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 .
Claim Status
Applicant’s election without traverse of claims 1 – 16 and 18 – 24 in the reply filed on July 28, 2026, is acknowledged.
Claims 17 and 25 – 30 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected elected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 28, 2026.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 – 5, 18 – 19, 21 – 22 and 23 – 24 are rejected under 35 U.S.C. 103 as being unpatentable over Panicker et al. (U.S. Patent Application Publication No. 2020/0048332 A1; hereinafter Panicker) in view of Parry et al. (U.S. Patent Application Publication No. 2021/0332115 A1; hereinafter Parry) and Armento et al. (Armento et al. The complement system in age-related macular degeneration, Cellular and Molecular Life Sciences, 2021).
Regarding claims 1 and 2, Panicker discloses expression vectors (para. [0149]) encoding an inhibitor for activated complement subcomponent C1s (para. [0009]). Further, Panicker discloses the use of single chain antibodies (para. [0031]). Panicker does not explicitly disclose either a single chain Fv and/or a Fab or a second nucleotide sequence encoding an inhibitor for complement factor Bb. However, Parry discloses humanized anti-complement factor BB antibodies and vectors (para. [0074]) that are designed to inhibit a complement pathway activity (para. [0008]). Parry discloses that in some embodiments, the antibody is selected from a group comprising a single-chain Fv scFV (para. [0011]). Parry discloses that the motivation for the use of the antibodies (para [0004]) is for treating a complement-mediated disease or disorder.
Armento provides the motivation for combining the two inventions by disclosing the role of the complement system (p. 4489, Fig. 1) in Age-related macular degeneration (AMD). The classical and alternative pathways each have a role in the progression of the disease (p. 4496 – 4497; Complement system and inflammation Sect.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the antibody constructs of Panicker and Parry to inhibit the classical and alternative pathways of the complement system as they both are over-activated in Age-related macular degeneration, according to Armento.
Regarding claims 3 and 4, (SEQ ID NO: 7 is 100% query match to SEQ ID NO: 14 of Panicker; ABSS results-08/10/2026 for SEQ ID NO: 7, Published_Applications_AA_Main, Result No. 2 – US16340991), (SEQ ID NO: 8 is 100% query match to SEQ ID NO: 22 of Panicker; ABSS results-08/10/2026 for SEQ ID NO: 8, Published_Applications_AA_Main, Result No. 2 – US16340991), (SEQ ID NO: 19 is 100% query match to SEQ ID NO: 19 of Parry; ABSS results-08/10/2026 for SEQ ID NO: 19, Published_Applications_AA_Main, Result No. 1 – US17234618), (SEQ ID NO: 20 is 100% query match to SEQ ID NO: 27 of Parry; ABSS results-08/10/2026 for SEQ ID NO: 20, Published_Applications_AA_Main, Result No. 1 – US17234618).
Regarding claim 5, (SEQ ID NO: 10 is 100% query match to SEQ ID NO: 29 of Panicker; ABSS results-08/10/2026 for SEQ ID NO: 10, Published_Applications_AA_Main, Result No. 2 – US16340991), (SEQ ID NO: 11 is 100% query match to SEQ ID NO: 30 of Panicker; ABSS results-08/10/2026 for SEQ ID NO: 11, Published_Applications_AA_Main, Result No. 1 – US16340991), (SEQ ID NO: 22 is 100% query match to SEQ ID NO: 34 of Parry; ABSS results-08/10/2026 for SEQ ID NO: 22, Published_Applications_AA_Main, Result No. 2 – US17234618), (SEQ ID NO: 23 is 100% query match to SEQ ID NO: 35 of Parry; ABSS results-08/10/2026 for SEQ ID NO: 23, Published_Applications_AA_Main, Result No. 1 – US17234618).
Regarding claim 6, Parry discloses introducing charge mutations (para. [0143]) for the anti-factor Bb antibodies.
Regarding claims 18 – 19 and 21 – 22 Panicker discloses the use of adeno-associated virus (AAV)-specific capsid proteins, inverted terminal repeats (ITR), and a transgene of interest; specifically AAV serotypes 1, 2, 3, 4 and 5 (paras. [0155 – 0156]). Panicker further discloses pharmaceutical compositions (para. [[0177]) and formulations (para. [0178]) that comprise pharmaceutically acceptable carriers (para. [0179]).
Regarding claims 23 – 24, Panicker discloses that the plasmids used in the invention have promoters that are compatible with the host cell and can express a peptide from a gene operably encoded within the plasmid (para. [0169]).
Claims 8 – 10 and 12 – 14 are rejected under 35 U.S.C. 103 as being unpatentable over Panicker, Parry, and Armento as applied to claims 1 – 6, 18 – 19 and 21 – 22 above, and further in view of Reddy et al. (U.S. Patent Application Publication No. 2011/0312505 A1; hereinafter Reddy) and Chien et al. (W.O. Patent Application Publication 2006/107617 A2; hereinafter Chien).
Regarding claims 8 – 9 and 14, Parry discloses an scFV antibody (Bb) fragment comprising the VH and Vl of an antibody and in some cases the Fv polypeptide further comprises a linker between the regions (para. [0104]). Reddy discloses an Anti-C1s scFV (Fig. 14, para. [0070]) in an invention related to methods and compositions for the identification of candidate antigen-specific variable regions as well as generation of antibodies or antigen-binding fragments that could have desired antigen specificity. Chien discloses/provides motivation for using a (G4S)2 linker (para. [0151]) in an invention related to methods and compositions for generating stably-linked complexes composed of homodimers, homotetramers, or dimers.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the C1s antibody fragment of Panicker with the Anti-C1s scFV of Reddy, and link it with the G4S2 linker of Chien to the Anti-Bb scFV of Parry. Doing so would (1) allow for smaller, single-chain antibody fragments that are optimized for tissue penetration to be utilized and (2) stably link the complexes together.
Regarding claim 10, Panicker discloses/provides motivation for using fusion proteins (para. [0050]) with heterologous and homologous leader sequences and constructs expressing a (para.[0155]) transgene of interest.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to use a fusion protein to impart properties from different “parent” proteins.
Regarding claims 12 – 13, Parry discloses a cleavable or non-cleavable peptide (para. [0185]). Chien discloses that Fc conjugated peptides heterodimer conjugates were more active than the single chain form in epithelial cells (para. [0083]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to arrange a single expression construct (orientations of claims 12 or 13) that is modified to express the heterodimer form of Chien for the increased activity disclosed, while utilizing the cleavable peptide of Parry to deliver a therapeutic payload.
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Panicker, Parry, Armento, Reddy, and Chien as applied to claims 8 – 10 and 12 – 14 above, and further in view of Aguilar-Cordova (U.S. Patent Application Publication No. 2004/0086485 A1).
Regarding claim 11, Panicker further discloses the use of suitable promoters and enhancer elements (paras. [0143 – 153]). Neither Panicker nor Parry explicitly disclose the use of bidirectional promoters. However, Aguilar-Cordova discloses, in an invention related to generating vectors for gene therapy, a bidirectional promoter (para. [0095]) and further discloses/provides motivation by stating that a limitation (para. [0025]) for the use of retroviral vectors is that viral inactivation occurs through the complement system.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the anti-Bb antibodies of Parry with the anti-C1 antibodies of Panicker with a fusion protein and the bidirectional promoter of Aguilar-Cordova. Doing so would allow for the simultaneous inhibition of the classical and alternative pathways of the complement system as discussed in the rejection of claim 1.
Claims 15 – 16 are rejected under 35 U.S.C. 103 as being unpatentable over Panicker, Parry, Armento, Reddy, and Chien as applied to claims 8 – 10 and 12 – 14 above, and further in view of Evans et al. (A.U. Patent Application Publication No. 4104299 A; hereinafter Evans).
Regarding claims 15 and 16, Neither Panicker nor Parry explicitly disclose an anti-C1s scFab. However, Evans discloses an scFab (p. 10, line 23 – 37) in an invention related to the use of antibodies that target complement protein C5 (anti-C5 antibodies) to treat inflammatory diseases. Evans further discloses/provides motivation by discussing the duration of action when comparing the scFab to the scFv antibody format, in which the ScFv format has the shortest duration of action.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify/exchange the scFv antibodies of Parry and Reddy with the scFabs of Evans in the orientation of instant claim 16 (A). Doing so would allow for a longer duration of action for a therapeutic agent to treat an inflammatory disease, according to Evans.
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 – 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 12, 15 and 16 of copending Application No. 19/332,406 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because SEQ ID NO: 7 of the instant application is 100% match to SEQ ID NO: 10 and 12 of the reference application (ABSS Search-08/10/2026 data for SEQ ID NO: 7, Published_Applications_AA_New: Result 1 and 4), SEQ ID NO: 8 of the instant application is 100% match to SEQ ID NO: 11 and 12 of the reference application (ABSS Search-08/10/2026 data for SEQ ID NO: 8, Published_Applications_AA_New: Result 1 and 4); SEQ ID NO: 19 of the instant application is 100% match to SEQ ID Nos: 20 and 22 of the reference application (ABSS Search-08/10/2026 data for SEQ ID NO: 19, Published_Applications_AA_New: Result 1 and 2); SEQ ID NO: 20 of the instant application is 100% match to SEQ ID Nos: 21 and 22, (ABSS Search-08/10/2026 data fir SEQ ID NO: 20, Published_Applications_Aa_New: Result 1 and 2); SEQ ID NO: 10 of the instant application is 100% match to SEQ ID NO: 12 of the reference application (ABSS Search-08/10/2026 data for SEQ ID NO: 10, Pending_Patents_AA_Main: Result 5); SEQ ID NO: 11 of the instant application is 100% match to SEQ ID NO: 12 of the reference application (ABSS Search-08/10/2026 data for SEQ ID NO: 11, Pending_Patents_AA_Main: Result 3); SEQ ID NO: 22 of the instant application is 100% match to SEQ ID NO: 22 of the reference application (ABSS Search-08/10/2026 data for SEQ ID NO: 22, Pending_Patents_AA_Main: Result 5); SEQ ID NO: 23 of the instant application is 100% match to SEQ ID NO: 22 of the reference application (ABSS Search-08/10/2026 data for SEQ ID NO: 23, Pending_Patents_AA_Main: Result 2). The two applications both read on treating dry age-related macular degeneration with anti-C1s and anti-Bb antibodies generated with the same complementarity determining regions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 30 and 31 of copending Application No. 19/229,314 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because SEQ ID NO: 7 of the instant application is 100% match to SEQ ID NO: 12 of the reference application (ABSS Search-08/10/2026 data for SEQ ID NO: 7, Pending_Patents_AA_Main: Result 3), SEQ ID NO: 8 of the instant application is 100% match to SEQ ID NO: 21 of the reference application (ABSS Search-08/10/2026 data for SEQ ID NO: 8, Pending_Patents_AA_Main: Result 3). The two applications both read on treating a neurodegenerative eye disease with anti-C1s antibodies dependent on a heavy chain variable region comprising the same heavy and light chain complementarity determining regions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 – 13 of U.S. Patent No. 11,242,382 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because SEQ ID NO: 20 of the instant application is 100% match to SEQ ID NO: 27 of the reference patent (ABSS Search-08/10/2026 data for SEQ ID NO: 20, Published_Applications_AA_Main: Result 1); SEQ ID NO: 19 of the instant application is 100% match to SEQ ID NO: 19 of the reference patent (ABSS Search-08/10/2026 data for SEQ ID NO: 19, Published_Applications_AA_Main: Result 1). SEQ ID NO: 22 of the instant application is 100% match to SEQ ID NOs: 32 – 34 of the reference patent (ABSS Search-08/10/2026 data for SEQ ID NO: 22, Issued_Patents_AA: Result 1 – 3); SEQ ID NO. 23 of the instant application is 100% match to SEQ ID NO: 35 of the reference patent (ABSS Search-08/10/2026 data for SEQ ID NO: 23, Issued_Patents_AA: Result 1). The two applications both read on treating a complement system disease with anti-Bb antibodies dependent on a heavy chain variable region comprising the same heavy and light chain complementarity determining regions.
Claims 1 – 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 25 of copending Application No. 18/644,528 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because SEQ ID NO: 19 of the instant application is 100% match to SEQ ID NO: 19 of the reference application (ABSS Search-08/10/2026 data for SEQ ID NO: 19, Pending_Patents_AA_Main: Result 1); SEQ ID NO: 20 of the instant application is 100% match to SEQ ID NO: 27 of the reference application (ABSS-08/10/2026 data for SEQ ID NO: 20, Pending_Patents_AA_Main: Result 1). The two applications both read on treating a complement system disease with anti-Bb antibodies dependent on a heavy chain variable region comprising the same heavy and light chain complementarity determining regions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8 – 10 and 15 – 17 of U.S. Patent No. 11,999,780 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because SEQ ID NO: 19 of the instant application is 100% match to SEQ ID NO: 19 of the reference patent (ABSS-08/10/2026 data for SEQ ID NO: 19, Issued_Patents_AA: Result 1); SEQ ID NO: 20 of the instant application is 100% match to SEQ ID NO: 27 of the reference patent (ABSS-08/10/2026 data for SEQ ID NO: 20, Issued_Patents_AA: Result 1); SEQ ID NO: 22 of the instant application is 100% match to SEQ ID Nos: 32 – 34 of the reference patent (ABSS-08/10/2026 data for SEQ ID NO: 22, Issued_Patents_AA: Result 1 – 3); SEQ ID NO: 23 of the instant application is 100% match to SEQ ID NO: 35 of the reference patent (ABSS-08/10/2026 data for SEQ ID NO: 23, Issued_Patents_AA: Result 1). The two applications both read on treating a complement system disease with anti-Bb antibodies dependent on a heavy chain variable region comprising the same heavy and light chain complementarity determining regions.
Claims 1 – 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 25, 26, 28, 29 and 31 of copending Application No. 19/697,989(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because SEQ ID NO: 8 of the instant application is 100% match to SEQ ID NO: 21 of the reference application (ABSS Search-08/10/2026 data for SEQ ID NO: 8, Pending_Patents_AA_New: Result 1); SEQ ID NO: 7 of the instant application is 100% match to SEQ ID Nos: 10 or 12 of the reference application (ABSS Search-08/10/2026 data for SEQ ID NO: 7, Pending_Patents_AA_New: Result 1 and 2); The two applications both read on treating a neurodegenerative eye disease with anti-C1s antibodies dependent on a heavy chain variable region comprising the same heavy and light chain complementarity determining regions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 7, 14 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 7, The ABSS sequence search did not return any viable candidates that match SEQ ID NO: 12 or SEQ ID NO: 24 at 100%.
Regarding claim 14, Element (v) an anti-C1s scFab, a (G4s)2 linker, and an anti-Bb scFV optionally comprising SEQ ID NO: 36 did not return any viable candidates that match 95% identity to SEQ ID NO: 36.
Regarding claim 20, The ABSS sequence search did not return any viable candidates that match SEQ ID NOs: 50 – 52 at 100%.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
Prosecution Insights