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
Claims 1, 8-9, 23, 30, 38-39 and 84 are amended. Claims 6-7, 35-36 are canceled. Claims 1, 8-9, 14, 19, 23, 25, 30-31, 38-39, 45, 49, 54-55 and 84 are pending and now evaluated on its merits.
Priority
This application claims domestic benefit to application 61/835,343, dated 04/17/2019.
Information Disclosure Statement
The information disclosure statement (IDS) dated 6/28/2026 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Response to Arguments
Applicant’s arguments, see Pages 2-3, filed 07/08/2026, with respect to the 103 rejections of claims 1, 6-9, 14, 19, 23, 25, 30, 35-36, 38-39 and 54-55 under Molina et al. (EP 3120851 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Reddy (WO 2020005932), Kobayashi et al. EGFR Exon 18 Mutations in Lung Cancer: Molecular Predictors of Augmented Sensitivity to Afatinib or Neratinib as Compared with First- or Third-Generation TKIs, November 2015, Pages 5305-5313 and Yu et al. First-generation EGFR tyrosine kinase inhibitor therapy in 106 patients with compound EGFR-mutated lung cancer: a single institution’s clinical practice experience, Cancer Comm, July 2018, Pages 1-13.
The teachings of Reddy and Kobayashi from the previous office action in combination with the teachings of Yu of exon 18 and 20 common and uncommon EGFR mutations read to claim invention of treating cancer in a subject comprising administration of an effective amount of poziotinib wherein the subject is determined to have a EGFR TKI resistant mutation residing on exon 18 of residue E709, S720 and exon 21 of residue L833.
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 23 and 39 are 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.
Claim 23 recites the limitation "L861R" in line 2. There is insufficient antecedent basis for this limitation in the claim. The limitation of L861R is not identified as an EGFR TKI resistant mutation residue per claim 1. As claim 23 is dependent on claim 1, it carries all the limitations of the claim which excludes residue L861.
Claim 39 recites the limitation "L858R/L792H" in line 2. There is insufficient antecedent basis for this limitation in the claim. The limitation of L858R is not identified as an EGFR TKI resistant mutation residue per claim 1. As claim 39 is dependent on claim 1, it carries all the limitations of the claim which excludes residue L858.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 8-9, 14, 19, 23, 25, 30-31, 38-39, 45, 49, 54-55 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over Reddy (WO 2020005932), which claims U.S. benefit effective filing date 06/25/2018, in view of Kobayashi et al. EGFR Exon 18 Mutations in Lung Cancer: Molecular Predictors of Augmented Sensitivity to Afatinib or Neratinib as Compared with First- or Third-Generation TKIs, November 2015, Pages 5305-5313 and Yu et al. First-generation EGFR tyrosine kinase inhibitor therapy in 106 patients with compound EGFR-mutated lung cancer: a single institution’s clinical practice experience, Cancer Comm, July 2018, Pages 1-13.
Regarding claims 1, 8-9, 14, 19, 23, 25, 30-31, 38-39, 45, 49, 54-55 and 84, Reddy teaches a method for treating non-small cell lung , breast , stomach, colon , pancreatic , prostate , myeloma, head and neck , ovarian , esophageal and metastatic cell carcinoma cancers (relevant to claims 54-55) (claim 18) by administration of poziotinib at an amount of .01 to 50 mg (relevant to claim 45) (para. 0052) in combination with another anti-cancer therapy (relevant to claim 49) (abstract). The anti-cancer therapy is selected from a list of agents which includes a mitotic inhibitor (not an antibody or TKI) (para. 0026). The combination treatment is taught as administered to a subject who has already been treated with an EGFR TKI (relevant to claim 25) (para. 0006) and has EGFR TKI resistant mutations of exon 18, 19, 20 and 21 (para. 0038).
Reddy additionally teaches the subjects may be determined to not have an EGFR mutation at residue C797 (relevant to claim 31) (para. 0038). In some embodiments one or more EGFR exon 20 mutations comprise one or more-point mutations, insertions, and/or deletions of 3-18 nucleotides between amino acids 763- 778 and in other embodiments the mutation is an exon 19 deletion (relevant to claim 39) (para 0038).
In terms of claims 14 and 19, the limitations to exon 19 and 21 residues are merely further limiting the residues on the exon and not stating the mutation is the particular residue on the exon.
Reddy fails to teach the limitation of claim 1 of the specific residues of exon 18-21 as the EGFR TKI resistant mutation.
Regarding claims 8-9, Kobayashi teaches 3% to 4% of all EGFR mutations are exon 18 mutations, which includes G719X, E709X, and exon 18deletion. Of the exon 18 mutations, codon 709 and 719 accounted for 84% (551/654) of all mutations, in which E709 and G719A being the most common (abstract, Pg. 5307 last para.).
Regarding claims 23 and 84, Yu teaches a study on patients with Lung cancer that harbor epidermal growth factor receptor (EGFR) mutations, the patients had common, uncommon and rear mutations. The mutations were evaluated on their sensitivity to TKI’s as to be used as treatment or resistance to the drug (abstract). Of the mutations Yu teaches exon 21 mutations of L833 and L858 as well as exon 18 mutations of S720 and E709 (Table 3).
Therefore, it would have been obvious for someone of ordinary skill in the art at the time of filing to have administered the composition taught by Reddy to treat a cancer that is resistant to EGFR TKI of E709 and S720 on exon 18 as well as L833 on exon 21. One would be motivated to do so from the teachings of Kobayashi of E709 being the most common exon 18 mutations and the teachings of Yu of L833 mutation on exon 21 being well known in the art, along with the teachings of Reddy of cancers having resistance to EGFR TKI of exon 18 and 21 mutations. There is a reasonable expectation of treating a cancer that is resistant to EGFR TKI in a subject wherein the subject has a mutation of E709 and/or S720 on exon 18 and L833 on exon 21 from the teachings of Reddy, Kobayashi and Yu.
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.
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
