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, 8, 11, 21, 31-36, and 163-164 are pending in the instant application.
Claims 2-7, 9-10, 12-20, 22-30, and 37-162 have been canceled.
Information Disclosure Statement
The Information Disclosure Statement received December 8th, 2025 has been fully considered by the examiner, except where marked with a strikethrough.
Withdrawn Objections/Rejections
Applicant’s amendment is sufficient to overcome the rejections of Claims 1, 8, 11, 21, 31-37, and 42-43 under 35 U.S.C. 112(a). Claims 37 and 42-43 have been canceled, rendering the rejection thereof moot. This rejection is hereby withdrawn.
Applicant’s amendment and traversal of the rejection of Claims 36-37 and 42-43 under 35 U.S.C. 112(a) for being enabling for treating lung cancer, but not any disorder or condition by modulating an epidermal growth factor in general is sufficient to overcome the rejection. Claims 37 and 42-43 have been canceled, rendering the rejection thereof moot. At Page 7, Third Paragraph of the remarks filed December 8th, 2025, Applicant notes the specification sufficiently discloses examples of the instantly claimed compounds’ efficacy in treating brain cancer. This rejection is hereby withdrawn.
The cancellation of Claims 37 and 42-43 renders the provisional rejection thereof on the ground of nonstatutory double patenting moot. The provisional rejection over Claims 37 and 42-43 is withdrawn.
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.
The provisional rejection of Claims 1, 8, 11, 21, and 31-36 on the ground of nonstatutory double patenting as being unpatentable over claims 6, 10-11, 26-28, 30, 32, 34, 36, and 38-39 of copending Application No. 18/027,312 (reference application) is maintained and extended to newly presented Claims 163 and 164.
Applicant has traversed this rejection on the basis that the instantly recited groups of R1 (the group corresponding to A in the reference application) are not an obvious selection for the compounds recited in the reference application.
The examiner does not find this argument persuasive.
As noted in the non-final rejection mailed August 7th, 2025, Claim 6 of the reference application is drawn to compounds having the structure Ie:
PNG
media_image1.png
170
268
media_image1.png
Greyscale
wherein A is heterocyclyl. Per the specification of the reference application, at Page 41, Fourth Paragraph, “heterocyclyl” refers to “substituted or unsubstituted non-aromatic ring structures, preferably 3- to 10-membered rings, more preferably 3- to 7-membered rings, whose rings include at least one heteroatom, preferably one to four heteroatoms, more preferably one or two heteroatoms. The Terms ‘heterocyclyl’ and ‘heterocyclic’ also include polycyclic ring systems having two or more cyclic rings in which two or more carbons are common to two adjoining rings wherein at least one of the rings is heterocyclic …” Based on this definition, each of the instantly recited moieties defining R1 at Claim 1 reads on a compound of formula Ie as recited in the reference application. For clarity, a full explanation of the overlapping scope of compounds claimed by the instant application and the reference application is provided below.
Claim 10 of the reference application narrows the scope of compounds to compounds of formula IIa:
PNG
media_image2.png
209
332
media_image2.png
Greyscale
Further, Claim 26 of the reference application narrows the scope of compounds to compounds of IIIa:
PNG
media_image3.png
214
325
media_image3.png
Greyscale
Compounds of IIIa in the reference application read on compounds of Formula (I) as recited in instant Claim 1 when the variables are defined as follows:
A is diazepanyl, as recited at reference Claim 32. Per the reference application’s aforementioned definition of heterocyclyl, above, and dependent Claim 34, heterocyclyl moieties can be substituted with methyl, trifluoromethyl, or fluoro. Therefore, the moieties
PNG
media_image4.png
108
178
media_image4.png
Greyscale
recited at instant Claim 1 read on these compounds when R2 is methyl.
R1a is hydrogen, as recited at reference Claim 28.
R1b is hydrogen, as recited at reference Claim 28.
R2 is hydrogen, as recited at reference Claim 6.
Each R5 is halo, as recited at Reference Claim 10.
Regarding instant Claim 35, reference Claim 36 is drawn to a pharmaceutical composition comprising the aforementioned compounds.
Regarding instant Claims 36 and 163-164, reference Claims 38-39 are drawn to a method of treating brain cancer and/or lung cancer comprising administering compounds encompassed by the limitations of each application, as described above.
In other words, both the instant application and the reference application are drawn to a group of overlapping compounds, as detailed above. The reference application and the instant application have the same effective filing date. Per MPEP 804 I., B., 1., (b) II., “If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application, or includes a compliant terminal disclaimer under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted.”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 8, 11, 21, 31-36, and 163-164 are rejected. No claim is allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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 Murray can be reached at (571) 272-9023. 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.
/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624