DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's preliminary amendment filed on 02/28/2024 is acknowledged.
Claims 442-461 are pending.
3. The following is a quotation of the first paragraph of pre-AIA 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.
4. Claims 459-460 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a polypeptide that binds PD-L2 and comprises CDR1, CDR2 and CDR3 form the same antibody, does not reasonably provide enablement for a polypeptide that binds PD-L2 and comprises CDR1, CDR2 and/or CDR3 form different antibodies.
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The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims without undue experimentation.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized in In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, limited working examples, the unpredictability in the art and the amount of experimentation required to enable one of skill in the art to make and use the claimed invention.
The claims recite amino acid sequences of CDR regions from seven independently obtained anti-PD-L2 antibodies (Examples 23-28, and Table B6), and read on polypeptides comprising CDR1, CDR2 and/or CDR3 are from different antibodies.
The ability of the claimed polypeptide to bind to the recited antigen is an essential feature of the claimed invention. It is well established in the art that the formation of an intact antigen-binding site generally requires at least three CDRs from either the heavy chain or the light chain. Specific interaction with the antigen requires the association of the complete heavy and light chain variable regions of the antibody, each of which consists of three CDRs, which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation are required in order to produce an antibody having antigen-binding function, and that proper association of heavy and light chain variable regions is required in order to form functional antigen binding sites. For example, D’Angelo et al. (2018) found that while different HCDR3s can be identified within a target-specific antibody population after in vitro selection, the majority of antibodies with the same HCDR3 sequence within unselected populations do not bind the target (e.g. the Abstract). Therefore, a person skilled in the art would readily ascertain that it is highly unlikely, or at least unpredictable, whether polypeptides as broadly recited by the claims would bind PD-L2.
The specification provides insufficient direction or guidance regarding how to produce functional polypeptides broadly defined by the claims. Undue experimentation would be required to make and use the invention commensurate with the scope of the claims based on the disclosure as-filed.
5. The following is noted regarding the claimed invention as compared to prior art teachings:
Claim 442 is directed to PD-L2-binding polypeptides defined by amino acid sequences having at least 80% identity to the recited CDR3 regions.
Amino acid sequences within the scope of the claim are taught in the prior art as part of various peptides or polypeptides. For example, a sequence identical to instant SEQ ID NO: 440 is comprised within SEQ ID NO: 64 of US 20090081178, and a sequence 85% identical to instant SEQ ID NO: 436 is comprised within SEQ ID NO: 4 of US 20040132135 (see SCORE).
Claim 442 further stipulates that in addition to the defined CDR3 sequences, PD-L2-binding polypeptides further comprise four framework regions (FR1 to FR4) and two complementarity determining regions (CDR1 and CDR2). While the amino acid sequences of these regions are not specified, the terms “framework region” and “complementarity determining region” have established meaning in antibody arts, so that a person skilled in the art would be able to ascertain whether a given polypeptide which comprises a CDR3 region also comprises FR1-FR4 and CDR1-CDR2 regions.
Based on available record, none of prior art peptides or polypeptides which comprise any of instantly recited CDR3 sequences also comprise FR1-FR4 or CDR1-CDR2 regions, nor does there appear to be any suggestion in the prior art to add such regions to produce PD-L2 binding polypeptides.
6. The following US Patents share a coinventor and/or an assignee with the present application, and disclose the subject matter of the present claims, but do not contain patented claims which would anticipate or make obvious the presently claimed invention: US 8907065, US 10087251, US 10208115, US 10844123, and US 11858997.
7. Claims 442-458 are allowable.
Claim 461 is objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all relevant limitations of the base claim and any intervening claims.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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