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: Applicant's election without traverse of Group I (claims 1-4, 6-7, 10, 12, 15-16, 19 -20 ), filed on 1/12/2026 is acknowledged. Claims 21 - 22, 25, 30-31, 33, and 35-36, withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/12/2026. Information Disclosure Statement 3. The information disclosure statements (IDS) submitted on 2/17/2026, 1/28/26, 10/29/24, 7/11/24, 2/28/24, 9/21/23, 8/16/23, 7/19/23 , and 6/16/2023 are in compliance with the provisions of 37 CFR 1.97 and have been considered by the examiner. Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section”. Claim Rejections - 35 USC § 112 (a) , written description 4. The following is a quotation 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 35 U.S.C. 112 (pre-AIA), first paragraph: 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. 4a. Claims 1 -4, 6-7, 10, 12, 15-16, 19 -20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicant has claimed a bispecific antibody or antigen binding fragments thereof binding to CD33 and CD7, wherein the bispecific antibody or antigen binding fragments comprises: a first binding region binding to human CD33 which has a K D binding affinity to CD33 of between about 1.36x10 -9 and about 9.23x10 -8 ; and a second binding region binding to human CD7 which has a K D binding affinity to CD7 of between about 3.56x10 -9 and about 2.29 x10 -7 , however , there is no recitation of structure of the CD33 and CD7 antibod ies recited in the claims, only a function has been recited , i.e. binding to CD33 and CD7 . Furthermore, there is no recitation of the structure of the bispecific antibody that bind s to CD33 and CD7 recited in any of claims 1-4, 6-7, 10, 12, 15-16, 19 -20 , nor is there a description of a bispecific antibody fragment that binds to a CD33 and CD7 . The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § (a) "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, January 5, 2001, S ee especially page 1106 , column 3). In Amgen Inc. v. Sanofi , 124 USPQ2d 1354 (Fed. Cir. 2017), relying upon Ariad Pharms., Inc. v. Eli Lily & Co. , 94 USPQ2d 1161 (Fed Cir. 2010), the following is noted. “ To show invention, a patentee must convey in its disclosure that is “had possession of the claimed subject matter as of the filing date. Demonstrating possession “requires a precise definition” of the invention. To provide this precise definition” for a claim to a genus, a patentee must disclose “a representative number of species within the scope of the genus of structural features common to the members of the genus so that one of skill in the art can visualize or recognize the member of the genus” (see Amgen at page 1358). ” In The Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412) 19 F. 3d 1559, the court held that disclosure of a single member of a genus (rat insulin) did not provide adequate written support for the claimed genus (all mammalian insulins). In this same case, the C ourt also noted: “A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. See Fiers , 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen ). It is only a definition of a useful result rather than a definition of what achieves that result. Many such genes may achieve that result. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder , 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin [e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). Accordingly, naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” The court has further stated that “Adequate written description requires a precise definition, such as by structure, formula, chemical name or physical properties, not a mere wish or plan for obtaining the claimed chemical invention.” Id. at 1566, 43 USPQ2d at 1404 (quoting Fiers. 984 F.2d at 1171, 25 USPQ2d at 1606). Also see Enzo-Biochem v. Gen-Probe 01-1230 (CAFC 2002). A s discussed above, Applicant has claimed a bispecific antibody or antigen binding fragments thereof binding to CD33 and CD7, wherein the bispecific antibody or antigen binding fragments comprises: a first binding region binding to human CD33 which has a K D binding affinity to CD33 of between about 1.36x10 -9 and about 9.23x10 -8 ; and a second binding region binding to human CD7 which has a K D binding affinity to CD7 of between about 3.56x10 -9 and about 2.29 x10 -7 . Recent court cases have indicated that recitation of an antibody which has specific functional properties in the absence of knowledge of the antibody sequences that give rise to said functional properties do not satisfy the requirements for written description. See for example AbbVie Deutschland GmbH v. Janssen Biotech. Inc. 759 F.3d 1285 (Fed. Cir. 2014) as well as Amgen v. Sanofi. (Fed Cir, 2017-1480. 10/5/2017). Indeed, in Amgen the C ourt indicates that that it is improper to allow patentees to claim antibodies by describing something that is not the invention, i.e. the antigen, as knowledge of the chemical structure of an antigen does not give the required kind of structure-identifying information about the corresponding antibodies, with the antibody-antigen relationship be analogized as a search for a key on a ring with a million keys on it. Also, it is not enough for the specification to show how to make and use the invention, i.e., to enable it (see Amgen at page 1361). An adequate written description must contain enough information about the actual makeup of the claimed products – “a precise definition, such as structure, formula, chemic name, physical properties of other properties, of species falling with the genus sufficient to distinguish the gene from other materials”, which may be present in “functional terminology when the art has established a correlation between structure and function” ( Amgen page 1361). In the instant case, the specification discloses cytotoxic activity for the claimed bispecific antibodies BVX100 , BVX1 1 0 , BVX120, BVX130, BVX140, BVX150, and BVX160 (page 49, Table 5) . The specification discloses on page 51, “ the BVX102, BVX152, BVX162, BVX110, BVX120 and BVX130 constructs all showed promise as therapeutics, and in particular BVX130 with BVX110 and BVX 120 showing similar activity.” The specification on page 42, Table 3, is an overview of the binding affinity (K D ) of each of the bispecific antibody candidates BVX100, BVX110, BVX120, BVX130, BVX140, BVX150, BVX160, BVX10 1 , BVX152, BVX16 1 , and BVX162 , compared to the wildtype . As such, the structure required of an antibody , such that it has all of the functions recited in the independent claims is not disclosed in the specification as filed. Applicant is reminded that the C ourts have long ruled that “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” See University of Rochester. 358 F.3d at 927, 69 USPQ2d at 1895. As such, disclosure of a screening assay to test for functional properties of an antibody does not provide evidence of possession of the antibody itself. It is well established in the art that the formation of an intact antigen-binding site requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three different complementarity determining regions, CDR1, CDR 2 and CDR 3, which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin (Janeway et al., 1997, S ee entire selection). It is also known that single amino acid changes in a CDR can abrogate the antigen binding function of an antibody (Rudikoff et al., 1982, S ee entire document, particularly the abstract and the middle of the left column of page 1982). However, as discussed above only a function for the claimed antibodies has been described , no structure whatsoever of the claimed antibodies has been recited in the instant specification and claims . Indeed, in AbbVie Deutschland GmbH v. Janssen Biotech. Inc. 759 F.3d 1285 (Fed. Cir. 2014) the C ourt ruled that all of the antibodies disclosed by AbbVie were all structurally similar as they were variants of a starting antibody named Joe9 and therefore did not serve to inform artisans as to the breadth of structures which had the recited function of cytokine binding. In the instant application, the instant claims recite antibodies merely by their function while the specification does not disclose structures which necessarily have the requisite functions. The instant specification fails to disclose structural information to indicate to artisans that Applicant had possession of the claimed antibodie s . Therefore, it appears that the broad genus of antibodies recited in Applicant’s claims lacks adequate written description because there is no structure recited for the antibodies in question to correlate with their recited functional activities. As such a skilled artisan would reasonably conclude that A pplicant was not in possession of the recited genus of antibodies. Therefore, there is insufficient written description for the genus of antibodies having the claimed “limitations” at the time the invention was made and as disclosed in the specification as filed under the written description provision of 35 USC 112. Appellant has been reminded that Vas-Cath makes clear that the written description provision of 35 USC 112 is severable from its enablement provision. (See page 1115.) Clai m Rejections - 35 USC § 112(b) 5. 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. 5 a . Claims 1 -4, 6-7, 10, 12, 15-16, 19 -20 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. Claim 1 is rejected and vague and indefinite for several reasons. Claim 1 is vague and indefinite because it is unclear how and by what method the K D binding affinity to CD33 and the K D binding affinity to CD 7 is determined . Furthermore, the absolute K D values can differ by the method used. Claim 1, line 3, is vague and indefinite because it recites “ K D binding affinity to CD33 of between about 1.36x10 -9 an d about 9.23x10 -8 …..…and K D binding affinity to CD 7 of between about 3.56x10 -9 and about 2.29 x10 -7 ” which can encompass “ 1 .0 x10 -9 and 10 x10 -8 ……and 5 x10 -9 and 3 x10 -7 ” or even “ 2.0 x10 -9 and 8 x10 -8 ……and 2 x10 -9 and 5 x10 -7 ”. Therefore, the metes and bounds of the limitation “about” are unclear. This rejection can be obviated by deleting the recitation of the term “about” from the claim. Similarly , claims 2, 15-16 , and 19-20 are rejected as vague and indefinite for the recitation of the term “about”. Claim 4 , line 3, is vague and indefinite because it recites “ reduced K D binding affinity for CD33 of up to about 70 fold… to about 68 fold” which can encompass “ reduced K D binding affinity for CD33 of up to 50 fold… to 80 fold” or even “ reduced K D binding affinity for CD33 of up to 60 fold… to 90 fold”. Therefore, the metes and bounds of the limitation “about” are unclear. This rejection can be obviated by deleting the recitation of the term “about” from the claim. Similarly , claims 7, 10, and 12, are rejected as vague and indefinite for the recitation of the term “about”. Claim 3 is vague and indefinite because it recites “ …the first binding region has a reduced K D binding affinity for CD33 ” , however, it is unclear what the “wild type K D binding affinity for CD33 is”. Similarly, claims 7 and 12, are rejected as vague and indefinite for the recitation of the term “ …. reduced K D binding affinity ”. Claim 12, line 5, is vague and indefinite because it recites “substantially the same K D binding affinity for CD33” and the metes and bounds of the term “substantially” are unclear. Is the K D binding affinity for CD33 the same or how different is the K D binding affinity for CD33? Claims 16, 19 and 20 are rejected as vague and indefinite because it is unclear by what method the fold selectivity is measured. Claim 6 is rejected as vague and indefinite insofar as it depend s on the above rejected claim 1 for its limitations. Claim Rejections - 35 USC § 102 (a)( 1 ) : 6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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. 6a . Claims 1 -4, 6-7, 10, 12, 15-16, and 19 -20 are rejected under 35 U.S.C. 102(a)( 1 ) as being anticipated by WO 2019/102234 A1. WO 2019/102234 A1 discloses a bispecific antibody (bi-Fab) binding to CD7 and CD33 in a synergistical manner (Figure 21) and Figure 23 shows that the bi-Fab conjugated to the toxin MMAE has a more than additive cell killing efficacy of cells expressing both CD7 and CD33 in comparison to individual antibodies binding only CD33 and CD7. Furthermore, Figure 27 shows that the bi-Fab kills CD7/CD33 double positive AML cells. T he K D binding affinity to CD33 and CD7 recited in the claims and fold reduction is unclear, and i n the absence of recitation of the 6 CRDs or the VH and VL amino acid sequences comprising the bi-specific antibody binding to CD33 and CD7, the antibody recited in the reference meets the limitations of the claimed antibody. Therefore, the reference anticipates claims 1 -4, 6-7, 10, 12, 15-16, 19 -20 , absent any evidence to the contrary. 6b. Claims 1 -4, 6-7, 10, 12, 15-16, 19 -20 are rejected under 35 U.S.C. 102(a)( 1 ) as being anticipated by Bethell Richard et al (2020). Bethell Richard et al (page 1, last paragraph) discloses a bispecific antibody drug-conjugate in which the anti-CD7 binding moiety has an affinity (K D ) of 3.6 nM and the CD33 binding Fab has an affinity (K D ) of 1.6 nM which falls within the ranges of K D binding affinity recited in the claims. In the absence of recitation of the 6 CRDs or the VH and VL amino acid sequences comprising the bi-specific antibody binding to CD33 and CD7, the antibody recited in the reference meets the limitations of the claimed antibody. Therefore, the reference anticipates claims 1 -4, 6-7, 10, 12, 15-16, 19-20 , absent any evidence to the contrary. Claim rejections – Provisional Double patenting Provisional Non-statutory double patenting rejection (obviousness-type ) 7 . 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 claims at issue 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 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 . Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). 7 a. Claim s 1 -4, 6-7, 10, 12, 15-16, 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-2, 5, and 36 of copending Application No. 18/ 265783 (‘ 783 ). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 in ‘ 783 (having the same inventor as the instant application), recites “ a bispecific antibody or antigen binding fragments thereof binding to CD33 and CD7, wherein the bispecific antibody or antigen binding fragments comprises a first binding region binding to human CD33 which comprises the sequences having at least 95% sequence identity to sequences: VH SEQ ID No. 81; and VL SEQ ID No. 85,and a second binding region binding to human CD7 which comprises the VH CDR1, VH CDR2, VH CDR3 of SEQ ID NO. 31 and the VL CDR1, VL CDR2, VL CDR3 of SEQ ID NO. 35 wherein the sequences are defined by IMGT numbering system. ” Instant claim 1 recites “ a bispecific antibody or antigen binding fragments thereof binding to CD33 and CD7, wherein the bispecific antibody or antigen binding fragments comprises: a first binding region binding to human CD33 which has a K D binding affinity to CD33 of between about 1.36x10 -9 and about 9.23x10 -8 ; and a second binding region binding to human CD7 which has a K D binding affinity to CD7 of between about 3.56x10 -9 and about 2.29 x10 -7 ”. Claims 1 -4, 6-7, 10, 12, 15-16, 19-20 in the instant application are generic to claims 1- 2, 5, 36, in the ‘ 783 application and encompass subject matter to which the claims in the ‘ 783 are a species because a bi-specific antibody as recited in instant claims 1 -4, 6-7, 10, 12, 15-16, 19-20 encompasse s the bi-specific antibody of claims 1- 2, 5, 36 of the ‘783 application. However, the claims in the ‘783 application are obvious from the instant claims because the claims in the ‘783 application are directed to one specific embodiment encompassed by the instant claims. The instant product include s the product claims of the ‘783 application and both sets of claims are of overlapping scope. It would have been obvious to one of ordinary skill in the art at the time the present invention was made, that a product as recited in the instant claims, included the product as recited in the claims of the ‘783 application . Therefore, the claimed invention is obvious over claim s 1, 2, 5, and 36 of ‘ 783 . This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion Claims 1 -4, 6-7, 10, 12, 15-16, and 19 -20 are rejected. No claim is allowed. Advisory Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to PREMA MARIA MERTZ whose telephone number is (571)272-0876 . The examiner can normally be reached on Monday to Thursday from 7:30am to 6:00pm. 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. Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form. /PREMA M MERTZ/ Primary Examiner, Art Unit 1674