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
This office action is in response to applicant’s reply filed on January 2, 2026.
Restrictions/Elections.
Applicant’s election without traverse of Group I (Claims 1-5 and 18-19) in the reply filed on January 2, 2026, is acknowledged.
NOTE: claims 6-12 do not fall within the invention of claims 1-5, since claims 1-5 relate to a composition, while claims 6-12 relate to a method of treating a disease.
Status of Claims
Claims 1-19 are currently pending and are the subject of this office action.
Claims 6-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 2, 2026.
Claims 1-5 and 18-19 are presently under examination.
Priority
The present application claims priority to provisional application No. 63/393,802 filed on 07/29/2022.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claims 1-4 encompass a composition comprising:
(a) one or more Nrf2 agonists;
(b) one or more 3CLpro inhibitors,
one or more protease inhibitors, and/or
one or more N4-hydroxycytidine nucleosides.
M.P.E.P. #2163 states: “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention….one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process”.
In Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc), the Federal Circuit stated that “the hallmark of written description is disclosure.” A specification adequately describes an invention when it “reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Id. at 1351. “A ‘mere wish or plan’ for obtaining the claimed invention is not adequate written description.” Centocor Ortho Biotech, Inc. v. Abbott Labs, 636 F.3d 1341, 1348 (Fed. Cir. 2011).
The description requirement of the patent statute requires a description of an actual invention, not merely an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984) (holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate’). This matter is of particular importance in the evaluation of claims drawn to a chemical genus which identifies a core compound bearing variable substituents. It has been held that “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification...demonstrates that the applicant has invented species sufficient to support a claim to a genus” with such breadth. Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2D 1161, 1171 (Fed. Cir. 2010). An adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties of species falling within the genus sufficient to distinguish the genus from other materials. Id., quoting Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997).
However, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species. Ariad, 94 USPQ2D at 1171. 35 U.S. C. 112, first paragraph, requires a description of the invention that “clearly allow[s] persons of ordinary skill in the art to recognize that the inventor invented what is claimed.” Ariad at 1172, quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (1562-63) (Fed. Cir. 1991) (emphasis added). A sufficient disclosure is one which reasonably conveys to one having ordinary skill in the art that the inventor had possession of the claimed subject matter as of the filing date of the application in question. Vas-Cath, 935 F.2d at 1563. The description must reasonably describe the invention, not simply indicate a result which one might achieve if one actually made the invention. Eli Lilly, 119 F.3d at 1568. To properly evaluate whether an applicant has complied with the written description requirement therefore requires an analysis of whether the skilled artisan would recognize, from the description provided, the applicants were in possession of sufficient compounds representing the full breadth of diversity of the genus claimed.
A description of a chemical genus will usually comprise a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the members of the genus, which features constitute substantial portion of the genus. See Univ. of California vs. Eli Lilly, 43 USPQ 2d 1398, 1406 (Fed. Cir. 1997). This is analogous to enablement of a genus under section 112 first, by showing enablement of a representative number of species within the genus. A chemical genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus.
Here, applicants have claimed an extraordinarily large genus of compositions comprising:
(a) one or more Nrf2 agonists;
(b) one or more 3CLpro inhibitors,
one or more protease inhibitors, and/or
one or more N4-hydroxycytidine nucleosides.
However, the specification discloses a very few examples of these compositions, (see for example claim 5)
The number of different compositions disclosed is very limited compared to what is claimed.
The size of the genus thus described is phenomenal, against which the applicants have offered evidence of being in possession of one or two of those compositions. This small set of compositions cannot be viewed as being reasonably representative of the genus of compositions in its claimed scope because no readily apparent combination of identifying characteristics is provided, other than the disclosure of those specific species as examples of the claimed genus, and in no way either represent the breadth of variable moieties which applicants have claimed, nor permit the skilled artisan to recognize that such claim breadth was actually in the applicants possession as of the time of filing the instant application.
Given the broad scope of the claimed subject matter, Applicant has not provided sufficient written description that would allow the skilled in the art to recognize that Applicant was in possession of most the compositions claimed.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4 and 18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Santulli (US 2024/0287608).
For claims 1-4 and 18, Santulli teaches a composition for the treatment of COVID-19 comprising among others: MitoQ (Mito Quinone, a Nrf2 agonist and a TPP compound), Nirmatrelvir (a 3CLpro inhibitor), Ritonavir (a protease inhibitor) and Molnupiravir (a N4-hydroxycytidine nucleoside) (see [0188] and claim 8).
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.
1) Claim(s) 5 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Santulli (US 2024/0287608) in view of Olagnier et. al. (Nature Communications (2020) 11:4938, pages 1-12, cited by Applicant).
Santulli teaches all the limitations of claims 5 and 19 (see above 102(a)(2) rejection), except for the presence of Dimethyl Fumarate (DMF). However, Olagnier teaches that DMF is effective in treating COVID-19.
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to combine several compositions (MitoQ, Nirmatrelvir, Ritonavir, Molnupiravir, and DMF) each of which is taught by the prior art to be useful for the same purpose (treating COVID-19), in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art (see MPEP 2144.06). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See also: In re Diamond, 360 F.2d 214, 53 C.C.P.A. 1172, 149 U.S.P.Q. 562 (C.C.P.A 1966).
All this would result in the practice of claims 5 and 19 with a reasonable expectation of success.
2) Claim(s) 1-4 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Santulli (US 2024/0287608)
For claims 1-4 and 18, Santulli teaches a composition for the treatment of COVDI-19 comprising among others: MitoQ (Mito Quinone, a Nrf2 agonist and a TPP compound), Nirmatrelvir (a 3CLpro inhibitor), Ritonavir (a protease inhibitor) and Molnupiravir (a N4-hydroxycytidine nucleoside). (see [0188] and claim 8).
Before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to combine several compositions (MitoQ, Nirmatrelvir, Ritonavir and Molnupiravir) each of which is taught by the prior art to be useful for the same purpose (treating COVID-19), in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art (see MPEP 2144.06). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See also: In re Diamond, 360 F.2d 214, 53 C.C.P.A. 1172, 149 U.S.P.Q. 562 (C.C.P.A 1966).
All this would result in the practice of claims 1-4 and 18 with a reasonable expectation of success.
3) Claim(s) 1-4 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nappi et. al. (Biomedicines (2022, February 14), 10:437 pages 1-18) in view of Skulachev et. al. (WO 2021/198786, April 5, 2021, cited by Applicant).
For claims 1-4 and 18, Nappi teaches that Molnupiravir, Nirmatrelvir and Ritonavir are effective drugs already approved by the FDA for the treatment of COVID-19 (see abstract and entire document). Nappi does not teach that MitoQ (mitoquinone or mitoquinol) is effective in treating COVID-19. However, Skulachev teaches that TPP compounds like MitoQ are effective in treating COVID-19 (see page 4, see page 5claim 4).
Before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to combine several compositions (Molnupiravir, Nirmatrelvir, Ritonavir and MitoQ) each of which is taught by the prior art to be useful for the same purpose (treating COVID-19), in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art (see MPEP 2144.06). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
See also: In re Diamond, 360 F.2d 214, 53 C.C.P.A. 1172, 149 U.S.P.Q. 562 (C.C.P.A 1966).
All this would result in the practice of claims 1-4 and 18 with a reasonable expectation of success.
4) Claim(s) 5 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nappi et. al. (Biomedicines (2022, February 14), 10:437 pages 1-18) in view of Skulachev et. al. (WO 2021/198786, April 5, 2021, cited by Applicant) as applied to claims 1-4 and 18 above, further in view of Olagnier et. al. (Nature Communications (2020) 11:4938, pages 1-12, cited by Applicant).
Nappi in view of Skulachev teaches all the limitations of claims 5 and 19, except for the presence of DMF. However, Olagnier teaches that DMF is effective in treating COVID-19.
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to combine several compositions (MitoQ, Nirmatrelvir, Ritonavir, and Molnupiravir, and DMF) each of which is taught by the prior art to be useful for the same purpose (treating COVID-19), in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art (see MPEP 2144.06). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See also: In re Diamond, 360 F.2d 214, 53 C.C.P.A. 1172, 149 U.S.P.Q. 562 (C.C.P.A 1966).
All this would result in the practice of claims 5 and 19 with a reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
January 8, 2026.
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