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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/26/2026 has been entered.
Applicants' arguments, filed 05/26/2028, 05/28/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103--Previous
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 13, 15-25 remain rejected under 35 U.S.C. 103 as being unpatentable over Lamb et al. (Targ Oncol, 2017) in view of Niederst et al. (JAMA Oncology 2016).
Lamb et al. provides a review of osimertinib in treatment of T790-positive advanced non-small cell lung cancer (NSCLC).
Lamb et al. teaches, “Osimertinib (Tagrisso™) is an oral, CNS-active third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets EGFR TKI-sensitizing mutations and crucially, the T790M mutation that often underlies acquired resistance to EGFR TKI therapy” (Abstract). Lamb et al. also teaches, “osimertinib treatment significantly prolonged progression-free survival (PFS; primary end point) compared with platinum-pemetrexed therapy at the time of the primary analysis” (Id.).
Note: Tagrisso tablets comprise osimertinib mesylate salt (claim 25).
Treatment guidelines “recommend osimertinib as a second-line and beyond treatment option in patients with EGFR T790M-positive metastatic NSCLC that has progressed following therapy with an approved first- or second-generation EGFR TKI” (p. 561, left column, 2nd paragraph). Second-line and beyond would have reasonably included stage III patients, including patients where the cancer is unresectable (see Huber et al. below). Note: Platinum-based doublet chemotherapy first-line treatment for most patients with advanced NSCLC as taught by Juergens et al. below.
“Osimertinib is available as 40 mg or 80 mg film-coated tablets. The recommended dosage of osimertinib is 80 mg taken orally once a day with or without food” (p. 561, left column, 1st paragaraph), as per claim 24.
Lamb et al. teaches a study comparing osimertinib oral treatment with platinum “intravenous pemetrixed (500 mg/m2 of body surface) plus either carboplatin (target area under the curve 5) or cisplatin (75 mg/m2) every three weeks” (p. 558 at 4.2 Phase III AUR3 Trial), wherein “[o]simertinib significantly prolonged median duration of PFS relative to platinum-pemetrixed based on investigator assessments (Table 1), with 70% reduction in the risk of disease pregression or death” (Id.).
Improvements in progression-free survival favored osimertinib “in all predefined subgroups, including those based on race (Asian vs. non-Asian), presence of CNS metastases, mutation co-occurring with EGFR T790 at baseline (ex19del vs. L858R)” (p. 558, right column, last paragraph).
Lamb et al. does not teach administration to patients wherein the disease has not progressed following definitive platinum-based chemoradiation therapy.
Niederst et al. discusses responses to osimertinib after disease progression in patients that had been receiving rociletinib.
Niederst et al. teaches, “The best responses to osimertinib in the AURA trial included 3 patients with PR, 4 with SD, and 2 with PD; the median PFS was 208 days (95% CI, 41-208 days)” (p. 541, right column, 3rd paragraph), where SD stands for Stable Disease. Niedest et al. further teaches, “Among 6 patients who transitioned directly from rociletinib to osimertinib . . . all derived clinical benefit from osimertinib with either prolonged SD or PR” (Id.).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to administer osimertinib to patients wherein the disease has not progressed following definitive platinum-based chemoradiation therapy since osimertinib has been shown to promote progression free survival, as taught by Lamb et al., and benefit patients with stable disease (not progressed) post-therapy, as taught by Niedest et al.
Platinum-based doublet chemotherapy is known as a first-line defense for NSCLC patients, as evidenced by Juergens et al. Since Lamb et al. teaches administering Osimertinib as a second line and beyond treatment option, the artisan would have been motivated to provide patients with a proven treatment to prolong their survival, after chemotherapy, unresected stage III, where their disease has not progressed.
That being said, it would have been obvious to administer to patients where the EGFR mutation-positive NSCLC is considered curable by chemoradiation therapy, wherein the chemoradiation therapy comprises concurrent or sequential chemoradiation therapy, platinum-based doublet chemotherapy, including cisplatin or carboplatin, non-platinum based agents, as per claim 20, or wherein the patient has not completed the chemoradiation therapy, as per claim 23.
Since the prior art teaches treating EGFR mutation-positive NSCLC patents generally, those having exon 19 deletions or L858R substitution mutations, would have been implicit.
Technological Background
1) The prior art made of record considered pertinent to applicant's disclosure Huber et al. (European Respiratory journal, 2013). Huber et al. is pertinent for teaching status and future strategies for unresectable stage III nonsmall cell lung cancer. Initially, “Stage III disease occupies an intermediate position between resectable stage I-II disease and unresectable stage IV disease, and encompasses a heterogeneous group of patients that vary in terms of prognosis, tumour stage and treatment” (p. 1120, 2nd paragraph).
The reference acknowledges the disappointment with the recommended therapy, i.e. chemotherapy, teaching, “Recommended therapy for patients with unresectable stage III disease is concurrent treatment with chemotherapy and thoracic radiotherapy, although even with this dual modality therapy survival remains disappointing” (Abstract).
With the discovery of somatic EGFR mutations found in patients with lung cancer, “[t]umours with these mutations are highly sensitive to EGFR tyrosine kinase inhibitors (TKIs), which have shown to be more effective than standard chemotherapy for patients with EGFR-mutated NSCLC” (p. 1121, 4th paragraph).
2) The prior art made of record considered pertinent to applicant's disclosure Mok et al. (New England Journal of Medicine, 2017). Mok et al. is pertinent for teaching, “Osimertinib had significantly greater efficacy than platinum therapy plus pemetrexed in patients with T790M-positive advanced non-small (including those with CNS metastases) in whom disease had progressed during first-line EGFR-TKI therapy” (Abstract).
3) The prior art made of record considered pertinent to applicant's disclosure Juergens et al., (Journal of Thoracic Oncology, 2017, OA 17.03). Juergens et al. is pertinent for teaching, “Platinum-based doublet chemotherapy is the standard-of-care first-line treatment for most patients with advanced NSCLC” (p. S1792, Background).
Response to Arguments
i) Applicant continues to argue that the cited references fail to teach or suggest administering osimertinib to EGFR mutation positive NSCLC having unresectable cancer, and the secondary references fail to cure this deficiency (p. 4-6).
The Examiner disagrees.
The patient population of the applicant’s method and the patient population of the prior art each have one thing in common, they all have cancer. At the time of applicant’s filing, it was known to treat cancer by administering cancer-fighting drugs. Like the patient population of applicant’s method, the patients of the prior at have EGFR mutation positive non-small cell lung cancer (NSCLC). Since Osimertinib is known for treating patients with EGFR mutation positive NSCLC, it would have been obvious to administer it to applicant’s patient population, i.e. patients with unresectable cancer. Whether the patient has an unresectable form of cancer or been subject to platinum-based chemoradiation therapy, it does not change the fact that they continue the possess EGFR mutation positive NSCLC, where the known treatment is the administration of Osimertinib.
Huber et al., in teaching strategies for treating stage III unresectable NSCLC patients, still recommended treating with EGFR tyrosine kinase inhibitors, i.e., “[t]umours with these mutations are highly sensitive to EGFR tyrosine kinase inhibitors (TKIs), which have shown to be more effective than standard chemotherapy for patients with EGFR-mutated NSCLC” (p. 1121, 4th paragraph).
It is well settled, “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”. KSR Int’l Co. v. Teleflex Inc.,, 550 U.S. 398, 416 (2007).
Applicant’s intended result from the administration of Osimertinib is “an improvement in one or more of improved progression free survival (PFS), or improved duration of response (DoR), or improved overall survival (OS)” (Specification at p. 3, lines 11-15), which is similar what was known concerning administration of Osimertinib to NSCLC patients at the time of applicant’s filing. Again, Lamb et al. teaches, “osimertinib treatment significantly prolonged progression-free survival (PFS; primary end point) compared with platinum-pemetrexed therapy at the time of the primary analysis” (Abstract). Niedest et al. also teaches, “Among 6 patients who transitioned directly from rociletinib to osimertinib . . . all derived clinical benefit from osimertinib with either prolonged SD or PR” (Id.).
Osimertinib is recognized in the prior art “as a second-line and beyond treatment option in patients with EGFR T790M-positive metastatic NSCLC that has progressed following therapy with an approved first- or second-generation EGFR TKI” (p. 561, left column, 2nd paragraph). Second line and beyond would have reasonably included Stage III, unresectable, NSCLC, which also makes it obvious to administer Osimertinib the applicant’s patient population.
Note: the prior art does not teach away from administering Osimertinib to applicant’s patient population insofar as it does not criticize, discredit, or otherwise discourage the administration of Osimertinib to locally advanced unresectable EGFR mutation-positive NSCLC patients. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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