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 .
DETAILED ACTION
RESPONSE TO AMENDMENT
Status of Application/Amendments/claims
2. Applicant’s amendment filed September 15, 2025 is acknowledged. Claims 2-21 are cancelled. Claim 1 is amended. Claims 22-28 are newly added. Claims 1 and new claims 22-28 are pending in this application. Election was made without traverse in the reply filed on May 22, 2023.
3. Claims 1 and 22-28 are under examination with respect to a p75NTR neurotrophin binding protein (NBP)-Fc fusion protein in this office action.
4. Applicant’s arguments filed on September 15, 2025 have been fully considered but they are not deemed to be persuasive for the reasons set forth below.
Specification
5. The objection to the specification is withdrawn in response to Applicant’s amendment to the specification.
.
Claim Rejections/Objections Withdrawn
6. The provisional rejection of claims 4-7, 9, 15-17 and 19-21 on the ground of nonstatutory double patenting as being unpatentable over claims 24-36 and 38 of copending Application No. 17/659991 is moot because the claims are canceled.
The provisional rejection of claims 4-7, 9, 15-17 and 19-21 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12-15, 21-30 of copending Application No. 18/975908 is moot because the claims are canceled.
The rejection of claims 1, 4-7, 9, 15-17 and 19-21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement due to new matter is withdrawn in response to Applicant’s amendment to the claims and cancelation of claims 4-7, 9, 15-17 and 19-21.
The rejection of claims 4-5, 9 and 17 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in response to Applicant’s amendment to the claims and cancelation of claims 4-7, 9, 15-17 and 19-21.
New Grounds of Rejection Necessitated by the Amendment
The following rejections are new grounds of rejections necessitated by the amendment filed on September 15, 2025.
Double Patenting
7. 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 and 22-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-6 and 9 of U.S. Patent No. 9764000, claims 5-6, 9 of U.S. Patent No. 10751389, claims 5-6 of U.S. Patent No. 12201672 in view of He et al. (Science, 2004; 304:870-875) and Ying et al. (J. Biol. Chem., 2012; 287:19399-19408).
The p75NTR (NBP) fusion protein recited in the claims or used in the method recited in the claims of the US976400 (the ‘000 patent), the US10751389 (‘the ‘389 patent), or the US12201672 (the ‘672 patent) comprises the p75NTR(NBP) connected to IgG Fc and wherein the p75NTR (NBP) fusion protein comprises instant SEQ ID NO:3. Thu, The p75NTR (NBP) fusion protein of the ‘000, the ‘389 and the ‘672 patents meets the limitation “the fusion protein comprising instant SEQ ID NO:3 “ recited in instant claims.
While the claims of the ‘000, the ‘389 and the ‘672 patents do not recite the limitation “dimer” or two monomers linked by a disulfide bond recited in claims 1 and d22-28, He et al. and Ying et al. teach these limitations and provide motivation and an expectation of success in generation of fusion protein dimer comprising the sequence of instant SEQ ID NO:3 because: i) the claimed fusion protein dimer comprising a p75NTR(NBP) fusion protein that comprises a p75NTR(NBP) and a IgFc, and comprises the instant SEQ ID NO:3; ii) He teaches that p75NTR or p75NTR(NBP) forms a homodimer via a disulfide bond on the cell surface, and NGF forms a homodimer via a disulfide bond and complexed with a p75NTR or p75NTR(NBP) dimer to execute their activity and downstream intracellular signaling (see p.873, col. 3, paragraph 3 to p. 875) and iii) Ying teaches that an IgFc fusion protein monomer is more soluble and does not affect binding or activity of the fusion protein (see p.19399, abstract).
A person of ordinary skill in the art would have recognized that selecting and applying the known features of forming a homodimer by the p75NTR(NBP) fusion protein or p75NTR(NBP)-IgFc fusion protein and the known technique disclosed by He and Ying to the p75NTR (NBP) fusion protein comprising instant SEQ ID NO:3 of the ‘000, the ‘389 and the ‘672 patents would have yielded the predictable result of generation of a fusion protein dimer comprising instant SEQ ID NO:3, wherein the fusion protein dimer comprises two monomers and each monomer comprises instant SEQ ID NO:3 and linked through a disulfide bond, and resulted in an improved product.
Using the known features of forming a homodimer by p75NTR(NBP) and/or IgFc via a disulfide bound to the p75NTR (NBP) fusion protein comprising instant SEQ ID NO:3 of the ‘000, the ‘389 and the ‘672 patents would generate a fusion protein dimer comprising instant SEQ ID NO:3, wherein the fusion protein dimer comprises two monomers and each monomer comprises instant SEQ ID NO:3 and linked through a disulfide bond, and expand application of the p75NTR (NBP) fusion protein comprising instant SEQ ID NO:3 of the ‘000, the ‘389 and the ‘672 patents in therapeutic and pharmaceutical purposes, and would increase patient’s satisfaction with treatment using the p75NTR (NBP) fusion protein comprising instant SEQ ID NO:3 because the activity of NGF and p75NTR(NBP) form a homodimer complex to execute their activity and downstream intracellular signaling.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known features of forming a homodimer by p75NTR(NBP) fusion protein or p75NTR(NBP)-IgFc fusion protein and the known technique disclosed by He and Ying to the p75NTR (NBP) fusion protein comprising instant SEQ ID NO:3 of the ‘000, the ‘389 and the ‘672 patents, and yield the predictable result of a fusion protein dimer comprising instant SEQ ID NO:3, wherein the fusion protein dimer comprises two monomers and each monomer comprises instant SEQ ID NO:3 and linked through a disulfide bond.
Therefore, instant claims are not patentably distinct from the claims of the ‘000, the ‘389 and the ‘672 patents because instant claims are obvious over the claims of the ‘000, the ‘389 and the ‘672 patents in view of He and Ying.
8. Claims 1 and 22-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24, 27-28, 33, 36 and 38 of copending Application No. 17/659991, claims 1, 12-15 and 21-30 of copending Application No. 18/975908, claims 9-22 of copending Application No. 19/294032, claims 1-9 of copending Application No. 19/397512, claims 1-9 of copending Application No. 19/397514 in view of He et al. (Science, 2004; 304:870-875) and Ying et al. (J. Biol. Chem., 2012; 287:19399-19408).
The polypeptide of SEQ ID NO:3 (i.e. comprising a p75NTR (NBP) and an IgG-Fc) recited in claims 24, 27-28, 33, 36 and 38 of the Application No. 17/659991 (the ‘991 Application) is 100% identical to instant SEQ ID NO:3 recited in instant claims (see the sequence alignment in search results).
The p75NTR(NBP) protein comprising a p75NTR(NBP) extracellular domain comprising one or more SEQ ID NO:4, 5, 6, 7 or 8 and an Ig Fc portion; wherein the p&5NTR(NBP) extracellular domain comprises instant SEQ ID NO:3; and a nucleic acid encoding the p75NTR(NBP) extracellular domain comprising SEQ ID NO:3 recited in claims 1, 12-15 and 21-30 of the Application No. 18/975908 (the ‘908 Application), which is 100% identical to instant SEQ ID NO:3 recited in instant claims (see the sequence alignment in search results).
The p75NTR(NBP)-Fc fusion protein recited in claims 9-22 of the Application No. 19/294032 (the ‘032 Application) comprises a p75NTR(NBP) portion and an Ig-Fc portion and wherein the p75NTR(NBP)-Fc fusion comprises SEQ ID NO:3, which is 100% identical to instant SEQ ID NO:3 instant SEQ ID NO:3 recited in instant claims (see the sequence alignment in search results).
The p75NTR(NBP)-Fc fusion protein and a nucleic acid molecule encoding the p75NTR(NBP)-Fc fusion protein recited in claims1-9 of the Application No. 19/397512 (the ‘512 Application) comprises a p75NTR(NBP) portion and an Ig-Fc portion and wherein the p75NTR(NBP)-Fc fusion comprises SEQ ID NO:3, which is 100% identical to instant SEQ ID NO:3 recited in instant claims (see the sequence alignment in search results).
The p75NTR(NBP)-Fc fusion protein and a nucleic acid molecule encoding the p75NTR(NBP)-Fc fusion protein recited in claims1-9 of the Application No. 19/397514 (the ‘514 Application) comprises a p75NTR(NBP) portion and an Ig-Fc portion and wherein the p75NTR(NBP)-Fc fusion comprises SEQ ID NO:3, which is 100% identical to instant SEQ ID NO:3 recited in instant claims (see the sequence alignment in search results).
While the claims of the ‘991, the ‘908, the ‘032, the 512 and the ‘514 Applications do not recite the limitation “dimer” or two monomers linked by a disulfide bond recited in claims 1 and d22-28, He et al. and Ying et al. teach these limitations and provide motivation and an expectation of success for the reasons set forth above.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select and apply the known features of forming a homodimer by p75NTR(NBP) fusion protein or p75NTR(NBP)-IgFc fusion protein and the known technique disclosed by He and Ying to the p75NTR (NBP) fusion protein comprising instant SEQ ID NO:3 of the ‘991, the ‘908, the ‘032, the 512 and the ‘514 Applications, and yield the predictable result of a fusion protein dimer comprising instant SEQ ID NO:3, wherein the fusion protein dimer comprises two monomers and each monomer comprises instant SEQ ID NO:3 and linked through a disulfide bond.
Therefore, instant claims are not patentably distinct from the claims of the ‘991, the ‘908, the ‘032, the 512 and the ‘514 Applications because instant claims are obvious over the claims of the ‘991, the ‘908, the ‘032, the 512 and the ‘514 Applications in view of He and Ying.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
10. NO CLAIM IS ALLOWED.
11. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chang-Yu Wang whose telephone number is (571)272-4521. The examiner can normally be reached on Monday-Thursday, 7:00am-5:30pm EST.
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Chang-Yu Wang
January 12, 2026
/CHANG-YU WANG/Primary Examiner, Art Unit 1675