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 .
Response to Amendment
The amendment filed 09 April 2026 in which claim 1 was amended has been entered.
Claims 1, 2, 7-14, and 19-23 are under examination on the merits.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, maintained and modified as to claims 1, 2, 7-14, 19-21, and 23). Claims 1-2, 7-14, 19-21, and 23 were rejected under 35 U.S.C. 103 as being prima facie obvious over Corti, IMGT, Janeway, Lanzavecchia, and Ravetch. In regards to the amendment of claim 1, Lanzavecchia teaches that the Fc moiety of the antibody is IgG1 (pg. 62, ¶2).
(Previous rejection, maintained as to claim 22). Claim 22 was rejected under 35 U.S.C. 103 as being prima facie obvious over Corti, IMGT, Janeway, Lanzavecchia, Ravetch, and Zhang.
Response to Arguments
Applicant contends of pages 4-6 of the Remarks submitted 09 April 2026 that that the claims are not obvious because the claimed antibody demonstrated an unexpected result of not inducing an anti-drug antibody response in NHPs.
In response: The result of the antibody not inducing an anti-drug antibody (ADA) response is not unexpected. Antibodies and the immune system are inherently unpredictable and it cannot be extrapolated from the results that the antibody will consistently not cause an ADA response. As evidenced by Maeda, et al. (MAbs. 2017 Jul;9(5):844-853., NPL-IDS, filed 04/09/2026, hereinafter Maeda) while 3 patient sera had evidence of an ADA response to the LS antibody, the remaining 12 patient sera did not (pg. 845, column 2, ¶2). Mackness, et al. (MAbs. 2019 Oct;11(7):1276-1288., NPL-IDS, filed 04/09/2026, hereinafter “Mackness”) further evidences with administering the LS antibody to 3 NHP, and of the two that were continued in the study (one was removed due to partial subcutaneous route of administration) neither NHP developed an ADA response (Table 3). Though the LS antibody does have a higher FcRn affinity, this is not reasonably predicative of the LS mutation causing or not causing and ADA response. Therefore, it is not unexpected that the LS antibody, when administered to NHP, did not cause an ADA response in the instant application.
Conclusion
NO CLAIMS ARE ALLOWED
THIS ACTION IS MADE FINAL. 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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/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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