Prosecution Insights
Last updated: October 25, 2026
Application No. 18/573,083

LIGAND-DRUG CONJUGATE AND USE THEREOF

Non-Final OA §102§112§DP
Filed
Dec 21, 2023
Priority
Jun 25, 2021 — CN PCT/CN2021/102377 +1 more
Examiner
HELLMAN, KRISTINA M
Art Unit
1654
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Coherent Biopharma (Suzhou) Limited
OA Round
1 (Non-Final)
65%
Grant Probability
Favorable
1-2
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 65% — above average
65%
Career Allowance Rate
470 granted / 722 resolved
+5.1% vs TC avg
Strong +56% interview lift
Without
With
+55.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 6m
Avg Prosecution
48 currently pending
Career history
767
Total Applications
across all art units

Statute-Specific Performance

§101
5.6%
-34.4% vs TC avg
§103
25.0%
-15.0% vs TC avg
§102
12.7%
-27.3% vs TC avg
§112
37.4%
-2.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 722 resolved cases

Office Action

§102 §112 §DP
DETAILED ACTION Examiner acknowledges receipt of the reply filed 7/20/2026, in response to the restriction requirement mailed 5/20/2026. Claims 1-5, 13, 14, 18, 28, 29, 31-33, 40, 45, 46, and 48-51 are pending. Claims 48-51 are withdrawn from further prosecution for the reasons set forth below. Claims 1-5, 13, 14, 18, 28, 29, 31-33, 40, 45, and 46 are being examined on the merits in this office action. Examiner Comment Thes status identifiers of claims 48-50 should be revised. Claim 51 is missing a status identifier. 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 . Election/Restrictions Applicant’s election of Group 1 (claims 1-5, 13, 14, 18, 28, 29, 31-33, 40, 45, and 46) in the reply filed on 7/20/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 48-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/20/2026. Applicant’s election of the following species in the reply filed on 7/20/2026 is acknowledged. Election was made without traverse. multi ligand moiety: PNG media_image1.png 204 327 media_image1.png Greyscale species of linker: PNG media_image2.png 117 330 media_image2.png Greyscale target cell surface molecule(s): TRPV6 and FOLR1 specific species of payload: PNG media_image3.png 244 318 media_image3.png Greyscale species of spacer: none fully defined conjugate compound: PNG media_image4.png 539 323 media_image4.png Greyscale Claims 1-5, 13, 14, 18, 28, 29, 31-33, 40, 45, and 46 read on the elected species. Priority The filing receipt dated 3/10/2025 provides the following information: PNG media_image5.png 98 622 media_image5.png Greyscale Specification Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01. The structures on at least pp 125-137 are too faint and pixelated to decipher. The use of the term Tween-80 and Tweens, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. See as-filed specification at paras [0091] and [0096]. Claim Objections Claims 2-5, 14, 18, 28, 29, 32, 33, 40 and 45 are objected to because of the following informalities: Claims 2-5 should be amended to simplify the claims- eliminate redundant claim language that is already recited in claim 1. The dependent claims needlessly repeat some claim language of claim 1. Claims 14 and 18 recite text that is too faint and pixelated to decipher. Claim 28 should be amended to recite “selected from the group consisting of:”; insert commas between the structures; and recite the term “and” between the last two structures. Claim 29 should be amended to recite “the group consisting of[[:]]”. The last line should be rewritten as a new dependent claim. The amended font in claim 29 is too faint and pixelated (please see file wrapper). Claims 32 and 33 recite acronyms which should be written out in full name in the first order of appearance in the claims. Claim 33 should further be amended to recite “i) TRPV6 and FOLR1; ii)[[,]] PSMA and FOLR1; iii)[[,]] or SSTR2 and FOLR1 Claim 40 should be amended to recite “wherein the multi-ligand moiety is selected from the group consisting of Claim 40 recites structures that are too faint and pixelated. Structures are not clearly set forth. See claim 40 at pp. 17-19. Claim 45 should be amended to recite “selected from the group consisting of:”; insert commas between the structures; and recite the term “and” between the last two structures. Appropriate correction is required. Improper Markush Grouping Claims 1-5, 13, 14, 18, 28, 29, 31-33, 40, 45, and 46 are rejected on the judicially-created basis that it contains an improper Markush grouping 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 § 706.03(y). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: The conjugate compound is extremely broad. The linker-payload moieties many varies, including an R variable. The R variable has 3 distinct structures giving rise to distinct backbone structures. This is further in combination with R5 correlating with a bond or 5 distinct structures. R6 is selected from a bond or 3 distinct structures. Peptide function is linked entirely to structure, particularly to amino acid sequence. Because the backbone structures are distinct with the different R, R5 and R6 variables, there is no common core structure and no substantial structural feature that can reasonably be linked to a common use for the claimed genus. It is further noted that multi-ligand moiety is of undefined sequence/structure leading to further variability amongst the conjugate compounds. In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. 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. Claims 29 and 40 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. Claim 29 recites the word “preferably”, which renders the claims indefinite for the following reasons: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(d). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "preferable" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim recites the broad recitation “payload is selected from the group …”, and the claim also recites the narrower statement of the range/limitation, “preferably, the payload is a small molecule compound”. To overcome this rejection, the last line of claim 29 should be rewritten as a new dependent claim. Claim 40 recites the limitation " the ligand moiety”. There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, claim 40 should be amended to recite “the multi-ligand moiety”. The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1-5, 13, 14, 18, 28, 29, 31-33, 40, and 46 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The courts have stated: “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163. Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated: “A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398. The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gostelli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618. In the instant case, the claims are drawn to a conjugate compound comprising a structure of a multi-ligand moiety-(linker-payload)q wherein the multi-ligand moiety comprises at least two ligands targeting different cell surface molecules, and the linker-payload has the recited structure. Claim 28 further recites various linkers. Claim 31 recites specific payloads. Claim 40 recites ligand moieties. Claim 45 recites specific conjugate compound. The specification states at para [0048] a “multi-ligand moiety” as described in this application comprises at least two ligands targeting different cell surface molecules. The term “targeting” as used herein refers to the specific binding of a ligand or a ligand-containing conjugate compound to a cell surface molecule to trigger or facilitate the endocytosis of the ligand or the ligand-containing conjugate compound by the target cell, and trigger or facilitate the ligand or the ligand-containing conjugate compound to be enriched around the target cell and/or enter the target cell (para [0049]). The claim terms are not limited by any specific structure as to what targets a given cell surface molecule. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus (or composition) must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). The term “payload” as used herein refers to a molecule or material to be delivered to a target cell or tissue (para [00464). Claim 29 recites the payload is selected from the group consisting of a small molecule compound, a nucleotide, and a peptide. Thus, the compounds that fall within the scope of “payload” is infinite. As noted in the above Markush rejection, variables R, R5, and R6 have significant diversity and increase variability of the backbone structure and compounds that fall within the instant claim scope. Accordingly, there are infinite combinations of targeting ligands, variables of the recited structures, and payloads. As stated earlier, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable the claims are broad generics with respect to all possible compounds encompassed by the claims. There are numerous compounds that can fall within the categories of ligands that target cell surface molecules, recite variables, and payloads but there is no guidance as to what specific compounds can physically be combined with each other to form the claimed conjugate compounds while retaining individual functional properties (e.g., cell targeting and bioactive property of “payload”). It must not be forgotten that the MPEP states that if a compound is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. Here, though the claims may recite some functional characteristics [e.g., cell targeting], the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond compounds disclosed in the examples in the specification. Moreover, the specification lacks sufficient variety of species to reflect this variance in the genus. The specification doesn’t provide any examples that encompass the numerous characteristics of the entire genus claimed. The specification appears to be limited to specific compounds that fall within a narrow scope of targeting ligands, R variables, and payloads, as opposed to the much broader scope of compounds that fall within the instant claim scope. Merely listing components in the specification is not sufficient to extrapolate to all combinations of targeting ligands, R variables, and payloads that are not only capable of being fused together but further retain their functional binding/targeting to the cell surface and payload bioactive properties, e.g. cytotoxic. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention. 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)(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. Claims 1, 2, 5, 14, 18, 28, 29, 31-33, 40, and 46 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Huang et al (WO 2020156513- previously cited; published 8/6/2020, earliest effective filing date 1/30/2019; Examiner refers to US equivalent U.S. 2022/0175761- previously cited). The applied reference has a common inventor and applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. Huang teaches conjugate compounds or a pharmaceutically acceptable salt thereof, comprising a payload and two targeting molecules, as well as pharmaceutical compositions comprising the conjugates (abstract). Regarding claims 1, 2, 5, 14, and 18, claims 55, 62, and 70 of the ‘293 application teach compound bi-ligand conjugates, e.g. CR19428 PNG media_image6.png 867 378 media_image6.png Greyscale wherein R is PNG media_image7.png 106 183 media_image7.png Greyscale PNG media_image8.png 104 254 media_image8.png Greyscale , m and n are 0, p = 1, R4 is H, R5 is CH2C(O)-NH-CH2-, and q = 1 (e.g., para [0042],claim 32). See also compounds CB20B, CB20BK, and CR19426. Regarding claim 13, R5 is not CH2C(O)-NH-CH2- (e.g., paras [0150-[0157]). Regarding claims 28, linkers include but are not limited to, PNG media_image9.png 206 506 media_image9.png Greyscale , compounds CR19428 (e.g., claims 29, 32). Regarding claim 29, the payload is selected from the group consisting of a small molecule compound, a nucleotide, a peptide and a protein (e.g., para [0025], [0080]). Regarding claim 31, compound CR19428 comprising a payload PNG media_image10.png 138 157 media_image10.png Greyscale . See also para [0239], and compounds CR19426, CB-60S, CB-60SK. Regarding claims 32 and 33, the targeting cell surface molecules include TRPV6, FOLR1, PMSA, and SSTR2 (e.g., paras [0020]-[0024], [0100]-[0106], [0134]). Compound CB-1020 binds TRPV6 and FOLRH1. At least compound CR19428 targets binding to FOLR1 and PSMA (FOLH1) cell surface molecules (para [0512]). Regarding claim 40, compound CR19428 comprising a ligand moiety of claim 40 (e.g., paras [0042], claim 32). See also compound CB-20BK including the second structure of claim 40; Table 3/ para [0186] teaching additional ligand moieties. Regarding claim 46, Huang teach a pharmaceutical composition comprising the conjugate compound (e.g., paras [0051]-[0057], [0193]-[0209], claim 35). Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1, 2, 5, 14, 18, 28, 29, 31-33, 40, and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-72 of copending Application No. 17426293 (hereinafter referred to as “the ‘293 application”). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. A notice of allowance was mailed 4/29/2026 and fees were paid 7/29/2026. The ‘293 application has not yet issued. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Regarding claims 1, 2, 5, 14, and 18, claims 55, 62, and 70 of the ‘293 application teach compound bi-ligand conjugates, e.g. CR19428 PNG media_image6.png 867 378 media_image6.png Greyscale wherein R is PNG media_image7.png 106 183 media_image7.png Greyscale PNG media_image8.png 104 254 media_image8.png Greyscale , m and n are 0, p = 1, R4 is H, R5 is CH2C(O)-NH-CH2-, and q = 1. Regarding claims 28, 29 and 31, claims 55, 62, and 70 of the ‘293 application teach compound CR19428 comprising a payload PNG media_image10.png 138 157 media_image10.png Greyscale and a linker of claim 28. Regarding claims 32 and 33, at least compound CR19428 of the ‘293 application (claims 55, 62, and 70) teach a compound that targets binding to FOLR1 and PSMA (FOLH1) cell surface molecules. See e.g. the ‘293 specification at p. 115. “[The specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Thus, even though the instant claims recite specificities not explicitly recited by the claims of the reference application, species of the instant claims encompassed by the claims of the reference application are disclosed in the specification of the reference application, and thus the instant claims are not patentably distinct from the claims of the reference application. Regarding claim 40, claims 55, 62, and 70 of the ‘293 application teach compound CR19428 comprising a ligand moiety of claim 40. Regarding claim 46, claim 56 of the ‘293 application teach a pharmaceutical composition comprising a conjugate compound. Conclusion No claims are allowed. Claims 1-5, 13, 14, 18, 28, 29, 31-33, 40, 45, 46, and 48-51 are pending. Claims 48-51 are withdrawn. Claims 1-5, 13, 14, 18, 28, 29, 31-33, 40, 45, and 46 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm. 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. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KRISTINA M HELLMAN/Examiner, Art Unit 1654
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Prosecution Timeline

Dec 21, 2023
Application Filed
Sep 30, 2026
Non-Final Rejection mailed — §102, §112, §DP (current)

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Prosecution Projections

1-2
Expected OA Rounds
65%
Grant Probability
99%
With Interview (+55.5%)
2y 6m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 722 resolved cases by this examiner. Grant probability derived from career allowance rate.

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