DETAILED ACTION
In application filed on 05/02/2022, Claims 1-4, 6-7, 9-16 and 18-22 are pending. Claims 1-4, 6-7, 9-16 and 18-22 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/02/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Enzelberger et al. (US20030008308A1) in view of Broyer et al. (US20170241878A1).
Regarding Claim 1, Enzelberger teaches an apparatus (See Para 0003…microfluidic devices), comprising:
a microfluidic channel (referred to as a central circulation loop 106 (i.e., the substantially circular flow channel) [Para 0077]) defining a fluid conduit (See Fig. 1…flow path from inlets 102a/b to output channel 108, including the central loop) and comprising an input port (referred to as a plurality of sample inputs 102 a and 102 b [Fig. 1; Para 0077]), an output port (referred to as output channel 108 [Para 0077]), and a plurality of reaction zones (referred to as a plurality of temperature regions 118, 120 and 122 [Fig. 1; Para 0082]; See Para 0020…Temperature is controlled at the temperature regions or reaction chambers) between (See Fig. 1….for between) the input port (referred to as a plurality of sample inputs 102 a and 102 b [Fig. 1; Para 0077]) and the output port (referred to as output channel 108 [Para 0077]); and
a pump (referred to as any of the two sets of pumps 114 a and 114 b (i.e., two sets of three control channels 116) [Para 0078]) situated between (See Fig.1…situated between) the plurality of reaction zones (See Fig. 1, refs 122 and 118…a plurality of temperature regions 118, 120 and 122 [Fig. 1; Para 0082]; See Para 0020…Temperature is controlled at the temperature regions or reaction chambers) and one of (See Fig. 1…for one of…) the input port (referred to as a plurality of sample inputs 102 a and 102 b [Fig. 1; Para 0077]) and the output port (referred to as output channel 108 [Para 0077]), wherein the pump (referred to as any of the two sets of pumps 114 a and 114 b (i.e., two sets of three control channels 116) [Para 0078]) includes:
a flexible membrane (referred to as any of the elastomer membranes [Para 0145; Fig. 14A-B, refs 1274, 1276]), and
first and second magnetic elements (referred to a magnetic particles [Para 0050, 0054], where the plurality of magnetic particles teaches the “first and second magnetic elements”);
wherein the first magnetic element (referred to any of the magnetic particles [Para 0050, 0054]) deforms (‘deflection’) the flexible membrane (See Figs. 14B-C for ‘situated along’; See Para 0145…deflection of both elastomer membranes 1274 and 1276 into the underlying flow channel 1204) in response the second magnetic element (referred to any of the magnetic particles [Para 0050, 0054].
Enzelberger does not teach that the microfluidic channel is situated between the first and second magnetic elements, and the movement of the second magnetic element.
In the analogous art of method of treating a biological sample, Broyer teaches that the microfluidic channel (See Annotated Fig. 7a) is situated between (See Annotated Fig. 7a…situated between) the first and second magnetic elements (See Annotated Fig. 7a), and the movement of the second magnetic element (See Para 0213…The movement M of the magnet supports, therein teaching the movement of the second magnetic element).
Broyer further teaches that the magnets thus placed on each side of the conveying channel toward the outlet orifice 360 a make it possible to capture microorganisms, in continuous flow, by movement of magnetic silica particles 2100 perpendicularly to the flow of the decomplexified sample (Para 0213).
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Annotated 7a, Broyer
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Enzelberger to incorporate that the microfluidic channel is situated between the first and second magnetic elements, and the movement of the second magnetic element, as taught by Broyer for the benefit of capturing microorganisms, in continuous flow, by movement of magnetic silica particles 2100 perpendicularly to the flow of the decomplexified sample, (Broyer, Para 0213), allowing for the provision of a simplified and universal process which makes it possible to treat and analyze blood samples of various types, in particular samples of whole blood, samples originating from blood cultures, samples of sterile body fluids enriched in culture medium or of non-sterile body fluids (Broyer, Para 0007).
In addition, Claim 1 recites the first magnetic element and the second magnetic elemtns and then recites how they function with respect to the flexible membrane. Claim 1 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 2, the apparatus of claim 1 is obvious over Enzelberger in view of Broyer (See Claim 1 rejection).
Enzelberger further teaches that the flexible membrane (referred to as any of the elastomer membranes [Para 0145; Fig. 14A-B, refs 1274, 1276]) is situated to define a (‘the’) portion of the microfluidic channel (referred to as a flow channel [Para 0008; Fig. 14C, ref. 1204]; See Annotated Fig. 14B for “the portion”).
In addition, Examiner submits that the claimed “portion of the microfluidic channel” is not specifically defined in the specification and will therefore be given the broadest reasonable interpretation in light of the specification. Any part, segment or region of the microfluidic channel will be considered a “portion of the microfluidic channel”. As such, any part or region of the “flow channel” would satisfy a “portion of the microfluidic channel”.
Regarding Claim 4, the apparatus of claim 1 is obvious over Enzelberger in view of Broyer (See Claim 1 rejection).
Enzelberger does not teach that the flexible membrane includes a PDMS layer.
In the analogous art of a membrane microfluidic valve and to a process for manufacturing a membrane microfluidic valve, Pugliese teaches that the flexible membrane includes a PDMS layer (See Para 0026… The membrane 4 is flexible and is also made of a polymeric material, in particular PDMS in one embodiment.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Enzelberger and Broyer to incorporate that the flexible membrane includes a PDMS layer, as taught by Pugliese for the benefit fabricating the membrane with a flexible material (Pugliese, Para 0026), allowing for the provision of microfluidic valves where there is an integration of microchannels and of mobile members, for operation, within the microstructure that forms the valve body (Pugliese, Para 0006) and these valves may be used in microfluidic circuits and devices in various sectors, for example for producing microreactors, systems for biochemical analyses, inkjet printing heads (Pugliese, Para 0004).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Enzelberger et al. (US20030008308A1) in view of Broyer et al. (US20170241878A1) as applied to claim 1 above, and further in view of Pais et al. (US20190001325A1).
Regarding Claim 3, the apparatus of claim 1 is obvious over Enzelberger in view of Broyer (See Claim 1 rejection). Enzelberger further teaches an actuator (referred to as a pneumatic controller [Para 0302]; Further See Para 0302… where the on-chip valves were actuated with a pneumatic controller).
Enzelberger and Broyer does not teach an actuator coupled to the first magnetic element to produce translation of the first magnetic element along the flexible membrane.
In the analogous art of a membrane microfluidic valve and to a process for manufacturing a membrane microfluidic valve, Pugliese teaches that an actuator (referred to as an actuator device 105, which comprises a permanent magnet 118 and an electromechanical drive 119 [Para 0042]) coupled to the first magnetic element (referred to as permanent magnet [Para 0042; Fig. 5, ref. 118]) to produce translation of the first magnetic element (See Para 0043… electromechanical drive 119 enables displacement of the magnet 118 …) along the flexible membrane (See Para 0021; Fig. 4, ref. 4…membrane; See Claim 12… the actuator device comprises an electromechanical drive configured to move the magnet material in the membrane between the active position and an inactive position).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Enzelberger and Broyer to incorporate that an actuator coupled to the first magnetic element to produce translation of the first magnetic element along the flexible membrane, as taught by Pugliese for the benefit of having the magnet configured to generate a magnetic field to retract the membrane into the recess (Pugliese, Para 0044, Claim 13), allowing for the provision of microfluidic valves where there is an integration of microchannels and of mobile members, for operation, within the microstructure that forms the valve body (Pugliese, Para 0006) and these valves may be used in microfluidic circuits and devices in various sectors, for example for producing microreactors, systems for biochemical analyses, inkjet printing heads (Pugliese, Para 0004).
The combination of Enzelberger, Broyer and Pugliese does not teach that the first magnetic element is a roller.
In the analogous art of methods and devices for simple, low power, automated processing of biological samples through multiple sample preparation and assay steps, Pais teaches that the first magnetic element is a roller (See Para 0153… actuating element containing a partially fixed magnetic roller for squeezing reagents out of the pouches… FIG. 23C and 23D show the reaction chamber being squeezed by the magnetic rolling elements to dispense its fluid into the next chamber.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of combination of Enzelberger, Broyer and Pugliese to incorporate that the first magnetic element is a roller, as taught by Pais for the benefit of squeezing reagents out of the pouches and to dispense its fluid into the next chamber (Pais, Para 0153), allowing for the provision of methods and devices for simple, low power, automated processing of biological samples through multiple sample preparation and assay steps. The methods and devices described facilitate the point-of-care implementation of complex diagnostic assays in equipment-free, non-laboratory settings (Pais, Para 0009).
Claims 10-13, 16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Enzelberger et al. (US20030008308A1) in view of Broyer et al. (US20170241878A1) and further in view of Pugliese et al. (US20140352819A1).
Regarding Claim 10, Enzelberger teaches an apparatus, comprising:
a microfluidic channel (referred to as a flow channel [Para 0008; Fig. 14c, ref. 1204]) being a fluid conduit (See Fig. 1…flow path from inlets 102a/b to output channel 108, including the central loop) and comprising an input port (referred to as a plurality of sample inputs 102 a and 102 b [Fig. 1; Para 0077]), an output port (referred to as output channel 108 [Para 0077]), and at least one reaction zone (referred to as a plurality of temperature regions 118, 120 and 122 [Fig. 1; Para 0082]; See Para 0020…Temperature is controlled at the temperature regions or reaction chambers) between (See Fig. 1….for between) the input port (referred to as a plurality of sample inputs 102 a and 102 b [Fig. 1; Para 0077]) and the output port (referred to as output channel 108 [Para 0077]); and
at least one pump (referred to as any of the two sets of pumps 114 a and 114 b (i.e., two sets of three control channels 116) [Para 0078]) situated between (See Fig.1…situated between) the at least one reaction zone (See Fig. 1, refs 122 and 118…a plurality of temperature regions 118, 120 and 122 [Fig. 1; Para 0082]; See Para 0020…Temperature is controlled at the temperature regions or reaction chambers) and one of (See Fig. 1…for one of…) the input port (referred to as a plurality of sample inputs 102 a and 102 b [Fig. 1; Para 0077]) and the output port (referred to as output channel 108 [Para 0077]),
wherein the at least one pump (referred to as any of the two sets of pumps 114 a and 114 b (i.e., two sets of three control channels 116) [Para 0078]) includes:
a flexible membrane (referred to as any of the elastomer membranes [Para 0145; Fig. 14A-B, refs 1274, 1276]),
first and second magnetic elements (referred to a magnetic particles [Para 0050, 0054], where the plurality of magnetic particles teaches the “first and second magnetic elements”);
wherein the first magnetic element (referred to any of the magnetic particles [Para 0050, 0054]) deforms (‘deflection’) the flexible membrane (See Figs. 14B-C for ‘situated along’; See Para 0145…deflection of both elastomer membranes 1274 and 1276 into the underlying flow channel 1204) in response the second magnetic element (referred to any of the magnetic particles [Para 0050, 0054], and
an actuator (referred to as a pneumatic controller [Para 0302]; Further See Para 0302… where the on-chip valves were actuated with a pneumatic controller).
Enzelberger does not teach that the microfluidic channel is situated between the first and second magnetic elements, and the movement of the second magnetic element.
In the analogous art of method of treating a biological sample, Broyer teaches that the microfluidic channel (See Annotated Fig. 7a) is situated between (See Annotated Fig. 7a…situated between) the first and second magnetic elements (See Annotated Fig. 7a), and the movement of the second magnetic element (See Para 0213…The movement M of the magnet supports, therein teaching the movement of the second magnetic element).
Broyer further teaches that the magnets thus placed on each side of the conveying channel toward the outlet orifice 360 a make it possible to capture microorganisms, in continuous flow, by movement of magnetic silica particles 2100 perpendicularly to the flow of the decomplexified sample (Para 0213).
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Annotated 7a, Broyer
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Enzelberger to incorporate that the microfluidic channel is situated between the first and second magnetic elements, and the movement of the second magnetic element, as taught by Broyer for the benefit of capturing microorganisms, in continuous flow, by movement of magnetic silica particles 2100 perpendicularly to the flow of the decomplexified sample, (Broyer, Para 0213), allowing for the provision of a simplified and universal process which makes it possible to treat and analyze blood samples of various types, in particular samples of whole blood, samples originating from blood cultures, samples of sterile body fluids enriched in culture medium or of non-sterile body fluids (Broyer, Para 0007).
The combination of Enzelberger and Broyer does not teach that an actuator coupled to the first magnetic element.
In the analogous art of a membrane microfluidic valve and to a process for manufacturing a membrane microfluidic valve, Pugliese teaches that an actuator (referred to as an actuator device 105, which comprises a permanent magnet 118 and an electromechanical drive 119 [Para 0042]) coupled to the first magnetic element (referred to as permanent magnet [Para 0042; Fig. 5, ref. 118]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Enzelberger and Broyer to incorporate that an actuator coupled to the first magnetic element, as taught by Pugliese for the benefit of having the magnet configured to generate a magnetic field to retract the membrane into the recess (Pugliese, Para 0044, Claim 13), allowing for the provision of microfluidic valves where there is an integration of microchannels and of mobile members, for operation, within the microstructure that forms the valve body (Pugliese, Para 0006) and these valves may be used in microfluidic circuits and devices in various sectors, for example for producing microreactors, systems for biochemical analyses, inkjet printing heads (Pugliese, Para 0004).
Regarding Claim 11, the apparatus of claim 10 is obvious over Enzelberger in view of Broyer in further view of Pugliese (See Claim 10 rejection).
Enzelberger teaches that the flexible membrane (referred to as any of the elastomer membranes [Para 0145; Fig. 14A-B, refs 1274, 1276]) is situated to define a (‘the’) of the portion of the microfluidic channel (referred to as a flow channel [Para 0008; Fig. 14C, ref. 1204]; See Annotated Fig. 14B for “the portion”).
Regarding Claim 12, the apparatus of claim 10 is obvious over Enzelberger in view of Broyer in further view of Pugliese (See Claim 10 rejection).
Enzelberger further teaches that the at least one reaction zone (referred to as cross-injection junctions or reaction chambers [Para 0112-0113, Fig. 5, ref. 502]) includes a plurality of reaction zones (referred to as cross-injection junctions or reaction chambers [Para 0112-0113, Fig. 5, ref. 502]) and the at least one pump (referred to as any of the peristaltic pumps, See Fig. 5, refs. 508) is operable to selectively direct (See Para 0097… a different reaction chamber is provided for each different temperature region that is needed to conduct the analysis of interest (of the sample); Also See Para 0105… Solution is transported between the different reaction chambers by selectively actuating the appropriate control channel) a sample (referred to as sample [Para 0097]) in the microfluidic channel (referred to as a flow channel [Para 0008; Fig. 14c, ref. 1204; or horizontal flow channels [Fig. 5, ref. 504]]; or primary flow channel [Para 0097; Fig. 2, ref. 210]) to each of the plurality of reaction zones (referred to as the plurality of reaction chambers [Para 0009; Para 0097, Fig. 2, any of refs. 208 a, 208 b and 208 c]).
In addition, Claim 12 recites a pump and then recites how the pump functions (…to selectively direct a sample) with respect to the microfluidic channel.
Claim 12 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 13, the apparatus of claim 12 is obvious over Enzelberger in view of Broyer in further view of Pugliese (See Claim 12 rejection).
Enzelberger teaches that the at least one pump (referred to the peristaltic pumps, See Fig. 5, refs. 508) includes a plurality of pumps (referred to as any of the peristaltic pumps, See Fig. 5, refs. 508) corresponding (See Fig. 5, refs. 508 for 5 pumps; and See Para 0099 for 5 reaction chambers, thereby teaching ‘corresponding’) to the plurality of reaction zones (referred to as the plurality of reaction chambers [Para 0009; Para 0097, Fig. 2, any of refs. 208 a, 208 b and 208 c]).
Regarding Claim 16, the apparatus of claim 10 is obvious over Enzelberger in view of Broyer in further view of Pugliese (See Claim 10 rejection).
Enzelberger further teaches that the at least one reaction zone (referred to as any of the temperature regions or reaction chambers [Para 0020]) comprises a heating element (See Para 160… a resistive heater) and at least one temperature sensor (See Para 0187… Sensors detecting temperature in the various temperature regions; Also See Para 0192…temperature detection is through the use of pyroelectric sensors).
Regarding Claim 18, the apparatus of claim 10 is obvious over Enzelberger in view of Broyer in further view of Pugliese (See Claim 10 rejection).
Enzelberger further teaches that the microfluidic channel (referred to as a flow channel [Para 0008; Fig. 14c, ref. 1204]) comprises a plurality of microfluidic channels (See Para 0057…a plurality of intersecting flow channels), each of the plurality of microfluidic channels (See Para 0057…a plurality of intersecting flow channels) defining the at least one reaction zone (See Para 0057…flow channels to form an array or matrix of reaction chambers or junctions at which reactions can occur).
Regarding Claim 19, the apparatus of claim 10 is obvious over Enzelberger in view of Broyer in further view of Pugliese (See Claim 10 rejection).
Enzelberger further teaches that the at least one reaction zone (See Para 0057… an array or matrix of reaction chambers or junctions at which reactions can occur) comprises a first reaction zone, a second reaction zone, and a third reaction zone (See Para 0099… three reaction chambers) and the at least one pump (referred to as any of the peristaltic pumps, See Fig. 5, refs. 508) is operable to repetitively direct (See Para 0005…PCR involves the repetition of heating (denaturation) and cooling (annealing)) a fluid sample (referred to as sample (that flows) [Para 0097]) in the microfluidic channel (referred to as a flow channel [Para 0008; Fig. 14c, ref. 1204; or horizontal flow channels [Fig. 5, ref. 504]]; or primary flow channel [Para 0097; Fig. 2, ref. 210]) to the first, second, and third reaction zones (referred to as the plurality of reaction chambers [Para 0009; Para 0097, Fig. 2, any of refs. 208 a, 208 b and 208 c]; Also See Para 0099… three reaction chambers)), wherein the first reaction zone(‘one of the three reaction chambers’) is associated with a denaturation temperature (See Para 0099… one of the three reaction chambers are utilized to accommodate the temperatures for performing any one of the annealing, extension and denaturation reactions), the second reaction zone(‘another of the three reaction chambers) is associated with an annealing temperature (See Para 0099… one of the three reaction chambers are utilized to accommodate the temperatures for performing any one of the annealing, extension and denaturation reactions), and the third reaction zone (‘the third of the three reaction chambers) is associated with an extension temperature for a polymerase chain reaction (See Para 0099… one of the three reaction chambers are utilized to accommodate the temperatures for performing any one of the annealing, extension and denaturation reactions), respectively (See Para 0099… With many nucleic acid amplification reaction, three reaction chambers are utilized to accommodate the temperatures for performing annealing, extension and denaturation; Further See Para 0246…including polymerase chain reaction).
In addition, Claim 19 recites a pump and then recites how the pump functions (…to repetitively direct a fluid sample…).
Claim 19 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 20, the apparatus of claim 19 is obvious over Enzelberger in view of Broyer in further view of Pugliese (See Claim 19 rejection).
Enzelberger further teaches that the first, second, and third reaction zones (referred to as three reaction chambers [Para 0102; Fig. 2, refs. 208a, 208b, 208c) are distributed sequentially (See Fig. 2 for the sequential distribution of the three reaction chambers) along the microfluidic channel (referred to as flow channel [Para 0104; Fig. 2, ref. 210]) from an input port (See Fig. 2, refs. 201 for the inlet system having sample inputs 202a, 202b) of the microfluidic channel (referred to as flow channel [Para 0104; Fig. 2, ref. 210]), and the at least one pump (referred to as any of the peristaltic pumps, See Fig. 5, refs. 508) is operable to repetitively direct (See Para 0005…PCR involves the repetition of heating (denaturation) and cooling (annealing)) the sample (referred to as sample [Para 0097]) in the microfluidic channel (referred to as a flow channel [Para 0008; Fig. 14c, ref. 1204; or horizontal flow channels [Fig. 5, ref. 504]]; or primary flow channel [Para 0097; Fig. 2, ref. 210]) toward the input port or away from the input port (See Fig. 2, refs. 201 for the inlet system having sample inputs 202a, 202b ; See Para 0102, Fig. 2, ref, 200 for “teaching away from the input port” where the arrow direction shows the transport of solution from the inlet system through the reaction chambers to the outlet flow channel).
In addition, Claim 20 recites a pump and then recites how the pump functions (…to repetitively direct a fluid sample…).
Claim 20 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Enzelberger et al. (US20030008308A1) in view of Broyer et al. (US20170241878A1) as applied to claim 1 above, and further in view of Miller et al. (US20120034633A1).
Regarding Claim 6, the apparatus of claim 1 is obvious over Enzelberger in view of Broyer (See Claim 1 rejection).
Enzelberger does not teach that each of the first and second magnetic elements is an electromagnet, and is coupled to a current source.
In the analogous art of an apparatus and method for rapid determination of analytes in liquid samples by immunoassay, Miller teaches that each of the first and second magnetic elements (referred to as the one or more high-field magnet [Para 0097]) is an electromagnet (See Para 0065… the high-field magnet comprises an electromagnet), and is coupled (See 0065… a reader, in which the immunosensing device is inserted and with which the immunosensing device is in electrical contact) to a current source (See Para 0065… The electric current may be provided by a reader; See Para 0059… A high-field magnet, e.g., a permanent magnet or an electromagnet, is positioned proximate to the immunosensor chip (e.g., below) or incorporated into the immunosensor chip).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Enzelberger and Broyer to incorporate that each of the first and second magnetic elements is an electromagnet, and is coupled to a current source, as taught by Miller for the benefit of using the one or more high-field magnets comprising an electromagnet to attract the beads in the conduit for receiving a sample mixed with beads substantially proximate to the sensing electrode (Miller, Para 0059, 0097), where the high-field magnet comprises an electromagnet in which the magnetic field is produced by the flow of electric current (Miller, Para 0065), allowing for the provision of improved immunosensing devices with greater sensitivity for the detection of analytes, including, for example, cardiac troponin I for early detection of myocardial infarction (Para 0011, Miller).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Enzelberger et al. (US20030008308A1) in view of Broyer et al. (US20170241878A1) as applied to claim 1 above, and further in view of Torniainen et al. (US20180214866A1).
Regarding Claim 7, the apparatus of claim 1 is obvious over Enzelberger in view of Broyer (See Claim 1 rejection).
Enzelberger further teaches the first magnetic element (referred to any of the magnetic particles [Para 0050, 0054]) deforms (‘deflection’) the flexible membrane (See Figs. 14B-C for ‘situated along’; See Para 0145…deflection of both elastomer membranes 1274 and 1276 into the underlying flow channel 1204) to select a sample volume (See Para0149… limited sample volume; Also see Para 0132 for total sample volume; See Para 0129…volume of liquid is known, thereby teaching “to select”); and a reaction zone volume (referred to as one of the plurality of reaction chambers [Para 0009; Para 0097, Fig. 2, any of refs. 208 a, 208 b and 208 c]) and selectively direct (See Para 0097… a different reaction chamber is provided for each different temperature region that is needed to conduct the analysis of interest) a sample (referred to as sample [Para 0097]) to a selected reaction zone (referred to as one of the plurality of reaction chambers [Para 0009; Para 0097, Fig. 2, any of refs. 208 a, 208 b and 208 c]) of plurality of reaction zones (referred to as the plurality of reaction chambers [Para 0009; Para 0097, Fig. 2, any of refs. 208 a, 208 b and 208 c]).
While Enzelberger teaches that in some instances, the plurality of reaction chambers are in fluid communication such that substantially all of the sample within the plurality of reaction chambers is collected at one of the plurality of reaction chambers upon actuation of the control channels associated with the other reaction chambers (Para 0009, Enzelberger), the combination of Enzelberger and Broyer does not explicitly teach a sample volume corresponding to a reaction zone volume.
In the analogous art of PCR devices comprise a fluid input, a fluid output, and a set of microfluidic channels that fluidly connect the fluid input and the fluid output, Torniainen teaches a sample volume (See Para 0047… small volumes of fluid (e.g., approximately 1 nL to approximately 1 pL; facilitate digital polymerase chain reaction processing of fluid samples) corresponding to a reaction zone volume (See Para 0022… a reaction chamber volume within a range of approximately 1 picoliter (pL) to approximately 1 nanoliter (nL)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the roller of the combination of Enzelberger and Broyer, to select a sample volume corresponding to a reaction zone volume, as taught by Torniainen for the benefit of facilitating the manipulation of small volumes of fluid (e.g., approximately 1 nL to approximately 1 pL.) (Torniainen, Para 0047) and for having a reaction chamber that is sized to process a single DNA template molecule for a PCR process (Torniainen, Para 0002) allowing for the digital polymerase chain reaction processing of fluid samples (Torniainen , Para 0047).
In addition, Claim 7 recites a first magnetic element and then recites how the first magnetic element functions (…to deform the flexible membrane…and to selectively directs a sample…). Claim 7 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Enzelberger et al. (US20030008308A1) in view of Broyer et al. (US20170241878A1) further in view of Torniainen et al. (US20180214866A1) as applied to claim 7 above, and further in view of Lee et al. (US20190091680A1).
Regarding Claim 9, the apparatus of claim 7 is obvious over Enzelberger in view of Broyer, in further view of Torniainen (See Claim 7 rejection).
Enzelberger further teaches “to shuttle (‘transported’) the sample volume (See Para 0009… sample can be transported) bidirectionally among (See Para 0009… sample can be transported between the reaction chambers) the reaction zones (referred to as reaction chambers [Para 0009])”.
The combination of Enzelberger, Broyer and Torniainen does not teach a controller coupled to the first magnetic element to shuttle the sample bidirectionally among the plurality of reaction zones.
In the analogous art of a device for microfluidic devices are used to perform biological or chemical reactions by manipulating small amounts of fluid, Lee teaches that a controller (See Para 0042… a controller configured to control the rotary drive unit and the magnetic module) coupled to the first magnetic element (See Para 0042…magnetic module) to shuttle the sample bidirectionally (See Para 0195… supplying a desired amount of the fluid sample to the reaction chamber 150; See Para 0198…When the second order reaction is completed in the reaction chamber 150, the platform is rotated at a high speed to dry the detection region 20 and remove the remaining fluid sample, thereby teaching “shuttle sample birectionally”) among the plurality of reaction zones (referred to as reaction chambers 150-1, 150-2 and 150-3 [Para 0141]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of combination of combination of Enzelberger, Broyer and Torniainen, to have a controller coupled to the first magnetic element to shuttle the sample bidirectionally among the plurality of reaction zones, as taught by Lee for the benefit of controlling the rotary drive unit and the magnetic module, facilitating fluid transfer from metering chamber to the reaction chamber (Lee, Para 0042-0043) and from the reaction chamber (Lee, Para 0042-0043), allowing for the provision of a microfluidic structure where a fluid such as a sample or reaction solution is adjusted to a fixed amount and the flow of the fluid through the chambers is regulated (Lee, Para 0006).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Enzelberger et al. (US20030008308A1) in view of Broyer et al. (US20170241878A1) further in view of Pugliese et al. (US20140352819A1) as applied to claim 13 above, and further in view of Tanner (US20060147329A1).
Regarding Claim 14, the apparatus of claim 13 is obvious over Enzelberger in view of Broyer in further view of Pugliese (See Claim 13 rejection).
Enzelberger further teaches that each pump of the polarity of pumps (referred to the peristaltic pumps, See Fig. 5, refs. 508) includes a respective actuator and a respective flexible membrane (referred to as any of the elastomer membranes [Para 0145; Fig. 14A-B, refs 1274, 1276]), each respective flexible membrane (referred to as an elastomeric membrane [Para 0009]; Also See Para 0145; Fig. 14A-B, refs 1274, 1276] for the elastomer membranes) extending in series (See Fig. 14B for the series arrangement of the elastomer membrane) along the microfluidic channel (referred to as flow channel [Fig. 14B,ref. 1204]).
The combination of Enzelberger, Broyer and Pugliese does not teach that each pump of the plurality of pumps includes a respective actuator.
In the analogous art of a pump comprises a pump body; an actuator; and, one or more active valves, Tanner teaches that each pump (See Para 0007, 0023…a pump comprises an actuator) of the plurality of pumps (referred to as the pumps [Para 0023]) includes a respective actuator (See Para 0023.. the pumps comprise a pump body for at least partially defining a pumping chamber; an actuator which acts upon a fluid in the pumping chamber ; See Para 0005… These pumps have different types of actuators).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified each pump of the plurality of pumps of the combination of Enzelberger, Broyer and Pugliese, to include a respective actuator, as taught by Tanner for the benefit of acting upon a fluid in the pumping chamber when coupled with active valves (Tanner, Para 0007), allowing for a controllable and adjustable flow of fluid through the valve and pump (Tanner, Para 0043).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Enzelberger et al. (US20030008308A1) in view of Broyer et al. (US20170241878A1) further in view of Pugliese et al. (US20140352819A1) further in view of Tanner (US20060147329A1) as applied to claim 14 above, and further in view of Torniainen et al. (US20180214866A1)
Regarding Claim 15, the apparatus of claim 14 is obvious over Enzelberger in view of Broyer in further view of Pugliese in further view of Tanner (See Claim 14 rejection).
Enzelberger further teaches “to deform (See Para 0145; Figs 14B-C for the deflection of both elastomer membranes 1274 and 1276) the respective flexible membrane (referred to as any of the elastomer membranes [Para 0145; Fig. 14A-B, refs 1274, 1276]) between disengaged (See Para 0145, Fig. 14C…causes both elastomer membrane 1276 to retract out from the underlying flow channel 1204)and engaged positions (See Para 0145; Fig. 14A…the deflection of both elastomer membranes 1274 and 1276 into the underlying flow channel 1204)”.
The combination of Enzelberger, Broyer, Pugliese and Tanner does not teach a pump controller operable to selectively set each of the respective actuators.
In the analogous art of PCR devices comprise a fluid input, a fluid output, and a set of microfluidic channels that fluidly connect the fluid input and the fluid output, Torniainen teaches a pump controller (referred to as controller to an inertial pump [Para 0035]) operable to selectively set each of the respective actuators (See Para 0035…. fluid actuators that may generate compressive and tensile fluid displacements to thereby cause fluid flow (i.e., movement).)
Torniainen further teaches that fluid actuators that may be implemented in inertial pumps described herein may include, for example, thermal resistor based actuators, piezo-membrane based actuators, electrostatic membrane actuators.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of the combination of Enzelberger, Broyer, Pugliese and Tanner to have a pump controller operable to selectively set each of the respective actuators, as taught by Torniainen for the benefit of controlling the pumping of fluid through electrical actuation (Para 0035, Torniainen) , allowing for the digital polymerase chain reaction processing of fluid samples (Torniainen , Para 0047).
In addition, Claim 15 recites a pump controller and actuators and then recites how both the pump controller and actuators functions with respect to the flexible membrane.
Claim 15 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Enzelberger et al. (US20030008308A1) in view of Broyer et al. (US20170241878A1) further in view of Pugliese et al. (US20140352819A1) as applied to claim 20 above, and further in view of Anderson et al. (WO2020032956A1).
Regarding Claim 21, the apparatus of claim 20 is obvious over Enzelberger in view of Broyer in further view of Pugliese (See Claim 20 rejection).
Enzelberger further teaches the microchannel (referred to as flow channel [Para 0104; Fig. 2, ref. 210]) and
the at least one pump (referred to as any of the peristaltic pumps, See Fig. 5, refs. 508) to repetitively direct (See Para 0008… one or more pumps for transporting fluid…; Also See Para 0005…PCR involves the repetition of heating (denaturation) and cooling (annealing)) the sample (referred to as sample [Para 0097]) to the first, second, and third reaction zones (referred to as three reaction chambers [Para 0102; Fig. 2, refs. 208a, 208b, 208c).
Enzelberger does not teach:
a fluid sensor operable to produce a signal indicative of a position of a liquid in the microfluidic channel; and
a controller coupled to the fluid sensor and operable to cause the at least one pump to repetitively direct the sample.
In the analogous art of a microfluidic device may include a fluid channel defined in a substrate, an impedance sensor positioned within the fluid channel, and control logic, Anderson teaches:
a fluid sensor (referred to as an impedance sensor [Para 0022]) operable to produce a signal (referred to as analog signal [Para 0022]) indicative of a position (‘location’) of a liquid (See Para 0022…analog signal that correlates with an amount of fluid within the fluid channel, the amount of fluid defining the location within the fluid channel at which the fluid is present) in the microfluidic channel (referred to as fluid channel [Para 0022]); and
a controller (See Para 0040…The control logic (120) of Fig. 1 may be any combination of hardware and computer-readable program code that is executed to force a current into the impedance sensors (103)) coupled to (See Para 0040..force current into…) the fluid sensor (See Para 0040…impedance sensors) and operable to cause the at least one pump (See Para 0041… the control logic (120) may send an activation signal to a pump device) to repetitively direct a liquid sample (See Para 0017…sample fluid; See Para 0032…solution based samples; Para 0041…the fluid) to a plurality of reaction zones (See Para 0074… a respective m-reaction chamber (501 -1 , 501- 2, collectively referred to herein as 501 )).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Enzelberger to include a fluid sensor operable to produce a signal indicative of a position of a liquid in the microfluidic channel; and a controller coupled to the fluid sensor and operable to cause the pump to repetitively direct the sample, as taught by Anderson for the benefit of achieving accurate and precise control of the movement of fluids within the various passageways within a microfluidic device (Anderson, Para 0019), allowing for the provision of microfluidic devices capable of processing low volumes of fluids to achieve multiplexing, automation, and high-throughput screening towards point of care diagnostics for medical diagnostics, food analysis, environmental monitoring, drug screening and other point of care applications (Anderson, Para 0016, 0017).
In addition, Claim 21 recites a fluid sensor, a controller and a pump then recites how the fluid sensor, the controller and the pump functions.
Claim 21 is an apparatus claim and MPEP 2114 recites that "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding Claim 22, the apparatus of claim 10 is obvious over Enzelberger in view of Broyer in further view of Pugliese (See Claim 10 rejection).
Enzelberger further teaches the microchannel (referred to as flow channel [Para 0104; Fig. 2, ref. 210]) and
the at least one pump (referred to as any of the peristaltic pumps, See Fig. 5, refs. 508) to direct (See Para 0008… one or more pumps for transporting fluid…) a sample (referred to as sample [Para 0097]) to a selected reaction zone (referred to as any of the three reaction chambers [Para 0102; Fig. 2, refs. 208a, 208b, 208c; Also See Para 0009…sample within the plurality of reaction chambers is collected at one of the plurality of reaction chambers).
Enzelberger does not teach:
a fluid sensor operable to produce a signal indicative of a position of a liquid in the microfluidic channel; and
a controller coupled to the fluid sensor and operable to cause the pump to direct a sample to a selected reaction zone.
In the analogous art of a microfluidic device may include a fluid channel defined in a substrate, an impedance sensor positioned within the fluid channel, and control logic, Anderson teaches:
a fluid sensor (referred to as an impedance sensor [Para 0022]) operable to produce a signal (referred to as analog signal [Para 0022]) indicative of a position (‘location’) of a liquid (See Para 0022…analog signal that correlates with an amount of fluid within the fluid channel, the amount of fluid defining the location within the fluid channel at which the fluid is present) in the microfluidic channel (referred to as fluid channel [Para 0022]); and
a controller (See Para 0040…The control logic (120) of Fig. 1 may be any combination of hardware and computer-readable program code that is executed to force a current into the impedance sensors (103)) coupled to (See Para 0040..force current into…) the fluid sensor (See Para 0040…impedance sensors) and operable to cause the at least one pump (See Para 0041… the control logic (120) may send an activation signal to a pump device) to repetitively direct a liquid sample (See Para 0017…sample fluid; See Para 0032…solution based samples; Para 0041…the fluid) to a selected reaction zone (See Para 0074… any of a respective m-reaction chamber (501 -1 , 501- 2, collectively referre