Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
The Examiner acknowledges receipt of Applicants’ Response to Restriction and Species Election Requirements, filed on 20 August 2026. Applicants did not amend claims in the Response. Upon finalization and entry of the Restriction/Species Requirements (see below), claims 1 – 7, 9 – 17, and 19 – 22 will be available for substantive examination.
Response to Restriction/Election
The Examiner acknowledges Applicants’ election, without traverse, of the invention of Group I, claims 1 – 7 and 9 – 17 in the Response filed on 20 August 2026. The Examiner further acknowledges Applicants’ election of the species calcium phosphate from the genus defined as ceramic system substance; nicotine from the genus identified as alkaline active pharmaceutical agent; and α-tricalcium phosphate from the genus identified as ceramic system hydration substance for further examination.
Claims 7, and 19 - 22 are hereby withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1 – 6 and 9 – 17 are under consideration to the extent that calcium phosphate is the ceramic system substance; nicotine is the alkaline active pharmaceutical agent; and α-tricalcium phosphate is the ceramic system hydration substance.
The Examiner notes that Applicants’ Response filed 20 August 2026 indicates that claims 1 – 7 and 9 – 17 encompass the elected species. However, claim 7 is directed to an opioid analgesic as the alkaline active pharmaceutical agent, which species Applicants did not elect. Therefore, claim 6 is included in the claims withdrawn pursuant to 37 CFR § 1.142(b), as being drawn to a nonelected invention.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statements (IDS’s) filed 20 August 2026, 15 June 2026, 10 July 2025, and 30 December 2024 which are now of record in the file.
Priority
The Examiner acknowledges receipt of papers submitted pursuant to 35 U.S.C. §§ 119(a)-(d), which papers are now of record in the file.
Rejections Pursuant to 35 U.S.C. § 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.
Claims 12 – 14 are rejected pursuant to 35 U.S.C. § 112(b), 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.
Claim 12 recites a limitation directed to “a portion of the alkaline active pharmaceutical agent or salt thereof, such as at least 20% by weight.” Use of the phrase, “such as,” renders the claim indefinite in that one of ordinary skill in the art would be uncertain as to whether the recitation is required. Appropriate correction or cancelation is required.
Claims 13 and 14 recite limitations including the term, “substantially.” The term “substantially” is a relative, or subjective, term that renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, with the result that one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office Action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 pursuant to 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 – 6, 9, 11, and 13 – 17 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 5,762,950 to Yli-Urpo, A., et al., issued 8 June 1998 (“Yli-Urpo ‘950”), US 2017/0275196 A1 to Ahmed, I., published 28 September 2017 (“Ahmed ‘011”), and US 2023/0158011 A1 to Nielsen, B. and K. Nielsen, published 25 May 2023 from an application claiming priority to 8 December 2017 (“Nielsen ‘011”), as evidenced by Applicants’ specification.
The Invention As Claimed
Applicants claim a composition comprising nicotine, and a chemically bonded ceramic system formed from α-tricalcium phosphate, wherein the composition gives a pH of at least 8 upon contact with saliva, wherein the nicotine has a pKa in the range of 7 to 10, wherein the total amount of nicotine contained within the composition is from about 0.5 mg to about 15 mg nicotine, calculated as the free base form, wherein the porosity of the chemically bonded ceramic system is from about 10 to about 70%, wherein the composition is capable of releasing substantially all of the alkaline active pharmaceutical agent or salt thereof upon contact with an aqueous liquid, wherein sodium carbonate and sodium bicarbonate are substantially absent from the composition, [INTENDED USE] wherein the composition is provided in the form of a permeable, sealed bag containing the solid, porous, chemically bonded ceramic system and nicotine, [INTENDED USE] wherein the bag further contains a filler, flavor, or a controlled release agent, and wherein the composition is a sublingual tablet, buccal tablet, wafer, or lozenge.
The Teachings of the Cited Art
Yli-Urpo ‘950 discloses a bioceramic system for delivery of a bioactive compound, which system comprises hydroxyapatite (HA), as well as additional calcium phosphate materials, such as bioactive glass, bioactive glass ceramic, or bioactive ceramic, which bioceramic system incorporates a bioactive compound (see Abstract), wherein the rate of dissolution/resorption of the system comprising hydroxyapatite, combined with other ceramics and/or glasses, can be tailored based on the identities and amounts of the other components (see Col. 1, ll. 45 – 50), wherein the additional calcium phosphate material is tricalcium phosphate (see Col. 3, ll. 22 – 24), wherein the combination of hydroxyapatite with ceramic can be used to obtain oral preparations that resorb more rapidly than if bioactive glass, glass ceramic, or ceramic alone has been used (see Col. 3, ll. 65 – 67), wherein the bioactive compound is a central nervous system drug, such as selegiline (see Col. 4, ll. 13 – 44), wherein the bioceramic system resorbs completely (see Col. 3, ll. 6 – 8), wherein, by changing the amount of hydroxyapatite in the bioceramic system the timing of the release of the bioactive compound can be regulated as desired (see Col. 4, ll. 54 – 56), wherein, at high pH values, increasing amounts of HA lead to decreasing resorption rates (see Col. 3, ll. 49 – 52), wherein the bioceramic system may be administered to a subject in an amount sufficient to release the desired amount of bioactive compound at a particular time or at a particular rate (see Col. 5, ll. 9 – 11), wherein the bioceramic system may be prepared by combining ground ceramic and hydroxyapatite and, if present, a matrix component, and forming a tablet, for example, by pressing using a mold (see Col. 5, ll. 15 – 18), and wherein the bioceramic system incorporating a bioactive compound is administered to a patient orally, and releases a bioactive compound through a mucous membrane (see Col. 4, ll. 61 – 65). The reference does not expressly disclose compositions comprising bioceramics wherein the bioceramic is α-tricalcium phosphate (α-TCP), or wherein the bioactive compound is nicotine, or bioceramic containing compositions systems wherein the amount of bioceramic is in a range of from 0.1 to 50% wgt, or compositions wherein the porosity of the bioceramic is from about 10% to about 70%, or compositions wherein the at least 20% wgt of the bioactive compound is located within the pores of the bioceramic, or compositions comprising bioceramics that are provided in the form of a permeable sealed bag, wherein the bag further comprises a filler, a flavor, or a controlled release agent. The teachings of Ahmed ‘011 and Nielsen ‘011 remedy those deficiencies.
Ahmed ‘011 discloses a method of manufacture of a powder comprising microspheres (see Abstract), wherein porous bodies can be useful in a range of applications including in the delivery of biological cells, growth factors, proteins and pharmaceutically active agents (see ¶[0002]), wherein the porous microspheres have an average particle size of 30 – 500 µm (see ¶[0005]), wherein the microspheres may be biocompatible and/or bioresorbable (see ¶[0006]), wherein the microspheres comprise a ceramic composition (see ¶[0007]), wherein the microspheres comprise α-tricalcium phosphate (α-TCP) (see ¶[0014]), wherein the microspheres are porous with an average pore diameter in the range of 10 – 100 µm (see ¶[0017]), wherein the microspheres have a total porosity of at least 40% to at least 80% (see ¶[0018]), wherein the microspheres comprise at least some interconnected porosity (see ¶[0018]), wherein the microspheres are loaded with at least one active agent, e.g. a pharmaceutically active agent, such as biological cells, e.g. stem cells, growth factors, proteins and/or other biological components (see ¶[0026]), and wherein the porous resorbable microspheres are loaded with chemical or biological drugs, or other active agents for release into the human body (see ¶[0199]).
Nielsen discloses an oral nicotine formulation for use in the alleviation of nicotine craving (see Abstract), wherein a high nicotine concentration in the oral cavity can be obtained, provided with a correspondingly high pH value facilitating a high uptake of nicotine (see ¶[0008]), wherein the formulation comprises nicotine in an amount of at least 0.5 mg per dosage (see ¶[0020]), or at least 4.0 mg (see ¶[0025]), wherein the oral nicotine formulation is provided in a pouch (see ¶[0030]), wherein the nicotine is provided as free nicotine base (see ¶[0088]), wherein the formulation is provided as a tablet having a weight of 25 to 200 mg (see ¶[0113]), or as a powder in an amount of 100 – 800 mg (see ¶[0115]), wherein a flavorant may be used as taste masking for the nicotine (see ¶[0188]; see also TABLE 8H), wherein the final powder composition is filled into pouches at a target fill weight of 400 mg powder per pouch (see ¶[0253]), and wherein the nicotine formulations are prepared with varying amounts of microcrystalline cellulose as a filler (see ¶[0235]; see also, TABLE 8C).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare a bioceramic system for delivery of a bioactive compound, which system comprises hydroxyapatite (HA), as well as additional materials, such as a bioactive ceramic, which bioceramic system incorporates a bioactive compound, wherein the rate of dissolution/resorption of the system comprising hydroxyapatite, combined with other ceramics, can be tailored based on the identities and amounts of the other components, wherein the additional calcium phosphate material is tricalcium phosphate, wherein the bioactive compound is a central nervous system drug, such as selegiline, wherein the bioceramic system resorbs completely, wherein the bioceramic system may be administered to a subject in an amount sufficient to release the desired amount of bioactive compound at a particular time or at a particular rate, wherein the bioceramic system may be prepared by combining ground ceramic and hydroxyapatite and, if present, a matrix component, and forming a tablet, for example, by pressing using a mold, and wherein the bioceramic system incorporating a bioactive compound is administered to a patient orally, and releases a bioactive compound through a mucous membrane, as taught by Yli-Urpo ‘950, wherein porous microspheres have an average particle size of 30 – 500 µm, wherein the microspheres may be biocompatible and/or bioresorbable, wherein the microspheres comprise a ceramic such as α-tricalcium phosphate (α-TCP), wherein the microspheres are porous with an average pore diameter in the range of 10 – 100 µm, wherein the microspheres have a total porosity of at least 40% to at least 80%, as taught by Ahmed ‘196, wherein the microspheres are loaded with at least one pharmaceutically active agent for release into the human body, as taught by, and wherein the oral nicotine formulation comprises nicotine in an amount of at least 0.5 mg per dosage, or at least 4.0 mg, wherein the oral nicotine formulation is provided in a pouch, wherein the nicotine is provided as free nicotine base, wherein the formulation is provided as a tablet having a weight of 25 to 200 mg, or as a powder, in an amount of 100 – 800 mg, wherein a flavorant may be used as taste masking for the nicotine, wherein the final powder composition is filled into pouches at a target fill weight of 400 mg powder per pouch, and wherein the nicotine formulations are prepared with varying amounts of microcrystalline cellulose as a filler, as taught by Nielsen’ 011 One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of Ahmed ‘196 as to the advantages, such as fluid access to the interior pores of the bioceramic material, that allows for dissolution of release of active ingredient from the pores, and by the teachings of Nielsen ‘011 to the effect that the disclosed nicotine formulations are capable of delivering an effective amount of nicotine.
With respect to claim 3, which claim recites a limitation directed to the active ingredient having a pKa in the range of 7 – 10, the nicotine necessarily has a pKa of 8.02 as evidenced by the specification (see p. 1, ll. 18 – 21), thus reading on claim 3.
With respect to claim 5, which claim recites a limitation directed to the nicotine being in the form of a salt, the Examiner notes that Applicants elected nicotine from the genus of active agents, and not a nicotine salt.
With respect to claims 6, 11, and 12, which claims recite limitations in the form of quantitative ranges, the Examiner notes that the cited references do not teach quantitative ranges that are exactly congruent with the claimed ranges. However, it is the Examiner’s position that the cited art teaches quantitative ranges that significantly overlap with the claimed ranges and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
With respect to claim 2, which claim recites a limitation directed to the compositions of the invention giving “a pH of at least 8 upon contact with saliva,” the Examiner notes that the cited art does not specifically disclose pH conditions after administration of the nicotine compositions of the invention. In this regard, the Examiner would first note that the limitation at issue is directed to a functional characteristic (what the composition does) of the compositions of the invention, and not to structural or compositional properties (what the composition is). In this regard, it is the Examiner’s position that the invention as claimed is not structurally distinguishable from the combination of references cited above in terms of the active (nicotine), the bioceramic (α-TCP), the loading of the active, the pKa of the active, the loading of the bioceramic, the porosity of the ceramic, and the presence of nicotine within the pores of the ceramic. The ability of the formulation to give a specific pH upon contact with saliva, therefore, is an inherent property of the invention taught by the cited references. Because the Patent and Trademark Office does not have the facilities for examining and comparing the claimed formulation with formulations according to the cited art, the burden of proof is upon Applicants to show an unobvious distinction between the structural and functional characteristics of the claimed formulation and the formulation of the prior art. See In re Best, 562 F.2d 1252, 195 U.S.P.O. 430 (CCPA 197), and Ex parte Gray, 10 USPO 2d 1922 1923 (PTO Bd. Pat. App. & Int.).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1 – 6, 9, 11, and 13 – 17 would have been obvious within the meaning of 35 USC § 103.
Claim 10 is rejected pursuant to 35 U.S.C. § 103 as obvious over Yli-Urpo ‘950, US Ahmed ‘011, and Nielsen ‘011, as applied in the above rejection of claims 1 – 6, 9, 11, and 13 – 17, and further in view of US 2005/0123502 A1 to Chan, S., et al., published 9 June 2005, identified on the IDS filed 15 June 2026, cite no. C1 (USPAT) (“Chan ‘502”), as evidenced by Applicants’ specification.
The Invention As Claimed
The invention with respect to claim 1 is described above. In addition, Applicants claim a composition wherein the chemically bonded ceramic system is present at from about 0.1 % to
about 50% by weight of the composition.
The Teachings of the Cited References
The teachings of Yli-Urpo ‘950, US Ahmed ‘011, and Nielsen ‘011, relied upon as in the above rejection of claims 1 – 6, 9, 11, and 13 – 17. The references do not disclose a chemically bonded ceramic system formed from α-tricalcium phosphate and comprising nicotine, wherein the chemically bonded ceramic system is present at from about 0.1 to about 50% wgt. The teachings of Chan ‘502 remedy that deficiency.
Chan ‘502 discloses an oral composition comprising nicotine (see Abstract), wherein the oral dosage form comprises one or more nicotine actives in an amount effective to reduce nicotine cravings, preferably within one hour of starting oral administration (see ¶[0015]), wherein the composition may comprise excipients for the purpose of obtaining desirable processing and physical qualities including enhancement of the dispersibility and stability of the active ingredient, such as one or more fillers, binders, disintegrants, lubricants, thickeners, sweeteners, flavorants, emulsifiers, antioxidants/preservatives, vitamins, tastemasking agents, and colorants (see ¶[0020]), wherein a binder (e.g., magnesium aluminum silicate) is present in an amount of at least 40%, or at least 70%, of the total weight of the composition (see ¶[0021]).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare a bioceramic system for oral delivery of nicotine from a bioceramic of α-TCP, in accord with Yli-Urpo ‘950, US Ahmed ‘011, and Nielsen ‘011, wherein the composition of the system comprise excipients for the purpose of obtaining desirable processing and physical qualities including enhancement of the dispersibility and stability of the active ingredient, such as fillers and/or binders, wherein the binder can be a ceramic is present in an amount of at least 40%, or at least 70%, of the total weight of the composition. One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by teachings of Chan ‘502 to the effect that the binder serves the purpose of obtaining desirable processing and physical qualities including enhancement of the dispersibility and stability of the active ingredient (see ¶[0002]).
In this regard, the Examiner notes that Applicants’ specification, at p. 12, ll. 12 – 20, teaches that the bioceramic can function as a binder in the disclosed formulations.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claim 10 would have been obvious within the meaning of 35 USC § 103.
Claim 12 is rejected pursuant to 35 U.S.C. § 103 as obvious over Yli-Urpo ‘950, US Ahmed ‘011, and Nielsen ‘011, as applied in the above rejection of claims 1 – 6, 9, 11, and 13 – 17, and further in view of US 2018/0049976 A1 to Bredenberg, S., et al., published 22 February 2018 (“Bredenberg ‘976”).
The Invention As Claimed
The invention with respect to claim 1 is described above. In addition, Applicants claim a composition comprising nicotine, and a chemically bonded ceramic system formed from α-tricalcium phosphate, wherein a portion of the nicotine, such as at least 20% by weight, is located within the pores in the chemically bonded ceramic system.
The Teachings of the Cited References
The teachings of Yli-Urpo ‘950, US Ahmed ‘011, and Nielsen ‘011, relied upon as in the above rejection of claims 1 – 6, 9, 11, and 13 – 17. The references do not disclose a chemically bonded ceramic system formed from α-tricalcium phosphate and comprising nicotine, wherein at least 20% by weight of the nicotine is located within the pores in the chemically bonded ceramic system. The teachings of Bredenberg ‘976 remedy that deficiency.
Bredenberg ‘976 discloses drug delivery device that includes a pharmaceutical composition that provides for the controlled release of active ingredients (see ¶[0001]), wherein the device can use ceramics as carriers in controlled-release pharmaceutical formulations (see ¶[0006]), wherein the ceramics of the device can comprise chemically bonded ceramics (non-hydrated, partly hydrated or fully hydrated ceramics, or combinations thereof) such as calcium phosphates, calcium sulphates, calcium carbonates, calcium silicates, calcium aluminates and magnesium carbonates (see ¶[0032]), wherein the use of these and other particular ceramics facilitates the formation of the drug delivery element in such a way that the active pharmaceutical ingredient would not be exposed to harsh conditions (e.g., high temperatures, such as temperatures exceeding 60° C) during formation, α-tricalcium phosphate being among those ceramics that are particularly preferred (see ¶[0033]), wherein, if the porous solid is formed by way of a chemical reaction (e.g., polymerization, active ingredient may be co-mixed with a precursor mixture comprising relevant reactants and, thereafter, located within the pores or voids that are formed during formation of the porous solid (i.e,. the three-dimensional carrier material network) itself (see ¶[0048]), wherein the active pharmaceutical ingredient is predominantly located within the pores of the porous solid, meaning that at least 50% by weight of the total amount of the active pharmaceutical ingredient present in the ceramic drug delivery element is located within the pores of the porous solid (see ¶[0049]), and wherein the active pharmaceutical ingredient may be incorporated into the carrier at any stage during its manufacture, such as prior to, or during, the formation drug delivery element (e.g., prior to the curing of the precursor material) (see ¶[0136]).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to
prepare a bioceramic system for oral delivery of nicotine from a bioceramic of α-TCP, in accord with Yli-Urpo ‘950, US Ahmed ‘011, and Nielsen ‘011, wherein system includes a pharmaceutical composition that provides for the controlled release of active ingredients, wherein the device uses ceramics as carriers in controlled-release pharmaceutical formulations, wherein the ceramics of the device can comprise chemically bonded ceramics such as α-TCP, wherein, if the porous solid is formed by way of a chemical reaction (e.g., polymerization, active ingredient may be co-mixed with a precursor mixture comprising relevant reactants and, thereafter, located within the pores or voids that are formed during formation of the porous solid (i.e,. the three-dimensional carrier material network) itself, wherein the active pharmaceutical ingredient is predominantly located within the pores of the porous solid, meaning that at least 50% by weight of the total amount of the active pharmaceutical ingredient present in the ceramic drug delivery element is located within the pores of the porous solid, and wherein the active pharmaceutical ingredient may be incorporated into the carrier at any stage during its manufacture, such as prior to, or during, the formation drug delivery element (e.g., prior to the curing of the precursor material), as taught by Bredenberg ‘976. One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of the reference to the effect that use of bioceramics facilitates the formation of the drug delivery system in such a way that the active pharmaceutical ingredient would not be exposed to harsh conditions (e.g., high temperatures, such as temperatures exceeding 60° C) during formation (see ¶[0033]).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claim 12 would have been obvious within the meaning of 35 USC § 103.
Obviousness-Type Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 – 6 and 9 – 17 are provisionally rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1 – 3, 5, 6, 8, 10 – 13, 16, and 17 of co-pending Application No. 18/852,956 (“the ‘956 application”), in view of Ahmed ‘196, Chan ‘502, and Bredenberg ‘976.
The instant claims have been described supra.
Claims 1 – 3, 5, 6, 8, 10 – 13, 16, and 17 of the ‘956 disclose an intraoral formulation comprising a solid, porous chemically bonded ceramic system, nicotine, or a salt thereof, and a pH regulating agent, wherein the solid, porous chemically bonded ceramic system is formed in the absence of the pH regulating agent, wherein the chemically bonded ceramic system contains calcium, wherein the chemically bonded ceramic system is based on a calcium phosphate, wherein the formulation produces a pH of at least 8 when it is brought into contact with saliva, wherein a portion of the nicotine or salt thereof is located within the pores of the chemically bonded ceramic system, and a permeable, sealed bag containing a solid, porous chemically bonded ceramic system, nicotine or a salt thereof, and a pH regulating agent, wherein the solid, porous chemically bonded ceramic system is formed in the absence of the pH regulating agent, and a sublingual tablet, buccal tablet, wafer, or lozenge containing an intraoral formulation according to Claim 1 and a bioadhesion and/or mucoadhesion promoting agent. The claims do not disclose a chemically bonded ceramic system comprising a-TCP that is present at from about 0.1 % to about 50% by weight of the composition, or a composition wherein at least 20% by weight of the nicotine is located within the pores in the a-TCP. The teachings of Ahmed ‘196, Chan ‘502, and Bredenberg ‘976, as set forth in the above obviousness rejection pursuant to 35 U.S.C. § 103 remedy those deficiencies
Thus, it would have been prima facie obvious to prepare a composition comprising nicotine and a bioceramic according to the disclosures of the enumerated claims of the ‘956 application, wherein the bioceramic is a-TCP, as taught by Ahmed ‘196, present at 40 – 70% wgt of the composition, as taught by Chan ‘502, and at least 50% wgt of the nicotine is in the pores of the a-TCP, as taught by Bredenberg ‘976.
Consequently, the enumerated claims of the ‘956 application are drawn to an invention that reads upon present claims 1 – 6 and 9 – 17, and, as such, are directed to an invention that is patentably indistinct.
This is a provisional obviousness-type double patenting rejection.
Claims 1 – 6 and 9 – 17 are provisionally rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1 – 3, 5, 6, 11 – 13, 16, and 17 of co-pending Application No. 18/831,626 (“the ‘626 application”), in view of Chan ‘502, Bredenberg ‘976, and Nielsen ‘011.
The instant claims have been described supra.
Claims 1 – 3, 5, 6, 11 – 13, 16, and 17 of the ‘626 disclose an intraoral formulation comprising a solid, porous chemically bonded ceramic system comprising calcium; nicotine, or a salt thereof, located in pores in the chemically bonded ceramic system; and a pH regulating agent; wherein the chemically bonded ceramic system of the intraoral formulation is formed in the absence of the pH regulating agent; and is formed in the presence of the nicotine or a salt thereof such that the nicotine, or salt thereof, is located in the pores in the chemically bonded ceramic system; wherein the intraoral formulation is in a pouch, wherein the chemically bonded ceramic system is based on a calcium phosphate, wherein the chemically bonded ceramic system is formed from alpha-tricalcium phosphate, wherein the formulation is prepared using a salt of nicotine, such as nicotine bitartrate dihydrate, wherein the formulation produces a pH of at least 8 when it is brought into contact with saliva, wherein the chemically bonded ceramic system is present at from 40% to 98% by weight of the intraoral formulation, wherein the intraoral formulation comprises about 0.5 mg to about 15 mg nicotine or salt thereof, calculated as free nicotine base, wherein the pouch is a permeable, sealed bag containing about 0.5 mg to about 15 mg nicotine, or salt thereof, calculated as free nicotine base. The claims do not disclose a composition wherein at least 20% of the nicotine is in the pores of the a-tricalcium phosphate. This deficiency is remedied by the teachings of Bredenberg ‘976, as set forth in the obvious obviousness rejection of claim 12.
Consequently, it would have been prima facie obvious to prepare a composition comprising nicotine and an α-tricalcium phosphate ceramic according to the disclosures of the claims of the ‘626 application, as taught by Bredenberg ‘976.
Thus, the enumerated claims of the ‘626 application are drawn to an invention that reads upon present claims 1 – 6 and 9 – 17, and, as such, are directed to an invention that is patentably indistinct.
This is a provisional obviousness-type double patenting rejection.
NO CLAIM IS ALLOWED.
CONCLUSION
Any inquiry concerning this communication or any other communications from the examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The examiner can normally be reached on M-F 8:30 am - 5:30 pm.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
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