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 29-56 filed January 16, 2026 are currently pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/16/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
37 C.F.R 1.132 Declaration
The 37 C.F.R 1.132 declaration by co-inventor Dr.Tara Rheault filed 01/16/2026 is acknowledged and has been carefully considered. Discussion of the declaration will occur within the body of this Office Action.
Response to Amendment
Applicant’s amendments, filed 01/16/2026 are acknowledged. Claims 1-28 have been canceled in their entirety. New claims 29-56 have been filed and comprise similar subject matter of originally filed claims 1-28 as the administered ensifentrine and patient population (COPD patient with moderate COPD as evidenced by [0013]-[0015] of the instant specification) are the same. New claims 29-56 narrow the inhalable formulation of ensifentrine administered to the patient with moderate COPD to distinct concentrations of ensifentrine and distinct concentrations of inactive ingredients including polysorbate 20, sorbitan monolaurate, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, sodium chloride and water. New claims 29-56 are also directed to the combination of said inhalable ensifentrine formulation with additional therapeutic agents such as a corticosteroid, long acting muscarinic receptor antagonist or long acting beta-adrenergic receptor agonist.
Withdrawn Rejection(s)
Applicants arguments and 37 C.F.R 1.132 declaration by co-inventor Dr.Tara Rheault are acknowledged and have been carefully considered. Ensifentrine is art-recognized as a dual PDE3/PDE4 inhibitor for the treatment of moderate COPD in patients for a duration of 4 weeks as taught by Mauer.
In view of the 37 C.F.R 1.132 declaration by co-inventor Dr.Tara Rheault, there is unpredictability in the field of treating moderate COPD patients with a PDE4 inhibitor for a duration of at least 12 weeks and wherein the PDE3/PDE4 inhibitor increases an average FEVi area under the curve (AUC) 0-12h post-dose of the human subject by at least 90 mL after 12 weeks of the administering. As recited in the declaration, is known in the art that PDE4 inhibitory compounds, including theophylline, roflumilast and cilomilast yield a reduced FEV1 effectiveness over the claimed duration of at least 12 weeks. Additionally, said PDE4 inhibitory compounds develop an art-recognized resistance or tachyphylaxis, as recited in Giustina, Susuki-Miyata and Vesbo (See declaration bullet-points 15-18). As shown in Tables 1-3 of the specification, Applicant has demonstrated that the claimed ensifentrine formulation increases an average FEVi area under the curve (AUC) 0-12h post-dose of the human subject by at least 90 mL after 12 weeks of the administering. In view of MPEP 716.02 and bullet-points 15-18 of the declaration, the results within Tables 1-3 of the instant specification are greater than expected in view of the combined prior art and are of practical significance.
Accordingly, the 35 U.S.C 103(a) rejections of record in view of the combined teachings of Maurer (European Respiratory Journal Vol. 52 abstract OA1940 published 2018) Spargo (WO2016/042313 published 03/24/2016), Grimbaldeston (WO2022/261417 published 12/15/2022 with priority to U.S. Provisional Application 63209624 filed 06/11/2021) and Laeschke US2013/0089579 published 04/11/2013).are withdrawn.
Applicant's arguments, filed 01/16/2026 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 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 29-42, 51-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-13, 15-16, 20-28 of copending Application No. 18417410 in view of Maurer (European Respiratory Journal Vol. 52 abstract OA1940 published 2018) and Grimbaldeston (WO2022/261417 published 12/15/2022 with priority to U.S. Provisional Application 63209624 filed 06/11/2021).
Claim 1 of Application 18417410 is directed to the treatment of COPD in a subject in need comprising administering ensifentrine inhalable formulation as embodied within instant claim 29. Claim 8 is directed to wherein the patient has moderate COPD, which overlaps with the patient population of the present claims as evidenced by [0013]-[0015] of the instant specification, wherein moderate COPD is defined by the same criteria of FEV₁/FVC < 0.7 and 50% ≤ FEV₁ < 80% predicted as found in present claim 29. Claims 8-13, 15-16, 20-28 of copending Application 18217410 are directed to the same ensifentrine formulation, the same particle size of ensifentrine found in present claims 37-38 and 40-41, the same therapeutic dose found in claims 29-32 and the same dosing frequency found in claims 31-35.
And while copending Application 18417410 does not teach administering said ensifentrine regimen for a duration of at least 12 weeks, Grimbaldeston teaches the method of treating COPD in a subject in need comprising administering a ST2 antagonist to a subject in need (abstract). Treatment of patients with moderate COPD and exacerbations is embraced within the methodology of Grimbaldeston (page 2 line 35-page 3 line 25, page 8 line 35-40). Grimbaldeston teaches administering said COPD therapeutic regimen for a period of at least 12 weeks, 24 weeks or 48 weeks, wherein said regimen improves lung function in said COPD patient with a mean difference measured by post-BD FEV1 of at least 0.09L (90 mL) at 12 weeks, 24 weeks or 48 weeks from the start of treatment comprising administering said therapeutic agent (page 4 lines 15-25, Figure 6).
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to administer the moderate COPD treating ensifentrine as in a nebulized form twice a day as embraced in claims 1 and 8-28 of copending Application 18417410 for at least 12 weeks in view of Maurer and Grimbaldeston. Motivation to administer RPL-554 in a nebulized form twice a day for a period of at least 12 weeks to treat moderate COPD logically flows from the fact that a nebulized formulation of RPL-554 in equal 1.5 mg doses, twice a day twice a day is taught by copending Application 18417410 and Maurer to be efficacious at treating moderate COPD in a subject in need coupled with the knowledge that treatment of COPD patients for a duration of at least 12 weeks is a well-established procedure in COPD treatment protocols, which in turn raises the reasonable expectation of success.
Regarding the limitations of wherein the method increases average FEV1 of the human subject by at least 90 mL or 100 mL 12 weeks following the administering to the human subject, properties (such as an increase in average FEV1 of the human subject by at least 90 mL or 100 mL 12 weeks following the administering to the human subject) that accrue from a process step of administering the aforementioned nebulized RPL-554 twice a day to a patient with moderate COPD as taught by copending Application 18417410, Maurer and Grimbaldeston, said properties are considered characteristic features of the claimed dosing methodology.
It is noted that MPEP 2112 discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to prove that subject matter shown to be in the prior art does not possess the characteristics relied on. In the present case, the burden is shifted to Applicant to prove that twice-a-day administration of nebulized ensifentrine does not increase the average FEV1 of the human patient with moderate COPD by at least 90 mL 12 weeks following the administration.
Claims 29-36, 38-43, 45, 47 and 49-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30, 32, 34-36, 38-43, 45-46 copending Application No. 18424452 (notice of allowance 01/29/2026).
Claim 30 of Application 18424452 is directed to the treatment of COPD in a subject in need comprising administering an inhalable ensifentrine formulation which overlaps with the formulation within instant claim 29. Claim 32 is directed to wherein the patient has moderate COPD, which overlaps with the patient population of the present claims as evidenced by [0013]-[0015] of the instant specification, wherein moderate COPD is defined by the same criteria of FEV₁/FVC < 0.7 and 50% ≤ FEV₁ < 80% predicted as found in present claim 29. Claims 38-40 are directed to the same therapeutic dose found in instant claims 29, 36 and 39 and the same dosing frequency found in instant claims 31-34. Claims 35-36 of copending Application 18424452 are directed to administration with a corticosteroid, or LABA agent or LAMA agent which overlaps with claims 43, 45-47 and 50 of the present claims. Claims 42-43 of copending Application 18424452 is directed to the administration of said ensifentrine formulation in a metered dose inhaler or nebulizer as found in instant claims 51-53, while claim 34 overlaps with the dosage regime of instant claims 49. Claim 45 of copending Application 18424452 is directed to the administration of said ensifentrine formulation for a duration of 24 weeks, which overlaps with present claims 29 and 54, 26.
Regarding the limitations of wherein the method increases average FEV1 of the human subject by at least 90 mL or 100 mL 12 weeks following the administering to the human subject, properties (such as an increase in average FEV1 of the human subject by at least 90 mL or 100 mL 12 weeks following the administering to the human subject) that accrue from a process step of administering the aforementioned nebulized ensifentrine twice a day to a patient with moderate COPD as taught by copending Application 18424452, said properties are considered characteristic features of the claimed dosing methodology.
It is noted that MPEP 2112 discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to prove that subject matter shown to be in the prior art does not possess the characteristics relied on. In the present case, the burden is shifted to Applicant to prove that twice-a-day administration of nebulized RPL-554, does not increase the average FEV1 of the human patient with moderate COPD by at least 90 mL 12 weeks following the administration.
Claims 29-50, 55-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 9-13, 15, 17-18, 20-21, 23-30 of copending Application No. 18424468.
Claim 1 of Application 18424468 is directed to the treatment of COPD in a subject in need comprising administering an inhalable ensifentrine formulation which overlaps with the formulation within instant claim 29. Claim 5 is directed to wherein the patient has moderate COPD which overlaps with the patient population of the present claims as evidenced by [0013]-[0015] of the instant specification, wherein moderate COPD is defined by the same criteria of FEV₁/FVC < 0.7 and 50% ≤ FEV₁ < 80% predicted as found in present claim 29.
Claims 9-10 and 15 of copending Application 18424468 are directed to the same therapeutic dose found in instant claims 29, 36 and 39, while claims 11-13 of copending Application 18424468 are directed to the same dosing frequency found in instant claims 31-35. Claims 17-18, 20 and 21 of copending Application 18424468 are directed to the ensifentrine particle percent weight and particle measurements found within present claims 37-38 and 40-41. Claims 24-30 of copending Application 18424468 are directed to administration with a corticosteroid, or LABA agent or LAMA agent which overlaps with claims 43-50 of the present claims.
Applicant traverses. Applicant asserts that the double patenting rejections in the event these provisional rejections become non-provisional rejections.
Response to Arguments
Applicant's arguments filed 01/16/2026 have been fully considered but they are not persuasive. As shown below, the presented claims are not found allowable. Secondly, Applicant’s statement that a terminal disclaimer will be filed when amended claims are found allowable does not comply with 37 CFR 1.111(b) (which only permits that objections and requirements as to form be held in abeyance):
37 CFR 1.111(b) states that in order to be entitled to reconsideration or further examination, the applicant or patent owner must reply to the Office action. The reply by the applicant or patent owner must be reduced to a writing which distinctly and specifically points out the supposed errors in the examiner’s action and must reply to every ground of objection and rejection in the prior Office action. The reply must present arguments pointing out the specific distinctions believed to render the claims, including any newly presented claims, patentable over any applied references. If the reply is with respect to an application, a request may be made that objections [“objections” does not include rejections] or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated. The applicant’s or patent owner’s reply must appear throughout to be a bona fide attempt to advance the application or the reexamination proceeding to final action. A general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references does not comply with the requirements of this section.
In the instant case, the Applicant has failed to distinctly and specifically point out the supposed errors in the examiner’s action and failed to point out the specific distinctions between the pending claims of the instant application and claims 1, 8-13, 15-16, 20-28 of copending Application 18417410 that make the instantly claimed patentable.
Nor has Applicant distinctly and specifically point out the supposed errors in the examiner’s action and failed to point out the specific distinctions between the pending claims of the instant application and claims 30, 32, 34-36, 38-43, 45-46 of copending Application 18424452 that make the instantly claimed patentable.
Nor has Applicant distinctly and specifically point out the supposed errors in the examiner’s action and failed to point out the specific distinctions between the pending claims of the instant application and claims 1, 5, 9-13, 15, 17-18, 20-21, 23-30 of copending Application 18424468 that make the instantly claimed patentable.
The examiner notes that any future response must address the non-statutory double patenting rejection of record, either by presenting arguments why the rejection is not applicable, or by filing a terminal disclaimer over the patent. A request to hold a (full) rejection in abeyance is not permitted, and will not be considered to be in compliance with 1.111, and will not be held as a bona fide attempt to advance the application to final action.
Conclusion
In view of the rejections set forth above, no claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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