DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/29/23 is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of claims 1-12 and 14-16 in the reply filed on 11/6/25 is acknowledged.
Claims 17-21, 22-24, and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/6/25.
Claim Objections
Claim 4 is objected to because of the following informalities: In the preamble, “automatic” should be “automated” to be consistent with the preamble of claim 1. Appropriate correction is required.
Claim Status
Claims 1-12 and 14-16 are examined. Claims 17-21, 22-24, and 25 are withdrawn and are not examined. Claims 13 and 17-25 are cancelled.
Claim Rejections - 35 USC § 103
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, 2, 4, 9, 10, 11, 14, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kinzer (US Pub 2022/0272801), in view of Nobile (US Pub 2017/0274376).
Regarding Claim 1, Kinzer teaches an automated nucleic acid extraction system comprising (the term automated nucleic extraction is directed to intended use):
an automatic nucleic acid extraction cartridge ([0065] Fig. 1 reactor) including:
a housing (housing system 23) comprising,
a sample port that receives a liquid biological sample (inlet 47);
a cell processing chamber comprising a mixing apparatus contained therein; a wash fluid chamber (chamber 53; [0181] Fig. 1 a mechanical mixing system 24 that has its mixing vanes 55 mounted in housing system 23);
a diverter valve having a first reversibly sealable output and a second reversibly sealable output (diverter valve 77); and
(c) an external magnetic field (ExMF) device configured to create an ExMF that drives the mixing apparatus ([0060] an electromagnetic reactor apparatus, means, and method for exposing bulk volumes of particles, such as free-flowing or semi-flowable grain or powders, so all of the particles receive near-uniform exposure to a radio frequency electric or magnet field, preferably without any preference of exposure to a surface or side of particulate. This limitation is directed to intended use of the device);
(e) a diverter valve control unit that controls the diverter valve, wherein the sample port is in one-way fluid communication with the cell processing chamber (diverter valve 77).
Kinzer is silent to a filter assembly comprising a filter member, a system body that comprises:(a) a first driver that provides the force to the first pressure exerting device to exert the negative pressure to the cell processing chamber and the positive pressure to the cell processing chamber, (b) a second driver that provides the force to the second pressure exerting device to exert a positive pressure to the wash fluid chamber, (d) a pathogen lysing device that engages the filter assembly and that lyses the one or more pathogens contained in the filter assembly; and the cell processing chamber is in one-way fluid communication with the filter assembly, the wash fluid chamber is in fluid communication with the filter assembly, and the filter assembly is in fluid communication with the diverter valve and (i) a waste conduit when the diverter valve is biased to the first reversibly sealable output and (ii) a pathogen nucleic acid conduit when the diverter valve is biased to the second reversibly sealable output.
Nobile teaches [0042] a syringe body having an outer barrel and an inner barrel, the outer barrel further comprising a first reservoir containing a first reagent; and a plunger piston configured to moveably couple to the outer syringe barrel, the plunger piston comprising an inner syringe barrel, and outer syringe barrel and a puncture-able separator positioned between the first and second reservoirs, the inner syringe barrel defining a second reservoir to receive a second reagent; wherein the puncture-able separator is configured to provide automatic sequential delivery of the first and second reagents. The outer barrel is the first driver and the inner barrel is the second driver. [0031] For example, the first processing fluid 187 may be used to liquefy the sample breaking it down into a form that allows passage through the filter 220 while the second processing fluid 192 may be subsequently introduced as a wash, preservative, or lysis agent for the microbes/pathogens retained on the filter 220. [0026] By operation of the plunger 165, sample 142 may be drawn from the sample tube 130 through the valve body 120 and introduced into the outer reservoir 180 where it is mixed with the first processing fluid 187. The resulting mixture may then be expelled through the capture tube 125 into the waste receptacle 145. [0027] The volume of air 189 contained in the reservoir 170 can then be made to pass over the filter and retained microbes/pathogens to aid in removing residual first processing fluid 187 and efficiently expelling into the waste reservoir 145.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added :(a) a first driver that provides the force to the first pressure exerting device to exert the negative pressure to the cell processing chamber and the positive pressure to the cell processing chamber, (b) a second driver that provides the force to the second pressure exerting device to exert a positive pressure to the wash fluid chamber, (d) a pathogen lysing device that engages the filter assembly and that lyses the one or more pathogens contained in the filter assembly; and the cell processing chamber is in one-way fluid communication with the filter assembly, the wash fluid chamber is in fluid communication with the filter assembly, and the filter assembly is in fluid communication with the diverter valve and (i) a waste conduit when the diverter valve is biased to the first reversibly sealable output and (ii) a pathogen nucleic acid conduit when the diverter valve is biased to the second reversibly sealable output, as taught by Nobile, to the device of Kinzer, to allow for an apparatus and methods for biological sample processing enabling isolation and concentration of microbial or pathogenic constituents from the sample, in the Abstract.
Regarding Claim 2, modified Kinzer teaches the automated nucleic acid extraction system of claim 1, wherein: (a) a liquid sample container comprises a liquid sample; (b) the cell processing chamber comprises a processing solution; the wash fluid chamber comprises a wash solution; (d) the filter member is configured to retain one or more pathogens; (e) the one or more pathogens comprises one or more bacteria, one or more virus, one or more eukaryotic pathogen, or a combination thereof ([0024] The outer barrel reservoir 180 may contain a first processing fluid such as a liquefaction reagent 187 selected based on the sample type and when mixed with the sample 142 may result, for example, in breaking down selected constituents of the sample 142. The constituents may include blood cells, sputum, or other components that are to be made to desirably pass through the capture tube 125 without being retained such that they may be separated from microbes/pathogens which will be retained by the sample tube 125. The liquefaction fluid 187 may be preloaded in the reservoir 180 in a predetermined quantity such that the apparatus 100 is made ready-to-use requiring little or no significant preparation before introduction of the sample 142. The reservoir 180 may further be sized to accommodate a selected volume of liquefaction fluid 187 and additionally provide an air volume 189. As will be described in greater detail, providing a selected volume of air 189 facilitates sample processing such as mixing and sample distribution to other components within the apparatus 100.
[0025] The inner barrel reservoir 185 may contain a second processing fluid such as a wash reagent 192 used to further process the sample 142. Similar to the first processing fluid 187, the second processing fluid 192 may be preloaded in the reservoir 185 in a predetermined quantity. The reservoir 185 may also be sized to accommodate a selected volume of air 194 facilitating sample processing and distribution);
(f) the first reversibly sealable output includes a region that can be reversibly pinched, compressed, or crimped to be in a sealed position that does not allow fluid to pass through (FIG. 3A illustrates exemplary positioning of the needle 225 prior to piercing the seal/gasket 175.); (g)the second reversibly sealable output includes a region that can be reversibly pinched,compressed, or crimped to be in a sealed position that does not allow fluid to pass through; (h) the first reversibly sealable output and the second reversibly sealable output are both in a sealed position; (i) the sample port and the cell processing chamber, the cell processing chamber and the filter assembly, the wash fluid chamber and the filter assembly, the filter member or filter assembly and the diverter valve are connected via a conduit; (j) the filter member has a pore size that retains one or more pathogens ([0036] As shown in FIG. 4B, upon suitable mixing of sample and first processing fluid, the mixture may be expelled or passed through the capture tube by compression or actuation of the outer plunger. The capture filter provides a desired surface or medium by which to retain and concentrate selected components of the processed sample. For example, microbes/pathogens may be retained on a filter or membrane having suitable porosity or molecular composition to permit passage of the processed liquid sample while selectively capturing microorganisms or other desired sample constituents.); (k) the filter member has a coating that has an affinity for or captures one or more pathogens; (l) the filter member is statically charged; (m) the filter member is made of a material that does not induce a fibrinogen-driven clotting reaction (this is a “not” limitation and is broad); (n) the processing solution makes the non-pathogenic components of the liquid sample filterable without lysing one or more bacterial pathogens, one or more eukaryotic pathogens, one or more viral pathogens, or a combination thereof; (o)the processing solution is a hypertonic solution relative to one or more non-pathogen eukaryotic cells of the liquid sample; or (p) the processing solution (i) does not lyse or break down one or more prokaryotic pathogens, (ii) does not lyse or breakdown one or more eukaryotic pathogens, (iii) does not lyse or break down one or more viral pathogens, (iv) lyses blood cells, (v) breaks down proteins, (vi) breaks down nucleic acids, (vii) suppresses clotting, (viii) lyses non- pathogen eukaryotic cells, or (ix) a combination thereof; or (q) a combination thereof ([0038] As shown in FIG. 4D, the sample processing assembly may be configured as separable subassemblies such that the sample tube retaining desired microbes or other constituents resultant from sample processing may be conveniently and quickly removed for further processing and/or analysis. In various embodiments, the components of the apparatus are fabricated from inexpensive materials and may be configured for single use or disposable. Additionally, the separable aspects of the apparatus aid in maintaining sterility and/or preventing contamination of the collected/retained material while reducing risk of exposure to the user.).
Regarding Claim 4, Kinzer teaches the automatic nucleic acid extraction system of claim 2 and (d) the mixing apparatus is a rotary mixer comprising a mixing body (see teachings of claim 1).
Kinzer is silent to (a) the conduit connecting the sample port and the cell processing chamber comprises a first one-way valve; (b) the conduit of the cell processing chamber and the filter assembly comprises a second one-way valve; (c) the conduit of the wash fluid chamber and the filter assembly comprises a third one-way valve; or (e) a combination thereof.
Nobile teaches in the related art of biological sample processing. [0069] Example 28 is directed to the apparatus of example 19, wherein the first one-way valve opens under a relative negative pressure and closes under a relative positive pressure. [0070] Example 29 is directed to the apparatus of example 19, wherein the second one-way valve closes under a relative negative pressure and closes under a relative positive pressure.
Regarding a third one-way valve, In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. See MPEP 2144.004 VI. B.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a first, second, and third one-way valves, as taught by Nobile, to the conduit, in the device, as taught by Kinzer, to allow for fluid flow in only one direction.
Regarding Claim 9, Kinzer teaches the automated nucleic acid extraction system of claim 4, wherein (a) the cell processing chamber includes a circular cross-section and the rotary mixer comprises a cylindrical mixing body that rotates freely within the circular cross-section of the cell processing chamber; (b) the rotary mixer further comprises two or more magnets inserted into the mixing body ([0078] FIG. 8A is an isometric view of an electromagnet reactor according to the invention showing a convective type of batch mixer that has uses powerful rare earth magnets as RF signal source that are placed in a cavity of a shaft with support bars that are transparent to EM energy from magnets for optimum exposure and subsequent absorption by particulate in process chamber.); or (c) a combination thereof.
Regarding Claim 10, Kinzer teaches the automated nucleic acid extraction system of claim 9, wherein (a) the two or more magnets are substantially evenly spaced or substantially symmetrically located about the rotational axis of the rotary mixer; (b) the two or more magnets have the same orientation of their polarity; (c) the mixing apparatus further comprises fluid engagement features extending upward from the cylindrical mixing body; (d) the cylindrical mixing body further comprises an open center, or (e) a combination thereof ([0078] FIG. 8A is an isometric view of an electromagnet reactor according to the invention showing a convective type of batch mixer that has uses powerful rare earth magnets as RF signal source that are placed in a cavity of a shaft with support bars that are transparent to EM energy from magnets for optimum exposure and subsequent absorption by particulate in process chamber.).
Regarding Claim 11, modified Kinzer teaches the automated nucleic acid extraction system of claim 10, wherein (i) the fluid engagement features are smooth enough to minimize cavitation or substantially eliminate cavitation, (ii) the fluid engagement features have, or the top of the cylindrical mixing body has, a substantially sinusoidal shape, (iii) the fluid engagement features create a vortex when spinning about a vertical axis, or (iv) a combination thereof ([0167] The radio frequency (RF) source circuitry generates a radio frequency signal through a circuit to an antenna that radiates an electromagnetic (EM) energy into a process chamber. It will be understood that EM energy can be high frequency alternating current, alternating voltage, current waves, or voltage waves. The EM energy can be a periodic high frequency signal having a fundamental frequency. The high frequency signal can have a sinusoidal waveform).
Regarding Claim 14, Kinzer teaches the automated nucleic acid extraction (the term automated nucleic extraction is directed to intended use) system of claim 13,
wherein (a) the system body further comprises a control unit that controls the first driver, the second driver, the ExMF creating device, the pathogen lysing device, the diverter valve, or a combination thereof ([0204] Mechanical movement system 104 in FIG. 5B shows three types of arms 142, 144, 146 with cut and folded flighting 143, ribbon flighting 145, and paddle 147. Movement system 104 includes a drive shaft 141);
(b) the system further comprises a system door that is attached to and articulated with the system body between an open position in which the cartridge is accessible and a closed position that produces an enclosed space where the cartridge is placed or located (Outgoing system 507 comprising a drop door 537, 538 rotatably supported on a hinge arm 571 that is moved by actuator 572 for movement into outlet opening to close process chamber 540 and for movement out of outlet opening to open process chamber 540 which allows bulk volume of particles to fall out of reactor 500.);
(c) the ExMF creating device includes two arms that together surround the cell processing chamber for creating the ExMF, each arm including one or more substantially evenly spaced or substantially symmetrically located field or stator coils; (d) the ExMF creating device senses the position of the one or more magnets of the rotary mixer relative to the field or stator coil using the back electromagnetic field (EMF) created by the permanent magnets of the rotary mixer passing by the field or stator coils ([0060] In accordance with the present invention, an electromagnetic reactor apparatus, means, and method for exposing bulk volumes of particles, such as free-flowing or semi-flowable grain or powders, so all of the particles receive near-uniform exposure to a radio frequency electric or magnet field, preferably without any preference of exposure to a surface or side of particulate);
(e) the ExMF creating device continuously examines whether the rotary mixer is rotating ([0060] an electromagnetic reactor apparatus, means, and method for exposing bulk volumes of particles, such as free-flowing or semi-flowable grain or powders, so all of the particles receive near-uniform exposure to a radio frequency electric or magnet field, preferably without any preference of exposure to a surface or side of particulate. This limitation is directed to intended use of the device);
(f) the ExMF creating device provides continuous intimation of how the rotary mixer is rotating (an electromagnetic reactor apparatus, means, and method for exposing bulk volumes of particles, such as free-flowing or semi-flowable grain or powders, so all of the particles receive near-uniform exposure to a radio frequency electric or magnet field, preferably without any preference of exposure to a surface or side of particulate. This limitation is directed to intended use of the device);
(g) the mixing apparatus (i) mixes at about 500 to about 7000 rotations per minute (RPM), (ii) mixes at least while the liquid sample is introduced into the cell processing chamber, (iii) mixes the liquid sample and the processing solution for about 3 to about 10 minutes, or (iv) a combination thereof ([0152]-[0159] mixers);
(h) the diverter valve control unit comprises a first actuator or pinching member for the first reversibly sealable output and a second actuator or pinching member for the second reversibly sealable output, wherein each actuator has a first position that seals the output and a second position that opens the output ([0184] Fig. 1, into 2-way diverter valve 77 where particulate can return to reactor 20 through spout 78 or leave system 28 through spout 79.);
(i) the first driver further comprises at least one force sensor that detects how much force is being exerted on the cell processing chamber ([0084] sensors),
(j) the second driver further comprises at least one force sensor that detects how much force is being exerted on the wash fluid chamber ([0084 sensors),
(k) the system body further comprising a waste reservoir that is in fluid communication with the end of the waste conduit not connected to the diverter valve ([0284] chambers);
(l) the mixing apparatus is a rotary mixer, and the ExMF creating device includes (i) two or more field or stator coils that are sequentially energized and that are placed around the cell processing chamber and in the same field as the rotatory mixer ([0284] Electromagnetic (EM) system 1121 comprising an inner Helmholz coil antenna 1137 connected to RF signal generating circuitry 1135 with circuit 1138 connected to forward end of antenna 1137, and circuit 1139 connected to reverse end of antenna 1137. Inner antenna system 1121 is in chambers 1151 surrounding the coils 1137 that are filled with a gas 1152 conducive to forming a plasma), or (ii) two or more synchronized magnets that are rotated around the cell processing chamber and in the same plane as the rotary mixer; or (m) a combination thereof (The examiner notes the limitation following “or” is optional).
Regarding Claim 15, Kinzer teaches the automated nucleic acid extraction system of claim 14, wherein (a) the two arms are articulated between a closed position that places the two arms around the cell processing chamber for creating the ExMF and an open position that permits the cell processing chamber to be positioned between the two arms; (b) one of the two arms of the ExMF creating device is mounted on the system body and the second of the two arms of the ExMF creating device is mounted on the system door; or (c) the first position of each of the actuators closes the output by pinching, compressing, or crimping a region of the output that can be reversibly pinched, compressed, or crimped ([0204] Mechanical movement system 104 in FIG. 5B shows three types of arms 142, 144, 146 with cut and folded flighting 143, ribbon flighting 145, and paddle 147. Movement system 104 includes a drive shaft 141).
Regarding Claim 16, Kinzer teaches the automated nucleic acid extraction system of claim 13, wherein (a) the diverter valve control unit comprises an actuator or pinching member that has a first position that pinches, compresses, or crimps for the first reversibly sealable output, a second position that pinches, compresses, or crimps for the second reversibly sealable output, and a third position that does not pinch, compress, or crimp either of the first or the second reversibly sealable outputs to the point of stopping the flow of fluid ([0340] Actuator system 1410 depicted in FIGS. 13B to 13D comprising actuator controller 1440, an actuator 1443, a circuit 1441 between input bus 1461 and actuator controller 1440, a circuit 1442 between output bus 1462 and actuator controller 1440, an actuator 1443 that receives energy (electricity, air, fluid) to from incoming line 1444a, 1444b from and actuator controller 1440 and returns energy via return line 1445a, 1445b to and actuator controller 1440 to adjust position of antenna 1424. Incoming line 1444a connects slip ring rotary connection pin 1451 and actuator 1443 and incoming line 1444b connects slip ring stationary connection pin 1453 and actuator controller 1440. Actuator controller 1440 comprising energy storage, piping, pumps, circuitry, or valves to supply energy to actuator 1443 and a return or recycle components to return energy from actuator 1443 to and actuator controller 1440.); (b) the pathogen lysing device comprises a heater that heats contents of the filter assembly to a temperature sufficient to lyse the one or more pathogens ([0210] Power system 105 is activated to rotate 1000 mechanical movement system 104 about the rotational axis 1200. The RF source 110 begins generating at least one RF signal(s) that is delivered to the antenna 114 through the circuit 111 and 112. The RF signals are converted into electromagnetic energy, which is emitted from the antenna 114 in the form of EM field which produces a reactive field in the process chamber 140. The EM field causes both conductive and dielectric heating to occur, primarily due to the molecular oscillation of polar molecules present in the bulk volume located in the process chamber 140.); a sonic or ultrasonic wave transmitter that transmits sound waves to contents of the filter assembly that are sufficient to lyse the one or more pathogens; or a combination thereof or (c) a combination thereof.
Claim Rejections - 35 USC § 103
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 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kinzer (US Pub 2022/0272801), in view of Nobile (US Pub 2017/0274376), and further in view of Walker (US Pub 2004/0142463).
Regarding Claim 3, modified Kinzer teaches the automated nucleic acid extraction system of claim 1, wherein (i) the cartridge further comprises: (a) a sampling device that is inserted into a liquid sample container (b) a liquid sample container holder; (c) a first pressure exerting device in fluid communication with the cell processing chamber; (d) a second pressure exerting device in fluid communication with the wash fluid chamber; (e) an extracted nucleic acid receptacle that is in fluid communication with the pathogen nucleic acid conduit (the examiner notes that the term “extracted nucleic acid” does not modify the kind of receptacle since the receptacle does not also positively recite a reagent that extracts nucleic acids); (f) a waste reservoir that is in fluid communication with the waste conduit or the first reversibly sealable output; or (g) a combination thereof (Nobile teaches [0042] a syringe body having an outer barrel and an inner barrel, the outer barrel further comprising a first reservoir containing a first reagent; and a plunger piston configured to moveably couple to the outer syringe barrel, the plunger piston comprising an inner syringe barrel, and outer syringe barrel and a puncture-able separator positioned between the first and second reservoirs, the inner syringe barrel defining a second reservoir to receive a second reagent; wherein the puncture-able separator is configured to provide automatic sequential delivery of the first and second reagents. The outer barrel is the first driver and the inner barrel is the second driver. [0031] For example, the first processing fluid 187 may be used to liquefy the sample breaking it down into a form that allows passage through the filter 220 while the second processing fluid 192 may be subsequently introduced as a wash, preservative, or lysis agent for the microbes/pathogens retained on the filter 220. [0026] By operation of the plunger 165, sample 142 may be drawn from the sample tube 130 through the valve body 120 and introduced into the outer reservoir 180 where it is mixed with the first processing fluid 187. The resulting mixture may then be expelled through the capture tube 125 into the waste receptacle 145. [0027] The volume of air 189 contained in the reservoir 170 can then be made to pass over the filter and retained microbes/pathogens to aid in removing residual first processing fluid 187 and efficiently expelling into the waste reservoir 145.)
Kinzer is silent to (ii) the filter assembly further comprises:(a) a thermally conductive element that transmits thermal energy to the filter member;(b) a metal element that transmits at least vibrational energy to the filter member; or (c) a combination thereof; or (iii) a combination thereof.
Walker teaches in the related art of a fluid sample. [0072] A filter can be made of any suitable material that prevents passage of insoluble particles, such as metal. [0163] A filtration chamber or the present invention is any chamber that can contain a fluid sample that comprises or engages at least one microfabricated filter of the present invention. A filtration chamber of the present invention can comprise one or more fluid-impermeable materials, such as but not limited to, metals.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted a metal filter, a taught by Walker, to the filter assembly, as taught by modified Kinzer, to allow for enriching cells, as taught by Walker, in the Abstract.
Regarding Claim 12, modified Kinzer teaches the automated nucleic acid extraction system of claim 3, further comprising (a) a first syringe holder that accepts a first syringe wherein the cell processing chamber is the hollow cylinder of the first syringe and the first pressure exerting device is a sliding plunger of the first syringe (Nobile teaches [0023] In various embodiments, the syringe 110 may comprise a two-stage assembly having an inner plunger/piston 155 and inner barrel 160. The inner barrel 160 may also serve as or be associated with an outer plunger/piston 165 that operates in connection with an outer barrel 170. The outer barrel 170 mates with the valve body 120 by the syringe coupler 115 such that sample 142 may be drawn into the barrel 170. A first plunger tip or gasket 175 separates an outer barrel reservoir 180 from and inner barrel reservoir 185 (FIG. 2). Each reservoir 180, 185 may contain various reagents and components used in sample processing.); (b) a second syringe holder that accepts a second syringe, wherein the wash fluid chamber is a hollow cylinder of the second syringe and the second pressure exerting device is a sliding plunger of the second syringe; or (c) a combination thereof (the examiner notes that the limitation “or” indicates that only (a) or (b) is required.)
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Kinzer (US Pub 2022/0272801), in view of Nobile (US Pub 2017/0274376), and further in view of Gorin (US Pub 2016/0091517).
Regarding Claims 5 and 6, modified Kinzer teaches the automated nucleic acid extraction system of claim 4, the first one-way valve, the second one-way valve, the third one-way valve, or a combination thereof.
Modified Kinzer is silent to comprise: a conduit having a hollow interior that includes a straight interior region and an expanding conical interior region located at the end of the conduit that fluid exits the one-way valve, and a partially conical elastomer valve pin or a frustoconical elastomeric valve pin that mates with the expanding conical interior region of the conduit, thereby causing a substantially or completely water-tight seal to form when there is flow or positive pressure from a fluid contacting the larger end of the valve pin, wherein (a) the valve pin comprises an extended cylindrical area that extends from the small end of the pin and that is smaller in diameter from the straight interior region of the one-way valve; (b) the taper angle of the expanding conical interior region and the valve pin is about 12 degrees to about 24 degrees; (c) the valve pin has a slightly greater taper angle than the expanding conical interior region of the valve; or (d) a combination thereof.
Gorin teaches in the related art of biological fluid sample. [0075] As will be described further below, in some embodiments the valves 160a-e can be individually actuated by pins that are translated towards and away from the valves 160a-e. To close the valves 160a-e, the pins can engage with and distend elastomer members of the valves 160a-e so that the elastomer member makes contact with a valve seat of the valves 160a-e. When such pins are retracted away from the elastomer members of the valves 160a-e, the elastomer members will rebound such that the elastomer member is no longer distended and then the valve is opened. The pins can be translated by solenoids in some embodiments.
Regarding a conical or frustoconical shape, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). See MPEP 2144.04 IV. B.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a conduit having a hollow interior that includes a straight interior region and an expanding conical interior region located at the end of the conduit that fluid exits the one-way valve, and a partially conical elastomer valve pin or a frustoconical elastomeric valve pin that mates with the expanding conical interior region of the conduit, thereby causing a substantially or completely water-tight seal to form when there is flow or positive pressure from a fluid contacting the larger end of the valve pin, wherein (a) the valve pin comprises an extended cylindrical area that extends from the small end of the pin and that is smaller in diameter from the straight interior region of the one-way valve; (b) the taper angle of the expanding conical interior region and the valve pin is about 12 degrees to about 24 degrees; (c) the valve pin has a slightly greater taper angle than the expanding conical interior region of the valve; or (d) a combination thereof, as taught by Gorin, in the first, second, and third one-way valves in the device of modified Kinzer, to allow for actuating the valves, as taught by Gorin, in [0127].
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kinzer (US Pub 2022/0272801), in view of Nobile (US Pub 2017/0274376), Walker (US Pub 2004/0142463), and further in view of Clay (US Pub 2014/0174207).
Regarding Claim 7, Kinzer teaches the automated nucleic acid extraction cartridge system of claim 3, wherein (a) the sampling device is inserted into the liquid sample in an upward direction; (b) the sampling device punctures the liquid sample container; (d) the first pressure exerting device is capable of providing positive pressure and negative pressure to the cell processing chamber; (e) the first pressure exerting device moves fluid into the cell processing chamber when a negative pressure is applied by the first pressure exerting device to the cell processing chamber; (f) the first pressure exerting device moves fluid into the filter assembly when a positive pressure is applied by the first pressure exerting device to the cell processing chamber; (g) the second pressure exerting device is capable of providing at least positive pressure to the wash fluid chamber; (h) the filter member retains one or more pathogens when the second pressure exerting device applies a positive pressure to the wash fluid chamber, thereby passing a portion of the wash solution through the filter assembly; (i) the extracted nucleic acid receptable receives the extracted nucleic acids when the second pressure exerting device passes a portion of the wash solution through the filter assembly after the one or more pathogens are lysed from the second reversibly sealable output; (j) the first pressure exerting device is a processing port that is capable of engaging a pressure driver from an external instrument that provides positive pressure and negative pressure to the processing port; (k) the second pressure exerting device is a wash fluid chamber port that is capable of engaging a pressure driver from an external instrument that provides at least positive pressure to the wash fluid chamber port; or (1) a combination thereof (see teachings of Kinzer, in view of Nobile over claim 1).
Kinzer is silent to (c) the sampling device includes a sampling needle and a venting needle, each being inserted into the liquid sample in the liquid sample container.
Clay teaches in the related art of sampling fluid. [0025] A conduit, preferably a sampling needle 70, is positioned within the sampling chamber 30, with an inlet 72 proximate the top of the sampling needle 70. Preferably, the inlet 72 is positioned so as to pierce the septum (not shown). The sampling needle 70 continues beneath the sampling chamber 30 to the bottom of the housing of the sampler 10, where the sampling needle 70 terminates at a sampling outlet 76. Venting needle 100 may be used to supply air to the vial 90 to prevent the formation of a vacuum in the vial 90 as fluid drains out of the vial 90. Otherwise, the low pressure volume that would form in the end of the vial 90 opposite the mouth 92 as the known chemical exits the vial would disrupt the smooth fluid flow from the vial 90. Air or other gas is supplied into the vial 90 through the venting needle 100 at a venting needle inlet 102 located proximate the end of the venting needle 100 that extends above the sampling chamber 30. In an alternative embodiment, the venting needle 100 extends out the bottom of the housing and is connected via a conduit to the discharge chamber 60 or to other replacement fluid sources. The end of the venting needle 100 opposite the venting needle inlet 102 extends into a venting chamber 110 located beneath the sampling chamber 30.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a sampling needle and a venting needle, as taught by Clay in the device of Kinzer, to allow for a conduit for fluid and a way to supply air to the container, as taught by Clay in [0025] and [0029].
Regarding Claim 8, modified Kinzer teaches the automated nucleic acid extraction system of claim 7, (a) the sampling needle has (i) a larger transfer capacity than the venting needle,(ii) a shorter length than the venting needle, or (iii) both; (b) the venting needle vents to the waste reservoir and/or the atmosphere, (c) the processing port seals the cell processing chamber;(d) the wash fluid chamber port seals the wash fluid chamber from the external environment; or (e) a combination thereof (Clay teaches in the related art of sampling fluid. [0025] A conduit, preferably a sampling needle 70, is positioned within the sampling chamber 30, with an inlet 72 proximate the top of the sampling needle 70. Preferably, the inlet 72 is positioned so as to pierce the septum (not shown). The sampling needle 70 continues beneath the sampling chamber 30 to the bottom of the housing of the sampler 10, where the sampling needle 70 terminates at a sampling outlet 76. Venting needle 100 may be used to supply air to the vial 90 to prevent the formation of a vacuum in the vial 90 as fluid drains out of the vial 90. Otherwise, the low pressure volume that would form in the end of the vial 90 opposite the mouth 92 as the known chemical exits the vial would disrupt the smooth fluid flow from the vial 90. Air or other gas is supplied into the vial 90 through the venting needle 100 at a venting needle inlet 102 located proximate the end of the venting needle 100 that extends above the sampling chamber 30. In an alternative embodiment, the venting needle 100 extends out the bottom of the housing and is connected via a conduit to the discharge chamber 60 or to other replacement fluid sources. The end of the venting needle 100 opposite the venting needle inlet 102 extends into a venting chamber 110 located beneath the sampling chamber 30.)
Conclusion
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798