FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed May 13, 2026.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
Claim 3 has been canceled.
Claims 1, 4, 5, 7-15, 17-30, 34, and 34 have been amended and incorporate no new matter.
New claims 36-40 have been added.
Thus, claims 1, 2, and 4-40 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
The information disclosure statement (IDS) submitted on May 13, 2026 was filed after the mailing date of the non-final action on Feb. 13, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
MAINTAINED REJECTIONS
The following rejection is maintained from the previous Office Action dated Feb. 13, 2026, on the ground that the references cited therein continue to read on the limitations of the amended claims.
Claims 1, 2, 4-8, 10, and 22-35 stand 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 pre-AIA the applicant regards as the invention.
In addition, this rejection is extended to new claims 36-40.
Independent claims 1, 22, 27, and 34 recite ALS compounds of formula (II),
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wherein, when Y is R-N, R comprises hydrogen, acetyl, an Rnase L-recruiting moiety according to Formula (III), a diaza-4,4'-oct-7-yn-1-oyl group comprising Formula (IV), or a succinoyl group comprising Formula (V).
In further limiting the scope of Formula (II), dependent claims 4, 23, 29, 35, and 40 similarly recite the phrase "R comprises."
The scope of Formula (II) is indefinite because "comprising" is open-ended and fails to limit the structural boundaries of the compounds of Formula (II), such that the substances included by Formula (II) cannot be readily distinguished from substances which are excluded.
As recognized by MPEP § 2111.03, the term “comprising”, which is syn-onymous with “including,” “containing,” or “charac-terized by,” is inclusive or open-ended and does not exclude additional, unrecited elements. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (“like the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.”) “Comprising” is a term of art used in claim language which means that the named elements are essential, but other ele-ments may be added and still form a construct within the scope of the claim. Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredi-ents even in major amounts”).
Because the scope of Formula (II) lacks a clear boundary, infringing compounds cannot be distinguished from non-infringing compounds, rendering the metes and bounds of the claims indefinite.
Suggested language to overcome this rejection is, for example, "R is selected from the group consisting of hydrogen, acetyl, Formula (III), Formula (IV), and Formula (V)."
RESPONSE TO ARGUMENTS
Applicant's arguments filed May 13, 2026 have been fully considered but they are not persuasive.
Regarding the rejection under 35 U.S.C. § 112(b) as being indefinite for employing the term "comprising" to define the scope of the claimed compounds, Applicant asserts that the amended claims would inform a skilled person with reasonable certainty as to their scope, and accordingly are definite (Remarks, p. 16).
However, the amended claims continue to employ the term "comprising" to define compounds of Formula (II), and thus remain indefinite, for the reasons set forth above.
Claim Objections
Claims 9 and 11-21 are 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 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).
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.
CORRESPONDENCE
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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