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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-5 and 13-20), and the species of SEQ ID NOs: 1-4 and 6 and amino acid sequence RAS (claims 1-5 and 13-20) and SEQ ID NOs: 31-32 and 37-38 (claims 2 and 14-17) in the reply filed on 5/28/2026 is acknowledged. Regarding the species election requirement, the elected species were not found in the prior art; thus, the species election restriction is withdrawn.
Claims 6-12 and 25-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II-III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/28/2026.
Claims 1-5 and 13-20 are examined below.
Priority
The present application claims benefit for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. CN202311203510.4, filed on 9/18/2023 in China.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Objections
Claims are objected to because of the following informalities:
In claim 1 line 2 Applicant uses the abbreviations “S100A8” and “S100A9”. It is recommended that abbreviations be accompanied by their full meaning at least at first instance that the abbreviation is used in order to improve clarity of the record and avoid confusion.
In claim 20 line 2, "an urine" appears to be a typographical error, namely it is suggested that "an urine" read as "a urine".
Furthermore, in claim 20 line 2, "the sample is a blood" appears to be a typographical error, namely it is suggested that "the sample is a blood" read as "the sample is blood".
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.
Claims 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 antibody or an antigen-binding fragment thereof that binds to S100A8 or S100A9, wherein the antibody or the antigen-binding fragment at least comprises one group or more groups selected from groups (i)-(iii) and/or groups (iv)-(v)…”.
However, it is not clear how the antibody or the antigen-binding fragment thereof can comprise more than one group from groups (i)-(iii) and/or groups (iv)-(v). The sequences of each of the groups appear to be CDRs belonging to the heavy chain variable region (VH) or the light chain variable region (VL) of the antibody (see for example the specification page 45 lines 1-5). Thus, it is not clear how the antibody or the antigen-binding fragment can comprise more than one group of VH-CDRs and VL-CDRs. A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Claim 2 recites “The antibody or the antigen-binding fragment thereof according to claim 1, comprising one or more group of amino acid sequences selected from groups (i)-(iii) and/or groups (iv)-(v):…and/or (vi) an amino acid sequence having at least 80%, 85%, 90%, 95%, 98% or 99% identity to VH and/or VL in each of the aforementioned groups”.
First, similar to claim 1 above, it is not clear how the antibody can comprise more than one group of amino acid sequences from the groups claimed because an antibody cannot comprise more than one set of VH and VL sequences. Second, it is not clear how the antibody or the antigen-binding fragment can comprise one group of amino acid sequences selected from groups (i)-(iii) and/or groups (iv)-(v) and/or (vi) because (vi) includes each of the aforementioned groups. In other words, it is not clear how the antibody claimed can comprise both groups (i)-(v) and (vi) because (vi) already encompasses groups (i-v). How can the antibody have multiple sets of VH and VL sequences that are 80%, 85%, 90%, 95%, 98% or 99% identity to VH and/or VL in each of the aforementioned groups? A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Claims 3-5 and 13-20 are included in this rejection because they depend from rejected claim 1 but fail to clarify the scope of patent protection sought.
Claim 18 recites “The kit according to claim 14 or 16…”. It is not clear what the scope of the claim is because it is not clear if the claim is dependent of claim 14 or 16. A person having ordinary skill in the art would not be capable of recognizing the metes and bounds of the claim.
Claim 19 recites “The kit according to claim 13,…optionally wherein the immunoassay comprises an enzyme linked immunosorbent assay (ELISA) method, an immunoblotting method, an immunohistochemistry method, an immunofluorescence method, a radioimmunoassay method, an immunocolloidal gold technique, or Point of Care Testing (POCT); and optionally wherein the immunoassay is ELISA”. Therefore, claim 19 reads on both a product and a process which is indefinite. A person having ordinary skill in the art would not be capable of recognizing the scope of the claim.
For these reasons the claims are rejected under 112b.
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 19-20 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 19 recites "The kit according to claim 13, wherein the kit is used to detect Sl00A8, Sl00A9, and/or a dimer of Sl00A8 and Sl00A9 in a sample by immunoassay; optionally wherein the immunoassay comprises an enzyme linked immunosorbent assay (ELISA) method, an immunoblotting method, an immunohistochemistry method, an immunofluorescence method, a radioimmunoassay method, an immunocolloidal gold technique, or Point of Care Testing (POCT); and optionally wherein the immunoassay is ELISA”. Note that “wherein the kit is used to detect Sl00A8, Sl00A9, and/or a dimer of Sl00A8 and Sl00A9 in a sample by immunoassay” merely recites the intended use of the kit and fails to limit the kit itself. Furthermore, the rest of the limitations are all optional and thus not required to be limiting the kit. For these reasons, it appears that claim 19 does not further limit claim 13.
Claim 20 recites “wherein the sample is a blood, a tissue, a cell, a body fluid, an urine, or a fecal extract, and preferably, the sample is a blood”. Therefore, claim 20 limits the intended use of the kit and fails to limit the kit itself. For this reason, it appears that claim 20 does not further limit claims 13 and 19.
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.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fischer and Beckmann (US 20210130478 A1) ("Fischer").
Fischer teaches “monoclonal antibodies that specifically bind to human IL-1 R7” (Abstract). Fischer further teaches that “the antibody or antigen-binding fragment comprises a heavy chain variable (VH) region is at least 85% identical to a VH region selected from the group consisting of VH regions of SEQ ID NO: 1 to 148” (para. 53). Fischer further teaches that “[t]he antibody according to the invention may also comprise a light chain variable (VL) region that is at least 85% identical to a VL region selected from the group consisting of VL regions of SEQ ID NO: 149 to 296” (para. 54). Note that SEQ ID NO: 10 of Fischer is 80.2% matched to instant SEQ ID NO: 31 and 80.7% matched to instant SEQ ID NO: 35, SEQ ID NO: 200 of Fischer is 87.3% matched to instant SEQ ID NO: 32, SEQ ID NO: 115 of Fischer is 77.5% matched to instant SEQ ID NO: 33, SEQ ID NO: 282 of Fischer is 90.5% matched to instant SEQ ID NO: 36, and SEQ ID NO: 222 of Fischer is 100% matched to SEQ ID NO: 28 and 89.5% matched to instant SEQ ID NO: 40.
Cao et al. (WO 2022052974 A1) (“Cao”).
Cao teaches “antibodies including antigen binding fragment thereof that specifically recognizing Interleukin-4 receptor α (IL-4Rα)” (Abstract). Cao further teaches the “ anti-IL-4Rα antibody, comprising:…an LCCDR1 comprising the amino acid sequence of any one of SEQ ID NOs: 31-40” (claim 2). Note that SEQ ID NO: 33 of Cao is 100% matched to instant SEQ ID NO: 10.
However, there are no prior art references that teach the antibody of claim 1. The claims appear to be free of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FERNANDO IVICH whose telephone number is (703)756-5386. The examiner can normally be reached M-F 9:30-6:00 (E.T.).
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/Fernando Ivich/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678
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