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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/02/2026 has been entered.
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.
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 1-6, 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over Dothie et al (US20150044696A1 published 02/12/2015; hereinafter Dothie) in view of Bohm et al (WO2015187868A2 published 12/10/2015; hereinafter Bohm).
Regarding claim 1, Dothie teaches an apparatus (a point-of-care diagnostic testing system – paragraph 310), comprising:
a fluidic cartridge (a microfluidic device – paragraph 1) carrying a flow cell (a sixth fluidic conduit 30 – Figs. 7A-C) and to be received by the cartridge receptacle (the microfluidic device is capable of being received in a cartridge receptacle – Figs. 7A-C), the fluidic cartridge comprising:
a rotary valve (a rotating valve 10 – Figs. 7A-C) comprising a rotary channel (a fluidic channel 12 – Figs. 7A-C);
a common channel (fifth fluidic conduit 28 – Figs. 7A-C) fluidly coupled to the rotary channel (fifth fluidic conduit 28 coupled to the fluidic channel 12 – Figs. 7A-C), the flow cell to be fluidly coupled to the common channel (the sixth fluidic conduit 30 is coupled to the fluidic channel 12 – Figs. 7A-C);
a first well (a sixth fluidic chamber 54 – Figs. 7A-C) and a second well (a fifth fluidic chamber 52 – Figs. 7A-C), each of the first well (a channel between the sixth fluidic chamber 54 and a sensor 104 – Figs. 7A-C) and the second well comprising a well channel (a conduit 106 connected to the fifth fluidic chamber 52 conduit 106 – Fig. 7C); and
a pump carried by the fluidics cartridge (a third moveable piston 82 and a stepper motor 110 – Figs. 7A-C), wherein the pump is positioned downstream of the flow cell (the third moveable piston 82 is downstream of the sixth fluidic conduit 30 – Figs. 7A-C).
However, Dothie does not teach an instrument, comprising: a cartridge receptacle; and a rotary valve drive assembly; a pressure source; and wherein the rotary valve drive assembly is to interface with the rotary valve to rotate the rotary valve to align the rotary channel with the well channel of the first well and to fluidly couple the common channel and the well channel of the first well, and wherein: a) the pressure source is positioned upstream of the first well and upstream of the rotary valve when the fluidic cartridge is received by the cartridge receptacle, and b) the pressure source is to pressurize the first well and to flow fluid from the first well, through the well channel and the common channel and to the flow cell.
Bohm teaches a system and method for controlling a rotary valve comprising an instrument (a base instrument 102 with a system controller 180 – Fig. 1), comprising:
a cartridge receptacle (a control side 198 configured to separably engage the mating side 114 of the removable cartridge 104 – Fig. 1); and
a rotary valve drive assembly (a valve actuator 183 comprising a rotating motor 189 – paragraph 81 and Fig. 1);
a pressure source (a system pump 119 may be configured to provide positive pressure – paragraph 81 and Fig. 1); and
wherein the rotary valve drive assembly is to interface with the rotary valve to rotate the rotary valve to align the rotary channel (a first rotational position – paragraph 81) with the well channel of the first well (a sample port 116 and a sample channel 131 connected to a sample-preparation region 132 – Fig. 1) (in the first rotational position the rotary valve 123 is connected to the sample ports 116 via the sample channel 131 and the sample-preparation region 132 – paragraph 81 and Fig. 1) and to fluidly couple the common channel (a reaction chamber channel from the rotary valve 123 to a reaction chamber 126 – paragraph 81 and Fig. 1) and the well channel of the first well (in the first rotational position the reaction chamber channel is connected to the sample channel 131 via the sample-preparation region 132 – paragraph 81 and Fig. 1), and wherein:
a) the pressure source is positioned upstream of the first well and upstream of the rotary valve when the fluidic cartridge is received by the cartridge receptacle (the system pump 119 is capable of providing positive pressure and is therefore deemed upstream of the sample port 116 and the rotary valve 123 – paragraph 81 and Fig. 1), and
b) the pressure source is to pressurize the first well and to flow fluid from the first well, through the well channel and the common channel and to the flow cell (the system pump 119 is capable of pressurizing the sample port 116 to flow a sample from the sample port 116, to the sample channel 131, to the reaction chamber channel, and then to the reaction chamber 126 – paragraph 81). Bohm teaches to use the system 100 to gain the ability to process data be automatically and allow a remote request through a communication link (paragraph 86).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cartridge, as taught by Dothie, with the system and instrument, taught by Bohm, to gain the ability to process data automatically and allow a remote request through a communication link. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Dothie and Bohm teach fluidic cartridges.
Regarding claim 2, Dothie, modified by Bohm, teaches the apparatus of claim 1, wherein the instrument comprises the pressure source (the system pump 119 in the base 102 – Bohm paragraph 81 and Fig. 1) and wherein the pressure source comprises a second pump (the system pump 119 – Bohm paragraph 81 and Fig. 1).
Regarding claim 3, Dothie, modified by Bohm, teaches the apparatus of claim 1, wherein the fluid comprises air (gas is vented through the first integral air vent 88 – Dothie Figs. 7A-C and paragraph 175).
Regarding claim 4, Dothie, modified by Bohm, teaches the apparatus of claim 1, wherein the fluidic cartridge comprises a flow cell chamber (a chamber in a sensor 104 – Dothie Figs. 7A-C) and the flow cell is to be received by the flow cell chamber (the sixth fluidic conduit 30 is received by the chamber in the sensor 104 – Dothie Figs. 7A-C).
Regarding claim 5, Dothie, modified by Bohm, teaches the apparatus of claim 1, wherein the first well comprises reagent (the sixth fluidic chamber 54 containing the defined volume of quench reagent 134 – Dothie paragraph 212).
Regarding claim 6, Dothie, modified by Bohm, teaches the apparatus of claim 5, wherein the reagent comprises liquid reagent (the quench reagent 134 is a liquid – Dothie paragraph 216).
Regarding claim 9, Dothie, modified by Bohm, teaches the apparatus of claim 1, wherein the instrument comprises an actuator to actuate the pump (the base 102 comprising a contact array 188 of electrical contacts capable of actuating the stepper motor 110 – Dothie Figs. 7A-C and Bohm Fig. 1).
Regarding claim 10, Dothie teaches an apparatus (a point-of-care diagnostic testing system – paragraph 310), comprising:
a fluidic cartridge (a microfluidic device – paragraph 1) carrying a flow cell (a sixth fluidic conduit 30 – Figs. 7A-C) and to be received by the cartridge receptacle (the microfluidic device is capable of being received in a cartridge receptacle – Figs. 7A-C), the fluidic cartridge comprising:
a well (a sixth fluidic chamber 54 – Figs. 7A-C);
a well channel coupled to the well (a channel between the sixth fluidic chamber 54 and a sensor 104 – Figs. 7A-C),
a common channel (fifth fluidic conduit 28 – Figs. 7A-C);
a valve (a rotating valve 10 – Figs. 7A-C); and
a pump carried by the fluidics cartridge (a third moveable piston 82 – Figs. 7A-C), wherein the pump is to be positioned downstream of the flow cell (the third moveable piston 82 is downstream of the sixth fluidic conduit 30 – Figs. 7A-C),
wherein the valve is actuatable to fluidly couple the well channel and the common channel (the valve 10 is capable of connecting the channel between the sixth fluidic chamber 54 and a sensor 104 to the fifth fluidic conduit 28 – Figs. 7A-C).
However, Dothie does not teach an instrument comprising a cartridge receptacle; a pressure source; and wherein: a) the pressure source is positioned upstream of the well and upstream of the valve when the fluidic cartridge is received by the cartridge receptacle, and b) the pressure source is to pressurize the well and to flow fluid from the well, through the well channel and the common channel and to the flow cell.
Bohm teaches a system and method for controlling a rotary valve comprising an instrument (a base instrument 102 with a system controller 180 – Fig. 1) comprising a cartridge receptacle (a control side 198 configured to separably engage the mating side 114 of the removable cartridge 104 – Fig. 1);
a pressure source (a system pump 119 may be configured to provide positive pressure – paragraph 81 and Fig. 1); and wherein
a) the pressure source is positioned upstream of the well and upstream of the valve when the fluidic cartridge is received by the cartridge receptacle (the system pump 119 is capable of providing positive pressure and is therefore deemed upstream of the sample port 116 and the rotary valve 123 – paragraph 81 and Fig. 1), and
b) the pressure source is to pressurize the well and to flow fluid from the well, through the well channel and the common channel and to the flow cell (the system pump 119 is capable of pressurizing the sample port 116 to flow a sample from the sample port 116, to the sample channel 131, to the reaction chamber channel, and then to the reaction chamber 126 – paragraph 81). Bohm teaches to use the system 100 to gain the ability to process data be automatically (paragraph 86).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cartridge, as taught by Dothie, with the system and instrument, taught by Bohm, to gain the ability to process data be automatically. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Dothie and Bohm teach fluidic cartridges.
Regarding claim 11, Dothie, modified by Bohm, teaches the apparatus of claim 10, wherein the instrument comprises the pressure source (the system pump 119 in the base 102 – Bohm paragraph 81 and Fig. 1) and wherein the pressure source comprises a second pump (the system pump 119 – Bohm paragraph 81 and Fig. 1).
Regarding claim 12, Dothie, modified by Bohm, teaches the apparatus of claim 10, wherein the fluid comprises air (gas is vented through the first integral air vent 88 – Dothie Figs. 7A-C and paragraph 175).
Regarding claim 13, Dothie, modified by Bohm, teaches the apparatus of claim 10, wherein the fluidic cartridge comprises a flow cell chamber (a chamber in a sensor 104 – Dothie Figs. 7A-C) and the flow cell is to be received by the flow cell chamber (the sixth fluidic conduit 30 is received by the chamber in the sensor 104 – Dothie Figs. 7A-C).
Regarding claim 14, Dothie, modified by Bohm, teaches the apparatus of claim 10, wherein the well comprises reagent (the sixth fluidic chamber 54 containing the defined volume of quench reagent 134 – Dothie paragraph 212).
Regarding claim 15, Dothie, modified by Bohm, teaches the apparatus of claim 14, wherein the reagent comprises liquid reagent (the quench reagent 134 is a liquid – Dothie paragraph 216).
Regarding claim 16, Dothie, modified by Bohm, teaches the apparatus of claim 10, the valve comprises a rotatory valve (a rotating valve 10 – Dothie Figs. 7A-C), the fluidic cartridge comprises a second well (a fifth fluidic chamber 52 – Dothie Figs. 7A-C) having a second well channel (a conduit 106 connected to the fifth fluidic chamber 52 conduit 106 – Dothie Fig. 7C).
However, Dothie, modified by Bohm, does not teach wherein the instrument comprises a rotary valve drive assembly, and wherein the rotary valve drive assembly is to interface with the rotary valve to rotate the rotatory valve to align the rotary channel with the second well channel of the second well and to fluidly couple the common channel and the second well channel of the second well.
Bohm a system and method for controlling a rotary valve comprising wherein the instrument (a base instrument 102 with a system controller 180 – Fig. 1) comprises
a rotary valve drive assembly (a valve actuator 183 comprising a rotating motor 189 – paragraph 81 and Fig. 1), wherein
the rotary valve drive assembly is to interface with the rotary valve to rotate the rotatory valve to align the rotary channel (a first rotational position – paragraph 81) with the second well channel of the second well (a sample port 116 and a sample channel 131 connected to a sample-preparation region 132 – Fig. 1) (in the first rotational position the rotary valve 123 is connected to the sample ports 116 via the sample channel 131 and the sample-preparation region 132 – paragraph 81 and Fig. 1) and to fluidly couple the common channel (a reaction chamber channel from the rotary valve 123 to a reaction chamber 126 – paragraph 81 and Fig. 1) and the second well channel of the second well (the first rotational position the reaction chamber channel is connected to the sample channel 131 via the sample-preparation region 132 – paragraph 81 and Fig. 1). Bohm teaches to use the system 100 to gain the ability to allow a remote request through a communication link (paragraph 86).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cartridge, as taught by Dothie as modified by Bohm, with the base instrument 102 and the system controller 180, taught by Bohm, to gain the ability to allow a remote request through a communication link. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Dothie and Bohm teach fluidic cartridges.
Claims 17-19 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Dothie in view of Bohm and Heiniger et al (US20060177351A1 published 8/10/2006; hereinafter Heiniger).
Regarding claim 17, Dothie teaches an apparatus (a point-of-care diagnostic testing system – paragraph 310), comprising:
a fluidic cartridge (a microfluidic device – paragraph 1) carrying a flow cell (a sixth fluidic conduit 30 – Figs. 7A-C) and to be received by the cartridge receptacle (the microfluidic device is capable of being received in a cartridge receptacle – Figs. 7A-C), the fluidic cartridge comprising:
a rotary valve (a rotating valve 10 – Figs. 7A-C) comprising a rotary channel (a fluidic channel 12 – Figs. 7A-C);
a common channel (fifth fluidic conduit 28 – Figs. 7A-C) fluidly coupled to the rotary channel (fifth fluidic conduit 28 coupled to the fluidic channel 12 – Figs. 7A-C), the flow cell is to be fluidly coupled to the common channel (the sixth fluidic conduit 30 is coupled to the fluidic channel 12 – Figs. 7A-C);
a first well (a sixth fluidic chamber 54 – Figs. 7A-C) and a second well (a fifth fluidic chamber 52 – Figs. 7A-C), each of the first well (a channel between the sixth fluidic chamber 54 and a sensor 104 – Figs. 7A-C) and the second well comprising a well channel (a conduit 106 connected to the fifth fluidic chamber 52 conduit 106 – Fig. 7C); and
a pump carried by the fluidics cartridge (a third moveable piston 82 – Figs. 7A-C), wherein the pump is to be positioned downstream of the flow cell (the third moveable piston 82 is downstream of the sixth fluidic conduit 30 – Figs. 7A-C),
However, Dothie does not teach an instrument comprising, a cartridge receptacle; a rotary valve drive assembly; and an in-situ testing assembly comprising a sensor; a pressure source; and wherein: a) the pressure source is positioned upstream of the first well and upstream of the rotary valve when the fluidic cartridge is received by the cartridge receptacle, b) the pressure source is to pressurize the first well and the sensor is to measure a parameter value, and c) the instrument is programed to use the parameter value to determine a presence of a leak or a blockage within the cartridge or the instrument.
Bohm teaches a system and method for controlling a rotary valve comprising an instrument (a base instrument 102 with a system controller 180 – Fig. 1) comprising,
a cartridge receptacle (a control side 198 configured to separably engage the mating side 114 of the removable cartridge 104 – Fig. 1);
a rotary valve drive assembly (a valve actuator 183 comprising a rotating motor 189 – paragraph 81 and Fig. 1); and
an in-situ testing assembly comprising a sensor (a detector to observe the biological sample – paragraph 50);
a pressure source (a system pump 119 may be configured to provide positive pressure – paragraph 81 and Fig. 1); and
wherein:
a) the pressure source is positioned upstream of the first well and upstream of the rotary valve when the fluidic cartridge is received by the cartridge receptacle (the system pump 119 is capable of providing positive pressure and is therefore deemed upstream of the sample port 116 and the rotary valve 123 – paragraph 81 and Fig. 1),
b) the pressure source is to pressurize the first well (the system pump 119 is capable of pressurizing the sample port 116 – paragraph 81) and the sensor is to measure a parameter value (detecting the designated reactions, and/or analyzing the designated reactions – paragraph 50) (system failure or malfunction has been detected – paragraph 49). Bohm teaches to use the system 100 to gain the ability to process data be automatically and allow a remote request through a communication link (paragraph 86).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the cartridge, as taught by Dothie, with the system and instrument, taught by Bohm, to gain the ability to process data be automatically and allow a remote request through a communication link. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Dothie and Bohm teach fluidic cartridges.
However, Dothie, modified by Bohm, does not teach the instrument is programed to use the parameter value to determine a presence of a leak or a blockage within the cartridge or the instrument.
Heiniger teaches a fluidic system wherein the instrument is programed to use the parameter value to determine a presence of a leak (if a leak were to occur in the dialysis membrane inside the tissue, the measurement liquid would flow out of the flow system and into the tissue. A malfunction of this kind can be determined, for example, by the associated drop in pressure or complete loss of pressure in the flow system – paragraph 5). Heiniger also teaches in the event of such a leak it is desirable to suppress the flow of liquid (paragraph 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device, as taught by Dothie as modified by Bohm, with the leak detection flow system, taught by Heiniger, to suppress the flow of liquid during a leak. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Dothie, Bohm, Heiniger teach microfluidic cartridges for sample processing.
Regarding claim 18, Dothie, as modified by Bohm modified by Heiniger, teaches the apparatus of claim 17, wherein the parameter value comprises a pressure value (measuring a control parameter, for example the pressure in the fluid system – Heiniger paragraph 4).
Regarding claim 19, Dothie, as modified by Bohm modified by Heiniger, teaches the apparatus of claim 17, further comprising a rotary valve drive assembly (a valve actuator 183 comprising a rotating motor 189 – Bohm paragraph 81 and Fig. 1) to interface with the rotary valve to rotate the rotary valve and the rotary channel relative to the well channels of the first well and the second well (the valve actuator 183 to move the movable valve 123 to a first rotational position relative to the cartridge 104 – Bohm paragraph 81).
Regarding claim 22, Dothie, as modified by Bohm modified by Heiniger, teaches the apparatus of claim 17, wherein the instrument comprises an actuator to actuate the pump (the base 102 comprising a contact array 188 of electrical contacts capable of actuating the stepper motor 110 – Dothie Figs. 7A-C and Bohm Fig. 1).
Regarding claim 23, Dothie, as modified by Bohm modified by Heiniger, teaches the apparatus of claim 17, further comprising a first valve (a first moveable piston 78 capable of stopping flow – Dothie Figs. 7A-C) and a second valve (a second moveable piston 80 capable of stopping flow – Dothie Figs. 7A-C), the valve positioned between the first valve and the second valve (the rotating valve 10 is between the first moveable piston 78 and the second moveable piston 80 – Dothie Figs. 7A-C).
Response to Arguments
Applicant’s addition arguments with respect to the 102/103 rejections of the claims have been considered, and due to amendments to the claims, a new rejection using different references is set forth above.
Conclusion
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/T.C.S./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796