DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 3, 4, 6, 9, 13, 14, 19, 21 and 24 in the reply filed on March 4, 2026 is acknowledged. The following species election is also acknowledged: QZ07, mutation at position 10 and related embodiments, and SEQ ID NO: 75. SEQ ID NO: 75 represents a mutant QZ07 E2 protein having the mutation Y10A. SEQ ID NO: 74 will rejoined with the elected species, representing a mutant QZ07 E2 protein having the mutation Y10P.
Please note that in the claim listing of November 13, 2023, there are two instances of claim 33. Correction is required in the next claim listing filed.
Drawings
The drawings are objected to because Figure 4 has amino acid sequences that must be identified by a sequence identifier.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In lieu of filing corrected drawing sheets, Applicant may amend the brief description of Figure 4 in the specification to include the sequence identifiers.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0051] of the published application has an amino acid sequence (FYLASLHKKALPT) that needs to be identified by a sequence identifier. Appropriate correction is required.
Claims Summary
Claim 1 is directed to a recombinant CSFV E2 protein comprising at least one mutation within the 6B8 epitope at residue 10 which leads to a specific inhibition of the binding of the 6B8 mAb to the mutated epitope. The 6B8 mAb is produced by a hybridoma deposited at CCTCC as C201820, or comprises VH and VL comprising SEQ ID NO: 7 and 8, respectively, or comprising the CDRs of the 6B8 mAb, or comprises VH and VL CDRs 1-3 comprising SEQ ID NO: 1-6, respectively (claim 3). The 6B8 epitope is defined by residues S14, G22, E24, E24/G25, Y10, D41 and/or R64 of the E2 protein (claim 4). The mutation at residue 10 of E2 is a substitution, specifically Y10A or Y10P (claim 6). The recombinant CSFV E2 protein is derived from field strain QZ07 (claim 9). Field strain QZ07 comprises SEQ ID NO: 11 (polyprotein amino acid sequence, see paragraph [0071] of the published application US 2024/0350610). The CSFV E2 protein comprises SEQ ID NO: 74 or 75 (claim 13). SEQ ID NO: 74 represents a mutant QZ07 E2 protein having the mutation Y10P. SEQ ID NO: 75 represents a mutant QZ07 E2 protein having the mutation Y10A.
In another embodiment, an Fc fragment is linked to the recombinant CSFV E2 protein (claim 14). Also claimed is a recombinant CSFV comprising the recombinant E2 protein (claim 19), and an immunogenic composition (claim 21). Claim 24 is directed to a method of preventing and/or treating diseases associated with CSFV in an animal, comprising administering the immunogenic composition.
Claim Rejections - 35 USC § 112
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.
Claims 1, 3, 4, 6, 9, 14, 19, 21 and 24 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.
Claims 1, 4 and 6 recite amino acid positions without a reference sequence identifier. Without a reference sequence, one would not know whether the amino acid position is the one that Applicant intends. Claims 3, 9, 14, 19, 21 and 24 are included in this rejection because they depend from claim 1.
Claim 9 is directed to an embodiment wherein the recombinant CSFV E2 protein is “derived from” field strain QZ07. The term “derived from” renders the metes and bounds of the claim undefined. It is not clear what structure is retained from QZ07 in the derived protein. Suggested language is “wherein the recombinant CSFV E2 protein is from field strain QZ07”.
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 1, 3, 4, 6, 9, 14, 19, 21 and 24 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 mAb 6B8 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 mAb 6B8. See 37 CFR 1.802. One cannot practice the claimed invention without the mAb 6B8, which is used to determine whether the mutated E2 protein has a mutated 6B8 epitope that is not bound by mAb 6B8. One cannot determine whether the E2 protein has the necessary characteristics without access to mAb 6B8. Therefore, access to mAb 6B8 is required to practice the invention. The specification does not provide a repeatable method for mAb 6B8 without access to the mAb 6B8 and it does not appear to be readily available material.
Deposit of mAb 6B8 in a recognized deposit facility would satisfy the enablement requirements of 35 U.S.C. 112, because the antibody 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.
It is noted that Applicant has made a deposit of mAb 6B8 at the CCTCC (accession number C2018120) on June 13, 2018 (see paragraph [0286] of the published application US 20240350610). However, the requirements of 37 CFR 1.801- 37 CFR 1.809 have not yet been met.
Claim 24 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of preventing diseases associated with CSFV, does not reasonably provide enablement for treating such diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The breadth of the claim encompasses treatment of a subject with a disease caused by CSFV infection, meaning amelioration of a symptom or symptoms in the subject already infected and exhibiting symptoms. The nature of the invention is the administration of a CSFV E2 protein that will induce an immune response against CSFV in an infected subject, thus improving their condition by reducing symptoms of disease.
Aside from disclosing treatment, the specification does not provide any guidance for actual treatment of infected, diseased animals. There are no working examples of treatment. The state of the art is that there is no treatment. Fan et al. (Microorganisms, April 2021, 9(4): 761, 17 pages) reports that vaccination is the primary strategy for preventing and controlling disease caused by CSFV, noting that suspected and infected pig herds are slaughtered (see pages 2-3, bridging paragraph, and page 3, first full paragraph). Risatti and Borca (Merck Manual Veterinary Manual, Classical Swine Fever, April 2025, 10 pages) teaches that there are no treatments for CSFV (see abstract on page 1).
Therefore, in view of the breadth of the claims, the nature of the invention, the limited teachings and working examples in the specification, the state of the art which also speaks to the low level of predictability, it would require undue experimentation to practice the claimed method of treatment. Amendment of the claim to remove the treatment embodiment would overcome this rejection.
Conclusion
No claim is allowed. Claim 13 is objected to for being dependent on a rejected claim but would otherwise be allowable if rewritten in independent form and if non-elected species were removed from the claim.
SEQ ID NO: 74 and 75 are free of the prior art of record.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
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