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 .
Status of the Application
The claims of 29July 2024 are entered.
The election of 15 June 2026 is entered.
Claims 50-67 and 69-86 have been canceled. Claims 1-49 and 68 are pending. Claims 1-4, 23-26, 46-49, and 68 are withdrawn without traverse. Claims 5-22 and 27-45 are being examined on the merits.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 5-22 and 27-45) and compound I in the reply filed on 15 June 2026 is acknowledged.
Claims 1-4, 22-26, 46-49, and 68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 15 June 2026.
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.
(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.
1. Claims 5-14 and 27-3 are rejected under 35 U.S.C. 102(a)(1) OR 102(a)(2) as being anticipated by Marshall et al. (WO 2021/007435 A1, published 14 January 2021, filed 9 July 2020, priority to 10 July 2019, hereafter referred to as ‘435).
The ‘435 application discloses Compound 11 that is identical to instant Compound 1, including the cytotoxin portion targeting topoisomerase 1 and the linked peptide Pv1 (see e.g. Example 11). ‘435 further discloses that Compound 11 is effective at treatment of a number of cancers when administered daily (see e.g. Examples F through J). The ‘435 application also discloses that the dosing of any of the compounds contained therein can range from 1 mg/kg to about 50 mg/kg and that appropriate dosages can be readily determined by one of ordinary skill in the art as needed (see e.g. p.108 lines 1-3 and 26-28). This anticipates claim 5.
With respect to claim 6, ‘435 discloses that Compound can also be administered intravenously (see e.g. p.197 lines 7-8).
With respect to claims 7-13, as noted above ‘435 discloses both a 1 mg/kg dosage as well as instructions that appropriate dosing can be readily determined by one of ordinary skill in the art before the effective filing date, i.e. one of ordinary skill in the art can also at once envision dosing below 1 mg/kg as claimed.
With respect to claim 14, daily dosing is reasonably a continuous dosing schedule.
With respect to claim 27, as noted above ‘435 discloses 1-50 mg/kg dosing. This can readily be converted to 5 mg/m2 to 100 mg/m2 (see Nair and Jacob for evidence, J. Basic Clin Pharm. 7:27-31).
With respect to claim 28, as noted above ‘435 discloses that IV administration can be a route for delivery.
With respect to claims 29-35, as noted above ‘435 discloses variable dosing as well as indicating that one of ordinary skill in the art can readily determine dosing as needed.
2. Claims 5-14 and 27-3 are rejected under 35 U.S.C. 102(a)(1) OR 102(a)(2) as being anticipated by Marshall et al. (US 2021/0009719 A1, published 14 January 2021, filed 9 July 2020, priority to 10 July 2019, hereafter referred to as ‘719).
The ‘719 application discloses Compound 11 that is identical to instant Compound 1, including the cytotoxin portion targeting topoisomerase 1 and the linked peptide Pv1 (see e.g. Example 11). ‘719 further discloses that Compound 11 is effective at treatment of a number of cancers when administered daily (see e.g. Examples F through J). The ‘719 application also discloses that the dosing of any of the compounds contained therein can range from 1 mg/kg to about 50 mg/kg and that appropriate dosages can be readily determined by one of ordinary skill in the art as needed (see e.g. [0271] and [0274]). This anticipates claim 5.
With respect to claim 6, ‘719 discloses that Compound can also be administered intravenously (see e.g. [0585]).
With respect to claims 7-13, as noted above ‘719 discloses both a 1 mg/kg dosage as well as instructions that appropriate dosing can be readily determined by one of ordinary skill in the art before the effective filing date, i.e. one of ordinary skill in the art can also at once envision dosing below 1 mg/kg as claimed.
With respect to claim 14, daily dosing is reasonably a continuous dosing schedule.
With respect to claim 27, as noted above ‘719 discloses 1-50 mg/kg dosing. This can readily be converted to 5 mg/m2 to 100 mg/m2 (see Nair and Jacob for evidence, J. Basic Clin Pharm. 7:27-31).
With respect to claim 28, as noted above ‘719 discloses that IV administration can be a route for delivery.
With respect to claims 29-35, as noted above ‘719 discloses variable dosing as well as indicating that one of ordinary skill in the art can readily determine dosing as needed.
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.
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.
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.
Claims 14-22 and 36-45 are rejected under 35 U.S.C. 103 as being unpatentable over Marshall et al. (WO 2021/007435 A1, published 14 January 2021, filed 9 July 2020, priority to 10 July 2019) OR Marshall et al. (US 2021/0009719 A1, published 14 January 2021, filed 9 July 2020, priority to 10 July 2019) and Lobacki et al. (US 2020/0405778 A1, published 31 December 2020, filed 17 August 2020, priority to 10 October 2018, hereafter referred to as ‘778).
The relevance of ‘435 or ‘719 is set forth above.
The difference between the prior art references and the claimed invention is that neither discloses continuous dosing or an intermittent dosing schedule.
The ‘778 application suggests treatment of onocology-treatment related conditions, including through administration of topoisomerase inhibitors (see e.g. [0007]. ‘778 also suggests increasing the efficacy of an anti-cancer therapy by using dosing schedules (see e.g. [0276]). In particular, intermittent dosing schedules of 1-14 days followed by resting periods of 1-14 days are suggested, as well as continuous dosing (see e.g. [0276]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of treatment of ‘435 or ‘719 by utilizing the dosing schedule as suggested by ‘778 in order to provide a specified treatment plan. The rationale comes from ‘435 or ‘719 already treating cancer and the skilled artisan recognizing that dose timing is important for proper treatment, which is provided by ‘778. There would have been a reasonable expectation of success because determination of dosing schedules is well within the level of ordinary skill in the art and concomitant to determining an appropriate dose.
With respect to claims 14 and 36, as noted above ‘778 suggests a continuous dosing schedule.
With respect to claims 15-22 and 38-45, as noted above ‘778 suggests intermittent dosing schedules encompassing the ranges as claimed.
With respect to claim 37, once weekly dosing falls within the range of ‘778.
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.
1. Claims 5-13 and 27-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 15 of U.S. Patent No. 11,634,508 B2 in view of Marshall et al. (WO 2021/007435 A1).
The ‘508 patent claims a compound matching Compound I as instantly claimed (see e.g. claims 13 and 15).
The difference between ‘508 and the claimed invention is that ‘508 does not claim a level of the compound nor does it claim a method of treating cancer.
The relevance of ‘435 is set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the compound of ‘508 could have readily be used in a method of treating cancer as disclosed in ‘435 since both ‘508 and ‘435 utilize the same compound. The overlapping compound gives the skilled artisan a rationale to use the method of ‘508. There would have been a reasonable expectation of success because of the identical compounds. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claims 6-13 and 27-35, as noted above the ‘435 application offers a disclosure leading to the claimed dosages, including those in mg/m2.
2. Claims 5-13 and 27-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17, and 18 of U.S. Patent No. 12,410,262 B2 in view of Marshall et al. (WO 2021/007435 A1).
The ‘262 patent claims a method of treating cancer utilizing a compound identical to Compound I as instantly claimed (see e.g. claims 1, 17, and 18).
The difference between ‘262 and the claimed invention is that ‘262 does not claim a specific dosage.
The relevance of ‘435 is set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of ‘262 could have been modified to utilize the dosing as in ‘435. The rationale comes from the overlapping compounds and goal of treating cancer. There would have been a reasonable expectation of success given the common method and compound containing in both ’262 and ‘435. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claims 6-13 and 27-25, as set forth above ‘435 provides for overlapping dosages and conversion to mg/m2.
3. Claims 5-13 and 27-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 51 of copending Application No. 19/281,226 in view of Marshall et al. (WO 2021/007435 A1).
The ‘226 application claims a method of treating ovarian cancer, breast cancer, colorectal cancer, lung cancer, kidney cancer, Ewing’s sarcoma, and solid tumors of childhood by administering a compound that is identical to Compound I as instantly claimed (see e.g. claim 51).
The difference between ‘226 and the claimed invention is that ‘226 does not claim a dosage level.
The relevance of ‘435 is set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of ‘226 could have been modified to utilize the dosing as in ‘435. The rationale comes from the overlapping compounds and goal of treating cancer. There would have been a reasonable expectation of success given the common method and compound containing in both ’226 and ‘435. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claims 6-13 and 27-25, as set forth above ‘435 provides for overlapping dosages and conversion to mg/m2.
This is a provisional nonstatutory double patenting rejection.
4. Claims 14-22 and 36-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 15 of U.S. Patent No. 11,634,508 B2 OR claims 1, 17, and 18 of U.S. Patent No. 12,410,262 B2 in view of Marshall et al. (WO 2021/007435 A1), and further in view of Lobacki et al. (US 2020/0405778 A1, published 31 December 2020, filed 17 August 2020, priority to 10 October 2018).
The relevance of the ‘508 or ‘262 patent in view of ‘435 is set forth above. The difference between the claimed patents and the instant claims is that ‘508 or ‘262 in view of ‘435 does not suggest dosing regimens.
The relevance of ‘778 is set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of ‘508 or ‘262 in view of ‘435 by including the dosing regimens suggested by ‘778. The rationale comes from the skilled artisan seeking a time period for administration of the claimed compositions in order to provide a defined treatment plan. There would have been a reasonable expectation of success because determination of dosing regimens is well within the level of ordinary skill in the art. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claims 14 and 36, as noted above ‘778 suggests a continuous dosing schedule.
With respect to claims 15-22 and 38-45, as noted above ‘778 suggests intermittent dosing schedules encompassing the ranges as claimed.
With respect to claim 37, once weekly dosing falls within the range of ‘778.
5.Claims 15-22 and 36-48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 51 of copending Application No. 19/281,226 in view of Marshall et al. (WO 2021/007435 A1), and further in view of Lobacki et al. (US 2020/0405778 A1, published 31 December 2020, filed 17 August 2020, priority to 10 October 2018).
The relevance of ‘226 and ‘435 is set forth above.
The difference between the ‘226 and ‘435 references and the claimed invention is that neither claims or discloses dosing regimens.
The relevance of ‘778 is set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of ‘226 in view of ‘435 by including the dosing regimens suggested by ‘778. The rationale comes from the skilled artisan seeking a time period for administration of the claimed compositions in order to provide a defined treatment plan. There would have been a reasonable expectation of success because determination of dosing regimens is well within the level of ordinary skill in the art. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claims 14 and 36, as noted above ‘778 suggests a continuous dosing schedule.
With respect to claims 15-22 and 38-45, as noted above ‘778 suggests intermittent dosing schedules encompassing the ranges as claimed.
With respect to claim 37, once weekly dosing falls within the range of ‘778.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached Mon-Thurs 7-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at (571) 270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658
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