Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 21-40 are pending as of the response and amendments filed on 1/27/26.
The 103 rejection over Magal in view of Shih is withdrawn in consideration of the amendments.
The nonstatutory double patenting rejections of record over US 11123285 B2; US 11969501 B2; and 17794935 are maintained for reasons of record. In the response filed on 1/27/16, Applicants have stated they will address these rejections at a later date. These rejections are reiterated below.
Claims 21-40 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.
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Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-17 of U.S. Patent No. 11123285 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to pharmaceutical compositions in the form of a thermoreversible gel comprising poloxamer 407 in overlapping weight percent ranges, and a growth factor selected from BDNF or neurotrophin-3. The concentration of growth factor recited by the patented claims, from about 0.1-20 mg/mL overlaps with the range recited by instant claims 35 and 37-40, and the concentration of poloxamer 407 recited in the patented claims from 14-17% by weight is included within the range of about 14-25% by weight recited by the instant claims. Additionally, other characteristics are recited by both sets of claims, including wherein the composition has a gelation temp from 20°C to 30°C (instant claim 22 & patented claim 2); a pH between 7-8 (instant claim 23 & patented claim 3); and as osmolarity between 250-320 mOsm/L (instant claim 25 & patented claim 4). The instant and patented claims are not patentably distinct, being drawn to compositions comprising BDNF or neurotrophin-3 and poloxamer 407.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11969501 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to pharmaceutical compositions in the form of a thermoreversible gel comprising poloxamer 407 in overlapping weight percent ranges, and a growth factor selected from BDNF or neurotrophin-3. The concentration of growth factor recited by the patented claims (see claims 15, and 17-20), from about 0.1-20 mg/mL overlaps with the range recited by instant claims 35 and 37-40, and the concentration of poloxamer 407 recited in the patented claims from 14-17% by weight is included within the range of about 14-25% by weight recited by the instant claims. Additionally, other characteristics are recited by both sets of claims, including wherein the composition has a gelation temp from 20°C to 30°C (instant claim 22 & patented claim 2); a pH between 7-8 (instant claim 23 & patented claim 3); a buffering agent (patented claim 4 & instant claim 24); wherein the composition further comprises NaCl (instant claim 26 & patented claim 6); and has an osmolarity between 250-320 mOsm/L (instant claim 25 & patented claim 5). The instant and patented claims are not patentably distinct, being drawn to compositions comprising BDNF or neurotrophin-3 and poloxamer 407.
Claims 21-23, 25, 27, and 29-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14, 16, and 20-23 of copending Application No. 17794935 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims require an otic formulation comprising a growth factor and poloxamer 407. The copending claims are drawn to a method of treating an otic disease or condition by administering a composition comprising a growth factor and an auris acceptable vehicle; copending claim 2 recites the growth factor as BDNF or neurotrophin-3, and copending claim 5 recites the auris acceptable vehicle as poloxamer 407. Additionally, copending claim 6 recites poloxamer 407 from about 15-17 wt%, which overlaps with the concentration of about 14-25% recited by the instant claims. Copending claim 7 recites the composition to have an osmolarity between 100-1000 mOsm/L, which overlaps with the osmolarity recited by instant claim 25; and copending claim 8 recites the composition pH between 7-8, which is recited by instant claim 23. The concentration of growth factor recited by copending claim 9 is from 0.0001-1% by weight, which corresponds to .001-10 mg/mL; this range overlaps with instant claims 35 and 37-40. The instant and copending claims are not patentably distinct, as the method of the copending claims requires administration of a composition that has very similar ingredients and characteristics as the instantly claimed one.
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