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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 15, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 18, 2026 has been considered by the examiner.
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 43-45, 47, 49, and 63-68 are rejected under 35 U.S.C. 103 as being unpatentable over Nitzel et al. (USPgPub 2017/0216423) and Weibel et al. (Schweizer Archiv für Tierheilkund. 2012 Oct 1; 154: 445-450).
Nitzel et al. claim a composition and a method that elicits a protective immune response against M. hyopneumoniae (M. hyo), PCV2, and Lawsonia intracellularis by intramuscular or intradermal administration of an M. hyo a soluble portion of a whole cell preparation, a recombinant PCV2 ORF2 protein expressed from a baculovirus, and a Lawsonia intracellularis antigen, see claims 1, 5, 6, and 13-16 in a single or multiple doses to a pig. The composition further comprises a carbomer adjuvant, see paragraphs [0124] and claim 10. These teachings correspond to limitations recited in instant claims 43-45, 47, 49, 65, 67, and 68. Claims 7-9, 17, 18, and paragraphs [0104, 0107, 0112, and 0116] of Nitzel et al. are drawn to the composition and method comprising additional antigens to provide protective efficacy selected from a genetically modified live PRRSV, as required by instant claims 63, 66, and 68.
Nitzel et al. do not mention whether the Lawsonia intracellularis antigen is live, as required by instant claims 43, 64, and 65.
Weibel et al. teach simultaneously administering Enterisol® Ileitis, comprising a live, attenuated Lawsonia intracellularis, and Ingelvac® CircoFLEXTM, comprising a baculovirus-expressed PCV2 ORF2 capsid protein, to suckling pigs, see the “Summary” and the first full paragraph on page 5.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have administered the Enterisol® Ileitis, comprising a live, attenuated Lawsonia intracellularis of Weibel et al. as the Lawsonia intracellularis antigen of Nitzel et al. because Weibel et al. teach the combined vaccination strategy against PCV2 and L. significantly increases growth in fattening pigs and concomitantly decreases pig mortality, see Figure 1 and Tables 3 and 4. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have administered the Enterisol® Ileitis, comprising a live, attenuated Lawsonia intracellularis of Weibel et al. as the Lawsonia intracellularis antigen of Nitzel et al. because Nitzel et al. also simultaneously administer a baculovirus-expressed PCV2 ORF2 capsid protein with a Lawsonia intracellularis antigen in claims 1, 5, 6, and 13-16.
Claims 48, 59, and 66 are rejected under 35 U.S.C. 103 as being unpatentable over Nitzel et al. and Weibel et al. as applied to claims 43-45, 47, 49, and 63-68 above, and further in view of O’Connell et al. (USPgPub 2017/0014513), of record.
See the teachings of Nitzel et al. and Weibel et al. above. In the last paragraph on page 9, Weibel et al. teach that the combined vaccine comprising PCV2 ORF2 and a live, Lawsonia intracellularis will reduce antibiotic application. Neither reference teaches concomitant treatment with an antibiotic, as required in instant claim 48, or administering an M. hyo bacterin, recited in instant claims 59 and 66.
Paragraph [0080] of O’Connell et al. states that the vaccine is additionally administered with an antibiotic and paragraph [0033] and claim 17 teaches a vaccine comprising an M. hyo bacterin.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have concomitantly administered the antibiotic and M. hyo bacterin of O’Connell et al. in the combined vaccine of Nitzel et al. and Weibel et al. to further reduce and/or inhibit bacterial infection. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have concomitantly administered the antibiotic and M. hyo bacterin of O’Connell et al. in the combined vaccine of Nitzel et al. and Weibel et al. because paragraphs [0032, 0033] and claims 1-4, 10, 16, 17, and 22 of O’Connell et al. are drawn to a method of inducing a protective immune response by vaccinating a pig by administering a live, attenuated Lawsonia intracellularis, a live Porcine Reproductive and Respiratory Syndrome Virus (PRRSV), a recombinant subunit of PCV that is administered intradermally or intramuscularly in claim 23.
Claims 50, 51, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Nitzel et al. and Weibel et al. as applied to claims 43-45, 47, 49, and 63-68 above, and further in view of Nogueira et al. (Veterinary Microbiology. 2013; 164: 131-138), of record.
See the teachings of Nitzel et al. and Weibel et al. above.
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 Nitzel et al. and Weibel 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 of Nogueira et al.
Conclusion
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/Shanon A. Foley/ Primary Examiner, Art Unit 1671
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