DETAILED ACTION
This office action is in response to applicant’s filling dated May 6, 2026.
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 1-2, 8-10, 13-14, and 20 are pending in the instant application. Acknowledgement is made of applicant’s remarks and amendments filed May 6, 2026. Acknowledgement is made of applicant’s cancellation of claims 3-7, 11-12, and 15-19.
Priority
The present application claims benefit of priority to provisional application 63/422,257 filed on November 3, 2022.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
New Rejections
Necessitated by Claim Amendment
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-2, 8, 13-14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dunn et al. (U, DUNN, L et al. “A phase I/Ib study of lenvatinib and cetuximab in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)” Journal of Clinical Oncology, Vol 38, No. 15 supplement, (25 May 2020) pp. 1-2), in view of Bernat-Peguera et al. (V, BERNAT-PEGUERA, A. et al. “FGFR inhibition overcomes resistance to EGFR-targeted therapy in epithelial-like cutaneous carcinoma” Clinical Cancer Research, Vol 27, No. 5, (1 March 2021) pp. 1-2), and Roskoski (W, Roskoski, R. “The Role of Fibroblast Growth Factor Receptor (FGFR) Protein-Tyrosine Kinase Inhibitors in the Treatment of Cancers Including those of the Urinary Bladder” Pharmacological Research, Vol 151, (2020) pp. 1).
Dunn et al. teaches of a phase 1/1b clinical trial for recurrent/metastatic head and neck squamous cell carcinoma patients where human patients who had a limited response to the EGRF inhibitor Cetuximab were given the FGFR inhibitor Lenvatinib (See e.g. page 1, abstract). Dunn then found that the pharmaceutical combination of both inhibitors produced improved efficacy justifying advancement in clinical trials (See e.g. page 1, abstract).
While Dunn teaches a method of treating a head and neck squamous cell carcinoma in patients with limited response to cetuximab with a combination of cetuximab and a FGFR inhibitor, it does not teach that such a treatment would be effective against cetuximab resistant cancers and that the FGFR inhibitor is erdafitinib.
However, Bernat-Peguera et al. conducted induced resistance to an EGFR inhibitor in squamous cell carcinomas through a previous regiment of the EGFR inhibitor gefitinib (See e.g. page 1, abstract). They found that the combination of both gefitinib EGRF inhibitor and a FGRF inhibitor were able to treat squamous cell carcinoma with an intrinsic or acquired resistance to EGFR inhibitors (See e.g. page 1 abstract). Bernat-Peguera further suggested that their results may be applicable to EGFR and FGFR inhibitor combinations in general for the treatment of EGFR inhibitor resistance in squamous cell carcinoma (See e.g. page 1, abstract).
Likewise, Roskoski teaches that both lenvatinib and erdafitinib are both anti-cancer therapeutics which have similar mechanisms as Type 1 1/2 inhibitors of fibroblast growth factor receptor (FGFR) (pp. 1, abstract).
A person of ordinary skill in the art before the effective filling date would have had a reasonable expectation of success in using the EGFR inhibitor cetuximab with the FGFR inhibitor erdafitinib to treat cetuximab resistant head and neck squamous cell carcinoma because Dunn et al. teaches a clinical study where cetuximab in combination with the FGFR inhibitor Lenvantinib were able to treat patients with head and neck squamous cell carcinoma exhibiting a limited response to cetuximab monotherapy, Bernat-Peguera found that FGFR inhibitors in combination with EGFR inhibitors can help overcome EGFR inhibitor resistance in squamous cell carcinomas mouse models, and Roskoski teaches that both Lenvantinib and Erdafitinib are anti-cancer drugs with an analogous mechanism of action which inhibits FGFR receptors. At the time of the invention, it would have been prima facie obvious for a person of ordinary skill in the art to substitute one functional equivalence (Lenvantinib) for another (Erdafitinib), since the prior art establishes that both function in similar manner with a reasonable expectation of success. Furthermore, the skilled artisan would have been motivated to use the cetuximab and erdafitinib to treat cetuximab resistant head and neck squamous cell carcinoma cancers because of a suggestion in Bernat-Peguera which identifies EGFR and FGFR inhibitor combinations being translationally relevant and opening new avenues to treat squamous cell carcinomas resistant to EGFR monotherapies. This suggestion would have led one of ordinary skill in the art to make the obvious modification of therapeutic protocol and cancer target from Dunn et al. however to act on cancer variants resistant to cetuximab and other EGFR inhibitor monotherapies.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Dunn et al., Bernat-Peguera et al., and Roskoski as applied to claims 1-2, 8, 13-14, and 20 above, and further in view of Collins (X, COLLINS, S. “When cancer treatments stop working: is it the end of the line” CURE. (3 November 2021) pp. 3-4).
Dunn, Bernat-Peguera, and Roskoski teach all the limitations of claims 9 and 10 (see above 103), except wherein the subject is first determined to be resistant to treatment by cetuximab.
However, Collins teaches a medical practice where a doctor determines if a cancer becomes resistant to a therapy the patient needs to switch or add new medications (See e.g. pages 3-4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the method of treating recurrent/metastatic head and neck squamous cell carcinoma patients who had a limited response to the EGRF inhibitor Cetuximab comprising administering cetuximab and erdafitinib as taught by the combination of Dunn, Bernat-Peguera, and Roskoski to first determine if a cancer is resistant to cetuximab monotherapies and if so to switch or add new medications following the general practice recited by Collins since it is known in the art that cetuximab in combination with an FGFR inhibitor is useful for treating head and neck squamous cell carcinoma with limited response to cetuximab monotherapy and that it is common medical practice includes a doctor determining if a cancer becomes resistant to a therapy the patient needs to switch or add new medications.
Response to Arguments
Since a new rejection was issued (see above), it is the Examiner’s belief that most of the arguments presented by Applicant have been considered/answered in the rejection itself.
Conclusion
Claims 1-2, 8-10, 13-14, and 20 are rejected. No claim is allowed.
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 AARON RAFANAN ULLMAN whose telephone number is (571)272-6623. The examiner can normally be reached 7:30 am to 5:00 pm M-F.
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/A.R.U./Examiner, Art Unit 1628 /Rayna Rodriguez/Primary Examiner, Art Unit 1628
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