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 .
DETAILED ACTION
Applicant’s election without traverse of Group I, claims 1-14 and 18, in the reply filed on 08/04/2026 is acknowledged. Applicant also elected the heavy and light chain framework regions of the instant SEQ ID NO(s): 20, 22, 24, 25, 27, 29, 31, and 33, respectively, and the heavy and light chain variable regions of SEQ ID NO(s): 10 and 17, respectively.
Claims 1-14, 18, and 20-22 are pending.
Claims 20-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/04/2026.
Claims 1-14 and 18 are under examination on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-14 and 18 have an effective filing date of 05/21/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly the information disclosure statement is being considered by the examiner.
Objection to the Drawings
The drawings are objected to, because many of the drawings are blurry and difficult to read, see Figs 4A, 6, 7, 13, and 15-17. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections
35 U.S.C. 102(a)(1)
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.
Claim(s) 1-5, 8, 9, 11-14, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leung et al. (WO 2018/070936, international publication date: 04/19/2018).
At [0002]-[0004], Leung et al. teach that “[c]arcinoembryonic antigen-related cell adhesion molecule 6 (CEACAM6) belongs to the carcinoembryonic antigen (CEA) family. CEACAM6 is a glycosyl phosphatidyl inositol (GPI) anchored cell surface glycoprotein that has been observed to be overexpressed in a variety of cancers including breast, pancreatic, colonic and non-small cell lung carcinoma. CEACAM6 acts as an oncogene in tumors and promotes cancer invasion, metastasis, anoikis resistance and chemoresistance, and inhibits differentiation… To date, there are a very limited number of anti-CEACAM6 monoclonal antibodies that could be used for antibody therapy or as antibody-drug conjugates for cancer treatment. There is therefore a need to develop novel antibodies against CEACAM6 that can be used for antibody therapy or as antibody-drug conjugates for cancer treatment…. In one aspect, there is provided an antigen-binding protein, or an antigen-binding fragment thereof, comprising (i) a heavy chain variable domain comprising a VHCDR1 having the amino acid sequence GNTFTSYVMH (SEQ ID NO: 3); a VHCDR2 having the amino acid sequence YINPYNDGTKYNEKFKG (SEQ ID NO: 4) and a VHCDR3 having the amino acid sequence STARATPYFYAMDY (SEQ ID NO: 5); and (ii) a light chain variable domain comprising a VLCDRl having the amino acid sequence KSSQSLLWSVNQNSYLS (SEQ ID NO: 6), a VLCDR2 having the amino acid sequence GASIRES (SEQ ID NO: 7), and a VLCDR3 having the amino acid sequence QHNHGSFLPYT (SEQ ID NO: 8).” It is noted that SEQ ID NO(s): 3-8 share 100% sequence homology with the instant SEQ ID NO(s): 1-6, respectively.
At [0064]-[0067], Leung et al. teach that “[i]n a first aspect, there is provided an antigen-binding protein, or an antigen-binding fragment thereof, comprising (i) a heavy chain variable domain comprising a VHCDR1 having the amino acid sequence GNTFTSYVMH (SEQ ID NO: 3); a VHCDR2 having the amino acid sequence YINPYNDGTKYNEKFKG (SEQ ID NO: 4) and a VHCDR3 having the amino acid sequence STARATPYFYAMDY (SEQ ID NO: 5); and (ii) a light chain variable domain comprising a VLCDR1 having the amino acid sequence KSSQSLLWSVNQNSYLS (SEQ ID NO: 6), a VLCDR2 having the amino acid sequence GASIRES (SEQ ID NO: 7), and a VLCDR3 having the amino acid sequence QHNHGSFLPYT (SEQ ID NO: 8)… The antigen-binding protein, or antigen-binding fragment thereof, may comprise heavy and light chain CDR regions that are about 80%, about 85%, about 90%, about 95%, about 96%, about 97%, about 98% or about 99% identical to the heavy and light chain CDR regions of (i) and (ii)… In one embodiment, the heavy chain variable region comprises the amino acid sequence SGPELVKPGASVKMSCKASGNTFTSYVMHWVKQKPGQGLEWIG YINPYNDGTKYNEKFKGKATLTSDKSSSTAYMELSSLTSEDSAVYYCARSTARATPYFYAMDYWGQGTSVTVSS as set forth in SEQ ID NO: l. Alternatively, the heavy chain variable region may comprise an amino acid sequence having about 80%, about 85%, about 90%, about 95%, about 96%, about 97%, about 98% or about 99% identity to the amino acid sequence set forth in SEQ ID NO: 1… In one embodiment, the light chain variable region comprises the amino acid sequence DILMTQSPSSLAVTAGEKVTMRCKSSQSLLWSVNQNSYLSWYQLKQGQPPKLLLYG ASIRESWVPDRFTGSGSGTDFTLTISNVHVEDLAVYYCQHNHGSFLPYTFGGGTKLEI
K as set forth in SEQ ID NO:2. Alternatively, the antigen-binding protein, or antigen-binding fragment thereof, may comprise a light chain variable region which comprises an amino acid sequence having about 80%, about 85%, about 90%, about 95%, about 96%, about 97%, about 98% or about 99% identity to the amino acid sequence set forth in SEQ ID NO:2.” SEQ ID NO: 1 of Leung comprises the instant SEQ ID NO(s): 1-3, respectively.
Furthermore SEQ ID NO: 1 of Leung et al. comprises a framework 4 region that is underlined in the sequence below: SGPELVKPGASVKMSCKASGNTFTSYVMHWVKQKPGQGLEWIGYINPYNDGTKYNEKFKGKATLTSDKSSSTAYMELSSLTSEDSAVYYCARSTARATPYFYAMDYWGQGTSVTVSS. It is noted that this framework 4 region shares at least 90% sequence homology with the framework 4 region of the instant SEQ ID NO: 10, which comprises the amino acid sequence WGQGTLVTVSS. It is further noted that the recitation of “ 90% sequence identity to at least one region other than a CDR of the VH…” does not require 90% sequence identity to, for example, an entire framework region of a particular VH, because the recitation of “at least one region other than a CDR of the VH” could be used to describe only a portion of a framework region. In either case the VH of Leung et al. comprises the VH CDRs of the instant SEQ ID NO(s): 1-3 and also comprises at least 90% sequence identity to at least one region other than a CDR of the VH amino acid sequence set forth in SEQ ID NO: 10.
Additionally SEQ ID NO: 2 of Leung et al. comprises a framework 4 region that is underlined in the sequence below: DILMTQSPSSLAVTAGEKVTMRCKSSQSLLWSVNQNSYLSWYQLKQGQPPKLLLYG ASIRESWVPDRFTGSGSGTDFTLTISNVHVEDLAVYYCQHNHGSFLPYTFGGGTKLEI
K. It is noted that this framework 4 region shares at least 90% sequence homology with the framework 4 region of the instant SEQ ID NO: 17, which comprises the amino acid sequence FGGGTKLEIK. It is further noted that the recitation of “ 90% sequence identity to at least one region other than a CDR of the VL…” does not require 90% sequence identity to, for example, an entire framework region of a particular VL, because the recitation of “at least one region other than a CDR of the VL” could be used to describe only a portion of a framework region. In either case the VL of Leung et al. comprises the VL CDRs of the instant SEQ ID NO(s): 4-6 and also comprises at least 90% sequence identity to at least one region other than a CDR of the VL amino acid sequence set forth in SEQ ID NO: 17. The antibody of Leung et al. meets the limitations of claims 1, 2, 4, 5, and 11.
With respect to claim 3, SEQ ID NO: 1 of Leung et al. comprises a framework 4 region that is underlined in the sequence below: SGPELVKPGASVKMSCKASGNTFTSYVMHWVKQKPGQGLEWIGYINPYNDGTKYNEKFKGKATLTSDKSSSTAYMELSSLTSEDSAVYYCARSTARATPYFYAMDYWGQGTSVTVSS. It is noted that this framework 4 region comprises at least one amino acid substitution compared with the instant framework 4 region of SEQ ID NO: 10, which comprises the amino acid sequence WGQGTLVTVSS. Additionally SEQ ID NO: 2 of Leung et al. comprises a framework 1 region that is underlined in the sequence below: DILMTQSPSSLAVTAGEKVTMRCKSSQSLLWSVNQNSYLSWYQLKQGQPPKLLLYG ASIRESWVPDRFTGSGSGTDFTLTISNVHVEDLAVYYCQHNHGSFLPYTFGGGTKLEIK. It is noted that this framework 1 region comprises at least one amino acid substitution compared with the instant framework 1 region of the instant SEQ ID NO: 17, which comprises the amino acid sequence DIVMTQSPDSLAVSLGERATINC.
With respect to claims 8 and 9, at p. 3, Leung et al. teach that antibodies of the invention may comprise antigen-binding fragments, such as scFv molecules.
With respect to claims 12 and 13, at p. 13, Leung et al. teach that antibodies of the invention may be conjugated to a radioisotope or to a cytotoxin, such as monomethyl auristatin E (MMAE).
With respect to claim 14, at p. 13, Leung et al. teach that antibodies of the invention may bind to a gefitinib resistant lung cancer cell.
With respect to claim 18, at [0005], Leung et al. teach that “[i]n another aspect, there is provided a composition comprising a physiologically acceptable carrier and a therapeutically effective amount of the antigen-binding protein, or an antigen-binding fragment thereof as disclosed herein.”
35 U.S.C. 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 8-14, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Leung et al. (WO 2018/070936, international publication date: 04/19/2018) and Liang et al. (US PG PUB 2019/0010246, publication date: 01/10/2019).
As indicated above the antibody of Leung et al. meets the limitations of an antigen-binding molecule comprising: (1) a heavy chain variable region (VH) comprising the VHCDR1 amino acid sequence of SEQ ID NO: 1, the VHCDR2 amino acid sequence of SEQ ID NO: 2, and the VHCDR3 amino acid sequence of SEQ ID NO: 3, and a light chain variable region (VL) comprising the VLCDR1 amino acid sequence of SEQ ID NO: 4, the VLCDR2 amino acid sequence of SEQ ID NO: 5, and the VLCDR3 amino acid sequence of SEQ ID NO: 6; wherein the VH as defined in (1) comprises at least 90% sequence identity to at least one region other than a CDR of the VH amino acid sequence set forth in SEQ ID NO: 10, and the VL as defined in (1) comprises at least 90% sequence identity to at least one region other than a CDR of the VL amino acid sequence set forth in SEQ ID NO: 17. Leung et al. do not teach or suggest an antigen-binding molecule comprises a light chain sequence having at least 70% sequence identity to SEQ ID NO: 84, and a heavy chain sequence having at least 70% sequence identity to SEQ ID NO: 85. This deficiency is remedied by Liang et al.
Liang et al. teach the human IgG1 constant region (SEQ ID NO: 1) and the human kappa light chain (SEQ ID NO: 2).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success at the effective filing date of the invention to combine the teachings of Leung et al. with those of Liang et al. to arrive at an antigen-binding molecule comprising: (1) a heavy chain variable region (VH) comprising the VHCDR1 amino acid sequence of SEQ ID NO: 1, the VHCDR2 amino acid sequence of SEQ ID NO: 2, and the VHCDR3 amino acid sequence of SEQ ID NO: 3, and a light chain variable region (VL) comprising the VLCDR1 amino acid sequence of SEQ ID NO: 4, the VLCDR2 amino acid sequence of SEQ ID NO: 5, and the VLCDR3 amino acid sequence of SEQ ID NO: 6; wherein the VH as defined in (1) comprises at least 90% sequence identity to at least one region other than a CDR of the VH amino acid sequence set forth in SEQ ID NO: 10, and the VL as defined in (1) comprises at least 90% sequence identity to at least one region other than a CDR of the VL amino acid sequence set forth in SEQ ID NO: 17, and wherein said antigen-binding molecule comprises a light chain sequence having at least 70% sequence identity to SEQ ID NO: 84, and a heavy chain sequence having at least 70% sequence identity to SEQ ID NO: 85. One of ordinary skill in the art would have been motivated to do so, because Leung et al. teach an antigen-binding molecule comprising: (1) a heavy chain variable region (VH) comprising the VHCDR1 amino acid sequence of SEQ ID NO: 1, the VHCDR2 amino acid sequence of SEQ ID NO: 2, and the VHCDR3 amino acid sequence of SEQ ID NO: 3, and a light chain variable region (VL) comprising the VLCDR1 amino acid sequence of SEQ ID NO: 4, the VLCDR2 amino acid sequence of SEQ ID NO: 5, and the VLCDR3 amino acid sequence of SEQ ID NO: 6; wherein the VH as defined in (1) comprises at least 90% sequence identity to at least one region other than a CDR of the VH amino acid sequence set forth in SEQ ID NO: 10, and the VL as defined in (1) comprises at least 90% sequence identity to at least one region other than a CDR of the VL amino acid sequence set forth in SEQ ID NO: 17. Furthermore Liang et al. teach the human IgG1 constant region (SEQ ID NO: 1) and the human kappa light chain (SEQ ID NO: 2). One of ordinary skill in the art would have been motivated to pair the antibody of Leung et al. with the heavy and light chain constant regions of Liang et al., because the resultant antibody would be useful for the treatment of CEACAM5/6-expressing cancers. Furthermore said antibody would comprise a light chain sequence having at least 70% sequence identity to SEQ ID NO: 84, and a heavy chain sequence having at least 70% sequence identity to SEQ ID NO: 85.
Allowable Subject Matter
Claims 6 and 7 are objected to as being dependent upon a rejected base claim, with respect to the elected heavy and light chain variable regions of SEQ ID NO(s): 10 and 17, respectively, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON B MOSELEY II whose telephone number is (571)272-6221. The examiner can normally be reached on M-F, 9:00-6:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
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