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 .
Election/Restrictions
2. Applicant's election with traverse of Group I, claims 1, 2, 6, 8-13, and 22-27, (drawn to the compound: (R)-N-ethyl-5-fluoro-N-isopropyl-2-((5-(2-(6-((2-methoxy-ethyl)(methyl)amino)-2-methylhexan-3-yl)-2,6-diazaspiro[3.4]octan-6-yl)-1,2,4-triazin-6-yl)oxy)benzamide besylate salt or a solvate thereof and its pharmaceutical composition thereof), in the reply filed on April 10, 2026 is acknowledged.
3. In view of Applicant’s arguments regarding the restriction between the inventions of Groups I and II, claims 3-5, and 21 are rejoined into Group I for examination.
4. Claims 7, 14-20 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention (i.e., Groups III-VII), there being no allowable generic or linking claim.
5. Claims 1-6, 8-13, and 21-27, are under examination and are the subject of this office action.
Priority
6. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
7. The information disclosure statements (IDS) submitted on August 16, 2024 and November 21, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner, please refer to the signed copies of Applicant’s PTO-1449 forms, attached herewith.
Claim Objections
8. Claim 1 is objected to for missing an article at the beginning of the claim. The claim should start with the phrase “A compound…”.
9. Claims 2 and 3 are objected to for missing the comma from between “claim 1” and “wherein”.
10. Claim 8 is objected to the following informalities:
Claim 8 is improperly dependent because it fails to include the dependent claim in line 1.
Claim 8 uses the improper article “A” at the beginning of the claim; the term “The” should be used.
Claim 8 recites: “[a] compound as claimed in claim…” in the preamble which is clunky. The claim should recite “The compound of claim …”.
Claim 8 is missing the preposition “for” between “claim” and “use” in line 1, and there should also be a comma after the term “for” is added.
11. Claim 9 is objected to for using the improper article “A” at the beginning of the claim; the term “The” should be used.
Claim 9 recites: “[a] compound as claimed in claim…” in the preamble which is clunky. The claim should recite “The compound of claim …”.
12. Claim 10 is objected to for missing a comma after “claim 9”. And, the term following “claim 9” (i.e., “where”) should be replaced with “wherein”.
Claim 10 recites: “[a] compound as claimed in claim…” in the preamble which is clunky. The claim should recite “The compound of claim …”.
13. Claim 11 is objected to for missing a comma after “claim 10” and before “in the” in lines 1; and
Claim 11 is objected to for reciting the abbreviated term (NPM1). The full name should be spelled out, i.e., nucleophosmin, followed by the abbreviated name in parentheticals, (NPM1).
14. Claim 12 is objected to for missing the article “the” before the term “cancer” in line 1.
15. Claim 13 is objected to reciting the abbreviated term MLL. The full name should be spelled out, i.e., menin mixed-lineage leukemia, followed by the abbreviated term in parentheticals, (MLL).
16. Claims 22 and 23 are objected to for missing a comma after “claim 6” and before “for use” in line 1.
And, Claims 22 and 23 recite: “The pharmaceutical composition as claimed in claim 6…” in the preamble which is clunky. The claim should recite “The pharmaceutical composition of claim 6…”.
17. Claim 24 is objected to for missing a comma after “claim 23”. And, the next term following “claim 23” (i.e, “where”) should be replaced with “wherein”.
Claim 24 recites: “The pharmaceutical composition as claimed in claim 23…” in the preamble which is clunky. The claim should recite “The pharmaceutical composition of claim 23…”.
18. Claim 25 is objected to for missing a comma after “claim 24” and before “for use” in lines 1-2; and
Claim 25 is objected to for reciting the abbreviated term (NPM1). The full name should be spelled out, i.e., nucleophosmin, followed by the abbreviated name in parentheticals, (NPM1).
19. Claim 27 is objected to reciting the abbreviated term MLL. The full name should be spelled out, i.e., menin mixed-lineage leukemia, followed by the abbreviated term in parentheticals, (MLL).
Claim Rejections - 35 USC § 112(b)
20. 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.
21. Claims 2-6, 8-10, 12, 22, 23 and 26 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.
22. Claims 2, 3, 6, 8, and 9 each recite the limitation "[t]he compound according to claim 1" or “[a] compound as claimed in claim 1” in the preamble. There is insufficient antecedent basis for this limitation in the claims, because there is no prior recitation of “a compound” in claim 1.
23. Claims 4, 5, 10, 12, 22, and 23 are rejected as being dependent upon and failing to further limit the rejected base claim from which they depend.
24. CLAIM 8 is rejected as being indefinite for reciting “A compound as claimed in claim use as a medicament.” It is unclear whether the claim is drawn to (a) a compound, or (b) an intended use of said compound as a medicament, or (c) a process of making a medicament/ the compound is used in making the medicament. If the claim is intended to be drawn to a use/ process, the claim does not set forth any steps involved in the “use”/ method/ process, such that it is unclear what is intended or embraced by said “use”/ method/ process. A claim is indefinite when it merely recites a “use,” but fails to define any active, positive steps delimiting how this “use” is actually practiced.
In view of a broadest reasonable interpretation of the purpose of applying prior art, claim 8 is construed as follows:
“A compound of claim 1, for use as a medicament.”
25. Claim 12 recites the limitation “…solid tumor cancers such as prostate cancer, lung cancer, breast cancer, pancreatic cancer, colon cancer, liver cancer, melanoma and glioblastoma “ in lines 2-3. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
26. Claim 26 recites the limitation “…solid tumor cancers such as prostate cancer, lung cancer, breast cancer, pancreatic cancer, colon cancer, liver cancer, melanoma and glioblastoma “ in lines 2-3. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112(a)
27. 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.
28. Claims 8-13 and 23-27 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for the instantly recited compound, (R)-N-ethyl-5-fluoro-N-isopropyl-2-((5-(2-(6-((2-methoxy-ethyl)(methyl)amino)-2-methylhexan-3-yl)-2,6-diazaspiro[3.4]octan-6-yl)-1,2,4-triazin-6-yl)oxy)benzamide besylate salt, its pharmaceutical composition and its in vivo efficacy in a murine model of acute myeloid leukemia (AML) (pages 66-68), is not considered enabled for use as a medicament (claim 8) or in the prevention or treatment of all types and kinds of cancer (claims 9 and 23), or the scope of cancers embraced by claims 10-13 and 24-27 including leukemias, lymphomas, myelomas or solid tumor cancers such as prostate cancer, lung cancer, breast cancer, pancreatic cancer, colon cancer, liver cancer, melanoma and glioblastoma.
29. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
30. The standard for determining whether the Specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? As recognized by the court in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), that is still the standard to be applied, determined by consideration of the Wands factors (MPEP 2164.01(A)); namely, nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered, with the most relevant factors discussed below
31. Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
32. In the instant case, the claimed invention pertains to the compound of claim 1 (alleged by the Specification to demonstrate Menin inhibition), or its pharmaceutical composition (claim 6) for use as a medicament (claim 8) or in the prevention or treatment of all types and kinds of cancer (claims 9 and 23), wherein the cancer is leukemia, myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPN) (claims 10 and 24) or (NPM1)-mutated leukemia (claims 11 and 25) or the scope of cancers embraced by “leukemias, lymphomas, myelomas or solid tumor cancers such as prostate cancer, lung cancer, breast cancer, pancreatic cancer, colon cancer, liver cancer, melanoma and glioblastoma” (claims 12 and 26) or acute leukemias, chronic leukemias, myeloid leukemias, myelogeneous leukemias, lymphoblastic leukemias, lymphocytic leukemias, Acute myelogeneous leukemias (AML), Chronic myelogenous leukemias (CML), Acute lymphoblastic leukemias (ALL), Chronic lymphocytic leukemias (CLL), T cell prolymphocytic leukemias (T-PLL), Large granular lymphocytic leukemia, Hairy cell leukemia (HCL), MLL-rearranged leukemias, MLL-PTD leukemias, MLL amplified leukemias, MLL-positive leukemias, and leukemias exhibiting HOX/MEIS1 gene expression signatures (claims 13 and 27).
33. The Relative Skill of those in the Art: Those practitioners who treat cancer(s) of any type (medical clinicians, pharmacists and/or pharmaceutical chemists) presumably would be highly skilled in the art.
34. The State of the Prior Art and the Level of Predictability in the Art: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.”
35. As discussed above, the instantly claimed invention pertains to the use of the Menin inhibitor compound of claim 1 or its pharmaceutical composition (claim 6) for use as a medicament (claim 8) or in preventing or treating the extremely broad scope of cancers embraced by claims 9, 12, 23, and 26, and types of leukemias of claims 10, 11, 13, 24, 25 and 27. The state of the art is that Menin inhibitors have demonstrated anticancer effects against a certain types of leukemias, wherein disruption of Menin/MLL interaction is a promising therapeutic approach for treating MLL rearranged leukemias and MLL-PTD-related leukemias, (Specification, page 2, first paragraph).
36. Applicants are claiming the use of a compound or composition of the claims as a medicament (claim 8) for treating any disease or disorder or for treating or preventing any type of cancer, including the vast scope of cancers embraced by any/all types of leukemias, lymphomas, myelomas, and solid tumor cancers such as prostate cancer, lung cancer, breast cancer, pancreatic cancer, colon cancer, liver cancer, melanoma and glioblastoma. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to therapeutic effects of the above listed cancers, whether or not the cancer is affected by the Menin inhibition would make a difference. As such, regarding claim 8, the Specification fails to describe or define what is embraced by the term “medicament” or the “use as a medicament” or the use of the compound for making a medicament/ the manufacture of a medicament. Regarding claim 9, the Specification fails to enable the skilled artisan to use the instant method to treat or prevent the full scope of the recited types of cancer encompassed by claims 9-13 and 12-17, however the Specification does provide support for increasing survival in mice bearing established OCI-AML3 xenograft tumors, (i.e., a model of acute myeloid leukemia (AML)) as demonstrated in pages 66-68 of the Specification and Figure 3.
37. Even though Applicant’s instant compound may have been identified as having Menin inhibitory activity as well as anti-cancer activity against AML tumors (Figure 3), as a practical matter its use as a therapeutic agents for treating/preventing the broad scope of types and kinds of cancers as claimed, remains extremely unpredictable. It is noted that the pharmaceutical art generally is unpredictable, requiring each embodiment to be individually assessed for physiological activity. The court in In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) held that, “in cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.'' In other words, the more unpredictable an area the more specific enablement is needed in order to satisfy the statute. In the instant case, it has not yet been established in the art that antiproliferative activity would be effective, or even desirable, across the broad range of recited cancer types.
38. Hence, in the absence of a showing of correlation between the full scope of cancers to be treated or prevented, using the compound of claim 1 or its pharmaceutical composition, one of skill in the art is unable to fully predict possible results from the use of said compound or composition (claim 8) or for treating or preventing the broad scope of cancers recited in claims 9-13 or 23-27. There is no question that certain of Applicant’s instant compounds may play a role in future methods of treating some of the aforementioned MLL-related leukemias (specifically AML). What is disputed is the claim that a compound of claim 1 or its composition could be taken by one skilled in the art at the time of filing and used as treatment/prevention for the full scope of cancers embraced by the claims without undue experimentation. There is simply not enough evidence to be found in the literature suggesting that Applicant’s compound is capable of being used in the manner recited, to treat or prevent each and every cancer that is encompassed by the claim language. In essence, there is no absolute predictability in pharmacology, even with compounds whose properties have been determined, despite the extraordinarily high skill possessed by the ordinary artisan.
39. The Amount of Direction Provided by the Inventor / Existence of Working Examples: The amount of direction provided by the Applicant is determined by the Specification and the working examples.
40. In the instant case, the Specification demonstrates the survival rate of mice established with only one type of tumor cell line, OCI-AML3, (acute myeloid leukemia) which have been treated with the compound of claim 1.
41. The Scope or Breadth of the Claims: As stated in MPEP 2164.01(c), “[w]hen a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation.” Thus, as stated in MPEP 2164.08, “[t]he focus of the examination inquiry is whether everything within the scope of the claim is enabled” (emphasis added). Indeed, the Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright, 999 F.2d 1557 (Fed. Cir. 1993) (emphasis added).
42. At the same time, however, it is also recognized that not everything necessary to practice the invention need be disclosed. Nor is it necessary that an Applicant test all the embodiments of his invention. In re Angstadt, 537 F.2d 498 (CCPA 1976) (emphasis added). In fact, as stated by the court in In re Buchner, 929 F.2d 660 (Fed. Cir. 1991), a patent need not teach, and preferably omits, what is well known in the art.
43. Accordingly, for purposes of enablement, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate in scope with the protection sought by the claims. Thus, while “a patent application is entitled to claim his invention generically” it is necessary that “he provide a disclosure sufficient to enable one skilled in the art to carry out the invention commensurate with the scope of his claims." Amgen, Inc, v. Chugai Pharmaceutical Co., Ltd. (Fed. Cir. 1991). As noted by the court in In re Fisher, 427 F.2d 833 (CCPA 1970), the scope of enablement must bear a “reasonable correlation” to the scope of the claims. See also Ak Steel Corp. v. Sollac, 344 F.3d 1234 (Fed. Cir. 2003) and In re Moore, 439 F.2d 1232 (CCPA 1971). As stated in MPEP 2164.08, resolution of this concern requires two stages of inquiry: “[t]he first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claim without undue experimentation”.
44. As to the first inquiry, as discussed above, the claims are drawn to the compound of claim 1 (alleged by the Specification to demonstrate Menin inhibition), or its pharmaceutical composition (claim 6) for use as a medicament (claim 8) or in the prevention or treatment of all types and kinds of cancer (claims 9 and 23), wherein the cancer is leukemia, myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPN) (claims 10 and 24) or (NPM1)-mutated leukemia (claims 11 and 25) or the scope of cancers embraced by “leukemias, lymphomas, myelomas or solid tumor cancers such as prostate cancer, lung cancer, breast cancer, pancreatic cancer, colon cancer, liver cancer, melanoma and glioblastoma” (claims 12 and 26) or acute leukemias, chronic leukemias, myeloid leukemias, myelogeneous leukemias, lymphoblastic leukemias, lymphocytic leukemias, Acute myelogeneous leukemias (AML), Chronic myelogenous leukemias (CML), Acute lymphoblastic leukemias (ALL), Chronic lymphocytic leukemias (CLL), T cell prolymphocytic leukemias (T-PLL), Large granular lymphocytic leukemia, Hairy cell leukemia (HCL), MLL-rearranged leukemias, MLL-PTD leukemias, MLL amplified leukemias, MLL-positive leukemias, and leukemias exhibiting HOX/MEIS1 gene expression signatures (claims 13 and 27). Thus it is evident that the claims are broad. Yet, as discussed above, the instant Specification discloses only 3 compound species encompassed by “PTGER3 inhibitor” as recited by the claims.
45. While claims 9 and 12 are directed to the use of said compound for preventing or treating any type of cancer, and claims 10-13 and 24-27 specify the types of cancers that fall within their scope, due to the unpredictable nature of cancer, the various types of recited cancers have different causative agents, involve different cellular mechanisms, and differ in treatment protocol. And, no single compound or class of compounds exist that are known to treat all cancers as a blanket therapeutic, e.g., the Merck® manual currently has many cancer treating agents (over 12,000 compounds), yet they are only known to treat a few cancers each. The argument that the cancers recited as treatable or preventable by the Applicants are all treated/ prevented by inhibiting Menin activity is insufficient support that the claimed method of administering the Menin inhibitor of claim 1 has specific efficacy in current available form for treating/preventing all of the cancers encompassed by claims 9-13 and 23-27.
As such, the claim is extremely broad with respect to the disclosure. The second inquiry is discussed in detail below.
46. Amount of Experimentation Necessary: In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the invention as claimed. After applying the Wands factors and analysis to claims 8-13 and 23-27, in view of the Applicant’s entire disclosure and the state of the art, it is concluded that the practice of the invention as claimed would not be enabled by the written disclosure. Thus, the specification fails to provide sufficient support for the broad use of the claimed Menin inhibitor for treating or preventing the full scope of cancers embraced by the claims. The Examiner suggests limiting the use of the compound of claim 1 to the treatment of cancers that are enabled by Applicant’s disclosure, i.e., the MLL-related leukemia AML, and deleting claim 8 as well as the term “prevention” from the claims.
Claim Rejections - 35 USC § 101
47. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
48. Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
CLAIM 8 recites: “A compound as claimed in claim use as a medicament.” It is not clear whether the claim recites (a) a product (a compound), or (b) the use of said compound as a medicament (i.e. intended use), or (c) a process of making a medicament. because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131,149 USPQ 475 (D.D.C. 1966).
Claim 8 is also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention. Looking to the specification, the invention relates to the compound of the present invention “for use as a medicament,” or “the use of the compound of the present invention, of the manufacture of a medicament,” (page 48, lines 5-7) but fails to describe or define what is embraced by the term “medicament” or the “use as a medicament” or the use of the compound for making a medicament/ the manufacture of a medicament. The Specification fails to provide any written description for claim 8 as presently written.
Double Patenting
49. 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).
50. 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).
51. 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.
52. 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.
53. Claims 1, 2, 6, 8-13 and 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,473,295 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because Applicant’s instant claims recite the following compound:
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54. U.S. Pat. No. 12,473,295 B2 recites the following:
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55. As such, the claims of U.S. Pat. No. 12,473,295 B2 recite the same compound that is instantly recited by Applicant, or a pharmaceutically acceptable salt or solvate thereof in claims 1-5. U.S. Pat. No. 12,473,295 B2 recites a pharmaceutical composition comprising said compound, and a pharmaceutically acceptable carrier or diluent in claim 9. U.S. Pat. No. 12,473,295 B2 recites methods of using said compound for treating leukemia wherein the leukemia is selected from myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPN), more specifically (NPM1)-mutated leukemia, acute leukemias, chronic leukemias, myeloid leukemias, myelogeneous leukemias, lymphoblastic leukemias, lymphocytic leukemias, Acute myelogeneous leukemias (AML), Chronic myelogenous leukemias (CML), Acute lymphoblastic leukemias (ALL), Chronic lymphocytic leukemias (CLL), T cell prolymphocytic leukemias (T-PLL), Large granular lymphocytic leukemia, Hairy cell leukemia (HCL), MLL-rearranged leukemias, MLL-PTD leukemias, MLL amplified leukemias, MLL-positive leukemias, and leukemias exhibiting HOX/MEIS1 gene expression signatures.
56. U.S. Pat. No. 12,473,295 B2 does not explicitly recite the besylate salt that is instantly recited by Applicant.
57. Yet, the Specification defines pharmaceutically acceptable salts of the compound of claim 1:
“The pharmaceutically acceptable salts as mentioned hereinabove or hereinafter are meant to comprise the therapeutically active non-toxic acid and base salt forms which the compounds of Formula (I) and solvates thereof, are able to form.
Appropriate acids comprise, for example, inorganic acids such as hydrohalic acids, e.g. hydrochloric or hydrobromic acid, sulfuric, nitric, phosphoric and the like acids; or organic acids such as, for example, acetic, propanoic, hydroxyacetic, lactic, pyruvic, oxalic (i.e. ethanedioic), malonic, succinic (i.e. butanedioic acid), maleic, fumaric, malic, tartaric, citric, methanesulfonic, ethanesulfonic, benzenesulfonic,” (column 9, lines 31-43).
A salt formed from benzenesulfonic acid is also known as benzenesulfonate and also known as besylate.
58. Therefore it would have been obvious to one skilled in the art to prepare the besylate salt form of the compound recited in claim 1, as guided by the Specification of U.S. Pat. No. 12,473,295 B2, with a reasonable expectation of success. Please refer to MPEP § 804 II.B.2(a), i.e. the specification of the reference patent may be relied upon to properly construe the scope of the reference claim, and “may be considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent.” See also In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970): those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application).
59. Regarding instant claims 9-13 and 23-27, which recite the instantly claimed compound or composition, “for use in the prevention or treatment of cancer,” the preambles recite a compound or composition, and while the use of a descriptive clause, i.e. “for use in…,” when referring to the contemplated use (i.e. “intended use”) of a claimed compound is proper, it is not a limitation and thus of no significance in determining the patentability thereof over the prior art, please refer to In re Thomas (CCPA 1949) 178 F2d 412, 84 USPQ 132. A “mere statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable.” In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969).
Therefore, claims 1, 2, 6, 8-13 and 23-27 are prima facie obvious over the claims of U.S. Pat. No. 12,473,295 B2.
Conclusion
60. Claims 1-28 are present in the application. Claims 3-5, 7, 14-21 and 28 are presently withdrawn. Claims 1, 2, 6, 8-13 and 23-27 are rejected. Claims 1, 8, 11, 13, 25, and 27 are objected to. No claim is presently allowed.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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