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
Claims 1, 2, 4, 6-9, 11-14, 17-19, 22, 25, 30, 32, 34, 37, 43, 50 and 53 are pending.
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 9/12/24, 3/19/25, and 2/23/26. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in DK on 3/18/24. It is noted, however, that applicant has not filed a certified copy of the PCT/DK2024/050052 application as required by 37 CFR 1.55. See failure of electronic retrieval dated 2/12/25.
Claim Objections
Claim 11 is objected to because of the following informalities:
In claim 11, lines 2-3 “sugar alcohol” is repeated in error.
Appropriate correction is required.
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.
Claims 1, 2, 4, 6-9, 11-14, 17-19, 22, 25, 30, 32, 34, 37, 43, 50 and 53 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 pre-AIA the applicant regards as the invention.
The term “fast” in claim 1 is a relative term which renders the claim indefinite. The term “fast” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how quickly the tablet must dissolve, and under what conditions, to be considered “fast”. For the purpose of examination, any orally disintegrating tablet will be considered fast. Claims 2, 4, 6-9, 11-14, 17-19, 22, 25, 30, 32, 34, 37, 43 and 53 are rejected as depending from and not clarifying claim 1.
The term “fast” in claim 50 is a relative term which renders the claim indefinite. The term “fast” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how quickly the tablet must dissolve, and under what conditions, to be considered “fast”. For the purpose of examination, any orally disintegrating tablet will be considered fast.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4, 6-9, 11-13, 17, 18, 22, 25, 30, 32, 37, 43, 50 and 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nielsen et al. (WO 2021/069036; cited in IDS).
Nielsen et al. teach a water-dissolvable compressed oral nicotine lozenge comprising a first module and a second module, the first and the second modules being fused by compression, the first module being a lozenge module comprising at least one sugar alcohol and the second module being a fast-disintegrating tablet (FDT) comprising at least one sugar alcohol and nicotine (e.g. page 1, line 28-page 2, line 2).
Regarding Claims 1, 2, 4, 6, 7, 11-13, 17, 18, 25, and 53, Nielsen et al. exemplify a formulation comprising a first and second module, and the second module comprises 3 wt% nicotine bi-tartrate (i.e. nicotine salt), 10 wt% superdisintegrant, 75 wt% mannitol (i.e. sugar alcohol) and 0 wt% flavor (e.g. Examples 41 and 42 on page 53).
Regarding Claims 8, 9, and 50, the second module of Examples 41 and 42 contain 0 wt% high intensity sweetener.
Regarding Claim 22, the examples of Nielsen are compressed tablets (e.g. pages 44-45 and 53).
Regarding Claim 30, Examples 41 and 42 comprise 3 wt% nicotine bi-tartrate in a 100 mg second module (e.g. page 52, lines 7-10, and page 53), which calculates to 3 mg nicotine bitartrate.
Regarding Claims 32 and 37, the second module of Examples 41 and 42 contain 5 wt% of a buffer.
Regarding Claim 43, the second module of Examples 41 and 42 contain does not contain dissolution modifiers (i.e. 0%).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 2, 4, 6-9, 11-14, 17-19, 22, 25, 30, 32, 34, 37, 43, 50 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen et al. (WO 2021/069036; cited in IDS).
Regarding Claims 1, 2, 4, 6-9, 1-13, 17, 18, 22, 25, 30, 32, 37, 43, 50 and 53 the teachings of Nielsen are described supra.
Regarding Claims 14 and 19, Examples 41 and 42 recite “Superdisintegrant” but do not identify a specific compound (e.g. page 53). However, examples 9-16 of Nielsen et al. teach that the superdisintegrant is crospovidone, and may otherwise be crosslinked cellulose (such as sodium carboxy methyl cellulose), crosslinked starch, crosslinked alginic acid, natural superdisintegrants, low-substituted hydroxypropylcellulose (L-HPC) and calcium silicate (e.g. page 47, lines 9-12). It would have been obvious to one of ordinary skill in the art at the time of filing to select crospovidone, or any of the recited superdisintegrants taught by Nielsen et al. for use in Examples 41 and 42 because Nielsen teaches that they are suitable for the tablets.
Regarding Claim 34, Examples 41 and 42 recite “Buffer” but do not identify a specific compound (e.g. page 53). However, examples 1-8 of Nielsen et al. teach that the buffer is sodium carbonate, and may otherwise be other carbonates, including monocarbonates, bicarbonates and sesquicarbonates, glycerinate, phosphate, glycerophosphate, acetate, glyconate or citrate of an alkali metal, ammonium, tris buffer, amino acids and mixtures thereof (e.g. page 46, lines 16-20). It would have been obvious to one of ordinary skill in the art at the time of filing to select sodium carbonate, or any of the recited buffers taught by Nielsen et al. for use in Examples 41 and 42 because Nielsen teaches that they are suitable for the tablets.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 4, 6-9, 11-14, 17-19, 22, 25, 30, 32, 34, 37, 43, 50 and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-11, 14, 15, 17, 20, 23, 25, 28, 31, 32, 35, 38, and 44-46 of copending Application No. 18/883,634 in view of Nielsen et al. (WO 2021/069036; cited in IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an orally disintegrating nicotine tablet, the tablet comprising nicotine, disintegrant, and at least one sugar alcohol (polyol).
Copending ‘634 does not claim wherein the tablet comprises less than 0.4% by weight of flavor. This is made up for by the teachings of Nielsen et al.
Nielsen et al. teach a water-dissolvable compressed oral nicotine lozenge comprising a first module and a second module, the first and the second modules being fused by compression, the first module being a lozenge module comprising at least one sugar alcohol and the second module being a fast-disintegrating tablet (FDT) comprising at least one sugar alcohol and nicotine (e.g. page 1, line 28-page 2, line 2). Nielsen et al. teach that nicotine stability is increased by facilitating separation of nicotine from flavor and thereby minimizing any flavor induced degradation of nicotine in the second module, and may be free of flavor (e.g. page 26, lines 20-31).
It would have been obvious to one of ordinary skill in the art at the time of filing to formulate the compositions of ‘634 to be free of flavor in order to obtain the benefits described by Nielsen et al. of nicotine stability. One of ordinary skill in the art would have predicted success because of the similarity in composition between copending ‘634 and Nielsen et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
Claim 1, 2, 4, 6, 7, 43 are met by copending claim 1 and Nielsen et al.
Claims 8, 9, 50 and 53 are met by Nielsen as described supra.
Claims 11 and 12 are met by copending claims 8 and 9.
Claim 13 is met by copending claim 10.
Claim 14 is met by copending claim 11.
Claim 17 is met by copending claim 14.
Claim 18 is met by copending claim 10.
Claim 19 is met by copending claim 17.
Claim 22 is met by copending claim 20.
Claim 25 is met by copending claim 23.
Claim 30 is met by copending claim 28.
Claim 32 is met by copending claim 31.
Claim 34 is met by copending claim 32.
Claim 37 is met by copending claim 35.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 4, 6-9, 11-14, 17-19, 22, 25, 30, 32, 34, 37, 43, 50 and 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/337,441 in view of Nielsen et al. (WO 2021/069036; cited in IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an orally disintegrating nicotine tablet, the tablet comprising nicotine, disintegrant, and at least one sugar alcohol (polyol).
Copending ‘441 does not claim wherein the tablet comprises less than 0.4% by weight of flavor. This is made up for by the teachings of Nielsen et al.
Nielsen et al. teach a water-dissolvable compressed oral nicotine lozenge comprising a first module and a second module, the first and the second modules being fused by compression, the first module being a lozenge module comprising at least one sugar alcohol and the second module being a fast-disintegrating tablet (FDT) comprising at least one sugar alcohol and nicotine (e.g. page 1, line 28-page 2, line 2). Nielsen et al. teach that nicotine stability is increased by facilitating separation of nicotine from flavor and thereby minimizing any flavor induced degradation of nicotine in the second module, and may be free of flavor (e.g. page 26, lines 20-31).
It would have been obvious to one of ordinary skill in the art at the time of filing to formulate the compositions of ‘441 to be free of flavor in order to obtain the benefits described by Nielsen et al. of nicotine stability. One of ordinary skill in the art would have predicted success because of the similarity in composition between copending ‘441 and Nielsen et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
Claim 1, 2, 4, 6, 7, 22, 32 are met by copending claim 1 and Nielsen et al.
Claims 8, 9, 50 and 53 are met by Nielsen as described supra.
Claims 11 and 12 are met by copending claims 17, 19 and 20.
Claim 13 is met by copending claim 5.
Claim 14 is met by copending claims 3 and 6.
Claim 17 is met by copending claim 2.
Claim 18 is met by copending claim 5.
Claim 19 is met by copending claim 3.
Claim 25 is met by copending claims 9 and 10.
Claim 30 is met by copending claim 8.
Claim 34 is met by copending claim 21.
Claim 37 is met by copending claim 15.
Claim 43 is met by copending claim 18.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 4, 6-9, 11-14, 17-19, 22, 25, 30, 32, 34, 37, 43, 50 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 20-25 of U.S. Patent No. 11,738,016.
Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an orally disintegrating nicotine tablet, the tablet comprising nicotine, disintegrant, and at least one sugar alcohol (polyol).
Patent ‘016 does not claim wherein the tablet comprises less than 0.4% by weight of flavor. This is made up for by the teachings of Nielsen et al.
Nielsen et al. teach a water-dissolvable compressed oral nicotine lozenge comprising a first module and a second module, the first and the second modules being fused by compression, the first module being a lozenge module comprising at least one sugar alcohol and the second module being a fast-disintegrating tablet (FDT) comprising at least one sugar alcohol and nicotine (e.g. page 1, line 28-page 2, line 2). Nielsen et al. teach that nicotine stability is increased by facilitating separation of nicotine from flavor and thereby minimizing any flavor induced degradation of nicotine in the second module, and may be free of flavor (e.g. page 26, lines 20-31).
It would have been obvious to one of ordinary skill in the art at the time of filing to formulate the compositions of Patent ‘016 to be free of flavor in order to obtain the benefits described by Nielsen et al. of nicotine stability. One of ordinary skill in the art would have predicted success because of the similarity in composition between Patent ‘016 and Nielsen et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
Claim 1, 2, 4, 6, 7, 11, 13, 14, 17-19, 22, 32, 34, 37, 43 and 53 are met by copending claim 1, and Nielsen et al.
Claims 8, 9, and 50 are met by Nielsen as described supra.
Claim 12 is met by patented claim 21.
Claim 25 is met by patented claim 5.
Claim 30 is met by patented claim 4.
Claims 1, 2, 4, 6-9, 11-14, 17-19, 22, 25, 30, 32, 34, 37, 43, 50 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,786,473.
Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an orally disintegrating nicotine tablet, the tablet comprising nicotine, disintegrant, and at least one sugar alcohol (polyol).
Patent ‘473 does not claim wherein the tablet comprises less than 0.4% by weight of flavor. This is made up for by the teachings of Nielsen et al.
Nielsen et al. teach a water-dissolvable compressed oral nicotine lozenge comprising a first module and a second module, the first and the second modules being fused by compression, the first module being a lozenge module comprising at least one sugar alcohol and the second module being a fast-disintegrating tablet (FDT) comprising at least one sugar alcohol and nicotine (e.g. page 1, line 28-page 2, line 2). Nielsen et al. teach that nicotine stability is increased by facilitating separation of nicotine from flavor and thereby minimizing any flavor induced degradation of nicotine in the second module, and may be free of flavor (e.g. page 26, lines 20-31).
It would have been obvious to one of ordinary skill in the art at the time of filing to formulate the compositions of Patent ‘473 to be free of flavor in order to obtain the benefits described by Nielsen et al. of nicotine stability. One of ordinary skill in the art would have predicted success because of the similarity in composition between Patent ‘473 and Nielsen et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
Claim 1, 2, 4, 6, 7, 13, 14, 17-19, 22, 32, 43 and 53 are met by copending claim 1, and Nielsen et al.
Claims 8, 9, 50 and 53 are met by Nielsen as described supra.
Claims 11 and 12 are met by patented claims 13-16.
Claim 25 is met by patented claim 4.
Claim 30 is met by patented claim 2.
Claim 34 is met by patented claim 6.
Claim 37 is met by patented claim 5.
Claims 1, 2, 4, 6-9, 11-14, 17-19, 22, 25, 30, 32, 34, 37, 43, 50 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,005,058.
Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an orally disintegrating nicotine tablet, the tablet comprising nicotine, disintegrant, and at least one sugar alcohol (polyol).
Patent ‘058 does not claim wherein the tablet comprises less than 0.4% by weight of flavor. This is made up for by the teachings of Nielsen et al.
Nielsen et al. teach a water-dissolvable compressed oral nicotine lozenge comprising a first module and a second module, the first and the second modules being fused by compression, the first module being a lozenge module comprising at least one sugar alcohol and the second module being a fast-disintegrating tablet (FDT) comprising at least one sugar alcohol and nicotine (e.g. page 1, line 28-page 2, line 2). Nielsen et al. teach that nicotine stability is increased by facilitating separation of nicotine from flavor and thereby minimizing any flavor induced degradation of nicotine in the second module, and may be free of flavor (e.g. page 26, lines 20-31).
It would have been obvious to one of ordinary skill in the art at the time of filing to formulate the compositions of Patent ‘058 to be free of flavor in order to obtain the benefits described by Nielsen et al. of nicotine stability. One of ordinary skill in the art would have predicted success because of the similarity in composition between Patent ‘058 and Nielsen et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
Claim 1, 2, 4, 6, 7, 11, 13, 17-19, 22, 32, 34, 37, 43 and 53 are met by copending claims 1 and Nielsen et al.
Claims 8, 9, 50 and 53 are met by Nielsen as described supra.
Claims 11 and 12 are met by patented claim 15.
Claims 14 and 17-19 are met by patented claim 17.
Claim 25 is met by patented claim 5.
Claim 30 is met by patented claim 3.
Claims 1, 2, 4, 6-9, 11-14, 17-19, 22, 25, 30, 32, 34, 37, 43, 50 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,115,155.
Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an orally disintegrating nicotine tablet, the tablet comprising nicotine, disintegrant, and at least one sugar alcohol (polyol).
Patent ‘155 does not claim wherein the tablet comprises less than 0.4% by weight of flavor. This is made up for by the teachings of Nielsen et al.
Nielsen et al. teach a water-dissolvable compressed oral nicotine lozenge comprising a first module and a second module, the first and the second modules being fused by compression, the first module being a lozenge module comprising at least one sugar alcohol and the second module being a fast-disintegrating tablet (FDT) comprising at least one sugar alcohol and nicotine (e.g. page 1, line 28-page 2, line 2). Nielsen et al. teach that nicotine stability is increased by facilitating separation of nicotine from flavor and thereby minimizing any flavor induced degradation of nicotine in the second module, and may be free of flavor (e.g. page 26, lines 20-31).
It would have been obvious to one of ordinary skill in the art at the time of filing to formulate the compositions of Patent ‘155 to be free of flavor in order to obtain the benefits described by Nielsen et al. of nicotine stability. One of ordinary skill in the art would have predicted success because of the similarity in composition between Patent ‘155 and Nielsen et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
Claim 1, 2, 4, 6, 7, 11, 12, 17, 22, 30, 32, 43 and 53 are met by copending claims 1 and 14, and Nielsen et al.
Claims 8, 9, 50 and 53 are met by Nielsen as described supra.
Claim 13 and 18 are met by patented claim 14.
Claim 14 and 19 are met by copending claim 15.
Claim 25 is met by patented claim 9.
Claim 34 is met by patented claim 4.
Claim 37 is met by patented claim 3.
Claims 1, 2, 4, 6-9, 11-14, 17-19, 22, 25, 30, 32, 34, 37, 43, 50 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,194,149.
Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an orally disintegrating nicotine tablet, the tablet comprising nicotine, disintegrant, and at least one sugar alcohol (polyol).
Patent ‘149 does not claim wherein the tablet comprises less than 0.4% by weight of flavor. This is made up for by the teachings of Nielsen et al.
Nielsen et al. teach a water-dissolvable compressed oral nicotine lozenge comprising a first module and a second module, the first and the second modules being fused by compression, the first module being a lozenge module comprising at least one sugar alcohol and the second module being a fast-disintegrating tablet (FDT) comprising at least one sugar alcohol and nicotine (e.g. page 1, line 28-page 2, line 2). Nielsen et al. teach that nicotine stability is increased by facilitating separation of nicotine from flavor and thereby minimizing any flavor induced degradation of nicotine in the second module, and may be free of flavor (e.g. page 26, lines 20-31).
It would have been obvious to one of ordinary skill in the art at the time of filing to formulate the compositions of Patent ‘149 to be free of flavor in order to obtain the benefits described by Nielsen et al. of nicotine stability. One of ordinary skill in the art would have predicted success because of the similarity in composition between Patent ‘149 and Nielsen et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
Claim 1, 2, 4, 6, 7, 13, 14, 17-19, 22, 25, 32, 43 and 53 are met by copending claims 1 and 13, and Nielsen et al.
Claims 8, 9, 50 and 53 are met by Nielsen as described supra.
Claim 11 is met by patented claim 13.
Claim 12 is met my patented claim 14.
Claim 25 is met by patented claim 4.
Claim 30 is met by patented claim 2.
Claim 34 is met by patented claim 6.
Claim 37 is met by patented claim 5.
Claims 1, 2, 4, 6-9, 11-14, 17-19, 22, 25, 30, 32, 34, 37, 43, 50 and 53 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 and 24 of U.S. Patent No. 12,433,881
Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim an orally disintegrating nicotine tablet, the tablet comprising nicotine, disintegrant, and at least one sugar alcohol (polyol).
Patent ‘881 does not claim wherein the tablet comprises less than 0.4% by weight of flavor. This is made up for by the teachings of Nielsen et al.
Nielsen et al. teach a water-dissolvable compressed oral nicotine lozenge comprising a first module and a second module, the first and the second modules being fused by compression, the first module being a lozenge module comprising at least one sugar alcohol and the second module being a fast-disintegrating tablet (FDT) comprising at least one sugar alcohol and nicotine (e.g. page 1, line 28-page 2, line 2). Nielsen et al. teach that nicotine stability is increased by facilitating separation of nicotine from flavor and thereby minimizing any flavor induced degradation of nicotine in the second module, and may be free of flavor (e.g. page 26, lines 20-31).
It would have been obvious to one of ordinary skill in the art at the time of filing to formulate the compositions of Patent ‘881 to be free of flavor in order to obtain the benefits described by Nielsen et al. of nicotine stability. One of ordinary skill in the art would have predicted success because of the similarity in composition between Patent ‘881 and Nielsen et al. It would have been obvious to one of ordinary skill in the art to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
Claim 1, 2, 4, 6, 7, 11, 13, 17, 18, 22, 32, 43 and 53 are met by copending claims 1 and 13, and Nielsen et al.
Claims 8, 9, 50 and 53 are met by Nielsen as described supra.
Claims 12 and 19 are met my patented claim 17.
Claim 14 is met by patented claim 2.
Claim 25 is met by patented claim 8.
Claim 30 is met by patented claim 6.
Claim 34 is met by patented claim 21.
Claim 37 is met by patented claim 15.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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