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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/11/2026 was filed after the mailing date of the non-final on 08/14/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
Claims 1, 89, 94, 101, 106, 113, 121, 122, 125, 139, 141, 144, 147-148, 292-297, 306, 308, and 403-424 are pending in this application. Claims 2-88, 90-93, 95-100, 102-105, 107-112, 114-120, 123-124, 126-138, 140, 142-143, 145-146, 149-291, 298-305, 307, and 309-402 have been cancelled by Applicant.
Examiner Notes
Claims 1, 89, 94, 101, 106, 113, 121, 122, 125, 139, 141, 144, 147-148, 292-297, 306, 308, and 403-424 are allowable over the prior art, but stand rejected over formal matters and/or provisional Non-Statutory Double Patenting (NSDP) rejections (see response to argument’s section at the end of this action).
Examiner would like to point out that attempts were made to overcome remaining issues with an Examiner’s Amendment in order to expedite allowance (see interview summary of record) however, no specific agreement was reached with Applicant.
Claim Objections
Claim 405 is objected to because of the following informalities: the commas after “x1 = 0” should be removed to read “x1 = 0 and x2 = 0; or x1 = 0 and x2 = 1; or x1 = 0 and x2 = 2”. Appropriate correction is required.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 417 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 417, the phrases "non-limiting exemplary mutations"; “non-limiting exemplary EGFR…”; and “e.g. …”; and every occurrence thereof, render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Also in claim 417, under the “amino acid position” column – row 709-710 has the parenthetical “(sometimes also called exon 18 deletion or del_18) – it is unclear if this limitation pertains to the “amino acid position” or to the “mutation” column. The same goes for all the bolded rows, for example, the one labeled “Exon 19 insertion (sometimes also called ins_19)” – is this supposed to be under the “amino acid position” column or the “mutation” column? (Please check every occurrence).
Further regarding claim 417, the lists of mutations in the tables are indefinite because reference to an external source (i.e. the superscripts next to all mutations cited) is not permitted in the claims as it amounts to an incorporation by reference of essential material.
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.
Claim 293 is 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 293 is rejected for failing to further limit claim 1, from which it depends. Claim 1 limits the X1 group of Formula I to
PNG
media_image1.png
45
87
media_image1.png
Greyscale
, however, in the compound below, the group corresponding to X1 is -O-(CH2)2-heterocycle.
PNG
media_image2.png
215
192
media_image2.png
Greyscale
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.
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, 89, 94, 101, 106, 113, 121, 122, 125, 139, 141, 144, 147-148, 292-297, 306, 308, and 403-424 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 4, 5, 8, 16, 51, 60, 76, 78, 183-186, 192-196, 199, 201-203, 215, 221, 232, 248-249, 255-257, 263, 269-270, 272-273, 276, 412-417, 425-427 of copending Application No. 18/030,211 (Copending ‘211). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1, 89, 94, 101, 106, 113, 121, 122, 125, 139, 141, 144, 147-148, 292-297, 306, 308, and 403-424, Copending ‘211 claims the compounds of Formula I and pharmaceutical compositions thereof, which render the instant claims obvious when: A (corresponding to instant ring A) is C6-10 aryl optionally substituted with 1-4 Rc; C (corresponding to instant
PNG
media_image3.png
72
75
media_image3.png
Greyscale
) is
PNG
media_image4.png
93
87
media_image4.png
Greyscale
, wherein Xb can be X1, wherein X1 is –(X2)mL1-R5, wherein m can be 1; X2 can be
PNG
media_image5.png
32
72
media_image5.png
Greyscale
; L1 can be C1-10 alkylene optionally substituted with 1-6 Ra (reading on instant L2 group) – all reading on instant X1 being
PNG
media_image6.png
47
86
media_image6.png
Greyscale
; and R5 can be Rg, which can be cycloalkyl, heteroaryl, aryl, etc. (corresponding to instant R6) (claims 1 and 413 of Copending ‘211).
PNG
media_image7.png
173
176
media_image7.png
Greyscale
Although Copending ‘211 does not teach ring C wherein the X1 group (corresponding to instant X1) is at the 3-position of the pyridine, Applicant is advised that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In re Norris, 179 F.2d. 970, 84 USPQ 458 (CCPA 1970). Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results. In re Finely, 81 USPQ 383 (CCPA 1949); 84 USPQ 458 (CCPA 1950).
Regarding instant claims 295, Copending ‘211 claims a method of treating cancer by administering the compounds of Formula I (claim 414 of Copending ‘211).
Regarding instant claims 296, Copending ‘211 speaks to a method of treating cancer comprising (a) determining that the cancer is associated with dysregulation of an EGFR gene (b) administering the compounds of Formula I (claims 415 and 417 of Copending ‘211).
Regarding instant claims 297, Copending ‘211 speaks to a method of treating an EGFR-associated cancer by administering the compounds of Formula I (claim 416 of Copending ‘211).
Regarding instant claim 306, Copending ‘211 speaks to a method of treating cancer wherein the dysregulation is EGFR a one or more-point mutation in the EGFR gene (claim 425 of Copending ‘211).
Regarding instant claim 308, Copending ‘211 speaks to a method of treating cancer wherein the one or more-point mutation is found in Table 1a or 1b of the specification – tables are the same as those in the instant disclosure (claim 427 of Copending ‘211).
Regarding claims 295-297, 306, 308, and 417-424, Applicant is advised that similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 89, 94, 101, 106, 113, 121, 122, 125, 139, 141, 144, 147-148, 292-294, and 403-416 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5, 7, 10-11, 21, 24, 29, 31, 33, 35, 37-43, 45, 48-49, 53-55, 57, 67, 71-74, and 77 of copending Application No. 18/849,887 (Copending ‘887). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1, 89, 94, 101, 106, 113, 121, 122, 125, 139, 141, 144, 147-148, 292-294, and 403-416, Copending ‘887 claims methods of making the compounds of Formula I below, and claims the compounds of Formula I (claims 75-78 of Copending ‘887). Copending ‘887’s compounds render the instant compounds obvious when: A is C6-10- aryl optionally substituted with 1-4 Rc; C can be
PNG
media_image8.png
62
71
media_image8.png
Greyscale
, wherein X can be
PNG
media_image9.png
46
88
media_image9.png
Greyscale
(reading on instant X1).
PNG
media_image10.png
126
175
media_image10.png
Greyscale
Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Copending ‘887’s disclosed formula. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Copending ‘887. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Applicant is reminded that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Claims/ Claim Objections
Claim amendments are acknowledged and have been entered. No new matter has been introduced.
Applicant’s arguments, see page 84, filed 02/11/2026, with respect to objections to the claims have been fully considered and are persuasive. The objections to the claims have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of new claims being added.
Claim Interpretation
Applicant’s clarification of claim interpretation is acknowledged.
Specification
Amendments to the specification are acknowledged and have been entered. No new matter has been introduced.
Applicant’s arguments, see page 83, filed 02/11/2026, with respect to objections to the specification have been fully considered and are persuasive. The objections to the specification have been withdrawn.
Sequence Listing
The sequence listing is acknowledged and has been entered. No new matter has been introduced.
Claim Rejections - 35 USC § 112(b)
Applicant’s arguments, see page 86, filed 02/11/2026, with respect to 35 USC § 112(b) rejections of the claims have been fully considered and are persuasive. The 35 USC § 112(b) rejections of the claims have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of new claims being added.
Claim Rejections - 35 USC § 102
Applicant’s arguments, see pages 86-87, filed 02/11/2026, with respect to 35 USC § 102 rejections of the claims have been fully considered and are persuasive. The 35 USC § 102 rejections of the claims have been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see page 87, filed 02/11/2026, with respect to 35 USC § 103 rejections of the claims have been fully considered and are persuasive. The 35 USC § 103 rejections of the claims have been withdrawn.
Double Patenting
Applicant's arguments filed 02/11/2026 have been fully considered but they are not persuasive.
Applicant requests provisional non-statutory double patenting (NSDP) rejections be held in abeyance until allowable subject matter is indicated. This is not persuasive. Claims stand rejected in view of provisional NSDP rejections of record.
Regarding provisional NSDP over Copending ‘887 and ‘211, with effective patent term filing dates of 03/24/2023 and 10/08/2021, respectively; Applicant is advised that, per MPEP § 804(1)(B)(1)(b)(i), if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date (effective patent term filing date of instant application is 09/22/2021), the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent. In the present case, however, the NSDP rejection is not the only remaining rejection, therefore, the provisional NSDP rejection over Copending ‘887 and ‘211 stand until all other formal matters are resolved.
Conclusion
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 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 JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
Examiner interviews are available via telephone 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, Kortney L. Klinkel can be reached at (571) 270-5239. 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.
/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
Prosecution Insights