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
Claims 1-6, 10-11, 20, 23 ,27, 89, 104, 146, 159-160, 165 and 168-169 are pending and now evaluated on its merit.
Priority
This application is a continuation of application 17/974,000, filed 10/26/2022, which claims domestic benefit to U.S. provisional application 63/272,437, dated 10/27/2021.
Information Disclosure Statement
The information disclosure statement (IDS) dated 08/07/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
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 104 is 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.
Claim 104 recites the limitation "wherein the cytokine release syndrome is induced by or associated with the viral infection" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 104 is dependent on claim 84 which fails to recite “viral infection” as a limitation, thus claim 104 is lacking antecedent basis.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 10-11, 20, 23, 27, 156, 159-160, 165 and 168 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Hu et al. (WO 2022179967 A1), which claims U.S. benefit dated 02/23/2021.
Regarding claims 1-6, 10-11, 20, 23, 27, 156, 159-160, 165 and 168, Hu teaches a method for treating and or preventing a subject as risk for COVID-19 (SARS-CoV-2), wherein COVID-19 is associated with pneumonia or Acute Respiratory Disorder Syndrome (ARDS) (relevant to claims 2-6, 10-11, 20, 23, 27 and 156) (Pg. 3, lines 34-36; Pg. 7, lines 23-25) comprising an oral administration of 2-{[5-(3- chlorophenyl)-3-hydroxypyridin-2-yl]formamido}acetic acid (vadadustat) at a dose of from 150 mg to 1800 mg daily. In some embodiments the vadadustat is administered at a dose of 900 mg or from 900 mg to 1800 mg daily for a 7-day, 14-day, 21-day or 28-day treatment (relevant to claims 1 and 159-160) (Pg. 7, lines 30-32; Pg. 15, lines 24-35).
Hu additionally teaches the vadadustat administered as a combination pharmaceutical composition, in which the composition contains one or more antiviral agents selected from olsetemivir, remdesivir, ganciclovir, lopinavir, ritonavir and zanamivir (relevant to claim 165) (Pg. 43, lines 1-5) and the severity of the disease is reduced as represented from the results of Table 1 (relevant to claim 168).
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.
Claim 169 is rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (WO 2022179967 A1).
The teachings of Hu for the above 102 rejections of claims 1-6, 10-11, 20, 23, 27, 156, 159-160, 165 and 168 are incorporated herein by reference.
Hu fails to teach the severity of the COVID-19 disease in a scale form. However, it would have been obvious for someone or ordinary skill in the art at the time of filing to have developed a scale of severity for testing and then treating a patient with COVID-19. One would have been motivated to do so as developing a scale to test a subject in which how severe a disease is will determine the process and dosage amount of treatment would have been routine experimentation and thus not a patentable limitation as per MPEP 2144.05 (II): "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 89 and 104 are rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (WO 2022179967 A1) in view of Yifan et al. Cytokine release syndrome in COVID-19: a major mechanism of morbidity and mortality, Int Rev Immunol, February 2021, Pages 1-14.
The teachings of Hu for the above 102 rejections of claims 1-6, 10-11, 20, 23, 27, 156, 159-160, 165 and 168 are incorporated herein by reference.
Hu fails to teach the treatment, prevention or risk of developing cytokine release syndrome in a patient infected with coronavirus.
Yifan teaches COVID-19 patients who suffer from acute respiratory distress syndrome (ARDS) and multi-organ dysfunction have high mortality and is closely related to the cytokine release syndrome (CRS). The molecular mechanisms for CRS in COVID-19 are related to the effects of the S-protein and N-protein of the virus and its ability to trigger NF-κB activation by disabling the inhibitory component IκB. This leads to activation of immune cells and the secretion of proinflammatory cytokines such as IL-6 and TNF-α. In COVID-19, it has been observed that there are high levels of proinflammatory cytokines, particularly IL-6, in the blood of patients, especially patients with severe disease (abstract, Page 10, 2nd column, 3rd para.).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have prevented the risk of developing cytokine release syndrome by administering vadadustat to treat COVID-19 from the teachings of Hu. One would have been motivated to do so because Yifan teaches patients suffering from COVID-19 and ARDS can develop cytokine release syndrome and Hu teaches the treatment of patients with COVID-19 and ARDS. There is a reasonable expectation of preventing the risk of developing cytokine release syndrome from the teachings of Hu and Yifan.
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 1-6, 10-11, 20, 23, 27, 89, 104, 156, 159-160, 165 and 168-169 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 26, 32, 34, 36, 39, 157-158, 160, 198-200, 202-208 of U.S. Patent No. 12629357. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 21, 26, 32, 34, 36, 39, 157-158, 160, 198-200, 202-208 of U.S. ‘357 teaches a once a day 900-1800 mg dosage of vadadustat to treat a respiratory viral infection of acute respiratory distress syndrome (ARDS), wherein the ARDS is associated and/or induced by coronavirus and prevents the risk of developing cytokine release syndrome.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
