DETAILED ACTION
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 without traverse of group I, claims 1-61, in the reply filed on 3/20/26, is acknowledged. Applicant has further elected alpha beta TCR as the species of TCR, and a species wherein the first antigen binding region binds to the first and antigen and the second antibody binding region binds to the second antigen. Applicant has further elected a first antigen binding region that binds CD19, having VH and VL of SEQ ID NO: 44 and 45, and a second antibody binding region that binds to CD20 having a VH and VL of SEQ ID NO: 54 and 55. Applicant further elects a species of TCR wherein only the alpha chain endodomain is deleted and is connected to a functional domain, wherein the function domain is OX40. Applicant has further elected a mutated TCR alpha chain having SEQ ID NO: 26 and a mutated TCR beta chain having SEQ ID NO: 6. Claims 62 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claims 11-31, 35, 37-39, 41, 43, 46-47, 52, 55-56, 58 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to non-elected species.
Claims 1-10, 32-34, 36, 40, 42, 44-45, 48-51, 53-54, 57, and 59-61 are being acted upon.
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 1-10, 32-34, 36, 40, 42, 44-45, 48-51, 53-54, 57, and 59-61 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.
The scope of the claimed modified TCR in claim 1 is unclear and indefinite. The claim recites that the TCR comprises a TCR alpha chain and a TCR beta chain, wherein at least one functional domain is connected to the C-terminal of the TCR alpha chain and/or beta chain, and wherein the TCR alpha chain comprises a first constant region and a first antigen binding region and the TCR beta chain comprise a second constant region and a second antigen binding region. A TCR is a heterodimer between a TCR alpha chain and a TCR beta chain, wherein the TCR alpha and TCR beta chain are comprised of a variable region which mediates antigen binding, and a constant region. Thus, the claim appears to be directed to a TCR comprising a TCR alpha chain and TCR beta chain (each with a variable-antigen binding region and a constant region). However, dependent claims, such as claim 2 or 49-50, specify that the antigen binding region is from an antibody, or is an scFv. It is unclear whether the claims intend to encompass a chimeric construct in which the variable region of the TCR alpha chain and beta chain is replaced with the antigen binding region of an antibody (see the structure depicted in Fig. 5a of Simon, 2025). Or do the claims require a TCR alpha chain and beta chain, including the TCR variable region, with an additional antibody antigen binding domain (see the structure in Fig. 1a of Baeuerle, 2019)? In other words, it is unclear whether the recitation that the alpha beta TCR comprises a “TCR alpha chain” would encompass only a portion thereof, such as the constant region, or whether an entire TCR-alpha chain is required, i.e. variable region and constant region. The specification on page 1 and 20 discloses that the variable region sequence of the TCR can be replaced by a variable region sequence of an antibody (see also the drawings). Therefore, for the purposes of examination, the claims are being interpreted as encompassing a TCR alpha chain in which the TCR variable region has been replaced with an antigen binding region of an antibody, for example.
Claim 1 is further indefinite in that the claim lacks antecedent basis for “the first antigen” and “the second antigen”. The claim does recite a “first antigen binding region”. However, the specification discloses on pages 13-14 that an “antigen binding region” refers to a domain that alone, or in combination with another antigen binding region, can specifically bind to a target antigen, and a heavy chain of an antibody as a type of antigen binding region. Thus, according to the specification, the first antigen binding region could be only a heavy chain domain, which would only function to bind to an antigen in combination with a light chain domain, i.e. another antigen binding region Therefore, the present claims would appear to encompass a VH as the first antigen binding domain and a VL as the he second antigen binding region, wherein said VH and VL in combination would bind to a target antigen. However, the fact that the claim also recites binding to the first and second antigen implies that each antigen binding domain must bind to a target. It is therefore not clear if the claim would encompass a VH as the first antigen binding region and a VL as the second antigen binding region, wherein the first (VH) and second (VL) antigen binding regions are combined to bind to a target antigen. Would this be within the scope of binding to the “first” and “second” antigen? Or do the claims actually require two complete antigen binding regions, i.e. two VHs and two VLs that combine to form two distinct antigen binding regions. The scope of the claims is unclear and indefinite. For the purpose of examination, the claims are being interested as excluding having only a single VH as the first antigen binding region and a single VL as the second antigen binding region (i.e. a Split ChTCR as depicted in Fig. 1A of Simon). That would binding a fist antigen only, while the claims require binding the first and second antigen. See, in contrast, Fig. 5a of Simon, wherein constructs with two VHs and two VLs are depicted, which would bind to a first and second antigen (which would be within the scope of the claim).
Claims 2 and 49-50 are indefinite in the recitation that “the antigen binding region” is derived from an antibody. The claims depend from claim 1, which recite a first antigen binding region and a second antigen binding region, and it is unclear if “the antigen binding region” in claims 2 and 49-51 refers to the first antigen binding region, the second antigen binding region, both or either.
Claim 3 recites the limitation "the natural endodomain" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the endodomain of a co-stimulatory molecule" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the natural endodomain" in line 1 . There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites the limitation "the endodomain of a costimulatory molecule" in line 2, “the endodomain of a co-inhibitor molecule” in line 4, “the endodomain of a cytokine receptor” in line 5, and “the domain” of an intracellular protein in the last line . There is insufficient antecedent basis for these limitations in the claim.
Claim 34 recites the limitation "the endodomain of a co-stimulatory molecule" in lines 2. There is insufficient antecedent basis for this limitation in the claim. Claim 34 is also unclear since it says that the endodomain of the co-stimulatory molecule is OX40 or ICOS, “optionally OX40”. The claim requires choosing either OX40 or ICOS, so further requiring “optionally OX40” is unclear and indefinite.
Claims 40 and 45 are indefinite in the recitation of particular amino acid positions of a mouse TCR alpha or beta chain. Different constant regions have different amino acid numberings and reference to a particular position, such a position 48, in the absence of a SEQ ID NO: renders the claims indefinite since position 48 would not be the same in all mouse constant regions. Furthermore, the use of “optionally” threonine is also indefinite, since it indicates that position 48 could be a different amino acid, i.e. it is unclear which TCR sequences and numberings are encompassed in the claims. For example, WO2018102795 discloses a wild-type murine TCR-alpha chain of 136 amino acids in length (see SEQ ID NO: 3022). The instant specification discloses SEQ ID NO: 3 as mouse wild type TCR-alpha which has 137 amino acids. Position 48, threonine, in SEQ ID NO: 3, corresponds to position 47 in the wild type murine TCR alpha chain of WO208102795 (see SEQ ID NO: 3022). Would the present claims encompass mutation of said threonine to cysteine at position 47, which corresponds to position 48 in SEQ ID NO: 3 or not? The scope of the claims is unclear and indefinite. Claims 40 and 45 also lacks antecedent basis for “the wild-type mouse TCR” in the second to last and last line. Amendment to recite the particular positions without the optional language and to recite that the amino acid positions are numbered according to a wild type TCR alpha constant region as shown in SEQ ID NO: 3, for example, would be remedial.
Claims 42 and 48 are indefinite in the recitation of “the nucleotide sequences” shown in for example SEQ ID NO: 6 and 26. Said sequences are not nucleotide sequences, but rather are amino acid sequences.
Claim 51, 53-54 lack antecedent basis for the limitation of “the antigen binding region specifically binding to CD19” or “the antigen binding region specifically binding to CD20”. Furthermore, in claim 1 from which the claims depend, there is an optional limitation wherein the first antigen is CD19 and the second antigen is CD20, or the first antigen is CD20 and the second antigen is CD19. It is unclear if the claims are limited to the VH/VL sequences recited in claims 51 and 53-54, or whether these limitations are still optional. For the purposes of examination, the limitations are being interpreted as referring to the first antigen binding region or the second antigen binding region, i.e. in claim 51 either the first or second antigen binding region in claim 1 comprises SEQ ID NO: 44 and 45.
Claim 57 recites that the TCR alpha chain comprises the amino acid sequence shown SEQ ID NO: 59, the TCR beta chain comprises the amino acid sequence shown SEQ ID NO: 60. The claim is unclear, since the claim recites two limitations, but does not specific “and” or “or” between the limitations. Amendment to recite “and” or “or” after SEQ ID NO: 59 would be remedial. For the purposes of examination, the claim is being interpreted as requiring both limitations. The claim is also unclear in a sequence “shown SEQ ID NO: 59”, for example. It is suggested to amend the claim to recite that the sequence is shown in SEQ ID NO: 59 and shown in SEQ ID NO: 60.
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.
Claim 10 is 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 10 recites that the linker is “optionally” (G4S)n. The claims depend from claims 9, which recite that the functional domain is connected directly or via a linker. Claim 10 is therefore directed to connection of a functional domain directly or via a linker, wherein the linker is optionally a (G4S)n. In other words, the linker is still an alternative embodiment in claim 10, and the optional limitation means that the linker could be also be generic. Therefore, claim 10 fails to further limit claim 9. Amendment to remove the first “optionally” from the claim would be remedial. Alternatively, amendment to recite wherein the functional domain is connected via a linker, optionally (G4S)n, would also be remedial. Applicant may also 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 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.
Claim(s) 1-2, 32-34, 36, 44, 49-51, 53-54, and 59-61 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2018/102795.
WO2018/102795 teaches a synthetic immune receptor polypeptide (SIR) that comprises a first antigen binding domain of an antibody, such as a scFv, and a TCR constant alpha domain, and a second antigen binding domain of an antibody, such as an scFV, and a TCR constant beta chain, wherein the scFV are specific for one or more target antigens (i.e. a first and second antigen), see page 3-6, 47 and Fig. 7, in particular. WO2018/102795 teaches that the target antigens include CD19 and CD20 (See pages 6-7 and paragraph 211, in particular). WO2018/102795 teaches immune effector T cells expressing the SIR and pharmaceutical compositions thereof (see paragraph 27 and page 31, in particular). WO2018/102795 teaches that the TCR constant regions can be murine and can contain mutants that facilitate optimal expression and pairing (see page 48, 86-87, and 171, in particular). WO2018/102795 teaches that the TCR-alpha constant region can be fused at its C-terminus to signaling chains, including costimulatory domains, i.e. “functional” domains, see page 78, in particular). WO2018/102795 teaches costimulatory domains of OX40 (see page 65, in particular). WO2018/102795 teaches using a CD19 antigen binding domain of antibody FMC63, which comprises the VH/VL and scFV sequence of SEQ ID NO: 3855, which are identical to SEQ ID NO: 44-45 and 39 of the instant claims (See paragraph 211, in particular). WO2018/102795 teaches using CD20 VH/VL from antibody 2C6 of SEQ ID NO: 18178, which comprises SEQ ID NO: 54 and 55 of the instant application (See page 137, in particular).
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.
Claim 1-10, 32-34, 36, 44, 49-51, 53-54, and 59-61 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2018/102795, in view of US 2018/0085457.
The teachings of WO2018/102795 are described above.
The reference differs from the claimed invention in that it does not explicitly teach deleting the natural endodomain of the TCR alpha chain.
The ‘457 publication teaches chimeric TCR having an antibody binding extracellular domain and an TCR alpha domains, wherein the intracellular domain of the TCR alpha is optionally present or that it can be replaced with a costimulatory intracellular domain such as OX40 (i.e. deleted endodomain, See page 14 Fig. 1A-1B). The ‘457 publication teaches that including the costimulatory domain can result in better performance, and that the co-stimulatory domain can be placed C-terminal to the transmembrane domain of the TCR transmembrane domain (i.e. deleted endodomain, see paragraphs 101 140 148 154).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to construct the synthetic immune receptor polypeptide of WO2018/102795, without the intracellular domain of the TCR alpha chain and wherein the costimulatory OX40 domain replaces it, i.e. direct connection to the C-terminal of the TCR alpha chain, as taught by the ‘457 publication. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because the ‘457 publication teaches that doing so provides for a functional chimeric TCR wherein with better performance.
Regarding claim 6, although WO2018/102795 does not explicitly teach that only the TCR alpha chain is connected to the costimulatory domain, the reference teaches that each chain has an optional accessory molecule that can optionally comprise a co-stimulatory molecule and that one of skill in the art will recognize that various TCRs can be combined. See also the ‘457 publication which depicts chimeric TCRs in which only one chain is linked to an intracellular functional domain (see Fig. 28, in particular). Thus, it would be obvious to use a costimulatory molecule in only one the chains, such as in the TCR alpha chain.
Regarding claims 5 and 10, it is noted that these depend from claim 4 or 9, respectively, wherein which recited connection directly or via linker. In other words claims 5 and 10, also encompass direct connection, or connection via a linker, wherein the linker is optionally G4S, and therefore, direct connection is also within the scope of claims 5 and 10.
Claim 1-2, 32-34, 36, 40, 42, 44-45, 48-51, 53-54, and 59-61 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2018/102795, in view of US US20190177395.
The teachings of WO2018/102795 are described above.
The reference differs from the claimed invention in that it does not explicitly teach SEQ ID NO: 6 or 26.
US20190177395 teaches modified, mutant murine TCR alpha and beta chain constant domains that increase expression and diminish mispairings (See paragraph 38-41, in particular). The ‘395 publication teaches a modified TCR alpha chain polypeptide of SEQ ID NO: 48, which comprises SEQ ID NO: 26 of the instant application, and modified TCR beta chain polypeptide of SEQ ID NO: 49, which comprises SEQ ID NO: 6 of the instant application. Said SEQ ID NO: 48 and 49 comprise the same mutations recited in instant claim 40 and 45, respectively.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use the modified TCR alpha and beta constant regions of the ‘395 publication, as the mutated murine constant regions in the synthetic immune receptor polypeptide of WO2018/102795. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because the ‘795 publication teaches that they provide for increased expression and diminished mispairing.
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 1-10, 32-34, 36, 40, 42, 44-45, 48-51, 53-54, and 59-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-12, 17-31, 39-40 of copending Application No. 17/790,237, in view of WO2018/102795, US US20190177395 and US 2018/0085457.
The ‘237 application claims a synthetic TCR comprising a TCR alpha chain containing a first antigen binding region and modified mouse constant region, and a TCR beta chain containing a second antigen binding region and a modified murine beta constant region, and wherein the first and second binding region independently bind to different target antigen (i.e. a first and second antigen), wherein the target antigen can be CD19 or CD20, and wherein the first and second antigen binding domains can be scFv. The ‘237 application claims the same VH and VL of the instant claims for CD19 and CD20 binding, or alternatively they would be obvious based on the teachings of WO2018/102795. The ‘237 application claims a T cell and pharmaceutical compositions comprising said synthetic TCR.
The ’237 application does not explicitly not claim linking to a functional domain at the C-terminus of the alpha chain, such as OX40, deletion of the endodomain, or the specific TCR alpha and beta chain constant region sequences of the instant claims. However, these limitations are obvious based on the teachings of WO2018/102795, the ‘395 publication and the ‘457 publication, for the same reasons set forth above.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10, 32-34, 36, 40, 42, 44-45, 48-50, and 59-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 47-64 of copending Application No. 19/133,096, in view of WO2018/102795, US US20190177395 and US 2018/0085457.
The ‘096 application claims a synthetic TCR comprising a TCR alpha chain containing a first antigen binding region and modified mouse constant region, and a TCR beta chain containing a second antigen binding region and a modified murine beta constant region, and wherein the first and second binding region each bind to LILRB4 (i.e. a first and second antigen), wherein the first and second antigen binding domains can be single domain antibodies. The ‘096 application claims that the C-terminus of the alpha chain is linked to a functional domain such as OX40 directly or via a linker, and that the intracellular region of the TCR alpha chain is deleted. The ‘096 application claims the same modified constant regions of the instant claims, or alternatively they would be obvious based on the teachings of WO2018/102795, US US20190177395 and US 2018/0085457. The ‘096 application claims a T cell and pharmaceutical compositions comprising said synthetic TCR.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10, 32-34, 36, 40, 42, 44-45, 48-51, 53-54, and 59-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 66-119 of copending Application No. 18/009,278, in view of WO2018/102795, US US20190177395 and US 2018/0085457.
The ‘278 application claims a modified TCR comprising a TCR alpha chain containing a first antigen binding region and modified mouse constant region, and a TCR beta chain containing a second antigen binding region and a modified murine beta constant region, wherein an OX40 endodomain is connected to the C-terminal of the TCR alpha chain directly or via a linker. The ‘278 application claims that the TCR alpha endodomain is deleted. The ‘278 application claims the same TCR alpha and beta constant regions of SEQ ID NO: 6 and 26 of the instant application. The ‘278 application claims that the first and second binding region independently bind to different target antigen (i.e. a first and second antigen), wherein the target antigen can be CD19 or CD20, and wherein the first and second antigen binding domains can be scFv. The ‘278 application claims the same VH and VL of the instant claims that bind to CD19 and CD20. Although the ‘278 application does not claim said VH/VL as scFV binding domains, it would be obvious to use said VH and VL linked to each chain of the TCR alpha and beta chain as an scFV, based on the teachings of WO2018/102795, US US20190177395 and US 2018/0085457 for the same reasons set forth above. The ‘278 application claims a T cell and pharmaceutical compositions comprising said synthetic TCR.
This is a provisional nonstatutory double patenting rejection.
Claims 1-10, 32-34, 36, 40, 42, 44-45, 48-50, and 59-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 18/278,639, in view of WO2018/102795, US US20190177395 and US 2018/0085457.
The ‘639 application claims a synthetic TCR comprising a TCR alpha chain containing a first antigen binding region against GPC3 and modified mouse constant region, and a TCR beta chain containing a second antigen binding region against GPC3 and a modified murine beta constant region (i.e. a first and second antigen that are the same antigen).. The ‘639 application claims that the C-terminus of the alpha chain is linked to a functional domain such as OX40 directly or via a linker, and that the intracellular region of the TCR alpha chain is deleted. The ‘639 application claims the same modified constant regions of the instant claims, or alternatively they would be obvious based on the teachings of WO2018/102795, US US20190177395 and US 2018/0085457. The ‘639 application claims a T cell and pharmaceutical compositions comprising said synthetic TCR. The ‘639 application does not explicitly claim that said first and second antigen binding region are an scFv, however, this would be obvious based on the teachings of WO2018/102795, US US20190177395 and US 2018/0085457, for the same reasons set forth above.
This is a provisional nonstatutory double patenting rejection.
No claim is allowed. Claim 57 is free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644