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 157-177 are pending and being examined on the merit.
Specification
Tables 2 and 3 of the instant specification (page 40 and 41) recite sequences that correspond to SEQ ID NOs:13, 14, and 15, and SEQ ID NOs:25, 26, and 27. However, the sequence listing for SEQ ID NOs:13-15 and 25-27 do not match the recited sequences on tables 2 and 3.
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.
Claims 157 and 159-177 are 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.
It is unclear whether the information in the parenthesis is an example of magnetic beads or if the magnetic beads are required to be capture beads.
Base claim 157 recites sequences followed by sequence identifiers in parenthesis. According to the sequence listing, the sequence identifiers recited do not correspond to the sequences preceding them. Thus, it is unclear if the claimed CDR sequences require the sequence recited or the sequence corresponding to the sequence identifiers.
Thus, the metes and bounds of the claims are unclear.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 167-169 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 157 is directed to an antibody comprising 6 defined CDR sequences. According to the instant specification, the antibody of claim 157 binds to CD163, which is expressed on myeloid-derived suppressor cell (page 40, table 2). Thus, the limitations of claims 167-169 do not further limit claim 157.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in 4 with 5
proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claim 158 is 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.
The following is a statement of reasons for the indication of allowable subject matter: The instant claimed anti-CD163 antibody comprising SEQ ID NOs:13-15 and 25-27 is obtained through affinity maturation of anti-CD163 AB101 (example 1), which comprises SEQ ID NOs:1-6, and is excluded in the proviso of based claim 1. Puri (WO2021016128 A1, IDS entered on March 27, 2024) disclosed the anti-CD163 antibody AB101, but does not disclose affinity maturation of the antibody to arrive at the instant claimed antibodies. Based on the state of the art, it is not obvious to modify the AB101 antibody to arrive at the instant claimed antibody comprising SEQ ID NOs:13-15 and 25-27.
Conclusion
Claims 157 and 159-177 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE WU whose telephone number is (571)272-5205. The examiner can normally be reached M-F 9-5PM.
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/JULIE WU/Supervisory Patent Examiner, Art Unit 1643