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
Applicant’s election without traverse of Group I, drawn to the crystalline or pharmaceutically acceptable solvate or hydrate thereof; and a pharmaceutical composition comprising said crystalline and at least one pharmaceutically acceptable excipient; and Crystalline Form I of N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl)phenyl)propane-1-sulfonamide as the elected crystalline species in the reply filed on November 10, 2025 is acknowledged.
Claims 15-16, 22-23, 30-33, 39, 41-42 and 53-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 10, 2025.
Status of the Claims
Acknowledgement is made of the receipt and entry of the amendment filed on November 10,
2026, wherein claims 1, 3-4, 10-11, 13, 15-16, 22-23, 25, 30-33, 39, 41-42 and 53-54 are unchanged; and claims 2, 5-9, 12, 14, 17-21, 24, 26-29, 34-38, 40, 43-52, and 55-65 are cancelled.
Claims 1, 3-4, 10-11, 13, 15-16, 22-23, 25, 30-33, 39, 41-42 and 53-54 are pending.
Claims 15-16, 22-23, 30-33, 39, 41-42 and 53-54 are withdrawn.
Claims 1, 3-4, 10-11, 13 and 25 are under examination in accordance with the elected invention and species.
Priority
The instant application 18/255,227 filed on May 31, 2023 is a 371 of PCT/US21/61375 filed
on December 1, 2021, which claims priority to, and the benefits of U.S. Provisional Application No.
63/120,588 filed on December 2, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2/9/2024, 12/20/2024, 8/21/2025 and 11/10/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Please note that foreign references without an English translation but have an English
translation of the abstract will only have the abstract considered by the Examiner.
Claim Objections
Claim 25 is objected to because of the following informalities:
Regarding claim 25, the recitation of "crystalline N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl)phenyl)propane-1-sulfonamide of claim 1" is missing a definite article -the-, which is a determiner that introduce the subject matter that has already been mentioned, in this case, claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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, 3-4, 11 and 13 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.
Regarding claim 1, independent claim should introduce the subject matter using the indefinite article -a- or -an- to establish proper antecedent basis. In the present case, the recitation of “[C]rystalline N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl)phenyl)propane-1-sulfonamide (Compound A)” without an article renders the claim indefinite, because it is not clear if applicant is intending to claim a single crystalline form of Compound A or is intending to claim a subject matter that is a mixture or a plurality of crystalline forms of Compound A. The lack of clarity renders the claim indefinite as one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claims 3-4, 11, 13, the term “substantially” recites in the phrase of “substantially the same” is a relative term which renders the claim(s) indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree. In the present case, the claim(s) and the specification do not clearly set forth what is considered to be substantially similar versus insubstantially similar. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Regarding claim 3, the recitation of “combinations thereof” renders the claim indefinite, because the plural form of combination (“combinations”) is used to refer to multiple sets of two or more things. In the present case, when the term “combinations” is used within the context of characteristics, it is not clear if applicant is intending to claim any combination of at least two characteristics from the list, or is intending to claim a combination of a first combination (a combination of at least two characteristics from the list) with a second combination (another combination of at least two characteristics from the list). If applicant is intending to refer to the second scenario, the “combinations thereof” recites therein requires the presence of at least four characteristics from the peak. The lack of clarity renders the claim indefinite as one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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 1, 3-4, 10-11, 13 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Instant claim 1 recites “[c]rystalline N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl)phenyl)propane-1-sulfonmnide (Compound A):
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or pharmaceutically acceptable solvate or hydrate thereof”. The specification discloses only two crystalline species of Compound A, which are Crystalline Form I and Crystalline Form II of Compound A. The specification does not disclose any other crystalline species of Compound A as broadly encompassed by the claim(s).
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plain for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications under the 35 U.S.C. 112.I "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5,2001), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter alia, "functional characteristics when coupled with a known or disclosed correlation between function and structure ..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover, although Eli Lilly and Enzo were decided within the factual context of DNA sequences, this does not preclude extending the reasoning of those cases to chemical structures in general. Univ. of Rochester v G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y. 2003).
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the present case, the specification only described two crystalline species of Compound A, specifically a crystalline form I in Example 2 and Fig. 1 and a crystalline form II in Example 3 and Fig. 4. Instant claim(s) recite three peaks in the X-ray powder diffraction pattern is insufficient to identify a specific crystalline species of Compound A, because it only provides one piece of information. A complete pattern containing at least four strongest reflections (major peaks) is often required to reveal the crystal's unique fingerprint. A single peak corresponds to a single interplanar spacing (d-spacing) from Bragg's Law, but a crystal structure is defined by the arrangement of all atoms within its unit cell, including lattice parameters, crystal system, and space group. In the absence of a sufficient recitation of a representative number of species for a claimed genus, while applicant is in possession of crystalline form I with an X-ray powder diffraction pattern as shown in Fig. 1 and a crystalline form II with an X-ray powder diffraction pattern as shown in Fig. 4, it is not apparent that Applicant was actually in possession of any specific crystalline species of N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl)phenyl)propane-1-sulfonmnide (compound A) or pharmaceutically acceptable solvate or hydrate thereof characterized by an X-ray diffraction pattern comprising the three peaks claimed in the dependent claims at the time the application was filed.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 10-11, 13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhu et al. (US-2013/0053384 A1; cited in the IDS filed on February 9, 2024).
Zhu et al. teaches a compound of Example 6, N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl) phenyl) propane-1-sulfonamide, having the structure of:
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is a compound of Formula I useful for treating cancer, such as colon carcinoma (see e.g., [0470]; [0415]). Zhu et al. further teaches compounds of Formula I also include crystalline and amorphous forms of those compounds, including, for example, polymorphs, pseudopolymorphs, solvates (including hydrates), unsolvated polymorphs (anhydrates), conformational polymorphs, and amorphous forms of the compounds, as well as mixtures thereof (see e.g., [0146]). Zhu et al. further teaches pharmaceutical compositions include at least one pharmaceutically acceptable carrier, diluent or excipient and at least one compound of Formula I, described herein as an active ingredient (see e.g., [394]).
In the present case, the fact that Zhu et al. teaches the compound of Example 6 includes crystalline forms, and a pharmaceutical composition comprising said compound with at least one pharmaceutically acceptable excipient, Zhu et al. anticipates the claimed invention.
Regarding claims 3, 10-11 and 13, the limitation(s) recites therein is drawn to the characteristics of crystalline compound A instantly claimed. Although Zhu et al. is silent regarding the characteristics of the crystalline form(s); However, the claimed characteristics will naturally flow from the teachings of Zhu et al., since a crystalline compound of Example 6 and its characteristics are inseparable.
Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s claimed crystalline is different and, if so, to what extent, from that of the discussed reference.
Therefore, the claimed invention is being anticipated by Zhu et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 10-11, 13 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 14 of U.S. Patent No. 10,561,652 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent are drawn to a compound, N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl) phenyl) propane-1-sulfonamide, or a pharmaceutically acceptable salt thereof (see e.g., claims 1 and 3); and a pharmaceutical composition comprising a pharmaceutically acceptable carrier and the compound (see e.g., claims 14). Please note the pharmaceutically acceptable carrier taught by the reference patent comprises excipients.
The reference patent clearly teaches compounds of Formula I also include crystalline and amorphous forms of those compounds, and that anticipates the claimed invention. Although the claims of the reference patent is silent regarding the characteristics of the crystalline form(s); However, the claimed characteristics will inevitably flow from the teachings of Zhu et al., since the compound of the reference patent, N-(2,4,5-trifluoro-3-(3-morpholinoquinoxaline-6-carbonyl) phenyl) propane-1-sulfonamide, includes a crystalline and the characteristics of crystalline are inseparable from the compound.
Conclusion
No claims are allowed.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628