DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claims 1-10 filed June 24, 2024 are currently pending. Claim 1 is independent.
Priority
Acknowledgement is made of the continuation of Application 16330900, now abandoned after a Patent Board Decision on 04/22/2024. Acknowledgement is also made of the national stage entry of PCT/IB2017/055394 filed 09/07/2017 which claims foreign priority to Application 201611030627 filed 09/07/2016.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/07/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sengupta (WO2014/201376 published 12/18/2014).
Claim 1 is directed to a method of inducing immune memory in a human subject having a cancer metastasis or a cancer relapse comprising administering to the subject an immune memory-inducing amount of a compound that is
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or a salt thereof.
Sengupta teaches compounds of Formula (I) including compound 25 which reads on the following claimed species wherein the linker is –CH2CH2- and lipid is cholesterol ([0068], [0244]-[0245] page 25). The structural limitations of compound 25 of Sengupta read on Compound 1 of the present claims. Sengupta teaches that said composition is efficacious for the treatment of cancer (claims 28-30). Sengupta teaches that the term cancer embraces the treatment of both primary and metastatic neoplasms ([0122]-[0124], [0134-0136]). Therefore, the examiner has interpreted that the methodology of Sengupta embraces the treatment of subjects comprising metastatic tumors by administering said compounds in order to inhibit tumor growth in the subject in need ([0122]-[0124], [0134-0136]). Administration of said compounds to treat said metastatic neoplastic disorders in human patients is taught in the methodology of Sengupta ([0127], [0164]).
Regarding the limitation of an immune-memory inducing amount of said compound, the phrase “immune memory inducing amount” is not defined in the specification or present claims. Working embodiments 1-2 embrace the administration of 20 mg/kg of compound 1 to 4T1-xenograft neoplastic patients in order to induce B-cell mediated immune response in tumors (page 54-57; Figure 3A). Applicant is reminded of MPEP 2131 wherein a specific example in the prior art which is within a claimed range anticipates the range. In the present case, Sengupta teaches administering said composition in doses of 10 mg/kg to 20 mg/kg, which reads on the immune-memory inducing amount ([0129]).
Regarding claim 3, preparation of said composition as a pharmaceutically acceptable salt is taught by Sengupta ([0147]).
Regarding claim 5, treatment of patients comprising cancers of the breast or ovaries is embraced in the methodology of Sengupta ([0122]-[0124], [0135-0136]).
Regarding the limitation of claims 6-7, Sengupta teaches intravenous administration of said antineoplastic compound, wherein said compound is formulated as a liposome ([0103]-[0106], [0133], [0142-0145], page 72).
Regarding the limitation wherein the administration of 10-20 mg/kg dose of compound 25 induces immune memory in the metastatic cancer patient, or triggers a humoral response through B-cells and memory T-cells in the metastatic cancer patient (claims 8-10), although said properties are not explicitly described in the cited prior art of Sengupta., the compound (compound 25), the active step of administration (intravenous administration), the dose (10-20 mg/kg) and the patient (a subject comprising metastatic tumors) are identical to that of instantly claimed. Therefore, the property of compounds of Formula (I) to yield the functional effect of inducing immune memory in the metastatic cancer patient embraced in the instant claims must necessarily be present in the prior art methodology of Sengupta because products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the prior art teaches the identical chemical or physical structure of the composition, (i.e., the same active agent, compound 25), and the composition is used in the same manner (i.e., administered in the same manner to the same metastatic cancer patient in the same therapeutically effective amount), the properties that Applicant discloses and/or claims must necessarily be present. Furthermore, as stated in MPEP 2112.02, “[u]nder the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered anticipated by the prior art device.”
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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(s) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sengupta (WO2014/201376 published 12/18/2014).
Claim 1 is directed to a method of inducing immune memory in a human subject having a cancer metastasis or a cancer relapse comprising administering to the subject an immune memory-inducing amount of a compound that is
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or a salt thereof.
Sengupta teaches compounds of Formula (I) including compound 25 which reads on the following claimed species wherein the linker is –CH2CH2- and lipid is cholesterol ([0068], [0244]-[0245] page 25). The structural limitations of compound 25 of Sengupta read on Compound 1 of the present claims. Sengupta teaches that said composition is efficacious for the treatment of cancer (claims 28-30). Sengupta teaches that the term cancer embraces the treatment of both primary and metastatic neoplasms ([0122]-[0124], [0134-0136]). Therefore, the examiner has interpreted that the methodology of Sengupta embraces the treatment of subjects comprising metastatic tumors by administering said compounds in order to inhibit tumor growth in the subject in need ([0122]-[0124], [0134-0136]). Administration of said compounds to treat said metastatic neoplastic disorders in human patients is also taught in the methodology of Sengupta ([0127], [0164]).
Regarding the limitation of an immune-memory inducing amount of said compound, the phrase “immune memory inducing amount” is not defined in the specification or present claims. Working embodiments 1-2 embrace the administration of 20 mg/kg of compound 1 to 4T1-xenograft neoplastic patients in order to induce B-cell mediated immune response in tumors (page 54-57; Figure 3A). Applicant is reminded of MPEP 2144.05 where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the present case, Sengupta teaches administering said composition in doses of 10 mg/kg to 20 mg/kg, which reads on the immune-memory inducing amount ([0129]).
Regarding claim 3, preparation of said composition as a pharmaceutically acceptable salt is taught by Sengupta ([0147]).
Regarding claim 5, treatment of patients comprising cancers of the cervix or ovaries is embraced in the methodology of Sengupta ([0122]-[0124], [0135-0136]).
Regarding the limitation of claims 6-7, Sengupta teaches intravenous administration of said antineoplastic compound, wherein said compound is formulated as a liposome ([0103]-[0106], [0133], [0142-0145], page 72).
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to select compound 25 in order to treat a metastatic cancer in a human subject in need in view of Sengupta, arriving at the presently claimed methodology.
Applicant is reminded of MPEP 2144.07 wherein art recognized suitability for an intended purpose supports a prima facie case of obviousness. Selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Applicant is also reminded that “[I]t is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).” In the instant case, the claimed compound 25 of Sengupta is taught as a suitable compound to treat cancer in a human subject in need, wherein cancer embraces treating both primary and metastatic tumors in an overlapping therapeutically effective amount. Accordingly, said skilled artisan would have readily predicted that selection of compound 25 and administering said compound 25 to a patient comprising a metastatic tumor in the therapeutically effective amount would have effectively treated the neoplastic disorder in the afflicted subject.
Regarding the limitation wherein the administration of 10-20 mg/kg dose of compound 25 induces immune memory in the metastatic cancer patient, or triggers a humoral response through B-cells and memory T-cells in the metastatic cancer patient (claims 8-10), although said properties are not explicitly described in the cited prior art of Sengupta, Applicant is reminded that properties that accrue from the process step of administering a 10-20 mg/kg dose of compound 25 to the metastatic cancer patient are considered characteristic features of the claimed therapeutic regimen.
It is noted that MPEP 2112 discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
In the present case the burden is shifted to Applicant to prove that the administration of a 10-20 mg/kg dose of compound 25 to the metastatic cancer patient will not induce immune memory in the metastatic cancer patient, nor trigger a humoral response through B-cells and memory T-cells in the metastatic cancer patient.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4-5, 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9 and 12 of U.S. Patent No. 10,081,648.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following. Claim 9 is directed to the method of treating cancer comprising administering a therapeutically effective amount of a compound of lipid-based platinum compound of claim 1. Claim 1 is directed to lipid-based platinum compounds of Formulas (I)-(V), which includes the presently claimed compound 1 (see claim 10).
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Col. 50 lines 45-65 teaches a therapeutically effective amount which includes dosages of 10 mg/kg-100 mg/kg, which overlaps with the amount embraced within the present claims. Col. 53 lines 1-5 embraces the treating of cancer, wherein the term cancer embraces the treatment of both primary and metastatic neoplasms. Therefore, the examiner has interpreted that the methodology of claims 9 and 12 embraces the treatment of subjects comprising metastatic tumors by administering said compounds in order to inhibit tumor growth in the subject in need.
Claim 12 embraces the methodology of claim 9, wherein the cancers read on the cancers of instant claim 5. Regarding the limitation of an immune-memory inducing amount of said compound, working embodiments 1-2 embrace the administration of 20 mg/kg of compound 1 to 4T1-xenograft neoplastic patients in order to induce B-cell mediated immune response in tumors (page 54-57; Figure 3A). In the present case, Col. 50 lines 45-65 of U.S. Patent 10,081,648 teaches a therapeutically effective amount includes dosages of 10 mg/kg-100 mg/kg, which overlaps with the amount embraced within the present claims. Applicant is reminded of MPEP 2144.05 where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding the limitation wherein the administration of therapeutically effective dose of a compound of claim 1 induces immune memory in the metastatic cancer patient, or triggers a humoral response through B-cells and memory T-cells in the metastatic cancer patient (claims 8-10), although said properties are not explicitly described in the cited U.S. Patent 10,081,648, the compound (claim 10), the active step of administration, the therapeutically effective dose (10-100 mg/kg) and the patient (a subject comprising metastatic tumors) are identical to that of instantly claimed. Therefore, the property of lipid-based platinum compounds of Formulas (I)-(V) to yield the functional effect of inducing immune memory in the metastatic cancer patient embraced in the instant claims must necessarily be present in the prior art methodology of claims 9, 12 of U.S. Patent 10,081,648 because products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the prior art teaches the identical chemical or physical structure of the composition, (i.e., the same active agent), and the composition is used in the same manner (i.e., administered in the same manner to the same metastatic cancer patient in the same therapeutically effective amount), the properties that Applicant discloses and/or claims must necessarily be present. Furthermore, as stated in MPEP 2112.02, “[u]nder the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered anticipated by the prior art device.”
Claims 1-2, 4-6 and 8-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-21 of U.S. Patent No. 10,730,899.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following. Claim 18 is directed to the method of treating cancer comprising administering a therapeutically effective amount of a compound of lipid-based platinum compound of claim 14. Claim 14 is directed to lipid-based platinum compounds of Formulas (VIII), which includes the presently claimed compound 1 (see claim 14, 26).
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Col. 53-col 54 teaches a therapeutically effective amount which includes dosages of 10 mg/kg-100 mg/kg, which overlaps with the amount embraced within the present claims. Col. 54 lines 40-65 embraces the treating of cancer, wherein the term cancer embraces the treatment of both primary and metastatic neoplasms. Therefore, the examiner has interpreted that the methodology of claims 18-20 embraces the treatment of subjects comprising metastatic tumors by administering said compounds in order to inhibit tumor growth in the subject in need.
Claim 19 embraces the methodology of claim 18, wherein the cancers read on the cancers of instant claim 5, while claim 20 embraces the routes of administration that are found in claim 6. Regarding the limitation of an immune-memory inducing amount of said compound, working embodiments 1-2 embrace the administration of 20 mg/kg of compound 1 to 4T1-xenograft neoplastic patients in order to induce B-cell mediated immune response in tumors (page 54-57; Figure 3A). In the present case, Col. 53-col 54 teaches a therapeutically effective amount includes dosages of 10 mg/kg-100 mg/kg, which overlaps with the amount embraced within the present claims. Applicant is reminded of MPEP 2144.05 where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding the limitation wherein the administration of therapeutically effective dose of a compound of claim 1 induces immune memory in the metastatic cancer patient, or triggers a humoral response through B-cells and memory T-cells in the metastatic cancer patient (claims 8-10), although said properties are not explicitly described in the cited U.S. Patent 10,730,899, the compound (claims 14, 20), the active step of administration, the therapeutically effective dose (10-100 mg/kg) and the patient (a subject comprising metastatic tumors) are identical to that of instantly claimed. Therefore, the property of lipid-based platinum compounds of Formulas (VIII) to yield the functional effect of inducing immune memory in the metastatic cancer patient embraced in the instant claims must necessarily be present in the prior art methodology of claims 18-21 of U.S. Patent 10,730,899 because products of identical chemical composition cannot exert mutually exclusive properties when prepared or used in the same manner under the same circumstances. In other words, if the prior art teaches the identical chemical or physical structure of the composition, (i.e., the same active agent), and the composition is used in the same manner (i.e., administered in the same manner to the same metastatic cancer patient in the same therapeutically effective amount), the properties that Applicant discloses and/or claims must necessarily be present. Furthermore, as stated in MPEP 2112.02, “[u]nder the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered anticipated by the prior art device.”
Conclusion
In view of the rejections set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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/GEORGE W KOSTURKO/Examiner, Art Unit 1621