DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed February 2, 2026. Currently, claims 1-20 are pending. Claims 11-20 have been withdrawn as drawn to non-elected subject matter.
Election/Restrictions
Applicant's election without traverse of Group I and White Spot Syndrome Virus and LAMP primer set of SEQ ID NO: 9-14, Claims 1-10 in the paper filed February 2, 2026 is acknowledged.
The response states “Applicant does not agree with the characterization” of the cited LOU references but does not provide any argument.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
This application contains claims 11-20 drawn to an invention nonelected with traverse in the paper filed February 2, 2026. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Priority
This application claims priority to
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Drawings
The drawings are acceptable.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The specification contains a list of references on pages 43-36 of the specification.
Improper Markush Rejection
Claims 8-10 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
A Markush claim contains an “improper Markush grouping” if:
(1) the species of the Markush group do not share a “single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a “single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent. See MPEP § 2117.
Here each species is considered to each of the different shrimp or fish pathogens and the corresponding primer sets.
The recited alternative species in the groups set forth here do not share a single structural similarity, as each different primer set is specific for a particular shrimp or fish pathogen that could be detected is itself located in a separate region of the genome and has its own structure. The pathogens and each of the primer sequences are directed to different genes. The genes for each of the pathogens do not share a single structural similarity since each consists of a different nucleotide sequences with different expression patterns. The only structural similarity present is that all detected positions are part of nucleic acid molecules. The fact that the markers comprise nucleotides per se does not support a conclusion that they have a common single structural similarity because the structure of comprising a nucleotide alone is not essential to the common activity of being correlated with colorectal cancer. Accordingly, the different pathogens and the primer sets do not share a single structural similarity.
MPEP 2117 (II)(A) provides the following guidance as to what constitutes a physical, chemical, or art recognized class:
A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein “there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved”
The recited pathogens or primer sets do not belong to a recognized chemical class because there is no expectation from the knowledge in the art that the pathogens or primer sets will behave in the same manner and can be substituted for one another with the same intended result achieved. In other words, there is no expectation from the knowledge in the art that each of the recited genes would function in the same way in the claimed method; it is only in the context of this specification that it was disclosed that all members of this group may behave in the same way in the context of the claimed invention. Further there is no evidence of record to establish that it is clear from their very nature that each of the recited genes possess a common property.
MPEP 2117 (II) further states the following:
Where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the compounds do not appear to be members of a recognized physical or chemical class or members of an art-recognized class, the members are considered to share a "single structural similarity" and common use when the alternatively usable compounds share a substantial structural feature that is essential to a common use. Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
The recited alternative species do not share a substantial common structure just because they all have a sugar phosphate backbone. The sugar phosphate backbone of a nucleic acid chain is not considered to be a substantial common structural feature to the group of primer sets being claimed because it is shared by ALL nucleic acids. Further, the fact that the genes all have a sugar phosphate backbone does not support a conclusion that they have a common single structural similarity because the structure of comprising a sugar phosphate backbone alone is not essential to the asserted common use.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Following this analysis, the claims are rejected as containing an improper Markush grouping.
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.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, the rejected claim(s) do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
Briefly, 1-10 are rejected because these claims are drawn to a nucleic acid molecule comprising 17-20 nucleotides of SEQ ID NO: 1.
Claims 1-7 are directed to LAMP primers to amplify one or more shrimp or fish pathogen-specific target polynucleotides via LAMP and a reagent. The F3, B3, LF and LB LAMP primers are fragments of the target sequences. Claims 8-10 are directed to nucleic acid fragments from the shrimp genome, i.e. known naturally occurring nucleic acids. Such isolated nucleic acid molecules, that are identical to fragments of naturally occurring nucleic acid molecules are not patent eligible subject matter, i.e. they are judicial exceptions to patentable subject matter.
Claim 2-7 further requires reagents including signal reagents, phenol red, neutral red, for example. The claims do not require the reagents are in a mixture. The claim encompasses all of the reagents in different tubes. The elements are not mixed.
MPEP 2106.04(b)(II) discusses products of nature. The MPEP specifically discusses DNA, primers and probes. The isolated DNA of Myriad and the primers of Ambry Genetics were described as products of nature by the courts. Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116-17, 106 USPQ2d 1972, 1979 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). The MPEP further states the “product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g., Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 ("Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.").” The Federal Circuit in Ambry Genetics reviewed “[t]he Supreme Court held ineligible claims directed to segments as short as 15 nucleotides, the same length as the primer claims at issue here, suggesting that even short strands identical to those found in nature are not patent eligible. Compare ’492 patent col. 170 ll. 32–38, with ’282 patent col. 153 ll. 66–67.”
In the instant case, the claims, embrace primers that are identical to naturally occurring gene fragments and clearly read on nature-based products that themselves do not exhibit markedly different characteristics from the naturally occurring gene. See e.g. Myriad in which one claim at issue was drawn to “[a]n isolated DNA having at least 15 nucleotides [an isolated DNA coding for a BRCA1 polypeptide having the amino acid sequence of SEQ ID NO: 2] (Myriad at 2113). The Court recognized that this claim, if valid, would have given Myriad exclusive right to isolate any strand of 15 or more nucleotides of an individual’s BRCA1 gene (paragraph bridging 2113 and 2114). This is directly analogous to the instant situation wherein Applicant’s claims cover probe and primer molecules that are fragments of a naturally occurring shrimp genome sequence. The Court held that “[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”, and that “Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together” (page 2118). The Court found that while Myriad had located and sequenced an important gene, Myriad had not created anything, and that “separating that gene from its surrounding genetic material is not an act of invention” (page 2118). Consistent with the findings of the Court in Myriad, the Office finds that the primers and probe molecules embraced by the instant clams are not patent eligible compositions of matter regardless of whether or not they are isolated from the genome. The Guidelines indicate that a change in biological function or activity maybe a characteristic of an isolated product that can provide a marked difference sufficient to distinguish over a naturally occurring product. However, in this case, as in the Ambry case, the function of the nucleic acids is the same function as the relevant portion of the naturally occurring sequence. Just as in nature, primers and probes utilize the innate ability of DNA to bind to itself.
Having established that the claims include a naturally occurring product that is a judicial exception, it must now be determined whether or not the claims recite an element or combination of elements that amount to significantly more than that exception, and whether those additional elements also amount to significantly more for the other claimed exception(s), which ensures that the claim does not have a preemptive effect with respect to any of the recited exceptions. To determine whether a claim that includes a nature-based product limitation recites a “product of nature” exception, an analysis is performed in which it is first determined if a claim includes a nature-based product that has markedly different characteristics from the corresponding naturally occurring product, and if it does not, then it is determined whether or not other elements of the claim are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself (see the Interim Guidance on Patent Subject Matter Eligibility published 12/16/2014 in the Federal Register at pages 74618-74633). In order to be markedly different the claimed product must possess at least one characteristic that is different from that of the counterpart.
In the instant case, only claim 3-7 recites any additional element, i.e. pH sensitive reagents. None of these limitations provides any significant addition to the judicial exceptions already claimed that would prevent the claims from having a pre-emptive effect on the use of the judicial exception. The presence of a signal reagent in a composition does not represent a modification that amounts to something significantly more than the judicial exception.
The fact that these natural products are organized into a kit with an intended use adds nothing to the judicial exceptions that would distinguish them from the naturally occurring material. The kit must be considered in the context of whether or not the combination can provide some way of ensuring it does not limit the public’s access to the naturally occurring material. That does not occur in this case because the naturally occurring material exists as a distinct entity within the kit, and is not integrated in terms of form or function with any other element of the kit. Therefore, the claims are properly rejected under 35 USC 101 as being drawn to patent-ineligible subject matter.
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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim(s) 1-2, 8, 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by He et al. (Aquaculture, Vol. 311, pages 94-99, 2011).
He teaches LAMP primers for the detection of white spot syndrome virus and reagents for the amplification. He teaches the LAMP primers were designed for VP28 gene of WSSV (abstract). Table 2 provides four LAMP primers, i.e. a set of primers, to specifically amplify WSSV and reaction reagents for performing the mLAMP assay. He teaches Bst DNA polymerase, as well as Tris-HCL, Triton, dNTPs and double distilled water (page 95, col. 2). He teaches SYBR Green I was used to turn orange to green and can be inspected by the naked eye (page 96, col. 1)(limitations of Claim 2).
With respect to Claim 10, He teaches amplifying the VP28 gene which is SEQ ID NO: 1 of the instant application. Thus, the primers amplify a region of at least 10 nucleotides of SEQ ID NO: 1.
Claim(s) 1-2, 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN101307364, published November 19, 2008.
CN101307364 teaches a set of primer pairs for specifically amplifying shrimp white spot syndrome virus (limitations of Claim 8). CN101307364 teaches amplification reagents including buffers, Triton X-10, SYBRGREEN, ammonium sulfate, for example. Example 1 provides a kit of LAMP reaction reagents including four primers and dNTPs. SYBRGREEN is a signal reagent (limitations of Claim 2).
With respect to Claim 9, The primers of SEQ ID NO: 1-4 of CN101307364 are 100% identical to SEQ ID NO: 9-12 of the instant application.
SEQ ID NO: 9 Downstream outer primer 5-TGGTGCCAAAGATTAACCCA-3.
SEQ ID NO: 10 Upstream outer primer 5-GGTCTCAGTGCCAGAGTAGG-3,
SEQ ID NO: 11 Downstream inner primer 5-ACCACACACAAAGGTGCCAACTCTTTGTCGGTAGCTCCAACA-3,
SEQ ID NO: 12 Upstream internal primer 5-ACCACCTTTGGCGCACCAATCGTGCACGTACATGTCGA-3,
With respect to Claim 10, CN101307364 teaches amplifying the VP28 gene which is SEQ ID NO: 1 of the instant application. Thus, the primers of SEQ ID NO: 9-12 amplify a region of at least 10 nucleotides of SEQ ID NO: 1.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN101307364, published November 19, 2008 in view of Poole et al. (PLOS One, Vol. 12, No. 2, e0169011, February 15, 2017).
CN101307364 teaches a set of primer pairs for specifically amplifying shrimp white spot syndrome virus (limitations of Claim 8). CN101307364 teaches amplification reagents including buffers, Triton X-10, SYBRGREEN, ammonium sulfate, for example. Example 1 provides a kit of LAMP reaction reagents including four primers and dNTPs. SYBRGREEN is a signal reagent (limitations of Claim 2).
CN101307364 does not teach pH sensitive reagents.
However, Poole teaches colorimetric test for diagnosis of infections using LAMP. Poole teaches pH sensitive dyes enhance visual detection of LAMP amplification and can be performed in portable, non-instrumented nucleic acid amplification. Poole teaches neutral red and phenol red dyes are pH sensitive colorimetric dyes. Poole teaches reactions containing neutral red changed from colorless before amplification to pink when positive, or to a brownish yellow in the no template control, whereas reactions containing phenol red were pink initially and remained pink if negative but turned yellow in the presence of template DNA (Fig 2). Both neutral and phenol red provide a clear distinction between positive and negative samples (page 5).
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention to modify the kit of CN1010307364 for detecting WSSV vp28 gene using LAMP to use a colorimetric detection means, namely phenol red or neutral red, as taught by Poole. Poole teaches the colorimetric kit may be easily adapted to accommodate multiple different primer/target combinations and the technology was simple and versatile. The ordinary artisan would have been motivated to have designed an easy and simple kit to allow for analysis in the field.
Conclusion
No claims allowable over the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached on (571)272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
March 19, 2026