DETAILED ACTION
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 amendments received 17OCT2025 are acknowledged.
Claims 2-6, 10-11, 17, 19-22, 24, and 32-36 have been canceled.
Claims 1, 16, 23, and 29 have been amended.
Claims 1, 7-9, 12-16, 18, 23, and 25-31 (i.e., claim 1 is independent) are pending and under examination in the instant application.
Priority
The present application is a 371 National Stage of PCT International Application No. PCT/US2020/063809, filed 08DEC2020, which claims the benefit of US Provisional Patent Application No. 62/945569, filed 09DEC2019. Applicant’s claim for the benefit of prior-filed application is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 17OCT2025 is/are acknowledged and the references cited therein have been considered.
Specification
Applicant’s arguments, see 9, Specification objections section, filed 17OCT2025, with respect to objections to the specification for minor informalities have been fully considered and said objections to the specification have been withdrawn in view of amendments to the specification filed as part of said response.
Claim Objections
Applicant’s arguments, see p 9, Claim objections section, filed 17OCT2025, with respect to objections to claim(s) 2 (i.e., claim 2 has been cancelled) for minor informalities have been fully considered and said objections are moot in view of claim amendments filed as part of said response.
Claim Rejections - 35 USC § 112
Indefiniteness
Applicant’s arguments, see p 9, Claim rejections under 35 USC §112(b) section, filed 17OCT2025, with respect to the rejection(s) of claim(s) 16 and 23 under 35 USC §112(b) have been fully considered and said rejections of claims 16 and 23 have been withdrawn in view of the claim amendments filed as part of said response.
Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 7-9, 12-16, 18, 23, and 25-28 stand rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In the instance of amended claim 1, the nature of the invention drawn to an anti-C3d antibody or antibody fragment, comprising a VL and VH, wherein the VL/VH pairs are at least 90% identical to specific SEQ ID NOs, wherein the VL and VH comprise LCDRs1-3 and HCDRs1-3 respectively, and wherein the method used to identify CDRs is the Kabat definition is not fully enabled. Claim 1 is not fully enabled because the specification and working examples lack support for making and using anti-C3d antibodies comprising at least 90% identity of the VH/VL pairs which comprise at least 90% identity to the CDRs (¶0031-0033 and ¶0059-0074) and furthermore, the specification does not support the deletion of amino acids, rather substitutions or additions to modify percent identity (¶0075-0086).
Applicant’s arguments, see p 9-12, Claim rejections under 35 USC §112(a) section, filed 17OCT2025, with respect to the rejection(s) of claim(s) 1-3, 7-9, 12-16, 18, 23, and 25-28 (claims 2-3 have been cancelled) under 35 USC §112(b) have been fully considered. Applicant argues that per the Declaration a skilled person would nonetheless identify the correct CDRs within the variable region sequences as claimed and that in Ex parte Keler, No 2019-006094 (PTAB, June 10, 2020) and Ex parte Campbell, No 2021-000865 (PTAB, July 20, 2021) antibody claims of this format have been found allowable under §112.
RESPONSE
Applicant’s arguments have been fully considered but are found non-persuasive essentially for the reasons of record and as described further below.
In response to Applicant’s argument that per the declaration a skilled person would nonetheless identify the correct CDRs within the variable region sequences as claimed the Declaration under 37 CFR 1.132 filed 17OCT2025 is insufficient to overcome the rejection of claims 1-3, 7-9, 12-16, 18, 23, and 25-28 (claims 2-3 have been cancelled) based upon insufficiency of disclosure under 35 USC §112(a) as set forth in the last Office action because: there is no evidence that one skilled in the art would have been able to make and use the anti-C3d antibody without the declaration reciting the facts which the specification itself should recite. See MPEP §716.09. In this instance, the declaration states that a skilled person would reasonably assume that any variable residues (i.e., Xaa residues in the CDRs) are not required and would proceed with the correct sequences of the antibodies presented in the working examples of the present application according to Kabat numbering (Declaration, ¶9). However, the Kabat numbering scheme for antibodies is sequence dependent, which defines the six hypervariable regions (i.e., three for each VL and VH) by residue positions (i.e., residues located in positions 24-34, 50-56, and 89-97 of the VL and residues located in positions 31-35b, 50-65, and 95-102 of the VH are characterized by significant variability), which were labeled as LCDRs1-3 and HCDRs1-3, respectively (Zhu, et al., Protein Eng Des Sel, 2025, 38, 1-18, see p 3, col 2). In this instance, using a CDR delimiting tool to analyze the CDRs of SEQ ID NOs: 66/67 (i.e., clone 3N02) using the Kabat numbering system, the tool is able to differentiate between the VL/VH and based on the numbering determine that the LCDR3 and HCDR3 of the sequences is different upon inclusion of the Xaa residues or exclusion of Xaa residues (see OA.APPENDIX).
Although the Examiner understands the unfortunateness of the error in the preparation of the related provisional patent application; the declaration does not sufficiently provide persuasive arguments that the information that must be read into the specification to make it complete would have been known to those of ordinary skill in the art and therefore does not overcome the 35 USC §112(a) rejection. Furthermore, the declaration by expert, Dr. Christoph Rader, suggests that one skilled in the art would assume that the Xaa residues should be removed from the CDRs and would account for the 90% identity to the VL/VH pairs in order to construct the anti-C3d antibodies of claim 1; however the disclosure does not describe that deletions of amino acids are an optional modification for percent identity rather additions or substitutions (¶0075-0086). Therefore, the necessary information to use the disclosure as a guide to make and use the anti-C3d antibodies excluding the Xaa residues in the CDRs was not described in the application or supported by the prior art and thus does not demonstrate that excluding the Xaa residues in the CDRs would be well-known to those of ordinary skill in the art to construct the anti-C3d antibodies based on the Kabat numbering scheme.
In response to Applicant’s arguments that antibody claims of this format have been found allowable under §112(a), both Ex parte Keler, No 2019-006094 (PTAB, June 10, 2020) and Ex parte Campbell, No 2021-000865 (PTAB, July 20, 2021) are related to overturning written description rejections rather than enablement, of which there were no enablement rejections raised in either case.
Although, the instant specification discloses % sequence identity as related to VH/VL pairs, for example at least 90% identity to SEQ ID NOs: 66/67; in further illustration, the specification discloses “or at least the CDRs thereof” (¶0060-0074). In this instance, at least 90% sequence identity to VH/VL pairs allows for 11-12 amino acid substitutions/additions, which are enabled to comprise 90% sequence identity to the SEQ ID NOs related to HCDRs1-3 and LCDRs1-3, respectively (i.e., max 1 amino acid substitution/addition or 1 amino acid deletion if deletions were disclosed per CDR). Therefore, based on the disclosure and the claims, the modifications of the VH/VL pairs are limited by the 90% identity to the CDR sequences. For example, SEQ ID NO: 67 comprises 123 amino acid residues (i.e., 12 amino acid substitutions/additions in total), which comprises SEQ ID NOs: 4-6 comprising 5, 16, and 17 amino acid residues (i.e., 0, 1, and 1 amino acid substitutions/additions/deletions), which in this instance leaves two amino acid residues which can be any naturally occurring amino acid and which will require one of ordinary skill in the art undue experimentation to determine which amino acid should be used in those positions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Applicant’s arguments, see p 12, Claim rejections under 35 USC §102 section, filed 17OCT2025, with respect to the rejection(s) of claim(s) 29-31 under 35 USC §102 have been fully considered and said rejections of claims 29-31 have been withdrawn in view of the claim amendments filed as part of said response.
Applicant’s claim amendments received as part of the 17OCT2025 response have necessitated the following new grounds of rejection.
Claims 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0333082 A1 (Wiestner, et. al, 17NOV2016), herein referred to as “’082.”
‘082 teaches an anti-C3d antibody (i.e., C3D8 clone) or antibody fragment and a polypeptide which comprises less than 50 total amino acids and which inhibits binding of the anti-C3d antibody to C3d set forth in SEQ ID NO: 19 (i.e., 100% QM to SEQ ID NO: 193 of the instant application) (Example 6 and Fig 11) (see OA.APPENDIX), a polynucleotide, and a method of preparing the polypeptide by immunizing an animal or screening for an antibody that binds the polypeptide (see ¶ 0007-0008 and claims 33-36).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference between the materials, (i.e., that the claims are directed to new materials and that such a difference would have been considered unexpected by one of ordinary skill in the art, that is, the claimed subject matter (e.g., inhibits binding of the anti-C3d antibody of claim 1)), if new, is unobvious. In the absence of evidence to the contrary, the burden is on the Applicant to prove that the claimed materials are different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Therefore, the prior art anticipates the invention as presently claimed.
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.
Applicant’s arguments, see p 12, Nonstatutory double patenting section, filed 17OCT2025, with respect to the rejection(s) of claim(s) 1-3, 7-9, 12-16, 23, and 25-28 (claims 2-3 have been cancelled) as being unpatentable over claims 2-13, 16, 18, 20, and 22-25 of co-pending Application No. 18/610978 have been fully considered. Applicant has asked that the provisional nonstatutory double patenting rejections be held in abeyance until the indication of otherwise found allowable subject matter. Given that the Applicant has not filed terminal disclaimers and has not amended the claims of the instant or co-pending applications to provide patentable distinctiveness, the provisional nonstatutory double patenting rejections of claims 1, 7-9, 12-16, 23, 25-28 are maintained.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. HOPKINS whose telephone number is (703)756-4666. The examiner can normally be reached Mon-Thurs 6:00 AM to 4:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (571)272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMANTHA LAKE HOPKINS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641