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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a compound of formula (I) (W-L-T), and a pharmaceutical composition comprising the compound of formula (I); and a compound species having the structure of:
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(see e.g., Compound 112 of Example 85 of the specification) as the compound species of formula (I) are maintained.
Please note the elected compound species is a compound of Formula (I)
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, wherein W has the structure of Formula (Ia)
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; X is N;
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is
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(i.e., R1 is -OH; R2 and R3 together with the phenyl-ring structure to which they are attached, form an substituted benzo-fused ring); L is
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(i.e., L is
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, wherein L1 is
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[oxyalkyl group], L2 is
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[heterocycloalkyl], and L3 is
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[heterocycloalkyl], wherein p is 0.
Claims 45-46, 48 and 66 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Expansion of Election of Species Requirement
A reasonable and comprehensive search of the elected species conducted by the Examiner determined that the prior art at the time of the present invention was such that it did not anticipate or renders obvious the elected compound species:
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.
In light of this discovery, a new search is conducted as necessitated by the amendments, and said search is expanded to the subject matter of the full scope of compound of formula (I) in addition to the compound species recites in claim 32.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on June 9, 2026, wherein claims 1, 3, and 8 are amended; claims 2, 4-7, 9, 11-31, 34-35, 37-44, 47, 49-65, and 67-91 are canceled; and claims 10, 32, 33, 36, 45-46, 48 and 66 are unchanged.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 8, 10, 32-33, 36, 45, 46, 48, 66 are pending.
Claims 45-46, 48 and 66 remain withdrawn.
Claims 1, 3, 8, 10, 32-33 and 36 are under examination in accordance with the elected invention and species along with the expanded compounds set forth in the Expansion of Election of Species Requirement section above.
Priority
The instant application 18/119,592 filed on March 9, 2023 claims priority to, and the benefits of Foreign Application No. CN202210359996.X filed on April 6, 2022, and Foreign Application No. CN202211110187.1 filed on September 13, 2022.
Receipt is acknowledged of a certified copy of foreign application No. CN202210359996.X filed on April 6, 2022 and CN202211110187.1 filed on September 13, 2022, which are both written in foreign language; however, based on the structure of compound species drawn therein, the Examiner noted the present application does not properly claim priority to the submitted foreign applications. Specifically, the foreign application No. CN202210359996. X only describes compound 1-58; and the foreign application No. CN202211110187.1 describes compound 1-160. Therefore, to the extent that the claims are drawn to the compound species of Formula (I) that is not a compound 1-160, the claims are not entitled to the benefit of both foreign applications, and will receive an effective filing date of March 9, 2023, which is the filing date of instant application; and to the extent that the claims are drawn to compound 59-160, the claims are not entitled to the benefit of foreign application No. CN202210359996.X, and will receive an effective filing date of September 13, 2022, which is the filing date of CN202211110187.1.
If this copy is being filed to obtain priority to the foreign filing date under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a), applicant must also file a claim for such priority as required by 35 U.S.C. 119(b) or 365(b), and 37 CFR 1.55. If the application was filed before September 16, 2012, the priority claim must be made in either the oath or declaration or in an application data sheet; if the application was filed on or after September 16, 2012, the claim for foreign priority must be presented in an application data sheet.
If the application being examined is an original application filed under 35 U.S.C. 111(a) (other than a design application), the claim for priority must be presented during the pendency of the application, and within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior foreign application. See 37 CFR 1.55(d)(1). If the application being examined is a national stage application under 35 U.S.C. 371, the claim for priority must be made within the time limit set forth in the PCT and Regulations under the PCT. See 37 CFR 1.55(d)(2). Any claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) not presented within the time period set forth in 37 CFR 1.55 is considered to have been waived. If a claim for foreign priority is presented after the time period set forth in 37 CFR 1.55, the claim may be accepted if the claim properly identifies the prior foreign application and is accompanied by a grantable petition under 37 CFR 1.55(e) to accept an unintentionally delayed claim for priority and the petition fee.
Action Summary
Applicant’s amendment to the claims filed on June 9, 2026 overcome each and every objection previously sets forth in the Final Office Action mailed on March 9, 2026.
Claim 3 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 are withdrawn in view of the claim amendments.
Claim 8 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends are withdrawn in view of the claim amendments.
Claims 1, 3, 8, 10, 32-33 and 36 rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives are maintained, but revisited and modified in view of the claim amendments. Specifically, applicant amends independent claim 1 by deleting the recitation of “is absent or” from the list of L; and that changes the scope of the claims.
Claims 1, 3, 8, 10, 32-33 and 36 provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-3, 8, 16, 26, 28, 36, 38, 42, 47-48, and 56 of copending Application No. 18/466,473 (reference application) are maintained.
Claim Rejections - 35 USC § 112
Claims 1, 3, 8, 10, 32-33 and 36 remain 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). 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.
A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
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:
Instant claim 1 recites “[a] compound of Formula (I), or a pharmaceutically acceptable salt, ester, hydrate, solvate, or stereoisomer thereof:
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… wherein: (i) W has a structure of Formula (Ia):
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… ii) L has the structure of L1-L2-L3, which is:
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….; and iii) wherein the E3-ligase binding group T is:
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…”. The Markush grouping of the compounds of Formula (I) with the combination of these different W, L and T moieties are improper, because the alternatives embraced by the Markush grouping do not share a substantial structure feature, and the alternated compound species do not a common use that flows from the substantial structure feature.
Instant claim 32 recites “[a] compound which is:
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…
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” that include a wide variety of alternated compound species that do not fall within the scope of instant Formula (I). The Markush grouping of these alternated compound species are so varied that they do not share a substantial structure feature, and a common use that flows from the substantial structure feature.
For instance, the Markush grouping of compounds of Formula (I) includes a variety of compound species that do not share a substantial structure feature. The Markush grouping of compounds of Formula (I) includes a variety of E3 ligase binding group T, such as
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,
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and
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that do not share a common structure feature. The Markush grouping of compounds of Formula (I) includes a variety of linker moiety L, such that L has the structure of
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and
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that do not belong to the same recognized chemical class and do not share any single structural similarities.
Furthermore, instant claim 32 recites vast variety of compound species, including compounds having the structure of:
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(see page 17, the very first compound),
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(see page 36, the 2nd compound), and
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(see page 35, the very first compound). It is noted that these compound species alternatives do not share a substantial structure feature and a common use that flows from the substantial structural feature. In the present case, these compound species only share the structure of:
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in common, and that does not constitute a significant portion of the compound as a whole. According to Wang et al. (WO 2021/041671 A1; cited in the previous Office Action), the compounds of Formula (I)
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, including
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(see e.g., p. 863, right column, 2nd row), bind to KRAS G12D and that inhibits the activity of KRAS G12D (see e.g., [0007];[0180]; Table 2); However, even though the compounds of Wang et al. share the same structure feature of:
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, the compounds of Wang et al. only bind to KRAS G12D and does not recruit E3 ligase, promoting ubiquitination and degradation. Therefore, it is not apparent that this common structure alone (“
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”) contributes to the substantial structure feature essential for the compound to give the claimed desired properties of recruiting an E3 ligase, promoting ubiquitination and subsequent degradation of KRAS-G12D. Same concept applies to the compound species of compound of Formula (I) noted above.
Each of these findings demonstrates that not all members recited in the Markush grouping belong to the same recognized chemical class and these members do not share a common use. In addition, the alternated compound species fail to share a substantial structural feature that is essential for recruiting an E3 ligase to the KRAS-G12D protein, promoting its ubiquitination and subsequent degradation.
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. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
Response to Arguments
Applicant's arguments filed on June 9, 2026 with respect to the rejection of claims 1, 3, 8, 10, 32-33 and 36 on the judicially-created basis that it contains an improper Markush grouping of alternatives have been fully considered but they are not persuasive.
In the present case, applicant amends independent claim 1 by deleting “is absent or” from the list of L, such that L of Formula (I) has to be a bivalent linking group that connects W and T together; and that changes the scope of the compound of Formula (I). Therefore, the rejection of record has been revisited and modified in view of the claim amendments.
In Summary, applicant argues the claim amendments now deletes embodiment where L is absent; and therefore, the compounds of present claim(s) now share a substantial structure feature as well as a common use that flows from the substantial structure feature. Applicant further argues T of Formula (I) defined in present claim 1 are specifically selected to preserve the integrity of the glutarimide-binding moiety, and are deigned to engage with cereblon in a manner identical to classical IMiDs (e.g., pomalidomide), ensuring that the glutarimide ring remains sterically accessible to facilitate optimal binding within the CRBN pocket; and therefore, the claimed invention retain potent CRBN-binding activity.
In response, applicant’s arguments are not found persuasive for the reasons set forth below:
Given that the claim amendment changes the scope of the Formula (I), Zhao et al. has been removed from the previous rejection of record as it is no longer needed; thus, the arguments with respect to Zhao et al. are moot. It is further noted that two references are cited by the applicant, i.e., Chamberlin et al. 2014 and Fischer et al 2014 (see e.g., page 50), in the reply filed on June 9, 2026; However, each of these references are not cited in the information disclosure statement nor provided in an appropriate affidavit or declaration. Therefore, the Examiner cannot comment on these references.
Even though the claim amendments now narrow the scope of Formula (I)
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recites in claim 1, the Markush grouping of these compound species of Formula (I) recites therein and the Markush grouping of the compound species recites in claim 32, which includes compounds that are not encompassed by instant Formula (I), still do not share any substantial structural feature in common, i.e. a significant structural element is shared by all of the alternatives or all alternatives belong to a recognized class of chemical compounds in the art to which the invention pertains.
Again, the grouping is improper if either (1) the members of the Markush grouping do not share a “single structural similarity” or (2) the members do not share a common use. Applicant’s assertion that each of these Markush grouping of compounds species shares a substantial structural feature and a common use that flows from the substantial structure feature appear to be mere arguments without objective evidence. Applicant does not provide any sound technical and scientific reasonings to support the structurally distinct compounds, e.g.,
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(see e.g., claim 32; p. 10, very first compound), and
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(see e.g., claim 32; p. 21, 2nd compound) are, in fact, sharing a substantial structural in common. The compound species only share the structure feature of:
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in common, and that clearly does not constitute a significant portion of the compound as a whole. In other words, the structure they have in common does not occupy a large portion of their structures. Same analysis is applicable to the compound of instant Formula (I)
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, drawn to a broad genus of compounds composed of structurally distinct species of W, L, and T, the only thing they have in common is
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. Again, these structures clearly do not occupy a large portion of their structures as well.
According to Wang et al. (WO 2021/041671 A1), the exemplary compound
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(see e.g., p. 863, right column, 2nd row) embraced by Formula (I)
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is known to inhibit the activity of KRAS G12D by binding to KRAS G12D (see e.g., [0007];[0180]; Table 2). Even though the compounds of Wang et al. also share the structure feature of
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in common, the compounds of Wang et al. only bind to KRAS G12D and does not recruit E3 ligase, promoting ubiquitination and degradation. Applicant fails to provide any objective evidence demonstrating that this structure feature alone constitutes a substantial structure essential for the compound to give the properties of recruiting an E3 ligase, promoting ubiquitination and subsequent degradation of KRAS-G12D.
In view of the foregoing, applicant’s assertion that the Markush grouping of compound species shares a substantial structure feature and a common use that flows from the substantial structure feature does not have any factual support. If applicant contends the structure feature of:
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or
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alone can recruit an E3 ligase, promote ubiquitination and subsequent degradation of KRAS-G12D, such evidence is respectfully requested.
Therefore, the rejection has been maintained, but revisited and modified in view of the claim amendments.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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, 3, 8, 10, 32-33 and 36 remain provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-3, 8, 16, 26, 28, 36, 38, 42, 47-48, and 56 of copending Application No. 18/466,473 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of reference application are drawn to a compound of formula (I) that overlaps in scope with the instant application. For instance, the claims of the reference application is drawn to a compound of formula (I) having the structure of:
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(referred to herein as Compound 1)(see e.g., claim 47). The claims of reference application further teaches the compound of Formula (I) or a pharmaceutically acceptable salt, ester, hydrate, solvate, or stereoisomer thereof:
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where: T is an E3-ligase binding group; wherein the E3-ligase binding group T has the structure of:
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, wherein Y3 is carbon or nitrogen (see e.g., claim 1). The claims of reference application are also drawn to a pharmaceutical composition comprising the compound or the pharmaceutically acceptable salt, ester, hydrate, solvate, or stereoisomers thereof, and a pharmaceutically acceptable excipient, carrier or diluent (see e.g., claim 48); wherein the composition is suitable for injection (see e.g., claim 56).
In the present case, the difference between the compound 1 of reference application recited above and the claimed compound of Formula (I), specifically, the elected compound species of Formula (I) is that the compound of the reference application has a nitrogen atom rather than a carbon atom at the Y3 position of Formula IIIa shown below (see shaded):
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. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the compound 1 of the reference application by substituting the nitrogen atom at the Y3 position with a carbon atom to arrive at the claimed invention. One would have been motivated to do so, because the claims of the reference application clearly teach the E3-ligase binding group T in Formula (I) with the structure of:
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can have carbon or nitrogen at Y3. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by the modified compound 1 of the reference application that substituted the nitrogen with a carbon at Y3 would have successfully arrive at a compound of Formula (I) useful for the same purpose; and therefore, by incorporating said modified compound 1 with a pharmaceutically acceptable excipient, carrier or diluent would have successfully arrive at a pharmaceutical composition suitable for injection.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed on June 9, 2026 with respect to the provisional rejection of claims 1, 3, 8, 10, 32-33 and 36 on the ground of non-statutory double patenting as being unpatentable over claims 1-3, 8, 16, 26, 28, 36, 38, 42, 47-48, and 56 of copending Application No. 18/466,473 have been fully considered.
In Summary, Applicant requests the double patenting rejections be held in abeyance until the identification of allowable subject matter.
In response, since Applicant did not put forth any arguments specifically against this obviousness-type double patenting rejection, the rejection on the record has been maintained for the same reasons of record and for the reasons set forth herein.
Conclusion
No claims are 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 Chihyi Lee whose telephone number is (571)270-0663. The examiner can normally be reached Monday - Friday 8:30 am - 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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