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 Status
The Amendment filed on 25Apr2023 is acknowledged in which claim(s) 3, 5-32, 35, 38-68, 71-75, 77-86, 88-92, 94-97, 99, and 110-112 were canceled by Applicant.
Applicant’s election without traverse of species of disease treated of claim 69 in the reply filed on 26Feb206 is acknowledged.
Claim(s) 1-2, 4, 33-34, 36-37, 98, and 100-109 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26Feb2026.
Claim(s) 69-70, 76, 87, and 93 is/are presented for examination on the merits.
Specification
The disclosure is objected to because of the following informalities:
The paragraph numbers 0001-0009 have 4 digits total, paragraph numbers 00010-00099 have 5 digits total, and paragraph numbers 000100-000246 have 6 digits total. The total number of digits for each paragraph number should be consistent throughout the disclosure.
Appropriate correction is required.
Claim Objections
Claim(s) 69 (and dependent claims 70, 76, 87, 93) is/are objected to because of the following informalities:
“…determining regions (CDRs) of SEQ ID NO…” in line 6 should be “…determining regions (CDRs), wherein HCDR1-3 comprise
“…comprising CDRs, wherein LCDR1-3 comprise .
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 69-70, 76, 87, and 93 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0251418 A1 (hereinafter “US418”), as evidenced by the instant specification.
Regarding instant claim(s) 69-70, 76, 87, 93, US418 teaches a method of treating transthyretin amyloidosis (ATTR) comprising administration of an anti-TTR antibody to a patient in need thereof [e.g., title, abstract; ¶ 0003-0006, 0025, 0174, 0187, 0193-0194, 0273-0274, 0281-0286]. US418 further teaches the subject/patient is a human [e.g., ¶ 0174], and that anti-TTR antibodies are administered in a therapeutically effective amount ( [e.g., ¶ 0282]. US418 further teaches the anti-TTR antibody comprises an Hu14G8VHv3 of SEQ ID NO: 66 and Hu14G8VLv3 of SEQ ID NO: 76 [e.g., ¶ 0226, 0397-0398], which have the same HCDR1-3 and LCDR1-3 (SEQ ID NOs: 1-3 and 4-6) sequences as the instant claimed antibody (see alignment below). With regards to the specific instant claimed NIS and/or GLS limitations that result from the current method of treating ATTR, something which is old (e.g., a method of treating ATTR comprising administering an anti-TTR antibody) does not become patentable upon the discovery of a new property (e.g., NIS and/or GLS outcomes), see MPEP 2112(I). Further, as evidenced by the instant specification, administration of the anti-TTR antibody recited above results in the instant claimed reductions of NIS (e.g., at least about 1) and/or GLS (e.g., about 0.5%) in human subjects with ATTR [e.g., ¶ 00045-00046, 00052-00055, 000162-000169].
Alignment of instant claimed HCDR1-3 (SEQ ID NOs: 1-3) with US418 humanized anti-TTR Ab VH domain (Anti-transthyretin hAb VH region Hu14G8VHv3; SEQ: 66):
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Alignment of instant claimed LCDR1-3 (SEQ ID NOs: 4-6) with US418 humanized anti-TTR Ab VL domain (Anti-transthyretin hAb VL region Hu14G8VLv3, SEQ:76):
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Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M CHATTIN whose telephone number is (571)270-0646. The examiner can normally be reached T-F 0600-1600 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY M. CHATTIN/Examiner, Art Unit 1643
/GARY B NICKOL/Primary Examiner, Art Unit 1643