NON-FINAL REJECTION
This application is a 35 U.S.C. 371 (national stage) application of PCT/US2021/055574, filed Oct. 19, 2021, which claims benefit of priority to Provisional Application 63,094/771, filed Oct. 21, 2020.
Claims 1-22, as amended, are pending.
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 .
Priority
Applicant' s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Mar. 12, 2025 and Apr. 18, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to compounds; and the compound species LQ141-47, having the structural formula,
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in the reply filed on Jan. 27, 2026 is acknowledged.
The elected compound reads on claims 1-5, 8, and 19-22.
Claims 6, 7, and 9-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Jan. 27, 2026.
Because the elected compound is free of the prior art, search and examination has been extended to the next species. See MPEP § 803.02.
Claims 1-5, 8, and 19-22 are currently pending and under consideration.
Claim Rejections – Improper Markush Grouping
Claims 1-5, 8, and 19-22 are rejected on the basis that the claims recite improper Markush groupings of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use.
A Markush grouping meets these requirements in two situations:
First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use.
Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush groupings encompassed by claim 1, drawn to compounds of formula PI-Linker-EL do not meet these criteria because the alternatives defined by claim 1 do not share both a single structural similarity and a common use, for the following reasons.
Specifically, the claims define the compound of formula PI-Linker-EL as follows:
claim 1 defines PI as an ENL ligand selected from thirteen (13) formulae 1, 1A, 1B, 1C, 1D, 1E, 1F, 2, 2A, 2B, 2C, 3, or 3A;
claim 3 defines the degrader/disruption tag EL as selected from seventeen (17) formulae 4A, 4B, 4C, 4D, 4E, 4F, 4G, 4H, 4I, 5A, 5B, 5C, 5D, 5E, 5F, 6A, or 6B;
claim 5 defines the Linker as selected from four (4) formulae 8, 8A, 8B, or 8C,
such that formula PI-Linker-EL comprises 13 x 17 x 4 = 884 core structures as combinations of PI, Linker, and EL.
Thus, the claims are drawn so broadly as to be unsearchable. Compounds of formula PI-Linker-EL encompass potentially millions of compounds which do not share a common structural core. Because they lack a single structural similarity, compounds of formula PI-Linker-EL are unlikely to exhibit a common biological activity across the entire genus, if any at all.
Further, while claim 19 limits the ENL ligand (PI) to formula 2B,
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;
claim 20 limits the ENL ligand (PI) to formula 35,
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;
claim 21 limits the degrader/disruption tag EL to formula 5A,
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;
and claim 22 limits the degrader/disruption tag EL to formula 7T,
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;
each of these depend from clam 1, which does not further limit or define the remaining portions of the compound. The limitations recited in the dependent claims merely reduce the number of core structures from hundreds to dozens, and, except for claim 5, do not limit or define the linker at all, such that a search for the compounds of formulae 2B/35 is not coextensive with a search for the compounds of formulae 5A/7T. Thus, the claims encompass innumerable distinct groups of alternatives which do not share a common structural core.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within each improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. See MPEP § 2117.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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.
Claims 1-5 and 19-22 are 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.
Specifically, claim 1 is drawn to a bivalent compound comprising PI-Linker-EL, wherein PI comprises an ENL ligand.
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 or method steps. 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”).
Further, formula PI-Linker-EL as recited by claims 1-2 is open-ended in that Linker and EL are undefined. While claims 3-5 and 19-22 further limit or define PI, Linker, or EL, they leave other portions of the compound undefined; and all depend from claim 1, and thus remain open to the inclusion of unrecited elements. These defects obscure the scope of the claimed compounds, rendering the metes and bounds of the claims indefinite.
Claim 8 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.
Specifically, claim 8 recites a list of compound species identified by an arbitrary alphanumeric code, which requires reference to Table 1 of the specification to determine the name or structure of the compound. Thus, claim 8 is equivalent to a claim drawn to "compounds of Table 1."
However, the claims are to be complete in themselves. As recognized by MPEP § 2173.05(s), incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant's convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). Therefore, a claim which refers to an external figure or table renders the metes and bounds of the claim indefinite.
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.
Claims 1, 3-5, 21, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qian et al. (WO 2017/030814, cited on PTO-892).
Qian et al. exemplify the compound of Example 165 (p. 159),
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which reads on formula PI-Linker-EL as recited by claims 1, 3-5, 21, and 22, wherein
PI is
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, wherein X is oxygen; Y is carbon; R2 is hydrogen; R4 is substituted C2-alkoxy; R1 is -C(O)-R5, to which the Linker is attached;
the Linker is a bond (formula 8 as recited by claim 5, wherein A, W, and B are null);
and the degrader/disruption tag EL is formula 7T as recited by claims 21-22,
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.
For the foregoing reasons, Qian et al. anticipates claims 1, 3-5, 21, and 22.
Conclusion
No claims are allowed.
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 9:00 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.
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/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629