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 .
Election/Restrictions
Applicant’s election without traverse of the species: (i) a substitution of the amino acid serine (S) at position S27e with aspartic acid (D) (claim 1 (i)) as the substitution selected from those listed in claim 1; (ii) the substitutions S27eD/R27fK/Y91F/H94Q (claim 4 (fff)) as the combination of substitutions selected from those listed in claim 4 parts (a) through (ttt); (iii) no substitution listed in claim 10; and (iv) the sequence of SEQ ID NO: 145, as containing the combination of substitutions listed in claim 11, in the reply filed on 7 July 2026 is acknowledged.
Claims 1-21 are pending and examined.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/02/2024 and 07/07/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-21 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.
Claim 1 recites an antigen-binding fragment of an antibody but only sets forth the light chain variable region. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The accepted meaning of a conventional antigen-binding fragment (Fab) means that it requires both a heavy chain segment and a full light chain to form a stable, standard binding site. Thus, it is unclear what the term “antigen-binding fragment” in claim 1, and all depending claims, is referring to. The term is indefinite because the specification does not clearly redefine the term in a manner that sets forth a meaning that is different from the literature.
Claim 1 recites CDRL1, CDRL2 and CDRL3; Claim 7 recites domains FR1, FR2 FR3 and FR4; Claim 8 recites CDRL2. None of these claims define what amino acids these regions consist of. Nor are these regions defined by the specification as filed. Thus, when read in light of the specification, these terms are indefinite. This affects the scope of all claims that depend from Claim 1.
Claims 9 and 10 recite substitution of amino acid W at position 50 with A, G, I, T or V; substitution of amino acid S at position 52 with F or I; substitution of amino acid T at position 53 with N or Y; and substitution of amino acid R at position 54 with K or V”. There is insufficient antecedent basis for these limitations in claim 1.
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 6-9 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 6 is indefinite wherein it recites the antibody or antigen-binding fragment of Claims 5/1: “wherein the light chain variable region comprises amino acid I at position 2, and/or amino acid Q at position 3”; claims 9 and 10 recites additional substitutions at positions 50-54 that are also not listed in claim 1. Since Claims 1 and 5 set forth the minimum requirements of the substitutions encompassed, and these do not include substitutions at residues 2 and/or 3; or residues 50-54, then claims 6 and 9 fail to further limit the scope of the parent claim(s).
Claim 7 has similar issues in that it recites the antibody or antigen-binding fragment of Claims 5/1: wherein the light chain variable region comprises one, two, three or four of the FR domains comprised in SEQ ID NO:123. Claims 1 and 5 set forth the minimum requirements of the substitutions and additional substitutions of FR domains is not included. This fails to further limit the scope of the parent claim.
Claim 8 has similar issues. To the extent that CDRL2 is not defined by either the claim or the specification, then it is unclear if the substitutions recited within Claim 1 comprise one, two, three or more amino acid substitutions within CDRL2.
To obviate these rejections, Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in 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
It should be noted that the light chain variable region of SEQ ID NOs: 14-150 and 161-173 (claims 11-13), which presumably incorporate all of the substitutions set forth in Claim 1 parts (a) through (v) and claim 4 parts (a) through (ttt), are free of the prior art. It appears that Applicant has provided no sequences that reflect the substitutions set forth in claim 10 parts (a) through (m). Nor are there sequences within the Sequence Listing that correspond to the nucleic acid molecules encoding SEQ ID NOs: 14-150 and 161-173; nor for the nucleic acid molecules encoding for the substitutions set forth in claim 10 parts (a) through (m).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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/STACEY N MACFARLANE/ Examiner, Art Unit 1675
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