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 Ail
Sequence requirements
This application contains sequence disclosures on pages 12-13 that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures.
Full compliance with the sequence rules is required in response to this Office Action. A complete response to this office action should include both compliance with the sequence rules and a response to the Office Action set forth below. Failure to fully comply with both these requirements in the time period set forth in this office action will be held non-responsive.
Remark
Preliminary amendment filed on Feb. 16, 2024 is acknowledged. Claims 3, 5, 10, 12, 14, 16-17 are amended New claim 18 is added.
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.
Claim 15 is rejected as a used claim. a claim only states the use of a product without any active steps. Because the claim that merely says “a use of compound X” without specifying how it is used or in what context can be considered indefinite.
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 1, 3, 5-11, 12-17 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 claim(s) 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.
In the instant case, the claims are drawn to a genus of amino acid sequences of VP2 protein variants, wherein the position of amino acid residue located at position 93 and 190 are replaced with any but not the amino acid residue located at position 93 and 190 of SEQ ID NO: 1. Therefore, it will be ended up with about 253 variants according to a random combination calculation. , the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163.02 states, "[a] n objective standard for determining compliance with the written description requirement is “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’ ". The courts have decided: The purpose of the "written description" requirement is broader than to merely explain how to "make and use"; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
The invention is, for purposes of the "written description" inquiry, whatever is now claimed. See Vas-Cathy, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, paragraph 1, "'Written Description” Requirement (66 FR 1099-1111, January 5, 2001) states, "possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention" (Id. at 1104).
The specification does not describe with any degree of particularity all of the members of the genus comprising any combinations of the two amino acid mutates in combination.
Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed
Therefore, absent a detailed and particular description of a representative number, or at least a substantial number of the members of the genus of amino acid molecules, the skilled artisan could not immediately recognize or distinguish members of the claimed genus of amino acid sequences. Moreover, since the specification has not identified which amino acid residue molecules of the genus of sequences, one skilled in the art would not recognize that Applicant had possession of the claimed invention at the time the application was filed. There is insufficient support the generic claims as provided by the Interim Written Description Guidelines published in the June 15, 1998 Federal Register at Volume 63, Number 114, pages 32639-32645.
The full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
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, 3, 5, 6, 7, 8-10, 11, 12-13, 14-17 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention. US10010605B2 (“605B2”) or WO2016049209A1 both to Audonnet et al. (The reference herein use is based on “605B2 for citation).
“605B2 teaches in the summary of invention a compositions or vaccines comprising an antigenic FMDV polypeptide and fragments and variants thereof and compositions or vaccines comprising recombinant viral vectors, such as a baculovirus expression in insect cells , expressing FMDV polypeptide and fragments and variants thereof are provided. The FMDV antigens may be modified to enhance the stability of FMDV empty capsids or FMDV VLPs (virus-like particles, i.e. VLP ). (1st para. Of Summery of Invention, claims 1-12). The modified P1 polypeptide comprises a cysteine substitution which is corresponding to the amino acid residue of in VP2 (S93C) and 190 of the amino acid sequence set forth in the claimed SEQ ID NO: 1 , which is corresponding to the S93C of VP2 and 179 of the reference SEQ ID NO:10 or 12 or even SEQ ID NOS: 2, 4, 6, 8,. . It is worth to not that , a broad scope of the claims under the rejection are not limited to the cysteine(C ) at position of 93 and 190 as asparagine (N) . It actually broadly read on broadly replacing the amino acid residue at 93 and 190 with any of the original amino acid residue located at 93 and190 of SEQ ID NO: 1 respectively.
The invention further encompasses the FMDV polynucleotides contained in a vector molecule or an expression vector and operably linked to a promoter element and optionally to an enhancer.
In another embodiment, the FMDV antigen is P1, VP0, VP3, VP1, VP2, VP4, 2A, 2B, or 3C.
In one embodiment, the nucleic acid molecule encoding one or more FMDV antigen(s) is a cDNA encoding FMDV P1 region and a cDNA encoding FMDV 3C protease of FMDV.
In one embodiment, the FMDV antigen may be a P1-3C polypeptide. In another embodiment, the FMDV antigen may be P1 alone, or P1-2A/2B1. In yet another embodiment, the FMDV antigen may be VP0-VP3. In another embodiment, the FMDV antigen may be VP4-VP2. In still another embodiment, the FMDV antigen may be 3C, or may be 3C with a 5′UTR optimized for expression in insect cells. In one embodiment, both P1-2A/2B1 and 3C polypeptides may be expressed in insect cells using a single construct and the expression may be regulated by one or more promoter sequences. In another embodiment, the FMDV antigen is a modified P1 or VP2.
In another embodiment, the FMDV antigen may be derived from FMDV O1 Manisa, O1 BFS or Campos, A24 Cruzeiro, Asia 1 Shamir, A Iran '96, A22 Iraq, SAT2 Saudi Arabia.
The present invention relates to an FMDV vaccine which may comprise an effective amount of a recombinant FMDV antigen or a recombinant viral vector expressing an FMDV antigen, and a pharmaceutically or veterinary acceptable carrier, excipient, adjuvant, or vehicle.
In another embodiment, pharmaceutically or veterinary acceptable carrier, excipient, adjuvant, or vehicle may be a water-in-oil emulsion. In yet another embodiment, the water-in-oil emulsion may be an oil-in-water emulsion.
Still further, the cited reference also teach that In an embodiment, the subject matter disclosed herein is directed to a method of vaccinating an ovine, bovine, caprine, or swine comprising administering to the ovine, bovine, caprine, or swine the FMDV antigen produced by a baculovirus vector in insect cells or a recombinant viral vector expressing an FMDV antigen
In an embodiment, the subject matter disclosed herein is directed to a method of eliciting an immune response comprising administering to the ovine, bovine, caprine, or swine a vaccine comprising the FMDV antigen produced by a baculovirus vector in insect cells or a recombinant viral vector expressing an FMDV antigen. In an embodiment, the subject matter disclosed herein is directed to a method of preparing a vaccine or composition comprising isolating an FMDV antigen produced by a baculovirus vector in insect cells or a recombinant viral vector expressing an FMDV antigen and optionally combining with a pharmaceutically or veterinary acceptable carrier, excipient, adjuvant, or vehicle.
To this context, claims 1, 3, 5-11, 12, 13-17 and 18 are anticipated by the cited reference.
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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