DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group II, claim 19, in the reply filed on September 10, 2026 is acknowledged. The traversal is on the ground(s) that the Office has not demonstrated that there would be a serious burden of search if restriction were not required. This is not found persuasive because burden of search is not a factor in determining lack of unity in a national stage application. In this instance, the technical feature of claim 1(a), of Group I, does not make a contribution over the prior art for reasons already of record in the previous correspondence. The requirement is still deemed proper and is therefore made FINAL.
The election of species, VH CDRs SEQ ID NO: 21-23 and VL CDRs SEQ ID NO: 24-26, and VH and VL SEQ ID NO: 1 and 2, of the antibody 30B8, is acknowledged.
Claims Summary
Claim 19 is directed to an anti-SARS-CoV-2 antibody comprising:
a VH comprising SEQ ID NO: 21-23, CDRs 1-3, respectively, and a VL comprising SEQ ID NO: 24-26, CDRs 1-3, respectively;
a VH comprising SEQ ID NO: 1, and a VL comprising SEQ ID NO: 2; or
a VH comprising a sequence expressed from or encoded by a nucleic acid comprising SEQ ID NO: 11, and a VL comprising a sequence expressed from or encoded by a nucleic acid comprising SEQ ID NO: 12
The elected sequences represent the VH/VL CDRs and VH/VL domains of antibody 30B8, a monoclonal antibody against SARS-CoV-2.
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.
Claim 19 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 23 of copending Application No. 18/699,102 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Instant claim 19 is directed to an anti-SARS-CoV-2 antibody comprising VH and VL CDRs 1-3, represented by SEQ ID NO: 21-26, and VH and VL domains represented by SEQ ID NO: 1 and 2. The copending claims are directed to a protein encompassing an antibody (claim 6) that competes with an antibody that comprises a VH and VL domain represented by SEQ ID NO: 5 and 6, which are identical to Applicant’s SEQ ID NO: 1 and 2, respectively. An antibody that competes with said antibody reads on Applicant’s antibody. The copending claims recite functional limitations that are not recited in the instant claims and are expected to functional characteristics inherent to an antibody comprising SEQ ID NO: 1 and 2 (Applicant’s antibody), since SEQ ID NO: 1 and 2 are identical the co-pending antibody’s SEQ ID NO: 5 and 6, respectively. The following table outlines the corresponding sequences between the two applications.
USSN 18/698,870
(this application)
USSN 18/699,102
(reference application)
SEQ ID NO: 1
SEQ ID NO: 5
SEQ ID NO: 2
SEQ ID NO: 6
SEQ ID NO: 11
SEQ ID NO: 15
SEQ ID NO: 12
SEQ ID NO: 16
SEQ ID NO: 21
SEQ ID NO: 29
SEQ ID NO: 22
SEQ ID NO: 30
SEQ ID NO: 23
SEQ ID NO: 31
SEQ ID NO:24
SEQ ID NO: 32
SEQ ID NO:25
SEQ ID NO: 33
SEQ ID NO:26
SEQ ID NO: 34
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
According to the MPEP 804, Chart I-B_AIA (different inventions), section I(B)(I)(b)(ii), which states that if both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome.
Conclusion
No claim is allowed.
The elected embodiments of claim 19(i) are free of the prior art of record, specifically the combination of CDRs SEQ ID NO: 21-26, and the combination of VH/VL SEQ ID NO: 1 and 2, and combination of VH/VL encoded by SEQ ID NO: 11 and 12.
Although the embodiments of claim 19, (ii)-(xv) are currently withdrawn from consideration as being non-elected species, please note that a sequence search for those embodiments of did not reveal any prior art in the claimed configurations of sequences. Should the provisional obviousness type double patenting rejection above be overcome, the species of claim 19, (ii)-(xv) would be rejoined. As for potential rejoinder of the non-elected invention of Group I, please note that withdrawn process claims that are not commensurate in scope with the allowable product claim will not be rejoined (see MPEP 821.04), and that rejoined process claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
