DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1, 3, 4, 25, 111, 112, and 114-147 are pending. Claims 2, 5-24, 26-110, and 113 are cancelled. Examiner previously required a restriction (dated October 21, 2025). In response, Applicant elected, without traverse, Group I which encompasses claims 1, 3, 4, and 25. Accordingly, claims 111, 112, and 114-147 are withdrawn.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/JP2021/048330, filed on December 24, 2021. This application also claims the benefits of foreign priority to JP2020-217707, filed on December 25, 2020 and JP2021-177849 filed on October 29, 2021.
Election/Restrictions
As a reminder, Applicant elected, without traverse, Group I which corresponds to claims 1, 3, 4, and 25. Applicant also elected the following species without traverse:
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and indicated claims 1, 3, 4, and 25 read on said species. The elected species was found in the prior art as discussed in the “Claim Rejections - 35 USC § 102” section below.
Examiner’s Note
According to MPEP § 2114, section II:
“‘[A]pparatus claims cover what a device is, not what a device does.’ Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a ‘recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus’ if the prior art apparatus teaches all the structural limitations of the claim.”
This can also be translated to a composition claim. A composition claim covers what a composition is, not what a composition does. Therefore, a claim containing a recitation with respect to the manner in which a claimed composition is intended to be employed does not differentiate the claimed composition from a prior art composition if the prior art composition teaches all the structural limitations of the claim. Therefore, claims 1, 3, 4, and 25 of the instant application are all composition claims that are directed towards a pharmaceutical composition comprising a CBP/P300 inhibitor and a pharmaceutically acceptable carrier.
Thus, even though claims 3 and 4 further limits the intended use of the pharmaceutical composition of claim 1, the recitation of an intended use does not alter the structural or compositional features of the pharmaceutical composition as claimed in claim 1. Accordingly, the pharmaceutical compositions recited in claims 1, 3, and 4 are identical in scope and claims 1, 3, and 4 are considered to be substantial duplicates of each other. See “Claim Objections” section below.
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities:
To be consistent with the specification:
Claim 1 should read “… a pharmaceutically acceptable additive.”
Claims 3 and 4 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections – Improper Markush Grouping
Claims 1, 3, 4, and 25 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) the species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the Specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons:
Depicted below are specific examples of CBP/P300 inhibitors that are also HAT inhibitors:
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Kesicki et al. (Kesicki) (WO 2016/044771; published March 24, 2016; pg. 39)
This compound is also disclosed in the instant application, pg. 15, Table, 1st row, 3rd compound.
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Naito et al. (Naito) (WO2018235966A1; published December 27, 2018; Example 35, para. 0362-0363).
This compound is also disclosed in the instant application, pg. 23, Table, 1st row, 1st compound.
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Michaelides et al. (Michaelides) (WO 2016/044770 A1; published March 24, 2016; Example 715, pg. 921)
This compound is the species elected by Applicant in response to the restriction requirement made by Examiner (dated October 21, 2025).
The three compounds depicted above are all reported to be histone acetyltransferase (HAT) inhibitors. However, each compound possesses a distinct core chemical scaffold with no common structural features readily apparent among them. Claim 25 further recites that the CBP/P300 inhibitor of claim 1 is a HAT inhibitor, a BRD inhibitor, an antisense nucleic acid for a transcriptional product of a gene encoding CBP or P300, a ribozyme for a transcriptional product of a gene encoding CBP or P300, or a nucleic acid having RNAi activity for a transcriptional product of a gene encoding CBP or P300, or a precursor thereof.
As demonstrated above, even within the category of small-molecule HAT inhibitors, there exists substantial structural diversity. Claim 25 expands the scope further to include additional structurally distinct classes of agents including nucleic acids and enzymes which bear no discernable structural similarity to small-molecule CBP/P300 inhibitors. Because the recited alternatives lack a shared structural feature, claims 1 and 25 are, therefore, rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives.
Claims 3 and 4, which are substantial duplicates of claim 1, are then also rejected.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR41.31 (a) (1) (emphasis provided).
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3 and 4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Since claims 3 and 4 are substantial duplicates of claim 1 (See “Claim Objections” and “Examiner’s note” sections above), these claims are not further limiting the subject matter of the claim upon which it depends (i.e., claim 1). Therefore, claims 3 and 4 are written in improper dependent form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Note on 35 USC § 102 and § 103 Rejections
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Michaelides et al. (Michaelides) (WO2016044770A1; published March 24, 2016).
Michaelides discloses spirocyclic HAT inhibitors (which are also CBP/P300 inhibitors: see pg. 1082, lines 19-20) as well as pharmaceutical compositions comprising such compounds and methods for treating various HAT-related conditions or diseases, including cancer, by administration of such compounds (abstract).
For example, Michaelides discloses the species elected by Applicant:
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(pg. 921, Example 715; herein, referred to as Michaelides-compound-715). To perform a TR-FRET histone acetyltransferase activity assay, each compound of interest (which includes Michaelides-compound-715 [i.e., the instantly elected species]) was dissolved in DMSO (pg. 1094, line 4). DMSO is a known pharmaceutical excipient (See McKim et al. Pharmaceutical Technology. 2008, 32; 1st sentence of article). In other words, Michaelides explicitly discloses a pharmaceutical composition comprising the instantly elected species and DMSO (a known pharmaceutical excipient) which reads on instant claims 1, 3, 4, and 25.
It is noted here that according to the instant specification, an excipient is an example of a pharmaceutically acceptable additive (pg. 184, para. 0088, 1st sentence).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant 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.
Claims 1, 3, 4, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over:
Michaelides et al. (Michaelides) (WO2016044770A1; published March 24, 2016).
As stated above, Michaelides discloses spirocyclic HAT inhibitors (which are also CBP/P300 inhibitors: see pg. 1082, lines 19-20) as well as pharmaceutical compositions comprising such compounds and methods for treating various HAT-related conditions or diseases, including cancer, by administration of such compounds (abstract).
Michaelides also states:
“The pharmaceutical compositions of the invention can be prepared by combining a compound of the invention with an appropriate pharmaceutically acceptable carrier, diluent or excipient, and may be formulated into preparations in solid, semi-solid, liquid or gaseous forms, such as tablets, capsules, powders, granules, ointments, solutions, suppositories, injections, inhalants, gels, microspheres, and aerosols” (pg. 518, lines 3-7).
“The pharmaceutical compositions of the invention may be prepared by methodology well known in the pharmaceutical art” (pg. 520, lines 25-26).
Therefore, even if Michaelides did not disclose a pharmaceutical composition comprising Michaelides-compound-715 and DMSO, one of ordinary skill in the art would have found it obvious before the effective filing date of the claimed invention to prepare a pharmaceutical composition comprising Michaelides-compound-715 (i.e., the instantly claimed compound) and a pharmaceutically acceptable carrier, diluent, or excipient (reads on instant claims 1, 3, 4, and 25). One of ordinary skill would have been motivated to prepare such a pharmaceutical composition, since:
Michaelides-compound-715 can inhibit tumor growth in vivo (pg. 1107, Table 13C),
Michaelides has directed POSITA how to prepare the pharmaceutical composition (pg. 518, lines 3-7; pg. 520, lines 25-26) and
pharmaceutical compositions are useful in facilitating the suitable administration of the therapeutic compound to a patient in need 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, 3, 4, and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 94 and 103 of U.S. Patent Application No. 19/047,358 (‘358) and
Claims 8 and 14 of U.S. Patent Application No. 19/177,218 (‘218).
Although the claims at issue are not identical, they are not patentably distinct from each other because there is significant overlap between the instant claims and the two claim sets from the co-pending applications.
Claims 94 and 103 of application ‘358 are directed towards a pharmaceutical composition comprising the compound of claim 1. Claim 103 is specifically directed towards a pharmaceutical composition comprising the compound of claim 1 combined with an additional drug. According to the specification of ‘358, the compound of claim 1 “has a strong inhibitory action on the HAT domain of CBP/P300” (pg. 6, line 2). In other words, claims 94 and 103 are directed towards a pharmaceutical composition comprising a CBP/P300 inhibitor (wherein the CBP/P300 inhibitor is a HAT inhibitor) which reads on instant claims 1, 3, 4, and 25. Even though the instant claims do not explicitly specify that the claimed pharmaceutical composition comprises a CBP/P300 inhibitor combined with an additional drug and the co-pending application claims do not explicitly specify that the pharmaceutical composition comprises a pharmaceutically acceptable carrier, the open-ended transitional phrase “comprising” in instant claims 1, 3, 4, and 25 as well as in claims 94 and 103 of ‘358 indicates that the composition disclosed in the instant case can also include other components like the additional drug disclosed in claim 103 of ‘358 and the composition disclosed in claim 94 of ‘358 can include other components like a pharmaceutically acceptable carrier as disclosed in instant claim 1. As such, claims 94 and 103 of ‘358 overlap in scope with instant claims 1, 3, 4, and 25.
Claims 8 and 14 of application ‘218 are directed towards a pharmaceutical composition comprising the compound of claim 1. Claim 14 is specifically directed towards a pharmaceutical composition comprising the compound of claim 1 combined with an additional drug. According to the specification of ‘218, the compound of claim 1 “has a strong inhibitory action on the HAT domain of CBP/P300” (pg. 6, line 2). In other words, claims 8 and 14 are directed towards a pharmaceutical composition comprising a CBP/P300 inhibitor (wherein the CBP/P300 inhibitor is a HAT inhibitor) which reads on instant claims 1, 3, 4, and 25. Even though the instant claims do not explicitly specify that the claimed pharmaceutical composition comprises a CBP/P300 inhibitor combined with an additional drug and the co-pending application claims do not explicitly specify that the pharmaceutical composition comprises a pharmaceutically acceptable carrier, the open-ended transitional phrase “comprising” in instant claims 1, 3, 4, and 25 as well as in claims 8 and 14 of ‘218 indicates that the composition disclosed in the instant case can also include other components like the additional drug disclosed in claim 14 of ‘218 and the composition disclosed in claim 8 of ‘218 can include other components like a pharmaceutically acceptable carrier as disclosed in instant claim 1. As such, claims 8 and 14 of ‘218 overlap in scope with instant claims 1, 3, 4, and 25.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624