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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 16, 2026 has been entered.
Claim Status
Claims 9-16, 18, 20, 27 are still pending.
Claims 1-8, 17, 19, 21 have been canceled.
Claims 9 and 27 have been amended.
Clams 22-26 have been withdrawn.
Claim Rejections - 35 USC § 102
Claim 9-15, 18, and 20 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Smith et. al. (US 20150336096 A1).
Regarding claim 9, Hansen teaches “A microfluidic device comprising:” (Fig. 1a and Para [0051], microfluidic device) “a sorting channel” (Fig. 1a and Para [0089], microfluidic channel region 112 through which a sample fluid may flow.)
“arranged in a substrate and” (Para [0180], In particular, a 1 mm thick glass substrate was provided for each device.)
The recitation “configured to flow a fluid sample comprising magnetized target entities;” is capability of the sorting channel. However taught by Smith (Fig. 1a and Paras [0089] and [0002], microfluidic channel region 112 through which a sample fluid may flow. Magnetic cell separation is a technique in which magnetic fields are used to isolate cells within a fluid sample. Typically, magnetic particles are selectively attached to one or more desired cells using antibodies that bind to the cell surface. Cells having the attached magnetic particles then can be confined or deflected using an applied magnetic field to isolate the magnetically labeled cells from other analytes in the fluid sample.)
“a magnet placed underneath the substrate under the sorting channel;” (Fig. 1a and Para [0029], Magnet 102, In aspect 41, according to any one of aspects 34 to 40, the methods further include placing a low magnetic permeability substrate, e.g., a non-magnetic substrate, on a surface of the one or more magnets)
Ward further teaches, “a permeability channel arranged in the substrate adjacent to and along a first side of the sorting channel and comprising a set of high magnetic permeability particles retained within the permeability channel;” (Fig. 1A and Paras [0089] and [0148], In some implementations, the high magnetic permeability material can be a composite material, such as a polymer, glass, or ceramic that contains high magnetic permeability particles. Magnetizable layer 104 may be composed of separate portions: a high magnetic permeability portion 106 having a magnetic permeability that is higher relative to an elongated low magnetic permeability portion 108).
The recitation “and wherein the magnet and the set of high magnetic permeability particles are configured to generate a deflecting magnetic field that causes a subset of magnetized target entities in the sorting channel to be deflected away from a first side of the sorting channel” is capability of the magnet and the set of high magnetic permeability particles. However, such capability is taught within (Para [0002], Cells having the attached magnetic particles then can be confined or deflected using an applied magnetic field to isolate the magnetically labeled cells from other analytes in the fluid sample.).
Further taught by Smith “and wherein the fluid sample does not flow through the permeability channel. (Abstract and Para [0089], A magnetizable layer adjacent to the one or more magnets, in which the magnetizable layer is configured to induce a gradient in the magnetic field of at least one of the magnets. A fluid sample may flow through the channel region 112, e.g., along the z-direction.).
Regarding claim 10, Ward teaches all of claim 9 as above. The recitation “wherein the set of magnetic permeability particles are configured to increase a gradient of the deflecting magnetic field” is capability of the magnetic permeability particles. Smith discloses the positively claimed structural elements of the magnetic permeability particles as claimed, such magnetic permeability particles are said to be fully capable of the recited adaptation in as much as recited and required herein.
Regarding claim 11, Smith teaches all of claim 9 as above. The recitation “wherein the set of magnetic permeability particles are configured to change a direction of force exerted by the deflecting magnetic field on the magnetized target entities” is capability of the magnetic permeability particles. However taught within (Para [0160], The cartridge may be rotatably fixed or translated with respect to the magnetizable layer of the instrument portion such that the direction of the force induced by the magnetic gradient changes relative to the flow direction of the microfluidic channel.)
Regarding claim 12, Smith teaches all of claim 9 as above. The recitation “wherein: the deflecting magnetic field causes a second subset of magnetized target entities in the sorting channel to be deflected towards a second side of the sorting channel;” is capability of magnetic permeability particles which as claimed are configured to generate the deflecting magnetic field. Therefore Smith discloses the positively claimed structural elements of the magnetic permeability particles as claimed, such magnetic permeability particles are said to be fully capable of the recited adaptation in as much as recited and required herein.
Further taught is “and the device further comprises: a second permeability channel adjacent to the second side of the sorting channel opposite to the first side of the sorting channel, wherein the second permeability channel comprises a second set of magnetic permeability particles.” (Paras [0019], [0090], and [0005], FIG. 1B is a top view of the magnetizable layer 104 with the cover 110 removed. As shown in FIG. 1B, the elongated low magnetic permeability portion 108 also extends along the z-direction. The foregoing and other embodiments can each optionally include one or more of the following features, alone or in combination. For example, in aspect 2 according to aspect 1, the high magnetic permeability material and the low magnetic permeability material are elongated. In aspect 3, according to any one of aspect 2 to 3, the device further includes a second high magnetic permeability material arranged at a distance from the first high magnetic permeability material to form a gap between them (e.g., a uniform gap), wherein the gap is filled with low magnetic permeability material. In aspect 4, according to aspect 3, the low magnetic permeability material in the gap is the same as the low magnetic permeability material in a remainder of the magnetizable layer.)
Therefore, the magnetizable layer containing additional magnetic permeability material which differs from the magnetic permeability material on the other side teaches to the second permeability channel.
Regarding claim 13, Smith teaches all of claim 12 as above in addition to “further comprising: a first collection channel extending from the first side of the sorting channel”…”and a second collection channel extending from the second side of the sorting channel” (Para [0018] In aspect 20, “according to aspects 1 to 19, the microfluidic devices include a deflection channel and, an output channel separate from the deflection channel, in which both the output channel and the deflection channel are fluidly coupled to an outlet of the microfluidic channel. Para [0024], in which the gradient in the magnetic field deflects the target analyte toward the channel away from an initial fluid flow trajectory of the fluid sample; and collecting the target analyte at an output of the deflection channel.) Therefore the deflection channel and the output channel are the first and second collection channels.
The recitations “such that the subset of magnetized target entities flows from the sorting channel to the first collection channel;”… and “such that the second subset of magnetized target entities flow from the sorting channel to the second collection channel.” are capability of the collection channels. Smith teaches both the output channel and the deflection channel are fluidly coupled to the microfluidic channel and are capable of having the magnetized target flow from the microfluidic channel (sorting channel) to both collection channels.
Regarding claim 14, Smith teaches all of claim 13 as above in addition to “further comprising: a magnetic permeability strip placed underneath the sorting channel in the substrate adjacent to the magnet, wherein the magnetic permeability strip extends longitudinally along a direction of fluid flow in the sorting channel,” (Para [0104], [0104] In some implementations, the magnetizable layer 104 may be composed of flexible magnetic tape in the form of a strip or foil, in which the tape material is used as the high magnetic permeability material. Flexible magnetic tape offers the advantage, in some cases, of being easy to apply to the one or more magnets 102 or the spacer layer 114. An adhesive may be formed on one side of the magnetic tape for adhering to the one or more magnets 102 or the spacer layer 114.).
The recitation “and the magnetic permeability strip is configured to intensify the gradient of the deflecting magnetic field” is capability of the magnetic permeability strip. Smith discloses the positively claimed structural elements of the magnetic permeability strip as claimed. As such, magnetic permeability strip are fully capable of the recited adaptation in as much as recited and required herein.
Regarding claim 15, Smith teaches all of claim 9 as above in addition to “further comprising a second sorting channel in the substrate and configured to receive a portion of the sample fluid flowing from the sorting channel.”(Para [0098], Other widths are possible as well. In some implementations, the width ws may extend beyond 100 mm to accommodate multiplexing in which multiple channels 112 are formed within the device 100, e.g., in parallel or in series.)
Regarding claim 18, Ward teaches all of claim 9 as above in addition to “wherein: the permeability channel includes an array of pillar structures sized to stabilize the set of magnetic permeability particles within the permeability channel.” (Fig. 5a, The distance between the portions 108 (i.e., the width of the high magnetic permeability portion 106 between portions 108may be similar to the widths of portions 108 and in the range of approximately 100 nm to approximately 100 μm.). Therefore, the 108 portions are pillar structures as shown in Fig. 5a.
Regarding claim 20, Ward teaches all of claim 9 as above in addition to “further comprising: a second magnet placed above the substrate; and wherein North poles of each of the magnet and the second magnet are facing an upward direction.” (Abstract, Fig. 21B, Para [0017], shows magnets and at least two on each side of the substrate have the north poles facing in the upward direction. This disclosure describes microfluidic devices that include one or more magnets. In aspect 18, according to any one of aspects 1 to 17, the microfluidic devices include an array of two or more magnets, each magnet having a magnetic pole orientation that is opposite to a magnetic pole orientation of an adjacent magnet in the array such that the magnetic field of each magnet in the array extends to an adjacent magnet in the array. In aspect 19, according to aspect 18, the elongated low magnetic permeability material can be substantially aligned with an interface between two adjacent magnets of the array.).
Claim Rejections - 35 USC § 103
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et. al. (US 20150336096 A1). and further in view of Kapur (US 9610582).
Regarding claim 16, Ward teaches all of claim 9 as above in addition to “further comprising: an inertial focusing channel in the substrate” (Para [0132], The inertial focusing stage 904 focuses cells in the center of microfluidic channel.).
Smith does not teach and comprising a set of asymmetric serpentine segments”.
Kapur teaches inertial focusing channel within (Para, [16], within the second microfluidic channel, and such that the particles within the second fluid sample are focused to one or more streamlines within an inertial focusing section of the particle concentration module. [25], By focusing the particles along defined streamlines, the particles can be positioned at precise locations prior to entering the concentrator region, which enables, in certain implementations, the concentrator to more effectively enrich the particle concentration within the buffer sample.) in addition to “and comprising a set of asymmetric serpentine segments,” (Para (47) Pre-focusing can be achieved using inertial focusing, where the structure and arrangement of the fluid pathways are designed to generate forces that drive particles within a fluid sample to desired streamlines. The particle focusing section shown in FIG. 5 includes a dividing wall 502 that separates two microfluidic channels 504 fluidly coupled to the output of the filter arrays. Each channel 504 has an undulating pathway defined by the surfaces of the dividing wall 502 and the outer channel walls, where the contour of the dividing wall surfaces match the contour of the outer channel wall it is facing. With the undulating pathways shown in FIG. 5, the microfluidic channels alternate between regions having relatively high curvature and regions having relatively low curvature.).
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 Smith to incorporate the teachings of Kapur wherein the inertial focusing channel comprises a set of asymmetric serpentine segments. Doing creates a device that does not need external forces to align particles for further processing and manipulation. Having the channel be asymmetric serpentine segments allows for more surface contact for the particles passing through the channel.
Further Smith does not explicitly teach “wherein the inertial focusing channel is connected to the sorting channel such that a portion of the sample fluid flows from the inertial focusing channel to the first side of the first sorting channel.” However, it would have been clearly within the ordinary skills of an artisan before the effective filing date of the claimed invention to have modified the invention of Smith by having the inertial focusing channel connected to the sorting channel to allow the sample to continue to flow. This is because Kapur teaches that the buffer passes the focusing channel and the particle concentration module contains the filter region, a focusing region, and a concentrator region within (Para [56]). Kapur teaches that the focusing channel is connected the concentrator module and teach Smith teaches fluid flow in the focusing state within para [0143]. Therefore, it would have been an obvious engineering choice, to better place the focusing channel in fluid communication with the sorting channel.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et. al. (US 20150336096 A1) as applied to claim 9 above, and further in view of Di et. al. (US 20190381497 A1).
Regarding claim 27, Smith teaches the deice of claim 9, but does not teach “wherein the set of high magnetic permeability particles is retained within the permeability channel by a set of pillars arranged near an end of the permeability channel.”.
Di teaches particle-drop structures in addition to “wherein the set of high magnetic permeability particles is retained within the permeability channel by a set of pillars arranged near an end of the permeability channel.” (Para [0110], [0114], and [0126], The drop-carrier particles 12 described herein can be manufactured using a novel fabrication method, called high-throughput Optical Transient Liquid Molding (OTLM). In this method, microfluidic posts, pillars, or other protuberances are formed in a microfluidic channel and used to generate complex sub-millimeter scale particles with shapes that consist of the orthogonal intersection of horizontally and vertically-extruded 2D patterns in a high-speed manner. he microfluidic channel 52 includes a sequence of posts or pillars 58 located in an upstream region A of the microfluidic channel 52 that, collectively, are used to generate the sculpted flow. Moreover, the fabrication of drop-carrier particles 12 inside PDMS channels depends on oxygen permeability inside the channel which provides a polymerization inhibition layer close to the walls.) Therefore, the channel that has permeability which has pillars inside teaches to the pillars near the end of the permeability channel.
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 Smith to incorporate the teachings of DI wherein the pillars are towards the end of the permeability channel. Doing so would generate complex sub-millimeter scale particles with shapes as taught by Di.
Response to Amendments
Claim Amendments
Amendments to claims have overcome claim objections set forth in the final office action dated 4/22/2026.
Response to Arguments
Applicant’s arguments, see Applicants Arguments and Remarks, filed July 16, 2026, with respect to the rejection(s) of claim(s) 9-16, 18, 20, and 27 under 102 (a)(1) and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of claim amendments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is (571)272-1557. The examiner can normally be reached M-F.
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/V.E.H./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
