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 .
Claim Objections
Claims 59, 63, and 66 are objected to because of the following informalities: the claim should clarify ‘further’ comprising the new component.
Claims 63 and 66 are objected to because of the following informalities: duplicate claims.
Claim 60 is objected to because of the following informalities: “sugar alcohol” repeated.
Claims 70 is objected to because of the following informalities: “or nicotine in any non-covalent binding” appears to be “non-covalently bound nicotine”.
Claims 76 is objected to because of the following informalities: an article such as “a” should follow “comprises” in line 2.
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities: page 1, lines 27-31 refer to prior art WO 2019/110072A1 as teaching “…, as a buccal tablet (i.e. positioning on the tongue”. “I.e.” means “in explanation”, meaning it equates that which precedes the “i.e.” to that which succeeds the “i.e.”. Here the “i.e.” equates “buccal” to “positioning on the tongue” and infers that equating to WO 2019/110072A1, which is inaccurate. The relevant portion in WO 2019/110072A1 (page 19) is shown below.
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As shown above, a sublingual tablet, a buccal tablet, and a tablet for melting on the tongue, are all listed as different types of oral administering. Therefore the use of “i.e.” in the specification here is inaccurate. This is important due to Applicant-owned prior art, which is cited below (Nielsen (US 20190175581 appears a counterpart to WO 2019/110072A1). Appropriate correction is required.
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.
(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.
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 60, 61, 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.
Claims 60 and 61 recite the limitation "the at least one sugar alcohol". Claims 64 and 65 recite the limitation "the disintegrant". There is insufficient antecedent basis for these limitations in the respective claims.
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.
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 (emphasis added)).
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 rage 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”.
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; 11/25/2024 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).
Conclusion
No claim is allowed.
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.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614