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 Arguments
The Applicant has provided a response, dated 12/15/2025, wherein the Applicant has provided amendments to the claims and arguments. Based upon these amendments and arguments, the 35 USC 112(b) rejection has been withdrawn. Furthermore, the claim amendments have provided for a method that appears free of the prior art, and as such, the method claims are considered allowable (claims 1, 7, 8, 10, 11, 29-32 and 36-38). The claims drawn to the apparatus (claims 16-18, 21, 23, 24, 26 and 27) continue to be obvious over the prior art and stand rejected for the previously provided reasons, as well as the rationale provided in response to the Applicant’s Arguments.
On page 10 of the Applicant’s Arguments, the Applicant points out that the prior art is does not explicitly discuss either a first or second “reaction chamber.” First, it must be noted that the rejection is based upon obviousness and the level of skill of the ordinary artisan, and as such, there should be no expectation that the prior art provides for the explicitly claimed limitation, the limitation must be only make the claimed limitation obvious, given the skills and knowledge of the ordinary artisan; the ordinary artisan does not possess zero knowledge of the field, the ordinary artisan possesses a Masters or PhD in the field (or adjacent field) and possesses ample applied knowledge. See MPEP 2141.03. When looking at Lu, et al (US Pat. 8,945,943), there is a solid support that includes a nucleic acid and an enzyme, wherein a target agent is applied. The target agent will liberate the enzyme, and this accounts for the reaction that would occur in the first “reaction chamber.” The liberated enzyme is then provided a substrate, wherein the substrate reacts and produces a product, wherein the product can be detected. See column 2, lines 7-40. This accounts for the reaction that would occur in the second “reaction chamber.” The detection of the product can be loaded into a sensor/test strip and provides for the limitation of claim 23. See column 2, lines 38-40. Therefore, while it is true that the prior art does not provide for an explicit disclosure of the claimed apparatus, the apparatus of Lu can be separated into parts that would parallel that of the claimed apparatus. For example, there is nothing non-obvious about providing the substrate of the second reaction chamber after the reaction of the first reaction chamber, since the substrate of the second reaction chamber could interfere with the reaction of the first reaction chamber. The purpose of Lu is to detect, among other things, glucose; if this is the case it would be clear and obvious to the ordinary artisan to keep the substrate, sucrose, separate from the enzyme, sucrase, because providing the substrate too early would lead to false positives.
As discussed above, all of the method claims appear to be free of the prior art and are allowable. The claims drawn to the apparatus are considered obvious for the reasons provided in the previous rejections and the response above. Claims 1, 7, 8, 10, 11, 29-32 and 36-38 are considered allowable, claims 16-18, 21, 23, 24, 26 and 27 continue to be rejected over the cited prior art.
Claim Rejections - 35 USC § 103
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 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.
Claims 16-18, 21, 23, 24, 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Lu, et al (US Pat 8,945,943) Toh, et al (Biosensors and Bioelectronics, 64, 392-402, 2015) and Candanosa (“Could a new tool for diabetes patients solve the problem of coronavirus testing? “Northeastern Global News, [Published May 1, 2020]; https://news.northeastern.edu/2020/05/01/can-a-new-tool-for-diabetes-patients-solve-the-problem-of-covid-19-testing/). Lu teaches an assay device that can rely on aptamer-based recognition molecules and can detect viruses. See column 2, lines 6-19; column 3, line 53. Lu provides for a solid support, which is interpreted as being the same as the claimed substrate. See column 8, lines 30-49. Lu teaches a first and second nucleic acid, wherein the first is a recognition nucleic acid and an enzyme is attached to the second nucleic acid. Lu appears to provide for the claimed process using glucose as the example analyte. See column 57, lines 1-19. Lu generally teaches viruses, and generally teaches aptamers, and as such, there is a reasonable motivation to create a detection assay that can detect viruses with aptamers; however, since Lu provides this combination as an implicit generality, Lu provides no reasonable expectation of success.
When consulting the prior art, the claimed method parallels enzyme-linked immunosorbent assays (ELISA) for the detection of viruses, but specifically relies on aptamers as the recognition molecules, whereas ELISA uses antibodies. It should be noted that these methods exist, and it is already known that aptamers can be put in place of antibodies, using similar ELISA methodology, to detect viruses. See Toh, page 392, “Abstract” section; page 396, Table 3. Additionally, the claimed linkages appear to be those of already established linkages for the use of aptamers with ELISA methodology. See page 397, Figures 4 and 5. Similar to the claimed enzymatic release, the methods described by Toh, and that of ELISA, utilize the same type of enzymes and catalyzed reactions. See page 393, “Introduction” section.
Finally, Toh notes that aptamer sequences can by acquired from the systematic evolution of ligands by exponential enrichment (SELEX) method. See page 393, “Generation of aptamers” section. Based upon Toh’s description of the method, it would be obvious, and well within the ordinary artisan’s skills to provide any sequence that is consistent with the claimed aptamers.
Although Lu generally described portable glucose sensors, it is not apparent that this technology could be predictably applied for viral sensing.
Candanosa provides for an article that describes the conversion of portable glucose monitors to sensors that can detect viruses like SARS-CoV-2 (COVID-19). See entire. Since it is clear that the device of Lu can be predictably modified to detect viruses, it would be obvious to apply the device of Lu to the conversion disclosed in Candanosa.
With respect to claim 16, Lu and Toh describe all of the scientific underpinning of the instant claim. When this viral detection method is applied to the glucose sensor of Lu, as described in Candanosa, the ordinary artisan would acquire the claimed device.
With respect to claim 17, both Lu and Toh can measure virus. As such, it appears as though they either explicitly or obviously fulfill the claimed limitation. Candanosa indicates that this modification would be plausible on the glucose monitor of Lu.
With respect to claim 18, the glucose monitoring device of Lu and Candanosa would provide for these limitations; if the monitor was attached to a conventional computer (data processing unit), the wireless communication would be fulfilled.
With respect to claim 21, Lu generally describes glucose monitoring devices. The claimed mixing tool/reaction chamber is a widely-used design.
With respect to claims 24, 26 and 27, although Lu generally describes the same enzymatic attachment, there is no description of how the nucleic acid sequence of the aptamers is provided. Toh appears to show the same attachment of enzymes to nucleic acid-based aptamers, with additional capture aptamer nucleic acid sequences. See page 397, Figures 4 and 5.
Allowable Subject Matter
Claims 1, 7, 8, 10, 11, 29-32 and 36-38 are allowed.
Conclusion
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 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 DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651