NON-FINAL REJECTION
This application, filed Jul. 12, 2023, claims benefit of priority to provisional application 63/389,249, filed Jul. 14, 2022.
Claims 1-9, 11-55, 58, and 59, as amended, are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to Group I, methods of administering a combination comprising a compound of formula (I) and a PD-1 inhibitor; and the compound of formula (Id) as the species of formula (I), having the structural formula,
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and nivolumab as the species of PD-1 inhibitor, in the reply filed on Dec. 18, 2025 is acknowledged. Claims 1-9, 11, 12, 14, 19, 21, 23-25, 45, 46, 49-55, 58, and 59 read on the elected species.
Claims 13, 15-18, 20, 22, 26-44, 47, and 48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Dec. 18, 2025.
Claims 1-9, 11, 12, 14, 19, 21, 23-25, 45, 46, 49-55, 58, and 59 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Dec. 5, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 112(d) – Improper Dependency
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.
Claim 14 is 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.
Specifically, claim 14 defines variable Y. However, claims 1 and 12 from which it depends do not recite any variable Y.
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.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 6-9, 11, 12, 14, 19, 21, 23-25, 45, 46, 49-55, and 58 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements. See MPEP § 2172.01.
Specifically, the omitted element is the core structure of formula (I), to which variable groups A, L1-E, R3a, R3b, R13a, and R13b, are attached, as shown in claim 4:
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.
This missing structural formula is interpreted as a typographical error, and is construed as the structure of the "formula (I)" recited but not depicted in independent claims 1 and 2.
In addition, independent claims 1, 2, and 4 recite the compound of formula (I) having "a structure," which is indefinite because "a" is an indefinite article, which is non-specific and open-ended; whereas "the" is a definite article, which is specific and refers to only one in particular. Therefore, "a structure" should be amended to "the structure."
Appropriate correction is required.
Claims 1-9, 11, 12, 14, 19, 21, 23-25, 45, 46, 49-55, 58, and 59 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, formula (I) variables R3, R3a, R3b, R4, R5, R6, R7, R8, R9, R10, R10, R11, R12, R13a, R13b, R14, as recited by claims 1, 2, 4, and 24, are all defined as "independently hydrogen or a substituent." However, the limitation "a substituent" renders the claims indefinite because "a substituent" is not further defined in the claims or in the specification, and thus can represent any functional group or moiety, without limit. While those skilled in the art generally understand what a substituent is, the term confers no particular limit on the functional groups or chemical moieties which may added to a compound of formula (I). Thus, one of ordinary skill in the art would not be reasonably apprised of the scope of the claimed invention.
The scope of the compounds encompassed by formula (I), with sixteen R groups bearing any substituent, and the nature of the steps required to prepare them, has no clear boundary. Thus, infringing compounds cannot be distinguished from non-infringing compounds, rendering the metes and bounds of the claims indefinite.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-9, 11, 12, 14, 19, 21, 23-25, 45, 46, and 51-55 are rejected under 35 U.S.C. 103 as being unpatentable over You et al. (US Pub. 2021/0139466), in view of Chen et al. (J. Med. Chem. 64, 10537-10556 (Jul. 20, 2021)) and Feng et al. (The FEBS Journal 289, 1214-1239 (Feb. 5, 2021) (all cited on PTO-892).
You et al. claim MLL1-WDR5 protein-protein interaction inhibitors of formula (I), and methods of treating acute leukemia in a subject, such as an acute leukemia having an MLL1 gene rearrangement type, comprising administering a compound of the formula (I) or a salt thereof (claims 9-10).
In particular, You et al. exemplify the compound of Example 8,
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which reads on formula (I) as recited by claims 1-9, 11, 12, 14, 19, 21, 23-25, 45, and 46, wherein A is
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wherein Y is -C(O)-, m is 0, and R15 is N-methylpiperazine; L1 is -NH-C(O)-; E is
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wherein X6 is CR6, and R6 is halo (chlorine); X5 is CR5, and R5 is methyl; X7 is CR7, and R7 is halo (fluorine); X4 is CR4, and R4 is amino (NH2); and X3 is CR3, and R3 is hydrogen;
X1 is NR1 and R1 is methyl; each X2 is CHR2a, and each R2a is hydrogen; and R3a, R3b, R13a, and R13b are each hydrogen.
Thus, You et al. disclose and claim methods of treating cancer in a subject having a tumor, comprising administering to the subject a compound of Formula I, as recited by claims 1-9, 11, 12, 14, 19, 21, 23-25, 45, and 46.
You et al. further claim compositions comprising a compound of formula (I) or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier (claim 8), as recited by claim 51.
You et al. differs from the instant claims in that the reference does not disclose administering compounds of formula (I) in combination with a PD-1 inhibitor. However, anti-PD-1 antibodies, e.g., nivolumab, were known to be effective in the treatment of cancer, particularly in combination with other therapies, as discussed below.
Feng et al. review combination therapies for treating cancer, in particular the anti-PD-1 antibody nivolumab, in combination with epigenetic drugs for treating various cancers, e.g., childhood relapsed or refractory acute myeloid leukemia (AML), and hematologic malignancies (Table 2). Feng et al. note that a phase 2 study investigating azacitidine and PD-1 antibody nivolumab in AML patients reveals that the combination therapy is safe and produces encouraging objective response rate and overall survival outcomes (p. 1229, right col.).
Thus, Feng et al. establish that the elected anti-PD-1 antibody, nivolumab, was known to be effective to treat acute leukemias when administered in combination with other drugs.
It is implicit in the combination therapies disclosed by Feng et al. that nivolumab is formulated in a composition with a pharmaceutically acceptable excipient, separately from the second anti-cancer agent, as recited by claim 51.
It is further implicit in the combination therapies disclosed by Feng et al. that nivolumab is a PD-1 inhibitor, a checkpoint inhibitor, and immunotherapy, which may be administered with a second anti-cancer agent in any order, i.e., prior to or subsequent to, as recited by claims 6 and 52-55.
Chen et al. review the many biological activities of WDR5 and the development of WDR5 inhibitors, and conclude that a synergistic combination can be achieved when WDR5-targeted inhibitors are administered in combination with other anticancer drugs. In particular, targeting the H3K4 methylation pathway regulated by MLL1 can enhance the function of PD1 antibodies. Thus, Chen et al. teach that combining WDR5 inhibitors with anti-PD-1 antibodies is an ideal choice (p. 10550, right col.).
Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to treat cancer, e.g., acute leukemias, by administering the compound of formula (I) as taught by You et al. in combination with nivolumab, as taught by Feng et al. with a reasonable expectation of success, because Chen et al. teach that a synergistic combination can be achieved when WDR5-targeted inhibitors are administered in combination with anti-PD-1 antibodies; and both anti-PD-1 antibodies, such as nivolumab, and the compounds of You et al. were each separately known in the treatment of acute leukemias.
As recognized by MPEP § 2144.06, “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
While the cited references may not explicitly disclose that treating cancer in a subject by administering the claimed combination results in:
increases one or more anti-tumor T cell types in a subject having a tumor, as recited by claim 2;
increases at least one anti-tumor T cell type in a tumor microenvironment of the tumor in the subject, as recited by claim 3;
induces at least a two-fold increase in expression of at least one gene associated with anti-tumor T cell infiltration, as recited by claim 4;
wherein the gene associated with an anti-tumor T cell is Batf2, Cd274 (PD-L1), Dnase1L3, Gbp2, Infg (Inf-γ), IL18 bp, IL24, Lag3, Pdcdl1g2 (PD-L2), Tgtp1, Tnfsf10, or a combination thereof, as recited by claim 5;
wherein the one or more T cell types comprise one or more of tumor-infiltrating T lymphocytes (TILs) and cytotoxic T lymphocytes (CTLs), as recited by claim 7;
wherein a ratio of tumor infiltrating leukocytes (TIL) to regulatory T cells (Tregs) in the tumor is increased, as recited by claim 8;
wherein one or more of regulatory macrophages (M2), tumor-associated myeloid cells (TAMCs), myeloid-derived suppressor cells (M-MDSCs) and polymorphonuclear myeloid-derived suppressor cells (PMN-MDSCs) are reduced in the subject, as recited by claim 9,
claims 2-5 and 7-9 are drawn to the result of administering a compound of formula (I) in combination with a PD-1 inhibitor, e.g., nivolumab, to treat cancer, e.g., an acute leukemia, as claimed by You et al.
All the molecular and cellular mechanisms by which a compound exerts its therapeutic effects are intrinsic in the methods of You et al., and occur each time the claimed combination is administered to the patient population in need of treatment for cancer, e.g., acute leukemias, regardless of whether anyone was aware of those molecular and cellular mechanisms. While the references may not explicitly recognize the claimed results, their discovery is tantamount only to finding a new property intrinsic in carrying out an old method.
Claims 1-9, 11, 12, 14, 19, 21, 23-25, 45, 46, 49-55, 58, and 59 are rejected under 35 U.S.C. 103 as being unpatentable over You et al. (US Pub. 2021/0139466), in view of Chen et al. (J. Med. Chem. 64, 10537-10556 (2021)) and Feng et al. (The FEBS Journal 289, 1214-1239 (Feb. 5, 2021) (all cited on PTO-892), as applied to claims 1-9, 11, 12, 14, 19, 21, 23-25, 45, 46, and 51-55 above.
As discussed above, You et al., Feng et al., and Chen et al. disclose, teach, and suggest methods of treating acute leukemias by administering a WDR5-inhibitor of formula (I) (Example 8) in combination with the PD-1 inhibitor nivolumab.
With regard to the elected species of formula (Id), as recited by claims 49, 50, 58, and 59, You et al. differs from the instant claims in that the compound of Example 8 lacks the fluoro and methyl substituents of the elected compound species of formula (Id) (shown below).
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However, the compound of Example 8 of You et al. is disclosed as a species of general
formula (I), having the structural formula,
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wherein X is hydrogen or halogen, e.g., fluoro (as in Example 21); and R4 is N-methylpiperazine or 1,2-dimethylpiperazine (claim 9).
Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to modify the central phenyl ring of Example 8 of You et al. by substituting a hydrogen with fluorine with a reasonable expectation of success, because MPEP § 2144.09 recognizes that positional isomers are prima facie obvious even in the absence of a teaching to modify. The isomer is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing the position isomers. Compounds that differ only in the placement of substituents in a ring system are not patentable absent a showing of unexpected properties. See In re Jones, 74 USPQ 152 (CCPA 1947).
Similarly, it would have been predictable to substitute the R4 piperazine ring with one, two, or three methyl groups, because, where a compound is disclosed to have a particular utility, one of ordinary skill in the art would have a reasonable expectation that modifying the compound by the interchange of hydrogen and alkyl would yield compounds having similar properties, and thus have been held to be obvious variants.
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 1-9, 11, 12, 14, 19, 21, 23-25, 45, 46, 49-55, 58, and 59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-60 of copending Application No. 18/926,888 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims would anticipate the examined claims.
Specifically, independent reference claim 1 is drawn to a method of treating cancer in a subject having a tumor;
independent reference claim 2 is drawn to a method of increasing one or more anti-tumor T cell types in a subject having a tumor; and
independent reference claim 4 is drawn to a method of inducing at least a two-fold increase in expression of at least one gene associated with anti-tumor T cell infiltration in a tumor in a subject having a tumor,
all three methods comprising the steps of administering to the subject a combination comprising:
(1) an MLL1-WDR5 protein-protein interaction inhibitor compound of Formula I, or a pharmaceutically acceptable salt thereof,
(2) a PD-1 inhibitor, or a pharmaceutically acceptable salt thereof, and
(3) a dose of radiation therapy,
wherein the compound of Formula I has the structure:
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,
wherein variables A, X1, X2, L1, E, R3a, R3b, R13a, and R13b are defined identically to formula (I) of the examined claims.
Further, reference claims 49 and 50 recite the compound of formula (Id), which is identical to the elected formula (Id) recited by the examined claims.
Thus, the reference claims merely add a third component (a dose of radiation therapy) to the otherwise identical combination recited by the examined claims, and would anticipate the examined claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 11, 12, 14, 19, 21, 23-25, 45, 46, 49-55, 58, and 59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-62 of copending Application No. 18/120,326 in view of You et al. (US Pub. 2021/0139466), Chen et al. (J. Med. Chem. 64, 10537-10556 (2021)), and Feng et al. (The FEBS Journal 289, 1214-1239 (Feb. 5, 2021) (all cited on PTO-892).
Reference claims 56-57 are drawn to methods for the treatment or prevention of acute leukemia with MLL1 gene rearrangement in a patient in need thereof, comprising administering to the patient a therapeutically acceptable dose of the compound of claim 1, or the pharmaceutical composition of claim 55.
Reference claim 55 is drawn to a pharmaceutical composition comprising a compound of claim 1, or a pharmaceutically acceptable salt or solvate thereof, and a pharmaceutically acceptable excipient.
Reference claim 1 is drawn to compounds of formula (I), or pharmaceutically acceptable salts or solvates thereof, having the following structure:
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which falls within the scope of formula (I) as recited by examined claim 1.
Further, reference claim 54 is drawn to compounds including, e.g.,
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; and
reference claims 58-62 are drawn to compounds, or pharmaceutically acceptable salts or solvates thereof, having the following structures:
Claim 58
Claim 59
Claim 60
Claim 61
Claim 62
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all of which fall within the scope of formula (I) as recited by examined claim 1.
The reference claims differ from the examined claims in that the reference claims do not recite administering compounds of formula (I) in combination with a PD-1 inhibitor. However, anti-PD-1 antibodies, e.g., nivolumab, were known to be effective in the treatment of cancer, particularly in combination with other therapies, as discussed below.
Feng et al. review combination therapies for treating cancer, in particular the anti-PD-1 antibody nivolumab, in combination with epigenetic drugs for treating various cancers, e.g., childhood relapsed or refractory acute myeloid leukemia (AML), and hematologic malignancies (Table 2). Feng et al. note that a phase 2 study investigating azacitidine and PD-1 antibody nivolumab in AML patients reveals that the combination therapy is safe and produces encouraging objective response rate and overall survival outcomes (p. 1229, right col.).
Thus, Feng et al. establish that the elected anti-PD-1 antibody, nivolumab, was known to be effective to treat acute leukemias when administered in combination with other drugs, as recited by examined claims 1, 2, and 4.
Chen et al. review the many biological activities of WDR5 and the development of WDR5 inhibitors, and conclude that a synergistic combination can be achieved when WDR5-targeted inhibitors are administered in combination with other anticancer drugs. In particular, targeting the H3K4 methylation pathway regulated by MLL1 can enhance the function of PD1 antibodies. Thus, Chen et al. teach that combining WDR5 inhibitors with anti-PD-1 antibodies is an ideal choice (p. 10550, right col.).
Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to treat cancer, e.g., acute leukemias, by administering a compound of formula (I) as recited by the reference claims, in combination with nivolumab, as taught by Feng et al. with a reasonable expectation of success, because Chen et al. teach that a synergistic combination can be achieved when WDR5-targeted inhibitors are administered in combination with anti-PD-1 antibodies; and both anti-PD-1 antibodies, such as nivolumab, and the compounds of formula (I) were each separately known in the treatment of acute leukemias.
As recognized by MPEP § 2144.06, “it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
With regard to the elected species of formula (Id), as recited by examined claims 49, 50, 58, and 59, the reference claims differ from the examined claims in that formula (I) of reference claim 1 excludes compounds of formula (Ia), (Ib), (Ic), and (Id), as recited by the examined claims 49, 50, 58, and 59.
lacks the fluoro and methyl substituents of the elected compound species of formula (Id) (shown below).
Reference formula (I)
Formula (Id) – Elected compound species
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However, the compound of Example 8 of You et al. is disclosed as a species of general
formula (I), having the structural formula,
You et al. formula (I)
You et al. compound of Example 8
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wherein X is hydrogen or halogen, e.g., fluoro (as in Example 21); and R4 is N-methylpiperazine or 1,2-dimethylpiperazine (claim 9).
Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to modify the central phenyl ring of Example 8 of You et al. by substituting a hydrogen with fluorine with a reasonable expectation of success, because MPEP § 2144.09 recognizes that positional isomers are prima facie obvious even in the absence of a teaching to modify. The isomer is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing the position isomers. Compounds that differ only in the placement of substituents in a ring system are not patentable absent a showing of unexpected properties. See In re Jones, 74 USPQ 152 (CCPA 1947).
Similarly, it would have been predictable to substitute the R4 piperazine ring with one, two, or three methyl groups, because, where a compound is disclosed to have a particular utility, one of ordinary skill in the art would have a reasonable expectation that modifying the compound by the interchange of hydrogen and alkyl would yield compounds having similar properties, and thus have been held to be obvious variants.
This is a provisional nonstatutory double patenting rejection.
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
WO 2019/046944.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. 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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/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629