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 .
Claims 1-91, 98, and 114 have been cancelled. Claims 116-119 were added by amendment on 8/14/2026.
The terminal disclaimer filed on 8/14/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 12,600,787 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The rejection of claims 92-115 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn in view of the claim amendments and applicant’s arguments.
The rejection of claims 92 and 95-109 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods as discussed below, does not reasonably provide enablement for all methods embraced by the claims, is withdrawn as indicated in the Interview Summary mailed 6/4/2026.
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 92-94, 103, 108, and 110 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ozzello et al. (available online 15 May 2020).
Applicant is not entitled to benefit of the filing date of provisional application 62/892,849 (filed 8/28/2019). The limitations of the instant claims are not present in the provisional application. The effective filing date for the instant claims is the filing date of PCT/US2020/048350 (filed 8/28/2020).
Ozzello et al. discloses administering teprotumumab to a subject with chronic TED where the subject meets the limitations of instant claims 92 and 110. Treatment resulted in reducing proptosis by more than 5 mm. The subject’s proptosis was greater than 3 mm above normal values for the subject’s race and gender at 23 mm OD, 28 mm OS. The CAS was 1. The subject was followed for two years with stable proptosis. The teprotumumab was administered by infusion (i.e. intravenously) in an 8-cycle treatment at 3-week intervals. See at least abstract, section 2 for the case report, section 4 conclusions.
While the reference does not specifically indicate the seven-item scale for the CAS, the instant specification acknowledges that the seven-item scale was generally used in clinical trials. See paragraph [0239] of the specification.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 92-94, 99-103, 108-109, 110, and 115 are rejected under 35 U.S.C. 103 as being unpatentable over Ozzello et al. (available online 15 May 2020) in view of Piantanida et al. (of record).
Ozzello et al. is applied as above. The dosage of teprotumumab is not explicitly disclosed.
Piantanida et al. discloses treatment of TED by an 8-cycle infusion of teprotumumab where the first infusion is 10 mg/kg and the subsequent infusions are 20 mg/kg for a multi-center clinical trial. The infusions are every three weeks. See at least page 885, right column, last paragraph.
It would have been obvious to use the dosages disclosed by Piantanida et al. in the infusion protocol disclosed by Ozzello et al. to treat chronic TED as this would have been the known protocol at the time of the effective filing date. One would have been motivated to do so in order to treat TED patients with low CAS and chronic disease using known administration methods. In addition, Ozzello et al. references the clinical trial and FDA approval of teprotumumab which would have used this protocol.
Claims 95-97, 104-107, 111-113, and 116-119 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Ozzello et al. does not disclose or suggest using other IGF1R inhibitor antibodies or treating subjects with the characteristics of claims 116-119. The subject treated in Ozzello et al. is not disclosed as having diplopia,
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 8/14/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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