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
Status of the Claims
1. Claims 1-34 are the original claims filed 3/21/2023. In the Preliminary Amendment of 3/21/2023, claims 1-4, 6-13, 19 and 23 are amended and claims 20, 24-25 and 34 are canceled. In the Response of 4/14/2026, claims 2-4, 6-14, 17, 19, 23, 32, and 33 are amended and claim 1 is canceled.
Claims 2-19, 21-23, and 26-33 are the pending claims.
Applicants’ amendment of the claims raises new grounds for rejection. The Office Action is final.
Priority
2. USAN 18/027,583, filed 03/21/2023, is a National Stage entry of PCT/US2021/ 051165, International Filing Date: 09/21/2021, PCT/US2021/051165 Claims Priority from Provisional Application 63/081,315, filed 09/21/2020, and PCT/US2021/ 051165 Claims Priority from Provisional Application 63/109,877, filed 11/05/2020.
Original description support for the humanized cetuximab clones H1-H11 is found in Provisional Application 63/109,877, filed 11/05/2020.
Information Disclosure Statement
3. As of 5/6/2026, no IDS is filed for this application.
Withdrawal of Objections
Specification
4. The objection to the disclosure because of informalities is withdrawn. Clean and marked-up copies of the specification are filed.
a) The specification is amended to delete embedded hyperlinks and/or other form of browser-executable codes.
b) The specification is amended to rectify the improper use of the term, i.e., ATCC, Tween, Triton, Tris, MabSelect, HisTrap, Octet, Expifectamine, OptiPRO, ExpiCHO, Clariostar, DynaPro, GraphPad, Vi-Cell, Acquity, Geneious, which is a trade name or a mark used in commerce.
c) The specification is amended to include the sequence identifiers (SEQ ID NO) in the figure legend to Figure 1.
d) The specification is amended to include the sequence identifier for “(G4S)4” in Example 4. AS regards the terms TVSS, TVSA, LTVL and LELK, the explanation provided in the Response that the terms are laboratory names for cetuximab construct variants is found persuasive.
Claim Objection
5. The objection to Claims 6, 9-12, 14, 17, 19, 23 and 32-33 because of informalities is withdrawn.
a) Claim 6 is amended to replace “a Fc domain” with “[a] an Fc domain.”
b) Claims 9-12, 17 and 23 are amended to punctuate the sequence grouping as per the structure recited for the corresponding claim.
c) Claim 17 [actually claim 14] is amended to replace: “a N-terminus and a C-terminus” with “[a] an N-terminus and a C-terminus”; “the N-terminal” with “the N-terminus”; and “the C-terminal” with “the terminus.”
d) Claim 19 is amended to replace: “a N-terminus and a C-terminus” with “[a] an N-terminus and a C-terminus”
e) Claim 32 is amended to reduce the excess verbiage:
A method for treating or preventing a cancer, of claim 29.
f) Claim 33 is amended to delete the dependency on claim 9.
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(b)
6. The rejection of Claims 19, 27 and 33 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn.
a) Claim 19 is amended to recite "the
b) Claim 27 is amended to recite "sequence".
c) Claim 33 is amended to delete the dependency from claim 9.
d) Claim 33 is amended to recite "said
Claim Rejections - 35 USC § 112(d)
7. The rejection of Claim 4 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 is withdrawn. Claim 4 is amended to delete the sequence has 95% identity to the sequence of SEQ ID NO: 57.
Claim Rejections - 35 USC § 112(a)
Written Description
8. The rejection of Claims 1-19, 21-23, and 26-33 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is moot for the canceled claim(s) and withdrawn for the pending claims. The pending claims are amended to recite the proviso that the CDR region for the corresponding VH and/ or VL sequence is 100%.
Rejection(s) Withdrawn-in-part/ Maintained-in-part
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
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.
Scope of Enablement
9. The rejection of Claim 32 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is:
Withdrawn-in-part: claim 32 is amended to delete treating and preventing an infectious disease or an autoimmune disease.
Maintained-in-part: claim 32 reads on treating or preventing any cancer with the pharmaceutical composition of claim 29.
Applicants allege claim 32 is amended to delete treating and preventing an infectious disease or an autoimmune disease.
Response to Arguments
Applicants have not identified intrinsic evidence nor provided extrinsic evidence to substantiate a preventative effect of the pharmaceutical composition in the treatment of any cancer. See the comments below excerpted from the Office Action of 10/14/2025.
Disclosure in the Specification
The extent of biological testing for an exemplary antibody-like protein was on a single tumor cell line, in vitro, and observed for BxPC-3:
T Cell-Dependent Cellular Cytotoxicity Luciferized BxPC-3 tumor cells (ATCC, CRL-1687) were cultured at 37 ◦C in 5% CO2, in RPMI 1640 media containing 10% fetal bovine serum. A total of 500 tumor cells (20 µL) per well were plated into a 384-well, white, flat-bottom polystyrene TC-treated microplate (Corning 3570) and incubated at 37 ◦C, 5% CO2. After 24 h, 2500 human pan T cells (20 µL) were added to reach an effector-to-target (E–T) ratio of 5:1, and 10 µL of antibody was added at a 5-fold dilution series to reach a final concentration of 0–30 nM. Cells were dispensed using a Multidrop bulk liquid dispenser (BIOTEK). Plates were incubated for an additional 72 h at 37 ◦C, 5% CO2, before luminescence-based cell viability quantification was performed. To quantify the luminescence produced by constitutively expressed firefly luciferase, the Bright-Glo Luciferase Assay System (Promega, E2620, Madison, WI, USA) was used. BrightGlo reagent was added (20 µL per well) at room temperature and luminescence was quantified with a luminescence-detecting plate reader (BMG Labtech). Antibody EC50 was determined by transforming the data in Microsoft Excel and analysis was performed with the GraphPad Prism 6 software “log(agonist) vs. response—variable slope (four parameters).” The resulting EC50 value is reported based on quadruplicate measurements.
The bispcific anti-EGFR x anti-CD3 clone tested for EC50 depleting EGFR+ BxPC3 cells used the H9 clone. Accordingly, the limited disclosure demonstrates a therapeutic effect in mediating cytotoxicity on a single cancer cell line, in vitro.
No where in the specification is there a demonstration of any one of the humanized cetuximab clones shown to have an effect on a cell model correlate to an autoimmune or infectious disease.
No where in the specification is there a demonstration of any one of the humanized cetuximab clones shown to have an effect on a cell model correlate in preventing a cancer
The scope of the claims must bear a reasonable correlation with the scope of enablement. See In re Fisher, 166 USPQ 19, 24 (CCPA 1970). "[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.'" Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1365 (Fed. Cir. 1997) (quoting In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993)).
The rejection is maintained.
New Grounds for Rejection
Claim Rejections - 35 USC § 112(b)
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
10. Claims 2-19, 21-23, and 26-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
a) Claims 2-19, 21-23, and 26-33 are indefinite for the parenthetical text, specifically, “(provided that the CDR region is 100%).” The phrase renders the claims indefinite because it is unclear whether the limitation(s) contained within the parentheses are part of the claimed invention or exemplary. See MPEP § 2173.05(d).
b) Claim 33 recites the limitation "a host cell such that the DNA sequence encoding the antibody-like protein of Clam 7 is expressed". There is insufficient antecedent basis for the limitation “the DNA sequence” in the claim much less in claims 26 and 28 from which the claim depends. Claim 26 is drawn to a nucleic acid sequence and claim 28 is drawn to a host cell comprising the nucleic acid sequence.
Conclusion
11. No claims are allowed.
12. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Julie 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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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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