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 133-161 are pending in the instant application. Claims 122-158 are amended and claims 1-132 are cancelled via the amendment filed February 18th, 2026.
Priority
This application claims priority to provisional application 63/391,210, filed July 21st, 2022 and 63/319,197, filed March 11th, 2022.
Withdrawn Objections
Applicant’s arguments and amendments, filed February 18th, 2026, with respect to the objection of claims 135-136, 138-142, 145, 147 and 152-155 have been fully considered and are persuasive. The objection of claims 135-136, 138-142, 145, 147 and 152-155 has been withdrawn.
Applicant has overcome this objection by amending the claims to replace “…as a stereoisomer, enantiomer, or tautomer, or mixture thereof; or a pharmaceutically acceptable salt, solvate or prodrug thereof” with “a stereoisomer, enantiomer, tautomer, or mixture thereof; or a pharmaceutically acceptable salt, solvate or prodrug thereof.”
Applicant’s arguments and amendments, filed February 18th, 2026, with respect to the objection of claim 157 have been fully considered and are persuasive. The objection of claim 157 has been withdrawn.
Applicant has overcome this objection by amending claim 157 to recite “The compound of claim 133, wherein the compound is selected from the group consisting of…”, insert “and” before the last compound and amend the last two lines of the claim to recite “or a stereoisomer, enantiomer, tautomer, mixture or pharmaceutically acceptable salt, solvate or prodrug thereof.”
Withdrawn Rejections
Applicant’s arguments and amendments, filed February 18th, 2026, with respect to the 112(b) rejection of claims 133, 135-136, 138-142, 145, 147 and 152-155 have been fully considered and are persuasive. The 112(b) rejection of claims 135-136, 138-142, 145, 147 and 152-155 has been withdrawn.
Applicant has overcome this rejection by amending claim 133 to replace every recitation of “comprising” with phrases of “consisting of” or “selected from the group consisting of”.
Applicant’s arguments and amendments, filed February 18th, 2026, with respect to the 102(a)(1) and 102(a)(2) rejection of claims 133, 138-142, 145 and 147 as being anticipated by Shen have been fully considered and are persuasive. The 102(a)(1) and 102(a)(2) rejection of claims 133, 138-142, 145 and 147 has been withdrawn.
Applicant has overcome this rejection by amending claim 133 to remove the option for R4a and R4b to be -S-R4c.
However, Applicant’s amendments have necessitated a new grounds rejection.
Restriction/Election
Applicant’s election without traverse of “compound I-68” to prosecute the invention of Group I, drawn to a compound of structure Ia, in the reply filed on October 3rd, 2025 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of the compound I-68 appears allowable. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the scope of claims 135, 152-155 and 157, as well as structural species:
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Since a non-elected species has been found not allowable, examination has been limited to claims directed to the elected species, which are presently claims 133, 135-36, 138-142, 145, 147, 152-155 and 157. Claims 133, 135-36, 138-142, 145, 147, 152-155 and 157 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 134,137,143-144,146,148-151,156 and 158-161 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention or species. Election was made without traverse in reply filed October 3rd, 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 (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)(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.
Claim(s) 133, 136, 138-142, 145 and 147 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Akioka et al (US 2016/0205935 A1), as evidenced by Mloston et al (Journal of Fluorine Chemistry 131 (2010) 829–843).
Akioka teaches the following compound:
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Regarding claim 133, this compound is embraced by instant structure Ia, wherein X1, X2 and X5 are CH, R4a and R4b are hydrogen, L1 is
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, wherein Lb is a direct bond and R1 is an immolative element, an ether bond, L2 is
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, wherein Lb is a substituted heteroalkene linker, and R2 is a payload, specifically CF3. CF3, trifluoromethyl is a glucocorticoid receptor agonist, as evidenced by Mloston et al (Journal of Fluorine Chemistry 131 (2010) 829–843). Mloston teaches that trifluoromethyl is recognized as an important pharmacophore displaying a key role in modulation of biological activity of the studied compounds, e.g. in binding ability and agonist activity of a glucocorticoid receptor ligand (page 840, right column, paragraph 1).
Regarding claim 136, the claim recite “wherein the amino acid element has one of the following structures..” however, the compound above does not contain an amino acid element. The claim from which claim 136 depends, claim 133, recites that the compound may contain an amino acid element but also may not. As the limitation of claim 136 is to the amino acid element of compounds of formula (Ia), the compound above reads on the claim.
Regarding claim 138, the claim recite “wherein heteroalkylene element has one of the following structures..” however, the compound above does not contain an heteroalkylene element. The claim from which claim 138 depends, claim 133, recites that the compound may contain a heteroalkylene element but also may not. As the limitation of claim 138 is to the heteroalkylene element of compounds of formula (Ia), the compound above reads on the claim.
Regarding claims 139-140, the claims recite “wherein the hydrophilic element has one of the following structures..” however, the compound above does not contain a hydrophilic element. The claim from which claims 139-140 depends, claim 133, recites that the compound may contain a hydrophilic element but also may not. As the limitation of claims 139-140 is to the hydrophilic element of compounds of formula (Ia), the compound above reads on the claim.
Regarding claim 142, the claim recite “wherein the trigger element has one of the following structures..” however, the compound above does not contain a trigger element. The claim from which claim 142 depends, claim 133, recites that the compound may contain a trigger element but also may not. As the limitation of claim 138 is to the trigger element of compounds of formula (Ia), the compound above reads on the claim.
Regarding claim 145, the claim recite “wherein the polar cap is..” however, the compound above does not contain a polar cap. The claim from which claim 145 depends, claim 133, recites that the compound may contain a payload but also may not. As the limitation of claim 145 is to the polar cap of compounds of formula (Ia), the compound above reads on the claim.
Regarding claim 147, as seen above, the payload is a glucocorticoid receptor agonist.
Allowable Subject Matter
Claims 135, 152-155 and 157 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Grace Kuckla whose telephone number is (703)756-5610. The examiner can normally be reached Monday-Friday 7:30-5.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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