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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Oct. 23, 2024. Claims 1-16 are pending and are currently examined.
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 12 and 14-16 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding the base claim 12, it requires a method of eliciting an immune response against serotype Asia foot-and-mouth disease virus (FMDV) in a subject, comprising administering to the subject a composition comprising the synthetic polypeptide at least 95% identical to SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, or SEQ ID NO: 8, thereby eliciting an immune response to serotype Asia FMDV.
For claim 15, it requires the method comprising administering to the subject a first composition comprising a synthetic polypeptide at least 98% identical to the amino acid sequence of SEQ ID NO: 2 and a second composition comprising a second synthetic polypeptide at least 95% identical to the amino acid sequence of SEQ ID NO: 4.
The written description rejection is made because the claims are interpreted as being drawn to a synthetic polypeptide recited as being “at least 95%” or “ at least 98%” identical to the amino acid sequence as claimed. This means that up to 5% or 2% amino acids sequences of the synthetic polypeptide can vary. The applicable standard for the written description requirement can be found in MPEP 2163; University of California v. Eli Lilly, 43 USPQ2d 1398 at 1407; PTO Written Description Guidelines; Enzo Biochem Inc. v. Gen-Probe Inc., 63 USPQ2d 1609; Vas- Cath Inc. v. Mahurkar, 19 USPQ2d 1111; and University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 (CAFC 2004).
The instant specification discloses an invention for a FMDV polypeptides having an amino acid sequence at least 80%...at least 95% …at least 98 or at least 99.9% identical to mosaic polypeptide Asia 2.1 capsid (FLC) (SEQ ID NO: 2), mosaic polypeptide Asia 2.2 capsid (FLC) (SEQ ID NO: 4), mosaic polypeptide Asia2.1 capsid (FMDLL3B3D) (SEQ ID NO: 6), or mosaic polypeptide Asia 2.2 capsid (FMD-LL3B3D) (SEQ ID NO: 8) (See e.g., [0064]). However, the specification does not provide information disclosing what these variations are and does not disclose which portions of the claimed SEQ ID NOs: 2, 4, 6 and 8 are essential to retain the ability to be a functional synthetic polypeptide that can elicit an immune response, or altered up to 5% or 2% and still retain being a function polypeptides as claimed. For example, SEQ ID NO: 2 has 731 amino acids in length. With 5% or 2% varies, there will be at least 14 amino acids changes. Kristensen et al.( PLoS Pathog. 2019 Jan 18;15(1):e1007509) teaches that they have identified a short region within the C-terminus of VP1 that is critical for the processing of the FMDV capsid precursor. This region contains a stretch of five amino acids that are very highly conserved amongst all FMDVs (See page 4, paragraph 3), and further discloses that the single amino acid substitutions VP1 Y185A and VP1 R188A were individually able to severely inhibit processing at both the VP0/VP3 and the VP3/VP1 junctions within the P1-2A precursor and had a deleterious effect on the level of the unprocessed product generated within cells (See page 9, paragraph 1). Here the teachings of Kristensen indicate that altering up to 5% or 2% may cannot retain being a function polypeptides as claimed.
The court clearly states in Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, that "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 page 1117.).
As discussed above, the skilled artisan cannot envision the detailed molecules structures including the amino acids sequence of the encompassed genus of the synthetic polypeptide that are at least 95% identical to SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, or SEQ ID NO: 8 or at least 98% identical to the amino acid sequence of SEQ ID NO: 2. Therefore, 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, 9, 12, 14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Audonnet et al. (WO2016049209A1, published on Mar. 31, 2016, hereinafter, “Audonnet”).
The base claim 1 is directed to a synthetic polypeptide comprising an amino acid sequence at least 95% identical to SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, or SEQ ID NO: 8.
The base claim 6 is directed to a recombinant foot-and-mouth disease virus (FMDV) comprising a synthetic polypeptide having an amino acid sequence at least 95% identical to SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, or SEQ ID NO: 8.
The base claim 12 is directed to a method of eliciting an immune response against serotype Asia foot-and-mouth disease virus (FMDV) in a subject, comprising administering to the subject a composition comprising the synthetic polypeptide at least 95% identical to SEQ ID NO: 2, SEQ ID NO: 4, SEQ ID NO: 6, or SEQ ID NO: 8, thereby eliciting an immune response to serotype Asia FMDV.
Audonnet describes a FMDV recombinant vaccines and uses thereof and teaches that their invention relates to compositions for combating Foot and Mouth Disease Virus (FMDV) infection in animals. The present invention provides pharmaceutical compositions comprising an FMDV antigen, methods of vaccination against FMDV, and kits for use with such methods and compositions (See Abstract; page 1, lines 8-11). Here the FMDV antigen comprises a polypeptide having the sequence as set forth in SEQ ID NO: 1, 2, 4, 5, 6, 8, 10, 12, 13 or 16 (See claim 7), where the SEQ ID NO: 13 has 98.5% identical to the claimed SEQ ID NO: 2 (See Table A below). Audonnet also teaches that the term "recombinant" means a polynucleotide semisynthetic, or synthetic origin which either does not occur in nature or is linked to another polynucleotide in an arrangement not found in nature (See page 16, lines 3-5).
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Accordingly, Audonnet teaches the base claims 1 and 6 by disclosing a SEQ ID NO: 13 that is 98.5% identical to SEQ ID NO: 2 as claimed. Audonnet also teaches the base claim 12 by disclosing that a compositions comprising an FMDV polypeptide, antigen such as SEQ ID NO: 13 that elicit an immunogenic response in an animal are provided by administering to the subject (See page 6, lines 7-17; page 8, lines 18-25), and further teaches that the FMDV antigen may be derived from FMD VO I Manisa, 01 BFS or Campos, A24 Cruzeiro, Asia I Shamir, A Iran '96, A22 Iraq, SAT2 Saudi Arabia (See page 18, lines 1-2) and FIG. 18B depicts the evolution of neutralizing antibody titers against FMD Asial Shamir and FMD A22 Iraq (See page 5, lines 21-22, and below).
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Regarding claims 3, 5, and 14, Audonnet teaches that the present invention relates to bovine, ovine, caprine, or swine vaccines or compositions which may comprise an effective amount of a recombinant FMDV antigen or a recombinant viral vector expressing FMDV antigen, and a pharmaceutically or veterinarily acceptable carrier, excipient, adjuvant, or vehicle (See e.g., page 7, lines 13-16).
Regarding claim 9, Audonnet teaches genes also refer to a nucleic acid fragment that expresses mRNA or functional RNA, or encodes a specific protein, and which includes regulatory sequences (See page 11, paragraph 1), where the term “nucleic acid” and "polynucleotide" encompasses RNA/DNA hybrids. The following are non-limiting examples of polynucleotides: a gene or gene fragment, exons, introns, mRNA… plasmids, vectors, isolated DNA of any sequence, isolated RNA of any sequence, nucleic acid probes and primers (See page 10, lines 27-32), and the FMDV antigen is encoded by a polynucleotide having the sequence as set forth in SEQ ID NO:3, 7, 9, 11, 14, 15, 17 or 20 (See claim 8, page 54).
Regarding claim 16, Audonnet teaches Pigs were 11-12 weeks of age on DO and received 2mL intramuscular infection of the vaccines (See page 44, lines 11-20).
Claims 4, 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Audonnet as applied to claims 1, 3, 5-6, 9, 12, 14 and 16 above and further in view of Yu et al. (CN103060278A, published on July 09, 2014).
Claims 4 and 8 require a first and a second synthetic polypeptide comprising a first synthetic polypeptide comprising an amino acid sequence at least 95% identical to SEQ ID NO: 2, and a second synthetic polypeptide comprising an amino acid sequence at least 95% identical to SEQ ID NO: 4, and optionally a pharmaceutically acceptable carrier.
Claim 15 requires a method comprising administering to the subject a first composition comprising a synthetic polypeptide at least 98% identical to the amino acid sequence of SEQ ID NO: 2 and a second composition comprising a second synthetic polypeptide at least 95% identical to the amino acid sequence of SEQ ID NO: 4.
Audonnet teaches that the goal of the study is to evaluate the prime-boost administration (two administrations) of two heterologous vaccines or administration at the same time ( one administration) of two heterologous vaccines in conventional swine or cattle to increase immune response, and also in MDA-positive pigs and cattle to overcome MDA and increase immune response (See page 52, lines 1-5). Here the compositions or vaccines comprising an antigenic FMDV polypeptide and fragments and variants thereof and compositions or vaccines comprising recombinant viral vectors expressing FMDV polypeptide and fragments and variants thereof are provided (See page 4, lines 8-15), where the polypeptide can have a sequence as SEQ ID NOs: 1, 2, 4, 5, 6, 8, 10, 12, 13 or 16 and variant or fragment thereof (See page 12, lines 29-32). By details, Audonnet teaches that a kit may comprise at least two vials: a first vial containing a vaccine or composition for the prime-vaccination according to the present invention, and a second vial containing a vaccine or composition for the boost vaccination according to the present invention (See dredging pages 27 and 28).
Accordingly, Audonnet teaches that two heterologous vaccine or composition can be administered to a subject, where the vaccine or composition can be the polypeptide of SEQ ID NO: 13. Based on Table A above, the SEQ ID NO: 13 has 98.5% identical to the amino acid sequence of SEQ ID NO: 2 as claimed. It would be obvious for one of ordinary skill in the art to select SEQ ID NO: 13 as the first polypeptide if needed and then use one of other SEQ ID NOs as second polypeptide. However, Audonnet is silent on if the second polypeptide is at least 95% identical to the amino acid sequence of SEQ ID NO: 4.
Yu teaches an invention that discloses an acid-resistant mutant strain of Asian type 1 foot-and-mouth disease virus, a capsid protein carried by it, a coding gene thereof and an application thereof. The present invention obtains two generations of virus groups of Asian type 1 foot-and-mouth disease virus P10 and P15 with acid resistance through acid pressure screening. 1. Rescued and obtained three acid-resistant mutant strains of Asian type 1 foot-and-mouth disease virus, the amino acid sequences of the capsid proteins carried by them are respectively shown in SEQ ID No.2, SEQ ID No.4 or SEQ ID No.6. The invention solves the problem of acid sensitivity of virus capsid in the production and storage process of FMDV inactivated vaccine and can provide high-quality seed virus for preparing Asia1 type FMDV inactivated vaccine (See Abstract). Here the SEQ ID NO: 2 of Yu has 96.5% identical to the amino acid sequence of SEQ ID NO: 4 as claimed (See Table B below).
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It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the known SEQ ID NO: 2 of Yu into Audonnet’s invention to arrive at an invention as claimed. One of skill in the art would be motivated to substitute one polypeptide sequence for another (See MPEP 2144.06: Substituting equivalents known for the same purpose), and use it as the second polypeptide as claimed. There would be a reasonable expectation of success to synthesize a first and second polypeptides as claimed.
Allowable Subject Matter
The SEQ ID NOs: 1-8 are free of prior art.
Accordingly, claims 2, 7, 10, 11 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUIXUE WANG whose telephone number is (571)272-7960. The examiner can normally be reached Monday-Friday 8:00 am to 4:30 pm, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. 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.
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/RUIXUE WANG/ Examiner, Art Unit 1672
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