DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment of 12/3/25 has been entered in full. Claims 1, 28 and 30-33 are amended. Claims 18-20, 23-25, 27 and 28 are canceled. Claims 1-3, 5, 7, 10, 14, 28, and 30-34 are pending.
Applicants' election without traverse of Group II, currently all pending claims, drawn to a method of treating a paraproteinemic neuropathy in a subject by administering an antagonist of complement factor C2, including C2a and C2b, was previously acknowledged. The elections of (1) multifocal motor neuropathy (MMN) as the species of paraproteinemic neuropathy, and (2) antibody as the species of antagonist structure, were also previously acknowledged.
Claims 1-3, 5, 7, 10, 14, 28 and 30-34 are under consideration, as they read upon the elected species.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (9/3/25).
All objections and/or rejections of canceled claims 20, 23, 25 and 27-28 are moot.
The objection to claim 33 at page is withdrawn in view of the claim amendments.
The rejection of claims 1-3, 5, 7, 10, 14, 33 and 34 at pages 3-7 under 35 U.S.C. 112(a) for failing to comply with the written description requirement is withdrawn in view of the amendments to the claims that limit the antagonist to that which was indicated in the rejection as meeting the written description requirement.
The rejection of claim 28 under 35 U.S.C. 102(a)(1) as being anticipated by Hack et al, U.S. Patent Application 9,944,717 is withdrawn in view of the amendments to claim 28 that limit the antibody used in the method to one wherein the VH domain comprises the amino acid sequence of SEQ ID NO: 8. As set forth at page 9 of the 9/3/25 Office action, Hack does not teach a VH domain sequence having 100% identity to SEQ ID NO: 8. Therefore, Hack does not anticipate claim 28 as amended.
The rejection of claims 28, 30 and 32 at pages 10-11 under 35 U.S.C. 103(a) as being unpatentable over Hack et al, U.S. Patent Application 9,944,717, and further in view of Blanchetot et al, U.S. Patent Application 20200239554 is withdrawn in view of Applicants’ statement at page 7 of the 12/3/25 reply that Blanchetot and the instant application “were both owned by the same entity no later than the effective filing date of the instant application” and “thus under 35 U.S.C. § 102(b)(2)(C), Blanchetot is not prior art under 35 U.S.C. § 102(a)(2)”.
The rejection of claim 28 on the ground of nonstatutory double patenting as being unpatentable over claims 9, 10 and 15 of Hack et al, U.S. Patent Application 9,944,717, is withdrawn for the same reasons as the withdrawal of the rejection of claim 28 under 102(a)(1); see above.
The rejection of claims 28, 30 and 32 at page 13 on the ground of nonstatutory double patenting as being unpatentable over claims 9-10 and 15 of Hack et al, U.S. Patent 9,944,717 and further in view of Blanchetot et al, U.S. Patent Application 20200239554, published 7/30/20 is withdrawn for the same reasons as the 103(a) rejection over the teachings of Hack et al in view of Blanchetot et al.
Maintained Objections and/or Rejections
Specification
At pages 2-3 of the 9/3/25 Office action, the disclosure was objected because the title of the invention was not descriptive, and appropriate correction was required. In response, Applicants have amended the title to “METHODS OF TREATING PARAPROTEINEMIC NEUROPATHY WITH ANTAGONISTS OF THE COMPLEMENT SYSTEM UPSTREAM OF COMPLEMENT FACTOR C5”. However, Applicants have concurrently narrowed the claims, and the amended title is no longer descriptive of what is currently claimed, which is limited to use of anti-C2 antibodies. The following title is suggested: “METHODS OF TREATING PARAPROTEINEMIC NEUROPATHY WITH ANTI-C2 ANTIBODIES”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5, 7, 10, 14 and 30-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hack et al, U.S. Patent Application 9,944,717, published 4/17/18 (cited on the 3/18/22 IDS). The earliest date to which the instant application claims priority is 5/21/19. This rejection was set forth at pages 8-9 of the 9/3/25 Office action for claims 1-3, 5, 7, 10, 14 and 31; Applicants’ amendments to the claims necessitate the addition of claim 30.
In the reply at page 7, Applicants argue that claim 1 has been amended “to be similar in scope to claim 30 as previously presented” and as “Claim 30 was not rejected for anticipation”, the claims are now “novel over the teachings of Hack”.
This argument has been fully considered but is not found persuasive. While it is acknowledged that claim 30 as previously presented was not included in the rejection, instant claim 1 has not been amended to incorporate the limitations of claim 30 as previously presented as stated by Applicants. Instead, claim 1 has been amended to incorporate the limitations of claim 27 as previously presented.
Specifically, claim 1 as amended now requires use of an anti-C2 antibody comprising a VH comprising HCDRs1-3 of SEQ ID NO: 4, 3 and 2 and a VL comprising LCDRs1-3 of SEQ ID NO: 7, 6 and 5. These limitations were found in claim 27 as previously presented, as shown here:
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266
660
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Claim 30, in contrast, as presented previously recited the following:
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110
654
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The limitations of this claim are not incorporated into claim 1 as currently presented.
Furthermore, claim 27 as previously presented was included in the rejection of record; see page 9 of the 9/3/25 Office action. As such, the teachings of Hack teach the limitations of claim 27 that are now incorporated into parent claim 1. As such, it is maintained that the teachings of Hack anticipate claims 1-3, 5, 7, 10, 14, 28 and 31.
In addition, claim 30 has been amended to depend from claim 1, and further to limit the antibody to one that is defined by comprising a VL of SEQ ID NO: 9. Previously, the claim required both a VH of SEQ ID NO: 8 and a VL of SEQ ID NO: 9. As set forth at page 9 of the 9/3/25 Office action: “Hack further teaches an antibody comprising the CDRs of the 5F2.4 antibody that has a VH of SEQ ID NO: 106 (col 6, line 61), which is 99.1% identical to instant SEQ ID No: 8, and a VL of SEQ ID NO: 101 (col 6, line 65), which is 100% identical to instant SEQ ID NO: 9”. Therefore, as the antibody claim 30 is now solely limited by the sequence of SEQ ID NO: 9, and this sequence is taught by Hack for the anti-CD2 antibodies of the invention taught therein, the teachings of Hack anticipate claim 30 as amended.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 33 and 34 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hack et al, U.S. Patent Application 9,944,717, published 4/17/18 (cited on the 3/18/22 IDS), as applied to claim 1 above, and further in view of Jinka et al, 2014. Curr Treat Options Neurol. 16:269 (cited previously). This rejection was set forth previously as page 11 of the 9/3/25 Office action.
Applicants’ arguments with regard to this rejection rely on the arguments set forth with respect to the anticipation rejection of parent claim 1, from which claims 33 and 34 depend, over Hack et al. As set forth above, these arguments are not persuasive, and thus the obviousness rejection of claims 33 and 34 is maintained for the reasons of record.
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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer (TD) 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 §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A TD must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains TD forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 5, 7, 10, 14 and 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 10 and 15 of Hack et al, U.S. Patent 9,944,717, published 4/17/18 (cited on the 3/18/22 IDS), and which shares an inventor (Hack) with the instant application. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons. This rejection was set forth at pages 12-13 of the 9/3/25 Office action for claims 1-3, 5, 7, 10, 14 and 31; Applicants’ amendments to the claims necessitate the addition of claim 30.
At page 8 of the reply, Applicants advance the same arguments with respect to this rejection as set forth with respect to the anticipation rejection of the claims over the teachings of Hack et al. These arguments are not found persuasive for the same reasons set forth above, and as such the rejection is maintained.
Claim 30 has been amended to depend from claim 1, and further to limit the antibody to one that is defined by comprising a VL of SEQ ID NO: 9. Previously, the claim required a VH of SEQ ID NO: 8 and a VL of SEQ ID NO: 9. In claim 1 of the ‘717 patent (Hack et al), part (b), the binding molecule comprises, in the alternative, an immunoglobulin heavy chain having a light chain variable region sequence of SEQ ID NO: 106. As set forth at page 9 of the 9/3/25 Office action, SEQ ID NO: 106 of the ‘717 patent (Hack et al) is 100% identical to the instant VL sequence of SEQ ID NO: 9. As such, claim 30 as amended is not patentably distinct from the claims of Hack et al.
Claims 33 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 10 and 15 of Hack et al, U.S. Patent 9,944,717, published 4/17/18 (cited on the 3/18/22 IDS), and which shares an inventor (Hack) with the instant application, as applied to claim 1 above, and further in view of Jinka et al, 2014. Curr Treat Options Neurol. 16:269 (cited previously). This rejection was set forth at page 13 of the 9/3/25 Office action.
Applicants’ arguments with regard to this rejection rely on the arguments set forth with respect to the double patenting rejection of parent claim 1, from which claims 33 and 34 depend, over the claims of Hack et al. As set forth above, these arguments are not persuasive, and thus the double patenting rejection of claims 33 and 34 is maintained for the reasons of record.
New objections and/or rejections necessitated by Applicants’ amendment
Claim Objections
Claims 1-3, 5, 7, 10, 14, 28 and 30-34 are objected to for the following informalities:
In claim 1, line 4, “antigen binding” should be “antigen-binding”. Compare with claims 31 and 32 , line 1 of each claim.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 2 and 14 each recite the limitation “the antagonist” in line 1. There is insufficient antecedent basis for this limitation in each claim. Specifically, parent claim 1 has been amended to remove the reference to “an antagonist”, and thus the antecedent basis for the recitation in each dependent claim is no longer present in the parent claim.
Claim 14 is further indefinite because it is unclear how the antibody of parent claim 1, which targets human C2b (per the specification at ¶ 213, published application), can inhibit each of C1, C1q, C1r, C1s, C2a, C3, C3a, C3b, C4, C4a and C4b, which are different proteins.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
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 extension fee 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 ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674