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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-14, and species A, the analyte processing and presentation apparatus is a microcolumn device, in the reply filed on 10/17/2025 is acknowledged.
Claims 5-13, 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/17/2025.
Please note that in the Office Action mailed 08/19/2025 on page 4 it states that the reply must also identify the claims readable on the elected species, including any claims subsequently added. In the response filed 10/17/2025, applicant indicated that claim 5 reciting “a flow-cell device” is withdrawn, and that newly added claim 17 is withdrawn. However, claims 6-10 are dependent on claim 5, and therefore are withdrawn as well and should have the status indicator “withdrawn”. Additionally, claims 11-13 are directed to the analyte processing and presentation apparatus comprising a plurality of flow cells which is directed to the non-elected species, and is therefore withdrawn as well and should have the status indicator “withdrawn”.
Further, claims 15-16 should have the status indicator “withdrawn”, please see MPEP 714.II.C.
Status of Claims
Claims 1-17 remain pending in the application, with claims 1-4, 14 being examined, and claims 5-13, 15-17 being withdrawn pursuant to the election filed 10/17/2025.
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 § 609.04(a) 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.
Claim Objections
Claims 2, 14 are objected to because of the following informalities:
Claim 2 recites “the electrochemical-sensor structure” on line 3, where it is suggested that for further clarity and consistency it be amended to recite “the electrochemical sensing structure” as it appears on line 5 of claim 1.
Claim 14 recites “the electrochemical-sensor structure” on line 3, where it is suggested that for further clarity and consistency it be amended to recite “the electrochemical sensing structure” as it appears on line 5 of claim 1.
Appropriate correction is required.
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bryan (US-2013/0026037-A1).
Regarding claim 1, Bryan teaches a system for detecting an infectious agent, the system comprising:
an analyte processing and presentation apparatus (layers 3-6) having a first port (loading port 10) for receiving a bodily fluid sample and a second port (see annotated Figure 2 below, where the arrow is pointing to one of four second ports present) for fluid communication with the first port (10) via one or more microfluidic channels (see annotated Figure 2 below, where the arrow is pointing to one of four microfluidic channels) ([0112], [0116], [0127] describes an embodiment that is an end-fill sampling plate for testing blood with a volume of 3 μL, where the device seen in Figure 2 may similarly receive that amount of sample, therefore the overall device of Bryan is a microfluidic device that will have microfluidic scale components, Figure 2);
an electrochemical sensing structure (base plate 2) for engaging the analyte processing and presentation apparatus (layers 3-6), the electrochemical sensing structure (2) comprising a sampling region (test zones 22) for fluid communication with the second port (see annotated Figure 2 below) of the analyte processing and presentation apparatus (layers 3-6) for receiving the bodily fluid sample therefrom, and a first circuitry comprising a first set of electrodes (electrodes 130) extending into the sampling region (22) for contacting the bodily fluid sample ([0140], Figures 2, 6); and
a bio-sensing apparatus (measurement device 200) comprising an analysis circuitry (plate port 210) for electrically coupling to the first circuitry of the electrochemical sensing structure (2) for detecting the infectious agent from the bodily fluid sample received in the sampling region (22) thereof ([0130], [0140], [0146] which describes an adaptor 300 fitting into plate port 210 by virtue of device end 320 that simulates the electrical contacts of otherwise directly compatible sampling plates therefore the plate port 210 has analysis circuitry that electrically couples to the base plate of the sampling plate seen in Figures 2 and 6, Figure 4).
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The limitations “a first port for receiving a bodily fluid sample”, “an electrochemical sensing structure for engaging the analyte processing and presentation apparatus”, and “analysis circuitry for electrically coupling to the first circuitry of the electrochemical sensing structure for detecting the infectious agent from the bodily fluid sample received in the sampling region thereof.” are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Bryan and the apparatus of Bryan is capable of receiving a bodily fluid sample, the mapped electrochemical sensing structure is capable of engaging the mapped analyte processing and presentation apparatus, and the mapped analysis circuitry is capable of coupling to the mapped first circuitry and is capable of detecting an infectious agent. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Bryan (see MPEP §2114).
Further, please note that the bodily fluid sample nor infectious agent from the bodily fluid sample have been positively recited in the claim, and are therefore not part of the claimed system.
Regarding claim 2, Bryan further teaches wherein the electrochemical sensing structure (2) further comprises an identification circuitry (RFID tag 150) separated from the first circuitry for indicating one or more biomarkers of the bodily fluid sample analyzable using the electrochemical-sensor structure (2) ([0071], [0072] see information tag may contain batch information pertaining to the production of the specific sampling plate and batch records include information regarding sampling plate’s parts and materials, [0173], Figure 5).
The RFID tag 150 seen in Figure 6 will similarly be placed on the upper most tape layer 6 seen in Figure 2. The base plate 2 (electrochemical sensing structure) will therefore comprise the RFID tag 150 due to the tag being placed on top of the base plate 2. The RFID tag 150 will be separated from the electrodes 130 on the base plate 2 by layers 3-6.
The limitation “for indicating one or more biomarkers of the bodily fluid sample analyzable using the electrochemical-sensor structure.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Bryan and the apparatus of Bryan is capable of indicating one or more biomarkers of the bodily fluid sample analyzable using the electrochemical-sensor structure. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Bryan (see MPEP §2114).
Further, please note that the biomarkers nor bodily fluid have been positively recited in the claim, and are therefore not a part of the claimed system.
Regarding claim 3, Bryan further teaches wherein the electrochemical sensing structure (2) is a testing strip (see Figure 2 where the base plate 2 is a testing strip).
Regarding claim 4, Bryan further teaches wherein the analyte processing and presentation apparatus (layers 3-6) is a microcolumn device (see Figure 2, where when layers 3-6 are assembled together they form a microcolumn device).
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.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bryan (US-2013/0026037-A1) in view of Lien (US-2005/0019211-A1).
Regarding claim 14, Bryan teaches the system of claim 1.
While Bryan does describe that sample, such as a blood sample, is loaded into the sampling plate via loading port 10 (Bryan; [0110]), Bryan does not teach one or more sample collection devices for using with the analyte processing and presentation apparatus for processing and presenting the bodily fluid sample to the electrochemical-sensor structure.
In the same problem solving area of applying a sample to a test strip, Lien teaches where a test strip has a sample applied through a pipette or the like by dropping (Lien; [0005]).
Bryan is silent with regards to the specific way blood is applied to the sampling plate via the loading port, therefore, it would have been necessary and thus obvious to look to the prior art for conventional ways of applying sample to sampling plates. Lien provides this conventional teaching showing that it is known in the art to use a pipette or the like. Therefore, it would have been obvious to one having ordinary skill in the art to use a pipette to apply the sample to the loading port because it is taught by Lien that pipettes are effective for applying sample to a test strip.
The limitation “one or more sample collection devices for using with the analyte processing and presentation apparatus for processing and presenting the bodily fluid sample to the electrochemical-sensor structure.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Bryan and the apparatus of modified Bryan is capable of processing and presenting bodily fluid to the electrochemical-sensor structure. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Bryan (see MPEP §2114).
Further, please note that the bodily fluid has not been positively recited in the claim, and is therefore not a part of the claimed system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571) 272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.Y.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796