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 .
Status of the Claims/Application
Claims 2-4, 7-9, 19-24, 27-30, 33-35 are cancelled. Claims 1, 5-6, 10, 14-15, 17-18, 26 and 32 are currently amended. Claims 1, 5-6, 10-18, 25-26, and 31-32 are currently pending and are under examination the merits herein.
Priority
The instant application 17/922319 filed on 10/28/2022 will be examined with a priority date of the Provisional application 63/017399 and 63/088680 filed on 04/29/2020 and 10/07/2020 respectively and of 371 of PCT/US21/29967.
New Grounds For Rejection
Applicant’s arguments, see Remarks pg. 8 para 1, filed 11/06/2025, with respect to the rejection of claim 12 under 35 USC 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of;
35 USC § 112 – Written Description
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.
Claims 15-18 are rejected 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. The claims 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to the LDLRAD3 viral decoy as a neutralizing antibody or antigen-binding fragment wherein it is an anti-LDLRAD3 antibody with specific binding attributes (Claim 15-18) for the LDLRAD3 protein on cell surface. The specification describes an anti-LDLRAD3 immune serum that was used to block SINV-VEEV-GFP infection (Spec para 00179). It is commonly known in the arts that an antibody consist of 6 complimentary determining regions (CDR) that are essential for the binding specificity to it “antigens” (to perform a specific function as related to their structure). The specification does provide sufficient description of the structure of the anti-LDLRAD3 antibody that exhibits a neutralizing effect but rather of an atni-LDLRAD3 immune serum. It is known in the art that immune serum contains antibodies naturally produced by the infected subject and therefore the anti-LDLRAD3 immune serum as illustrated by applicant is not sufficient written description for justification that the applicant is in possession of the neutralizing anti-LDLRAD3 antibody having the necessary CDRs structure that binds the antigen thereby acting as a neutralizing antibody. It is also know in the art that the design and engineering of antibodies with suitable affinity, stability, and other factors is challenging (Rabia et al. Understanding and overcoming trade-offs between antibody affinity, specificity, stability and solubility. Biochem Eng J. 2018 Sep 15;137:365-374) due to the fact one improving one factor such as binding affinity can affect stability of the antibody. Further, although there has been advances in state of the art towards computational design of antibodies, it is still a challenge to accurately model the CDR-H3 loop which is critical for the binding affinity of the antibody (Hummer et al. Advances in computational structure-based antibody design. Curr Opin Struct Biol. 2022 Jun;74:102379) and therefore sufficient written description of the structure of the neutralizing anti-LDLRAD3 antibody is required to show that the applicant is in possession of the invention as claimed.
Response to Arguments
Applicant’s amendments/arguments, see remarks, filed 11/06/2025, with respect to claims 1-3, 10, 15 and 25 have been fully considered and are persuasive. The objection and rejections under 35 USC 112(b), 35 USC 103 and NSDP of claims 1, 10, 15, 25 have been withdrawn.
Reason for Allowance
Claims 1, 5-6, 10-14, 25-26 and 31-32 are allowed.
The following is an examiner’s statement of reasons for allowance:
The amendment to the claims file on 11/06/2025, have been fully considered and are not found to be the basis for any new grounds of rejection against the claims. Therefore, the claims are allowed for the reasons previously of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMMANUEL LED YOUTCHOM PENDIE whose telephone number is (571)272-6313. The examiner can normally be reached Mon - Fri: 8AM - 5PM CST.
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/EMMANUEL LED YOUTCHOM PENDIE/Examiner, Art Unit 1647
/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647