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 .
Status of Claims
Claims 3-4, 10, 69-100, 142-158 and 177-181 are pending in the instant application. Claims 3, 143 and 144 are amended via the amendment filed March 19th, 2026.
Priority
This is a 35 U.S.C. 371 National Stage filing of l Application No. PCT/US2021/031282 filed May 7th, 2021, which claims priority to 63/053,056, filed July 17th, 2020 and 63/022,479, filed May 9th, 2020.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed February 17th, 2026 was considered by the Examiner.
Withdrawn Rejections
Applicant’s arguments, filed March 19th, 2026, with respect to the 112(b) rejection of claims 143 and 144 have been fully considered and are persuasive. The 112(b) rejection of claims 143-144 has been withdrawn.
Applicant has overcome the rejection by amending the claims to remove the term “substantially” in the claims.
Applicant’s arguments, filed March 19th, 2026, with respect to the 102(a)(2) rejection of claims 3, 75-100, 158 and 177-178 have been fully considered and are persuasive. The 102(a)(2) rejection of claims 3, 75-100, 158 and 177-178 has been withdrawn.
Applicant has overcome this rejection by amending claim 3 to remove the option for Rc to be heteroaryl.
Applicant’s arguments, filed March 19th, 2026, with respect to the 103 rejection of claims 3-4, 75-100, 158 and 177-178 over Sporn in view of Phua have been fully considered and are persuasive. The 102(a)(2) rejection of claims 3, 75-100, 158 and 177-178 has been withdrawn.
Applicant has overcome this rejection by amending claim 3 to remove the option for Rc to be heteroaryl.
Applicant’s arguments, filed March 19th, 2026, with respect to the 103 rejection of claims 3, 75-100, 158 and 177-181 over Sporn in view of Chin have been fully considered and are persuasive. The 102(a)(2) rejection of claims 3, 75-100, 158 and 177-178 has been withdrawn.
Applicant has overcome this rejection by amending claim 3 to remove the option for Rc to be heteroaryl.
Maintained Rejections
Applicant's arguments filed March 19th, 2026, with respect to the 103 rejection of claims 3, 10, 69-73, 79-100, 142-146, 147-151, 155 and 177-178 over Huizenga and Landeka and Meyer have been fully considered but they are not persuasive. However, Applicant’s aments have necessitated changes to the previously presented rejections under 35 U.S.C. 103.
See response to remarks.
Response to Remarks
Applicant’s arguments with respect to 112(b) rejection, 102(a)(2) rejection and 103 rejections over Sporn have been considered but are moot as Applicant’s amendments have overcome the rejections.
However, the 103 rejections over Huizenga are not persuasive for the reasons explained below.
Applicant begins to traverse the 103 rejection over Huizenga on the basis that Huizenga does not teach or suggest methods of treating coronavirus comprising administration of a presently claimed compound alone.
In response, as stated in the previous Office action, Huizenga teaches a method for reducing the ill effects of a viral infection in a subject in need thereof, comprising administering to the subject an antioxidant defense activator such as the methyl ester of bardoxolone (CDDO-Me):
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(claim 45, which finds support in claim 34 of the priority document).
This compound is of the instant invention. Further, instant claim 3 recites that the method is “comprising administering to the patient a therapeutically effective amount of a compound…”. As the claim recites “comprising”, this is open ended language and thus, an additional compound can be administered along with the compound of instant formula V.
On p. 11 of the remarks, Applicant argues that Huizenga merely teaches that the compound of instant formula V has antioxidant defense activators and not for use alone to reduce the ill effects of a virus and/or treat a patient infected with a coronavirus on its own.
However, Huizenga teaches compositions, including the compound above, for use in treating, preventing or reducing the ill effects resulting from severe acute respiratory syndrome coronavirus 2 (page 1, paragraph 3). As such, Huizenga teaches the administration of a compound of instant formula V for to a patients struggling with coronavirus.
On p. 12-13 of the remarks, Applicant further argues that Huizenga, Landeka and Meyer, separately or together, do not teach or suggest the instant invention.
In response, for the reasons explained above, the instant invention is obvious in view of Huizenga, Landeka and Meyer.
In view of the above, the 103 rejections over Huizenga in view of Landeka and Meyer are maintained and altered as necessitated by Applicant’s amendments.
Response to Restriction/Election Requirement
Applicant’s election without traverse of compound RTA 402, in the reply filed on October 6th, 2025 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species is not allowable. Therefore, according to MPEP 803.02:
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability.
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush claim and claims to the elected species will be rejected, and claims to the nonelected species will be held withdrawn from further consideration.
As the elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 3-4, 10, 69-100, 142-158 and 177-181 have been examined to the extent that they are readable on the elected compound RTA 402. Any additional issues below that address subject matter outside the scope of the search and examination discussed above are presented in the interest of compact prosecution since they were discovered incidental to said search and examination.
Claim Objections
Claims 152-154 and 156-157 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Maintained 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.
The factual inquiries 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.
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, 10, 69-73, 74-78, 79-100, 158 and 177-178 stand rejected under 35 U.S.C. 103 as being unpatentable over Huizenga et al (WO 2021/202245, which claims priority to application No. 63/004, 449, filed 04/02/2020).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Huizenga teaches a method for reducing the ill effects of a viral infection in a subject in need thereof, comprising administering to the subject an antioxidant defense activator such as the methyl ester of bardoxolone (CDDO-Me):
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(claim 45, which finds support in claim 34 of the priority document).
This compound is embraced by the formula of instant claim 3, wherein Y is –(CH2)mC(O)Rc, wherein m is 0, and Rc is alkoxy.
Huizenga further teaches that the viral infection is caused by a serve acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (claim 53, which finds support in claim 33 of the priority document).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Huizenga dos not teach an explicit embodiment where the compound above was administered to a patient.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding claim 3, while the prior art does not explicitly teach and embodiment where the compound above was administered to a patient, Huizenga teaches a compound of instant claim 3 and it’s utility in treating a viral infection caused by a serve acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A person having ordinary skill in the art would have been motivated to screen the example compounds of the prior art in the particular utilities to determine which would provide optimum treatment outcome.
Regarding claim 10, the compound above is compound RTA 401 of instant claim 10.
Regarding claims 69-70, Huizenga teaches an example with elderly patients with presumed COVID-19 (Patient 1,which finds support in Example 1 of the priority document). Huizenga teaches that the patients had serial chest x-rays preformed. Regarding claim 71, Huizenga teaches that the patients room air O2% sat was 93 (Patient 1, which finds support in Example 1 of the priority document). Regarding claims 72-73, Huizenga teaches that the patent sat on high flow nasal O2 (Patient 1,which finds support in Example 1 of the priority document).
Regarding claims 74-78, Huizenga teaches that the virus if COVID-19 (field).
Regarding claims 79-100, The prior art is silent regarding “inhibits replication of SARS-CoV-2, suppresses or prevents a cytokine storm, suppresses or prevents lung inflammation, treats or prevents inflammation-induced liver damage, treats or prevents acute lung injury, treats or prevents kidney damage, treats or prevents acute kidney injury, improves kidney function, increases the patient’s estimated glomerular filtration rate, treats or prevents acute respiratory distress syndrome, treats or prevents seizures, treats or prevents brain inflammation, reduces the hospitalization time, reduces the time spent in the intensive care unit, delayed the need for hospitalization, increases the probability of survival, prevents the need for non-invasive mechanical ventilation, prevents the need for invasive mechanical ventilation, prevents respiratory failure, lowers the patient’s WHO score and prevents the need for renal replacement therapy”.
However: “inhibits replication of SARS-CoV-2, suppresses or prevents a cytokine storm, suppresses or prevents lung inflammation, treats or prevents inflammation-induced liver damage, treats or prevents acute lung injury, treats or prevents kidney damage, treats or prevents acute kidney injury, improves kidney function, increases the patient’s estimated glomerular filtration rate, treats or prevents acute respiratory distress syndrome, treats or prevents seizures, treats or prevents brain inflammation, reduces the hospitalization time, reduces the time spent in the intensive care unit, delayed the need for hospitalization, increases the probability of survival, prevents the need for non-invasive mechanical ventilation, prevents the need for invasive mechanical ventilation, prevents respiratory failure, lowers the patient’s WHO score and prevents the need for renal replacement therapy” will inevitably flow from the teachings of the prior art (see above rejection), since the same compound (a compound of instant claim 3) is being administered to the same subjects (a subject suffering from COVID-19). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “inhibits replication of SARS-CoV-2, suppresses or prevents a cytokine storm, suppresses or prevents lung inflammation, treats or prevents inflammation-induced liver damage, treats or prevents acute lung injury, treats or prevents kidney damage, treats or prevents acute kidney injury, improves kidney function, increases the patient’s estimated glomerular filtration rate, treats or prevents acute respiratory distress syndrome, treats or prevents seizures, treats or prevents brain inflammation, reduces the hospitalization time, reduces the time spent in the intensive care unit, delayed the need for hospitalization, increases the probability of survival, prevents the need for non-invasive mechanical ventilation, prevents the need for invasive mechanical ventilation, prevents respiratory failure, lowers the patient’s WHO score and prevents the need for renal replacement therapy”, by practicing the method taught by the prior art: “the administration of a compound of instant claim 3 to a patient suffering from COVID-19”, one will also be “inhibits replication of SARS-CoV-2, suppresses or prevents a cytokine storm, suppresses or prevents lung inflammation, treats or prevents inflammation-induced liver damage, treats or prevents acute lung injury, treats or prevents kidney damage, treats or prevents acute kidney injury, improves kidney function, increases the patient’s estimated glomerular filtration rate, treats or prevents acute respiratory distress syndrome, treats or prevents seizures, treats or prevents brain inflammation, reduces the hospitalization time, reduces the time spent in the intensive care unit, delayed the need for hospitalization, increases the probability of survival, prevents the need for non-invasive mechanical ventilation, prevents the need for invasive mechanical ventilation, prevents respiratory failure, lowers the patient’s WHO score and prevents the need for renal replacement therapy” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“inhibits replication of SARS-CoV-2, suppresses or prevents a cytokine storm, suppresses or prevents lung inflammation, treats or prevents inflammation-induced liver damage, treats or prevents acute lung injury, treats or prevents kidney damage, treats or prevents acute kidney injury, improves kidney function, increases the patient’s estimated glomerular filtration rate, treats or prevents acute respiratory distress syndrome, treats or prevents seizures, treats or prevents brain inflammation, reduces the hospitalization time, reduces the time spent in the intensive care unit, delayed the need for hospitalization, increases the probability of survival, prevents the need for non-invasive mechanical ventilation, prevents the need for invasive mechanical ventilation, prevents respiratory failure, lowers the patient’s WHO score and prevents the need for renal replacement therapy”) of the method taught by the prior art (“the administration of a compound of instant claim 3 to a patient suffering from COVID-19”).
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Regarding claim 158, Huizenga teaches that the dose is from about 25mg-100mg.
Regarding claims 177-178, Huizenga teaches that the composition is a tablet formulated for oral administration (page 57, which finds support on page 5, paragraph 1 of the priority document).
Claims 147-151 are rejected under 35 U.S.C. 103 as being unpatentable over Huizenga et al (WO 2021/202245, which claims priority to application No. 63/004, 449, filed 04/02/2020, which is incorporated here by reference, and in further view of Landeka et al (WO 2019/014412 A1).
The rejection of claims 3, 10, 69-73, 79-100 and 177-178 above is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Huizenga does not teach that the compound of instant claim 10 is present in a crystalline form in the method of treating coronavirus. However, as seen in the rejection above a method of treating coronavirus with the compound of instant claim 10 has been rendered obvious
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
The prior art does not teach that the compound of instant claim 10 is present in a crystalline form.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
However, Landeka reaches crystalline polymorphs of Bardoxolone methyl,
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, and pharmaceutical compositions thereof (paragraph [0001)). As Huizenga teaches a method wherein the above compound is administered to treat covid, one of ordinary skill in the art would have been motivate to administer the compound in the crystalline form as Landeka teaches crystalline forms of the compound of instant claim 10, the same compound as taught by Huizenga.
Regarding claim 147, Landeka teaches a crystalline form of the above compound which comprises peaks at 6.2, 12.4, 15.4, 18.6 and 24.9 degrees 2-theta ± 0.2 degrees 2-theta (paragraph [0033]). Regarding claim 148, Landeka teaches that the crystalline form has an additional peak at 17.1 degrees 2-theta ± 0.2 degrees 2-theta (paragraph [0034]).
Regarding claim 149, Landeka also teaches another crystalline form of the compound which comprises peaks at 3.6, 7.1, 10.8, 12.4 and 16.5 degrees 2-theta ± 0.2 degrees 2-theta (paragraph [0039]). Regarding claim 150, Landeka further teaches that the form has additional peaks at 12.9, 13.9, 14.8, 18.6 and 20.6 degrees 2-theta ± 0.2 degrees 2-theta (paragraph [0039]). Regarding claim 151, Landeka teaches that the form has a Raman spectrum having peaks at 2949, 1671, 1618 and 1464 ± 4 cm¹ (paragraph [0041]).
Claim(s) 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Huizenga et al (WO 2021/202245, which claims priority to application No. 63/004, 449, filed 04/02/2020) in view of Phua et al (Clin Chest Med 29 (2008) 323–328).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Huizenga teaches a method for reducing the ill effects of a viral infection in a subject in need thereof, comprising administering to the subject an antioxidant defense activator such as the methyl ester of bardoxolone (CDDO-Me):
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(claim 45, which finds support in claim 34 of the priority document).
This compound is embraced by the formula of instant claim 3, wherein Y is –(CH2)mC(O)Rc, wherein m is 0, and Rc is alkoxy.
Huizenga further teaches that the viral infection is caused by a serve acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (claim 53, which finds support in claim 33 of the priority document).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not explicitly teach that the subjects treated requires mechanical ventilation for up to 2 days prior to treatment.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, regarding claim 4, Phua teaches that 20% to 30% of SARS patients required mechanical ventilation (page 1, left column, paragraph 1). As Sporn teaches a method of treating COVID-19 with a compound of instant claim 3, one of ordinary skill in the art would recognize that the subjects in the art could have required mechanical ventilation as Puha teaches that 30% of SARS patients required ventilation.
Claims 142-146 and 155 stand rejected under 35 U.S.C. 103 as being unpatentable over Huizenga et al (WO 2021/202245, which claims priority to application No. 63/004, 449, filed 04/02/2020, which is incorporated here by reference, and in further view of Meyer et al (US 2011/0281955 A1).
The rejection of claims 3, 10, 69-73, 79-100 and 177-178 above is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Huizenga does not teach that the compound of instant claim 10 is present in a crystalline form in the method of treating coronavirus. However, as seen in the rejection above a method of treating coronavirus with the compound of instant claim 10 has been rendered obvious
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
The prior art does not teach that the compound of instant claim 10 is present in a crystalline form.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2141.02)
However, Meyer reaches crystalline polymorphs of Bardoxolone methyl,
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, and pharmaceutical compositions thereof (paragraph [0001)). As Huizenga teaches a method wherein the above compound is administered to treat covid, one of ordinary skill in the art would have been motivate to administer the compound in the crystalline form as Meyer teaches crystalline forms of the compound of instant claim 10, the same compound as taught by Huizenga.
Regarding claim 142, Meyer teaches that the crystalline form has an X-ray diffraction pattern (CuKα) comprising significant diffraction peaks at about 8.8, 12.9, 13.4, 14.2 and 17.4°2θ (paragraph [0067]). Regarding claim 143, Meyer teaches that the crystalline form has an X-ray pattern diffraction pattern as shown in FIG 1A or FIG 1B (paragraph [0067]). Regarding claims 155, Meyer teaches that the crystalline form has a halo peak at approximately 13.5°2θ and a Tg in the range from about 125° C. to about 130° C (paragraph [0067]).
Claim(s) 3 and 179-181 are rejected under 35 U.S.C. 103 as being unpatentable over Huizenga et al (WO 2021/202245, which claims priority to application No. 63/004, 449, filed 04/02/2020) in view of Chin et al (WO 2015/027206 A1).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Huizenga teaches a method for reducing the ill effects of a viral infection in a subject in need thereof, comprising administering to the subject an antioxidant defense activator such as the methyl ester of bardoxolone (CDDO-Me):
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(claim 45, which finds support in claim 34 of the priority document).
This compound is embraced by the formula of instant claim 3, wherein Y is –(CH2)mC(O)Rc, wherein m is 0, and Rc is alkoxy.
Huizenga further teaches that the viral infection is caused by a serve acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (claim 53, which finds support in claim 33 of the priority document).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not explicitly teach that the compound of instant claim 3 is formulated as a solid dispersion comprising the compound and methacrylic acid – ethyl acrylate copolymer.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Chin teaches a method that comprises the administration of compounds of instant claim 3 (claim 1):
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.
Chin further teaches that the compounds of the above formula are formulated as a solid dispersion comprising the compound and an excipient (claim 259). Chin also teaches that the excipient is a methacrylic acid – ethyl acrylate copolymer, wherein the copolymer methacrylic acid and ethyl acrylate at a 1:1 ratio (claim 261).
As such, regarding claims 179-181, one of ordinary skill in the art would have been motivated to alter the teachings of Huizenga to include the compound of instant claim 3 in a solid dispersion formulation with a methacrylic acid – ethyl acrylate copolymer in a ratio of 1:1 as Chin teaches the same compound in the solid dispersion formulation.
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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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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