DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-4, 6-14 and 16-22 are pending. Claims 5 and 15 are canceled.
3. Claims 1-4, 6-14 and 16-22 are under examination.
Priority
4. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
5. The information disclosure statements (IDS) submitted on 12/8/2023 and 2/20/2024 have been considered by the examiner.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 1-3, 7-13 and 17-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating a patient who has cancer, comprising administering to said patient a population of activated T cells that kill cancer cells that present on the cell surface a peptide consisting of the amino acid sequence of SEQ ID NO: 1, wherein the cancer is non-small cell lung cancer or ovarian cancer, does not reasonably provide enablement for a method of treating a patient who has cancer, comprising administering to said patient a population of activated T cells that kill cancer cells that present on the cell surface a peptide consisting of the amino acid sequence of SEQ ID NO: 1, wherein the cancer is small cell lung cancer, renal cell cancer, brain cancer, gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, leukemia, breast cancer, Merkel cell carcinoma, melanoma, urinary bladder cancer, uterine cancer, gallbladder and bile duct cancer or esophageal cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404,
''Factors to be considered in determining whether a disclosure would
require undue experimentation have been summarized by the board in Ex
parte Forman. They include (1) the quantity of experimentation necessary,
(2) the amount of direction or guidance presented, (3) the presence or
absence of working examples, (4) the nature of the invention, (5) the state
of the prior art, (6) the relative skill of those in the art, (7) the predictability
or unpredictability of the art, and (8) the breadth of the claims.''
The nature of the invention
The claims are drawn to a method of treating a patient who has cancer, comprising administering to said patient a population of activated T cells that kill cancer cells that present on the cell surface a peptide consisting of the amino acid sequence of KVLEHVVRV (SEQ ID NO: 1), wherein the cancer is non-small cell lung cancer, small cell lung cancer, renal cell cancer, brain cancer, gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, leukemia, breast cancer, Merkel cell carcinoma, melanoma, ovarian cancer, urinary bladder cancer, uterine cancer, gallbladder and bile duct cancer, or esophageal cancer.
The nature of the invention is cancer immunotherapy.
The invention is in a class of invention, which the CAFC has characterized as ''the unpredictable arts such as chemistry and biology.'' Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The breadth of the claims and quantity of experimentation
The claims encompass treating non-small cell lung cancer, small cell lung cancer, renal cell cancer, brain cancer, gastric cancer, colorectal cancer, hepatocellular cancer, pancreatic cancer, prostate cancer, leukemia, breast cancer, Merkel cell carcinoma, melanoma, ovarian cancer, urinary bladder cancer, uterine cancer, gallbladder and bile duct cancer, or esophageal cancer.
The quantity of the experimentation is extreme large in view of the breadth of the claims and unpredictability of cancer treatment.
The state of the prior art
Jia et a. (Clinical and Developmental Immunology, 2010, Article ID 567594, 7 pages) teaches that MAGE-A4 is one of genes that are abundantly expressed by many tumors of different histological types, such as urothelial carcinoma, bladder
cancer, lung cancer, ovarian neoplasm, esophageal squamous, cell carcinoma, and oral squamous cell carcinoma (page 1, para 2).
Li et al. (CN 105219714A1, pub. date: 1/6/2016, English translation attached) teaches a method of treating a patient having ovarian cancer, comprising
administering to the patient activated cytotoxic T cells that selectively recognize ovarian cancer cell which presents a MAGE-A4-A2/3 peptide consisting of SEQ ID NO:3 (KVLEHVVRV, the instant SEQ ID NO:1), wherein the T cells are produced by contacting T cells with dendritic cells (DC) that have been loaded with the peptide, the peptide is presented by HLA-A2 (also known as HLA-A*02) ([0010], [0015], [0019], [0021], [0026], [0046], [0052], and claims of the English translation).
The predictability or lack thereof in the art
It is unpredictable which tumor presents the instant SEQ ID NO:1. Without actual data, one skilled in the art would not know the presentation of peptide KVLEHVVRV on the cell surface of cancers other than non-small cancer lung cancer, melanoma and ovarian cancer, much less to kill these cancer cells that present on the cell surface the peptide KVLEHVVRV with T cells with a reasonable expectation of success.
Mahr et al. (US 10,000,547, date of patent: 6/19/2018, effectively filed date: 3/27/2015) discloses ALLEEEEGV (SEQ ID NO:245), which is a MAGE-A4 peptide (Table 2). Mahr et al. shows that the MAGE-A4 peptide ALLEEEEGV (SEQ ID NO: 245) is presented on the cell surface of non-small cell lung cancer (NSCLC), urinary bladder cancer (UBC), and gallbladder adenocarcinoma and cholangiocarcinoma (GBCCCC). This MAGE-A4 peptide ALLEEEEGV, however, is not presented on the cell surface of hepatocellular carcinoma (Table 4B). Even though MAGE-A4 is overexpressed in hepatocellular carcinoma, as evidenced by Zhang et al (Tissue Antigens 2002 60: 365–371, page 366).
Nakatsugawa et al. (International Journal of Oncology 39: 1041-1049, 2011) teaches how a Lengsin (206-215)-specific CTL clone failed to recognize tumor cells expressing Lengsin, even though this same clone showed efficient recognition against HLA-A*0201+ target cells in the presence of exogenously added peptide (page 1045, column 2, para 1). Nakatsugawa et al. teaches that CTLs induced by reverse immunology approaches often fail to recognize HLA-matched tumor targets expressing specific genes (page 1048, para 1). Lengsin(206-215)-specific CTL clone 3C9 and Lengsin(270-279)-specific CTL clone 1A1 showed approximately similar avidity in peptide titration experiments. CTL clone 1A1 recognized target cells expressing Lengsin; however, CTL clone 3C9 failed. For this reason, Lengsin (206-215) might not be processed and presented on target cells (page 1047, column 1, para 3).
Working examples and guidance in the specification
The instant specification teaches that MAGE4 is strongly overexpressed (++) in head and neck cancer and non-small cell lung cancer, and moderately overexpressed (+) in ovarian cancer (Example 4 and Table 10).
Considering the teachings of the instant specification and the knowledge in the prior art together, it is evident that the skilled artisan is not enabled to practice the breadth of the claimed method of treatment in the absence of undue experimentation. One reason this is so is because merely knowing that MAGE-A4 mRNA is expressed in a given cancer cell line does not provide the skilled artisan with any information about if any given cancer expresses a KVLEHVVRV (SEQ ID NO:1) on its cell surface in sufficient levels that it can be efficiently recognized and killed by T cells.
The evidence provided in the specification is insufficient to enable the treatment of cancers as broadly claimed. While it is understood that the absence of working examples should never be the sole reason for rejecting a claims as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art such as in vivo cancer treatment using activated CTL is required for practice of the claimed invention.
The scope of the claims must bear a reasonable correlation with the scope of enablement. In re Fisher, 166 USPQ 18(CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute.
Level of skill in the art
The level of the skill in the art is deemed to be high.
Conclusion:
In view of the quantity of experimentation necessary, the limited working examples, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breadth of the claims, it would take undue experimentation to practice the claimed invention.
Claim Rejections - 35 USC § 102
8. 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.
9. Claims 1, 3, 6, 11, 13 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (CN 105219719A1, pub. date: 1/6/2016, English translation attached).
Li et al. teaches a method of treating a patient having ovarian cancer, comprising
administering to the patient activated cytotoxic T cells that selectively recognize ovarian cancer cell which presents a MAGE-A4-A2/3 peptide consisting of SEQ ID NO:3 (KVLEHVVRV, the instant SEQ ID NO:1), wherein the T cells are produced by contacting T cells with dendritic cells (DC) that have been loaded with the peptide, the peptide is presented by HLA-A2 ([0021], [0026], [0052] of the English translation).
Claim Rejections - 35 USC § 103
10. 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.
11. Claims 1, 3, 6-11, 13 and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN 105219719A1, pub. date: 1/6/2016, English translation attached), in view of Fristche et al. (US 2011/0229504A1, pub. date: 9/22/2011).
The teachings of Li et al. have been set forth above as they apply to claims 1, 3, 6, 11, 13 and 16.
Regarding claims 7-10 and 17-22, Li does not teach that the activated T cells are administered with an adjuvant such as IL-2, IL-7, IL-15 or IL-21.
Fristche et al. teaches an in vitro method for producing activated cytotoxic T lymphocytes (CTL), the method comprising contacting in vitro CTL with antigen loaded human class I or II MHC molecules expressed on the surface of a suitable antigen-presenting cell (APC) for a period of time sufficient to activate said CTL in an antigen specific manner, wherein the antigen is loaded onto class I or II MHC molecules expressed on the surface of a suitable antigen-presenting cell by contacting a sufficient amount of the antigen with an antigen-presenting cell, wherein the antigen is a peptide ([0201], [0202]), the peptide binds to HLA-A*02 ([0082), the antigen presenting cell is dendritic cell or macrophage ([0316]). Fristche et al. teaches a method of killing target cells in a patient which target cells aberrantly express a polypeptide comprising the peptide, a method of treating a patient who has cancer, the method comprising administering to the patient an effective number of the activated cytotoxic T lymphocytes (CTL) ([0205], [0318], [0319], [0338]), wherein the T cells that are administered to the patient may be from the patient (i.e. they are autologous T cells) or from another individual, e.g. a healthy individual ([0320]), from PBMC or from tumor infiltrating lymphocytes ([0316]), wherein the activated CTL can be administered with one or more adjuvants such as IL-2, IL-7, IL-15 or IL-21 ([0326], [0330]), the activated CTL can be expanded ([0064]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the patent to administer the activated CTL cells with an adjuvant such as IL-2, IL-7, IL-15 or IL-21 in view of Fristche. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Fristche et al. teaches that the activated CTL can be administered with one or more adjuvants such as IL-2, IL-7, IL-15 or IL-21 ([0326], [0330]).
12. Claims 1-3, 6, 11-13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (CN 105219719A1, pub. date: 1/6/2016, English translation attached), in view of Tsunoda et al. (US2010/0040641A1, pub. date: 2/18/2010).
The teachings of Li et al. have been set forth above as they apply to claims 1, 3, 6, 11, 13 and 16.
Regarding claims 2 and 12, Li does not teach that activated T cells are produced by transducing T cells with a T cell receptor (TCR) that binds the peptide of SEQ ID NO:1 in a complex with an MHC class I molecule on the surface of the cancer cells
Tsunoda et al. teaches that cytotoxic T cells can be prepared by transduction with nucleic acids encoding polypeptides of TCR subunits that form TCR and bind to a peptide in the context of HLA-A2 ([0338] and claim 21), the nucleic acids
encoding the TCR subunits can be incorporated into suitable vectors for example
retroviral vectors ([0336] and [0337]). Tsunoda et al. teaches that the transduced CTLs
are capable of homing to cancer cells in vivo, expanded by well-known culturing
method in vitro, and can be used to treat cancer in a patient in need thereof ([0338]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified the method of Li to activate T cells by transducing the T cells with a viral vector expressing a TCR that binds to the peptide and to treat ovarian cancer with the activated T cells in view of Tsunoda et al. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Tsunoda et al. teaches that cytotoxic T cells can be prepared by transduction with nucleic acids encoding polypeptides of TCR subunits that bind to a peptide in the context of HLA-A2 ([0152] and claim 21), and the transduced CTLs are capable of homing to cancer cells in vivo, expanded by well- known culturing method in vitro, and can be used to treat cancer in a patient in need thereof ([0338]).
Double Patenting
13. 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.
14. Claims 1-4, 6-14 and 16-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,626,160, in view of Fristche et al. (US 2011/0229504A1, pub. date: 9/22/2011).
Claims 1-20 of U.S. Patent No. 10,626,160 disclose a method of treating a patient who has cancer that presents a peptide consisting of the amino acid sequence of KVLEHVVRV (SEQ ID NO: 1, instant SEQ ID NO:1) in a complex with HLA-A*02, comprising administering to the patient a population of transformed CD8+ T cells expressing at least one vector encoding a T cell receptor (TCR), wherein the TCR comprises SEQ ID NO: 42, SEQ ID NO: 43, SEQ ID NO: 44, SEQ ID NO: 50, SEQ ID NO: 51, and SEQ ID NO: 52, wherein the TCR is capable of binding to a peptide consisting of the amino acid sequence of KVLEHVVRV (SEQ ID NO: 1) in a complex with HLA-A*02, and wherein the cancer is selected from non-small cell lung cancer (NSCLC), melanoma, and ovarian cancer (OC), wherein the population of transformed cells are produced by a method comprising isolating a cell from a subject, transforming the cell with at least one vector encoding the TCR to produce a transformed cell, and expanding the transformed cell to produce the population of transformed cells, wherein the population of transformed cells are administered in the form of a pharmaceutical composition, the pharmaceutical composition comprises a chemotherapeutic agent selected from the group consisting of asparaginase, busulfan, carboplatin, cisplatin, daunorubicin, doxorubicin, fluorouracil, gemcitabine, hydroxyurea, methotrexate, paclitaxel, rituximab, vinblastine, and vincristine.
The claims of the patent anticipate instant claims 1, 2, 4, 6, 11, 12, 14 and 16.
The claims of the patent do not teach that the activated T cells are cytotoxic T cells (CTL) produced by contacting T cells with an antigen presenting cell that expresses the peptide in a complex with an MHC class I molecule on the surface of the antigen presenting cell, for a period of time sufficient to activate said T cel, and the activated T cells are administered with an adjuvant such as IL-2, IL-7, IL-15 or IL-21.
Fristche et al. teaches an in vitro method for producing activated cytotoxic T lymphocytes (CTL), the method comprising contacting in vitro CTL with antigen loaded human class I or II MHC molecules expressed on the surface of a suitable antigen-presenting cell (APC) for a period of time sufficient to activate said CTL in an antigen specific manner, wherein the antigen is loaded onto class I or II MHC molecules expressed on the surface of a suitable antigen-presenting cell by contacting a sufficient amount of the antigen with an antigen-presenting cell, wherein the antigen is a peptide ([0201], [0202]), the peptide binds to HLA-A*02 ([0082), the antigen presenting cell is dendritic cell or macrophage ([0316]). Fristche et al. teaches a method of killing target cells in a patient which target cells aberrantly express a polypeptide comprising the peptide, a method of treating a patient who has cancer, the method comprising administering to the patient an effective number of the activated cytotoxic T lymphocytes (CTL) ([0205], [0318], [0319], [0338]), wherein the T cells that are administered to the patient may be from the patient (i.e. they are autologous T cells) or from another individual, e.g. a healthy individual ([0320]), from PBMC or from tumor infiltrating lymphocytes ([0316]), wherein the activated CTL can be administered with one or more adjuvants such as IL-2, IL-7, IL-15 or IL-21 ([0326], [0330]), the activated CTL can be expanded ([0064]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the patent to activate CTL cells by contacting T cells with an antigen presenting cell that expresses the peptide in a complex with an MHC class I molecule on the surface of the antigen presenting cell for a period of time sufficient to activate the T cel and administer the activated CTL cells with an adjuvant such as IL-2, IL-7, IL-15 or IL-21 in view of Fristche. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Fristche et al. teaches an in vitro method for producing activated cytotoxic T lymphocytes (CTL), the method comprising contacting in vitro CTL with antigen loaded human class I or II MHC molecules expressed on the surface of a suitable antigen-presenting cell (APC) for a period of time sufficient to activate the CTL and the activated CTL can be administered with one or more adjuvants such as IL-2, IL-7, IL-15 or IL-21 ([0326], [0330]).
15. Claims 1-4, 6-14 and 16-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,889,629, in view of Tran et al. (WO2016/053339A1, pub. date: 4/7/2016, filing date: 10/2/2014).
Claims 1-20 of U.S. Patent No. 10,889,629 disclose a method of treating a patient who has cancer that presents a peptide consisting of the amino acid sequence of KVLEHVVRV (SEQ ID NO: 1, instant SEQ ID NO:1) in a complex with HLA-A*02, comprising administering to the patient a population of transformed CD8+ T cells expressing at least one vector encoding a T cell receptor (TCR), wherein the TCR comprises SEQ ID NO: 58, SEQ ID NO: 59, SEQ ID NO: 60, SEQ ID NO: 66, SEQ ID NO: 67, and SEQ ID NO: 68, wherein the TCR is capable of binding to a peptide consisting of the amino acid sequence of KVLEHVVRV (SEQ ID NO: 1) in a complex with HLA-A*02, and wherein the cancer is selected from non-small cell lung cancer (NSCLC), melanoma, and ovarian cancer (OC), wherein the population of transformed cells are produced by a method comprising isolating a cell from a subject, transforming the cell with at least one vector encoding the TCR to produce a transformed cell, and expanding the transformed cell to produce the population of transformed cells, wherein the population of transformed cells are administered in the form of a pharmaceutical composition, the pharmaceutical composition comprises a chemotherapeutic agent selected from the group consisting of asparaginase, busulfan, carboplatin, cisplatin, daunorubicin, doxorubicin, fluorouracil, gemcitabine, hydroxyurea, methotrexate, paclitaxel, rituximab, vinblastine, and vincristine.
The claims of the patent anticipate instant claims 1, 2, 4, 6, 11, 12, 14 and 16.
The claims of the patent do not teach that the activated T cells are cytotoxic T cells (CTL) produced by contacting T cells with an antigen presenting cell that expresses the peptide in a complex with an MHC class I molecule on the surface of the antigen presenting cell, for a period of time sufficient to activate said T cel, and the activated T cells are administered with an adjuvant such as IL-2, IL-7, IL-15 or IL-21.
Fristche et al. teaches an in vitro method for producing activated cytotoxic T lymphocytes (CTL), the method comprising contacting in vitro CTL with antigen loaded human class I or II MHC molecules expressed on the surface of a suitable antigen-presenting cell (APC) for a period of time sufficient to activate said CTL in an antigen specific manner, wherein the antigen is loaded onto class I or II MHC molecules expressed on the surface of a suitable antigen-presenting cell by contacting a sufficient amount of the antigen with an antigen-presenting cell, wherein the antigen is a peptide ([0201], [0202]), the peptide binds to HLA-A*02 ([0082), the antigen presenting cell is dendritic cell or macrophage ([0316]). Fristche et al. teaches a method of killing target cells in a patient which target cells aberrantly express a polypeptide comprising the peptide, a method of treating a patient who has cancer, the method comprising administering to the patient an effective number of the activated cytotoxic T lymphocytes (CTL) ([0205], [0318], [0319], [0338]), wherein the T cells that are administered to the patient may be from the patient (i.e. they are autologous T cells) or from another individual, e.g. a healthy individual ([0320]), from PBMC or from tumor infiltrating lymphocytes ([0316]), wherein the activated CTL can be administered with one or more adjuvants such as IL-2, IL-7, IL-15 or IL-21 ([0326], [0330]), the activated CTL can be expanded ([0064]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the patent to activate CTL cells by contacting T cells with an antigen presenting cell that expresses the peptide in a complex with an MHC class I molecule on the surface of the antigen presenting cell for a period of time sufficient to activate the T cel and administer the activated CTL cells with an adjuvant such as IL-2, IL-7, IL-15 or IL-21 in view of Fristche. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Fristche et al. teaches an in vitro method for producing activated cytotoxic T lymphocytes (CTL), the method comprising contacting in vitro CTL with antigen loaded human class I or II MHC molecules expressed on the surface of a suitable antigen-presenting cell (APC) for a period of time sufficient to activate the CTL and the activated CTL can be administered with one or more adjuvants such as IL-2, IL-7, IL-15 or IL-21 ([0326], [0330]).
Conclusion
16. No claims are allowed.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached on Monday-Friday 8am-5pm.
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/HONG SANG/Primary Examiner, Art Unit 1643
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