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 .
Response to Amendment
The preliminary amendment filed 09/22/2023 is acknowledged. Claim 4 is amended and claims 2, 7 and 8 are canceled. No restriction is being imposed in this case. Claims 1 and 3-6 are under examination.
Sequence Rules
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). The instant application is not in compliance with the sequence rules, particularly 37 CFR 1.821(d), which requires that reference be made to a particular sequence identifier (SEQ ID NO: X) in the specification and claims at each disclosure of a sequence encompassed by the definitions set forth in 37 CFR § 1.821(a)(1) and (a)(2). See also MPEP 2422.04 which states, “[i]t should be noted, though, that when a sequence is presented in a drawing, regardless of the format or the manner of presentation of that sequence in the drawing, the sequence must still be included in the Sequence Listing and the sequence identifier (“SEQ ID NO: X”) must be used, either in the drawing or in the Brief Description of the Drawings.” Specifically, Figure 2A contains an amino acid sequence without any corresponding sequence identifiers. Appropriate correction is required.
Drawings
The drawings are objected to because they are blurry, particularly Figure 1C and Figure 2. 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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See, specifically, p. 7, paragraph [0023]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
In independent claim 1, both the antibody and the fragment thereof require a light chain variable region consisting of SEQ ID NO: 1 and a heavy chain variable region consisting of SEQ ID NO: 2.
Claim Objections
Claim 1 is objected to because of the following informalities. Claim 1 is interpreted as having the structure set forth in (I) of the claim, but it is grammatically awkward and redundant. The claim could be amended to recite something like:
An antibody or fragment thereof on annexin A2
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
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 5 and 6 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. Claims 5 and 6 depend from claim 4, and all three claims encompass a pharmaceutical composition comprising the antibody of claim 1. Claim 5 recites the pharmaceutical composition according to claim 4, which is for use in diagnosis or treatment of cancer and claim 5 recites that the cancer is colorectal or oral cancer. Any terminology in the preamble that limits the structure of the claimed invention must be treated as a claim limitation (see MPEP 2111.02(I), citing Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257, 9 USPQ2d 1962, 1966 (Fed. Cir. 1989)). For instance, the recitation of a “pharmaceutical” composition in claims 4-6 indicate a structural limitation because it implies the composition must be formulated so that it is compatible with use in a living organism. Nevertheless, the recitation of “for use” in diagnosis or treatment of cancer, wherein the cancer is colorectal or oral cancer in claims 5 and 6 is an intended use that does not limit the structure of the pharmaceutical composition. Since the intended use statements in claims 5 and 6 do not limit the structure of the pharmaceutical composition, they do not properly limit claim 4. Applicant may cancel the claims, amend the claims to place them in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements. Note, however, if the claims were rewritten in independent form, they would constitute duplicate claims (see MPEP § 608.01(m)).
Closest Prior Art
The references by Cua and colleagues (US Patent 10,654,921 and WO2018/021972) disclose a monoclonal antibody that binds to an N-linked glycan on annexin A2, however, they do not disclose the light chain variable region consisting of SEQ ID NO: 1 and the heavy chain variable region consisting of SEQ ID NO: 2 as required by the instant claims.
Conclusion
Claim 1 is objected to and claims 5 and 6 are rejected. Claims 1, 3 and 4 contain allowable subject matter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675