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, 11, 19 and 21-28 have been presented for examination on the merits.
Suggestion: Canceled claims can be combined and identified. For example,
2-10 (cancelled).
Priority
This Application is a continuation of Application No. 17/886,124 (Patent No. 12,029,709) filed on 08/11/2022.
Claim Objections
Claims 24 and 26 are objected to because of the following informalities: claims 24 and 26 recite the temperature as 25 ͦ C. This should be written as 25˚C.
Appropriate correction is required.
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, 11, 19 and 21-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,029,709. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the reference claims. The said instant claims are generic to all that is recited in reference claims. That is, the reference claims fall entirely within the scope of the instant claims.
Specifically, the examined claims and reference claims are directed to a dry powder inhalable formulation consisting essentially of or consisting of: (i) crystalline epinephrine bitartrate; and (ii) crystalline α-lactose monohydrate present at between about 50% w/w and about 99% w/w of the entire formulation.
The differences between the examined claims and reference claims are mainly in the arrangement of limitations. That is, the examined claims are variant or a modification of the reference claims.
Examined claim 28 is rejected over the reference claims 1 and 5, because the dry powder of claim 1 and the method of treating a disease of claim 5 would necessarily require the claimed dry powder composition to be delivered.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Liu et al (US 20180056022).
Liu et al disclose that the said dry powder formation of the inhalable epinephrine for PP-DPI formulation comprises approximately 0.01 mg to about 2.00 mg of epinephrine or its equivalent compounds; such as from about 0.22 mg to about 0.25 mg. The dry powder formulation may comprise about 95.00% to about 99.99% (w/w) of a carrier, such as inhalable lactose (See [0085]).
Liu et al exemplify a formulation is Example 8, which is a therapeutic kit for relieving respiratory symptoms made by packing a dry powder inhaler and 20 capsules of epinephrine with net weight of 0.22 mg each. Epinephrine is mixed with an inhalable lactose as a carrier. The mix is homogenized and packed in capsules for pulmonary administration using a PP-DPI (See [0108]).
The pharmaceutical active agent may be used in the form of salts, esters or solvates to thereby optimize the activity and/or stability of the medicament (See [0075] and [0132]).
Dalvi et al (9,980,904).
Dalvi et al teach a capsule containing a dry powder formulation comprising an inhalable active pharmaceutical ingredient and a carrier (See abstract).
Dalvi et al teach a dry powder formulation containing a micronised active ingredient and a coarse carrier. The active ingredient needs to be in micronised form (typically a mass median aerodynamic diameter of 1-5 µm, more typically 2-4 µm). This size of particle is able to penetrate the lung on inhalation. Examples of particulate carriers include lactose, preferably lactose and most preferably α-lactose monohydrate (See col. 3, lines 4-15).
Claims 1, 11, 19 and 21-28 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X. 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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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616