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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/19/2025 has been entered.
Change of Examiner
The case had been previously examined by Daniel Carcanague. Please note that the case has been assigned to a new examiner. Any inquiry concerning this communication or earlier communications should be directed to Izabela Schmidt whose telephone number is (703)756-4787.
Priority
Instant application 17/766,498 filed on 04/04/2022 claims benefit as follow:
CONTINUING DATA:
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Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/27/2025 was in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Application
The amendment filled on 03/19/2026 has been entered.
Claims 1, 4, 10, 11, 12, 18, 19, 20, 26, 27, 28 are pending.
Claims 11, 12, 18 19, 20, 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/02/2025.
Response to Arguments/Amendments
Claims 1, 4 and 28 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evans (British Journal of Pharmacology 2018, 175, 1744–1759, IDS).
Applicant’s amendment has overcome the 102 rejection of record, therefore the rejection is withdrawn.
Unless re-stated herein any outstanding ground of objection or rejection is withdrawn.
However, Applicant’s amendment necessitated new ground of rejection presented in this office action.
The present office action replaces all prior versions or listing of rejections in the present application.
Election/Restrictions
Scope of Search
The Examiner has followed the guidelines found in MPEP 803.02 regarding the provisional election of species and the search and examination of the Markush generic claims:
“Should applicant, in response to a rejection of a Markush claim, overcome the rejection by amending the Markush claim to exclude the species anticipated or rendered obvious by the prior art, the amended Markush claim will be examined again. The examination will be extended to the extent necessary to determine patentability of the Markush claim. In the event prior art is found during this examination that anticipates or renders obvious the amended Markush claim, the claim will be rejected and the action can be made final…”
Applicant’s amendment has excluded from scope the species cited in the previous office action.
The search is now expended to additional species encompassed by the formula (I) recited in instant claim 1.
The expended species are:
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and
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compound Io3-135 (also known as CAS Registry Number 2126765-00-0, entered to STN 08 Sep 2017) and compound Ia19-135 (also known as CAS Registry Number 2131403-62-6, entered to STN 08 Sep 2017).
The search has not been extended unnecessarily to cover all nonelected species.
New / Maintained Objections / Rejections
To the extent that the below stated grounds of objection and rejection might be considered to represent new grounds, they have been necessitated by Applicant’s amendment to independent claim 1, which excludes the previously cited prior art species from the scope of the claims.
Claim Objections
Claims 10 and 27 are objected to as depending from a rejected base claim.
Claim 10 recites the single compound of the elected species and claim 27 recites a grouping of closely related species.
The claims are not allowable since they each depend directly or indirectly from rejected claim 1.
See pages 6-7 of the office action mailed on 06/18/2025 as to the closest prior art and the reasons why the elected species is allowable.
Regarding claim 27, as stated in the previous office action (mailed 11/19/206), the activity of the PIEZO1 agonist potency of the known compound of Yoda1 is highly sensitive to structural modifications and that there is no reasonable expectation of success in exchanging the thioether sulfur atom with an oxygen atom as asserted in the ground of the rejection mailed on 06/18/2025. Therefore, the species listed in claim 27 are allowable for at least the same reasons and/or in view of Applicant’s arguments submitted on 09/18/2025 with respect to the withdrawn rejection of claim 27 over Evans (British Journal of Pharmacology 2018, 175, 1744–1759, IDS) in view of Caterina Barillari and Nathan Brown ("Classical Bioisosteres", Chapter 2 in Bioisosteres in Medicinal Chemistry, Wiley-VCH, 2012, pages 15-29).
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 4 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 4 recites “the compound of claim 1, wherein R4A and R4B are each hydrogen, Q3 is S, Q4 is S, A is a substituted or unsubstituted pyrazinyl, or any combination thereof”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 4 recites the broad recitation “R4A and R4B are each hydrogen, Q3 is S, Q4 is S, A is a substituted or unsubstituted pyrazinyl or any combination thereof”, and the claim also recites specific compounds wherein R4A and R4B are each hydrogen, Q3 is S, Q4 is S, A is a substituted or unsubstituted pyrazinyl which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether (a) the claim require specific compounds wherein R4A and R4B are each hydrogen, Q3 is S, Q4 is S, and A is a substituted or unsubstituted pyrazinyl or (b) the claims require only some, but not all, variable groups to meet the options listed in the claim since this claim is construed as “a combination thereof”.
Further, it is not clear what additional combinations of the recited variable groups are embraced by the scope of this claim. Therefore, claim 4 is indefinite because the meets and bounds of the claim are unclear.
Claim Rejections - 35 USC § 102
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 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP3210469A1 (published 2017-08-30) and evidenced by CAS Registry Number 2126765-00-0 (entered to STN 08 Sep 2017) and evidenced by CAS Registry Number 2131403-62-6 (entered to STN 08 Sep 2017).
Please note that English machine translation of EP3210469A1 is provided (printed from Google Patents 3/31/2026)
EP3210469A1 teaches:
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Specifically, EP3210469A1 teaches:
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EP3210469A1 teaches “Compounds 03-1 to 03-798 of general formula (Io3), wherein R3, R4, Y, A1, A2, A3, A4, and A5 correspond to the definitions (Nos. 1 to 798; corresponding to compounds 03-1 to 03-798) in Table 1 above” (see page 121, lines 25-35).
Compound Io3-135 (see Table 1):
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Io3-135 (also known as CAS Registry Number 2126765-00-0, entered to STN 08 Sep 2017) is a species of examined formula (I)
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wherein:
Q1 is N, Q2 is R3, and R1 is hydrogen and R3 is hydrogen;
R4A and R4B are each hydrogen;
Q3 is S;
Q4 is NR7; and R7 is aryl;
A is unsubstituted heteroaryl having one N in the heteroaryl ring (pyridine).
Further, EP 3210469 discloses compound Ia19 (see compound Ia19 and Table 1)
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EP3210469A1 teaches “Compounds A19-1 to A19-798 of general formula (Ia19), wherein R3, R4, Y, A1, A2, A3, A4, and A5 correspond to the definitions (Nos. 1 to 798; corresponding to compounds A19-1 to A18-799) in Table 1 above.” (see page 79, lines 28-36)
Compound Ia19-135 (see table 1):
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Ia19-135 (also known as CAS Registry Number 2131403-62-6, entered to STN 08 Sep 2017) is a species of examined formula (I) wherein:
Q1 is N, Q2 is R3, and R1 is hydrogen and R3 is hydrogen;
R4A and R4B are each hydrogen;
Q3 is S;
Q4 is NR7; and R7 is C1 alkyl.
A is unsubstituted heteroaryl having two N in the heteroaryl ring (unsubstituted pyrazinyl).
Please note that the exclusionary proviso in instant claim 1: “wherein each of R1, R2, and R3 are not hydrogen if R4A and R4B are each hydrogen, Q3 and Q4 are each S, and A is an unsubstituted heteroaryl” does not exclude these species from scope since R2 is not hydrogen and Q4 is not S.
Regarding instant claim 28, EP3210469A1 teaches a spray solution comprising the above compound(s) wherein the “spray solution can have other conventional constituents, such as solvents, formulation auxiliaries, in particular water” (see machine translation, page 184, first full paragraph/or the original document in German, page 204, paragraph [0702]).
MPEP 2131.02 III states “A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." In the instant case, since EP3210469A1 teaches solutions comprising the above compounds in water, thus, a person of ordinary skill would at once envisage a pharmaceutical composition comprising a therapeutically effective amount of the compound(s) taught by EP3210469A1 and water. It should be noted that water is the most widely used pharmaceutically acceptable carrier and diluent.
Conclusion
Claims 1, 4 and 28 are rejected.
Claims 10, 27 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/I.S./Examiner, Art Unit 1621
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621