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. 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.
3. Claims 1-11 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) Claim 1 is indefinite in the recitations of “heavy chain framework 4 region (VH-FR4)” and “heavy chain CDR-3,” because the nature or identity of these regions are unknown. Framework regions and CDRs are sufficiently defined within the structure of antibody molecules, but the meaning of these terms as applied to structurally undefined “antigen binding protein” is unclear.
(ii) Claim 1 is further indefinite in the recitation of “the last amino acid residue of a heavy chain CDR-3,” because said amino acid may be defined differently depending on the numbering scheme sued, such as Kabat, Chothia, IMGT, AbM or Contact definition.
(iii) Claim 3 is indefinite in the recitation of “framework region 4 polypeptide (FR3-CDR3-FR4),” because of the contradiction between the definition “framework region 4 polypeptide” and the recited formula, which comprises FR3.
(iv) Claim 5 is indefinite, because location of the carboxy-terminal cysteine is unclear. Claim 1 recites an antigen-binding protein, which may comprise any number of different polypeptide chains. Claim 5 recites an additional polypeptide without specifying its relation to any of the polypeptides of claim 1. Any of the polypeptides may comprise C-terminal cysteine, not necessarily a VH-FR4-containing polypeptide.
(v) Claims 2-11 are indefinite, because they encompass the indefinite limitations of the claim(s) on which they depend.
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
4. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
5. Claims 1-4 and 6-11 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Walker L. (US Pat. Pub. No. 20200223906).
Walker teaches anti-RSV antibody No. 262, which comprises a heavy chain of SEQ ID NO: 482 (Table 6).
Instant SEQ ID NO: 43 is identical to amino acids 110-120 of Walker’s SEQ ID NO: 482 (see SCORE). Amino acids 110-120 is the C-terminal sequence of SEQ ID NO: 482, adjacent to CDR-3 of SEQ ID NO: 487 (Table 6) at positions 97-109 of SEQ ID NO: 482. Accordingly, amino acids 110-120 of Walker’s SEQ ID NO: 482 constitute the heavy chain framework 4 region (VH-FR4), and so Walker’s antibody No. 262 is within the scope of instant claims 1-4.
Walker further teaches that the anti-RSV antibodies of the invention are formulated in pharmaceutical compositions (e.g. [0179]), or labeled with a detectable reporter molecule (i.e. a detection-promoting agent) such as a fluorescent moiety (e.g. [0192]). Since the antibodies are recombinantly produced, polynucleotides, expression vectors and host cells are inherent in teachings of the antibodies.
6. 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 of this title, 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.
7. Claims 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Walker L. (US Pat. Pub. No. 20200223906) in view of Kelley et al. (US Patent No. 10407510).
As explained in section 5 above, Walker teaches an antibody within the scope of instant claim 1, and conjugates of the antibody with detection promoting agents.
Although Walker does not specifically exemplify an antibody with a C-terminal cysteine, addition of cysteine to C-termini of antibody polypeptide chains was known and routinely used in the art to facilitate conjugation of various detection or therapeutic moieties. For example, Kelley teaches and claims antibody conjugates comprising an engineered cysteine at the C-terminus of heavy or light chain (e.g. claims 1, 41 and 44-47).
The motivation to add cysteine to the C-terminus of Walker’s antibody would have been provided by Walker’s teachings of antibody conjugates in combination with art-recognized advantages of using a free sulfhydryl group of cysteine for covalent attachment of certain chemical groups. The expectation of success would have been provided by the routine nature of the procedure and by the recognition that a C-terminal addition is less likely to interfere with protein structure and function, as compared to addition at an internal site.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
8. The following is noted regarding potential issues of nonstatutory double patenting:
The present application was filed on 08/06/2025 as a Divisional of USSN 18/690,247, issued on 09/09/2025 as US Patent No. 12410252, which claims a PD-1 binding protein wherein the heavy chain variable domain comprises a glycine at position 108 and/or an arginine at position 110 relative to SEQ ID NO: 24. These positions are the same as the positions identified in instant claim 1.
During prosecution of USSN ‘247, a Requirement for Restriction/Election dated 03/28/2025 was issued, and subsequently maintained, which set forth the claims directed to the subject matter patented in US ‘252 and the claims directed to the subject matter of instant claims as separate groups.
The third sentence of 35 U.S.C. 121 prohibits the use of a patent issuing on an application in which a requirement for restriction has been made, or on an application filed as a result of such a requirement, as a reference against any divisional application in a nonstatutory double patenting rejection, if the divisional application is filed before the issuance of the patent. Accordingly, the instant claims are not subject to the grounds of nonstatutory double patenting rejection over the claims of the ‘252 patent.
9. The following prior art is cited of record but not presently relied upon:
US Pat. Pub. No. 20200101142 teaches an antigen-binding protein comprising instant SEQ ID NO: 44 (see SCORE).
10. Conclusion: no claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 8:30 AM – 5 PM.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644