Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Detailed Action
Filing Receipt and Priority
The filing receipt mailed 01/24/2026 states that the instant application is a 371 of PCT/US2022/028504, filed 05/10/2022, which claims benefit of 63/187,001, filed 05/11/2021.
The instant claims find support in the provisional application. Therefore, the effective filing date is 05/11/2021.
Information Disclosure Statement
The information disclosure statement submitted 05/06/2026 has been considered.
Restriction/Species Election
Applicant’s election of Group II, claims 31, 2-7, 10-17, 19, 20, 23-24, 27, 30-31 is acknowledged.
Applicant’s election of the following species is also acknowledged. Applicant has elected bupropion, zonisamide, and e-cigarettes.
Claim Interpretation
Claim 31 states the limitation “nicotine replacement or substitution product”. The specification does not explicitly define this term. However, the specification in para. [0057] states “suitable nicotine replacement or substitution products for the methods herein…are not particularly limited and broadly includes any products that can deliver nicotine to a subject user through non-combustible ways.” The specification in para. [0051] states “the method comprises administering to the subject the nicotine replacement or substitution product, such as an e-cigarette, nicotine patch, nicotine gum, nicotine lozenge, nicotine pouch, nasal spray nicotine dissolvable nicotine product, sublingual nicotine tablet, nicotine inhaler…and/or a modified risk tobacco product…”. These are repeated in para. [0058]. Considering the use within the specification, the term “nicotine replacement or substitution product” is interpreted to mean “nicotine replacement and/or nicotine substitution product” as exemplified by the specification.
Claim Objections
Claim 31 currently states “A method of treatment for facilitating a subject to switch from combustible cigarettes to e-cigarettes or another nicotine replacement or substitution product, or for reducing a subject’s craving for combustible cigarettes, or for treating dependency addiction, or withdrawal associated with combustible cigarettes in a subject, wherein the subject is a smoker, the method comprising administering to the subject: a) bupropion or hydroxybupropion; and b) an anticonvulsant or a GABAergic agent.”
The claim is essentially drawn to 3 related methods which are a) for facilitating a subject to switch from combustible cigarettes to e-cigarettes or another nicotine replacement or substitution product, b) for reducing a subject’s craving for combustible cigarettes in a subject, and c) for treating dependency, addiction, or withdrawal associated with combustible cigarettes. The claim language separates these methods out using only commas which is how applicant also separates limitations within the three methods. The claim would read better if the methods are separate via semi-colons as shown below.
“A method of treatment for facilitating a subject to switch from combustible cigarettes to e-cigarettes or another nicotine replacement or substitution product; or for reducing a subject’s craving for combustible cigarettes; or for treating dependency addiction, or withdrawal associated with combustible cigarettes in a subject, wherein the subject is a smoker, the method comprising administering to the subject: a) bupropion or hydroxybupropion; and b) an anticonvulsant or a GABAergic agent.”
Rejections
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 27 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 31 states “A method of treatment for facilitating a subject to switch from combustible cigarettes to e-cigarettes…the method comprising administering to the subject: a) bupropion or hydroxybupropion; and b) an anticonvulsant or a GABAergic agent.”
Claim 27 claims specific effects of the method which are i) “reduced the subject’s daily consumption of combustible cigarettes”, ii) “reduces the subject expired air CO level by 20% or more compared to baseline and/or reduces the urinary NNAL…by 20% or more compared to baseline”; and/or iii) “reduces the subject’s craving for combustible cigarettes.”
The specification para. [0070] outlines the study design and states “This single-group, small-scale, open-label study (N=24) evaluated the impact of combination zonisamide and bupropion on the process of switching from combustible cigarettes (CC) to an e-cigarette. There was a data collection period of at least five days to obtain baseline date on use of combustible cigarettes. Participants enrolled in the study received a G6 e-cigarette at V2 for ad libitum use. After the first week of e-cigarette use, (at V3) participants were given zonisamide…and began extended-release bupropion dosing…in addition to continued use of the G6.” Fig. 1 of the disclosure outlines the full schedule of the study.
The claimed method only requires the administration of bupropion and zonisamide. However, the claimed effects of claim 27 are the result of administration bupropion and zonisamide in conjunction with e-cigarette use. Effectively, claim 27 claims results that are not the result of the claimed method according to claim 31.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Indefiniteness
Claims 31, 2-7, 10-17, 19-20, 23-24, and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 31 states “A method of treatment for facilitating a subject to switch from combustible cigarettes to e-cigarettes or another nicotine replacement or substitution product, or for reducing a subject’s craving for combustible cigarettes or for treating dependency, addiction, or withdrawal associated with combustible cigarettes in a subject, wherein the subject is a smoker, the method comprising administering to the subject: a) bupropion or hydroxybupropion; and b) an anticonvulsant or a GABAergic agent.”
The claim is drawn to a method of treatment comprising a method comprising administering an unknown amount of bupropion and a GABAergic agent (elected zonisamide). The specification in para [0075] discusses effective doses of zonisamide. Para. [0076] discusses effective amounts of bupropion. However, neither of these amounts or even “an effective amount” are claimed in claim 31.
Dependent claim 2 specifies an amount of bupropion but not zonisamide. Dependent claim 10 specifies an amount of zonisamide but not bupropion.
As claims 3-7, 11-17, 19-20, 23-24, and 27 are dependent on claims 31, 2, and 10 they are also rejected.
For the purpose of examination, examiner assumes 100 mg of Zonisamide is an effective amount as discussed in para. [0075] and 150-300 mg of bupropion per day is an effective amount as discussed in para. [0076].
Antecedent Basis
Claim 7 recites the limitation "pharmaceutically acceptable salt" in l. 2. Claims 2 and 31 from which claim 7 depends from do not mention a “pharmaceutically acceptable salt”. Therefore, there is insufficient antecedent basis for the limitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
KSR Rationales
The MPEP in section 2143, subsection I gives examples of Rationales for supporting a conclusion of obvious. These rationales are non-exhaustive and include (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Claim(s) 2-7, 10-17, 19-20, 23-24, and 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tam (US2008/0103179), in view of FDA (FDA drug label for WELLBUTRIN®, dated 2017, reference ID 4094044, url= https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018644s052lbl.pdf, accessed 05/28/2026), Beard (CNS Drugs, 2016, 30:951-983), Rehman (Drug Design, Development and Therapy, 2020:14 3777-3786), Rűther (International Journal of Hygiene and Environmental Health, 221, 2018, 191-198), Caponnetto (Health Psychology Research, 2020, 8:9463), and Pulvers (Nicotine & Tobacco Research, Vol. 16, No. 5, 2014, 591-599).
Regarding claims 31, 2, 10-17, Tam is drawn to an invention for treating “diabetes, hypertension, migraine, epilepsy, sleep apnea, depression, impulse control disorders or alcohol addiction which involves treating a subject with a sympathomimetic agent… in combination with an anticonvulsant sulfamate compound…or an anticonvulsive sulfonylurea (e.g. zonisamide)” (abstract). Tam in para. [0037] and [0039] contemplates combinations of zonisamide, in amounts of 20 mg to 200 mg, with bupropion (50mg to 200 mg) or phentermine. Tam in para. [0092] contemplates sequential administration and simultaneous administration.
Regarding claims 2-7, an FDA label for bupropion (WELLBUTRIN®) teaches doses for bupropion (p. 1, Dosage and Administration), a starting dose of 200 mg given as 100 mg twice daily, teaches sustained-release formulations and immediate release forms (sec. 5.4, para. 2 and 3), oral administration (p. 17, Animal Data), and a hydrochloric salt form (p. 20, sec. Description).
Regarding claim 30, Beard is drawn to pharmacological agents to “aid smoking cessation and tobacco harm reduction” (title). Beard in its abstract states “A wide range of support is available to help smokers quit and to aid attempts at harm reduction, including three first-line smoking cessation medications: nicotine replacement therapy, varenicline and bupropion.” Beard in sec. 3.3.5, para. 1 states “Three other drugs that may also offer some utility for smoking cessation include zonisamide…”.
Specifically, regarding claim 7, an FDA label for bupropion, in sec. Description, teaches a pharmaceutical salt version of bupropion.
This is further affirmed by Rehman where on p. 3778, right col., para. 2, it states “A pilot clinical study for smoking cessation showed that Zonisamide (a sulfonamide derivative decreased nicotine withdrawal and craving.”
Therefore, at least between Tam, Beard, and Rehman, one of ordinary skill in the art would find it obvious to combine zonisamide and bupropion to reduce a subject’s craving for combustible cigarettes or for treating dependency, addiction, or withdrawal associated with combustible cigarettes.
Regarding claims 19 and 20, Rűther in its introduction states “In recent years, the electronic cigarette (e-cigarette) has established itself internationally as an alternative to the tobacco cigarette, and some studies have shown that e-cigarettes can be used also to aid smoking cessation.” This is affirmed by Caponnetto which, in sec. Conclusion, states, “Although e-cigarettes have not been proven to be totally safe, evidence suggests that they may be less harmful alternatives to combustible cigarette smoking. The findings from these studies, conducted with first generation and second-generation e-cigarettes, suggests that the provision of e-cigarettes can significantly reduce traditional cigarette consumption and CO expire breath without worsening of general state of health and without showing significant and serious Adverse Events (AEs).” Therefore, it would be obvious to one of ordinary skill that reducing cravings of combustible cigarettes would lead to subjects adopting e-cigarette use more readily.
Regarding claim 24, Pulvers discusses methods of classifying smokers. Pulvers on p. 592, sec. Participants states “These participants were current smokers (i.e. smoked at least one cigarette in the past 30 days), had smoked at least 100 cigarettes in their lifetime, smoked for at least 1 year, smoked at their current rate (i.e. daily or nondaily) for at least 6 months, and had not participated in any smoking cessation treatment in the past 30 days.” Pulvers continues “Nondaily smokers smoked at least one cigarette on 4-24 days in the past 30 days…Daily smokers smoked 25-30 days in the past 30 days and were further stratified into light daily smokers (≤10 cigarettes per days; CPD) and moderate to heavy daily smokers (> 10 CPD).” This teaching indicates that one of ordinary skill in the art would at least be able to determine to what degree a subject would be considered a “smoker”.
Regarding claim 23, none of the references above discuss “obesity” as condition to be treated. Within the art, obesity and/or weight loss is not tied directly to smoking cessation. Therefore, one of ordinary skill would find it obvious to administer bupropion and zonisamide to smokers who are not in need of treatment of obesity.
The combination of bupropion and zonisamide is contemplated by Tam. The art recognizes both bupropion and zonisamide as compounds effective for smoking cessation and/or quitting smoking. The art also recognizes e-cigarettes as potential alternative to combustible cigarettes while a smoker reduces nicotine intake to quit smoking. The MPEP section 2144.06 states
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)
Therefore, it would have been prima facie obvious at the time of the effective filing date for one of ordinary skill in the art to have combined administering bupropion with administering zonisamide to reduce a subject’s craving for combustible cigarettes and/or for treating dependency, addiction, or withdrawal associated with combustible cigarettes. One of ordinary skill would also find it prima facie obvious to administer bupropion in combination with zonisamide in order to facilitate a subject to switch from combustible cigarettes to electronic cigarettes. One of ordinary skill would find motivation to make the combination as each of zonisamide, bupropion, and e-cigarettes are known within the art to be effective for affecting smoking cessation.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
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