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 .
Response to Arguments
Applicant’s arguments, see Remarks page 12, filed 18 July 2025, with respect to the objections to the drawings have been fully considered and are persuasive in light of applicant’s amendments. The objections to the drawings have been withdrawn.
Applicant’s arguments, see Remarks page 12, filed 18 July 2025, with respect to the Claim Rejections under 35 USC 112(b) have been fully considered and are persuasive in light of applicant’s amendments. The rejections under 112(b) have been withdrawn.
Applicant’s arguments, see Remarks page 13, filed 18 July 2025, with respect to the rejection(s) of claim(s) 1-3 and 11-12 under 35 USC 102 have been fully considered and are persuasive in light of the amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 USC 103, as obvious over Okamoto et al in view of Cho et al.
Applicant’s arguments, see Remarks page 13, filed 18 July 2025, with respect to the rejection(s) of claim(s) 1-3 and 11-12 under 35 USC 102 have been fully considered and are persuasive in light of the amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 USC 103, as obvious over Okamoto et al in view of Cho et al.
Detailed rejections of each claim begin on page 4 of this action. To briefly address applicant’s arguments;
Regarding claim 1, the examiner does not find applicant’s arguments regarding the shape of the magnets persuasive in light of the case law regarding changes in shape. In the interest of furthering prosecution, however, the examiner has provided references from the prior art which disclose the claimed shape of the magnets.
Regarding claim 2, the claim is directed to an apparatus, not a method of intended use. Moreover, the limitation of “during a B/F separation…” is broad enough that the broadest reasonable interpretation includes stopping the disk, removing the magnet from the chamber, and restarting rotation.
Regarding claim 5, applicant’s arguments regarding Okamoto’s teaching away from the claimed length of the first magnet unit is persuasive. However, the examiner does not believe that instant application shows unexpected results stemming from the size and shape of the magnets, and that one of ordinary skill in the art would be able to determine the size, shape, and position of the magnet as results-effective variables. Claim 5 is rejected in further view of Gwynn et al, which teaches that one of ordinary skill in the art would be able to select an appropriately sized magnet according to desired system performance.
Regarding claim 11, applicant’s arguments are persuasive in light of the amended claims. Rejections have been made under 35 USC 103, in view of Wong et al, which includes a magnet unit positioned outside of the sample analysis substrate.
Regarding claim 18, the claim is directed to an apparatus, not a method of intended use. The structural limitations of claim 18 are taught in the prior art, and the device of Wong et al would be capable of separately moving the actuators to agitate liquid. Accordingly, the limitation of “during agitation of the liquid sample in the chamber” is not sufficient to define the claimed invention against the prior art.
Regarding claim 30, in the interest of furthering prosecution, the examiner has included an evidentiary reference showing that agitation of a liquid including magnetic particles by manipulating the position of a magnet was taught before the effective filing date of the claimed invention.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Okamoto et al (US 20170131305 A1) in view of Cho et al (US 20080171400 A1).
With regards to claim 1, Okamoto et al teaches;
The claimed "sample analysis device that rotates and stops a sample analysis substrate retaining a liquid sample to cause a binding reaction between an analyte in the liquid sample and a ligand immobilized to surfaces of magnetic particles" has been read on the taught ([0008], “A substrate for sample analysis, a sample analysis device, a sample analysis system, and a method of removing the liquid from a liquid containing magnetic particles according to one aspect of the present application…”; [0002], "In this technique, the substrate for sample analysis is allowed to rotate, etc., thereby effecting transfer, distribution, mixing of solutions, analysis of components within an analyte solution, and so on."; [0032], "…a primary antibody 304 having a magnetic particle 302 immobilized to whose surface […] and, an antigen 306 […] are allowed bind through an antigen-antibody reaction."; The sample analysis device reads on a sample analysis device.);
The claimed, "the sample analysis substrate being capable of being mounted to or detached from the sample analysis device" has been read on the taught ([0093], "…the substrate for sample analysis with the first chamber being filled with the liquid is placed on a turntable of the sample analysis device…"; the substrate reads on the sample analysis substrate. The substrate placed on a turntable of the sample analysis device reads on the substrate being capable of being mounted to the sample analysis device);
The claimed substrate including "a plate-shaped base substrate having a predetermined thickness" has been read on the taught ([0135], "In the present embodiment, the substrate 100′ of the substrate 100 for sample analysis is composed of a base substrate 100a…"; Base substrate 100a reads on a base substrate; [0129], "The substrate 100 for sample analysis includes a substrate 100′ having a rotation axis 101 and a plate shape with a predetermined thickness." Substrate 100', composed of base substrate 100a, having a plate shape with predetermined thickness reads on a plate-shaped base substrate having a predetermined thickness.);
The claimed substrate including "a chamber within the base substrate, the chamber being a space in which to cause the binding reaction" has been read on the taught ([0129], "The substrate 100 for sample analysis includes a […] reaction chamber 107, each located in the substrate 100′."; Reaction chamber 107 reads on a chamber within the base substrate being a space in which to cause the binding reaction.);
The claimed sample analysis device comprising "a turntable to support the sample analysis substrate mounted thereon" has been read on the taught ([0093], "…the substrate for sample analysis with the first chamber being filled with the liquid is placed on a turntable of the sample analysis device…"; a turntable of the sample analysis device reads on a turntable.);
The claimed sample analysis device comprising "a motor to rotate the turntable" has been read on the taught ([0068], "a sample analysis device, [0069] including a motor to rotate the substrate…");
The claimed sample analysis device comprising "a drive circuit to control rotation and stopping of the motor" has been read on the taught ([0096], “…a drive circuit to control rotation…");
The claimed sample analysis device comprising "a first magnet unit to generate a force for attracting the magnetic particles" has been read on the taught ([0145], "Moreover, the magnet 106 may be provided on the sample analysis device 200.");
The claimed sample analysis device comprising "a first actuator to move the first magnet unit to change relative positions of the first magnet unit and the sample analysis substrate" has been read on the taught ([0146], "As another example of providing the magnet 106 on the sample analysis device 200, for example, the sample analysis device 200 may include a driving mechanism which moves the magnet 106…"; The driving mechanism reads on a first actuator);
The claimed sample analysis device comprising "a control circuit to control operation of the motor, the drive circuit, and the first actuator" has been read on the taught ([0072], "…a control circuit including an arithmetic unit, a memory, and a program which is stored in the memory and executable by the arithmetic unit, to control based on the program an operation of the motor, the rotation angle detection circuit, the origin detector, and the drive circuit…");
The claimed “wherein the first magnet unit has a first shape that is a whole shape of a circle, a partial shape of a circle, a whole shape of a ring, or a partial shape of a ring” has been read on the taught ([0087], “…the magnet has a bow shape protruding toward the rotation axis and different magnetic poles respectively at the rotation axis side and an opposite side from the rotation axis.”).
However, Okamoto et al does not explicitly disclose wherein the first magnet unit has a first shape that is a whole shape of a circle, a partial shape of a circle, a whole shape of a ring, or a partial shape of a ring and wherein when viewed from a direction parallel to a rotation axis of the sample analysis substrate, a center of the circle or the ring overlaps the sample analysis substrate.
In the analogous art of microfluidic devices using magnetic separation, Cho et al teaches;
The claimed “wherein the first magnet unit has a first shape that is a whole shape of a circle, a partial shape of a circle, a whole shape of a ring, or a partial shape of a ring and wherein when viewed from a direction parallel to a rotation axis of the sample analysis substrate, a center of the circle or the ring overlaps the sample analysis substrate” has been read on the taught ([0012], “The magnet may be […] formed in the shape of a ring having a radius corresponding to the distance from the rotation center of the rotary body to the curved portion outside the rotary body along the rotation trace of the curved portion.”; Figure 1a shows the magnet overlapping the sample analysis substrate.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample analysis device as taught by Okamoto et al with the ring-shaped overlapping magnet as taught by Cho et al. According to MPEP 2143(I)(B), simple substitution of one known element for another to obtain predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Okamoto et al teaches a device which differs from the claimed device only by the substitution of an arc-shaped magnet wherein the center of the magnet does not overlap the sample analysis substrate. The substituted components of a ring-shaped magnet with a center that overlaps the sample analysis substrate are known in the art, as shown in Cho et al. One of ordinary skill in the art could have substituted the known element of a ring-shaped magnet with a center overlapping the sample analysis substrate into the device of Okamoto, for the predictable result of focusing magnetic particles over an area defined by the magnetic flux pattern of the overlapping magnet.
With regards to claim 2, the device of claim 1 is obvious over Okamoto et al in view of Cho et al.
Okamoto et al additionally teaches;
The claimed "wherein, during a B/F separation (Bound/Free Separation) for separating reacted substance from unreacted substance within the chamber, the first actuator moves the first magnet unit to a position where the magnetic particles in the chamber are attracted by the first magnet unit" has been read on the taught ([Claim 2], "… a driving mechanism to […] insert the magnet into the receptacle of the substrate for sample analysis and remove the magnet in the receptacle…"; The driving mechanism reads on the first actuator. Inserting and removing the magnet reads on the first actuator moving the magnet.).
Okamoto et al additionally teaches that the device is designed for use during a B/F separation, reciting ([0146], “The magnet 106 may be configured to be capable of being detachable in adaptation with B/F separation…”; [0045], “…the inventors have specifically sought techniques which achieve B/F separation… They have also arrived at a substrate for sample analysis which can achieve more reliable B/F separation with the aid of magnet positioning.”).
Ultimately, the limitation “during a B/F separation for separating reacted substance from unreacted substance within the chamber” is functional language and has been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Okamoto et al in view of Cho et al teaches all of the structural limitations of the apparatus as defined in claim 2, this additional limitation does not define the instant application over the prior art.
With regards to claim 3, the device of claim 2 is obvious over Okamoto et al in view of Cho et al.
Okamoto et al additionally teaches;
The claimed “wherein the first magnet unit comprises a single magnet having the first shape or a plurality of magnets arranged along the first shape” has been read on the taught ([0087], “…the magnet has a bow shape protruding toward the rotation axis and different magnetic poles respectively at the rotation axis side and an opposite side from the rotation axis.”; The magnet reads on a single magnet having the first shape.).
With regards to claim 4, the device of claim 1 is obvious over Okamoto et al in view of Cho et al.
Okamoto et al additionally teaches;
The claimed "wherein the sample analysis substrate is circular" has been read on the taught ([0137], "…the substrate 100′ of the substrate 100 for sample analysis has a circular shape in the present embodiment…");
Okamoto et al does not explicitly disclose that "the first shape of the first magnet unit is a whole shape of the circle, a partial shape of the circle, or a shape of the ring such that a sum of central angles thereof is not less than 90 degrees and not more than 360 degrees."
Cho et al teaches;
The claimed “the first shape of the first magnet unit is a whole shape of the circle, a partial shape of the circle, a whole shape of the ring, or a partial shape of the ring such that a central angle thereof is not less than 90 degrees and not more than 360 degrees” has been read on the taught ([0012], “The magnet may be […] formed in the shape of a ring…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample analysis device as taught by Okamoto et al with the ring-shaped magnet as taught by Cho et al. According to MPEP 2143(I)(B), simple substitution of one known element for another to obtain predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Okamoto et al teaches a device which differs from the claimed device only by the substitution of an arc-shaped magnet. The substituted component of a ring-shaped magnet is known in the art, as shown in Cho et al. One of ordinary skill in the art could have substituted the known element of a ring-shaped magnet into the device of Okamoto, for the predictable result of focusing magnetic particles over an area defined by the magnetic flux pattern of the magnet.
With regards to claim 6, the device of claim 1 is obvious over Okamoto et al in view of Cho et al.
Okamoto et al additionally teaches;
The claimed "wherein the sample analysis substrate is circular" has been read on the taught ([0137], "…the substrate 100′ of the substrate 100 for sample analysis has a circular shape in the present embodiment…");
Okamoto et al does not explicitly disclose a radius size of the circle or the ring is determined in accordance with a distance from a center of rotation of the sample analysis substrate to the chamber.
Cho et al additionally teaches;
The claimed "a radius size of the circle or the ring is determined in accordance with a distance from a center of rotation of the sample analysis substrate to the chamber” has been read on the taught ([0011], “The magnet may be affixed to the rotary body at a position adjacent to the curved portion or be formed in the shape of a ring having a radius corresponding to the distance from the rotation center of the rotary body to the curved portion…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample analysis device as taught by Okamoto et al with the magnet having a radius determined in accordance with a distance from a center of rotation of the sample analysis substrate to the chamber as taught by Cho et al. According to MPEP 2143(I)(B), simple substitution of one known element for another to obtain predictable results may be prima facie obvious. In the case of the instant invention, the prior art of Okamoto et al teaches a device which differs from the claimed device only by the substitution of a magnet whose radius is not determined in accordance with a distance. The substituted component of a magnet with a radius related to a distance from the center of rotation is known in the art, as shown in Cho et al. One of ordinary skill in the art could have substituted the known element into the device of Okamoto, for the predictable result of focusing magnetic particles over an area defined by the magnetic flux pattern of the magnet.
With regards to claim 7, the device of claim 1 is obvious over Okamoto et al in view of Cho et al.
Okamoto et al additionally teaches;
The claimed “wherein the first shape of the first magnet unit is a whole or a part of the ring” has been read on the taught ([0087], “…the magnet has a bow shape protruding toward the rotation axis and different magnetic poles respectively at the rotation axis side and an opposite side from the rotation axis.”).
The claimed "the first actuator moves the first magnet unit during the B/F (Bound/Free) separation so that a central position regarding a radial direction of the ring matches a position in the chamber that is the farthest from the center of rotation of the sample analysis substrate" has been read on the taught ([0146], "Among these inner surfaces, the magnet 106 is disposed near a side face portion that is the most distant from the rotation axis 101.").
The limitation “the first actuator moves the first magnet unit during the B/F (Bound/Free) separation so that a central position regarding a radial direction of the ring matches a position in the chamber that is the farthest from the center of rotation of the sample analysis substrate” is functional language and has been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Okamoto et al in view of Cho et al teaches all of the structural limitations of the apparatus as defined in claim 7, this additional limitation does not define the instant application over the prior art.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Okamoto et al (US 20170131305 A1) in view of Cho et al (US 20080171400 A1) and further in view of Gwynn et al (US 20130132006 A1).
With regards to claim 5, the device of claim 1 is obvious over Okamoto et al in view of Cho et al.
Okamoto et al additionally teaches;
The claimed "wherein the sample analysis substrate is circular" has been read on the taught ([0137], "…the substrate 100′ of the substrate 100 for sample analysis has a circular shape in the present embodiment…");
The claimed “the first shape of the first magnet unit is a partial shape of the circle or a partial shape of the ring” has been read on the taught ([0087], “…the magnet has a bow shape protruding toward the rotation axis and different magnetic poles respectively at the rotation axis side and an opposite side from the rotation axis.”).
However, this combination does not explicitly disclose wherein a length along a circumferential direction of the first magnet unit is longer than a length along a circumferential direction of the chamber.
In the analogous art of magnetic particle processing units, Gwynn et al teaches the advantages of larger magnet sizes, as read on the taught ([0305], “A large magnet also collects the magnetically responsive microparticles along the culvert 211 but distributes them over a larger portion of the interior surface. The larger magnet may collect the magnetically responsive microparticles more rapidly, and the system can more readily resuspend the distributed pellet. Both of these attributes reduce processing time.”);
Gwynn et al additionally teaches optimizing magnet size and shape, as read on the taught ([0501], “Separation magnets 804 of different processing lanes 116 may be of different shapes and sizes, advantageously permitting the system to generate "pellets" of magnetically responsive solid or particulate phase materials with different sizes and geometries when the field of the separation magnet is applied to an assay cartridge 200, advantageously allowing optimization of pellet dimensions for specific processing steps.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Okamoto et al in view of Cho et al to include a first magnet unit with a length along its circumferential direction which is longer than a length along a circumferential direction of the chamber. The prior art of Gwynn et al clearly indicates that magnet shape and size was well-known in the art to be a result-effective variable, which could be optimized according to other considerations, such as the desired pellet sizes within a processing cartridge. This teaching, in light of Cho et al’s teaching of a magnet with a radius which overlaps the circumferential dimensions of a channel so as to restrain particle motion (see Cho et al [0030] and Figure 1), renders the limitations of claim 5 obvious to one of ordinary skill in the art.
Claims 8-12, 13-27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Okamoto et al (US 20170131305 A1) in view of Cho et al (US 20080171400 A1) and further in view of Wong et al (US 20210146361 A1, effectively filed 21 July 2017).
With regards to claim 8, the device of claim 1 is obvious over Okamoto et al in view of Cho et al.
Okamoto et al additionally teaches that the first actuator is capable of moving the magnet, and that the actuator may be a robotic arm ([0215], “…the sample analysis device 200 includes a driving mechanism which inserts the magnet 160 in the receptacle 120 of the substrate 100 for sample analysis being placed on the turntable 201a, and removes the magnet 160 from the substrate 100 for sample analysis. The driving mechanism is a robot arm, for example.”).
However, Okamoto et al does not explicitly disclose “wherein the first actuator moves the first magnet unit along a direction that is parallel to a rotation axis of the sample analysis substrate.”
In the analogous art of disk-based assays, Wong et al teaches;
The claimed “wherein the first actuator moves the first magnet unit along a direction that is parallel to a rotation axis of the sample analysis substrate” has been read on the taught ([0033], “Such an actuator may be suitable for moving the magnet in any axis. Preferably, a linear actuator may be configured to move the magnet along an x-axis of a planar surface of a mounted microfluidic system, such as along the radius of a microfluidic assay disc.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a magnet movable by a robotic arm as taught by Okamoto et al in view of Cho et al with the actuator suitable for moving the magnet in any axis, as taught by Wong et al, for the benefit of allowing a specific control over the magnetic particles, and to allow a wide range of microfluidic systems to be mounted and used (Wong et al, [0035], “The present invention allows for more specific control of the movement of magnetic beads, and any liquid and/or particulate solids associated therewith, through the microfluidic channels and chambers of a mounted microfluidic system…”; [0051], “In certain embodiments, mounting the one or more magnets on an adjustable mounting assembly allows for fine tuning of the position of the one or more magnets in a z-axis in relation to a microfluidic system mounted on the apparatus. Thus allowing for a wider range of different microfluidic systems to be mounted and used with embodiments described herein.”).
With regards to claim 9, the device of claim 1 is obvious over Okamoto et al in view of Cho et al.
Okamoto et al additionally teaches that the first actuator is capable of moving the magnet, and that the actuator may be a robotic arm ([0215], “…the sample analysis device 200 includes a driving mechanism which inserts the magnet 160 in the receptacle 120 of the substrate 100 for sample analysis being placed on the turntable 201a, and removes the magnet 160 from the substrate 100 for sample analysis. The driving mechanism is a robot arm, for example.”).
However, neither Okamoto et al nor Cho et al explicitly disclose “wherein the first actuator moves the first magnet unit along a direction that is perpendicular to a rotation axis of the sample analysis substrate.”
In the analogous art of disk-based assays, Wong et al teaches;
The claimed “wherein the first actuator moves the first magnet unit along a direction that is perpendicular to a rotation axis of the sample analysis substrate” has been read on the taught ([0033], “Such an actuator may be suitable for moving the magnet in any axis.”; [0050], “Thus, in some embodiments, the adjustable mounting assembly is configured to allow positioning of the magnet in a position along a Z-axis.”; The actuator allowing movement in any axis, including a z-axis, reads on movement in a direction that is perpendicular to a rotation axis.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a magnet movable by a robotic arm as taught by Okamoto et al in view of Cho et al with the actuator suitable for moving the magnet in any axis, as taught by Wong et al, for the benefit of allowing a specific control over the magnetic particles, and to allow a wide range of microfluidic systems to be mounted and used (Wong et al, [0035], “The present invention allows for more specific control of the movement of magnetic beads, and any liquid and/or particulate solids associated therewith, through the microfluidic channels and chambers of a mounted microfluidic system…”; [0051], “In certain embodiments, mounting the one or more magnets on an adjustable mounting assembly allows for fine tuning of the position of the one or more magnets in a z-axis in relation to a microfluidic system mounted on the apparatus. Thus allowing for a wider range of different microfluidic systems to be mounted and used with embodiments described herein.”).
With regards to claim 10, the device of claim 9 is obvious over Okamoto et al in view of Cho et al and further in view of Wong et al.
Neither Okamoto et al nor Cho et al explicitly disclose wherein the first actuator moves the first magnet unit to a position at which the first magnet unit and the sample analysis substrate do not overlap as viewed from a direction that is parallel to the rotation axis of the sample analysis substrate.
Wong et al teaches;
The claimed “wherein the first actuator moves the first magnet unit to a position at which the first magnet unit and the sample analysis substrate do not overlap as viewed from a direction that is parallel to the rotation axis of the sample analysis substrate” has been read on the taught ([0046], “Where additional clearance is required, […] the magnet may be mounted on an actuator suitable for moving the magnet in an x-axis, such as a linear actuator, wherein this actuator may be rotated away from and/or towards the mounted microfluidic device. Rotating the actuator rod in one direction will move the magnet clear of any obstruction while rotation in the other direction will enable the magnet to contact the disc.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device capable of moving a magnet perpendicular to the plane of the rotation as taught by Okamoto et al in view of Cho et al and further in view of Wong et al, with the actuator capable of moving the magnet away from the microfluidic device as taught by Wong et al, for the benefit of moving the magnet away from any obstruction when manipulating the disc/substrate (Wong et al, [0046], “Rotating the actuator rod in one direction will move the magnet clear of any obstruction while rotation in the other direction will enable the magnet to contact the disc.”).
With regards to claim 11, the device of claim 1 is obvious over Okamoto et al in view of Cho et al.
Okamoto et al additionally teaches;
The claimed “wherein the first magnet unit is located on an opposite side of the sample analysis substrate from the turntable” has been read on the taught ([0138], "In the present embodiment, the base substrate 100a and the cover substrate 100b are utilized respectively as an upper face and a lower face."; [Claim 5], “The substrate for sample analysis of claim 3, wherein the magnet is closer to the upper face portion than to the opening of the channel.”; The magnet on the upper face of the substrate reads on the magnet unit being located on an opposite side of the sample analysis substrate from the turntable).
Neither Okamoto et al nor Cho et al explicitly disclose wherein the first magnet unit is located outside of the sample analysis substrate.
In the analogous art of disk-based assays, Wong et al teaches;
The claimed “wherein the first magnet unit is located outside of the sample analysis substrate” has been read on the taught ([0041], “Alternatively, the one or more actuators may be configured to position the one or more magnets at a fixed distance from the surface of a mounted microfluidic system.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample analysis device including a magnet unit as taught by Okamoto et al in view of Cho et al, with the magnet located outside of the sample analysis substrate as taught by Wong et al, for the benefit of allowing a specific control over the magnetic particles (Wong et al, [0035], “The present invention allows for more specific control of the movement of magnetic beads, and any liquid and/or particulate solids associated therewith, through the microfluidic channels and chambers of a mounted microfluidic system…”).
With regards to claim 12, the device of claim 1 is anticipated by Okamoto et al.
Okamoto et al additionally teaches;
The claimed “wherein the first magnet unit is located on a same side of the sample analysis substrate as the turntable” has been read on the taught ([0217], “In the second example, the magnet 106 is attached to the turntable which supports the substrate 100 for sample analysis.”; The magnet attached to the turntable reads on the magnet unit being located on the same side of the sample analysis substrate as the turntable.).
Neither Okamoto et al nor Cho et al explicitly disclose wherein the first magnet unit is located outside of the sample analysis substrate.
In the analogous art of disk-based assays, Wong et al teaches;
The claimed “wherein the first magnet unit is located outside of the sample analysis substrate” has been read on the taught ([0041], “Alternatively, the one or more actuators may be configured to position the one or more magnets at a fixed distance from the surface of a mounted microfluidic system.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample analysis device including a magnet unit as taught by Okamoto et al in view of Cho et al, with the magnet located outside of the sample analysis substrate as taught by Wong et al, for the benefit of allowing a specific control over the magnetic particles (Wong et al, [0035], “The present invention allows for more specific control of the movement of magnetic beads, and any liquid and/or particulate solids associated therewith, through the microfluidic channels and chambers of a mounted microfluidic system…”).
With regards to claim 13, the device of claim 2 is obvious over Okamoto et al in view of Cho et al.
Neither Okamoto et al nor Cho et al explicitly disclose a second magnet unit distinct from the first magnet unit; and a second actuator to move the second magnet unit along a direction that is perpendicular to a rotation axis of the sample analysis substrate to change relative positions of the second magnet unit and the sample analysis substrate.
In the analogous art of disk-based assays, Wong et al teaches;
The claimed “a second magnet unit distinct from the first magnet unit” has been read on the taught ([0038], “It shall be understood that the apparatus may optionally comprise multiple magnets. Where multiple magnets are used, each magnet may be housed on a separate actuator.”);
The claimed “a second actuator to move the second magnet unit along a direction that is perpendicular to a rotation axis of the sample analysis substrate to change relative positions of the second magnet unit and the sample analysis substrate” has been read on the taught ([0038], “Where multiple magnets are used, each magnet may be housed on a separate actuator.”; [0033], “Such an actuator may be suitable for moving the magnet in any axis.”; Moving the magnet in any axis reads on moving the second magnet unit along a direction that is perpendicular to a rotation axis of the sample analysis substrate.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a magnet unit and an actuator as taught by Okamoto et al in view of Cho et al, with the second magnet unit as taught by Wong et al, for the benefit of allowing a specific control over the magnetic particles (Wong et al, [0035], “The present invention allows for more specific control of the movement of magnetic beads, and any liquid and/or particulate solids associated therewith, through the microfluidic channels and chambers of a mounted microfluidic system…”).
With regards to claim 14, the device of claim 13 is obvious over Okamoto et al in view of Cho et al and further in view of Wong et al.
Okamoto et al additionally teaches;
The claimed “a single magnet having a second shape that is a whole shape of a circle, a partial shape of a circle, a whole shape of a ring, or a partial shape of a ring, or a plurality of magnets arranged along the second shape” has been read on the taught ([0087], “…the magnet has a bow shape protruding toward the rotation axis and different magnetic poles respectively at the rotation axis side and an opposite side from the rotation axis.”).
With regards to claim 15, the device of claim 1 is obvious over Okamoto et al in view of Cho et al.
Neither Okamoto et al nor Cho et al explicitly disclose wherein the first actuator is a stepping motor or a linear motor.
In the analogous art of disk-based assays, Wong et al teaches;
The claimed “wherein the first actuator is a stepping motor or a linear motor” has been read on the taught ([0033], “According to some embodiments, the actuator may comprise a linear actuator.”).
According to MPEP 2143(I)(B), simple substitution of one known element for another to obtain predictable results may support a prima facie finding of obviousness with regards to the combination. In the case of the instant application, Okamoto et al in view of Cho et al contained a device which differed from the claim only by the recitation of a generic actuator, rather than a stepping motor or a linear motor. As shown by Wong et al, the components and function of a linear motor were known in the art. One of ordinary skill in the art could have substituted a linear motor in place of a generic actuator, with the predictable result of creating a device which can move a magnetic unit by use of the linear motor. As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a first actuator as taught by Okamoto et al in view of Cho et al with the linear motor as taught by Wong et al to yield the expected result of a device which can move the magnetic unit.
With regards to claim 16, the device of claim 13 is obvious over Okamoto et al in view of Cho et al and further in view of Wong et al.
Neither Okamoto et al nor Cho et al explicitly disclose wherein the first actuator and the second actuator are a stepping motors or a linear motors.
Wong et al additionally teaches;
The claimed “wherein the first actuator and the second actuator are a stepping motors or a linear motors” has been read on the taught ([0038], “Where multiple magnets are used, each magnet may be housed on a separate actuator.”; [0033], “According to some embodiments, the actuator may comprise a linear actuator.”).
According to MPEP 2143(I)(B), simple substitution of one known element for another to obtain predictable results may support a prima facie finding of obviousness with regards to the combination. In the case of the instant application, the combination of Okamoto et al in view of Cho et al contained a device which differed from the claim only by the recitation of a generic actuator, rather than a stepping motor or a linear motor. As shown by Wong et al, the components and function of a linear motor were known in the art. One of ordinary skill in the art could have substituted a linear motor in place of a generic actuator, with the predictable result of creating a device which can move a magnetic unit by use of the linear motor. As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a first actuator and second actuator as taught by Okamoto et al in view of Cho et al with the linear motor as taught by Wong et al to yield the expected result of a device which can move the magnetic units.
With regards to claim 17, the device of claim 13 is obvious over Okamoto et al in view of Cho et al and further in view of Wong et al.
Okamoto et al at additionally teaches;
The claimed “wherein the first magnet unit is located on an opposite side of the sample analysis substrate from the turntable” has been read on the taught ([0138], "In the present embodiment, the base substrate 100a and the cover substrate 100b are utilized respectively as an upper face and a lower face."; [Claim 5], “The substrate for sample analysis of claim 3, wherein the magnet is closer to the upper face portion than to the opening of the channel.”; The magnet on the upper face of the substrate reads on the magnet unit being located on an opposite side of the sample analysis substrate from the turntable);
The claimed “wherein… the second magnet unit is located on a same side of the sample analysis substrate as the turntable” has been read on the taught ([0217], “In the second example, the magnet 106 is attached to the turntable which supports the substrate 100 for sample analysis.”; The magnet attached to the turntable reads on the magnet unit being located on the same side of the sample analysis substrate as the turntable.).
However, neither Okamoto et al nor Cho et al explicitly disclose wherein the first magnet unit is located outside of the sample analysis substrate and the second magnet unit is located outside of the sample analysis substrate.
Wong et al additionally teaches;
The claimed “wherein the first magnet unit is located outside of the sample analysis substrate” and “the second magnet unit is located outside of the sample analysis substrate” has been read on the taught ([0043], “Where the apparatus comprises two or more magnets, these may be independently positioned above or below the microfluidic system.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a magnet located in a compartment as taught by Okamoto et al in view of Cho et al and further in view of Wong et al with the magnets independently positioned above or below the microfluidic system as taught by Wong et al, for the benefit of allowing a specific control over the magnetic particles (Wong et al, [0035], “The present invention allows for more specific control of the movement of magnetic beads, and any liquid and/or particulate solids associated therewith, through the microfluidic channels and chambers of a mounted microfluidic system…”).
With regards to claim 18, the device of claim 1 is obvious over Okamoto et al in view of Cho et al.
Neither Okamoto et al nor Cho et al explicitly disclose a second magnet unit to generate an attractive force for attracting the magnetic particles; and a second actuator to move the second magnet unit to change relative positions of the second magnet unit and the sample analysis substrate, wherein, the first magnet unit is disposed at a first face that is perpendicular to the rotation axis of the sample analysis substrate; the second magnet unit is disposed at a second face that is perpendicular to the rotation axis of the sample analysis substrate, the second face being opposite to the first face; the control circuit controls operation of the second actuator; and during agitation of the liquid sample in the chamber, the first actuator and the second actuator alternately move the first magnet unit and the second magnet unit to a position where the magnetic particles in the chamber are attracted by the first magnet unit and the second magnet unit.
In the analogous art of disk-based assays, Wong et al teaches;
The claimed “a second magnet unit to generate an attractive force for attracting the magnetic particles; and a second actuator to move the second magnet unit to change relative positions of the second magnet unit and the sample analysis substrate” has been read on the taught ([0038], “Where multiple magnets are used, each magnet may be housed on a separate actuator.”; [0033], “Such an actuator may be suitable for moving the magnet in any axis.”);
The claimed “wherein, the first magnet unit is disposed at a first face that is perpendicular to the rotation axis of the sample analysis substrate; the second magnet unit is disposed at a second face that is perpendicular to the rotation axis of the sample analysis substrate, the second face being opposite to the first face” has been read on the taught ([0043], “Where the apparatus comprises two or more magnets, these may be independently positioned above or below the microfluidic system.”; [0115], “As depicted in FIG. 3, in some embodiments, multiple magnets 3 may be mounted on actuators 2a which are positioned above and below a mounted assay disc.”; Magnets positioned above and below a mounted assay disc reads on the magnet units disposed at a first face and at a second face that is opposite to the first face, the faces being perpendicular to the rotation axis of the sample analysis substrate (see Fig 3.);
The claimed “the control circuit controls operation of the second actuator” has been read on the taught ([0052], “The apparatus may comprise a controller configured to control the one or more actuators and the turntable to enable the magnet to trace a desired path across a mounted microfluidic system.”; The controller reads on the control circuit which controls operation of the second actuator.);
The claimed “first actuator and the second actuator are capable of alternately move the first magnet unit and the second magnet unit to a position where the magnetic particles in the chamber are attracted by the first magnet unit and the second magnet unit” has been read on the taught ([0038], “Where multiple magnets are used, each magnet may be housed on a separate actuator.”; [0033], “Such an actuator may be suitable for moving the magnet in any axis.”; [0043], “Where the apparatus comprises two or more magnets, these may be independently positioned above or below the microfluidic system.”; Separate actuators with magnets which are independently positioned, and which are suitable for moving the magnet in any axis read on the first actuator and second actuator being capable of alternately moving the first magnet unit and the second magnet unit.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a magnet unit and an actuator as taught by Okamoto et al, with the second magnet unit as taught by Wong et al, for the benefit of allowing a specific control over the magnetic particles (Wong et al, [0035], “The present invention allows for more specific control of the movement of magnetic beads, and any liquid and/or particulate solids associated therewith, through the microfluidic channels and chambers of a mounted microfluidic system…”).
The limitations of “to generate an attractive force for attracting the magnetic particles,” “to change relative positions of the second magnet unit and the sample analysis substrate” and “during agitation of the liquid sample in the chamber, the first actuator and the second actuator alternately move the first magnet unit and the second magnet unit to a position where the magnetic particles in the chamber are attracted by the first magnet unit and the second magnet unit” are examples of functional language describing the intended use of the apparatus; as such, they have been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Okamoto et al in view of Cho et al and further in view of Wong et al teaches all of the structural limitations of the apparatus as defined in claim 18, this additional limitation does not define the instant application over the prior art.
With regards to claim 19, the device of claim 18 is obvious over Okamoto et al in view of Cho et al and further in view of Wong et al.
Okamoto et al additionally teaches;
The claimed “wherein the first face is a face that is opposite to the turntable with respect to the sample analysis substrate” has been read on the taught ([0138], "In the present embodiment, the base substrate 100a and the cover substrate 100b are utilized respectively as an upper face and a lower face."; The upper face reads on an upper face. See also figure 3B).
The claimed magnet unit having “a second shape that is a partial shape of a circle, a whole shape of a ring, or a partial shape of a ring” has been read on the taught ([0087], “…the magnet has a bow shape protruding toward the rotation axis and different magnetic poles respectively at the rotation axis side and an opposite side from the rotation axis.”).
With regards to claim 20, the device of claim 19 is obvious over Okamoto et al in view of Cho et al and further in view of Wong et al.
Neither Okamoto et al nor Cho et al explicitly disclose the first magnet unit comprises a single magnet having the first shape and the second magnet unit comprising a single magnet having the second shape.
Wong et al additionally teaches;
The claimed “a single magnet having the first shape or a plurality of magnets arranged along the first shape” and “a single magnet having the second shape or a plurality of magnets arranged along the second shape” have been read on the taught ([0038], “It shall be understood that the apparatus may optionally comprise multiple magnets. Where multiple magnets are used, each magnet may be housed on a separate actuator.”);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample analysis device including a first and second magnet unit with a first and second shape as taught by Okamoto et al in view of Cho et al and further in view of Wong et al with the multiple magnets as taught by Wong et al, for the benefit of allowing a specific control over the magnetic particles (Wong et al, [0035], “The present invention allows for more specific control of the movement of magnetic beads, and any liquid and/or particulate solids associated therewith, through the microfluidic channels and chambers of a mounted microfluidic system…”).
With regards to claim 21, the device of claim 19 is obvious over Okamoto et al in view of Cho et al and further in view of Wong et al.
Neither Okamoto et al nor Cho et al explicitly disclose wherein the first actuator capable of causing the first magnet unit to approach the sample analysis substrate and move away from the sample analysis substrate, and the second actuator capable of causing the second magnet unit to move away from the sample analysis substrate and approach the sample analysis substrate.
Wong et al teaches;
The claimed “the first actuator capable of causing the first magnet unit to approach the sample analysis substrate and move away from the sample analysis substrate, and the second actuator capable of causing the second magnet unit to move away from the sample analysis substrate and approach the sample analysis substrate” has been read on the taught ([0038], “Whe