DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-12, 14, 16, 19, 22, and 28 in the reply filed on 04/29/2026 is acknowledged.
Claims 25-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/29/2026.
Status of the claims
Claims 13, 15, 17-18, 20-21, 23-24, and 29-50 were cancelled in a previous communication. Claims 25-27 are withdrawn.
Claims 1-12, 14, 16, 19, 22, and 28 are currently under examination.
Information Disclosure Statement
Initialed and dated copies of Applicants’ information disclosure statements (IDS) filed on
07/22/2024 is attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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.
Claim 22 is 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 22 recites the limitation "the 6-methylnicotine" in line 2. There is insufficient antecedent basis for this 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-12, 14, 16, 19, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US20210169790A1, Published 06/10/2021) in view of Pan et al. (CN114437025A, Published 05/06/2022) further in view of Agren et al. (WO2021219624A1, Published 11/04/2021).
Applicant’s invention
The Applicants claims are drawn to a smoking cessation product for oral delivery, comprising: a. an oral pouch comprising a saliva-permeable non-woven fabric; and b. a composition contained within the oral pouch, the composition comprising: i. a 6-methylnicotine salt or complex; and ii. a filler.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1 and 6, Johnson teaches an oral pouched product, comprising a fleece material in the form of a pouch and containing a material, the fleece material comprising fibers and a releasable component (claim 16). Johnson also teaches the pouched products comprise at least one fleece material that may be in the form of a nonwoven fabric (paragraph [0057]). Johnson further teaches that the substrate may include at least one filler component such as mannitol (paragraph [0129]) as well as microcrystalline cellulose (paragraph [0131]).
Regarding claims 2 and 11-12, Johnson teaches one or more humectant may be employed such as glycerin, propylene glycol, and the like (paragraph [0156]). Johnson also teaches the releasable component may comprise one or more flavoring agents (paragraph [0006]). Johnson further teaches the substrate material also may include one or more sweeteners such as fructose, sucrose, glucose, maltose, saccharin, aspartame, acesulfame, monosaccharides, and disaccharides (paragraph [0154]). Johnson continues to teach that the releasable component (i.e., inner payload) may be encapsulated in a plurality of capsules (paragraph [0007]).
Regarding claim 7, Johnson teaches in certain embodiments, that the substrate material may include one or more binding agents such as pectin (paragraph [0155]) and the binder can be natural gums derived from plans such as gum Arabic (paragraph [0156]).
Regarding claim 8, Johnson teaches that the substrate materials can comprise pH adjusters such as sodium carbonate and sodium bicarbonate (paragraph [0157]).
Regarding claim 14, Johnson teaches that fleece materials of the present disclosure may be configured to have improved characteristics with respect to organoleptic properties and/or dissolution profile. A “fleece material” according to the present disclosure may be formed from various types of fibers (e.g., conventional cellulosic fibers (e.g., such as viscose fibers (paragraph [0061]).
Regarding claim 16, Johnson teaches
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in Fig. 1 a pouched product, wherein the fleece material is in the form of a pouch 102, which contains a substrate material 104. The fleece material in the form of a pouch comprises a releasable component 106 (paragraph [0054]). Johnson further teaches that in some embodiments, the two or more discrete portions may be sealed together by applying pressure and or heat to the layered portions. In some embodiments, the seal may be applied across the entirety of the layered portions or, alternatively, the layered portions may be sealed only in specified portions thereof. For example, the layered portions of fleece material (i.e., first and second non-woven fabric) may be sealed only along the periphery of the discrete portions such that the inner cross section of the product is bulkier when compared with the sealed peripheral edges (paragraph [0117]).
Regarding claim 19, Johnson teaches the particular percentages of active ingredients present will vary depending upon the desired characteristics of the particular product. Typically, an active ingredient or combination thereof is present in a total concentration of at least about 0.001% by weight of the overall product, not including the fleece material, such as in a range from about 0.001% to about 20% (paragraph [0071]).
Regarding claim 28, Johnson teaches products configured for oral use may take various forms, including pouchless products which can be in the form of an oral film (paragraph [0172]) wherein the products comprising the fleece materials of the present disclosure may be a dissolvable product that is capable of lasing in the user’s mouth for a given period of time until it completely dissolves (paragraph [0173]). Johnson further teaches binders such as pectin, sodium alginate, pullulan (i.e., film-forming saliva-soluble polymer) (paragraph [0155]).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Johnson does not teach 6-methylnicotine salt or complex; wherein the 6- methylnicotine salt is selected from the group consisting of 6-methylnicotine hydrochloride, 6-methylnicotine dihydrochloride, 6-methylnicotine monotartrate, 6-methylnicotine bitartrate, 6-methylnicotine bitartrate dihydrate, 6-methylnicotine sulphate, 6-methylnicotine malate, 6- methylnicotine benzoate, 6-methylnicotine citrate, 6-methylnicotine levulinate, 6- methylnicotine zinc chloride monohydrate, 6-methylnicotine salicylate, and combinations thereof; wherein the 6- methylnicotine complex is selected from the group consisting of 6-methylnicotine cyclodextrin complex, 6-methylnicotine polacrilex, and combinations thereof; and wherein the 6- methylnicotine cyclodextrin complex comprises p-cyclodextrin (beta-cyclodextrin). However these deficiencies are cured by Pan et al. and Agren.
In the analogous art of nicotine, Pan teaches the invention relates to racemic 6-methylnicotine (abstract). Pan also teaches that the nicotine of the above-mentioned new type of tobacco products, as the core functional component, can make the people who quit smoking get nicotine supplement and reduce the withdrawal reaction (background section, first paragraph). Pan also teaches it is necessary to provide a racemic 6-methylnicotine with a simple preparation process and better sensory experience (Summary of the invention, first paragraph). Pan further teaches the preparation method of racemic 6-methylnicotine according to the above technical scheme of the present invention is simple in process, does not need to perform chiral resolution, and has low cost. Tests have proved that when the racemic 6-methylnicotine prepared by the above preparation method is used in a new type of tobacco product, it has a strong sense of satisfaction and throat hit, and has better sensory experience, which is beneficial to application (Summary of the invention, sixth paragraph).
In the analogous art of nicotine oral delivery, Agren teaches there is provided a nicotine oral delivery product containing a composition enclosed in a water insoluble pouch, wherein said pouch is permeable for saliva and dissolved components of the composition, the composition comprising a source of nicotine and a cellulose derivative (abstract). Agren also teaches examples of suitable sources of nicotine include tobacco, nicotine salt, nicotine base, wherein suitable nicotine salts include, but are not limited to the following: nicotine hydrochloride, nicotine dihydrochloride, nicotine monotartrate, nicotine bitartrate, nicotine bitartrate dihydrate, nicotine sulphate, nicotine zinc chloride monohydrate and nicotine salicylate, and mixtures thereof and nicotine beta-cyclodextrin inclusion complexes (pages 3-4, lines 29-33 and 1-12). Agren further teaches preferably, the source of nicotine of the composition of the nicotine oral delivery product of the present invention is stabilized nicotine. Preferably, the source of nicotine is nicotine polacrilex (nicotine bound to an ion-exchange resin such as Amberlite IRP64 or Purolite C115HMR or Doshion P551) (page 4, lines 22-25).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have 6-methylnicotine in Johnson’s oral pouched product. One would have understood in view of Pan the nicotine of the above-mentioned new type of tobacco products, as the core functional component, can make the people who quit smoking get nicotine supplement and reduce the withdrawal reaction (background section, first paragraph). Pan also teaches it is necessary to provide a racemic 6-methylnicotine with a simple preparation process and better sensory experience (Summary of the invention, first paragraph). The skilled artisan would have been motivated to have 6-methylnicotine in Johnson’s oral pouched product to take advantage of the benefit that the preparation method of racemic 6-methylnicotine according to the above technical scheme of the present invention is simple in process, does not need to perform chiral resolution, and has low cost. Tests have proved that when the racemic 6-methylnicotine prepared by the above preparation method is used in a new type of tobacco product, it has a strong sense of satisfaction and throat hit, and has better sensory experience, which is beneficial to application (Summary of the invention, sixth paragraph) taught by Pan. The skilled artisan would have had a reasonable expectation of success because Johnson teaches the one or more active ingredients may be selected from the group consisting of a nicotine (paragraph [0006]), and Pan teaches the nicotine of the above-mentioned new type of tobacco products, 6-methylnicotine, as the core functional component, can make the people who quit smoking get nicotine supplement and reduce the withdrawal reaction (background section, first paragraph).
With regards to the limitations wherein the 6- methylnicotine salt is selected from the group consisting of 6-methylnicotine hydrochloride, 6-methylnicotine dihydrochloride, 6-methylnicotine monotartrate, 6-methylnicotine bitartrate, 6-methylnicotine bitartrate dihydrate, 6-methylnicotine sulphate, 6-methylnicotine malate, 6- methylnicotine benzoate, 6-methylnicotine citrate, 6-methylnicotine levulinate, 6- methylnicotine zinc chloride monohydrate, 6-methylnicotine salicylate, and combinations thereof; wherein the 6- methylnicotine complex is selected from the group consisting of 6-methylnicotine cyclodextrin complex, 6-methylnicotine polacrilex, and combinations thereof, it would have been obvious to have a salt or complex of 6-methylnicotine in Johnson’s oral pouched product. Johnson teaches the active ingredient comprises a nicotine component. By “nicotine component” is meant any suitable form of nicotine (e.g., free base or salt) for providing oral absorption of at least a portion of the nicotine present (paragraph [0094]) and Typically, the nicotine component is selected from the group consisting of nicotine free base, a nicotine salt such as hydrochloride, dihydrochloride, monotartrate, bitartrate, sulfate, salicylate, and nicotine zinc chloride (paragraph [0095]); at least a portion of the nicotine can be in the form of a resin complex of nicotine, where nicotine is bound in an ion-exchange resin, such as nicotine polacrilex (paragraph [0096]). It would have been obvious to one of ordinary skill in the art to have a salt or complex of 6-methylnicotine in Johnson’s oral pouched product because Johnson teaches salts and complexes of nicotine can be used as the active ingredient which is the nicotine component.
With regards to the limitation wherein the 6- methylnicotine cyclodextrin complex comprises β-cyclodextrin (beta-cyclodextrin), it would have been obvious to one of ordinary skill to have β-cyclodextrin (beta-cyclodextrin) as the complex in Johnson’s oral pouch product. Johnson teaches One would have understood in view of Agren that examples of suitable sources of nicotine include tobacco, nicotine salt, nicotine base, wherein suitable nicotine salts include, but are not limited to the following: nicotine beta-cyclodextrin inclusion complexes (pages 3-4, lines 29-33 and 1-12). It would have been obvious to one of ordinary skill in the art to have β-cyclodextrin (beta-cyclodextrin) as the complex in Johnson’s oral pouch product because Johnson teaches complexes of nicotine can be used as the active ingredient which is the nicotine component and Agren teaches nicotine beta-cyclodextrin inclusion complexes (pages 3-4, lines 29-33 and 1-12) as a suitable source of nicotine.
With regards to the limitation wherein the pH of an aqueous solution of the composition is in a range of 7.0 to 9.5, it would have been obvious to one of ordinary skill in the art to optimize the pH of the composition because Johnson teaches that the substrate materials can comprise pH adjusters such as sodium carbonate and sodium bicarbonate (paragraph [0157]). Therefore, it would have been obvious to optimize the pH of the composition using the pH adjusters by routine experimentation to achieve the desired results. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 (II). With regards to the limitation wherein the composition is free of a pH adjuster, the Examiner points out that Johnson teaches that in certain embodiments that the substrate materials can comprise a pH adjuster, therefore, it is not required for the composition to comprise a pH adjuster (i.e., free of a pH adjuster).
With regards to the limitation wherein the composition comprises 0.5 mg to 10mg of the 6-methylnicotine, it would have been obvious to optimize the concentration of the 6-methylnicotine because Johnson teaches the particular percentages of active ingredients present will vary depending upon the desired characteristics of the particular product. Typically, an active ingredient or combination thereof is present in a total concentration of at least about 0.001% by weight of the overall product, not including the fleece material, such as in a range from about 0.001% to about 20% (paragraph [0071]). Therefore, it would have been obvious to optimize the concentration of the 6-methylnicotine by routine experimentation to achieve the desired results. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 (II).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US20210169790A1, Published 06/10/2021) in view of Pan et al. (CN114437025A, Published 05/06/2022) further in view of Agren et al. (WO2021219624A1, Published 11/04/2021) further in view of Cheetham et al. (PLoS ONE 17(4), Published 04/14/2022).
Applicant’s invention
Johnson, Pan and Agren render obvious all the limitations of instant claim 1. Applicants claim 22 further adds the limitation wherein the 6-methylnicotine comprising the 6-methylnicotine salt or complex comprises at least 90% (S)-6-methylnicotine, based on the total weight of 6-methylnicotine.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 22, Johnson teaches the one or more active ingredients may be selected from the group consisting of a nicotine (paragraph [0006]), and Pan teaches the nicotine of the above-mentioned new type of tobacco products, 6-methylnicotine, as the core functional component, can make the people who quit smoking get nicotine supplement and reduce the withdrawal reaction (background section, first paragraph). Pan further teaches in the preparation method of artificially synthesized nicotine, racemic nicotine contains two configurations of nicotine, R and S (background section, second paragraph).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Johnson, Pan and Agren does not teach wherein the 6-methylnicotine comprising the 6-methylnicotine salt or complex comprises at least 90% (S)-6-methylnicotine, based on the total weight of 6-methylnicotine. However this deficiency is cured by Cheetham.
Cheetham teaches there is significant regulatory and economic need to distinguish analytically between tobacco-derived nicotine (TDN) and synthetic nicotine (SyN) in commercial products. Currently, commercial e-liquid and oral pouch products are available that contain tobacco-free nicotine, which could be either extracted from tobacco or synthesized. While tobacco products that contain TDN are regulated by FDA Center for Tobacco Products, those with SyN are currently not in the domain of any regulatory authority. This regulatory difference provides an economic incentive to use or claim the use of SyN to remain on the market without submitting a Premarket Tobacco Product Application. TDN is ~99.3% (S)-nicotine, whereas SyN can vary from racemic (50/50 (R)/(S)) to ≥ 99% (S)-nicotine, i.e., chemically identical to the tobacco-derived compound (abstract). Cheetham also teaches the (S)-enantiomer possesses the well-known pharmacological properties associated with tobacco use (Fig 1). SyN is commonly produced as a racemic (50:50) mixture of both the (S)- and (R)-enantiomers that then may be enriched to produce ≥ 99% (S)-nicotine. The exception to this is a chemoenzymatic approach patented by Zanoprima Lifesciences that enzymatically reduces myosmine to produce ≥ 99% (S)-nornicotine, followed by methylation to yield (S)-nicotine (Scientific context section). Cheetham further teaches Radiocarbon analysis offers a definitive method to differentiate tobacco-derived nicotine from synthetic nicotine for regulatory purposes and that other tobacco products such as modern oral products (e.g., pouches, tablets, gum, discs) will also be analyzed in future work (conclusion section).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have the 6-methylnicotine salt or complex comprises at least 90% (S)-6-methylnicotine, based on the total weight of 6-methylnicotine. Pan teaches the nicotine of the above-mentioned new type of tobacco products, 6-methylnicotine, as the core functional component, can make the people who quit smoking get nicotine supplement and reduce the withdrawal reaction (background section, first paragraph), wherein the artificially synthesized nicotine, racemic nicotine contains two configurations of nicotine, R and S (background section, second paragraph). One would have understood in view of Cheetham that the regulatory difference provides an economic incentive to use or claim the use of SyN to remain on the market without submitting a Premarket Tobacco Product Application. TDN is ~99.3% (S)-nicotine, whereas SyN can vary from racemic (50/50 (R)/(S)) to ≥ 99% (S)-nicotine, i.e., chemically identical to the tobacco-derived compound (abstract). Cheetham also teaches the (S)-enantiomer possesses the well-known pharmacological properties associated with tobacco use (Fig 1). SyN is commonly produced as a racemic (50:50) mixture of both the (S)- and (R)-enantiomers that then may be enriched to produce ≥ 99% (S)-nicotine. The exception to this is a chemoenzymatic approach patented by Zanoprima Lifesciences that enzymatically reduces myosmine to produce ≥ 99% (S)-nornicotine, followed by methylation to yield (S)-nicotine (Scientific context section). Cheetham further teaches Radiocarbon analysis offers a definitive method to differentiate tobacco-derived nicotine from synthetic nicotine for regulatory purposes and that other tobacco products such as modern oral products (e.g., pouches, tablets, gum, discs) will also be analyzed in future work (conclusion section). It would have been obvious to one of ordinary skill to have the 6-methylnicotine salt or complex comprises at least 90% (S)-6-methylnicotine, based on the total weight of 6-methylnicotine because Pan teaches the nicotine of the above-mentioned new type of tobacco products, 6-methylnicotine, is artificially synthesized nicotine, racemic nicotine contains two configurations of nicotine, R and S (background section, second paragraph) and Cheetham teaches SyN is commonly produced as a racemic (50:50) mixture of both the (S)- and (R)-enantiomers that then may be enriched to produce ≥ 99% (S)-nicotine. The exception to this is a chemoenzymatic approach patented by Zanoprima Lifesciences that enzymatically reduces myosmine to produce ≥ 99% (S)-nornicotine, followed by methylation to yield (S)-nicotine (Scientific context section).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFUA BAMFOAA BOATENG whose telephone number is (703)756-1358. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
AFUA BAMFOAA BOATENGExaminer, Art Unit 1617
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