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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 26, 2026 has been entered.
Claim Status
Claims 26-27, 30-31, 34-35, and 37-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 5, 2025.
Claims 1, 3, 6-9, 12-13, and 17-25 are under consideration in this office action.
Withdrawn Rejections
The rejection of claims 1, 3, 6-9, 12-13, and 17-25 under 35 U.S.C. 112(a) as failing to comply with the written description requirement is withdrawn in view of applicant’s amendment of claim 1 to limit the targeting domains to specific amino acid sequences.
Modified Rejections Necessitated by Amendment
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.
Claims 1, 3, 6-9, 12-13, and 17-25 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/062604, published April 13, 2017 (“Vallera”; see IDS from 4/17/2024) in view of US 2020/0123236A1, filed October 17, 2017 (“Guenaga”; PTO-892 from 1/27/2026).
The instant claims are directed to a compound comprising a NK engaging domain comprising SEQ ID NO: 11, SEQ ID NO: 18, or amino acid 10240 of SEQ ID NO: 5, a NK activating domain linked to the NK engaging domain comprising IL-15 of SEQ ID NO: 4 (or functional variant comprising a N72D or N72A amino acid substitution), and a targeting domain that is operably linked to the NK activating domain and the NK engaging domain, wherein the targeting domains comprises SEQ ID NO: 8, 15, 25, 26, 27, 30, 31, 39, or 40.
Vallera teaches a compound comprising an NK engaging domain, an NK activating domain operably linked to the NK engaging domain, and a targeting domain that selectively binds to a viral antigen and is operably linked to the NK activating domain and the NK engaging domain (pg 1, ln 25-28), as in the claim 1.
The NK engaging anti-CD16 domain of Vallera comprises the amino acid sequence of SEQ ID NO: 20 (pg 57, ln 16-19), which comprises SEQ ID NO: 18 of instant claim 1.
Vallera teaches that the NK activating domain can include IL-15 (pg 15 ln 8-14); which comprises the amino acid sequence of SEQ ID NO: 15. SEQ ID NO: 15 identical to instant SEQ ID NO: 4, as in instant claim 1. Vallera also teaches variants of IL-15 with N72D or N72A amino acid substitution (pg 15 ln 25-29), as in instant claim 1.
The targeting domain can selectively bind to a target on a cell infected by a virus, such as HIV (pg 15, ln 3-4), as in instant claims 1 and 3.
Vallera teaches that the NK engaging domain can include an antibody or a fragment thereof (pg 2, ln 1-2) or a nanobody (pg 31, ln 1-5), as in instant claim 6, and that a fragment thereof includes scFv, Fab, and Fv (pg 13, ln 14-10), as in claim 7. The fragment of the nanobody may be camelid (pg 31, ln 5-8), as in instant claims 8-9.
Vallera teaches that the targeting moiety can include an antibody or a fragment thereof (e.g., ScFv, or a Fab) (pg 2, ln 3-5), as in instant claims 12-13.
The molecule of Vallera can include a flanking sequence linking any two of the domains (pg 2, ln 25-26), as in instant claim 17; in some cases, the molecule can have more than one flanking sequence (pg 2, ln 26-27), as in claim 18. Vallera teaches that the flanking sequences are upstream and downstream of the NK activating domain (pg 29, ln 5-8), as in instant claim 19.
Further, Vallera teaches that the first flanking sequence is C-terminal to the anti-NK scFv and a second flanking sequence is N-terminal to the targeting domain (Vallera claim 23), as in instant claim 20.
In some embodiments, the compound may comprise a second targeting domain (Vallera claim 24), a second NK activating domain (Vallera claim 26, or a second NK engaging domain (Vallera claim 25), as in instant claims 21-23, respectively.
Vallera teaches a composition comprising the compound and a pharmaceutically acceptable carrier (Vallera claim 48; pg 37, ln 1-3), as in instant claim 25.
Vallera does not teach the targeting domain comprising SEQ ID NOs: 25 and 26, SEQ ID NOs: 30 and 31, or SEQ ID NOs: 39 and 40, as required by amended claim 1.
Guenaga teaches a multi-specific antibody that binds to HIV antigen of SEQ ID NO: 20 [0196]. The HIV antigen binding domain of SEQ ID NO: 20 is comprised of instant SEQ ID NOs: 25 and 26 of instant claim 1; Guenaga teaches the targeting domain of claim 1.
Instant claim 24 is directed to a compound of SEQ ID NO: 24, which is comprised of, in order, instant SEQ ID NOs: 18 (the NK engaging domain), 4 (NK activating domain), 25 and 26 (targeting domain). Vallera teaches the NK engaging and activating domains (see pg 3-4 of this office action) and Guenaga teaches the targeting domain of instant SEQ ID NOs: 25 and 26.
Given that Vallera teaches all the features of the compound of claim 1 except the HIV antigen binding domain and further given that Guenaga teaches the claimed HIV antigen binding domain, it would have been obvious to one of ordinary skill in the art to use the antibody of Guenaga in the compound of Vallera and thereby arrive at the presently claimed invention. This is because the artisan has good reason to pursue the known options within their technical grasp to obtain predictable results. Such would amount to the simple substitution of one functionally equivalent element for another (i.e. the antibody of Guenaga for the HIV antigen targeting domain of Vallera) to obtain predictable results. The motivation to do so comes from Vallera, which teaches the potential clinical benefit compounds targeting HIV virus infected cells for the treatment of disease (pg 15, ln 3-4). As is stated in MPEP §2144.06, substituting one equivalent element for another known for the same purpose renders an invention obvious and an “express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)."
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, 3, 6-9, 12-13, and 17-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9, 12-14, and 19 of U.S. Patent No. 11,098,100 in view of in view of US 2020/0123236A1, filed October 17, 2017 (“Guenaga”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are directed to overlapping subject matter: a compound comprising an NK engaging domain comprising SEQ ID NO: 18, an NK activating domain operably linked to the NK engaging domain comprising IL-15, and a targeting domain that selectively binds to an HIV antigen and is operably linked to the NK activating domain and NK engaging domain.
Claim 1 of ‘100 teaches a compound comprising an NK engaging domain of amino acid residues 19-140 of SEQ ID NO: 14, which is comprised of instant SEQ ID NO: 18 for the NK engaging domain of instant claim 1. The NK activating domain of ‘100 comprises SEQ ID NO: 15 and the amino acid substitutions N72A and N72D, as in the NK activating domain comprised of IL-15 of instant SEQ ID NO: 4 or a functional variant thereof, of instant claims 1.
Claims 4-5 of ‘100 teach an NK engaging moiety that is an antibody or a binding fragment thereof (including scFv, F(ab)2, or Fab); which reads on instant claims 6-7. Claims 7-8 of ‘100 teach a targeting moiety comprising an antibody or binding fragment thereof (including scFv), which reads on instant claims 12-13. The antibody/nanobody of claim 14 of ‘100 is human, humanized, or camelid, as in instant claim 8.
The linkers of claims 12-13 of ‘100 read on the flanking sequences of instant claims 19-20. These linkers are the same as those in SEQ ID NO: 7 of instant claim 24.
Although claim 19 of ‘100 teaches a targeting domain that binds to an antigen of HIV, ‘100 does not teach the targeting domain comprising SEQ ID NOs: 25 and 26, SEQ ID NOs: 30 and 31, or SEQ ID NOs: 39 and 40, as required by amended claim 1.
Guenaga teaches a multi-specific antibody that binds to HIV antigen of SEQ ID NO: 20 [0196]. The HIV antigen binding domain of SEQ ID NO: 20 is comprised of instant SEQ ID NOs: 25 and 26 of instant claim 1; Guenaga teaches the targeting domain of claim 1.
Instant claim 24 is directed to a compound of SEQ ID NO: 24, which is comprised of, in order, instant SEQ ID NOs: 18 (the NK engaging domain), 4 (NK activating domain), 25 and 26 (targeting domain). Vallera teaches the NK engaging and activating domains (see pg 3-4 of this office action) and Guenaga teaches the targeting domain of instant SEQ ID NOs: 25 and 26.
Given that ‘100 teaches the compound of instant claim 1 and further given that Guenaga teaches the claimed antibody that bind to HIV antigen, it would have been obvious to one of ordinary skill in the art to use the antibody of Guenaga in the composition of claim 1 of ‘100 and thereby arrive at the presently claimed invention. This is because the artisan has good reason to pursue the known options within their technical grasp to obtain predictable results. Such would amount to the simple substitution of one functionally equivalent element for another (i.e. the antibody of Guenaga for the HIV antigen targeting domain of ‘100) to obtain predictable results.
The scope of the reference claims fully overlaps with the instant claims, and thus, it would have
been obvious to one of ordinary skill in the art that the method of ‘100 is the same as that of the instant application and the indicated claims are not patentably distinct from each other.
Claims 1, 3, 6-9, 12-13, and 17-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-8 of U.S. Patent No. 11,098,101 in view of in view of US 2020/0123236A1, filed October 17, 2017 (“Guenaga”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are directed to overlapping subject matter: a compound comprising an NK engaging domain comprising instant SEQ ID NO: 18, an NK activating domain operably linked to the NK engaging domain comprising IL-15, and a targeting domain that selectively binds to an HIV antigen and is operably linked to the NK activating domain and NK engaging domain.
Claim 1 of ‘101 teaches a compound comprising an NK engaging domain of amino acid residues 19-140 of SEQ ID NO: 14, which is comprised of instant SEQ ID NO: 18 for the NK engaging domain of instant claim 1. The NK activating domain of ‘101 comprises SEQ ID NO: 15 and the amino acid substitutions N72A and N72D, as in the NK activating domain comprised of IL-15 of instant SEQ ID NO: 4 or a functional variant thereof, of instant claim 1.
Claims 3-4 of ‘101 teach an NK engaging moiety that is an antibody or a binding fragment thereof (including scFv, F(ab)2, or Fab); as in instant claims 6-7. The antibody/nanobody of claim 5 of ‘101 is human, humanized, or camelid, as in instant claim 8.
The linkers of claims 7-8 of ‘101 read on the flanking sequences of instant claims 19-20. These linkers are the same as those in SEQ ID NO: 7 of instant claim 24.
Although claim 1 of ‘101 teaches a targeting domain that binds to an antigen of HIV, ‘101 does not teach the targeting domain comprising SEQ ID NOs: 25 and 26, SEQ ID NOs: 30 and 31, or SEQ ID NOs: 39 and 40, as required by amended claim 1.
Guenaga teaches a multi-specific antibody that binds to HIV antigen of SEQ ID NO: 20 [0196]. The HIV antigen binding domain of SEQ ID NO: 20 is comprised of instant SEQ ID NOs: 25 and 26 of instant claim 1; Guenaga teaches the targeting domain of claim 1.
Instant claim 24 is directed to a compound of SEQ ID NO: 24, which is comprised of, in order, instant SEQ ID NOs: 18 (the NK engaging domain), 4 (NK activating domain), 25 and 26 (targeting domain). Vallera teaches the NK engaging and activating domains (see pg 3-4 of this office action) and Guenaga teaches the targeting domain of instant SEQ ID NOs: 25 and 26.
Given that ‘101 teaches the compound of instant claim 1 and further given that Guenaga teaches the claimed antibody that binds to HIV antigen, it would have been obvious to one of ordinary skill in the art to use the antibody of Guenaga in the composition of claim 1 of ‘101 and thereby arrive at the presently claimed invention. This is because the artisan has good reason to pursue the known options within their technical grasp to obtain predictable results. Such would amount to the simple substitution of one functionally equivalent element for another (i.e. the antibody of Guenaga for the HIV antigen targeting domain of ‘101) to obtain predictable results.
The scope of the reference claims fully overlaps with the instant claims, and thus, it would have
been obvious to one of ordinary skill in the art that the method of ‘100 is the same as that of the instant application and the indicated claims are not patentably distinct from each other.
Double Patenting (New)
Claims 1, 3, 6-9, 12-13, and 17-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-8 of U.S. Patent No. 12,606,604 in view of in view of US 2020/0123236A1, filed October 17, 2017 (“Guenaga”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are directed to overlapping subject matter: a compound comprising an NK engaging domain comprising instant SEQ ID NO: 18, an NK activating domain operably linked to the NK engaging domain comprising IL-15, and a targeting domain that selectively binds to an HIV antigen and is operably linked to the NK activating domain and NK engaging domain.
Claim 1 of ‘604 teaches a compound comprising an NK engaging domain of amino acid residues 19-140 of SEQ ID NO: 14, which is comprised of instant SEQ ID NO: 18 for the NK engaging domain of instant claim 1. The NK activating domain of ‘604 comprises SEQ ID NO: 15 and the amino acid substitutions N72A and N72D, as in the NK activating domain comprised of IL-15 of instant SEQ ID NO: 4 or a functional variant thereof, of instant claim 1.
Claim 4 of ‘604 teach an NK engaging moiety that is an antibody or a binding fragment thereof (including scFv, F(ab)2, or Fab); as in instant claims 6-7. The antibody/nanobody of claim 10 of ‘604 is human, humanized, or camelid, as in instant claim 8.
The linkers of claims 8-12 of ‘604 read on the flanking sequences of instant claims 19-20. These linkers are the same as those in SEQ ID NO: 24 of instant claim 24.
Although claim 1 of ‘604 teaches a targeting domain that binds to an antigen of HIV, ‘604 does not teach the targeting domain comprising SEQ ID NOs: 25 and 26, SEQ ID NOs: 30 and 31, or SEQ ID NOs: 39 and 40, as required by amended claim 1.
Guenaga teaches a multi-specific antibody that binds to HIV antigen of SEQ ID NO: 20 [0196]. The HIV antigen binding domain of SEQ ID NO: 20 is comprised of instant SEQ ID NOs: 25 and 26 of instant claim 1; Guenaga teaches the targeting domain of claim 1.
Instant claim 24 is directed to a compound of SEQ ID NO: 24, which is comprised of, in order, instant SEQ ID NOs: 18 (the NK engaging domain), 4 (NK activating domain), 25 and 26 (targeting domain). Vallera teaches the NK engaging and activating domains (see pg 3-4 of this office action) and Guenaga teaches the targeting domain of instant SEQ ID NOs: 25 and 26.
Given that ‘604 teaches the compound of instant claim 1 and further given that Guenaga teaches the claimed antibody that binds to HIV antigen, it would have been obvious to one of ordinary skill in the art to use the antibody of Guenaga in the composition of claim 1 of ‘604 and thereby arrive at the presently claimed invention. This is because the artisan has good reason to pursue the known options within their technical grasp to obtain predictable results. Such would amount to the simple substitution of one functionally equivalent element for another (i.e. the antibody of Guenaga for the HIV antigen targeting domain of ‘604) to obtain predictable results.
The scope of the reference claims fully overlaps with the instant claims, and thus, it would have
been obvious to one of ordinary skill in the art that the method of ‘604 is the same as that of the instant application and the indicated claims are not patentably distinct from each other.
Response to Arguments
Applicant's arguments filed April 24, 2026 have been fully considered but they are not persuasive. Applicant argues that Guenaga does not disclose or suggest a compound comprising a NK engaging domain, an NK activating domain, and a targeting domain of SEQ ID NOs: 25 and 26, SEQ ID NOs: 30 and 31, or SEQ ID NOs: 39 and 40 and that one of skill in the art would find no motivation in Guenaga to generate a compound that includes the single HIV antigen binding domain (remarks, pg 11). While Guenaga does not disclose all the features of the presently claimed compound, it is not necessary for this secondary reference to do so, because Vallera already teaches this feature. Further, it is noted that the instant rejection was not necessarily established based on Guenaga teaching an NK engager compound, but rather, it was to establish that the sequence of HIV antigen binding domain was already known in the art. As such, the combined references render the present claims obvious, and applicant’s arguments against the references individually are therefore not found persuasive. Applicant is reminded that the test for obviousness is not whether the features of the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981). Applicant’s arguments do not show how the combined teachings of the cited references and the knowledge/skills contained therein cannot render the rejected claims obvious.
Applicant argues that one of skill in the art would have no good reason to pursue the known options within their technical grasp to obtain predictable results, because one of skill in the art would not expect predictable results nor any expectation of success in generating any useful compound that does not include at least two HIV targeting domains (remark, pg 11). According to the specification, the targeting domain binds a marker on a target cell (pg 8). Since HIV antigen binding domain of Guenaga is used according to its established function, and there is no evidence of criticality regarding the claimed HIV antigen binding domains, the claimed compound is obvious over the combined teachings of Vallera and Guenaga. As is stated in MPEP §2144.06, substituting one equivalent element for another known for the same purpose renders an invention obvious and an “express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)."
In the response filed on April 24, 2026, applicant requests that the nonstatutory double patenting rejections over U.S. Patents 11,098,100 and 11,098,101 to be held in abeyance until notification of allowable subject matter in the present application. The applicant is reminded that a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer. Such a response is required even when the nonstatutory double patenting rejection is provisional. See MPEP 804.I.B.1. The rejections are maintained for the reasons of record.
Conclusion
No claim is allowed.
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Jennifer Benavides
Examiner
Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
Prosecution Insights