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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/03/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 11 recites the limitation "2 mg to about 4 mg" in claim 1. There is insufficient antecedent
basis for this limitation in the claim.
Claim 12 recites the limitation "3 mg" in claim 1. There is insufficient antecedent basis for this
limitation in the claim.
The only concentration for ensifentrine in claim 1 is 1.2 mg/ml. The concentrations used in claims 11 and 12 are higher than the concentration of claim 1. The 1.2 mg/ml does not support the concentrations of 2-4 m6 and 3 mg.
Double Patenting
Claims 1-13, 15, 16, 20-28 and 30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19,247,374 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap.
The claims of the instant application are drawn to a method of treating chronic obstructive pulmonary disease (COPD) in a human subject, the method comprising administering to the human subject by inhalation a liquid pharmaceutical composition comprising:
(a)
ensifentrine particles at a concentration of about 1.2 mg/mL, wherein the ensifentrine particles comprise ensifentrine or a pharmaceutically acceptable salt thereof;
(b)
polysorbate 20 at a concentration of about 0.5 mg/mL;
(c)
sorbitan monolaurate at a concentration of about 0.05 mg/mL;
(d)
sodium dihydrogen phosphate dihydrate at a concentration of about 0.744 mg/mL;
(e)
disodium hydrogen phosphate dihydrate at a concentration of about 0.853 mg/mL;
and
(f)
sodium chloride at a concentration of about 8.6 mg/mL,
wherein the liquid pharmaceutical composition provides a blood plasma concentration of ensifentrine after administration by inhalation to the human subject, the blood plasma
concentration of ensifentrine comprising one or more of:
a mean Cmax of from about 400 pg/mL to about 720 pg/mL;
a mean AUCo-tau of from about 2000 pg/mL*h to about 3000 pg/mL*h; and
a mean Tₘₐₓ of from about 0.6 hours to about 1.5 hours.
The claims of the copending application are drawn to a composition of ensifentrine encompassing the claimed concentration and having all the claimed secondary ingredients. The claims of the instant application comprise the composition of the claims of the copending application. A product by process reads on the product for examination purpose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-13, 15, 16, 20-28 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,409,180. Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap.
The claims of the instant application are drawn to a method of treating chronic obstructive pulmonary disease (COPD) in a human subject, the method comprising administering to the human subject by inhalation a liquid pharmaceutical composition comprising:
(a)
ensifentrine particles at a concentration of about 1.2 mg/mL, wherein the ensifentrine particles comprise ensifentrine or a pharmaceutically acceptable salt thereof;
(b)
polysorbate 20 at a concentration of about 0.5 mg/mL;
(c)
sorbitan monolaurate at a concentration of about 0.05 mg/mL;
(d)
sodium dihydrogen phosphate dihydrate at a concentration of about 0.744 mg/mL;
(e)
disodium hydrogen phosphate dihydrate at a concentration of about 0.853 mg/mL;
and
(f)
sodium chloride at a concentration of about 8.6 mg/mL,
wherein the liquid pharmaceutical composition provides a blood plasma concentration of ensifentrine after administration by inhalation to the human subject, the blood plasma
concentration of ensifentrine comprising one or more of:
a mean Cmax of from about 400 pg/mL to about 720 pg/mL;
a mean AUCo-tau of from about 2000 pg/mL*h to about 3000 pg/mL*h; and
a mean Tₘₐₓ of from about 0.6 hours to about 1.5 hours.
The claims of the U.S. Patent are drawn to a composition of ensifentrine encompassing the claimed concentration and having all the claimed secondary ingredients. The claims of the instant application comprise the composition of the claims of the U.S. patent. A product by process reads on the product for examination purpose.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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