DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restriction
Applicant’s election without traverse of Group I and Species A, corresponding to claims 1-8 and 12-32, in the reply filed on 7/6/2026 is acknowledged.
Claims 9-11 and 33-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/6/2026.
Status of the Claims
Claims 1-36 are pending. Claims 9-11 and 33-36 are withdrawn. Claims 1-36 have been amended.
Claim Objections
Claims 1, objected to because of the following informalities:
In claim 1, “methyl cyclopentenolone, methyl cyclopentenolone” should be “methyl cyclopentenolone”;
In claim 16, "the flavoring agent" should be "the at least one flavoring agent" (aligning with claim 1, from which claim 16 depends);
In claim 19, “the chemosensory” should be “the at least one chemosensory irritant” (aligning with claim 18, from which claim 19 depends);
In claim 20, "the chemosensory irritant" should be “the at least one chemosensory irritant” (aligning with claim 18, from which claim 20 depends);
In claim 23, “at least one organic” should be “at least one organic acid” (as claim 26, which depends from claim 23, refers back to "the at least one organic acid");
In claim 24, "the substituted pyridine compound" should be "the at least one substituted pyridine compound" (aligning with claim 23, from which claim 24 depends);
In claim 25, "the organic acid" should be "the at least one organic acid" (aligning with claim 23, from which claim 25 depends);
In claim 29, "the chemosensory irritant" should be “the at least one chemosensory irritant” (aligning with claim 28, from which claim 29 depends);
In claim 30, "the chemosensory irritant" should be “the at least one chemosensory irritant” (aligning with claim 28, from which claim 30 depends).
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7, 12-15, 17-26, 28, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 9, 10-14, 43, and 45 of U.S. Patent No. US 11,964,958 B1. Although the claims at issue are not identical, they are not patentably distinct from each other because the chemical structures of the compositions claimed in US 11,964,958 B1 overlap the chemical structures of the compositions claimed in the instant application.
Claims 1-2, 4-7, 12-13, 18, and 23-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-13 and 18 of U.S. Patent No. US 12,358,889 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the chemical structures of the compositions claimed in US 12,358,889 B2 overlap the chemical structures of the compositions claimed in the instant application.
Claims 1-2, 4-7, 12-26, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-9, 11-13, and 26 of U.S. Patent No. US 12,358,888 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the chemical structures of the compositions claimed in US 12,358,888 B2 overlap the chemical structures of the compositions claimed in the instant application.
Claims 1-8, 12-13, 15, 23-26, 28-29, and 31-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6 and 16 of U.S. Patent No. US 12,478,091 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the chemical structures of the compositions claimed in US 12,478,091 B2 overlap the chemical structures of the compositions claimed in the instant application.
Claims 1-8, 12-27, and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-14, and 21 of U.S. Patent No. US 12,497,381 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the chemical structures of the compositions claimed in US 12,497,381 B2 overlap the chemical structures of the compositions claimed in the instant application.
Claims 1-8, 12-27, and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27, 31-34, 36-37, 39-43, and 45-46 of copending Application No. 18/238,709 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the chemical structures of the compositions claimed in 18/238,709 overlap the chemical structures of the compositions claimed in the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented (the examiner notes that while a Notice of Allowance was mailed for 18/238,709 on 9/14/2026, the patent has not yet been issued; if not addressed, when the patent for 18/238,709 issues, this provisional rejection would become a nonprovisional rejection).
Claims 1-7, 12-19, 23-29, and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, and 21 of copending Application No. 18/826,821 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the chemical structures of the compositions claimed in 18/826,821 overlap the chemical structures of the compositions claimed in the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4-7, 12-16, 18-19, 23-26, 28-29, and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim1-2, 4-5, 9-10, and 20 of copending Application No. 19/222,752 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the chemical structures of the compositions claimed in 19/222,752 overlap the chemical structures of the compositions claimed in the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maggio (US 2013/0224300 A1).
Maggio discloses a composition (“therapeutic compositions including a therapeutic agent in a non-aqueous matrix”, Abstract), comprising:
at least one substituted pyridine compound of Formula (I):
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(I), or a salt, or mixed salt thereof (therapeutic agent may be “norcotinine”, ¶ 0045, see chemical structure of norcotinine provided below), wherein:
A is selected from:
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(see chemical structure of norcotinine provided below);
R1, R2, R3, R4 and R5 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, substituted alkenyl, and
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(R1, R2, R3, R4 and R5 are H, see chemical structure of norcotinine provided below);
R6 and R7 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R6 and R7 together are =O (R6 and R7 together are =O; see chemical structure of norcotinine provided below);
R8, R9, R10, R11, and R12 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl (R8, R9, R10, R11 are H, and R12 is not applicable to the selected structure of A, see chemical structure of norcotinine provided below);
R13 and R14 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R13 and R14 together are =O (R13 and R14 are not applicable to the selected structure, see chemical structure of norcotinine provided below);
n is an integer from 1 to 10 (n is not applicable to the selected structure, see chemical structure of norcotinine provided below); and
R15 and R16 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R15 and R16 together with the N atom to which they are bonded form a 3-8 membered optionally substituted heterocyclic ring (R15 and R16 are not applicable to the selected structure, see chemical structure of norcotinine provided below),
with the proviso that if A is
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and R5 is methyl, then R1, R2, R3, R4, R6, R7, R8, R9, R10, and R11 cannot all be H (not applicable as R5 is not methyl, see chemical structure of norcotinine provided below); and
at least one flavoring agent comprising benzyl alcohol (the non-aqueous matrix may include “benzyl alcohol”, ¶ 0058),
wherein the composition is entirely devoid of (R) or (S) nicotine (while nicotine is listed as another option for the therapeutic agent of the composition in ¶ 0045, the selected therapeutic agent is norcotinine, which is not nicotine).
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Norcotinine Chemical Structure
Regarding claim 8, Maggio discloses the composition of claim 1, as stated above. Maggio discloses wherein the at least one substituted pyridine compound has a structure according to Formula (IB):
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(IB), or a salt, or mixed salt thereof (see chemical structure of norcotinine provided in the rejection of claim 1 above).
Claims 23-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osdene et al. (US 5,015,741).
Regarding claim 23, Osdene discloses a composition (“acid addition salts” of “nicotine analog compounds”, Col. 4, Lines 33-35) comprising:
at least one substituted pyridine compound of Formula (I):
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(I), or a salt, or mixed salt thereof (nicotine analog Example III, “(R,S)-1(3-Dimethylaminopropyl)-2-(3-pyridyl)pyrrolidine”, Col. 6, Lines 8-9, see chemical structure of Example III below, annotated by examiner, which can be in salt form, Col. 4, Lines 33-35), wherein:
A is selected from:
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(see chemical structure of Example III below, annotated by examiner);
R1, R2, R3, R4 and R5 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, substituted alkenyl, and
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(R1, R2, R3, R4 are H, and R5 is
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, see chemical structure of Example III below, annotated by examiner);
R6 and R7 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R6 and R7 together are =O (R6 and R7 are H, see chemical structure of Example III below, annotated by examiner);
R8, R9, R10, R11, and R12 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl (R8, R9, R10, R11 are H, and R12 is not applicable to the selected structure of A, see chemical structure of Example III below, annotated by examiner);
R13 and R14 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R13 and R14 together are =O (R13 and R14 are H, see chemical structure of Example III below, annotated by examiner);
n is an integer from 1 to 10 (n is 3, see chemical structure of Example III below, annotated by examiner); and
R15 and R16 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R15 and R16 together with the N atom to which they are bonded form a 3-8 membered optionally substituted heterocyclic ring (R15 and R16 are each CH3, which is alkyl, see chemical structure of Example III below, annotated by examiner),
with the proviso that if A is
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and R5 is methyl, then R1, R2, R3, R4, R6, R7, R8, R9, R10, and R11 cannot all be H (not applicable as R5 is not methyl, see chemical structure of Example III below, annotated by examiner); and
at least one organic acid comprising acetic acid or salts thereof (“acetic acid”, Col. 4, Line 37, which can be used to form a salt of the nicotine analog, Col. 4, Lines 33-35),
wherein the composition is entirely devoid of (R) or (S) nicotine (the composition contains nicotine analogs/derivatives rather than nicotine, in order to avoid negative effects of nicotine, Col. 1, Lines 49-59).
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Example III, Annotated by Examiner
Regarding claim 24, Osdene discloses the composition of claim 23, as stated above. Osdene further discloses wherein the at least one substituted pyridine compound is (S)-N,N-dimethyl-3-(2-(pyridin-3-yl)pyrrolidin-1-yl)propan-1-amine (the at least one substituted pyridine compound of Formula (I) in the rejection of claim 23 above is the racemic mixture of R and S enantiomers of Example III, (R,S)-1(3-Dimethylaminopropyl)-2-(3-pyridyl)pyrrolidine, where the S enantiomer is (S)-N,N-dimethyl-3-(2-(pyridin-3-yl)pyrrolidin-1-yl)propan-1-amine).
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.
Claims 1-4, 12-23, and 25-32 are rejected under 35 U.S.C. 103 as being unpatentable over Keller et al. (US 2023/0148660 A1) in view of Osdene et al. (US 5,015,741).
Regarding claim 1, Keller discloses a composition (“products configured for oral use” comprising “sensory agents”, ¶ 0088-0089) comprising a basic amine (“nicotine or other basic amine”, ¶ 0156, where nicotine and its derivatives/analogs are basic amines due to the pyrrole group as well as substituted pyridine compounds due to the pyridine group) and at least one flavoring agent comprising geraniol (“geraniol”, ¶ 0121),
wherein the composition is entirely devoid of (R) or (S) nicotine (“0% by weight of nicotine”, ¶ 0193).
However, Keller does not explicitly disclose that the basic amine is at least one substituted pyridine compound of Formula (I) as claimed.
Osdene, in the same field of endeavor, discloses a composition comprising at least one substituted pyridine compound of Formula (I):
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(I), or a salt, or mixed salt thereof (nicotine analog Example III, “(R,S)-1(3-Dimethylaminopropyl)-2-(3-pyridyl)pyrrolidine”, Col. 6, Lines 8-9, see chemical structure of Example III below, annotated by examiner), wherein:
A is selected from:
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(see chemical structure of Example III below, annotated by examiner);
R1, R2, R3, R4 and R5 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, substituted alkenyl, and
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(R1, R2, R3, R4 are H, and R5 is
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, see chemical structure of Example III below, annotated by examiner);
R6 and R7 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R6 and R7 together are =O (R6 and R7 are H, see chemical structure of Example III below, annotated by examiner);
R8, R9, R10, R11, and R12 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl (R8, R9, R10, R11 are H, and R12 is not applicable to the selected structure of A, see chemical structure of Example III below, annotated by examiner);
R13 and R14 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R13 and R14 together are =O (R13 and R14 are H, see chemical structure of Example III below, annotated by examiner);
n is an integer from 1 to 10 (n is 3, see chemical structure of Example III below, annotated by examiner); and
R15 and R16 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R15 and R16 together with the N atom to which they are bonded form a 3-8 membered optionally substituted heterocyclic ring (R15 and R16 are each CH3, which is alkyl, see chemical structure of Example III below, annotated by examiner),
with the proviso that if A is
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and R5 is methyl, then R1, R2, R3, R4, R6, R7, R8, R9, R10, and R11 cannot all be H (not applicable as R5 is not methyl, see chemical structure of Example III below, annotated by examiner).
Osdene also discloses a benefit to including the at least one substituted pyridine compound of Formula (I) in a composition in that it provides desired effects while avoiding negative effects associated with nicotine (Col. 1, Lines 56-59). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used the at least one substituted pyridine compound of Formula (I) taught by Osdene in the composition of Keller, in order to obtain this benefit.
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Example III, Annotated by Examiner
Alternatively regarding claim 1, Keller discloses a composition (“products configured for oral use” comprising “sensory agents”, ¶ 0088-0089) comprising a basic amine (“nicotine or other basic amine”, ¶ 0156, where nicotine and its derivatives/analogs are basic amines due to the pyrrole group as well as substituted pyridine compounds due to the pyridine group) and at least one flavoring agent comprising geraniol (“geraniol”, ¶ 0121),
wherein the composition is entirely devoid of (R) or (S) nicotine (“0% by weight of nicotine”, ¶ 0193).
However, Keller does not explicitly disclose that the basic amine is at least one substituted pyridine compound of Formula (I) as claimed.
Osdene, in the same field of endeavor, discloses a composition comprising at least one substituted pyridine compound of Formula (I):
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(I), or a salt, or mixed salt thereof (nicotine analog Example XXVII, “(R,S)-6-(N,N-Dimethyl-3-aminopropyl)nicotine”, Col. 16, Lines 55, see chemical structure of Example XXVII below, annotated by examiner), wherein:
A is selected from:
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(see chemical structure of Example XXVII below, annotated by examiner);
R1, R2, R3, R4 and R5 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, substituted alkenyl, and
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(R1 is
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; R2, R3, R4 are H; and R5 is CH3, which is alkyl; see chemical structure of Example XXVII below, annotated by examiner);
R6 and R7 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R6 and R7 together are =O (R6 and R7 are H, see chemical structure of Example XXVII below, annotated by examiner);
R8, R9, R10, R11, and R12 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl (R8, R9, R10, R11 are H, and R12 is not applicable to the selected structure of A, see chemical structure of Example XXVII below, annotated by examiner);
R13 and R14 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R13 and R14 together are =O (R13 and R14 are H, see chemical structure of Example XXVII below, annotated by examiner);
n is an integer from 1 to 10 (n is 3, see chemical structure of Example XXVII below, annotated by examiner); and
R15 and R16 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R15 and R16 together with the N atom to which they are bonded form a 3-8 membered optionally substituted heterocyclic ring (R15 and R16 are each CH3, which is alkyl, see chemical structure of Example XXVII below, annotated by examiner),
with the proviso that if A is
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and R5 is methyl, then R1, R2, R3, R4, R6, R7, R8, R9, R10, and R11 cannot all be H (not applicable as although R5 is methyl, R1 is
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, see chemical structure of Example XXVII below, annotated by examiner).
Osdene also discloses a benefit to including the at least one substituted pyridine compound of Formula (I) in a composition in that it provides desired effects while avoiding negative effects associated with nicotine (Col. 1, Lines 56-59). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used the at least one substituted pyridine compound of Formula (I) taught by Osdene in the composition of Keller, in order to obtain this benefit.
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Example XXVII, Annotated by Examiner
Regarding claim 2, Keller in view of Osdene discloses the composition of claim 1, as stated above. Osdene discloses wherein the at least one substituted pyridine compound has a structure according to Formula (IA):
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(IA), or a salt, or mixed salt thereof (see chemical structure of Example III in the rejection of claim 1 above, annotated by examiner).
Regarding claim 3, Keller in view of Osdene discloses the composition of claim 1, as stated above. Osdene discloses wherein the at least one substituted pyridine compound has a structure according to Formula (IA-1):
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(IA-1), or a salt, or mixed salt thereof (see chemical structure of Example III in the rejection of claim 1 above, annotated by examiner).
Regarding claim 4, Keller in view of Osdene discloses the composition of claim 1, as stated in the alternate rejection of claim 1 above. Osdene discloses wherein the at least one substituted pyridine compound has a structure according to Formula (IA-2):
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(IA-2), or a salt, or mixed salt thereof (see chemical structure of Example XXVII in the alternate rejection of claim 1 above, annotated by examiner).
Regarding claim 12, Keller in view of Osdene discloses the composition of claim 1, as stated above. Osdene discloses wherein the at least one substituted pyridine compound has a structure according to Formula (IAA):
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(IAA), or a salt, or mixed salt thereof (see chemical structure of Example III in the rejection of claim 1 above, annotated by examiner), with the proviso that if R5 is CH3, then R1, R2, R3, and R4 cannot all be H (not applicable as R5 is not CH3, see chemical structure of Example III in the rejection of claim 1 above, annotated by examiner).
Regarding claim 13, Keller in view of Osdene discloses the composition of claim 1, as stated above. Osdene discloses wherein the at least one substituted pyridine compound is
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(see chemical structure of Example III in the rejection of claim 1 above, annotated by examiner).
Regarding claim 14, Keller in view of Osdene discloses the composition of claim 1, as stated above. Keller also discloses the composition further comprising an organic acid comprising acetic acid (“nicotine or other basic amine is employed in association with at least a portion of an organic acid”, ¶ 0156, where the organic acid comprises “acetic acid”, ¶ 0170).
Regarding claim 15, Keller in view of Osdene discloses the composition of claim 14, as stated above. Keller discloses wherein the organic acid comprises acetic acid (“acetic acid”, ¶ 0170).
Regarding claim 16, Keller in view of Osdene discloses the composition of claim 1, as stated above. Keller also discloses wherein the at least one flavoring agent further comprises linalool (“linalool”, ¶ 0121).
Regarding claim 17, Keller in view of Osdene discloses the composition of claim 1, as stated above. Keller also discloses the composition further comprising a solvent comprising at least one of propylene glycol or glycerin (“solvents or solubilizing agents (e.g., inclusion in the composition of glycerin or propylene glycol)”, ¶ 0162).
Regarding claims 18 and 19, Keller in view of Osdene discloses the composition of claim 1, as stated above. Keller also discloses the composition further comprising at least one chemosensory irritant, wherein the at least one chemosensory irritant comprises linalool (“linalool”, ¶ 0121).
Regarding claims 18, 20, 21, and 22, Keller in view of Osdene discloses the composition of claim 1, as stated above. Keller also discloses the composition further comprising at least one chemosensory irritant, wherein the at least one chemosensory irritant is a spice additive exhibiting a spiciness of from about 1,000 to about 20,000,000 Scoville Heat Units (SHU), wherein the spice additive is capsaicin (“capsaicin”, ¶ 0090).
Regarding claim 23, Keller discloses a composition (“products configured for oral use” comprising “sensory agents”, ¶ 0088-0089) comprising a basic amine (“nicotine or other basic amine”, ¶ 0156, where nicotine and its derivatives/analogs are basic amines due to the pyrrole group as well as substituted pyridine compounds due to the pyridine group) and at least one organic acid comprising acetic acid (“nicotine or other basic amine is employed in association with at least a portion of an organic acid”, ¶ 0156, where the organic acid comprises “acetic acid”, ¶ 0170),
wherein the composition is entirely devoid of (R) or (S) nicotine (“0% by weight of nicotine”, ¶ 0193).
However, Keller does not explicitly disclose that the basic amine is at least one substituted pyridine compound of Formula (I) as claimed.
Osdene, in the same field of endeavor, discloses a composition comprising at least one substituted pyridine compound of Formula (I):
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(I), or a salt, or mixed salt thereof (nicotine analog Example III, “(R,S)-1(3-Dimethylaminopropyl)-2-(3-pyridyl)pyrrolidine”, Col. 6, Lines 8-9, see chemical structure of Example III below, annotated by examiner), wherein:
A is selected from:
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(see chemical structure of Example III below, annotated by examiner);
R1, R2, R3, R4 and R5 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, substituted alkenyl, and
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(R1, R2, R3, R4 are H, and R5 is
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1
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, see chemical structure of Example III below, annotated by examiner);
R6 and R7 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R6 and R7 together are =O (R6 and R7 are H, see chemical structure of Example III below, annotated by examiner);
R8, R9, R10, R11, and R12 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl (R8, R9, R10, R11 are H, and R12 is not applicable to the selected structure of A, see chemical structure of Example III below, annotated by examiner);
R13 and R14 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R13 and R14 together are =O (R13 and R14 are H, see chemical structure of Example III below, annotated by examiner);
n is an integer from 1 to 10 (n is 3, see chemical structure of Example III below, annotated by examiner); and
R15 and R16 are independently selected from H, alkyl, substituted alkyl, cycloalkyl, substituted cycloalkyl, alkenyl, and substituted alkenyl, or R15 and R16 together with the N atom to which they are bonded form a 3-8 membered optionally substituted heterocyclic ring (R15 and R16 are each CH3, which is alkyl, see chemical structure of Example III below, annotated by examiner),
with the proviso that if A is
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and R5 is methyl, then R1, R2, R3, R4, R6, R7, R8, R9, R10, and R11 cannot all be H (not applicable as R5 is not methyl, see chemical structure of Example III below, annotated by examiner).
Osdene also discloses a benefit to including the at least one substituted pyridine compound of Formula (I) in a composition in that it provides desired effects while avoiding negative effects associated with nicotine (Col. 1, Lines 56-59). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used the at least one substituted pyridine compound of Formula (I) taught by Osdene, which is also a basic amine, as the basic amine in the composition of Keller, in order to obtain this benefit.
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Example III, Annotated by Examiner
Regarding claim 25, Keller in view of Osdene discloses the composition of claim 23, as stated above. Keller also discloses wherein the at least one organic acid further comprises citric acid (“more than one organic acid may be present”, and the organic acid can comprise “citric acid”, ¶ 0181).
Regarding claim 26, Keller in view of Osdene discloses the composition of claim 23, as stated above. Keller also discloses wherein the at least one organic acid comprises a mixture of citric acid and acetic acid, or salts thereof (“more than one organic acid may be present”, and the organic acid can comprise “citric acid”, ¶ 0181, in addition to “acetic acid”, ¶ 0170).
Regarding claim 27, Keller in view of Osdene discloses the composition of claim 23, as stated above. Keller also discloses the composition further comprising a solvent comprising propylene glycol or glycerin (“solvents or solubilizing agents (e.g., inclusion in the composition of glycerin or propylene glycol)”, ¶ 0162).
Regarding claims 28 and 29, Keller in view of Osdene discloses the composition of claim 23, as stated above. Keller also discloses the composition further comprising at least one chemosensory irritant, wherein the at least one chemosensory irritant comprises linalool (“linalool”, ¶ 0121).
Regarding claims 28, 30, and 31, Keller in view of Osdene discloses the composition of claim 23, as stated above. Keller also discloses the composition further comprising at least one chemosensory irritant, wherein the at least one chemosensory irritant is a spice additive exhibiting a spiciness of from about 1,000 to about 20,000,000 Scoville Heat Units (SHU), wherein the spice additive comprises capsaicin (“capsaicin”, ¶ 0090).
Regarding claim 32, Keller in view of Osdene discloses the composition of claim 23, as stated above. Keller also discloses the composition further comprising at least one flavoring agent (“flavoring agents”, ¶ 0094).
Allowable Subject Matter
Claims 5 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The specific .
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY G CULBERT whose telephone number is (571)270-0874. The examiner can normally be reached Monday-Friday 9am-4pm.
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/COURTNEY G CULBERT/Examiner, Art Unit 1747
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