DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, 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 10-23 are pending in the instant invention. According to the Amendments to the Claims, filed August 19, 2026, claims 10, 21 and 23 were amended and claims 1-9 were cancelled.
Status of Priority
This invention claims priority under 35 U.S.C. § 119(a-d) to: a) JP 2023-029739, filed February 28, 2023; and b) JP 2022-138548, filed August 31, 2022.
Status of Restrictions / Election of Species
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The inventor’s or joint inventor’s affirmation of the following election, without traverse, in the reply filed on August 19, 2026, is acknowledged: a) Group I - claims 10, 16-18 and 20-23; and b) substituted heteroaryl (MYT inhibitor) of formula (1) - p. 172, formula (2).
Similarly, the inventor or joint inventor should further note that the requirement was made FINAL in the Non-Final Rejection, mailed on February 19, 2026.
Likewise, the inventor or joint inventor should further note that this invention contains claims 11-15 and 19, drawn to nonelected inventions, without traverse, in the reply filed on August 19, 2026. A complete reply to the Final Rejection may include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.02.
Next, the inventor or joint inventor should further note that the sections of U.S.C. Title 35 that formed the basis of prior rejections formulated, as well as any references supporting said rejections, that are not included with this Office action, may be found in the Non-Final Rejection, mailed on February 19, 2026.
Moreover, the inventor or joint inventor should further note that any rejections and/or objections of record not explicitly addressed herein below, are hereby withdrawn, in light of the inventor’s or joint inventor’s arguments and/or the Amendments to the Claims, filed August 19, 2026.
Thus, a second Office action and prosecution on the merits of claims 10, 16-18 and 20-23 is contained within.
Status of Claim Rejections - 35 U.S.C. § 112(a)
The inventor’s or joint inventor’s arguments, on pages 9-10 of the Remarks, filed August 19, 2026, with respect to claims 20 and 22, have been fully considered, but are not persuasive. Consequently, the rejection of claims 20 and 22, made in the Non-Final Rejection, mailed on February 19, 2026, is hereby maintained for the reasons of record.
The inventor or joint inventor primarily argues that the Office has not shown that a person of ordinary skill in the art would need undue experimentation to prepare a solvate as defined in this invention. Similarly, the inventor or joint inventor further argues that the Office inappropriately reads into the term, solvate.
In response to the inventor’s or joint inventor’s argument that (1) the Office has not shown that a person of ordinary skill in the art would need undue experimentation to prepare a solvate as defined in this invention, and that (2) the Office inappropriately reads into the term, solvate, the Examiner respectfully disagrees, since [T]he specification must teach how to make and use the invention, not teach how to figure out for oneself how to make and use the invention. {See In re Gardner, 166 USPQ 138 (CCPA 1970)}.
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Likewise, the inventor’s or joint inventor’s elected invention is directed to Group I, drawn to a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor represented by the formula (I), or a solvate thereof, to the cancer patient…. Based on the guidance provided by the specification and, absent any evidence to the contrary, it is presently unclear whether a solvate of a substituted heteroaryl represented by the formula (1), such as 2-amino-1-(3-hydroxy-2,6-dimethylphenyl)-5,6-dimethyl-1H-pyrrolo[2,3-b]pyridine-3-carboxamide dihydrate, shown to the left above, possesses utility as a therapeutic agent, useful in a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I), or a solvate thereof, to the cancer patient.
The Examiner requires that the inventor or joint inventor discretely indicate where the specification enables one of ordinary skill in the art to make and/or use (perform) the method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor represented by the formula (I), to the cancer patient…, to overcome this rejection.
The inventor or joint inventor should note that (a) [I]t is not the function of claims to specify impossible or inoperative species {See In re Anderson, 176 USPQ 33I (CCPA 1973); and In re Angstadt, 190 USPQ 214, 219 (CCPA 1976)}, and that (b) [A] rejection under 35 U.S.C. § 112(a) is proper if the claims contain a significant number of seemingly inoperative embodiments. {See In re Corkill, 771 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985); In re Langer, 503 F. 2d 1380, 183 USPQ 288 (CCPA 1974); and Schering Corp. v. Gilbert, 153 F.2d 428, 68 USPQ 84 (2d Cir. 1946), mod’g, Schering Corp. v. Gilbert, 67 USPQ 42 (SDNY 1945)}.
Next, the inventor or joint inventor should further note that the enablement requirement refers to the requirement of 35 U.S.C. § 112(a) that the specification describe how to make and how to use (perform) the invention. The invention that one skilled in the art must be enabled to make and use (perform) is that defined by the claims of the particular invention or patent.
Then, the inventor or joint inventor should further note that the purpose of the requirement that the specification describe the invention in such terms that one skilled in the art can make and use the claimed invention is to ensure that the invention is communicated to the interested public in a meaningful way. The information contained in the disclosure of an invention must be sufficient to inform those skilled in the relevant art how to both make and use the claimed invention. A patent claim is invalid if it is not supported by an enabling disclosure.
Consequently, the inventor or joint inventor should further note that [T]he enablement requirement ensures that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims. {See National Recovery Technologies Inc. v. Magnetic Separation Systems Inc., 49 USPQ2d 1671 (Fed. Cir. 1999); and Sitrick v. Dreamworks LLC, 85 USPQ2d 1826 (Fed. Cir. 2008)}.
Moreover, the inventor or joint inventor should further note that any analysis of whether a particular claim is supported by the disclosure in an invention requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use (perform) the claimed invention. The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision which postured the question: [I]s the experimentation needed to practice the invention undue or unreasonable? {See Minerals
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, Ltd.,
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, 242 U.S. 261, 271 (1916). That standard is still the one to be applied. {See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)}.
Accordingly, the inventor or joint inventor should further note that [T]he specification must provide sufficient teaching such that one skilled in the art could make and use the full scope of the invention, without undue experimentation. {See In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988); United States v. Telectronics, Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988); and CFMT Inc. v. Yieldup International Corp., 68 USPQ2d 1940 (Fed. Cir. 2003)}.
Furthermore, the inventor or joint inventor should also note that [O]nce the Examiner has weighed all the evidence and establishes a prima facie case of lack of enablement for the claimed invention, the burden falls on the inventor or joint inventor to present persuasive arguments, supported by suitable proofs where necessary, that one skilled in the art would be able to make and/or use the claimed invention using the invention as a guide. {See In re Brandstadter, 484 F.2d 1395, 1406-07, 179 USPQ 286, 294 (CCPA 1973)}.
Also, the inventor or joint inventor should further note that [T]o establish enablement for the claimed invention, the inventor or joint inventor may submit factual affidavits or declarations under 37 CFR § 1.132 or cite references to show what one skilled in the art knew at the time of filing the invention. {See In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991); and MPEP § 2164.05}.
As a result of the Amendments to the Claims, filed August 19, 2026, and to clarify the record, the original rejection, made in the Non-Final Rejection, mailed on February 19, 2026, is included below in the section entitled New Claim Rejections - 35 U.S.C. § 112(a).
Status of Claim Rejections - 35 U.S.C. § 112(b)
The inventor’s or joint inventor’s arguments, on page 10 of the Remarks, filed August 19, 2026, with respect to claims 10, 16-18 and 20-23, have been fully considered, but are not persuasive. Consequently, the rejections of claims 10, 16-18 and 20-23, made in the Non-Final Rejection, mailed on February 19, 2026, are hereby maintained for the reasons of record.
The inventor or joint inventor primarily argues that a person of ordinary skill in the art would understand the metes and bounds of the expression, (cancer patient) characterized as having RB1 gene mutation positivity, a decrease in expression of an RB1 gene or protein, or positive expression of hyperphosphorylated RB1 protein, in view of this invention. Similarly, the inventor or joint inventor further argues that one of ordinary skill in the art viewing the specification would understand that the phrase, optionally substituted, is definite.
In response to the inventor’s or joint inventor’s argument that (1) a person of ordinary skill in the art would understand the metes and bounds of the expression, (cancer patient) characterized as having RB1 gene mutation positivity, a decrease in expression of an RB1 gene or protein, or positive expression of hyperphosphorylated RB1 protein, in view of this invention, and that (2) one of ordinary skill in the art viewing the specification would understand that the phrase, optionally substituted, is definite, the Examiner respectfully disagrees, since 35 U.S.C. § 112(b) requires that the claims particularly point out the subject matter that the inventor or joint inventor regards as the invention.
Likewise, the inventor or joint inventor should further note that [A] claim referring to the specification is improper. {See Ex parte Fressola, 27 USPQ 2d 1608 (BPAI 1993)}.
Next, the inventor or joint inventor should further note that [W]hen the scope of the claims can’t be determined when considered in light of the specification, a rejection under 35 U.S.C. § 112(b) is proper. {See In re Wiggins, 488 F.2d 538, 179 USPQ 421 (CCPA 1973)}.
Then, the inventor or joint inventor should further note that [A]s the statutory language of particular[ity] and distinct[ness] indicates, claims are required to be cast in clear terms, as opposed to ambiguous, vague or indefinite terms. It is the claims that notify the public of what is within the protections of the patent and what is not. {See Merrill v. Yeomans, 94 US 568, 573-74 (1876); United Carbon Co. v. Binney & Smith Co., 317 US 228, 236, 55 USPQ 381 (1942)}.
Moreover, the inventor or joint inventor should further note that [T]he USPTO may properly reject a patent invention claim as indefinite for failure to meet statutory requirements of 35 U.S.C. § 112(b) if the PTO identifies ways in which claim language is ambiguous, vague, incoherent, opaque or otherwise unclear in describing and defining the claimed invention, and if the inventor or joint inventor thereafter fails to provide satisfactory response by, for example, modifying language, providing separate definition of unclear language, or, if appropriate, persuasive explanation as to why language is not unclear, since this prima facie case determination is grounded both in the PTO’s responsibility to examine a claim to ensure that it particularly points out and distinctly claims subject matter and in examination’s attendant interactive process. {See In re Packard, 110 USPQ2d 1785 (Fed. Cir. 2014)}.
Furthermore, the inventor or joint inventor should also note that [R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the inventor or joint inventor to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112(b) as indefinite. {See Ex Parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008)}.
Also, the inventor or joint inventor should further note that it is well established that the specification may not impose a further limitation upon the plain meaning of the claim language. As stated in the Supreme Court, [S]ome persons seem to suppose that a claim in a patent is like a nose of wax, which may be turned and twisted in any direction by merely referring to the specification, so as to make it include something more than or something different from what its words express. The context may undoubtedly be resorted to, and often is resorted to, for the purpose of better understanding the meaning of the claim, but not for the purpose of changing it and making it different from what it is. The claim is a statutory requirement, prescribed for the very purpose of making the patentee define precisely what his invention is, and it is unjust to the public, as well as an evasion of the law, to construe it in a manner different from the plain meaning of its terms. {See White v. Dunbar, 119 US 47, 51-52, 1886 CD 494, 497-498 (1886)}.
As a result of the Amendments to the Claims, filed August 19, 2026, and to clarify the record, the original rejection, made in the Non-Final Rejection, mailed on February 19, 2026, is included below, in the section entitled New Claim Rejections - 35 U.S.C. § 112(b).
Status of Claim Rejections - 35 U.S.C. § 103
The inventor’s or joint inventor’s arguments, on pages 11-12 of the Remarks, filed August 19, 2026, with respect to claims 10, 16-18 and 20-23, have been fully considered, but are not persuasive. Consequently, the rejection of claims 10, 16-18 and 20-23, made in the Non-Final Rejection, mailed on February 19, 2026, is hereby maintained for the reasons of record.
The inventor or joint inventor primarily argues that the Office’s inherency analysis is flawed. Similarly, the inventor or joint inventor further argues that the record is not sufficient to establish a prima facie case of obviousness against the claimed invention based on the cited refences.
In response to the inventor’s or joint inventor’s argument that (1) the Office’s inherency analysis is flawed, and that (2) the record is not sufficient to establish a prima facie case of obviousness against the claimed invention based on the cited refences, respectively, the Examiner respectfully disagrees, since MPEP § 2144-I states that [T]he rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. {See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988); Ex parte Clapp, 227 USPQ 972 (Bd. Pat. App. & Inter. 1985); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993)}.
Likewise, the Examiner recognizes that [O]bviousness can only be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. {See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); and In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992)}.
In the present instance, the inventor or joint inventor should further note that Guarducci, et al. [npj Breast Cancer, 38, 2018] teach that modulation of cyclin E1 (CCNE1) and retinoblastoma 1 (RB1) activity, including overexpression of cyclin E1 (CCNE1) and down-regulation of retinoblastoma 1 (RB1), are alternative and/or concomitant events in the treatment of patients having hormone receptor-positive breast cancer [see Abstract and Introduction].
Next, the inventor or joint inventor should further note that [T]he fact that the inventor or joint inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. {See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)}.
Moreover, the inventor or joint inventor should further note that if intent is to rely on unexpected or unforeseen results, attention is invited to MPEP § 716. Absent clear, convincing, side-by-side, date-demonstrating unobviousness vis-à-vis the prior art commensurate with the scope of protection sought, the claims are considered prima facie obvious.
Furthermore, the inventor or joint inventor should also note that since arguments of counsel may not take the place of factually supported objective evidence in the record, [A]n assertion of what seems to follow from common experience, which is merely deemed as attorney argument, is not the kind of factual evidence that is required to rebut a prima facie case of obviousness. {See In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)}.
Also, the inventor or joint inventor should further note that rebuttal evidence may be appropriately submitted by way of an affidavit or declaration under 37 CFR 1.132.
As a result of the Amendments to the Claims, filed August 19, 2026, and to clarify the record, the original rejection, made in the Non-Final Rejection, mailed on February 19, 2026, is amended below, in the section entitled New Claim Rejections - 35 U.S.C. § 103.
New Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying the substituted heteroaryls represented by the formula (1).
The following title is suggested: SUBSTITUTED HETEROARYLS AS MYT1 INHIBITORS.
Appropriate correction is required.
New Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of formula (1) into the abstract, to overcome this objection.
New Claim Objections
Claim 10 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b), and/or compliance with the Requirement for Restriction/Election of Species, mailed on October 7, 2025, the existing recitation should be replaced with the following recitation:
A method for treating cancer in a cancer patient, wherein the method comprises administering to the cancer patient in need thereof a combination of a chemotherapeutic agent and a therapeutically effective amount of a myelin transcription factor 1 (MYT1) inhibitor compound represented by the formula (1):
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(1)
or a pharmaceutically acceptable salt thereof,
wherein:
R1 is H, halogen, CN, C1-6 alkyl, C1-6 alkylene-C2-9 heterocyclyl, C1-6 alkylene-C1-9 heteroaryl, C2-6 alkenyl, C2-6 alkynyl, C(O)NR8R8, NR7R7, OR7, S(O)2R7A, S(O)2NR8R8, C3-8 cycloalkyl, C3-8 cycloalkenyl, C2-9 heterocyclyl, C6-10 aryl, C1-9 heteroaryl, or Q-R7B, wherein the C1-6 alkyl, C1-6 alkylene-C2-9 heterocyclyl, C1-6 alkylene-C1-9 heteroaryl, C2-6 alkenyl, C2-6 alkynyl, C3-8 cycloalkyl, C3-8 cycloalkenyl, C2-9 heterocyclyl, C6-10 aryl, and C1-9 heteroaryl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, (=NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl;
X is CR2 or N;
Y is CR2 or N;
Z is CR2 or N;
each R2 is independently H, halogen, CN, C1-6 alkyl, C1-6 alkylene-C2-9 heterocyclyl, C1-6 alkylene-C1-9 heteroaryl, C2-6 alkenyl, C2-6 alkynyl, C(O)NR8R8, NR7R7, OR7, S(O)2R7A, S(O)2NR8R8, C3-8 cycloalkyl, C3-8 cycloalkenyl, C2-9 heterocyclyl, C6-10 aryl, C1-9 heteroaryl, or Q-R7B, wherein each C1-6 alkyl, C1-6 alkylene-C2-9 heterocyclyl, C1-6 alkylene-C1-9 heteroaryl, C2-6 alkenyl, C2-6 alkynyl, C3-8 cycloalkyl, C3-8 cycloalkenyl, C2-9 heterocyclyl, C6-10 aryl, and C1-9 heteroaryl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; or
R1 and R2 of X, taken together with the carbon atoms to which they are attached, form a C3-6 cycloalkylene, wherein the C3-6 cycloalkylene is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, alkyl, alkenyl, alkynyl, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; or
R1 and R2 of Z, taken together with the carbon atoms to which they are attached, form a C3-6 cycloalkylene, wherein the C3-6 cycloalkylene is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, alkyl, alkenyl, alkynyl, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl;
each Q is independently C1-6 alkylene, C2-6 alkenylene, C2-6 alkynylene, C3-8 cycloalkylene, C3-8 cycloalkenylene, C2-9 heterocyclylene, C6-10 arylene, or C1-9 heteroarylene;
wherein each C1-6 alkylene, C2-6 alkenylene, and C2-6 alkynylene is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; and
wherein each C3-8 cycloalkylene, C3-8 cycloalkenylene, C2-9 heterocyclylene, C6-10 arylene, and C1-9 heteroarylene is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, alkyl, alkenyl, alkynyl, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl;
each R7B is independently C1-6 alkyl, C(O)NR8R8, NR7R7, OH, O(alkyl), S(O)2R7A, S(O)2NR8R8, C2-9 heterocyclyl, C6-10 aryl, or C1-9 heteroaryl;
wherein each C1-6 alkyl and O(alkyl) is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; and
wherein each C2-9 heterocyclyl, C6-10 aryl, and C1-9 heteroaryl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, alkyl, alkenyl, alkynyl, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl;
each R8 is independently H, C1-6 alkyl, alkylene-OC2-6 alkyl, C1-6 alkylene-C6-10 aryl, C3-8 cycloalkyl, C6-10 aryl, or C1-9 heteroaryl;
wherein each C1-6 alkyl, C1-6 alkylene, and alkylene-OC2-6 alkyl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; and
wherein each C3-8 cycloalkyl, C6-10 aryl, and C1-9 heteroaryl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, alkyl, alkenyl, alkynyl, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; or
two R8, taken together with the nitrogen atom to which they are attached, form a C2-9 heterocyclyl;
R5 is H or NR7R7;
each R7 is independently H, C1-6 alkyl, C1-6 alkylene-C6-10 aryl, C1-6 alkylene-C1-9 heteroaryl, S(O)2R7A, C3-8 cycloalkyl, C2-9 heterocyclyl, C6-10 aryl, or C1-9 heteroaryl;
wherein each C1-6 alkyl and C1-6 alkylene is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; and
wherein each C3-8 cycloalkyl, C2-9 heterocyclyl, C6-10 aryl, and C1-9 heteroaryl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, alkyl, alkenyl, alkynyl, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; or
two R7, taken together with the nitrogen atom to which they are attached, form a C2-9 heterocyclyl;
R6 is C(O)R7A, C(O)NHR8, or S(O)2R7A;
R7A is C1-6 alkyl, C3-8 cycloalkyl, or C6-10 aryl;
wherein the C1-6 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; and
wherein the C3-8 cycloalkyl or C6-10 aryl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, alkyl, alkenyl, alkynyl, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl;
R3 is halogen or C1-6 alkyl, wherein the C1-6 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl; and
R4 is halogen or C1-6 alkyl, wherein the C1-6 alkyl is optionally substituted with one or more substituents independently selected from the group consisting of halo, CN, NO2, C(O)NH2, C(O)NH(alkyl), C(O)N(alkyl)2, NH2, =NH, =N(alkyl), =N(heterocyclyl), =N(aryl), N3, OH, O(alkyl), =O, O(heterocyclyl), O(aryl), Si(alkyl)3, SH, S(alkyl), S(O)2alkyl, S(O)₂NH2, =S, cycloalkyl, cycloalkenyl, cycloalkynyl, cycloalkoxy, heterocyclyl, aryl, and heteroaryl;
wherein the cancer patient is characterized as having a retinoblastoma 1 (RB1) gene mutation positivity, a decrease in expression of a retinoblastoma 1 (RB1) gene or protein, or positive expression of a hyperphosphorylated retinoblastoma 1 (RB1) protein.
Appropriate correction is required. See MPEP § 2173.02.
Claim 16 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 10, wherein the retinoblastoma 1 (RB1) gene mutation comprises a mutation causing insertion of at least one amino acid residue to the wild-type retinoblastoma 1 (RB1) protein, a mutation causing substitution of at least one amino acid residue to the wild-type retinoblastoma 1 (RB1) protein, a mutation causing deletion of at least one amino acid residue to the wild-type retinoblastoma 1 (RB1) protein, and/or a mutation causing addition of at least one amino acid residue to the wild-type retinoblastoma 1 (RB1) protein.
Appropriate correction is required. See MPEP § 2173.02.
Claim 17 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 10, wherein the retinoblastoma 1 (RB1) gene mutation is selected from the group consisting of a nonsense mutation, a frameshift mutation, a splice site mutation, a homozygous deletion, and a heterozygous deletion.
Appropriate correction is required. See MPEP § 2173.02.
Claim 18 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 10, wherein the retinoblastoma 1 (RB1) gene mutation is a mutation decreasing a function of retinoblastoma 1 (RB1).
Appropriate correction is required. See MPEP § 2173.02.
Claim 20 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 10, wherein:
R1 is C1-6 alkyl;
X is CR2;
Y is N;
Z is CR2;
R6 is C(O)NHR8;
R5 is NR7R7;
R3 is C1-6 alkyl; and
R4 is C1-6 alkyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 21 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a) and/or 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
The method according to claim 10, wherein the compound represented by the formula (1) comprises an excess of the atropisomer represented by the formula (1A):
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(1A).
Appropriate correction is required. See MPEP § 2173.02.
Claim 22 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The method according to claim 10, wherein the compound represented by the formula (1) is a compound represented by the formula (2):
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(2)
or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 23 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a) and/or 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
The method according to claim 10, wherein the chemotherapeutic agent is selected from the group consisting of an alkylating agent, an antibody-drug conjugate, an anticancer antibiotic, an antimetabolite, a mitosis inhibitor, a platinating agent, and a topoisomerase inhibitor, or a combination thereof.
Appropriate correction is required. See MPEP § 2173.02.
New Claim Rejections - 35 U.S.C. § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. § 112:
(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.
Method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient
Claims 20 and 22 are rejected under 35 U.S.C. § 112(a) because the specification, while being enabling for performing a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor compound represented by the formula (I) to the cancer patient, does not reasonably provide enablement for performing a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. A method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient, as recited in claims 20 and 22, respectively, has not been adequately enabled in the specification to allow any person having ordinary skill in the art, at the time this invention was made, to make and/or use (perform) a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient.
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) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor or joint inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. {See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986); and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988)}.
The above factors, regarding the instant invention, are summarized as follows:
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(a) Breadth of the claims - the breadth of the claims includes a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor compound represented by the formula (I), shown to the right, or a solvate thereof, to the cancer patient;
(b) Nature of the invention - the nature of the invention is performance of a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor compound represented by the formula (I), shown to the right above, or a solvate thereof, to the cancer patient;
(c) State of the prior art - Nature Reviews: Drug Discovery, as provided in the file and cited in the Non-Final Rejection, mailed on February 19, 2026, offers a snapshot of the state of the drug development art. Herein, drug development is stated to follow the widely accepted Ehrlich model which includes: (1) development of a broad synthetic organic chemistry program; (2) subsequent testing of compounds in an appropriate laboratory model for the disease to be treated; and (3) screening of compounds with low toxicity in prospective clinical trials (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205). Moreover, WO 22/213204, as provided in the file, cited on the IDS, and cited in the Non-Final Rejection, mailed on February 19, 2026, illustrates the synthesis of substituted heteroaryls represented by the formula (1), and/or methods of use thereof {Fourtounis, et al. WO 22/213204, 2022};
(d) Level of one of ordinary skill in the art - the artisans performing the inventor’s or joint inventor’s method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor compound represented by the formula (I) to the cancer patient, or a solvate thereof, would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience;
(e) Level of predictability in the art - Synthetic organic chemistry is quite unpredictable (See In re Marzocchi and Horton 169 USPQ at 367 ¶3). Similarly, it is unclear based on the combination of the instant specification, and Fourtounis, et al. in WO 22/213204, as provided in the file, cited on the IDS, and cited in the Non-Final Rejection, mailed on February 19, 2026, whether performance of the instantly recited method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient is enabled. Moreover, the following excerpt is taken from Vippagunta, et al., as provided in the file and cited in the Non-Final Rejection, mailed on February 19, 2026, with respect to the synthesis of solvates of substituted heteroaryls represented by the formula (1) {Vippagunta, et al. Advanced Drug Delivery Reviews, 48, 2001, 18}:
Predicting the formation of solvates or hydrates of a compound and the number of molecules of water or solvent incorporated into the crystal lattice of a compound is complex and difficult. Each solid compound responds uniquely to the possible formation of solvates or hydrates and hence generalizations cannot be made for a series of related compounds. Certain molecular shapes and features favor the formation of crystals without solvent; these compounds tend to be stabilized by efficient packing of molecules in the crystal lattice, whereas other crystal forms are more stable in the presence of water and/or solvents. There may be too many possibilities so that no computer programs are currently available for predicting the crystal structures of hydrates and solvates.
(f) Amount of direction provided by the inventor - the invention lacks direction with respect to making and/or using (performing) a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient;
(g) Existence of working examples - the inventor or joint inventor has provided sufficient guidance to make and/or use (perform) a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor compound represented by the formula (I) to the cancer patient; however, the disclosure is insufficient to allow extrapolation of the limited examples to enable performing the instantly recited method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient. The specification lacks working examples of performing a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient.
Within the specification, [A]t least one specific operative embodiment or example of the invention must be set forth. The example(s) and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP § 608.01(p) and MPEP § 2173.05.
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(h) Quantity of experimentation needed to make or use the invention based on the content of the disclosure - predicting whether a recited compound, and/or solvate thereof, is in fact one that produces a desired physiological effect at a therapeutic concentration and with useful kinetics, is filled with experimental uncertainty, and without proper guidance, would involve a substantial amount of experimentation (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205-213). Similarly, the specification, as originally filed, including any references incorporated therein, fails to provide the necessary support required by 35 U.S.C. § 112(a) to enable performing the instantly recited method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient. Thus, it is unclear, based on the guidance provided by the specification, whether a solvate of a substituted heteroaryl represented by the formula (1), such as 2-amino-1-(3-hydroxy-2,6-dimethylphenyl)-5,6-dimethyl-1H-pyrrolo[2,3-b]pyridine-3-carboxamide dihydrate, shown to the left above, possesses utility as a therapeutic agent, useful in a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the invention was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {See In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
The determination that undue experimentation would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. (See In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404). These factual considerations are discussed comprehensively in MPEP § 2164.08 (scope or breadth of the claims), § 2164.05(a) (nature of the invention and state of the prior art), § 2164.05(b) (level of one of ordinary skill), § 2164.03 (level of predictability in the art and amount of direction provided by the inventor or joint inventor), § 2164.02 (the existence of working examples) and § 2164.06 (quantity of experimentation needed to make or use the invention based on the content of the disclosure).
Based on a preponderance of the evidence presented herein, the conclusion that the inventor or joint inventor is insufficiently enabled for making and/or using (performing) a method for treating cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and a solvate of an MYT1 inhibitor compound represented by the formula (I) to the cancer patient, is clearly justified.
The examiner suggests amending the claims, particularly as stated in the section above entitled New Claim Objections, to overcome this rejection.
New Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 10, 16-18 and 20-23 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 10 recites the functional limitation and/or physicochemical property, A method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient. wherein the cancer patient is characterized as having RB1 gene mutation positivity, a decrease in expression of an RB1 gene or protein, or positive expression of hyperphosphorylated RB1 protein, in lines 1-5 of the claim.
Similarly, the inventor or joint inventor should further note that the aforementioned recited functional limitation and/or physicochemical property of the patient administered thereto in the instantly recited method for treating cancer of a cancer patient renders the instant invention ambiguous, vague, incoherent, opaque and/or otherwise unclear to the examiner and fails to meet the statutory requirements of 35 U.S.C. § 112(b), since the recited limitation merely states a functional limitation and/or physicochemical property without providing any clarity regarding how the functional limitation and/or physicochemical property is imparted.
Likewise, the inventor or joint inventor should further note that the instantly recited functional limitation and/or physicochemical property does not appear to emanate from and/or does not appear to be an inherent or salient property of the patient administered thereto within the instantly recited method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient.
Next, the inventor or joint inventor should further note that the examiner is uncertain whether the instantly recited method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient, requires an additional unrecited component to be administered to the cancer patient to impart the recited functional limitation and/or physicochemical property.
Consequently, the inventor or joint inventor should further note that since the instantly recited method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient incorporates the aforementioned ambiguous, vague, incoherent, opaque and/or otherwise unclear recited functional limitation and/or physicochemical property, the instantly recited method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient is rendered indefinite under 35 U.S.C. § 112(b), since one of ordinary skill in the art may not reasonably determine the metes and bounds of the instantly recited method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient due to an inability to establish the metes and bounds encompassed by the recited functional limitation and/or physicochemical property.
Then, the inventor or joint inventor should further note that [A] claim which omits matter disclosed to be essential to the invention, as described in the specification or in other statements of record, may also be rejected under 35 U.S.C. § 112(a), as not enabling. {See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976); and MPEP § 2164.08(c)}.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claim, to overcome this rejection.
Claims 20 and 21 are further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that the phrase, optionally substituted, in claim 20, with regard to R1, R2, R3, R4, R7, R7A, R7B, R8, and/or Q, respectively, is a relative phrase which renders the claim indefinite. The phrase, optionally substituted, is not defined by the claims, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification defines the term, substituent, using a boiler plate list of functional groups, such as amino, alkoxy, etc., and further discloses that the substituents themselves may be further substituted; however, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the substituted heteroaryls represented by the formula (1) administered within the method for treating or preventing cancer of a cancer patient have been rendered indefinite by the use of the phrase, optionally substituted, with regard to R1, R2, R3, R4, R7, R7A, R7B, R8, and/or Q, respectively.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled New Claim Objections, to overcome this rejection.
New Claim Rejections - 35 U.S.C. § 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 10, 16-18 and 20-23 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Fourtounis, et al. in WO 22/213204, in view of Guarducci, et al. npj Breast Cancer, 38, 2018, 1-10.
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The inventor or joint inventor should note that the instant invention recites a method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient, shown to the left, where R6 = -C(O)NHR8, wherein R8 = -H; R5 = -NR7R7, wherein each R7 = -H; R1 = -C1-6 alkyl; X = CR2, wherein R2 = -C1-6 alkyl; Y = N; Z = CR2, wherein R2 = -H; R3 = -C1-6 alkyl; and R4 = -C1-6 alkyl, respectively, wherein the cancer patient is characterized as having a retinoblastoma 1 (RB1) gene mutation positivity, a decrease in expression of a retinoblastoma 1 (RB1) gene, or positive expression of a hyperphosphorylated retinoblastoma 1 (RB1) protein.
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Similarly, the inventor or joint inventor should further note that Fourtounis, et al. (WO 22/213204), as provided in the file, cited on the IDS, and cited in the Non-Final Rejection, mailed on February 19, 2026, teaches a method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient, shown to the right, where R6 = -C(O)NHR8, wherein R8 = -H; R5 = -NR7R7, wherein each R7 = -H; R1 = -CH3; X = CR2, wherein R2 = -CH3; Y = N; Z = CR2, wherein R2 = -H; R3 = -CH3; and R4 = -CH3, respectively, wherein the cancer patent is a cancer patient overexpressing cyclin E1 (CCNE1) {method - p. 2, lines 4-21; and compound(s) - p. 40, no. 164, no. 165 and no. 166}.
Likewise, the inventor or joint inventor should further note that Guarducci, et al. [npj Breast Cancer, 38, 2018], as provided in the file and cited in the Non-Final Rejection, mailed on February 19, 2026, teaches that modulation of cyclin E1 (CCNE1) and retinoblastoma 1 (RB1) activity, including overexpression of cyclin E1 (CCNE1) and down-regulation of retinoblastoma 1 (RB1), are alternative and/or concomitant events in the treatment of patients having hormone receptor-positive breast cancer [see Abstract and Introduction].
Next, the inventor or joint inventor should further note that the only difference between the instantly recited method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient and Fourtounis’s method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient is the instantly recited method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient comprises a cancer patient characterized as having a retinoblastoma 1 (RB1) gene mutation positivity, a decrease in expression of a retinoblastoma 1 (RB1) gene, or positive expression of a hyperphosphorylated retinoblastoma 1 (RB1) protein, whereas Fourtounis’s method for treating… cancer of a cancer patient, the method comprising administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient comprises a cancer patient overexpressing cyclin E1 (CCNE1).
Then, the inventor or joint inventor should further note that in the chemical arts, it is widely accepted that [S]tructural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions or compounds, creates a prima facie case of obviousness. {See Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., No. 06-1329, slip op. at 9 (Fed. Cir. June 28, 2007) (quoting In re Dillon, 919 F.2d 688, 692 [16 USPQ2d 1897] (Fed. Cir. 1990) (en banc)); and In re Papesch, 315 F.2d 381 [137 USPQ 43] (C.C.P.A. 1963)}.
Moreover, the inventor or joint inventor should further note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Furthermore, the inventor or joint inventor should also note that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Also, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Comparably, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Analogously, the inventor or joint inventor should further note that [W]here general conditions of a claim are disclosed
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the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation. {See In re Aller, Lacey and Hall, 220 F.2d 454, 105 USPQ 233 (CCPA 1955)}.
Additionally, the inventor or joint inventor should also note that [M]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. {See In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979); and MPEP § 2145}.
Correspondingly, the inventor or joint inventor should further note that [G]ranting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. {See In re Wiseman, 596 F.2d 1022, 201 USPQ 661 (CCPA 1979); In re Baxter Travenol Labs, 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991); and MPEP § 2145}.
Consequently, since: a) Fourtounis teaches a method for treating… cancer of a cancer patient, wherein the method comprises administering a combination of a chemotherapeutic agent and an MYT1 inhibitor which is identical to the MYT1 inhibitor administered within the instantly recited method for treating… cancer of a cancer patient, wherein the method comprises administering a combination of a chemotherapeutic agent and an MYT1 inhibitor; b) Fourtounis teaches a method for treating… cancer of a cancer patient, wherein the method comprises a cancer patient overexpressing cyclin E1 (CCNE1); c) Guarducci teaches that modulation of cyclin E1 (CCNE1) and retinoblastoma 1 (RB1) activity, including overexpression of cyclin E1 (CCNE1) and down-regulation of retinoblastoma 1 (RB1), are alternative and/or concomitant events in the treatment of cancer patients; d) the courts have recognized that [S]tructural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions or compounds, creates a prima facie case of obviousness; e) the courts have further recognized that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer; f) the courts have further recognized that [T]he claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable; g) the courts have further recognized that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated; h) the courts have further recognized that [I]f the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present; i) the courts have further recognized that [W]here general conditions of a claim are disclosed
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the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation; j) the courts have further recognized that [M]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention; and k) the courts have further recognized that [G]ranting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art, one having ordinary skill in the art, before the effective filing date of the recited invention, would have been motivated to utilize the teachings of Fourtounis and Guarducci and perform Guarducci’s method for treating… cancer of a cancer patient, wherein the method comprises administering a combination of a chemotherapeutic agent and an MYT1 inhibitor to the cancer patient, in an alternatively treatable patient characterized as requiring modulation of retinoblastoma 1 (RB1) activity, including having a retinoblastoma 1 (RB1) gene mutation positivity, a decrease in expression of a retinoblastoma 1 (RB1) gene, or positive expression of a hyperphosphorylated retinoblastoma 1 (RB1) protein, with a reasonable expectation of methodical success and/or similar therapeutic activity, rendering claims 10, 16-18 and 20-23 obvious.
Here, the inventor or joint inventor should further note that, although not explicitly discussed herein, the Fourtounis reference contains additional MYT1 inhibitor species that may be administered to the cancer patient in combination with a chemotherapeutic agent to obviate the instantly recited method for treating… cancer of a cancer patient. Consequently, any amendments to the claims and/or arguments formulated to overcome rejections rendered under 35 U.S.C. § 103(a) should address this reference as a whole and should not be limited to the species discussed or disclosed explicitly herein.
Now, the inventor or joint inventor should also note that this invention currently names joint inventors. In considering patentability of the claims under 35 U.S.C. § 103(a), the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention, absent any evidence to the contrary. The inventor or joint inventor is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Finally, the inventor or joint inventor should further note that in the event the determination of the status of the invention as subject to AIA 35 U.S.C. § 103 (or as subject to pre-AIA 35 U.S.C. § 103) is incorrect, any correction of the statutory basis for the instant rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Allowable Subject Matter
No claims are allowed.
Conclusion
The inventor’s or joint inventor’s arguments and/or the Amendments to the Claims, filed August 19, 2026, necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). The inventor or joint inventor is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The Examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The Examiner is also available on alternate Fridays.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
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