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 .
Status of Claims
Claims 1-17 remain pending in the application, with claims 1-4 and 14 being examined and claims 5-13, 15-17 being withdrawn pursuant to the election filed 10/17/2025.
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 is missing a period at the end of the claim.
Appropriate correction is required.
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.
Claim(s) 1-4, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yassinzadeh (US-5700695-A) in view of Bhullar (US-2010/0219071-A1).
Please see column 7 lines 13-17 of Yassinzadeh which describes that where Figures 3 and 1 have corresponding parts are referred to with corresponding reference numerals, where this is seen to apply for Figures 4 and 5 as well. Therefore reference will be need to be made to previous figures when describing the corresponding components seen in Figure 5.
Regarding claim 1, Yassinzadeh teaches a system, the system comprising:
an analyte processing and presentation apparatus (needle cannula 8) having a first port (sample port 10) for receiving a bodily fluid sample and a second port for fluid communication with the first port via one or more microfluidic channels (column 4 lines 9-10, column 1 lines 64-67 and column 2 lines 1-10 see sample collection apparatus used for collecting a blood sample that includes a receptacle body having a thermal pressure chamber and a sample port where the receptacle body includes a body member and a needle cannula extending from the body member and the tip of the needle cannula defining the sample port, column 7 lines 55-61 describing Figure 4 where needle cannula 8 can be held in place by an adhesive or through other methods, see Figure 5 which is described to be similar to Figure 4 and similarly has a needle cannula 8. The needle cannula 8 will have two ports: the sample port 10 and the opening on other end of the needle cannula. These two ports will be connected by a microfluidic channel);
an electrochemical sensing structure (base 4c and cover) for engaging the analyte processing and presentation apparatus (8), the electrochemical sensing structure (4c and cover) comprising a sampling region (measurement chamber 26c) for fluid communication with the second port of the analyte processing and presentation apparatus (8) for receiving the bodily fluid sample therefrom, and a first circuitry comprising a first set of electrodes (terminals 50 and ion-selective electrodes 52) extending into the sampling region (26c) for contacting the bodily fluid sample (column 4 lines 7-10, Figure 5 base is labeled 4c and cover not shown make up the electrochemical sensing structure, column 7 lines 55-61 where because the needle cannula 8 is held in place by adhesive or through other methods it is a separate part from base 4c and cover, where the cover and base 4c will be for engaging the needle 8, column 7 lines 64-66 see terminals 50 connect to ion-selective electrodes 52 placed within the measurement chamber 26c, column 8 lines 13 see apparatus 2c (Figure 5) would be suitable for any electrochemical assay), and
a bio-sensing apparatus (meter) comprising an analysis circuitry for electrically coupling to the first circuitry (50 and 52) of the electrochemical sensing structure (4c and cover) (column 8 lines 6-15 see a meter coupled to terminals 50 could be used to measure the resistance of resistor 54 to obtain calibration information for ion-selective electrodes 52, thus the meter will have analysis circuitry for electrically coupling to terminals 50 and ion-selective electrodes 52, the meter not being shown in the figures).
Column 10 lines 59-67 describes that other modifications to the disclosed embodiments includes the electrodes being used for measurement can be potentiometric, ampereometric, or conductometric electrodes such as cationic electrodes, pH measuring electrodes, anionic electrodes or polorographic electrodes in addition to ion-selective electrodes. Column 4 lines 17-27 describes where a reagent 18 may be used and could be a variety of analyte detection reagents such as enzymes, enzyme substrates, chromogens, immunoassay reagents, chemiluminescent reagents, electroluminescent reagents, redox reagents, kinetic assay reagents, other chemical reagents. While a reagent 18 is described in reference to Figure 3 placed along slot 24a, a reagent is not described in reference to Figure 5. However, column 8 lines 13-15 describe that the device of Figure 5 is suitable for any for any electrochemical assay such as glucose, electrolytes such as potassium or sodium, or blood gases (column 8 lines 13-15), and therefore one skilled in the art would find it obvious that an enzyme reagent for glucose would be present in the device seen in Figure 5. However, Yassinzadeh does not teach detecting an infectious agent.
In the analogous art of electrochemical biosensors, Bhullar teaches an electrochemical reagent (Bhullar; [0001], [0032]).
Specifically, Bhullar teaches a biosensor 10 having electrodes 14 and 13 that are created on or isolated from conductor 13 on a first surface 22 of substrate 12 (Bhullar; [0016], [0018], Figures 1-4). [0020] describes where the electrodes 14 and 16 cooperate with one another to define an electrode array 36. [0032] describes an electrochemical reagent 62 positioned on the array 36 that provides electrochemical probes for specific analytes, where non-limiting examples of analytes include enzymes, viruses or virus particles, where glucose is listed as a preferable analyte.
It would have been obvious to one skilled in the art to modify the reagent of Yassinzadeh such that it detects viruses as taught by Bhullar because Bhullar teaches that the choice of the specific reagent depends on the specific analyte or analytes to be measured and are well known to those of ordinary skill in the art, and because Bhullar teaches that a virus is desirably and effectively detected by the electrochemical sensor (Bhullar; [0032], [0033]).
Examiner further finds that the prior art contained a device/method/product (i.e., a device) which differed from the claimed device by the substitution of component(s) (i.e., reagent being used to detect glucose) with other component(s) (i.e., reagent being used to detect a virus), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., reagent for detecting glucose for the reagent detecting a virus), and the results of the substitution (i.e., detection of a desirable analyte) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the reagent for detecting glucose of reference Yassinzadeh with the electrochemical probe for detecting a virus of reference Bhullar, since the result would have been predictable.
Regarding claim 2 modified Yassinzadeh teaches the system of claim 1. Yassinzadeh does not teach wherein the electrochemical sensing structure further comprises an identification circuitry separated from the first circuitry for indicating one or more biomarkers of the bodily fluid sample analyzable using the electrochemical sensing structure.
In the analogous art of electrochemical biosensors, Bhullar teaches code patterns (Bhullar; [0001]).
Specifically, Bhullar teaches a biosensor 10 having an electrical-support substrate 12, electrical conductor 13 positioned on substrate 12 that is disrupted to define electrodes 14, 16, a spacer 18, and a cover substrate 20 (Bhullar; [0016], Figures 1-4). [0015] describes where a code pattern can be read in multiple ways such as electrically, where they show contrast in their electrical conductivity or their resistance. As seen in Figures 1, 2, and 4 the discernible code pattern 40 is formed, where the pattern can be provided in an electrical readable form, where the patterns could show contrast in their electrical conductivity aided by coating with a second conductive material from the electrical conductor 13 (Bhullar; [0022], [0023]). [0026] describes that the code patterns uniquely identifies an individual biosensor or batch of biosensors. [0040] describes where the provided meter reads the code pattern 40 when the biosensor 10 is inserted into the meter.
It would have been obvious to one skilled in the art to modify the device of Yassinzadeh such that it includes the electrically readable code patterns as taught by Bhullar because Bhullar teaches that the code patterns allow for individual biosensors or a batch of biosensors to be uniquely identified (Bhullar; [0026]).
The electrically readable code pattern 40 will be an identification circuitry that will be separate from the terminals 50 and ion-selective electrodes 52 (first circuitry) of Yassinzadeh.
The limitation “for indicating one or more biomarkers of the bodily fluid sample analyzable using the electrochemical sensing 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 Bhullar and the electrically readable code pattern of Bhullar is capable of indicating one or more biomarkers of the bodily fluid sample analyzable. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Bhullar (see MPEP §2114).
Regarding claim 3, modified Yassinzadeh teaches the system of claim 1. Yassinzadeh further teaches wherein the electrochemical sensing structure (4c and cover) is a testing strip (see Figure 3 which shows a cover 6a, where Figure 5 will similarly have its own cover where together with the base 4c will make a testing strip).
Regarding claim 4, modified Yassinzadeh teaches the system of claim 1. Yassinzadeh further teaches wherein the analyte processing and presentation apparatus (8) is a microcolumn device (the needle cannula 8 is a microcolumn).
Regarding claim 14, modified Yassinzadeh teaches the system of claim 1.
Yassinzadeh column 2 lines 5-20 describes where a thermal pressure chamber holds air or other gas that is heated to reduce the density of the gas within the thermal pressure chamber prior to taking the sample, where when the sample port is placed in contact with the liquid sample, the gas within the thermal pressure cools and a partial vacuum is created within the thermal pressure chamber that draws a liquid sample into the measurement chamber. As seen in Figure 5 and described in column 7 lines 65-67 and column 8 lines 1-5 of Yassinzadeh it includes a thick film resistor 54 which allows for rapid and precise control of the temperature of gas within the chamber.
Column 8 lines 16-36 of Yassinzadeh describes a sample collection apparatus 2d together with a direct contact heater 56 and temperature sensor 58, where the heater 56 provides moderately fast response time. Column 8 lines 38-60 describe two other ways of heating the device and describe heating and cooling of the thermal pressure chamber. Therefore one skilled in the art would find it obvious that the heater seen in Figure 6 is similarly heating the thermal pressure chamber.
Examiner finds that the prior art contained a device/method/product (i.e., the device seen in Figure 5) which differed from the claimed device by the substitution of component(s) (i.e., thick film resistor for heating the thermal pressure chamber) with other component(s) (i.e., a separate heater), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., thick film resistor for a separate heater), and the results of the substitution (i.e., heating the gas within the thermal pressure chamber) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the thick film resistor for the separate heater, since the result would have been predictable.
The separate heater is a sample collection device that is used with the needle cannula that moves the sample through the needle cannula to the sample chamber and to the ion-selective electrodes, where moving the sample through is processing and presenting the sample to the ion-selective electrodes.
Response to Arguments
Applicant’s arguments, see page 7, filed 07/13/2026, with respect to the rejection(s) of claim(s) 1-4 under 35 USC 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yassinzadeh (US-5700695-A) and Bhullar (US-2010/0219071-A1).
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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