DETAILED ACTION
Applicant’s amendment and remarks filed January 8, 2026 are acknowledged and entered. The elected species of antigen is SEQ ID NO: 34. Claim 18 is withdrawn from consideration being directed to non-elected subject matter. Claims 12, 19, 26 and new claims 32-39 are under examination.
Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment.
Claim Listing
The claim listing filed January 8, 2026 has several claim status identifiers that are incorrect. Claims 19, 34 and 38 are not withdrawn. Claims 34 and 38 are not currently amended since they were newly introduced with the filing of the amendment of January 8, 2026.
Claims Summary
Claim 12 is directed to a recombinant protein comprising:
A unit of an Fc fusion comprising a CH2 domain and CH3 domain of an IgG; the Fc fusion comprises the substitution mutations E345R, E430G and S440Y (claim 33).
A unit of an antigen that is not an epitope of the IgG; the antigen comprises SEQ ID NO: 34 (claims 19 and 34); SEQ ID NO: 34 is a norovirus epitope whose sequence is LPQEWVQYFYQEAAPA;
A unit of a VH domain of the IgG;
A unit of a CH1 domain of the IgG;
An epitope tag consisting of SEQ ID NO: 1 whose sequence is YKLDIS;
A unit of a VL domain of the IgG; and
A unit of a CL domain of the IgG;
Wherein the unit of the antigen is linked to the unit of the VH domain at the N-terminus, or to the CH3 domain of IgG at the C-terminus;
Wherein the unit of the CH1 domain is linked to the CH2 and to the unit of the VH domain;
Wherein the unit of the VL domain is linked to the unit of the CL domain;
Wherein the unit of the CL domain is linked to the CH1 domain; and
Wherein the unit of the antigen is linked to:
The CH3 domain at the C-terminus and the epitope tag is linked to the C-terminus of the antigen; or
The unit of the VH domain at the N-terminus and the epitope tag is linked to the C-terminus of the CH3 domain.
The IgG is 6D8 antibody (claim 32), which is a monoclonal antibody against the GP1 protein of Ebola virus (see paragraph [0040] of the published application, US 2023/0105415 A1).
Also claimed is a method of inducing an immune response by administering the recombinant protein (claim 26).
In another embodiment, there are two units of: the antigen, the Fc fusion, the VH domain, the CH1 domain, the epitope tag, the VL domain and the CL domain, wherein a disulfide bond formed at the linkage of the CH1 and CH2 domain links the two units of the Fc fusion (claim 35). The IgG is 6D8 (claim 36). The Fc fusion comprises the substitution mutations E345R, E430G and S440Y (claim 37). The unit of antigen comprises SEQ ID NO: 34 (claim 38).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/980,012, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, the embodiments that do not find support in the provisional application are:
Claims 19, 34 and 38, the embodiment of SEQ ID NO: 34 (elected species)
Claims 26 and 39, the method of inducing an immune response
Therefore, the earliest effective filing date for claims 19, 26, 34, 38 and 39 is the filing date of PCT/US2021/019090, February 22, 2021.
Claim Objections
(New Objections) Claims 26, 33 and 35-39 are objected to because of the following informalities:
Claim 26 and 39 recite, “selected from the recombinant protein of claim 12”. There is only one recombinant protein in claim 12, so there is no other protein from which to select.
Claims 33 and 37 recite “S440Y.1” [emphasis added], which appears to be a typo.
Claim 35, line 7 has a typo in the phrase “two unit”. Claims 36-38 are dependent on claim 35.
Further, Applicant is advised that should claims 34 and 39 be found allowable, claims 19 and 26 will be objected to under 37 CFR 1.75 as being substantial duplicates thereof, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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 32, 33, 36 and 37 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is apparent that monoclonal antibody 6D8 is required to practice the claimed invention because it is a necessary limitation for the success of the invention as stated in the claims. As a required element it must be known and readily available to the public or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the enablement requirements of 35 U.S.C. § 112, first paragraph, may be satisfied by a deposit of the antibody. See 37 CFR 1.802. One cannot practice the claimed invention without the 6D8 antibody. Therefore, access is required to practice the invention. The specification does not provide a repeatable method for obtaining the monoclonal antibody without access to it, and it does not appear to be readily available material.
The specification indicates that the 6D8 antibody refers to a monoclonal antibody against the GP1 protein of Ebola virus, described in Wilson et al. (Science, 2000, 287:1664-1666, of record in the IDS filed 10/17/2024) and Huang et al. (Vaccine, 2010, 106(1):9-17, not provided in an IDS, nor in the response filed 01/08/2026 as Exhibit A). Wilson et al. discloses the 6D8 antibody, but does not appear to provide any sequences for the antibody. Huang et al. was not provided by Applicant for consideration as Exhibit A (referenced in Applicant’s remarks), however, for purposes of compact prosecution, the Huang et al. reference is supplied by the Office. Huang et al. refers to 6D8 heavy and light chain subunits as well as heavy and light chains, but no sequences appear to have been provided.
In Applicant’s remarks filed 01/08/2026, Applicant asserts that the heavy and light chain variable regions and their humanized constant regions are disclosed in Wilson et al. and Huang et al. Applicant also argues that the specification teaches plant codon optimization and expression which one of ordinary skill would be able to perform, thus obtaining the full 6D8 coding sequence without undue experimentation.
In response to Applicant’s arguments, even if the sequences of the heavy and light chain variable regions and their humanized constant regions are provided in Wilson et al. or Huang et al., the entire sequence of the full antibody must be disclosed, not just variable domains and humanized constant regions. If the entire sequence of the antibody is not provided, then one would not have access to the entire antibody. Further, the process of plant codon optimization cannot take place when no base sequences have been provided. Even if the base sequences were provided, the exact optimization method (i.e., which codons, which locations, frequencies, plant cells, conditions, etc.) would need to be disclosed in order to arrive at the exact sequence of what Applicant refers to as a “6D8” antibody. Lastly, Applicant should specify whether the 6D8 antibody refers to the murine 6D8 of Wilson et al., or the humanized 6D8 of Huang et al. This can only be done by identifying the 6D8 antibody with sequences in the claims, if the specification is able to support such limitations.
Deposit of the antibody in a recognized deposit facility would satisfy the enablement requirements of 35 U.S.C. 112, because the strains would be readily available to the public to practice the invention claimed, see 37 CFR 1.801- 37 CFR 1.809.
If a deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made at an acceptable depository and that the following criteria have been met:
(a) during the pendency of this application, access to the invention will be afforded to one determined by the Commissioner to be entitled thereto;
(b) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained for a term of at least thirty (30) years and at least five (5) years after the most recent request for the furnishing of a sample of the deposited material;
(d) a viability statement in accordance with the provisions of 37 CFR 1.807; and
(e) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.803 - 37 CFR 1.809 for additional explanation of these requirements.
Conclusion
Claim 12 is allowable. Claims 19 and 34, with regard to the elected species of SEQ ID NO: 34, are free of the prior art of record, but they are objected to because they recite non-elected sequences.
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.
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/STACY B CHEN/Primary Examiner, Art Unit 1672