DETAILED NOTICE
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 August 2026 has been entered.
Claim Status
Claims 1-2, 7-14, and 19-23 are under examination on the merits.
Claim Objections
Claim 1 is objected to because the claim should state the target antigen of the binding molecule. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 does not recite the 6 CDRs making the claim indefinite. The 6 CDRs should be listed and labeled as HCDR1, LCDR2, etc.
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 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.
(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 on pages 4-7 of the Remarks submitted 19 August 2026 that the claims are not obvious because the claimed antibody demonstrates unexpected results of not inducing an anti-drug response in NHPs. Applicant further contends that the examiner’s reliance on inherent unpredictability in misplaced, that in vitro RF binding does not relate to in vivo ADA response, and that the prior art teaches away from the claimed invention.
In response:
The result of the antibody not inducing an anti-drug antibody (ADA) response is not unexpected. It cannot be extrapolated from the results shown and the prior art that the claimed antibody will consistently not cause an ADA response. The LS mutation claimed has been shown in the prior art to both cause an ADA response and not cause an ADA response (see Madea and Mackness). While Mades and Mackness use an in vitro binding to rheumatoid factor (RF) as a surrogate for ADA rather than a direct measure in vivo for ADA, in vitro methods are suitable surrogates for in vivo responses. Madea (pg. 845 column 2, ¶2) and Mackness (Table 3) both show that ADA responses do not consistently occur and therefore it cannot be expected that the LS mutation would always lead to an ADA response. Madea and Mackness do discuss that using the LS mutation may not be suitable in humans as the fact that any ADA response was occurring, this does not change the fact that the ADA response does not occur consistently when the LS mutation is present. The lack of an ADA response shown by Applicant with an antibody with the LS mutation is not an unpredictable result as it has not been shown previously in the prior art that an ADA response consistently occurs with the LS mutation. Applicant has also failed to show data proving that the lack of an ADA response from the claimed antibody will consistently occur.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 ET.
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
