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 .
DETAILED ACTION
Claims 1-18 are pending in the present application.
Priority
The following continuity data is acknowledged in the present application file:
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Information Disclosure Statement
The Information Disclosure Statement(s) filed 10/05/2023, 11/19/2024, 04/11/2025 and 07/15/2025 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
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.
Claim 11 is 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.
Present claim 11 is drawn to a method of treating a patient comprising administering to a patient in need thereof a therapeutically effective amount of the compound according to claim 1.
The present specification provides compounds of formula (I) and compositions thereof as suitable for the treatment and amelioration of various cancers and fibrotic diseases. See page 24, lines 15-18 as well as page 81, line 25 to page 84 for exemplary compounds of formula (I); page 16, line 24 to page 18, line 23 for the list of cancers and tumors which may be treated by administration of a pharmaceutical composition comprising a compound of present formula (I); and page 38, line 24 to page 39, line 20 for the list of fibrotic diseases which may be treated by administration of a pharmaceutical composition comprising a compound of present formula (I). The therapeutic effect in the treatment of cancer and/or the prevention of resistance is largely attributed to the inhibition of p300 and CBP function. See page 3, lines 29-31.
The specification also provides in data in Assay 1 detailing the multiple myeloma cellular efficacy for compounds of the invention as well as data in Assay 2 detailing the CBP bromodomain binding affinity for compounds of the invention. See pages 80-84 of the present disclosure.
The person of skill in the art would be able to extrapolate from the exemplary compounds and data present in the specification how to treat a proliferative disorder via administration of a compound of formula (I) of the disclosure.
There are no methods provided in order to extrapolate the method for the treatment of any disease, disorder or condition, which includes diseases other than proliferative diseases or conditions.
The Applicant is reminded of the written description guidelines set out by the USPTO in MPEP 2163:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
While the genus of diseases, disorders or conditions of the present invention are described by the specification to comprise proliferative disorders (e.g. cancer), the description of treatment for proliferative diseases or conditions is not sufficiently detailed to show that the Applicant was in possession of the full scope of the claimed invention, a method for the treatment of any disease, disorder or condition, at the time of filing.
Namely, that the definitions of proliferative diseases or conditions described above, while not being indefinite, are not sufficiently detailed in order to stand on their own as being adequately described. Therefore, the “representative number of species” standard is used to determine whether the claims are adequately described.
MPEP 2163 goes on to describe what a "representative number of species" is:
What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. For example, in the molecular biology arts, if an applicant disclosed an amino acid sequence, it would be unnecessary to provide an explicit disclosure of nucleic acid sequences that encoded the amino acid sequence. Since the genetic code is widely known, a disclosure of an amino acid sequence would provide sufficient information such that one would accept that an applicant was in possession of the full genus of nucleic acids encoding a given amino acid sequence, but not necessarily any particular species. Cf. In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993) and In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1.
The species described in the specification do not cover the entire genus such that it is a representative sample of the genus as the species are close together in structure and only describe an extremely small portion of the claimed genus.
Therefore, the present claim 11 lacks the required written description and is properly rejected under 35 U.S.C. 112(a).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 5 is provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 5 of copending Application No. 19/179,235 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claim 5 of the ‘235 application discloses a compound having the following formula
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or a pharmaceutically acceptable salt, solvate, cocrystal tautomer, or a mixture thereof.
Present claim 5 is directed to a compound of present formula (I) of present claim 1, wherein the compound is as pictured below.
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Present claim 1 provides a compound of formula (I) or a pharmaceutically acceptable salt, solvate, cocrystal tautomer, or a mixture thereof.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 7, 11, 15 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-3 of copending Application No. 18/011,734 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to the same subject matter.
Claim 1 of the ‘734 application discloses a method of treating fibrotic disease comprising administering to a patient in need thereof a compound of formula (I) as pictured below.
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Claim 9 of the ‘734 application discloses a compound of claim 1 of the ‘734 application, wherein R1 is unsubstituted or substituted heterocyclyl or carbocyclyl.
Claim 11 of the ‘734 application discloses a compound of claim 1 of the ‘734 application, wherein
X2 and X3 are N, and X1 is CH;
E is -CH2-;
R21 is CH3;
R6x is CH3; and
Ring A does not form a bicyclic moiety
Claims 12-16 of the ‘734 application discloses wherein the fibrotic disease is idiopathic pulmonary fibrosis (IPF) or non-alcoholic steatohepatitis (NASH). See present claim 18.
The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim maybe relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. Also see MPEP 804, subsection II.B.1.
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The specification of the ‘734 application discloses specific examples of compounds of formula (I), and in particular compound 00131 in Example 14 on page 159-160 which corresponds to a compound of present formula (I) wherein, R3a is a 5-membered heterocyclic ring comprising two N heteroatoms and R3b is H.
However, compound 00131 of the ‘734 application is excluded from the present claims by way of proviso at the end of present claim 1.
A hydrogen to methyl substitution is presumed to be an obvious variant against a claim to a compound, and the burden is on the Applicant to rebut the presumption with some sort of secondary consideration. In re Wood, 582 F.2d 638, 199 U.S.P.Q. 137 (C.C.P.A. 1978).
The ’734 application teaches a compound of present formula (I) (compound 00131) where R3a = H or C0 alkyl. Substitution of R3a = C0 alkyl of the compound 00131 of the ‘734 application for where R3a = C1 alkyl of the present invention is presumed to be an obvious variant. One of ordinary skill in the art would have a reasonable expectation of success at arriving at the compound of present claim 7 based on compound 00131 of the ‘734 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, 10-13 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 3, 6 and 14 of U.S. Patent No. 12,472,179. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter.
Claim 1 of the ‘179 Patent discloses a method of treating a patient suffering from cancer, wherein the cancer exhibits an oncogenic alteration in the KRAS, wherein the oncogenic alteration is caused by at least one base mutation in the KRAS gene resulting in the amino acid substitution G12C in the KRAS, the method comprising administering a combination of (i) a CBP/p300 bromodomain inhibitor and (ii) a KRAS inhibitor to said patient. See present claims 11-13 and 17.
Claim 3 of the ‘179 Patent discloses the method according to claim 1 of the ‘179 Patent, wherein the CBP/p300 bromodomain inhibitor is selected from the group consisting of Compound A, Compound C, Compound 00030, Compound 00071, CCS1477, GNE-781, GNE-049, SGC-CBP30, CPI-637, FT-6876, Compound 462, Compound 424 and Compound 515.
Claim 6 of the ‘179 Patent discloses the method according to claim 1 of the ‘179 Patent, wherein the cancer is selected from the group consisting of lung cancer, colorectal cancer and pancreatic cancer. See present claims 12 and 16.
Claim 14 of the ‘179 Patent discloses a pharmaceutical dosage form comprising (i) a CBP/p300 bromodomain inhibitor and (ii) a KRAS G12C inhibitor. See present claim 10.
The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim maybe relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. Also see MPEP 804, subsection II.B.1.
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The ‘179 Patent discloses the structure of Compound C in col. 15. Compound C of the ‘179 Patent to the corresponds to a compound of present formula (I) wherein, R3a is a 5-membered heterocyclic ring comprising two N heteroatoms and R3b is H.
However, Compound C of the ‘179 Patent is excluded from the present claims by way of proviso at the end of present claim 1.
A hydrogen to methyl substitution is presumed to be an obvious variant against a claim to a compound, and the burden is on the Applicant to rebut the presumption with some sort of secondary consideration. In re Wood, 582 F.2d 638, 199 U.S.P.Q. 137 (C.C.P.A. 1978).
The ’179 Patent teaches a compound of present formula (I) (compound 00131) where R3a = H or C0 alkyl. Substitution of R3a = C0 alkyl of the Compound C of the ‘179 Patent for where R3a = C1 alkyl of the present invention is presumed to be an obvious variant. One of ordinary skill in the art would have a reasonable expectation of success at arriving at the compound of present claim 7 based on Compound C of the ‘179 Patent.
The ‘179 Patent also discloses the following in col. 17:
In general, a pharmaceutical composition according to the present invention can comprise various pharmaceutically acceptable excipients which will be selected depending on which functionality is to be achieved for the composition. A “pharmaceutically acceptable excipient” in the meaning of the present invention can be any substance used for the preparation of pharmaceutical dosage forms, including coating materials, film-forming materials, fillers, disintegrating agents, release-modifying materials, carrier materials, diluents, binding agents and other adjuvants. Typical pharmaceutically acceptable excipients include substances like sucrose, mannitol, sorbitol, starch and starch derivatives, lactose, and lubricating agents such as magnesium stearate, disintegrants and buffering agents.
Regarding present claim 10, which is drawn to a pharmaceutical composition comprising the compound according to present claim 1 and a pharmaceutically acceptable carrier, diluent or excipient, the ‘179 Patent discloses compositions comprising compounds according to present claim 1, further comprising various pharmaceutically acceptable excipients.
Claims 1-4, 7, 11-14 and 16-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1 and 8 of copending Application No. 18/012,278 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter.
Claim 1 of the ‘278 application discloses a method of treating a patient suffering from non-small cell lung cancer (NSCLC), wherein the NSCLC exhibits an oncogenic alteration in the EGFR, the method comprising administering a combination of (i) a CBP/p300 bromodomain inhibitor and (ii) an EGFR inhibitor to said patient. See present claims 11-14 and 16-17.
Claim 8 of the ‘278 application discloses the method according to claim 1 of the ‘278 application, wherein the CBP/p300 bromodomain inhibitor comprises Compound C.
Compound C of the ‘278 application to the corresponds to a compound of present formula (I) wherein, R3a is a 5-membered heterocyclic ring comprising two N heteroatoms and R3b is H.
However, Compound C of the ‘278 application is excluded from the present claims by way of proviso at the end of present claim 1.
A hydrogen to methyl substitution is presumed to be an obvious variant against a claim to a compound, and the burden is on the Applicant to rebut the presumption with some sort of secondary consideration. In re Wood, 582 F.2d 638, 199 U.S.P.Q. 137 (C.C.P.A. 1978).
The ‘278 application teaches a compound of present formula (I) (compound 00131) where R3a = H or C0 alkyl. Substitution of R3a = C0 alkyl of the Compound C of the ‘179 Patent for where R3a = C1 alkyl of the present invention is presumed to be an obvious variant. One of ordinary skill in the art would have a reasonable expectation of success at arriving at the compound of present claim 7 based on Compound C of the ‘278 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 7, 10-13 and 16-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 6-8 of U.S. Patent No. 12,478,624. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter.
Claim 1 of the ‘624 Patent discloses a compound of formula (I), wherein the compound of formula (I) comprises several compounds that are encompassed by the definition of formula (I) of present claim 1. Claim 1 of the ‘624 Patent discloses the following compound
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,
which corresponds to a compound of present formula (I) wherein, R3a is a 5-membered heterocyclic ring comprising two N heteroatoms and R3b is H.
Claim 2 of the ‘624 Patent discloses a pharmaceutical composition comprising: a compound as defined in claim 1 of the ‘624 Patent, or a pharmaceutically acceptable salt, solvate, cocrystal, tautomer, racemate, enantiomer, or diastereomer or mixture thereof, and one, or more pharmaceutically acceptable excipient(s) or carrier(s). See present claim 10.
Claim 6 of the ‘624 Patent a method of treating or ameliorating a cancer, the method comprising administering to a patient in need thereof a therapeutically effective amount of the pharmaceutical composition of claim 2. See present claim 10.
Claim 7 of the ‘624 Patent discloses the method of claim 6 of the ‘624 Patent, wherein the cancer is selected from melanoma, non-small cell lung cancer, prostate cancer, bile duct cancer, bladder cancer, pancreatic cancer, thyroid cancer, ovarian cancer, colorectal tumor, hairy cell leukemia, acute myeloid leukemia, multiple myeloma, liver cancer, breast cancer, esophageal cancer, head and neck cancer and glioma. See present claims 11-12 and 16.
Claim 8 of the ‘624 Patent discloses the method of claim 6 of the ‘624 Patent, wherein said pharmaceutical composition is administered in combination with a second therapeutic agent, wherein said second therapeutic agent is an anti-cancer agent. See present claims 13 and 17.
However, the compound of claim 1 of the ‘624 Patent is excluded from the present claims by way of proviso at the end of present claim 1.
A hydrogen to methyl substitution is presumed to be an obvious variant against a claim to a compound, and the burden is on the Applicant to rebut the presumption with some sort of secondary consideration. In re Wood, 582 F.2d 638, 199 U.S.P.Q. 137 (C.C.P.A. 1978).
The ‘624 Patent teaches a compound of present formula (I) where R3a = H or C0 alkyl. Substitution of R3a = C0 alkyl of the compound of the ‘624 Patent for where R3a = C1 alkyl of the present invention is presumed to be an obvious variant. One of ordinary skill in the art would have a reasonable expectation of success at arriving at the compound of present claim 7 based on compound of the ‘624 Patent.
Claim 1-5 and 10 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 10 of copending Application No. 19/179,235 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same subject matter.
Claim 5 of the ‘235 application discloses a compound having the following formula:
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or a pharmaceutically acceptable salt, solvate, cocrystal tautomer, or a mixture thereof. The compound of claim 5 of the ‘235 application anticipates a compound of present claims 1-5.
Claim 10 of the ‘235 application discloses a pharmaceutical composition comprising a pharmaceutically effective amount of the compound according to claim 5 of the ‘235 application or a pharmaceutically acceptable salt, solvate, cocrystal, tautomer or a mixture thereof, and a pharmaceutically acceptable carrier, diluent or excipient. See present claim 10.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 6 and 8-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1-5, 7 and 10-18 are rejected.
Claims 6 and 8-9 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626