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 II and/or species of SEQ ID NO: 1, in the reply filed on 08JUN2026 is acknowledged.
Claims 1-2, 14-15, 18-19, and 70-71 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species.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 08JUN2026.
Claim Status
Claims 2, 14-15, 18-19, 32-36, 53-54, 60, and 70 have been amended.
Claims 3-13, 16-17, 20-26, 31, 37-52, 55-59, and 61-69 have been canceled.
Claims 1-2, 14-15, 18-19, 27-30, 32-36, 53-54, 60, and 70-71 are pending in the instant application (i.e., Claim(s) 1 and 27 is/are independent).
Claims 1-2, 14-15, 18-19, and 70-71 are withdrawn.
Claims 27-30, 32-36, 53-54, and 60 are examined on the merits.
Priority
The present application is a 371 National Stage of PCT International Application No. PCT/US2021/059182, filed 12NOV2021, which claims the benefit of US Provisional Patent Application No. 63/113739, filed 13NOV2020 and US Provisional Patent Application No. 63/229017, filed 03AUG2021. Applicant’s claim for the benefit of prior-filed application is acknowledged.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 19DEC2023 is/are acknowledged and the references cited therein have been considered.
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 35-36 and 60 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.
Claims 35-36 and 60, recite the phrase "optionally," which renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(h)(II).
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.
Written Description
Claims 27-30, 32-36, 53-54, and 60 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Scope of the claimed genus:
Applicant has broadly claimed a method of producing a genetically engineered T cell comprising contacting the nucleic acid encoding a CAR targeting a lineage-specific cell-surface antigen associated with a hyperproliferative disease with a T cell obtained from a first subject and the method further comprising administering the genetically engineered T cell to a second subject in need thereof, and the method further comprising producing a genetically engineered HSC comprising contacting a RNA-guided nuclease and guide RNA or a nucleic acid encoding the same, wherein the guide RNA targets a gene encoding the lineage-specific surface antigen, wherein the genetically engineered HSC is not targeted by the CAR. No claims recite any specific or particular structure of the CAR or the structure of the RNA-guided nuclease and guide RNA that gives rise to the specific lineage-specific cell-surface antigen binding or knockout functions, respectively.
State of the relevant art:
Artisans are well aware that knowledge of a given antigen (for instance a specific epitope of a lineage-specific cell-surface antigen) provides no information concerning the sequence/structure of antibodies or antigen binding moiety of a CAR 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.
It is noted that applicant has not claimed a product, but rather a method of administering a product. However, artisans must reasonably be in possession of a product in order to be in possession of methods of administering said product. As has been discussed above, the broadest claims describe the administered product based upon what it does, such as bind/target a lineage-specific cell-surface antigen. However, as has been made clear by recent court cases as well as USPTO guidance, describing an antibody simply by what it binds is not sufficient to provide adequate written description for the recited genus. Indeed, as taught by Edwards et al., Lescar et al., and Goel et al., the number of potential antibody structures (i.e., sequences) which can bind to the same antigen is literally astronomical. As such describing the administered reagent based upon what it binds, where it binds, or its function fails to necessarily provide a structure that gives rise to the aforementioned properties.
Accordingly, the skilled artisan would be unable to envisage the genetically engineered T cells or genetically engineered HSC that function to bind or target a lineage-specific cell-surface antigen thereof a priori given the current state of the prior art.
Description of representative species in the specification:
MPEP § 2163 states that “a representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species.
To support such broad claims, the specification teaches a single CD33 CAR which was expressed in mobilized T cells or non-mobilized T cells and showed non-distinguishable efficacy in vivo. However, given the immense breadth of the claims and the depth and diversity of the antigen binding domain of the CAR as described above, such a disclosure would not reasonably be considered representative of the genus: a CAR, which is only described by its binding target (i.e., a lineage-specific cell-surface antigen).
Identifying characteristics and structure/function correlation:
In the absence of a representative number of species, the written description requirement for a claimed genus may be satisfied 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 claimed genus.
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 court 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). Recent court cases have emphasized the need for correlation between a well-defined structure and recited functional limitations. For example, the courts 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). In Amgen v. Sanofi, the court 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. As such, knowledge of where an antibody binds provides no information as to what such an antibody necessarily looks like (i.e., its primary amino acid structure).
It should also be noted that the USPTO has released a Memo on the Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials, 02/22/2018. See https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf. This Memo clarifies the applicability of USPTO guidance regarding the written description requirement of 35 U.S.C. § 112(a) concerning the written description requirement for claims drawn to antibodies and states: “In view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional.” Further, the courts have indicated that the enablement and written description requirements of 35 USC 112 are separable as can be seen in for example Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111.
To meet this requirement in the instant case, the specification must describe structural features that the skilled artisan as of the effective filing date would have expected to convey the claimed a lineage-specific cell-surface antigen binding activity.
The specification discloses a single structure the would function as a CAR targeting CD33, but does not specify alternative structures that would function for binding any lineage-specific cell-surface antigen.
Therefore, as presently written, the claimed broad genus of a CAR targeting a lineage-specific cell-surface antigen lacks adequate written description because there does not appear to be any correlation between the structure of a CAR and the ability to bind any lineage-specific cell-surface antigen. Thus, one of ordinary skill in the art would reasonably conclude that the applicant was not in possession of the full breadth of the claimed genus at the time the instant application was filed.
Logically, if applicant was not in possession of the agent which is being administered, applicant also was not in possession of methods of administering such reagents at the time the instant application was filed.
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 27-30, 34-35, 53-54, and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,571,445, herein referred to as “’445.” Although the claims at issue are not identical, they are not patentably distinct from each other because the method of the ‘445 patent anticipates the method of the instant application.
Issued claims of the ‘445 patent:
Instant Application patent claims, underline corresponds to direct mapping to claim 1 of the ‘445 patent and italics corresponds to the additional claim limitations.
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27. A method, comprising contacting a mobilized lymphocyte obtained from a first subject with a heterologous nucleic acid encoding a chimeric antigen receptor (CAR) targeting a lineage-specific cell-surface antigen associated with a hyperproliferative disease, thereby producing a genetically engineered lymphocyte expressing the CAR.
28. The method of claim 27, further comprising administering the genetically engineered lymphocyte, or a descendant thereof, to a second subject, wherein the second subject is in need thereof.
29. The method of claim 28, wherein the second subject has, or has been diagnosed with, the hyperproliferative disease.
30. The method of claim 28, wherein the first subject is different from the second subject or wherein the first subject is the same as the second subject.
34. The method of claim 28, wherein the genetically engineered lymphocyte, or a descendant thereof, is administered in combination with a hematopoietic stem cell transplant comprising genetically engineered hematopoietic stem cells that have reduced expression or lack expression of the lineage-specific cell surface antigen, or express a variant form of the lineage-specific cell-surface antigen that is not recognized or is recognized at a reduced level by the CAR.
35. The method of claim 27, further comprising contacting a hematopoietic stem cell obtained from the first subject with an RNA-guided nuclease and guide RNA or a nucleic acid encoding the same, wherein the guide RNA targets a gene encoding the lineage-specific cell-surface antigen, thereby producing a genetically engineered hematopoietic stem cell that has reduced expression or lacks expression of the lineage-specific cell-surface antigen or expresses a variant form of the lineage-specific cell-surface antigen, wherein the genetically engineered hematopoietic stem cell is not targeted by the CAR; and optionally wherein the method further comprises administering the genetically engineered hematopoietic stem cell, or a descendant thereof, to the second subject.
53. The method of claim 27, wherein the hyperproliferative disease is a hematopoietic malignancy.
54. The method of claim 53, wherein the wherein the hematopoietic malignancy is: (i) a myeloid malignancy or a lymphoid malignancy; (ii) Hodgkin's lymphoma, non-Hodgkin's lymphoma, leukemia, or multiple myeloma; and/or (iii) acute myeloid leukemia or myelodysplastic syndrome.
60. The method of claim 35, wherein (i) the RNA-guided nuclease is a CRISPR/Cas nuclease, optionally wherein the CRISPR/Cas nuclease is a Cas9 nuclease, an SpCas nuclease, an SaCas nuclease, or a Cpflnuclease;(ii) the nucleic acid encoding the guide RNA and/or the RNA-guided nuclease is an RNA, preferably an mRNA or an mRNA analog; and/or (iii) the guide RNA comprises one or more nucleotide residues that are chemically modified, one or more nucleotide residues that comprise a 2' O-methyl moiety, one or more nucleotide residues that comprise a phosphorothioate, and/or one or more nucleotide residues that comprise a thioPACE moiety.
Per MPEP §2113, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself (i.e., the patentability of the product does not depend on its method of production). In this instance, the claimed product-by-process are the genetically engineered T cells, and the ‘445 patent teaches immune cells comprising a CAR targeting CD33. Given that the ‘445 patent teachings are drawn to a modified immune cell comprising a CAR targeting CD33, while the instant claimed invention can be any lineage-specific cell-surface antigen CAR wherein the nucleic acid encoding said CAR is contacted with a mobilized T cell, the ‘445 patent necessarily anticipates the breadth of the instant claimed invention.
Therefore, because the methods comprise administering a genetically engineered HSC and a genetically engineered T cell for the treatment of a hematopoietic malignancy, there is no clear difference in the scope between the products of the instant application and the ’445 patent.
Claims 27-30, 33-35, 53-54, and 60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6, 8, 10-12, 15-20, 22, 25, 27, 31, 35, and 37-38 of co-pending Application No. 18/026092; 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 method of the reference application anticipates the method of the instant application. Specifically, both methods are for treating a hematopoietic malignancy comprising administering an effective amount of an immune cell expressing a CD33 targeting CAR and further comprises administering a population of HSCs to the subject which are genetically engineered to reduce or eliminate the expression of CD33, optionally wherein the immune cells, the HSCs, or both are allogenic or autologous (i.e., the genetically engineered immune cells and/or the HSCs are from different or the same subject).
The co-pending claims of the reference application recite: A method of treating a hematopoietic malignancy, comprising administering to a subject in need thereof an effective amount of an agent targeting CD33, wherein the agent is an immune cell expressing a chimeric receptor (CAR), wherein the CAR comprises: an antigen-binding domain that binds CD33 comprising a heavy chain variable region and/or a light chain variable region; a transmembrane domain comprising a transmembrane domain of a protein selected from CD8a or CD28; and an intracellular signaling domain comprising a functional signaling domain of CD3 (i.e., claim 19). The method of claim 19, wherein the method further comprises administering a population of hematopoietic cells to the subject, wherein the hematopoietic cells are genetically-engineered such that the gene encoding CD33 that is targeted by the antigen-binding domain is engineered to reduce or eliminate the expression of CD33, optionally wherein the immune cells, the hematopoietic cells, or both are allogenic or autologous (i.e., claim 20). The method of claim 20, wherein the hematopoietic cells are hematopoietic stem cells, optionally wherein the hematopoietic stem cells are from bone marrow cells or peripheral blood mononuclear cells (PBMCs) or wherein the hematopoietic stem cells are CD34+/CD33 (i.e., claim 22). The method of claim 19, wherein the hematopoietic cells are prepared by editing the endogenous gene encoding for CD33 to reduce or eliminate the expression of CD33, optionally wherein the endogenous gene is edited using a CRISPR system (i.e., claim 25). The method of claim 19, wherein the subject has or has been diagnosed with a hematopoietic malignancy or pre-malignancy characterized by the expression of CD33 on malignant cells or pre-malignant cells; or the subject had Hodgkin's lymphoma, non-Hodgkin's lymphoma, leukemia, or multiple myeloma, optionally wherein the leukemia is acute myeloid leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, acute lymphoblastic leukemia, or chronic lymphoblastic leukemia (i.e., claim 27). The method of any one of claims 19-34, wherein the CAR further comprises one or more co-stimulatory domains; optionally wherein the one more co-stimulatory domains comprise a functional signaling domain of 4-1BB and/or CD28 (i.e., claim 35). The method of claim 19, wherein the encoded CAR (i) comprises an amino acid sequence of any one of SEQ ID NOs: 10, 13, 16, 19, 22, 25, 29, 33, 36, 39, 42, 45, 48, 51, 54, 57, and 60-92; or (ii) comprises an amino acid sequence having 95-99% identity to any one of SEQ ID NOs: 10, 13, 16, 19, 22, 25, 29, 33, 36, 39, 42, 45, 48, 51, 54, 57, and 60-92 (i.e., claim 37) (i.e., SEQ ID NO: 19 is 100% query match to SEQ ID NO: 1 of the instant application, see OA.APPENDIX).
In this instance, because the method comprises administering a genetically engineered anti-CD33 CAR immune cell and further comprises administering genetically engineered HSCs, there is no clear difference in the scope between the methods 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 methods 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.
Claim Rejections - 35 USC § 102
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.
(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.
Claims 27-30, 33, 35-36, 53-54, and 60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2017/066760 A1 (The Trustees of Columbia University in the City of NY, et al., 20APR2017, included in IDS), herein referred to as “’760.”
‘760 teaches the preparation of second and third generation CARs and the corresponding CAR T cells targeting CD33 and methods of treatment further comprising administration of genetically modified HSCs for the treatment of AML patients (see entire document, specifically see Example 3). ‘760 teaches autologous HSC and stimulation of of AML patients by administration of G-CSF (see Example 3). Furthermore, ’760 teaches that the CRISPR/Cas9 system is used to modify HSC from the patient after treatment with CD33 CAR-T cells, and to re-infuse the genetically engineered HSCs to the patient (Example 3).
Therefore, the prior art anticipates the invention as presently claimed.
Claims 27-30, 32, 35-36, 53-54, and 60 are rejected under 35 U.S.C. 102(a)([1]) as being anticipated by WO 2018/160768 A1 (Vor Biopharma, Inc., et al., 07SEP2018, included in IDS), herein referred to as “’768.”
‘768 teaches methods of treating a hematopoietic malignancy, comprising administering to a subject in need thereof: (i) an effective amount of a cytotoxic agent targeting cells expressing a lineage-specific cell-surface protein, wherein optionally the cytotoxic agent comprises an antigen-binding fragment that specifically binds a lineage-specific cell-surface protein, and (ii) a population of HCs wherein the HCs are manipulated such that they or descendants thereof have reduced binding to the cytotoxic agents (see entire document, specifically see claim 1). ‘768 further teaches that the donor HSCs are edited and administered to the patient and then etoposide is administered followed by the CAR T cell therapy is administered, which can be repeated multiple times (see Figure 1, Example 3).
Therefore, the prior art anticipates the invention as presently claimed.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (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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/SAMANTHA LAKE HOPKINS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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