013
23373 7590 03/10/2021
SUGHRUE MION, PLLC
2000 PENNSYLVANIA AVENUE, N.W.
SUITE 900
WASHINGTON, DC 20006
EXAMINER
LANE, DANIEL E
ART UNIT PAPER NUMBER
3715
NOTIFICATION DATE DELIVERY MODE
03/10/2021 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):
PPROCESSING@SUGHRUE.COM
USPTO@sughrue.com
sughrue@sughrue.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte JOSEPH PANDOLFINO
____________

Appeal 2020-004844
Application 16/047,948
Technology Center 3700
____________

Before BIBHU R. MOHANTY, BRUCE T. WIEDER, and
KENNETH G. SCHOPFER, Administrative Patent Judges.

WIEDER, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 seeks review under 35 U.S.C. § 134 from the Examiner’s
final rejection of claims 1, 2, 4, 5, 46–54, 57, and 58. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.

CLAIMED SUBJECT MATTER
Appellant’s invention relates to “a method of transitioning a smoker
of conventional cigarettes to an aerosol device.” (Spec. ¶ 9.)2

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 Joseph
Pandolfino. (Appeal Br. 2.)
2 References to “Spec.” refer to the substitute specification filed
May 9, 2019.
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Claims 1, 46, 51, and 57 are the independent claims on appeal.
Claim 1 is illustrative. It recites:
1. A method of transitioning a smoker of conventional
cigarettes to a tobacco heating device, the method comprising:
providing the smoker a transition kit including a supply of
very low nicotine cigarettes, a tobacco heating device, and
information and recommendations for using said cigarettes and
tobacco heating device during a transitional period,
wherein the supply of very low nicotine cigarettes equals
at least 20 percent of the number of conventional cigarettes the
smoker smokes per day multiplied by the number of days in the
transitional period,
wherein the very low nicotine cigarettes contain equal to
or less than 2.0 mg of nicotine per cigarette,
wherein the transitional period is less than 85 days, and
wherein the information and recommendations include the
following:
instructions for the smoker to stop smoking
conventional cigarettes at a first time point, commencing
the transitional period, and after the first time point to
smoke the very low nicotine cigarettes from the supply of
very low nicotine cigarettes without restriction during the
transitional period;
recommendations or instructions that upon the
smoker experiencing an overwhelming craving for a
conventional cigarette, to use the tobacco heating device
without restriction at a second time point;
recommendations or instructions that after the
second time point until the end of the transitional period,
the smoker may also smoke the very low nicotine
cigarettes without restriction; and
recommendations or instructions for the smoker to
stop smoking the very low nicotine cigarettes at the end of
the transitional period and to continue to use the tobacco
heating device.

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REJECTIONS
Claims 1, 2, 4, 5, 46–54, 57, and 58 are rejected under 35 U.S.C.
§ 112(b) as indefinite for failing to particularly point out and distinctly claim
the subject matter which the inventor regards as the invention.
Claims 1, 2, 4, 5, 46–54, 57, and 58 are rejected under 35 U.S.C.
§ 101 as directed to a judicial exception without significantly more.
Claims 1, 2, 5, 47, 48, 52, 53, 57, and 58 are rejected under 35 U.S.C.
§ 103 as unpatentable over Hayden McRobbie et al., Complementing the
Standard Multicomponent Treatment for Smokers With Denicotinized
Cigarettes: A Randomized Trial, Nicotine & Tobacco Research 1134–41
(2016)3 (hereinafter “McRobbie”), Stop smoking treatments, National
Health Service, last reviewed July 19, 2016
(https://www.nhs.uk/conditions/stop-smoking-treatments/) (hereinafter
“NHS”), Konstantinos E. Farsalinos, et al., Nicotine Delivery to the Aerosol
of a Heat-Not-Burn Tobacco Product: Comparison With a Tobacco
Cigarette and E-Cigarettes, Nicotine & Tobacco Research 1–6 (2017)
(hereinafter “Farsalinos”), and Maurice R. Smith, et al., Evaluation of the
Tobacco Heating System 2.2. Part 1: Description of the system and the
scientific assessment program, Regulatory Toxicology and Pharmacology
(2016) (hereinafter “Smith”).
Claims 46, 50, and 51 are rejected under 35 U.S.C. § 103 as
unpatentable over McRobbie and NHS.

3 Advance access publication June 4, 2015.
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Claims 4, 49, and 54 are rejected under 35 U.S.C. § 103 as
unpatentable over McRobbie, NHS, Farsalinos, Smith, and Applicant’s
admitted prior art (see Spec. ¶ 87).

ANALYSIS
The § 112(b) rejection
The Examiner determines that the term “overwhelming craving” as
used in independent claims 1, 46, 51, and 57 “is a relative term which
renders the claim[s] indefinite.” (Final Action 4.) Specifically,
[t]he term “overwhelming craving” is not defined by the claim,
the specification does not provide a standard for ascertaining the
requisite degree, and one of ordinary skill in the art would not be
reasonably apprised of the scope of the invention. While [sic]
the specification provides a non-limiting characterization of an
“overwhelming craving” as “such a strong desire to smoke a
conventional cigarette that the smoker’s mind is made up or
virtually made up that the smoker needs, and is going to smoke,
a conventional cigarette.” See para. 149. This is non-limiting
because the disclosure identifies that an overwhelming craving
“may be characterized” as this. Furthermore, this “strong desire”
wherein the smoker’s mind is “made up or virtually made up”
characterization does not provide a standard for ascertaining the
requisite degree, and one of ordinary skill in the art would not be
reasonably apprised of the scope of the invention.

(Id. at 4–5.)
Appellant argues
that the artisan of ordinary skill would have understood the term
“craving” to mean a “desire” (Specification at ¶ 149, supra). The
artisan of ordinary skill would also have understood the
magnitude of the “overwhelming craving,” as expressly set forth
in the Specification. “An overwhelming craving may be
characterized as such a strong desire to smoke a conventional
cigarette that the smoker’s mind is made up or virtually made up
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that the smoker needs, and is going to smoke, a conventional
cigarette.” Specification at ¶ 149, supra. Thus, the specification
apprises the skilled artisan with reasonable clarity, Nautilus, 134
S. Ct. at 2124, as to the nature of the “overwhelming craving,”
as recited in claim 1.

(Appeal Br. 14.) Appellant further argues that the Examiner
vilifies Appellant’s selection of the term “may” in the
Specification, “may” is used instead of “is” because there could
be many other ways to characterize an overwhelming craving
including, for example, desiring a cigarette so terribly that a
sugary snack must be eaten. Thus, the term “overwhelming
craving” for a conventional cigarette needs no additional
explanation because the common English usage of the term is
clear: a strong desire for a conventional cigarette.

(Reply Br. 4.)
The Federal Circuit has stated that
when the USPTO has initially issued a well-grounded rejection
that identifies ways in which language in a claim is ambiguous,
vague, incoherent, opaque, or otherwise unclear in describing
and defining the claimed invention, and thereafter the applicant
fails to provide a satisfactory response, the USPTO can properly
reject the claim as failing to meet the statutory requirements of
§ 112(b).

In re Packard, 751 F.3d 1307, 1311 (Fed. Cir. 2014).
“[W]e employ a lower threshold of ambiguity when reviewing a
pending claim for indefiniteness than those used by post-issuance reviewing
courts.” Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008)
(precedential). Specifically, “if a claim is amenable to two or more plausible
claim constructions, the USPTO is justified in requiring the applicant to
more precisely define the metes and bounds of the claimed invention by
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holding the claim unpatentable under 35 U.S.C. § 112[(b)], as indefinite.”
Id.; see also In re Packard, 751 F.3d at 1311.
As an initial matter, we note that Appellant amended claims 1, 46,
and 57 from reciting “a craving” to reciting “an overwhelming craving,” i.e.,
Appellant distinguishes a craving from an overwhelming craving. (See
Amendment Under 37 C.F.R. § 1.111 filed Dec. 12, 2019 at 3, 6, 10, 12–13.)
Appellant argues that the term “craving” means “a ‘desire.’” (Appeal Br 14.)
Appellant cites to paragraph 149 of the Specification in support of this
proposed definition. However, we do not find such a definition in
paragraph 149. Applying a broadest reasonable interpretation, we determine
that the term “craving” includes “an intense, urgent, or abnormal desire or
longing.” Craving, Merriam-Webster.com, https://www.merriam-
webster.com/dictionary/craving (last visited Feb. 24, 2021).
Appellant argues that the term “[a]n overwhelming craving may be
characterized as such a strong desire to smoke a conventional cigarette that
the smoker’s mind is made up or virtually made up that the smoker needs,
and is going to smoke, a conventional cigarette.” (Appeal Br. 14 (quoting
Spec. ¶ 149).) Appellant argues that the term could also include “desiring a
cigarette so terribly that a sugary snack must be eaten,” i.e., so desiring a
cigarette that an action is taken other than smoking a cigarette. (Reply
Br. 4.) It is unclear how one would determine if a smoker experienced a
craving or an overwhelming craving. More specifically, it is unclear where
one would draw a line between an intense, urgent, or abnormal desire (a
craving) and a strong desire/desiring so terribly (an overwhelming craving).
In short, the meaning of the term “an overwhelming desire” is unclear.
Therefore, we are not persuaded that the Examiner erred in rejecting
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independent claims 1, 46, and 57 or the claims that depend from claims 1,
46, and 57 (claims 2, 4, 5, 47–50, and 58) under § 112(b).
Claim 51 does not recite “an overwhelming craving.” Rather,
claim 51 recites the smoker “deciding to smoke.” The Examiner interprets
this term as “experiencing an overwhelming craving,” and for the reasons
discussed above, rejects claim 51 under § 112(b). (Final Action 3.)
Appellant argues that “the artisan of ordinary skill would have
understood that a smoker ‘deciding to smoke’ has made an affirmative
decision to smoke.” (Appeal Br. 17.) We agree with Appellant. Claim 51
does not require a craving. Claim 51 requires that a decision be made, i.e.,
the smoker deciding to smoke. Therefore, we will reverse the rejection of
independent claim 51 and the claims that depend from claim 51 (claims 52–
54) under § 112(b).

The § 101 rejection
“Whoever invents or discovers any new and useful process, machine,
manufacture, or composition of matter, or any new and useful improvement
thereof, may obtain a patent therefor, subject to the conditions and
requirements of this title.” 35 U.S.C. § 101. Section 101, however,
“contains an important implicit exception: Laws of nature, natural
phenomena, and abstract ideas are not patentable.” Alice Corp. v. CLS Bank
Int’l, 573 U.S. 208, 216 (2014) (quoting Ass’n for Molecular Pathology v.
Myriad Genetics, Inc., 569 U.S. 576, 589 (2013)).
Alice applies a two-step framework, earlier set out in Mayo
Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66
(2012), “for distinguishing patents that claim laws of nature, natural
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phenomena, and abstract ideas from those that claim patent-eligible
applications of those concepts.” Alice, 573 U.S. at 217.
Under the two-step framework, it must first be determined if “the
claims at issue are directed to a patent-ineligible concept.” Id. at 218. If the
claims are determined to be directed to a patent-ineligible concept, e.g., an
abstract idea, then the second step of the framework is applied to determine
if “the elements of the claim . . . contain[] an ‘inventive concept’ sufficient
to ‘transform’ the claimed abstract idea into a patent-eligible application.”
Id. at 221 (citing Mayo, 566 U.S. at 72–73, 79).
With regard to step one of the Alice framework, we apply a “directed
to” two prong test to: 1) evaluate whether the claim recites a judicial
exception, and 2) if the claim recites a judicial exception, evaluate whether
the claim “appl[ies], rel[ies] on, or use[s] the judicial exception in a manner
that imposes a meaningful limit on the judicial exception, such that the claim
is more than a drafting effort designed to monopolize the judicial
exception.” See USPTO, 2019 Revised Patent Subject Matter Eligibility
Guidance, 84 Fed. Reg. 50, 54 (Jan. 7, 2019) (hereinafter “2019 Guidance”).
The Examiner determine that claim 1 “amounts to the abstract idea
grouping of a certain method of organizing human activity because it is
managing personal behavior or interactions between people (including social
activities, teaching, and following rules or instructions) by merely
encompassing a set of instructions to manage a person’s smoking behavior.”
(Final Action 6.)
Appellant argues that “the claimed limitations do not recite, and are
not directed to, only an abstract concept in any form” (Appeal Br. 23), and
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that “the claims are directed to a practical application in the field of tobacco
harm reduction” (id. at 30).
Under step one of the Alice framework, we “look at the ‘focus of the
claimed advance over the prior art’ to determine if the claim’s ‘character as a
whole’ is directed to excluded subject matter.” Affinity Labs of Texas, LLC
v. DIRECTV, LLC, 838 F.3d 1253, 1257 (Fed. Cir. 2016) (quoting Elec.
Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016)).
The “directed to” inquiry . . . cannot simply ask whether the
claims involve a patent-ineligible concept, because essentially
every routinely patent-eligible claim involving physical products
and actions involves a law of nature and/or natural phenomenon
. . . . Rather, the “directed to” inquiry applies a stage-one filter
to claims, considered in light of the specification, based on
whether “their character as a whole is directed to excluded
subject matter.” Internet Patents Corp. v. Active Network, Inc.,
790 F.3d 1343, 1346 (Fed. Cir. 2015).

Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335 (Fed. Cir. 2016). In
other words, the first step of the Alice framework “asks whether the focus of
the claims is on the specific asserted improvement in [the relevant
technology],” id. at 1335–36, or, instead, on a process in which additional
elements do “no more than generally link the use of [the abstract idea] to a
particular technological environment or field of use,” 2019 Guidance at 55.
The Specification provides evidence as to what the claimed invention
is directed. In this case, the Specification discloses that the invention relates
to “a method of transitioning a smoker of conventional cigarettes to an
aerosol device.” (Spec. ¶ 9.)4 Claim 1 provides further evidence. Claim 1

4 The Specification discloses that “[i]n the method, the aerosol device may
include a tobacco heating device and a supply of tobacco sticks.” (Spec.
¶ 10.)
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recites “providing the smoker a transition kit including a supply of very low
nicotine cigarettes, a tobacco heating device, and information and
recommendations for using said cigarettes and tobacco heating device during
a transitional period.” The remainder of claim 1 merely adds detail to the
nature of the cigarettes and the information and recommendation, e.g., that
the “cigarettes contain equal to or less than 2.0 mg of nicotine per cigarette,”
and that the information and recommendations include “instructions for the
smoker to stop smoking conventional cigarettes,” “recommendations or
instructions that upon the smoker experiencing an overwhelming craving . . .
to use the tobacco heating device,” and “recommendations or instructions for
the smoker to stop smoking the very low nicotine cigarettes at the end of the
transitional period.”
The instructions and recommendations recited in claim 1 are clearly
intended to be followed by the smoker. In view of the above, we agree with
the Examiner that claim 1 recites “managing personal behavior or
relationships or interactions between people (including social activities,
teaching, and following rules or instructions),” i.e., certain methods of
organizing human activity. (See 2019 Guidance at 52; see also Final
Action 6.)
With regard to the recitation in claim 1 of providing cigarettes and a
tobacco heating device, we note that in Mayo, the claim at issue recited
“administering a drug . . . to a subject having [the medical condition].”
Mayo, 566 U.S. at 74. The Supreme Court stated that the “‘administering’
step simply refers to the relevant audience” and that “the prohibition against
patenting abstract ideas cannot be circumvented by attempting to limit the
use of the formula to a particular technological environment.” Id. at 78
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(internal quotations omitted). In other words, “the administering step . . .
simply describes giving the drug to a patient with a certain disorder.” Endo
Pharm. USA, Inc. v. Teva Pharm. USA, Inc., 919 F.3d 1347, 1354 (Fed.
Cir. 2019). Similarly, the “providing” step in Appellant’s claim 1 simply
refers to the relevant audience for the recited information and
recommendations, i.e., it simply describes giving the cigarettes, heating
device, and information to the smoker.5
Nonetheless, Appellant seeks to analogize claim 1 to the hypothetical
claim 2 presented in Example 43 associated with the 2019 Guidance.
(Appeal Br. 28–33 (citing Subject Matter Eligibility Examples: Abstract
Ideas (available at https://www.uspto.gov/sites/default/files/
documents/101_examples_37to42_20190107.pdf at 2–6 (hereinafter “2019
Examples”))).)
In Example 43, hypothetical claims 1 and 2 recite:
1. A treatment method comprising:
(a) calculating a ratio of C11 to C13 levels measured in a
blood sample from a patient diagnosed with Nephritic

5 In a footnote, Appellant notes that independent claim 51 recites
“administering . . . very low nicotine cigarettes without restriction” and
“administering the aerosol device without restriction.” (Appeal Br. 28 n.2.)
However, Appellant does not present a persuasive argument in response to
the Examiner’s claim interpretation “that the term ‘administer’ (and any of
its variations, such as administered, administering, etc.) is interpreted as
‘provide information and recommendations for using cigarettes and an
aerosol device, including instructions’. . . . The originally filed disclosure is
particularly silent regarding any interpretation of the term ‘administer’ in the
medical context of administering a drug.” (Final Action 3.) In view of the
preceding, we determine that a broadest reasonable interpretation of the
claim term “administering” includes providing, i.e., providing information
and recommendations as well as very low nicotine cigarettes and an aerosol
device.
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Autoimmune Syndrome Type 3 (NAS-3) to identify the patient
as having a non-responder phenotype;
(b) administering a treatment to the patient having a non-
responder phenotype.

2. The method of claim 1, wherein the treatment is a non-
steroidal agent capable of treating NAS-3.

The 2019 Examples explain that claim 1 of Example 43 does not
recite patent-eligible subject matter. Limitation (a) recites both a
mathematical calculation and a mental process (2019 Examples at 4), and
limitation (b) “fails to meaningfully limit the claim because it does not
require any particular application of the recited calculation, and is at best the
equivalent of merely adding the words “apply it” to the judicial exception”
(id.).
In describing claim 2 of Example 43, the 2019 Examples state that
this limitation has more than a nominal relationship to the
judicial exception because it uses the recited abstract idea in a
manner that imposes a meaningful limit on it, i.e., the abstract
idea is used to identify the patient as being non-responsive to
glucocorticoids, and the patient is then administered a treatment
that is particular to that identified phenotype (i.e., a drug that is
not a glucocorticoid or other steroid.

(Id. at 6.) In contrast, Appellant’s claim 1 performs no tests before
providing the kit to the smoker. Nor is the smoker identified as in need of
the kit. We do not find Appellant’s argument persuasive.
In view of the above, we are not persuaded that the Examiner erred in
determining that claim 1 recites elements “amount[ing] to . . . managing
personal behavior or interactions between people (including social activities,
teaching, and following rules or instructions) by merely encompassing a set
of instructions to manage a person’s smoking behavior.” (Final Action 6.)
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With regard to our analysis under prong two, we note that the
limitations of claim 1 are recited at a high level of generality. For example,
claim 1 recites “instructions for the smoker to stop smoking conventional
cigarettes . . . and . . . to smoke the very low nicotine cigarettes . . . without
restriction during the transitional period,” and “recommendations or
instructions . . . to use the tobacco heating device without restriction at a
second point in time.” These limitations do not require a particular
application of a treatment and do not meaningfully limit the claim.
Further, we do not find any indication in the Specification that the
claimed invention effects a transformation or reduction of a particular article
to a different state or thing. Nor do we find anything of record to indicate
that the claimed invention applies or uses the judicial exception in some
other meaningful way beyond generally linking the use of the judicial
exception to a particular technological environment, such that the claim as a
whole is more than a drafting effort designed to monopolize the exception.
In sum, we do not find anything of record that indicates that the claimed
invention “appl[ies], rel[ies] on, or use[s] the judicial exception in a manner
that imposes a meaningful limit on the judicial exception, such that the claim
is more than a drafting effort designed to monopolize the judicial
exception.” (See 2019 Guidance at 54–55.)
Thus, under prong one of the two prong test in the 2019 Guidance,
claim 1 recites an abstract idea, i.e., certain methods of organizing human
activity; and, under prong two, additional elements in claim 1 do not “apply,
rely on, or use the judicial exception in a manner that imposes a meaningful
limit on the judicial exception, such that the claim is more than a drafting
effort designed to monopolize the judicial exception.” (See 2019 Guidance
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at 54.) As such, under step one of the Alice framework, claim 1 is directed
to an abstract idea, and we move to step two.
Step two of the Alice framework has been described “as a search for
an ‘ “inventive concept” ’ –i.e., an element or combination of elements that
is ‘sufficient to ensure that the patent in practice amounts to significantly
more than a patent upon the [ineligible concept] itself.’” Alice, 573 U.S.
at 217–18 (brackets in original) (quoting Mayo, 566 U.S. at 72–73).
Appellant argues that claim 1 recites “‘significantly more’ than a mere
abstract concept.” (Appeal Br. 35.) Appellant points to the claim recitations
of very low nicotine cigarettes, an aerosol device,6 and information and
recommendations. (Id.)
As an initial matter, we note that Appellant does not argue that
Appellant invented very low nicotine cigarettes, i.e., cigarettes “contain[ing]
equal to or less than 2.0 mg of nicotine per cigarette.” (Claim 1; see also
Reply Br. 11.) With regard to the number of cigarettes included in the kit,
claim 1 sets only a minimum, i.e., “at least 20 percent of the number of
conventional cigarettes the smoker smokes per day multiplied by the number
of days in the transitional period.” (Id.) There is no upper limit to the
number of cigarettes in the kit. Nor does Appellant argue that Appellant
invented a tobacco heating or aerosol device.
Moreover, the instructions and recommendations provided with the kit
do not require a particular application, that is, the recommendations and
instructions merely provide, e.g., “that upon the smoker experiencing an
overwhelming craving for a conventional cigarette, to use the tobacco

6 Claim 1 recites a tobacco heating device rather than an aerosol device.
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heating device without restriction at a second time point” and “that after the
second time point until the end of the transitional period, the smoker may
also smoke the very low nicotine cigarettes without restriction.” In short,
the recommendations and instructions provided in claim 1 merely generally
apply the abstract idea. This does not provide an inventive concept. See
BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. 2018)
(“It has been clear since Alice that a claimed invention’s use of the ineligible
concept to which it is directed cannot supply the inventive concept that
renders the invention ‘significantly more’ than that ineligible concept.”).
Taking the claim elements separately, the functions performed in
claim 1 by the low nicotine cigarettes and the tobacco heating device are
purely conventional. Considered as an ordered combination, the low
nicotine cigarettes and tobacco heating device add nothing that is not already
present when the elements are considered separately. For example, claim 1
does not purport to improve the functioning of the cigarettes or the tobacco
heating device. Nor does it effect an improvement in any other technology
or technical field. Instead, claim 1 amounts to nothing significantly more
than an instruction to apply the abstract idea using generic components
performing routine functions. That is not enough to transform an abstract
idea into a patent-eligible invention. See Alice, 573 U.S. at 225–26. We are
not persuaded that the Examiner erred in rejecting claim 1.
Nonetheless, Appellant seeks to analogize claim 1 to the claims in
BASCOM Global Internet Services, Inc. v. AT&T Mobility LLC, 827 F.3d
1341 (Fed. Cir. 2016). (Appeal Br. 10.) Specifically, Appellant argues that
“[l]ike the claims in Bascom [sic], claims of the present application provide
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a non-generic arrangement of elements.” (Appeal Br. 37.) We do not find
this argument persuasive.
In BASCOM, the court determined that “an inventive concept can be
found in the non-conventional and non-generic arrangement of known,
conventional pieces.” BASCOM, 827 F.3d at 1350. Specifically, “[t]he
inventive concept described and claimed in the ’606 patent is the installation
of a filtering tool at a specific location, remote from the end-users, with
customizable filtering features specific to each end user.” Id. at 1350. The
Federal Circuit determined that this “particular arrangement of elements is a
technical improvement over prior art ways of filtering.” Id. Here, however,
claim 1 does not recite any particular configuration of the low nicotine
cigarettes or the tobacco heating device. And, as discussed above, the
limitations of claim 1 are recited at a high level of generality. Appellant
does not persuasively argue why the claimed transition kit, i.e., the low
nicotine cigarettes, the tobacco heating device, and the instructions and
recommendations to the smoker, are analogous to a filtering tool installed at
a specific location with customizable features, that provides a technical
improvement in filtering.
Appellant also argues that “the pertinent inquiry is whether the claim
would pre-empt the judicial exception.” (Appeal Br. 38.) We do not find
this argument persuasive. Preemption is not a separate test.
“Where a patent’s claims are deemed only to disclose patent ineligible
subject matter under the Mayo framework, as they are in this case,
preemption concerns are fully addressed and made moot.” Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015).
In other words, “preemption may signal patent ineligible subject matter,
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[but] the absence of complete preemption does not demonstrate patent
eligibility.” Id.
In view of the above, we are not persuaded that the Examiner erred in
rejecting claim 1. Claims 2, 4, 5, 46–54, 57, and 58 are not separately
argued and fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv).7

The § 103 rejections
Obviousness is a legal conclusion involving a determination of
underlying facts.
Under § 103, the scope and content of the prior art are to be
determined; differences between the prior art and the claims at
issue are to be ascertained; and the level of ordinary skill in the
pertinent art resolved. Against this background, the obviousness
or nonobviousness of the subject matter is determined. Such
secondary considerations as commercial success, long felt but
unsolved needs, failure of others, etc., might be utilized to give
light to the circumstances surrounding the origin of the subject
matter sought to be patented.

KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting Graham v.
John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966)).
With regard to the scope and content of the prior art, the Examiner
finds that

7 Although the claims are nominally recited as method claims, they recite a
kit that includes instructions. The method being simply to provide the kit.
The Supreme Court “has long warn[ed] … against interpreting § 101 in
ways that make patent eligibility depend simply on the draftsman’s art.”
Alice, 573 U.S. at 226 (quoting Mayo, 566 U.S. at 72) (internal quotations
omitted). Regardless, the Examiner does not undertake a printed matter
analysis with regard to the patentable weight to be afforded the claimed
information and recommendations. We decline to undertake such analysis in
the first instance.
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McRobbie identifies that the NRT [(nicotine replacement
therapy)] is used according to standard practice under the
National Health Service’s Stop Smoking Service (NHS SSS),
and the NHS SSS standard practice regarding NRT is to
recommend using an NRT to alleviate cravings (NHS, pg. 2,
Where to get it and how to use it, “Inhalators, gum and sprays act
more quickly and may be better for alleviating cravings [than
nicotine patches].”).
Therefore, it would have been obvious to one of ordinary
skill in the art before the effective filing date of the claimed
invention for McRobbie to include recommendations or
instructions that upon the smoker experiencing an overwhelming
craving for a conventional cigarette, to use the aerosol device
without restriction at a second time point because it is standard
practice to use an NRT to alleviate cravings in general, which
necessarily includes overwhelming cravings.

(Final Action 16–17.) Further, the Examiner finds that “[n]owhere in
McRobbie is an explicit negative statement or suggestion” regarding the use
of denicotinized cigarettes (DNCs) to transition smokers to e-cigarettes.
(Answer 12.) “In fact, Appellant’s own citation from McRobbie
(“Electronic cigarettes ... may be a safer and more acceptable behavioral
replacement than DNCs.” McRobbie at 1140.) provides explicit motivation
for using DNCs to transition smokers to e-cigarettes.” (Id.)
Appellant argues that “[n]owhere does McRobbie mention or even
suggest ‘using DNCs to transition smokers to e-cigarettes.” (Reply Br. 13.)
In particular, Appellant argues that “McRobbie was not referring to
transitioning to e-cigarettes in any way, shape or form; the authors were
simply speculating that using electronic cigarettes (e-cigarettes), and not
denicotinized cigarettes (which were the behavioral replacement in their
subject trial), may be a more acceptable behavioral replacement for quitting
smoking.” (Id. (emphasis omitted).)
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McRobbie discloses
explor[ing] the efficacy and the mechanism of action of DNCs
when combined with a standard NHS Stop Smoking Service
(NHS SSS) program. Our hypothesis was that complementing
current NHS SSS treatments with DNCs, to address the
nonnicotine factors associated with smoking, and to help
extinguish smoking behavior, would result in lower urges to
smoke than ST [(standard treatments)] alone.

(McRobbie at 1135.) McRobbie’s study design involved smokers who
“were randomized (1:1 within pharmacotherapy group) on their TQD
[(target quit date)] to either the intervention group, where they received
standard NHS SSS treatment and a 2-week supply of DNCs
(DNC+ST), or the control group (ST).” (Id.)
[P]articipants were offered a range of NRTs (patch, gum,
inhalator, lozenge, mini lozenge, microtabs, nasal spray, and
mouth spray, including combination NRT), or varenicline, to use
for up to 12 weeks on prescription. . . . Participants were
randomized on the TQD and were sequentially allocated (via a
concealed envelope) to receive either DNC+ST or ST.

(Id.) McRobbie also noted that “[i]t is not clear how best to utilize DNCs in
treatment” and that “[e]lectronic cigarettes, which also offer some sensory
and behavioral input but without tobacco, may be a safer and more
acceptable behavioral replacement than DNCs.” (Id. at 1140.) In short, the
relied on portions of McRobbie disclose transitioning from smoking
conventional cigarettes to not smoking through the use of DNCs, but raises
the question of whether it would be safer and more acceptable to transition
from smoking conventional cigarettes to not smoking through the use of
electronic cigarettes. (See id.)
Therefore, we disagree with the Examiner that the relied on portions
of McRobbie provide “explicit motivation for using DNCs to transition
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20
smokers to e-cigarettes.” (See Answer 12.) Specifically, the relied on
portions of McRobbie disclose transitioning from smoking conventional
cigarettes, to an NRT (or combination NRT), to not smoking, rather than a
transition from smoking conventional cigarettes, to smoking DNCs, to
smoking electronic cigarettes.
In view of the above, we are persuaded that the Examiner erred in
rejecting claim 1 under § 103. The Examiner relies on similar findings in
rejecting independent claims 46, 51, and 57, and for similar reasons we are
persuaded of error. Therefore, we will reverse the rejections of claims 1, 2,
4, 5, 46–54, 57, and 58.

CONCLUSION
The Examiner’s rejection of claims 1, 2, 4, 5, 46–50, 57, and 58 under
35 U.S.C. § 112(b) is affirmed.
The Examiner’s rejection of claims 51–54 under 35 U.S.C. § 112(b) is
reversed.
The Examiner’s rejection of claims 1, 2, 4, 5, 46–54, 57, and 58 under
35 U.S.C. § 101 is affirmed.
The Examiner’s rejections of claims 1, 2, 4, 5, 46–54, 57, and 58
under 35 U.S.C. § 103 are reversed.

Specifically:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 2, 4, 5, 46–
54, 57, 58
112(b) Indefiniteness 1, 2, 4, 5,
46–50, 57,
58
51–54
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Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 2, 4, 5, 46–
54, 57, 58
101 Eligibility 1, 2, 4, 5,
46–54, 57,
58

1, 2, 5, 47, 48,
52, 53, 57, 58
103 McRobbie, NHS,
Farsalinos, Smith
1, 2, 5, 47,
48, 52, 53,
57, 58
46, 50, 51 103 McRobbie, NHS 46, 50, 51
4, 49, 54 103 McRobbie, NHS,
Farsalinos, Smith,
Applicant’s
admitted prior art
4, 49, 54
Overall Outcome 1, 2, 4, 5,
46–54, 57,
58

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).

AFFIRMED