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 § 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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cheah “Integrated Platform Addressing the Finger-Prick Blood Processing Challenges of Point-of-Care Electrical Biomarker Testing” Analytical Chemistry, January 2022, 94,1256-1263 in view of Temiz et al. (US 2020/0108385).
Regarding claim 1, Cheah teaches a biosensor cartridge comprising:
a circuit board (fig. 1b, shows PCB carrier) configured to be electrically connected to an external diagnostic device (an external diagnostic device is not positively recited and is not being interpreted as being required in claim 1), the circuit board including a connection terminal (see fig. 1b which has connection terminals on the far left of the PCB board);
a sensor chip (fig. 1b, sensor with fluidic channels, sample sampling chamber, blood filtering membrane) configured to:
detect a target material from an applied analysis specimen, and transmit an electrical signal, generated by reacting with the detected target material, to the connection terminal of the circuit board (this limitation does not further structurally limit the instant claim. Applicant should claim a type of sensor chip that detects, i.e. electrochemical sensor. Cheah is structurally capable of performing the above functions in that an electrochemical sensor sits ontop of the PCB carrier which transmits the sensor data to the connection terminal); and
a housing (see fig. 1b which shows housing) accommodating the circuit board and the sensor chip so that the connection terminal is exposed (see fig. 1a-c which shows connection terminal exposed outside of the housing).
Cheah does not teach the housing including a QR code having stored therein encrypted sensor information.
Temiz teaches an electrochemical biosensor cartridge (fig. 1) that comprises a circuit board (20), having an electrochemical sensor (14/51/52) thereon, and a cover layer (16) having a QR code (19d, fig. 8a-9c) thereon for providing reference data, or data encoded for security key so that the authenticity of the device can be verified (para 97,100). It would have been obvious to one having an ordinary skill in the art at the time of the invention to modify Cheah to provide a QR code to the housing in order to provide reference data or authenticity of the biosensor as is taught by Temiz (para 97,100).
Regarding claim 2, the biosensor cartridge of claim 1, the modified Cheah teaches wherein the connection terminal protrudes from a side surface of the housing (see fig. 1a-c, terminal protrudes from side of housing), and wherein the QR code is attached to a lower surface of the housing. Regarding the placement of the QR code, it would have been obvious to one having an ordinary skill in the art to modify Cheah to place the QR code on a side that is exposed once the housing is inserted into the diagnostic device to allow for scanning while inserted (see fig. 8a-8c of Temiz).
Regarding claim 3, the biosensor cartridge of claim 1, the modified Cheah teaches wherein the sensor chip comprises: a sensor area including a channel (see fig. 1b, fluidic channels) having a reaction material reacting with the target material (sampling chamber, having reagents); and a pad area (area under sensor) for transmitting the electronic signal from the sensor area to the circuit board (PCB has a cutout for receiving the sensor therein on a pad area).
Regarding claim 4, the biosensor cartridge of claim 3, the modified Cheah teaches wherein the sensor area further comprises: a substrate (sensor), a channel area formed on the substrate (fluidic channels), the channel area including at least one channel (fluidic channels, fig. 1b), a source electrode and a drain electrode spaced apart from each other by the at least one channel (FET electrochemical sensor inherently has a drain and source electrode), a gate electrode spaced apart from the source electrode and the drain electrode and introducing bias voltage to the analysis specimen (FET electrochemical sensor inherently has a gate electrode, and a passivation layer formed on the source electrode, the drain electrode and the gate electrode (FET electrochemical sensor setup).
Regarding claim 5, the biosensor cartridge of claim 4, the modified Cheah teaches wherein the housing includes an accommodating portion in the form of a hole having an inclined surface (sampling chamber or washing chamber), and wherein the accommodating portion extends from an upper surface of the housing and exposes the sensor area of the sensor chip and for accommodating the analysis specimen (sampling chamber is in fluid communication from the top of the housing and with the sensor area).
Regarding claim 6, the biosensor cartridge of claim 1, the modified Cheah teaches wherein the encrypted sensor information includes at least one of the sensor chip type, linker information, probe material information, product ID, board ID, and manufacturer information (This limitation does not further structurally limit the instant claim because a QR code is not a program or is a QR code a processor that stores a program. A QR code is simply a barcode and not a piece of executable code. An external destination such as a website, contact information or text is needed to process the QR code).
Regarding claim 7, Cheah teaches a diagnostic device for a biosensor cartridge that generates an electronic detection signal depending on a target material in an applied analysis specimen, the diagnostic device comprising:
a main board the main board having an internal space for mounting at least one functional module (diagnostic device as seen in fig. 1a which has an onboard computer for interacting with the biosensor connection terminal);
a cover member for accommodating the main board (housing as seen in fig. 1a);
a front panel (upper clam shape casing) for covering an upper surface of the cover member and providing a display area (front surface has a display), the front panel including an insertion hole for receiving the biosensor cartridge (see fig. 1a);
a control module (computer processor that connects to the biosensor connection terminal) mounted on the main board, for analyzing the detection signal from the biosensor cartridge and displaying a presence of the target material in the display area.
Cheah does not teach a QR reading module exposed by the insertion hole,
the QR reading module being for reading a QR code of the biosensor cartridge.
Temiz teaches a diagnostic device (fig. 6, 7, 8a-8c, ref. 90/80b/80c/80d) that interacts with an electrochemical biosensor cartridge (fig. 1) that comprises a circuit board (20), having an electrochemical sensor (14/51/52) thereon, and a cover layer (16) having a QR code (19d, fig. 8a-9c) thereon for providing reference data, or data encoded for security key so that the authenticity of the device can be verified (para 97,100). The diagnostic device (80a/80b/80c,90) connect to the biosensor cartridge as seen in fig. 6-8) and comprises electrical contacts to connect to the biosensor connection terminal, processing programs thereon to process the results of the biosensor data, and a detector to detect the QR code (para 93, 97). Further the QR code can be scanned by a smartphone as seen in fig. 8a-8c) It would have been obvious to one having an ordinary skill in the art at the time of the invention to modify Cheah to provide a QR code to the housing in order to provide reference data or authenticity of the biosensor as is taught by Temiz (para 97,100).
Regarding claim 8, the diagnostic device of claim 7, the modified Cheah teaches wherein the control module communicates with a server through a network to perform genuine product certification involving certifying whether the biosensor cartridge inserted into the insertion hole is genuine (this limitation does not further structurally limit the instant claim. Application should claim processor program language that would positively recite program steps. The modified Cheah does verify cartridge via the QR code for authenticity, Temiz, para 97).
Regarding claim 9, the diagnostic device of claim 8, the modified Cheah teaches wherein the control module obtains sensor information from the QR code read by from the QR reading module and performs the genuine product certification with the server based on the sensor information (this limitation does not further structurally limit the instant claim. Application should claim processor program language that would positively recite program steps. The server is not positively recited in the instant claims as it can be remote and just send signals. The modified Cheah does verify cartridge via the QR code for authenticity, Temiz, para 97).
Regarding claim 10, the diagnostic device of claim 9, the modified Cheah teaches wherein the server is among a plurality of servers, and wherein the control module transmits a certification request to a highest priority server among the plurality of servers, and based on a certification response being not received within a predetermined time, the control module transmits the certification request to the next highest priority server (this limitation does not further structurally limit the instant claim. Application should claim processor program language that would positively recite program steps. The server is not positively recited in the instant claims as it can be remote and just send signals. The modified Cheah does verify cartridge via the QR code for authenticity, Temiz, para 97, 100 discloses remote data stored on a server corresponding to a QR code).
Regarding claim 11. The diagnostic device of claim 10, the modified Cheah teaches wherein the control module reads the detection signal from the biosensor cartridge in response to the biosensor cartridge being certified as genuine and reads whether the target material is present (this limitation does not further structurally limit the instant claim. Application should claim processor program language that would positively recite program steps. The modified Cheah teaches detect analyte within a sample fluid applied to the biosensor, see abstract Cheah; The modified Cheah does verify cartridge via the QR code for authenticity, Temiz, para 97, 100).
Regarding claim 12, the diagnostic device of claim 11, the modified Cheah teaches wherein the control module receives read correction data for the biosensor cartridge from the server when the certification is completed and updates a read algorithm by the read correction data (this limitation does not further structurally limit the instant claim. Application should claim processor program language that would positively recite program steps. The modified Cheah teaches detect analyte within a sample fluid applied to the biosensor, see abstract Cheah; The modified Cheah does verify cartridge via the QR code for authenticity, Temiz, para 97, 100).
Regarding claim 13, the diagnostic device of claim 7, the modified Cheah teaches wherein the QR reading module includes a QR reader device for photographing the QR code and a light source module disposed around the QR reader device for irradiating light to an opening of the front panel (Temiz teaches an optical scanner that reads the QR code, see fig. 8a, which is a smart phone).
Regarding claim 14, the diagnostic device of claim 13, the modified Cheah teaches wherein the front panel includes: a light guide part through which light is delivered from the light source module to the QR reading module (Temiz teaches an optical scanner that reads the QR code, see fig. 8a, which is a smart phone), the light guide part including an inclined surface having a width that becomes narrower from the opening of the front panel; and a light guide plate disposed on the inclined surface of the light guide part and converting the light from the light source module to a planar light source and delivering the light to an upper portion of the front panel (Temiz teaches an optical scanner that reads the QR code, see fig. 8a, which is a smart phone).
Regarding claim 15, the diagnostic device of claim 7, the modified Cheah teaches wherein the control module matches sensor information for the biosensor cartridge inserted in the insertion hole and a reading result of the biosensor cartridge, and stores matching data (this limitation does not further structurally limit the instant claim. Application should claim processor program language that would positively recite program steps. The modified Cheah teaches detect analyte within a sample fluid applied to the biosensor and has a remote server, see abstract Cheah; The modified Cheah does verify cartridge via the QR code for authenticity and sends collected data to a server for matching, Temiz, para 97, 100).
Regarding claim 16, the diagnostic device of claim 15, the modified Cheah teaches further comprising a battery providing a power source to the at least one functional module, wherein the biosensor diagnostic device is provided as a portable integrated device (the modified Cheah inherently as a batter within the diagnostic device since it is portable and has onboard diagnostics and displays that need power to function).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday, Tuesday, Thursday, Friday, 8-6.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758