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 .
Claims 1-24 are pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 24 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph,
as failing to comply with the enablement requirement. The claim(s) contains subject matter
which was not described in the specification in such a way as to enable one skilled in the art to
which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In evaluating the enablement question, several factors are to be considered. In re
Wands, 8 USPQ2d 1400 (Fed. Cir. 1988); Ex parte Forman, 230 USPQ 546. The factors
include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack
thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of
working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed.
The nature of the instant invention has claims which embrace quaternary ammonium
compounds. The method of use of the compounds of Formula (I) of the instant invention where
an additional active ingredient such as an exogenous large pore receptor agonist is included in
the compositions. Exogenous large pore receptor agonist includes TRP1A receptor agonists,
TRPV 1-4 receptor agonists, TRPMS agonists, ASIC agonists, P2X receptor agonists,
acetaminophen, NSAIDs, 15 glucocorticoids, narcotics, tricyclic antidepressants, amine
transporter inhibitors, anticonvulsants, anti-proliferative and immune modulatory agents, an
antibody or antibody fragment, an antibiotic, a polynucleotide, a polypeptide, a protein, an anti
cancer agent, a growth factor, and a vaccine. The specification does not define that which is
intended in the additional active ingredients, i.e. which exogenous large pore receptor agonist,
TRP1A receptor agonists, TRPV 1-4 receptor agonists, TRPMS agonists, ASIC agonists, P2X
receptor agonists, acetaminophen, NSAIDs, 15 glucocorticoids, narcotics, tricyclic
antidepressants, amine transporter inhibitors, anticonvulsants, anti-proliferative and immune
modulatory agents, an antibody or antibody fragment, an antibiotic, a polynucleotide, a
polypeptide, a protein, an anti-cancer agent, a growth factor, a vaccine, etc.
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.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. The following reasons apply:
Claim 20 recites the broad recitation neuropathic pains including peripheral neuropathy, and the claim also recites neuropathic pains which is the narrower statement of neuropathic pains including peripheral neuropathy. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 20, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 20, the phrase "i.e." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d)
Claim 20 recites the broad recitation dry eye syndrome, and the claim also recites chronic ocular pain which is the narrower statement of dry eye syndrome. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 20 recites the broad recitation procedural pain, and the claim also recites i.e., pain associated with injections, draining an abscess, surgery, dental procedures, ophthalmic procedures, ophthalmic irritation, conjunctivitis (e.g., allergic conjunctivitis), eye redness, dry eye, arthroscopies and use of other medical instrumentation, cosmetic surgical procedures, dermatological procedures, setting fractures, biopsies, and the like which is the narrower statement of the procedural pain. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8, 10, 14 and 16-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee, U.S. Patent No. 10,835,505. Lee teaches the compounds and compositions of the compounds of formula (I) where RA is methyl; RB is methyl; RC is H; X1 is NHC(O); RD is H; RE is H; RF is ethyl; RG is ethyl; RH is phenyl; and Y- is
PNG
media_image1.png
151
275
media_image1.png
Greyscale
, -OH, and CH3C(O)O- as set forth in Table 1 and example 7.
Claim(s) 1-8, 10 and 14-24 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Wyrwa et al., WO 2018/029347. Wyrwa teaches the compounds, compositions and method of use of the compounds of formula (I) where RA is methyl; RB is methyl; RC is H; X1 is -NHC(O)-; each of RD and RE is H; RF is ethyl; RG is ethyl; RH is phenyl substituted by NH2, OH, -C(O)OH, -C(O)NHCH2C(O)OCH2CH3, CH(CH3)-C(O)OCH3, -CH2-C(O)OCH3, -C(O)OCH3, -NH-C(O)OC(CH3)3, OCH3, -C(O)NHCH2C(O)NHCH2C(O)OCH2CH3, etc.; and Y- is Br or CI anion as set forth in examples 3 11, 20, 21, 23, etc. The generic structure of Wyrwa encompasses the instantly claimed compounds of formula (I) (see Formula I, page 1) as claimed herein. The examples listed above differ only in the nature of the R¹, R², R³, R4, R5, R6, R7, R8, R9, R10, R11 and X- substituents of the quaternary amine compounds of formula (I). Page 2, lines 22-27 defines the instant substituents R¹-R10 independently represent hydrogen, halogen, C1-C5 alkyl, C1-C4 alkoxy, C1-C20 alkoxycarbonyl, -NH-P, -O-P, -(Y)n-COOR¹³, -(Y)n-COOM or -(Y)n-C(O)NR14R15; R¹¹ is hydrogen or C1-C10 alkyl; X- as halogenide, pseudo halogenide, sulfate, benzoate, acetate, trifluoroacetate, hydroxide, saccharinate or capsaicinate. The compounds of the instant invention are generically embraced by Wyrwa in view of the interchange ability of the instant the R¹, R², R³, R4, R5, R6, R7, R8, R9, R10, R11 and X- substituents of the quaternary amines. Thus, one of ordinary skill in the art at the time the invention was made would have been motivated to select for example H for each of the R¹, R², R³, R4, R5 substituents of the reference as well as other possibilities from the generically disclosed alternatives of the reference and in so doing obtain the instant compounds in view of the equivalency teachings outlined above.
Claim(s) 1-8, 10, 14 and 17-24 is/are rejected under 35 U.S.C. 102(a)(2) as being
anticipated by Wang et al., U.S. Patent No. 10,525,143. Wang teaches the compounds,
compositions and method of use of the compounds of formula (I) where RA is methyl; RB is methyl; RC is H; X1 is NHC(O); RD is H; RE is H; RF is ethyl; RG is ethyl; RH is phenyl substituted
by -O-C(O)CH2CH2C≡CH, -O-C(O)CH3, -O-CH2C≡CH and Y is I-, as set forth in examples 2
and 11.
Claim(s) 1-8, 10, 14, 16 and 17 is/are rejected under 35 U.S.C. 102(a)(2) as being
anticipated by Weisman et al., U.S. Patent Application Publication No. 2016/0258083. Weisman teaches the compounds and compositions of the compounds of formula (I) where RA is methyl; RB is methyl; RC is H; X1 is NHC(O); RD is H; RE is H; RF is ethyl; RG is ethyl; RH is phenyl; and Y- is
PNG
media_image1.png
151
275
media_image1.png
Greyscale
, -O-C(O)OH, CH3C(O)O- and -O-C(O) CH3C(OH)(CH2CO2H)2, as set forth in paragraph [0272].
Claim(s) 1, 3-8, 10, 14 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al., CN 105566148. Yang teaches the compounds of formula (I) where RA is methyl or ethyl; RB is methyl or ethyl; RC is H; X¹ is NRZC(O); RD is H; RE is H; RF is methyl or ethyl; RG is methyl or ethyl; RH is phenyl; RZ is H, CH2CO2C2H5, CH2O2H5 or CH2OCH3; and Y- is -OOC-Q where Q is Q1-4, Q2-1, Q2-2, Q2-3, Q3-7, Q3-8, Q6-1, Q6-2, Q8-1, Q8-2, Q9-1 as set forth on page 15 and the examples on pages 16-23.
Claim(s) 1, 3-8, 10 and 14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bachor et al., Analytical and Bioanalytical Chemistry. Bachor teaches the compounds of formula (I) where RA is methyl; RB is methyl; RC is H; X1 is NR²C(O); RD is H or D; RE is H or D; RF is ethyl; RG is ethyl; RH is phenyl; RZ is H or D; and Y- is
PNG
media_image2.png
148
89
media_image2.png
Greyscale
as set forth in examples a)-h) in Fig. 1.
Claim(s) 1-8, 10, 14, 16 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Janmejay et al., U.S. Patent Application Publication No. 2009/0306429. Janmejay teaches the compounds and compositions of the compounds of formula (I) where RA is methyl; RB is methyl; RC is H; X1 is NHC(O); RD is H; RE is H; RF is ethyl; RG is ethyl; RH is phenyl; and Y- is
PNG
media_image2.png
148
89
media_image2.png
Greyscale
, Cl-, -OH, capsaicinate, eruciate, linolate, linolenate and palmitate, as set forth in paragraphs [0002], [0003] and examples 1, 2, 3, 4, 5, 6 and 7.
Claim(s) 1-8, 10, 14, 16 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hughes et al., U.S. Patent Application Publication No. 2003/0068276. Hughes teaches the compounds and compositions of the compounds of formula (I) where RA is methyl; RB is methyl; RC is H; X1 is NHC(O); RD is H; RE is H; RF is ethyl; RG is ethyl; RH is phenyl; and Y- is
PNG
media_image2.png
148
89
media_image2.png
Greyscale
, Cl-, capsaicinate and saccharide, as set forth in paragraph [0066], example 5 and claim 6.
Claim(s) 1-8, 10, 14, 16 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blum et al., U.S. Patent No. 6,207,290. Blum teaches the compounds and compositions of the compounds of formula (I) where RA is methyl; RB is methyl; RC is H; X1 is NHC(O); RD is H; RE is H; RF is ethyl; RG is ethyl; RH is phenyl; and Y- is
PNG
media_image2.png
148
89
media_image2.png
Greyscale
, Cl-, oleate and saccharide, as set forth in column 2, lines 42-44 and claim 26.
Claim(s) 1-8, 10, 14, 16 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blum et al., U.S. Patent No. 5,891,919. Blum teaches the compounds and compositions of the compounds of formula (I) where RA is methyl; RB is methyl; RC is H; X1 is NHC(O); RD is H; RE is H; RF is ethyl; RG is ethyl; RH is phenyl; and Y- is
PNG
media_image2.png
148
89
media_image2.png
Greyscale
, Cl-, OH-,
PNG
media_image3.png
150
619
media_image3.png
Greyscale
as set forth in example 1 and claim 18.
Claim(s) 1-8, 10 and 14-16 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Haraguchi et al., U.S. Patent No. 5,409,805. Haraguchi teaches the compounds of formula (I) where RA is methyl or ethyl; RB is H, methyl or ethyl; RC is H; X1 is-NHC(O)-; each of RD and RE is H; RF is ethyl or methyl; RG is ethyl or methyl; RH is phenyl optionally substituted with methyl; and Y- is CI, Br, I, Ph-COO, 4-methylphenyl-COO, 2,4,6-trimethylphenyl-COO, 2-methylphenyl-COO anion as set forth in examples I-1 through I-16, etc. The generic structure of Haraguchi encompasses the instantly claimed compounds of formula (I) (see Formula I, column 3) as claimed herein. The examples listed above differ only in the nature of the R¹, R², R³, m, n and X- substituents of the quaternary amine compounds of formula (I). Column 3, lines 28-34 defines the instant substituents R¹ is a halogen, an alkyl or alkenyl; R² is a halogen, alkyl, alkenyl or alkoxy; R³ is a lower alkyl; m and n each represent an integer of 0 to 5; and X- represents an anion such as a halogen ion, a sulfate, nitrate, perchlorate, a hydroxyl, an aliphatic or aromatic carboxylic acid or a sulfonic acid. The compounds of the instant invention are generically embraced by Haraguchi in view of the interchange ability of the instant the R¹, R², R³, m, n and X- substituents of the quaternary amines. Thus, one of ordinary skill in the art at the time the invention was made would have been motivated to select for example Br for the R³ substituent of the reference as well as other possibilities from the generically disclosed alternatives of the reference and in so doing obtain the instant compounds in view of the equivalency teachings outlined above.
Claim(s) 1-8, 10, 14 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Payne et al., GB 2 212 814. Payne teaches the compounds of formula (I) where RA is methyl; RB is methyl; RC is H; X¹ is NHC(O); RD is H; RE is H; RF is ethyl; RG is ethyl; RH is phenyl; and Y- is benzoate, cyclamate, stearate and CI as set forth in examples 1-21.
Claim(s) 1-8, 10, 14, 16 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saroli, Zeitschrift fuer Lebensmittel-Untersuchung. Saroli teaches the compounds and compositions of the compounds of formula (I) where RA is H or methyl; RB is H or methyl; RC is H or methyl; X¹ is NHC(O); RD is H; RE is H; RF is methyl or ethyl; RG is methyl or ethyl; RH is phenyl; and Y- is benzoate, and CI as set forth in examples 21-25.
Claim(s) 1-8, 10, 14, 16 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saroli, Naturwissenschaften. Saroli teaches the compounds and compositions of the compounds of formula (I) where RA is methyl; RB is methyl; RC is H; X¹ is NHC(O); RD is H; RE is H; RF is methyl or ethyl; RG is methyl, ethyl, butyl and CH2-phenyl; RH is phenyl; and Y- is CI as set forth in examples 8 and 11-14.
Claim(s) 1-8, 10 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Minkoff, U.S. Patent No. 4,005,038. Minkoff teaches the compounds of formula (I) where RA is methyl; RB is methyl; RC is H; X¹ is NHC(O); RD is H; RE is H; RF is ethyl; RG is ethyl; RH is phenyl; and Y- is benzoate or octanoate as set forth in examples I-VIII.
Claim(s) 1, 3-8, 10, 14 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hay, U.S. Patent No. 3,080,327. Hay teaches the compounds and compositions of the compounds of formula (I) where RA is methyl; RB is methyl; RC is H; X¹ is NHC(O); RD is H; RE is H; RF is methyl, ethyl, propyl and butyl; RG is methyl, ethyl, propyl and butyl; RH is phenyl or chlorophenyl; and Y- is benzoate, o-aminobenzoate, m-aminobenzoate, p aminobenzoate, o-chlorobenzoate, m-chlorobenzoate, p-chlorobenzoate, o-toluate, m-toluate, p-toluate, phthalate, tartrate, oxalate, as set forth in examples 1-14, 22-24, etc.
Claim(s) 1-5, 7, 9, 10 and 13-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roche Products Ltd., GB 751522. GB 751522 teaches the compounds and compositions of the compounds of formula (I) where RA is H; RB is H; RC is propoxy, -O-CH2-Ph,-O-CH=CH=CH2, butoxy, methoxy,-O-CH(CH3)2 or ethoxy; X¹ is NHC(O); RD is H or methyl; RE is H or methyl; RF is methyl, ethyl or propyl; RG is methyl, ethyl or propyl; or RF and RG taken together form a piperidin-1-yl ring; RH is phenyl, nitrophenyl, acetylphenyl or chlorophenyl; and Y- is Br, CI or I, as set forth in examples 1-5, 7-19. 21-25, etc.
Claim(s) 1-5, 7, 9-11, 14 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by J.R. Geigy A.-G, GB 692332. GB 692332 teaches the compounds and compositions of the compounds of formula (I) where RA is H; RB is H; RC is CF3; X¹ is NHC(O); RD is H or ethyl; RE is H; RF is methyl; RG is methyl; RH is 3,4-dichlorophenyl; and Y- is Br or CI as set forth in examples 25, 26, etc.
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 1-5, 9-14 and 17-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,927,096. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds, compositions and method of use of the compounds of formula (I) embrace the compounds, compositions and method of use of the compounds of formula (I) of U.S. '096 where RA is CO2RT, X¹ is-NRZC(O)-, RF and RG together with the N+ to which they are attached form an optionally substituted 5- to 10-membered heterocyclic ring having zero, one, or more heteroatoms in addition to the N+ and RH is CH2-aryl or CH2-heteroaryl.
Claims 1-13 and 15-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,780,083. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds, compositions and method of use of the compounds of Formula I of U.S. '083 embraces the compounds, compositions and method of use of the compounds of the instant invention where RA and RB are methyl; RC is H; X¹ is NHC(=O); RD is H, methyl or ethyl; RE is H; RF and RG together with the N+ to which they are attached form an optionally substituted heterocyclic ring having zero, one or more nitrogen atoms in addition to the N+; RH is phenyl; and Y- is a pharmaceutically acceptable anion.
Claims 1-11, 13 and 15-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6-8 and 10-13 of U.S. Patent No. 11,377,422. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds, compositions and method of use of the compounds of formula (I) are embraced by the compounds, compositions and method of use of the compounds of formula (I) of U.S. '422 where RF and RG together with the N+ form and substituted 5-8 membered ring and RH is benzyl.
Claims 1-13 and 15-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,968,179. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds, compositions and method of use of the compounds of the instant invention are embraced by the compounds, compositions and method of use of the compounds of formula (I) in U.S. '179 where RF and RG together with the N+ to which they are attached form an optionally substituted heterocyclic ring having zero, one or more nitrogen atoms in addition to the N+.
Claims 1-5, 9-13 and 17-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,643,404. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds, compositions and method of use of the compounds of formula (I) embrace the compounds, compositions and method of use of the compounds of formula (I) in U.S. '404 where RA is CO2RT, X¹ is-NRZC(O)- and RH is CH2-aryl or CH2-heteroaryl.
Claims 1-13 and 15-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 17-24 of U.S. Patent No. 12,195,428. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds, compositions and method of use of the compounds of the instant invention are embraced by the compounds, compositions and method of use of the compounds of formula (I) in U.S. '428 where RF and RG together with the N+ to which they are attached form a substituted heterocyclic ring having zero, one or more nitrogen atoms in addition to the N+.
Claims 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,603,355. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds, compositions and method of use of the compounds of the instant invention are embraced by the compounds, compositions and method of use of the compounds of formula (I) in U.S. '355 where RF and RG together with the N+ to which they are attached form an optionally substituted heterocyclic ring having zero, one or more nitrogen atoms in addition to the N+.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624