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 .
Status of Claims
Claims 1-20 are pending and examined.
Claims 1,3-10, and 13-20 are rejected.
Allowable Subject Matter
Claims 2 and 11-12 are allowed.
Priority
This application is a 371 of PCT/CN2022/091452, filed on 05/07/2022. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CHINA 202110501179.9, filed on 05/08/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Duplicate Claims Warning (Claim Objections)
Applicant is advised that claim 2 is allowable, and as such, claims 3-10 are objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Similarly, claim 12 is allowable, and as such, claims 13-18 are objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
While the claims are worded differently, they are directed to an identical polymorph.
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 6 and 16 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.
The term “substantially” in claims 6 and 16 is a relative term which renders the claims indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The lack of clarity renders the claims indefinite since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim Rejections - 35 USC § 112
Claims 19 and 20 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 20 refers to colorectal cancer in the preamble but does not require a subject in need thereof. To overcome this rejection, add the phrase to a “subject in need thereof” to claims 19 and 20.
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.
Claim 19 is 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 a method for inhibiting MNK2 in a subject in that has colon cancer, does not reasonably provide enablement for a method for inhibiting MNK1 and MNK2 in any and all subjects. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include: 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 regard to the instant claims, with the most relevant factors discussed below.
Nature of the Invention: The nature of the invention is complex in that Claim 19 is drawn to a method for inhibiting MNK1/2, which comprises administering to a subject a therapeutically effecting amount of the crystal form A according to claim 2.
However, the Applicant has not showed through working example that the claimed crystal form A affects MNK1, and only working examples drawn to MNK2 are provided. Additionally, the Applicant only shows working example for a colon cancer cell line, while claim 19, as written, is drawn to any and all subjects.
Breadth of the Claims: The claims are broad in that the claims recite a method for
Inhibiting MNK1 and MNK2 in any and all subjects by administering a therapeutically effective amount of crystal form A, but the Applicant does not demonstrate activity of the compound in MNK1, and does not demonstrate the method in any and all subjects, only a colon cancer cell line. The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims.
Guidance of the Specification and Existence of Working Examples: The specification demonstrates inhibitory activity of the claimed compound against MNK2 protein kinase in HCT116 cell strain p-eIF4E, and CT-26 cells, colon cancer cell lines.
However, no working examples are given for a method of inhibiting MNK1 and MNK2 in any and all subjects. While it is noted that the applicant has shown some data for activity against MNK2 in a colon cancer cell line using the claimed compound, the applicant is not enabled for a method of inhibiting MNK1 and MNK2 in any and all subjects.
Predictability and State of the Art: The state of the art at the time the invention was made was unpredictable and underdeveloped. It is known in the art that a related compound, eFT508, also known as Tomivosertib, has activity against MNK1 and MNK2. However, eFT508 contains notable structural differences from the Applicant’s claimed compound, as seen below. (Applicant’s compound – left; eFT508 – right)
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The assumption that the Applicant’s compound would share the MNK1/2 inhibition property of eFT508 cannot be made, as there are considerable changes to the core structure of the Applicant’s compound that go beyond what one skilled in the art would consider routine and obvious.
Roy, Kunal, and Arkaprava Banerjee. Activity Cliffs. SpringerBriefs in Molecular Science, Cham, Springer Nature Switzerland, 2025. Accessed 13 Feb. 2026 – teaches that even small structural changes can lead to dramatic and unexpected changes in activity.
Amount of Experimentation Necessary: The quantity of experimentation necessary to carry out the claimed invention is high, as the skilled artisan could not rely on the prior art or instant specification to teach how to inhibit MNK1 and MNK2 in any and all subjects.
In order to carry out the claimed invention, one of ordinary skill in the art would have to confirm the activity of cocrystal form A in both MNK1 and MNK2, and administer the claimed cocrystal form A in any and all subjects.
In view of the breadth of the claims and the lack of guidance provided by the specification as well as the unpredictability of the art, the skilled artisan would have required an undue amount of experimentation to make and/or use the claimed invention. Therefore, claim 19 is not considered to be fully enabled by the instant specification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-10, and 13-18 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. In particular, claims 2-10 are directed to an identical polymorph (crystal form A), and claims 12-18 are directed to an identical polymorph (crystal form B). 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.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
(Of Note: The following double patenting rejection is NONPROVISIONAL)
Claim 1 is rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of the U.S. Patent No. 12,492,215:
1-18 (for instant claims 1).
Although the claims are not identical, they are not patentably distinct from one another because the claims of the ’215 patent is drawn to the same compound of the instant application. The co-pending claims 1-18 are drawn to the compound of the instant application, as seen in instant claim 1. While the range of structures claimed in the co-pending application is broader than the single species of compound claimed in the instant application, the co-pending claims anticipate the instant claimed species. Further, the toluene sulfonic acid salt is taught by the ‘215 patent (See col. 13, line 64).
It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of U.S Pat. No. 12,492,215.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OROD MOTEVALLI whose telephone number is (571)272-6026. The examiner can normally be reached Monday - Friday 7:30AM - 5PM.
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/OROD MOTEVALLI/Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628