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 Arguments and Amendment filed, 12/11/2025, wherein the Amendment amended claims 1, 4, 7, 10-12, and 17-18, and cancelled claims 9.
Claims 1-2, 4, 7-8, and 10-18 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Claim Objections
Applicant’s amendment to claim 7 is sufficient to overcome this objection.
Applicant’s deletion of claim 9 is sufficient to overcome this objection.
35 U.S.C. § 112(d)
Applicant’s amendment to claim 4 is sufficient to overcome this rejection.
35 U.S.C. § 102 and 103
Applicant’s amendment to independent claims 1, 17, and 18 is sufficient to overcome these rejections.
REJECTIONS—MAINTAINED, MODIFIED, & NEW
The amendment to independent claim 1, and deletion of species of ACE2 modulators in independent claims 17-18, have resulted in the below new objections, 112(a) rejections, 112(b) rejections, 112(d) rejections, and prior art rejections.
Claim Objections
(Maintained and New) Claims 10 and 18 are objected to because of the following informalities:
-(Maintained) In claims 10 and 18, the “Table” recitations should be replaced with the compounds of Tables 2-8.
Applicant is reminded that where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim, MPEP 2173.05(s).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)-New Matter
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.
(New) Claim 4 is 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 new matter rejection.
In claim 4, the recitation “the one symptom of a coronavirus infection in a subject is an inflammatory condition” is new matter.
On pg. 7, Remarks, Applicant states that support for the amended claim language can be found in at least original claims 1-16. However, original claims 1-16 do not provide support for “inflammatory condition” as a symptom of coronavirus. Original claim 3 recites “A method of preventing or treating an acute inflammatory condition in a subject infected with a coronavirus,” but it does not recite the inflammatory condition as a symptom of a coronavirus.
A careful review of the specification does not provide support for “the one symptom of a coronavirus infection in a subject is an inflammatory condition.” Similar to the original claims, the specification provides support for a method of preventing or treating an acute inflammatory condition in a subject infected with a coronavirus. See pgs. 2-3, 25, 34, 39, 46, 50, 61, 69, 71-72, 83, 90-91.
Claim Rejections - 35 USC § 112(b)
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 1-2, 4, 7-8, and 10-16 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.
-In claim 1, lines 3-5, the phrase “a therapeutically effective amount of an angiotensin converting enzyme-2 (ACE2) modulator selected from the group comprising; wherein the angiotensin converting enzyme-2 (ACE2) modulator is selected from the group consisting of,” renders the claim indefinite. It is not clear if “selected from the group comprising” is a typo and the ACE2 modulator is limited to the ACE2 modulators recited in the Markush group “wherein the angiotensin converting enzyme (ACE2) modulator is selected from the group consisting of,” or if the ACE2 modulator is any one of the ACE2 modulators recited in the Markush group and any other ACE2 modulator.
In view of compact prosecution, for the purpose of applying prior art, “selected from the group comprising” is interpreted as a typo and the claim is interpreted as “a therapeutically effective amount of an angiotensin converting enzyme-2 (ACE2) modulator, wherein the angiotensin converting enzyme-2 (ACE2) modulator is selected from the group consisting of.”
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Rejections - 35 USC § 112(d)
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.
(New) Claim 10 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.
Note: See the claim interpretation of claim 1 in the 112(b) rejection above.
Claim 1 recites “ACE2 modulators selected from the group consisting of: (S,S)-2-(1-Carboxy-2(3-(3,5-dichlorobenzyl)-3H-imidazol-4-yl)-ethylamino)-4-methylpentanoic acid. . .2-Hydroxy-5[(7-hydroxy-8-methyl-6-nitro-2-oxochromene-3-carbonyl)amino]benzoic acid (Nicousamide); and salts and any combinations thereof.” As such, the ACE2 modulator(s) in claim 1 is selected from a closed Markush group. However, claim 10, which depends from claim 1, recites a second Markush group of ACE2 modulators that is unrelated to the group recited in claim 1. As such, claim 10 fails to further limit the subject matter of the claim upon which it depends.
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 Interpretation
-In claims 13, 17, and 18, the “depot system” is interpreted as a sustained-release formulation (abstract; Cunningham, “Formulation of depot delivery systems,” published 2010, PTO-892 of 09/11/2025).
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 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.
(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.
(New) Claims 1, 7-8, and 15-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US PG Pub 2023/0149361 to Razaz (effectively filed 03/29/2020, PTO-892).
Regarding claims 1 and 16, Razaz teaches a method of treating or preventing an infectious disease caused by coronavirus in a subject in need thereof by administering a therapeutically effective amount of an ACE2 inhibitor, such as MLN-4760,
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(pgs. 11-12, claims 1, 8, 17-20).
Razaz teaches a “therapeutically effective amount” as an amount sufficient to provide a therapeutic benefit in the treatment of the disease, disorder, or condition, or to delay or minimize one or more of the symptoms associated with the disease, disorder, or condition ([0021]).
Regarding claims 7-8, Razaz specifically teaches COVID-19, which is caused by SARS-CoV-19, as the infectious disease (pg. 11, claims 2-4).
Regarding claim 15, Razaz teaches humans as the subject ([0017]).
(New) Claims 17 and 18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 00/66104 to Acton (published 2000, IDS of 12/22/2025).
Acton teaches ACE-2 inhibiting compounds and compositions thereof (title, abstract).
Acton teaches a pharmaceutical composition comprising a pharmaceutically acceptable carrier and an effective amount of an ACE-2 inhibiting compound to treat an ACE-2 associated state, wherein the ACE-2 inhibiting compound is
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, instant MLN-4760 (pgs. 88, 103, 113-114, 117-118, claims 62, 91, 108-109), or
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(ED & EF), a compound of instant Table 3, (pgs. 78, 103, 104, 113-114, 116-118, claims 62, 64, 90, 92-94, 108-109).
Acton teaches that the compositions are preferably administered for oral administration, and exemplifies capsules and tablets as administration forms (pg. 52, lines 10-15).
Acton exemplifies its test compounds as tested in 5% DMSO, wherein DMSO meets the limitations of a pharmaceutically acceptable excipient, and the composition of the test compound combined with the DMSO is in the form of a solution (pg. 63, lines 20-23).
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and
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(ED & EF), are exemplified as test compounds (pgs. 78 and 85-86).
(New) Claim 18 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO2007/124617 to Xie (Original and Translation, published 2007, PTO-892), as evidenced by STN Registry Search of WO2007/124617 (PTO-892).
Xie teaches:
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, a compound of instant Table 4 (Original—pgs. 59, 61-63, claims 1, 2, 9; Translation, pgs. 58-59, 61-63 claims 1-2, 9-- R-X = NH, R11 = 4'-OH, R6 = NO2, R7 and R8 = H, #9), as evidenced by pg. 86 STN Registry.
Xie teaches the compound in a pharmaceutical composition with pharmaceutically acceptable carriers (Translation, pg. 61, claim 13), wherein the composition is a tablet, capsule, liquid oral solution, pill, injection, and more (Translation pg. 61, claim 14).
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 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.
(New) Claims 1, 7-8, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over US PG Pub 2023/0149361 to Razaz (effectively filed 03/29/2020, PTO-892).
Razaz is applied to claims 1, 7-8, and 15-16 as discussed above, and incorporated herein.
While Razaz teaches a method of treating a symptom of coronavirus by administering MLN-4760, it differs from that of instant claims 12-14, and 17 in that it does not exemplify compositions and specific composition forms.
Razaz teaches administration of its compounds in pharmaceutically acceptable compositions comprising excipients ([0022], [0026], [0028], [0057], [0060], [0081], [0092]-[0104]). The compositions can be administered orally, topically, intravenously, and by other means ([0094]). Elixirs, solutions, capsules, tablets and other forms of the composition are taught ([0095]-[0101]).
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 compositions comprising excipients in administrable forms as the vehicle for the compounds of Razaz, to arrive at instant claims 12-14 and 17. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Razaz teaches it compounds as administered to a subject and therefore a composition is necessitated for such administration,
-Razaz teaches its compounds in compositions comprising excipients,
-Razaz teaches its compositions as administered orally, intravenously and more, and
-Razaz teaches that its composition can be in the form of elixirs, solutions, capsules, tablets and other forms.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a form of the compound that is acceptable and therapeutically effective for administration to a subject.
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over US PG Pub 2023/0149361 to Razaz (effectively filed 03/29/2020, PTO-892) as applied to claims 1, 7-8, and 12-17 above, and further in view of US 2023/0129326 to Ostrov (effectively filed 04/07/2020, PTO-892 of 09/11/2025).
Razaz is applied as discussed above and incorporated herein.
While Razaz teaches a method of treating a symptom of coronavirus, such as SARS-CoV-2, by administering MLN-4760, it differs from that of instant claims 2 and 4 in that it does not teach treating specific symptoms of coronavirus.
Ostrov teaches a method of treating a subject suffering from an infection by a SARS-CoV-related betacoronavirus by administering an ACE2 inhibitor, such as diphenhydramine (pg. 20-21, claims 1, 4-13; pg. 2, beginning in [0017]).
Ostrov teaches cytokine storm, ARDS, and others as symptoms of a SARS-related betacoronavirus infection, and specifically SARS-CoV-2 ([0173]-[0175]).
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 symptoms, such as cytokine storm and ARDS, as treated by the methods of Razaz, to arrive at instant claims 2 and 4. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Razaz and Ostrov are both directed toward a method of treating SARS-CoV-2/Covid-19 by administering ACE-2 inhibitors,
- Razaz teaches a “therapeutically effective amount” as an amount sufficient to provide a therapeutic benefit to delay or minimize one or more of the symptoms associated with the disease, ([0021]), and
-Ostrov specifically teaches cytokine storm, ARDS, and other symptoms of coronavirus, as treated by the administration of a ACE2 inhibitor.
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a method of treating coronavirus that treats the symptoms of coronavirus.
Claims 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US PG Pub 2023/0149361 to Razaz (effectively filed 03/29/2020, PTO-892) as applied to claims 1, 7-8, and 12-17 above, and further in view of WO 00/66104 to Acton (published 2000, IDS of 12/22/2025).
Razaz is applied as discussed above and incorporated herein.
While Razaz teaches a method of treating a symptom of coronavirus, by administering a composition comprising MLN-4760, it differs from that of instant claims 10 and 18 in that it does not additionally teach an ACE2 modulator from Tables 2-8.
Acton teaches ACE-2 inhibiting compounds and compositions thereof for the treatment of an ACE-2 associated disease state (title, abstract; pg. 5, lines 1-11; pgs. 116-117, claims 92, 106).
Acton teaches compound
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(ED & EF), a compound of instant Table 3, as the ACE-2 inhibiting compound, and teaches this compound as having **, good inhibition of human ACE-2, and ***, very good inhibition of ACE-2 (pgs. 78, 103, 104, 113-114, 116-118, claims 62, 64, 90, 92-94, 108-109).
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 add
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to the methods of Razaz, to arrive at instant claims 10 and 18. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Razaz teaches ACE2 receptor inhibitors for the treatment of coronavirus
-Acton teaches
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as having good and very good inhibition of ACE-2 activity, and
-"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), MPEP 2144.06.
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a more potent method of treating coronavirus by inhibiting ACE2.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over US PG Pub 2023/0149361 to Razaz (effectively filed 03/29/2020, PTO-892) as applied to claims 1, 7-8, and 12-17 above, and further in view of US 2012/0129908 to Nebolsin (published 2012, PTO-892 of 09/11/2025).
Razaz is applied as discussed above and incorporated herein.
While Razaz teaches a method of treating a symptom of coronavirus, such as SARS-CoV-2, by administering MLN-4760, it differs from that of instant claim 11 in that it does not teach a dosing regimen.
Nebolsin teaches a method of treating a pathogenic infectious disease by administering to a patient, the glutaryl histamine,
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, the ACE-2 inhibitor ingavirin (an ACE2 inhibition taught on pg. 16 of the instant specification) (pgs. 5-6, claim 11), wherein the disease is SARS caused by genotype IV coronavirus (claim 15).
Nebolsin teaches daily doses ([0032]; pg. 3, Example 3).
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 daily administration as the dosage regimen of Razaz, to arrive at instant claim 11. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Razaz and Nebolsin are both directed toward a method of treating coronavirus by administering ACE-2 inhibitors,
-Nebolsin teaches daily administration of an ACE2 inhibitor to treat coronavirus,
- Razaz teaches a “therapeutically effective amount” as an amount sufficient to provide a therapeutic benefit to delay or minimize one or more of the symptoms associated with the disease, ([0021]), and
-Razaz teaches that the amount of compound administered will be determined by a physician, in the light of the relevant circumstances, including the chosen route of administration, the age, weight, and response of the individual patient, and the severity of the patient’s symptoms ([0100]).
As such, an ordinary skilled artisan would have been motivated to make such a selection to predictably arrive at a dosage regimen that is therapeutically effective for the treatment of coronavirus.
Response to Arguments
The above rejections are new, as necessitated by the amendments to the claims. As such, the arguments filed 12/11/2025, are not relevant to the above rejections.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 12/22/2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622