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 the Claims
Claims 1, 2, 7, 8, and 11-15 are pending. Acknowledgment is made of the cancellation of claims 3-6 and the addition of new claims 12-15 in the reply filed 09/23/2025.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Instant application is a U.S. National Stage Entry of PCT/CN2021/101779, filed 06/23/2021. PCT/CN2021/101779 claims priority of foreign applications CN202110563762.2, filed 05/22/2021, and CN202010579560.2, filed 06/23/2020. Therefore, the effective filing date is 06/23/2020.
Information Disclosure Statement
The information disclosure statement filed 02/20/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the NPL reference by Hirayama Yoshinaki does not have an English translation provided. It has been placed in the application file, but the information referred to in this reference only has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Restriction Requirement
Applicant’s election without traverse of Group I, directed to a crystalline form of a mesylate salt of formula (I), which reads on claims 1, 2, 7, and 12-15, in the reply filed on 09/23/2025 is acknowledged.
Claims 8 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/23/2025.
Objections – Drawings
The drawings are objected to for minor informalities.
37 C.F.R. 1.84 states (emphasis added):
(t) Numbering of sheets of drawings.
The sheets of drawings should be numbered in consecutive Arabic numerals, starting with 1, within the sight as defined in paragraph (g) of this section. These numbers, if present, must be placed in the middle of the top of the sheet, but not in the margin. The numbers can be placed on the right-hand side if the drawing extends too close to the middle of the top edge of the usable surface. The drawing sheet numbering must be clear and larger than the numbers used as reference characters to avoid confusion. The number of each sheet should be shown by two Arabic numerals placed on either side of an oblique line, with the first being the sheet number and the second being the total number of sheets of drawings, with no other marking.
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(u) Numbering of views.
(1) The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.
The numbering of pages on the drawings is not in the middle of the top of the sheet, and the view numbers are not preceded by the abbreviated “FIG.”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 12-15 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.
Claim 2 recited the limitations associated with the X-ray powder diffraction pattern of crystalline form II-A. Figure 105 from the specification provides the data of 2θ values associated with form II-A. By definition, then, an X-ray powder diffraction of a crystal of form II-A will generate these peaks necessarily, as they are an inherent property of form II-A.
Therefore, claims 12-15, which recite features and 2θ values associated with form II-A, would not be further limiting the scope of claim 2, from which these claims depend, since the features and 2θ values associated with form II-A are inherent properties of form II-A, as demonstrated by Figure 105.
This rejection would be overcome by removing “crystalline form II-A” from the claims.
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 and 7 are rejected under 35 U.S.C. 103 as being obvious over Zhu et al. (WO 2020200158 A1, filed 30 March 2020), hereinafter referred to as reference ‘158, English translation provided.
The applied reference has a common inventor and applicant 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).
Reference ‘158 teaches, on page 20, compound 16, which is the compound of formula (I) from instant claim 1. Claim 9 teaches a pharmaceutical composition comprising said compound. It is taught, on page 31 of the English translation, that “[T]he compounds of formula (I), formula (II), formula (III), and formula (IV) and formula (V) (including salts and solvates thereof) may exist in crystalline form. … Those skilled in the art can understand, for example, by changing or adjusting the conditions used in the crystallization/recrystallization of compounds of formula (I), formula (II), formula (III), and formula (IV) and formula (V). It is possible to produce different polymorphs.” The mesylate salt of the compounds is taught on page 31 of the English translation.
Reference ‘158 fails to explicitly teach an embodiment comprising a crystalline form of the mesylate salt of formula (I).
However, the prior art teaches that a mesylate salt of the compound may be formed, and also teaches the crystallization of said compound, including the salts thereof.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to make a crystalline form of a mesylate salt of formula (I) since the prior art suggests doing this.
One would have a reasonable expectation of success since the prior art suggests that multiple polymorphs can be made of the compound and its mesylate salt.
Claim 2 is objected to as being dependent upon a rejected claim.
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.
Nonstatutory 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 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-6 of copending Application No. 18/002,578 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘578 teaches, in claims 1 and 4, a mesylate salt of a compound of formula (I), which is the compound of instant claim 1. Claim 5 teaches the mesylate salt in a ratio of 1:1 with the compound of formula (I). Claim 6 teaches a pharmaceutical composition comprising said salt of formula (I).
Application ‘578 fails to explicitly teach a crystalline form of the mesylate salt of formula (I).
However, it would be prima facie obvious to one of ordinary skill in the art to make a crystalline form of a drug, as this is well-known in the art.
One of ordinary skill in the art would be motivated to make a crystalline form of the 1:1 ratio of mesylate to formula (I) taught in Application ‘578 because crystallization is often employed to purify compounds in drug development in order to test the stability and efficacy of drugs.
One would have a reasonable expectation of success because the crystallization of known compounds is common practice in the art, especially with respect to drug development.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Advisory Notice
Claim 2 appears allowable if rewritten in independent form. The prior art reference above does not teach or suggest a specific crystalline form of a mesylate salt of formula (I) that has the X-ray diffraction pattern described in instant claim 2.
Conclusion
Claims 1, 7, and 12-15 are rejected.
Claim 2 is objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 9-5.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624