DETAILED ACTION
In application filed on 07/09/2024, Claims 22-43 are pending. The claim set submitted on 12/22/2024 is considered because this is the most recent claim set with some preliminary amendments. Claims 22-36 and 43 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 09/24/2024, 02/12/2026 and 06/22/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 06/22/2026 is acknowledged. Claims 37-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/22/2026.
Group I, Claims 22-36 and 43 are considered on the merits below.
Claim Rejections - 35 USC § 112
Claims 23-27, 29, 31 and 33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 23 , 29 and 31 and 32 recites the limitation “an actuation force”.
Is this “an actuation force” same as the “an actuation force” in Claim 22?
For the purpose of expedited prosecution, Examiner interprets “an actuation force” in Claims 23, 29 and 31 as “the actuation force”.
Appropriate correction is required.
Moreover, Claims 24-27 are rejected by virtue of dependency on Claim 23.
Claim 25 recites the limitation " said amplification well pouch sealing layer" in the claim. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of expedited prosecution, the limitation " said amplification well pouch sealing layer" is interpreted by the Examiner as "sealing layer".
Moreover, Claims 26-27 are rejected by virtue of dependency on Claim 25.
Claim 32 recites the limitation " said plurality of reagent wells" in the claim. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of expedited prosecution, the limitation " said plurality of reagent wells" is interpreted by the Examiner as "a plurality of reagent wells".
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 22-27, 29-32, 35-36 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over by Battrell et al. (US20100112723A1, submitted in IDS on 09/04/2024) in view of Kayyem et al. (US20140194305A1, submitted in IDS on 09/04/2024) and further in view of Koeda (US20130210081A1).
Regarding 22, Battrell teaches a microfluidic device (See Abstract… Microfluidic cartridges for agglutination reaction) comprising:
a reagent-dispensing unit (referred to as reagent dispensing apparatus (1007) [Para 0186]) comprising at least one reagent pouch (referred to as a reagent pouch (1005) [Para 0187]; or reagent pack [Para 0086])) comprising one or more reagents (See Para 0188…an dispensing reagent) and a sealing layer (referred to as Foil Pouch: an on-board liquid reagent-filled pack or sacculus mounted under an elastic (or deformable) diaphragm, intended to be ruptured when the reagent is needed [Para 0086]);
a microfluidic cartridge (referred to as microfluidic cartridge [Para 0081]) comprising a plurality of wells (See Para 0081… with internal fluid-handling mesostructures by convention having at least one dimension less than 500 mm. These fluidic structures may include microfluidic channels, chambers,…vents, vias, …inlets, nipples, and … means, for example.); and
at least one plunger (referred to as diaphragm [Para 0086]) configured to contact (See Para 0086…diaphragm forces the reagent pack) said at least one reagent pouch (referred to as a reagent pouch (1005) [Para 0187]; or reagent pack [Para 0086])) and apply an actuation force (‘pressure on the diaphragm) to said at least one reagent pouch (referred to as a reagent pouch (1005) [Para 0187]; or reagent pack [Para 0086])) to rupture said sealing layer (See Para 0086…A “sharp” such as a metal chevron or plastic spike, is place beneath the reagent pack so that pressure on the diaphragm forces the reagent pack against the sharp and ruptures it) and dispense (See Para 0030…the whole blood sample stream and the hydrated antibody reagent stream are introduced into a common microfluidic reaction channel and flow one on top of the other until they exit the channel) said one or more reagents (See Para 0188…an dispensing reagent) to said plurality of wells (See Para 0081… with internal fluid-handling mesostructures by convention having at least one dimension less than 500 mm. These fluidic structures may include microfluidic channels, chambers,…vents, vias, …inlets, nipples, and … means, for example.).
Battrell does not teach:
at least one actuator element comprising spatially oriented magnets;
wherein said microfluidic cartridge is configured to receive magnetic particles;
wherein said microfluidic cartridge and said at least one actuator element are positioned proximate and substantially parallel to each other, and wherein rotation of said microfluidic cartridge causes the spatially oriented magnets to transport said magnetic particles between said wells.
In the analogous art of biochip cartridges and instrument devices for the detection and/or analysis of target analytes from patient samples, Kayyem teaches:
at least one actuator element (referred to as magnetic actuator [Para 0086]; or magnets [Para 0143]; See Para 0243…magnetic actuators) comprising spatially oriented magnets (referred to as magnetic actuator [Para 0086]; or magnets [Para 0143]; See Para 0243…magnetic actuators; Examiner, under BRI, submits that the magnets having a position as part of the device are spatially oriented);
wherein said microfluidic cartridge (referred to as biochip cartridges and instrument devices]) is configured to receive magnetic particles (See Para 0007…the LRM further comprises an aliquot of capture beads, particularly magnetic capture beads);
wherein said microfluidic cartridge (referred to as biochip cartridges and instrument devices]) and said at least one actuator element (referred to as magnetic actuator [Para 0086]; or magnets [Para 0143]; See Para 0243…magnetic actuators) are positioned proximate and substantially parallel to each other (See Para 0250…these magnetic actuator(s) are found in the top bay, although they may also be found in the bottom bays, or both….optionally using more than one magnetic actuators in more than one location in the top bay. , thereby teaching “positioned proximate and substantially parallel to each other” ), and wherein rotation (See Para 0249… The rapidly rotating (thousands rpm) “impeller” is associated with a lysis “bead beating” chamber, (in contrast to the mixing chamber which usually employs a slowly rotating (about 100 rpm) “mixing paddle”, thereby teaching “rotation”) of said microfluidic cartridge (referred to as biochip cartridges and instrument devices]) causes the spatially oriented magnets (referred to as magnetic actuator [Para 0086]; or magnets [Para 0143]; See Para 0243…magnetic actuators; Examiner, under BRI, submits that the magnets having a position as part of the device are spatially oriented) to transport said magnetic particles (See Para 0007…the LRM further comprises an aliquot of capture beads, particularly magnetic capture beads) between said wells (referred to as LRM (Para 0007).
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 microfluidic device of Battrell to include: at least one actuator element comprising spatially oriented magnets; wherein said microfluidic cartridge is configured to receive magnetic particles; and wherein said microfluidic cartridge and said at least one actuator element are positioned proximate and substantially parallel to each other, and wherein rotation of said microfluidic cartridge causes the spatially oriented magnets to transport said magnetic particles between said wells, as taught by Kayyem for the benefit of holding the beads in place (Kayyem, Para 0086), allowing for the detection and/or analysis of target analytes from patient samples (Kayyem, Abstract).
The combination of Battrell and Kayyem does not teach “wherein said microfluidic cartridge is configured for a) incremental forwards and backwards rotation about a central axis and in a predetermined sequence corresponding to steps in an assay process sequence, or b) continuous rotation for less than or equal to 360 degrees about a central axis”.
In the analogous art of a biological sample reaction apparatus, Koeda teaches “wherein said microfluidic cartridge (referred to as a thermal cycler [Abstract]) is configured for b) continuous rotation for less than or equal to 360 degrees about a central axis (See Para 0007…. the biological sample reaction apparatus disclosed in the JP-A-2009-136250 applies thermal cycles to the reaction mixture by continuously rotating the biological sample reaction chip. However, the reaction mixture moves in a chamber of the biological sample reaction chip along the continuous rotation …; Examiner under BRI submits that a 360 degrees turn implies a rotation).
The limitation “a) incremental forwards and backwards rotation about a central axis and in a predetermined sequence corresponding to steps in an assay process sequence, or” is viewed as optional and thus not required by the claim.
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 microfluidic device of Battrell and Kayemm to include “wherein said microfluidic cartridge is configured for a) incremental forwards and backwards rotation about a central axis and in a predetermined sequence corresponding to steps in an assay process sequence, or b) continuous rotation for less than or equal to 360 degrees about a central axis” for the benefit of keeping the reaction mixture at a desired temperature for a desired period of time (Koeda, Para 0007), allowing for the provision of biotips or reaction apparatuses that realize PCR that is accurate, requires a shorter period of time, and uses a minimized amount of reagent and sample (Koeda, Para 0005).
In addition, Claim 22 recites a microfluidic device and then recites how the microfluidic device functions with respect to the magnets and wells. Claim 22 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 23, the microfluidic device of claim 22 is obvious over Battrell in view of Kayyem and further in view of Koeda.
The combination of Battrell and Koeda does not teach that the said plurality of wells comprises at least one amplification well coupled to an amplification well pouch comprising a sealing layer and a sharp object or protrusion configured to rupture said sealing layer and dispense an amplified product contained within said amplification well when an actuation force is applied to the amplification well pouch.
In the analogous art of biochip cartridges and instrument devices for the detection and/or analysis of target analytes from patient samples, Kayyem teaches that the said plurality of wells (referred to as amplification area which is divided into three zones, that can be used individually (e.g. three droplets are processed essentially simultaneously [Para 0087]) comprises at least one amplification well (See Para 0087…any of the three zones of the amplification area) coupled to an amplification well pouch (referred to as blister 182 [Para 0215]) comprising a sealing layer (referred to as internal dimple 184 [Para 0215]) and a sharp object or protrusion (referred to as fixed spike [Para 0215]) configured to rupture (See Para 0215… The inverted dimple is punctured by the fixed spike 186) said sealing layer (referred to as internal dimple 184 [Para 0215]) and dispense an amplified product (See Para 0215…permitting fluid within the blister 182 to flow) contained within said amplification well (See Para 0087…any of the three zones of the amplification area) when an actuation force (See Para 0215…he inverted dimple is punctured by the fixed spike, thereby teaching “ an actuation force” ) is applied to the amplification well pouch (referred to as blister 182 [Para 0215]).
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 microfluidic device of Battrell and Koeda to include that the said plurality of wells comprises at least one amplification well coupled to an amplification well pouch comprising a sealing layer and a sharp object or protrusion configured to rupture said sealing layer and dispense an amplified product contained within said amplification well when an actuation force is applied to the amplification well pouch, as taught by Kayyem for the benefit of allowing for fluid to flow within the biochip cartridges and instrument devices (Kayyen, Para 0215), allowing for for the detection and/or analysis of target analytes from patient samples (Kayyem, Abstract).
In addition, Claim 23 recites a microfluidic device of Claim 22 and then recites how microfluidic device of Claim 22 functions. Claim 23 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 24, the microfluidic device of claim 23 is obvious over Battrell in view of Kayyem and further in view of Koeda.
The combination of Battrell and Koeda does not teach that the at least one actuator element comprises a plurality of spatially oriented mechanical elements configured to apply said actuation force to said amplification well pouch at a predefined time in an assay sequence and actuate the at least one sharp object or protrusion to rupture the sealing layer.
In the analogous art of biochip cartridges and instrument devices for the detection and/or analysis of target analytes from patient samples, Kayyem teaches that the at least one actuator element (referred to as magnetic actuator [Para 0086]; or magnets [Para 0143]; See Para 0243…magnetic actuators) comprises a plurality of spatially oriented mechanical elements configured to apply said actuation force to said amplification well pouch (referred to as blister 182 [Para 0215]) at a predefined time in an assay sequence (See Para 0174… In addition, the blisters can be ruptured and the reagents held in place as needed until dispensing; e.g. the release of the reagents can be time separated from dispensing the reagents) and actuate the at least one sharp object or protrusion (referred to as fixed spike [Para 0215]) to rupture (See Para 0215… The inverted dimple is punctured by the fixed spike 186) the sealing layer (referred to as internal dimple 184 [Para 0215]).
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 microfluidic device of Battrell and Koeda to include that the at least one actuator element comprises a plurality of spatially oriented mechanical elements configured to apply said actuation force to said amplification well pouch at a predefined time in an assay sequence and actuate the at least one sharp object or protrusion to rupture the sealing layer, as taught by Kayyem for the benefit allowing the generation of magnetic fields on all or part of the biochip as needed, for example to collect and wash magnetic beads that have adhered nucleic acid target samples (Kayyem, Para 0243), allowing for for the detection and/or analysis of target analytes from patient samples (Kayyem, Abstract).
In addition, Claim 24 recites a microfluidic device of Claim 23 and then recites how microfluidic device of Claim 23 functions. Claim 24 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 25, the microfluidic device of claim 23 is obvious over Battrell in view of Kayyem and further in view of Koeda.
Battrell teaches wherein said microfluidic cartridge (referred to as microfluidic cartridge [Para 0081]) further comprises an integrated lateral flow strip (See Para 0028…These tests also require a gel reader and a centrifuge. Some type of physical barrier (e.g., column/gel matrices, lateral flow strips, or separation membranes) is used separate free red cells and agglutinated red cell clumps. The separation step inherently results in a longer time to test result.) separated from; to said lateral flow strip for detection (See Para 0021…These tests also require a gel reader and a centrifuge. Some type of physical barrier (e.g., column/gel matrices, lateral flow strips, or separation membranes) is used separate free red cells and agglutinated red cell clumps. The separation step inherently results in a longer time to test result.).
The combination of Battrell and Koeda does not teach that “said amplification well by said amplification well pouch sealing layer, wherein rupture of said amplification well pouch allows said amplification product to flow”.
In the analogous art of biochip cartridges and instrument devices for the detection and/or analysis of target analytes from patient samples, Kayyem teaches that said amplification well (See Para 0087…any of the three zones of the amplification area) by said amplification well pouch sealing layer (referred to as internal dimple 184 [Para 0215]), wherein rupture (See Para 0174… Other embodiments use a uniform blister material that can only rupture in a particular location (e ) of said amplification well pouch (referred to as blister 182 [Para 0215]) allows said amplification product to flow (See Para 0174.. the blisters can be ruptured and the reagents held in place as needed until dispensing; e.g. the release of the reagents can be time separated from dispensing the reagents; See Para 0113… (i.e. in the case of nucleic acids, the sample may be the products of an amplification reaction, including both target and signal amplification as is generally described in PCT/US99/01705, such as PCR amplification reaction).)
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 microfluidic device of Battrell and Koeda to include that ““said amplification well by said amplification well pouch sealing layer, wherein rupture of said amplification well pouch allows said amplification product to flow”, as taught by Kayyem, for the benefit of facilitating PCR reactions on the chip (Kayyem, Para 0020), allowing for for the detection and/or analysis of target analytes from patient samples (Kayyem, Abstract).
In addition, Claim 25 recites a microfluidic device of Claim 24 and then recites how microfluidic device of Claim 24 functions. Claim 25 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 26, the microfluidic device of claim 24 is obvious over Battrell in view of Kayyem and further in view of Koeda.
The combination of Battrell and Koeda does not teach the said at least one actuator element comprises one or more spatially oriented heater elements configured to provide stable single temperature heat or thermal cycling for isothermal or polymerase chain reaction (PCR) based amplification of nucleic acids.
In the analogous art of biochip cartridges and instrument devices for the detection and/or analysis of target analytes from patient samples, Kayyem teaches that said at least one actuator element (referred to as magnetic actuator [Para 0086]; or magnets [Para 0143]; See Para 0243…magnetic actuators) comprises one or more spatially oriented heater elements (See Para 0020… each bay comprises at least a first off resistive chip heater and/or a second off chip Peltier heater; See Para 0086… (in this case, provided by resistive heaters) configured to provide stable single temperature heat or thermal cycling for isothermal or polymerase chain reaction (PCR) based amplification of nucleic acids (See Para 0152… on-chip thermal components, e.g. resistive heaters for PCR thermocycling, are used. In this embodiment, resistive heater(s) can be placed underneath the electrode grid pathway of pads to result in thermal zones for amplification, exonuclease digestion, reverse transcription, target elution, and the electrochemical detection).
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 microfluidic device of Battrell and Koeda to include that the said at least one actuator element comprises one or more spatially oriented heater elements configured to provide stable single temperature heat or thermal cycling for isothermal or polymerase chain reaction (PCR) based amplification of nucleic acids, as taught by Kayyem, for the benefit of facilitating PCR reactions on the chip (Kayyem, Para 0020), allowing for for the detection and/or analysis of target analytes from patient samples (Kayyem, Abstract).
In addition, Claim 26 recites a microfluidic device of Claim 25 and then recites how microfluidic device of Claim 25 functions. Claim 26 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 27, the microfluidic device of claim 26 is obvious over Battrell in view of Kayyem and further in view of Koeda.
The combination of Battrell and Koeda does not teach wherein said at least one actuator element comprises a first actuator element comprising said spatially oriented magnets and a second actuator element comprising said one or more spatially oriented heater elements, and wherein said microfluidic cartridge is sandwiched between said first actuator element and said second actuator element.
In the analogous art of biochip cartridges and instrument devices for the detection and/or analysis of target analytes from patient samples, Kayyem teaches that wherein said at least one actuator element (referred to as magnetic actuator [Para 0086]; or magnets [Para 0143]; See Para 0243…magnetic actuators) comprises a first actuator element (See Para 0243…any one of the magnetic actuators) comprising said spatially oriented magnets (See Para 0143… beads bound with the target analytes are manipulated using magnets; See Para 0086…e.g. by holding the beads in place using a magnetic actuator ) and a second actuator element (See Para 0243…another of the any one of the magnetic actuators) comprising said one or more spatially oriented heater elements (See Para 0020… each bay comprises at least a first off resistive chip heater and/or a second off chip Peltier heater; See Para 0086… (in this case, provided by resistive heaters), and wherein said microfluidic cartridge (See Abstract…This invention provides biochip cartridges and instrument devices for the detection and/or analysis of target analytes from patient samples.) is sandwiched between (See Para 0251…the bays each optionally comprise a capture and latching mechanism to control both the positioning of the consumable (e.g. the loading of the cartridge in the correct orientation), thereby teaching “sandwiched between” ) said first actuator element (See Para 0243…any one of the magnetic actuators) and said second actuator element (See Para 0243…another of the any one of the magnetic 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 microfluidic device of Battrell and Koeda to include that “wherein said at least one actuator element comprises a first actuator element comprising said spatially oriented magnets and a second actuator element comprising said one or more spatially oriented heater elements, and wherein said microfluidic cartridge is sandwiched between said first actuator element and said second actuator element” , as taught by Kayyem, for the benefit allowing the generation of magnetic fields on all or part of the biochip as needed, for example to collect and wash magnetic beads that have adhered nucleic acid target samples (Kayyem, Para 0243), allowing for for the detection and/or analysis of target analytes from patient samples (Kayyem, Abstract).
In addition, Claim 27 recites a microfluidic device of Claim 26 and then recites how microfluidic device of Claim 26 functions. Claim 27 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 29, the microfluidic device of claim 22 is obvious over Battrell in view of Kayyem and further in view of Koeda.
Battrell teaches:
at least one inlet conduit (referred to as sample port 103 [Para 0170]);
at least one reagent well (referred to as reagent pouch [Para 0193]);
at least one waste well (referred to as a suction pressure pulse distribution channel in turn connected to the downstream termini of the reaction channels [Para 0191]);
wherein the inlet conduit (referred to as sample port 103 [Para 0170]), the reagent well (referred to as reagent pouch [Para 0193]), and the waste well (referred to as a suction pressure pulse distribution channel in turn connected to the downstream termini of the reaction channels [Para 0191]) are fluidically connected and configured such that there is an interface between the sealing layer (referred to as Foil Pouch: an on-board liquid reagent-filled pack or sacculus mounted under an elastic (or deformable) diaphragm, intended to be ruptured when the reagent is needed [Para 0086]) of said at least one reagent pouch (referred to as a reagent pouch (1005) [Para 0187]; or reagent pack [Para 0086])) and the inlet conduit (referred to as sample port 103 [Para 0170]) such that one or more reagents (See Para 0188…an dispensing reagent)are delivered into the reagent well (referred to as reagent pouch [Para 0193]) via the inlet conduit (referred to as sample port 103 [Para 0170]) when an actuation force is applied to the at least one reagent pouch (referred to as a reagent pouch (1005) [Para 0187]; or reagent pack [Para 0086])) of the reagent dispensing unit (referred to as reagent dispensing apparatus (1007) [Para 0186]) and any excess reagent (See Para 0153… Passive flow in the downstream flow control channel is sustained until the excess upstream liquid volume is emptied or until capillary force no longer overcomes resistance.) that overflows out of the reagent well (referred to as reagent pouch [Para 0193]) is collected in the waste well (referred to as a suction pressure pulse distribution channel in turn connected to the downstream termini of the reaction channels [Para 0191]).
In addition, Claim 29 recites a microfluidic device of Claim 22 and then recites how microfluidic device of Claim 22 functions. Claim 29 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 30, the microfluidic device of claim 22 is obvious over Battrell in view of Kayyem and further in view of Koeda.
The combination of Battrell and Koeda does not teach a locking mechanism configured to lock the at least one plunger in a depressed position, thereby preventing backflow of said one or more reagents into the at least one reagent pouch.
In the analogous art of biochip cartridges and instrument devices for the detection and/or analysis of target analytes from patient samples, Kayyem teaches: a locking mechanism (referred to as hinge top [Para 0136]; See Para 0136… In some embodiments, the sealing mechanism includes a clip, lock or tab that, once closed, will permanently prevent accidental reopening without compromising the integrity of the cartridge) configured to lock the at least one plunger (See Para 0225… the plunger 274 ) in a depressed position (See Para 0225… actuating the plunger 274 downwardly into the aperture ) , thereby preventing backflow of said one or more reagents (‘a fluid’) into the at least one reagent pouch (‘a liquid regent module (LRM) comprising a plurality of blisters ‘) (See Para 0182… one way valves find use, such that a fluid is moved from the LRM into the chamber volume and cannot backflow or return to the LRM.).
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 microfluidic device of Battrell and Koeda to include: a locking mechanism configured to lock the at least one plunger in a depressed position, thereby preventing backflow of said one or more reagents into the at least one reagent pouch, as taught by Kayyem for the benefit of preventing accidental reopening of the sample entry port without compromising the integrity of the cartridge (Kayyem, Para 0136), allowing for the detection and/or analysis of target analytes from patient samples (Kayyem, Abstract).
In addition, Claim 30 recites a microfluidic device of Claim 22 and then recites how microfluidic device of Claim 22 functions. Claim 30 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 31, the microfluidic device of claim 30 is obvious over Battrell in view of Kayyem and further in view of Koeda.
The combination of Battrell and Koeda does not teach that the locking mechanism comprises barbed pins inside a locking bore configured to restrict the motion of the at least one plunger to a direction that facilitates the depressing of the at least one reagent pouch during the application of actuation force.
In the analogous art of biochip cartridges and instrument devices for the detection and/or analysis of target analytes from patient samples, Kayyem teaches that the locking mechanism (referred to as hinge top [Para 0136]; See Para 0136… In some embodiments, the sealing mechanism includes a clip, lock or tab that, once closed, will permanently prevent accidental reopening without compromising the integrity of the cartridge) comprises barbed pins (See Para 0136…lock; See Para 0244…lock-in mechanisms, etc.; See Para 0097…several suitable latching mechanisms for locking the chip into the bay) inside a locking bore (See Para 0097…alignment pin holes) configured to restrict the motion (See Para 0097…in a biochip cartridge to “lock in” the electrode/pogo connectors.) of the at least one plunger (See Para 0225… plunger 274) to a direction that facilitates the depressing (See Para 0225…The blister 262 is collapsed by actuating the plunger 274 downwardly into the aperture 272) of the at least one reagent pouch (referred to as ‘a liquid regent module (LRM) comprising a plurality of blisters [Para 0007]; See Para 0223…Plunger 274 is disposed above the blister housing cover 270)) during the application of actuation force (See Para 0215…the inverted dimple is punctured by the fixed spike, thereby teaching “ an actuation force”).
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 microfluidic device of Battrell and Koeda to include that the locking mechanism comprises barbed pins inside a locking bore configured to restrict the motion of the at least one plunger to a direction that facilitates the depressing of the at least one reagent pouch during the application of actuation force, as taught by Kayyem for the benefit of preventing accidental reopening of the sample entry port without compromising the integrity of the cartridge (Kayyem, Para 0136), allowing for the detection and/or analysis of target analytes from patient samples (Kayyem, Abstract).
In addition, Claim 31 recites a microfluidic device of Claim 30 and then recites how microfluidic device of Claim 30 functions. Claim 31 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 32, the microfluidic device of claim 22 is obvious over Battrell in view of Kayyem and further in view of Koeda.
Battrell teaches that said microfluidic cartridge (referred to as microfluidic cartridge [Para 0081]) comprises a primary channel (referred to as a microfluidic reaction channel[Abstract]) connecting said plurality of reagent wells (See Abstract… with at least two intake channels).
In addition, Claim 32 recites a microfluidic device of Claim 22 and then recites how microfluidic device of Claim 22 functions. Claim 32 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 35, the microfluidic device of claim 22 is obvious over Battrell in view of Kayyem and further in view of Koeda.
Battrell teaches comprising a sample inlet port (referred to as a sample inlet well (1602) [Para 0202]) through which a sample may be injected introduced (See Para 0202… A sample 1601 may be introduced into a sample inlet well (1602) and will fill sample inlet channel or distribution manifold 1603) into the microfluidic device (See Abstract… Microfluidic cartridges for agglutination reaction; See Para 0202…a device).
In addition, Claim 35recites a microfluidic device of Claim 22 and then recites how microfluidic device of Claim 22 functions. Claim 35 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 36, the microfluidic device of claim 30 is obvious over Battrell in view of Kayyem and further in view of Koeda.
Battrell teaches wherein said microfluidic cartridge (referred to as microfluidic cartridge [Para 0081]) comprises one or more lyophilized or gel reagents (See Para 0209…A droplet (2002) of a solution is generally printed or pipetted into the channel (2001) and allowed to dry with heating or by lyophilization….The dried material containing surfactant is rapidly rehydrated by a reagent or by a sample entering the channel).
In addition, Claim 36 recites a microfluidic device of Claim 22 and then recites how microfluidic device of Claim 22 functions. Claim 36 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 43, the microfluidic device of claim 22 is obvious over Battrell in view of Kayyem and further in view of Koeda.
The combination of Battrell and Koeda does not teach a single motor configured to power said microfluidic device and complete an assay process
In the analogous art of biochip cartridges and instrument devices for the detection and/or analysis of target analytes from patient samples, Kayyem teaches a single motor (See Para 0249… one or more mixing motor(s) to drive impeller(s) of the mixing chamber(s)) configured to power (See Para 0249… to drive impeller(s) of the mixing chamber(s). The impellers can also be magnetically driven, removing the need to mechanically couple their movement) said microfluidic device (See Abstract… biochip cartridges and instrument devices for the detection and/or analysis of target analytes from patient samples.) and complete an assay process (See Para 0015… The lighting component indicates the status of the bay, which status can independently and optionally be selected from the group consisting of empty, cartridge present, cartridge assay underway, cartridge assay complete, and error).
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 microfluidic device of Battrell and Koeda to include a single motor configured to power said microfluidic device and complete an assay process, as taught by Kayyem for the benefit of driving impeller(s) of the mixing chamber(s) (Kayyem, Para 0249), allowing for the detection and/or analysis of target analytes from patient samples (Kayyem, Abstract).
In addition, Claim 43 recites a microfluidic device of Claim 22 and then recites how microfluidic device of Claim 22 functions. Claim 43 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 28 is rejected under 35 U.S.C. 103 as being unpatentable over Battrell et al. (US20100112723A1, submitted in IDS on 09/04/2024) in view of Kayyem et al. (US20140194305A1, submitted in IDS on 09/04/2024) and further in view of Koeda (US20130210081A1) as applied to claim 22 above, and further in view of Anderson et al. (US20110201099A1)
Regarding Claim 28, the microfluidic device of claim 22 is obvious over Battrell in view of Kayyem and further in view of Koeda.
The combination of Battrell, Kayyem and Koeda does not teach that said continuous rotation is powered by a wind-up spring.
In the analogous art of assay cartridges are described that have a detection chamber, preferably having integrated electrodes, and other fluidic components which may include sample chambers, waste chambers, conduits, vents, bubble traps, reagent chambers, dry reagent pill zones, Anderson teaches that said continuous rotation (See Para 0028…rotating) is powered by a wind-up spring (referred to as a spring loaded rotating latch [Para 0028]).
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 microfluidic device of Battrell, Kayyem and Koeda to include that said continuous rotation is powered by a wind-up spring, as taught by Anderson for the benefit of providing for the rotation of the latch (Anderson, Para 0028), allowing for the provision of diagnostics systems that are small enough and easy enough to use so that they can be used by unskilled operators in decentralized clinical settings, but at the same time maintaining the low cost, diverse assay menu, and/or high performance of tests carried out on traditional clinical analyzers in central laboratories (Anderson, Para 0005).
Claims 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Battrell et al. (US20100112723A1, submitted in IDS on 09/04/2024) in view of Kayyem et al. (US20140194305A1, submitted in IDS on 09/04/2024) and further in view of Koeda (US20130210081A1) as applied to claim 22 above, and further in view of Ching et al. (US20160101421A1)
Regarding Claim 33, the microfluidic device of claim 22 is obvious over Battrell in view of Kayyem and further in view of Koeda.
The combination of Battrell and Koeda does not teach a plunger and a plurality of reagent pouches and wherein said plunger are configured to simultaneously apply said actuation force to each of the plurality of reagent pouches so as to dispense the one or more reagents from the plurality of reagent pouches simultaneously.
In the analogous art of biochip cartridges and instrument devices for the detection and/or analysis of target analytes from patient samples, Kayyem teaches that a plunger (referred to as plunger [Para 0223]) and a plurality of reagent pouches (referred to as a plurality of blisters [Para 0007]) and wherein said plunger (referred to as plunger [Para 0223]) is configured to simultaneously apply said actuation force (See Para 0225…The blister 262 is collapsed by actuating the plunger 274 downwardly in the aperture 272. Plunger 274 may be actuated by any suitable mechanism,) to each of the plurality of reagent pouches (referred to as a plurality of blisters [Para 0007]) so as to dispense the one or more reagents (See Para 0225… plunger 274 presses the actuator plate 276 against the blister 262, thereby collapsing the blister 262 and displacing fluid from the blister 262) from the plurality of reagent pouches simultaneously(referred to as a plurality of blisters [Para 0007]).
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 microfluidic device of Battrell and Koeda to include a plunger and a plurality of reagent pouches and wherein said plunger are configured to simultaneously apply said actuation force to each of the plurality of reagent pouches so as to dispense the one or more reagents from the plurality of reagent pouches simultaneously, as taught by Kayyem for the benefit of displacing fluid from the blister (Kayyem, Para 0225), allowing for the detection and/or analysis of target analytes from patient samples (Kayyem, Abstract).
The combination of Battrell, Kayyem and Koeda does not a plurality of plungers.
In the analogous art of an apparatus includes a housing, a reaction vial and a transfer mechanism, Ching teaches a plurality of plungers (See Para 0210…The reagent plungers 6214 a, 6214 b, 6214 c can be contacted and/or actuated by an actuation assembly of an instrument, such as, for example, the actuation assembly 3600 of the instrument 3002 described herein).
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 microfluidic device of Battrell , Kayyem and Koeda to include a plurality of plungers, as taught by Ching for the benefit of introducing the reagents into the elution chamber 6190 via the passageways (Ching, Para 0215), allowing for the provision of improved apparatus and methods for performing nucleic acid isolation, amplification and detection (Ching, Para 0010).
In addition, Claim 33 recites a microfluidic device of Claim 22 and then recites how microfluidic device of Claim 22 functions. Claim 33 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 34, the microfluidic device of claim 22 is obvious over Battrell in view of Kayyem and further in view of Koeda.
The combination of Battrell and Koeda does not teach a plunger and a plurality of reagent pouches, wherein said plunger comprise spatially oriented protrusions with varying depths so as to make contact with a desired reagent pouch from among the plurality of reagent pouches in a predetermined sequence so as to sequentially dispense the one or more reagents into the microfluidic cartridge.
In the analogous art of biochip cartridges and instrument devices for the detection and/or analysis of target analytes from patient samples, Kayyem teaches a plunger (referred to as plunger [Para 0223]) and a plurality of reagent pouches (referred to as a plurality of blisters [Para 0007]), wherein said plunger (referred to as plunger [Para 0223]) comprise spatially oriented protrusion (See Para 0223… a plunger point 275) with varying depth (under BRI, a plunger point can have any depth)…See Para 0223… a plunger point 275) so as to make contact with a desired reagent pouch (referred to as any of a plurality of blisters [Para 0007]) from among the plurality of reagent pouches (referred to as a plurality of blisters [Para 0007]) in a predetermined sequence so as to sequentially (See Para 0290…The instrument, comprising a CPU, then executes a number of operational steps to initiate and complete the appropriate assay and generate a patient report.) dispense the one or more reagents (See Para 0225… plunger 274 presses the actuator plate 276 against the blister 262, thereby collapsing the blister 262 and displacing fluid from the blister 262) into the microfluidic cartridge(referred to as biochip cartridges and instrument devices]).
The combination of Battrell, Kayyem and Koeda does not a plurality of plungers.
In the analogous art of an apparatus includes a housing, a reaction vial and a transfer mechanism, Ching teaches a plurality of plungers (See Para 0210…The reagent plungers 6214 a, 6214 b, 6214 c can be contacted and/or actuated by an actuation assembly of an instrument, such as, for example, the actuation assembly 3600 of the instrument 3002 described herein).
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 microfluidic device of Battrell , Kayyem and Koeda to include a plurality of plungers, as taught by Ching for the benefit of introducing the reagents into the elution chamber 6190 via the passageways (Ching, Para 0215), allowing for the provision of improved apparatus and methods for performing nucleic acid isolation, amplification and detection (Ching, Para 0010).
In addition, Claim 34 recites a microfluidic device of Claim 22 and then recites how microfluidic device of Claim 22 functions. Claim 34 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
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