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/Restriction
Applicant elected, without traverse, Group I invention and species, compound of formula (1) crystalline monohydrate form, on August 18, 2026.
Claims 1-4 read on elected invention and species.
Claims 7-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected inventions.
Claims 5-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species.
Claim Status
Claims 1-8 are pending.
Claims 5-8 are withdrawn.
Claims 1-4 are currently under examination in this office action.
Priority
This instant application 18/679,934 filed on May 31, 2024 is a divisional of U.S. Application No. 17/464,166 (now US patent No.12030873) filed on September 1, 2021, which is a continuation of U.S. Application No. 16/604,002(now US patent No. 11142518), filed on October 9, 2019, which is a national stage filing under section 371 of International Application No. PCT/1B2018/052745, filed on April 20, 2018, and published on October 25, 2018 as WO 2018/193410, which claims priority to Great Britain Application No. 1706327.2, filed on April 20, 2017.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of foreign GB Application No. 1706327.2 was filed in parent application No.16/604,002.
Information Disclosure Statement
The information disclosure statements filed on 09/19/2024 and 11/08/2024 are being considered by the Examiner.
Claim Interpretation
Instant claimed compound of formula I, (2R)-2-(6-{5-chloro-2-[(oxan-4-yl)amino]pyrimidin-4-yl}-1-oxo-2,3-dihydro-1H-isoindol-2-yl)-N-[(1S)-1-(3-fluoro-5-methoxyphenyl)-2-hydroxyethyl]propanamide ( CAS#2095719-92-7) (AKA Beroterkib or ASTX029), is an investigational cancer drug as an ERK1/2 inhibitor (See https://pubchem.ncbi.nlm.nih.gov/compound/Beroterkib-anhydrous).
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.
Claims 1-4 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 recites compound of formula 1 is “substantially crystalline hydrate form”. Claims 3 and 4 recites “substantially crystalline monohydrate form”. Instant Spec ( PGPub US 2025/0002481 A1 [0034] discloses: The term “substantially crystalline” refers to forms of the compound of formula (l) in which it is from 50% to 100% crystalline. Within this range, the compound of formula (l) may be at least 55% crystalline, or at least crystalline, crystalline, crystalline, or at least 70% crystalline, or at least or at least 90% crystalline, or at least or at least 98% crystalline, or at least crystalline, or at least 99.5% crystalline, or at least 99.9% crystalline, for example 100% crystalline. It’s not clear how many molecules of water per molecule of compound I is considered as substantially crystalline monohydrate form, 0.6 molecule of water or 1.5 molecule of water per molecule of compound of formula (l) ? The term “substantially” renders instant claims indefinite since if does not clearly set forth the metes and bounds of the patent protection desired.
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11142518. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims are drawn to (2R)-2-(6-{5-chloro-2-[(oxan-4-yl)amino]pyrimidin-4-yl}-1-oxo-2,3-dihydro-1H-isoindol-2-yl)-N-[(1S)-1-(3-fluoro-5-methoxyphenyl)-2-hydroxyethyl]propanamide, having the formula (1) or a tautomeric form thereof, in a substantially crystalline form.
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Reference claim 2 recites at least 55% crystalline.
Reference claims 3-10 further recite characterization of the substantially crystalline form.Reference claim 10 recites the crystalline form exhibits a weight loss between 85° C and 130° C when subjected to thermogravimetric analysis.
Reference claims are silent about the crystalline form is substantially crystalline hydrate form. A skilled artisan would have known the weight loss in thermogravimetric analysis might due to hydrate or solvate. The Spec of reference application also discloses crystalline form of compound (1) is a monohydrate and the crystal form contains one molecule of water of crystallization (See Col 5.). Thus, instant claimed crystalline hydrate form is within the scope of reference claimed crystalline form.
Conclusion
No claim is allowed.
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/L.M./Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
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