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 1-28 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 28 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 compound 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.
Claims 1-19 and 21-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The following reasons apply:
Claim 1 recites the broad recitation heterocyclic ring having zero, one or more heteroatoms in addition to the N+, including but not limited to a heteroaryl ring, and the claim also recites heterocyclic ring having zero, one or more heteroatoms in addition to the N+ which is the narrower statement of two or three of RD, RE, RF, RG and RH together with the N+ form an optionally substituted heterocyclic ring. 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 11 recites the limitation "aryl and heteroaryl" in the definition of RF, RG and RH. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "arylalkyl and heteroarylalkyl" in the definition of RH. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "
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190
298
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” in the definition of RH. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "aralkyl and heteroaralkyl" in the definition of RH. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "aryl and heteroaryl" in the definition of Z. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 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 24, 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 24, 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 24 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 24 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) 1-20 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 Martin et al., U.S. Patent No. 4,233,055. Martin teaches the compounds of formula (I) where RA is CO2RT; RT is ethyl; RB is methyl; RC is H; X¹ is-NHC(O)-; each of RD and RE is H; RF and RG together complete a pyrrolidine ring; RH is ethyl; and Y- is CI anion as set forth in example 177. The generic structure of Martin encompasses the instantly claimed compounds of formula (I) (see Formula I, page 3) as claimed herein. The examples within the table differ only in the nature of the instant RA substituent of the quaternary amine compounds of formula (I). Column 2, lines 37-48 defines the instant substituent RA as an alkoxycarbonyl. The compounds of the instant invention are generically embraced by Martin in view of the interchange ability of the instant RA; RT; RB; RC; X¹; RD, RE; RF; RG; RH; and Y- is an anion substituent 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 -CO2Me or-CO2Et for the RA 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) 1-3, 6, 7, 21 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vigante et al., LV 15002. Vigante teaches the compounds and compositions of the compounds of formula (I) where RA is CO2Me; RB is H; RC is H; X¹ is NHC(O); RD is H; RE is H; RF, RG and RH together with the N+ form a 5-amino-isoquinolin-2-ium, 3-carboxy-pyridin-1-ium and 3-ethoxycarbonyl-pyridin-1-ium; and Y- is Br as set forth in examples 2 and 4 in line 1 and example 1 in line 2.
Claim(s) 1-3, 6, 7, 15, 19 and 21-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hamprecht et al., U.S. Patent No. 8,841,309. Hamprecht teaches the compounds, compositions and method of use of the compounds of formula (I) where RA is CO2Me; RB is H; RC is H; X¹ is NHC(O); RD is H; RE is H; RF and RG together form and substituted piperidin-1-ium; RH is methyl; and Y- is CI as set forth in example 72.3.
Claim(s) 1-3, 6, 7 and 21-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beckwith et al., U.S. Patent Application Publication No. 2008/0207718. Beckwith teaches the compounds, compositions and method of use of the compounds of formula (I) where RA is CO2Et; RB is H; RC is H; X¹ is NHC(O); RD is H; RE is H; RF, RG and RH together with the N+ form a substituted pyrrolo[1,2-a]imidazolium; and Y- is halogen such as CI as set forth in examples 259 and 285.
Claim(s) 1-3, 6, 7, 21 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bell, U.S. Patent No. 3,574,216. Bell teaches the compounds and compositions of the compounds of formula (I) where RA is CO2Et; RB is H; RC is 4-CI; X¹ is NHC(O); RD is H; RE is H; RF, RG and RH togetherwith the N+ form a pyridinium; and Y- is CI as set forth in example llb.
Claim(s) 1-3, 6 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dumitrascu, Revista de Chimie. Dumitrascu teaches the compounds of formula (I) where RA is CO2Me; RB is H; RC is H; X¹ is NHC(O); RD is H; RE is H; RF, RG and RH together with the N+ form a phthalazinium; and Y- is I as set forth in the Caplus printout.
Claim(s) 1-3, 6 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rehwald, Journal fuer Praktische Chemie. Rehwald teaches the compounds of formula (I) where RA is CO2Et; RB is H; RC is H; X¹ is NHC(O); RD is H; RE is H; RF, RG and RH together with the N+ form a pyridinium; and Y- is CI as set forth in 22a.
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.
Claims 1-10, 15, 16, 19-28 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bean et al., WO 2017/024037. The generic structure of Bean encompasses the instantly claimed compounds, compositions and method of use of the compounds of formula (I) (see Formula I, page 3) as claimed herein. Examples 1-12 and 21-27 differs only in the nature of the RA substituent of the quaternary amine compounds of formula (I). Page 3, lines 4-16 defines the instant substituents RA is CO2RT; RT is C1-4 alkyl; RB is H, halogen or C1-4 alkyl; RC is H, halogen, C1-4 alkyl, C2-4 alkenyl, C2-4 alkynyl, ORI, NRJRK, NRLC(O)RM, S(O)RN, S(O)2RN, SO2RORP, SO2NRQRR, SO2RS, CO2RT, C(O)RU, and C(O)NRVRW; X¹ is-NRZC(O)-; each of RD and RE is independently selected from H, C1-4 alkyl, C2-4 alkenyl, C2-4 alkynyl, C2-4 heteroalkyl, optionally substituted with halogen, C3-8 cyclic alkyl, aryl or heteroaryl, and C3-6 cycloalkyl or RD and RE together form a 3-6-memebered heterocyclic or heteroalkyl ring; RF and RG together complete a heterocyclic ring having at least one nitrogen atom: RH is C1-4 alkyl, C2-4 alkenyl, C2-4 alkynyl, C2-4 heteroalkyl, optionally substituted with halogen, C3-8 cyclic alkyl, aryl or heteroaryl, and C3-6 cycloalkyl; and Y- is an anion. The compounds of the instant invention are generically embraced by Bean in view of the interchange ability of RA; RT; RB; RC; X¹; RD, RE; RF; RG; RH; and Y- is an anion substituent 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 -CO2Me or CO2Et for the RA 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.
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 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-11 and 13-20 of U.S. Patent No. 10,934,263. 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. '263 where RA is CO2RT, X¹ is -NRZC(O)-; RF and RG together with the N+ form an optionally substituted heteroaryl ring.
Claims 1-28 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) are embraced by the compounds, compositions and method of use of the compounds of formula (I) of U.S. '404 where RA is CO2RT, X¹ is -NRZC(O)-; RF and RG together with the N+ form an optionally substituted heteroaryl ring.
Claims 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-13 and 16-19 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 formula (I) are embraced by the compounds, compositions and method of use of the compounds of formula (I) of U.S. '355 where RA is CO2RT, X¹ is -NRZC(O)-; RF and RG together with the N+ form an optionally substituted heteroaryl ring.
Claims 1-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6-11 and 13-20 of U.S. Patent No. 11,512,058. 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. '058 where RA is CO2RT, X¹ is -NRZC(O)-; RF and RG together with the N+ form an optionally substituted heteroaryl ring.
Claims 1-28 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) are embraced by 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+ form an optionally substituted heteroaryl ring.
Claims 1-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 11 and 12 of copending Application No. 18/925,166 (reference application). 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 18/925,166 where RA is CO2RT, X¹ is -NRZC(O)-; RF and RG together with the N+ form an optionally substituted heteroaryl ring.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-14 and 17-24 of copending Application No. 18/905,381 (reference application). 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 18/905,381 where RA is CO2RT, X¹ is -NRZC(O)-; RF and RG together with the N+ form an optionally substituted heteroaryl ring.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 10-15 and 17-24 of copending Application No. 18/899,307 (reference application). 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 18/899,307 where RA is CO2RT, X¹ is -NRZC(O)-; RF and RG together with the N+ form an optionally substituted heteroaryl ring.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-14 and 16-23 of copending Application No. 19/231,962 (reference application). 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 19/231,962 where RA is CO2RT, X¹ is -NRZC(O)-; RF and RG together with the N+ form an optionally substituted heteroaryl ring.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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).
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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.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
