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
1. This application is a 371 of PCT/CN2021/110859 08/05/2021; FOREIGN APPLICATIONS: CHINA 202010790872.8 08/07/2020.
Claims 11, 14-17, 19-33 are pending.
Claim Rejections/Objections Withdrawn
2. The rejections of canceled claims are withdrawn. The rejection of claims 11, 14-17, 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for 29 instances of "preferably" and “more preferably”, 11 instances of "e.g." and multiple instances of “such as” "for example" and parenthesis is withdrawn based upon the amendments. The rejection of claims 11-12, 14-16, 21 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for an optional oxidized or unoxidized oxidation state is withdrawn based upon the amendments. The rejection of claims 11, 14, 16, on the judicially-created basis that it contains an improper Markush grouping of alternatives is withdrawn based upon the amendments. The rejection of claims 11, 14-17, 21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for prodrugs is withdrawn based upon the amendments. The rejection of claims 11-12, 14, and 21 under 35 U.S.C. 102(a)(1) as being anticipated by Suehiro is withdrawn based upon the amendments. The rejection of claims 11-12, 14-16 and 21 under 35 U.S.C. 102(a)(1) as being anticipated by Schubart is withdrawn based upon the amendments. The rejection of claims 17 under 35 U.S.C. 103 as being unpatentable over Schubart as applied to claims 11-12, 14-16 and 21 and further in view of Shah is withdrawn based upon the amendments. The rejection of claims 17 and 11, 14-16 and 21 based upon the amendment to claim 11, under 35 U.S.C. 103 as being unpatentable over Schubart further in view of Talele is withdrawn. Applicant's arguments filed May 8, 2026 have been fully considered and are persuasive. According to the specification, the claimed compounds are more than four times as active as the closest prior art compound LNP023 in the hemolysis assay1. The claimed compound also has a nearly nine-fold increase in RMax (RU) (Table 1). According to the reply, this is unexpected [Remarks page 37/38]. Having compared the closest prior art, LNP023 is the clinical lead, and presented evidence of unpredicted therapeutic advantages, the prima facie case of obviousness has been overcome based upon unexpected results. The claims are reasonably commensurate in scope, and other species in the instant claims have additional chemical distinctions over the Schubart compounds besides the cyclopropyl group. The rejection is withdrawn based upon unexpected results.
Claim Rejections/Objections Maintained/ New Grounds of Rejection
3. The rejection of claims 11-12, 14-16 and 21 under 35 U.S.C. 102(a)(1) as being anticipated by Adams US 20160152605 is maintained. While some of the anticipatory species have been removed by amendment, at least the genus is still anticipated as explained below. Various new grounds of rejection are set forth below.
Response to Restriction Election
4. Applicant’s election of group I and the species,
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in the reply filed on January 6, 2026 was previously acknowledged. As detailed in the following rejections, the generic claim encompassing the elected species was not found patentable. The search and examination was continued until prior art was found that anticipated or rendered obvious a non-elected species that falls within the scope of the generic Markush claim reading on the elected species. As per MPEP 803.02 II. C. “[T]he examiner must continue to search the species of the claim unless the claim has been found to be unpatentable over prior art.” The examiner “need not continue to search the claim if the claim is rejected over prior art”. [ibid. D.] Therefore, the search and examination is restricted to the claims reading on the elected species, and claims not reading on the elected species are held withdrawn.
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.
(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.
5. Claim(s) 11, 14-16 and 21, 23-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adams US 20160152605 (cited as a 3rd party disclosure). Adams teaches the compounds of claim 11 Formula I including but not limited to the compounds of Formula IIIa on page 3:
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This structure has all of the feature of the elected species including the piperidine of claim 17. The R6 group is defined as C1-C4 -alkyl. There are a number of specific examples of this formula shown including but not limited to those on pages 91 ff. such as example 20, 17-30:
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These are compounds reading on claim 11 where R1 is C1alkoxy (methoxy), R2, R4 -R6 are H, R3 is methyl, R7 is H, WYZ are not variable, R8 is C6 aryl (phenyl) substituted by Rj, Rj is a C1 alkyl substituted by two Rp, one is oxo and the other is -OH, R11 is H, R10 is alkyl.2
6. Claim(s) 11, 14-17 and 21, 23-28 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chen US20240109861. Chen teaches the compounds of claim 11 Formula I including but not limited to the compounds on page 6 ff:
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These are compounds reading on claim 11 where R1 is C1alkoxy (methoxy), R2, R4 -R6 are H, R3 is methyl, R7 is H, WYZ are not variable, R8 is C6 aryl (phenyl) substituted by Rj, Rj is a C1 alkyl substituted by two Rp, one is oxo and the other is -OH, R11 is H, R10 is C1-6 alkyloxy substituted with 1, 2 or more Rk, where Rk is cyclopropane, cyclobutane, or a cycloalkyl (cyclobutane, cyclopropane, optionally substituted with halogen), a heterocyclyl (THF, oxetane). Some of these compounds appear in claim 17 and 28.
Conclusion
7. 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).
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 DAVID K O'DELL whose telephone number is (571)272-9071. The examiner can normally be reached on Monday - Friday 9:30 - 7:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 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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/DAVID K O'DELL/ Primary Examiner, Art Unit 1621
1 The specification defines the control compound (Example-26c, W02015009616A1) as LNP023 of Schubart.
2 R¹⁰ is defined as “C1-6 alkyloxy substituted with 1, 2 or more Rk; or R¹⁰ is selected from the following groups unsubstituted or substituted with 1, 2 or more halogen or C1-6 alkyl: C3-8 cycloalkyl, 3- to 6- membered heterocyclyl, C3-6 cycloalkyloxy, and 3- to 6-membered heterocyclyloxy;” The second portion with an alkyl can be interpreted at least two ways, “R¹⁰ is selected from the following groups unsubstituted or substituted with 1, 2 or more halogen or C1-6 alkyl:” It could be that C1-6 alkyl is a possible definition of R10 or it is a substituent of the groups that follow the colon. It is currently ambiguous and either interpretation is reasonable.
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