DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Election/Restrictions
Applicant’s election in the reply filed on 10 April 2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants provided a compliant species election of compound A:
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, wherein:
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.
The search for Applicants’ elected species retrieved prior art. Therefore, the Markush search will not be extended unnecessarily for additional species in this Office Action.
Claims 1-27 read on the elected species. Claims 1-3, 5, 7-8, 12-16, 18, 20-22, and 24-25 are original. Claims 4, 6, 9-11, 17, 19, 23, and 26-27 are previously presented.
Current Status of 18/560,233
This Office Action is responsive to the amended claims of 10 April 2026.
Claims 1-27 have been examined on the merits.
Priority
The instant application’s effective filing date is 11 May 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 18 July 2025; 21 November 2024; and 17 August 2024, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 12-13 are objected to because they reference “or pharmaceutical composition of claim 11”. While claim 11, drawn to a combination of compounds (which is a “composition”) is inherently a “pharmaceutical composition” and hence not a lack of antecedent basis (35 USC 112(b) or 35 USC 112(d) rejection, it would be better for claim 11 to explicitly state “a pharmaceutical composition”. Claim 9 is already drawn to said pharmaceutical composition.
Kindly strike “or pharmaceutical composition of claim 11” from claims 12-13 to render moot this objection.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11-13 and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating hematopoietic disorders such as AML and ALL MLL-leukemias, does not reasonably provide enablement for preventing all hematopoietic disorders (as claimed within claims 11-13 and 27) 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.
The Wands Factors used in an (scope of) enablement rejection include (per MPEP 2164.01(a)):
1. The breadth of the claims:
The broadest reasonable interpretation (BRI) of instant claim 11-13 and 27 is drawn to a method (method implied by intended use “for use in the prevention or treatment of …”) to treat or prevent any disease that could be considered “hematopoietic” with the combination of instant claims 1 or 14.
2. The Nature of the Invention:
The invention belongs to medicinals, more specifically, the administration of MLL inhibitors of genus formula I with at least one other therapeutic agent per instant claims 1 or 14.
The BRI of instant claims 1-13 and 27 does not define the scope of hematopoietic diseases to be treated or prevented with the combination therapy of instant claims 1 or 14.
3. The state of the prior art:
A review of the prior art shows that MLL inhibitors such as compound A
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(from prior art reference JANSSEN, citations, below), is used to treat hematopoietic disorders such as MLL-leukemias, such as AML and ALL (see “Abstract” and page 5 of JANSSEN reference – complete citations in prior art rejection, below).
Furthermore, the prior art reference KENG (complete citations in prior art rejection, below), teaches the hypomethylating agents decitabine and azacitidine are used in treatment of MLL-leukemia (see Table 1 page 84).
However, nothing in the prior art supports preventing hematopoietic disorders, such as leukemias. In fact, the reference LEUKEMIA (UT Southwestern Medical Center. “Leukemia Awareness and Prevention.” Published: March 11, 2018. Accessed: 19 July 2026. Available from: < https://utswmed.org/conditions-treatments/leukemia/leukemia-awareness-and-prevention/ > ), discloses that “there is no known way to prevent leukemia” (see page 3).
4. The Level of one of ordinary skill:
The level of one of ordinary skill includes the knowledge/skill to engage in a reasonable amount of experimentation to make and use the combination of instant claims 1 and 14 to treat leukemias with known MLL inhibitors of formula I and adjuvant therapy that is also known to treat leukemia.
However, no one has skill to engage in the undue burdensome level of experimentation required to provide guidance/enablement for preventing the scope of all hematopoietic disorders, especially when one sub-type of hematopoietic disorder: leukemia, cannot be prevented (see, above).
5. The level of predictability in the art:
The art is predictable to make the instantly claimed pharmaceutical combinations /compositions. However, the art does not provide predictability as to which hematopoietic diseases can be prevented since we know leukemia cannot be prevented. To generate this level of guidance, one has to engage in undue burdensome experimentation (since no predictability in the art) to test the pharmaceutical combination/composition against every hematopoietic disease known to humanity to determine if the pharmaceutical composition can prevent said disease(s). This level of experimentation would be required to match the scope of the instant claims.
6. The amount of direction provided by the inventor:
While the Specification provides guidance that Applicants used their claimed combination to treat leukemia mice models (see pages 191-219), the Specification does not provide direction for preventing the undefined scope of hematopoietic diseases, such as leukemias, per the BRI of instant claims 1 and 14.
7. The existence of working examples; and
While the Specification provides guidance that Applicants used their claimed combination to treat leukemia mice models (see pages 191-219), the Specification does not provide direction for preventing the undefined scope of hematopoietic diseases, such as leukemias, per the BRI of instant claims 1 and 14.
8. The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
The undefined scope of hematopoietic diseases per the BRI of instant claims 1 and 14 would require an undue amount of experimentation to use the invention as claimed to prevent any hematopoietic disease, such as leukemia with the instantly claimed combination.
Moreover, the amount of experimentation required to prevent any of the claims’ hematopoietic diseases would be undue as well, absent evidence in the Specification or prior art.
Therefore, claims 11-13 and 27 are rejected under 35 USC 112(a) for lacking enablement for the scope of preventing all hematopoietic diseases including the concept of preventing leukemias (per BRI of instant claims 1 and 14).
To render moot this scope of enablement rejection: Applicants should delete “prevent” and/or “prevention”/”preventing” (and synonyms thereof) from all the claims.
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 17-18 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.
Claim 17 recites the limitation "The method according to claim 1". There is insufficient antecedent basis for this limitation in the claim.
The limitation “The method according to claim 1” renders the metes and bounds of claim 17 undefined (hence rendering claim 17 indefinite under 35 USC 112(b)) since the artisan does not know to what method of claim 1 Applicants are referencing. In fact, claim 1 is a composition-of-matter claim and not a method claim hence underscoring why claim 17 lacks antecedent basis to claim 1.
Claim 18, which refers back to claim 17 is similarly rejected as indefinite under 35 USC 112(b) since claim 18 does not remedy the rationale underpinning the basis for rejecting claim 17.
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 17-18 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.
Dependent claim 17, drawn to “The method of claim 1” improperly further limits parent claim 1, since claim 1 is a composition-of-matter claim and not a method claim. Therefore, method claim 17 is rejected under 35 USC 112(d) since it does not properly further limit composition-of-matter claim 1.
Claim 18, which refers back to claim 17 is similarly rejected under 35 USC 112(d) since claim 18 does not remedy the rationale underpinning the basis for rejecting claim 17.
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 § 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 1-5, 9-18, and 23-27 are rejected under 35 U.S.C. 103 as being obvious over:
JANSSEN (WO 2021/121327 A1, referenced in IDS of 17 August 2024),
in view of:
KENG (Keng, M., et al. “MLL-Rearranged Acute Lymphoblastic Leukemia.” Current Hematologic Malignancy Reports. (2020), Vol 15, pp 83-89),
and in further view of:
HE (He, Yan, et al. “The Selection of a Pharmaceutical Salt – The Effect of the Acidity of the Counterion on Its Solubility and Potential Biopharmaceutical Performance.” J. Pharm. Sci. (2018), 107: 419-425).
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The instant claims are drawn to a combination of MLL inhibitor of instant formula I and “at least one other therapeutic agent”.
Determining the scope and contents of the prior art:
The prior art reference JANSSEN teaches Applicants’ elected compound A:
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, or pharmaceutically acceptable salts, and solvates thereof (see page 36).
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and variable X2 is N; and R3 is -C3alkyl-NR8aR8b wherein R8a is methyl and R8b is C2alkyl further substituted with methoxy. JANSSEN teaches that compound A belongs to JANSSEN formula I which are menin/MLL protein/protein interaction inhibitors (see “Abstract”). This teaches the MLL inhibitor of formula I limitation of instant claims 1 and 14 and other claims. This teaches instant claims 2 and 15.
The prior art JANSSEN teaches the above MLL inhibitor compound A is used in treating MLL leukemia (see “Abstract”), including AML and ALL (page 5).
The prior art JANSSEN teaches pharmaceutical compositions comprising said compound A, above, and a pharmaceutically acceptable carrier (page 5).
The prior art reference KENG teaches the hypomethylating agents decitabine and azacitidine are used in treatment of MLL-leukemia (see Table 1 page 84).
The HE prior art reference teaches that besylate salt is a common well-known pharmaceutically acceptable salt exhibiting good aqueous solubility, stability, process scalability, and tablet compressibility (page 425).
Ascertaining the differences between the prior art and the claims at issue:
While JANSSEN teaches Applicants’ elected species of instant genus formula I, JANSSEN is silent as to the “one other therapeutic agents” per instant claims 1 and 14.
While KENG teaches the hypomethylating agents decitabine and azacitidine are used in treatment of MLL-leukemia (see Table 1 page 84), the KENG reference is silent as to the MLL inhibitor compounds of instant genus formula I.
While HE teaches that besylate salt is a common well-known pharmaceutically acceptable salt exhibiting good aqueous solubility, stability, process scalability, and tablet compressibility (page 425), it does not teach either the MLL inhibitor of instant genus formula I or the hypomethylating adjuvant therapy.
Resolving the level of ordinary skill in the pertinent art.
The artisan is knowledgeable in use of the “one other therapeutic agents” of instant claims 1 and 14, such as use of hypomethylating agent in treating MLL leukemias. Furthermore, the artisan is knowledgeable in use of the MLL inhibitor compounds of instant genus formula I to treat MLL leukemias.
Considering objective evidence present in the application indicating obviousness or nonobviousness:
The instant claims are prima facie obvious in light of the combination of references JANSSEN in view of: KENG and HE.
The artisan would be expected to combine the JANSSEN compound A:
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(page 36), which is a MLL inhibitor compound (“Abstract”) of instant genus formula I, since it is known to be used in treating MLL leukemia (see “Abstract”) with a hypomethylating agent (from KENG reference) such as either decitabine or azacitidine, which are also known to be used in treatment of MLL-leukemia (see KENG Table 1 page 84). The artisan would be motivated to combine the compound A MLL inhibitor compound of instant genus formula I with the hypomethylating agents decitabine or azacitidine since both the MLL inhibitor compound A and the hypomethylating agents are both known to be useful in treating MLL-leukemia (see JANSSEN and KENG citations, above).
"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). In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023): “That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine”. See MPEP 2144.06 (I).
Moreover, the artisan would be expected to combine the MLL inhibitor compound A from JANSSEN with besylate salt as the species of “pharmaceutically acceptable salt thereof” since besylate salt is well-known pharmaceutically acceptable salt (HE page 425).
The artisan would be motivated to combine the MLL inhibitor compound A (JANSEEN) with besylate salts since besylate salts exhibit good aqueous solubility, stability, process scalability, and tablet compressibility (HE page 425). Thus, the compound that besylate salt is paired with would benefit by the besylate salt’s added aqueous solubility, stability, and process scalability by addition of besylate salt to active pharmaceutical ingredient: compound A (JANSSEN).
This teaches instant claims 1-5, 9-18, and 23-27.
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 1-5, 9-18, and 23-27 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-25 of co-pending Application No. 18/560,242 (reference application). The reference amended claims of 8 June 2026 and the instant amended claims of 10 April 2026 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. For example, the reference claims 1-10, drawn to a combination comprising: (1) MLL inhibitor compound A of formula I:
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, or a pharmaceutically acceptable (besylate) salt or solvate thereof, wherein:
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and further wherein: variable X2 is N; and R3 is -C3alkyl-NR8aR8b wherein R8a is methyl and R8b is C2alkyl further substituted with methoxy, and also (2) azacitidine, or pharmaceutically acceptable salt or solvate thereof (“a hypomethylating agent” (“antineoplastic agent”)) anticipates instant claims 1-5, drawn to same.
Moreover, reference claims 11-15, drawn to pharmaceutical compositions comprising said combination and a pharmaceutically acceptable carrier for use in a medicament to treat hematopoietic disorders such as MLL leukemias, including AML and ALL, anticipates instant claims 9-13, drawn to same.
Furthermore, the reference claims 16-25, drawn to methods of use thereof to treat said leukemias, anticipates instant claims 14-18 and 23-27, drawn to same.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 9-18, and 23-27 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-28 of co-pending Application No. 18/570,727,
in further view of:
KENG (Keng, M., et al. “MLL-Rearranged Acute Lymphoblastic Leukemia.” Current Hematologic Malignancy Reports. (2020), Vol 15, pp 83-89).
Determining the scope and contents of the prior art:
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are prima facie obvious over the reference claims in view of the teachings of KENG.
The reference claim 1, drawn to the MLL inhibitor formula I compound A:
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, or pharmaceutically acceptable (besylate) salts, and solvates thereof, wherein:
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and variable X2 is N; and R3 is -C3alkyl-NR8aR8b wherein R8a is methyl and R8b is C2alkyl further substituted with methoxy, teaches the instant MLL inhibitor of formula I of claims 1-3.
Furthermore, the reference claims 6-7 drawn to pharmaceutical compositions comprising said compound A, above, and a pharmaceutically acceptable carrier, teaches instant claim 9, drawn to same.
The reference claims 8-13, drawn to use of compound A in treating MLL leukemia, including AML and ALL, teaches instant claims 10-13, drawn to same.
The reference claims 14 and 22-28, drawn to use thereof to treat MLL leukemia, including AML and ALL, teaches instant claims 14-16 and 22-27, drawn to same.
The prior art reference KENG teaches the hypomethylating agents decitabine and azacitidine are used in treatment of MLL-leukemia (see Table 1 page 84).
Ascertaining the differences between the prior art and the claims at issue:
While reference claims teach the Applicants’ elected species of instant claims 1-3, and other claims, above, the reference claims are silent as to the “one other therapeutic agents” per instant claims 1 and 14.
While KENG teaches the hypomethylating agents decitabine and azacitidine are used in treatment of MLL-leukemia (see Table 1 page 84), the KENG reference is silent as to the MLL inhibitor compounds of instant genus formula I.
Resolving the level of ordinary skill in the pertinent art.
The artisan is knowledgeable in use of the “one other therapeutic agents” of instant claims 1 and 14, such as use of hypomethylating agent in treating MLL leukemias. Furthermore, the artisan is knowledgeable in use of the MLL inhibitor compounds of instant genus formula I to treat MLL leukemias.
Considering objective evidence present in the application indicating obviousness or nonobviousness:
The instant claims are prima facie obvious in light of the combination of the reference claims in view of KENG.
The artisan would be expected to combine the reference claims’ 1-2 (and other claims, per, above) compound A:
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, and (besylate) pharmaceutically acceptable salts or solvates thereof, which is a MLL inhibitor compound of instant genus formula I, since it is known to be used in treating MLL leukemia (see reference claims 9-13 and 24-28) including AML and ALL (see reference claims 9-13 and 24-28) with a hypomethylating agent (from KENG reference) such as either decitabine or azacitidine, which are also known to be used in treatment of MLL-leukemia (see KENG Table 1 page 84). The artisan would be motivated to combine the compound A MLL inhibitor compound of instant genus formula I of reference claims 1-2 with the hypomethylating agents decitabine or azacitidine (from KENG) since both the MLL inhibitor compound A and the hypomethylating agents are both known to be useful in treating MLL-leukemia (see above cited reference claims and KENG citations, above).
"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). In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023): “That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine”. See MPEP 2144.06 (I).
This teaches instant claims 1-5, 9-18, and 23-27.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 6-8 and 19-22 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.
Claims 1-5, 9-18, and 23-27 are not presently allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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