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
The present application claims priority to the applications, 63/174,750 and PCT/US2022/024927, with effective filing dates of 14 April 2021 and 14 April 2022, respectively.
Claim Status
This Office Action is in response to Applicant’s Amendment filed, 27 April 2026, wherein Applicant amended claims 1, 4-9, 12, 15, 23, and 25, canceled claims 11, 14, and 20-22, and added new claims 27-31. Claims 17-19 were previously canceled.
Claims 1-10, 12-13, 15-16, and 23-31 are pending.
Rejections Withdrawn
Claim Rejections – 35 U.S.C. § 112
1. Claims 1, 4, 9, 11-12, 14, and 20-21 were rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement. Claims 1, 9, 12, and 20 specified the generic term “a protein tyrosine phosphatase 4A3 inhibitor” and claims 4, 11, 14, and 21 specified a PTP4A3 inhibitor of structure:
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. Claims 11, 14, and 20-21 were canceled. Applicant’s amendment, see page 2-3 and 6-7, with respect to claims 1, 4, 9, and 12, has been fully considered. The rejection of claims 1, 4, 9, and 12 has been withdrawn.
2. Claims 1, 5, 9, 12, 15, and 20 were rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement. Claims 1, 9, 12, and 20 specified a viral infection, and claims 5 and 15 specified an influenza A infection. Claim 20 was canceled. Applicant’s amendment and argument, see pages 2, 4, 6-7, and 12, with respect to claims 1, 5, 9, 12, and 15 has been fully considered. The rejection of claims 1, 5, 9, 12, and 15 has been withdrawn.
3. Claims 1, 9, 12, 20, and 23 were rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement. Claims 1, 9, 12, 20, and 23 specified a subject. Claim 20 was canceled. Applicant’s amendment, see pages 2 and 6-8 with respect to claims 1, 9, 12, and 23 has been fully considered. The rejection of claims 1, 9, 12, and 23 has been withdrawn.
4. Claims 1-2, 4-5, 9, 11-12, 14-15, and 20-21 were rejected under 35 U.S.C. 112(a) for failing to comply with the enablement requirement. Claims 11, 14, and 20-21 were canceled. Claims 1-2, 4-5, 9, 12, and 15 specified a viral infection, and claims 5 and 15 specified an influenza A infection. Applicant’s amendment, see pages 2-4, 6-7, and 11-12 with respect to claims 1-2, 4-5, 9, 12, and 15 has been fully considered. The rejection of claims 1-2, 4-5, 9, 12, and 15 has been withdrawn.
Claim Rejections – 35 U.S.C. § 102
5. Claim 1 was rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lazo (WO 2020/102243; filed 12 Nov 2019; of record; see PTO-892 filed 26 Jan 2026) as evidenced by Wu (Brit. J. Cancer, 2003, 89, 672-675; of record; see PTO-892 filed 26 Jan 2026).
Applicant amended claim 1 to specify a coronavirus or influenza A viral infection. Applicant’s argument, see page 13, has been fully considered. The 102(a)(1) and 102(a)(2) rejection of claim 1 has been withdrawn.
Rejections: New/Modified or Maintained
Claim Rejections – 35 U.S.C. § 112
6. (Maintained) Claims 6, 8, 23, and 25 were rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement. Claims 6 and 23 specified the generic term “a protein tyrosine phosphatase 4A3 inhibitor” but now have been amended to specify
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, wherein R4 is H, OH, and OC1-4 alkyl.
Applicant’s amendment and arguments, see pages 4, 7-8, and 11-12 have been fully considered, but they are not persuasive.
Applicant argues that a patent specification must describe the claimed invention in sufficient detail that one skilled in the art could reasonably conclude that the inventor had possession of the claimed invention. However, Rivas (“A Screen of FDA-approved drugs identifies inhibitors of Protein Tyrosine Phosphatase 4A3 (PTP4A3 or PRL-3),” BioRxiv, 2020, 1-30; of record; see PTO-892 filed 26 Jan 2026) and McQueeney (Oncotarget, 2018, 9(9), 8223-8240; of record; see PTO-892 filed 26 Jan 2026) teach that (1) there is no well-established class of PTP4A3 inhibitors; (2) pharmacokinetic and off-target concerns with several PTP4A3 inhibitors, in particular JMS-053, have prevented further development; (3) there is no available structure of PRL-3 in complex with any inhibitor and that this lack of information makes it challenging to define residues in PRL-3 and functional groups in the compounds that are key to PRL-3-inhibitor interaction; and (4) close structural analogs to JMS-053 that are inactive (see page 4-5 of the Action mailed 26 Jan 2026).
Thus, the rejection of claims 6, 8, 23, and 25 as being unpatentable under 35 U.S.C. 112 is maintained.
7. (Maintained) Claims 6, 8, 23, and 25 were rejected under 35 U.S.C. 112(a) for failing to comply with the enablement requirement.
Claims 6, 8, 23, and 25 were amended to specify a PTP4A3 inhibitor of genus:
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, wherein R4 is H, OH, and OC1-4 alkyl, and a human or mouse subject.
Applicant’s amendment and arguments, see pages 4-6, 7-9, and 11-12 have been fully considered, but they are not persuasive.
Applicant argues that it is well-settled that Applicant need not have actually reduced the invention to practice, that enablement does not require a working example, and that experimentation is allowed so long as it is not undue.
Applicant is enabled for the following: a method of (1) treating or preventing a SARS-CoV-2 or influenza A via administration of KVX-053 (R4 = H; also known as JMS-053) in vitro, in mouse, and in humans, (2) reducing inflammation and/or damage resulting from a SARS-CoV-2 via administration of KVX-053 in vitro, in mouse, and in humans, and (3) treating chemical damage via administration of KVX-053 in vitro, in mouse, and in humans.
Regarding PTP4A3 inhibitor, Rivas and McQueeney teach that (1) there is no well-established class of PTP4A3 inhibitor; (2) pharmacokinetic and off-target concerns with several PTP4A3 inhibitors, in particular JMS-053, have prevented further development; (3) there is no available structure of PRL-3 in complex with any inhibitor and that this lack of information makes it challenging to define residues in PRL-3 and functional groups in the compounds that are key to PRL-3-inhibitor interaction; and (4) close structural analogs to JMS-053 that are inactive (see page 11-12 of the Action mailed 26 Jan 2026).
Accordingly, Applicant is specifically not enabled for a PTP4A3 inhibitor wherein R4 is OH or OC1-4 alkyl (see the Action, specifically pages 9-13: state of the art, predictability of the art, and working examples).
Thus, the rejection of claims 6, 8, 23, and 25 as being unpatentable under 35 U.S.C. 112 is maintained.
Claim Rejections – Nonstatutory Double Patenting
8. (Maintained) Claims 1-16 and 20-26 were rejected on the ground of nonstatutory double patenting over claims 3, 7, and 9-11 of U.S. Patent No. 10,308,663. Claims 11, 14, and 17-22 were canceled. Applicant requests the rejection be held in abeyance until the claims are found allowable in the instant application.
Applicant’s arguments have been fully considered, but they are not persuasive. Applicant requests that the rejection be held in abeyance until allowable subject matter is identified. A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03. Therefore, an application must not be allowed unless the required compliant terminal disclaimer(s) is/are filed and/or the withdrawal of the nonstatutory double patenting rejection(s) is made of record by the examiner. See MPEP § 804(I)(B)(1).
Thus, the rejection of claims 1-16 and 20-26 on the ground of nonstatutory double patenting over claims 3, 7, and 9-11 of U.S. Patent No. 10,308,663 is maintained.
9. (Maintained) Claims 1-16 and 23-26 were rejected on the ground of nonstatutory double patenting over claims 2-3 and 6-7 of U.S. Application No. 17/309,259 (previously referred to as U.S. Publication 2022/0017534). Claims 11 and 14 were canceled. Applicant requests the rejection be held in abeyance until the claims are found allowable in the instant application.
Applicant’s arguments have been fully considered, but they are not persuasive. Applicant requests that the rejection be held in abeyance until allowable subject matter is identified. A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03. Therefore, an application must not be allowed unless the required compliant terminal disclaimer(s) is/are filed and/or the withdrawal of the nonstatutory double patenting rejection(s) is made of record by the examiner. See MPEP § 804(I)(B)(1).
Thus, the rejection of claims 1-16 and 23-26 on the ground of nonstatutory double patenting over claims 2-3 and 6-7 of U.S. Application No. 17/309,259 is maintained.
10. (Maintained) Claims 1-16 and 23-26 were rejected on the ground of nonstatutory double patenting over claims 7-8 and 11-12 of U.S. Application No. 17/309,260 (previously referred to as U.S. Publication 2021/0395266). Claims 11 and 14 were canceled. Applicant requests the rejection be held in abeyance until the claims are found allowable in the instant application.
Applicant’s arguments have been fully considered, but they are not persuasive. Applicant requests that the rejection be held in abeyance until allowable subject matter is identified. A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional. As filing a terminal disclaimer, or filing a showing that the claims subject to the rejection are patentably distinct from the reference application’s claims, is necessary for further consideration of the rejection of the claims, such a filing should not be held in abeyance. Only compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. Replies with an omission should be treated as provided in MPEP § 714.03. Therefore, an application must not be allowed unless the required compliant terminal disclaimer(s) is/are filed and/or the withdrawal of the nonstatutory double patenting rejection(s) is made of record by the examiner. See MPEP § 804(I)(B)(1).
Thus, the rejection of claims 1-16 and 23-26 on the ground of nonstatutory double patenting over claims 7-8 and 11-12 of U.S. Application No. 17/309,260 is maintained.
11. (Maintained) Claims 1-16 and 23-26 were rejected under 35 U.S.C. 103 as being unpatentable over Panoutsopoulos (Genes & Diseases, 2020, 7, 528-534; of record; see PTO-892 filed 26 Jan 2026) in view of McQueeney (Oncotarget, 2018, 9(9), 8223-8240; of record; see PTO-892 filed 26 Jan 2026). Claims 11, 14, and 17-22 were canceled.
Applicant argues that Panoutsopoulos and McQueeney together or alone fail to teach or suggest 7-imino-2-phenylthieno[3,2-c]pyridine-4,6(5H,7H)-dione (JMS-053, wherein R4 is H), a coronavirus, a human subject, a mouse subject, treating a SARS-CoV-2 associated disease, disorder, or condition, reducing or inhibiting induction of an inflammatory cytokine, or treating or preventing chemical damage to a lung from the cytokine storm.
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that Panoutsopoulos and McQueeney do not teach nor suggest 7-imino-2-phenylthieno[3,2-c]pyridine-4,6(5H,7H)-dione (KVX-053, wherein R4 is H), a coronavirus, a human subject, a mouse subject, treating a SARS-CoV-2 associated disease, disorder, or condition, reducing or inhibiting induction of an inflammatory cytokine, or treating or preventing chemical damage to a lung from the cytokine storm, Panoutsopoulos and McQueeney teach a method of (1) treating SARS-CoV-2 and diseases/conditions arising therein via small molecules (see the Action, page 15, mailed 26 Jan 2026); (2) reducing or inhibiting induction of an inflammatory cytokine (see the Action, page 18, mailed 26 Jan 2026); (3) reducing or inhibiting a pulmonary disease (see the Action, page 18, mailed 26 Jan 2026); (4) treating or preventing chemical damage to a lung from the cytokine storm associated with SARS-CoV-2 (see the Action, page 19, mailed 26 Jan 2026); and (5) 7-imino-2-phenylthieno[3,2-c]pyridine-4,6(5H,7H)-dione (JMS-053, wherein R4 is H) in a mouse subject (see the Action, pages 16, mailed 26 Jan 2026).
Thus, the rejection of claims 1-10, 12-13, 15-16, and 23-26 as being unpatentable over Panoutsouplos in view of McQueeney is maintained.
12. (Maintained) Claims 16 and 20-22 were rejected under 35 U.S.C. 103 as being unpatentable over Panoutsopoulos (Genes & Diseases, 2020, 7, 528-534; of record; see PTO-892 filed 26 Jan 2026) and McQueeney (Oncotarget, 2018, 9(9), 8223-8240; of record; see PTO-892 filed 26 Jan 2026) and further in view of Lazo ‘663 (U.S. Patent No. 10,308,663, issued 4 Jun 2019; of record; see PTO-892 filed 26 Jan 2026). Claims 20-22 were canceled.
Applicant’s amendment and arguments, see page 19, with respect to the rejection of claims 16, have been fully considered, but they are not persuasive. Claim 16 depends upon claim 1. Applicant relies upon the amendment and arguments over claim 1 to overcome the rejection of claim 16. However, Applicant’s amendment and arguments over claim 1 were not persuasive.
Thus, the rejection of claim 16 as being unpatentable over Panoutsopoulos and McQueeney in view of Lazo ‘663 is maintained.
13. (New) Claims 27-31 are rejected under 35 U.S.C. 103 as being unpatentable over Panoutsopoulos (Genes & Diseases, 2020, 7, 528-534; of record; see PTO-892 filed 26 Jan 2026) in view of McQueeney (Oncotarget, 2018, 9(9), 8223-8240; of record; see PTO-892 filed 26 Jan 2026).
Panoutsopoulos teaches a method of treating SARS-CoV-2 via small molecules in humans (abstract). Panoutsopoulos further teaches the mechanism of infection of SARS-CoV-2 in that the virus gains access to host cell cytosol by proteolytic cleavage of S protein, which is followed by fusion of viral and cellular membranes and release of the viral genome into the cytoplasm (page 529, column 2, paragraph 1).
Regarding claim 27, Panoutsopoulos fails to teach a PTP4A3 inhibitor.
McQueeney teaches the PTP4A3 inhibitor: (page 8226, Figure 2A). Further, McQueeney specifies that PTP4A3 has a central role in metastases formation and angiogenesis and leads to an altered microenvironment and creates a dysfunctional endothelium, which loses critical barrier properties (page 8224, column 1, paragraph 1) as evidenced by Peng (Molecule Cancer, 2009, 8(110), 1-13). Peng teaches that PRL-3 (another name for PTP4A3) plays a causative role in promoting cell motility, invasion, and metastasis (page 2, column 1, paragraph 1; page 2, column 1, paragraph 2). McQueeney further specifies that JMS-053 restored compromised barrier function and can target endothelial cell hyperpermeability, which enables infiltration of cells and soluble proteins (page 8233, column 1, paragraph 2; page 8233, column 2, paragraph 2).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select the PTP4A3 inhibitor of McQueeney
to develop a method of treating SARS-CoV-2 in humans via KVX-053, which is JMS-053 as defined in the specification (page 44, lines 11-15) to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Panoutsopoulos teaches small molecules and drugs that are already in use and FDA approved for other diseases, and show promise for treatment of COVID-19,
-Panoutsopoulos teaches the S-protein—receptor interaction is the primary determinant for a coronavirus to infect a host cell and governs tissue specificity of the virus,
-Panoutsopoulos teaches fusion occurs within acidified endosomes and allows for mixing of viral and cellular membranes, resulting in release of viral genome into the cytoplasm,
- Panoutsopoulos teaches a method of reducing or inhibiting induction of an inflammatory cytokine via a small molecule and that cytokines are known to be elevated among SARS-CoV-2 patients, creating a cytokine storm which leads to acute respiratory distress syndrome, and specifically teaches inhibiting IL-1, IL-6, and TNF (page 532, column 1, paragraph 2),
-McQueeney teaches JMS-053 displayed anticancer activity in a murine xenograft model of drug resistant human ovarian cancer and that JMS-053 is a potent PTP4A3 inhibitor,
-McQueeney teaches that PTP4A3 has a central role in metastases formation and angiogenesis, ultimately leading to an altered microenvironment,
-McQueeney teaches that PTP4A3 phosphatases interact with a variety of protein partners, including cell surface receptors, and
-McQueeney teaches that JMS-053 exposure restored compromised barrier function and that JMS-053 and can target endothelial cell hyperpermeability, which enables infiltration of cells and soluble proteins.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a method of treating or preventing SARS-CoV-2 infection via administration of the PTP4A3 inhibitor, JMS-053, to reduce or inhibit infudction of a plurality of inflammatory cytokines comprising IL-1β, IL-6, or TNFα.
Regarding claim 28, Panoutsopoulos teaches treating a SARS-CoV-2 via small molecule in a human (abstract).
Regarding claim 29, Panoutsopoulos teaches treating a SARS-CoV-2 via small molecule in a human (abstract), and McQueeney teaches the PTP4A3 inhibitor, JMS-053 (page 8226, Figure 2A). As Applicant does not further specify a certain concentration dosage of JMS-053 for reducing or inhibiting spike protein-induced endothelial barrier disruption and cytokine release, claim 29 does not specify and addition step but an additional effect. Thus, claim 29 recites an additional effect of a claimed method. Consequently, the combination of Panoutsopoulos and McQueeney teaches administration of JMS-053 that reduces or inhibits spike protein-induced endothelial barrier disruption and cytokine release.
Regarding claim 30, Panoutsopoulos teaches treating a SARS-CoV-2 via small molecule in a human (abstract). Additionally, Panoutsopoulos specifically teaches inhibiting IL-1, IL-6, and TNF (page 532, column 1, paragraph 2), and McQueeney teaches the PTP4A3 inhibitor, JMS-053 (page 8226, Figure 2A). As Applicant does not further specify a certain concentration dosage of JMS-053 for decreasing accumulation of one or more type of inflammatory cytokines of the human subject relative to a human subject not treated with the PTP4A3 inhibitor, claim 30 does not specify and addition step but an additional effect. Thus, claim 30 recites an additional effect of a claimed method. Consequently, the combination of Panoutsopoulos and McQueeney teaches administration of JMS-053 that decreases accumulation of one or more type of inflammatory cytokines of the human subject relative to a human subject not treated with the PTP4A3 inhibitor.
Regarding claim 31, Panoutsopoulos teaches treating a SARS-CoV-2 via small molecule in a human (abstract). Additionally, Panoutsopoulos specifically teaches inhibiting IL-1, IL-6, and TNF (page 532, column 1, paragraph 2), and McQueeney teaches the PTP4A3 inhibitor, JMS-053 (page 8226, Figure 2A). As Applicant does not further specify a certain concentration dosage of JMS-053 wherein one or more types of inflammatory cytokines comprise IFNγ, IL-1β, IL-6, IL-17, MCP-1, KC, TNFα, MIP-1α, claim 31 does not specify and addition step but an additional effect. Thus, claim 31 recites an additional effect of a claimed method. Consequently, the combination of Panoutsopoulos and McQueeney teaches administration of JMS- wherein one or more types of inflammatory cytokines comprise IFNγ, IL-1β, IL-6, IL-17, MCP-1, KC, TNFα, MIP-1α.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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