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 June 23, 2026. Currently, claims 1-20 are pending. Claims 8-20 have been withdrawn as drawn to non-elected subject matter.
All arguments have been thoroughly reviewed but are deemed non-persuasive for the reasons which follow. This action is made FINAL.
Any objections and rejections not reiterated below are hereby withdrawn.
The Improper Markush rejection has been withdrawn in view of the amendments to the claims to remove the elected subject matter.
The 101 rejection has been withdrawn in view of the amendments to the claims to require the loop forward and loop backward primer that integrate the judicial exceptions. It is noted that pH sensitive signal reagents do exist in nature. However, the BIP and FIP primers are not naturally occurring. The incorporation of the BIP and FIP primers into a master mix constitute an integration of the naturally occurring products.
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 claims have been amended on June 23, 2026. Claims 8-10 and 11-20 have been withdrawn as directed to non-elected subject matter.
The response states “Applicant does not agree with the characterization” of the cited LOU references but does not provide any argument.
Claims 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 8-20 drawn to an invention nonelected with traverse. 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.
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 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN101307364, published November 19, 2008 in view of Parida et al. (Rev. Med. Virol. Vol. 18, pages 407-421, 2008) and further in view of Poole et al. (PLOS One, Vol. 12, No. 2, e0169011, February 15, 2017).
CN101307364 teaches a set of LAMP primer pairs for specifically amplifying shrimp white spot syndrome virus. CN101307364 teaches amplifying the VP28 gene which is SEQ ID NO: 1 of the instant application. 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. 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,
CN101307364 does not teach a master mix comprising size LAMP primers or pH sensitive reagents.
The prior art is replete with teaching of how to design LAMP primers. Commercially available programs for primer design for LAMP primers including loop forward and loop backward primers was well known at the time the invention was made. For example, Parida teaches LAMP primers may be designed that are highly sensitive and specific. Parida teaches Primer Explorer (LAMP primer designing support is available (page 408, col. 2). The primer set for LAMP amplification includes a set of 6 primers including loop primers which accelerate the amplification reaction by binding to additional sites that are not accessed by internal primers (page 408, col. 2). Figure 1 illustrate a schematic of primer design for RT-LAMP assay. Parida teaches the loop primers are located on opposite strands of the target and between f1 and f2 and b1 and b2 (page 409). Parida teaches particular conditions and criteria for designing ideal LAMP primers including CG content, Tm and stability of primer ends (page 409).
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 six LAMP primers. The ordinary artisan would have been motivated to have added loop forward and loop backward primers because Parida teaches these primers allow an assay to be accelerated. Design of LAMP primers according to the particular teachings of Parida would have been obvious absent unexpected results. The ordinary artisan would have had a reasonable expectation of success that designing LAMP primers according to the guidance in Parida and/or the commercially available computer programs would have yielded primers that detected the expected target. With respect to Claim 3, SEQ ID NO: 13-14, the guidance provided Parida would render these primers designed to the loop structure obvious. Parida teaches the loop primers are located on opposite strands of the target and between f1 and f2 and b1 and b2 (page 409). Thus, designing these primers in this region would have been obvious including SEQ ID NO: 13-14. As noted in In re Aller, 105 USPQ 233 at 235, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that the primer selection performed was other than routine, that the products resulting from the optimization have any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art.
Further, the ordinary artisan would have been motivated 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.
Response to Arguments
The response traverses the rejection. The response asserts the combination of CN’364 and Poole don’t teach the loop primers corresponding to SEQ ID NO: 13-14. It is noted Claim 3 is the only claim that requires SEQ ID NO: 13-14. However, in view of Parida, design of primers having SEQ ID NO: 13-14 would have been obvious. The genus of possible primers that may be designed within the parameters taught by Parida render the primers obvious.
The response further argues the motivation to combine Poole and CN’364 is not a simple substitution. This argument has been considered but is not convincing because the ordinary artisan would have recognized that modifying a set of primers that detected the target using SYBR Green I would require minor modifications within the skill of the art. Parida teaches numerous methods for monitoring RT-LAMP amplifications thru spectrophotometric analysis or visual inspection, visual turbidity, or visual fluorescence. Poole teaches pH sensitive dyes enhance visual detection of LAMP amplification and can be performed in portable, non-instrumented nucleic acid amplification. Substituting an alternative detection method known in the art to detect and monitor LAMP assays would have provided a reasonable expectation of success. The ordinary artisan would have been motivated to have used a known visual detection method for detecting target sequences in LAMP reactions.
Finally, the response argues Poole does not describe WSSV detection and does not provide primer design for WSSV primer system. This argument has been reviewed but is not persuasive. The prior art, namely CN’364 teaches using identical SEQ ID NO: 9-12 primers for detecting a known target sequence of WSSV. The combination of references teaches the WSSV detection. The ordinary artisan would have a reasonable expectation of success that pH based detection could be used on WSSV assays.
Thus, for the reasons above and those already of record, the rejection is maintained.
Conclusion
No claims allowable over the art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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). He teaches amplifying the VP28 gene which is SEQ ID NO: 1 of the instant application.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
July 22, 2026
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