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 amendment and remarks, filed 4/2/26, are acknowledged.
Claims 1-2, 13-14, and 21 have been amended.
Claims 1-3, 7-8, 12-21 are pending and are under examination.
In view of Applicant’s claim amendments, the previous grounds of rejection are withdrawn.
The following are new grounds of rejection necessitated by Applicant’s claim amendments. Applicant’s arguments relevant to the new grounds of rejection will be addressed below.
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.
Claim 2 is 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.
Claim 2 recites the limitation "the tumor neoantigenic construct covalently bound" in line 2 and in line 4. There is insufficient antecedent basis for this limitation in the claim. Amendment to recite the tumor neoantigenic construct covalently linked thereto would be remedial.
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, 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2008/019366 (of record), in view of Reeves, 1996 (of record), WO 2017/118695 (of record), and Hoang, 2009.
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 can be dendritic cells and that they take up and phagocytose the particles (See page 3 and 12, in particular). WO2008/019366 teaches that the antigen is attached via covalent methods ( 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. WO2008/019366 teaches polystyrene particles or iron oxide particles (i.e. paramagnetic, see pages 5 and 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. WO2008/019366 teaches covalently attaching the antigen to the particle by engineering an unpaired cysteine residue for attachment of the antigen to the particle or wherein the covalent attachment if via a covalently linked tag (See page 14-15, in particular). WO2008/019366 teaches a particle:APC ratio of 5:1 to 20:1 (See paragraph 26 and Fig. 1, in particular). 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.
The reference differs from the claimed invention in that it does not explicitly teach a tumor neoantigen construct comprising three, four, five, or six covalently linked peptides, each peptide having a mutated amino acid, wherein the construct is at least 20 and less than 150 amino acids, polystyrene particles that are also paramagnetic or performing the expansion for 1 to 4 weeks.
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 for 14 days 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, which are performed every 14 days. Reeves teaches that doing so can further expand tumor antigen specific T cells (see pages 5674-5675, in particular).
WO 2017/118695 teaches tumor antigen vaccine constructs comprising a plurality of tumor neoepitope peptides that are linked together as a fusion construct, i.e. covalently linked peptides (see pages 11-12, in particular). WO 2017/118695 teaches that each neoepitope comprises a cancer specific mutation (see pages 4-10, in particular). WO 2017/118695 teases that increasing the numbers of neoepitopes in a tumor vaccine antigen leads to an increase in immune response, and that at least 3 neoepitope peptides, such as 5 neoepitopes should be incorporate to efficiently be able to “hit” all tumor cells and avoid tumor escape (see page 12, in particular). WO 2017/118695 teaches that the length of the antigenic unit comprising the neoepitope peptides can be about 30 amino acids, about 50 amino acids or about 100 amino acids in length (See page 14, in particular).
Hoang teaches that polystyrene microparticles can be made by incorporation of iron oxide nanoparticles embedded therein such that the polystyrene microparticles have paramagnetic properties, which can be useful for cell separation.
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 neoantigen construct of WO 2017/118695, as the tumor neoantigen in the method taught by WO2008/019366. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because WO 2017/118695 teases that increasing the numbers of neoepitopes in a tumor vaccine antigen leads to an increase in immune response, and that at least 3 neoepitope peptides, such as 5 neoepitope should be incorporate to efficiently be able to “hit” all tumor cells and avoid tumor escape.
Furthermore, optimizing the timeframe for T cell expansion would be well within the purview of the ordinary artisan, since Reeves teaches that a 14 day culture is effective to expand T cells with antigen loaded APCs. It also 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 constructs containing phagocytose 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.
It also would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to include iron oxide, as taught by Hoang, in the polystyrene particles of WO2008/019366. The ordinary artisan at the time the invention was made would have been motivated to do since Hoang teaches it confers paramagnetic properties to the polystyrene microparticles which can be useful for cell separation. Furthermore, the ordinary artisan would have a reasonable expectation of success, since WO2008/019366 teaches that both polystyrene and iron oxide are materials suitable for use in the microparticles of the disclosed invention.
Applicant’s argument filed 4/2/26 have been fully considered, but they are not persuasive.
Applicant argues that WO2008/019366 includes lists of particles that one might consider to deliver the antigen, but only exemplifies yeast particles, which are larger that the size range of the present claims which recite a particle size of 0.5 to 1.5 uM.
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
WO2008/019366 explicitly teaches the use of polystyrene particles, and teaches suitable sizes can range from 0.3 uM to 20 uM, and it would be obvious to select particle sizes within the disclosed range, such as a 1 uM particle size.
Applicant further argues that the antigen delivery system of WO2008/019366 requires specific types of site specific conjugation and when chemical bonding between the antigen and yeast particles was tested, the construct was not able to prime CD8 T cells, citing Example 7. Applicant argues that the antigen construct of WO2008/019366 must be bound to the particle by Aga-1-Agag2, which is expressly not used in the present claims, because in the amended claims, the antigen is attached to the polystyrene particles by chemical covalent bonding.
Example 7 examines site specific chemical conjugation using reductive animation via lysine residues in the tumor antigen that are covalently linked to the particle, which inhibits release in the early phagosome.
The covalent attachment methods disclosed by WO2008/019366 are not limited to the chemical conjugation example cited by Applicant. In fact, WO2008/019366 specifically teaches that when a particle other than a yeast cells is to be used, covalent attachment methods that directly conjugate a protein covalently by amino acids residues in the antigen should be avoided since they may impede antigen release (See page 14, in particular). WO2008/019366 teaches that to avoid this problem, the antigen maybe engineered to have an unpaired cysteine residue in a polypeptide region flanking the antigen for attachment to the particle (see page 14, in particular). Alternatively, WO2008/019366 teaches that the antigen can be attached covalently to the particle via the use of an tag as part of the antigenic construct (see pages 14-15).
The instant claims are not limited to the type of attachment used for the antigen construct, so long as it is covalently linked. Furthermore, the claims recite that the method “comprises” the recited steps and that the particles or antigen “comprise” the mutated peptides, which is an open term that does not exclude unrecited steps or elements. The covalent linkages disclosed by WO2008/019366 such as covalently linking the antigen construct to the particle using an engineered cysteine residue or by the use of a tag would be within the scope of the instant claims.
Claims 8, 15-19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2008/019366 (of record), in view of Reeves, 1996 (of record), WO2017/118695 (of record), and Hoang, 2009, as applied to claim 1, and further in view of WO2016/053339 (of record) and Schreiber (of record)
The teachings of the WO2008/019366, Reeves, 1996, WO2017/118695 and Hoang, 2009 are described above.
The references differ 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, to the cancer treatment method made obvious above. In particular, it would be obvious to perform intravenous administration of the T cells or use a tumor as the source of T cells, 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). Furthermore, it would be obvious to perform the method made obvious above, 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.
Claims 2 is rejected under 35 U.S.C. 103 as being unpatentable over US WO2008/019366 (of record), in view of Reeves, 1996 (of record), WO2017/118695 (of record), and Hoang, 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 WO2008/019366, Reeves, 1996, WO2017/118695 and Hoang, 2009 are described above.
The references differ from the claimed invention in that they do 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 20 is rejected under 35 U.S.C. 103 as being unpatentable over US WO2008/019366 (of record), in view of Reeves, 1996 (of record), WO2017/118695 (of record), and Hoang, 2009, as applied to claim 1, and further in view of US 2018/0078624.
The teachings of the WO2008/019366, Reeves, 1996, WO2017/118695 and Hoang, 2009 are described above.
The references differ from the claimed invention in that they do not explicitly teach administering the T cells without any chemotherapy.
The ‘624 publication teaches that activated T cell immunotherapies can be administered as a first line therapy alone, or alternatively in conjugation with another therapy such as chemotherapy.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to optimize the T cell cancer treatment method made obvious above, by administering the T cells alone as a first line therapy, i.e. to a patient that has not been administered any chemotherapy. 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).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over US WO2008/019366 (of record), in view of Reeves, 1996 (of record), WO2017/118695 (of record), and Hoang, 2009, as applied to claim 1, and further in view of US 2001/0055752.
The teachings of the WO2008/019366, Reeves, 1996, WO2017/118695 and Hoang, 2009 are described above.
The references differ from the claimed invention in that they do not explicitly teach that the particle, the APC, and T cells are contacted simultaneously.
The ‘752 publication teaches that APCs can be loaded with an antigen for a period of time sufficient for uptake, and thereafter T cells can be added, or alternatively T cells can be added simultaneously with the APC and the antigen that is taken up by the APC for activating and expanding antigen specific T cells (See paragraphs 40, 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 optimize the T cell expansion method made obvious above by simultaneously contacting the T cells, the antigen particles and the APCs, as taught by the ‘752 publication. The ordinary artisan at the time the invention was made would have been motivated to do so as a matter of convenience and additionally do 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).
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 1-3, 7-8, 12-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-19, 21-36 of copending Application No. 17,417,601 in view of WO2008/019366, Reeves, 1996, WO 2017/118695, Hoang, 2009, Bang Laboratories, 2011, Yoon, 2008, Schreiber, US 2001/0055752, WO2016/053339 and US 2018/0078624.
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 covalently 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 that the T cells are activated by contacting APCs with a phagocytosable particle comprising a neoantigen construct associated therewith, wherein the neoantigen comprise two or more covalently linked neoepitope peptides that are covalently linked and are 3 to 25 amino acids in length. Regarding the size and composition of the particles, the ‘601 application claims administering a phagocytosable particle prior to harvested the T cells and APCs, wherein the particle is 0.5 um to 2 um and comprises polystyrene and a paramagnetic core. 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 paramagnetic polystyrene particles of the claimed sizes and having an antigen construct with the claimed features based on the teachings of the other cited references 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 other cited references for the reasons set forth above.
Claims 1-3, 7-8, 12-21 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 WO2008/019366, Reeves, 1996, WO 2017/118695, Hoang, 2009, Bang Laboratories, 2011, Yoon, 2008, Schreiber, US 2001/0055752, WO2016/053339 and US 2018/0078624.
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 the other cited 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 cited references for the reasons set forth above.
Applicant argues that the provisional double patenting rejections should be withdrawn since the instant application has an earlier patent term filing date.
The rejection will be withdrawn when the provisional double patenting rejection is the only rejection remaining. Since the instant claims are rejected on other grounds, the provisional double patenting rejections are maintained.
Claims 1-3, 7-8, 12-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 51-81 of copending Application No. 18/999,139, in view of WO2008/019366, Reeves, 1996 (of record), WO 2017/118695 (of record), Hoang, 2009.
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.
The limitations regarding the specific size of the neoantigen construct, particle size and composition (polystyrene), cell: particle ratios, and other limitations are obvious based on the teachings of WO2008/019366, Reeves, 1996, WO 2017/118695, Hoang for the reasons set forth above.
This is a provisional nonstatutory double patenting rejection.
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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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
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