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 .
DETAILED ACTION
Status of the Claims
Claims 1-9, 11, 14, 18, 34, 39, 42, 45, 50-52 and 54-58 are currently pending. Claim 58 has been withdrawn. Claims 1-9, 11, 14, 18, 34, 39, 42, 45, 50-52 and 54-57 are rejected.
Response to Amendment/Arguments
The amendment filed 01/27/2026 is compliant with the requirements of 37 CFR 1.121(c), accordingly the amendment has been entered. Applicant’s arguments have been fully considered and are addressed below:
35 USC § 112 Rejections
The rejections of claims 50 and 51 under 35 USC 112(b) have been overcome by the amendments to said claims. The rejections have been withdrawn.
The rejection of claim 9 under 35 USC 112(d) has been overcome by the amendments to said claim. The rejection has been withdrawn.
Double Patenting Rejection
Applicant has requested the rejection of claims 1-9, 11, 14, 18, 34, 39, 42, 45 and 50-52 for nonstatutory double patenting over the claims of application 17/916,773 be held in abeyance until allowable subject matter is determined. See remarks filed 01/27/2026. The rejection is still considered proper and is therefore maintained.
Election/Restrictions
Newly submitted claim 58 is directed to an invention that lacks unity with the invention originally claimed for the following reasons:
Claims 1-9, 11, 14, 18, 34, 39, 42, 45, 50-52 and 54-57 (Group I) and claim 58 (Group II) lack unity of invention because there are no technical features shared between the independent claims. Group II (claim 58) is drawn to a method of treating a cancer in a subject by administering a Myt1 inhibitor, which is not necessarily one the of claimed compounds of Group I.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 58 is withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Double Patenting - Updated
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 1-9, 11, 14, 18, 34, 39, 42, 45, 50-52 and 54-57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-16, 18, 20, 23, 27, 43, 48, 51, 54, 59 and 61 of copending Application No. 17/916,773 (reference application).
Claim 11 of the copending application recites a method of using a compound of Formula (IA) as a Myt1 inhibitor. Formula (I) of the reference application is identical to Formula (IA) of instant claim 2. Further, reference claims 12, 13, 14, 15, 16, 20, 23, 27, 43, 48, 51, 54 and 59 claim compounds identical to those in instant claims 3, 4, 5, 6, 7, 11, 14, 18, 34, 39, 42, 45 and 50, respectively. Reference claim 18, which recites the limitation wherein R3 is optionally substituted C1-6 alkyl or chlorine, is a subgenus that anticipates instant claim 9 which recites the limitation wherein R3 is optionally substituted C1-6 alkyl or halogen. Moreover, each compound of reference claim 59 is identical to compounds of present claims 50 and 51. Thus, claims 1-7, 9, 11, 14, 18, 34, 39, 42, 45 and 50-51 are anticipated by the reference claims.
Regarding instant claim 8, drawn to a compound of formula III of claim 6,
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, wherein R2A is hydrogen, optionally substituted C1-6 alkyl or halogen, reference claim 59 recites compound 328,
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. Compound 328 reads on instant claim 8 wherein Y is N; R1 and R2 are each H; R3 and R4 are each C1 alkyl (methyl); R5 is -N(R7)2 wherein R7 is hydrogen; R6 is -C(O)NH(R8) wherein R8 is H; and R2A is H. Thus, claim 8 is anticipated by the reference claims.
Regarding instant claim 52, drawn to a pharmaceutical composition comprising the compound of claim 1, reference claim 61 discloses that the claimed inhibitor is administered as a pharmaceutical composition. Thus, claim 52 is anticipated by the reference claims.
Regarding instant claims 54-57, drawn to the compounds
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and
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, and compositions thereof, reference claim 59 discloses several comparable compounds, such as deuterated compounds 292 and 293,
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, as well as de-methylated compounds 193 and 195,
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. These reference compounds are nearly identical to the compounds of instant claims 54-57, except that either two methyl groups are deuterated or one methyl is removed in the reference claims. A person having ordinary skill in the art would expect these compounds to have similar properties given their similar structural features. Additionally, reference claim 61 discloses the Myt1 inhibitor being administered as a pharmaceutical composition. Thus, claims 54-57 are anticipated by the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-9, 11, 14, 18, 34, 39, 42, 45, 50-52 and 54-57 are rejected.
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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, Amy L. Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.F./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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