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
This is an office action in response to Applicant’s arguments and remarks filed on 11 May 2026. Claims 1-35 are pending in the application. Claims 1-4 and 22-24 are previously withdrawn. Claims 5-21 and 25-35 are being examined herein.
Status of Objections and Rejections
The objection to claim 34 is withdrawn in view of amendments.
The rejection of claims 5-10, 20, 26, 28-30, and 32 under 32 U.S.C. § 102(a)(1) in view of Kapur (US 20160123858 A1) are maintained.
The rejection of claims 11-14 and 25 under 32 U.S.C. § 103 in view of Kapur (US 20160123858 A1) in view of Suteria, et. al. ("Microfluidic bypass manometry: highly parallelized measurement of flow resistance of complex channel geometries and trapped droplets”) are maintained.
The rejection of claims 15-19, 21, 27, 31, and 33-35 under 32 U.S.C. § 103 in view of Kapur (US 20160123858 A1) are maintained.
Response to Arguments
Applicant's arguments filed 11 May 2026 have been fully considered but they are not persuasive.
Applicant first argues that Kapur does not teach “an expanded well having a cross-sectional area greater than that of each of the straight segments, thereby inhibiting particle collisions” (Remarks, pg. 8, par. 04 – pg. 10, par 01).
The above argument is two-fold, first that Kapur does not teach and expanded well and the second regarding the functional limitation of the channels.
First, Examiner respectfully disagrees that Kapur is silent to “an expanded well having a cross-sectional area greater than that of each of the straight segments.” As seen in the provided Figure 1 below (of Kapur), the cross-sectional area at the end of the first segment of the main channel is seen by the arrow along the dashed line and the cross-sectional area of the expanded well is seen by the second arrow.
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Second, Examiner disagrees that said well and channel geometry does not “inhibit(ing) particle collision.” Kapur teaches the geometry of the areas between the island making of the expanded well and junctions are done to so prevent clogging because there is sufficient room fluid and particle flow (Kapur, par. 0138). While Kapur does not explicitly disclose the geometry inhibits collisions, one of ordinary skill in the art will understand that a geometry that prevents clogs through providing sufficient space will also inhibit collisions (that can lead to unpredictable particle movement and therefore clogging).
Applicant secondly argues Kapur could not be modified by Suteria as the two teach differing confluence geometries at the confluence junctions and that Suteria does not disclose repeated bifurcation-confluence pairs (Remarks, pg. 11, par. 01).
Examiner respectfully disagrees as both Kapur and Suteria teach how channel geometry influences the fluid stream and thus concentrations of particles within the fluid stream (Kapur, par. 0005) (Suteria, pg. 348, Section “D. Flow resistance of complex channel geometry,” par. 01). Further, while Examiner focuses on the geometry of a singular main channel/bypass channel geometry, Suteria teaches these bypass channels can be made in series (Suteria, Fig. 1a). Because both teach modifying channel geometry to create a specific modification in the flow stream when a secondary stream is introduced through a bypass channel, it would have been obvious for one of ordinary skill in the art to modify the outlet and proceeding inlet of the bypass channel from the main channel of Kapur to more closely resemble said sequence of Suteria because altering the geometry of the junctions optimizes the flow to avoid flow instability (Suteria, pg. 345, section "B. Geometric Optimization of the Network Design").
Suteria further teaches these bypass channels can be used in a series (Fig. 1a).
Applicant offers no additional arguments for the dependent claims outside of their dependence to independent claim 5 (Remarks, pg. 11, par. 02-04).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7, 11-14, and 24 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
After amendments, independent claim 5 now incorporates claim 7 in its entirety; therefore, claim 7 fails to further limit the subject matter of the claim upon which it depends. Claims 11-14 and 24 are rejected based on their dependence to claim 7.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 5-10, 20, 26, 28-30, and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kapur (US 20160123858 A1)
Regarding claim 5, Kapur teaches a microfluidic device with at least two channels separated by islands to influence the flow through the channel (Abstract). Kapur teaches the design of the microfluidic device is for the control of movement of particles within the channels of the device (par. 0005) (for performing particle localization on a plurality of particle). Kapur teaches microfluidic device 100 comprises a fluidic channel that splits into two streams 106 (bypass channel, see upper arrow in provided Fig. 1 below) and 108 (main channel, see lower arrows) (Fig. 1; par. 0074) (a fluidic channel comprising a main channel and a bypass channel).
The lower main channel 108 comprises three linear segments (as indicated by the three lower arrows in provided Figure 1 below) with each segment separated by a gap 114. The first gap 114 (left circle) diverging into two microchannels and the second gap 114 (right circle) converging back to the main channel 108 again (the main channel comprising: at least three straight segments; at least one bifurcating junction; and at least one confluence junction). The first gap 114 comprises the inlet to the bypass channel 106 and the gap 114 comprises the outlet from the bypass channel 106 (Fig. 1) (the bypass channel comprising: at least one inlet; and at least one outlet).
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Kapur teaches the gaps 114 make a Y-cross structure as indicated by the non-90 degree angle at gap 114 defined by the corner of island 110 (Fig. 1). In other words, the lack of 90 degree angle that defines the T-shaped structure is not indicated; therefor, the gaps form Y-shaped/Y-cross structure (wherein each of the bifurcation and confluence junction has a Y-cross structure). Kapur teaches the gap 114 had three segments (Fig. 1). The three segments being a first segment (leftmost, lower arrow) and second segment (middle, lower arrow) that make up main channel 108, and a third segment that branches into bypass channel 106 (upper arrow) (Fig. 1 below) (the Y-cross structure comprising: three ends comprising; two ends connected to the straight segments; and one end connected to the bypass channel). The “Y-cross structure” can be further seen in the second provided Figure 1 below.
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Kapur teaches the angled shape of the island lends to an expanded well portion as indicated by the square in provided Figure 1 above. As seen in the provided Figure 1 below, the cross-sectional area at the end of the first segment of the main channel is seen by the arrow along the dashed line and the cross-sectional area of the expanded well is seen by the second arrow (and an expanded well having a cross-sectional area greater than that of each of the straight segments). Kapur teaches the geometry of the areas between the island making of the expanded well and junctions are done to so prevent clogging because there is sufficient room fluid and particle flow (par. 0138). While Kapur does not explicitly disclose the geometry inhibits collisions, one of ordinary skill in the art will understand that a geometry that prevents clogs through providing sufficient space will also inhibit collisions (that can lead to unpredictable particle movement and therefore clogging) (thereby inhibiting particle collisions).
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Regarding claim 6, Kapur teaches the fluidic device can be made out of a plurality of polymers including but not limited to polymethylmethacrylate (PMMA), polycarbonate (PC), or cyclo olefin polymer (COP) (par. 0182) (wherein the fluidic channel is made of cyclic olefin copolymer (COC), polymethylmethacrylate (PMMA), or polycarbonate (PC)).
Regarding claim 7, Kapur teaches the gaps 114 make a Y-cross structure as indicated by the non-90 degree angle at gap 114 defined by the corner of island 110 (Fig. 1). In other words, the lack of 90 degree angle that defines the T-shaped structure is not indicated; therefor, the gaps form Y-shaped/Y-cross structure (wherein each of the bifurcation and confluence junction has a Y-cross structure). Kapur teaches the gap 114 had three segments (Fig. 1). The three segments being a first segment (leftmost, lower arrow) and second segment (middle, lower arrow) that make up main channel 108, and a third segment that branches into bypass channel 106 (upper arrow) (Fig. 1 below) (the Y-cross structure comprising: three ends comprising; two ends connected to the straight segments; and one end connected to the bypass channel). Kapur teaches the angled shape of the island lends to an expanded well portion as indicated by the square in provided Figure 1 below (and an expanded well).
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Regarding claim 8, Kapur teaches the dimensions of the microfluidic channel can vary depending on the size and shape of the particle(s) being separated (par. 0151). Kapur teaches one such example wherein the depth (height) of the channel is 52 µm and the width is as low at 10 µm attributing to an aspect ratio of 5.2 (AR = H/W) (wherein the fluidic channel is formed with a high-aspect-ratio). Kapur further teaches main channel 108 is primarily a rectangular shape (see the outlined area in provided Fig. 1 below) (rectangular channel cross section). As seen in "Particle Shift" regions of Figure 1, the size and shape of the channels influence the movement of particle 102 and is (at least partially) due to inertial lift forces (par. 0005, 0007) (to confine the particles into a pair of focal points in a mid-plane by inertial focusing).
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Regarding claim 9, Kapur teaches the dimensions of the microfluidic channel can vary depending on the size and shape of the particle(s) being separated (par. 0151). Kapur teaches one such example wherein the depth (height) of the channel is 52 µm and the width is as low at 10 µm attributing to an aspect ratio of 5.2 (AR = H/W) (wherein the fluidic channel has an aspect ratio larger than unity).
Examiner wants to further note that the ability of the channel " to confine the particles into a pair of focal points in a mid-plane by inertial focusing" is drawn to a functional limitation of the device.
Regarding claim 10, Kapur teaches the fluidic device can be made out of a plurality of polymers including polydimethylsiloxane (PDMS) (par. 0182) fluidic channel (wherein the fluidic channel is made of silicone comprising polydimethylsiloxane).
Regarding claim 20, Kapur teaches fluidic channel 100 comprises a series of islands 110 creating gaps 114 to form bifurcation and confluence junctions (Fig. 1) (wherein the fluidic channel is configured to have multiple bifurcation and confluence junctions forming an overall asymmetric structure). Kapur teaches operating flow rate influences the focusing and separation of the particles (par. 0144). Kapur teaches that the optimal flow rate of the system results in the flow rate of the focusing channel (particle containing main channel 108) decreases when compared to the siphoned fluid (particle-free bypass channel 106) meaning the volumetric flow rate of the particle-free fluid is larger by the time the final segment is reached (par. 0203) (to achieve a volumetric flow rate of the particle-free fluid that is about equal to or larger than a volumetric flow rate of the particle-carrying fluid in a last straight segment connected to a last confluence junction for size-insensitive single-stream particle focusing).
Regarding claim 26, Kapur teaches the dimensions of the microfluidic channel can vary depending on the size and shape of the particle(s) being separated (par. 0151). Kapur teaches main channel 108 is primarily a rectangular shape (see the outlined area in provided Fig. 1 below) (wherein the fluidic channel is formed with a rectangular channel cross section). Kapur teaches one such example wherein the depth (height) of the channel is 52 µm and the width is as low at 10 µm attributing to an aspect ratio of 5.2 (par. 0152-0154) (having a height H and a width W each between 1 micrometer and 10 millimeters and an aspect ratio AR… larger than 1.33). As seen in "Particle Shift" regions of Figure 1, the size and shape of the channels influence the movement of particle 102 and is (at least partially) due to inertial lift forces and keeping particles in a desired channel (Fig. 1; par. 0005, 0007) (for partitioning inertial force field into two compartments).
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Examiner wants to further note that the ability of the channel "for partitioning inertial force field into two compartments" is drawn to a functional limitation of the device.
Regarding claim 28 and 29, Kapur teaches the device can accommodate a wide range of particle sized depending on the size of the channel (par. 0151); giving a specific example with a particle having the diameter of 8 microns (par. 0152) (wherein the particle size is between 0.1 micrometers and 10 millimeters) (wherein the particle size is between 5.6 and 30 micrometers).
Examiner furthers notes defining the particle size is drawn to an intended use of the device, as a particle, and therefore the particle size, are not positively recited elements of the device, but merely an object the device acts upon.
Regarding claim 30, Kapur teaches fluidic channel has four distinct blocks as seen in provided Figure 1 below (wherein the fluidic channel comprises four blocks including). The first block is seen in the leftmost outline, and in this block is a linear segments that has no separation between particles within the fluid, but the particles 102 experience inertial forces as seen by the small downward arrow (Fig. 1; par. 0075) (a block A that is a straight segment at beginning to initiate inertial focusing to peripherally sheath particles). The second block is seen in the middle, lower outline, and in this block a first portion of particle-free fluid is separated from the fluid with particles and the particles experience inertial forces pulling them downward once again (Fig. 1; par. 0077) (a block B that is a bifurcation junction dividing certain previously generated sheath fluid to a bypass channel and a straight segment with sufficiently long length recovers the sheathing). The third block is seen in the rightmost outline, and in this block the island 110 separating the two channels terminates reconnecting the main channel 108 to bypass channel 106 (Fig. 1; par. 0077-0078) (a block C that is a confluence junction returning certain sheath fluid to a main channel to temporally localize particles in the straight segment). The fourth block is seen in the middle, upper outline, and in this block siphoned, particle-free fluid flows (Fig. 1; par. 0076-0078) (and a block D that is the bypass channel in which only sheath fluid flows).
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Regarding claim 32, Kapur teaches wherein the length and width is influenced by the size of the particle (par. 0072) and the length of the island, which corresponds with the length of second block B, is also influences by the distance between the islands, which corresponds with the length of block C (par. 0139). Kapur teaches one example wherein the length of the island is 50-1000 µm (1 mm) (par. 0149), with a specific example having an island of 200 µm (wherein a length LB1 of the block B…is configured to be on a scale of hundreds of micrometers). Kapur further teaches the distance between the islands/gaps can be 100, 200, 500, or 750 µm (par. 0155) (a length LC1 and a length LC2 of the block C each is configured to be on a scale of hundreds of micrometers).
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 11-14 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Kapur (US 20160123858 A1) in view of Suteria, et. al. ("Microfluidic bypass manometry: highly parallelized measurement of flow resistance of complex channel geometries and trapped droplets;" citations made with respect to previously provided copy).
Regarding claim 11, Kapur teaches the microfluidic device has a basic configuration comprising (wherein the fluidic channel is configured to have a basic form, comprising):
At least two straight sections, see outlined sections in provided Figure 1 below, for focusing particles, see arrows attaches to particle 102 (par. 0075-0076) (two straight segments for inertial focusing to generate peripheral particle-free fluid).
Between the straight segments, a gap 114 is present to produce a stream of fluid to the upper bypass channel 106 and keeping particles in the lower main channel 108 (Fig. 1; par. 0077-0078) (one bifurcation junction for partitioning the particle-free fluid to the bypass channel from particle-carrying fluid and concentrating the particle-carrying fluid in the main channel).
After island 110, an additional gap 114 serves as the confluence junction (Fig. 1) (one confluence junction).
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Kapur is silent to the one confluence junction is for sheathing the particle-carrying fluid by the particle-free fluid in the bypass channel and temporally localize particle distribution within a smaller area of the cross-sectional area of the fluidic channel.
Suteria teaches a microfluidic device for the analysis of co-flowing laminar streams with applications in particle focusing (Abstract). Suteria teaches a fluidic channel with a lower main channel (three lower arrows in provided Fig. 2b below) and a bypass channel (upper arrow), a first junction (above left outline in provided Figure 2b below) diverging into two microchannels and a second junction (above right outline) converging into a single microchannel again (Fig. 2b). Suteria further teaches these bypass channels can be used in a series (Fig. 1a). As seen in Figure 2b, the flow/stream show as the fluid in the bypass channel is reintroduced to the main channel, the fluid from the main channel is sheathed into a smaller area of the main channel. To summarize, Suteria teaches that when fluid reaches a confluence junction, it is an inherent property of the sheath flow narrows the area of fluid in the main channel.
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Further, examiner notes "for sheathing the particle-carrying fluid by the particle-free fluid in the bypass channel and temporally localize particle distribution within a smaller area of the cross-sectional area of the fluidic channel" is drawn to a functional limitation of the confluence junction. Suteria further teaches the geometry and the bypass have to be optimized to avoid flow instability and ensure the flow is fully developed at entrances and avoid secondary flows (pg. 345, section "B. Geometric Optimization of the Network Design").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the shape of the confluence junctions of Kapur to have the fluid from the bypass channel sheath the fluid in the main channel as taught by Suteria because altering the geometry of the junctions optimizes the flow to avoid flow instability (Suteria, pg. 345, section "B. Geometric Optimization of the Network Design") with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 12, modified Kapur teaches when the fluid containing particles 102 reaches gap 114 (bifurcating junction) a portion of the fluid that does not contain particles is separated from the particles 102 into bypass channel 106 (Fig. 1) (wherein a slide of particle-free fluid is formed in the bifurcating structure as a self-generated sheath fluid). Modified Kapur teaches the inertial focusing is influenced by islands 110 and not the junctions points (par. 0076) (without affecting the inertial focusing).
Regarding claim 13, modified Kapur teaches multiple parameters go into influencing how much fluid is extracted (wherein a thickness of the particle-free fluid is determined by). First Kapur teaches the design of the channel itself influences the fluid shifting region, like the size of the gap 114 (par. 0121, 0124-0125) (geometry of the channel). Second, Kapur teaches the target particle Reynolds number is influenced by particle size (par. 0137) (sizes of the particles). Finaly Kapur teaches the particle Reynolds number, in combination with other factors, influence the fluid shift to prevent particles from entering the bypass channel (par. 0135-0137) (a Reynolds number of the particle-carrying fluid). Kapur teaches the fluid shift at gaps 114 are not limited to the influence of the above, but a plurality of factors come together in order to optimize the process of fluid extraction from particles and focusing the particles in the main channel (par. 0143-0144).
Regarding claim 14, modified Kapur teaches operating flow rate influences the focusing and separation of the particles (par. 0144). Modified Kapur teaches that the optimal flow rate of the system results in the flow rate of the focusing channel (particle containing main channel 108) decreases when compared to the siphoned fluid (particle-free bypass channel 106) meaning the volumetric flow rate of the particle-free fluid is larger by the time the final segment is reached (par. 0203) (wherein a volumetric flow rate of the particle-free fluid is… larger than a volumetric flow rate of the particle-carrying fluid in a last straight segment connected to a last confluence junction).
Regarding claim 25, modified Kapur teaches when optimizing the system, they Reynolds number of the particle/fluid in main channel 108 is larger, specifically greater than 100 (par. 0136) (wherein the Reynolds number of the particle-carrying fluid is between 1 and 2000).
Claims 15-19, 21, 27, 31, and 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Kapur (US 20160123858 A1).
Regarding claim 15, Kapur teaches in the configuration as seen in Figure 1 the series of gaps 114 results in multiple fluid shifts wherein fluid is extracted from main channel 108 to bypass channel 106 (Fig. 1; par. 0078) (wherein the TIS system is configured to attain different sheath-extraction conditions, including: multiple… extractions).
Kapur is silent to the multiple extractions being small-volume extractions.
However, Kapur teaches the fluid extraction through the fluid shift is a result of fluidic resistance, and the fluidic resistance is further attributed to number of islands 110, distance between islands 110 (gap 114 size), and channel width of bypass channel 106 (par. 0078). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify number of islands 110, distance between islands 110 (gap 114 size), and channel width of bypass channel 106 to include a small-volume extraction; a large-volume extraction; or multiple small-volume extractions.
Regarding claim 16, Kapur teaches the limitations as applied to claim 15 (see above).
Kapur is silent to wherein the small-volume extraction is configured to have a slide of fluid that has a thickness smaller than a distance between a center of a smallest particle to be focused and a nearest wall of the channel.
However, Kapur teaches the fluid extraction through the fluid shift is a result of fluidic resistance, and the fluidic resistance is further attributed to number of islands 110, distance between islands 110 (gap 114 size), and channel width of bypass channel 106 (par. 0078). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify number of islands 110, distance between islands 110 (gap 114 size), and channel width of bypass channel 106 wherein the small-volume extraction is configured to have a slide of fluid that has a thickness smaller than a distance between a center of a smallest particle to be focused and a nearest wall of the channel.
Regarding claim 17, Kapur teaches the limitations as applied to claim 15 (see above).
Kapur is silent to wherein the large-volume extraction is configured to have a slide of particle-free fluid which has a thickness smaller than a distance between a center of a largest particle to be focused and a nearest wall and larger than a distance between a center of a smallest particle to be focused and the nearest wall.
However, Kapur teaches the fluid extraction through the fluid shift is a result of fluidic resistance, and the fluidic resistance is further attributed to number of islands 110, distance between islands 110 (gap 114 size), and channel width of bypass channel 106 (par. 0078). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify number of islands 110, distance between islands 110 (gap 114 size), and channel width of bypass channel 106 wherein the large-volume extraction is configured to have a slide of particle-free fluid which has a thickness smaller than a distance between a center of a largest particle to be focused and a nearest wall and larger than a distance between a center of a smallest particle to be focused and the nearest wall.
Regarding claim 18, Kapur teaches the limitations as applied to claim 15 (see above). Kapur further teaches an embodiment where multiple extractions take place through a series of islands 110 and gaps 114 between the island (Fig. 1) (multiple… extractions).
Kapur is silent to the multiple extractions being small-volume extractions and wherein they are configured to have multiple stages of the small-volume extraction, the large-volume extraction, or a combination of both.
However, Kapur teaches the fluid extraction through the fluid shift is a result of fluidic resistance, and the fluidic resistance is further attributed to distance between islands 110 (gap 114 size) and channel width of bypass channel 106 (par. 0078). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify distance between islands 110 (gap 114 size), and channel width of bypass channel 106 for the multiple extractions to be small volume extractions, and further the small volume extractions be configured to have multiple stages of the small-volume extraction, the large-volume extraction, or a combination of both.
Regarding claim 19, Kapur teaches a series of gaps 114 within the fluidic channel 100 in a repeated pattern (Fig. 1) (wherein the fluidic channel is configured to have a pattern, including: a blocked form).
Regarding claim 21, Kapur teaches the limitations as applied to claim 5 (see above).
Kapur is silent to wherein the fluidic channel is configured to have a varied form to introduce a particle collision in the bifurcation junction for cell deformation.
Kapur teaches a secondary shape of the islands 612 that separate the main channel 608 that carries particles from the particle-free bypass channel 606 (Fig. 6A). As seen in Figure 6A, the fluid that is introduced to the device 600 from an input/source 601 the particles/cells collide with island 612 while focusing the stream (Fig. 6A; par. 0107). This collision can specifically be seen in the circled region of provided Figure 6A below (wherein the fluidic channel is configured to have a varied form to introduce a particle collision in the bifurcation junction for cell deformation). Kapur teaches this embodiment of the islands 612 and device 600 allows for the siphoning device to be paired with pre-siphoning steps as part of a larger microfluidic device (par. 0107).
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It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the shape of the islands and therefore the bifurcation junction as taught by Kapur to have a shape that allows particles to collide with the island as taught by a second embodiment of Kapur because such geometry accommodates larger volumes of sample when coupled within a larger microfluidic device (Kapur, par. 0107) with reasonable expectation of success. MPEP 2143 (I)(G).
Regarding claim 27, Kapur teaches the limitations as applied to claim 26 (see above).
Kapur is silent to wherein the height H is about 80 micrometers, the width W is between 20 and 60 millimeters, and the aspect ratio AR is between 1.33 and 4.
Kapur teaches the microfluidic device can have a wide range of dimensions; however, Kapur specifically teaches the dimensions of the microfluidic channel can vary depending on the size and shape of the particle(s) being separated (par. 0151). In other words, the size of the particle(s) being analyzed will determine the optimal size (height and width) of the channels (par. 0151-0152). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the size of the channels and thus aspect ratio based on the size of the particle(s) being analyzed wherein the height H is about 80 micrometers, the width W is between 20 and 60 millimeters, and the aspect ratio AR is between 1.33 and 4.
Regarding claim 31, Kapur teaches the limitations as applied to claim 30 (see above). Kapur teaches wherein the length and width is influenced by the size of the particle (par. 0072) and the length of the island, which corresponds with the length of second block B, is also influences by the distance between the islands (par. 0139). Kapur teaches one example wherein the length of the island is 1000 µm (1 mm) (par. 0149) (and a length LB2 of the block B is configured to be on a scale of a few millimeters).
Kapur is silent to wherein a length LA1 of the block A is configured to be on a scale of tens of millimeters.
Kapur teaches a second embodiment wherein the inlet, focusing unit 805, leading to the siphoning region, concentrating units 801, is significantly longer than the second block B (Fig. 8). This correlates focusing unit 805 to correspond with first block A. While no lengths are specifically stated, when turning to Figure 8, the total length of the focusing unit 805 is tens of times longer than the individual islands making up the concentrating units 801 (wherein a length LA1 of the block A is configured to be on a scale of tens of millimeters). Kapur teaches this embodiment allows for the siphoning/inertial focusing region with separate channels to be part of a larger microfluidic device (Fig. 8; par. 0160-0162).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the inlet of the first embodiment of Kapur to further comprise a larger inlet channel as taught by the second embodiment of Kapur because it allows for pairing the focusing device to a larger microfluidic system (Kapur, Fig. 8; par. 0160-0162) with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 33, Kapur teaches the limitations as applied to claim 30 (see above).
Kapur is silent to wherein a width of a fully developed stream to the block D, WFD, is configured to be between 0 to 60 micrometers.
Kapur teaches design parameters, including width of the channels, heavily influences the particle and fluid shifting region (par. 0121). Kapur teaches the width of the of the bypass channel 106 (corresponding to 1605 of figure 16) is selected based on the desired fluidic conductance of the corresponding island unit (par. 0131). Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the width of the bypass channel of fourth block D wherein a width of a fully developed stream to the block D, WFD, is configured to be between 0 to 60 micrometers.
Regarding claim 34, Kapur teaches an angled/tapers shape to island 110. In provided Figure 1 below, a bolded horizontal line shows assists in showing the angled created by tapered island 110 within the channel with the channel walls. The leftmost angled line illustrates the angle of the expanded well created by the taper. The angle that corresponds to θB2 of the block B is to the right of the angled line extending down to the horizontal line. While no specific angle is stated, it is clear in the depiction that the around 135 degrees. The rightmost angled line illustrates the angle of the confluence junction. The angle corresponds to angle θC2 of the block C is to the right of the angled line extending down to the horizontal line. While no specific angle is stated, it is clear in the depiction that the around 135 degrees (and an angle θB2 of the block B and an angle θC2 of the block C each is between 120 degrees and 180 degrees).
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Kapur is silent to wherein a width WB2 of the block B and a width WC2 each is between 1 micrometer and 10 millimeters
Kapur teaches design parameters, including width of the channels, heavily influences the particle and fluid shifting region (par. 0121). Kapur teaches the width of the of the bypass channel 106 (corresponding to 1605 of figure 16) is selected based on the desired fluidic conductance of the corresponding island unit (par. 0131). Similarly to the bypass channel, the main channel 108 (corresponding to 1607 of Figure 16) has a width that is selected based on the desired fluidic conductance of the corresponding island unit. Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the width of the main channel of second block B and third block C wherein a width WB2 of the block B and a width WC2 each is between 1 micrometer and 10 millimeters.
Regarding claim 35, Kapur teaches an angled/tapers shape to island 110. In provided Figure 1 below, a bolded horizontal line shows assists in showing the angled created by tapered island 110 within the channel with the channel walls. The leftmost angled line illustrates the angle of the expanded well created by the taper. The angle that corresponds to θB2 of the block B is to the right of the angled line extending down to the horizontal line. While no specific angle is stated, it is clear in the depiction that the around 135 degrees. The rightmost angled line illustrates the angle of the confluence junction. The angle corresponds to angle θC2 of the block C is to the right of the angled line extending down to the horizontal line. While no specific angle is stated, it is clear in the depiction that the around 135 degrees (and an angle θB2 of the block B and an angle θC2 of the block C each is between 120 degrees and 170 degrees).
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Kapur is silent to wherein a width WB2 of the block B and a width WC2 of the block C each is between 40 micrometers and 100 millimeters.
Kapur teaches design parameters, including width of the channels, heavily influences the particle and fluid shifting region (par. 0121). Kapur teaches the width of the of the bypass channel 106 (corresponding to 1605 of figure 16) is selected based on the desired fluidic conductance of the corresponding island unit (par. 0131). Similarly to the bypass channel, the main channel 108 (corresponding to 1607 of Figure 16) has a width that is selected based on the desired fluidic conductance of the corresponding island unit. Since this particular parameter is recognized as a result-effective variable (i.e. a variable which achieves a recognized result), the determination of the optimum or workable ranges of said variable can be characterized as routine experimentation. See MPEP 2144.05 (II)(A). Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the width of the main channel of second block B and third block C wherein a width WB2 of the block B and a width WC2 of the block C each is between 40 micrometers and 100 millimeters.
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.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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