DETAILED ACTION
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 .
Claims objection
Claims 11-13 and 15-21 are objected to under 37 CFR 1.75(c) as being in improper form because of multiple dependent claims 12-13 15 and 16-21. See MPEP § 608.01(n). Usually these claims would not be further treated on the merits. However, for a compact prosecution, they are included in following rejections.
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 4-7, 9-11, 13, 15, 16, 17 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Fleming et al. (Front. Microbiol., 23 January 2017, Volume 8 - 2017 | https://doi.org/10.3389/fmicb.2017.00046.
Fleming et al. teach a mutated orf virus, which is chemokine binding protein (CBP) -knock-out orf virus (CBP-ko virus) (See Abstract), wherein OV112 or ORF 112 or ORFV 112 is the gene encoding the CBP genes as evidenced by Yamada et al. (Appl Microbiol Biotechnol. 2022 Dec 9;107(2-3):835–851). doi: 10.1007/s00253-022-12323-0. See Abstract and the 5th Par.of Introduction)
Fleming et al. also teach methods for constructing and isolating as well as expressing the recombinant CBP for such mutant orf virus. They also teach methods for detecting or measuring the CBP gene expression at a nucleic acid level by either northern blot and/or PCR. For the protein level is performed by the recombinant CBP purification as well as binding analysis with ELISA. These assays are performed as comparative analysis for both non-mutated orf virus and CBP knock-out the orf virus mutant as well (See section of Materials and Methods for detail, Figs 1-3 , 4-18).
Fleming et al. also teach preparing the wild-type orf virus or CBP-ko virus in a pharmaceutical accepter carrier PBS (See composition and delivered into different animal models mouse or sheep with different viruses as well as different dosages groups from 103, 105 or 107 p.f.u . by injection from day 3 to 8 via p.i or intradermal injection (See Figs. 1-9).
Therefore, the limitations of claims 1-2, 4-7, 9-11, 13, 15, 16, 17 are explicitly and/or implicitly taught by the cited reference.
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 19-21 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.
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.
Claim 14 is rejected under 35 U.S.C. 112, first paragraph, as containing 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.
The specification is objected to under 35 U.S.C. § 112, first paragraph, as failing to provide an adequate written description of the invention and failing to provide an enabling disclosure without complete evidence either that the claimed biological materials are known and readily available to the public or complete evidence of the deposit of the biological materials.
In the instant case, the invention is directed to a method using an isolated reassorted reovirus, wherein the said reovirus according to the disclosure is deposited with CCTCC V20202 While the specification provides the deposit number for the claimed orf virus mutant in claim 14 and description as specification, it is an insufficient assurance that the required deposit has been made and all the conditions of 37 CFR 1.801-1.809 met.
If the deposit is made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty and that all restrictions upon public access to the deposited material will be irrevocably removed upon the grant of a patent on this application. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State.
If the deposit is not made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR 1.801-1.809 regarding availability and permanency of deposits, assurance of compliance is also required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request; (b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application; (c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and (d) the deposits will be replaced if they should become nonviable or non-replicable.
If a deposit is made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the biological material described in the specification as filed is the same as that deposited in the depository, stating that the deposited material is identical to the biological material described in the specification and was in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR 1.801-1.809 for further information concerning deposit practice.
This rejection affects dependent claims too.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAO Q LI whose telephone number is (571)272-0904. The examiner can normally be reached M-F 8 am to 8 pm EST.
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/Primary Examiner, Art Unit 1671
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