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 .
Election/Restrictions
Applicant’s election without traverse of species I (claims 1-11, 14-20) in the reply filed on 5/8/2026 is acknowledged.
Claims 12-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/8/2026.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 10, 14, and 20 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Tsai et al (WO 2014121394 A1).
Regarding claim 1, Tsai et al teach a microfluidic device (p. 2), comprising: a channel, comprising converging and diverging portions (Fig. 7: channel with reservoir 510); and a plurality of magnets arranged next to the channel (Fig. 7: 540); wherein the plurality of magnets is arranged to apply a magnetic field across the channel to capture magnetic particles in diverging portions of the channel where a velocity of a liquid in the channel is reduced (Fig. 7: 540 capture particles in reservoir 510).
Regarding claim 2, Tsai et al teach the plurality of magnets comprises a first magnet, a second magnet, and a third magnet,(P. 9 lines 5-8: array of magnets and one or more magnets below the container) the first magnet is beneath the channel (Tsai: P. 9 lines 7-8: one or more magnets can also be placed below the container), and the channel extends between the second magnet and the third magnet (P. 9 lines 5-6: array of magnets encircle a portion of the container).
Regarding claim 3, Tsai et al teach wherein the second and third magnets are permanent magnets or electromagnets (P. 9 lines 8-9: electromagnets or permanent magnets).
Regarding claim 5, Tsai et al teach the first magnet is one magnet of an array of first magnets (Fig. 7: 540) ; and the first magnets of the array of first magnets are spaced apart along a direction of flow through the channel (Fig. 7: direction of flow from inlet to outlet).
Regarding claims 10 and 20, Tsai teach a first inlet (Fig. 8 Mixture inlet) in fluid communication with the channel and a second inlet in fluid communication with the channel (Fig. 8: sheath flow inlet); the first inlet communicates with the channel along a longitudinal axis of the channel (Fig. 8); and the second inlet communicates with the channel radially outward of the longitudinal axis of the channel such that liquid injected into the channel through the second inlet is radially outward of liquid injected into the channel through the first inlet. (p. 16 lines 12-25; Fig. 8: it is noted that radially outward reads on the angle of the inlet channel is radially outward from the longitudinal axis of the channel)
Regarding claim 14, Tsai et al teach a microfluidic device, comprising: a substrate defining a channel (p. 19 20-25: PMMA microfluidic device), the channel extending between an inlet and an outlet, the channel alternatingly widening and narrowing to define a plurality of chambers in a direction of flow along the channel between the inlet and the outlet (Fig. 7: reservoir 510); and a plurality of magnets arranged about the channel and configured to apply a magnetic field to the chambers to capture magnetic particles in the chambers. (Fig. 7: 540 magnets)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai in view of Weissleder et al (US 20130271250).
Regarding claim 4, Tsai et al teach the first magnet made from rare-earth permanent magnet or other magnets. Tsai is silent to the first magnet comprises a soft superparamagnetic material. Weissleder et al teach magnet arrays made from superparamagnetic material such as iron oxide (Para. 0006,0054: superparamagnetic materials to form magnet array; it is noted that superparamagnetic iron oxide is considered soft as it allows for the external magnetic field to turn on or off the magnetism of the superparamagnetic material). It is desirable to provide magnetic array using superparamagnetic materials to provide added control over the magnetic force. Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the soft superparamagnetic material of Weissleder for the permanent magnet of Tsai to provide the above advantage of having added control over the magnets.
Claim(s) 6-7, 15-16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al.
Regarding claim 6, 15, Tsai et al teach the channel comprises a plurality of chambers (Fig. 7: 510), each chamber comprising a portion of the channel wherein walls of the channel diverge in the direction of flow to a widest portion of the diverging portion and subsequently converge from the widest portion to a narrowest portion (Fig. 7: walls diverge and converge to form the reservoir 510); and first magnets of the array of first magnets are positioned beneath the chambers of the channel along a direction of flow through the channel. (Fig. 7: 540 magnet is positioned outside the reservoir; Tsai teach one or more magnets can also be placed below the container). Tsai is silent to the specific embodiment of magnet 540 is beneath the channel. Furthermore, the Courts have held that the mere rearrangement of parts, without any new or unexpected results, is within the ambit of a person of ordinary skill in the art (MPEP 2144.04 VI.C). See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Therefore, it would have been obvious to a person of ordinary skill in the art to rearrange the magnet of 540 to be beneath the channel as suggested by Tsai to place the magnet beneath the container in order to contain the magnetic particles in the reservoir 510.
Regarding claim 7, 19, Tsai et al teach sequential chambers of the channel are spaced apart from each other along the flow direction by narrower connecting portions (Fig. 7; narrow channels between reservoirs 510), Tsai is silent to the particular dimensions of the widest diameter of the chamber and the widest diameter of the connecting portions. In re Boesch (205 USPQ 215) teaches the optimization of a result effective variable is ordinarily within the skill of the art. A result effective variable is one that has well known and predictable results. The choice of a ratio of the widest diameter of the chambers of the channel and a widest diameter of connecting portions of the channel is a result effective variable that gives the well-known and expected results of providing adequate size to capture the magnetic particles while allowing fluid to flow to the next reservoir. In the absence of a showing of unexpected results, the Office maintains the ratio of 2:1 to 4:1 of the widest diameter of the chambers of the channel and a widest diameter of connecting portions of the channel would have been within the skill of the art as optimization of a results effective variable.
Regarding claim 16, Tsai et al teach the plurality of magnets comprises a first magnet, a second magnet, and a third magnet,(P. 9 lines 5-8: array of magnets and one or more magnets below the container) the first magnet is beneath the channel (Tsai: P. 9 lines 7-8: one or more magnets can also be placed below the container), and the channel extends between the second magnet and the third magnet (P. 9 lines 5-6: array of magnets encircle a portion of the container).
Claim(s) 8, 11, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai in view of Jaiswal et al, "Micromagnetic Cancer Cell Immobilization and Release for Real-Time Single Cell Analysis" Journal of Magnetism and Magnetic Materials, Volume 427, 1 April 2017, Pages 7-13.
Regarding claim 8, Tsai teach magnets, but are silent to first magnets of the array of first magnets have an ellipsoid shape or an arrow shape. Jaiswal et al teach micromagnet array under a microfluidic channel has an arrow shape (Fig. 1). The magnets are used to immobilize cells with beads within the microfluidic channel. It is noted that the shape of a device without any mechanical function cannot be relied on to patentably distinguish the claimed invention from the prior art unless it results in a product which is distinct from the reference product (see MPEP 2144.04(I)), and changes in shape are 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)). Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the arrow shaped magnet of Jaiswal for the magnet array of Tsai to provide the above advantage of providing a shape that immobilizes cells with beads within the microfluidic channel.
Regarding claims 11 and 17, Tsai teach magnets in a microfluidic device (P. 19 line 24). Tsai is silent to the microfluidic device comprises a first substrate and a second substrate, the first substrate being arranged on top of the second substrate; the second magnet and the third magnet are on the first substrate; and the first magnet is on the second substrate and aligned with the channel on the first substrate above on the first magnet; the substrate is a first substrate, and the microfluid device further comprises a second substrate, the first substrate being arranged on top of the second substrate; the plurality of permanent magnets is on the first substrate; and the first magnet array is on the second substrate and aligned with the channel on the first substrate above the first magnet array.
Jaiswal et al teach a first substrate with the second and third magnet device (Fig.2A shows solenoid arms on either side of the microfluidic) and the second substrate below the first substrate having the micromagnet array (Fig. 1: substrate below the PDMS film). It is desirable to provide the arrangement of the first substrate with the second and third magnets and the second substrate with the first magnet array to provide the microfluidic channel with adequate magnets to capture the cells with magnetic beads within the channel. Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the multiple substrates of Jaiswal to the device of Tsai to provide the above advantage of providing the microfluidic channel with adequate magnets to capture the cells with magnetic beads within the channel.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai in view of Jaiswal et al, "Micromagnetic Cancer Cell Immobilization and Release for Real-Time Single Cell Analysis" Journal of Magnetism and Magnetic Materials, Volume 427, 1 April 2017, Pages 7-13 and further in view of Weissleder et al (US 20130271250).
Regarding claim 18, Tsai teach magnets, but are silent to first magnets of the array of first magnets have an ellipsoid shape or an arrow shape. Jaiswal et al teach micromagnet array under a microfluidic channel has an arrow shape (Fig. 1). The magnets are used to immobilize cells with beads within the microfluidic channel. It is noted that the shape of a device without any mechanical function cannot be relied on to patentably distinguish the claimed invention from the prior art unless it results in a product which is distinct from the reference product (see MPEP 2144.04(I)), and changes in shape are 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)). Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the arrow shaped magnet of Jaiswal for the magnet array of Tsai to provide the above advantage of providing a shape that immobilizes cells with beads within the microfluidic channel.
Tsai/Jaiswal are silent to the first magnet comprises a soft superparamagnetic material. Weissleder et al teach magnet arrays made from superparamagnetic material such as iron oxide (Para. 0006,0054: superparamagnetic materials to form magnet array; it is noted that superparamagnetic iron oxide is considered soft as it allows for the external magnetic field to turn on or off the magnetism of the superparamagnetic material). It is desirable to provide magnetic array using superparamagnetic materials to provide added control over the magnetic force. Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the soft superparamagnetic material of Weissleder for the permanent magnet of Tsai to provide the above advantage of having added control over the magnets.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al in view of Esfandyarpour et al (US 20150376692)
Regarding claim 9, Tsai teach a length dimension is greater than a width dimension (Fig. 7), but is silent length dimensions are perpendicular to the flow direction of the channel.
Esfandyarpour et al teach magnetic elements of an array oriented perpendicular to control flow by either capturing carriers or by setting them up to flow straight through (Fig. 5A, Para. 0161: magnetic elements with length is greater than width dimension of an array may be oriented perpendicular to flow) It is advantageous to provide the length dimension perpendicular to the flow to allow for control of where the magnetic beads are captured and where the beads are allowed to flow through. Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the orientation of Tsai magnet array to be perpendicular to the flow as in Esfandyarpour et al to provide the above advantage of allowing for control of where the magnetic beads are captured and where the beads are allowed to flow through.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Dennis White/Primary Examiner, Art Unit 1758
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