DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/23/2025 has been entered.
Applicants' arguments, filed 10/23/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) dated 04/30/2024 complies with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 103 - Obviousness
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 21-22 and 24-41 stand rejected under 35 U.S.C. 103 as being unpatentable over Reddick (U.S. 2014/0255452 – provided as citation no. 121 on IDS dated 7/6/2021) in view of Strickland (U.S. 2009/0133703) and Pederson (U.S. 2012/0039981).
Reddick teaches an oral pouch comprising nicotine (e.g. Abstract, [0029]). The nicotine may be absorbed on a porous carrier such as microcrystalline cellulose [0050]. The composition may contain natural or artificial sweeteners such as sucralose and/or mannitol, binders such as HPMC, pH control agents such as sodium bicarbonate, and natural flavors such as mint, cinnamon, or cherry [0050]. The compositions may be formulated inside an outer coating [0050][0053](Figures 4a, 4b). Outer coatings can provide delayed release and include materials such as celluloses, carnauba wax and shellac [0050], [0053]. The pouch may be made of fleece material [0027]. The nicotine is present in amounts less than 5wt% [0046]. It is preferred that the compositions be free of tobacco components other than nicotine [0041]. Suitable forms of nicotine include fatty acid salts [0043].
Reddick does not explicitly teach the addition of the amount of tobacco or flavor in the composition. This deficit is cured by the teachings of Strickland and Pederson.
Strickland teaches a tobacco film comprising polysorbate 80, propylene glycol monostearate, microcrystalline cellulose, HPMC, cinnamon and sucralose were uniformly dispersed [0037-0039]. The film ingredients are described in Table A1 reproduced below;
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The ingredients were formed into a foam to increase the dissolution rate [0037]. No tobacco was used in the film [0039]. Rather, titanium dioxide and colorant were added [0039]. The films produced are taught to disintegrate in the mouth (e.g. dissolve) [0038][0107]. The products may be placed in a bag that is formed from an open or highly porous material such as fabric [0233]. Upon placement into the oral cavity, the water soluble film layer dissolves or disintegrates ([0101], [0233]). Strickland teaches that the compositions can be made into gel or gel beads [0200]. Exemplary gel formats include alginate, pectin, carrageenan, HPMC and starches [0201]. Suitable formats for the composition are starches and alginates [0026]. Strickland teaches the range of fiber used in the composition to be about 2% to about 40% (Strickland at Table A1 and Examples). Strickland teaches the range of starch used in the composition to be about 1% to about 40% (Strickland at Table A1 and Examples). Strickland further teaches the embodiments with about 1% to about 40% flavoring (Strickland at Table A1 and Examples).
Strickland does not teach the addition of erythritol.
Pederson teaches a nicotine containing pouch [0086] wherein the sweetener is erythritol [0156].
It would have been prima facie obvious to a person having ordinary skill in the art following the teachings of Reddick to include carrageenan in place of HPMC given Strickland recognizes the carrageenan and HPMC as equivalents. MPEP 2144.06.
Similarly, Pederson recognizes erythritol and mannitol as equivalent non-sugar sweeteners, so one of ordinary skill in the art would have been motivated to include erythritol in the composition of Reddick.
It would have been prima facie obvious to a person having ordinary skill in the art following the teachings of Reddick to include about 1% to about 40% starch in the composition given Strickland recognizes the suitability of this an amount of starch for its intended use in tobacco delivery compositions. See MPEP 2144.07. The range of about 1% to about 40% taught by Strickland overlaps the instantly claimed amount of about 30% to about 70%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
It would have been prima facie obvious to a person having ordinary skill in the art following the teachings of Reddick to include about 1% to about 40% flavor in the composition given Strickland recognizes the suitability of this an amount of flavor for its intended use in flavored tobacco delivery compositions. See MPEP 2144.07. The range of about 1% to about 40% taught by Strickland overlaps the instantly claimed amount of about 1% to about 20%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Obviousness Remarks
Applicant's arguments filed 10/23/2025 have been fully considered but they are not persuasive.
Applicant argues that the cited prior art does not teach the amended limitations.
The Examine does not agree. Strickland teaches a tobacco film comprising polysorbate 80, propylene glycol monostearate, microcrystalline cellulose, HPMC, cinnamon and sucralose were uniformly dispersed [0037-0039]. The film ingredients are described in Table A1 reproduced below;
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The ingredients were formed into a foam to increase the dissolution rate [0037]. No tobacco was used in the film [0039]. Rather, titanium dioxide and colorant were added [0039]. The films produced are taught to disintegrate in the mouth (e.g. dissolve) [0038][0107]. The products may be placed in a bag that is formed from an open or highly porous material such as fabric [0233]. Upon placement into the oral cavity, the water soluble film layer dissolves or disintegrates ([0101], [0233]). Strickland teaches that the compositions can be made into gel or gel beads [0200]. Exemplary gel formats include alginate, pectin, carrageenan, HPMC and starches [0201]. Suitable formats for the composition are starches and alginates [0026]. Strickland teaches the range of fiber used in the composition to be about 2% to about 40% (Strickland at Table A1 and Examples). Strickland teaches the range of starch used in the composition to be about 1% to about 40% (Strickland at Table A1 and Examples). Strickland further teaches the embodiments with about 1% to about 40% flavoring which includes flavoring oils (Strickland at Table A1 and Examples). It would have been prima facie obvious to a person having ordinary skill in the art following the teachings of Reddick to include about 1% to about 40% starch in the composition given Strickland recognizes the suitability of this an amount of starch for its intended use in tobacco delivery compositions. See MPEP 2144.07. The range of about 1% to about 40% taught by Strickland overlaps the instantly claimed amount of about 30% to about 70%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). It would have been prima facie obvious to a person having ordinary skill in the art following the teachings of Reddick to include about 1% to about 40% flavor in the composition given Strickland recognizes the suitability of this an amount of flavor for its intended use in flavored tobacco delivery compositions. See MPEP 2144.07. The range of about 1% to about 40% taught by Strickland overlaps the instantly claimed amount of about 1% to about 20%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Thus, Applicants argument that Reddick, Strickland and Pederson does not teach or suggest the amended limitations is unpersuasive.
Applicants argue that the cited prior art does not teach or suggest an encapsulated agent wherein the encapsulated agent comprises an exterior wall and an interior portion comprising a lipid and a component selected from the group consisting of an active agent, a flavorant, and combinations thereof.
Examiner disagrees. Claim 21 recites an oral product comprising a mixture within a porous pouch, wherein the mixture comprises a particulate non-tobacco filler material, a nicotine component, and an encapsulated agent, wherein the encapsulated agent comprises an exterior wall and an interior portion comprising a lipid and a component selected from the group consisting of an active agent, a flavorant, and combinations thereof. Applicants are reminded that the claims are given their broadest reasonable interpretation during examination. MPEP 2111. Reddick teaches nicotine containing products may have an outer coating such as carnauba wax, shellacs, glazing compositions, and surface polishing agents [0050]. Such a coating may be used to provide delayed release of the active agent [0053]. The coating is distinct from the pouch material, which is preferably fleece. Here, the skilled artisan is a person designing drug release dosages (i.e. M.D. or synthetic chemist) and having ordinary creativity. MPEP 2142.03. Such a person is not an automaton, but a person having the ability put teachings together like pieces of a puzzle. Id. As such, a person having ordinary skill in the art would find it prima facie obvious to coat the active agent (see e.g. particles of fig 4a) and place the coated nicotine fatty acid salt containing particles into in the fleece pouch for administration. As such, the active agent and lipid (i.e. fatty acid) are located inside a coating and the coated particles are located inside the pouch. This orientation appears to be different from that proposed by Applicants (argument at p.7). Examiner notes that while Reddick suggests an embodiment where a fatty acid is used in a coating for sustained release [0054], Reddick also permits the fatty acid form of nicotine to be located inside a modified release coating. Depending on the coating selected, the skilled artisan would have a reasonable expectation of providing delayed or sustained release of the nicotine active agent. Thus, Applicants argument that Reddick does not teach or suggest coating the active agent with a lipid and including the coated mixture inside the pouch is unpersuasive.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/ patents/apply/applying-online/eterminal-disclaimer.
Claims 21-22 and 24-41 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of US Patent No.12,496,276 B2 previously U.S. Patent Application No 17/170,998 (reference patent) in view of Reddick (U.S. 2014/0255452 – provided as citation no. 121 on IDS dated 7/6/2021), Strickland (U.S. 2009/0133703), and Pederson (U.S. 2012/0039981).
It would be prima facie obvious to have used the amounts taught in Reddick, Strickland and Pederson for the composition taught in the reference patent because the reference claims (see claims 11-25) and the prior art teach a porous pouch comprising nicotine, filler, encapsulating agents, oil and flavor agents. See MPEP 2144.07.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
Double Patenting Remarks
Applicants request the rejection be held in abeyance until allowable subject matter is identified.
Since terminal disclaimers have not yet been filed, the non-statutory double patenting rejections are maintained.
Conclusion
No claims are currently allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612