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 .
Applicant’s reply has overcome the objection to the specification and the objection to claim 8.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 15, 2025 has been considered by the examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 43-45, 47-49, 59, 61, and 63-68 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by O’Connell et al. (USPgPub 2017/0014513), of record.
Claims 1-4, 10, 16, 17, and 22 of O’Connell et al. anticipates a method of inducing a protective immune response by vaccinating a pig by administering a vaccine comprising administering a live, attenuated Lawsonia intracellularis, a live Porcine Reproductive and Respiratory Syndrome Virus (PRRSV), and a killed Mycoplasma hyopneumoniae bacterin. Paragraphs [0032 and 0033] of O’Connell et al. teach that the vaccine additionally comprises a killed porcine circovirus (PCV) antigen or a recombinant subunit thereof. Claim 23 recites that the vaccine is administered intradermally or intramuscularly. These teachings anticipate instant claims 43-45, 59, and 63-68. Paragraph [0053] states that the vaccine is provided in a single administration, anticipating instant claim 47. Paragraph [0080] states that the vaccine is additionally administered with an antibiotic, anticipating instant claim 48. Paragraph [0043] of O’Connell et al. states that the vaccine induces a protective immune response and prevents clinical disease, anticipating instant claim 49. Paragraphs [0029, 0033, 0056, 0057, and 0072] of O’Connell et al. anticipate the vaccine additionally comprising an adjuvant, anticipating instant claim 61.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 60 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connell et al. and Galvin et al. (US 9,120,859), of record.
See the teachings of O’Connell et al. above. O’Connell et al. do not teach that the PCV antigen or recombinant subunit thereof is a polypeptide expressed from an ORF2 gene, as recited in instant claim 60, or that the adjuvant is a carbomer, as recited in instant claim 62.
Galvin et al. claim an immunogenic composition comprising PCV2 ORF 2 expressed from a baculovirus vector in claims 1, 5, 7, 8, and 11-13. In column 13, lines 14-25, Galvin et al. teach that the PCV2 ORF2 dose is between 2-400 µg. In column 17, lines 14-16, Galvin et al. teach that the adjuvant is a carbomer.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have expressed PCV2 ORF2 from the ORF2 gene of Galvin et al. as the PCV antigen or recombinant subunit of O’Connell et al. with a reasonable expectation of success because Galvin et al. teach that the PCV2 ORF component is protective in claims 9 and 10 in a multivalent composition additionally comprising Lawsonia intracellularis, inactivated M. hyo. and a modified live PRRSV (in column 15, lines 26-31 and 48-53) in claims 1 and 4-10, that is administered as a single dose in claims 17, 18, and 20-22. One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have incorporated carbomer of Galvin et al. as the adjuvant of O’Connell et al. with a reasonable expectation of success because O’Connell et al. teach adjuvants include polymers in paragraph [0072].
Claims 50, 51, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over O’Connell et al. and Galvin et al. as applied to claims 43-45, 47-49, and 59-68 above, and further in view of Nogueira et al. (Veterinary Microbiology. 2013; 164: 131-138), of record.
See the teachings of O’Connell et al. and Galvin et al. above. Both references teach a protective composition comprising a live Lawsonia intracellularis, PCV antigen or recombinant subunit, an inactivated M. hyo. and a modified live PRRSV components, administered to pigs in a single administration. See paragraphs [0033, 0053] and claims 1-4, 10, 16, 17, and 22 of O’Connell et al. and column 15, lines 26-31 and 48-53 and claims 1 and 4-13, 17, 18, and 20-22 of Galvin et al.
Neither reference teaches a protective immune response against Lawsonia intracellularis resulting in a reduction in intestinal lesions and fecal shedding in vaccinated pigs compared to unvaccinated pigs. However, since both O’Connell et al. and Galvin et al. teach protective compositions against Lawsonia intracellularis, the reduction in intestinal lesions and fecal shedding in vaccinated pigs compared to unvaccinated pigs would have been an inherent phenomenon prior to the instant effective filing date as evidenced by Nogueira et al. In response to virulent Lawsonia intracellularis challenge, pigs vaccinated with a live Lawsonia intracellularis vaccine presented a reduction of intestinal lesions and the duration and magnitude of bacterial shedding in feces, see sections 2.4, 2.5 and Figure 3.
Response to Arguments
Applicant points to the amendment to claim 43 and asserts that O’Connell does not teach inducing a protective immune response by administering a live Lawsonia intracellularis and one or more antigens of PCV. Applicant argues that O’Connell et al. do not test a multivalent vaccine and no immunogenicity data is disclosed.
Applicant ‘s arguments and a review of the teachings in O’Connell et al. have been fully considered, but are found unpersuasive. O’Connell anticipates a live, attenuated Lawsonia intracellularis in paragraph [0071], Table 1B, and is specifically recited in claim 17. Paragraphs [0032 and 0034] list killed porcine circovirus antigen and/or a recombinant subunit of PCV, which satisfies at least one or more antigens of PCV instantly recited. Paragraphs [0011, 0034-0036, 0043, 0049, 0051, 0073-0079] and claims 22 and 23 of O’Connell are drawn to methods of preventing a disease in a pig through administering a vaccine of the present invention. The vaccine administered by O’Connell comprises at least the following components: a live, attenuated Lawsonia intracellularis, a live Porcine Reproductive and Respiratory Syndrome Virus (PRRSV), a killed Mycoplasma hyopneumoniae bacterin, and a killed porcine circovirus (PCV) antigen and/or a recombinant subunit thereof. The entire thrust of O’Connell’s invention is a liquid vaccine that comprises multiple live and inactivated porcine (prophylactic) vaccines in a stable formulation, see paragraphs [0031-0036, 0039-0041, 0046, 0070, 0071] and Tables 1A-1C. The monovalent and multivalent vaccines, combined in the liquid formulation of O’Connell, have protective efficacy. Therefore, protective efficacy data provided by O’Connell would have been redundant and unnecessary. O’Connell’s liquid formulation possesses the requisite components to stabilize combinations of live vaccines to be administered to protect pigs against infection and clinical disease.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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/Shanon A. Foley/ Primary Examiner, Art Unit 1671