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
Priority
This is a National Stage Application of International Application No. PCT/KR2022/003112 filed March 4, 2022, claiming priority based on Korean Patent Application No. 10-2021-0028980 filed March 4, 2021, and Korean Patent Application No. 10-2021- 0073554 filed June 7, 2021, that is hereby acknowledged by the Examiner.
Status of the Claims
The amendment dated 04/22/2024 is acknowledged. Claims 1-15 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/22/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Drawings
The drawing filed on 04/22/2024 are acknowledged and accepted by the Examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-2 and 4-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hahn et al. “Hahn” (WO2018/030878) in view of Nitzel et al. “Nitzel” (WO2013/152083 also published as KR10-2018-0049221, (IDS of record dated 04/22/2024).
The claims are directed to a multivalent vaccine composition for prevention of porcine mycoplasma and porcine circovirus infections comprising: (i) a porcine Mycoplasma hyopneumoniae (Mhp) strain; (ii) a porcine Mycoplasma hyorhinis (Mhr) strain; (iii) a porcine Mycoplasma hyopneumoniae-derived recombinant P97 protein; and (iv) a porcine circovirus type 2 (PCV2)-derived recombinant protein.
Regarding claims 1-2 and 14-15, Hahn discloses a recombinant protein for vaccine preparation for preparing a vaccine for the prevention of porcine mycoplasma infection, and a vaccine composition for preventing porcine mycoplasma hyopneumoniae and mycoplasma hyorhinis infection comprising a recombinant protein. When the recombinant proteins for vaccine preparation of the present invention are added to a vaccine composition for the prevention of porcine mycoplasma infection, the recombinant proteins for vaccine preparation of the present invention can exert an excellent defense effect over conventional commercial vaccines by increasing an immune response against porcine mycoplasma hyopneumoniae and porcine mycoplasma hyorhinis strains and an immune response against a P97 protein. Therefore, the recombinant protein for vaccine preparation of the present invention and the vaccine composition using the same can effectively prevent diseases caused by infection of mycoplasma hyopneumoniae and mycoplasma hyorhinis, in particular, porcine mycoplasma pneumonia and porcine mycoplasma arthritis (Abstract). Hahn states “therefore, an object of the present invention is to provide a recombinant protein for vaccine production for the prevention of swine mycoplasma hyopneumoniae infection and a vaccine composition for preventing mycoplasma hyopneumoniae infection comprising the same, consisting of the amino acid sequence represented by SEQ ID NO: 1. will be. Another object of the present invention is composed of the amino acid sequence represented by SEQ ID NO: 13, a recombinant protein for vaccine production for the prevention of pig mycoplasma hyopneumoniae and mycoplasma hyornithosis infection and mycoplasma hyopneumoniae comprising the same And it is to provide a vaccine composition for preventing mycoplasma hyorinis infection” (Description), whereby SEQ ID NO: 13 has 100% sequence identity to SEQ ID NO: 1 of the present invention(SEQ ID NO: 13 below, claim 11 of Hahn).
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Hahn does not teach a PCV2-derived recombinant protein.
Nitzel, however, discloses multivalent immunogenic composition including a soluble portion of a Mycoplasma hyopneumoniae (M.hyo) whole cell preparation; and a porcine circovirus type 2 (PCV2) antigen, wherein the soluble portion of the M.hyo preparation is substantially free of both (i) IgG and (ii) immunocomplexes comprised of antigen bound to immunoglobulin (Abstract, claims 1, 4 and 8 of Nitzel). Additionally, Nitzel discloses the composition comprising an additional antigen that can be protective against a microorganism that causes disease in pigs and states “In some embodiments, the PCV2/M.hyo composition of the present invention further includes at least one additional antigen. In one embodiment, the at least one additional antigen is protective against a microorganism that can cause disease in pigs. In one embodiment, the microorganism includes bacteria, viruses, or protozoans. In another embodiment, the microorganism is selected from, but is not limited to, the following: porcine reproductive and respiratory syndrome virus (PRRSV), porcine parvovirus (PPV), Haemophilus parasuis, Pasteurella multocida, Streptococcum suis, Staphylococcus hyicus, Actinobacilllus pleuropneumoniae, Bordetella bronchiseptica, Salmonella choleraesuis, Salmonella enteritidis, Erysipelothrix rhusiopathiae, Mycoplama hyorhinis” (page 3 lines 26-32 to page 4 lines 1-4; claims 10-13 of Nitzel).
Accordingly, it would have been obvious to one of ordinary skill in the art to generate a multivalent vaccine composition for prevention of porcine mycoplasma and porcine circovirus infections comprising: (i) a porcine Mycoplasma hyopneumoniae (Mhp) strain; (ii) a porcine Mycoplasma hyorhinis (Mhr) strain; (iii) a porcine Mycoplasma hyopneumoniae-derived recombinant P97 protein as disclosed by Hahn, whereby a PCV-2 recombinant protein is combined with the multivalent vaccine composition of Mhp and Mhr as disclosed by Nitzel. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success given the fact that Nitzel explicitly teaches that the PCV-2 recombinant protein can be combined with the Mhp and Mhr for protection against a microorganism that can cause disease in pigs (page 3 lines 26-32 to page 4 lines 1-4; claims 10-13 of Nitzel). Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claim s 4-7, the limitations of concentration and doses of the strains, Hahn discloses a porcine Mycoplasma hyopneumoniae strain at a concentration of 5.0x 106 to 5.0x1010 CCU/ml, and comprising 25 µg/dose of Mycoplasma hyopneumoniae-derived recombinant protein P97 (see table 1 and claim 2); and the feature of Hahn wherein a PCV2 ORF2 recombinant protein is included at a level of at least 0.2 ug antigen (µg/ml) with respect to 1 ml of the final immunogenic composition (see paragraph [0072]), inasmuch, the limitations pertaining to concentrations and doses of the strains, it is not inventive and considered routine and obvious. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. According to section 2144.05 of the M.P.E.P., "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). See MPEP § 2144.05 (II) (“Generally, differences in concentration … will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration … is critical.”). Accordingly, it would have been obvious for one of ordinary skill to determine the appropriate concentration of the compositions dosage in the methods disclosed by the prior art by routine experimentation procedures known in the art in order to optimize the amount of vaccine dosage to arrive at the currently claimed amount.
Regarding claims 8-9, Hahn discloses the Mycoplasma hyopneumoniae strain can be inactivated (claims 5 and 15).
Regarding claims 10-11, Hahn discloses the composition can comprise an excipient, e.g. IMS1313 (section 2.3 Preparation of the vaccine).
Regarding claims 12-13, Hahn discloses a method of inoculating the multivalent vaccine into pigs by intramuscular, subcutaneous, transdermal, intravenous and oral routes (claim 8 and Description).
Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 3 is rejected under 35 U.S.C. 103(a) as being unpatentable over Hahn et al. “Hahn” (WO2018/030878) in view of Nitzel et al. “Nitzel” (WO2013/152083 also published as KR10-2018-0049221, (IDS of record dated 04/22/2024) as applied to claim 1 above, and further in view of NCBI (GenBank Accession No. AUV50101.1, February 3, 2018). The teachings of Hahn et al. and Nitzel et al. are outlined above and incorporated herein.
Regarding claim 3, Hahn does not explicitly disclose SEQ ID NO: 2.
NCBI, however, discloses porcine circovirus 2 (PCV2) capsid protein (GenBank AUV50101.1) consisting of 100% sequence identity to SEQ ID NO: 2 of the present invention.
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It would have been obvious to one of ordinary skill in the art to generate a multivalent vaccine composition for prevention of porcine mycoplasma and porcine circovirus infections comprising: (i) a porcine Mycoplasma hyopneumoniae (Mhp) strain; (ii) a porcine Mycoplasma hyorhinis (Mhr) strain; (iii) a porcine Mycoplasma hyopneumoniae-derived recombinant P97 protein as disclosed by Hahn, comprising a PCV2 capsid protein having the amino acid sequence as disclosed by NCBI. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success given the knowledge that the PCV2 capsid protein sequence was known in the art thus would have led a skilled artisan to utilize known proteins in the use of immunogenic compositions, specifically polyvalent vaccine compositions for the treatment of porcine diseases. Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Barry Chestnut whose telephone number is (571)270-3546. The examiner can normally be reached on M-Th 8:00 to 4:00.
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.
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/BARRY A CHESTNUT/Primary Examiner, Art Unit 1672
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