Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group I (method treating cancer) and election of compound 4419; election of breast cancer and election of the species of cancer characteristic MnSOD with an AcK68 mutation in the reply filed on 09/08/25 is acknowledged. Claims 6, 8, 10, 33, 35, 52, and 65-70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/08/25.
Claims 1-2, 6, 8-10, 22, 24, 32-33, 35, 44, and 53-70 are currently pending in the application. However, due to a restriction requirement, claims 6, 8, 10, 33, 35, 52, and 65-70 are withdrawn from further consideration and claims 1-2, 9, 22, 24, 32, 44, and 53-64 are being examined on the merits herein.
Thus the requirement is deemed proper and is therefore made final.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. The earliest application that provides adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application is PCT application No. PCT/US20/35725. Thus, the priority date of the instant invention is June 02, 2020.
IDS
The information disclosure statements (IDS) submitted on 01/04/23 (5 of them), 03/10/23, 07/01/24, and 07/11/24 are acknowledged and have been entered. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
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 primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicant(s) regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claims 1-2, 9, 22, 24, 32. 44, and 53-64 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Firstly, independent claim 1 recites that “W, together with the nitrogen…” on line 26 and ”the hydrogen attached to the nitrogen..” on line 30. Specifically, the macrocycle contains at least 3 Nitrogen and thus it is unclear with “nitrogen” is applicant referring to. The same issue exists in claims 2, 22, 24, 32, 44,
As a result of the above inconsistencies, the aforementioned claims are unable to be examined as disclosed given that the scope of the claimed subject matter would not be able to be determined by one of ordinary skill in the art. However, for the sake of compact prosecution, the Examiner will construe that “the nitrogen” being referred to is the closest nitrogen do the W at the bottom of the macrocycle.
Provisional 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 22, 24, 32, 44, and 53-64 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 13-14, 51-52, 65-66, 87, and 113 of U.S. Patent Application No. 18/072,223 (hereinafter Gius US Patent Application No. ‘223). Although the conflicting claims are not completely identical, they are not patentably distinct from each other because both applications are directed to a method of treating cancer with a characteristic of a level of MnSOD with AcK68 mutation comprising administering a pentaaza macrocyclic ring containing compound. The claimed invention is rendered obvious by U.S. Patent Application Gius ‘223 as the claimed invention teaches a broad genus of a cancer with a subset of characteristics comprising administering a pentaaza macrocylic compound of formula (I) whereas Gius ‘224 teaches a subgenus of the same cancer comprising administering the same pentaaza macrocyclic compound wherein said characteristic further include additional characteristic such as Ki67 excess protein and excess level of OCT4. Thus, the aforementioned claims of the instant application are rendered obvious as discussed hereinabove and are prima facie obvious over the cited claims of corresponding U.S. Patent Application No. 18/072,223.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1-2, 9, 22, 24, 44, and 53-64 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 91-92, 95-100, and 103 of U.S. Patent Application No. 17/566,335 (hereinafter Beardsley US Patent No. ‘335). Although the conflicting claims are not completely identical, they are not patentably distinct from each other because both applications are directed to a method of treating cancer comprising administering a pentaaza macrocyclic ring containing compound. The claimed invention is rendered obvious by U.S. Patent Application Beardsley ‘335 as the claimed invention teaches a subgenus of a cancer with a subset of characteristics comprising administering a pentaaza macrocylic compound of formula (I) whereas Beardsley ‘335 teaches a broad genus of cancer comprising administering the same pentaaza macrocyclic compound and a CTLA-4 and/or anti-PDL1 and/or an anti-PD1 inhibitor and further addition of chemotherapy. While the instant invention is silent on addition of an additional therapeutic agent, the instant invention recites the term comprising which does not exclude addition of other drugs to the method. Thus, the aforementioned claims of the instant application are rendered obvious as discussed hereinabove and are prima facie obvious over the cited claims of corresponding U.S. Patent No. 17/566,335.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented
Claims 1-2, 9, 22, 24, 44, and 53-64 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-3, 6, and 15-16 of U.S. Patent No. 12,220,420 (hereinafter Beardsley US Patent Application No. ‘420). Although the conflicting claims are not completely identical, they are not patentably distinct from each other because both applications are directed to a method of treating cancer comprising administering a pentaaza macrocyclic ring containing compound. The claimed invention is rendered obvious by U.S. Patent Beardsley ‘420 as the claimed invention teaches a subgenus of a cancer with a subset of characteristics comprising administering a pentaaza macrocylic compound of formula (I) whereas Beardsley ‘420 teaches a subgenus of cancer such as lung cancer and breast cancer comprising administering the same pentaaza macrocyclic compound and a thioredoxin inhibitor, auranofin. While the instant invention is silent on addition of a thioredoxin inhibitor, the instant invention recites the term comprising which does not exclude addition of other drugs to the method. Thus, the aforementioned claims of the instant application are rendered obvious as discussed hereinabove and are prima facie obvious over the cited claims of corresponding U.S. Patent No. 12,220,420.
Claims 1-2, 9, 22, 24, 44, and 53-64 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 7, and 10 of U.S. Patent No. 11,246,950 (hereinafter Beardsley US Patent No. ‘950). Although the conflicting claims are not completely identical, they are not patentably distinct from each other because both applications are directed to a method of treating cancer comprising administering a pentaaza macrocyclic ring containing compound. The claimed invention is rendered obvious by U.S. Patent Beardsley ‘950 as the claimed invention teaches a subgenus of a cancer with a subset of characteristics comprising administering a pentaaza macrocylic compound of formula (I) whereas Beardsley ‘950 teaches a broad genus of cancer comprising administering the same pentaaza macrocyclic compound and a CTLA-4 and/or anti-PDL1 and/or an anti-PD1 inhibitor. While the instant invention is silent on addition of an additional therapeutic agent, the instant invention recites the term comprising which does not exclude addition of other drugs to the method. Thus, the aforementioned claims of the instant application are rendered obvious as discussed hereinabove and are prima facie obvious over the cited claims of corresponding U.S. Patent No. 12,220,420.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 9, 22, 24, 32, 44, and 53-64 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Beardsley et al. (WO2018/191676; cited and filed on an IDS 1449) in view of Zhu et al. (Nature Communications, June 2019, Vol. 10, No. 2399, pgs. 2570-2579; cited and filed on an IDS 1449).
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.
Beardsley et al. teach a combination of cancer immunotherapy with pentaaza macrocyclic complex in a mammalian afflicted with cancer including administering an immune checkpoint inhibitor along with a pentaaza macrocyclic ring complex of Formula (I) and wherein formula (I) is administered prior to, concomitantly, or after administration of the immune checkpoint inhibitor in order to increase the response to the checkpoint inhibitor (instant claim 53; see abstract and para 0008, 0012, & 0014). Importantly, preferred compounds include 4419 (see pg. 31). In addition, Beardsley et al. teach that the immunotherapy inhibitor include various compounds including PD-1 inhibitors, anti-PDL1 and anti-PDL2 inhibitors, anti-CTLA4 inhibitors, or ipilimumab, pembrolizumab, nivolumab, etc.. (see para 00197). Moreover, Beardsley et al. teach additional cancer therapies can be added to the method of treating cancer including radiation therapy, chemotherapy such as docetaxel (instant claim 53; i.e. hormone receptor associated therapeutic agent that inhibits Androgen receptor; instant claim 32) (see para. 0214, 0216, 272, & 285). Additionally, Beardsley et al. teach treatment of various cancers including breast cancer (i.e. elected species), adenomas, carcinomas, etc..(see para 0240-0242 and 0386).
Beardsley et al. do not specifically teach that the cancer has the characteristic of a level of MnSOD that is acetylated at AcK68 that exceeds a predetermined threshold level. Additionally, Beardsley et al. do not teach selecting a patient by obtaining a tissue sample, testing, and determining suitability for said treatment with a pentaaza macrocyclic compound. Beardsley et al. also failed to disclose a secondary threshold level for MnSOD utilizing an average of 6 non-cancerous samples.
Zhu et al. teach that Manganese superoxide dismutase (MnSOD) typically functions as a tumor suppressor but MnSOD-K68 acetylation mimic mutant functions as a tumor promoter wherein said mutant changes from an MnSODK68 stoichiometry in breast cancer cells homotetramer complex to a monomeric form (see abstract). Additionally, Zhu et al. obtained samples and tested ER+ MCF7 (breast cancer cells) with WT, and lenti-MnSODK68R, and lenti-MnSODK68Q and found that mutant cells or lenti-MnSODK68Q grew in the absence of estrogen supplementation (see Result Section; fig. 1). Moreover, in breast cancer cells MnSODAcK68 was found to have a decrease in detoxification activity, its primary function (see figure 5). This suggests that tumors with said mutants possessed increased growth characteristics and estrogen independent estrogen growth capability (see results section, paragraph 2, figures 1-2). Overall, these results provide evidence that MnSOD AcK68 promotes tumorigenesis and functions as a tumor promoter (see abstract and Discussion).
Thus, to one of ordinary skill in the art at the time of the invention would have found it obvious to utilize compound 4419 as taught by Beardsley et al. since Beardsley et al. demonstrated effective treatment of breast cancer cells utilizing said pentaaza macrocyclic complex compound. Additionally, one skilled in the art would have followed the teachings of Zhu and select a patient to be treated based on the levels of MnSOD Ack68 since Zhu teaches that said mutant shifts from a protective antioxidant tetramer to a tumor promoting monomer and therapy resistance and thus measuring and testing the levels of tetramer to monomer in a given sample tissue would have indicated to one of ordinary skill in the art which patients would be treatable by and in need of treatment of the method of Beardsley. Given the teachings of Beardsley and Zhu et al., one of ordinary skill would have been motivated to utilize the pentaaza macrocyclic compound with the reasonable expectation of providing a method that is useful in treating breast cancer including patients displaying high level of MnSOD AcK68 mutation.
Conclusion
Claims are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Director Patricia Mallari whose telephone number is 571-272-4729. The Supervisory Primary Examiner can normally be reached on 12:00-8:00 PM EST M-F at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642