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 .
Claim 4 is cancelled. Claims 1-3 and 5-11 are pending and under examination.
Priority
This application is a continuation of PCT/JP2022/021103 filed on 5/23/2022, which claims priority to US provisional application 63/192,366 filed on 5/24/2021.
Objections and Rejections Withdrawn
The objection over the title is withdrawn as applicant has provided an acceptable title that has some more detail.
The rejection under USC 112(a) – Scope of Enablement is withdrawn per applicant’s amendment and arguments to add “cancer”.
The rejection under USC 103 over Kasagi and Hu is withdrawn per applicant’s amendments and arguments. Particularly Hu’s dose is higher and over a weekly schedule as compared to applicant’s amended claim.
The rejection under USC 103 over Kasagi, Hu and CN101185634A is withdrawn per applicant’s amendments and arguments.
The rejections under obviousness type double patenting in view of Hu are withdrawn, however, due to amendment other references were added to teach the dosing limitation as obvious in regards to the cited patents and copending application.
As these rejections are withdrawn, applicant’s arguments toward these rejections are moot. Applicant’s amendment to indicate a more restricted rate as well as limiting to only once every two weeks needed new search and consideration of the prior art.
New Rejections – As Necessitated by Amendments
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 and 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kasagi WO 2018181963 (in applicant’s IDS) in view of Inspire (Ovarian Cancer, Borderline3 post from Sept 21, 2013 at 4:27 PM, https://www.inspire.com/groups/ovarian-cancer/discussion/topotecan-44/) and Morris et al (The Oncologist, 2002, volume 7, pages 29-35).
Kasagi teaches “a liposome composition and a pharmaceutical composition, which exhibit a high AUC. Provided are a liposome composition including a hydrophilic polymer-modified diacylphosphatidylethanolamine, a dihydrosphingomyelin, and cholesterols as components of a liposome membrane, in which the liposome composition encapsulates a drug, an inner water phase thereof contains ammonium sulfate, and a molar ratio of sulfate ions in the inner water phase to the drug in an entire water phase is 0.36 or more; and a pharmaceutical composition including the liposome composition” (abstract, claims 1-3 and 9 of Kasagi). Kasagi teaches the drug being topotecan in the formulation (claim 2 of Kasagi and examples 1-8 of Kasagi). Kasagi teaches “the dihydrosphingomyelin is dihydrosphingomyelin containing a long-chain alkyl group having 16 and 18 carbon atoms, and the encapsulating drug is topotecan or a salt thereof” (claim 9 of Kasagi). Kasagi teaches “wherein the hydrophilic polymer-modified diacylphosphatidylethanolamine is a polyethylene glycol- or methoxy polyethylene glycol-modified diacylphosphatidylethanolamine” (claim 4 of Kasagi). Kasagi teaches “wherein the percentage of cholesterols in the liposome is 35 to 43 mol %” (claim 6 of Kasagi). Kasagi provides for the composition being an anticancer composition and cancers including small cell lung cancer, breast cancer, prostate cancer, colon cancer, cervical cancer, childhood solid tumor, renal cancer and others. Kasagi teaches mice administered the formulations with topotecan lipsomes to calculate AUC (Measurement of AUC). Kasagi teaches administering to a mouse cancer model (subcutaneous transplant mouse model with human lung cancer cells (Efficacy test using A549…). Kasagi provides for tumor volume being measured from the start of administration (see figures 3 and 4). Kasagi teaches a pH of the outer aqueous phase being 5.5 to 8.5 (claim 8 of Kasagi). Kasagi teaches administered once a week twice (Efficacy test using A549…). In measure of AUC, area under the curve was found after a single administration (Measurement of AUC). Kasagi provides that dosage and number of administrations of doses can be set according to the type of drug. Kasagi provides for intravenous injection or infusion as a route of administration.
Kasagi does not teach administered at dose rate of 0.1 mg/m2 body surface area to 10 mg/m2 body surface area, in terms of topotecan per administration of claim 1. Kasagi does not teach for 5 minutes to 360 minutes in a single infusion administration of claim 11.
Inspire teaches the doctor changed a patients dose of topotecan from once a week for three weeks, followed by one week off for four week cycles to once every two weeks (Borderline3 post from Sept 21, 2013). Thus, doctors were able to change the time frame of administration.
Morris teaches alternate dosing schedules for topotecan in the treatment of ovarian cancer (title and abstract). Morris teaches IV bolus and intravenous infusions (abstract). Morris teaches dose regimens of 1.5 mg/m2/day as 30 minute IV bolus or 2.5 mg/m2 given as 30 minute IV infusion (first column and second column of page 31). Morris notes optimizations are made to increase efficacy, decrease toxicity and increase convenience of administration (abstract).
One of ordinary skill in the art before the time of filing would have provided a topotecan infusion dosage or IV bolus within the range of applicant’s claims for treating cancer as taught by Kasagi as Inspire recognizes a doctor can make adjustments to once every two weeks for topotecan while known administrations in Morris include 1.5 mg/m2 and 2.5 mg/m2 in treating ovarian cancer. Morris also recognizes the ability to optimize dosing regiments for better efficacy and less toxicity while also considering patient convenience. Therefore, there was a reasonable expectation of success in administering Kasagi’s formulations by teachings of Inspire and Morris to patients with cancer to have efficacy against the cancer while having tolerable toxicity.
Claim(s) 1-3 and 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kasagi WO 2018181963 (in applicant’s IDS) in view of Inspire (Ovarian Cancer, Borderline3 post from Sept 21, 2013 at 4:27 PM, https://www.inspire.com/groups/ovarian-cancer/discussion/topotecan-44/); Morris et al (The Oncologist, 2002, volume 7, pages 29-35) and CN101185634A (provided with Google English translation).
Kasagi, Inspire and Morris teach the claims as discussed above.
Kasagi, Inspire and Morris do not teach all the cancers provided in the group of the claims. This rejection is to provide other species of cancer where topotecan would help treat.
CN ‘634 teaches a formulation with topotecan as the active (abstract). CN ‘634 provides for treating skin carcinoma and cerebral tumor among others (English translation and claim 10 of ‘634). Cerebral is a portion of the brain.
One of ordinary skill in the art before the time of filing would have utilized the topotecan formulation of Kasagi in subjects with various cancers including skin carcinomas and cerebral cancers/tumors seen as treatable with topotecan formulations with the reasonable expectation of success in treating such cancers using methods motivated by Kasagi, Inspire and Morris.
Non-Statutory 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 1-3 and 5-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-9, 12-15 of U.S. Patent No. 11413244 in view of Inspire (Ovarian Cancer, Borderline3 post from Sept 21, 2013 at 4:27 PM, https://www.inspire.com/groups/ovarian-cancer/discussion/topotecan-44/) and Morris et al (The Oncologist, 2002, volume 7, pages 29-35). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for treating cancer with a similar formulation of topotecan having similar liposomes. ‘244 provides the genus of cancer, and thus, it would be obvious for one of ordinary skill in the art to use this with patients affected by a cancer.
‘244 does not provide for intravenous infusion for a time range as claimed, particular cancers of the claims or the limitation of “administered at dose rate of 0.1 mg/m2 body surface area to 10 mg/m2 body surface area, in terms of topotecan per administration of claim 1”.
Inspire teaches the doctor changed a patients dose of topotecan from once a week for three weeks, followed by one week off for four week cycles to once every two weeks (Borderline3 post from Sept 21, 2013). Thus, doctors were able to change the time frame of administration.
Morris teaches alternate dosing schedules for topotecan in the treatment of ovarian cancer (title and abstract). Morris teaches IV bolus and intravenous infusions (abstract). Morris teaches dose regimens of 1.5 mg/m2/day as 30 minute IV bolus or 2.5 mg/m2 given as 30 minute IV infusion (first column and second column of page 31). Morris notes optimizations are made to increase efficacy, decrease toxicity and increase convenience of administration (abstract).
One of ordinary skill in the art before the time of filing would have provided a topotecan infusion dosage or IV bolus within the range of applicant’s claims to treating cancer of ‘244 as Inspire recognizes a doctor can make adjustments to once every two weeks for topotecan while known administrations in Morris include 1.5 mg/m2 and 2.5 mg/m2 in treating ovarian cancer. Morris also recognizes the ability to optimize dosing regiments for better efficacy and less toxicity while also considering patient convenience. Therefore, there was a reasonable expectation of success in administering ‘244’s formulations by teachings of Inspire and Morris to patients with cancer to have efficacy against the cancer while having tolerable toxicity.
Claims 1-3 and 5-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-11, 14 and 15 of U.S. Patent No. 11446247 in view of Inspire (Ovarian Cancer, Borderline3 post from Sept 21, 2013 at 4:27 PM, https://www.inspire.com/groups/ovarian-cancer/discussion/topotecan-44/) and Morris et al (The Oncologist, 2002, volume 7, pages 29-35). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for treating cancer with a similar formulation of topotecan having similar liposomes. ‘247 provides the genus of cancer, and thus, it would be obvious for one of ordinary skill in the art to use this with patients affected by a cancer.
‘247 does not provide for intravenous infusion for a time range as claimed, particular cancers of the claims or the limitation of “administered at dose rate of 0.1 mg/m2 body surface area to 10 mg/m2 body surface area, in terms of topotecan per administration of claim 1”.
Inspire teaches the doctor changed a patients dose of topotecan from once a week for three weeks, followed by one week off for four week cycles to once every two weeks (Borderline3 post from Sept 21, 2013). Thus, doctors were able to change the time frame of administration.
Morris teaches alternate dosing schedules for topotecan in the treatment of ovarian cancer (title and abstract). Morris teaches IV bolus and intravenous infusions (abstract). Morris teaches dose regimens of 1.5 mg/m2/day as 30 minute IV bolus or 2.5 mg/m2 given as 30 minute IV infusion (first column and second column of page 31). Morris notes optimizations are made to increase efficacy, decrease toxicity and increase convenience of administration (abstract).
One of ordinary skill in the art before the time of filing would have provided a topotecan infusion dosage or IV bolus within the range of applicant’s claims to treating cancer of ‘247 as Inspire recognizes a doctor can make adjustments to once every two weeks for topotecan while known administrations in Morris include 1.5 mg/m2 and 2.5 mg/m2 in treating ovarian cancer. Morris also recognizes the ability to optimize dosing regiments for better efficacy and less toxicity while also considering patient convenience. Therefore, there was a reasonable expectation of success in administering ‘247’s formulations by teachings of Inspire and Morris to patients with cancer to have efficacy against the cancer while having tolerable toxicity.
Claims 1-3 and 5-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-9, 14-16 of U.S. Patent No. 12370186 in view of Inspire (Ovarian Cancer, Borderline3 post from Sept 21, 2013 at 4:27 PM, https://www.inspire.com/groups/ovarian-cancer/discussion/topotecan-44/) and Morris et al (The Oncologist, 2002, volume 7, pages 29-35). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for treating cancer with a similar formulation of topotecan having similar liposomes. ‘186 provides the genus of cancer, and thus, it would be obvious for one of ordinary skill in the art to use this with patients affected by a cancer.
‘186 does not provide for intravenous infusion for a time range as claimed, particular cancers of the claims or the limitation of “administered at dose rate of 0.1 mg/m2 body surface area to 10 mg/m2 body surface area, in terms of topotecan per administration of claim 1”.
Inspire teaches the doctor changed a patients dose of topotecan from once a week for three weeks, followed by one week off for four week cycles to once every two weeks (Borderline3 post from Sept 21, 2013). Thus, doctors were able to change the time frame of administration.
Morris teaches alternate dosing schedules for topotecan in the treatment of ovarian cancer (title and abstract). Morris teaches IV bolus and intravenous infusions (abstract). Morris teaches dose regimens of 1.5 mg/m2/day as 30 minute IV bolus or 2.5 mg/m2 given as 30 minute IV infusion (first column and second column of page 31). Morris notes optimizations are made to increase efficacy, decrease toxicity and increase convenience of administration (abstract).
One of ordinary skill in the art before the time of filing would have provided a topotecan infusion dosage or IV bolus within the range of applicant’s claims to treating cancer of ‘186 as Inspire recognizes a doctor can make adjustments to once every two weeks for topotecan while known administrations in Morris include 1.5 mg/m2 and 2.5 mg/m2 in treating ovarian cancer. Morris also recognizes the ability to optimize dosing regiments for better efficacy and less toxicity while also considering patient convenience. Therefore, there was a reasonable expectation of success in administering ‘186’s formulations by teachings of Inspire and Morris to patients with cancer to have efficacy against the cancer while having tolerable toxicity.
Claims 1-3 and 5-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-9, 11 of U.S. Patent No. 12370214 in view of Hu et al (Taiwanese Journal of Obstetrics and Gynecology, Feb 2015, volume 54, pages 43-47). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for treating cancer with a similar formulation of topotecan having similar liposomes. ‘214 provides the genus of cancer, and thus, it would be obvious for one of ordinary skill in the art to use this with patients affected by a cancer.
‘214 does not provide for intravenous infusion for a time range as claimed, particular cancers of the claims or the limitation of “administered at dose rate of 0.1 mg/m2 body surface area to 10 mg/m2 body surface area, in terms of topotecan per administration of claim 1”.
Inspire teaches the doctor changed a patients dose of topotecan from once a week for three weeks, followed by one week off for four week cycles to once every two weeks (Borderline3 post from Sept 21, 2013). Thus, doctors were able to change the time frame of administration.
Morris teaches alternate dosing schedules for topotecan in the treatment of ovarian cancer (title and abstract). Morris teaches IV bolus and intravenous infusions (abstract). Morris teaches dose regimens of 1.5 mg/m2/day as 30 minute IV bolus or 2.5 mg/m2 given as 30 minute IV infusion (first column and second column of page 31). Morris notes optimizations are made to increase efficacy, decrease toxicity and increase convenience of administration (abstract).
One of ordinary skill in the art before the time of filing would have provided a topotecan infusion dosage or IV bolus within the range of applicant’s claims to treating cancer of ‘214 as Inspire recognizes a doctor can make adjustments to once every two weeks for topotecan while known administrations in Morris include 1.5 mg/m2 and 2.5 mg/m2 in treating ovarian cancer. Morris also recognizes the ability to optimize dosing regiments for better efficacy and less toxicity while also considering patient convenience. Therefore, there was a reasonable expectation of success in administering ‘214’s formulations by teachings of Inspire and Morris to patients with cancer to have efficacy against the cancer while having tolerable toxicity.
Claims 1-3 and 5-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 9 of copending 18/516,010. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets provide for treating cancer with a similar formulation of topotecan having similar liposomes. ‘010 provides the species of Merkel cancer (a cancer of applicant’s claims), and thus, it would be seen for one of ordinary skill in the art to use this with patients affected by this cancer. ‘010 provides for intravenous administration and the dose rate of the applicant’s claims. Intravenous administration of ‘010 is a genus that includes injections and infusions.
This is a provisional double patenting rejection as the claims have not yet been patented.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613