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 1-3, 5-19, and 21-25 are pending as of the response and amendments filed on 7/28/26. Claims 4 and 20 have been canceled.
The 103 rejections of record over Wollin in view of Kinsey; and over Wollin in view of Kinsey, further in view of Wade are withdrawn in consideration of the amendments.
Regarding the provisional nonstatutory double patenting rejections of record over the claims of 19/169921 and 19/210846, Applicants have requested these rejections be held in abeyance until otherwise allowable subject matter has been identified. The nonstatutory double patenting rejections of record are maintained and updated below to account for the amended claims.
Claims 1-3, 5-19, and 21-25 were examined and are rejected.
Claim Rejections-Nonstatutory 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 1-3, 5-19, and 21-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6-11, 13-15, and 17-20 of copending Application No. 19/169921 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass treating the interstitial lung disease, pulmonary fibrosis, by administering a dry powder composition comprising nintedanib and a diketopiperazine. In particular, both sets of claims recite the diketopiperazine as crystalline particles of fumaryl diketopiperazine (see copending claim 8 & instant claim 1); wherein the crystalline particles have overlapping specific surface area ranges (see copending claim 9 & instant claim 10); wherein nintedanib is provided at doses per day that overlap (see instant claim 5 & copending claim 10); and wherein nintedanib is provided in the composition for oral inhalation in a cartridge, wherein the cartridge contains up to 30 mg. of the composition (see copending claims 15 & 19, & instant claims 1 & 13). Additionally, both sets of claims recite further administering a prostaglandin analog, including Treprostinil (instant claims 22 & 25, and copending claims 3 & 7). As such, the instant and copending claims are obvious variants of each other and are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5-19, and 21-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/210846 (reference application) in view of Wade et. al., WO 2008098196 A1 (of record). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass a dry powder composition comprising nintedanib and diketopiperazine particles and a method of treating the interstitial lung disease, pulmonary fibrosis, by administering a dry powder composition comprising nintedanib and diketopiperazine particles. In particular, both sets of claims recite the diketopiperazine as crystalline particles of fumaryl diketopiperazine (see copending claim 4 & instant claim 1); wherein the crystalline particles have the same specific surface area ranges (see copending claim 10 & instant claim 10); wherein nintedanib is provided at doses that overlap (see instant claim 5 & copending claim 12); wherein nintedanib is provided in the composition for oral inhalation in a cartridge (see copending claim 13 & instant claim 13); wherein the cartridge contains up to 30 mg. of the composition (see copending claim 13, & instant claims 1 & 13); wherein the dry powder composition has one or more excipients selected from a surfactant, an amino acid, or phospholipid (copending & instant claim 3); wherein the dry powder is amorphous (copending & instant claim 6); and wherein the crystalline particles have a pore size ranging from about 23 nm to about 30 nm (instant & copending claim 11). Instant claims 22-25 differ from the copending claims by reciting further administering a prostaglandin analog, including Treprostinil. However, it would have been prima facie obvious to have added this step to the method of the copending claims. Wade teaches administration of Treprostinil for treating interstitial lung disease such as pulmonary fibrosis and IPF (title & abstract; para [0002-0005], [0010]). Wade teaches Treprostinil can be administered by inhalation in solid or liquid dosage forms (para [0011], [0014], [0035]). Treatment of pulmonary fibrosis and IPF is exemplified (para [0049-0051], [0077-0082]). Wade teaches Treprostinil can be administered in combination with other agents used to treat pulmonary disease (para [0012]). Therefore, it would have been prima facie obvious to have added the step of administering by inhalation a formulation containing Treprostinil, since this formulation is also taught for the treatment of IPF, and have had a reasonable expectation of success.
As such, the instant and copending claims are obvious variants of each other and are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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