DETAILED ACTION
Response to Amendment
The amendments filed 18 June 2026 is acknowledged. The amendment largely moved limitations of a dependent claim into the independent and removed “means for” (or equivalent) language. Claims 1-3, 7-11, 15, and 28 are pending. Claims 4-6, 16-19, 21, and 25-27 have been cancelled
Regarding the office action dated 24 March 2026 and in light of applicant’s amendments:
The objections to claims 1(c), 8, and 10 are withdrawn. The objection to claim 1(d) is maintained and reiterated below.
The rejection of claim 28 under 35 USC § 101 is maintained.
The rejections of claims 1-3, 7-11, 15, and 28 under 35 USC § 112(b) are withdrawn.
The rejection of claim 11 is rejected under 35 USC § 112(d) are withdrawn.
The rejections of claims 1, 7, and 11 under 35 USC § 102(a)(1) are withdrawn. However, the amendments necessitate a new ground of rejection of these claims under 35 USC § 103 which is presented below. As claims 2, 3, 8, 9, 10, and 15 ultimately depend from claim 1, new grounds of rejections are similarly presented for these claims.
The rejection of claim 28 under 35 USC § 102(a)(1) is maintained and reiterated below.
As claims 4-6, 16-19, 21, and 25-27 have been cancelled, any rejections of them are moot.
Claim Objections
Claim 1 is objected to because of the following informality: section (d), L1 states “a sample” which should be “the sample”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 28 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (including a product of nature) without significantly more.
The claim recites “a nucleic acid sequence with 90% or more identity to any of SEQ ID NOs: 1-4”. When these sequences are searched, they each show 100% concordance with naturally occurring sequences (see comparison table below). This judicial exception is not integrated into a practical application because there are no additional limitations in the claim which would do so. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements. Therefore, claim 28 does not contain eligible subject matter.
SEQ ID NO: 1 compared to Accession #MT072717
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56
261
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SEQ ID NO: 2 compared to Accession #MT072717
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56
251
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SEQ ID NO: 3 compared to Accession #MH300639
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54
257
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SEQ ID NO: 4 compared to Accession #MH300629
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52
248
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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.
Claim 28 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Korzik (Korzik et al. PLoS ONE. 12 Mar 2020; 15(3): e0229512 and associated data, previously cited).
Korzik discloses a sequence (Accession #MT072717) from the mitochondrion of P. setiferus (white shrimp) which shows 100% similarity to both SEQ ID NOs: 1 and 2. Therefore, the sequence of Korzik anticipates both claimed sequences.
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 1, 7, 8, 11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Taboada (Taboada L et. al. Food Chemistry. 2017 Oct 15; 233:182-9, previously cited) in view of Dobosy (Dobosy JR et al. BMC Biotechnology. 2011 Aug 10. 11(80): 1-18, previously cited) as evidenced by Cytiva (Cytiva. Illustra puReTaq Ready-To-Go PCR Beads Product Booklet. 2021 (27955701PL AI): 1-18, previously cited) and American Laboratory Trading (American Laboratory Trading. Applied Biosystems 2720 Thermal Cycler. Accessed: March 3, 2026, previously cited).
Taboada discloses a method for the molecular identification of seafood products. This method analyzed the mitochondrial cytochrome b gene via PCR amplification followed by detection using a lateral flow dipstick (Taboada, p183). First, a sample from a fish product was digested in a microcentrifuge tube and the DNA isolated using the Wizard DNA Clean-Up System kit from Promega (Taboada, Supplementary Data 3). To perform PCR amplification, Taboada used the PureTaq™ Ready-To-Go™ PCR bead system. These beads contain all the reagents necessary to perform PCR (with the exception of template and primer) and are provided predispensed (aka premixed) in either PCR tubes or in the wells of a PCR plate (aka a container) (Cytiva, p4). To each well or tube, Taboada added primers (forward and reverse), template DNA, and sterile water to a final volume of 25uL (Taboada, p184). This reaction mix was then thermocycled using an Applied Biosystems 2720 Thermal Cycler (Taboada, p184). This instrument has a footprint of 8.3in x 14.2in and weighs 13.5lbs (according to American Laboratory Trading), thus meeting the requirements of “portable” device as outlined in the instant specification. Finally, the amplified product was detected via lateral flow dipstick, allowing for the visual detection of a positive or negative result within 5 minutes. This positive or negative result was used to determine if the food product had been accurately labeled (Taboada, p184).
Taboada does not teach that the amplification reagents used in their method include rhPCR primers, RNase H2 enzyme, or RNase H2 enzyme buffer.
However, Dobosy teaches an enzyme coupled PCR assay used to increase primer specificity, termed rhPCR, which is particularly useful in the detection of single nucleotide polymorphisms (SNPs). In this method, primers are modified to contain a single RNA reside at the 3`-end, which prevents extension by DNA polymerase. When the primer hybridizes to its target, RNase H2 enzyme cleaves the RNA from the primer, thus activating it and initializing PCR (Dobosy, p2). The cleavage reaction takes place by incubating the substrate in “Mg Cleavage Buffer” (aka RNase H2 enzyme buffer) for 20 minutes at 70oC (Dobosy, p3). Dobosy further teaches that this enzyme/primer system is compatible with any thermostable DNA polymerase and little to no modification of the reaction set up (cycling times, temperatures, etc.) is required (Dobosy, p2).
As Taboada’s method relies on the identification of SNPs in small segments of the cytochrome b mitochondrial DNA sequence of the target species (Taboada, p184) and rhPCR is adaptable for use with any existing PCR system, one of ordinary skill in the art prior to the effective filing date of the claimed invention would have been motivated to adapt the method of Taboada by using rhPCR chemistry in order to improve primer specificity resulting in a method better able to distinguish between closely related fish species.
A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Claims 2, 3, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Taboada and Dobosy, as applied to claim 1 above, in view of Korzik.
Taboada and Dobosy are applied to the relevant teachings of claim 1 as previously discussed and are incorporated herein by reference. However, Taboada and Dobosy do not teach applying their method of identifying commercial fish products to the identification of shellfish (specifically L. setiferus) nor the use of the claimed primers.
Korzik teaches that 21% of seafood in the United States is mislabeled which can have consequences such as exacerbating over-fishing, negative human health impacts, and perpetuating human rights abuses in international fisheries (Korzik p2). Korzik specifically focused on the impact of seafood mislabeling in the context of shrimp. In pursuit of this goal, Korzik applied standard DNA barcoding techniques to evaluate the mislabeling of three different shrimp species (F. aztecus, L. setiferus, and F. duorarum), finding that 34% of shrimp sold by vendors in North Carolina were mislabeled (Korzik, abstract, p2). Taboada teaches that use of these DNA barcoding techniques are complex, requiring skilled personnel, high analysis time, and the use of expensive equipment (Taboada p183).
Therefore, one of ordinary skill in the art prior to the effective filing date of the claimed invention looking to address the issue of improperly labeled seafood products, would be motivated to use the method of Taboada and Dobosy to analyze shellfish products for the presence or absence of L. setiferus DNA as this method represents an easy-to-use and highly specific alternative to the complex barcoding techniques used by Korzik.
Finally, as the cytochrome b sequences (i.e., the targets of the claimed primers) are well characterized and well suited for species differentiation using analysis methods like that of Taboada and Dobosy, standard primer design principles (i.e. primer length, melting temperature, GC content) would provide clear and predictable guidance for generating suitable primers. Accordingly, developing primers for this known genomic region would have been akin to choosing from a finite number of predictable primer candidates and, therefore, obvious to try.
The Supreme Court decided that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. Therefore, choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, E.).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Taboada and Dobosy, as applied to claim 1 and 8 above, and as evidenced by Cytiva and Kreader (Kreader C. Applied and Environmental Microbiology. 1996 Mar; 62(3): 1102-1106, previously cited)
Taboada and Dobosy are applied to the relevant teachings of claim 1 and 8 as previously discussed and are incorporated herein by reference. When performing PCR amplification of a sample, Taboada used the PureTaq™ Ready-To-Go™ PCR bead system which provides predispensed amplification reagents. Each of these beads contains stabilizers, BSA, dNTPs, polymerase, and reaction buffer (Cytiva, p4). The inclusion of BSA in a reaction mixture provides relief from the effects of inhibition (Kreader, abstract); therefore, its inclusion in the PCR bead system would impart inhibitor resistant properties.
Response to Arguments
Applicant’s arguments filed 18 June 2026 have been fully considered but they are not persuasive. They are summarized below and responded to in kind.
Arguments regarding the rejection of claim 28 under 35 USC § 101 and 102(a)(1):
The claims have been amended to require “a pair of primers” and grouped the recited SEQ ID NOs accordingly. Applicant argues that this confines the SEQ ID NOs to primer sequences that function as part of the Applicant’s amplification system. They state that the claimed 90% or greater identity range represents a non-naturally occurring design space and that by placing them in pairs, they are no longer representing a single genomic segment, but represents an engineered combination designed for primer function. Applicant further argues that primers are man-made tools configured to have specific functions and thus have markedly different utility and properties from any naturally occurring nucleic acids and are integrated into a practical application. Finally, Korzik discloses shrimp mitochondrial sequences which could at most be used as a template from which to design primer sequences, but does not teach the particular combinations of sequences “arranged as in the claim”, a requirement of anticipation. As such, neither Korzik or Spielmann disclose isolated primer pairs designed to have a defined degree of identity or be capable of use in a rhPCR/lateral flow/qPCR system.
Response:
Although primers are synthetically created, the court found in Ambry Genetics that primers are not markedly different than their corresponding strands of DNA in nature because they have the same genetic structure and nucleotide sequence (see MPEP 2106.04(c)(II)(C)(2)). Furthermore, the ability to serve as a starting material for amplification is innate to DNA itself, and was not created or altered by the patentee (University of Utah Research Foundation V. Ambry Genetics Corp., 774 F.3d 755, 113 USPQ2d 1241 (Fed. Cir. 2014)).
Regardless of the intent of requiring 90% sequence identity or the pairing of the sequences, what is being claimed are pairs of sequences which are identical to their natural counterparts. Placing them in pairs simply identifies two naturally occurring sequences at once. Therefore, these limitations do not impart meaningful structural or functional differences that would distinguish them from said natural counterparts.
Arguments regarding the obviousness of combining Taboada and Dobosy:
Applicant argues that the use of rhPCR chemistry is not an obvious design choice and reflects the specific difficulties that arise from differentiating closely related species found in complex seafood matrices. They specifically point to the increased allelic and species-level specificity imparted by an rhPCR system, citing the similarities in the mitochondrial barcoding regions of seafood species. Neither Taboada or the cited seafood barcoding references suggest using a rhPCR system and Dobosy is directed towards SNP genotyping, not seafood product identification. None of the cited references teach configuring the primers to work with a portable amplification system and lateral flow readout. As such, the Applicant asserts that the inclusion of rhPCR chemistry represents a non-obvious adaptation to solve a specific, real-world problem.
Response:
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
This notwithstanding, in response to applicant's argument that Dobosy’s use of rhPCR chemistry for SNP identification does not address the specific challenges faced in seafood identification, it is noted that Dobosy teaches rhPCR provides improved specificity, stating that “biological requirements sometimes necessitate that primers are placed in suboptimal locations which lead to problems with the formation of primer dimers and/or misamplification of homologous sequences” (abstract). One of ordinary skill in the art would have understood that the improvement taught by Dobosy would be applicable in Tabaoda’s endeavors, Tabaoda teaching: “In our experience in the case of gadoids, cytochrome b provides sufficiently significant interspecies nucleotide differences to enable the design of specific primer systems…The developed method is based on the existence of SNPs in small segments of the cytochrome b mitochondrial DNA sequence from the four target species.” (page 185, paragraph spanning the columns, emphasis provided). Therefore, Tabaoda’s method involves amplifying homologous sequences from different species.
In response to Applicant’s arguments that Dobosy does not “teach configuring rhPCR primers and RNase H2 chemistry to function robustly in a portable footprint amplification device with lateral-flow readout”, Applicant has not provided any evidence or reasoning as to why, or how, rhPCR primers and enzymes would need to be changed or “configured” in order to work in a portable footprint amplification device with lateral flow readout (which device, incidentally, is not a required element of the claimed method). Applicant presents no evidence or reasoning as to why the reaction would work in whatever instrument setup was used by Dobosy, but not in a “portable” device. Arguments presented by the applicant cannot take the place of evidence in the record (MPEP 716.01(c)).
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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/K.N.K./Examiner, Art Unit 1681
/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
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