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 .
Status of Application
Claims 1-20 are pending in this application.
No claims have been amended.
All pending claims are under examination.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on November 20, 2023 (2); April 2, 2025; April 25, 2025; August 8, 2025; October 9, 2025; November 27, 2025; November 6, 2025; December 19, 2025; and February 2, 2026 is acknowledged. Signed copies are attached to this office action.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,617,716; 11,872,308; and 12,097,287; 18/514,634 (patent number not yet assigned); and claims 1-15 of U.S. Patent No. 12,414,916.
Although the claims at issue are not identical, they are not patentably distinct from each other because patented claims recite the intranasal device having an overlapping composition utilized in the instant claims. All the patented claims recite an intranasal device comprising a reservoir and a dry powder epinephrine, which provides the same dosage, in a carrier pharmaceutical composition. Additional components can be added including a polysorbate, citrate, or stabilizer. However, many of the additional components are recited in dependent claims. It is also noted that all the claims recite “comprising” language allowing for the inclusion of additional components.
It is noted there are numerous applications and patents with shared inventors/assignees. Applicant is requested to identify any additional potential double patenting conflicts.
Allowable Subject Matter
The closest prior art is the of Fleming et al. (WO 2015/034822; cited on IDS dated November 20, 2023) which discloses Fleming discloses intranasal formulations for the treatment of cardiopulmonary resuscitation (CPR), cardiac life support (CLS), anaphylaxis and/or anaphylactoid reactions (abstract).
Fleming discloses the dry powder composition is contained in an apparatus comprising a reservoir that holds the dry powder and has a means for expelling the pharmaceutical dose in the form of a spray. The reservoir contains multiple doses. The apparatus is contained in packaging (paragraph 0046).
The formulation is a dry powder formulation comprising an anti-anaphylactic or anti-anaphylactoid agent, for example epinephrine. A single dose of the agent is about 0.01 mg to about 10 mg (paragraph 0021).
The dry powder MAY further comprise a vasodilator (paragraph 0035). The recitation of MAY indicates that a vasodilator is not a required component.
The dry powder composition further comprises a pharmaceutically acceptable carrier (paragraph 0037).
Fleming does not disclose the use of a citric acid (citrate). Since the instant claims are drawn to a dry powder formulation, there is no motivation to include a citrate which is used with the art to adjust the pH of a solution.
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 at 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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