DETAILED ACTION
All rejections and objections not mentioned below have been withdrawn.
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 .
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, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 63/114,787 and 63/115,879, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The PRO applications lack support for structures similar to 9-ING-41 and only provides for 9-ING-41. Thus a priority date of 11/17/2021 was given for all claims.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/04/2023 is being considered by the examiner.
Claim Objections- New Due to Amendment
Claims 3-5 are objected to because of the following informalities: the CID numbers should be drawn as chemical structures as the claims need to be complete within themselves. MPEP 2173.05(t) Appropriate correction is required.
Claim Rejections - 35 USC § 103- Modified Due to Amendments
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) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over UGOLKOV (UGOLKOV et al., WO 2020123813 A1, 2020-06-18, previously provided).
The reference UGOLKOV teaches “The diseases that may be treated using the methods of the present disclosure include any diseases or conditions which are characterized by elevated expression of a GSK- 3 isoform. Such diseases include cancers, such as, for example, breast cancer, brain cancer, esophagus cancer, stomach cancer, lung cancer, liver cancer, kidney cancer, thyroid gland cancer, spleen cancer, pancreatic cancer, colon cancer, skin cancer, ovarian cancer, uterus cancer, prostate cancer, bladder cancer, testicular cancer, osteosarcoma, or fibrosarcoma. In some embodiments, the cancer is breast cancer, pancreatic cancer, or colon cancer. In some embodiments, the cancer is breast cancer. In other embodiments, the cancer is pancreatic cancer. In yet other embodiments, the cancer is colon cancer” [0065] and “In some aspects, the present disclosure is directed to a method of the preceding aspects wherein the cancer is breast cancer, brain cancer, esophagus cancer, stomach cancer, lung cancer, liver cancer, kidney cancer, thyroid gland cancer, spleen cancer, pancreas cancer, large bowel cancer, skin cancer, ovarian cancer, uterus cancer, prostate cancer, bladder cancer, testicular cancer, osteosarcoma, fibrosarcoma” [0018]. This helps to teach claims 3-5.
The reference UGOLKOV teaches “In some aspects, the present disclosure is directed to a method of treating disease in a subject in need thereof by a) obtaining a tissue sample from the subject; b) measuring the expression level of a GSK-3 isoform in the sample, wherein the measuring is performed by immunohistochemical staining; c) comparing the expression level of the GSK- 3 isoform in the tissue sample with the expression level of that GSK-3 isoform in a control sample; and d) administering an effective amount of an inhibitor of the GSK-3 isoform to the subject if an elevated expression level of the GSK-3 isoform in the tissue sample is detected when compared to the expression level of the GSK-3 isoform in the control sample” [0008] and “In some aspects, the present disclosure is directed to a method of the preceding aspects wherein the inhibitor of the GSK-3 isoform is 9-ING-41, tideglusib, or LY2090314” [0013]. This helps to teach claims 3-5.
The reference UGOLKOV teaches “In some embodiments, the GSK-3 inhibitor is administered in combination with a second therapeutic agent, wherein the second therapeutic agent is an anti cancer agent” [0081] and “The present disclosure relates to methods of using immunohistochemical staining to identify tumor cells expressing GSK-3 or GSK-3a and use of such methods to identify cancers susceptible to treatment with inhibitors specific to these target” [0002]. This helps to teach claim 3.
The reference UGOLKOV teaches “In still other embodiments, the second therapeutic agent is one or more of …nivolumab…” [0083]. As acknowledged by the instant specification [0005] and [0044], nivolumab is aPD- 1/PD-L1 therapy. In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963) ("From the standpoint of patent law, a compound and all its properties are inseparable."). This helps to teach claims 3-5.
The reference UGOLKOV does not specifically teach the methods of claims 3-5 and instead requires picking and choosing of variables.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified UGOLKOV to get the methods of the instant invention because the application simply rearranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement. Thus one would be motivated to do so to treat colon cancer with a reasonable expectation of success since such treatment for colon cancer has already been taught in the reference. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Double Patenting- Modified Due to Amendments
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 3-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-13 of copending Application No. 18/841,719 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other .
The application ‘719 claims:
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This anticipates claims 3-5.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 3-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-21 of copending Application No. 18/230,872 and 1-13 of copending Application No. 18/841,719 in view of UGOLKOV (UGOLKOV et al., WO 2020123813 A1, 2020-06-18).
The application ‘872 claims:
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The application ‘719 claims:
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The application ‘872 teaches does not teach specifically teach a GSK-3 inhibitor with structural similarity to 9-ING-41 (all claims) or the combination of the specific drugs of claims 3-5.
The secondary references further teach that all needed changes would be obvious as outlined in the 103 rejection (which is incorporated herein by reference).
It would have been prima facie obvious to one of ordinary skill in the art to have modified application ‘872 and ‘719 with UGOLKOV because application ‘872 and ‘719 teach inhibiting GSK-3 activity for the treatment of cancer and UGOLKOV teaches 9-ING-41 as a GSK-3 inhibitor. Thus one would be motivated to treat cancer by administering 9-ING-41 and one would have a reasonable expectation of success because it is a known GSK-3 inhibitor.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 04/08/2026 have been fully considered but they are not persuasive.
Rejections under 35 USC 103
The applicants argue the following:
“Ugolkov teaches histochemical staining methods for detecting GSK-3 isoforms, and treatment of all forms of cancer in which elevated expression of a GSK-3 isoform is detected. See for example the first sentence of paragraph [0077] of Ugolkov et al. The objective of Ugolkov et al., as stated in paragraph [0007], is to demonstrate "methods of identifying tumor cells that are expressing one or more GSK-3 isoforms so that inhibitors of specific GSK-3 isoforms may be administered to such patients." The present invention, on the other hand, does not teach that the colorectal cancer being treated must exhibit elevated expression of a GSK-3 isoform. Rather, the present inventors demonstrated that GSK-3 inhibition can increase the sensitivity of colorectal cancer to immune cells. It would not be obvious in view of Ugolkov et al. to treat colon cancer in which an elevated expression of GSK-3 had been demonstrated”
This is not persuasive because the examiner need not show that it would have been obvious to treat colon cancer in which an elevated expression of GSK-3 had been demonstrated, the examiner only needs to show the instant invention, which is the treatment of a colorectal cancer in a subject by administering 9-ING-41 and an immunotherapy is obvious. Since it would have been obvious as taught by Ugolkov et al. to treat colon cancer (a type of colorectal cancer) with 9-ING-41 and an immunotherapy (nivolumab) the instant claims have been rejected.
The applicants argue the following:
“One skilled in the art upon reading Ugolkov et al. would also not be taught how to treat colorectal cancer with a reasonable expectation of success. Not only do the present claims lack a requirement to demonstrate elevated levels of GSK-3, but Ugolkov et al. state that their methods can be used to treat ANY type of disease in which elevated levels of GSK-3 are demonstrated, including any type of cancer. It is well-known at the USPTO that substantial evidence is necessary to demonstrate that a method can be used to treat ANY type of cancer. However, Ugolkov et al. do not provide evidence that even one type of cancer can be treated by their method, let alone any type of cancer. Because Ugolkov et al. does not teach treating colorectal cancer with a reasonable expectation of success, Applicants respectfully submit that the present amended claims are non- obvious in view of Ugolkov et al”
This is not persuasive because even if no evidence is provided Ugolkov still suggest treating colon cancer and thus it would have been obvious to do so whether or not they had actual attempted the experiment. Additionally, Ugolkov does not teach the treatment of any cancer but those that are linked to an elevated expression of a GSK- 3 isoform( as pointed out by the applicant). Thus they would have a reasonable expectation to be treated by GSK-3 inhibitor. Furthermore, "Obviousness does not require absolute predictability of success.” Id. at 903, 7 USPQ2d at 1681".
Finally, the applicants argue unexpected results. The unexpected results argument was also not persuasive because unexpected results must be commensurate in scope with the claims. This is however not the case the claims are much broader than the unexpected results listing compound CID: 150974278, compound CID: 137495982, compound CID-59140652:andcompound CID: 16741640 and any immunotherapy or any immune checkpoint therapy or any aPD- 1/PD- Li therapy which have not been shown to have unexpected results in all combinations.
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100C). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F .2d 731,741,218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.). To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
Double Patenting
No arguments have been made against the double patenting rejections and instead the applicants have requested that these rejections be held in abeyance until allowable subject matter has been identified, at which point a terminal disclaimer will be filed.
Conclusion
Claims 3-5 are rejected.
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 ALISON AZAR SALAMATIAN whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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