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 .
Election/Restrictions
Applicant’s election without traverse of Group I ( claims 1, 16 – 18, 20 – 21, 24 – 26, 29,and 32 – 34) drawn to a method of treating a respiratory disease or disorder in a subject in need thereof, comprising administering to said subject via nasal inhalation or oral inhalation a composition comprising a therapeutically effective amount of a compound of Formula IIq:
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wherein R1-5, p, m, and n are defined and the species election of 4-(5-(4-fluoropiperidine-1-carbonyl)-1H-pyrrolo[2,3-b]pyridin-1-yl)benzamide of structure
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in the reply filed on October 31st, 2025 is acknowledged.
Claims 37, 39 – 41, 44, and 47 – 48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II (an inhalation system for the treatment or prophylaxis of a respiratory disease or disorder), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 31st, 2025.
However, the initial search of the elected species 4-(5-(4-fluoropiperidine-1-carbonyl)-1H-pyrrolo[2,3-b]pyridin-1-yl)benzamide of structure
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was found to be free of the prior art. Thus the search was expanded to non-elected chemical species; hence all non-elected species have been rejoined. Therefore, the species election requirement set forth in the restriction requirement mailed September 4th, 2025 has been withdrawn; nevertheless, the restriction requirement between Group I and Group II is still maintained.
Hence claims 1, 16 – 18, 20 – 21, 24 – 26, 29, and 32 – 34 are being examined on the merits herein.
Claim Objections
Claims 18, 20 – 21, 24 – 26, 29, and 32 – 34 are 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.
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, and 16 – 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 6, 15, 53, and 91 of copending Application No. 18/292856 to Dugar et. al. (herein after Dugar’856) in view of Zhou et. al. ((2015), Inhaled formulations and pulmonary drug delivery systems for respiratory infections, Advanced Drug Delivery Reviews, 85, 83 – 99).
Dugar’856 recite a compound having the structure of Formula (V), or a pharmaceutically acceptable salt or solvate thereof:
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(reference claim 4) wherein reference X2-4 are N (reference claim 6); wherein reference X2 is N and X4 is CR3c (reference claim 15); reference W is -CR6R6-, wherein each R6 is independently H, halogen, -NR8R9, -OR10,-C(O)R10,-C(O)OR10,-C(O)NR8R9,or substituted or unsubstituted C1 -C6 alkyl (reference claim 53). Moreover, Dugar’856 recite a method of inhibiting 15-hydroxyprostaglandin dehydrogenase (15-PGDH) in a subject in need thereof, comprising administering to the subject a compound of (reference) claim 4 (reference claim 91).
However, Dugar’856 fails to define what reference R1 and R2 can be (instant claim 1).
Nevertheless, the specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) ("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004)(MPEP 804(II)(B)(1)). Thus as evidenced by the reference specification reference R1 and R2 are each independently H (instant claim 1) (reference specification page 21 paragraph 0088).
However, Dugar’856 fail to recite a method of treating a respiratory disease or disorder in a subject wherein the administration is via nasal inhalation or oral inhalation (instant claim 1 and 16).
Nevertheless, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). Moreover, it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003)(MPEP 804(II)(B)(1)). Thus as evidenced by the reference specification the compounds of the disclosure can treat lung fibrosis, including pulmonary fibrosis, pulmonary hypertension, chronic obstructive pulmonary disease (COPD)(instant claim 17), asthma (reference specification page 76 paragraph 0211).
However, Dugar’856 fails to recite the administration via nasal inhalation or oral inhalation (instant claims 1 and 16).
Nevertheless, Zhou et. al. teach that lower respiratory infections are particular problematic not only due to their high mortality and morbidity rates but also due to their escalating financial burden to the global healthcare system (page 83 column 1 paragraph 1). Moreover, Zhou et.al. teach that in general, respiratory infections are difficult to treat because microbes reside deep in the airways where only a small proportion of drug can access after traditional oral or parenteral administration (page 83 column 1 paragraph 2). Furthermore, Zhou et. al. teach that delivery of antibiotics directly to the respiratory tract provides an attractive solution in such situations because it allows higher drug concentrations to be achieved at the target site with lower systemic exposures (page 83 column 1 paragraph 2). Additionally, Zhou et. al. teach that in a pharmacokinetic study involving the nebulisation of colistin methanesulfonate solution (2 million IU) in cystic fibrosis patients clearly demonstrated that high drug concentrations could be achieved in the sputum (Cmax 6 mg/l) and maintained above MIC90 for a prolonged period (e.g. 12 h) with negligible systemic drug exposure (Cmax b0.3 mg/l) (page 83 column 1 paragraph 2). Thus Zhou et. al. suggest the potential superiority of inhalation (instant claim 16) administration for the treatment of lower respiratory infections.
Therefore, it would have been obvious before the effective filing date of the instant application to use the compound of copending Dugar’856 in a method of treating a respiratory disease or disorder in a subject in view of Zhou et. al. that is via administration through nasal inhalation or oral inhalation. One of ordinary skill in the art would have been motivated to make the modification and have a reasonable expectation of success because as evidenced by the reference specification the compounds of the disclosure, which overlap in structural features with the instant application, can treat lung fibrosis, including pulmonary fibrosis, pulmonary hypertension, chronic obstructive pulmonary disease (COPD). Moreover, as taught by Zhou et. al., given that only a small proportion of drugs can access the lower respiratory tract via traditional oral or parenteral administration; inhalation administration can delivery drugs directly to the respiratory tract providing higher drug concentrations at the target site with lower systemic exposures.
This is a provisional nonstatutory double patenting rejection.
Claims 1, and 16 – 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 18, and 20 of U.S. Patent No. 11345702 B1 to Rai et. al. (herein after Rai’702; cited on the IDSS dated February 18th, 2025) in view of Zhou et. al. ((2015), Inhaled formulations and pulmonary drug delivery systems for respiratory infections, Advanced Drug Delivery Reviews, 85, 83 – 99).
Rai’702 recite a compound having the structure of Formula (V), or a pharmaceutically acceptable salt or solvate thereof:
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(reference claims 1 – 18; instant claim 1). Moreover, Rai’702 recite a method of inhibiting 15-hydroxyprostaglandin dehydrogenase (15-PGDH) in a subject in need thereof, comprising administering to the subject a compound of (reference) claim 1 (reference claim 20).
However, Rai’702 fail to recite a method of treating a respiratory disease or disorder in a subject is via nasal inhalation or oral inhalation (instant claim 1).
Nevertheless, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). Moreover, it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003)(MPEP 804(II)(B)(1)). Thus as evidenced by the reference specification the compounds of the disclosure can treat lung fibrosis, including pulmonary fibrosis, pulmonary hypertension, chronic obstructive pulmonary disease (COPD)(instant claim 17), asthma (reference specification column 378 lines 48 – 61).
However, Rai’702 fails to recite the administration via nasal inhalation or oral inhalation (instant claims 1 and 16).
Nevertheless, Zhou et. al. teach that lower respiratory infections are particular problematic not only due to their high mortality and morbidity rates but also due to their escalating financial burden to the global healthcare system (page 83 column 1 paragraph 1). Moreover, Zhou et.al. teach that in general, respiratory infections are difficult to treat because microbes reside deep in the airways where only a small proportion of drug can access after traditional oral or parenteral administration (page 83 column 1 paragraph 2). Furthermore, Zhou et. al. teach that delivery of antibiotics directly to the respiratory tract provides an attractive solution in such situations because it allows higher drug concentrations to be achieved at the target site with lower systemic exposures (page 83 column 1 paragraph 2). Additionally, Zhou et. al. teach that in a pharmacokinetic study involving the nebulization of colistin methanesulfonate solution (2 million IU) in cystic fibrosis patients clearly demonstrated that high drug concentrations could be achieved in the sputum (Cmax 6 mg/l) and maintained above MIC90 for a prolonged period (e.g. 12 h) with negligible systemic drug exposure (Cmax b0.3 mg/l) (page 83 column 1 paragraph 2). Thus Zhou et. al. suggest the potential superiority of inhalation (instant claim 16) administration for the treatment of lower respiratory infections.
Therefore, it would have been obvious before the effective filing date of the instant application to use the invention of Rai’702 in a method of treating a respiratory disease or disorder in a subject in view of Zhou et. al. that is via administration through nasal inhalation or oral inhalation. One of ordinary skill in the art would have been motivated to make the modification and have a reasonable expectation of success because as evidenced by the reference specification the compounds of the disclosure, which overlap in structural features with the instant application, can treat lung fibrosis, including pulmonary fibrosis, pulmonary hypertension, chronic obstructive pulmonary disease (COPD). Moreover, as taught by Zhou et. al., given that only a small proportion of drugs can access the lower respiratory tract via traditional oral or parenteral administration; inhalation administration can delivery drugs directly to the respiratory tract providing higher drug concentrations at the target site with lower systemic exposures.
Discussion of the Prior art
The closet prior art of International Publication Number WO 2010/124119 A1 to Bian et. al. (herein after Bian’119; cited in the restriction dated October 31st, 2025) teach species compound 1043 1-(4-Fluorobenzyl)-5-({3-[4-(1,3-thiazol-2-ylcarbonyl)piperazin-1-yl]azetidin-1-yl}carbonyl)-1H-pyrrolo[2,3-b]pyridine of structure
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(page 352 Row 4) wherein instant R1 has a methyl unit -CH2- between the pyrrolo[2,3-b]pyridine ring and the 4-fluorobenzyl; instant R2 and R3 come together to form oxo; instant p is 0; instant R4 is (4λ-piperazin-1-yl)(thiazol-2-yl)methanone. Additionally, Bian’119 teach compounds of the disclosure which includes compound 1043 as useful in methods for treating, ameliorating and / or preventing a disease, a syndrome, a condition or a disorder that is affected by the inhibition of MGL (page 10 lines 11 – 13) which includes inflammatory hyperalgesia (page 11 line 3) and further includes cough, asthma, chronic obstructive pulmonary disease (page 11 line 9). Moreover, Bian’119 teach that compounds of the disclosure can be administered by inhalation (intratracheal or intranasal) (page 32 lines 26 – 27).
However, Bian’119 fails to teach a method wherein the compound of Formula (I) has instant R4 is independently selected from halo, -NR6R7, -OR8, -C(O)R8, -C(O)OR8,-C(O)NR6R7, -SOR9, -SO2R9, -SO2NR6R7, -NR10C(O)R8, -NR10C(O)NR6R7, -NR10SO2R8, -NR10SO2NR6R7, C1-6alkyl, C1-6haloalkyl, C3-10cycloalkyl, C6-10aryl, and 5-to 10-membered heteroaryl or two R4s are taken together with the carbon atoms to which they are attached and any intervening atoms to form a C3-10cycloalkyl (claim 1). Moreover, Bian’119 fails to teach a method wherein the compound of Formula (I) has the 4-fluorobenzyl attached directly to the pyrrolo[2,3-b]pyridine ring (claim 1).
Furthermore, while the prior art might provide a motivation for either removing the methyl unit between the 4-fluorobenzyl and the pyrrolo[2,3-b]pyridine ring or substituting cyclohexyl(thiazol-2-yl)methanone for (4λ-piperazin-1-yl)(thiazol-2-yl)methanone the prior art does not provide motivation to make both changes. Thus the prior art of Bian’119 fails to anticipate or render obvious the method of instant claims 1, 16 – 18, 20 – 21, 24 – 26, 29,and 32 – 34 which uses a compound of instant Formula IIq. Hence the instant claims 1, 16 – 18, 20 – 21, 24 – 26, 29,and 32 – 34 are free of the prior art.
Conclusion
Claims 1, and 16 – 17 are rejected. Claims 18, 20 – 21, 24 – 26, 29, and 32 – 34 are objected.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627