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
Restriction/Election
1. Applicant’s election of Group I (claims 1-12) in the reply filed on 06/03/2026 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
2. Claims 1-14 are pending. Claims 1-12 are currently under consideration. Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Information Disclosure Statement
3. It is noted that the information disclosure statement has not been filed yet in this application.
Drawings
4. The drawing filed on 11/10/2023 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
5. The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 1-12 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Claim 1 is drawn to a monoclonal antibody comprising a light chain sequence and a heavy chain sequence. However, claim 1 recites two nucleotide sequences, not amino acid sequences. Claim 2 is drawn to a composition comprising a murine monoclonal antibody which binds to a glycoside portion of a Tn antigen and has the IgM isotype, whereas claim 6 is drawn to a composition comprising an antibody raised against an entirely carbohydrate immunogen. The claims do not require that the anti-antibodies possess any particular conserved structure nor other disclosed distinguishing feature. Claims 3-5 and 7-12 depend from claims 1, 2 or 6. Thus, the claims encompass a genus of antibodies without any structural features.
For each claim drawn to a genus, MPEP §2163 II.A.3(a) ii) (page 2100-189) states, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”. In the instant case, the specification discloses a murine IgM monoclonal antibody generated from Tn-PS A1 (Example 4), which comprises a light chain sequence and a heavy chain sequence encoded by the nucleic acid sequences set forth in SEQ ID NO: 1 or 2, respectively (Example 4). The instant disclosure is insufficient to support the broad genus of anti- antibodies and compositions comprising the antibodies.
It is well established in the art that the formation of an intact antigen binding site of an antibody routinely requires the association of the complete heavy and light chain variable regions of a given antibody. It is expected that proper association of heavy and light chain variable regions is required in order to form a functional antigen binding site (Paul, Fundamental Immunology, 3rd Edition, 1993, pages 292-295; in particular page 293, column 1, lines 3-8; column 1, line 31 to column 2, line 9; column 2, lines 27-30). Furthermore, the prior art does not provide compensatory structural or correlative teachings sufficient to enable one of skill to identify what other claimed antibodies might be. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of the instantly claimed antibodies.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
7. The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
8. Claims 1, 4-5, and 8-12 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i). Claims 1, 4-5, and 8-12 recite a monoclonal antibody comprising a light chain sequence of SEQ ID NO: 1 and/or a heavy chain sequence of SEQ ID NO: 2. However, SEQ ID NO: 1 and SEQ ID NO: 2 are nucleic sequences, not amino acid sequences.
(ii). Claim 3 is indefinite because it recites “wherein the composition is substantially free of additional peptides or proteins”. It is unclear what the metes and bounds of the limitation are.
Claim Rejections[Symbol font/0xBE]35 USC § 102 (a)(1)
9. 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.
10. Claims 2-3 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Blixt et al. (Glycobiology 22 (4): 529–542, 2012).
Blixt et al. teach a murine monoclonal antibody which binds to a glycoside portion of a Tn antigen, and has the IgM isotype (see, e.g., Abstract). Thus, the teachings of Blixt et al. meet the limitations of claims 2-3.
11. Claim 6 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Silva et al. (Cancer Immunol Immunother 61:581–585, 2012).
Silva et al. teach a composition comprising an antibody (a murine anti-Tn IgG3 antibody) raised against an entirely carbohydrate immunogen, Tn-PS A1 (see, e.g., Abstract). Thus, the teachings of Silva et al. meet the limitations of claim 6.
Conclusion
12. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674
June 21, 2026
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