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 .
Current Status
This action is responsive to the amended claims of 03/03/2026. Claims 31-40, 42, and 52 are pending. Claims 32 and 52 are withdrawn. Claims 31, 33-40, and 42 have been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of non-small cell lung cancer, S768dupSVD, and poziotinib in the reply filed on 03/03/2026 is acknowledged.
A search for the elected species retrieved prior art (see SEARCH 5-6 of the attached search notes). Thus, in accordance with Markush search practice, the search will not be unnecessarily extended to further species in this action.
The elected species read on claims 31, 33-40, and 42.
Claims 32 and 52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/03/2026.
Priority
The effective filing date for the examined claims is 01/29/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/09/2024, 06/20/2024, 12/18/2024, 04/14/2025, and 07/01/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to because Figs. 1A-E, 2, 3A-B, 4A, 4C, 6A, 7A, 7E, 7G, 8A-D, 8F, and 11 contain text which is difficult to read due to small size, low resolution, and/or light color (i.e., the text is not black). Please provide higher resolution drawings wherein the text resolution, size, and/or color is improved to increase readability. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 31, 33-40, and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ROBICHAUX (WO 2018/094225; provided IDS of 04/09/2024).
Regarding claims 31 and 42, ROBICHAUX teaches a method of treating cancer in a subject comprising administering an effective amount of poziotinib to the subject who has been determined to have one or more exon 20 insertion EGFR mutations (Pg. 49 claims 1-2). Further, the presence of the EGFR mutation is determined by nucleic acid sequencing or PCR analysis (Pg. 49 claim 11) of tumor tissue (Pg. 3 ¶9); i.e., by analysis of tumor DNA. ROBICHAUX teaches the mutation is S768dupSVD (Pg. 49 claim 7).
Note, ROBICHAUX does not use the term exon 20 “near-loop” insertion. However, since ROBICHAUX describes the EGFR mutation as an exon 20 insertion and teaches the species S768dupSVD of instant claim 42, the Examiner understands the teachings of ROBICHAUX to be equivalent to the “near-loop” insertion of the instant claim 31.
Regarding claims 33-34, ROBICHAUX teaches the cancer is non-small cell lung cancer (NSCLC) (Pg. 50 claim 18).
Regarding claims 35-38, ROBICHAUX teaches the subject has undergone chemotherapeutic treatment (Pg. 23 ¶77). Further, ROBICHAUX teaches clinical responses to EGFR TKIs were investigated in patients with NSCLC tumors having EGFR exon 20 insertions – these patients had reduced progression free survival (PFS) which demonstrates the limited activity of EGFR TKIs in such tumors (Pg. 34 ¶107) and resistance to first line therapy (Pg. 9 ¶26 & Pg. 1/9 Fig. 1A). ROBICHAUX teaches patients with S768dupSVD mutation display resistance to EGFR inhibitors erlotinib and afatinib (Pg. 10 ¶29 & Pg. 4/9 Fig. 4A). Thus, the subject was determined to be resistant to a previously provided cancer therapy.
ROBICHAUX further teaches the purpose of the invention is to identify novel therapies to overcome the innate drug resistance of NSCLC tumors harboring exon 20 insertion mutations in EGFR (Pg. 2 ¶6). ROBICHAUX teaches poziotinib is a potent EGFR inhibitor which can be used to target EGFR exon 20 insertions which are resistant to other EGFR TKIs (Pg. 12 ¶37).
Thus, the artisan would immediately envisage the method of ROBICHAUX wherein the subject was previously treated with a cancer therapy (instant claim 35) which comprised a chemotherapy that is an EGFR kinase inhibitor, e.g., erlotinib or afatinib, (instant claims 36-37) and wherein the subject was determined to be resistant to the cancer therapy (instant claim 38).
Note, ROBICHAUX defines “chemotherapy” as the use of drugs to treat cancer (Pg. 26 ¶86), e.g., the treatment with erlotinib or afatinib.
Regarding claims 39-40, ROBICHAUX teaches the method of treatment further comprising an additional anti-cancer therapy (Pg. 50 claim 12) wherein the additional therapy is chemotherapy, radiotherapy, or immunotherapy (Pg. 50 claim 13).
Therefore, ROBICHAUX anticipates instant claims 31, 33-40, and 42.
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 31, 33-34, 39-40, and 42 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,446,302. Although the claims at issue are not identical, they are not patentably distinct from each other.
The reference claims are drawn to a method of treating cancer in a subject comprising administering an effective amount of poziotinib to the subject having a tumor that has been determined to have one or more EGFR exon 20 insertion mutations (ref claims 1-4) wherein the mutation is chosen from A763insFQEA, A767insASV, S768dupSVD, V769insASV, D770insSVD, D770insNPG, H773insNPH, N771del insGY, N771del insFH, and N771dupNPH (ref claim 5-6 & 16-18). These mutations are species of the instant claims 31 and 42. Note, while the reference claims do not recite the phrase “near-loop” to describe the exon 20 insertion mutation, since the claims recite species thereof, the Examiner understands the reference claims to be equivalent to the instant exon 20 “near-loop” insertion mutations.
Further, the disclosure of U.S. Patent No. 11,446,302 is referred to in order to understand the determination method of the claimed EGFR mutations, in accordance with MPEP 804(II)(B)(1): “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970).”
In this case, the disclosure provides the presence of an EGFR exon 20 mutation is determined by nucleic acid sequencing or PCR analyses of tumor tissue (Pg. 12 Col. 2 Line 45-48). Thus, the mutation is determined by analysis of tumor DNA.
The reference claims are further drawn to the method wherein the cancer is non-small cell lung cancer (ref claim 15) and a variety of other cancers further recited in reference claim 15. These are species of the instant claims 31 and 33-34.
The reference claims further recite the method further comprising administering an additional anti-cancer therapy including chemotherapy, radiotherapy, or immunotherapy (ref claims 7-14). These are species of the instant claims 31 and 39-40.
Thus, the reference claims anticipate the instant claims.
Claims 31, 33-35, 37-40, and 42 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-2, 7-9, 13, 15-16, 27-28, 32-33, and 124-126 of copending Application No. 19/097,461 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The reference claims are drawn to a method of treating cancer in a subject comprising administering an effective amount of poziotinib to the subject wherein the subject has been determined to have one or more EGFR exon 20 insertion mutations (ref claim 1-2 & 7-8) wherein the mutation is one of the species listed in ref claims 15-16: e.g., A767insTLA, V769insGVV, V769L, V769insGSV, V769ins MASVD, D770insGY, D770insG, D770insY, H773Y, N771insSVDNR, N771insHH, P772insDNP, H773insAH, H773insH, and V774insHV (ref claims 13 & 15-16). These are species of in the instant claims 31 and 42. Note, while the reference claims do not recite the phrase “near-loop” to describe the exon 20 insertion mutation, since the claims recite species thereof, the Examiner understands the reference claims to be equivalent to the instant exon 20 “near-loop” insertion mutations.
Further, the disclosure of Application No. 19/097,461 is referred to in order to understand the determination method of the claimed EGFR mutations, in accordance with MPEP 804(II)(B)(1), above. In this case, the disclosure provides the presence of an EGFR exon 20 mutation is detected by DNA sequencing of tumor tissue (Pg. 26 ¶42). Thus, the mutation is determined by analysis of tumor DNA.
The reference claims are drawn to the method wherein the cancer is non-small cell lung cancer (ref claim 33) and other various species recited in reference claim 32. These are species of in the instant claims 31 and 33-34.
The reference claims are also drawn to the method wherein the subject has been previously administered a tyrosine kinase inhibitor and shown resistance to said inhibitor (ref claim 9). This reads on instant claims 35 and 37-38.
The reference claims are also drawn to the method further comprising administering an additional anti-cancer therapy (ref claim 27) which is chemotherapy, radiotherapy, or immunotherapy (ref claim 28) and may be chosen from various species of drugs/chemotherapies recited in reference claims 124-126. These are species of instant claims 31 and 39-40.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 31 and 33-39 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1, 6-9, 14, 23, 25, 30-31, 35-36, 38-39, 45, 49, 54-55, and 84 of copending Application No. 17/604,560 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The reference claims are drawn to a method of treating cancer in a subject comprising administering an effective amount of poziotinib, wherein the subject has been determined to have one or more EGFR-TKI resistant mutations chosen from a series of species of exon 18, exon 19, exon 20, and exon 21 mutations: E709, L718, G719, S720, G724, L747, A755, K757, D761, S784, L792, G796, S811, L833, V834, T854, L861, and L858 (ref claims 1, 6-9, 14, 23, 30-31, 35-36, 38-39, 45, and 84). While the reference claims do not refer to these as “classical-like” or “P-loop aC-helix” mutations, the amino acid designations listed above appear in the further dependent claims 32 and 52 (currently withdrawn). Thus, Examiner understands these mutations as species of the mutations i) and iii) recited in instant claim 31.
Further, the disclosure of Application No. 17/604,560 is referred to in order to understand the determination method of the claimed EGFR mutations, in accordance with MPEP 804(II)(B)(1), above. In this case, the disclosure provides the presence of an EGFR exon 20 mutation is detected by DNA sequencing of tumor (Pg. 15 ¶49). Thus, the mutation is determined by analysis of tumor DNA.
The reference claims are also drawn to the method wherein the cancer is non-small cell lung cancer (ref claim 55) and a variety of other species as recited in reference claim 54. These are species of instant claims 31 and 33-34.
Further, the reference claims are drawn to wherein the subject was previously administered and is resistant to the EGFR-TKI (ref claim 25). This reads on instant claims 35-38 wherein the previous therapy is an EGFR kinase inhibitor/a chemotherapy which the patient is resistant to.
The reference claims also recite the method further comprising administering an additional anti-cancer therapy (ref claim 49). This reads on instant claim 39.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Note, withdrawn claims 32 and 52 could be subject to an NSDP over the co-pending application 17/604,560 in a future search extension since these claims recite EGFR mutant species which overlap/relate to the species recited in the reference claims.
Conclusion
Claims 31, 33-40, and 42 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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