DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-10 are pending. Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim 10 is currently under examination.
Response to Amendment
The Amendment filed 9/15/25 has been entered. Claim 10 is pending. Applicant’s amendments to claim 10 have overcome some of the objections and 112(b) rejection previously set forth in the Non-Final Office Action mailed 8/7/25.
Response to Arguments
Applicant’s arguments, see pages 4-5, filed 9/15/25, with respect to the rejection of claim 10 under 35 USC 103 have been fully considered and are found unpersuasive, and the rejection documented in the Non-Final mailed on 8/7/25 has been revised to address the claim amendments filed 9/15/25. More detailed responses to Applicant’s arguments are provided at the end of each maintained rejection.
Claim Objections
Claim 10 remains/is objected to because of the following informalities:
lines 5 and 11 do not require fully spelling out the taxonomic name after the first introduction. Appropriate correction is required.
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.
Claim 10 remains/is rejected under 35 U.S.C. 103 as being unpatentable over Tian et al. (2014; NPL citation U in PTO-892 filed 8/7/25; "Single Nucleotide Polymorphisms in Growth Hormone Gene and Their Association with Growth Traits in Siniperca chuatsi (Basilewsky)"; Int. J. Mol. Sci. 2014, 15(4), 7029-7036; https://doi.org/10.3390/ijms15047029) in view of Laghari et al. (2018; NPL citation V in PTO-892 filed 8/7/25; "Functional, signalling and transcriptional differences of three distinct type I IFNs in a perciform fish, the mandarin fish Siniperca chuatsi"; Developmental & Comparative Immunology, Volume 84, Pages 94-108, https://doi.org/10.1016/j.dci.2018.02.008).
This revised/updated rejection is necessitated by claim amendments filed 9/15/25.
Relevant to claim 10, Tian et al. Abstract teaches “our results demonstrated that these SNPs in GH gene could influence growth performance of S.chuatsi and could be used for marker-assisted selection (MAS) in this species.”
This teaching reads on claim 10 A germplasm breeding method for Siniperca chuatsi.
Further relevant to claim 10, Tian et al. teaches “Total 282 individuals (approximately age 1 year) in the mixed pedigrees of S. chuatsi population were randomly obtained… Total genomic DNA was extracted from fin clips…” (page 7033, section “3.1. Samples Collection and Preparation”).
This teaching reads on claim 10 (1) extracting a genomic DNA of S. chuatsi to be tested.
Further relevant to claim 10, Tian et al. teaches “Three pairs of primers were designed using Primer Premier 5 software… to amplify the S. chuatsi… partial regions” (page 7033, section “3.2. Primer Design and Polymerase Chain Reaction (PCR) Amplification”).
This teaching reads on claim 10 (2) performing PCR amplification on the genomic DNA of the Siniperca chuatsi using a primer pair… to obtain a PCR amplification product.
Further relevant to claim 10, Tian et al. teaches “Fragments in 282 individuals were sequenced by direct sequencing... Sequence mutations differing between individuals were detected… SNPs were identified and genotyped…” (page 7034, section “3.3. Single Nucleotide Polymorphism Identification and Genotyping”).
This teaching reads on claim 10 (3) sequencing the PCR amplification product, comparing a result of the sequencing with an SNP molecular marker.
Although Tian et al. teaches a germplasm breeding method based on the Growth Hormone gene and not resistance to infectious spleen and kidney necrosis virus, this limitation was known in the prior art and taught by Laghari et al.
Relevant to claim 10, Laghari et al. teaches that “To examine the effect of virus infection on IFN gene expression, head-kidney (Fig. 2C) and spleen (Fig. 2C) were collected and examined from fish infected with ISKNV. In general, a similar trend in the increase of IFNc and IFNh expression was observed in head-kidney (Fig. 2C) and spleen (Fig. 2D) …” (page 99, column 1, section “3.2. In vivo and in vitro expression of type I IFN genes”, paragraph 2).
Additionally relevant to claim 10, Laghari et al. teaches “In the present study, the overexpression of IFNc or IFNh in MFF-1 cells resulted in the increase of their own expression, and also IRF3 and IRF7 expression, and in the significant increase of STAT1, STAT2, IRF9, Mx and VIPERIN expression, indicating that these IFN genes are involved in the IFN signalling pathway to evoke immune response against viral infection in mandarin fish, and can provoke a subsequent increase of IFN production. STAT1 and STAT2 can also be phosphorylated following the overexpression of IFNc and IFNh, and it is thus expected that antiviral effect was observed for IFNc and IFNh, as viral titre was reduced in IFNc or IFNh overexpressing cells following the ISKNV infection” (page 106, column 2, paragraph 1).
Collectively, these Laghari et al. disclosures teach that IFNh participates in S. chuatsi antiviral response.
Although Laghari et al. did not use nucleotide sequences of the primer pair are as shown in SEQ ID NO. 11 and SEQ ID NO. 12 to amplify the IFNh region, alignments of SEQ ID NO. 11 and SEQ ID NO. 12 (see ABSS Sequence Search, pages 1 and 140; NPL citation W in PTO-892 filed 8/7/25) demonstrate 100% match to Siniperca chuatsi type I interferon h (IFNh) gene, GenBank Accession KY768923. The skilled artisan would find it obvious and common practice to design primers, such as SEQ ID NO. 11 and SEQ ID NO. 12, using common software like the Tian et al. commercially available Primer Premier 5 software.
The broadest reasonable interpretation of a nucleotide sequence of the SNP molecular marker is as shown in SEQ ID NO. 1 includes fragments of the SEQ ID NO. 1 sequence. SEQ ID NO. 1 demonstrates high similarity to publicly available KY768923.1 GenBank Accession for the Siniperca chuatsi type I interferon h (IFNh) gene sequence (see NPL citations U, V, and W in PTO-892 filed on 6/13/25). Thus, the Laghari et al. characterizations of IFNh and viral response read on the instant SNP molecular marker.
Further relevant to claim 10, Laghari et al. teaches that “For the analysis of gene expression following virus infection, fish… were each injected intraperitoneally with 100 ml ISKNV solution at a concentration of 1×106 TCID50/ml (n = 4) or with the equivalent volume of DMEM as control (n = 4). As the organ/tissue samples were rather enormous, the head-kidney and spleen samples from virus infected fish were collected at 3, 6, 12, 24, 36, 48, 72, 96, 120, 144, 168 hpi for the gene expression analysis until all infected fish died” (page 96, column 2, paragraph 3).
The alignment of SEQ ID NO. 1 and KY768923.1 (the GenBank Accession for S. chuatsi IFNh) is provided within NPL citation V in PTO-892 filed on 6/13/25, and a segment of the alignment is provided below. The 376th position of SEQ ID NO. 1 perfectly aligns with the GenBank Accession, with both sequences containing the base A determined to be susceptible to ISKNV.
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The Laghari et al. teaching of all the infected fish dying, in combination with the presence of the 376th base of SEQ ID NO. 1 being the base A, obviates to the skilled artisan that this position and base correspond to ISKNV susceptibility.
The skilled artisan would find it prima facie obvious to include the Laghari et al. IFNh-mediated viral response within the germplasm breeding method of Tian et al. It is noted that Tian et al. and Laghari et al. are analogous disclosures to the instant S. chuatsi genomics. The skilled artisan would have been motivated to combine the analogous art.
Tian et al. teaches “The Chinese perch Siniperca chuatsi (Basilewsky) is one of the chief economic freshwater fishes for aquaculture in China, with worldwide production of 252,622 tons in 2010 [citation]. Due to its delicious flesh, fast-growing and broad temperature tolerance range, nowadays it has been cultured in many provinces of China, mostly in Guangdong Province [citation]. However, with the rapid development of the culture industry, some commercially desirable characteristics (growth, disease resistance and suitability) of the cultured stocks have declined [citation]. These have led commercial breeders to incorporate significant selection for increased growth rate in breeding programs by marker-assisted selection (MAS)” (page 7030, first paragraph of “1. Introduction”).
As additional motivation, Laghari et al. teaches “It is considered that this comprehensive study will provide insights into the functional understanding of type I IFN system in teleost fish, and may also have wide implications in aquaculture practice of perciform fish” (page 95, column 1, paragraph 3).
Thus, the skilled artisan would have been motivated by the Tian et al. teaching that disease resistance markers, such as the Laghari et al. IFNh genotype, would be desirable for marker-assisted selection (or germplasm breeding method). The teachings of Tian et al. in view of Laghari et al. render obvious determining whether a base at any position corresponding to the result of the sequencing confers ISNKNV resistance, and eliminating the S. chuatsi with ISNKNV susceptibility, as the skilled artisan would be motivated to improve the economically-important S. chuatsi breeding methodologies.
The skilled artisan would have a reasonable expectation of success based on the disclosures of Tian et al. in view of Laghari et al. as discussed in the preceding paragraphs.
Applicant’s Arguments
Applicant has amended claim 10 to include “the 376th base of SEQ ID NO. (A) is determined to be susceptible to ISKNV and the 376th base of SEQ ID NO. 2 (G) is determined to be resistant to ISKNV” (Remarks 9/15/25, page 5, paragraph 2). Applicant argues that “The combined teaching of Tian and Laghari fails to teach or suggest at least these elements of claim 10. Accordingly, claim 10 is allowable over the combined teaching of Tian and Laghari” (Remarks 9/15/25, page 5, paragraph 3).
Response to Applicant’s Arguments
Laghari et al. does teach the amended claim limitations.
As discussed above, Laghari et al. teaches that ISKNV-infected fish died with the 376th base of SEQ ID NO. 1 (or IFNh) corresponding to the base A. The skilled artisan would recognize that DNA is a double-stranded molecule and that base pair complementarity allows for either A/T or C/G to be present within any given position. Thus, the skilled artisan would be strongly motivated to negatively select against this SNP conferring susceptibility, resulting in S. chuatsi with the C/G base and ISKNV resistance.
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.
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/SARAH JANE KENNEDY/Examiner, Art Unit 1682
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