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 .
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 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.
Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “structural similarity” in claims 1-12 is a relative term which renders the claims indefinite. The term “structural similarity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. A persons of ordinary skill in the art would not know what would be included in the scope of the claim because it is unclear what would be consider similar in structure and what would not. For example a methyl addition might be considered similar in structure but would an ethyl addition also be considered similar? It would be uncertain to one of ordinary skill in the art what structures would be considered similar as no specific definition or structural limitations are set.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 8 does not properly further limit claim 7 as it simply recites the same steps as already listed in claim 7. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over UGOLKOV (UGOLKOV et al., WO 2020123813 A1, 2020-06-18).
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 1-2.
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 1-2.
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 4-5.
The reference UGOLKOV does not specifically teach the methods of claims 1-5 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 cancer with a reasonable expectation of success since such treatment for 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.
Claim(s) 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (Peyman et al., US-20200289534-A1, 2020-09-17) in view of UGOLKOV (UGOLKOV et al., WO 2020123813 A1, 2020-06-18).
The reference Peyman teaches “In one embodiment, a method of drug delivery described for treatment of respiratory tract inflammatory diseases caused by various viruses, such as influenza, parainfluenza, SAR or coronaviruses, COVID-2 or COVID-19, etc. EBV, Herpes virus, etc., or bacterial infections, etc. where the anti-viral medication is administered with a cell pathway inhibitor to block an inflammatory response of the tissue which does not inhibit an immune response like steroids, the cell pathway inhibitor being, for example, a GSK 269962 inhibitor or GSK inhibitors, such as synthetic small-molecule ATP-competitive inhibitors, and substrate-competitive inhibitors, non-ATP-competitive inhibitors, where FRAT/GBP competes with Axin inhibiting GSK-3 activity …” [0697]. This helps to teach claims 6-12.
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The reference Peyman teaches ( reference claims):
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This helps to teach claims 6-8.
The reference Peyman teaches “In one embodiment, the GSK-3 inhibitor lithium chloride at mM concentrations or SB-216763, a GSK-3β cell-permeable inhibitor can be added to the solution of Rock inhibitors or the ointments to interrupt the Wnt pathway and reduce localized skin inflammation and enhance the nerve growth after the skin surgery or inflammatory skin or mucosa diseases preventing severe fibrosis of the tissue” [0607]. This helps to teach claim 9.
The reference Peyman teaches “The method according to claim 1, wherein the biocompatible drug is administered to the patient by inhalation, orally, intravenously, or combinations thereof”(reference claim 10). This helps to teach claim 10.
The reference Peyman teaches does not teach specifically teach a GSK-3 inhibitor with structural similarity to 9-ING-41.
The UGOLKOV has been discussed supra and is incorporated herein by reference.
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 Peyman with UGOLKOV because Peyman teaches inhibiting GSK-3 activity for the treatment of COVID-19 and UGOLKOV teaches 9-ING-41 as a GSK-3 inhibitor. Thus one would be motivated to treat COVID-19 by administering 9-ING-41 and one would have a reasonable expectation of success because it is a known GSK-3 inhibitor.
Claim(s) 6-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (Peyman et al., US-20200289534-A1, 2020-09-17) in view of UGOLKOV (UGOLKOV et al., WO 2020123813 A1, 2020-06-18) further in view of Xie (Xie et al., US-20200261907-A1, 2020-08-20).
The Peyman and UGOLKOV has been discussed supra and do not disclose the monitoring of claim 11.
The reference Xie teaches “In some embodiment, the invention relates to formation of label-free graphene sensor on micro-needle tip. An array of micro-needles can be fabricated with label-free sensors mounted on top, capable of minimally invasive penetration through the skin to access the blood stream to monitor cytokine concentrations in-vivo”[0135] and “Nanowell array sensors, such as illustrated in FIG. 29, are particularly useful for rapid, point-of-care detection of cytokines or other small molecules. For example, nanowell sensor arrays can be used detect and/or monitor ‘cytokine storm’ in patients suffering from respiratory virus infections, such as Corona Virus Disease 2019 (COVID-19). It is thought that in some COVID-19 patients, the patient's immune system is overreacting to the virus. The problem, known broadly as a ‘cytokine storm, can happen when the immune system triggers a runaway response, e.g., releasing too many cytokines, such as interleukin 6 (IL-6), which causes more damage to its own cells than to the invader (e.g., virus) it is trying to fight” [0209] and “In an embodiment, the target analyte is a protein (e.g., a cytokine) and the sample is serum (e.g., from mammalian blood)”[0006].
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 Peyman with UGOLKOV because Peyman teaches inhibiting GSK-3 activity for the treatment of COVID-19 and UGOLKOV teaches 9-ING-41 as a GSK-3 inhibitor. Thus one would be motivated to treat COVID-19 by administering 9-ING-41 and one would have a reasonable expectation of success because it is a known GSK-3 inhibitor.
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 Peyman and UGOLKOV with Xie because Peyman teaches inhibiting GSK-3 activity for the treatment of COVID-19 and Xie teaches monitoring the ‘cytokine storm’ in patients suffering from respiratory virus infections, such as Corona Virus Disease 2019 (COVID-19). One would be motivated to do so to track the treatment of the infection and would have a reasonable expectation of success because COVID-19 has been shown to be track this way already by Xie.
Claim(s) 6-10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (Peyman et al., US-20200289534-A1, 2020-09-17) in view of UGOLKOV (UGOLKOV et al., WO 2020123813 A1, 2020-06-18) further in view of MECHOLD ( MECHOLD et al., EP 1767946 A1, 2007-03-28).
The Peyman and UGOLKOV has been discussed supra and do not disclose the monitoring of claim 12.
The reference MECHOLD teaches “A doctor monitors the level of lithium in the blood with blood tests. Possible adverse effects of lithium include tremor, muscle twitching, nausea, vomiting, diarrhea, thirst, excessive urination, and weight gain” [0008]. This helps to teach claim 12.
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 Peyman with UGOLKOV because Peyman teaches inhibiting GSK-3 activity for the treatment of COVID-19 and UGOLKOV teaches 9-ING-41 as a GSK-3 inhibitor. Thus one would be motivated to treat COVID-19 by administering 9-ING-41 and one would have a reasonable expectation of success because it is a known GSK-3 inhibitor.
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 Peyman and UGOLKOV with MECHOLD because Peyman teaches inhibiting GSK-3 activity for the treatment of COVID-19 and the GSK-3 inhibitor lithium and MECHOLD teaches monitoring lithium in patients because of lithium toxicity. One would be motivated to do so to limit adverse effects of lithium and would have a reasonable expectation of success because if one monitors the level of lithium one can avoid toxic levels.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 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 1-5.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-12 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), further in view of Peyman (Peyman et al., US-20200289534-A1, 2020-09-17), further in view of Xie (Xie et al., US-20200261907-A1, 2020-08-20) further in view of MECHOLD ( MECHOLD et al., EP 1767946 A1, 2007-03-28).
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 applications ‘719 and ‘872 do not teach the COVID treatment of claims 6-12.
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 with UGOLKOV because application ‘872 teaches 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.
It would have been prima facie obvious to one of ordinary skill in the art to have modified applications ‘719 and ‘872 with Peyman and UGOLKOV because Peyman teaches inhibiting GSK-3 activity for the treatment of COVID-19 and applications ‘719 and ‘872 teaches 9-ING-41 or GSK-3 inhibitors. Thus one would be motivated to treat COVID-19 by administering 9-ING-41 and one would have a reasonable expectation of success because it is a known GSK-3 inhibitor.
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 Peyman and UGOLKOV with Xie because Peyman teaches inhibiting GSK-3 activity for the treatment of COVID-19 and Xie teaches monitoring the ‘cytokine storm’ in patients suffering from respiratory virus infections, such as Corona Virus Disease 2019 (COVID-19). One would be motivated to do so to track the treatment of the infection and would have a reasonable expectation of success because COVID-19 has been shown to be track this way already by Xie.
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 Peyman and UGOLKOV with MECHOLD because Peyman teaches inhibiting GSK-3 activity for the treatment of COVID-19 and the GSK-3 inhibitor lithium and MECHOLD teaches monitoring lithium in patients because of lithium toxicity. One would be motivated to do so to limit adverse effects of lithium and would have a reasonable expectation of success because if one monitors the level of lithium one can avoid toxic levels.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-12 are rejected.
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.S./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627