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 .
All previous objections and rejections not reiterated herein were overcome by claim amendments and arguments, filed May 11th, 2026, have been fully considered and found persuasive. As such all objections and rejections not reiterated herein have been withdrawn.
Election/Restrictions
Claims 1, 16 – 18, 20 – 21, 25 – 26, 29, and 32 – 34 are currently pending in the application. However, due to a restriction requirement, claims 37, 39 – 41, 44, and 47 – 48 are withdrawn and have been cancelled by the applicant. Hence claims 1, 16 – 18, 20 – 21, 25 – 26, 29, and 32 – 34 are still being examined on the merits herein.
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, 16 – 18, 20 – 21, 25 – 26, 29, and 32 – 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4, 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) and Sorino et. al. ((2020), Inhalation therapy devices for the treatment of obstructive lung diseases: the history of inhalers towards the ideal inhaler, European Journal of Internal Medicine, 75, page 15 – 18).
Dugar’856 recite a compound having the structure of Formula (V), or a pharmaceutically acceptable salt or solvate thereof:
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. See reference claim 4. See examined claim 1. Further, Dugar’856 recite a compound with specific structural limitations that overlap with the compounds administered in the method of the instant application. See reference claims 92 – 109. See examined claim 1. Thus both Dugar’856 and the examined application have overlapping chemical species. Moreover, Dugar’856 recite a pharmaceutical composition comprising a compound of claim 4, or a pharmaceutically acceptable salt or solvate thereof, and a pharmaceutically acceptable excipient. See reference claim 109. Additionally, 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 claim 4. See reference claim 110. See examined claim 1.
However, while Dugar’856 does recite a pharmaceutical composition comprising a compound having the structure of Formula (V); Dugar’856 fail to recite whether the compound or composition of the reference is useful in a method of treating a respiratory disease or disorder in a subject where the administration is via nasal inhalation or oral inhalation by a device. See examined claims 1, and 16 – 17. Moreover, Dugar’856 fails to recite whether the compound or composition of the reference is formulated as recited in dependent examined claims 18, 20 – 21, 25 – 26, 29, and 32 – 34. See examined claims 18, 20 – 21, 25 – 26, 29, and 32 – 34.
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). See 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), asthma which are respiratory diseases and/or disorders. See reference specification page 76 paragraph 0211. See examined claim 17.
However, Dugar’856 fails to recite whether the compound or composition of the reference is formulated as recited in dependent examined claims 18, 20 – 21, 25 – 26, 29, and 32 – 34. See examined claims 18, 20 – 21, 25 – 26, 29, and 32 – 34.
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. See 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. See 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. See 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). See page 83 column 1 paragraph 2. Thus Zhou et. al. suggest the potential superiority of inhalation administration for the treatment of lower respiratory infections. See examined claims 16, 26, and 29. Furthermore, Zhou et. al. teach that in one study where an example active pharmaceutical ingredient (API) was delivered using a brush powder generators in a rabbit model at three dosages that included 0.5 mg/kg. See page 82 Table 4 row 6. Thus, Zhou et.al. suggest the ability to administer an API using a brush powder generator at 0.5 mg/kg or 500 µg/kg. See examined claim 32.
However, Zhou et. al. fails to teach whether the compound or composition of the reference is formulated as recited in dependent examined claims 18, 20 – 21, 25, and 32 – 34. See examined claims 18, 20 – 21, 25, and 32 – 34.
Nevertheless, Sorino et. al. teach that when a drug is administered orally, intravenously or intramuscularly, it enters the blood stream and it can reach most organs and tissues including the airways. See page 15 column 1 paragraph 1. Moreover, Sorino et. al. teach that inhaling a medication, especially for diseases of the airways, allows for a relatively faster onset of action, using a lower dose of active principle and causing fewer side effects in districts where its action is not needed. See page 15 column 1 paragraph 2. Furthermore, Sorino et. al. teach that the drug's particles must be of adequate size with breathed in particles with a diameter > 10 μm stopped at the level of mouth and pharynx where they can be absorbed, especially if swallowed. See page 15 column 1 paragraph 2. Additionally, Sorino et. al. teach that the particles with a diameter between 5 and 10 μm settle in the trachea and main bronchi while particles between 2 and 5 μm in diameter can actually reach the small airways. See page 15 column 1 paragraph 2 and column 2 paragraph 1. See examined claim 21.
Furthermore, Sorino et. al. teach that the devices used to administer inhaled drugs play a crucial role in the management of airway diseases. See page 16 column 1 paragraph 1. Additionally, Sorino et. al. teach that there are four main different types of inhalers are widely used: nebulizers, dry powder inhalers (DPIs), pressurized metered- dose inhalers (pMDIs), and soft mist inhalers (SMIs). See page 16 column 1 paragraph 2 and Table 1. See examined claim 25. Also, Sorino et. al. teach that a typical pMDI consists of: (1) a metal canister containing the medication in solution or suspension together with a liquefied gas propellant under pressure; (2) a metering valve allowing to dispense precise doses of drug; (3) a plastic mouthpiece allowing the patient to actuate the device and convey the particles into the airways. See page 17 column 1 paragraph 2. Moreover, Sorino et. al. teach that to actuate a typical pMDI, the user presses down on the top of the canister. See page 17 column 1 paragraph 2. See examined claim 18. Moreover, Sorino et. al. teach that some DPIs have pre-metered single doses that are contained in capsules to be inserted in the device and pierced before inhalation while others are multi-unit dose with a reservoir of powder and a definite mechanism that loads the desired amount of drug. See page 17 column 2 paragraph 6. See examined claims 33 and 34.
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 and further in view of Sorino et. al. to use an inhalation device such as DPI or pMDI. 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. Furthermore, as taught by Sorino et. al., are four main different types of inhalers are widely used thus it would have been within the purview of one of ordinary skill in the art to select any one of the known types of inhaler as a device to administer examined claim 1 compounds in a method of treating a respiratory disease or disorder. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because inhalation of an API was known in the art to allow for a relatively faster onset of action, using a lower dose of active principle and causing fewer side effects in districts where its action is not needed.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 16 – 18, 20 – 21, 25 – 26, 29, and 32 – 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 18, and 20 of U.S. Patent No. US 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) and Sorino et. al. ((2020), Inhalation therapy devices for the treatment of obstructive lung diseases: the history of inhalers towards the ideal inhaler, European Journal of Internal Medicine, 75, page 15 – 18).
Rai’702 recite a compound having the structure of Formula (IIq), or a pharmaceutically acceptable salt or solvate thereof:
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. See reference claims 1. See examined claim 1. Further, Rai’702 recite a compound with specific structural limitations that overlap with the compounds administered in the method of the instant application. See reference claims 2 – 18. See examined claim 1. Thus both Rai’7026 and the examined application have overlapping chemical species. Moreover, Rai’702 recite a pharmaceutical composition comprising a compound of claim 1, or a pharmaceutically acceptable salt or solvate thereof, and a pharmaceutically acceptable excipient. See reference claim 19. Additionally, 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 claim 1. See reference claim 20. See examined claim 1.
However, while Rai’702 does recite a pharmaceutical composition comprising a compound having the structure of Formula (IIq); Rai’702 fail to recite whether the compound or composition of the reference is useful in a method of treating a respiratory disease or disorder in a subject where the administration is via nasal inhalation or oral inhalation by a device. See examined claims 1, and 16 – 17. Moreover, Rai’702 fails to recite whether the compound or composition of the reference is formulated as recited in dependent examined claims 18, 20 – 21, 25 – 26, 29, and 32 – 34. See examined claims 18, 20 – 21, 25 – 26, 29, and 32 – 34.
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). See 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), asthma which are respiratory diseases and/or disorders. See reference specification column 378 lines 48 – 61. See examined claim 17.
However, Rai’702 fails to recite whether the compound or composition of the reference is formulated as recited in dependent examined claims 18, 20 – 21, 25 – 26, 29, and 32 – 34. See examined claims 18, 20 – 21, 25 – 26, 29, and 32 – 34.
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. See 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. See 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. See 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). See page 83 column 1 paragraph 2. Thus Zhou et. al. suggest the potential superiority of inhalation administration for the treatment of lower respiratory infections. See examined claims 16, 26, and 29. Furthermore, Zhou et. al. teach that in one study where an example active pharmaceutical ingredient (API) was delivered using a brush powder generators in a rabbit model at three dosages that included 0.5 mg/kg. See page 82 Table 4 row 6. Thus, Zhou et.al. suggest the ability to administer an API using a brush powder generator at 0.5 mg/kg or 500 µg/kg. See examined claim 32.
However, Zhou et. al. fails to teach whether the compound or composition of the reference is formulated as recited in dependent examined claims 18, 20 – 21, 25, and 32 – 34. See examined claims 18, 20 – 21, 25, and 32 – 34.
Nevertheless, Sorino et. al. teach that when a drug is administered orally, intravenously or intramuscularly, it enters the blood stream and it can reach most organs and tissues including the airways. See page 15 column 1 paragraph 1. Moreover, Sorino et. al. teach that inhaling a medication, especially for diseases of the airways, allows for a relatively faster onset of action, using a lower dose of active principle and causing fewer side effects in districts where its action is not needed. See page 15 column 1 paragraph 2. Furthermore, Sorino et. al. teach that the drug's particles must be of adequate size with breathed in particles with a diameter > 10 μm stopped at the level of mouth and pharynx where they can be absorbed, especially if swallowed. See page 15 column 1 paragraph 2. Additionally, Sorino et. al. teach that the particles with a diameter between 5 and 10 μm settle in the trachea and main bronchi while particles between 2 and 5 μm in diameter can actually reach the small airways. See page 15 column 1 paragraph 2 and column 2 paragraph 1. See examined claim 21.
Furthermore, Sorino et. al. teach that the devices used to administer inhaled drugs play a crucial role in the management of airway diseases. See page 16 column 1 paragraph 1. Additionally, Sorino et. al. teach that there are four main different types of inhalers are widely used: nebulizers, dry powder inhalers (DPIs), pressurized metered- dose inhalers (pMDIs), and soft mist inhalers (SMIs). See page 16 column 1 paragraph 2 and Table 1. See examined claim 25. Also, Sorino et. al. teach that a typical pMDI consists of: (1) a metal canister containing the medication in solution or suspension together with a liquefied gas propellant under pressure; (2) a metering valve allowing to dispense precise doses of drug; (3) a plastic mouthpiece allowing the patient to actuate the device and convey the particles into the airways. See page 17 column 1 paragraph 2. Moreover, Sorino et. al. teach that to actuate a typical pMDI, the user presses down on the top of the canister. See page 17 column 1 paragraph 2. See examined claim 18. Moreover, Sorino et. al. teach that some DPIs have pre-metered single doses that are contained in capsules to be inserted in the device and pierced before inhalation while others are multi-unit dose with a reservoir of powder and a definite mechanism that loads the desired amount of drug. See page 17 column 2 paragraph 6. See examined claims 33 and 34.
Therefore, it would have been obvious before the effective filing date of the instant application to use the compound of invention 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 and further in view of Sorino et. al. to use an inhalation device such as DPI or pMDI. 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. Furthermore, as taught by Sorino et. al., are four main different types of inhalers are widely used thus it would have been within the purview of one of ordinary skill in the art to select any one of the known types of inhaler as a device to administer examined claim 1 compounds in a method of treating a respiratory disease or disorder. Moreover, one of ordinary skill in the art would have had a reasonable expectation of success because inhalation of an API was known in the art to allow for a relatively faster onset of action, using a lower dose of active principle and causing fewer side effects in districts where its action is not needed.
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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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. See page 352 Row 4. See claim 1. 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 which includes inflammatory hyperalgesia and further includes cough, asthma, chronic obstructive pulmonary disease. See page 10 lines 10 – 11, and page 11 line 3 and line 9. Moreover, Bian’119 teach that compounds of the disclosure can be administered by inhalation (intratracheal or intranasal). See 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. See 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 simultaneously. Thus the prior art of Bian’119 fails to anticipate or render obvious the method of claims 1, 16 – 18, 20 – 21, 25 – 26, 29, and 32 – 34 which uses a compound of instant Formula IIq. Hence the claims 1, 16 – 18, 20 – 21, 25 – 26, 29, and 32 – 34 are free of the prior art.
Conclusion
Claims 1, 16 – 18, 20 – 21, 25 – 26, 29, and 32 – 34 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
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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