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 .
Claims 1-21 are pending and are under examination.
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 1-9 and 11-21 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 claims are indefinite in the recitation of a particle comprising a tumor neoantigen construct “tightly associated” to a particle. The term “tightly” is a relative term which renders the claim indefinite. The term “tightly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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, 3-7, 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2008/019366 (of record).
WO2008/019366 teaches a method of treating cancer by comprising contacting a viable APC in vitro with an antigenic preparation comprising a particle having an antigen attached thereto and stimulating a patient’s viable T cells with the APCs outside the body so as to expand antigen specific T cells, and then the T cells are transplanted back into the body (expanding and activating T cells, See pages 9-10 and paragraph 41, in particular). WO2008/019366 teaches that the APCs take up and phagocytose the particles (See page 3 and 12, in particular). WO2008/019366 teaches that the antigen is attached via covalent methods, i.e. tightly associated ( see pages 12-14, in particular). WO2008/019366 teaches the antigen is a cancer antigen, such as a mutant oncogenic form of p53 protein, i.e. a neoantigen, and that the subject is one which is in need of an antigen specific immune response specific to the antigen, i.e. the p53 is expressed by the cancer cell in the subject, see abstract and pages 3-4 in particular. It would be obvious that multiple copies of the antigen would be attached, i.e. two or more neoantigen constructs having the same amino acid sequence. It is also noted that p53 protein, which is hundreds of amino acids in length, would be comprised of numerous different peptide epitopes that are covalently linked to each other via peptide bonds, and would include a mutated epitope, and therefore the limitations of claim 5 would be inherent when using said mutated p53 protein taught in WO2008/019366. WO2008/019366 teaches iron oxide particles (i.e. paramagnetic, see pages 12-14, in particular). WO2008/019366 teaches that the APC are provided from the treated animal, i.e. from the subject (see paragraph 37, in particular). WO2008/019366 teaches that particles attached to antigens are useful for delivery to antigen presenting cells to induce antigen specific T cell response, and that many suitable preparations can be used with a size limit of about 0.3 uM to 20 uM (see paragraph 13, in particular). It would be obvious to optimize the size of the particles and selecting a particle such as a 1 uM or 2 uM particle from within the range specifically disclosed by the reference would be well within the purview of the ordinary artisan. Regarding the limitation that CD4 helper and CD8 T cells are expanded, WO2008/019366 teaches experimental examples demonstrating that APC having phagocytosed a particles can present antigen to CD4 and CD8 T cells, and that including CD4 T cells along with CD8 T cells is important in providing T cell help to enhanced cellular immune responses (see page 33, in particular). Thus, it would be obvious to include both CD4 and CD8 T cells in the expansion and administration method used for treating cancer, in order to provide T cell help. Regarding claim 3, WO2008/019366 teaches experiments wherein APC are prepared for use in vitro to activate T cells, wherein they are washed before contact with the T cells (see paragraph 83, in particular). It would also be obvious to use the same washing procedure before administration of the T cells in vivo, i.e. removing particles from the T cells.
Claim 13-14, is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2008/019366 (of record), as applied to claim 1 above, in further in view of Reeves, 1996.
The teachings of WO2008/019366 are described above.
The reference differs from the claimed invention in that it does not explicitly teach contacting the T cells with a second antigen presenting cell in vitro.
Reeves teaches methods of in vitro expansion of anti-tumor T cells using APC presenting tumor antigens and T cells obtained from cancer patients, wherein the T cells are cultured by stimulating a first time with said APCs, and then the T cells are restimulated with a second population of antigen loaded APCs to further expand antigen specific T cells (See pages 5674, in particular). Reeves teaches that the APCs are loaded with the same antigen in each restimulation. Reeves teaches that doing so can further expand tumor antigen specific T cells (see pages 5674-5675, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to restimulate the T cells of WO2008/019366, using a second population of APCs loaded with the same antigen containing phagocytosable particles, as taught by Reeves. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success in order to further expand the tumor specific T cells.
Claim 1, 3-8, 10-11, 15-19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2008/019366 (of record), in view of WO2016/053339 (of record) and Schreiber, 2011.
The teachings of WO2008/019366 are described above.
The reference differs from the claimed invention in that it does not explicitly teach intravenous administration of the T cells, T cells derived from a tumor, treating solid tumors or hematological malignancy.
WO2016/053339 teaches mutated tumor antigen sequences for use in loading into APC for presentation to autologous T cells to provide antigen specific T cells (see page 1, in particular). WO2016/053339 teaches that doing so provides a “personalized” population of T cells that are specific for amino acid sequences encoded by cancer specific mutations, and can destroy cancer cells while minimizing destruction of normal, non-cancerous cells (see page 6, in particular). WO2016/053339 teaches obtaining T cells from a variety of sources in the patient, including the tumor and that the T cells can contain CD4 and CD8 T cells (See paragraph 39). WO2016/053339 teaches that doing so provides a “personalized” population of T cells that are specific for amino acid sequences encoded by cancer specific mutations, and can destroy cancer cells while minimizing destruction of normal, non-cancerous cells. WO2016/053339 teaches that T cells are suitable for treating a variety of tumors, including solid tumors such as breast cancer, as well as hematological malignancies (See paragraph 64, in particular) WO2016/053339 teaches that T cell administration can induce regression of all tumors including primary (i.e. non-metastatic) and metastatic tumors (See paragraph 133, in particular). Additionally, the reference would also render obvious treating patients with primary tumors before metastasis, since WO2016/053339 teaches that the tumor antigen can be obtained from a primary tumor sample (See paragraph 30, in particular). WO2016/053339 also teaches that the method may further comprise specifically selecting and sorting antigen specific T cells, which would result in separation of the T cells from the APCs (see paragraph 40, in particular). WO2016/053339 teaches using multiple mutated tumor antigen peptides to stimulate the T cells (Se paragraph 48, in particular). WO2016/053339 teaches intravenous administration of the T cells (see paragraph 55, in particular). WO2016/053339 teaches that T cells are suitable for treating a variety of tumors, including solid tumors such as breast cancer, as well as hematological malignancies (See paragraph 64, in particular). WO2016/053339 teaches administration of the T cells more than one time (see paragraph 128, in particular)
Schreiber teach the concept of immunoediting, wherein an initial immunotherapy can treat a tumor, but that dormant tumor cells can remain which are immunoedited resulting in loss of tumor antigen expression, and leading to a reemergence of tumor growth of an antigen loss-tumor variant (i.e. a relapse, see Fig. 3 and page 1569, in particular).
Therefore, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to apply the teachings of WO2016/053339 and Schreiber, to the cancer treatment method of WO2008/019366. In particular, it would be obvious to perform intravenous administration of the T cells or use a tumor as the source of T cells of WO2008/019366, as taught by WO2016/053339. Doing so would involve choosing among a finite number of predictable options which could be pursued with a reasonable expectation of success. A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (see KSR International Co. V. Telefex Inc 82 USPQ2d 1385). Even though WO2016/053339 teaches a neoantigen for the reasons set forth above, it would also be obvious to use the neoantigenic constructs of WO2016/053339 as the tumor antigen for attachment to the phagocytosable particles in WO2008/019366, because WO2016/053339 teaches that they provide a “personalized” population of T cells that are specific for amino acid sequences encoded by cancer specific mutations, and can destroy cancer cells while minimizing destruction of normal, non-cancerous cells. Furthermore, it would be obvious to perform the method of WO2008/019366 to treat cancer types including solid tumors, metastatic, non-metastatic, breast cancer of hematological malignancies, since WO2016/053339 teaches they are treatable by administration of antigen specific T cells. Furthermore, it would be obvious to further administer a second T cell population in the event of a relapse to further treat cancer, as WO2016/053339 teaches that multiple T cell administrations are possible. Furthermore, it would be obvious when doing so that one could use a different tumor neoantigen to treat a relapse that is due to tumor reemergence via an antigen loss variant, as taught by Schreiber. The ordinary artisan would be motivated to do so in order to effectively treat such relapses in which the antigen used in the first treatment had been subjected to immunoediting, creating an antigen loss variant.
Claim 1, 3-12, 15-20, is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0224402, in view of WO2016/053339 and Vidard, 1996 and Tran, 2009 (all of record).
The ‘402 publication teaches a method of treating cancer in a subject comprising expanding antigen specific T cells by providing a paramagnetic particle having immobilized thereto tumor cell antigens, contacting said particle with viable APCs in vitro such that the beads and antigens are phagocytosed by the APCs, and contacting said APCs with viable T cells from a subject to provide for activation and expansion of antigen specific T cells and further administering the T cells to the subject (see pages 1, 3, 8-9, in particular). The ‘402 publication teaches that the antigens can be from heat treated tumor cells, from tumor cell lysates, or can be tumor/cancer antigen polypeptides and can be covalently bound to the particles (see pages 1-2 and 9, in particular). The ‘402 publication specifically teaches that any tumor antigen would be useful in the context of the present invention (see paragraph 81). The ‘402 publication teaches cancers/solid tumors such as breast cancer, lung cancer, and colo-rectal cancer or hematological malignancies (see paragraph 128, in particular). The ‘402 publication teaches that the T cells can be isolated after culture by positive selection (i.e. removing the APC/particle, see page 9, in particular). The ‘402 publication teaches that the T cells can be from PBMC or from a tumor and teaches autologous T cells for treating cancer (i.e. from the subject, see page 5 and paragraph 63 and 133, in particular). The ‘402 publication teaches that in an embodiment, PBMC from a subject are cultured directly in the presence of the antigen, such that APC present in the sample are loaded with the antigen which is presented to T cells in the sample (i.e. APCs from the subject and concurrent contact, See paragraphs 76 and 87, in particular). The ‘402 publication teaches that the particle can be microsphere or nanoparticle (see page 5, in particular). The ‘402 publication teaches expanding CD4 and CD8 T cells (see paragraph 8, in particular). The ‘402 publication further teaches restimulating the antigen specific T cells with the antigen (see page 11, in particular). The ‘402 publication teaches that the particles can be DYNABEADSTM (i.e. a polystyrene, paramagnetic particle, see page 8, in particular) and specifically M-280 Dynabeads as an exemplary bead size (i.e. 2.8 uM, see paragraph 89, in particular). The ‘402 publication teaches that the antigen specific T cells are activated by culturing T cells with antigen loaded APC (see paragraph 85). The ‘402 publication teaches activation in a growth medium sufficient to support the expansion of antigen specific T cells (see paragraph 101, in particular). The ‘402 publication teaches that the antigen specific T cels can be administered intravenously (see paragraph 124, in particular). The ‘402 publication teaches administration of the T cells before or after other therapeutic, such as chemotherapy (see paragraph 138, in particular). Thus, it would be obvious that one could administer the T cells before chemotherapy in a manner such that the chemotherapy is administered after, i.e. not within 1 week before (see paragraph 138). The ’402 publication teaches administration of the T cells multiple times (See paragraph 132, in particular).
The reference differs from the claimed invention in that it does not explicitly teach a mutated tumor neoantigenic construct or that the particle has a largest dimension of 0.5- 2 uM.
Vidard, antigen conjugated polystyrene particles with a size of 1-2 uM are efficiently taken up by antigen presenting cells for inducing T cell responses (see, for example, Fig. 3).
Tran teaches that microparticles of 500 nM to 3 uM are suitable for use for antigen delivery to antigen presenting cells, and can enhance cross-presentation of exogenous antigen for inducing CD8 T cells response (See abstract, page 1358 and 1360, in particular).
WO2016/053339 teaches mutated tumor antigen sequences for use in loading into APC for presentation to autologous T cells to provide antigen specific T cells (see page 1, in particular). WO2016/053339 teaches that doing so provides a “personalized” population of T cells that are specific for amino acid sequences encoded by cancer specific mutations, and can destroy cancer cells while minimizing destruction of normal, non-cancerous cells (see page 6, in particular). WO2016/053339 teaches that T cell administration can induce regression of all tumors including primary (i.e. non-metastatic) and metastatic tumors (See paragraph 133, in particular). Thus, based on the teachings of the reference, it would be obvious to also treat patients with primary tumors before metastasis, since WO2016/053339 teaches that the tumor antigen can be obtained from a primary tumor sample (See paragraph 30, in particular). WO2016/053339 teaches using multiple different tumor neoantigens.
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 a particle size within the range of 0.5-2 uM, such as a 1-2 uM particle, as taught by Vidard or Tran, in the method of the ‘402 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 references teach that said particle sizes are suitable for delivery of conjugated antigens into antigen presenting cells for inducing a T cell response. Thus, optimization of particle size would be routine and a particular size of 1-2 uM in particular would be well within the purview of the ordinary artisan. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Furthermore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a tumor cell comprising a mutated tumor antigen, or a mutated tumor antigen peptide, and to treat metastatic and non-metastatic tumors, as taught by WO2016/053339, as the antigen for immobilization on the particle and the type of cancer in the method of the ‘402 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 WO2016/053339 teaches that doing so provides a “personalized” population of T cells that are specific for amino acid sequences encoded by cancer specific mutations, and can destroy cancer cells while minimizing destruction of normal, non-cancerous cells. For example, the ‘402 publication teaches particles immobilized with heat killed tumor cells or tumor cell lysates, which would comprise numerous tumor specific polypeptide antigens, and it would be obvious to use a tumor sample comprising mutated, patient specific tumor antigens based on the teachings of WO2016/053339. These lysates comprise tumor antigen polypeptides with mutated amino acid sequences associated with a cancer in the subject. Furthermore, a tumor antigen polypeptide would comprise multiple different peptide epitopes that are covalently linked together, and including peptides comprising between 10 and 25 amino acids.
Alternatively, it would also be obvious to use the tumor peptide antigens taught by WO2016/053339. WO2016/053339 teaches using mutated peptide pools (i.e. more than one peptide) and also teaches that the peptides comprising the mutated amino acid can be flanked by contiguous amino acids from the endogenous protein on either side of the mutation, such as about 20 amino acids, i.e. a polypeptide of at least 40 amino acids. For example, this polypeptide would comprise a 10 amino acid mutated peptide covalently linked to two 15 amino acid peptides that flank the 10 amino acid peptide (i.e. three covalently linked peptides), thus meeting the limitations of the present claims.
Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over US 2004/0224402, WO2016/053339, Vidard, 1996 and Tran, 2009, as applied to claim 1 above, and further in view of Bang Laboratories, 2011, and Yoon, 2008 (both of record)
The teachings of the ‘402 publication, WO2016/053339,Vidard, and Tran are described above. While the ‘402 publication teaches heat-killed tumor cells, the reference differs from the claimed invention in that it does not explicitly teach a sterilizing wash comprising subjecting the particle with associated polypeptide to a temperature of at least 90 degrees C.
Yoon teaches that heat denatured tumor specific protein antigens elicit increased T cell responses (see page 130-131, in particular). Yoon teaches that the denaturation can expose hydrophobic residues that are immunogenic (see page 142, in particular). Yoon teaches heat treatment by boiling, i.e. temperatures above 90 degrees C (see page 131, in particular).
Bang Laboratories teaches that paramagnetic, polystyrene particles with covalently attached proteins can be boiled to denature the protein, and without loss of attached protein (see page 2-3, in particular). Bang also teaches that particle suspensions can be sterilized by pasteurization, i.e. heat treatment (see page 2, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to heat treat the tumor antigen particles made obvious above, as further taught by Yoon and Bang. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because Yoon teaches that heat denatured tumor specific protein antigens elicit increased T cell responses, and Bang teaches Bang Laboratories teaches that paramagnetic particles with covalently attached proteins can be boiled to denature the protein, and without loss of attached protein. Furthermore, it would also be obvious to subject the particles/polypeptides to boiling in order to sterilize the particles, since Bang teaches that particles can be subjected to pasteurization (heat) to sterilize the particles..
Claim 13-14, is/are rejected under 35 U.S.C. 103 as being unpatentable over 2004/0224402, WO2016/053339, Vidard, 1996 and Tran, 2009, as applied to claim 1 above, in further in view of Kurokawa, 2001.
The teachings of the cited references are described above.
The reference differs from the claimed invention in that it does not explicitly teach contacting the T cells with a second antigen presenting cell in vitro.
Kurokawa teach that restimulation using antigen presenting cells loaded with tumor antigen in a first and second step, wherein the antigen presenting cells are loaded in the same manner and with the same antigen results in was optimal for T cell expansion (see abstract and entire document).
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 same antigen in a second APC preparation as the first step to restimulate the T cells in the method made obvious by the ‘402 application, WO2016/053339, Vidard, and Tran, as taught by Kurokawa. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation since Kurokawa teaches that it was optimal for T cell expansion.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over 2004/0224402, WO2016/053339, Vidard, 1996 and Tran, 2009, as applied to claim 1 above, in further in view of Schreiber, 2011
The teachings of the cited references are described above.
They do not teach explicitly teach treating relapsing cancer after T cell administration, wherein the T cells are produced with a different antigen.
Schreiber teach the concept of immunoediting, wherein an initial immunotherapy can treat a tumor, but that dormant tumor cells can remain which are immunoedited resulting in loss of tumor antigen expression, and leading to a reemergence of tumor growth of an antigen loss-tumor variant (i.e. a relapse, see Fig. 3 and page 1569, in particular).
Therefore, it would be obvious that to administer further doses of the T cells, as taught by the ‘402 publication, in the event of a relapse to further treat cancer. Furthermore, it would be obvious when doing so that one could use a different tumor neoantigen to treat a relapse that is due to tumor reemergence via an antigen loss variant, as taught by Schreiber. The ordinary artisan would be motivated to do so in order to effectively treat such relapses in which the antigen used in the first treatment had been subjected to immunoediting, creating an antigen loss variant.
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.
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Claims 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-19, 35-36 of copending Application No. 17,417,601 in view of 2004/0224402, WO2016/053339, Tran, Vidard, Schreiber, 2011, Kurokawa, 2001, Bang Laboratories, 2011, and Yoon, 2008.
The ‘601 application claims a method of treating cancer in a subject comprising producing anti-tumor T cells by an expansion and activation method comprising contacting a phagocytosable particle with an APC from the subject, wherein the phagocytosable particle has tumor neoantigen construct tightly associated thereto, contacting T cells sample from the subject with the APC in vitro and administering the T cells to the subject. The ‘601 application claims treating solid cancer, breast cancer or colon cancer. The ‘601 application claims that the T cells and APCs are harvested from the subject. The ‘601 application also claims further administering APCs loaded with the phagocytosable particles, wherein the phagocytosable particles have the same size and polymer, paramagnetic properties as recited in the instant claims. It would therefore be obvious to use the same particles in the in vitro T cell activation step. Alternatively, it would be obvious to use paragamagnetic polystyrene particles as taught by the ‘402 publication, Tran, and Vidard, for the reasons set forth above.
The ‘601 application does not explicitly claim using CD4 and CD8 T cells, intravenous administration, treating metastatic or non-metastatic cancer, hematological malignancies, not administering chemotherapy within 1 week, sterilizing the particles, restimulating the T cells, removing the APC/particles, or to administering a second dose of the T cells. However, it would be obvious do so based on the teachings of the ‘402 publication, WO2016/053339, Yoon and Bang Laboratories, Schreiber, and Kurokawa for the reasons set forth above.
Claims 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-29, 34-35 of copending Application No. 18/003,279, in view of 2004/0224402, WO2016/053339, Bang Laboratories, 2011, Yoon, 2008, Schreiber, and Kurokawa.
The ‘279 application claims a method of treating cancer in a subject comprising harvesting T cells from the subject, expanding anti-cancer T cells in vitro by contacting the T cells with APC that have phagocytosed a particle, and administering the expanded anticancer T cells to the subject. The ‘279 application claims that the phagocytosable particle has an antigenic construct tightly associated thereto, wherein the antigen comprising a epitope of an amino acid sequence that is expressed by a cancer cell in the subject. It would be obvious to use a neoepitope and a particle size and properties as recited in the present claims, based on the teachings of WO2016/053339, the ‘420 application, Vidard, and Tran for the reasons set forth above. It would be obvious to use covalent association, CD4 and CD8 T cells, intravenous administration, treating metastatic or non-metastatic sold cancer, hematological malignancies, not administering chemotherapy within 1 week, sterilizing the particles, to restimulate the T cells, removing the APC/particles, or to administer a second dose of the T cells based on the teachings of the ‘402 publication, WO2016/053339, Yoon, Bang Laboratories, Schreiber, and Kurokawa for the reasons set forth above.
Claims 1-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 51-81 of copending Application No. 18/999,139.
The copending application claims a method of treating cancer in a subject comprising administering to the subject anti-tumor T cells producing by contacting a phagocytosable particle with an APC, wherein the phagocytosable particle has tumor neoantigen construct tightly associated thereto, and contacting T cells samples from the subject with the APC in vitro to expand the T cells. The copending application claims three or more tumor neoantigen construct comprising peptides that induce T cells, i.e. epitopes, that the antigens are expressed in cancer cells of the subject, performing a sterilizing wash by heating to a temperature of at least 90 degrees Celsius, and that the particles are covalently linked to the antigen and that the particles. The copending application claims further removing the particles from the T cell sample, that the particle has paramagnetic properties, that the antigen presenting cell is from the subject, a polymer particle, and a size of less than 5.6 uM, and therefore the size range of the present claims would be routinely optimizable. The copending application claims concurrently contacting the particle, the antigen presenting cell and the T cell, and further contacting with a second phagocytosable particle and a second antigen presenting cell. The copending application claims treating solid metastatic cancer, colon cancer, or hematological malignancies, intravenous administration, and not administering chemotherapy in the week prior to T cell administration. The copending application claims the cancer is relapsing cancer that has be previously treated with a first anti-tumor T cell, and that the second anti-tumor T cells are produce using different neoantigens epitopes. The copending application claims using CD4 and CD8 T cells and that the T cells are derived from a tumor.
It is noted that even though the present application is a divisional of the ‘139 copending application, the 121 prohibition does not apply because the claims of the two applications are not consonant with the restriction requirement issued in the earliest filed parent application, since both applications claim the subject matter of group 2, i.e. methods of treating cancer comprising administering anti-tumor T cells.
This is a provisional nonstatutory double patenting rejection.
No claim is allowed.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644