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 .
Application Status
2. Applicant’s Amendment and Response, submitted June 3, 2026 has been reviewed by the examiner and entered of record in the file. Claims 25, 26, 43, 48-50, 55, and 58 are amended. Claims 1, 2, 9, 11, 12, 19, 23, 37, 40, and 44 are cancelled.
3. Claims58-60, 81 and 85 (Group II), drawn to a method of use, remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, without traverse, there being no allowable generic or linking claim.
4. In view of Applicant’s amendments to the claims, the scope of the independent invention that encompasses the elected species is expanded to include all compound species of Formula (II).
5. Claims 25, 26, 43, 48-50, and 55 are under examination with the previously defined scope of the independent invention and are the subject of this office action.
Priority
6. Receipt is acknowledged of the English language translation of foreign priority People’s Republic of China Application No. CN202211101617.3, submitted June 3, 2026. However, it is noted that the translation is not a certified translation.
Please refer to 37 CFR 1.55:
“(4) If an English language translation of a non-English language foreign application is required, it must be filed together with a statement that the translation of the certified copy is accurate.”
Therefore Applicant is not entitled to the foreign priority date until a certified copy of the English language translation as required by CFR 1.55.
Previous Claim Rejections - 35 USC § 112(b)
7. 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.
8. Claims 2, 25, 26, 37, 43 and 44 were previously rejected and claim 26 remains 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.
9. Claim 2 was previously rejected as being indefinite regarding the limitation:
“optionally wherein the substituted or unsubstituted acyl is saturated or unsaturated aliphatic acyl or aroyl; the substituted or unsubstituted oligopeptide is a dipeptide, a tripeptide, or a tetrapeptide; and/or the substituted or unsubstituted alkylthio is thiocarbonyl,”
10. In view of the cancellation of claim 2, the previous indefiniteness rejection is withdrawn.
11. Claim 25 was previously rejected as lacking antecedent basis regarding the limitation of Formula (II) or Formula (IIA), and for lacking antecedent basis for the moieties “R11,” “W,” “X1,” “X2,” “X3,” “Y1a,” “Y1b,” or “Y2,” because Applicant failed to define any of said moieties in claim 1, and only R11 is defined in claim 25.
In view of Applicant’s amendment to claim 25, the previous indefiniteness rejection is withdrawn.
12. Claim 26 was previously rejected as lacking antecedent basis regarding the recitation of the “W”, “X1“, “R11“, “Y2“, “Y1a “, and “Ylb“ moieties.
In view of Applicant’s amendment to claim 25, the previous indefiniteness rejection is overcome regarding the W”, “X1”, and “R11” moieties.
However, Applicant’s amendment to the Y2 limitation: “and/or Y2 is fluorine(F)” in line 2 are confusing. It is not clear if the claim is intending to define each of the moieties W, X1, R11, AND Y2; or if the claim is intending to define the moieties W, X1, R11, OR Y2.
It is also noted that the parentheticals recited in claim 26, i.e., “(H)” and “(F),” were not previously recited in claim 25 and are not necessary. For clarity and consistency between the claims, it is recommended that that the parentheticals be deleted.
Therefore the rejection of claim 26 is maintained.
13. Claim 37 was previously rejected regarding the definition of the X3 moiety:
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or a lone pair of electrons; and for insufficient antecedent basis for reciting the moieties “6a,” and “6b.” In view of the cancellation of claim 37, the previous indefiniteness rejection is withdrawn.
14. Claim 43 was previously rejected as lacking antecedent basis for the limitations of the subgenus of Formula (VII); and for insufficient antecedent basis for the moieties “R9,” or “R10,” because Applicant failed to previously define said moieties in claim 1 or in claim 43. In view of the cancellation of claim 43, the previous indefiniteness rejection is withdrawn.
15. Claim 44 was previously rejected for insufficient antecedent basis for the moieties “R9,” or “R10,” because Applicant failed to previously define said moieties in claim 43 or in claim 44. In view of the cancellation of claim 43, the previous indefiniteness rejection is withdrawn.
16. Claim 55 was previously rejected because the phrase "e.g.” (for example) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In view of the amendment to delete the limitation of "e.g.” and the exemplary modes of administration in claim 55, the previous indefiniteness rejection is. withdrawn.
Previous Claim Rejections - 35 USC § 112(a)
17. Claims 1, 2, 25, 26, 37, 43, 44, 48-50, and 55 were previously 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 claims contain 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.
18. In view of Applicant’s amendatory changes to delete claims 1, 2, 37, and 44, and limit the scope of the recited compounds to the genus of compounds of Formula (II),
which correspond to the exemplary compound species in Table 2 (at pages 19-36), the previous rejection under 35 USC 112(a) is withdrawn.
Previous Claim Rejections - 35 USC § 102
19. Claims 1, 2, 25, 26, 37, and 55 were previously rejected under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Wang et al., WO 2021041671 A1 (published March 4, 2021 and cited on Applicant’s IDS of January 31, 2024).
20. In view of Applicant’s amendatory changes and cancellations, which limit the recited compounds to the genus of instant Formula (II), the previous anticipatory rejections are withdrawn.
21. However, please refer to the newly grounds of rejection made below.
New Claim Rejections - 35 USC § 102
22. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
23. Claims 25, 26, and 48 are rejected under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Wang et al., WO 2022015375 A1 (published January 20, 2022 and cited on Applicant’s IDS of January 31, 2024).
Claim 25, as amended, is drawn to a compound according to Formula (II):
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R11 is hydrogen or halogen; W is oxygen; X1 and X2 are hydrogen, C1-20 saturated alkoxycarbonyl,
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, wherein R1 is hydrogen, methyl, ethyl, propyl, isopropyl, C3-C6 cycloalkyl, or aryl; R2 is hydrogen, C1-C20 saturated alkyl, C3-C8 carbocyclic or heterocyclic hydrocarbyl, or bridged ring hydrocarbyl; R9 is C2-C20 saturated alkanoyl; R10 is C2-C20 saturated or unsaturated alkanoyl or C2-C20 substituted or unsubstituted alkanoyl; with the proviso that X1 and X2 are not both hydrogen; “X3” is
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or a lone pair of electrons; “Y1a “ and “Ylb“ are both hydrogen; and “Y2“ is hydrogen or halogen. Claim 26 is drawn to claim 25, and limits wherein W is oxygen; X1 is hydrogen; R11 is hydrogen; and Y2 is fluorine.
Claims 48 is drawn to a compound selected from the group recited in claim 48, more specifically the compound
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(page 12, third row, first compound).
24. Wang et al. teach the following compound species:
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(Example 470) which is identical to a compound according to Applicant’s Formula (II), wherein R11 is fluorine; W is O; X1 is hydrogen; Y2 is fluorine; X3 is a pair of electrons; and X2 is
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, wherein R1 and R2 are hydrogen (page 484). The compound of Example 470 is also recited in instant claim 48:
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(page 12, third row, first compound). Wang et al. teach the
following compound species:
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(Example 471) which is identical to a compound according to Applicant’s Formula (II), wherein R11 is fluorine; W is O; X1 is hydrogen; Y2 is fluorine; X3 is a pair of electrons; and X2 is
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, wherein R1 is hydrogen and R2 is C9 alkyl (page 486); and the compound species:
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(Example 472) which is identical to a compound according to Applicant’s Formula (II), wherein R11 is fluorine; W is O; X1 is hydrogen; Y2 is fluorine; X3 is a pair of electrons; and X2 is
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, wherein R1 is hydrogen and R2 is C15 alkyl (page 487); and the compound species:
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(Example 475) which is identical to a compound according to Applicant’s Formula (II), wherein R11 is fluorine; W is O; Y2 is fluorine; X3 is a pair of electrons; X1 is C9 alkoxycarbonyl; and X2 is
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, wherein R1 is hydrogen and R2 is C9 alkyl (page 492); and the compound species:
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(Example 476) which is identical to a compound according to Applicant’s Formula (II), wherein R11 is fluorine; W is O; Y2 is fluorine; X3 is a pair of electrons; X1 is C15 alkoxycarbonyl; and X2 is
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, wherein R1 is hydrogen and R2 is C15 alkyl (page 494).
As such, claims 25, 26 and 48 are anticipated.
Previous Claim Rejections - 35 USC § 103
25. Claim 48 was previously rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., WO 2021041671 A1.
26. In view of Applicant’s amendatory changes to narrow the claims to the genus of compounds of formula (II) wherein “X1” and “X2” cannot both be hydrogen, the previous obviousness rejection is withdrawn.
New Claim Rejections - 35 USC § 103
27. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
28. Claims 48, 50, 55, 106 and 107 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., WO 2022015375 A1 (published January 20, 2022 and cited on Applicant’s IDS of January 31, 2024), as applied to claims 25, 26, and 48, above.
Claims 48 is drawn to a compound selected from the group recited in claim 48, more specifically the compound
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(page 12, second row, second compound), and the compound
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(page 12, second row, last compound).
29. Wang et al. teach a genus of functionally related compounds having the same
core structure that is instantly recited by Applicant, (see Formula (II) at pages 4-6) and specifically disclose the following species, differing solely in the length of the side alkyl chain “Z” (corresponding to Applicant’s instant “R2” moiety).
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30. The genus of compounds disclosed by Wang et al. fully encompasses the
compounds of the instant invention and also demonstrates KRas inhibitory activity, in
particular, KRas G12D, (paragraph [0007]),
Yet, Wang et al. generically indicate that the “Z” substituent can be –(CH2)n-CH3 or C1-C3 alkyl (see paragraph [00028]). As such, one of skill in the art would have been guided by Wang et al. to modify the compound species:
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by adding successive -CH2- groups to the “Z” alkyl chain, in order to prepare the recited compounds
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and
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, with the expectation that structurally similar compounds are presumed to possess similar properties. And, compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09 II. One skill in the art before the effective filing date of the claimed invention would have been motivated to modify the compound(s) of Wang et al. and prepare the instantly claimed compound with a reasonable expectation of success, i.e., a structurally similar compound with KRas G12D inhibitory activity.
As such, claim 48 is prima facie obvious.
Claim 50 is drawn to a pharmaceutical composition comprising the compound or the pharmaceutically acceptable salt, of claim 25 and a pharmaceutically acceptable excipient, carrier or diluent, (more specifically, wherein the composition is suitable for administration by injection (claim 55), for subcutaneous, intravenous, intramuscular, or intraperitoneal administration.
(claim 107)).
Claim 106 is drawn to a pharmaceutical composition comprising the compound or the pharmaceutically acceptable salt of claim 48 and a pharmaceutically acceptable excipient, carrier or diluent.
31. Wang et al. teach pharmaceutical compositions comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier, excipient or diluent, wherein said composition is suitable for administration by injection:
“In another aspect, the invention provides pharmaceutical compositions comprising a KRas G12D inhibitor according to the invention and a pharmaceutically acceptable carrier, excipient, or diluent. Compounds of the invention may be formulated by any method well known in the art and may be prepared for administration by any route, including, without limitation, parenteral, intraperitoneal, intradermal, intracardiac, intraventricular, intracranial, intracerebrospinal, intrasynovial, intrathecal administration, intramuscular injection, intravitreous injection, intravenous injection, intra-arterial injection, oral, buccal, sublingual, transdermal, topical, intranasal, intratracheal, intrarectal, subcutaneous, and topical administration. In certain embodiments, compounds of the invention are administered intravenously in a hospital setting. In one embodiment, administration may be by the oral route. In some embodiments, the provided pharmaceutical compositions may be administered to a subject in need of treatment by injection systemically, such as by intravenous injection; or by injection or application to the relevant site, such as by direct injection via syringe, or direct application to the site when the site is exposed in surgery; or by topical administration,”
see paragraph [00182].
32. Therefore, one skilled in the art before the effective filing date of the claimed invention would have been motivated to prepare the compound(s) of Wang et al. in the form of a pharmaceutical composition comprising a pharmaceutically acceptable carrier, excipient, or diluent, for administration by injection, with a reasonable expectation of success.
As such, claims 50, 55, 106 and 107 are prima facie obvious.
Claim Objections
33. Claims 43 and 49 are objected to as being dependent upon a base claim that is rejected under 35 U.S.C. 102.
Conclusion
34. Claims 25, 26, 43, 48-50, 55, 58-60, 81, 85, 106 and 107 are present in the application. Claims 58-60, 81 and 85 are withdrawn from consideration as directed to non-elected subject matter. Claims 25, 26, 48, 50, 55, 106 and 107 are rejected. Claims 43 and 49 are objected to. No claim is presently allowable.
35. 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.
36. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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, 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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/JANET L COPPINS/Examiner, Art Unit 1628
/Rayna Rodriguez/Primary Examiner, Art Unit 1628
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