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 amendment and remarks filed on 04/02/2026 are acknowledged.
Claims 1-11 are pending.
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 immunoglobulins, i.e. antibody molecules, but the meaning of these terms as applied to structurally undefined “immunoglobulin binding domain” or “antigen binding domain” is unclear. A person of skill in the art would be aware that domains capable of binding to immunoglobulins or other antigens do not necessarily comprise CDRs or framework regions of immunoglobulins.
(ii) Claim 1 is further indefinite in the recitation of “the last amino acid residue of the carboxyl terminus of the heavy chain CDR-3,” because “the carboxyl terminus of the heavy chain CDR-3” is defined differently by the commonly used numbering schemes Kabat, Chothia, IMGT, AbM and Contact definition.
(iii) Claim 1 is further indefinite in the listing of “antigen binding proteins” PD-1, connexin26, etc., because none of the listed proteins is an antigen binding protein.
(iv) 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 stand rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Walker L. (US 20200223906; of record).
Applicant’s arguments have been fully considered but have not been found convincing.
Applicant asserts that Walker “does not disclose the specified VH-FR4 comprising at least one of: a glycine residue positioned six amino acid residues from the last amino acid residue of the carboxyl terminus of the heavy chain CDR-3, and an arginine residue positioned eight amino acid residues from the last amino acid residue of the carboxyl terminus of the heavy chain CDR-3.”
Contrary to applicant’s assertion, as explained in section 5 of the previous office action, Walker discloses the specified VH-FR4 comprising instant SEQ ID NO: 43 (amino acids 110-120 of Walker’s SEQ ID NO: 482), which comprises a glycine residue positioned six amino acid residues from the last amino acid residue of the carboxyl terminus of the heavy chain CDR-3.
The listing of specific “antigen binding proteins” in claim 1 is not deemed to limit the scope of the claim because, as noted in subsection 3(iii) above, none of the listed proteins is an antigen binding protein.
Accordingly, the ground of rejection presented in section 5 of the previous office action are maintained for the reasons of record, as they apply to the amended claims, and are incorporated by reference herein as if reiterated in full.
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 stand rejected under 35 U.S.C. 103 as being unpatentable over Walker L. (US 20200223906) in view of Kelley et al. (US Patent No. 10407510) (both of record).
Applicant’s argument and the examiners response are the same as in section 5 above. Accordingly, the ground of rejection presented in section 7 of the previous office action are maintained for the reasons of record, as they apply to the amended claims, and are incorporated by reference herein as if reiterated in full.
8. Conclusion: no claim is allowed.
9. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
10. 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 9 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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