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 .
Response to Amendment
The Amendment filed 06/09/2026 has been entered. Claims 1-15 remain pending in the application. Claims 6-15 have been withdrawn. Claims 1-5 are being examined herein.
Status of Objections and Rejections
The rejections under 35 U.S.C. 103 are being withdrawn in view of Applicant’s amendment.
New grounds for rejections under 35 U.S.C. 102 and 103 are necessitated by Applicant’s amendments.
Claim Rejections - 35 USC § 102
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.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Njoroge (US 20140087359 A1).
Regarding claim 1, Njoroge teaches a method comprising:
receiving, at a microfluidic channel (lysis/mixing chamber 120)(para. 0212, and Figs. 1 and 2), a biologic sample including a cell (abstract, para. 0212);
providing a magnetic field within the microfluidic channel using a first magnet (191)(one of the electromagnets, paras. 0148, 0212-0213 and Fig. 2), wherein the magnetic field attracts a first plurality of magnetic particles (half of the magnetic beads) disposed within the microfluidic channel (Fig. 2);
activating a first resistor (resistive heater 160) disposed within the microfluidic channel (paras. 0087, 0091) and on top of the first magnet (Fig. 1, and resistive heater 160 is on top of magnet 191. See also Fig. 8) to agitate a volume of fluid (para. 0126 and 0212, activating resister heater 106 heats up the fluid in the channel to augment mechanical lysis. The heating leads to increase in kinetic motion to agitate a volume of fluid) within the microfluidic channel in alignment with a direction of the magnetic field (para. 126, heating increase lysis efficiency, and thus the agitation results from the heating is in alignment with the magnetic field).
in response to agitating a volume of fluid, moving the first plurality of magnetic particles through the microfluidic channel to lyse the cell and to release cellular material from the cell (paras. 0127 and 0212).
Regarding claim 2, Njoroge teaches all of the elements of the current invention as stated above with respect to claim 1. Njoroge further teaches wherein moving the first plurality of magnetic particles includes moving the first plurality of magnetic particles at a different velocity than a velocity of surrounding fluid (para. 0212, mixing of magnetic particles which necessitates magnetic particles and surrounding fluid moving at different velocities), thereby generating local shear near the cell (para. 0212, mixing of magnetic particles mechanically lyses cells).
Regarding claim 3, Njoroge teaches all of the elements of the current invention as stated above with respect to claim 1. Njoroge teaches the method further including heating the first plurality of magnetic particles (paras. 0126 and 0212, resistive heater increases the chamber temperature and thus heats up the magnetic particles) prior to agitating the volume of fluid (the heating causes the agitation, and thus prior to agitation) to control magnetic properties of the first plurality of magnetic particles (increase of temperature changes magnetic moment of the magnetic particles).
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.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Njoroge (US 20140087359 A1) in view of Kim et al. (US 20060140051 A1)(provided by the Applicant’s IDS of 05/29/2023).
Regarding claim 4, Njoroge teaches all of the elements of the current invention as stated above with respect to claim 1. Njoroge further teaches the method further including: applying energy to the first magnet to provide the magnetic field; and removing the energy to remove the magnetic field and release the first plurality of magnetic particles prior to activating the first resistor.
Njoroge teaches the method utilizing magnetic beads actuated by electromagnets to mechanically lyse the cells (paras. 0212-0213, 0222, Fig. 2). Njoroge further teaches the electromagnets that are situated below the channel generate friction force and collisions between the cells and magnetic beads (para. 222). Njoroge does not explicitly teach how the electromagnets generate the friction force and collision and thus fails to teach applying energy to the first magnet to provide the magnetic field; and removing the energy to remove the magnetic field.
However, Kim teaches a method for mechanically lysing cells in a channel using a set of electromagnets and magnetic particles. Kim further teaches two electromagnets are arranged above and two below the channel (Figs. 3-4) and each electromagnet being alternatively turned on and off in a cycles causes mixing of the magnetic beads and samples (para. 0030).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the configuration of the electromagnets taught by Njoroge to dispose two electromagnets above the channel and leaving two electromagnets below the channel as taught by Kim (Fig. 3), and to have modified the method include teach applying energy to the first magnet to provide the magnetic field; and removing the energy to remove the magnetic field as taught by Kim (Kim, para. 0030) in order to cause generate friction force and collisions for cell lysis (Kim, para. 00052 and Njoroge, para. 0212) with a reasonable expectation of success (MPEP 2143)(I)(G).
The teachings of modified Njoroge yields the method including: applying energy to the first magnet (one of the electromagnets at the bottom) to provide the magnetic field (Kim, para. 0030, Fig. 4); and removing the energy to remove the magnetic field (Kim, para. 0030, Fig. 4) and release the first plurality of magnetic particles (each of the electromagnet is being alternately turned on and off. The magnetic beads are released from the one of the electromagnets when the electromagnet is turned off) prior to activating the first resistor (Njoroge, para. 0069, resistive heater maintains temperature, through heating/cooling, for a period which involves the resistive heater being activated and deactivated throughout the lysis process, and thus prior to one of these activations of the resistive heater, the one of the electromagnet is being turned off).
In the alternative, if it is not seen that Modified Njoroge teaches the recited order of removing the energy to remove the magnetic field and release the first plurality of magnetic particles prior to activating the first resistor, this rejection is also put forth. It has been held that performing steps (the step of removing the energy to remove the magnetic field and release the first plurality of magnetic particles and the step of activating the first resistor) simultaneously or in a different sequence in the absence of new or unexpected results (still the same result of cells being lysed) involves only routine skill in the art. See MPEP 2144.04(IV)C. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the order of the method taught by Njoroge with removing the energy to remove the magnetic field and release the first plurality of magnetic particles prior to activating the first resistor because one of ordinary skill in the art would have been motivated to removing the energy to remove the magnetic field and release the first plurality of magnetic particles prior to activating the first resistor because doing so helps maintain an optimal temperature in the chamber during lysis while still accomplishes the result of cell lysis.
Regarding claim 5, Njoroge teaches all of the elements of the current invention as stated above with respect to claim 1.
Njoroge teaches a method to performs mechanical cell lysis by that include providing a magnetic field within the microfluidic channel using a first magnet (one of the electromagnets 191), wherein the magnetic field attracts magnetic particles (half of the magnetic beads) disposed within the microfluidic channel (120); and activating a first resistor (resistive heater 160) disposed within the microfluidic channel to agitate a first volume of fluid within the microfluidic channel as discussed above (see claim 1).
Njoroge teach having only one group of lysing elements that includes the first magnet (one of one of the electromagnets) and a first resistor (resistive heater) and thus does not teach a second magnet and a second resistor and thus fails to teach
providing a second magnetic field within the microfluidic channel using a second magnet, wherein the second magnetic field attracts a second plurality of magnetic particles disposed within the microfluidic channel; and
activating a second resistor disposed within the microfluidic channel to agitate a second volume of fluid within the microfluidic channel, and in response, moving the second plurality of magnetic particles through the microfluidic channel, wherein the first plurality and second plurality of magnetic particles are to lyse the cell, and the first magnet and the first resistor are downstream from the second magnet and the second resistor within the microfluidic channel.
However, Kim teaches a microfluidic device comprising a microchannel, electromagnets and microbeads for mixing and lysing cells (para. 0003). Kim teaches the electromagnets are actuators for fluid motion that drive the microbeads to lysing cells. Kim teaches the device can comprise one or more than one groups of lysing elements including one set of electromagnets (Fig. 3) or more than one sets of electromagnets (Fig. 7), respectively. Kim teaches the benefit of having more than one group of lysing elements (electromagnets) is so that each group providing sufficient mixing/lysing for a zone in the microchannel (para. 0042), to avoid dead volume (para. 0005).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one group of lysis element (one set of electromagnets and a resistive heater) in microfluidic channel taught by modified Njoroge to include an additional group of lysis elements (additional set of electromagnets and resistive heater) in a zone upstream of the first magnet and the first resistor to ensure there is sufficient fluid motion in the entire chamber as taught by Kim in order to prevent having a dead volume with a reasonable expectation of success (Kim, Fig. 7 and paras. 0005 and 0042) (MPEP 2143)(I)(G). Furthermore, Njoroge discloses the claimed invention except for the second magnet and second resistor. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have duplicate the magnet and resistor, since it have been held that a mere duplication of working parts of a device involves only routine skill in the art. One would have been motived to duplicate the magnet and resistor for the purpose of sufficient mixing and avoiding have a dead volume. “Mere duplication of parts has no patentable significance unless a new and unexpected result is produced” In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) See MPEP 2144.04(VI)(B).
The teachings of modified Njoroge would yield providing a second magnetic field within the microfluidic channel using a second magnet (one of electromagnets in the 2nd set), wherein the second magnetic field attracts a second plurality of magnetic particles (the other half of the beads) disposed within the microfluidic channel; and
activating a second resistor (an additional resistive heater) disposed within the microfluidic channel to agitate a second volume of fluid within the microfluidic channel, and in response, moving the second plurality of magnetic particles through the microfluidic channel, wherein the first plurality and second plurality of magnetic particles are to lyse the cell, and the first magnet and the first resistor are downstream from the second magnet and the second resistor within the microfluidic channel (the additional set of electromagnets and resistive heater are placed upstream of the first set of electromagnet and resistive heater).
Response to Arguments
Applicant’s arguments, see pp. 6-7, filed 06/09/2026, with respect to rejections under 35 U.S.C. 103 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
/M.L.C./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758
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