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 – 65 are pending.
Claims 29 – 31, 33 – 36, 38, 47 – 48, 55 and 64 are rejected.
Claims 32, 37, 39 – 46, 49 – 54, 56 – 63 and 65 are withdrawn.
Election of Species
This application contains claims directed to the following patentably distinct species:
A compound of Formula (I), and
A disease or condition mediated by Her2.
The compound species are independent or distinct because
(1) The species as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; and (2) the species do not overlap in scope, i.e., are mutually exclusive. For example, the compound of Formula (I):
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, wherein A is N; E1 is C(CN); E2 is N; R1 and R2 join with the carbon atoms to which they are attached to form a saturated heterocyclic ring; G is -W-X-Y; W is a bond, X is aryl and Y is -C0-C4alkylene-1-yl-1H-pyrrole-2,5-dione, has a materially different structural design compared to the compound as claimed in claim 63:
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. Each of the structures would possess different function or effect. Thus, the species are mutually exclusive.
(3) In addition, the species as claimed are not obvious variants based on the current record. See MPEP § 806.05(j).
The disease or condition species are independent or distinct because the method for treating a subject with lung cancer, comprising administering to the subject an effective amount of the compound of Formula (I) would have materially different mode of operation than the method for treating a subject with osteoporosis. Thus, the diseases or condition species as claimed are considered mutually exclusive and are not obvious variants based on the current record. See MPEP § 806.05(j).
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
For example, a search for compound of Formula (I):
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, wherein A is N; E1 is C(CN); E2 is N; R1 and R2 join with the carbon atoms to which they are attached to form a saturated heterocyclic ring; G is -W-X-Y; W is a bond, X is aryl and Y is -C0-C4alkylene-1-yl-1H-pyrrole-2,5-dione, would not encompass or likely to result in finding art pertinent to the scope of the compound as claimed in claim 63:
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. Thus, each of the compound species would require a different field of search and search for each different compound of Formula (I) would require a serious burden on the examiner if restriction is not required.
Further, for example, a search for the method for treating a subject with lung cancer, comprising administering to the subject an effective amount of the compound of Formula (I) would not encompass or likely to result in finding art pertinent to the scope of the method for treating a subject with osteoporosis. Thus, each of the species of diseases or conditions mediated by Her2 would require a different field of search and search for each different disease or condition would require a serious burden on the examiner if restriction is not required
Applicant is required under 35 U.S.C. 121 to elect (a) a single disclosed species of the compound of Formula (I), and (b) a single disclosed species of diseases or conditions mediated by Her2, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 29 – 65 are generic.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. Applicant is requested to identify each of the variables (e.g., A, E1 – E2, R1 – R4, G, L1, L1a, R3a, W, X, Y, L2, R, Q, J1 – J4 and Ra – Rd) associated with the Formula (I). An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
Traversal
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
Joint Inventors
Applicant is reminded that upon the cancelation of claims to a non-elected species, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Telephonic Election/ Restriction
During a telephone conversation with Applicant’s representative, Grant Margulieux, on October 16, 2025, a provisional election was made without traverse to prosecute the compound species as claimed in claim 55:
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.
The compound reads on the structure of Formula (I) (claims 29 and 64):
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, wherein:
A is CH;
E1 is N;
E2 is C(R4), wherein R4 is H;
R1 is C1 alkyl;
R2 is -O-heteroaryl ([1,2,4]triazolo[1,5-a]pyridine-7-yl);
G is -L1-R3;
L1 is a bond,
R3 is a 6-membered heterocyclic (piperidin-1-yl) ring, wherein the nitrogen atom is substituted with -L2-R;
L2 is -C(O);
R is ethenyl substituted with 1 Q group;
Q is -C1 alkylene-NRaRb; and
Ra and Rb are each C1 alkyl.
The compound reads on the structure of Formula (IVh) (claims 47 – 48):
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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.
Applicant further elected the disease species of breast cancer. Affirmation of this election must be made by applicant in replying to this Office action.
Examination: Applicant’s elected compound and disease species reads on claims 29 – 31, 33 – 36, 38, 47 – 48, 55 and 64. Applicant’s elected species are not allowable. However, in the interest of compact prosecution, examination of the Markush-type claim has been extended to include the compound of Formula (I), wherein:
L1 is C1 alkylene,
R3 is a 6-membered heterocyclic (piperazin-1-yl) ring; and
R is an unsubstituted ethenyl.
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 – 46, 49 – 54, 56 – 63 and 65 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.
Priority
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Information Disclosure Statement
The information disclosure statements (IDS) submitted on February 12, 2024 and December 31, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Objections
Claims 29, 34 and 64 are objected to because of the following informalities:
Claim 29, page 3, line 9: The phrase “L1a is -C0-C6 alkylene-C(O)N(H)-, -C0-C6 alkylene-S(O)2N(H)-” is grammatically incorrect because it is missing proper conjunction between the group of alternatives. In order to overcome the objection, Applicant may amend the phrase as follows: “L1a is -C0-C6 alkylene-C(O)N(H)-, or -C0-C6 alkylene-S(O)2N(H)-”.
Claim 34, page 5, line 12 of the claim: The phrase “… v) and antibody body conjugate…” contains a typographical error because it improperly recites the term “and”. In order to overcome the objection, Applicant may amend to delete the term “and” in the phrase.
Claim 34, page 6, line 16: The phrase “… A2AR, A2BR; or xxiii) agonists…” contains a typographical error because it improperly recites the term “or”. In order to overcome the objection, Applicant may amend to delete the term “or” in the phrase.
Claim 64, page 19, line 9: The phrase “L1a is -C0-C6 alkylene-C(O)N(H)-, -C0-C6 alkylene-S(O)2N(H)-” is grammatically incorrect because it is missing proper conjunction between the group of alternatives. In order to overcome the objection, Applicant may amend the phrase as follows: “L1a is -C0-C6 alkylene-C(O)N(H)-, or -C0-C6 alkylene-S(O)2N(H)-”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 29 – 30, 33 – 36, 47 – 48, 51 – 52, and 55 are rejected under 35 U.S.C. 112(a) because the specification, while enabling for the method for treating a subject with a disease or condition mediated by Her2, wherein the disease or condition is selected from lung cancer, breast cancer, stomach cancer, ovarian cancer, colon cancer bladder cancer, uterine cervical cancer, head and neck cancer, gastric cancer, esophageal cancer and uterine serous endometrial carcinoma (see, claim 31), does not reasonably provide enablement for the method for treating the complete scope of all types of diseases or conditions mediated by Her2, as recited in the instant claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
MPEP 2164.01(a) states:
“There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure”
The Breath of the Claims and Nature of the Invention
The claims are drawn 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 (I):
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.
Thus, the nature of the invention includes the method for treating the complete scope of all diseases or conditions mediated by Her2, said method comprising administering an effective amount of the compound of Formula (I).
The State of the Prior Art and the Predictability or Lack thereof in the Art
There is no drug in the prior art that can treat all types of diseases or conditions mediated by Her2, including cancers. There has been no success in the prior art in achieving such treatment method as encompassed by the instant claims using a known drug. For example, it is known that the compound of formula (I) can be used as HER2 inhibitors to treat diseases such as breast cancer, gastric cancer, colorectal cancer, esophageal cancer and lung cancer. See, e.g., Chen et al. WO 2019/214651 A1 as evidenced by Chen et al., US 2021/0323979 A1, paragraphs [0109]-[0110], Table 2, both cited in IDS dated February 12, 2024 and December 31, 2025 respectively. However, the state of the art does not teach there is a single drug known to treat each cancer in a subject. For example, in 2018 the World Health Organization acknowledged that “[a] correct diagnosis is essential to treat children with cancer because each cancer requires a specific treatment regimen that may include surgery, radiotherapy, and chemotherapy… [e]arly diagnosis consists of 3 components: awareness by families and accessing care, clinical evaluation, diagnosis and staging (determining the extent to which a cancer has spread), and access to treatment”. See, e.g., page 3.
The nature of pharmaceutical arts is that it involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities. There is no absolute predictability even in view of the seemingly high level of skill in the art. Thus, the pharmaceutical art is unpredictable since it requires each embodiment to be individually assessed for physiological activity. The more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970).
The Amount of Direction Provided and Existence of Working Examples
The specification teaches that the method for treating a subject with a disease or condition mediated by Her2, wherein the disease or condition is lung cancer, breast cancer, stomach cancer, ovarian cancer, colon cancer bladder cancer, uterine cervical cancer, head and neck cancer, gastric cancer, esophageal cancer and uterine serous endometrial carcinoma. See, e.g., paragraphs [0403], [0521], [0568], and [0606]. However, there are no data or guidance that is sufficiently described in the specification or known to a person having ordinary skill in the art to support that the claimed compounds can be used to treat complete scope of all types of diseases or conditions mediated by Her2 in a subject.
The Quantity of Experimentation Needed
The quantity of experimentation needed is undue. One of ordinary skill in the art, without direction, would be unable to treat the entire scope of all types of diseases or conditions mediated by Her2 in a subject using the instant claimed compounds.
As a result of the broad and unpredictable nature of the invention and the lack of specific guidance from the specification, it is respectfully submitted that the quantity of experimentation needed to make and use the invention would be great. Note that there must be sufficient disclosure, either through illustrative examples or terminology, to teach those of ordinary skill how to make and use the invention as broadly as it is claimed. In re Vaeck, 947 F.2d 488, 496 & n.23, 20 USPQ2d 1438, 1445 * n.23 (Fed. Cir. 19991). Also, note that the amount of guidance or direction needed to enable the invention is inversely related to the degree of predictability in the art. In re Fisher, 839, 166 USPQ 24. Thus, although a single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements, in cases involving unpredictable factors, such as most chemical reactions and physiological activity, more teaching or guidance is required. In re Fisher, 427 F.2d 839, 166 USPQ 24; Ex Parte Hitzeman, 9 USPQ 2d 1823.
The specification fails to provide sufficient support for the broad use of the method for treating cancer in a subject in need thereof. The prior art also does not provide sufficient guidance and as a result, a person skilled in the art would recognize that the instantly claimed invention is unpredictable and would require an unreasonable amount of experimentation and clinical trials to assess the entire scope of the claimed invention and test whether all cancers can be treated by using claimed compound as encompassed in the present claims, with no reasonable expectation of success.
In order to overcome the rejection, Applicant may amend the present claims to recite specific cancers “lung cancer, breast cancer, stomach cancer, ovarian cancer, colon cancer bladder cancer, uterine cervical cancer, head and neck cancer, gastric cancer, esophageal cancer and uterine serous endometrial carcinoma” (see, claim 31), that are sufficiently enabled by the specification.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 29 – 31, 38 and 64 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Chen–I WO 2019/214651 A1 (publ. November 14, 2019; effect. filed May 8, 2018) as evidenced by Chen–II, US 2021/0323979 A1, both cited in IDS dated February 12, 2024 and December 31, 2025 respectively.
Chen–I teaches a compound of generic formula (I) as presented below:
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. See, e.g., Chen–I, page 1. Chen–I specifically teaches the compound of Example 10 as presented below:
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. See, e.g., Chen–I, page 12, 3rd column, 4th row; paragraph [0208]-[0210]. Chen–I further teaches the method of using said compound as a medicament for treating diseases related to HER2, specifically breast cancer, gastric cancer, colorectal cancer, esophageal cancer and lung cancer. See, e.g., Chen–II, paragraphs [0109]-[0110]. Chen–II also teaches in vitro cell proliferation inhibitory activity of the compounds against NCI-N87 (gastric carcinoma cells) and BT-474 (breast cancer cells). See, e.g., Chen–II, Table 2.
The prior art would have anticipated the instant claims as presented below:
Claims 29 – 31 and 38, 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 (I):
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, wherein:
A is CH;
E1 is N;
E2 is C(R4), wherein R4 is H;
R1 is C1 alkyl;
R2 is -O-heteroaryl ([1,2,4]triazolo[1,5-a]pyridine-7-yl);
G is -L1-R3;
L1 is C1 alkylene,
R3 is a 6-membered heterocyclic (piperazin-1-yl) ring, wherein the nitrogen atom is substituted with -L2-R;
L2 is -C(O); and
R is an unsubstituted ethenyl.
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 teachings of Chen–I and Chen–II, the compound of Example 10 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 31 and 38).
Claim 64, directed to a method for treating a subject with breast cancer, said method comprising administering to the subject an effective amount of a compound of Formula (I):
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, wherein:
A is CH;
E1 is N;
E2 is C(R4), wherein R4 is H;
R1 is C1 alkyl;
R2 is -O-heteroaryl ([1,2,4]triazolo[1,5-a]pyridine-7-yl);
G is -L1-R3;
L1 is C1 alkylene,
R3 is a 6-membered heterocyclic (piperazin-1-yl) ring, wherein the nitrogen atom is substituted with -L2-R;
L2 is -C(O); and
R is an unsubstituted ethenyl.
The limitation “for treating a subject with a disease or condition selected from lung cancer… uterine serous endometrial carcinoma” 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, but does not impart any specific limitations to the structure. Based on the teachings of Chen–I and Chen–II, the compound of Example 10 is capable of treating a subject with a disease or condition, specifically breast cancer.
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 – 31, 33 – 36, 38, 47 – 48, 55 and 64 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 1 in US ‘948 claim a compound of Formula (I):
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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 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 – 31 and 38, 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 (I) (claims 29 and 64):
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, wherein:
A is CH;
E1 is N;
E2 is C(R4), wherein R4 is H;
R1 is C1 alkyl;
R2 is -O-heteroaryl ([1,2,4]triazolo[1,5-a]pyridine-7-yl);
G is -L1-R3;
L1 is a bond,
R3 is a 6-membered heterocyclic (piperidin-1-yl) ring, wherein the nitrogen atom is substituted with -L2-R;
L2 is -C(O);
R is ethenyl substituted with 1 Q group;
Q is -C1 alkylene-NRaRb; and
Ra and Rb are each C1 alkyl.
The compound reads on the structure of Formula (IVh) (claims 47 – 48):
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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 31 and 38).
With respect to claims 33 – 36, the specification of US ‘948 also defines that the method further comprises administering one or more therapeutic agents, specification ado-trastuzumab emtansine, trastuzumab, . See, e.g., columns 59 and 81, and Embodiments 123, 233 and 234.
Claim 64, directed to a method for treating a subject with breast cancer, said method comprising administering to the subject an effective amount of a compound of Formula (I):
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, wherein:
A is CH;
E1 is N;
E2 is C(R4), wherein R4 is H;
R1 is C1 alkyl;
R2 is -O-heteroaryl ([1,2,4]triazolo[1,5-a]pyridine-7-yl);
G is -L1-R3;
L1 is a bond,
R3 is a 6-membered heterocyclic (piperidin-1-yl) ring, wherein the nitrogen atom is substituted with -L2-R;
L2 is -C(O);
R is ethenyl substituted with 1 Q group;
Q 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, specifically breast cancer.
Claims 29 – 31, 33 – 36, 38, 47 – 48, 55 and 64 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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260
310
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.
Claim 43 specifically claims the method according to claim 31, wherein the compound is:
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405
636
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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 – 31 and 38, 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 (I) (claims 29 and 64):
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246
294
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, wherein:
A is CH;
E1 is N;
E2 is C(R4), wherein R4 is H;
R1 is C1 alkyl;
R2 is -O-heteroaryl ([1,2,4]triazolo[1,5-a]pyridine-7-yl);
G is -L1-R3;
L1 is a bond,
R3 is a 6-membered heterocyclic (piperidin-1-yl) ring, wherein the nitrogen atom is substituted with -L2-R;
L2 is -C(O);
R is ethenyl substituted with 1 Q group;
Q is -C1 alkylene-NRaRb; and
Ra and Rb are each C1 alkyl.
The compound reads on the structure of Formula (IVh) (claims 47 – 48):
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188
384
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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 31 and 38).
With respect to claims 33 – 36, the specification of US ‘948 also defines that the method further comprises administering one or more therapeutic agents, specification ado-trastuzumab emtansine, trastuzumab, pembrolizumab and nivolumab. See, e.g., columns 59 and 81, and Embodiments 123, 233 and 234.
Claim 64, directed to a method for treating a subject with breast cancer, said method comprising administering to the subject an effective amount of a compound of Formula (I):
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246
294
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, wherein:
A is CH;
E1 is N;
E2 is C(R4), wherein R4 is H;
R1 is C1 alkyl;
R2 is -O-heteroaryl ([1,2,4]triazolo[1,5-a]pyridine-7-yl);
G is -L1-R3;
L1 is a bond,
R3 is a 6-membered heterocyclic (piperidin-1-yl) ring, wherein the nitrogen atom is substituted with -L2-R;
L2 is -C(O);
R is ethenyl substituted with 1 Q group;
Q 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, specifically breast cancer.
Claims 29 – 31, 33 – 36, 38, 47 – 48, 55 and 64 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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236
304
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.
Claim 4 specifically claims the pharmaceutical composition, wherein the compound is:
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368
552
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.
The claims in US ‘843 render the instant claims unpatentable for anticipatory-type double patenting as presented below:
Claims 29 – 31 and 38, 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 (I) (claims 29 and 64):
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246
294
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, wherein:
A is CH;
E1 is N;
E2 is C(R4), wherein R4 is H;
R1 is C1 alkyl;
R2 is -O-heteroaryl ([1,2,4]triazolo[1,5-a]pyridine-7-yl);
G is -L1-R3;
L1 is a bond,
R3 is a 6-membered heterocyclic (piperidin-1-yl) ring, wherein the nitrogen atom is substituted with -L2-R;
L2 is -C(O);
R is ethenyl substituted with 1 Q group;
Q is -C1 alkylene-NRaRb; and
Ra and Rb are each C1 alkyl.
The compound reads on the structure of Formula (IVh) (claims 47 – 48):
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188
384
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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 ‘843, 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 31 and 38).
With respect to claims 33 – 36, 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].
Claim 64, directed to a method for treating a subject with breast cancer, said method comprising administering to the subject an effective amount of a compound of Formula (I):
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246
294
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, wherein:
A is CH;
E1 is N;
E2 is C(R4), wherein R4 is H;
R1 is C1 alkyl;
R2 is -O-heteroaryl ([1,2,4]triazolo[1,5-a]pyridine-7-yl);
G is -L1-R3;
L1 is a bond,
R3 is a 6-membered heterocyclic (piperidin-1-yl) ring, wherein the nitrogen atom is substituted with -L2-R;
L2 is -C(O);
R is ethenyl substituted with 1 Q group;
Q 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 ‘843, the compound is capable of treating a subject with a disease or condition, specifically breast cancer.
Claims 29 – 31, 33 – 36, 38, 47 – 48, 55 and 64 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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552
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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 – 31 and 38, 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 (I) (claims 29 and 64):
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246
294
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, wherein:
A is CH;
E1 is N;
E2 is C(R4), wherein R4 is H;
R1 is C1 alkyl;
R2 is -O-heteroaryl ([1,2,4]triazolo[1,5-a]pyridine-7-yl);
G is -L1-R3;
L1 is a bond,
R3 is a 6-membered heterocyclic (piperidin-1-yl) ring, wherein the nitrogen atom is substituted with -L2-R;
L2 is -C(O);
R is ethenyl substituted with 1 Q group;
Q is -C1 alkylene-NRaRb; and
Ra and Rb are each C1 alkyl.
The compound reads on the structure of Formula (IVh) (claims 47 – 48):
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188
384
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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 31 and 38).
With respect to claims 33 – 36, 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].
Claim 64, directed to a method for treating a subject with breast cancer, said method comprising administering to the subject an effective amount of a compound of Formula (I):
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246
294
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, wherein:
A is CH;
E1 is N;
E2 is C(R4), wherein R4 is H;
R1 is C1 alkyl;
R2 is -O-heteroaryl ([1,2,4]triazolo[1,5-a]pyridine-7-yl);
G is -L1-R3;
L1 is a bond,
R3 is a 6-membered heterocyclic (piperidin-1-yl) ring, wherein the nitrogen atom is substituted with -L2-R;
L2 is -C(O);
R is ethenyl substituted with 1 Q group;
Q 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 ‘838, the compound is capable of treating a subject with a disease or condition, specifically breast cancer.
Conclusion
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.
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/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626