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 .
Status of the Claims
Claims 29 – 30, 32 – 45, 51 – 55 and newly added claims 66 – 81 are pending.
Claims 29 – 30, 33 – 36, 38, 51 – 52, 55, 68 and 76 – 81 are rejected.
Claims 32, 37, 39 – 45, 53 – 54, 66 – 67, 69 – 75 and 80 – 81 are withdrawn.
Response to Applicant’s Remarks
Applicant’s amendments and remarks filed on May 11, 2026 have been fully considered.
The objection to claim 29 is withdrawn in view of amendment to delete the limitation “L1a is -C0-C6 alkylene-C(O)N(H)-, -C0-C6 alkylene-S(O)2N(H)-”.
The objections to claim 34 are withdrawn in view of amendments to correct the typographical errors.
The objection to claim 64 is withdrawn in view of cancellation of said claim.
The rejection under 35 U.S.C. 112(a) of claims 29 – 30, 33 – 36, 47 – 48, 51 – 52, and 55 is withdrawn in view of amendments to recite specific cancers that are sufficiently enabled in claim 29.
The rejection under 35 U.S.C. 102(a)(1)/(a)(2) of claims 29 – 30 and 38 (claims 31 and 64 are cancelled) as being anticipated by Chen–I WO 2019/214651 A1 as evidenced by Chen–II, US 2021/0323979 A1 is withdrawn in view of amendments to limit the scope to Formula (IVh) in the claims.
Regarding the nonstatutory double patenting rejection of claims 29 – 30, 33 – 36, 38 and 55 (claims 31, 47 – 48 and 64 are cancelled) as being unpatentable over claims 1 – 27 of U.S. Patent No. 12,145,948 B2, and the provisional nonstatutory double patenting rejection of claims 29 – 30, 33 – 36, 38 and 55 (claims 31, 47 – 48 and 64 are cancelled) as being unpatentable over claims 31 – 38, 40 and 43 of copending Application No. 18/917,796, Applicant’s arguments are addressed below:
On page 16, 2nd paragraph – 4th paragraph, Applicant stated that claim 29 has been amended to include three additional features differentiating from U.S. Patent ‘948 and copending Application ‘796. Applicant argue that the instant claims are novel and non-obvious because the instant claims do not encompass the entirety of the scope of the claims in US ‘948 and the pending claims of ‘796. However, it is noted that the limitations of the additional features were addressed in the Non-Final rejection dated February 11, 2026. See, page 20, 2nd paragraph – page 21, 2nd paragraph, and page 25, 2nd paragraph – page 26, 2nd paragraph. The amendments to recite additional features are not sufficient to differentiate the instant claims from the claims in U.S. Patent ‘948 and copending Application ‘796. Therefore, the arguments are not sufficient and the rejections are maintained. The rejections have only been amended to address the new amendments and the claims pending in the instant application.
Regarding the provisional nonstatutory double patenting rejections of claims 29 – 30, 33 – 36, 38 and 55 (claims 31, 47 – 48 and 64 are cancelled) as being unpatentable over claims 1 – 4 and 19 – 20 of copending Application No. 19/057,843, and 1 and 19 – 20 of copending Application No. 19/057,838, Applicant refer to MPEP 804(I)(B)(1)(b)(i) and state the instant application under examination has the earlier patent term filing date and the provisional rejection would be the only pending rejections. Thus, the rejections should be withdrawn. However, since the provisional double patenting rejections are not the only pending rejections (in view of the maintained rejections over U.S. Patent ‘948 and copending Application ‘796 discussed above), the provisional nonstatutory double patenting rejections over copending applications ‘843 and ‘838 are maintained. The rejections have only been amended to address the new amendments and the claims pending in the instant application.
Examination: Applicant’s amendments necessitate extending the search. For prior art purposes, the search has been extending to include the complete scope of the instant claims. Pursuant to Federal Register, Vol. 76, No. 27, dated February 9, 2011, page 7166 (middle column):
“Under principles of compact prosecution, the examiner should also require the applicant to elect a species or group of indistinct species for search and examination (i.e., an election of species). If the examiner does not find the species or group of indistinct species in the prior art, then the examiner should extend the search to those additional species that fall within the scope of a permissible Markush claim. In other words, the examiner should extend the search to the species that share a single structural similarity and a common use. The improper Markush claim should be examined for patentability over the prior art with respect to the elected species or group of indistinct species…within the scope of a proper Markush claim.”
Subject matter not embraced by the elected embodiment or the scope searched is therefore withdrawn from further consideration. Claims 32, 37, 39 – 45, 53 – 54, 66 – 67, and 69 – 75 and 80 – 81 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a nonelected compound and disease species, there being no allowable generic or linking claim.
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.
Claim 55 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 55 recites the limitation “The method according to claim 29, wherein the compound of Formula (I) is…”. Emphasis added. See, line 1-2 of the claim. However, independent claim 29 is amended to recite the compound of Formula (IVh). Emphasis added. There is insufficient antecedent basis for the limitation “compound of Formula (I)” in claim 55. In order to overcome the rejection, Applicant may amend to replace “Formula (I)” with “Formula (IVh)”.
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 29 – 30, 33 – 36, 38, 51 – 52, 55, 68 and 76 – 81 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 27 of U.S. Patent No. 12,145,948 B2 (US ‘948), as cited in IDS dated December 31, 2025. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 18 in US ‘948 claim a compound of Formula (IVh):
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Claim 24 specifically claims the compound
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With respect to the instant claims, the claims in US ‘948 do not specifically recite the method for treating a subject with disease or condition mediated by Her2, said method comprising modulating Her2 in the subject by administering to the subject an effective amount of said compound. The conflicting claims in US ‘948 are being directed to a different statutory class of invention (instantly claimed compounds of Formula (I) rather than the method of using the compound), the Federal Circuit, in Sun v. Lilly, recounts its own decisions in Geneva and Pfizer,
In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent. `
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1800 (Fed. Cir. 2010).
In reaffirming its holding in Geneva and Pfizer, the Court finds that a "claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use.” (Id. at 1801, quoting Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86. The Court reasserts this notion by stating,
[i]t would shock one's sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. Pfizer, 518 F.3d at 1363 n.8 (emphases added); Geneva, 349 F.3d at 1386 (quoting In re Byck, 48 F.2d 665, 666 [9 USPQ 205] (CCPA 1931)).
Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 at 1802 (Fed. Cir. 2010).
See also section 804 IIb of the M.P.E.P.
In the instant case, the specification in US ‘948 identifies the utility of the compound of Formula (I) to treat a subject “with a disease or condition mediated, at least in part, Her2 (e.g., Her2 wild-type tumors, Her2 mutated tumors including Her2 with YVMA insertion mutations), said method comprising administering to the subject an effective amount of a compound according to Formula (I)”. See, e.g., column 3, lines 16-22. The specification also defines:
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. See, e.g., bridging paragraph between columns 14-15. Since said utility of the compound as claimed in US ‘948 is identical to the utility of the compound claimed in the instant claims, the claims in US ‘948 render the instant claims 1 – 15 unpatentable for obviousness-type double patenting as presented below:
Claims 29 – 30, 38, 51 – 52 and 68, directed to a method for treating a subject with a disease or condition mediated by Her2, said method comprising administering to the subject an effective amount of a compound of Formula (IVh) (claim 29):
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, wherein:
Q1 is H;
One Q2 is H, and the other is -C1 alkylene-NRaRb; and
Ra and Rb are each C1 alkyl.
The limitation “for treating a subject with a disease or condition mediated by Her2” is an intended use limitation as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended use only requires that the compound of Formula (I) for treating a subject with a disease or condition mediated by Her2, but does not impart any specific limitations to the structure. Based on the claims and specification of US ‘948, the compound is capable of treating a subject with a disease or condition mediated by Her2, specifically a cancer with a Her2 YVMA insertion mutation (claim 30) and breast cancer (claims 38 and 68).
With respect to claims 33 – 36 and 76 – 81, the specification of US ‘948 also defines that the method further comprises administering one or more therapeutic agents, specification ado-trastuzumab emtansine, trastuzumab deruxtecan, pembrolizumab, novolumab carboplatin or capecitabine. See, e.g., columns 59 and 80-81, and Embodiments 123, and 232 – 234.
With respect to claim 55, the compound is
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Claims 29 – 30, 33 – 36, 38, 51 – 52, 55, 68 and 76 – 81 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31 – 38, 40 and 43 of copending Application No. 18/917,796 (US ‘796) (reference application US 2025/0276983 A1), as cited in IDS dated December 31, 2025. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 31 in US ‘796 claim a method for treating a subject with cancer, said method comprising administering to the subject an effective amount of a compound of Formula (I):
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Claim 32 claims the method according to claim 31, wherein the compound is:
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Claim 43 specifically claims the method according to claim 31, wherein the compound is:
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With respect to claim 29, the claims in US ‘796 do not specifically recite that the cancer is mediated by Her2.
MPEP §804(II)(B)(1)(3rd paragraph) states:
“The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim”.
MPEP §804(II)(B)(1)(5th paragraph) also states:
“In construing the claims of the reference patent or application, a determination is made as to whether a portion of the specification, including the drawings and claims, is directed to subject matter that is within the scope of a reference claim… [b]ecause that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim”.
In the instant case, a portion of the disclosure was analyzed to properly construe the scope of the claims in US ‘796. The disclosure of US ‘796 teaches a method for treating a subject with a disease or condition mediated by Her2, wherein the disease is breast cancer. See, e.g., Embodiments 118-119 and 122. Because the above portion of the disclosure is an embodiment of the claims of US ‘796, the claims in US ‘796 render the instant claims unpatentable for anticipatory-type double patenting as presented below:
Claims 29 – 30, 38, 51 – 52 and 68, directed to a method for treating a subject with a disease or condition mediated by Her2, said method comprising administering to the subject an effective amount of a compound of Formula (IVh) (claim 29):
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, wherein:
Q1 is H;
One Q2 is H, and the other is -C1 alkylene-NRaRb; and
Ra and Rb are each C1 alkyl.
The limitation “for treating a subject with a disease or condition mediated by Her2” is an intended use limitation as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended use only requires that the compound of Formula (I) for treating a subject with a disease or condition mediated by Her2, but does not impart any specific limitations to the structure. Based on the claims and specification of US ‘948, the compound is capable of treating a subject with a disease or condition mediated by Her2, specifically a cancer with a Her2 YVMA insertion mutation (claim 30) and breast cancer (claims 38 and 68).
With respect to claims 33 – 36 and 76 – 81, the specification of US ‘948 also defines that the method further comprises administering one or more therapeutic agents, specification ado-trastuzumab emtansine, trastuzumab deruxtecan, pembrolizumab, novolumab carboplatin or capecitabine. See, e.g., columns 59 and 80-81, and Embodiments 123, and 232 – 234
With respect to claim 55, the compound is
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Claims 29 – 30, 33 – 36, 38, 51 – 52, 55, 68 and 76 – 81 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 4 and 19 – 20 of copending Application No. 19/057,843 (US ‘843) (reference application US 2025/0345339 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 19 in US ‘843 claims a method for treating cancer modulated by HER2 in a subject, the method comprising administering to the subject an effective amount of a pharmaceutical composition of claim 1. Claim 1 in US ‘843 claims a pharmaceutical composition comprising a compound of Formula (I):
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Claim 4 specifically claims the pharmaceutical composition, wherein the compound is:
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The claims in US ‘843 render the instant claims unpatentable for anticipatory-type double patenting as presented below:
Claims 29 – 30, 38, 51 – 52 and 68, directed to a method for treating a subject with a disease or condition mediated by Her2, said method comprising administering to the subject an effective amount of a compound of Formula (IVh) (claim 29):
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, wherein:
Q1 is H;
One Q2 is H, and the other is -C1 alkylene-NRaRb; and
Ra and Rb are each C1 alkyl.
The limitation “for treating a subject with a disease or condition mediated by Her2” is an intended use limitation as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended use only requires that the compound of Formula (I) for treating a subject with a disease or condition mediated by Her2, but does not impart any specific limitations to the structure. Based on the claims and specification of US ‘948, the compound is capable of treating a subject with a disease or condition mediated by Her2, specifically a cancer with a Her2 YVMA insertion mutation (claim 30) and breast cancer (claims 38 and 68).
With respect to claims 33 – 36 and 76 – 81, claim 20 in US ‘843 claims the method comprising administering (a) the compound of Formula (I), and (b) optionally one or more additional therapeutic agents. MPEP §804(II)(B)(1)(3rd paragraph) states:
“The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim”.
MPEP §804(II)(B)(1)(5th paragraph) also states:
“In construing the claims of the reference patent or application, a determination is made as to whether a portion of the specification, including the drawings and claims, is directed to subject matter that is within the scope of a reference claim… [b]ecause that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim”.
In the instant case, a portion of the disclosure was analyzed to properly construe the scope of the therapeutic agents. The disclosure of US ‘843 also defines that the method further comprises administering one or more therapeutic agents, specifically trastuzumab, pembrolizumab and nivolumab. See, e.g., paragraphs [0175]-[0177].
With respect to claim 55, the compound is
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Claims 29 – 30, 33 – 36, 38, 51 – 52, 55, 68 and 76 – 78 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19 – 20 of copending Application No. 19/057,838 (US ‘838) (reference application US 2025/0276984 A1), as cited in IDS dated December 31, 2025. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 20 in US ‘838 claims a method for treating cancer in a subject, the method comprising administering to the subject an effective amount of the solid form of claim 1. Further, Claim 1 in US ‘838 claims a solid form of Compound 1:
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With respect to claim 29, the claims in US ‘838 do not specifically recite that the cancer is mediated by Her2.
MPEP §804(II)(B)(1)(3rd paragraph) states:
“The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim”.
MPEP §804(II)(B)(1)(5th paragraph) also states:
“In construing the claims of the reference patent or application, a determination is made as to whether a portion of the specification, including the drawings and claims, is directed to subject matter that is within the scope of a reference claim… [b]ecause that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim”.
In the instant case, a portion of the disclosure was analyzed to properly construe the scope of the claims in US ‘838. The disclosure of US ‘838 teaches a method for treating a subject with a disease or condition mediated by Her2, wherein the disease is breast cancer. See, e.g., paragraphs [0035]-[0037], and . Because the above portion of the disclosure is an embodiment of the claims of US ‘838, the claims in US ‘796 render the instant claims unpatentable for anticipatory-type double patenting as presented below:
Claims 29 – 30, 38, 51 – 52 and 68, directed to a method for treating a subject with a disease or condition mediated by Her2, said method comprising administering to the subject an effective amount of a compound of Formula (IVh) (claim 29):
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, wherein:
Q1 is H;
One Q2 is H, and the other is -C1 alkylene-NRaRb; and
Ra and Rb are each C1 alkyl.
The limitation “for treating a subject with a disease or condition mediated by Her2” is an intended use limitation as governed by MPEP §2111.02(II). Intended use limitations are interpreted based on the structural limitations they impart to the invention. In this case, the intended use only requires that the compound of Formula (I) for treating a subject with a disease or condition mediated by Her2, but does not impart any specific limitations to the structure. Based on the claims and specification of US ‘948, the compound is capable of treating a subject with a disease or condition mediated by Her2, specifically a cancer with a Her2 YVMA insertion mutation (claim 30) and breast cancer (claims 38 and 68).
With respect to claims 33 – 36 and 76 – 78, the disclosure of US ‘838 also defines that the method further comprises administering an additional therapeutic agent, specifically pertuzumab, margetuximab, trastuzumab, ado-trastruzumab and trastuzumab deruxtecan. See, e.g., paragraph [037].
With respect to claim 55, the compound is
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Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 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.
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.
/Sagar Patel/Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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