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 Group I, claims 1-17, in the reply filed on 06/30/2026 is acknowledged.
Claim 18 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/30/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 12, claim 12 recites “the outer wall” in lines 1-2. It is unclear if “the outer wall” is referring to the outer wall of the inlet chamber or the outer wall of the outlet chamber established in claim 11.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 11-12, and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Loutherback et al. (WO 2018018017 A1; cited in the IDS filed 12/28/2023)
Regarding claim 1, Loutherback teaches a microfluidic device (abstract; Fig. 2F) for concentrating target particles in a fluid sample using dielectrophoresis (DEP) (interpreted as an intended use, see MPEP 2114; paragraph [0096] teaches DEP forces are applied in the flow paths and sequestration pens via electrodes to manipulate, transport, separate, and sort micro-objects, such as transferring a micro-object into a desired pen; therefore, the device is capable of concentrating target particles using DEP by manipulating or transferring the particles to desired pens), the microfluidic device comprising:
an inlet chamber comprising a fluid inlet (Fig. 2F, interpreted as the top left inlet 107 and channel or chamber associated with the inlet) for receiving the fluid sample ([0053] teaches an inlet for fluid entering the microfluidic circuit);
an outlet chamber comprising a fluid outlet (Fig. 2F, interpreted as the bottom right outlet 107 and channel or chamber associated with the outlet) for discharging the fluid sample ([0053] teaches an outlet for fluid exiting the microfluidic circuit); and
a plurality of DEP channels (Fig. 2F, channels 122 having flow paths 106; [0096] teaches DEP forces are applied in the flow paths), each DEP channel fluidically connected to the inlet chamber and to the outlet chamber (Fig. 2F, teaches the channels 122 are fluidically connected to the top left inlet 107 and channel or chamber associated with the inlet and the bottom right outlet 107 and channel or chamber associated with the outlet) such that a fluid path from the fluid inlet to the fluid outlet is provided through each of the DEP channels (Fig. 2F, flow paths 106 is provided from the top left inlet 107 to the bottom left outlet 107), wherein each of the fluid paths has a fluid resistance that is substantially the same ([0073] teaches equal pressure in each channel and the channels have matched resistance).
Regarding claim 2, Loutherback teaches (see below annotated Fig. 2F) wherein the plurality of DEP channels (Fig. 2F, channels 122) is fluidically connected to the inlet chamber (Fig. 2F, interpreted as the top left inlet 107 and channel or chamber associated with the inlet) at spaced apart positions along an elongate portion of the inlet chamber (Fig. 2F shows each channel 112 connected to the inlet chamber at spaced apart positions along an elongate portion of the inlet chamber, i.e. channels 112 are spaced vertically along the vertical elongate portion of the inlet chamber prior to the start of channels 112) and are fluidically connected to the outlet chamber (Fig. 2F, interpreted as the bottom right outlet 107 and channel or chamber associated with the outlet) at spaced apart positions along an elongate portion of the outlet chamber (Fig. 2F shows each channel 112 connected to the outlet chamber at spaced apart positions along an elongate portion of the outlet chamber, i.e. channels 112 are spaced vertically along the vertical elongate portion of the outlet chamber prior at the ends of channels 112).
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Annotated Fig. 2F of Loutherback: Annotations pointing to the elongate portions of the inlet and outlet chambers.
Regarding claim 3, Loutherback further teaches the microfluidic device according to claim 2, wherein the elongate portion of the inlet chamber and the elongate portion of the outlet chamber comprise respective elongate walls of the inlet chamber and the outlet chamber (see below annotated Fig. 2F; Fig. 2F teaches the top left inlet chamber and bottom right outlet chamber comprises respective elongate walls where the channels 112 connect).
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Annotated Fig. 2F of Loutherback: Annotations pointing to the elongate walls of the inlet and outlet chambers.
Regarding claim 4, Loutherback further teaches the microfluidic device according to claim 2, wherein the fluid inlet (see above annotated Fig. 2F, top left fluid inlet 107) is positioned along the elongate portion of the inlet chamber before a first DEP channel of the plurality of DEP channels (see above annotated Fig. 2F, top left fluid inlet 107 is positioned to the left of and along the elongate portion of the inlet chamber, and before one of the channels 112, i.e. a first DEP channel).
Regarding claim 5, Loutherback further teaches the microfluidic device according to claim 2, wherein the fluid inlet (see above annotated Fig. 2F, top left fluid inlet 107) is positioned at an end of the inlet chamber (Fig. 2F, top left fluid inlet 107 is positioned at a top end or top left end of the inlet chamber).
Regarding claim 6, Loutherback further teaches the microfluidic device according to claim 2, wherein the fluid outlet (see above annotated Fig. 2F, bottom right fluid outlet 107) is positioned along the elongate portion of the outlet chamber after a final DEP channel of the plurality of DEP channels (see above annotated Fig. 2F, bottom right fluid outlet 107 is positioned to the right of and along the elongate portion of the outlet chamber, and after one of the channels 112, i.e. a final DEP channel).
Regarding claim 7, Loutherback further teaches microfluidic device according to claim 2, wherein the fluid outlet (see above annotated Fig. 2F, bottom right fluid outlet 107) is positioned at an end of the outlet chamber (Fig. 2F, bottom right fluid outlet 107is positioned at a top end or bottom right end of the outlet chamber).
Regarding claim 11, Loutherback further teaches the microfluidic device according to claim 1, wherein one or both of an outer wall of the inlet chamber (Fig. 2F, interpreted as the top left wall of the inlet chamber around the top left inlet 107) and an outer wall of the outlet chamber (Fig. 2F, interpreted as the bottom right wall of the outlet chamber around the bottom right outlet 107) has a continuous curved shape along at least part of a length thereof (Fig. 2F teaches the walls around the inlet 107 and outlet 107 has a continuous curved shaped along at least a part of a length thereof, i.e. at least partially circular).
Regarding claim 12, Loutherback further teaches the microfluidic device according to claim 11, wherein the outer wall forms part of the fluid inlet or the fluid outlet (Fig. 2F, the circular shaped outer walls around the top left inlet 107 and bottom right outlet 107 are interpreted as forming part of the fluid inlet 107 or fluid outlet 107, i.e. the fluid inlet comprises the top left inlet 107 and the outer wall around the inlet and the fluid outlet comprises the bottom right outlet 107 and the outer wall around the outlet).
Regarding claim 14, Loutherback further teaches the microfluidic device according to claim 1, wherein each DEP channel of the plurality of DEP channels has a fluid resistance that is substantially the same ([0073] teaches equal pressure in each channel and the channels have matched resistance).
Regarding claim 15, Loutherback further teaches the microfluidic device according to claim 1, wherein the microfluidic device is a microfluidic cassette (Fig. 2F teaches a microfluidic device that is interpreted as a microfluidic cassette).
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 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Loutherback as applied to claim 4 above, and further in view of Yoon et al. (US 20190344270 A1).
Regarding claim 8, Loutherback fails to teach: the microfluidic device according to claim 4, wherein the inlet chamber is shaped such that the fluid resistance increases from the fluid inlet along the elongate portion of the inlet chamber and the outlet chamber is shaped such that the fluid resistance decreases towards the fluid outlet along the elongate portion of the outlet chamber.
Yoon teaches systems for cell analysis (abstract) including a microfluidic device including a plurality of channels comprising an entrance channel, an exit channel, and a plurality of parallel chambers between the entrance channel and exit channel (Fig. 1; [0008]). Yoon teaches an inlet chamber (Fig. 1C, entrance channel) is shaped such that the fluid resistance increases from a fluid inlet along an elongate portion of the inlet chamber (Fig. 1 and [0069],[0105] teaches the entrance channel tapers smaller towards the escape channel, therefore fluid resistance would increase along the elongate portion of the entrance channel towards the escape channel due to the decrease in area) and an outlet chamber (Fig. 1C, exit channel) is shaped such that the fluid resistance decreases towards a fluid outlet along the elongate portion of the outlet chamber (Fig. 1 and [0069],[0105] teaches the exit channel tapers larger towards a downstream direction, therefore fluid resistance would decrease along the elongate portion of the exit channel towards the downstream direction due to the increase in area). Yoon teaches the tapered entrance and exit channel maintain flow velocity and prevent cell adhesion to the substrate; and the device design is highly adaptive to different capture chamber designs and allows cell and bead retrieval without clogging issues ([0069]). Yoon teaches the entrance channels were tapered smaller and the exit channels were tapered larger to maintain the flow velocity in the channel ([0105]).
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 the inlet chamber and the outlet chamber of Loutherback to incorporate Yoon’s teachings of an inlet chamber that tapers smaller and an outlet chamber that tapers larger (Fig. 1; [0008], [0069],[0105]) to provide: the microfluidic device according to claim 4, wherein the inlet chamber is shaped such that the fluid resistance increases from the fluid inlet along the elongate portion of the inlet chamber and the outlet chamber is shaped such that the fluid resistance decreases towards the fluid outlet along the elongate portion of the outlet chamber. Doing so would have a reasonable expectation of successfully improving maintenance of flow velocity, prevention of adhesion of cells to the device, improving adaptivity of the device, and improving particle retrieval without clogging issues as taught by Yoon ([0069],[0105]).
Regarding claim 9, modified Yoon fails to teach: the microfluidic device according to claim 8, wherein the inlet chamber is shaped such that a cross-sectional area of the inlet chamber decreases from the fluid inlet along the elongate portion of the inlet chamber and the outlet chamber is shaped such that a cross-sectional area of the outlet chamber increases towards the fluid outlet along the elongate portion of the outlet chamber.
Yoon teaches systems for cell analysis (abstract) including a microfluidic device including a plurality of channels comprising an entrance channel, an exit channel, and a plurality of parallel chambers between the entrance channel and exit channel (Fig. 1; [0008]). Yoon teaches an inlet chamber (Fig. 1C, entrance channel) is shaped such that the fluid resistance increases from a fluid inlet along an elongate portion of the inlet chamber (Fig. 1 and [0069],[0105] teaches the entrance channel tapers smaller towards the escape channel, therefore fluid resistance would increase along the elongate portion of the entrance channel towards the escape channel due to the decrease in area) and an outlet chamber (Fig. 1C, exit channel) is shaped such that the fluid resistance decreases towards a fluid outlet along the elongate portion of the outlet chamber (Fig. 1 and [0069],[0105] teaches the exit channel tapers larger towards a downstream direction, therefore fluid resistance would decrease along the elongate portion of the exit channel towards the downstream direction due to the increase in area). Yoon teaches wherein the inlet chamber (Fig. 1C, entrance channel) is shaped such that a cross-sectional area of the inlet chamber decreases from the fluid inlet along the elongate portion of the inlet chamber (Fig. 1 and [0069],[0105] teaches the entrance channel tapers smaller towards the escape channel, therefore cross-sectional area of the inlet chamber decreases along the elongate portion of the entrance channel towards the escape channel) and the outlet chamber (Fig. 1C, exit channel) is shaped such that a cross-sectional area of the outlet chamber increases towards the fluid outlet along the elongate portion of the outlet chamber (Fig. 1 and [0069],[0105] teaches the exit channel tapers larger towards a downstream direction, therefore cross-sectional area of the outlet chamber increases along the elongate portion of the exit channel towards the downstream direction). Yoon teaches the tapered entrance and exit channel maintain flow velocity and prevent cell adhesion to the substrate; and the device design is highly adaptive to different capture chamber designs and allows cell and bead retrieval without clogging issues ([0069]). Yoon teaches the entrance channels were tapered smaller and the exit channels were tapered larger to maintain the flow velocity in the channel ([0105]).
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 the inlet chamber and the outlet chamber of Loutherback to incorporate Yoon’s teachings of an inlet chamber that tapers smaller and an outlet chamber that tapers larger (Fig. 1; [0008], [0069],[0105]) to provide: the microfluidic device according to claim 8, wherein the inlet chamber is shaped such that a cross-sectional area of the inlet chamber decreases from the fluid inlet along the elongate portion of the inlet chamber and the outlet chamber is shaped such that a cross-sectional area of the outlet chamber increases towards the fluid outlet along the elongate portion of the outlet chamber. Doing so would have a reasonable expectation of successfully improving maintenance of flow velocity, prevention of adhesion of cells to the device, improving adaptivity of the device, and improving particle retrieval without clogging issues as taught by Yoon ([0069],[0105]).
Regarding claim 10, modified Loutherback further teaches the microfluidic device according to claim 8 (see above claim 8), wherein the fluid resistance increases from the fluid inlet along the elongate portion of the inlet chamber by a corresponding amount as the fluid resistance decreases towards the fluid outlet along the elongate portion of the outlet chamber (see above claim 8, modified Loutherback provides the inlet chamber tapering smaller, i.e. resistance increases, and the outlet chamber tapering larger, i.e. resistance decreases, which occurs by a corresponding amount since the change in shape of the inlet and outlet chambers are occurring along the same direction as shown in Yoon in Fig. 1).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Loutherback as applied to claim 1 above, and further in view of Pizzi et al. (US 20210154671 A1).
Regarding claim 13, Loutherback fails to teach: the microfluidic device according to claim 1, wherein each of the fluid paths has substantially the same length.
Pizzi teaches a microfluidic device for concentrating particles (abstract). Pizzi teaches the device can be used for accumulating cells in a precise position by dielectrophoresis ([0132]). Pizzi teaches embodiments where microchannels have the same length ([0049]) and embodiments where the microchannels have different lengths ([0057],[0061]).
Since Pizzi teaches known alternatives of microchannels with the same length or different lengths, 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 the fluid paths of Loutherback to incorporate Pizzi’s teachings of microchannels have the same length ([0049]) to provide: the microfluidic device according to claim 1, wherein each of the fluid paths has substantially the same length. Doing so would have a reasonable expectation of successfully allowing for parallel fluid processing of particles.
Additionally, since Pizzi teaches known alternatives of microchannels with the same length or different lengths ([0049],[0057],[0061]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the fluid paths of Loutherback to incorporate Pizzi’s teachings of microchannels have the same length ([0049]) to provide: the microfluidic device according to claim 1, wherein each of the fluid paths has substantially the same length. The result of the substitution would have been predictable, such as allowing for parallel fluid processing of particles. See MPEP 2143(I)(B).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Loutherback as applied to claim 1 above, and further in view of Dholakia et al. (US 20140073027 A1).
Regarding claim 16, Loutherback fails to teach: the microfluidic device according to claim 1, wherein the fluid inlet is connected to a first microfluidic channel of the microfluidic device and the fluid outlet is connected to a further microfluidic channel of the microfluidic device such that a fluid sample can pass from the first microfluidic channel to the further microfluidic channel.
Dholakia teaches a microfluidic system for channeling cells in a fluid flow (abstract; Figs. 5-6). Dholakia teaches the microfluidic system includes inlets and outlets (Figs. 5-6; [0012], [0035]). Dholakia teaches the inlet and outlet ports are connected to tubing, where the ports are fixed to the inlet and outlet to connect microfluidic tubing with minimal dead volumes ([0061]; Fig. 6).
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 the fluid inlet and fluid outlet of Loutherback to incorporate Dholakia’s teachings of microfluidic systems with ports, inlets and outlets, and microfluidic tubing connected to the inlets and outlets, to provide: the microfluidic device according to claim 1, wherein the fluid inlet is connected to a first microfluidic channel of the microfluidic device and the fluid outlet is connected to a further microfluidic channel of the microfluidic device such that a fluid sample can pass from the first microfluidic channel to the further microfluidic channel. Doing so would have a reasonable expectation of successfully allowing for proper fluidic connection of the fluid inlet and fluid outlet to respective microfluidic channels or tubing (e.g. to an upstream and downstream compartment such as a fluid source or waste compartment) while minimizing dead volume.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Loutherback as applied to claim 1 above, and further in view of O’Halloran et al. (US 20190176151 A1).
Regarding claim 17, Loutherback further teaches the microfluidic device according to claim 1, wherein each of the plurality of DEP channels comprises a microfluidic channel (Fig. 2F, microfluidic channels 122 having flow paths 106; [0096] teaches DEP forces are applied in the flow paths). Loutherback fails to teach the microfluidic channel associated with one or more DEP electrodes, wherein the one or more DEP electrodes are arranged to selectively capture target particles flowing through the microfluidic channel.
Loutherback teaches DEP forces are applied across the fluidic medium in the flow path via one or more electrodes to manipulate, transport, separate, and sort micro-objects located therein ([0096]). Loutherback teaches DEP forces are applied to one or more portions of the microfluidic circuit to transfer micro-objects to desired locations, such as to a sequestration pen ([0096]).
O’Halloran teaches devices for concentrating target cells using DEP (abstract; Fig. 4), wherein the device includes a plurality of DEP channels (14”), wherein each of the plurality of DEP channels comprises a microfluidic channel (Fig. 4, channels 14;’ [0053] teaches the device is a microfluidic device, therefore the channels are microfluidic channels) associated with one or more DEP electrodes (Fig. 4 and [0098] teaches each channel 14 is associated with electrodes 5”that apply DEP forces), wherein the one or more DEP electrodes are arranged to selectively capture target particles flowing through the microfluidic channel ([0098] teaches electrodes 5” are activated to trap target cells as the sample flows through). O’Halloran teaches the electrodes DEP electrodes results in the media becoming enriched with target cells ([0098]).
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 each of the plurality of DEP channels of Loutherback to incorporate O’Halloran’s teachings of a plurality of DEP channels each with DEP electrodes (Fig. 4; [0098]) and Loutherback’s teachings of DEP forces applied to multiple portions of the microfluidic circuit ([0096]) to provide: each of the plurality of DEP channels comprises the microfluidic channel associated with one or more DEP electrodes, wherein the one or more DEP electrodes are arranged to selectively capture target particles flowing through the microfluidic channel. Doing so would have a reasonable expectation of successfully improving trapping of desired target cells within each DEP channel, therefore improving concentration or enrichment of the sample as taught by O’Halloran.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yasuda et al. (US 20120088295 A1) teaches a device for concentration cells (abstract; Fig. 2) including a plurality of parallel flow paths (1050), an oblique interdigitated electrode (2010) for concentration is provided in the middle of the concentration portion parallel flow paths, an inlet (1010) and outlet (1020). Yasuda teaches dielectrophoretic force can be applied in the direction of a branched flow path for sorting concentrated particulates ([0058]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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