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
Acknowledgement is made of the response filed on April 23, 2026. In that response, claims 59-61, 63-68, 70, and 76 were amended. Claims 54, 55, and 57-81 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 80 and 81 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 80 recites “method for treatment of nicotine craving, …, wherein the maximum plasma concentration (Cmax) of nicotine is increased by administration between the lip and gum compared to administration on the tongue”. Claim 81 recites the same language but for the underlined parts: “…wherein the maximum plasma concentration (Cmax) of nicotine is increased by administration between the lip and gum compared to sublingual administration”.
The methodology for determining adequacy of written description entails (1) for each claim, determining what the claim as a whole covers, (2) reviewing the entire application to understand how applicant provides support for the claimed invention including each element and/or step, and (3) determining whether there is sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention as a whole at the time the application was filed. MPEP §2163(II). Also the “written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice …, reduction to drawings …, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” MPEP §2163(II)(A)(3)(a)(ii) (citations omitted). The “Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 ‘merely by clearly describing one embodiment of the thing claimed’.” Id. (citations omitted).
(1) Here each claim as a whole covers a method for treatment of nicotine craving, comprising administering an orally disintegrating tablet (ODT) between the lip and gum, such that Cmax of nicotine is increased by administration compared to the tongue (claim 80), or sublingual administration (claim 81). The sole structural limitations of the ODT include nicotine and a pH regulator, i.e., any forms at any concentrations of nicotine and a pH regulator, in any ODT structure, and any pH, among others.
(2) The entire application has been to understand how applicant provides support for the claimed invention. Figure 4 shows comparatively increased Cmax of nicotine for the “lip-gum” as compared to “on tongue” and “sublingual” ODT administrations (Fig.4 and accompanying text). The data in Figure 4 concerns “ODT(22)” in Table 3G, comprising a specific formulation comprising about 6% nicotine bitartrate and 5.0% sodium carbonate, and further comprises substances including microcrystalline cellulose, crospovidone, etc. There is no other comparative data that support claims 80 and 81, regarding the increased Cmax of nicotine from sublabial (under lip) administration, for any formulation other than ODT(22). In other words there is no other description of a representative number of species of ODTs, e.g. “by actual reduction to practice …, reduction to drawings …, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics” MPEP §2163(II)(A)(3)(a)(ii) (citations omitted), sufficient to show the applicant was in possession of the genus of the ODTs administered between the lip and gum that result in comparatively increased Cmax of nicotine as in claims 80 and 81. The specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 ‘merely by clearly describing one embodiment of the thing claimed’ (id.).
(3) Therefore it is determined that there is not sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention as a whole at the time the application was filed.
Response to Arguments
Applicant's arguments filed April 23, 2026 have been fully considered but they are not persuasive. Applicant argues that because claims 80 and 81 are directed to orally disintegrating tablets or ODTs as prepared in Examples 1-10, and ODTs (21), (22), and (23) in the disclosure, there is sufficient written description. (Remarks, 9 second para., April 23, 2026.) Applicant further argues the data in Table 9 shows “the ODTs result in significantly higher Cmax when used between the gum and lip as compared to” use on the tongue or sublingually. (Remarks, 9 last para.).
In response it is noted that claims 80 and 81 recites, further to ODTs, “wherein the maximum plasma concentration (Cmax) of nicotine is increased by administration between the lip and gum compared to” either on the tongue or sublingual administration. As noted above there is no other comparative data regarding the increased Cmax of nicotine from sublabial (under lip), i.e., between lip and gum, administration as compared to sublingual or on-tongue administrations, for any formulation other than ODT(22). The data in Table 9 only shows comparison to sublingual and on-tongue administration only for ODT(22). Furthermore ODTs (21) through (23) differed from each other only in the dosage of nicotine (Specification para.0298). Therefore they do not provide any additional disclosure to support the diversity of ODT formulations encompassed by claims 80 and 81.
Applicant further relies on the disclosure regarding “manufacturing a nicotine ODT” to argue that it provides “very detailed exemplification and guidance”. (Remarks, 10, April 23, 2026.).
The argument misses the mark: the issue is the lack of adequate support for the increased comparative Cmax recited in claims 80 and 81, not aspects of nicotine-comprising ODTs in general.
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 80, and 81 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 80 and 81 it is noted that the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim’ and thus be indefinite”, including “when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear.” MPEP 2173.05(g) (citations omitted). The following factors are considered “when examining claims that contain functional language to determine whether the language is ambiguous”. Id.
(1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim. These factors are examples of points to be considered when determining whether language is ambiguous and are not intended to be all inclusive or limiting. Other factors may be more relevant for particular arts. The primary inquiry is whether the language leaves room for ambiguity or whether the boundaries are clear and precise. MPEP 2173.05(g).
Here claim 80 recites “method for treatment of nicotine craving, …, wherein the maximum plasma concentration (Cmax) of nicotine is increased by administration between the lip and gum compared to administration on the tongue”. Claim 81 recites the same language but for the underlined parts: “…increased by administration between the lip and gum compared to sublingual administration”. Claims 80 and 81 however do not set a clear indication of the scope of the subject matter covered by the claim because it does not set forth well-defined boundaries of the invention, i.e., the particular structure and/or components regarding how the “nicotine is provided” that obtains the increased Cmax. Claims 80 and 81 only require, for components, an orally disintegrating tablet comprising nicotine and “a pH regulating agent”. The claims do not specify the agent and its concentration, the target pH, the degree of regulation, and so on. Therefore one of ordinary skill in the art would not know, simply from the claim terms, what particular structure and/or steps are encompassed by the claim, that increases the Cmax as compared to administration on the tongue or the sublingual administration. The skilled person could look to the disclosure; however the features that Applicant discloses for increasing the Cmax (Fig.4 and accompanying text; see rejection under 35 U.S.C. 112(a)) is recited in claims 80 and 81. In other words claims 80 (and 81) “only states a problem solved or a result obtained”. Therefore the boundaries of claims 80 and 81 are not clear and precise.
Response to Arguments
Applicant's arguments filed April 23, 2026 have been fully considered but they are not persuasive. Applicant contends the claims are “definite because the reagents and steps for performing the methods are clearly recited” and Applicant has explained what an ODT is. (Remarks, 11, April 23, 2026.)
The Office is familiar with ODTs, from prior art. The issue again is that claims 80 and 81 do not set a clear indication of the scope of the subject matter covered by the claim because it does not set forth well-defined boundaries of the invention, i.e., the particular structure and/or components regarding how the “nicotine is provided” that obtains the increased Cmax. Claims 80 and 81 only require, for components, an orally disintegrating tablet comprising nicotine and “a pH regulating agent”. The claims do not specify the agent and its concentration, the target pH, the degree of pH regulation, and so on.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 54, 55, and 57-81 are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen (US 20190175581) in view of The ADME Encyclopedia (Buccal Route of Drug Delivery, The ADME Encyclopedia pp.222-31 (2022)) as evidenced by Kindvall (US 20220095671) and Thorsen (US 20190134207).
Nielsen teaches “an orally disintegrating nicotine tablet for nicotine craving relief comprising a pressed powder formulation, the tablet being designed to disintegrate within a period of less than 60 seconds upon oral administration, the powder formulation comprising an amount of nicotine and a pH regulating agent” (abstract; see entire document) and “methods used to employ nicotine more efficiently from fast disintegrating tablets applied orally by the sublingual or buccal route” (para.0001).
Nielsen does not specifically teach positioning the tablet between the lip and gum as in claims 54 and 55.
The ADME Encyclopedia however teaches that “buccal route of drug delivery” involves placing a dosage form within the buccal cavity, specifically including between the upper or the lower lip and the gum (p.223 Fig.1 left, and accompanying text).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Nielsen and The ADME Encyclopedia and place Nielsen’s tablet between the lip and gum as recited in the instant claim(s). The skilled person would have been motivated to do so because Nielsen teaches buccal administration, and The ADME Encyclopedia specifically teaches placing a dosage form between the lip and gum. Furthermore Kindvall evidences prior art teaching on buccal administration, including placement between lip and gum, of a nicotine product comprising a pH adjusting agent (para.0041; see title; abstract).
Regarding claims 57 and 78, Nielsen’s tablet of 25-200 mg is designed to disintegrate within a period of less than 60 seconds upon oral administration (abstract; para.0078).
Regarding claims 58 and 69, the tablet is compressed using force within the range in claim 69 (paras.0065, 0131 Table 2).
Regarding claims 59-61, Nielsen teaches including sugar alcohols (paras.0083-84, .0153, 0176-77, 0140 Table 3C mannitol at about 60-80%, Tables 3D, 3E).
Regarding claims 62-68, superdisintegrants such as crospovidone may comprise, e.g., 5.0%, 2.5%, by weight of the tablet (paras.0060-75, 0109, Tables 3D, 3E).
Regarding claims 70-73, Nielsen teaches the dosage and forms of nicotine recited (see, e.g., paras.0057, 0093, 0114).
Regarding claims 75-77, the tablet comprises a pH regulating agent in an amount of at least 2.7 percent by weight of said tablet (paras.0076-77).
Regarding claim 79, Thorsen evidences that “dissolution modifiers” include trehalose, alginate, and cellulose (para.0238). Nielsen teaches these as sweeteners and disintegrants (paras. 0109, 0152, 0154) and a sweetener comprises under 1.0% (Tables 3C-3E). A “chemical composition and its properties are inseparable”, MPEP § 2112.01(II), and therefore trehalose when used as a sweetener in Nielsen’s tablet, would be a “dissolution modifier”.
Response to Arguments
Applicant's arguments filed April 23, 2026 have been fully considered but they are not persuasive. Applicant argues neither The ADME Encyclopedia nor Kindvall is drawn to ODTs comprising nicotine, and it does not teach or suggest that buccal administration “is specifically directed to placement between the lip and the gum”, but “anywhere in the oral cavity”. (Remarks, 13, April 23, 2026.)
In response to applicant's argument that The ADME Encyclopedia is not drawn to ODTs comprising nicotine, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here Nielsen teaches nicotine comprising ODTs “applied orally by the sublingual or buccal route” (para.0001). The ADME Encyclopedia teaches “Buccal Tablet” placed between the lip and the gum, which is illustrated expressly in Figure 1, left side. The buccal administration achieves “rapid onset of action and highest bioavailability when compared with the oral route” (p.243). In other words the buccal route is not “anywhere in the oral cavity” as Applicant argues. Kindvall evidences prior art teaching on buccal administration, including placement between lip and gum, of a nicotine product comprising a pH adjusting agent (para.0041; see title; abstract).
Applicant further argues that Kindvall also “broadly defines buccal placement”, citing paragraph 0030 and 0041. (Remarks, 13.)
The Office disagrees. Paragraph 0030 states “oral” and “oral use” means “use in the oral cavity of a human, such as buccal placement”. “Such as” indicates a species or subset of the preceding, not equivalent to it. Similarly paragraph 0041 states “for use in the oral cavity, such as by buccal placement (e.g. by placing the pouched product between the upper or lower gum and the lip or cheek),…”.
Applicant next cites the Encyclopedia Britannica and the prescribing information for fentanyl buccal tablets to argue that “a recognized meaning of the term ‘buccal’ is the mouth” and therefore “a buccal tablet is equivalent to an oral tablet”. (Remarks, 14.)
In response it is noted that the proposed interpretation, i.e., “’buccal’ is the mouth”, is inconsistent with Nielsen. Nielsen states as follows.
Orally disintegrating tablets may be intended for use as a sublingual tablet for positioning under the tongue, as a buccal tablet, as a tablet for melting on the tongue, or for other types of oral administering. (Para.0105.)
Here Nielsen distinguishes sublingual, buccal, “on the tongue”, and “other types of oral administering” as discrete from each other.
Applicant argues further that there is no reasonable expectation of success in placing Nielsen’s ODT between the gum and lip because conventional use of nicotine ODTs was on the tongue or sublingually and the pouch was placed between the gum and lip. (Remarks, 15.)
However the skilled person would have had a reasonable expectation of success because Nielsen expressly teaches, “[c]ontrary to expectations, experiments have shown that the permeability of nicotine across the buccal mucosa decreases relatively little when increasing the concentration of nicotine” (para.0009).
Applicant next argues “unexpected results” of enhanced nicotine absorption and lessened burning from placing the ODT between the lip and the gum as supported by data in Examples 8 through 10. (Remarks, 15-16.)
In response it is noted that the evidence of non-obviousness must be reasonably commensurate in scope with the claimed invention. MPEP § 2145 (citations omitted). All of Examples 8 through 10 used ODT(21), ODT(22), and ODT(22), differing from each other solely in the amount of nicotine and made up of the specific ingredients and concentrations in Table 3G (paras.0298, 0271 pre-grant publication US 2025/0082579). Example 9 tested ODT(22) only. Example 10 tested ODT(21) only. Therefore it is determined that the evidence of non-obviousness is not reasonably commensurate in scope with the scope of the present claims.
Applicant next complains that the Office did not “specifically explain the rejection” of claims 80 and 81. (Remarks, 17.)
In response it is noted that claims 80 and 81 are rejected (in addition to lack of adequate written description) as indefinite under35 U.S.C. 112(2) because the metes and boundaries of the claimed subject matter cannot be ascertained. As has been explained this is because the claims “merely recite a description of a problem to be solved or a function or result achieved by the invention”. Specifically the claims do not set forth well-defined boundaries of the invention, i.e., the particular structure and/or components regarding how the “nicotine is provided” that obtains the increased Cmax. Claims 80 and 81 only require, for components, an orally disintegrating tablet comprising nicotine and “a pH regulating agent”. The claims do not specify the agent and its concentration, the target pH, the degree of regulation, and so on. Therefore one of ordinary skill in the art would not know, simply from the claim terms, what particular structure and/or steps are encompassed by the claim, that increases the Cmax as compared to administration on the tongue or the sublingual administration.
Furthermore the increased Cmax would occur as a result of the “administering” the ODT. Such a clause “in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”, as in the instant claim. MPEP § 2111.04 (citations omitted). Here Nielsen in view of The ADME Encyclopedia renders prima facie obvious “an orally disintegrating nicotine tablet for nicotine craving relief comprising a pressed powder formulation, the tablet being designed to disintegrate within a period of less than 60 seconds upon oral administration, the powder formulation comprising an amount of nicotine and a pH regulating agent” wherein the tablet is “applied orally by the sublingual or buccal route”, including between the lip and the gum. The administration of ODT nicotine tablets as recited in claims 80 and 81 reads on this. Furthermore The ADME Encyclopedia teaches that the buccal route, including between the lip and the gum, attains “rapid onset of action and highest bioavailability when compared with the oral route” (The ADME Encyclopedia, Fig. 1 and accompanying text; p.243).
Applicant argues that dependent claims 55 and 57-79 depend from claim 54 which it argues is allowable. (Remarks, 17, April 23, 2026.)
The Office finds neither claim 54 nor any claims depending therefrom allowable as discussed in the foregoing.
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 54, 55, and 57-81 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 8-11, 14, 15, 17, 20, 23, 25, 31, 32, 35, 38, 44, and 46 of copending Application No. 18883634 (reference application; 11/27/2024 claim set) in view of The ADME Encyclopedia (Buccal Route of Drug Delivery, The ADME Encyclopedia pp.222-31 (2022)).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a disintegrating nicotine tablet for fast nicotine craving relief and a method of administering the same, the tablet comprising nicotine, disintegrant, and at least one sugar alcohol, wherein the tablet comprises an amount of dissolution modifier. The ‘634 application’s dependent claims 31 and 32 recite a pH regulating agent. The difference is that the ‘634 application’s claims recite “wherein the amount of dissolution modifier is no more than 2% by weight of the tablet” versus the 1% in instant claim 79. However the ranges are substantially overlapping with optimization considered prima facie obvious. The ‘634 application does not claim positioning the ODT between the lip and gum. The ADME Encyclopedia however teaches that “buccal route of drug delivery” involves placing a dosage form within the buccal cavity, specifically including between the upper or the lower lip and the gum (p.223 Fig.1 left, and accompanying text). It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of the ’634 claims and The ADME Encyclopedia and place Nielsen’s tablet between the lip and gum. The skilled person would have been motivated to do so because the ‘634 application teaches placing the tablet “between the gum and lip” (para.0038; see para.0136), and The ADME Encyclopedia specifically teaches placing a dosage form between the lip and gum.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 54, 55, and 57-81 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11738016 in view of The ADME Encyclopedia (Buccal Route of Drug Delivery, The ADME Encyclopedia pp.222-31 (2022)) as evidenced by Kindvall (US 20220095671).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to fast orally disintegrating nicotine tablet for nicotine craving relief and method of use thereof wherein the ODT tables comprises nicotine, a pH regulating agent and a disintegrant at overlapping concentration ranges. The ‘016 patent’s claims recite further limitations, such as a polyol and its concentration, and therefore anticipate the present claims. The ‘016 patent does not claim positioning the ODT between the lip and gum. The ADME Encyclopedia however teaches that “buccal route of drug delivery” involves placing a dosage form within the buccal cavity, specifically including between the upper or the lower lip and the gum (p.223 Fig.1 left, and accompanying text). It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of the ‘016 patent’s claims and The ADME Encyclopedia and place the ODT between the lip and gum. The skilled person would have been motivated to do so because the ‘016 patent teaches buccal administration (col.9 lines 55-58), and The ADME Encyclopedia teaches buccal administration specifically includes placing a dosage form between the lip and gum. Furthermore Kindvall evidences prior art teaching on buccal administration, including placement between lip and gum, of a nicotine product comprising a pH adjusting agent (para.0041; see title; abstract).
Claims 54, 55, and 57-81 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12005058 in view of The ADME Encyclopedia (Buccal Route of Drug Delivery, The ADME Encyclopedia pp.222-31 (2022)) as evidenced by Kindvall (US 20220095671).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to an orally disintegrating nicotine tablet for nicotine craving relief comprising a pressed powder formulation, wherein the tablet disintegrates within a period of less than 300 seconds upon oral administration, wherein the pressed powder formulation comprises an amount of nicotine, a pH regulating agent, and a disintegrant at overlapping concentration ranges. The ‘058 patent’s claims recite further limitations, such as a polyol and its concentration, and therefore anticipate the present claims. The ‘058 patent does not claim positioning the ODT between the lip and gum. The ADME Encyclopedia however teaches that “buccal route of drug delivery” involves placing a dosage form within the buccal cavity, specifically including between the upper or the lower lip and the gum (p.223 Fig.1 left, and accompanying text). It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of the ‘058 patent’s claims and The ADME Encyclopedia and place the ODT between the lip and gum. The skilled person would have been motivated to do so because the ‘058 patent teaches buccal administration (col.9 lines 57-60), and The ADME Encyclopedia teaches buccal administration specifically includes placing a dosage form between the lip and gum. Furthermore Kindvall evidences prior art teaching on buccal administration, including placement between lip and gum, of a nicotine product comprising a pH adjusting agent (para.0041; see title; abstract).
Claims 54, 55, and 57-81 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12433881 in view of The ADME Encyclopedia (Buccal Route of Drug Delivery, The ADME Encyclopedia pp.222-31 (2022)) as evidenced by Kindvall (US 20220095671).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to an orally disintegrating nicotine tablet for nicotine craving relief comprising a pressed powder formulation, wherein the tablet disintegrates within a period of less than 300 seconds upon oral administration, wherein the pressed powder formulation comprises an amount of nicotine, a pH regulating agent, and a disintegrant at overlapping concentration ranges. The ‘881 patent’s claims recite further limitations, such as a polyol and its concentration, and therefore anticipate the present claims. The ‘881 patent does not claim positioning the ODT between the lip and gum. The ADME Encyclopedia however teaches that “buccal route of drug delivery” involves placing a dosage form within the buccal cavity, specifically including between the upper or the lower lip and the gum (p.223 Fig.1 left, and accompanying text). It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of the ‘881 patent’s claims and The ADME Encyclopedia and place the ODT between the lip and gum. The skilled person would have been motivated to do so because the ‘881 patent teaches buccal administration (col.9 lines 57-60), and The ADME Encyclopedia teaches buccal administration specifically includes placing a dosage form between the lip and gum. Furthermore Kindvall evidences prior art teaching on buccal administration, including placement between lip and gum, of a nicotine product comprising a pH adjusting agent (para.0041; see title; abstract).
Response to Arguments
Applicant's arguments filed April 23, 2026 have been fully considered but they are not persuasive. Applicants requested that the provisional rejection(s) be held in abeyance. (Remarks, 18.)
The provisional double patenting rejection(s) is/are maintained for the reasons discussed herein. They will be maintained until Applicant submits properly executed terminal disclaimer or arguments that effectively overcome the rejection(s).
Applicant next states the “claims of the present applications are patentably distinct from the claims of” the reference patents, and “USP ‘016 USP ‘058, or USP’881 in combination with ADME, as evidenced by Kindvall, do not render claims 54, 55, and 57-81 unpatentable” for “the reasons discussed above” regarding the rejection under 35 U.S.C. 103. (Remarks, 18-19.)
The double patenting rejections are maintained based on the Office’s responses to the “the reasons discussed above”.
Conclusion
Applicant requested the Examiner to “contact the undersigned representative before issuing a subsequent Action”. (Remarks, 20, April 23, 2026.)
It is unclear what purpose is served by such a contact. This Action serves the notice function.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/H. SARAH PARK/Primary Examiner, Art Unit 1614
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