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 .
Response to Amendment
The Amendment filed 12/22/2025 in which claims 1 and 8 were amended, claims 2-4 were canceled, has been entered. Claims 12-19 were previously withdrawn.
Claims 1, 5-8 are under examination on the merits.
Drawings
(Previous objection, withdrawn) Applicant’s amendments to the Drawings submitted on 12/22/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed 08/20/2025.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 12/22/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed on 08/20/2025.
Claim Objections
(Previous objections, withdrawn as to claims 1, 8). Applicant’s amendments to claims 1, 3 have overcome previous objections to those claims.
(New objection, as to claim 5). Claim 5 is objected to because it recites two sentences and two periods. See MPEP 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
(Previous rejection, withdrawn as to claims 1-8) Claims 1-8 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
See claims 1, 5-8 as submitted on 12/22/2025.
The previous rejections of claims 2-4 are moot in view of Applicant’s cancelation of these claims.
Applicant’s amendment to the instant claims filed on 12/22/2025 has overcome previous rejection to claims 1, 5-8.
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.
(Previous rejection, withdrawn as to claims 2-4, maintained and modified as necessitated by amendment as to claims 1, 5-8) Claims 1, 5-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
See claims 1, 5-8 as submitted on 12/22/2025.
The previous rejections of claims 2-4 are moot in view of Applicant’s cancelation of these claims.
It is noted that amended claim 1 recites the limitations previously recited by claims 2-4. However, as previously discussed these limitations we already previously analyzed for eligibility in accordance with their broadest reasonable interpretation.
As previously indicated, these claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. In view of the Subject Matter Eligibility Test for Products and Processes and the Steps cited below (See flowchart at pages 10-11 at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf ).
The claims are directed to a process, which is one of the four statutory categories of invention (Step 1: YES).
The claims are directed to a method comprising a step of determining or appreciating the presence or absence of viral CHIKV, DNV1, DNV2, DENV3, DNV4 and ZIKV sequences in a sample. The instant claims are further directed to a step of distinguishing which of the viral sequences encoding CHIKV, DNV1, DNV2, DENV3, DNV4 and ZIKV genes are present in the sample. The steps of determining and distinguishing can be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). As such, the instant claims recite judicial exceptions (JEs) in the form of a law of nature and abstract idea (Step 2A, Prong One: YES).
The crux of the claimed method is the appreciation of the presence or absence of viral nucleic acids sequences of CHIKV, DNV1, DNV2, DENV3, DNV4 and ZIKV in a sample. Obtaining and detecting the nucleic acids in a biological sample would constitute insignificant extra-solution activities.
It is noted that the claims further require “performing reverse transcription polymerase chain reaction.” This not a particular field of use, but, rather, a generic way to obtain a read out from an existing sequence in a biological sample. Hence, the instant claim do not recite additional elements that integrate the judicial exception (abstract idea) into a practical application. Integration into a practical application requires an additional element(s) or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception (See for example, Slide 18 of 2019 PEG training at http://ptoweb.uspto.gov/patents/exTrain/101.html). Further, the steps of “determining” and “distinguishing” in claim 1 are performed separately from the RT-PCR assay. There is no improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a). Further, generally linking of the use of the judicial exception to a particular technological environment or field of use is not indicative of integration into a practical application – see MPEP 2106.05(h)”.
As such, the instant claims do not recite additional elements that integrate the JEs into a practical application (Step 2A, Prone Two: NO).
It was well-understood, routine, and conventional (WURC) at the time of filing to perform an RT-PCR assay (see Metsky et al. and Cheu, both cited below). As such, beyond the JEs, the instant claims only recite WURC data-gathering steps and generic instructions to apply the JE. These constitute insignificant extra-solution activities, which do not reasonably provide an inventive concept.
As such, the instant claims do not recite significantly more than the JE (Step 2B: NO).
Accordingly, the instant claims do not constitute patent eligible subject matter under 35 U.S.C § 101.
Claim Rejections - 35 USC § § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(Previous rejection, withdrawn as to claims 2-4, maintained and modified as necessitated by amendment as to claims 1, 5-7) Claims 1-7 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Metsky et al. Prior art of record.
See claims 1, 5-7 as submitted on 12/22/2025.
The previous rejections of claims 2-4 are moot in view of Applicant’s cancelation of these claims.
Regarding amended claim 1, it is noted that claim 1 recites the limitations previously recited by claims 2-4. However, those limitations are already taught by Metsky et al. As previously noted, Metsky et al. teach a method of detecting, differentiating, and/or quantifying multiple flaviviruses including Zika, chikungunya, and dengue viruses serotypes 1-4 (Abstract, page 2) comprising a RT-PCR amplification-based panel for a range of pathogens including DENV1–4, CHIKV, and ZIKV as a low-cost routine diagnostic procedure (Abstract, ¶¶ [0012], [0079], [0145]).
Metsky et al. further teach wherein the target regions are encoded by CHIKV E1 protein consensus sequence, DENV1 NS5, DENV2 NS5, DENV3 NS5, DENV4 capsid protein, and ZIKV NS5. These target regions are shown by Metsky et al.’s target sequences as follows, (see below for alignments). It Is noted that amended claim 1 recites the target regions in SEQ ID NOs: 1-6 corresponding to CHIKV E1 protein consensus sequence, DENV1 NS5, DENV2 NS5, DENV3 NS5, DENV4 capsid protein, and ZIKV NS5, respectively. The probe sequences for the indicated viruses recited in claim 1 share 100% identity with the target regions. Therefore, instant probe sequences in SEQ ID NOs: 19, 12, 23, 15, 27, 8 which correspond to probe sequences of CHIKV E1 protein consensus sequence, DENV1 NS5, DENV2 NS5, DENV3 NS5, DENV4 capsid protein, and ZIKV NS5, respectively are contained within instant SEQ ID NOs: 1-6. Metsky et al. further teach these precise sequences as follows:
SEQ ID NO: 8383 is target sequence comprising CHIKV E1 protein, which shares 100% identity with instant probe sequence SEQ ID NO: 19 and target region in instant SEQ ID NO: 1
SEQ ID NO: 55008 is target sequence comprising DENV-1 NS5 protein, which shares 100% identity with instant probe sequence SEQ ID NO: 12 and target region in instant SEQ ID NO: 2
SEQ ID NO: 56214 is target sequence comprising DENV-2 NS5 protein, which shares 100% identity with instant probe sequence SEQ ID NO: 23 and target region in instant SEQ ID NO: 3
SEQ ID NO: 54693 is target sequence comprising DENV-3 NS5 protein, which shares 100% identity with instant probe sequence SEQ ID NO: 15 and target region in instant SEQ ID NO: 4
SEQ ID NO: 56869 is target sequence comprising DENV-4 capsid protein, which shares 100% identity with instant probe sequence SEQ ID NO: 27 and target region in instant SEQ ID NO: 5
SEQ ID NO: 1142 is target sequence comprising ZIKV NS5 protein, which shares 100% identity with instant probe sequence SEQ ID NO: 8 and target region in instant SEQ ID NO: 6
Metsky et al. further teach primer and probe sequences targeting the regions as explained above. Metsky et al. teach primer and probe sequences which share 100% sequence identity with instant primer and probes sequences as shown below. The claimed primer and probe sequences share over 90% sequence identity with Metsky et al.’s sequences as shown in the alignments below:
CHIKV E1 protein:
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183
872
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CHIKV forward primer, Qy is instant SEQ ID NO: 18, Db is Metsky et al.’s SEQ ID NO: 8383
CHIKV reverse primer (Qy is instant SEQ ID NO: 21, Db is Metsky et al.’s SEQ ID NO: 7444
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191
875
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CHIKV probe: Qy is instant SEQ ID NO: 19, Db is Metsky et al.’s SEQ ID NO: 8383
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177
864
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Greyscale
DENV-1 NS5 protein:
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183
867
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DENV-1 forward primer, Qy is instant SEQ ID NO: 10, Db is Metsky et al.’s SEQ ID NO: 55114
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178
861
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Greyscale
DENV-1 reverse primer, Qy is instant SEQ ID NO: 13, Db is Metsky et al.’s SEQ ID NO: 55112
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167
858
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Greyscale
DENV-1 probe, Qy is instant SEQ ID NO: 12, Db is Metsky et al.’s SEQ ID NO: 55008
DENV-2 NS5 protein:
DENV-2 forward primer, Qy is instant SEQ ID NO: 22, Db is Metsky et al.’s SEQ ID NO: 55964
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184
858
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Greyscale
DENV-2 reverse primer, Qy is instant SEQ ID NO: 24, Db is Metsky et al.’s SEQ ID NO: 56476
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172
864
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Greyscale
DENV-2 probe, Qy is instant SEQ ID NO: 23, Db is Metsky et al.’s SEQ ID NO: 56214
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175
866
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Greyscale
DENV-3 NS5 protein:
DENV-3 forward primer, Qy is instant SEQ ID NO: 14, Db is Metsky et al.’s SEQ ID NO: 56485
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167
859
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Greyscale
DENV-3 reverse primer, Qy is instant SEQ ID NO: 17, Db is Metsky et al.’s SEQ ID NO: 372276
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173
856
media_image11.png
Greyscale
DENV-3 probe, Qy is instant SEQ ID NO: 15, Db is Metsky et al.’s SEQ ID NO: 54693
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172
859
media_image12.png
Greyscale
DENV-4 capsid protein:
DENV-4 forward primer, Qy is instant SEQ ID NO: 25, Db is Metsky et al.’s SEQ ID NO: 57236
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176
863
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Greyscale
DENV-4 reverse primer shared 91.1% sequence identity to Metsky et al.’s SEQ ID NO: 372397, Qy is instant SEQ ID NO: 28, Db is Metsky et al.’s SEQ ID NO: 372397
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169
858
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Greyscale
DENV-4 probe, Qy is instant SEQ ID NO: 27, Db is Metsky et al.’s SEQ ID NO: 56869
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160
858
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Greyscale
ZIKV NS5 protein:
ZIKV forward primer, Qy is instant SEQ ID NO: 7, Db is Metsky et al.’s SEQ ID NO: 2397
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172
874
media_image16.png
Greyscale
ZIKV reverse primer, Qy is instant SEQ ID NO: 9, Db is Metsky et al.’s SEQ ID NO: 361427
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178
861
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Greyscale
ZIKV probe, Qy is instant SEQ ID NO: 8, Db is Metsky et al.’s SEQ ID NO: 1142
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176
875
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Greyscale
Regarding claim 5, it is noted that no amendments were introduced to claim 5 in the amendment filed on 12/22/2025. As previously explained, Metsky et al. teach wherein the primers and probes are conjugated to a fluorescent label and a quencher (¶¶ [0165]-[168]).
Regarding claims 6 and 7, it is noted that no amendments were introduced to claims 6 and 7 in the amendment filed on 12/22/2025. As previously explained, Metsky et al. teach a whole blood sample (¶ [0044]).
Accordingly, the rejection of claims 1-7 is maintained for reasons of record.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
(Previous rejection, maintained and modified as necessitated by amendment as to claim 8) Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Metsky et al., as applied to claims 1-7 above, in view of Cheu R. Prior art of record.
See claim 8 as submitted on 12/22/2025.
Regarding amended claim 8, it is noted that all of the amendments were made to overcome the previous rejections under 35 U.S.C. 112(b), second paragraph set forth in the Non-Final Office Action mailed on 12/04/2024. No new limitations were introduced in the amendment filed on 12/22/2025. Accordingly, the rejection under 35 U.S.C. § 103 set forth in the previous Non-Final Office Action mailed on 08/20/2025 still applies to amended claim 8. As previously explained, Metsky et al. teach the method of claim 1. Metsky does not teach wherein the sample is whole blood treated with EDTA.
However, Cheu teaches blood sample handling for analysis comprising RT-PCR (page 1). Cheu further teaches treatment of whole blood samples with EDTA to prevent coagulation (page 1, Fig. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the EDTA treatment to whole blood samples as taught by Cheu into the method taught by Metsky et al. for the benefit of preventing coagulation in a sample of whole blood for RT-PCR analysis. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in incorporating a EDTA treatment in the method taught by Metsky et al. given that the methods of preventing coagulation in a whole blood sample are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Accordingly, the limitations of claim 8 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive.
Applicant contends on page 14 and 15 of the Remarks submitted on 12/22/2025:
“Amended claim 1 simultaneously detects six viruses by performing RT-PCR with the list of primers and probes that are only disclosed in the present application. Therefore, the RT-PCR of the present application performed with the specific primers and probes is an active step that is not merely data gathering as the specific primers and probes of the present application allow technical improvements over diagnostic methods in the art as discussed below. The method of the present application therefore includes a practical application and is significantly more than a judicial exception”… “The selection of oligonucleotides, primers and probes provided in amended claim 1 are not mere design alternative primers and sequences / nucleotide sequences that can be easily obtainable through the sequences in the art. Instead, the primers and probes are specifically designed according to the consensus sequences in the present application and have been experimentally validated.”
In response:
As indicated above, the crux of the claimed invention is the appreciation of the presence or absence of viral nucleic acids sequences of CHIKV, DNV1, DNV2, DENV3, DNV4 and ZIKV in a sample. Obtaining and detecting the nucleic acids in a biological sample would constitute insignificant extra-solution activities. RT-PCR is a widely practiced routine, conventional method, exceptionally well-understood in the art (WURC). Further, the cited prior art teaches primer probe design and it is well within the purview of one of ordinary skill in the art to design and optimize primer probe sets that allow for optimal detection. Further, the instant rejection is in view of instant claim language. Although the claims are interpreted in light of the Specification, limitations from the Specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is noted that the instant claims recite the open-ended language of “comprising”. See MPEP 2111.03.
Applicant contends on page 14 of the Remarks submitted on 12/22/2025:
“Claim 2 of the present application discloses target regions or fragments encoded by sequences SEQ ID NO: 1 to 6 and not SEQ ID NO: 19, 12, 23, 15, 27 and 8 as alleged by the Office. Therefore, the sequences in claim 2 are different from the sequences that the Office alleges to be the same as Metsky. Regarding claim 4, there are sequences recited that are not disclosed by Metsky (i.e., SEQ ID NO: 32, SEQ ID NO: 33, SEQ ID NO: 11, SEQ ID NO: 16, SEQ ID NO: 20 and SEQ ID NO: 26). The combination of all the primers and probes of the present application are novel in view of Metsky.”
In response:
As indicated above, amended claim 1, (previous claim 2, as submitted on 03/29/2022) recites the target regions in SEQ ID NOs: 1-6 corresponding to CHIKV E1 protein consensus sequence, DENV1 NS5, DENV2 NS5, DENV3 NS5, DENV4 capsid protein, and ZIKV NS5, respectively. The probe sequences for the indicated viruses recited in claim 1 share 100% identity with the target regions. Therefore, instant probe sequences in SEQ ID NOs: 19, 12, 23, 15, 27, 8 which correspond to probe sequences of CHIKV E1 protein consensus sequence, DENV1 NS5, DENV2 NS5, DENV3 NS5, DENV4 capsid protein, and ZIKV NS5, respectively are contained within instant SEQ ID NOs: 1-6. Metsky et al. teach these precise sequences as show above. With respect to the sequences allegedly not disclosed by Metsky et al. (i.e., SEQ ID NO: 32, SEQ ID NO: 33, SEQ ID NO: 11, SEQ ID NO: 16, SEQ ID NO: 20 and SEQ ID NO: 26), it is noted that these sequences comprise second primer or probes and they are recited in the alternative to sequences taught by Metsky et al. Further, these sequences are taught by Metsky et al. as they correspond to the same target regions as the first primer-probe sequences.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-R 8:00 AM - 5:00 PM.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
Prosecution Insights