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 Invention I and species of a bispecific antibody wherein the CD3 antigen binding domain comprises SEQ ID NOs: 11-106-13 and 60-17-61 and the GPC3 antigen binding domain comprises SEQ ID NOs: 134-135-136 and 11-116-128 in the reply filed on 12FEB2026 is acknowledged.
Claims 14, 16, and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species. Election was made without traverse in the reply filed on 12FEB2026.
Claim Status
Claims 1, 3-10, and 12-16 have been amended.
Claims 17-18 are new.
Claims 1-18 are pending in the instant application (i.e., Claim(s) 1 is/are independent).
Claims 14, 16, and 18 are withdrawn.
Claims 1-13, 15, and 17 are examined on the merits.
Priority
The present application is a 371 National Stage of PCT International Application No. PCT/CN2021/135153, filed 02DEC2021, which claims foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of Chinese Application No. CN 202011402162.X filed on 02DEC2021 has been received and is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 01AUG2023 and 02AUG2023 is/are acknowledged and the references cited therein have been considered.
Specification
The disclosure is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see for example p 5). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 3-8 and 10 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.
Regarding claims 3-8 and 10, the phrases “preferably” and/or “more preferably” render the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. Per MPEP §2173.05(d) description of examples or preferences should be properly set forth in the specification rather than the claims.
Claim 4 recites the limitations "the first heavy chain variable region…and/or the first light chain variable region,” which in this instance is dependent on claim 1; however claim 1 does not mention the a first VL and/or a first VH and therefore there is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitations "the HCDRs1-3” and “the LCDRs” as well as the “VH and VL” which in this instance is dependent on claim 1; however claim 1 does not mention HCDRs1-3, LCDRs1-3, VH, or VL for the second binding domain and therefore there is insufficient antecedent basis for this limitation in the claim.
Claims 6 recites the limitations "the first light chain variable region," “the second light chain variable region,” “the first heavy chain variable region,” “the second heavy chain variable region,” and “the Fc portion of the first antigen-binding portion and the second antigen-binding portion” which in this instance is dependent on claim 1; however claim 1 does not mention a first VL/VH, a second VL/VH, or Fc and therefore there is insufficient antecedent basis for this limitation in the claim. Furthermore, because of the lack of reference to a first or second VL/VH (i.e., by SEQ ID NO or otherwise) the mutations and the location of said mutations are unclear.
Claim 8 recites the limitations "the second heavy chain variable region…and the second light chain variable region,” which in this instance is dependent on claim 1; however claim 1 does not mention the a second VL and/or a second VH and therefore there is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitations "the first heavy chain variable region…and/or the first light chain variable region” and "the second heavy chain variable region…and/or the second light chain variable region” which in this instance is dependent on claim 1; however claim 1 does not mention the a first/second VL and/or a first/second VH and therefore there is insufficient antecedent basis for this limitation in the claim.
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 9-13, 15, and 17 are 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. With regard to claims 9, 10-13 (partially), 15 (partially), and 17 (partially) the limitation of an antibody or antigen-binding portion thereof that binds to GPC3 (i.e., a monospecific antibody), the antibody comprising [the] first antigen-binding portion according to claim 1 (i.e., a bispecific antibody), fails to include all the limitations of the claim 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.
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 1-13, 15, and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling and having support for:
“1. A bispecific antibody or antigen-binding portion thereof, comprising:
(a) a first antigen-binding portion or an antigen-binding fragment thereof comprising a first binding domain that binds to a GPC3 antigen on the surface of a target cell, comprising a first heavy chain and a first light chain and
(b) a second antigen binding portion or an antigen binding fragment thereof comprising a second binding domain that binds to a CD3 antigen on the surface of a T cell, comprising a second heavy chain and a second light chain;
wherein the first heavy chain comprises a first VH which comprises HCDRs1-3 and the first light chain comprises a first VL which comprises LCDRs1-3, wherein the first HCDRs1-3 and the first LCDRs1-3 are selected from the group consisting of:
i) SEQ ID NOs: 11, 12, 13 and SEQ ID NOs: 16, 17, 18, respectively;
ii) SEQ ID NOs: 11, 21, 13 and SEQ ID NOs: 16, 17, 18, respectively;
iii) SEQ ID NOs: 11, 12, 13 and SEQ ID NOs: 16, 17, 26, respectively;
iv) SEQ ID NOs: 11, 12, 13 and SEQ ID NOs: 16, 17, 29, respectively;
v) SEQ ID NOs: 32, 33, 13 and SEQ ID NOs: 16, 17, 18, respectively;
vi) SEQ ID NOs: 11, 21, 13 and SEQ ID NOs: 38, 17, 39, respectively;…and
xix) SEQ ID NOs: 11, 106, 13 and SEQ ID NOs: 98, 17, 61, respectively and
wherein the second heavy chain comprises a second VH which comprises HCDRs1-3 and the second light chain comprises a second VL which comprises LCDRs1-3, wherein the second HCDRs1-3 and the second LCDRs1-3 are selected from the group consisting of:
i) SEQ ID NOs: 134, 135, 136 and SEQ ID NOs: 115, 116, 128, respectively;
ii) SEQ ID NOs: 134, 135, 136 and SEQ ID NOs: 115, 116, 117, respectively; and
iii) SEQ ID NOs: 134, 135, 136 and SEQ ID NOs: 122, 123, 117, respectively.” (Claim 1 combined with the preference limitations of claim 3 and partial preference limitations of claim 5).
-AND-
“The bispecific antibody or antigen-binding portion thereof according to claim 1,
wherein the first VH and the first VL are selected from the group consisting of:
i) SEQ ID NO: 9 and SEQ ID NO: 14, respectively;… and
xx) SEQ ID NO: 111 and SEQ ID NO: 96, respectively.” (Claim 4)
-AND-
“The bispecific antibody or antigen-binding portion thereof according to claim 1,
wherein the second VH and the second VL are selected from the group consisting of:
i) SEQ ID NO: 132 and SEQ ID NO: 126, respectively;… and
vii) SEQ ID NO: 158 and SEQ ID NO: 126. (Partial preference limitations of claim 5).
-AND-
“The bispecific antibody or antigen-binding portion thereof according to claim 1,
wherein the first HC and the first LC are selected from the group consisting of:
i) SEQ ID NO: 164 and SEQ ID NO: 162, respectively; and
ii) SEQ ID NO: 172 and SEQ ID NO: 170, respectively.” (Claim 7)
-AND-
“The bispecific antibody or antigen-binding portion thereof according to claim 1,
wherein the first HC and the first LC are set forth in SEQ ID NO: 164 and SEQ ID NO: 162, respectively and the second HC and the second LC are set forth in SEQ ID NO: 168 and SEQ ID NO: 166 respectively; or
wherein the first HC and the first LC are set forth in SEQ ID NO: 172 and SEQ ID NO: 170, respectively and the second HC and the second LC are set forth in SEQ ID NO: 168 and SEQ ID NO: 166 respectively.” (Claim 8)
-AND-
“A nucleic acid encoding the bispecific antibody or antigen-binding portion thereof according to claim 1,
wherein the nucleic acid encoding the first VH and the first VL are selected from the group consisting of:
i) SEQ ID NO: 10 and SEQ ID NO: 15, respectively;…and
xx) SEQ ID NO: 112 and SEQ ID NO: 97, respectively; or
wherein the nucleic acid encoding the first HC and the first LC are selected from the group consisting of:
i) SEQ ID NO: 165 and SEQ ID NO: 163, respectively and
ii) SEQ ID NO: 173 and SEQ ID NO: 171, respectively; and
wherein the nucleic acid encoding the second VH and the second VL are selected from the group consisting of:
i) SEQ ID NO: 133 and SEQ ID NO: 127, respectively;… and
vii) SEQ ID NO: 159 and SEQ ID NO: 127, respectively; or
wherein the nucleic acid encoding the second HC and the second LC are set forth in SEQ ID NO: 169 and SEQ ID NO: 167, respectively; or
wherein the nucleic acid encoding the first HC and the first LC are set forth in SEQ ID NO: 165 and SEQ ID NO: 163, respectively and the nucleic acid encoding the second HC and the second LC are set forth in SEQ ID NO: 169 and SEQ ID NO: 167 respectively; or
wherein the nucleic acid encoding the first HC and the first LC are set forth in SEQ ID NO: 173 and SEQ ID NO: 171, respectively and the nucleic acid encoding the second HC and the second LC are set forth in SEQ ID NO: 169 and SEQ ID NO: 167 respectively. (Claim 10)
-AND-
“A composition comprising the bispecific antibody or antigen-binding portion thereof according to claim 1, a nucleic acid encoding the bispecific antibody or antigen-binding portion thereof according to claim 1, a vector containing the nucleic acid encoding the bispecific antibody or antigen-binding portion thereof according to claim 1, or a cell comprising the nucleic acid or vector encoding the bispecific antibody or antigen-binding portion thereof according to claim 1 and a pharmaceutically acceptable carrier.” (Claim 13)
-AND-
“A kit comprising the bispecific antibody or antigen-binding portion thereof according to claim 1, a nucleic acid encoding the bispecific antibody or antigen-binding portion thereof according to claim 1, a vector containing the nucleic acid encoding the bispecific antibody or antigen-binding portion thereof according to claim 1, or a cell comprising the nucleic acid or vector encoding the bispecific antibody or antigen-binding portion thereof according to claim 1.” (Claim 15);
does not reasonably provide enablement or support for more.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims nor does it provide sufficient description to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed had possession of the claimed invention.
With regard to antibodies, it should be pointed out that 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, 2 and 3, which provide the majority of the contact residues for the binding of the antibody to its target epitope. And in the instance of a bispecific antibody, it is well known in the art, that such a construct comprises two pairs of VH/VL regions (i.e., one pair for each binding domain) and each VH/VL pair consists of six CDRs for a total of 12 CDRs (Brinkmann, et al., MABS, 2017, 9, 182-212, see p 183, col 1, ¶1 and Fig 1-2). 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., Immunobiology: The Immune System in Health and Disease, 5th edition, 2001). It is also known that single amino acid changes in a CDR can abrogate the antigen binding function of an antibody (Rudikoff, et al., PNAS, 1982, 79, 1979-1983 see entire document, particularly the abstract and the middle of the left column of p 1982). Thus, based upon the prior art, skilled artisans would reasonably understand that it is the structure of the CDRs within an antibody which gives rise to the functional property of antigen binding, the epitope to which said CDRs bind is an inherent property which appears to necessarily be present due to conservation of critical structural elements, namely the CDR sequences themselves. Furthermore, the pairing propensity of any two given germlines depends to a large extent on the sequence and conformation of HCDR3, which is highly variable and if HCDR3 is fixed, different VH/VL pairs can result in significant stability differences (Chiu, et al., Antibodies, 2019, 8, 1-80, Section 2.1.3). Therefore, the art supports that the nondegenerate CDR sequences for each antigen binding domain and the specific pairing of the VH and VL sequences for each antigen binding domain are necessary structural features to maintain functional binding.
Artisans are also well aware that knowledge of a given antigen (for instance a specific epitope of CD3) provides no information concerning the sequence/structure of antibodies that bind the given antigen. For example, Edwards et al. teach that over 1,000 different antibodies to a single protein can be generated, all with different sequences spanning almost the entire heavy and light chain germline repertoire (42/49 functional heavy chain germlines and 33 of 70 V-lambda and V-kappa light chain germlines, and with extensive diversity in the HCDR3 region sequences (that are generated by VDJ germline segment recombination) as well (Edwards, et al., J Mol Biol, 2003, 334, 103-118, see entire document). Goel et al. disclose the synthesis of three monoclonal antibodies that bind to the same short (12-mer) peptide and found that the sequences of these antibodies which bound the same epitope exhibited diverse V gene usage indicating their independent germline origin (Goel, et al., J Immunol, 2004, 173, 7358-7367, see entire document). Further, it should be noted that degenerate binding of the same structural motif by antibodies does not require the existence of sequence homology or identity at any of their CDRs or other chemical similarities at the antigen-binding sites; side chain mobility of epitope residues can confer steric and electrostatic complementarity to differently shaped combining sites, allowing functional mimicry to occur (Lescar et al., J Biol Chem, 1995, 270, 18067-18076, see entire document, in particular Abstract and Discussion). As such, it does not seem possible to predict the sequence/structure of an antibody that binds a given antigen as there does not appear to be any common or core structure present within all antibodies that gives rise to the function of antigen binding. Further, given data such as that of Edwards et al. indicating the diversity of sequences in a population of antibodies that bind to a given antigen, no number of species appears to reasonably represent the breadth of the genus of antibodies that bind the given antigen in the instant application.
The specification discloses that all claimed antibody structures, whether directed to GPC3, CD3, and GPC3 x CD3 include both the heavy chains and the light chains. There are no instances wherein only the HCs or only the LCs function to bind to said targets. In addition to including both the heavy chains and the light chains, all antibody structures of the specification comprise six specific nondegenerate CDRs for each antigen rather than a mix and match of amino acid sequences as recited in claims 1, 2, 3 (partially), 4 (partially), 5 (partially), and 10 (partially). Furthermore, in the instance of claim 1, the second binding portion is claimed by a function (i.e., binding to CD3 on the surface of a T cell), rather than a specific structure, which is not fully supported in the specification to include all anti-CD3 binding structures. Claims 2-13, 15, and 17 are also rejected since they depend on claim 1, but do not remedy this deficiency. Therefore, claims 1-13, 15, and 17 as presently claimed are rejected because the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims nor does it provide sufficient description to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed had possession of the claimed invention.
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 1-8, 10-13 and 15 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20 and 22-38 of co-pending Application No. 18/038159; herein referred to as the “reference application.” Although the claims at issue are not identical, they are not patentably distinct from each other because the bispecific antibody binding to CD3 and GPC3 of claim 27 of the reference application anticipates the bispecific antibody binding to CD3 and GPC3 of the instant application. Specifically, the bispecific antibodies of the reference and instant application comprise CD3 antigen binding domains which comprise the same six nondegenerate CDRs and also specifically bind GPC3 and furthermore, the claims of both applications recite compositions and kits thereof.
The co-pending claims of the reference application recite: A bispecific antibody or antigen-binding fragment thereof comprising:
(a) first antigen binding portion, comprising a first LC and HC, wherein the first LC is a kappa LC and the first antigen binding domain binds to a first antigen; and
(b) second antigen-binding portion comprising a second LC and HC, wherein the second LC is a lambda LC and comprises a second binding domain that binds to a second antigen;
wherein the first antigen is not BCMA and the second antigen is CD3; and
wherein the second LC comprises LCDRs1-3 of SEQ ID NOs: 7, 8, 21 and HCDRs1-3 of SEQ ID NOs: 26, 27, 28; and
wherein the first antigen-binding portion does not comprise (i) a specific set of sequences; or (ii) a specific set of sequences (i.e., SEQ ID NOs: 7, 8, 21, 26, 27, and 28 are 100% query match to SEQ ID NOs: 115, 116, 128, 134, 135, and 136 of the instant application, see OA.APPENDIX) (i.e., claim 20). The bispecific antibody or antigen-binding fragment thereof according to claim 20, wherein a second light chain variable region of the second antigen-binding portion has a Gln40Glu mutation (VaCD3: Gln40Glu) relative to the sequence set forth in SEQ ID NO: 18; and a second heavy chain variable region of the second antigen-binding portion has a Gln39Lys mutation (VHCD3: Gln39Lys) relative to the sequence set forth in SEQ ID NO: 50 (i.e., claim 22). The bispecific antibody or antigen-binding fragment thereof according to claim 20, wherein the second light chain of the second antigen-binding portion is the amino acid sequence of SEQ ID NO: 58; and the second heavy chain of the second antigen- binding portion is the amino acid sequence of SEQ ID NO: 60; or the second light chain of the second antigen-binding portion is the amino acid sequence of SEQ ID NO: 66; and the second heavy chain of the second antigen-binding portion is the amino acid sequence of SEQ ID NO: 68 (i.e., SEQ ID NOs: 66 and 68 of the reference application are 100% query match to SEQ ID NOs: 166 and 168 of the instant application, see OA.APPENDIX) (i.e., claim 24). The bispecific antibody or antigen-binding fragment thereof according to claim 20, wherein the first antigen is a tumor antigen (i.e., claim 25). The bispecific antibody or antigen-binding fragment thereof according to claim 25, the tumor antigen is selected from: CD 19, CD20, CD22, CD30, CD38, CD72, CD180, CD171(L1CAM), CD123, CD133, CD138, CD37, CD70, CD79a, CD79b, CD56, CD74, CD166, CD71, CLL-1/CLECK12A, ROR1, GPC3, mesothelin, CD33/IL3Ra, c- Met, PSCA, PSMA, glycolipid F77, EGFRvIII, GD-2, MY-ESO-1, Her2, Her3, MUC1, MUC17, Claudin18 or MAGEA3 (i.e., claim 26). The bispecific antibody or antigen-binding fragment thereof according to claim 26, the tumor associated antigen is selected from CD20 and GPC3 (i.e., claim 27). he bispecific antibody or antigen-binding fragment thereof according to claim 20, wherein the Fc portion of the first antigen-binding portion and/or the second antigen-binding portion of the bispecific antibody adopts a knob-into-hole structure; and/or the first antigen-binding portion and/or the second antigen-binding portion of the bispecific antibody further has a Ser228Pro mutation, Leu235Glu mutation and/or Pro329Ala mutation, wherein the numbering is according to the EU numbering system (i.e., claim 28). A nucleic acid encoding the bispecific antibody or antigen-binding portion thereof according to claim 20 (i.e., claim 29). The nucleic acid according to claim 29, wherein the nucleic acid encoding the second light chain of the second antigen-binding portion is the nucleotide sequence of SEQ ID NO: 59, and the nucleic acid encoding the second heavy chain of the second antigen- binding portion is the nucleotide sequence of SEQ ID NO: 61; or the nucleic acid encoding the second light chain of the second antigen-binding portion is the nucleotide sequence of SEQ ID NO: 67, and the nucleic acid encoding the second heavy chain of the second antigen-binding portion is the nucleotide sequence of SEQ ID NO: 69 (i.e., SEQ ID NOs: 67 and 69 are 100% query match to SEQ ID NOs: 167 and 169 of the instant application) (i.e., claim 30). A vector comprising the nucleic acid according to claim 29 (i.e., claim 31). A cell comprising the nucleic acid according to claim 29 or a vector comprising the nucleic acid (i.e., claim 32). A composition comprising the bispecific antibody or antigen-binding portion thereof according to claim 20, a nucleic acid encoding the bispecific antibody or antigen- binding portion thereof, a vector comprising the nucleic acid and/or a cell comprising the nucleic acid or the vector (i.e., claim 33). A kit comprising the bispecific antibody or antigen-binding portion thereof according to claim 20, or a nucleic acid encoding the bispecific antibody or antigen-binding p[or]tion thereof, or a vector comprising the nucleic acid, or a cell comprising the nucleic acid or the vector, or a compos[i]tion comprising the bispecific antibody or antigen-binding portion thereof, or antibody-drug conjugate comprising the bispecific antibody or antigen-binding portion thereof covalently attached to a therapeutic moiety (i.e., claim 35).
In this instance, because claim 27 of the reference application is silent on the specific CDRs of the first antigen binding domain of GPC3, the specification was consulted to determine the scope of the generic GPC3 antigen binding portion. Per the specification of the reference application, the GPC3 antigen binding domain comprises the HC of SEQ ID NO: 90 and the LC of SEQ ID NO: 88 (i.e., SEQ ID NO: 90 comprises the HCDRs1-3 of SEQ ID NOs: 11, 106, and 13 of the instant application and SEQ ID NO: 88 comprises the LCDRs1-3 of SEQ ID NOs: 60, 17, and 61 and both are 100% query match to the HC/LC of SEQ ID NOs: 164 and 162, of the instant application, see OA.APPENDIX). Therefore the GPC3 binding domain of claim 27 of the reference application encompasses the claimed GPC3 binding domain of the instantly claimed invention.
In this instance, because the CD3 x GPC3 bispecific antibody comprise the same twelve nondegenerate CDRs there is no clear difference in the scope between the products of the instant and reference applications. In response, it is suggested that applicant either file a terminal disclaimer or amend the claims such that a clear and unmistakable line of separation exists between the products claimed in the instant application and those of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. HOPKINS whose telephone number is (703)756-4666. The examiner can normally be reached Mon-Thurs 6:00 AM to 4:00 PM EST.
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/SAMANTHA LAKE HOPKINS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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