DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
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 10 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites a compound according to claim 1 wherein said compound is the compound of example 1 – 983; without stating the chemical name or chemical structure. Applicant is reminded that, where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure, table, or in the instant case to specific example numbers, "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). (See MPEP 2173.05(s)).
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 – 12, and 15 – 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 6, 8 – 9, 14 – 21 of copending Application No. 19/111955 to Herrmann et. al. (reference application; herein after Herrmann’955).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending applications direct to overlapping macrocyclic compounds (reference claims 1 - 6; instant claims 1 – 10, and 17), pharmaceutical compositions comprising said macrocycles (reference claims 8, and 16 – 18; instant claims 12, and 18 – 19), and method of treating cystic fibrosis comprising administering said macrocyclic compounds (reference claims 14 – 15, and 19 – 21; instant claims 11, 15 – 16, and 21 – 23). Specifically, copending Herrmann’955 recites a crystalline form of (3S, 7S, 10R, 13R)-13-benzyl-20-fluoro-7-isobutyl-N-(2-(3-methoxy-1,2,4-oxadiazol-5-yl)ethyl)-6,9-dimethyl-1,5,8, 11-tetraoxo-10-(2,2,2-trifluoroethyl)-1,2,3,4,5,6, 7,8,9, 10, 11, 12, 13, 14-tetradecahydro-[1]oxa[4, 7, 10, 14]tetraazacycloheptadecino[16,17-f]quinoline-3-carboxamide (instant claim 17) which is an encompassed species of a compound of (instant) Formula (I)
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(reference claims 1 - 6; instant claims 1 – 10, and 17).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 12, and 15 – 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 – 12, and 16 – 25 of copending Application No. 19/111782 to Bolli et. al. (reference application; Bolli’782).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending applications direct to pharmaceutical compositions comprising said macrocycles (reference claims 1 – 12, and 16 – 19; instant claims 12, and 18 – 19), and method of treating cystic fibrosis comprising administering said macrocyclic compounds (reference claims 20 – 25; instant claims 11, 15 – 16, and 21 – 23). Specifically, copending Bolli’782 recites a pharmaceutical composition comprising, as active principles, a compound of (reference) Formula (I)
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(reference claims 1 – 12, and 16 – 19) which is encompassed by instant Formula (I)
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(instant claims 1 – 10, and 17).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 12, and 15 – 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 11, and 15 – 19 of copending Application No. 19/112147 to Bolli et. al. (reference application; Bolli’147).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending applications direct to a compound of overlapping macrocyclic formula (reference claims 1 – 10; instant claims 1 – 10, and 17), pharmaceutical compositions comprising said macrocycles (reference claims 11, and 16; instant claims 12, and 18 – 19), and method of treating cystic fibrosis comprising administering said macrocyclic compounds (reference claims 15, and 17 – 19; instant claims 11, 15 – 16, and 21 – 23). Specifically, copending Bolli’782 recites a pharmaceutical composition comprising, as active principles, a compound of (reference) Formula (I)
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(reference claims 1 – 10) which is encompassed by instant Formula (I)
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(instant claims 1 – 10, and 17).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Discussion of the prior art
The following is an examiner’s statement of reasons for allowance: claims 1 – 12, and 17 – 19 direct to a compound and compositions comprising a compound of Formula (I)
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wherein R1-4, X, and Ar1-2 are defined. Moreover, claims 15 – 16, and 20 – 23 direct to a method of treatment of CFTR-related diseases and disorders, said method comprising administering to a subject in need thereof an effective amount of a compound according to claim 1, or of a pharmaceutically acceptable salt thereof.
The closet prior art of Hutt et. al. ((2011), Potential Agents for Treating Cystic Fibrosis: Cyclic Tetrapeptides That Restore Trafficking and Activity of ΔF508-CFTR, ACS Med Chem Lett, 2, 703 – 707; cited on the IDS dated January 22nd, 2024) teach that cystic fibrosis (CF) is a hereditary loss-of-function disease that affects various tissues of the respiratory and gastrointestinal systems, resulting in progressive disability and early death that is caused by defective trafficking and/or function of the CF transmembrane conductance regulator (CFTR) protein, a cAMP-activated channel that conducts chloride and bicarbonate ions across the apical plasma membrane, and controls trans-epithelial sodium ion transport (page 703 column 1 paragraph 1). Furthermore, Hutt et. al. teach cyclic tetrapeptides, structurally related to the HDAC inhibitor natural product apicidin, that correct the maturation of ΔF508-CFTR from the ER, resulting in robust cell surface channel activity (page 704 column 1 paragraph 1). Specifically, Hutt et. al. teach compound 18 of the structure
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wherein instant Ar1 = triazole; instant R2 = CH3; instant R1 = H, instant R4 = -(CH2)5(C=O)CH2CH3; instant Ar2 = indole (page 704 column 2 Chart I). Moreover, Hutt et. al. teach that compound 18 had an ΔF508-CFTR fold increase value of 80 ± 10 at 1 µM (page 705 column 1 Table I).
However, Hutt et. al. fails to teach a compound of formula (I)
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wherein the Ar1 ring is between a carbonyl and an ether functional group; there is an X or methyl unit between N-R1 and the carbonyl; there is a methyl unit between the O and CH-CH2-Ar2 substituents; and instant R4 = -CO-NH-R41 (claim 1). Moreover, the prior art fails to teach a motivation for making all four changes described previously to the prior art compound 18. Therefore, since the prior art fails to anticipate or render obvious the compounds of formula (I) instant claims 1 – 12, and 17 – 19 are free of the prior art. Furthermore, claims 15 – 16, and 20 – 23 which direct to a method of treatment of CFTR-related diseases and disorders, are enabled for modulating F508del-CFTR tagged U2OS cell lines at EC50 nmol/l (instant specification page 333 – 340). Additionally, since instant claims 15 – 16, and 20 – 23 depend on the use of compounds of instant claim 1; and instant claim 1 is free of the prior art, the methods of instant claims 15 – 16, and 20 – 23 are also free of the prior art.
Conclusion
Claim 1 – 12, and 15 – 23 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
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