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 .
Application Status
The preliminary amendment filed on 6/06/2025 is acknowledged. Claims 1-4, 15-16, 23-24, 35, 43-44, 55, 63-64, 75, 83-84, 95, 103-104, 115, 123-124, 135, 143-144, 155, 163-164, 175, 183-187 and 189-194 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement filed on 8/27/2024 is acknowledged and has been considered except where lined though.
Claim Objections
Claim 83 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 63. 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).
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)(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.
Claim(s) 1-4, 15, 23-24, 43-44, 55, 63-64, 83-84, 95, 103-104, 123, 143, 163-164, 175, 183-187 and 189-194 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kinnate Biopharma Inc. (WO2021/247969, 2021-12-09, IDS) as evidenced by Ivanisevic, I., McClurg, R.B. and Schields, P.J. (2010). Uses of X-Ray Powder Diffraction In the Pharmaceutical Industry. In Pharmaceutical Sciences Encyclopedia, S.C. Gad (Ed.).
The applied reference has a common inventor 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. 102(a)(2) 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) if the same invention is not being claimed; 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 in the reference 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.
The WO document teaches a compound having the structure
PNG
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273
170
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, wherein the compound is obtained as a white solid following concentration from acetonitrile in water (paragraphs 00626 and 00660). Moreover, the WO document teaches pharmaceutical compositions comprising said compounds and methods of treating cancer comprising administering a pharmaceutical composition (see claims 34 and 39-40 of the WO document). Thus, while the prior art does not specifically disclose the X-Ray diffraction patterns, endothermic peaks or thermogravimetric analysis of the compound, it is reasonable to assume that at least one X-Ray diffraction peak, a similar endothermic peak and/or thermogravimentric analysis substantially similar to at least Form 1 would be present since the specification teaches that Form 1 was obtained in an acetonitrile/water solvent system contains the diffraction pattern as shown in Figure 2 with peaks identified in Table 1, a theoretical water content of 3.3% and two melting peaks at 104oC and 194oC which correspond to melting of Form V and Form II. Moreover, a comparison of the X-ray diffraction peaks shows that at least a 2-theta value of 11.8o+/-0.3 is found in forms 1-3, 5-6 and 8-9. Thus, for at least the claims with the single peaks it is reasonable to assume that the compound of the prior art would such peaks. Ivanisevic et al. teach that it is not uncommon for two patterns to share some but not all of the peak positions, wherein this can be a coincidence or it can be due to one of the samples being a mixture of multiple phases, including the phase in the other sample (page 12, 2nd full paragraph). Applicants are reminded that the Office does not have the facilities and resources to determine the analytical information of the solid of the prior art. Burden is on Applicants to show that the solid of the prior art does not possess the claimed limitations. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01.
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 ) 1-4, 15, 23-24, 43-44, 55, 63-64, 83-84, 95, 103-104, 123, 143, 163-164, 175, 183-187 and 189-194 rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 2, 5 and 6 of U.S. Patent No. 12,331,039. Although the claims at issue are not identical, they are not patentably distinct from each other because the US Patent claims a compound referred to as 3-[2-(1-Cyclopropyl-4,6-difluoro-1,3-benzodiazol-5-yl)ethynyl]-1-[(3S,5R)-5-(methoxymethyl)-1-(prop-2-enoyl)pyrrolidin-3-yl]-5-(methylamino)pyrazole-4-carboxamide or solvates thereof and a pharmaceutical composition comprising said compound. It is noted that the US Patent does not specifically claim that the compound is a solid. However, the specification of the US patent teaches that 3-[2-(1-Cyclopropyl-4,6-difluoro-1,3-benzodiazol-5-yl)ethynyl]-1-[(3S,5R)-5-(methoxymethyl)-1-(prop-2-enoyl)pyrrolidin-3-yl]-5-(methylamino)pyrazole-4-carboxamide was obtained as a white solid following concentration from acetonitrile in water (column 480, step 17).
Claims 1, 2, 5 and 6 of U.S. Patent No. 12,331,039 recites the same compound and pharmaceutical composition as the methods of examined claims 189-194. Claims 1, 2, 5 and 6 of U.S. Patent No. 12,331,039 differs from examined claims 189-194 because it is drawn to a compound or pharmaceutical composition rather than a method of treating a disease or disorder using the compound or composition comprising the compound.
The portion of the specification of 12,331,039 that describes subject matter that falls within the scope of claims 1, 2, 5 and 6 may be relied upon to properly construe the scope of that claim, including all of the composition’s disclosed uses or utilities. (MPEP 804(II)(B)(1)). In Sun Pharm. v. Lilly, the Court affirms this use of the specification and states,
A ‘claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use,’ extends to any and all such uses disclosed in the specification of the earlier patent.
. . .
[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . . and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted.
611 F.3d 1381, 1387 (Fed. Cir. 2010).
In this case, the specification of the US Patent describes the utility of the compound or composition of claims 1, 2, 5 and 6 to include treating diseases, such as cancer. (col. 2, lines 44-49). Claims 189-194, drawn to a method of using a the compound or composition to treat diseases, are not patentably distinct from claim 1, 2, 5 and 6 of the US Patent, drawn to the identical compound and pharmaceutical composition, which is disclosed in the specification to be useful for treating diseases.
Conclusion
Claims 16, 75, 115, 124, 135, 144 and 155 are rejected 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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