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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 20, 2026 has been entered.
Status of Application
Receipt of Applicant’s Remarks and Amended Claims filed on May 20, 2026 is acknowledged.
Claims 1-2, 4-10, and 12-20 are pending in this application.
Claims 1, 9, and 17 have been amended.
Claims 3 and 11 have been cancelled.
All pending claims are under prosecution in this application.
Withdrawn Rejections
Double Patenting
The rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,414,916 in view of Fleming et al. (WO 2015/034822) has been withdrawn in view of the amendment to claims 1, 9, and 17 to recite “wherein the pharmaceutical composition has a moisture content of between about 3% and 6%”.
The provisional rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/514,634 in view of Fleming et al. (WO 2015/034822) has been withdrawn in view of the amendment to claims 1, 9, and 17 to recite “wherein the pharmaceutical composition has a moisture content of between about 3% and 6%”.
The provisional rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/417,683 in view of Fleming et al. (WO 2015/034822) has been withdrawn in view of the amendment to claims 1, 9, and 17 to recite “wherein the pharmaceutical composition has a moisture content of between about 3% and 6%”.
Newly Applied Rejections
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 1-2, 4-10, and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,414,916 in view of O’Connor (US 2025/0049862).
Although the claims at issue are not identical, they are not patentably distinct from each other. Both the instant claims and the patented claims recite an intranasal device comprising a reservoir and a means for discharging a dose (a delivery head) and a dry powder epinephrine composition (within encompassing dosing amounts), a carrier and a citrate. The instant claims additionally recite “wherein the pharmaceutical composition has a moisture content of between about 3% and 6%” and properties of the formulation.
However, O'Connor discloses a spray dried biotherapeutic matrix for administration by inhalation (abstract). Epinephrine is disclosed for inclusion into the composition (paragraph 0299).
Delivery of an inhalable dry powder through a DPI can be used. However, a therapeutic must be formulated as an inhalable dry powder to be used in a DPI successfully. This powder must possess specific moisture contents (usually very low, between 1 and 5%) for stability purposes, as well as particular aerodynamic properties to ensure the powder can be delivered properly and reliably (paragraph 0203).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have adjusted the moisture content of the dry powder formulation for stability purposes, as well as particular aerodynamic properties to ensure the powder can be delivered properly and reliably.
Additionally, as discussed previously, the recitation of “wherein the intranasal device is configured to deliver the dose of the pharmaceutical composition into a body via a delivery aperture to produce at least one of:
(A) a relative mean maximum epinephrine plasma concentration after the dose is delivered into the body (Cmax) that is greater than a Cmax of a first reference dose and less than a Cmax of a second reference dose, or
(B) a time to reach a maximum epinephrine plasma concentration (Tmax) that is earlier than a Tmax of the first reference dose and later than a Tmax of the second reference dose; and
wherein the first reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via a manual injection, and the second reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via an autoinjector.
Is considered properties of the composition and the administration of said composition by the Examiner. Since the instant claims and the patented claims recite the same composition administered in an intranasal device , it would necessarily have the same properties.
Claims 1-2, 4-10, and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/417,683 (Application has been allowed but has not issued) in view of O’Connor (US 2025/0049862).
Although the claims at issue are not identical, they are not patentably distinct from each other. Both the instant claims and the patented claims recite an intranasal device comprising a reservoir and a means for discharging a dose (a delivery head) and a dry powder epinephrine composition (within encompassing dosing amounts), a carrier and a citrate. The instant claims additionally recite “wherein the pharmaceutical composition has a moisture content of between about 3% and 6%” and properties of the formulation.
However, O'Connor discloses a spray dried biotherapeutic matrix for administration by inhalation (abstract). Epinephrine is disclosed for inclusion into the composition (paragraph 0299).
Delivery of an inhalable dry powder through a DPI can be used. However, a therapeutic must be formulated as an inhalable dry powder to be used in a DPI successfully. This powder must possess specific moisture contents (usually very low, between 1 and 5%) for stability purposes, as well as particular aerodynamic properties to ensure the powder can be delivered properly and reliably (paragraph 0203).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have adjusted the moisture content of the dry powder formulation for stability purposes, as well as particular aerodynamic properties to ensure the powder can be delivered properly and reliably.
Additionally, as discussed previously, the recitation of “wherein the intranasal device is configured to deliver the dose of the pharmaceutical composition into a body via a delivery aperture to produce at least one of:
(A) a relative mean maximum epinephrine plasma concentration after the dose is delivered into the body (Cmax) that is greater than a Cmax of a first reference dose and less than a Cmax of a second reference dose, or
(B) a time to reach a maximum epinephrine plasma concentration (Tmax) that is earlier than a Tmax of the first reference dose and later than a Tmax of the second reference dose; and
wherein the first reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via a manual injection, and the second reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via an autoinjector.
Is considered properties of the composition and the administration of said composition by the Examiner. Since the instant claims and the patented claims recite the same composition administered in an intranasal device , it would necessarily have the same properties.
Claims 1-2, 4-10, and 12-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/514,634 in view of O’Connor (US 2025/0049862).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the patented claims recite an intranasal device comprising a reservoir and a means for discharging a dose (a delivery head) and a dry powder epinephrine composition, a carrier and a citrate. The instant claims additionally recite “wherein the pharmaceutical composition has a moisture content of between about 3% and 6%” and properties of the formulation.
However, O'Connor discloses a spray dried biotherapeutic matrix for administration by inhalation (abstract). Epinephrine is disclosed for inclusion into the composition (paragraph 0299).
Delivery of an inhalable dry powder through a DPI can be used. However, a therapeutic must be formulated as an inhalable dry powder to be used in a DPI successfully. This powder must possess specific moisture contents (usually very low, between 1 and 5%) for stability purposes, as well as particular aerodynamic properties to ensure the powder can be delivered properly and reliably (paragraph 0203).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have adjusted the moisture content of the dry powder formulation for stability purposes, as well as particular aerodynamic properties to ensure the powder can be delivered properly and reliably.
Additionally, as discussed previously, the recitation of “wherein the intranasal device is configured to deliver the dose of the pharmaceutical composition into a body via a delivery aperture to produce at least one of:
(A) a relative mean maximum epinephrine plasma concentration after the dose is delivered into the body (Cmax) that is greater than a Cmax of a first reference dose and less than a Cmax of a second reference dose, or
(B) a time to reach a maximum epinephrine plasma concentration (Tmax) that is earlier than a Tmax of the first reference dose and later than a Tmax of the second reference dose; and
wherein the first reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via a manual injection, and the second reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via an autoinjector.
Is considered properties of the composition and the administration of said composition by the Examiner. Since the instant claims and the patented claims recite the same composition administered in an intranasal device , it would necessarily have the same properties.
It is noted there are numerous applications and patents with shared inventors/assignees. Applicant is requested to identify any additional potential double patenting conflicts.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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