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 Claims
Claims 57-76 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 8/7/25. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
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 57-76 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 - 18 of U.S. Patent No. 12280088, Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
Both sets of claims refer to dry powder composition comprising particles, wherein the particles comprise a peptide consisting of FTTFTVT (SEQ ID NO: 2), wherein the dry powder composition is formulated for use in a dry powder inhaler, with a particles have a median particle diameter between about 1 μm to about 5 μm, and produced by ball milling, wet milling, or cryogenic milling, stable for at least 6 months. The current application claims are obvious variation of the patented claims the copending application claims
· Both sets of claims recite using the same compositions and/or derivatives thereof. The compositions recited in the claims are anticipatory of each other.
In view of the foregoing, the patented claims and the current application claims are obvious variations of each other.
Claims 57-76 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 - 29 of U.S. Patent No. 12280089, Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
Although the claims of the patent are to a method of treating chronic obstructive pulmonary disease administering a dry powder formulation comprising a peptide, or a pharmaceutically acceptable salt thereof, and wherein the dry powder formulation does not comprise a pharmaceutically acceptable carrier or excipient; wherein the peptide's amino acid sequence is FTTFTVT (SEQ ID NO: 2), wherein the dry powder composition is formulated for use in a dry powder inhaler, with a particles have a median particle diameter between about 1 μm to about 5 μm, and produced by ball milling, wet milling, or cryogenic milling, stable for at least 6 months.
The claims differ in that the instant claims recite a dry powder composition comprising particles, wherein the particles comprise a peptide comprising an amino acid sequence of FTTFTVT (SEQ ID NO: 2) or a pharmaceutically acceptable salt thereof, wherein the peptide does not comprise an amino acid sequence of KASFTTFTVTKGS (SEQ ID NO: 4), wherein the dry powder composition is formulated for use in a dry powder inhaler.
· Thus, the process of treating chronic obstructive pulmonary disease is therefore part of the obvious variation of the instant claims compared to the patented claims.
In view of the foregoing, the patented claims and the current application claims are obvious variations of each other.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 9/27/26
