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 .
Claim Status
Applicant’s reply filed on 11/13/2025 is acknowledged. Claims 1, 3, 5, 7, and 8 have been amended. Claims 2, 4, and 6 are cancelled.
Claims 1, 3, 5, 7-8, and 11 are pending and under examination.
Rejections Withdrawn
All objections and rejections are withdrawn in view of applicant’s amendments filed 11/13/2025.
New Grounds of Rejection
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.
Claims 1, 3, 5, 7-8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Faget (US9376493B2, published 06/28/2016, PTO-892 07/15/2025) in view of Querfeld (Cancer Immunol Res. 2018 Aug;6(8):900-909) and Mehra (JAMA Dermatol. 2015 Jan;151(1):73-7, PTO-892 07/15/2025).
The disclosure of Faget is directed to antibodies directed against ICOS which inhibit ICOS and ICOS-L interactions (see Abstract). The disclosure of Faget originates from the same inventive entity of the instant application and discloses the generation and characterization of the anti-ICOS monoclonal antibodies of the instant application (Pg. 23, Column 23, Paragraph 3).
Regarding claim 1, pertaining to a method of treating cutaneous T cell lymphoma (CTCL) in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of an anti-ICOS antibody, Faget discloses the following limitations:
Anti-ICOS monoclonal antibodies deposited at the CNCM under the accession numbers CNCM I-4176, CNCM I-4177, CNCM I-4178, CNCM I-4179, and CNCM I-4180 and their corresponding CDR sequences (Pgs. 13 and 14).
A method of treatment of a patient in need comprising administering an anti-ICOS antibody of the disclosure, wherein the patient has a human malignant lymphoma (Faget claims 3 and 4)
The disclosure of Faget does not disclose (1) the subject in need has Sézary syndrome or (2) the antibody is conjugated to a cytotoxic moiety.
These deficiencies are taught by Querfeld and Mehra.
Querfeld:
The disclosure of Querfeld is directed to the evaluation of immune checkpoint expression as a marker of T cell dysregulation across the continuum of CTCL disease stages to guide the use of checkpoint inhibitors in the treatment of CTCL (Pg. 901, Left column, Full paragraph 2, Lines 8-13).
Regarding claims 1 and 3, wherein the CTCL is Sézary syndrome, Querfeld compared mRNA expression between early-stage mycosis fungoides and advanced-stage mycosis fungoides/Sézary syndrome and determined that the more advanced disease state displayed higher expression of immune checkpoint genes, including ICOS (Fig. 3B). Querfeld concludes the data of the disclosure provides a rationale for immune checkpoint inhibition to reverse T cell exhaustion in the treatment of disease (Pg. 907, Right column, Full paragraph 1, Lines 17-23).
Mehra:
The disclosure of Mehra is directed to a report of three patients with mycosis fungoides and one patient with Sézary syndrome who were treated with brentuximab vedotin, a conjugate of an anti-CD30 antibody and MMAE (Abstract, Importance section).
Regarding claims 1, 5, 7, 9 and 11, wherein the antibody is conjugated to the antimitotic agent MMAE, Mehra teaches administration of the anti-CD30/MMAE conjugate to patients (Pg. 73, Right column, Paragraph 1). Mehra teaches that brentuximab vedotin treatment was an effective neoadjuvant treatment in two patients, reducing the disease burden and enabling allogenic stem cell transplantation.
It would have been prima facie obvious to one having ordinary skill in the art at the time of filing to use the anti-ICOS antibodies of Faget (1) in a method to treat Sézary syndrome and (2) conjugated to antimitotic agent MMAE. One would have been motivated to do so because (1) Querfeld teaches ICOS expression is upregulated in Sézary syndrome indicating the potential for anti-ICOS treatment to reduce the exhausted phenotype found in advanced CTCL and (2) Mehra teaches the antitumor effects of an antibody-drug conjugate comprising a CTCL antigen antibody conjugated to MMAE. There would be an expectation of success in using the antibodies as part of an antibody-drug conjugate as taught by Mehra in a method to treat Sézary syndrome as taught by Querfeld because Mehra teaches the efficacy of targeting Sézary syndrome with an antibody-drug conjugate comprising MMAE and Querfeld teaches that ICOS is upregulated in Sézary syndrome and would thus be a suitable therapeutic target.
Response to Applicant’s Remarks
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive.
The applicant asserts no combination of the cited references makes the claimed invention obvious as presently amended (Remarks, Pg. 6). The applicant has amended the claims to require the specific antibodies of the disclosure and conjugation to a cytotoxic moiety to the independent claim and has limit treatment to Sézary syndrome in claim 3.
In response, the updated rejection includes a reference that teaches increased expression of ICOS in Sézary syndrome, which would render treatment with anti-ICOS antibodies obvious. The examiner has also reaffirmed that treatment of ICOS-related disease comprising the administration of known anti-ICOS antibodies conjugated to a known cytotoxic moiety is also obvious.
Conclusion
No claims are allowed.
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 CAROL ANN CHASE whose telephone number is (571)270-0934. The examiner can normally be reached Monday-Friday 9:00am-6:00pm.
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/CAROL ANN CHASE/ Examiner, Art Unit 1646
/HONG SANG/ Primary Examiner, Art Unit 1646