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 Claims
Claims 1-13, 15-17, 19-20, 23, and 25 are rejected and under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 25 recites “the prior USC therapy". However, there is insufficient antecedent basis for this limitation, as “USC therapy” is not previously introduced in the claims. Claim 23, on which claim 25 depends, refers to a “prior therapeutic regimen”, but does not further define that a “prior therapeutic regimen” comprises a “prior USC therapy”. It is not clear as to what the Applicant regards as a “USC therapy”, since there is no recitation of the phrase in any of the prior claims from which this claim depends or within this claim itself.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 non-obviousness.
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) 1-13, 15-17, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu, J.F. (Phase II Study of the WEE1 Inhibitor Adavosertib in Recurrent Uterine Serous Carcinoma), Journal of Clinical Oncology, Vol. 39, no.14, pp. 1531-1539 (Year: 2021) in view of Huang, P., et. al. (WO 2019/173082 A1; Published 09/12/2019).
Liu teaches a method of treating a subject having uterine serous carcinoma (USC) by administering to human subjects, Adavosertib, a similar compound to the Applicant’s claimed ZN-C3 with the same mechanism as a WEE1 inhibitor, at a dose of 300 mg orally once daily on days 1 through 5 and 8 through 12 of a 21-day cycle until disease progression (5 days on, 2 days off) (See page 1531; Patients and Methods). This dosing schedule taught by Liu teaches the Applicant’s periodic and intermittent dosing limitations.
Liu further teaches that eligible subjects of the method had advanced, metastatic, or recurrent USC and that 29% of patients with recurrent uterine serous carcinoma, a subtype of endometrial cancer, responded to the treatment and 47% were free of cancer progression six months after being treated (See page 1531; Results).
Liu does not teach the Applicant’s compound, ZN-C3, or a dosing other than 300mg of adavosertib a day.
Huang teaches the Applicants claimed compound, (R) 2-allyl- 1 -(7-ethyl-7-hvdroxv-6,7-dihvdro-5H-cvclopenta[blpvridin-2-vl)-6-((4-(4- methylpiperazin- 1 -yl)phenyl)amino)-1,2-dihydro-3H-pyrazolo[3,4-dlpyrimidin-3-one], also known as ZN-C3, or Azenosertib(See page 70; Example 9B), and that the compound or a pharmaceutically acceptable salt thereof can be administered to a subject orally (See page 43; Col. 0129), in a therapeutically effective amount (See page 2; Col. 0006), to treat uterine cancer (See page 48; Col. 0138).
Huang also suggests that the amount of the compound may be administered in an amount between 1 to 500 mg (See pages 51-52; Col. 0147), that the desired dose may be a single dose or divided doses administered at appropriate intervals (See pages 51-52; Col. 0148), and that the dosage amount and interval may be adjusted individually to provide plasma levels of the active moiety which are sufficient to maintain the modulating effects, or minimal effective concentration (MEC) (See pages 51-52; Col. 0150). Huang supports the idea that limitations such as splitting a dose into smaller, equally spaced-out administrations is a routine solution in the medical art to overcome patient specific dosing requirements.
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The chemical structures of the Applicant’s ZN-C3 (left) and comparable WEE1 inhibitor, adavosertib (right), are shown above. These structures are highly similar, with the only differences between them being the ring closure comprising of an additional carbon in ZN-C3, as well as an ethyl group attached to the bottom five carbon ring in ZN-C3, compared to the methyl group in adavosertib. It would be obvious to one skilled in the art, before the applicants effective filing date, that these minor alterations in structure of adavosertib to arrive at the Applicant’s ZN-C3 in the context of an overall highly similar shared structure, provides a reasonable expectation of success in conserving the WEE1 inhibition mechanism.
"An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
It would have been prima facie obvious to one skilled in the art, before the Applicant’s effective filing date, to modify the method taught by Liu of treating USC by orally administering adavosertib, a potent WEE1 inhibitor shown through clinical trial to be effective in treating advanced and recurrent USC, to a subject having USC, and instead use ZN-C3, a comparable WEE1 inhibitor as taught by Huang, to arrive at the Applicant’s claimed method of treating a subject having advanced or recurrent uterine serous carcinoma (USC), the method comprising orally administering a therapeutically effective amount of (R) 2-allyl- 1 -(7-ethyl-7-hvdroxv-6,7-dihvdro-5H-cvclopenta[blpvridin-2-vl)-6-((4-(4- methylpiperazin- 1 -yl)phenyl)amino)-1,2-dihydro-3H-pyrazolo[3,4-dlpyrimidin-3-one[[ZN-c3]], or a pharmaceutically acceptable salt thereof, at a dose of 200mg per day to about 350mg per day, at the various time intervals and dosing frequencies as claimed, to a subject with advanced or recurrent USC.
Claim(s) 23 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu, J.F. (Phase II Study of the WEE1 Inhibitor Adavosertib in Recurrent Uterine Serous Carcinoma), Journal of Clinical Oncology, Vol. 39, no.14, pp. 1531-1539 (Year: 2021) in view of Huang, P., et. al. (WO 2019/173082 A1; Published 09/12/2019), as applied to claims 1-13, 15-17, and 19-20 above, and further in view of Makker, V. (Treatment of Advanced or Recurrent Endometrial Carcinoma with Doxorubicin in Patients Progressing after Paclitaxel/Carboplatin: Memorial Sloan-Kettering Cancer Center (MSKCC) Experience from 1995-2009), International Journal of Gynecological Cancer, Vol. 23, no.5, pp. 929-934 (Year: 2013), further in view of
Makker, V. (Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer), Journal of Clinical Oncology, Vol. 38, no.26, pp. 2981-2992 (Year: 2020), further in view of
Fader, A.N. (Randomized Phase II Trial of Carboplatin-Paclitaxel Versus Carboplatin-Paclitaxel-Trastuzumab in Uterine Serous Carcinomas That Overexpress Human Epidermal Growth Factor Receptor 2/neu), Journal of Clinical Oncology, Vol. 36, no.20, pp. 2044-2051 (Year: 2018), further in view of
Aghajanian, C. (Phase II Trial of Bevacizumab in Recurrent or Persistent Endometrial Cancer: A Gynecologic Oncology Group Study), Journal of Clinical Oncology, Vol. 29, no.16, pp. 2259-2265 (Year: 2011).
The teachings of Liu and Huang are set forth above and applies as before. However, neither Liu and Huang teach the Applicant’s limitations of the method, wherein the subject was previously treated for the USC by a prior therapeutic regimen, and wherein the regimen comprises a USC therapy comprising at least one selected from Carboplatin, Paclitaxel, Bevacizumab, Trastuzumab, Pembrolizumab, Lenvatinib and Doxorubicin.
The first reference by Makker listed (referred to herein as Makker 1), teaches a method wherein Doxorubicin, Paclitaxel, and Carboplatin (See page 929: Abstract) are administered to patients with advanced or recurrent USC (See pages 4; Patient Characteristics).
The second reference by Makker listed (referred to herein as Makker 2), teaches a method wherein Lenvatinib and pembrolizumab are administered to patients with advanced or recurrent USC (See page 1; Methods).
Fader teaches a method wherein trastuzumab is administered with carboplatin and paclitaxel to patients with advanced or recurrent USC (See page 2044; Abstract).
Aghajanian teaches a method wherein Bevacizumab is administered to patients with advanced or recurrent USC (See page 2259; Abstract).
Makker, Fadder, and Aghajanian collectively teach the use of Carboplatin, Paclitaxel, Bevacizumab, Trastuzumab, Pembrolizumab, Lenvatinib and Doxorubicin in the treatment of advanced or recurrent USC. There medicaments were known in the art, before the Applicant’s filing date, to be used in the art for treating advanced or recurrent USC, and thus any claim limitation requiring the subject of the method to have previously been treated with these routine medicaments is obvious.
One skilled in the art would have had sufficient teaching, suggestion, or motivation, prior to the Applicant’s effective filing date, to modify the method taught by Liu of treating USC by orally administering adavosertib, a potent WEE1 inhibitor shown through clinical trial to be effective in treating advanced and recurrent USC, to a subject having USC, and instead use ZN-C3, a comparable WEE1 inhibitor as taught by Huang, to arrive at the Applicant’s claimed method of treating a subject having advanced or recurrent uterine serous carcinoma (USC), the method comprising orally administering a therapeutically effective amount of (R) 2-allyl- 1 -(7-ethyl-7-hvdroxv-6,7-dihvdro-5H-cvclopenta[blpvridin-2-vl)-6-((4-(4- methylpiperazin- 1 -yl)phenyl)amino)-1,2-dihydro-3H-pyrazolo[3,4-dlpyrimidin-3-one[[ZN-c3]], or a pharmaceutically acceptable salt thereof, at a dose of 200mg per day to about 350mg per day, at the various time intervals and dosing frequencies as claimed, to a subject with advanced or recurrent USC. One skilled in the art would have further had sufficient teaching, suggestion, or motivation, prior to the Applicant’s effective filing date, to use this method in subjects who have previously been treated for advanced or recurrent USC with routine medicaments in the art such as Carboplatin, Paclitaxel, Bevacizumab, Trastuzumab, Pembrolizumab, Lenvatinib and Doxorubicin.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
(Of Note: The following double patenting rejections are PROVISIONAL)
Claims 1-13, 15-17, 19-20, 23, and 25 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent Application No. 19/045,327: 12, 30, 46, 51, 62, and 63 (for present claims 1-13, 15-17, 19-20, 23, and 25), in view of Liu, J.F. (Phase II Study of the WEE1 Inhibitor Adavosertib in Recurrent Uterine Serous Carcinoma), Journal of Clinical Oncology, Vol. 39, no.14, pp. 1531-1539 (Year: 2021) further in view of Huang, P., et. al. (WO 2019/173082 A1; Published 09/12/2019), further in view of
Makker, V. (Treatment of Advanced or Recurrent Endometrial Carcinoma with Doxorubicin in Patients Progressing after Paclitaxel/Carboplatin: Memorial Sloan-Kettering Cancer Center (MSKCC) Experience from 1995-2009), International Journal of Gynecological Cancer, Vol. 23, no.5, pp. 929-934 (Year: 2013),
further in view of
Makker, V. (Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer), Journal of Clinical Oncology, Vol. 38, no.26, pp. 2981-2992 (Year: 2020),
further in view of
Fader, A.N. (Randomized Phase II Trial of Carboplatin-Paclitaxel Versus Carboplatin-Paclitaxel-Trastuzumab in Uterine Serous Carcinomas That Overexpress Human Epidermal Growth Factor Receptor 2/neu), Journal of Clinical Oncology, Vol. 36, no.20, pp. 2044-2051 (Year: 2018),
further in view of
Aghajanian, C. (Phase II Trial of Bevacizumab in Recurrent or Persistent Endometrial Cancer: A Gynecologic Oncology Group Study), Journal of Clinical Oncology, Vol. 29, no.16, pp. 2259-2265 (Year: 2011).
(Of Note: This rejection will support the rejections that follow below where applicable.)
Although the claims are not identical, they are not patentably distinct from one another because the claims of the co-pending application are also drawn to the same compound and method of the instant application, with comparable and obvious limitations such as formulation modifications using the claimed compound in a comparable method, and obvious dosing regimens and routes of administration using the claimed compound in a comparable method. The co-pending claims 12, 30, 46, 51, 62, and 63 are all drawn to the same compound (ZN-c3 and corresponding names and structures) and formulations thereof, used in comparable methods of administration to a subject with cancer, with a further limitation of that cancer being USC, as taught in Applicant’s claims 1-13, 15-17, 19-20, 23, and 25. A notable limitation in the method of the co-pending that is not in that of the Applicant includes an additional step of detecting a polymorphism in a subject, thereby identifying a sensitivity to the claimed compound, ZN-C3. The co-pending method requiring this additional limitation anticipates the Applicant’s method without the limitation. Notable limitations in the method of the Applicant that are not in that of the co-pending include oral dosing, the specific dosing amounts and regimens claimed, such as specific doses of ZN-C3 being from 150mg to 350mg administered in single or multiple doses, different dosing schedules within a weekly time frame (intermittent and periodic dosing), as well as use of additional therapeutic agents known to be effective for USC, and the requirement that the subject was previously treated with these therapeutic agents prior to being administered the claimed compound, ZN-C3. However, these limitations are not patentably distinct, as they are routine and obvious.
Liu teaches a method of treating a subject having uterine serous carcinoma (USC) by administering to human subjects, Adavosertib, a similar compound to the Applicant’s claimed ZN-C3 with the same mechanism as a WEE1 inhibitor, at a dose of 300 mg orally once daily on days 1 through 5 and 8 through 12 of a 21-day cycle until disease progression (5 days on, 2 days off) (See page 1531; Patients and Methods). This dosing schedule taught by Liu teaches the Applicant’s periodic and intermittent dosing limitations.
Liu further teaches that eligible subjects of the method had advanced, metastatic, or recurrent USC and that 29% of patients with recurrent uterine serous carcinoma, a subtype of endometrial cancer, responded to the treatment and 47% were free of cancer progression six months after being treated (See page 1531; Results).
Liu does not teach the Applicant’s compound, ZN-C3, or a dosing other than 300mg of adavosertib a day.
Huang teaches the Applicants claimed compound, (R) 2-allyl- 1 -(7-ethyl-7-hvdroxv-6,7-dihvdro-5H-cvclopenta[blpvridin-2-vl)-6-((4-(4- methylpiperazin- 1 -yl)phenyl)amino)-1,2-dihydro-3H-pyrazolo[3,4-dlpyrimidin-3-one], also known as ZN-C3, or Azenosertib(See page 70; Example 9B), and that the compound or a pharmaceutically acceptable salt thereof can be administered to a subject orally (See page 43; Col. 0129), in a therapeutically effective amount (See page 2; Col. 0006), to treat uterine cancer (See page 48; Col. 0138).
Huang also suggests that the amount of the compound may be administered in an amount between 1 to 500 mg (See pages 51-52; Col. 0147), that the desired dose may be a single dose or divided doses administered at appropriate intervals (See pages 51-52; Col. 0148), and that the dosage amount and interval may be adjusted individually to provide plasma levels of the active moiety which are sufficient to maintain the modulating effects, or minimal effective concentration (MEC) (See pages 51-52; Col. 0150). Huang supports the idea that limitations such as splitting a dose into smaller, equally spaced-out administrations is a routine solution in the medical art to overcome patient specific dosing requirements.
However neither Liu and Huang teach the Applicant’s limitations of the method, wherein the subject was previously treated for the USC by a prior therapeutic regimen, and wherein the regimen comprises a USC therapy comprising at least one selected from Carboplatin, Paclitaxel, Bevacizumab, Trastuzumab, Pembrolizumab, Lenvatinib and Doxorubicin.
The first reference by Makker listed (referred to herein as Makker 1), teaches a method wherein Doxorubicin, Paclitaxel, and Carboplatin (See page 929: Abstract) are administered to patients with advanced or recurrent USC (See pages 4; Patient Characteristics).
The second reference by Makker listed (referred to herein as Makker 2), teaches a method wherein Lenvatinib and pembrolizumab are administered to patients with advanced or recurrent USC (See page 1; Methods).
Fader teaches a method wherein trastuzumab is administered with carboplatin and paclitaxel to patients with advanced or recurrent USC (See page 2044; Abstract).
Aghajanian teaches a method wherein Bevacizumab is administered to patients with advanced or recurrent USC (See page 2259; Abstract).
It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of co-pending application 19/045,327, further in view of Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13, 15-17, 19-20, 23, and 25 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent Application No. 18/004,628: 38, 39, 40, 44 (for present claims 1-13, 15-17, 19-20, 23, and 25), in view of Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned).
Although the claims are not identical, they are not patentably distinct from one another because the claims of the co-pending application are also drawn to the same compound and method of the instant application, with comparable and obvious limitations such as formulation modifications using the claimed compound in a comparable method, and obvious dosing regimens and routes of administration using the claimed compound in a comparable method. The co-pending claims 38, 39, 40, and 44 are all drawn to the same compounds and formulations thereof, used in comparable methods as taught in Applicant’s claims 1-13, 15-17, 19-20, 23, and 25. It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of co-pending application 18/004,628, further in view of Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13, 15-17, 19-20, 23, and 25 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent Application No. 17/998,561: 1 and 24 (for present claims 1-13, 15-17, 19-20, 23, and 25), and Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned).
Although the claims are not identical, they are not patentably distinct from one another because the claims of the co-pending application are also drawn to the same compound and method of the instant application, with comparable and obvious limitations such as formulation modifications using the claimed compound in a comparable method, and obvious dosing regimens and routes of administration using the claimed compound in a comparable method, differentiating the two. The co-pending claims 1 and 24 are all drawn to the same compounds and formulations thereof, used in comparable methods as taught in Applicant’s claims 1-13, 15-17, 19-20, 23, and 25. Notable limitations in the method of the co-pending application that are not in that of the instant application, include the administration of an alternate compound in addition to ZN-C3. The method of the co-pending requiring this additional limitation anticipates the instant method without the limitation. It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of co-pending application 17/998,561, further in view of Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13, 15-17, 19-20, 23, and 25 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent Application No. 19/201,378: 1, 2, 6, 8, 9, 14, 29, and 30 (for present claims 1-13, 15-17, 19-20, 23, and 25), Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned.
Although the claims are not identical, they are not patentably distinct from one another because the claims of the co-pending application are also drawn to the same compound and method of the instant application, with comparable and obvious limitations such as formulation modifications using the claimed compound in a comparable method, and obvious dosing regimens and routes of administration using the claimed compound in a comparable method, differentiating the two. The co-pending claims 1, 2, 6, 8, 9, 14, 29, and 30 are all drawn to the same compounds and formulations thereof, used in comparable methods as taught in Applicant’s claims 1-13, 15-17, 19-20, 23, and 25. It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of co-pending application 19/201,378, further in view of Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13, 15-17, 19-20, 23, and 25 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent Application No. 18/389,654: 2 and 4 (for present claims 1-13, 15-17, 19-20, 23, and 25), and Huang, P., et. al. (WO 2019/173082 A1; Published 09/12/2019).
Although the claims are not identical, they are not patentably distinct from one another because the claims of the co-pending application are also drawn to the same compound and method of the instant application, with comparable and obvious limitations such as formulation modifications using the claimed compound in a comparable method, and obvious dosing regimens and routes of administration using the claimed compound in a comparable method, differentiating the two. The co-pending claims 2 and 4 are drawn to the same compounds and formulations thereof, used in comparable methods as taught in Applicant’s claims 1-13, 15-17, 19-20, 23, and 25. A notable limitation in the method of the co-pending that is not in that of the instant application, is the assay to determine if the subject has an altered function of CCNE1. However, the co-pending method requiring this additional limitation anticipates instant method without the limitation. It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of co-pending application 18/389,654, further in view of Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13, 15-17, 19-20, 23, and 25 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent Application No. 18/648,164: 1, 2, 4, and 14 (for present claims 1-13, 15-17, 19-20, 23, and 25), and Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned.
(Of Note: Co-pending 18/648,164 contains claims that are indefinite and not distinctly categorized under a statutory category (Product/Method). The following rejection applies to the extent that the co-pending claims are directed to a method of using the compound to treat a subject.)
Although the claims are not identical, they are not patentably distinct from one another because the claims of the co-pending application are also drawn to the same compound and method of the instant application, with comparable and obvious limitations such as formulation modifications using the claimed compound in a comparable method, and obvious dosing regimens and routes of administration using the claimed compound in a comparable method, differentiating the two. The co-pending claims 1, 2, 4, and 14 are drawn to the same compounds and formulations thereof, used in comparable methods as taught in Applicant’s claims 1-13, 15-17, 19-20, 23, and 25. A notable limitation in the method of the co-pending that is not in that of the instant application, is the use of a compound in addition to ZN-C3. However, the method requiring this limitation anticipates the instant method without the additional compound.
It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of co-pending application 18/648,164, and Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13, 15-17, 19-20, 23, and 25 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent Application No. 18/634055: 1, 2, 4, and 11 (for present claims 1-13, 15-17, 19-20, 23, and 25), and Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned.
(Of Note: Co-pending 18/634055 contains claims that are indefinite and not distinctly categorized under a statutory category (Product/Method). The following rejection applies to the extent that the co-pending claims are directed to a method of using the compound to treat a subject.)
Although the claims are not identical, they are not patentably distinct from one another because the claims of the co-pending application are also drawn to the same compound and method of the instant application, with comparable and obvious limitations such as formulation modifications using the claimed compound in a comparable method, and obvious dosing regimens and routes of administration using the claimed compound in a comparable method, differentiating the two. The co-pending claims 1, 2, 4, and 11 are drawn to the same compounds and formulations thereof, used in comparable methods as taught in Applicant’s claims 1-13, 15-17, 19-20, 23, and 25. A notable limitation in the method of the co-pending that is not in that of the instant application, is the use of an anti-CD47 antibody compound in addition to ZN-C3. However, the copending method requiring this compound anticipates the instant method without the additional compound.
It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of co-pending application 18/634055, in view of Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13, 15-17, 19-20, 23, and 25 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent Application No. 19/201,446: 1,2,3,27,29, and 34 (for present claims 1-13, 15-17, 19-20, 23, and 25), in view of Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned.
Although the claims are not identical, they are not patentably distinct from one another because the claims of the co-pending application are also drawn to the same compound and method of the instant application, with comparable and obvious limitations such as formulation modifications using the claimed compound in a comparable method, and obvious dosing regimens and routes of administration using the claimed compound in a comparable method, differentiating the two. The co-pending claims 1,2,3,27,29, and 34 are drawn to the same compounds and formulations thereof, used in comparable methods as taught in Applicant’s claims 1-13, 15-17, 19-20, 23, and 25. A notable limitation in the method of the co-pending that is not in that of the instant application, is the selection of a subject with a characterized Cyclin E1 status. However, the co-pending method requiring this limitation anticipates the instant method without the additional limitation.
It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of co-pending application 19/201,446, and Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13, 15-17, 19-20, 23, and 25 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent Application No. 18/793,337: 1, 6-20, and 22-23 (for present claims 1-13, 15-17, 19-20, 23, and 25), in view of Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned.
Although the claims are not identical, they are not patentably distinct from one another because the claims of the co-pending application are also drawn to the same compound and method of the instant application, with comparable and obvious limitations such as formulation modifications using the claimed compound in a comparable method, and obvious dosing regimens and routes of administration using the claimed compound in a comparable method, differentiating the two. The co-pending claims 1, 6-20, and 22-23 are drawn to the same compounds and formulations thereof, used in comparable methods as taught in Applicant’s claims 1-13, 15-17, 19-20, 23, and 25.
It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of co-pending application 18/793,337, and Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(Of Note: The following double patenting rejections are NONPROVISIONAL)
Claims 1-13, 15-17, 19-20, 23, and 25 are rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent Application No. 16/971,254: 125, 126, and 127 (for present claims 1-13, 15-17, 19-20, 23, and 25), in view of Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned.).
Although the claims are not identical, they are not patentably distinct from one another because the claims of the co-pending application are also drawn to the same compound and method of the instant application, with comparable and obvious limitations such as formulation modifications using the claimed compound in a comparable method, and obvious dosing regimens and routes of administration using the claimed compound in a comparable method, differentiating the two. The co-pending claims 125, 126, and 127 are drawn to the same compounds and formulations thereof, used in comparable methods as taught in Applicant’s claims 1-13, 15-17, 19-20, 23, and 25.
It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of co-pending application 16/971,254, and Liu, Huang, Makker, Fader, and Aghajanian, as previously mentioned.
Claims 1-13, 15-17, 19-20, 23, and 25 are rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent Application No. 16/635348: 46,47, and 49 (for present claims 1-13, 15-17, 19-20, 23, and 25), in view of Huang, Makker, Fader, and Aghajanian, as previously mentioned.
Although the claims are not identical, they are not patentably distinct from one another because the claims of the co-pending application are also drawn to the same compound and method of the instant application, with comparable and obvious limitations such as formulation modifications using the claimed compound in a comparable method, and obvious dosing regimens and routes of administration using the claimed compound in a comparable method, differentiating the two. The co-pending claims 46, 47, and 49 are drawn to the same compounds and formulations thereof, used in comparable methods as taught in Applicant’s claims 1-13, 15-17, 19-20, 23, and 25.
It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of co-pending application 16/635348, and Huang, Makker, Fader, and Aghajanian, as previously mentioned.
Conclusion
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/OROD MOTEVALLI/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628