Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
Claims 1-35 and 40-42 are currently pending.
Claims 36-39 are cancelled.
Claims 1-35 and 40-42 have been considered on the merits.
Specification
The disclosure is objected to because of the following informalities: the use of trademarks.
The use of the terms FACSuite™ on pg. 34 para. 1; Ficoll-Paque™ on pg. 34 para. 2; TexMACS™ media on pg. 34 para. 2; GlutaMax™ on pg. 34 para. 2; and CTL-test™ medium on pg. 34 para. 2, which are a trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6, 8, 9, 11, 13-16, 22-31 and 33-35 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Bot et al. (WO 2016/191756 A1) (ref. of record).
With respect to claim 1, Bot teaches treating cancer a patient by administering T cell therapy (0003-0004 and 0055). It is noted that claim 1 requires a dose of IL-2 which is less than about 2.0 MIU/m2/day and this would include no administration of IL-2.
With respect to claims 1, 6, 8 and 9, Bot teaches the method where the patient does not receive a dose of IL-2. Therefore, Zhou teaches the dose of IL-2 administered to the patient is less than 2.0 MIU/m2/day as recited in claim 1, IL-2 is administered for less than 14 days as recited in claim 6, the IL-2 dose is the same dose each day as recited in claim 8, and the total dose of IL-2 administered to the patient is less than 2.0 MIU/m2 as recited in claim 9.
With respect to claims 11, 13 and 14, Bot teaches the method where a single dose of T cells is administered (0211 and 0260-0261). With respect to claim 11, this would occur on day 0. With respect to claim 15, Bot teaches the agents may be delivered subcutaneously (0047). With respect to claim 16, Bot teaches T cell therapy is selected from adoptive T cell therapy, tumor-infiltrating lymphocyte (TIL) immunotherapy, autologous cell therapy, engineered autologous cell therapy (eACT), and allogeneic T cell transplantation (0104).
With respect to claims 22 and 25-31, Bot teaches conditioning the patient with a dose of cyclophosphamide between 200 to 2000 mg/m2/day and a dose of fludarabine between 20 to 90 mg/m2/day (0003-0004 and 0007-0009). With respect to claims 26-31 Bot teaches the method where the dose of cyclophosphamide is 300 mg/m2/day and the dose of fludarabine is 30 mg/m2/day (0092). With respect to claim 23, Bot teaches administering cyclophosphamide and fludarabine for three days prior to the administration of a therapeutically effective amount engineered CAR T cells to the patient (0014 and 0067). With respect to claim 24, Bot teaches the administering of cyclophosphamide and fludarabine at least six days, five days, and four days prior to the administration of the T cell therapy (0097 and 0101).
With respect to claim 33, Bot teaches the method for treating melanoma, bladder cancer, esophageal cancer, ovarian cancer, lymphoma, small bowel cancers, pancreatic cancer, head and neck cancers, thyroid cancer, and sarcomas (0055). With respect to claim 34, Bot teaches the claimed method therefor the intended result of the method having reduced toxicity or reduced side effects in the patient would be inherent to practicing the method of Bot. With respect to claim 35, Bot teaches the method where the patient is human (0075).
Therefore, the reference anticipates the claimed subject matter.
Claims 1-3, 5, 8, 10-12, 15, 16, 20 and 33-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yee et al. (Proceedings of the National Academy of Sciences, 2002) (ref. of record).
With respect to claims 1 and 5, Yee teaches a method of treating metastatic melanoma (cancer) by coadministering T cell infusions (T cell therapy) with increasing doses of s.c. IL-2 at 0.25, 0.5, and 1.0 x106 units/m2 twice daily for 14 days following the T cell infusion (abstract, pg. 16168 Col. 2 para. 3-4, and Fig. 1). With respect to claims 1-3, the doses of IL-2 at 0.25, 0.5, and 1.0 x106 units/m2 twice daily taught by Yee would be 0.5, 1.0, and 2.0 MIU/m2/day (abstract, pg. 16168 Col. 2 para. 3-4, and Fig. 1).
With respect to claim 8, Yee teaches the method where the dose of IL-2 is the same for 14 days following the T cell infusion (pg. 16168 Col. 2 para. 3-4 and Fig. 1). With respect to claims 10-12, Yee teaches the method where the first dose of IL-2 is administered on the same day (day 0) as the T cell therapy and is administered daily on days 0-9 (pg. 16168 Col. 2 para. 3-4 and Fig. 1). With respect to claim 15, Yee teaches that the IL-2 is delivered by s.c. (subcutaneously) (pg. 16168 Col. 2 para. 4).
With respect to claim 16, Yee teaches the method where the T cell therapy is adoptive and where autologous cytotoxic T lymphocytes (CTLs) were generated from autologous dendritic cells (autologous cell therapy and engineered autologous cell therapy (eACT) (abstract and pg. 16168 Col. 2 para. 2).
With respect to claim 20, Yee teaches that the CTL clones (T cells) were expanded in serial IL-2 at 25-50 units/ml every 2-3 days (less than 1000 IU/ml) pg. 16168 Col. 2 para. 2).
With respect to claim 33, Yee teaches the method for treating metastatic melanoma (cancer) (abstract, pg. 16168 Col. 2 para. 3-4, and Fig. 1). With respect to claim 34, Yee teaches the claimed method therefor the intended result of the method having reduced toxicity or reduced side effects in the patient would be inherent to practicing the method of Yee. With respect to claim 35, Yee teaches the method where the patient is human (abstract).
Therefore, the reference anticipates the claimed subject matter.
Claims 1, 6, 8, 9, 11, 16-21, and 33-35 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Zhou et al. (US 2018/0078624 A1).
With respect to claim 1, Zhou teaches a method of treating cancer by administering a T cell therapy (abstract and 0003). With respect to claims 1, 6, 8 and 9, Zhou does not teach treating the patient with a dose of IL-2. Therefore, Zhou teaches the dose of IL-2 administered to the patient is less than 2.0 MIU/m2/day as recited in claim 1, IL-2 is administered for less than 14 days as recited in claim 6, the IL-2 dose is the same dose each day as recited in claim 8, and the total dose of IL-2 administered to the patient is less than 2.0 MIU/m2 as recited in claim 9. Although Zhou does not explicitly teach administering a T cell therapy on day 0 as recited in claim 11, this is an arbitrary designation of a day and the day of administering in Zhou can be considered day 0 (abstract and 0018).
With respect to claim 16, Zhou teaches T cell therapy is selected from adoptive T cell therapy, tumor-infiltrating lymphocyte (TIL) immunotherapy, autologous cell therapy, engineered autologous cell therapy (eACT), and allogeneic T cell transplantation (0007, 0046, 0112, 0173, 0337, 0473, 0494, and 0605). With respect to claim 17, Zhou teaches the method where the T cells targets neoantigens (abstract and 0027). Zhou teaches that the it is precision therapy method that is customized for the individual using neoantigen peptides (abstract). With respect to claim 18, Zhou teaches the method where T cells targets clonal neoantigens (0223). With respect to claim 19, Zhou teaches the method where the T cells have been selectively expanded to target clonal neoantigens (0160, 0223 and 0367). With respect to claim 21, Zhou teaches the method where the T cells express a chimeric antigen receptor or a TCR which specifically binds to a clonal neoantigen or an affinity-enhanced TCR which specifically binds to a clonal neoantigen (0083, 0112, 0161-0163, 0278, 0315, and 0326, 0334).
With respect to claim 20, Zhou teaches expanding the T cells in the presence of IL-2 at a concentration of 200 U/mL (0017 and 0176).
With respect to claim 33, Zhou teaches the method for treating hepatic cellular carcinoma (liver cancer), cervical cancer, lung cancer, colorectal cancer, lymphoma, renal cancer (kidney cancer), breast cancer, pancreatic cancer, gastric cancer, esophageal cancer, ovarian cancer, prostate cancer, melanoma and brain cancer (0028, 0140, and 0424).
With respect to claim 34, Zhou teaches the claimed method therefor the intended result of the method having reduced toxicity or reduced side effects in the patient would be inherent to practicing the method of Zhou.
With respect to claim 35, Zhou teaches the method where the patient is human (0012).
Therefore, the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-12, 15, 16, 20 and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Yee et al. (Proceedings of the National Academy of Sciences, 2002) (ref. of record) as evidenced by Cai et al. (US 2009/0324539 A1)(ref. of record).
With respect to claims 1 and 5, Yee teaches a method of treating metastatic melanoma (cancer) by coadministering T cell infusions (T cell therapy) with increasing doses of s.c. IL-2 at 0.25, 0.5, and 1.0 x106 units/m2 twice daily for 14 days following the T cell infusion (abstract, pg. 16168 Col. 2 para. 3-4, and Fig. 1). With respect to claims 1-3, the doses of IL-2 at 0.25, 0.5, and 1.0 x106 units/m2 twice daily taught by Yee would be 0.5, 1.0, and 2.0 MIU/m2/day (abstract, pg. 16168 Col. 2 para. 3-4, and Fig. 1).
With respect to claim 8, Yee teaches the method where the dose of IL-2 is the same for 14 days following the T cell infusion (pg. 16168 Col. 2 para. 3-4 and Fig. 1). With respect to claims 10-12, Yee teaches the method where the first dose of IL-2 is administered on the same day (day 0) as the T cell therapy and is administered daily on days 0-9 (pg. 16168 Col. 2 para. 3-4 and Fig. 1). With respect to claim 15, Yee teaches that the IL-2 is delivered by s.c. (subcutaneously) (pg. 16168 Col. 2 para. 4).
With respect to claim 16, Yee teaches the method where the T cell therapy is adoptive and where autologous cytotoxic T lymphocytes (CTLs) were generated from autologous dendritic cells (autologous cell therapy and engineered autologous cell therapy (eACT) (abstract and pg. 16168 Col. 2 para. 2).
With respect to claim 20, Yee teaches that the CTL clones (T cells) were expanded in serial IL-2 at 25-50 units/ml every 2-3 days (less than 1000 IU/ml) pg. 16168 Col. 2 para. 2).
With respect to claim 33, Yee teaches the method for treating metastatic melanoma (cancer) (abstract, pg. 16168 Col. 2 para. 3-4, and Fig. 1). With respect to claim 34, Yee teaches the claimed method therefor the intended result of the method having reduced toxicity or reduced side effects in the patient would be inherent to practicing the method of Yee. With respect to claim 35, Yee teaches the method where the patient is human (abstract).
Yee does not teach the method where the IL-2 is administered once daily as recited in claim 4. Similarly, Yee does not teach the method where the IL-2 is administered for less than 4 days as recited in claim 6, where it is administered daily for about 10 days as recited in claim 7. Likewise, Yee does not teach the method where the total dose of IL-2 that administered does not exceed 10 MIU/m2 as recited in claim 9. Although Yee does not teach the same number of days of administering IL-2 as in claims 4, 6 and 7 or the total amount of IL-2 that is administered, one of ordinary skill in the art would recognize that the duration of administration and the total amount of a therapeutic agent is a result effective variable and that the duration and total amount of a therapeutic agent such as IL-2 would be matter of routine optimization as evidenced by Cai. Cai teaches that the timing and duration of the administration of the cytotoxic T lymphocytes (CTL, T cell therapy) and cytokine such as IL-2 may be selected by the artisan based on routine experimentation and guidance (abstract, 0002, and 0040).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 17-19 and 21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Yee as evidenced by Cai (as applied to claims 1-12, 15, 16, 20 and 33-35 above), and further in view of Zhou et al. (US 2018/0078624 A1).
The teachings of Yee can be found in the previous rejection above.
Yee does not teach the method where the T cells targets neoantigens as recited in claim 17, where T cells targets clonal neoantigens as recited in claim 18, or where the T cells have been selectively expanded to target clonal neoantigens as recited in claim 19. Likewise, Yee does not teach the method where the T cells express a chimeric antigen receptor or a TCR which specifically binds to a clonal neoantigen or an affinity-enhanced TCR which specifically binds to a clonal neoantigen as recited in claim 21.
However, Zhou teaches a similar method of treating cancer by administering a T cell therapy (abstract and 0003). With respect to claim 17, Zhou teaches the method where the T cells targets neoantigens (abstract and 0027). With respect to claim 18, Zhou teaches the method where T cells targets clonal neoantigens (0223). With respect to claim 19, Zhou teaches the method where the T cells have been selectively expanded to target clonal neoantigens (0160, 0223 and 0367). With respect to claim 21, Zhou teaches the method where the T cells express a chimeric antigen receptor or a TCR which specifically binds to a clonal neoantigen or an affinity-enhanced TCR which specifically binds to a clonal neoantigen (0083, 0112, 0161-0163, 0278, 0315, 0326, and 0334). Zhou teaches that the method is a precision therapy method that is customized for the individual using neoantigen peptides (abstract).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Yee so that the T cells targets neoantigens, clonal neoantigens, where the T cells have been selectively expanded to target clonal neoantigens, and where T cells express a chimeric antigen receptor or a TCR which specifically binds to a clonal neoantigen or an affinity-enhanced TCR which specifically binds to a clonal neoantigen for the benefit of effectively treating cancer by targeting specific tumor antigens in subjects as taught by Zhou. It would have been obvious to one of ordinary skill in the art to modify the method of Yee so that the T cells targets neoantigens, clonal neoantigens, where the T cells have been selectively expanded to target clonal neoantigens, and where T cells express a chimeric antigen receptor or a TCR which specifically binds to a clonal neoantigen or an affinity-enhanced TCR which specifically binds to a clonal neoantigen, since similar methods of treating cancer by administering a T cell therapy were known to include such T cells and to be effective as taught by Zhou. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification, since Zhou teaches such T cell therapies are effective.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 1-16, 20, 22-35 and 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Yee et al. (Proceedings of the National Academy of Sciences, 2002) (ref. of record) as evidenced by Cai et al. (US 2009/0324539 A1)(ref. of record) and in view of Bot et al. (WO 2016/191756 A1)(ref. of record)
With respect to claims 1 and 5, Yee teaches a method of treating metastatic melanoma (cancer) by coadministering T cell infusions (T cell therapy) with increasing doses of s.c. IL-2 at 0.25, 0.5, and 1.0 x106 units/m2 twice daily for 14 days following the T cell infusion (abstract, pg. 16168 Col. 2 para. 3-4, and Fig. 1). With respect to claims 1-3, the doses of IL-2 at 0.25, 0.5, and 1.0 x106 units/m2 twice daily taught by Yee would be 0.5, 1.0, and 2.0 MIU/m2/day (abstract, pg. 16168 Col. 2 para. 3-4, and Fig. 1).
With respect to claim 8, Yee teaches the method where the dose of IL-2 is the same for 14 days following the T cell infusion (pg. 16168 Col. 2 para. 3-4 and Fig. 1). With respect to claims 10-12, Yee teaches the method where the first dose of IL-2 is administered on the same day (day 0) as the T cell therapy and is administered daily on days 0-9 (pg. 16168 Col. 2 para. 3-4 and Fig. 1). With respect to claim 15, Yee teaches that the IL-2 is delivered by s.c. (subcutaneously) (pg. 16168 Col. 2 para. 4).
With respect to claim 16, Yee teaches the method where the T cell therapy is adoptive and where autologous cytotoxic T lymphocytes (CTLs) were generated from autologous dendritic cells (autologous cell therapy and engineered autologous cell therapy (eACT) (abstract and pg. 16168 Col. 2 para. 2).
With respect to claim 20, Yee teaches that the CTL clones (T cells) were expanded in serial IL-2 at 25-50 units/ml every 2-3 days (less than 1000 IU/ml) pg. 16168 Col. 2 para. 2).
With respect to claims 33 and 40, Yee teaches the method for treating metastatic melanoma (cancer) (abstract, pg. 16168 Col. 2 para. 3-4, and Fig. 1). With respect to claims 34 and 41, Yee teaches the claimed method therefor the intended result of the method having reduced toxicity or reduced side effects in the patient would be inherent to practicing the method of Yee. With respect to claims 35 and 42, Yee teaches the method where the patient is human (abstract).
Yee does not teach the method where the IL-2 is administered once daily as recited in claim 4. Similarly, Yee does not teach the method where the IL-2 is administered for less than 4 days as recited in claim 6, where it is administered daily for about 10 days as recited in claim 32, or where it is administered daily for about 10 days at a dose of 1.0 MIU/m2/day as recited in claim 32. Likewise, Yee does not teach the method where the total dose of IL-2 that administered does not exceed 10 MIU/m2 as recited in claim 9. Although Yee does not teach the same number of days of administering IL-2 as in claims 4, 6 and 7 or the total amount of IL-2 that is administered, one of ordinary skill in the art would recognize that the duration of administration and the total amount of a therapeutic agent is a result effective variable and that the duration and total amount of a therapeutic agent such as IL-2 would be matter of routine optimization as evidenced by Cai. Cai teaches that the timing and duration of the administration of the cytotoxic T lymphocytes (CTL, T cell therapy) and cytokine such as IL-2 may be selected by the artisan based on routine experimentation and guidance (abstract, 0002, and 0040).
Yee does not teach the method where a single dose of T cell therapy is administered and on day 0 only as recited in claims 13 and 14, respectively, and a single dose of T cell therapy as recited in claim 32. However, Bot teaches a similar method of treating cancer a patient by administering T cell therapy (0003-0004 and 0055). Bot further teaches the method where a single dose of T cells are administered and is effective in treating some subjects (0211 and 0260-0261). Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Yee so that a single dose of T cell therapy is administered on day 0 for the benefit of effectively treating cancer in subjects as taught by Bot. It would have been obvious to one of ordinary skill in the art to modify the method of Yee so that a single dose of T cell therapy is administered on day 0, since similar methods of treating cancer by administering a T cell therapy were known to only administer the T cells once and that one dose can be effective as taught by Bot. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification, since Bot teaches that a single dose of T cell therapy may be effective.
Yee does not teach the method where the subjects are administered a lymphodepleting agent prior to administration of the T cell therapy as recited in claims 22-32.
However, Bot teaches a similar method of treating cancer a patient by administering T cell therapy (0003-0004 and 0055). With respect to claims 22 and 25-31, Bot teaches conditioning the patient with a dose of cyclophosphamide between 200 to 2000 mg/m2/day and a dose of fludarabine between 20 to 90 mg/m2/day (0003-0004 and 0007-0009). With respect to claims 28, 31, 32, and 34, Bot teaches the method where the dose of cyclophosphamide is 300 mg/m2/day and the dose of fludarabine is 30 mg/m2/day (0092). With respect to claim 23, Bot teaches administering cyclophosphamide and fludarabine for three days prior to the administration of a therapeutically effective amount engineered CAR T cells to the patient (0014 and 0067). With respect to claim 24, Bot teaches the administering of cyclophosphamide and fludarabine at least six days, five days, and four days prior to the administration of the T cell therapy (0097 and 0101). Bot further teaches that preconditioning a patient with one or more immunosuppressive chemotherapy drugs prior to T cell infusion increases the effectiveness of the cells (0006).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the method of Yee to include the administration of a lymphodepleting agent prior to the administration of the T cell therapy including administering cyclophosphamide and fludarabine in the claimed amounts and dosages for the benefit of improving the effectiveness of the T cell therapy as taught by Bot. It would have been obvious to one of ordinary skill in the art to modify the method of Yee to include the administration of a lymphodepleting agent prior to the administration of the T cell therapy including administering cyclophosphamide and fludarabine in the claimed amounts and dosages, since similar methods of treating cancer by administering a T cell therapy were known to include the administration of a lymphodepleting agent prior to the administration of the T cell therapy including administering cyclophosphamide and fludarabine in the claimed amounts and dosages as taught by Bot. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification, since Bot teaches to the administration of lymphodepleting agents prior to the administration of the T cell therapy including administering cyclophosphamide and fludarabine in the claimed amounts and dosages that a single dose of T cell therapy is effective.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632