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 .
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.
Claims 10-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khattak et al. (US 2015/0064693). This rejection was applied in Paragraphs 10-15 of the Non-Final Rejection mailed 10/02/25. The rejection remains in effect. Please see Response to Arguments below.
Response to Arguments
Applicant’s arguments, filed 04/02/26, with respect to the rejection(s) of claims 10-15 under Double Patenting as set forth in Paragraphs 2-6 of the Non-Final Rejection mailed have been fully considered and are persuasive. Applicant submitted a proper terminal disclaimer with the response on 04/02/26, therefore, the Double Patenting rejection has been withdrawn.
Applicant’s arguments, filed 04/02/26, with respect to the rejection(s) of claims 1-9 under 35 U.S.C. 101 have been fully considered and are persuasive. Applicant has argued the preparation and analyzing steps require more than a mental process and are not steps that can be performed in the human mind. In addition, Applicant has argued that the claimed method is a practical application that provides significantly more than an abstract idea. See pages 5-7 of Applicant’s Remarks. Upon further consideration, the Examiner agrees. Therefore the rejection has been withdrawn.
Applicant’s arguments, filed 04/02/26, with respect to the rejection(s) of claim(s) 10-15 under 35 U.S.C. 102(a)(1) as being anticipated have been fully considered but they are not persuasive. Applicant has argued that the prior art “Khattak does not explicitly disclose a single cartridge that is configured with the specific tripartite sensor arrangement for concurrently detecting a protein, a genetic component, and a small molecule biomarker as recited in claim 10. Further, it does not disclose that the single cartridge includes first, second, and third reservoirs storing first, second, and third processing reagents, respectively, where said first, second and third processing reagents are suitable for preparing the sample for delivery to said first, second and third sensor, respectively” as recited in claim 10. See pages 7-8 of Applicant’s Remarks.
The Examiner respectfully disagrees and submits Applicant’s arguments are beyond the scope of the claim as currently written. The Examiner notes the claim as currently written recites “a first reservoir for storing at least a first processing reagent, a second reservoir for storing a second processing reagent, a third reservoir for storing a third processing reagent,”. The Examiner submits the highlighted phrases are directed to an intended use of the device – the reservoirs are to be used to store reagents – and that the reagents are not positively recited in the claim. Therefore, the reagents are not given patentable weight with respect to being in the reservoirs. The Examiner submits the Khattak reference teaches a first reservoir (824), second reservoir (828) and third reservoir (826) with each reservoir capable of containing a processing reagent.
The Examiner also notes the claim as currently written recites “at least a first sensor configured for detection of at least one protein in the sample, at least a second sensor configured for detection of at least one genetic component in the sample, at least a third sensor configured for detection of a small molecule biomarker in the sample,”. The Examiner submits the highlighted terms “configured for detection (of a compound)” are also intended uses of the sensors and do not confer any particular structural feature that is required in order to detect the listed compound(s). The Examiner notes that some embodiments of the device includes sensor elements having attached binding elements, however it appears in some embodiments the sensor is “configured for detection” of the compound based on the processing reagent in the detection chamber and not based on any particular structural element of the sensor.
The Examiner submits that in giving the claim its broadest reasonable interpretation, the Examiner considers the second type of described embodiment simply requires three sensors that are capable of performing the detection of the listed compound. The Examiner further submits the Khattak reference teaches a first sensor (758a), a second sensor (758b), and third sensor (758c) that are capable of performing the detection function recited in the claim if provided with the proper reagents.
In summary, in the case of the both the reservoirs and sensors, the Examiner submits the recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Allowable Subject Matter
Claims 1-9 are allowed.
The following is an examiner’s statement of reasons for allowance: Claim 1 recites a method for preparation of a biological sample indicative of a presence of an emergent variant of a known pathogen that includes the steps of preparing a first portion of the biological sample in a first reservoir and analyzing the portion of the biological sample to detect a structural protein, if any, that exhibits a homology of at least about 80% among different known variants of the pathogen; and preparing a second portion of the biological sample in a first reservoir and analyzing the second portion in a second reservoir to detect any one of a plurality of genetic components, if any, in the sample, where each of said plurality of genetic components is unique to one of the known variants of the pathogen; wherein a detection of said structural protein and a lack of detection of any of said plurality of genetic components is indicative of a presence of an emergent variant of the pathogen in the sample. The Examiner submits the combination of features highlighted above is not taught or suggested by the current cited prior art.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 August 22, 2026
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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