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
Claims 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/8/25.
Claim Rejections - 35 USC § 102
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 1-16 and 19-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Esquivel-Upshaw et al. (US 2021/0003528 and fully incorporated US 2020/0333286).
Regarding claim 1, Esquivel-Upshaw discloses a biosensor cartridge comprising:
circuit board (para 48, fig. 14-16) including a connection terminal (portion of cartridge that connects to external device) configured to be electrically connectable to an external diagnostic device (see fig. 4-5; the external diagnostic device is not positively stated in the instant claim);
a sensor chip (portion of cartridge that houses reactant) including a reactant (anti-sars-Cov-2 Antibody, para 53), the sensor chip being 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 because the target material in a specimen is not positively recited as part of the biosensor cartridge. Esquivel-Upshaw is structurally capable of performing the above function due to the same structures being recited in claim 1); and
a housing accommodating the circuit board and the sensor chip so that the connection terminal is exposed (see fig. 13, 16 which shows exposed circuit board terminal and opening at an opposite end to allow a test sample to be applied to the biosensor cartridge),
the housing including an accommodating portion configured to accommodate the analysis specimen and expose the sensor chip to the analysis specimen (see fig. 13, 16 which shows exposed circuit board terminal and opening at an opposite end to allow a test sample to be applied to the biosensor cartridge).
Regarding claim 2, the biosensor cartridge of claim 1, wherein the connection terminal protrudes from one side surface of the housing (see fig. 13,16), and wherein the connection terminal includes at least three pins disposed in parallel on the circuit board and separated from each other (see fig. 13, 16).
Regarding claim 3, the biosensor cartridge of claim 2, wherein the sensor chip further includes a pad area (reactant area) configured to transmit the electrical signal from the sensor area (reactant area) to the circuit board (terminal end that connects to analytic device), and wherein the sensor area includes: a board (substrate); a channel area formed on the board and including at least one channel (See fig. 16); a source electrode (see fig. 1 of US 2020/0333286; FET/mosfet sensors have gate, drain, source electrodes); a drain electrode (see fig. 1 of US 2020/0333286; fig 16 shows channels that area separated by drain and gate) spaced apart from the source electrode by the at least one channel; and a gate electrode see (fig. 1 of US 2020/0333286) spaced apart from the source electrode and the drain electrode and configured to apply a bias voltage to the analysis specimen (this limitation is not positively recited as the voltage source is not positively recited); and a passivation layer covering the sensor chip (fig. 1 of US 2020/0333286) and open only an upper portion of the channel area and the gate electrode (see fig. 1, 13 and 16).
Regarding claim 4, the biosensor cartridge of claim 3, wherein the sensor chip further includes: a source pad connected to the source electrode (fig. 1 of US 2020/0333286); a drain pad connected to the drain electrode (fig. 1 of US 2020/0333286); and a gate pad connected to the gate electrode (fig. 1 of US 2020/0333286), wherein the source pad, the drain pad and the gate pad are formed in the pad area of the sensor chip (the pad is located at the sensor chip area where the reactant interacts with the sample), and wherein the circuit board further includes: a board opening that opens the sensor area of the sensor chip (the board opening is interpreted as the sample opening that is open to accept the sample and is structurally connected to the sensor area); and a plurality of connection pads formed around the board opening (fig. 14-15, para 53), each of the plurality of connection pads overlapping a respective one of the source pad, the drain pad and the gate pad (see figs 8-16).
Regarding claim 5, the biosensor cartridge of claim 4, wherein each of the plurality of connection pads is connected one-to-one to each of the source pad, the drain pad, and the gate pad of the sensor chip, and wherein the biosensor cartridge further includes a plurality of connecting members performing one-to-one connection of connection pads of the circuit board to the source pad, the drain pad, and the gate pad of the sensor chip (see figs. 8-16).
Regarding claim 6, the biosensor cartridge of claim 5, wherein the housing includes a lower housing and an upper housing (1515 fig. 15) facing the lower housing (substrate 1509) and forming a space accommodating the sensor chip and the circuit board (see fig. 15); wherein the sensor chip is disposed on an inner surface of the lower housing, and the circuit board is disposed on the sensor chip so that the sensor area of the sensor chip is opened and the pad area of the sensor chip comes into contact with the plurality of connection pads of the circuit board; and wherein the plurality of connecting members are attached between the pad area of the sensor chip and the plurality of connection pads of the circuit board (see fig. 15-16).
Regarding claim 7, the biosensor cartridge of claim 6, wherein the plurality of connecting members include a first surface in contact with a connection pad of the circuit board and a second surface angled (vertical from base substrate) from the first surface and in contact with a pad area of the circuit chip, and wherein the plurality of connecting member conduct electricity between the circuit board and the sensor chip through an elastic contact (plastic, para 31) with the circuit board and the sensor chip (see fig. 15-16).
Regarding claim 8, the biosensor cartridge of claim 6, wherein the upper housing and the lower housing are fused and integrated and accommodate the sensor chip and the circuit board (fused is a process that is not given any structure weight in claims directed to a device. The prior art provides an adhesive layer 1512 between upper housing 1515 and lower housing 1509).
Regarding claim 9, the biosensor cartridge of claim 1, wherein the circuit board further includes: a first surface (1509) on which the connection terminal is formed; and a reinforcing member (adhesive layer 1512 or structure 1515) that entirely covers a second surface of the circuit board, the second surface of the circuit board being opposite to the first surface.
Regarding claim 10, the biosensor cartridge of claim 4, wherein the housing includes an upper surface, wherein the accommodating portion (sample opening of fig. 13) of the housing is recessed from the upper surface of the housing, has an inclined surface (90 degree inclined surface), has a diameter that gradually decreases away from the upper surface (See fig. 13 sample opening), and accommodates the analysis specimen for being introduced into the sensor area of the sensor chip, and wherein the biosensor cartridge further includes a sealing part (adhesive layer 1512; para 55) sealing between an end of the inclined surface and the sensor area (see fig. 13).
Regarding claim 11, the biosensor cartridge of claim 10, wherein the sealing part includes a sealing opening having a larger diameter than a diameter of the end of the inclined surface (see fig. 15, channel is included in the adhesive layer which is larger diameter than the inclined surface opening for the sample as seen in fig. 15), and wherein the sealing opening is aligned with the accommodating portion and the sensor chip so that the sealing opening exposes the sensor area (see fig. 15).
Regarding claim 12, the biosensor cartridge of claim 10, wherein the inclined surface of the accommodating portion includes a step portion coupled to an end surface of the board opening in an area in contact with the board opening of the circuit board (see fig. 15).
Regarding claim 13, the biosensor cartridge of claim 12, wherein the housing includes a lower housing (1509), and an upper housing (1515) facing the lower housing and forming a space accommodating the sensor chip and the circuit board (between the two housing layers), and wherein the sealing part (1515 is an adhesive) is formed of a material different from that of the upper housing and is sequentially molded, injected, and cured to be integrated with the upper housing (this limitation is drawn to a process limitation and does not further structurally limit the instant claims).
Regarding claim 14, the biosensor cartridge of claim 13, wherein the upper housing is formed by injecting a resin into a mold, and wherein the sealing portion is formed by injecting silicone on the inclined surface of the accommodation portion (this limitation is drawn to a process limitation and does not further structurally limit the instant claims).
Regarding claim 15, the biosensor cartridge of claim 10, wherein the accommodating portion further includes a guide wall protruding upwards from the upper surface of the housing and accommodating the specimen (see the white portion in fig 13 that surrounds the sample application site).
Regarding claim 16, the biosensor cartridge of claim 15, wherein the accommodating portion further includes a guide groove that is recessed to surround the guide wall on the upper surface of the housing and accommodates the analysis specimen flowing from the guide wall (see the white portion in fig 13 that surrounds the sample application site).
Regarding claim 19, Esquivel-Upshaw discloses a biosensor cartridge comprising:
a housing including: an upper surface (1515; fig. 13, 15) having an accommodating portion in the form of an inclined recessed hole (vertical recessed hole in the upper surface 1515 being at 90 degrees to the lower surface), and a lower surface (1509);
a circuit board (see fig. 15, 16) including: a plurality of connection pads (area which contacts the sample and reactant), and a connection terminal (portion that connects to external diagnostic device) configured to be electrically connectable to an external diagnostic device (see fig. 4-5; the external diagnostic device is not positively stated in the instant claim); and
a sensor chip (portion of cartridge that houses reactant) including a reactant (anti-sars-Cov-2 Antibody, para 53) in electrical contact with the plurality of connection pads of the circuit board (the sensor chip is in contact with the circuit board to transmit the signal/reaction to the connection terminal and then to the external diagnostic device), the sensor chip includes a reactant (anti-sars-Cov-2 Antibody, para 53) and the sensor chip being configured to:
detect a target material from an analysis specimen, and transmit an electrical signal to the connection terminal of the circuit board, the electrical signal being generated by a reaction of the reactant with the analysis specimen (this limitation does not further structurally limit the instant claim because the target material in a specimen is not positively recited as part of the biosensor cartridge. Esquivel-Upshaw is structurally capable of performing the above function due to the same structures being recited in claim 19).
Regarding claim 20, the biosensor cartridge of claim 19, further comprising a plurality of connecting members (the length of contacts between the circuit board and the sensor chip area having the reactant) disposed between the circuit board and the sensor chip, wherein the sensor chip includes a plurality of pads, and wherein the plurality of pads are in electrical contact with the plurality of connection pads of the circuit board via the plurality of connecting members (see fig. 8-16).
Regarding claim 21, the biosensor cartridge of claim 20, wherein each of the plurality of connecting members includes: a first planar surface (upper surface of lower surface 1509) in contact with a respective one of the plurality of connection pads of the circuit board; and a second surface having a curved shape and in contact with a respective one of the plurality of pads of the sensor chip (see fig. 13).
Regarding claim 22, the biosensor cartridge of claim 21, wherein each of the plurality of connecting members further includes a bending portion extending from the second surface and towards the first surface, and wherein the bending portion causes the second surface to be elastically deformable (the substrate is made of plastic is structurally capable of being bent. There is not structure that makes a bending portion in the instant claim like slats or cuts that would reduce mechanical stiffness).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758