Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Claim in the reply filed on 10/13/2025 is acknowledged.
Claims 2, 3, 33-36, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected medical product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/13/2025.
Claims 1, 4-6, 10, 11, 13, 14, 24, 38-42 are pending examination in this response.
Claim Status
Claims 1, 4-6, 10, 11, 13, 14, 24, 38-42 are pending.
Claims 2, 3, 33-36 are withdrawn.
Claims 7-9, 12, 15-23, 25-32, 37 are canceled.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4, 5, 6, 10, 11, 13, 14, 38, 41, and 42 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.
Claim 1 recites the limitation "the target nucleic acid " in lines 16 and 17. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction to “the target nucleic acid sequence” is suggested.
Claims 4, 5, 6, 10, 11, 13, 14, 38, 41, and 42 depend on claim 1.
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.
Claims 1, 4, 5, 6, 10, 11, 13, 14, 38, 41, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Battrell et. al. (WO 2007106579 A2) in view of Zhou et. al. (US 9132398 B2).
Regarding claim 1, Battrell teaches a “ point-of-need diagnostic device” (Page 6, Offer differential laboratory diagnosis of a plurality of microbes or viruses in real time at the point-of-care) “for detecting a target nucleic acid sequence in a sample,” (Abstract, nucleic acid extraction, amplification, and detection from clinical samples are disclosed); “the device comprising a housing with a sample inlet for receiving the sample,” (Page 14 and 23,These fluidic structures may include chambers, valves, vents, vias, pumps, inlets, Both classes pneumatic control elements are similar in construction, comprising a liquid inlet, ) “wherein the housing contains therein:
(a) a nucleic acid binding stage” (Page 21, The assays of the present invention have three stages: extraction, amplification, and detection.) “that is optionally movable comprising a permeable nucleic acid binding substrate” (Page 17, Nucleic Acid Target Capture Assembly refers to a combination of a solid phase nucleic acid affinity binding substrate and a means for positioning the binding substrate in the fluid path of a microfluidic device. Binding substrates include filters, beads, frits, fluidized beds, and solid surfaces in general) “and an eluate outlet by which an eluate may exit the binding stage;” (Fig. 2 and Page 23, the nucleic acid eluate is transported through micro fluidic channels by ganged valves under pneumatic control into one or more channels or chambers for amplification.);
“(b) a wash reservoir containing a wash buffer;” (Page 24, The magnetic capture beads are typically stored in a dried form and are reconstituted with rehydration and wash buffer from the rehydration and wash buffer pouch before mixing with the amplification products.)
“(c) an elution reservoir containing an elution buffer” (Page 22, Elution buffer pouch. By using the eluate itself as the rehydration medium for the dehydrated PCR mix in the amplification subcircuits, target sequences are not further diluted. Accordingly, elution buffer, by design, serves as PCR buffer. Elution buffer is designed to be bifunctional, and seamlessly integrates sample preparation and PCR amplification in a way not previously attempted at the microscale.);
”(d) a amplification stage” (Page 21, The assays of the present invention have three stages: extraction, amplification, and detection.) ”that is optionally movable comprising an eluate inlet for receiving the eluate from the nucleic acid binding stage” (Page 23, Turning now to Fig. 2, the nucleic acid eluate is transported through micro fluidic channels by ganged valves under pneumatic control into one or more channels or chambers for amplification.) “at least one reaction chamber comprising a nucleic acid amplification reagent,” (Pages 14, 23, and 28, These include single or multiple interfaces with interfacing reaction chambers on the cartridge. Obviously, other microchannels and functionalities may be added, for example a chamber between the nucleic acid capture assembly and the amplification assembly for use in forming cDNA from mRNA. These bellows chambers can be used, we have found, as reaction chambers, as in PCR. Exemplary reagents for a nucleic acid amplification reaction include, but are not limited to, buffer, metal ion (for example magnesium salt), chelator, polymerase, primer, template, nucleotide triphosphate, label, dye, nuclease inhibitor, and the like. Reagents for enzyme reactions include, for example, substrates, chromogens, cofactors, coupling enzymes, buffer, metal ions, inhibitors and activators. Not all reagents are reactants. Simultaneously, reagents and control template in the control amplification channel (which does not receive sample) are rehydrated with elution buffer directly from the elution buffer chamber. This negative control chamber is used to check for nucleic acid contamination in the device.)” and an amplicon outlet by which an amplified sample may exit the amplification stage; ”(Page 28, After the required number of cycles, the amplified material is expelled from the chambers to the detection station.)
“(e) a running buffer reservoir containing a running buffer; and” (Pages, 6, 14, and 25, reagents for a nucleic acid amplification reaction include, but are not limited to, buffer, metal ion (for example magnesium salt), chelator, polymerase, primer, template, nucleotide triphosphate, label, dye, nuclease inhibitor, and the like. Reagents for enzyme reactions include, for example, substrates, chromogens, cofactors, coupling enzymes, buffer, metal ions, inhibitors and activators. Not all reagents are reactants. A sample entry port, a nucleic acid target capture assembly chamber, a lysis buffer chamber, a wash reagent chamber, an elution buffer chamber, a rehydration buffer chamber, a vented waste chamber, a PCR fluidics and thermal interface assembly, a mag mixer chamber, a mag bead reservoir, and a detection chamber. The disclosed ' single-entry microfluidic devices utilize a plurality of microfluidic channels, valves, filters, pumps, liquid barriers, on-board reagent reservoirs, and other elements organized as a combination of fluidic subcircuits that extract nucleic acids from the sample, amplify putative target nucleic acid sequences, and detect assay results in a format accessible to the user.). Therefore the reagents which are buffers that are not a reactant teaches to the running buffer. The reagent reservoirs teach to the running buffer reservoir.
Further taught “(f) a detection device” (Page 7 and 34 and, multiplex detection devices. Other embodiments include an on-board "multiplex detection chamber", whereby multiple results, as from a panel of tests, are displayed in a user-friendly visual format.). The recitation “that provides a readout that indicates whether the target nucleic acid is present in the sample,” is capability of the detection device. Battrell discloses the positively claimed structural elements of the detection device as claimed, such detection device is said to be fully capable of the recited adaption in as much as recited and required herein.
Further the recitation “wherein the nucleic acid binding stage is configured such that it can be positioned to be in fluid communication with the sample inlet, the wash reservoir, the elution reservoir, and the amplification stage via the eluate outlet; wherein the amplification stage is configured to be in fluid communication with the running buffer reservoir and the detection device via the amplicon outlet” is capability of the nucleic acid binding stage and the amplification stage.
Battrell discloses the positively claimed structural elements of the nucleic acid binding stage and the amplification stage as claimed, such nucleic acid binding stage and amplification stage are said to be fully capable of the recited adaption in as much as recited and required herein.
Further Battrell teaches within Page 21, fluidic subcircuits which are integrated together to form a single device and therefore can be configured in such a way which is recited within the claims. (Page 21, The assays of the present invention have three stages: extraction, amplification, and detection. The microfluidic devices disclosed here are formed from three fluidic subcircuits corresponding to these functions integrated together in a single device.).
The recitation “wherein in the nucleic acid binding stage is optionally (i) configured to move in response to a mechanical force or a modulation in a magnetic potential or an electric potential” is optional capability of the nucleic acid binding stage.
Battrell discloses the positively claimed structural elements of the nucleic acid binding stage as claimed, such nucleic acid binding stage are said to be fully capable of the recited adaption in as much as recited and required herein.
Further Battrell teaches movement due to the use of a magnet within Page 37 which provides additional parts which would assist in the capability function of the nucleic acid binding stage. (Page 37, The beads were first captured with a magnet positioned on the bottom of the detection chamber and the excess solution was removed. The magnet was then used to smear the bead paste onto, through and across the test pads, and the mixture was then allowed to incubate 1 min. With the magnet positioned on the bottom of the well, the well was gradually filled with blocking solution. The magnet was moved along the flow of the buffer, creating a bead front on the bottom layer of the detection chamber.).
Further taught by Battrell is “(ii) comprises a sponge ramp;” (Page 17, Wick: is a bibulous material used to propulse fluid flow by capillary wetting in place of, or in concert with, microfluidic pumps. The bibulous core typically includes a fibrous web of natural or synthetic fibers, and also often includes certain absorbent gelling materials usually referred to as "hydrogels," "superabsorbent" or "hydrocolloid" materials. Materials include papers, sponges,); “(iii) the permeable nucleic acid binding substrate comprises laminated silica microspheres; or” (Page 12 and 17, These materials as used generally are particles having dimensions smaller than a magnetic domain, and may be formed into particles, beads or microspheres with binders such as latex polymers (generically), silica, as is generally well known and inclusive of such materials as are commercially available. Binding substrates include filters, beads, frits, fluidized beds, and solid surfaces in general. Materials include silica, derivatized silica, alumina, zirconia, treated latex beads, and the like.
The remaining of the claim 1 is optional as it recites any combination of features is optional. Although optional Battrell teaches to the any combination thereof in that: “(iv) any combination thereof; wherein the device optionally comprises one or more valves for controlling the migration of sample through the device;” (Page 21, A bellows pump and associated check valves is optionally used to effect fluid transport.).
Battrell does not explicitly teach the recitation “wherein the wash reservoir is optionally in fluid communication with a wash sponge or wash hopper; wherein the elution reservoir is optionally in fluid communication with an elution sponge or elution hopper.” However, as mentioned above, the feature is an optional feature. Further taught “wherein the housing is optionally configured to interface with a lysis cartridge;” (Page 35, In other embodiments, detection of cancer cells in blood or tissues is contemplated. Protocols for adapting mammalian cell lysis to a microfluidic card of the present invention are anticipated.).
Battrell does not explicitly teach “and wherein the housing is optionally configured to interface with a controller.” Battrell does teach a controller within (Pages 16 and 26 and Claims 44 and 48, Microfluidic valves: include a genus of hydraulic, mechanic, pneumatic, magnetic, and electrostatic actuator flow controllers with at least one dimension smaller than 500 urn. An apparatus of claim 43, wherein said PCR fluidics and thermal interface assembly comprises a pair of bellows pumps and two off-device thermal controllers with heat transfer elements, each thermal controller configured for operation at a fixed temperature and contacted with one of said pair of bellows pumps at said heat transfer element. The apparatus is run by a microprocessor with valve logic programming configured to control the pneumatic actuation of the valve and diaphragm elements.).
However, Zhou teaches microfluidic device for analyzing a sample of interest including a nucleic acid amplification area, a nucleic acid analysis area, and a network of fluid channels in addition to “and wherein the housing is optionally configured to interface with a controller.” (column 14 lines 41-44, The microfluidic device can also comprise, or be coupled to, a differential pressure delivery system, e.g., a controller capable of sequentially activating the valves to operate the valves and pumps formed on the substrate). 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 Battrell to incorporate the teachings of Zhou wherein the wherein the housing is optionally configured to interface with a controller. Doing so increases power management, decreases thermal issues and allows the system to function on its own.
Regarding claim 4 modified Battrell teaches all of claim 1 as above in addition to “wherein the device further comprises a controller configured to interface with the housing and provide the mechanical force or modulate the magnetic potential or the electric potential” (Page 16, Microfluidic valves: include a genus of hydraulic, mechanic, pneumatic, magnetic, and electrostatic actuator flow controllers with at least one dimension smaller than 500 urn.). Further taught “to move the moveable nucleic acid binding stage into or out of fluid communication with the sample inlet, the wash reservoir, the elution reservoir, and the amplification stage or actuate the one of more valves for controlling the migration of sample through the device at predetermined times” (Page 16, Pillow: an on-board reagent pack formed from a deformable sacculus, for example a mylar microbag, optionally enclosed in a pneumatically actuated device for puncturing to bag to release its contents at a controlled time. Blister pack: an on-board reagent pack under a deformable (or elastic) diaphragm. Used to deliver reagents by pressurizing the diaphragm and may appose a "sharp", such as a metal chevron, so that pressure on the diaphragm ruptures the "pillow" (see pillow). These may be used with check valves or closable vents to produce directional fluid flow and reagent delivery.) Therefore, the actuate the one or more valves for controlling sample throughout device at predetermined times is taught. The pillows work with the valves to release reagents at controlled times.
Further teaching “wherein the controller optionally comprises--
wherein the controller optionally comprises-- (i) a movable magnet, (ii) a microcontroller configured to execute a set of instructions for moving the moveable nucleic acid binding stage into or out of fluid communication with the sample inlet, the wash reservoir, the elution reservoir, and the amplification stage or actuating the one or more valves for controlling the migration of sample through the device,” (Page 26, The apparatus is run by a microprocessor with valve logic programming configured to control the pneumatic actuation of the valve and diaphragm elements. The apparatus optionally further has an off-device magnetic field for manipulation of a magnetic microbead reagent, the magnet is optionally mounted in a movable carriage),; “(iii) a heating element,” (Page 33 and 38, A single block TEC with ramp temperature control was used in early development of the assay. In this embodiment, Peltier chips are used to control heat transfer to and from a suitably sized heat sink under control of a PID controller. The device was then fully assembled and placed in a pneumatic controller with variable temperature TEC heating blocks positioned under the PCR fluidics and thermal interface assembly.); “(iv) a power source, (v) a readout device,” (Page 7, Other embodiments include an on-board "multiplex detection chamber", whereby multiple results, as from a panel of tests, are displayed in a user-friendly visual format);“or (vi) any combination of (i), (ii), (iii), (iv), and (v).” Therefore Battrell teaches to the any combination of of (i), (ii), (iii), (iv), and (v).
Regarding claim 5, modified Battrell teaches all of claim 1 as above in addition to “wherein the device comprises a lysis cartridge comprising a filter” (Page 25, A second microchannel fluidly interconnecting the lysis chamber with the nucleic acid target capture assembly chamber. The lysate is then passed through a nucleic acid target capture assembly, which has non-specific, reversible affinity for nucleic acids.); “configured to separate particulates from a liquid lysis sample” (Page 22, The lysate is then passed through a nucleic acid target capture assembly, which has non-specific, reversible affinity for nucleic acids. The target capture material is generally an electropositive hydrophilic material); “and a sample evacuation device” (Page 25, A fourth microchannel fluidically and valvedly interconnecting the nucleic acid target capture assembly chamber and the wash buffer chamber. A fifth microchannel fluidically and valvedly interconnecting the nucleic acid target capture assembly chamber and the elution buffer chamber.); “wherein- (i) the filter is optionally a filter membrane or a porous foam filter” (Page 22, The target capture assembly may be, for example, a silica surface, a fiber matrix or filter composed of materials such as silica, a bed of silica or aluminum oxide beads, a fritted plug of derivatized zirconium, and the like, adapted to the dimensions, hydrostatic pressures, and flow rates of a microfluidic device.); “(ii) the filter optionally further comprises a chemical contaminant sequestration material,” (Page 22, The target capture material is generally an electropositive hydrophilic material, typically also rich in hydroxyl groups. ). The recitation “(iii) the sample evacuation device is a manually or automatically actuated plunger” is not explicitly taught within Battrell however its not a required feature claimed. Battrell teaches a valve within (Pages 3, 4, 22, 23, and 25 A fourth microchannel fluidically and valvedly interconnecting the nucleic acid target capture assembly chamber and the wash buffer chamber. A fifth microchannel fluidically and valvedly interconnecting the nucleic acid target capture assembly chamber and the elution buffer chamber. Following discharge of the lysate from the nucleic acid target capture assembly to waste under control of a valve, the retentate is then rinsed with wash reagent from the solvent wash pouch, and the wash reagent is also discharged to waste under valve control. Turning now to Fig. 2, the nucleic acid eluate is transported through micro fluidic channels by ganged valves under pneumatic control into one or more channels or chambers for amplification.). In addition, US Patent application 2003008308 teaches a plunger-type peristaltic pump elements within (Pages 3 and 4 of Battrell (Pages 3 and 4, These elastomeric elements were termed "isolation valves" but also served as positive displacement pumps in the devices, again by impinging on the fluid channel under positive pneumatic pressure, whereby the elastomeric element was reversibly deformed and protruded into the fluid channel in the manner of a series of plunger-type peristaltic pump elements.). Further taught “(iv) the sample evacuation device is incapable of evacuating a sample from the lysis cartridge unless a fluid connection is formed between with a sample inlet of a diagnostic device and the lysis cartridge” (Page 25, A first microchannel fluidically and valvedly interconnecting the sample port and the lysis chamber; c. A second microchannel fluidly interconnecting the lysis chamber with the nucleic acid target capture assembly chamber; d. A third microchannel fluidically and valvedly interconnecting the lysis chamber with the lysis buffer pouch chamber; e. A fourth microchannel fluidically and valvedly interconnecting the nucleic acid target capture assembly chamber and the wash buffer chamber; f. A fifth microchannel fluidically and valvedly interconnecting the nucleic acid target capture assembly chamber and the elution buffer chamber). Therefore the recitation “or (iv) or any combination of (i), (ii), (iii), and (iv).” is taught as at least one of the (i), (ii), (iii), and (iv) groups is taught above.
Regrading claim 6, modified Battrell teaches all of claim 5 as above in addition to “wherein the device further comprises a controller configured to interface with the housing and provide the mechanical force or modulate the magnetic potential or the electric potential to” (Page 16, Microfluidic valves: include a genus of hydraulic, mechanic, pneumatic, magnetic, and electrostatic actuator flow controllers with at least one dimension smaller than 500 urn.); “move the moveable nucleic acid binding stage into or out of fluid communication with the sample inlet, the wash reservoir, the elution reservoir, and the amplification stage or actuate the one of more valves for controlling the migration of sample through the device at predetermined times,” (Page 16, Pillow: an on-board reagent pack formed from a deformable sacculus, for example a mylar microbag, optionally enclosed in a pneumatically actuated device for puncturing to bag to release its contents at a controlled time. Blister pack: an on-board reagent pack under a deformable (or elastic) diaphragm. Used to deliver reagents by pressurizing the diaphragm and may appose a "sharp", such as a metal chevron, so that pressure on the diaphragm ruptures the "pillow" (see pillow). These may be used with check valves or closable vents to produce directional fluid flow and reagent delivery.) Therefore, the actuate the one or more valves for controlling sample throughout device at predetermined times is taught. The pillows work with the valves to release reagents at controlled times. Further taught “wherein the controller optionally comprises- (i) a movable magnet, (ii) a microcontroller configured to execute a set of instructions for moving the moveable nucleic acid binding stage into or out of fluid communication with the sample inlet, the wash reservoir, the elution reservoir, and the amplification stage or actuating the one or more valves for controlling the migration of sample through the device” (Page 26, The apparatus is run by a microprocessor with valve logic programming configured to control the pneumatic actuation of the valve and diaphragm elements. The apparatus optionally further has an off-device magnetic field for manipulation of a magnetic microbead reagent, the magnet is optionally mounted in a movable carriage); “(iii) a heating element” (Page 33 and 38, A single block TEC with ramp temperature control was used in early development of the assay. In this embodiment, Peltier chips are used to control heat transfer to and from a suitably sized heat sink under control of a PID controller. The device was then fully assembled and placed in a pneumatic controller with variable temperature TEC heating blocks positioned under the PCR fluidics and thermal interface assembly.); “(iv) a power source, (v) a readout device, or” (Page 7, Other embodiments include an on-board "multiplex detection chamber", whereby multiple results, as from a panel of tests, are displayed in a user-friendly visual format); “(vi) any combination of (i), (ii), (iii), (iv), and (v).” Therefore Battrell teaches to the any combination of of (i), (ii), (iii), (iv), and (v).
Regarding claim 10, modified Battrell teaches all of claim 1 as above in addition to, “wherein the nucleic acid binding substrate comprises a silica membrane and/or silica microspheres.” (Page 17, nucleic acid affinity binding substrate and a means for positioning the binding substrate in the fluid path of a microfluidic device. binding substrates include filters, beads, frits, fluidized beds, and solid surfaces in general. Materials include silica, derivatized silica, alumina, zirconia, treated latex beads, and the like).
Regarding claim 11, modified Battrell teaches all of claim 1 as above in addition to, “wherein the amplification stage comprises a multiplicity of reaction chambers” (Page 8, Fig. 13 is a plan view of an amplification subcircuit having two reciprocating bellows pump chambers with independently controllable fixed temperature thermal interfaces. These bellows chambers can be used, we have found, as reaction chambers, as in PCR); “and is configured for:(a) amplification of two or more different target nucleic acids; or (b) amplification of one or more target nucleic acids and a positive control.” (Page 24, A separate detection channel or chamber for a negative control is optionally provided, because the detection of any amplicons in the negative control reaction would invalidate the assay and indicate contamination of the device or reagents. A positive control may also be provided.).
Regarding claim 13, modified Battrell teaches all of claim 1 as above. The recitation “wherein the nucleic acid amplification reagent comprises:(a) a DNA polymerase, one or more primers, and nucleoside triphosphates; or (b) a reverse transcriptase, DNA polymerase, one or more primers, and nucleoside triphosphates.” is capability of the amplification stage and the reagent. Modified Battrell discloses the positively claimed structural elements of the amplification stage and reagent as claimed, such amplification stage and reagent are said to be fully capable of the recited adaption in as much as recited and required herein.
Regarding claim 14, modified Battrell teaches all of claim 13. The recitation “wherein the nucleic acid amplification reagent comprises an ICP8 annealase and, optionally, a helicase or a nuclease.” is capability of the amplification stage. Battrell discloses the positively claimed structural elements of the amplification stage and a reagent e as claimed, such amplification stage and reagent are said to be fully capable of the recited adaption in as much as recited and required herein. However, Battrell also teaches the reagent comprising a nuclease inhibitor within (Page 14, Exemplary reagents for a nucleic acid amplification reaction include, but are not limited to, buffer, metal ion (for example magnesium salt), chelator, polymerase, primer, template, nucleotide triphosphate, label, dye, nuclease inhibitor, and the like.).
Regarding claim 38, modified Battrell teaches all of claim 1 as above in addition to, “wherein the device comprises one or more valves for controlling the migration of sample through the device.” (Page 27, Fig. 8 depicts an array of valves for distribution of a fluid.).
Regarding claim 41, modified Battrell teaches all of claim 1 as above in addition to “wherein the housing is configured to interface with the lysis cartridge.” (Page 25, A second microchannel fluidly interconnecting the lysis chamber with the nucleic acid target capture assembly chamber.).
Regarding claim 42, modified Battrell teaches all of claim 1 in addition having Zhou teach “wherein the housing is configured to interface with the controller.” as already stated within claim 1.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Battrell et. al. (WO 2007106579 A2) in view of Zhou et. al. (US 9132398 B2) as applied to claim 1 above, and in further view of Gerdes (US 5989813).
Regarding claim 24, Battrell teaches all of claim 1 but does not explicitly teach “wherein the detection device is a lateral flow device.”. Battrell does highlight that US 5989813 teaches a by lateral flow, bifunctional amplicon complexes are detected as trapped aggregates excluded from the fibrous matrix on page 4.
Gerdes teaches a detection of amplified nucleic acid sequences using bifunctional haptenization and dyed microparticles in addition to “wherein the detection device is a lateral flow device.” within (Column 3 lines 29-35, This invention is based on a novel concept for a method for detecting specific DNA or RNA sequences. The present invention is defined by agglutination through the linking of microparticles with two distinct haptens, and alternatively, by linking microparticles to a capture zone on a lateral flow membrane or a filtration membrane with two distinct haptens.).
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 Battrell to incorporate the teachings of Gerdes wherein the wherein the detection device is a lateral flow device. Doing so provides a fast detection which is essential in a point of need diagnostic device.
Claims 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Battrell et. al. (WO 2007106579 A2) in view of Zhou et. al. (US 9132398 B2) as applied to claim 1 above, and in further view of Zoval et. at. (WO 2005069005 A1).
Regarding claim 39, modified Battrell teaches all of claim 1 as above but does not teach “wherein the wash reservoir is in fluid communication with the wash sponge or wash hopper.”.
Zoval teaches methods and apparatus for carrying out analysis of a sample and or extraction of an analyte in a sample and the detection and analysis of target nucleic acid sequences present in test samples. In addition, to “wherein the wash reservoir is in fluid communication with the wash sponge or wash hopper.”(Page 16 lines 19-25, The sponge 100 containing bound analyte is then washed to remove non-specifically bound analyte or other non-specific contaminants present on the capture area by placing the sponge 100 in a wash buffer 128; Steps VII and VIII. The sponge 100 is compressed and decompressed repeatedly in Step IX to facilitate removal of non-specifically bound contaminants. After the washing step, the wash buffer 128 is then squeezed out of the sponge). Therefore the when the sponge is in the wash buffer the sponge is in fluid communication with the wash reservoir.
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 Battrell to incorporate the teachings of Zoval wherein the wash reservoir is in fluid communication with the wash sponge or wash hopper. Doing so provides for a device in which non-needed binding products can be removed and this process in incorporated into the device which provides for faster processing and ultimately detection.
Regarding claim 40, modified Battrell teaches all of claim 1 as above but does not teach “wherein the elution reservoir is in fluid communication with the elution sponge or elution hopper.”.
Zoval teaches “wherein the elution reservoir is in fluid communication with the elution sponge or elution hopper.” within (Page 16 lines 25 and 26, the sponge is then moved to an analyte collection vessel 130 containing elution reagents 132).
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 Battrell to incorporate the teachings of Zoval wherein the elution reservoir is in fluid communication with the elution sponge or elution hopper. Doing so provides for a device in which the flow rate of the buffer is regulated which allows for optimal detection.
Conclusion
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798