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 .
Priority
The instant application, filed 04/12/2024, is a national stage entry of PCT/CN2022/125080, filed 10/13/2022, and which claims foreign priority to PCT/CN2021/133363, filed 11/26/2021, and PCT/CN2021/123848, filed 10/14/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR § 1.55.
Preliminary Amendments and Claim Status
The preliminary amendment filed on 06/16/2025 is acknowledged and entered.
Claims 1, 4, 10, 12, 27, 28, 32, 33, 43, 78, 80, 81, 83, 85-87, 92, and 93 are amended;
Claims 2, 3, 5, 6, 8, 9, 11, 13-26, 29-31, 34-42, 44-47,82, 84, 88-91, and 94-98 are cancelled;
Claims 1, 4, 7, 10, 12, 27, 28, 32, 33, 43, 78, 80, 81, 83, 85-87, 92, and 93 are pending and are under prosecution.
Information Disclosure Statement
The Information Disclosure Statement filed on 07/15/2024, 06/17/2025, 05/29/2026, and 08/20/2026 are acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statements are considered.
Specification
The disclosure is objected to because of the following informalities:
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Throughout the specification, two-dimensional representations of compounds of inconsistent rendering are present. For consistency, and to prevent issues with the printing of the compounds, it is required that the compounds be of sufficient and self-consistent resolution. For example, throughout Table 3, it is apparent that more than one form of structure generation has been used to generate the two-dimensional structures of the compounds taught within the disclosure. For example, on pages 103 (left) and 113 (right) of the instant specification, four different rendering qualities of compounds are shown, each differing in the level of clarity and resolution exhibited. Applicant is kindly requested to correct the inconsistencies, and to submit compounds of higher resolution. This may be remedied by submitting a substitute specification or an amendment to the specification.
Further, the lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which Applicant may become aware in the specification.
Appropriate correction is required.
Drawings
The drawings filed on 04/12/2024 objected to under 37 CFR § 1.83(a) and 1.85 for being of insufficient quality, hindering examination:
The different data types are indistinguishable in Figures 1A, 1B, 7, and 12. It appears that the original figures rely on color-coding of the data, a feature not available in the black and white drawings. Thus, the drawings do not permit examination. For example:
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. In the instant case, the data is indistinguishable due to lack of color differentiation. The figures must be remade with shapes or line-types used to describe the different data points.
The different data types are indistinguishable in Figures 1A, 1B, 7, and 12. The figures lack a complete or fully legible figure key to describe the different data types. Thus, the drawings do not permit examination. For example:
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. In the instant case, the figure key is entirely illegible. The figures must be remade with a legible figure key describing the different types of data found in the figures.
The figure axes are indistinguishable in Figures 1A, 1B, 6C, 6D, 7, 10B, 11B, 12, and 13. The figures submitted are of low resolution, and the axes are not legible. Thus, the drawings do not permit examination. For example:
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. In the instant case, the examiner is unable to distinguish the data axes points. The figures must be remade with legible axes to permit interpretation of the presented data.
For the reasons set forth above, the drawings are not of sufficient quality to permit examination. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR § 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR § 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR § 1.81. Extensions of time may be obtained under the provisions of 37 CFR § 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. § 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
Claim Objections
Claims 1, 4, 7, 78, and 86 are objected to for the following informalities:
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The two-dimensional representations of compounds, substituents, and formulas within the claims are of low-resolution inconsistent rendering are present. The compounds, substituents, and formulas appear pixelated, warped, and/or grainy. Most often, the shading is inconsistent throughout the claims. For example: 1) 2)
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. In the first example, the text is pixelated and grainy. In the second example, the text is both warped and grainy. To prevent issues with printing, it is required that the two-dimensional representations be of sufficient and self-consistent resolution.
Claims 86 is objected to for missing claim language:
The claim recites “or a pharmaceutically acceptable thereof.” The phrasing of the claim is missing a noun following “acceptable.” Under the broadest reasonable interpretation set forth by MPEP § 2111, and in view of the claim set as a whole, it is presumed that applicant intended to recite “a pharmaceutically acceptable salt thereof.” As written, the claim language does not recite this term. Appropriate correction is required to render the claim complete and consistent with the intended scope.
Claim 87 is objected to for depending on a rejected claim, (claim 1).
Removed anticipation and obviousness rejections. Kept this here so I could preserve your comment. Please delete this line altogether if satisfactory.
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. § 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 7, 10, 12, 27, 28, 32, 33, 43, 78, 80, 81, 83, 85, 86, 92, and 93 are rejected under 35 U.S.C. § 112(a) or 35 U.S.C. § 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. § 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims # of the instant application are drawn to compounds having following substituents:
L2 is a bond, —O—, —NR4A—, —NR4B—C(═O)—, —NR4B—C(═O)—(C1-C3alkylene)-NR4A—, —NR4B—C(═O)—(C1-C3alkylene)-O—, —(C1-C3alkylene)-NR4B—C(═O)—, —C(═O)NR4A—, —C1-C3alkylene-, —C2-C3 alkenylene-, —C2-C3alkynylene-, C3-C8 cycloalkylene, or C2-C8 heterocyclene;
R1 is hydrogen, halogen, —CN, —NO2, —OR4A, —NR4AR4B, —C(═O)R4A, —C(═O)OR4A, —C(═O)NR4BR4A, C1-3-C6 alkyl, C1-C6 haloalkyl, C1-C6 heteroalkyl, C3-C8 cycloalkyl, C2-C68 heterocyclyl, aryl or heteroaryl, or two R1, together with the atom(s) to which they are connected, optionally form C3-C13 cycloalkyl, C3-C12 heterocyclyl, aryl, or heteroaryl;
R1A is selected from hydrogen, halogen, —OCH3, —NH2, —NHCH3, —N(CH3)2, —C(═O)CH3, —C(═O)OCH3, —C(═O)NH2, —C(═O)NHCH3, —C(═O)N(CH3)2, —CH3, —CHF2, —CF3, —CH2CH3, —CH(CH3)2, —C(CH3)3, cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, or phenyl;
R1B is selected from hydrogen, halogen, —OCH3, —NH2, —NHCH3, —N(CH3)2, —C(═O)CH3, —C(═O)OCH3, —C(═O)NH2, —C(═O)NHCH3, —C(═O)N(CH3)2, —CHF2, —CF3, or phenyl;
R2 is hydrogen, C1-C6 alkyl, C3-C8 cycloalkyl, OH, or O—C1-C4 alkyl;
R3 is hydrogen, halogen, —CN, —NO2, —OR4A, —NR4AR4B, —C(═O)R4A, —C(═O)OR4A, —C(═O)NR4BR4A, —OC(═O)R4A, —N(R4A)C(═O)R4B, C1-C6 alkyl, C1-C6 haloalkyl, C1-C6 heteroalkyl, C3-C8 cycloalkyl, C2-C8 heterocyclyl, aryl, or heteroaryl, or two R3, together with the atom(s) to which they are connected, optionally form C3-C13 cycloalkyl, C2-C12 heterocyclyl, aryl, or heteroaryl;
R4A and R4B is hydrogen, C1-C6 alkyl, C2-C6 alkenyl, C2-C6 alkynyl, C1-C6 haloalkyl, C1-C6 heteroalkyl, C3-C8 cycloalkyl, C2-C8 heterocyclyl, aryl, or heteroaryl, or R4A and R4B, together with the atom(s) to which they are connected, optionally form C2-C12 heterocyclyl;
p is 1, 2 or 3;
X1 is O, S, or NR5;
R5 is hydrogen, C1-C6 alkyl, C1-C6 haloalkyl, C1-C6 heteroalkyl, C3-C8 cycloalkyl, or C2-C8 heterocyclyl;
L1 is —(CH2)p1C(═O)NH(CH2CH2O)p2—(CH2)p3—, —(CH2)p1C(═O)NH(CH2)p2—, —(CH2)p1NHC(═O)—(CH2CH2O)p2—(CH2)p3—, —(CH2)p1NHC(═O)—(CH2)p2—, —(CH2)p1C(═O)—(CH2CH2O)p2—(CH2)p3—, —(CH2)p1C(═O)—(CH2)p2—, —(CH2)p1NH(CH2CH2O)p2—(CH2)p3—, —(CH2)p1NH(CH2)p2—, —(CH2CH2O)p2—(CH2)p3—, or —(CH2)p2—;
p1 is an integer selected from 0 to 8;
p2 is an integer selected from 1 to 15;
p3 is an integer selected from 0 to 8.
A is
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;
XC 1 is CRC 3 or N;
XC 2 is CRC 3 or N;
YC 1 is O, S, or —C(RC 2)═C(RC 2)—;
YC 2 is C(RC 7)2, or NRC 7;
RC 1 as hydrogen or optionally substituted C6-C10 aryl or 5 to 10 membered heteroaryl;
RC 1 is optionally substituted C6 aryl, optionally substituted with 1-4 halogen, CN, NO2, NRC 4RC 5, C1-C8 alkyl, C1-C8 haloalkyl, C1-C8 alkoxy, or C1-C8 alkoxyalkyl;
RC 2 is independently hydrogen, halogen, CN, NO2, NRC 4RC 5, —C(═O)RC 6, —C(═O)ORC 4, —C(═O)NRC 4RC 5, —OC(═O)RC 6, —N(RC 4)C(═O)RC 6, C1-C8 alkyl, C1-C8 heteroalkyl, C2-C8 alkynyl, C1-C8 haloalkyl, C1-C8 alkoxy, C1-C8 alkoxyalkyl, or C1-C8 alkylaryl;
RC 3 is hydrogen, halogen, CN, NO2, NRC 4RC 5, C1-C8 alkyl, C1-C8 haloalkyl, C1-C8 alkoxy, C1-C8 alkoxyalkyl, aryl, or heteroaryl;
RC 4 is from hydrogen, C1-C8 alkyl, C1-C8 haloalkyl, C1-C8 alkoxyalkyl, C1-C8 heteroalkyl, C3-C8 cycloalkyl, C2-C8 heterocyclyl, aryl, or heteroaryl, or RC 4 and RC 5 together with the atom(s) to which they are connected optionally form a 3-20 membered heterocyclyl ring;
RC 5 is from hydrogen, C1-C8 alkyl, C1-C8 haloalkyl, C1-C8 alkoxyalkyl, C1-C8 heteroalkyl, C3-C8 cycloalkyl, C2-C8 heterocyclyl, aryl, or heteroaryl, or RC 4 and RC 5 together with the atom(s) to which they are connected optionally form a 3-20 membered heterocyclyl ring;
RC 6 is from hydrogen, C1-C8 alkyl, C1-C8 haloalkyl, C1-C8 alkoxyalkyl, C1-C8 heteroalkyl, C3-C8 cycloalkyl, C2-C8 heterocyclyl, aryl, or heteroaryl, or RC 4 and RC 5 together with the atom(s) to which they are connected optionally form a 3-20 membered heterocyclyl ring;
RC 7 is hydrogen, NRC 4RC 5, ORC 4, —C(═O)RC 6, —C(═O)ORC 6, —C(═O)NRC 4RC 5, —(C1-C8 alkyl)—C(═O)NRC 4RC 5, —OC(═O)RC 6, —N(RC 8)C(═O)RC 6, C1-C8 alkyl, C1-C8 haloalkyl, C1-C8 heteroalkyl, C3-C8 cycloalkyl, C2-C8 heterocyclyl, or two of RC 7, together with the atom(s) they are connected, optionally form a C3-C8 cycloalkyl, or C2-C8 heterocyclyl;
x4C is 1, 2, or 3.
Target binding protein is:
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35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111,1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim’s enablement is not equally conclusive of that claim’s satisfactory written description"). The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert, denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaffv. Wells Bees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); EliLilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm.,927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). An application specification may show actual reduction to practice by describing testing of the claimed invention.
In the present case, the important factors leading to a conclusion of inadequate written description is the lack of a representative number of species that characterizes the entire claimed genus and accounts for variations between species of the genus.
In the instant specification, there is no disclosure of compounds having the following claimed substituents:
L2 as bond, —O—, —(C1-C3alkylene)-NR4B—C(═O)—, —C1-C3alkylene-, —C2-C3 alkenylene-, —C2-C3alkynylene-, C3-C8 cycloalkylene, or C2-C8 heterocyclene;
R1 as —CN, —NR4AR4B, —C(═O)R4A, —C(═O)OR4A, —C(═O)NR4BR4A, C4-C6 alkyl, C2-C6 haloalkyl, C1-C6 heteroalkyl, C4-C8 cycloalkyl, C2-C5 or C7-C8 heterocyclyl, aryl or heteroaryl, or two R1, together with the atom(s) to which they are connected, optionally form C3-C13 cycloalkyl, C3-C12 heterocyclyl, aryl, or heteroaryl;
R1A as —NH2, —NHCH3, —N(CH3)2,—C(═O)NH2, —C(═O)NHCH3, —C(═O)N(CH3)2, —CHF2, —C(CH3)3, cyclobutyl, cyclopentyl, or cyclohexyl;
R1B as —OCH3, —NH2, —NHCH3, —N(CH3)2, —C(═O)CH3, —C(═O)NH2, —C(═O)NHCH3, —C(═O)N(CH3)2, or —CHF2;
R2 as C1-C6 alkyl, C3-C8 cycloalkyl, OH, or O—C1-C4 alkyl;
R3 as —CN, —NO2, —OR4A, —C(═O)R4A, —C(═O)OR4A, —C(═O)NR4BR4A, —OC(═O)R4A, —N(R4A)C(═O)R4B, C2-C6 alkyl, C1-C6 haloalkyl, C1-C6 heteroalkyl, C3-C8 cycloalkyl, C2-C8 heterocyclyl, aryl, or heteroaryl, or two R3, together with the atom(s) to which they are connected, optionally form C3-C13 cycloalkyl, C2-C12 heterocyclyl, aryl, or heteroaryl;
R4A and R4B as C2-C6 alkyl, C2-C6 alkenyl, C2-C6 alkynyl, C1-C6 haloalkyl, C1-C6 heteroalkyl, C3-C8 cycloalkyl, C2-C8 heterocyclyl, aryl, or heteroaryl, or R4A and R4B, together with the atom(s) to which they are connected, optionally form C2-C12 heterocyclyl;
p as 3; p
X1 as NR5;
R5 as hydrogen, C1-C6 alkyl, C1-C6 haloalkyl, C1-C6 heteroalkyl, C3-C8 cycloalkyl, or C2-C8 heterocyclyl;
L1 as—(CH2)p1NHC(═O)—(CH2CH2O)p2—(CH2)p3—, —(CH2)p1C(═O)—(CH2CH2O)p2—(CH2)p3—, —(CH2)p1C(═O)—(CH2)p2—, —(CH2)p1NH(CH2CH2O)p2—(CH2)p3—, —(CH2)p1NH(CH2)p2—, —(CH2CH2O)p2—(CH2)p3—, or —(CH2)p2—;
p1 is an integer selected from 5 to 8
p2 is an integer selected from 12 to 18;
p3 is an integer selected from 5 to 8;
A as
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XC 1 as CRC 3;
XC 2 as CRC 3;
YC 1 as O and —C(RC 2)═C(RC 2)—;
YC 2 as C(RC 7)2, or NRC 7;
RC 1 as hydrogen or optionally substituted C7-C10 aryl or 5 to 10 membered heteroaryl;
RC 1 as optionally substituted C6 aryl, optionally substituted with 2-4 halogen, CN, NO2, NRC 4RC 5, C1-C8 alkyl, C1-C8 haloalkyl, C1-C8 alkoxy, or C1-C8 alkoxyalkyl;
RC 2 as hydrogen, halogen, CN, NO2, NRC 4RC 5, —C(═O)RC 6, —C(═O)ORC 4, —C(═O)NRC 4RC 5, —OC(═O)RC 6, —N(RC 4)C(═O)RC 6, C2-C8 alkyl, C1-C8 heteroalkyl, C2-C8 alkynyl, C1-C8 haloalkyl, C1-C8 alkoxy, C1-C8 alkoxyalkyl, or C1-C8 alkylaryl;
RC 3 as hydrogen, halogen, CN, NO2, NRC 4RC 5, C2-C8 alkyl, C1-C8 haloalkyl, C1-C8 alkoxy, C1-C8 alkoxyalkyl, aryl, or heteroaryl;
RC 4 as hydrogen, C1-C8 alkyl, C1-C8 haloalkyl, C1-C8 alkoxyalkyl, C1-C8 heteroalkyl, C3-C8 cycloalkyl, C2-C8 heterocyclyl, aryl, or heteroaryl, or RC 4 and RC 5 together with the atom(s) to which they are connected optionally form a 3-20 membered heterocyclyl ring;
RC 5 as hydrogen, C1-C8 alkyl, C1-C8 haloalkyl, C1-C8 alkoxyalkyl, C1-C8 heteroalkyl, C3-C8 cycloalkyl, C2-C8 heterocyclyl, aryl, or heteroaryl, or RC 4 and RC 5 together with the atom(s) to which they are connected optionally form a 3-20 membered heterocyclyl ring;
RC 6 as hydrogen, C1-C8 alkyl, C1-C8 haloalkyl, C1-C8 alkoxyalkyl, C1-C8 heteroalkyl, C3-C8 cycloalkyl, C2-C8 heterocyclyl, aryl, or heteroaryl;
RC 7 as hydrogen, NRC 4RC 5, ORC 4, —C(═O)RC 6, —C(═O)ORC 6, —C(═O)NRC 4RC 5, —(C1-C8 alkyl)—C(═O)NRC 4RC 5, —OC(═O)RC 6, —N(RC 8)C(═O)RC 6, C1-C8 alkyl, C1-C8 haloalkyl, C1-C8 heteroalkyl, C3-C8 cycloalkyl, C2-C8 heterocyclyl, or two of RC 7, together with the atom(s) they are connected, optionally form a C3-C8 cycloalkyl, or C2-C8 heterocyclyl;
x4C as 1 or 3;
Target binding protein as
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The instant specification (pages115-196) teaches compounds which are characterized as having only the following substituents:
L2 is —NR4A—, —NR4B—C(═O)—, —NR4B—C(═O)—(C1-C3alkylene)-NR4A—, —NR4B—C(═O)—(C1-C3alkylene)-O—, and—C(═O)NR4A—,
R1 is hydrogen, halogen,—NO2, —OR4A, C1-C3 alkyl, C1 haloalkyl, C3 cycloalkyl, C6 heterocyclyl,
R1A is hydrogen, halogen, —OCH3, —C(═O)CH3, —C(═O)OCH3, —CH3, —CF3, —CH2CH3, —CH(CH3)2, cyclopropyl, and phenyl.
R1B is hydrogen, halogen,—C(═O)OCH3, —CF3, and phenyl.
R2 is hydrogen;
R3 is hydrogen, halogen, —NR4AR4B, and CH3
R4A and R4B are hydrogen and CH3
p is 1 or 2
X1 is O and S
R5 is not exemplified;
L1 is —(CH2)p1C(═O)NH(CH2CH2O)p2—(CH2)p3—, —(CH2)p1C(═O)NH(CH2)p2—,—(CH2)p1NHC(═O)—(CH2)p2—
p1 is an integer selected from 0 to 4;
p2 is an integer selected from 1 to 11;
p3 is an integer selected from 0 to 3;
A is
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XC 1 is N;
XC 2 is N;
YC 1 is S
YC 2 is C(RC 7)2, or NRC 7; YC 2 as C(RC 7)2, or NRC 7; YC 2 is not exemplified;
RC 1 is substituted C6 aryl or 5 to 10 membered heteroaryl;
RC 1 substituted C6 aryl, optionally substituted with 1 halogen;
RC 2 is CH3
RC 3 is CH3
RC 4 is not exemplified;
RC 5 is not exemplified;
RC 6 is not exemplified;
RC 7 is not exemplified
x4C is 2;
Target binding protein is
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Therefore, the compounds and methods described in the instant specification detail only a limited number of the total substituents claimed (see substituents 1-29, above). All working examples presented in the instant specification are related to the compounds containing a fraction of the total claimed substituents (see substituents 59-87, above).
There are no working examples in the instant specification for the wide range of substituents claimed, but for which evidence of possession has not been provided (see substituents 30-58, above). Thus, the instant specification does not provide any evidence that Applicant was in possession of the full claimed scope of the invention prior to the effective filing of the instant application.
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966(1997); In re Gosteli, 872 F.2d 1008, 1012,10 USPQ2d 1614, 1618 (Fed Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.") Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. For example, disclosure of only a method of making the invention and the function may not be sufficient to support a product claim other than a product-by-process claim. See, e.g., Fiers v. Revel, 984 F.2d at 1169, 25 USPQ2d at 1605; Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021.
Thus, since Applicant has not described in adequate detail methods to synthesize compounds containing the claimed substituents, or provided evidence that said compounds have been characterized, or that they exist, an ordinary skilled artisan could not completely envisage Applicants’ invention. Moreover, it is clear that the written description requirement has not been met since Applicant has not provided any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application. Thus, claims 1, 4, 7, 10, 12, 27, 28, 32, 33, 43, 78, 80, 81, 83, 85, 86, 92, and 93 of the instant application are not supported by the instant specification and thus a rejection under 35 U.S.C. § 112 (a) for failing to comply with the written description requirement is proper.
Claim 92 is rejected under 35 U.S.C. § 112 (a), or 35 U.S.C. § 112 (pre-AIA ) first paragraph, because the specification, while being enabling for a method of degradation of cyclin D1/D2/D3, CDK4, BRD4, and P33/CBP using a small subset of compounds claimed it does not reasonably provide enablement for a method of degrading the target protein comprising contacting the protein with a compound of Formula (I). The specification does not provide sufficient information to support the claimed invention.
The instant specification fails to provide information that would allow the skilled artisan to fully practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) the nature of the invention;
(2) the state of the prior art;
(3) the relative skill of those in the art;
(4) the predictability or unpredictability of the art;
(5) the breadth of the claims;
(6) the amount of direction or guidance presented;
(7) the presence or absence of working examples; and
(8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: Claim 92 of the instant application are drawn to a method of degrading the target protein comprising contacting the protein with a compound of Formula (I).
Breadth of the claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. The rejected claims are extremely broad. Applicant claims that the claimed compounds can be used to degrade any target protein using the compounds instantly claimed. Thus, the cited claims are deemed very broad since these claims read on degrading a large range of target proteins comprising contacting the protein with a large range of compounds.
State of the Prior Art: There are no art recognized methods that could be used to establish that the instantly claimed compounds can target and degrade the large range of proteins encompassed by the instant claims. According to Meyers et al. (ACS Chem Biol, Volume 19, pages 58−68, published January 9, 2024), hereinafter Meyers, although are >600 E3 ligases in the human proteome, most degraders have exploited only a small number of E3 ligases (page 58). Meyers teaches structurally similar DDB1-binding scaffolds linked to BRD4 protein-targeting moieties. The compounds of the disclosure exhibited only partial success in degrading the protein target of the study. Specifically, only the short BRD4 isoform was degraded within the study, while the long isoform was unsuccessful as a target (page 61, Figure 3). Furthermore, four different linkers were tested, but none achieved more than modest degradation (page 63). As such, targeted degradation of DDB1-based molecular degraders targeting BRD4 is known in the art to be limited by the target protein, as well as the compounds used for degradation.
Predictability/Unpredictability in the Art: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that the recitation includes treating any disease mediated by protein kinases. Thus, the skilled artisan would view that successfully targeting the large number of proteins for degradation comprising the contacting of the protein using the target compounds, is highly unpredictable, as the success of the degradation is demonstrated to be target dependent. As such, contemporaneous work employing a structurally analogous recruiter demonstrates that even well precedented, and favorable degradation targets like BRD4 achieve only partial, isoform selective, or incomplete degradation with DDB1-based recruiters.
Guidance of the Specification/Working Examples: Applicant has only provided working examples of the degradation of a small, structurally narrow set of protein targets. Specifically, the degradation of Cyclin D1/D2/D3 and CDK4 by compounds CPD-042 and 049, BRD4 by compound CPD-253, and P300/CBP by CPD-191 (pages 501-511). There is no data for the vast remainder of the claimed genus, including dozens of structurally unrelated target binding moieties recited in the specification, such as kinase inhibitors, MDM2 inhibitors, HDAC inhibitors, hormone receptor ligands, HIV integrase/HCV protease inhibitors, etc. Thus, the specification fails to provide sufficient evidence in support the broad use of the claimed compounds for targeting integrating any protein target using the broad range of compounds claimed.
The Quantitation of Experimentation Required: In order to practice Applicants invention, it would be necessary for one to design and conduct an exhaustive amount of complex experiments to demonstrate that the claimed compounds could be used to target and degrade a large number of proteins encompassed by the instant claims. The population of proteins mentioned in the instant specification is lengthy (e.g., kinase inhibitors, MDM2 inhibitors, HDAC inhibitors, hormone receptor ligands, HIV integrase/HCV protease inhibitors) and thus the quantitation of experimentation is unreasonably large. Therefore, in order to practice the claimed invention, the amount of experimentation required would be considered undue and burdensome.
In conclusion, Genentech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”. A method of degrading a target protein, comprising contacting the target protein with the compounds as claimed is not enabled by the instant specification.
Claims 93 are rejected under 35 U.S.C. § 112 (a), or 35 U.S.C. § 112 (pre-AIA ) first paragraph, because the specification, while being enabling for the degradation of proteins within particular cancer cell lines disclosed in the specification, it does not reasonably provide enablement for a method for the treatment of cancer comprising the administration of the instantly claimed compounds. The specification does not provide sufficient information to support the instant claims.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added).
By way of background, three cases are of particular relevance to the question of enablement of a method of treating cancers broadly or even generally:
In In re Buting, 57 CCPA 777, 418 F.2d 540, 163 USPQ 689, the claim was drawn to “The method of treating a malignant condition selected from the group consisting of leukemias, sarcomas, adenocarcinomas, lymphosarcomas, melanomas, myelomas, and ascitic tumors” using a small genus of compounds. The Court decided that human testing “limited to one compound and two types of cancer” was not “commensurate with the broad scope of utility asserted and claimed”.
In Ex parte Busse, et al., 1 USPQ2d 1908, claims were drawn to “A therapeutic method for reducing metastasis and neoplastic growth in a mammal” using a single species. The decision notes that such utility “is no longer considered to be “incredible”, but that “the utility in question is sufficiently unusual to justify the examiner's requirement for substantiating evidence. Note also that there is also a dependent claim 5 which specified “wherein metastasis and neoplastic growth is adenocarcinoma, squamous cell carcinoma, melanoma, cell small lung or glioma.” The decision notes that “even within the specific group recited in claim 5 some of the individual terms used actually encompass a relatively broad class of specific types of cancer, which specific types are known to respond quite differently to various modes of therapy.”
In Ex parte Stevens, 16 USPQ2d 1379 a claim to “A method for therapeutic or prophylactic treatment of cancer in mammalian hosts” was refused because there was “no actual evidence of the effectiveness of the claimed composition and process in achieving that utility.”
The instant specification fails to provide information that would allow the skilled artisan to fully practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) the nature of the invention;
(2) the state of the prior art;
(3) the relative skill of those in the art;
(4) the predictability or unpredictability of the art;
(5) the breadth of the claims;
(6) the amount of direction or guidance presented;
(7) the presence or absence of working examples; and
(8) the quantity of experimentation necessary.
All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the invention: Claims 93 of the instant application are drawn to a method for the treatment of cancer comprising the administration of the instantly claimed compounds.
Breadth of the claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. Applicant claims that the claimed compounds can be used to treat any cancer. Cancer is not one disease, or cluster of closely related disorders. It is a group of more than 100 different and distinctive diseases, which have in common only some loss of controlled cell growth. Cancers are highly heterogeneous at both the molecular and clinical level, something seen especially in, for example, the cancers of the breast, brain and salivary glands. They can occur in pretty much every part of the body. Thus the cited claims are deemed very broad since these claims read on treating a long range of cancers including breast cancer, ovarian cancer, bladder cancer, endometrial cancer, uterine cancer, prostate cancer, lung cancer (including NSCLC, SCLC, squamous cell carcinoma or adenocarcinoma), esophageal cancer, head and neck cancer, colorectal cancer, kidney cancer (including RCC), liver cancer (including HCC), pancreatic cancer, stomach (i.e., gastric) cancer, thyroid cancer, and melanoma, as recited in the instant specification (paragraph [0596]).
State of the Prior Art: There are no art recognized methods that could be used to establish that broad range of cancers claimed can be commonly addressed using the claimed therapeutic method. Additionally, the disclosure does not discuss, or demonstrate through working examples, a method using the claimed agents. Additionally, there are no art recognized methods that could be used to identify subjects who would have predictably developed the broad spectrum of the aforementioned cancers in order to determine that the cancers were treated using the claimed methods.
Regarding common disease mechanisms and biomarkers, McKean et al. (Biomarkers in precision cancer immunotherapy: Promise and challenges. American Society of Clinical Oncology – Educational Book (2020), 40, p.e275-e291), hereinafter McKean, teach that although ongoing studies and trials investigate the use of multiple biomarkers predictive of patient response or harm, none of these are comprehensive in predicting potential benefit (of treatment). This unmet need for validated biomarkers is largely secondary to a prohibitive complexity within tumor parenchyma and microenvironment, dynamic clonal and proteomic changes to therapy, heterogenous host immune defects, and varied standardization among sample preparation and reporting (abstract). McKean also teach that treatment failures occur even in ICI patient cohorts, despite respective prescreening with biomarkers such as PD-L1 tumor proportion scores (p.e275). Regarding gene expression profiles specifically, McKean teaches that an important concept within gene expression profiles is that the predictive utility of such algorithms may be dependent on individual therapy plans. Data suggest that signaling and transcriptomic patterns may correlate only with response to therapy of directly related targets (p.e280). Unrelated immune pathways may require separate and individualized gene expression assays for different therapies (p.e280). Therefore, the selection of a particular therapy for any specific type of cancer is unpredictable, and requires individualized assays that are fully described to achieve correlation.
Predictability/Unpredictability in the Art: The pharmaceutical arts, particularly the treatment of cancer, are well-recognized as highly unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. The courts have upheld that in unpredictable arts, a greater degree of specificity is required to satisfy the enablement requirement. Cancer comprises a heterogeneous group of diseases with distinct molecular drivers, signaling pathways, and therapeutic responses. As such, a person of ordinary skill in the art would recognize the inhibition of cancer- implicated enzymes in vitro, do not reliably predict therapeutic efficacy across different cancers, cancer subtypes, or patient populations. The translation of enzyme inhibition or cell line activity into effective cancer treatment depends on numerous factors, including tumor biology, compensatory signaling mechanisms, tissue specific effects, toxicity, and therapeutic window, none of which are addressed in a comprehensive or predictive manner in the instant specification.
Moreover, one of skill in the art would recognize that it is highly unpredictable in regard to therapeutic effects, side effects and toxicity generated by administering a singular class of compounds for treating all the diseases and cancers encompassed by the claims.
Guidance of the Specification/Working Examples: regarding cancer, has only provided working examples of cellular and anti-proliferation data for a limited number of compounds used to treat a small subset of cancer cell lines. Applicant showed anti-proliferation data for compounds CPD-031 and CPD-002 in non-small cell lung cancer, triple negative breast cancer, ovarian cancer, pancreatic cancer, and thyroid cancer cell lines (page 507). Apoptosis data is provided in ER+ breast cancer for CPD-343 (page 507). This small subset of successful compounds pales in comparison to the large number of compounds claimed, as well as the cancers encompassed by the claims in light of the instant specification.
Thus, applicant has only demonstrated that a select number of compounds are capable of demonstrating cytotoxic or antiproliferative activity against cultured cells. The specification provides no direction about efficacy, distribution, or dosing in a living subject. The specification contains no pharmacokinetic or toxicology data for any compound. As such, there is no evidence that the observed cell culture activity would translate into therapeutic effect in vivo. Thus, the specification fails to provide sufficient evidence in support of the broad treatment of all cancers encompassed by the instant claims.
The Quantitation of Experimentation Required: In order to practice Applicants invention, it would be necessary for one to design and conduct an exhaustive amount of complex experiments to demonstrate that the large range of instantly claimed compounds can treat the broad range of cancers claimed. Therefore, in order to practice the claimed invention, the amount of experimentation required would be considered undue and burdensome. Such experimentation would necessarily include cancer specific validation of therapeutic efficacy, optimization of dosing regimens, assessment of toxicity and side effect profiles, and identification of responsive versus nonresponsive cancer subtypes. The specification provides only limited in vitro data demonstrating activity in the numerous additional cancers recited in the claims. Cell death in culture does not equate to treatment of cancer. Given the well-known, high failure rate of translating in vitro cytotoxicity into in vivo efficacy, extrapolating from the assays provided to a method of treating a broad range of cancers would be considered an unreasonable amount of experimentation. Accordingly, determining which cancers may be effectively treated would require extensive, individualized experimentation, amounting to undue burden.
In conclusion, Genentech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”. A method of treating cancer comprising the administration of a compound of Formula (I) is not enabled by the instant specification.
Improper Markush Rejection
Claims 1 4, 7, 12, 27, 28, 32, 33, 43, 48, 79-81, 83, 85, 86, 92, and 93 are rejected on the basis of containing an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
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The Markush grouping of the claims is improper because the alternatives defined by the Markush grouping do not share a single structural similarity. The cited claims of the instant application claim a compound represented by the following general formulas recited in claim 1 as Formula (I): comprising a wide range of target protein binding moieties (A), linkers (L1), and DDB binding moieties (B).
Considering B, which is defined according to Formula (II) (right), ring Q encompasses any 5-membered monocyclic heteroaryl. Some limited examples of possible ring moieties encompassed by the definition of Q are included herein (left), which vary both in their structural composition, as well as in their chemical
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properties. As a result, the definition of ring Q is determined to be an improper Markush grouping.
Further considering linker L1, the linker is not limited by the independent claim 1, and can be anything considered a “linker,” beyond the already large range of linkers defined within the specification (see pages 59 - 67). Thus, the definition of L1 is determined to be an improper Markush grouping.
Further considering linker L2, the linker is defined as being a wide range: bond, —O—, —NR4A—, —NR4B—C(═O)—, —NR4B—C(═O)—(C1-C3alkylene)-NR4A—, —NR4B—C(═O)—(C1-C3alkylene)-O—, —(C1-C3alkylene)-NR4B—C(═O)—, —C(═O)NR4A—, —C1-C3alkylene-, —C2-C3 alkenylene-, —C2-C3alkynylene-, C3-C8 cycloalkylene, or C2-C8 heterocyclene. These definitions vary widely from being absent altogether, ether, amine, amide, saturated/unsaturated alkyl, and cyclic or heterocyclic alkyl. Therefore, wide range of definitions describing L2 is determined to be an improper Markush grouping.
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Further considering the target protein binding moiety (A), which is defined as binding to BRD4, a large number of structurally distinct compounds are known to bind BDR4. For example, Zhang et al. (Euro J Med Chem, Volume , Article 117495, published June 5, 2025), hereinafter Zhang, teaches a small selection of structurally distinct compounds which are known to bind BRD4 (left, See Figure 1B of Zhang). Even in consideration of claim 78-81, 83, and 85, wherein A more is specifically defined as having the structure of Formula (C-1), (C-2), (C-3), (C-4), (C-5), or (C-6), the formulas do not share structural similarity among the representative structures. For instance, (C-1), (C-2), and (C-3) are tricyclic while (C-4), (C-5), and (C-6) are bicyclic, wherein heteroatom’s can be O, N, and S. This results in a large range of target binding proteins which do not share a common structure. Therefore, the BRD4 target binding moiety as instantly claimed reads on a large range of structurally distinct compounds, which does not constitute a proper Markush grouping.
Members of a Markush group share a "single structural similarity" when they belong to the same recognized physical or chemical class or to the same art-recognized class. A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted for the other, with the expectation that the same intended result would be achieved. Such is not the case in the instant claims because none of the rings in each of the core structures of each of the general formulas are obvious variants nor could they be substituted for one another with a reasonable expectation of similar results.
Thus, the claims are rejected since the Markush claim contains an improper Markush grouping because the members of the Markush group do not share a single structural similarity.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Correspondence
No claim is allowed.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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