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 .
Election/Restrictions
Applicant’s amendment filed 1/2/2026 is acknowledged. Claims 2-4, 6, and 8 are canceled.
Applicant’s election without traverse of Group I, claims 1-3, drawn to a method for producing African swine fever virus or a vaccine containing African swine fever virus, in the reply filed on 6/6/2026 is acknowledged. Upon further consideration, the Claim 9 is being re-assigned to Group I, because it depends from independent claim 2, which is part of Group I.
Claims 5, 7 & 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/6/2025.
Claims 1 and 9 are under examination on the merits.
Objections and Rejections Removed
The previous objections and rejections are hereby removed due to Applicant’s amendment submitted 1/2/2026:
Claim objection: the previous objection to claim 1 for minor informalities.
35 U.S.C. §112(b): the previous rejection of claims 3 and 9 as being indefinite.
Maintained Rejections
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous Rejection Maintained in Part) Claims 1 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Borca (US Patent No. 9808520 B1, published 11/7/2017; hereinafter referred to as “Borca”) in further view of Takenouchi (Front Vet Sci. 2017 Aug 21; PMID: 28871285; hereinafter referred to as “Takenouchi”). The rejection of claims 2 and 3 is hereby withdrawn due to cancellation of those claims.
The claimed invention encompasses a method for producing African swine fever virus, comprising the steps of bringing an immortalized porcine kidney macrophage into contact with African swine fever virus to proliferate the virus in the immortalized porcine kidney macrophage, and wherein the immortalized porcine kidney macrophage is an immortalized macrophage obtained by introducing a lentivirus encoding SV40 large T antigen and a lentivirus encoding porcine-derived telomerase reverse transcriptase, or a lentivirus encoding SV40 large T antigen and porcine-derived telomerase reverse transcriptase into a porcine-derived kidney macrophage, as recited in claim 1.
Another embodiment of the claimed invention encompasses a method for producing a vaccine containing African swine fever virus, comprising the steps of: bringing an immortalized porcine kidney macrophage into contact with African swine fever virus to proliferate the virus in the immortalized porcine kidney macrophage; isolating the proliferated African swine fever virus; and mixing the isolated African swine fever virus with a pharmacologically acceptable carrier or medium, wherein the immortalized porcine kidney macrophage is an immortalized macrophage obtained by introducing a lentivirus encoding SV40 large T antigen and a lentivirus encoding porcine-derived telomerase reverse transcriptase, or a lentivirus encoding SV40 large T antigen and porcine-derived telomerase reverse transcriptase into a porcine-derived kidney macrophage, as recited in claim 9.
The Prior Art
Borca teaches ASFV infection (and propagation) of primary swine macrophages (Examples 1 and 2), and use of the ASFV as a vaccine (col. 1, para. 1; claims 3-5). Borca also teaches construction of a vector that encodes a β-glucuronidase reporter under control of the ASFV p72 late gene promoter, which was used to construct recombinant ASFV (Example 2). The vaccines against ASFV taught by Borca comprises ASFV and a pharmaceutically acceptable carrier or diluent (p. 6, cols. 5-6, bridging para.). However, Borca does not teach immortalized porcine kidney macrophages.
Takenouchi teaches a macrophage cell line derived from immortalized porcine kidney, which was obtained by introducing a lentiviral vector encoding an SV40 large T antigen and a porcine telomerase reverse transcriptase in the macrophage cell line (Abstract). Takenouchi specifically teaches that the immortalized porcine kidney macrophages retain the characteristics of primary macrophages and can be used to develop cellular models for porcine pathogen infection processes.
It would have been obvious to one of ordinary skill in the art to modify the teachings of Borca to incorporate use of the immortalized porcine macrophage cell line disclosed by Takenouchi to infect and propagate ASFV. One of ordinary skill in the art would have been motivated to propagate ASFV for uses such as a vaccination. There would be a reasonable expectation of success because Borca propagated ASFV in primary swine macrophages for use as a vaccine and Takenouchi demonstrated the suitability of its immortalized porcine kidney cell for use in cellular models of porcine pathogen infection. Therefore, claims 1 and 9 were prima facie obvious before the priority date of the instant invention.
Response to Arguments
Applicant's arguments filed 1/2/2026 have been fully considered but they are not persuasive.
Applicant presents the following arguments:
Before the effective filing date of the present application, it would not have been obvious to a person skilled in the art to conceive of using immortalized macrophages instead of the primary cultured macrophages in ASFV infection.
Sanchez clearly shows that two types of ASFV (NHV/P68 and Amenia/07) can infect primary cultured macrophages (PAM) but neither of them infects immortalized macrophages (IPAM-WT). On the other hand, the Examples provided in the present spec. clearly demonstrate that IPKM can be infected with multiple types of ASFV. Furthermore, the susceptibility of IPKM to ASFV is significantly higher than that of the primary cultured swine blood macrophages disclosed by Borca.
Further, as shown in Carrascosa, the ASFV production capacity is equivalent between primary cultured blood macrophages and primary cultured alveolar macrophages. In other words, the susceptibility of blood macrophages to ASFV is approximately equal to that of alveolar macrophages.
In contrast, Tables 2-3 of the present spec. show that IPKM are more susceptible to ASFV than primary cultured alveolar macrophages. Therefore, it can be interpreted that the ASFV production capacity of IPKM is greater than that of the primary cultured alveolar macrophages, which, in turn, is approximately equal to that of primary cultured blood macrophages.
Further, Takenouchi neither discloses nor suggests the high susceptibility of IPKM to ASFV.
Applicant’s arguments are not persuasive because:
The examiner acknowledges the teachings of Sanchez that two types of ASFV (NHV/P68 and Amenia/07) can infect primary cultured macrophages (PAM) but neither strain as efficiently infects an immortalized macrophage cell line (IPAM-WT; Figure 4), and Table 1 of the instant specification, which shows that all 4 tested strains of ASFV could infect primary alveolar macrophages and IPKMs, but some strains could not replicate in one immortalized porcine alveolar macrophage cell line, 3D4/21, nor some other cell lines. However, immortalized porcine macrophage cell lines are known in the art to support ASFV infection, see Weingartl (J Virol Methods. 2002 Jul;104(2):203-16; Figure 4). Notably, the cell line IPAM-WT from Sanchez is noted as ATCC CRL-2845, which is also known as 3D4/2 (see 34D/2 CRL-2845. ATCC. 8-page-printout. Retrieved from atcc.org/products/crl-2845 on 3/23/2026); this cell line, along with several other immortalized macrophage cell lines, 3D4/21 and 3D4/31, were developed in Weingartl by transfection of primary porcine alveolar macrophages with a plasmid encoding neomycin resistance gene and SV40 large T antigen (Weingartl, Abstract). Weingartl demonstrates that ASFV-Lisbon 61 and ASFV-Lillie strains each replicate in 3D4/2, 3D4/21 and 3D4/31 cells (Table 3).
Taken together, it appears that there are strain-to-strain differences in ASFV’s capacity to infect immortalized macrophage cell lines--Weingartl does establish that immortalized porcine macrophages (granted that they are alveolar), can support ASFV infection. Applicant confirmed that with their own work. Sanchez confirms that other ASFVs may not infect some porcine immortalized macrophages. So really, it appears to depend on the ASFV type. However, the claim is drawn to a generic ASFV. While the teachings of Sanchez are important, they are not commensurate in scope with the claims, because the ASFV in the claims is generic.
Conclusion
THIS ACTION IS MADE FINAL. 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.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY MARK SIFFORD whose telephone number is (571)272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671
/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671