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, 4-7, 9-11, 14, 16-17, 19-23, 25-27 filed March 23, 2026 are currently pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/23/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Applicant’s amendments, filed 03/23/2026 are acknowledged. In view of the cancelation of claim 8, the pending 35 U.S.C. 112 paragraph D rejection of record is withdrawn. In addition, in view of Applicant’s amendments to claims 26-27, the pending 35 U.S.C 112 paragraph B rejection of record is withdrawn.
Applicant's arguments, filed 03/23/2026 have been fully considered. Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and objections presently being applied to the instant application.
Double Patenting-Rejection(s) Maintained
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, 4-7, 9-11, 14, 16-17, 19-23 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9, 11-15, 17-28 of copending Application No. 18417864 (reference application) in view of Grimbaldeston (WO2022/261417 published 12/15/2022).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and claims 1-9, 11-15, 17-28 of copending Application 18417864 are directed to treating moderate COPD in a subject comprising administering via inhalation a therapeutically effective amount of the same inhalable ensifentrine formulation embraced within the present claims. Claims 18-24 embrace a combination therapy further comprising a LAMA, LABA or corticosteroid therapy as found in present claims 20-21. As evidenced by page 37 of the present specification, a patient with moderate to severe COPD comprises an FEV1 of 30%-70% which is the same patient population and FEV1 embodied within the present claims.
The difference between the instant claims and that of claims 1-9, 11-15, 17-28 of copending Application 18417864 is that the moderate COPD patient in copending Application 18417864 is not explicitly described as comprising at least one or more exacerbations as presently claimed.
Grimbaldeston (WO2022/261417 published 12/15/2022) teaches treating COPD in a subject in need comprising an ST inhibitor wherein the COPD patient population comprises a baseline blood eosinophil count of < 170 eosinophils/L (claims 1-6). Grimbaldeston teaches COPD exacerbations and that the frequency of exacerbations increases with the severity of the disease and the decline of lung function (page 2 lines 20 to page 3 line 20). Grimbaldeston teaches that COPD exacerbations affect patients with moderate COPD (page 3 lines 1-20).
Therefore, one of ordinary skill in the art prior to the time of the invention knowing that an inhalable ensifentrine is efficacious at treating COPD patients comprising one or more exacerbations wherein said patient comprises a blood eosinophil count of less than 300 cell/mL as taught in the present claims, said artisan would have found it prima facie obvious to administer to administer said ensifentrine therapy to a COPD patient with moderate COPD as found in copending Application 18417864, in view of Grimbaldeston. Motivation to administer the ensifentrine therapeutic regimen to a COPD patient with moderate COPD flows logically from the fact that Grimbaldeston teaches that patients with moderate COPD comprise exacerbations and the presently claimed COPD treatment is efficacious in patients comprising at least one or more COPD exacerbations. Accordingly, said artisan would have readily predicted that the claimed ensifentrine regimen would have effectively reduced COPD exacerbations in the patient with moderate COPD.
Applicant traverses. Applicant asserts that in light of the unexpected results in the 1.132 declaration by Dr. Tara Rhealt, the copending double patenting rejection is no longer applicable.
Response to Arguments
Applicant’s arguments, filed 03/23/2026 are acknowledged and have been carefully considered. Regarding Applicant’s contention that the unexpected results in the 1.132 declaration by Dr. Tara Rhealt are sufficient to overcome the double patenting rejection of record, the examiner is not persuaded. The presently claimed methodology is not patentably distinct from the methodology embodied within claims 1-9, 11-15, 17-28 of copending Application 18417864. Both the present claims and claims 1-9, 11-15, 17-28 of copending Application 18417864 are directed to treating the same disease state of moderate COPD in a subject comprising administering via inhalation a therapeutically effective amount of the same inhalable ensifentrine formulation embraced within the present claims. Claims 18-24 embrace a combination therapy further comprising a LAMA, LABA or corticosteroid therapy as found in present claims 20-21. As evidenced by page 37 of the present specification, a patient with moderate to severe COPD comprises an FEV1 of 30%-70% which is the same patient population and FEV1 embodied within the present claims.
It is further noted that the study of 800 patients with COPD and blood eosinophil count of < 150 eosinophils/L found in pages 38-40 of the instant specification wherein reduction in COPD exacerbations was observed is the same 800 COPD patients treated with the same ensifentrine formulation found in pages 8-11 of the specification of copending Application 18417864. As such, said species of unexpected results asserted by the Applicant in the present application merely claims the known functional effect of the moderate COPD patient population treated within the same ensifentrine formulation embodied within claims 1-9, 11-15, 17-28 of copending Application 18417864. See AbbVie Inc. v. Kennedy Inst. of Rheumatology Trust, No. 13-1545 (Fed. Cir. 2014).
While claims 1-9, 11-15, 17-28 of copending Application 18417864 do not explicitly described as comprising at least one or more exacerbations as presently claimed, Grimbaldeston teaches COPD exacerbations and that the frequency of exacerbations increases with the severity of the disease and the decline of lung function (page 2 lines 20 to page 3 line 20). Grimbaldeston teaches treating COPD in a subject in need comprising an ST inhibitor wherein the COPD patient population comprises a baseline blood eosinophil count of < 170 eosinophils/L (claims 1-6). Grimbaldeston further teaches that COPD exacerbations affect patients with moderate COPD, the same patient population treated with the same inhalable ensifentrine formulation embraced within the present claims (page 3 lines 1-20). As such, said skilled artisan would not consider there to be a patentable difference in patient population identified in claims 1-9, 11-15, 17-28 of copending Application 18417864 and that of the present claims.
Thus, one of ordinary skill in the art prior to the time of the invention knowing that an inhalable ensifentrine is efficacious at treating COPD patients comprising one or more exacerbations wherein said patient comprises a blood eosinophil count of less than 300 cell/mL as taught in the present claims, said artisan would have found it prima facie obvious to administer to administer said ensifentrine therapy to a COPD patient with moderate COPD as found in copending Application 18417864, in view of Grimbaldeston. Motivation to administer the ensifentrine therapeutic regimen to a COPD patient with moderate COPD flows logically from the fact that Grimbaldeston teaches that patients with moderate COPD comprise exacerbations and the presently claimed COPD treatment is efficacious in patients comprising at least one or more COPD exacerbations. Accordingly, said artisan would have readily predicted that the claimed ensifentrine regimen would have effectively reduced COPD exacerbations in the patient with moderate COPD.
Claims 1, 4-7, 9-11, 14, 16-17, 19-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-13, 15, 17-21, 23-30 of copending Application No. 18424468 (reference application) in view of Grimbaldeston (WO2022/261417 published 12/15/2022).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and claims 1-13, 15, 17-21, 23-30 of copending Application No. 18424468 are directed to treating moderate to severe COPD in a subject comprising administering via inhalation a therapeutically effective amount of the same inhalable ensifentrine formulation embraced within the present claims for at least 12 weeks. The duration of at least 24 weeks found within the present claim 27 overlaps with the duration at least 12 week dosing frequency of copending Application 18424468. Claims 24-30 embrace a combination therapy further comprising a LAMA, LABA or corticosteroid therapy as found in present claims 20-21. As evidenced by page 37 of the present specification, a patient with moderate to severe COPD comprises an FEV1 of 30%-70% which is the same patient population and FEV1 embodied within claims 1-13, 15, 17-21, 23-30 of copending Application No. 18424468.
The difference between the instant claims and that of claims 1-13, 15, 17-21, 23-30 of copending Application No. 18424468 is that the COPD patient in copending Application 18424468 comprising moderate to severe COPD is not explicitly described as comprising at least one or more exacerbations as presently claimed.
Grimbaldeston (WO2022/261417 published 12/15/2022) teaches treating COPD in a subject in need comprising an ST inhibitor wherein the COPD patient population comprises a baseline blood eosinophil count of < 170 eosinophils/L (claims 1-6). Grimbaldeston teaches COPD exacerbations and that the frequency of exacerbations increases with the severity of the disease and the decline of lung function (page 2 lines 20 to page 3 line 20). Grimbaldeston teaches that COPD exacerbations affect patients with moderate and severe COPD (page 2 to page 3 lines 1-20).
Therefore, one of ordinary skill in the art prior to the time of the invention knowing that ensifentrine is efficacious at treating moderate to severe COPD patients comprising one or more exacerbations wherein said patient comprises a blood eosinophil count of less than 300 cell/mL as taught in the present claims, said artisan would have found it prima facie obvious to administer to administer said ensifentrine therapy to a COPD patient with moderate or severe COPD as found in copending Application 18424468, in view of Grimbaldeston. Motivation to administer the ensifentrine therapeutic regimen to a COPD patient with moderate to severe COPD flows logically from the fact that Grimbaldeston teaches that patients with moderate to severe COPD comprise exacerbations and the presently claimed COPD treatment is efficacious in moderate to severe COPD patients comprising at least one or more COPD exacerbations. Accordingly, said artisan would have readily predicted that the claimed ensifentrine regimen would have effectively reduced COPD exacerbations in the patient with moderate to severe COPD.
Applicant traverses. Applicant asserts that in light of the unexpected results in the 1.132 declaration by Dr. Tara Rhealt, the copending double patenting rejection is no longer applicable.
Response to Arguments
Applicant’s arguments, filed 03/23/2026 are acknowledged and have been carefully considered. Regarding Applicant’s contention that the unexpected results in the 1.132 declaration by Dr. Tara Rhealt are sufficient to overcome the double patenting rejection of record, the examiner is not persuaded. The presently claimed methodology is not patentably distinct from the methodology embodied within claims 1-13, 15, 17-21, 23-30 of copending Application No. 18424468. Both the present claims and claims 1-13, 15, 17-21, 23-30 of copending Application No. 18424468 are directed to treating the same disease state of moderate to severe COPD in a subject comprising administering via inhalation a therapeutically effective amount of the same inhalable ensifentrine formulation embraced within the present claims for the same duration of at least 12 weeks. Claims 24-30 embrace a combination therapy further comprising a LAMA, LABA or corticosteroid therapy as found in present claims 20-21. As evidenced by page 37 of the present specification, a patient with moderate to severe COPD comprises an FEV1 of 30%-70% which is the same patient population and FEV1 embodied within the present claims.
It is further noted that the study of 800 patients with COPD and blood eosinophil count of < 150 eosinophils/L found in pages 38-40 of the instant specification wherein reduction in COPD exacerbations was observed is the same 800 COPD patients treated with the same ensifentrine formulation found in pages 9-11 of the specification of copending Application 18424468. As such, said species of unexpected results asserted by the Applicant in the present application merely claims the known functional effect of the moderate to severe COPD patient population treated within the same ensifentrine formulation embodied within claims 1-13, 15, 17-21, 23-30 of copending Application No. 18424468. See AbbVie Inc. v. Kennedy Inst. of Rheumatology Trust, No. 13-1545 (Fed. Cir. 2014).
While claims 1-13, 15, 17-21, 23-30 of copending Application No. 18424468 do not explicitly described as comprising at least one or more exacerbations as presently claimed, Grimbaldeston teaches COPD exacerbations and that the frequency of exacerbations increases with the severity of the disease and the decline of lung function (page 2 lines 20 to page 3 line 20). Grimbaldeston teaches treating COPD in a subject in need comprising an ST inhibitor wherein the COPD patient population comprises a baseline blood eosinophil count of < 170 eosinophils/L (claims 1-6). Grimbaldeston further teaches that COPD exacerbations affect patients with moderate COPD, the same patient population treated with the same inhalable ensifentrine formulation embraced within the present claims (page 3 lines 1-20). As such, said skilled artisan would not consider there to be a patentable difference in patient population identified in claims 1-13, 15, 17-21, 23-30 of copending Application No. 18424468 and that of the present claims.
Thus, one of ordinary skill in the art prior to the time of the invention knowing that an inhalable ensifentrine is efficacious at treating COPD patients comprising one or more exacerbations wherein said patient comprises a blood eosinophil count of less than 300 cell/mL as taught in the present claims, said artisan would have found it prima facie obvious to administer to administer said ensifentrine therapy to a COPD patient with moderate to severe COPD as found in copending Application 18424468, in view of Grimbaldeston. Motivation to administer the ensifentrine therapeutic regimen to a COPD patient with moderate COPD flows logically from the fact that Grimbaldeston teaches that patients with moderate COPD comprise exacerbations and the presently claimed COPD treatment is efficacious in patients comprising at least one or more COPD exacerbations. Accordingly, said artisan would have readily predicted that the claimed ensifentrine regimen would have effectively reduced COPD exacerbations in the patient with moderate COPD.
Claims 1, 4-7, 9-11, 14, 16-17, 19-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 11-19 and 23-29 of copending Application No. 18417410 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and claim 1, 8, 11-19 and 23-29 of copending Application No. 18417410 are directed to treating moderate COPD in a subject comprising administering via inhalation a therapeutically effective amount of the same inhalable ensifentrine formulation embraced within the present claims. Claims 17-19 of copending Application 18417410 embrace the ensifentrine formulation found within the present claims. As evidenced by page 37 of the present specification, a patient with moderate to severe COPD comprises an FEV1 of 30%-70% which is the same patient population and FEV1 embodied claims 1, 8, 11-19 and 23-29 of copending Application 18417410. The dosing frequency embraced within present claims 19-23 overlaps with the dosing frequency found within claims 23-29 of copending Application 18417410.
While it is noted that claims 1, 8, 11-19 and 23-29 of copending Application No. 18417410 do not explicitly disclose that the moderate to severe COPD patient comprises a blood eosinophil count of less than 300 cells/L as embodied within the present claims, said sub-patient population of moderate to severe COPD patients comprising at least a COPD exacerbation comprising a blood eosinophil count of less than 300 cells/L lies inside the genus moderate COPD patient population embraced within claims 1, 8, 11-19 and 23-29 of copending Application 18417410 treated with administration of the same inhalable ensifentrine formulation. As such practicing the methodology of the present claims anticipates the methodology of that claims 1, 8 and 11-19 and 23-29 of copending Application No. 18417410.
Applicant traverses. Applicant asserts that in light of the unexpected results in the 1.132 declaration by Dr. Tara Rhealt, the copending double patenting rejection is no longer applicable.
Response to Arguments
Applicant’s arguments, filed 03/23/2026 are acknowledged and have been carefully considered. Regarding Applicant’s contention that the unexpected results in the 1.132 declaration by Dr. Tara Rhealt are sufficient to overcome the double patenting rejection of record, the examiner is not persuaded. The presently claimed methodology is not patentably distinct from the methodology embodied within claims 1, 8, 11-19 and 23-29 of copending Application No. 18417410. Both the present claims and claims 1, 8, 11-19 and 23-29 of copending Application No. 18417410 are directed to treating the same disease state of moderate to severe COPD in a subject comprising administering via inhalation a therapeutically effective amount of the same inhalable ensifentrine formulation embraced within the present claims. As evidenced by page 37 of the present specification, a patient with moderate to severe COPD comprises an FEV1 of 30%-70% which is the same patient population and FEV1 embodied within the present claims.
It is noted that the study of 800 patients with COPD and blood eosinophil count of < 150 eosinophils/L found in pages 38-40 of the instant specification wherein reduction in COPD exacerbations was observed is the same 800 COPD patients treated with the same ensifentrine formulation found in pages 17-19 of the specification of copending Application 18417410. It is additionally noted that claims 1, 8, 11-19 and 23-29 of copending Application No. 18417410 do not explicitly disclose that the moderate to severe COPD patient comprises a blood eosinophil count of less than 300 cells/L as embodied within the present claims. Said sub-patient population of moderate to severe COPD patients comprising at least a COPD exacerbation comprising a blood eosinophil count of less than 300 cells/L of the present claims lies inside the genus moderate COPD patient population embraced within claims 1, 8, 11-19 and 23-29 of copending Application 18417410 treated with administration of the same inhalable ensifentrine formulation. As such, said species of unexpected results asserted by the Applicant in the present application merely claims the known functional effect of the moderate to severe COPD patient population treated within the same ensifentrine formulation embodied within claims 1, 8 and 11-19 and 23-29 of copending Application No. 18417410. See AbbVie Inc. v. Kennedy Inst. of Rheumatology Trust, No. 13-1545 (Fed. Cir. 2014).Therefore, practicing the methodology of the present claims anticipates the methodology of that claims 1, 8 and 11-19 and 23-29 of copending Application No. 18417410, and evidence of secondary considerations cannot overcome a rejection based on anticipation.
Claims 1, 4-7, 9-11, 14, 16-17, 19-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30, 32 and 34-46 of copending Application No. 18424452 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and claims 30, 32 and 34-46 of copending Application No. 18424452 are directed to treating COPD in a subject who has experienced exacerbations comprising administering via inhalation a therapeutically effective amount of the same inhalable ensifentrine formulation embraced within the present claims for a duration of at least 24 weeks (claim 45) which reads on the same dosing frequency found within present claims. As evidenced by page 37 of the present specification, a patient with moderate to severe COPD comprises an FEV1 of 30%-70% which is the same patient population and FEV1 embodied claims 30, 32 and 34-46 of copending Application No. 18424452. Claims 35-36 embrace a combination therapy further comprising a LAMA, LABA or corticosteroid therapy as found in present claims 20-21.
While it is noted that claims 30, 32 and 34-46 of copending Application No. 18424452 do not explicitly disclose that the moderate to severe COPD patient comprises a blood eosinophil count of less than 300 cells/L as embodied within the present claims, said sub-patient population of moderate to severe COPD patients comprising at least a COPD exacerbation comprising a blood eosinophil count of less than 300 cells/L lies inside the genus moderate to severe COPD patients comprising at least a COPD exacerbation patient population embraced within 30, 32, 34-46 of copending Application No. 18424452. As such, practicing the methodology of the present claims anticipates the methodology of that of claims 30, 32 and 34-46 of copending Application No. 18424452.
Applicant traverses. Applicant asserts that in light of the unexpected results in the 1.132 declaration by Dr. Tara Rhealt, the copending double patenting rejection is no longer applicable.
Response to Arguments
Applicant’s arguments, filed 03/23/2026 are acknowledged and have been carefully considered. Regarding Applicant’s contention that the unexpected results in the 1.132 declaration by Dr. Tara Rhealt are sufficient to overcome the double patenting rejection of record, the examiner is not persuaded. The presently claimed methodology is not patentably distinct from the methodology embodied within claims 30, 32 and 34-46 of copending Application No. 18424452. Both the present claims and claims 30, 32 and 34-46 of copending Application No. 18424452 are directed to treating the same disease state of moderate to severe COPD in a subject who has experienced an exacerbation comprising administering via inhalation a therapeutically effective amount of the same inhalable ensifentrine formulation embraced within the present claims. As evidenced by page 37 of the present specification, a patient with moderate to severe COPD comprises an FEV1 of 30%-70% which is the same patient population and FEV1 embodied within the present claims.
It is noted that the study of 800 patients with COPD and blood eosinophil count of < 150 eosinophils/L found in pages 38-40 of the instant specification wherein reduction in COPD exacerbations was observed is the same 800 COPD patients treated with the same ensifentrine formulation found in pages 10-12 of the specification of copending Application 18424452. It is further noted that claims 30, 32 and 34-46 of copending Application No. 18424452 do not explicitly disclose that the moderate to severe COPD patient comprises a blood eosinophil count of less than 300 cells/L as embodied within the present claims. Said sub-patient population of moderate to severe COPD patients comprising at least a COPD exacerbation comprising a blood eosinophil count of less than 300 cells/L of the present claims lies inside the genus moderate COPD patient population embraced within claims 30, 32 and 34-46 of copending Application No. 18424452 treated with administration of the same inhalable ensifentrine formulation. As such, said species of unexpected results asserted by the Applicant in the present application merely claims the known functional effect of the moderate to severe COPD patient population treated within the same ensifentrine formulation embodied within claims 30, 32 and 34-46 of copending Application No. 18424452. See AbbVie Inc. v. Kennedy Inst. of Rheumatology Trust, No. 13-1545 (Fed. Cir. 2014).Therefore, practicing the methodology of the present claims anticipates the methodology of that claims 30, 32 and 34-46 of copending Application No. 18424452, and evidence of secondary considerations cannot overcome a rejection so based.
Claims 1, 4-7, 9-11, 14, 16-17, 19-23 and 25-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of copending Application No. 19044950 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following. Claims 1-31 of copending Application 19044950 are directed to treating COPD in a resistant patient an inhalable pharmaceutical composition comprising ensifentrine. Embraced within the methodology of claims 1-31 is treating moderate COPD patients and severe COPD patients. As evidenced by page 37 of the specification, a patient with moderate to severe COPD comprises an FEV1 of 30%-70% as found in the present claims. In addition, claim 1-31 of copending Application embrace administering an inhalable ensifentrine composition comprising (a) particles comprising the ensifentrine or the pharmaceutically acceptable salt at a concentration of from 1 to 1.4 mg/mL; (b) polysorbate 20 at a concentration of 0.3 to 0.7 mg/mL;(c) sorbitan monolaurate at a concentration of from 0 to 0.1 mg/mL;(d) sodium dihydrogen phosphate dihydrate at a concentration of from 0.5 to 1 mg/mL;(e) disodium hydrogen phosphate dihydrate at a concentration of from 0.5 to 1 mg/mL;(f) sodium chloride at a concentration of from 5 to 10 mg/mL (claims 22-31) which is the same inhalable ensifentrine formulation found within the present claims.
While it is noted that claims 1-31 of copending Application No. 19044950 do not explicitly disclose that the moderate to severe COPD patient comprises a blood eosinophil count of less than 300 cells/L as embodied within the present claims, said sub-patient population of moderate to severe COPD patients comprising at least a COPD exacerbation comprising a blood eosinophil count of less than 300 cells/L lies inside the genus moderate COPD patient population embraced within claims 1-31 of copending Application No. 19044950 treated with administration of the same inhalable ensifentrine formulation. As such practicing the methodology of the present claims anticipates the methodology of that claims 1-31 of copending Application No. 19044950.
Applicant traverses. Applicant asserts that in view of MPEP 804.1(B)(1)(b)(i), wherein if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent. Applicant contends that as application 19044950 is later filed than the present case, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent.
Response to Arguments
Applicant’s arguments filed 03/23/2026 are acknowledged and have been carefully considered. However, said argument is unpersuasive. MPEP 804(B)(1)(b)(1), MPEP 1490(VI)(D)(2)(a) and MPEP 2701 state that if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
In the instant case, and as shown above, the provisional double patenting rejections of record with copending Applications 18417864, 18417410, 18424452 and 18424468 remain and the double patenting rejection of record with copending Application 19044950 is not the only rejection remaining in the application. As such, the provisional double patenting rejection of record with later filed Application 19044950 will not be withdrawn and is maintained for the reasons of record.
Conclusion
In view of the rejections set forth above, no claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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/GEORGE W KOSTURKO/ Primary Examiner, Art Unit 1621
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