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 .
Election/Restriction
Upon further consideration, Examiner withdraws the restriction requirement between Group I (Claims 140-146 and 156) and Group II (Claims 140-146 and 156) as well as the species election requirement A-C as set forth in the Office action mailed on 03/20/2025. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Claim Status
Claim listing filed on November 26, 2025 is pending. Claims 1-139 and 141 are canceled. Claim 140 is amended. Claims 147-155 and 157-169 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions. Claims 140, 142-146, and 156 are examined upon their merits.
Information Disclosure Statement
The information disclosure statement filed on 12/23/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections and Rejections
Applicant’s cancelation of Claim 141 has rendered all previous rejections directed to this claim moot.
Applicant’s amendments to the specification have overcome all objections of record, and the specification objections are withdrawn.
The rejection of claims 140, 143-146, and 156 under 35 U.S.C. 112(b) as being indefinite are withdrawn in view of Applicant’s amendments that remove the indefinite functional language in Claim 140. Note, “the antibody” recited in Claims 143-146 and 156 is interpreted as “the antibody that specifically binds to VV B5 or the antibody that specifically binds to VV A56” as defined in lines 1-2 of Claim 140.
The rejection of claims 140, 142-146, and 156 under 35 U.S.C. 112(a) as failing to comply with the written description and enablement requirements are withdrawn in view of Applicant’s amendments. Claim 140 is now directed to two anti-VV B5 antibodies and four anti-VV A56 antibodies that each comprise a defined set of CDR amino acids sequences with support in Tables 1 and 3 of the specification (of record). There is proper written description and enablement for the variation in variable heavy and light chain sequences recited in Claim 142, because Claim 142 requires the CDR limitations of Claim 140. Tsurushita et al. Methods. 2005 (of record) teaches that antibody humanization was routine practice in the art prior to the effective filing date of the instant invention. Specifically, Tsurushita teaches that the goal of antibody humanization is to generate human-like variable regions by transferring CDR residues and a minimal number of key framework amino acids from a donor mouse monoclonal antibody onto an acceptor human framework without losing antigen-binding affinity and specificity (section 2, paragraph 1). The computer-guided antibody humanization technique and experimental procedures were both understood and successfully applied in antibody engineering (section 2, paragraph 2). Therefore, one of ordinary skill would understand how to vary 30% of the variable heavy and light chain sequences while keeping the CDR sequences constant to adapt the antibody framework for the appropriate intended species.
Claim Rejections - 35 USC § 112 (New, necessitated by amendment)
Claims 140, 142-146, and 156 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 140 recites “an antibody that specifically binds to VV B5 or VV A56, wherein the antibody comprises” SEQ ID NOs: 35-40 or SEQ ID NOs: 43-48. It is unclear if the antibody comprising CDR SEQ ID NOs: 35-40 or SEQ ID NOs: 43-48 is an antibody that binds to VV B5 or VV A56. In contrast, Claim 140 clearly defines that the antibody that specifically binds to VV A56 comprises CDR SEQ ID NOs: 11-16; 3-8; 19-24; or 27-32. Claims 142-146 and 156 depend from Claim 140 and do not further define the antibody comprising CDR SEQ ID NOs: 35-40 or SEQ ID NOs: 43-48. Specifically, Claim 142 references “the antibody that specifically binds to VV B5” in lines 1-2 and it is unclear if that refers to the antibody comprising CDR SEQ ID NOs: 35-40 or SEQ ID NOs: 43-48. For the purpose of compact prosecution, Claim 140 is interpreted as “an antibody that specifically binds to VV B5 or VV A56, wherein the antibody that specifically binds to VV B5 comprises” SEQ ID NOs: 35-40 or SEQ ID NOs: 43-48. Support for this interpretation is found in specification Table 3 that defines antibodies comprising CDR SEQ ID NOs: 35-40 or SEQ ID NOs: 43-48 as anti-VV B5 antibodies. Therefore, Claim 140 is directed to an antibody that specifically binds to VV B5 comprising CDR SEQ ID NOs: 35-40 or 43-48, and an antibody that specifically binds to VV A56 comprising CDR SEQ ID NOs: 11-16; 3-8; 19-24; or 27-32. However, appropriate correction is required to overcome the indefinite claim language.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 142 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 142 recites wherein the anti-VV B5 antibody comprises a variable heavy chain and light chain comprising at least 70% identity to the amino acid sequences set forth in SEQ ID NO: 33 and 34, respectively. Claim 142 depends from Claim 140 which defines wherein the anti-VV B5 antibody comprises CDR SEQ ID NOs: 43-48. However, SEQ ID NOs: 33 and 34 do not comprise SEQ ID NOs: 43-48 meaning that Claim 142 fails to include all the limitations of the claim upon which it depends. This same problem is repeated such that: SEQ ID NOs: 41 and 42 (Claim 142) do not comprise SEQ ID NOs: 35-40 (Claim 140); SEQ ID NOs: 9 and 10 (Claim 142) do not comprise SEQ ID NOs: 3-8, 19-24, or 27-32 (Claim 140); SEQ ID NOs: 1 and 2 (Claim 142) do not comprise SEQ ID NOs: 11-16, 19-24, or 27-32 (Claim 140); SEQ ID NOs: 17 and 18 (Claim 142) do not comprise SEQ ID NOs: 11-16, 2-8, or 27-32 (Claim 140); SEQ ID NOs: 25 and 26 (Claim 142) do not comprise SEQ ID NOs: 11-16, 3-8, or 19-24 (Claim 140); SEQ ID NOs: 9 and 62 (Claim 142) do not comprise SEQ ID NOs: 3-8, 19-24, or 27-32 (Claim 140); and SEQ ID NOs: 9 and 63 (Claim 142) do not comprise SEQ ID NOs: 3-8, 19-24, or 27-32 (Claim 140). Overall, Claim 142 is rejected for failing to include all the limitations of Claim 140 upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Specifically, Applicant could potentially overcome the 112(d) rejection by adding claim language the maps the appropriate CDR sequences of Claim 140 to the corresponding heavy and light variable chain sequences of Claim 142.
Double Patenting
The provisional rejection of Claims 140, 142-146, and 156 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 109, 112, 125-126, and 139 of copending U.S. App. No. 18/282,507 in view of Tsurushita et al. Methods. 2005 (of record) and Ahmad et al. Clin Dev Immunol. 2012 (of record) is maintained.
Applicant's arguments filed November 26, 2025 have been fully considered but they are not persuasive. Applicant cites MPEP § 804(I)(B)(1)(b)(i) and argues that because the instant application has the earlier patent term filing date and the provisional double-patenting rejection is the only rejection remaining of record, it is appropriate to withdraw the rejection. However, the provisional double-patenting rejection is not the only rejection of record (see rejections above). Therefore, the provisional double-patenting rejection is appropriately maintained.
Allowable Subject Matter
No claim is allowed. However, an antibody that specifically binds to VV B5 and comprises the CDRs comprising SEQ ID NOs: 35-40 or SEQ ID NOs: 43-48 and an antibody that specifically binds to VV A56 and comprises the CDRs comprising SEQ ID NOs: 11-16; 3-8; 19-24; or 27-32 is free of the prior art.
Conclusion
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 SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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/SARAH COOPER PATTERSON/Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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