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 .
Status of the Claims
This office action is in response to Applicant’s amendment filed 11/17/2025.
Claims 1-65 are pending and are subject to this Office Action.
Claim 44 is amended.
Claims 48 and 61-63 are cancelled.
Claim 65 is previously withdrawn.
Response to Amendment
The Examiner notes that, regarding the IDS filed 05/22/2024, all references have been considered. The Examiner thanks the Applicant for the explanation of relevance for non-patent literature document 26 (Kharkevich).
The Examiner notes that the double patenting rejections over Patent Nos. 12,016,366; 11,540,557; 11,399,562 and Application No. 17/009,446 are withdrawn due to amendments to the claims filed 11/17/2022. The conflicting claims did not appropriately teach or make obvious the amended water, sugar alcohol content and water-insoluble fiber content in combination. The Examiner notes that rejections over Patent Nos. 11,805,802; 12,245,627 and 11,096,412 are modified below.
Response to Arguments
Applicant’s arguments, see pages 11-18, filed 11/17/2025, with respect to the 103 rejection of claim 44 have been fully considered but they are not persuasive. Claim 44 has been amended to include subject matter of cancelled claims 48 and 60-63, in addition to newly presented limitations to the water, sugar alcohol and water-insoluble fiber contents. Prior art reference Gerardi does not teach at least one water-insoluble fiber as claimed Therefore, the rejection has been withdrawn. However, Aspgren et al. (US 20180140007 A1), previously cited in the rejection of claims 60-63, teaches this limitation. Therefore, claim 44 is rejected in further view of Aspgren.
On page 12, the Applicant argues that Gerardi does not teach the water amount required by amended claim 44.
The Examiner disagrees. Gerardi teaches water in an amount of 15 % - 65 % by weight of the composition ([0071] teaches a water content of at least 10%, generally about 10% to about 60%. The claimed range overlaps the range taught by the prior art and is therefore considered prima facie obvious).
On pages 12-13 the Applicant argues that moist nicotine product is not an alternative to dry nicotine product, and as such, one having ordinary skill would not be motivated to increase the water content of the composition of Gerardi.
The Examiner notes that Gerardi teaches an overlapping range. Therefore, no modification is needed to make obvious the claimed composition, and the argument is therefore not persuasive.
On pages 14-17 (Additional Remarks) the Applicant appears to argue against impermissible hindsight reasoning and a lack of reasonable expectation of success. However, the Applicant does not specify the portion of the rejection to which this argument refers. It is therefore unclear if the Applicant is arguing against the Examiner’s rejection or merely making note of these two concepts.
The following is a modified rejection based on amendments to the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to 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 44-48, 52-53, 60 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Gerardi et al. (US 20210169890 A1) in view of Aspgren et al. (US 20180140007 A1).
Regarding claim 44, Gerardi teaches a non-tobacco oral nicotine pouch composition (pouched product 100 containing material 104; [0115]), comprising:
water in an amount of 15 % - 40 % by weight of the composition ([0071] teaches a water content of at least 10%, generally about 10% to about 60%. The claimed range overlaps the range taught by the prior art and is therefore considered prima facie obvious);
Nicotine ([0074]);
and at least one sugar alcohol in an amount of 10% to 50% by weight of the pouch composition ([0082] teaches that a sugar alcohol may be present in an amount of 0.1% to 20% by weight. The claimed range overlaps the range taught by the prior art and is therefore prima facie obvious),
wherein the pouch composition is free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol ([0083] teaches that humectants such as propylene glycol may be added to some embodiments but are not required by all embodiments. Thus, Gerardi does not explicitly disclose that these humectants are necessary to the invention).
Gerardi further teaches that the oral nicotine pouch may comprise a cellulosic filler ([0009], [0069]).
Gerardi does not specify that the cellulosic filler is a water-insoluble fiber.
Aspgren, directed to a non-tobacco oral nicotine pouch composition (oral pouched product; [0054]), comprising: moisture, including water, in an amount of at least 15% by weight of the pouch composition ([0065]); nicotine ([0056]); and at least one sugar alcohol ([0056]), wherein the pouch composition is free of humectants (Aspgren does not explicitly disclose that these humectants are necessary to the invention), teaches the use of water-insoluble fiber fillers ([0055], [0063]) in an amount of 10% to 45% by weight of the pouch composition ([0063] teaches 1% to 60%. claimed range overlaps the range taught by the prior art and is therefore prima facie obvious), wherein the least one water-insoluble fiber is selected from maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, bamboo fibers, and combinations thereof ([0055], [0063]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Gerardi by using a water-insoluble fiber filler in an amount of 10% to 45% by weight of the pouch composition as taught by Aspgren because both Gerardi and Aspgren are directed to oral nicotine pouches comprising fillers, Aspgren teaches that water-insoluble fiber is an art-recognized filler for oral nicotine pouches, and this involves applying a known teaching to a similar product to yield predictable results.
Regarding claim 45, Gerardi teaches the pouch composition is further free of humectants consisting of modified starch, triacetin, polyethylene glycol (PEG), pectin, and xanthan gum (Xanthan gum, pectin, polyethylene glycol mentioned as potential polymeric components in [0052], [0064] and [0066], respectively. However, these components are not explicitly required by Gerardi).
Regarding claim 46, Gerardi teaches that the pouch composition comprises 0 - 0.4% by weight of humectants ([0083] teaches about 0.1% to about 1% humectants. The claimed range overlaps the range taught by the prior art and is therefore considered prima facie obvious).
Regarding claim 47, Gerardi teaches that the pouch composition is free of humectants ([0083] teaches that humectants such as propylene glycol may be added but are not required).
Regarding claim 48, Gerardi teaches that the pouch composition comprises the at least one sugar alcohol in an amount of at least 1% by weight of the composition ([0082] teaches the at least one sugar alcohol in an amount of about 0.1% to about 20%. The claimed range overlaps the range taught by the prior art and is therefore considered prima facie obvious).
Regarding claim 52, Gerardi teaches that the pouch composition comprises the nicotine in an amount of at least 0.1% by weight ([0077] teaches nicotine in an amount of about 0.1% to about 10%, which anticipates the claimed range).
Regarding claim 53, Gerardi teaches that the nicotine is selected from the group consisting of a nicotine salt, nicotine free base, nicotine-ion exchange resin combination, nicotine bound to cellulose, and mixtures thereof ([0073-0076]).
Regarding claim 64, Gerardi teaches a pH regulating agent ([0085]).
Claims 49-51 are rejected under 35 U.S.C. 103 as being unpatentable over Gerardi and Aspgren as applied to claim 44 above, and further in view of Wittorff (US 20190350857 A1).
Regarding claim 49, Gerardi does not explicitly teach that the at least one sugar alcohol comprises non-directly compressible (non-DC) grade sugar alcohol.
Wittorff, directed to a non-tobacco oral nicotine composition ([0003]), comprising nicotine ([0030]) and at least one sugar alcohol ([0013-0014]), teaches that the pure form of sugar alcohols is non-DC ([0013]). Wittorff further teaches that non-DC sugar alcohols may improve taste ([0009]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Gerardi by non-DC grade sugar alcohol as taught by Wittorff because both Gerardi and Wittorff are directed to non-tobacco oral nicotine compositions comprising sugar alcohols, one having ordinary skill in the art would recognize that there are two forms of sugar alcohols for oral products, and this involves choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. One having ordinary skill in the art may also expect a sugar alcohol to be provided in its pure non-DC form when no processing, granulation, or agglomeration is specified.
Regarding claim 50, Gerardi teaches that the at least one sugar alcohol is selected from the list consisting of xylitol, maltitol, mannitol, erythritol, isomalt, lactitol, and any combination thereof ([0082]).
Gerardi does not explicitly teach that the at least one sugar alcohol comprises non-directly compressible grade sugar alcohol.
Wittorff, directed to a non-tobacco oral nicotine composition ([0003]), comprising nicotine ([0030]) and at least one sugar alcohol ([0013-0014]), teaches that the pure form of sugar alcohols is non-DC ([0013]). Wittorff further teaches that non-DC sugar alcohols may improve taste ([0009]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Gerardi by non-DC grade sugar alcohol as taught by Wittorff because both Gerardi and Wittorff are directed to non-tobacco oral nicotine compositions comprising sugar alcohols, one having ordinary skill in the art would recognize that there are two forms of sugar alcohols for oral products, and this involves choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. One having ordinary skill in the art may also expect a sugar alcohol to be provided in its pure non-DC form when no processing, granulation, or agglomeration is specified.
Regarding claim 51, Wittorff teaches that the non-directly compressible (non-DC) grade sugar alcohol(s) is provided as particles, which have not been subject to granulation or agglomeration steps ([0011-0013]).
Claims 54-58 are rejected under 35 U.S.C. 103 as being unpatentable over Gerardi and Aspgren as applied to claim 44 above, and further in view of Phililps et al. (US 20190200667 A1).
Regarding claim 54, Gerardi teaches a nicotine-ion exchange resin with a nicotine content of about 0.1% to about 10% by weight of the pouch composition ([0076-0077]).
Gerardi does not explicitly teach the amount of exchange resin by weight of the pouch composition.
Phililps, directed to a non-tobacco oral nicotine pouch composition ([0020]), comprising: moisture in an amount of at least 10% by weight of the pouch composition ([0027]); nicotine ([0028]); and at least one sugar alcohol ([0033], [0035]), wherein the pouch composition is free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose and glycerol (Phililps does not explicitly disclose that these humectants are necessary to the invention), teaches that a nicotine resin can include 20-40 weight percent nicotine ([0030]).
Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art that the exchange resin of Gerardi may include 20-40% nicotine by weight as taught by Phililps because both Gerardi and Phililps are directed to non-tobacco oral nicotine pouch compositions containing nicotine-ion exchange resins, Gerardi is silent to the amount of resin compared to the amount of nicotine and one with ordinary skill would be motivated to look to prior art for a known and suitable nicotine-ion exchange resin, and this involves applying a known teaching to a similar product to yield predictable results.
A nicotine content of about 0.1% to about 10% by weight of the pouch composition wherein the resin includes 20-40% by weight nicotine corresponds to a nicotine-ion exchange resin combination in an amount corresponding to 0.5 to 25% by weight of the pouch composition. The claimed range of 0.1-20% overlaps the range taught by the prior art and is therefore prima facie obvious.
Regarding claim 55, Gerardi teaches that the nicotine-ion exchange resin combination comprises nicotine complexed with ion exchange resin ([0076]).
Regarding claim 56, Gerardi teaches that the nicotine-ion exchange resin combination comprises free-base nicotine mixed with ion exchange resin ([0076] states that "at least a portion of the nicotine can be in the form of a resin complex", indicating that the nicotine-ion exchange resin combination may comprise free-base nicotine (as in [0074]) mixed with ion exchange resin).
Regarding claim 57, Phililps teaches that the nicotine-ion exchange resin combination comprises nicotine in an amount of between 5 and 50% by weight ([0030] teaches that the nicotine-ion exchange resin combination comprises nicotine in an amount of between 20% and 40% by weight, which anticipates the claimed range).
Regarding claim 58, Gerardi teaches that the ion-exchange resin comprises one or more resins selected from the group consisting of a copolymer of methacrylic acid and divinylbenzene, the copolymer containing carboxylic functional groups ([0076] teaches the use of Amberlite IRP64, which is a copolymer of methacrylic acid and divinylbenzene, the copolymer containing carboxylic functional groups).
Regarding claim 59, Gerardi teaches that the ion-exchange resin comprises polacrilex resin ([0076]).
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.
Rejection 1
Claim 44 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of Patent No. 11,805,802.
Although the claims at issue are not identical, they are not patentably distinct from each other because the above sets of claims are directed to a non-tobacco oral nicotine pouch composition comprising: water in an amount of 15 % to 40% by weight of the pouch composition; nicotine; and at least one sugar alcohol in an amount of 10% to 50% by weight of the pouch composition; wherein the pouch composition comprises at least one water-insoluble fiber in an amount of 10% to 45% by weight of the pouch composition wherein the at least one water-insoluble fiber is selected from wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, bran fibers, bamboo fibers, chemically unmodified powdered cellulose, and combinations thereof.
The claims differ in that the conflicting claims do not specify that the pouch composition is free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol. However, these components are not required by the conflicting claims and are therefore not considered to be necessary to the inventions. Thus, the conflicting claims are considered to teach that the pouch composition is free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol.
The claims further differ in that conflicting claims recite additional limitations directed to the composition. However, the conflicting claims still include all required components are rejected base claim 44. Therefore, all elements of rejected base claim 44 are present.
Rejection 2
Claim 44 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 3-4 of Patent No. 12,245,627 in view of Aspgren et al. (US 20180140007 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the above sets of claims are directed to a non-tobacco oral nicotine pouch composition comprising: water in an amount of 15 % to 40% by weight of the pouch composition; nicotine; and at least one sugar alcohol in an amount of 10% to 50% by weight of the pouch composition; wherein the pouch composition comprises at least one water-insoluble fiber in an amount of 10% to 45% by weight of the pouch composition.
The conflicting claims differ in that they do not teach wherein the at least one water-insoluble fiber is selected from wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, bran fibers, bamboo fibers, chemically unmodified powdered cellulose, and combinations thereof.
Aspgren, directed to a non-tobacco oral nicotine pouch composition (oral pouched product; [0054]), comprising: moisture, including water, in an amount of at least 15% by weight of the pouch composition ([0065]); nicotine ([0056]); and at least one sugar alcohol ([0056]), wherein the pouch composition is free of humectants (Aspgren does not explicitly disclose that these humectants are necessary to the invention), wherein the pouch composition comprises at least one water-insoluble fiber filler ([0055], [0063]) in an amount of 10% to 45% by weight of the pouch composition ([0063] teaches 1% to 60%. claimed range overlaps the range taught by the prior art and is therefore prima facie obvious), teaches that the least one water-insoluble fiber is selected from maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, apple fibers, cocoa fibers, bamboo fibers, and combinations thereof ([0055], [0063]).
It would be obvious for one having ordinary skill in the art to modify the conflicting claims by using an insoluble fiber of the type taught by Aspgren because both the conflicting claims and Aspgren are directed to oral nicotine pouch compositions, Aspgren teaches types of water insoluble fibers known in the art, and this involves applying a known teaching to a similar product to yield predictable results.
The claims further differ in that the conflicting claims do not specify that the pouch composition is free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol. However, these components are not required by the conflicting claims and are therefore not considered to be necessary to the inventions. Thus, the conflicting claims are considered to teach that the pouch composition is free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol.
The claims further differ in that conflicting claims recite additional limitations directed to the composition. However, the conflicting claims still include all required components are rejected base claim 44. Therefore, all elements of rejected base claim 44 are present.
Rejection 3
Claims 44 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 14 and 16 of Patent No. 11,096,412 in view of Gerardi et al. (US 20210169890 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the above sets of claims are directed to a non-tobacco oral nicotine pouch composition comprising: water in an amount of 15 % to 40% by weight of the pouch composition; nicotine; and at least one sugar alcohol; wherein the pouch composition comprises at least one water-insoluble fiber in an amount of 10% to 45% by weight of the pouch composition wherein the at least one water-insoluble fiber is selected from wheat fibers, pea fibers, rice fiber, maize fibers, oat fibers, tomato fibers, barley fibers, rye fibers, sugar beet fibers, buckwheat fibers, potato fibers, cellulose fibers, apple fibers, cocoa fibers, bran fibers, bamboo fibers, chemically unmodified powdered cellulose, and combinations thereof.
The claims differ in that the conflicting claims do not teach sugar alcohol in an amount of 10% to 50% by weight of the pouch composition.
Gerardi, directed to a non-tobacco oral nicotine pouch composition (pouched product 100 containing material 104; [0115]), comprising: water in an amount of 15 % - 65 % by weight of the composition ([0071] teaches a water content of at least 10%, generally about 10% to about 60%. The claimed range overlaps the range taught by the prior art and is therefore considered prima facie obvious); nicotine ([0074]); and at least one sugar alcohol ([0082]), teaches a sugar alcohol content in an amount of 10% to 50% by weight of the pouch composition ([0082] teaches that a sugar alcohol may be present in an amount of 0.1% to 20% by weight. The claimed range overlaps the range taught by the prior art and is therefore prima facie obvious).
It would be obvious for one having ordinary skill in the art to modify the conflicting claims by using the sugar alcohol content as taught by Gerardi because both the conflicting claims and Gerardi are directed to oral nicotine pouch compositions, the conflicting claims are silent as to a sugar alcohol composition and one with ordinary skill would be motivated to look to prior art for a known and suitable compositions, and this involves applying a known teaching to a similar product to yield predictable results.
The claims differ in that the conflicting claims do not specify that the pouch composition is free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol. However, these components are not required by the conflicting claims and are therefore not considered to be necessary to the inventions. Thus, the conflicting claims are considered to teach that the pouch composition is free of humectants consisting of alginate, propylene glycol, hydroxypropyl cellulose, and glycerol.
The claims further differ in that conflicting claims recite additional limitations directed to the composition. However, the conflicting claims still include all required components are rejected base claim 44. Therefore, all elements of rejected base claim 44 are present.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.D./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755