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 .
Applicant’s election of the invention of Group I, and of the species of nucleic acids
(i) which encode the VH CDR amino acid sequences of SEQ ID NOs: 44,45 and 84, and which encode the VL CDR amino acid sequences of SEQ ID NOs: 54-56;
(ii) which encode the VH of SEQ ID NO: 78 and the VL of SEQ ID NO: 61;
(iii) the primary signaling domain derived from CD3 zeta comprising amino acid SEQ ID NOs: 9 or 10;
(iv) the costimulatory signaling domain signaling domain comprising a functional signaling domain derived from 4-1BB comprising amino acid SEQ ID NO: 7, all without traverse, as
set forth with the remarks filed 4-23-26 are acknowledged.
Applicant’s further election of the sub-species of nucleic acid comprised within the genus of nucleic acids which encode the VH CDR amino acid sequence of SEQ ID NO: 84 which encodes the VH CDR3 of SEQ ID NO: 76 set forth with the remarks filed 6-16-26 is further acknowledged.
Claims 1, 2, 4-13, 36-43, 45, 48, 50-52, and 61 are pending and under examination as they read on of the species of nucleic acids
(i) which encode the VH CDR amino acid sequences of SEQ ID NOs: 44,45 and 84, and which encode the VL CDR amino acid sequences of SEQ ID NOs: 54-56;
(ii) which encode the VH of SEQ ID NO: 78 and the VL of SEQ ID NO: 61;
(iii) the primary signaling domain derived from CD3 zeta comprising amino acid SEQ ID NOs: 9 or 10;
(iv) the costimulatory signaling domain signaling domain comprising a functional signaling domain derived from 4-1BB comprising amino acid SEQ ID NO: 7,
and further as claims 2 and 45 encompass an isolated CAR / an isolated anti-BCMA binding domain that comprises the VH CDR amino acid sequences of SEQ ID NOs: 44,45 and 84, and the VL CDR amino acid sequences of SEQ ID NOs: 54-56.
Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located in Tables 3 and 4. SEQ ID NOs: 84 and 85 as set forth in these table do not match SEQ ID NOs: 84 and 85 as set forth in the sequence listing filed 3-16-23. For example, in the sequence listing SEQ ID NO: 84 is “REWVPWGESWLFDY” while in Table 3 SEQ ID NO: 84 is as follows:
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Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
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 4-13 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. Claims 4-13 recite that the nucleic acid of claim 1 comprises certain VH CDR3 sequences either explicitly (as in claim 4) or implicitly (as in the 100% identical variants of claims 5-13) that are not present in base claim. For example, base claim 1 comprises the VH CDR3 sequence of SEQ ID NO: 84, “REWVPWGESWLFDY,” as compared to dependent claim 4 which recites the VH CDR3 of SEQ ID NO: 76, “REWWGESWLFDY,” or as compared to the SEQ ID NOs: 78, 80 and 82 polypeptides of claims 5, 9, 10 and 12 which also comprise the VH CDR3 of SEQ ID NO: 76 (REWWGESWLFDY), or as compared to the SEQ ID NOs: 79, 81 and 83 polynucleotides of claims 6, 11 and 13 which encode the VH CDR3 of SEQ ID NO: 76 (REWWGESWLFDY). Thus, dependent claims 4-13 fail 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 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, 2, 4-13, 36-43, 45, 48, 50-52 and 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12383601, cited herewith. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claim anticipates the instant claims.
In particular, certain reference claims encodes the polypeptides of SEQ ID NOs: 214 and 218 / are drawn to the polypeptides of SEQ ID NOs: 214 and 218 which encompass in their breadth a CAR comprising a BCMA binding domain comprising CDRs / comprising VH and VL variable domains that read on the instant claims.
For example, reference SEQ ID NO: 214 comprises the CDRs of instant SEQ ID NOs: 44,45,76 and 54,55,56:
MALPVTALLLPLALLLHAARPEVQLLESGGGLVQPGGSLRLSCAASGFTFSSYAMSWVRQAPGKGLEWVSAISGSGGSTYYADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARREWWGESWLFDYWGQGTLVTVSSGGGGSGGGGSGGGGSGGGGSDIQMTQSPSSLSASVGDRVTITCRASQSISSYLNWYQQKPGKAPKLLIYAASSLQSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQSYSTPLTFGQGTKVEIKTTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACDIYIWAPLAGTCGVLLLSLVITLYCKRGRKKLLYIFKQPFMRPVQTTQEEDGCSCRFPEEEEGGCELRVKFSRSADAPAYQQGQNQLYNELNLGRREEYDVLDKRRGRDPEMGGKPRRKNPQEGLYNELQKDKMAEAYSEIGMKGERRRGKGHDGLYQGLSTATKDTYDALHMQALPPRGSGATNFSLLKQAGDVEENPGPMALPVTALLLPLALLLHAARPEIVMTQSPATLSLSPGERATLSCRASQDISKYLNWYQQKPGQAPRLLIYHTSRLHSGIPARFSGSGSGTDYTLTISSLQPEDFAVYFCQQGNTLPYTFGQGTKLEIKGGGGSGGGGSGGGGSQVQLQESGPGLVKPSETLSLTCTVSGVSLPDYGVSWIRQPPGKGLEWIGVIWGSETTYYQSSLKSRVTISKDNSKNQVSLKLSSVTAADTAVYYCAKHYYYGGSYAMDYWGQGTLVTVSSTTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACDIYIWAPLAGTCGVLLLSLVITLYCKRGRKKLLYIFKQPFMRPVQTTQEEDGCSCRFPEEEEGGCELRVKFSRSADAPAYQQGQNQLYNELNLGRREEYDVLDKRRGRDPEMGGKPRRKNPQEGLYNELQKDKMAEAYSEIGMKGERRRGKGHDGLYQGLSTATKDTYDALHMQALPPR
Moreover, reference SEQ ID NO: 218 comprises the CDRs of instant SEQ ID NOs: 44,45,46 and 54,55,56:
MALPVTALLLPLALLLHAARPEVQLLESGGGLVQPGGSLRLSCAASGFTFSSYAMSWVRQAPGKGLEWVSAISGSGGSTYYADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARREWVPYDVSWYFDYWGQGTLVTVSSGGGGSGGGGSGGGGSGGGGSDIQMTQSPSSLSASVGDRVTITCRASQSISSYLNWYQQKPGKAPKLLIYAASSLQSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQSYSTPLTFGQGTKVEIKTTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACDIYIWAPLAGTCGVLLLSLVITLYCKRGRKKLLYIFKQPFMRPVQTTQEEDGCSCRFPEEEEGGCELRVKFSRSADAPAYQQGQNQLYNELNLGRREEYDVLDKRRGRDPEMGGKPRRKNPQEGLYNELQKDKMAEAYSEIGMKGERRRGKGHDGLYQGLSTATKDTYDALHMQALPPRGSGATNFSLLKQAGDVEENPGPMALPVTALLLPLALLLHAARPEIVMTQSPATLSLSPGERATLSCRASQDISKYLNWYQQKPGQAPRLLIYHTSRLHSGIPARFSGSGSGTDYTLTISSLQPEDFAVYFCQQGNTLPYTFGQGTKLEIKGGGGSGGGGSGGGGSQVQLQESGPGLVKPSETLSLTCTVSGVSLPDYGVSWIRQPPGKGLEWIGVIWGSETTYYQSSLKSRVTISKDNSKNQVSLKLSSVTAADTAVYYCAKHYYYGGSYAMDYWGQGTLVTVSSTTTPAPRPPTPAPTIASQPLSLRPEACRPAAGGAVHTRGLDFACDIYIWAPLAGTCGVLLLSLVITLYCKRGRKKLLYIFKQPFMRPVQTTQEEDGCSCRFPEEEEGGCELRVKFSRSADAPAYQQGQNQLYNELNLGRREEYDVLDKRRGRDPEMGGKPRRKNPQEGLYNELQKDKMAEAYSEIGMKGERRRGKGHDGLYQGLSTATKDTYDALHMQALPPR
Furthermore, reference claims 9-12, 19 and 20 are dependent on reference claim 7 and further recite the following elements:
9. A vector comprising the nucleic acid molecule claim 7.
10. An isolated cell or a population of cells comprising the nucleic acid molecule of claim 7.
11. A method of making a cell comprising transducing a cell with the vector of claim 9.
12. A method of making an RNA-engineered cell comprising introducing an in vitro transcribed RNA or synthetic RNA into a cell, wherein the RNA comprises the nucleic acid molecule of claim 7.
19. The vector of claim 9, wherein the vector is chosen from a DNA vector, a RNA vector, a plasmid, a lentivirus vector, an adenoviral vector, or a retrovirus vector.
20. The isolated nucleic acid molecule of claim 7, wherein the encoded polypeptide comprising the first CAR and the second CAR comprises the amino acid sequence of SEQ ID NO: 214, 216, 218, 220, 222, or an amino acid having at least 95%, 96%, 97%, 98%, or 99% identity thereto.
Likewise, reference claims 1-6 and 13-18 are drawn to various cells comprising nucleic acids encoding a CAR comprising a BCMA binding domain comprising CDRs / comprising VH and VL variable domains that read on the instant claims.
Additionally, reference claim 8 is drawn to “[a]n isolated polypeptide, wherein the polypeptide comprises: (a) a first CAR comprising a first antigen-binding domain which binds to BCMA (a BCMA CAR) and a first transmembrane domain; a first intracellular signaling domain comprising a co-stimulatory signaling domain and a first primary signaling domain; and (b) a second CAR comprising a second antigen-binding domain which binds to CD19 (a CD19 CAR) and a second transmembrane domain; a second intracellular signaling domain comprising a second co-stimulatory signaling domain; and a second primary signaling domain; and wherein the first CAR and the second CAR each comprise an HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, and LCDR3 as recited in one of SEQ ID NO: 214, 216, 218, 220, or 222,” which anticipates instant claims 2 and 45.
Thus, the reference claims anticipate the instant claims.
Claims 1, 2, 4-13, 36-41, 43, 50 and 61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 34 of U.S. Patent No. 12630604, cited herewith. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
Reference claim 34 is drawn to, “[a] method of making a population of cells that express a chimeric antigen receptor (CAR), the method comprising: (i) contacting a population of cells with an agent that stimulates a CD3/TCR complex and/or an agent that stimulates a costimulatory molecule on the surface of the cells; (ii) contacting the population of cells with a nucleic acid molecule encoding the CAR, thereby providing a population of cells comprising the nucleic acid molecule; and (iii) harvesting the population of cells for storage or administration; wherein step (ii) is performed together with step (i) or less than 18 hours after the beginning of step (i), and step (iii) is performed no later than 48 hours after the beginning of step (i), wherein
the CAR comprises an antigen binding domain that binds to BCMA, and wherein: (a) the CAR comprises a heavy chain variable region (VH) comprising the amino acid sequence of SEQ ID NO: 93, or an amino acid sequence having at least 90% sequence identity thereto; and a light chain variable region (VL) comprising the amino acid sequence of SEQ ID NO: 102, or amino acid sequence having at least 90% sequence identity thereto; (b) the CAR comprises a VH comprising the amino acid sequence of SEQ ID NO: 52, or an amino acid sequence having at least 90% sequence identity thereto; and a VL comprising the amino acid sequence of SEQ ID NO: 61, or amino acid sequence having at least 90% sequence identity thereto; (c) the CAR comprises a VH comprising the amino acid sequence of SEQ ID NO: 70, or an amino acid sequence having at least 90% sequence identity thereto; and a VL comprising the amino acid sequence of SEQ ID NO: 61, or amino acid sequence having at least 90% sequence identity thereto; (d) the CAR comprises a VH comprising the amino acid sequence of SEQ ID NO: 78, or an amino acid sequence having at least 90% sequence identity thereto; and a VL comprising the amino acid sequence of SEQ ID NO: 61, or amino acid sequence having at least 90% sequence identity thereto; (e) the CAR comprises a VH comprising the amino acid sequence of SEQ ID NO: 112, or an amino acid sequence having at least 90% sequence identity thereto; and a VL comprising the amino acid sequence of SEQ ID NO: 118, or amino acid sequence having at least 90% sequence identity thereto; (f) the CAR comprises a VH comprising the amino acid sequence of SEQ ID NO: 112, or an amino acid sequence having at least 90% sequence identity thereto; and a VL comprising the amino acid sequence of SEQ ID NO: 124, or amino acid sequence having at least 90% sequence identity thereto; (g) the CAR comprises a VH comprising the amino acid sequence of SEQ ID NO: 145, or an amino acid sequence having at least 90% sequence identity thereto; and a VL comprising the amino acid sequence of SEQ ID NO: 154, or amino acid sequence having at least 90% sequence identity thereto; (h) the CAR comprises a VH comprising the amino acid sequence of SEQ ID NO: 168, or an amino acid sequence having at least 90% sequence identity thereto; and a VL comprising the amino acid sequence of SEQ ID NO: 173, or amino acid sequence having at least 90% sequence identity thereto; (i) the CAR comprises an scFv comprising the amino acid sequence of any one of SEQ ID NOs: 64, 72, 80, 105, 120, 126, 156, or 175, or an amino acid sequence having at least 90% identity thereto; (j) the CAR comprises the amino acid sequence of any one of SEQ ID NOs: 66, 74, 82, 107, 122, 128, 158, 177, or 257, or an amino acid sequence having at least 90% identity thereto; and/or (k) the nucleotide sequence encoding the CAR comprises the nucleotide sequence of any one of SEQ ID NOs: 67, 75, 83, 106, 108, 123, 129, 159, 178, or 258, or a nucleotide sequence having at least 90% identity thereto.”
The reference polypeptide sequences of SEQ ID NOs: 52, 61, 64, 66, 70, 72, 74, 78, 80, 82, and the reference polynucleotide sequences of SEQ ID NOs: 67, 75 and 83 are identical to polypeptide and polynucleotide sequences having the SEQ ID NOs: of the instant claims. Moreover, the reference polynucleotide sequences of SEQ ID NOs: 67, 75 and 83 encompass in their breadth the polynucleotide sequences of SEQ ID NOs: 53, 62, 65, 67, 71, 73, 75, 79, 81 and 83 of the instant claims. Note further that reference SEQ ID NOs: 66, 74 and 82 are full length CAR polypeptide sequences comprising an anti-BCMA scFv, joined to a hinge domain, such as the CD8a hinge of instant SEQ ID NO: 2, which is in turn joined to a transmembrane domain, such as the CD8 Transmembrane domain of instant SEQ ID NO: 6, which is joined to a costimulatory signaling domain, such as the 4-1BB costimulatory signaling domain of instant SEQ ID NO: 7, which is in turn joined to a primary signaling domain, such as the CD3 zeta domain of instant SEQ ID NO: 9.
According to the reference specification at col. 29, 2nd paragraph (emphasis added), “The term ‘Chimeric Antigen Receptor’ or alternatively a ‘CAR’ refers to a recombinant polypeptide construct comprising at least an extracellular antigen binding domain, a transmembrane domain and a cytoplasmic signaling domain (also referred to herein as ‘an intracellular signaling domain’) comprising a functional signaling domain derived from a stimulatory molecule as defined below. In some embodiments, the domains in the CAR polypeptide construct are in the same polypeptide chain, for example, comprise a chimeric fusion protein. In some embodiments, the domains in the CAR polypeptide construct are not contiguous with each other, for example, are in different polypeptide chains, for example, as provided in an RCAR as described herein.”
Thus, to practice reference claim 34 the ordinarily skilled artisan must necessarily have in their possession nucleic acids and polypeptides comprising the nucleic acids and polypeptides of the instant claims, i.e., the polynucleotide sequences of SEQ ID NOs: 53, 62, 65, 67, 71, 73, 75, 79, 81 and 83 and nucleic acids encoding the polypeptide sequences of SEQ ID NOs: 52, 61, 64, 66, 70, 72, 74, 78, 80, 82, and in all instances said polypeptides or said polynucleotides must be joined to a transmembrane domain and a cytoplasmic signaling domain (also referred to herein as ‘an intracellular signaling domain’). Indeed, as described above, reference SEQ ID NOs: 66, 74 and 82 are full length CAR polypeptide sequences comprising a hinge domain, such as the CD8a hinge of instant SEQ ID NO: 2, that joins the anti-BCMA scFv to a transmembrane domain, such as the CD8 Transmembrane domain of instant SEQ ID NO: 6, which is joined to a costimulatory signaling domain, such as the 4-1BB costimulatory signaling domain of instant SEQ ID NO: 7, and a primary signaling domain, such as the CD3 zeta domain of instant SEQ ID NO: 9.
Moreover, in practicing the method of reference claim 34 the ordinarily skilled artisan will necessarily be producing the cell of claim 50.
Therefore, reference claim 34 anticipates instant claims 1, 2, 4-13, 36-41, 43, 50 and 61.
Claims 1, 2, 4-13, 36-43, 45, 48, 50-52, and 61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-84 of copending Application No. 19/262,665 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are drawn to nucleic acids encoding CARs comprising amino acid sequences comprising the particular SEQ ID NOs: recited in the instant claims, as well as CARs per se comprising amino acid sequences comprising the particular SEQ ID NOs: recited in the instant claims.
For example, reference claim 29 is drawn to the following isolated cell comprising a CAR “…wherein: (i) the first antigen-binding domain comprises a HC CDR1, HC CDR2, HC CDR3, LC CDR1, LC CDR2, and LC CDR comprising the amino acid sequences of: (a) SEQ ID NOs: 86, 87, 88, 95, 96, and 97, respectively; (b) SEQ ID NOs: 44, 45, 76, 54, 55, and 56, respectively; or (c) SEQ ID NOs: 44, 45, 46, 54, 55, and 56, respectively, and the second antigen-binding domain comprises a HC CDR1, HC CDR2, HC CDR3, LC CDR1, LC CDR2, and LC CDR3 comprising the amino acid sequences of SEQ ID NOs: 295 and 245-249, respectively; (ii) the first antigen-binding domain comprises a VH and VL comprising the amino acid sequences of: (a) SEQ ID NOs: 93 and 102, respectively; (b) SEQ ID NOs: 78 and 61, respectively; or (c) SEQ ID NOs: 52 and 61, respectively, and the second antigen-binding domain comprises a VH and VL comprising the amino acid sequences of SEQ ID NOs: 250 and 251, respectively; (iii) the first antigen-binding domain comprises a scFv comprising the amino acid sequence of SEQ ID NO: 105, 80, or 64, and the second antigen-binding domain comprises a scFv comprising the amino acid sequence of SEQ ID NO: 211; or (iv) the first antigen-binding domain is encoded by the nucleic acid sequence of SEQ ID NO: 253, 106, 81, or 65, and the second antigen-binding domain is encoded by the nucleic acid sequence of SEQ ID NO: 212,”wherein at least reference SEQ ID NOs: 44, 45, 76, 54, 55, and 56; reference SEQ ID NOs: 44, 45, 46, 54, 55, and 56; VH and VL comprising the amino acid sequences of SEQ ID NOs: 78 and 61 or SEQ ID NOs: 52 and 61; and the first antigen-binding domain comprises a scFv comprising the amino acid sequence of SEQ ID NO: 80 or 64, are identical to various SEQ ID NOs: of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 45 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Abujoub et al. (20260035473, cited herewith).
The applied reference has some common inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The VL and VH CDRs of the R1F2 clone of Tables 1C-1 and 1C-2 of Abujoub are encompassed by SEQ ID NOs: (44,45,84) and (54,55 and 56) as set forth in the final row of Table 3 of the instant specification.
Thus, the “…BCMA binding molecule that specifically binds to human BCMA and comprises CDR-L1, CDR-L2 and CDRL3 sequences set forth in Table…1C-1…and the corresponding CDR-Hl, CDR-H2 and CDR-H3 sequence set forth in Table 1C-2….” of claim 1 of Abujoub anticipates claim 45.
Claim 45 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of copending Application No. 19/081446 (reference application).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY S SKELDING whose telephone number is (571)272-9033. The examiner can normally be reached M-F 9-5 EST.
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/ZACHARY S SKELDING/Primary Examiner, Art Unit 1644
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