DETAILED ACTION
A non-final Office action was mailed 8 July 2025 (“Office Action”).
Applicant’s reply to the Office Action was received 6 January 2026 (“Reply”).
Status of the Claims
The listing of claims filed with the Reply has been examined.
Claims 1–20 are pending. Claims 1–20 are amended.
Status of Rejections and Objections
The text of those sections of Title 35, U.S. Code and/or text providing the basis for non-statutory double patenting rejections not included in this action are set forth in the Office Action.
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Objections to the Specification
Claim 1 recites: M(1), R5, R6, R7, R8, and R9. Claim 17 recites: M(1).
The specification is objected to because there is insufficient antecedent basis for those variables in the specification. Applicant must amend the specification when adding new terms to a claim (without adding new matter) so the claims have support in the specification. See MPEP 608.01(o).
Appropriate correction is required.
Claim Objections
Claims 11 and 15 are objected to for minor informalities.
Claim 11 recites “BET.” Claim 15 recites “IFNs.”, To avoid confusion, acronyms should be defined in the claims, at least in the first instance (e.g., change “BET” to “bromodomain and extraterminal domain (BET).” Applicant should confirm the specification defines the acronym and provides support for the amendment and, if needed, amend the specification accordingly without adding new matter.
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 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.
(i) Claims 2–5 and 17–20 are rejected under 35 U.S.C. § 112(d) 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.
Claims 2, 4, and 5 depend from claim 1. Claims 17–20 depend from claim 15.
Claims 2–5 and 17–20 recite, “[R1-R2] may independently contain varying amounts of isotopic substitution.”
Claims 1 and 15 do not describe any R variable as “may independently contain varying amounts of isotopic substitution.”
Claims 2–5 and 17–20 are improper dependent claims because they encompass subject matter that is outside the scope of the subject matter in claims 1 and 15, respectively; i.e., they fail to incorporate all the limitations of the claim to which they refer.
Claim 3 depends from claim 1. Claim 1 recites a definition for R5. Claim 3 recites a different definition of R5 that includes options not recited in the definition of R5 in claim 1 (e.g., hydroxyl).
Claim 4 depends from claim 1. Claim 1 recites a definition for R2. Claim 4 recites a different definition of R2 that includes options not recited in the definition of R2 in claim 1.
Claim 5 depends from claim 1. Claim 1 recites a definition for R2. Claim 5 recites a different definition of R2 that includes options not recited in the definition of R2 in claim 1 (all except morpholine).
Claims 17–20 depend from claim 15.
Claim 15 recites: “R2 is selected from morpholine or piperazine.”
Variable R2 in claim 15 corresponds to the substituent with M(1) or M in claims 17–20.
Claims 17–20 recite, “M(1) is independently oxygen (O) or sulfur (S) or N-R1.”
When M(1) = O, the substituent is a morpholine.
When M(1) = N-R1 and R1 = H, the substituent is a piperazine.
Claims 18–20 depend from claim 15.
Claim 15 recites: “M is independently oxygen (O) or sulfur (S).”
Claims 18–20 each “M is independently oxygen (O) or sulfur (S) or N-R1.”
Claim 15 additionally recites a definition for each of R1, R2, and R3. Claim 18 recites a different definition for R1, R2, and R3 that includes options not recited in the definition for R1, R2, and R3 in claim 15.
Accordingly, Claims 2-5 and 17-20 do not comply with 112(d). Appropriate correction is required.
Double Patenting
(i) Claims 15–20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 and 7 of U.S. Pat. No. 11,472,814 (reference claims) [IDS].
17/922,045
11,472,814
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The instant claims are directed to a method of treating acute respiratory distress syndrome, among other things, by administering a compound of Formula V (above left).
Reference claim 7 is directed to a method of treating acute respiratory distress syndrome, among other things, by administering a compound of Formula V (above right).
The conflicting claims are not identical because the instant claims characterize acute respiratory distress syndrome as a “complication arising from a coronavirus infection” and the reference claims include other diseases. The conflicting claims, however, are directed to treating at least one of the same disorders with the same compounds. One of ordinary skill in the art would have had a reasonable expectation of success at treating the same disorder with the same compounds. Furthermore, an infringer of a patent granted based on the instant claims would also be an infringer of the reference claims and vice versa.
(ii) Claims 15–20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1–3 and 9 of U.S. Pat. No. 10,308,662 (reference claims).
17/922,045
10,308,662
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The instant claims are directed to a method of treating acute respiratory distress syndrome, among other things, by administering a compound of Formula I (above left).
Reference claim 1 is directed to a method of treating a viral infection by administering a compound of Formula I (above right). Reference claim 7 is directed to a method of treating acute respiratory distress syndrome, among other things.
The conflicting claims are not identical because the instant claims characterize acute respiratory distress syndrome as a “complication arising from a coronavirus infection” and the reference claims include other diseases. The conflicting claims, however, are directed to treating at least one of the same disorders with the same compounds. One of ordinary skill in the art would have had a reasonable expectation of success at treating the same disorder with the same compounds. Furthermore, an infringer of a patent granted based on the instant claims would also be an infringer of the reference claims and vice versa.
(iii) Claims 15–20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Pat. No. 10,174,032 (reference claims) [IDS].
17/922,045
10,174,032
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The instant claims are directed to a method of treating acute respiratory distress syndrome, among other things, by administering a compound of Formula I (above left).
Reference claim 1 is directed to a compound of Formula I (above right). The reference claims do not disclose the utility of the compounds. The specification can be reviewed to see what the utility is. MPEP § 804(II)(B)(1) (“The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed.”). In this case, the specification states the compounds are useful for treating acute respiratory distress syndrome. (US10,174,032 at 42:8–9) (col:lines).
The conflicting claims are not identical because the instant claims characterize acute respiratory distress syndrome as a “complication arising from a coronavirus infection.” The specification corresponding to the reference claims does not exclude obtaining acute respiratory distress syndrome from a coronavirus infection. Accordingly, despite how the mammal obtained acute respiratory distress syndrome in the instant claims, the subject matter in the conflicting claims is directed to treating at least one of the same disorders with the same compounds. One of ordinary skill in the art would have had a reasonable expectation of success at treating the same disorder with the same compounds.
Conclusion
No claims are allowed.
Claims 1–5 and 15–20 are rejected.
Claims 6–14 are objected to for depending on a rejected claim and/or for the reasons stated above.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.M.N./Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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