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 .
Continued Examination Under 37 CFR 1.114
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 4/30/2026 has been entered.
Specification
The use of the term Drambuie [0213], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 21 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.
Regarding claim 21, it is unclear whether the recitation of “an aqueous phase” actually requires the oral pouch product to contain an aqueous phase, and whether the partition coefficient exists without the presence of an aqueous phase. The claim is therefore indefinite. For the purposes of this Office action, the limitation will not be considered to limit claim 1.
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 (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 1-3, 5-9, 12 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gao (US 9,999,243) in view of McDermott (US 12,161,146).
Regarding claims 1-2 and 21, Gao discloses a tobacco lozenge including a body that is receivable in the oral cavity containing a soluble fiber matrix and exhausted tobacco fiber, which are considered to form a dry mixture including a cellulosic material and nicotine (abstract). Gao does not explicitly disclose the liquid mixture including a liquid triglyceride. The nicotine is liquid nicotine (column 11, lines 45-53), and water is provided at between 2 weight percent to 10 weight percent (column 15, lines 9-18). The lozenge is wrapped by a dissolvable film made from Shellac (column 7, lines 12-40), which is considered to meet the claim limitation of a hydrophobic material. Gao does not explicitly disclose (a) the liquid nicotine being dissolved in a liquid triglyceride and (b) the moisture content being within the claimed range.
Regarding (a), McDermott teaches an oral product including a fibrous substrate and a carrier liquid that includes nicotine (abstract) and aids in distribution of the active ingredient into a user’s saliva (column 5, lines 7-22). The liquid carrier is MCT oil (column 5, lines 7-22), which is considered to meet the claim limitation of a liquid triglyceride.
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the liquid nicotine of Gao with the MCT oil carrier liquid of McDermott. One would have been motivated to do so since McDermott teaches that placing nicotine in a carrier liquid aids in distribution of the active ingredient into a user’s saliva.
Regarding (b), one of ordinary skill in the art would recognize that the claimed moisture range is obvious. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See MPEP § 2144.05 (I).
Regarding claim 3, McDermott teaches that water is an alternative carrier liquid to the MCT (column 5, lines 7-22), indicating that liquid carriers with MCT omit water.
Regarding claim 5, Gao discloses that the nicotine is absorbed into the tobacco fiber (column 1, lines 38-60), indicating that, in the combination, the MCT would also be absorbed since it is also a liquid.
Regarding claim 6, Gao discloses that lozenge also includes microcrystalline cellulose (column 13, lines 48-67), which would evidently be a part of the solid mixture since it isn’t a liquid.
Regarding claim 7, modified Gao teaches all the claim limitations as set forth above. Gao additionally discloses that the lozenge includes between 0.5 mg and 10 mg nicotine. Modified Gao does not explicitly teach the nicotine weight falling within the claimed range.
However, one of ordinary skill in the art would recognize that the claimed nicotine range is obvious. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See MPEP § 2144.05 (I).
Regarding claims 8 and 9, Gao discloses that the lozenge includes flavorants (column 4, lines 21-38).
Regarding claim 12, one of ordinary skill in the art would recognize that Shellac cannot be woven and is therefore a non-woven material.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gao (US 9,999,243) in view of McDermott (US 12,161,146) as applied to claim 1 above, and further in view of Mola (EP 2428126).
Regarding claim 10, modified Gao teaches all the claim limitations as set forth above. Modified Gao does not explicitly teach a seam.
Mola teaches a smokeless oral product comprising a permeable pouch formed from material such as polyolefin polymers [0012]. The polyolefin polymer may include polyethylene and polypropylene [0044]. Applicant’s specification discloses that polyethylene and polypropylene are considered hydrophobic materials [0033]. The oral pouch exterior containing seams [0036].
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the porous pouch of Gao from the polyethylene and polypropylene of Mola. One would have been motivated to do so since modified Gao teaches a pouch for an oral product and Mola teaches a permeable pouch made from polyethylene and polypropylene. The selection of a known material based on its suitability for its intended use supports prima facie obviousness. See MPEP § 2144.07.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gao (US 9,999,243) in view of McDermott (US 12,161,146) as applied to claim 1 above, and further in view of Aspgren (US 2018/0271139).
Regarding claim 11, modified Gao teaches all the claim limitations as set forth above. Modified Gao does not explicitly teach a total weight of the product.
Aspgren teaches that the total weight of commercially available oral pouch products is between 0.3 and 1.7 grams [0023].
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the weight of the product of modified Gao fall within the range of Aspgren. One would have been motivated to do so since Aspgren teaches a suitable weight for an oral pouch product.
Claims 13-16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gao (US 9,999,243) in view of McDermott (US 12,161,146) and Gentilcore (WO 2021/219490).
Regarding claims 13-14 and 16, Gao discloses a tobacco lozenge including a body that is receivable in the oral cavity containing a soluble fiber matrix and exhausted tobacco fiber, which are considered to form a dry mixture including a cellulosic material and nicotine (abstract). Gao does not explicitly disclose the liquid mixture including a liquid triglyceride. The nicotine is liquid nicotine (column 11, lines 45-53), and water is provided at between 2 weight percent to 10 weight percent (column 15, lines 9-18). The lozenge is wrapped by a dissolvable film made from Shellac (column 7, lines 12-40), which is considered to meet the claim limitation of a hydrophobic material. Gao does not explicitly disclose (a) the liquid nicotine being dissolved in a liquid triglyceride, (b) the moisture content being within the claimed range and (c) the outer wrapper containing an elastomeric material.
Regarding (a), McDermott teaches an oral product including a fibrous substrate and a carrier liquid that includes nicotine (abstract) and aids in distribution of the active ingredient into a user’s saliva (column 5, lines 7-22). The liquid carrier is MCT oil (column 5, lines 7-22), which is considered to meet the claim limitation of a liquid triglyceride.
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the liquid nicotine of Gao with the MCT oil carrier liquid of McDermott. One would have been motivated to do so since McDermott teaches that placing nicotine in a carrier liquid aids in distribution of the active ingredient into a user’s saliva.
Regarding (b), one of ordinary skill in the art would recognize that the claimed moisture range is obvious. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See MPEP § 2144.05 (I).
Regarding (c), Gentilcore teaches a chewable nonwoven fabric for an oral pouched product (abstract) made from thermoplastic polyurethane (page 6, lines 35-40).
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the porous pouch of Gao from the nonwoven fabric of Gentilcore. One would have been motivated to do so since Gentilcore teaches a fabric that makes an oral pouch chewable. The selection of a known material based on its suitability for its intended use supports prima facie obviousness. See MPEP § 2144.07.
Regarding claim 15, McDermott teaches that water is an alternative carrier liquid to the MCT (column 5, lines 7-22), indicating that liquid carriers with MCT omit water.
Regarding claims 18 and 19, Gao discloses that the lozenge includes flavorants (column 4, lines 21-38).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Gao (US 9,999,243) in view of McDermott (US 12,161,146) and Gentilcore (WO 2021/219490) as applied to claim 13 above, and further in view of Goode (WO 2016/099960).
Regarding claim 17, modified Gao teaches all the claim limitations as set forth above. Modified Gao teach the outer wrapping of the pouch having no seams.
Goode teaches an oral pouch product inside a tubular enclosure having no seams (abstract) so that seam failure forcing a user to cease using the product and remove loose snuff from his mouth (page 3, lines 8-21).
It would therefore have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the pouch of modified Gao from the seamless material of Goode. One would have been motivated to do so since Goode teaches that seamless pouches avoid the disadvantages of seam failure.
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 1-3, 6, 8-9, 13-15, 18-19 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 12,295,412 (hereafter referred to as Chen). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1, 13 and 21, Chen claims an oral pouch product comprising a wrapper defining a cavity, a filling material in the cavity, the filling material including a dry mixture including a cellulosic material and a liquid mixture including a triglyceride oil and liquid nicotine being dissolved in the oil (claim 1). One of ordinary skill in the art would recognize that the oil is liquid since it would otherwise be unable to dissolve the liquid nicotine. The oil is present in an amount from 10 weight percent to 50 weight percent (claim 8), and the pouch contains less than 5 weight percent water (claim 1). The pouch includes an elastomer (claim 29) which is polyurethane (claim 31), which is considered to meet the claim limitation of a hydrophobic material. Chen does not explicitly claim the claimed ranges being obvious.
However, one of ordinary skill in the art would recognize that the claimed ranges are obvious. In the case where claimed ranges “overlap or lie inside ranges disclosed by prior art” a prima facie case of obviousness exists. See MPEP § 2144.05 (I).
Regarding claims 2 and 14, Chen claims that the triglyceride is a medium chain triglyceride (claim 12).
Regarding claims 3 and 15, Chen claims that the liquid mixture includes only oil and nicotine (claim 1), indicating that it is water free.
Regarding claim 6, Chen claims that the cellulosic material includes MCC (claim 3).
Regarding claims 8-9 and 18-19, Chen claims the cellulosic material including a flavorant (claim 23).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL E SPARKS whose telephone number is (571)270-1426. The examiner can normally be reached Monday-Friday, 9:00 am-5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Louie can be reached at 571-270-1241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUSSELL E SPARKS/ Primary Examiner, Art Unit 1755
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