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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 406, Adhesive-free region; 451, Waste outlet; 608, First surface; 712, Pneumatic supply conduit.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “500” has been used to designate both “Second part” and “First part” (see page 33).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “712” has been used to designate both “Pneumatic supply conduits” and “Pneumatic actuators” (see page 33).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 3 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.
Claim 3 recites the limitation "the thickness" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the examiner interprets claim 3 to mean “wherein a thickness of the flow cell layer…”
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.
(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, 2, 9, 16, 17, 25, 28 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al (US 20100261286 A1).
With regards to claim 1, Kim et al teaches;
The claimed “a liquid handling device” has been read on the taught ([0002] “The field of the invention relates generally to microfluidic devices…”);
The claimed “a fluidic layer comprising a network of channels” has been read on the taught has been read on the taught ([0071], “…the photoresist layer 14 is provided with a distinctive pattern of chambers and channels which cooperate to allow for an expeditious analyte testing.”);
The claimed “a sealing layer arranged to seal the network of channels to form a plurality of conduits” has been read on the taught ([0055], “…A top surface of the photoresist layer 14 is directly bonded to or otherwise attached to the cover layer 16.”; [0079], “Laminating the support 22, the photoresist layer 14 and the cover layer 16, e.g., in the manner described below, provides for a well-defined flow path through the microfluidic device 10.”);
The claimed “wherein the sealing layer comprises a plurality of holes” has been read on the taught ([0072], “Cover layer 16 is provided with an aperture 48 aligning with the inlet chamber 36…”; [0059], “Cover layer 16 has apertures aligning with the pads 32.”);
The claimed “a flow cell layer comprising an aperture” and “wherein the sealing layer is disposed between the fluidic layer and the flow cell layer” have been read on the taught ([0090], “Upper housing part 52 includes a substantially planar base 68 having a sample well 70 aligning with the aperture 48 in the cover layer 16 and thus the inlet chamber 36.”; Upper housing part 52 reads on a flow cell layer. An aperture 48 reads on an aperture);
The claimed “a measurement chamber in fluidic communication with at least one of the plurality of conduits via one of the plurality of holes” has been read on the taught ([0071], “…the photoresist layer 14 includes […] a detection chamber 44 connected to the mixing channel 42 and a set of absorbent channels 46 connected to the detection chamber 44.”);
The claimed “wherein the measurement chamber is defined in part by the aperture in the flow cell layer” has been read on the taught ([0090], “Base 68 may include a detection chamber window 74 which is positioned to align with the detection chamber 44.”).
With regards to claim 2, the device of claim 1 is anticipated by Kim et al.
Kim et al additionally teaches;
The claimed “wherein each of the plurality of holes is aligned with one end of a respective one of the network of channels” has been read on the taught ([0072], “Cover layer 16 is provided with an aperture 48 aligning with the inlet chamber 36.”; See also Figure 1, which shows openings overtop the electrical pads 32, which are aligned with the end of the channels.).
With regards to claim 9, the device of claim 1 is anticipated by Kim et al.
Kim et al additionally teaches;
The claimed “wherein the measurement chamber comprises a first end and a second end opposite to the first end, a first one of the plurality of conduits is in fluidic communication with the first end of the measurement chamber via a first one of the plurality of holes, a second one of the plurality of conduits is in fluidic communication with the second end of the measurement chamber via a second one of the plurality of holes and the second one of the plurality of conduits is aligned with a longitudinal centreline running through the measurement chamber” has been read on the taught (see annotated Figure 3F below, which shows measurement chamber having two ends, two conduits, and the start of the conduits aligned with the longitudinal centreline of the chamber as marked in purple);
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With regards to claim 16, Kim et al teaches;
The claimed “a liquid handling device” has been read on the taught ([0002] “The field of the invention relates generally to microfluidic devices…”);
The claimed “a fluidic layer comprising a network of channels” has been read on the taught ([0071], “…the photoresist layer 14 is provided with a distinctive pattern of chambers and channels which cooperate to allow for an expeditious analyte testing.”);
The claimed “a sealing layer arranged to seal the network of channels to form a plurality of conduits” has been read on the taught ([0055], “…A top surface of the photoresist layer 14 is directly bonded to or otherwise attached to the cover layer 16.”; [0079], “Laminating the support 22, the photoresist layer 14 and the cover layer 16, e.g., in the manner described below, provides for a well-defined flow path through the microfluidic device 10.”);
The claimed “wherein the sealing layer comprises an aperture” has been read on the taught ([0072], “Cover layer 16 is provided with an aperture 48 aligning with the inlet chamber 36…”; [0059], “Cover layer 16 has apertures aligning with the pads 32.”);
The claimed “a measurement chamber in fluidic communication with at least one of the plurality of conduits” has been read on the taught ([0071], “…the photoresist layer 14 includes […] a detection chamber 44 connected to the mixing channel 42 and a set of absorbent channels 46 connected to the detection chamber 44.”);
The claimed “wherein the measurement chamber is defined in part by the aperture in the sealing layer” has been read on the taught ([0090], “Base 68 may include a detection chamber window 74 which is positioned to align with the detection chamber 44.”).
With regards to claim 17, the device of claim 16 is anticipated by Kim et al.
Kim et al further teaches;
The claimed “wherein the sealing layer is arranged to cover the fluidic layer, and wherein the sealing layer directly contacts the fluidic layer” has been read on the taught ([0055], “…A top surface of the photoresist layer 14 is directly bonded to or otherwise attached to the cover layer 16.”; [0079], “Laminating the support 22, the photoresist layer 14 and the cover layer 16, e.g., in the manner described below, provides for a well-defined flow path through the microfluidic device 10.”).
With regards to claim 25, the device of claim 16 is anticipated by Kim et al.
Kim et al further teaches;
The claimed “the measurement chamber comprises a first end and a second end opposite to the first end, a first one of the plurality of conduits is in fluidic communication with the first end of the measurement chamber, a second one of the plurality of conduits is in fluidic communication with the second end of the measurement chamber, the second one of the plurality of conduits is aligned with a longitudinal centreline running through the measurement chamber, and an angle between the second one of the plurality of conduits and the longitudinal centreline is about 180 degrees” has been read on the taught (see annotated Figure 3F on page 6, which shows measurement chamber having two ends, two conduits, and the start of the conduits aligned with the longitudinal centreline of the chamber as marked in purple).
With regards to claim 28, the device of claim 1 is anticipated by Kim et al.
Kim et al further teaches;
The claimed “wherein the liquid handling device is a diagnostic cartridge, wherein the diagnostic cartridge is a microfluidic cartridge” has been read on the taught ([0106], “…the invention may be used in the following types of assays: […] Infectious disease assays […] DNA diagnostics…”; [0125], “The microfluidic device 10 can then be installed into a housing 50 to form a rapid assay kit 26.”; rapid assay kit 26 reads on a cartridge. A kit capable of performing infectious disease assays and DNA diagnostics reads on a diagnostic cartridge.).
With regards to claim 29, the device of claim 16 is anticipated by Kim et al.
The claimed “wherein the liquid handling device is a diagnostic cartridge, wherein the diagnostic cartridge is a microfluidic cartridge” has been read on the taught ([0106], “…the invention may be used in the following types of assays: […] Infectious disease assays […] DNA diagnostics…”; [0125], “The microfluidic device 10 can then be installed into a housing 50 to form a rapid assay kit 26.”; rapid assay kit 26 reads on a cartridge. A kit capable of performing infectious disease assays and DNA diagnostics reads on a diagnostic cartridge.).
Claim Rejections - 35 USC § 103
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 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 3, 15, 19 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (US 20100261286 A1).
With regards to claim 3, the device of claim 1 is anticipated by Kim et al.
Kim et al does not explicitly disclose “wherein the thickness of the flow cell layer defines a height of the measurement chamber.” However, the examiner believes this to be an obvious change in size or proportion. Per MPEP 2144(IV)(A), changes in dimension do not render the claimed device patentably distinct from the prior art, provided that a device having the claimed relative dimensions would not perform differently from the prior art device. Please see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). As the specification does not disclose any unexpected results occurring from the thickness of the flow cell layer defining a height of the measurement chamber, the device of claim 3 is not patentably distinct from Kim et al.
With regards to claim 15, the device of claim 1 is anticipated by Kim et al.
Kim et al does not explicitly disclose “the liquid handling device comprises a plurality of measurement chambers; the flow cell layer comprises a plurality of apertures; and each of the plurality of measurement chambers is defined in part by a corresponding one of the plurality of apertures in the flow cell layer.” However, the examiner believes this to be a mere duplication of parts. Per MPEP 2144(IV)(B), mere duplication of parts has no patentable significance unless a new and unexpected result is produced. As the specification does not explicitly disclose any unexpected results occurring from the number of measurement chambers and associated structures, the device of claim 15 is not patentably distinct from Kim et al.
With regards to claim 19, the device of claim 16 is anticipated by Kim et al.
Kim et al does not explicitly disclose “wherein the thickness of the sealing layer defines a height of the measurement chamber.” However, the examiner believes this to be an obvious change in size or proportion. Per MPEP 2144(IV)(A), changes in dimension do not render the claimed device patentably distinct from the prior art, provided that a device having the claimed relative dimensions would not perform differently from the prior art device. Please see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). As the specification does not disclose any unexpected results occurring from the thickness of the flow cell layer defining a height of the measurement chamber, the device of claim 16 is not patentably distinct from Kim et al.
With regards to claim 27, the device of claim 16 is anticipated by Kim et al.
Kim et al does not explicitly disclose “the liquid handling device comprises a plurality of measurement chambers, the sealing layer comprises a plurality of apertures, and each of the plurality of measurement chambers is defined in part by a corresponding one of the plurality of apertures in the sealing layer.” However, the examiner believes this to be an obvious change in size or proportion. Per MPEP 2144(IV)(A), changes in dimension do not render the claimed device patentably distinct from the prior art, provided that a device having the claimed relative dimensions would not perform differently from the prior art device. Please see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). As the specification does not disclose any unexpected results occurring from the thickness of the flow cell layer defining a height of the measurement chamber, the device of claim 27 is not patentably distinct from Kim et al.
Claims 4, 7, 10, 12 – 14, 20, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (US 20100261286 A1) in view of Shkolnikov et al (US 20190076839 A1).
With regards to claim 4, the device of claim 1 is anticipated by Kim et al.
Kim et al further teaches;
The claimed “wherein: the measurement chamber comprises a first end and a second end opposite to the first end; a first one of the plurality of conduits is in fluidic communication with the first end of the measurement chamber via a first one of the plurality of holes; and a second one of the plurality of conduits is in fluidic communication with the second end of the measurement chamber via a second one of the plurality of holes” has been read on the taught (see annotated Figure 3F on page 6, which shows measurement chamber having two ends, two conduits, and the start of the conduits aligned with the longitudinal centreline of the chamber as marked in purple).
However, Kim et al does not explicitly disclose wherein the measurement chamber comprises a first tapering portion extending between the first end and a central portion of the measurement chamber, and in the first tapering portion, the angle between a wall of the measurement chamber and a longitudinal centreline running through the measurement chamber is less than 30 degrees, optionally between about 15 degrees and about 25 degrees.
In the analogous art of microfluidic device designs, Shkolnikov et al teaches;
The claimed “the measurement chamber comprises a first tapering portion extending between the first end and a central portion of the measurement chamber” has been read on the taught ([0025], “Well 30 comprises sides 34 and floor 36.”; [0026], “Sides 34 have a profile 45 with an interior angle 47 that, at a target location within the well, is smaller than other interior angles of the profile 45.”; [0027], “…profile 45 is illustrated as having a tear-drop shape…”; A tear-drop shape reads on having a tapering portion.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microfluidic device including chambers as taught by Kim et al with the tapering chamber as taught by Shkolnikov, for the predictable benefit of minimizing the amount of fluid stuck in corners of the chamber, as taught by Shkolnikov ([0026], “As a result, during liquid is less likely to be held up or retained by capillary action between or within corners or acute angles. At the same time, capillary action assists in wicking liquid towards the target location 50.”).
Regarding the limitation “in the first tapering portion, the angle between a wall of the measurement chamber and a longitudinal centreline running through the measurement chamber is less than 30 degrees, optionally between about 15 degrees and about 25 degrees,” Shkolnikov et al explicitly teaches an acute interior angle, as read on the taught ([0026], “In the example illustrated, interior angle 47 is smaller than all other interior angles of profile 45. In contrast to angle 47, remaining interior angles of well 30 are either curved or rounded and greater than 90°.”).
However, Shkolnikov et al does not explicitly disclose the claimed “in the first tapering portion, the angle between a wall of the measurement chamber and a longitudinal centreline running through the measurement chamber is less than 30 degrees, optionally between about 15 degrees and about 25 degrees.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tapered chamber of Kim et al in view of Shkolnikov with the angle between a wall of the measurement chamber and a longitudinal centreline running through the measurement chamber is less than 30 degrees, optionally between about 15 degrees and about 25 degrees, as a matter of optimization within prior art conditions. The retention of liquid in the chamber will depend on the properties of the fluid (including surface tension), the pressure within the chamber, and the overall volume of the chamber. Per MPEP 2144.05(II)(A), optimization within prior art conditions supports a case of prima facie obviousness. As the specification does not explicitly disclose the criticality of the angle, and as Shkolnikov et al teaches the desirability of an acute angle, the exact angle between a wall of the measurement chamber and a longitudinal centreline would have been obvious to one of ordinary skill in the art.
With regards to claim 7, the device of claim 4 is obvious over Kim et al in view of Shkolnikov et al.
Kim et al does not explicitly disclose wherein the measurement chamber comprises a second tapering portion extending between the central portion and the second end and wherein, in the second tapering portion, the angle between a wall of the measurement chamber and a longitudinal centreline running through the measurement chamber is less than 30 degrees.
Shkolnikov et al further teaches;
The claimed “wherein the measurement chamber comprises a second tapering portion extending between the central portion and the second end” has been read on the taught ([0052], “In the example illustrated, profile 645 is diamond-shaped with discharge port 640 at opposite points of the diamond.”; A diamond shape reads on a second tapering portion.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microfluidic device including chambers as taught by Kim et al with the tapering chamber as taught by Shkolnikov, for the predictable benefit of minimizing the amount of fluid stuck in corners of the chamber, as taught by Shkolnikov ([0052], “As a result, during withdrawal or discharging of liquid from well 630, liquid is less likely to be held up or retained by capillary action between or within corners or acute angles. At the same time, during withdrawal or discharge of liquid from well 630, capillary action resulting from each angle 647 assists in wicking liquid towards the respective discharge port 640.”).
Shkolnikov et al further teaches wherein the tapering portions have an acute angle, as read on the taught ([0052], “In the example illustrated, the smallest interior angle 647, the angle between the opposing sides of the interior of well 630 on opposite horizontal sides of the respective discharge port 640, is an acute angle, less than 90 degrees.”).
However, Shkolnikov et al does not explicitly disclose the claimed “wherein, in the second tapering portion, the angle between a wall of the measurement chamber and a longitudinal centreline running through the measurement chamber is less than 30 degrees.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tapered chamber of Kim et al in view of Shkolnikov with the angle between a wall of the measurement chamber and a longitudinal centreline running through the measurement chamber having less than 30 degrees, as a matter of optimization within prior art conditions. The retention of liquid in the chamber will depend on the properties of the fluid (including surface tension), the pressure within the chamber, and the overall volume of the chamber. Per MPEP 2144.05(II)(A), optimization within prior art conditions supports a case of prima facie obviousness. As the specification does not explicitly disclose the criticality of the angle, and as Shkolnikov et al teaches the desirability of an acute angle, the exact angle between a wall of the measurement chamber and a longitudinal centreline would have been obvious to one of ordinary skill in the art.
With regards to claim 10, the device of claim 9 is obvious over Kim et al in view of Shkolnikov et al.
Kim et al additionally teaches;
The claimed “wherein an angle between the second one of the plurality of conduits and the longitudinal centreline is greater than or equal to 150 degrees” has been read on the taught (see Figure 3F, provided on page 6 of this action, which shows the of the plurality of conduits extending from the longitudinal centreline at 180 degrees, which is greater than 150 degrees).
With regards to claim 12, the device of claim 4 is obvious over Kim et al in view of Shkolnikov et al.
Kim et al does not explicitly disclose wherein the first end is a first rounded end with a first constant curvature and the second end is a second rounded end with a second constant curvature.
Shkolnikov et al further teaches;
The claimed “wherein the first end is a first rounded end with a first constant curvature” has been read on the taught ([0026], “In contrast to angle 47, remaining interior angles of well 30 are either curved or rounded and greater than 90°.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the chamber as taught by Kim et al in view of Shkolnikov et al to have a first rounded end with a curvature as taught by Shkolnikov et al, for the predictable benefit of allowing liquids to be fully removed from the container ([0026], “As a result, during liquid is less likely to be held up or retained by capillary action between or within corners or acute angles.”).
Regarding the limitation “the second end is a second rounded end with a second constant curvature,” the embodiments of Shkolnikov et al explicitly teach a straight narrowing to an outlet channel.
However, given Shkolnikov’s teachings of a double-ended wedge shaped chamber (see Figure 10), and their teaching of a curvature (see eg [0026]), it would have been obvious to one of ordinary skill in the art to modify the second end of the chamber as taught by Shkolnikov with a rounded end having a second constant curvature, to prevent retention of liquid in corners as taught by Shkolnikov et al ([0026], “As a result, during liquid is less likely to be held up or retained by capillary action between or within corners or acute angles.”). Per MPEP 2143(I)(A), use of a known technique to improve similar devices in the same way may be prima facie obvious.
With regards to claim 13, the device of claim 12 is obvious over Kim et al in view of Shkolnikov et al.
Kim et al in view of Shkolnikov et al does not explicitly disclose “a radius of the first one of the plurality of holes is equal to a radius of the first constant curvature; and/or a radius of the second one of the plurality of holes is equal to a radius of the second constant curvature.” However, the examiner believes this to be an obvious change in size or proportion. Per MPEP 2144(IV)(A), changes in dimension do not render the claimed device patentably distinct from the prior art, provided that a device having the claimed relative dimensions would not perform differently from the prior art device. Please see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). As the specification does not disclose any unexpected results occurring from the thickness of the flow cell layer defining a height of the measurement chamber, the device of claim 13 is not patentably distinct from Kim et al.
With regards to claim 14, the device of claim 12 is obvious over Kim et al in view of Shkolnikov et al.
Kim et al in view of Shkolnikov et al does not explicitly disclose “an origin of the first one of the plurality of holes is coincident with an origin of the first constant curvature; and/or an origin of the second one of the plurality of holes is coincident with an origin of the second constant curvature” However, the examiner believes this to be an obvious rearrangement of parts. Per MPEP 2144(VI)(C), the origin of the plurality of holes (and thus, the channels and inlets) would be an obvious matter of design choice that does not modify the operation of the device (please see In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) ).
Additionally, Shkolnikov et al shows the inlets and outlets of the chambers located at the center of a first curvature in figure 1A.
With regards to claim 20, the device of claim 16 is obvious over Kim et al in view of Shkolnikov et al.
Kim et al further teaches;
The claimed “the measurement chamber comprises a first end and a second end opposite to the first end, a first one of the plurality of conduits is in fluidic communication with the first end of the measurement chamber; and a second one of the plurality of conduits is in fluidic communication with the second end of the measurement chamber” has been read on the taught (see annotated Figure 3F on page 6, which shows measurement chamber having two ends, two conduits, and the start of the conduits aligned with the longitudinal centreline of the chamber as marked in purple).
However, Kim et al does not explicitly disclose wherein the measurement chamber comprises a first tapering portion extending between the first end and a central portion of the measurement chamber and in the first tapering portion, the angle between a wall of the measurement chamber and a longitudinal centreline running through the measurement chamber is less than 30 degrees, optionally between about 15 degrees and about 25 degrees.
In the analogous art of microfluidic device designs, Shkolnikov et al teaches;
The claimed “the measurement chamber comprises a first tapering portion extending between the first end and a central portion of the measurement chamber” has been read on the taught ([0025], “Well 30 comprises sides 34 and floor 36.”; [0026], “Sides 34 have a profile 45 with an interior angle 47 that, at a target location within the well, is smaller than other interior angles of the profile 45.”; [0027], “…profile 45 is illustrated as having a tear-drop shape…”; A tear-drop shape reads on having a tapering portion.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microfluidic device including chambers as taught by Kim et al with the tapering chamber as taught by Shkolnikov, for the predictable benefit of minimizing the amount of fluid stuck in corners of the chamber, as taught by Shkolnikov ([0026], “As a result, during liquid is less likely to be held up or retained by capillary action between or within corners or acute angles. At the same time, capillary action assists in wicking liquid towards the target location 50.”).
Regarding the limitation “in the first tapering portion, the angle between a wall of the measurement chamber and a longitudinal centreline running through the measurement chamber is less than 30 degrees, optionally between about 15 degrees and about 25 degrees,” Shkolnikov et al explicitly teaches an acute interior angle, as read on the taught ([0026], “In the example illustrated, interior angle 47 is smaller than all other interior angles of profile 45. In contrast to angle 47, remaining interior angles of well 30 are either curved or rounded and greater than 90°.”).
However, Shkolnikov et al does not explicitly disclose the claimed “in the first tapering portion, the angle between a wall of the measurement chamber and a longitudinal centreline running through the measurement chamber is less than 30 degrees, optionally between about 15 degrees and about 25 degrees.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tapered chamber of Kim et al in view of Shkolnikov with the angle between a wall of the measurement chamber and a longitudinal centreline running through the measurement chamber is less than 30 degrees, optionally between about 15 degrees and about 25 degrees, as a matter of optimization within prior art conditions. The retention of liquid in the chamber will depend on the properties of the fluid (including surface tension), the pressure within the chamber, and the overall volume of the chamber. Per MPEP 2144.05(II)(A), optimization within prior art conditions supports a case of prima facie obviousness. As the specification does not explicitly disclose the criticality of the angle, and as Shkolnikov et al teaches the desirability of an acute angle, the exact angle between a wall of the measurement chamber and a longitudinal centreline would have been obvious to one of ordinary skill in the art.
With regards to claim 23, the device of claim 20 is obvious over Kim et al in view of Shkolnikov et al.
Kim et al does not explicitly disclose wherein the measurement chamber comprises a second tapering portion extending between the central portion and the second end and wherein, in the second tapering portion, the angle between a wall of the measurement chamber and a longitudinal centreline running through the measurement chamber is less than 30 degrees.
Shkolnikov et al further teaches;
The claimed “wherein the measurement chamber comprises a second tapering portion extending between the central portion and the second end” has been read on the taught ([0052], “In the example illustrated, profile 645 is diamond-shaped with discharge port 640 at opposite points of the diamond.”; A diamond shape reads on a second tapering portion.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microfluidic device including chambers as taught by Kim et al with the tapering chamber as taught by Shkolnikov, for the predictable benefit of minimizing the amount of fluid stuck in corners of the chamber, as taught by Shkolnikov ([0052], “As a result, during withdrawal or discharging of liquid from well 630, liquid is less likely to be held up or retained by capillary action between or within corners or acute angles. At the same time, during withdrawal or discharge of liquid from well 630, capillary action resulting from each angle 647 assists in wicking liquid towards the respective discharge port 640.”).
Shkolnikov et al further teaches wherein the tapering portions have an acute angle, as read on the taught ([0052], “In the example illustrated, the smallest interior angle 647, the angle between the opposing sides of the interior of well 630 on opposite horizontal sides of the respective discharge port 640, is an acute angle, less than 90 degrees.”).
However, Shkolnikov et al does not explicitly disclose the claimed “wherein, in the second tapering portion, the angle between a wall of the measurement chamber and a longitudinal centreline running through the measurement chamber is less than 30 degrees.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tapered chamber of Kim et al in view of Shkolnikov with the angle between a wall of the measurement chamber and a longitudinal centreline running through the measurement chamber having less than 30 degrees, as a matter of optimization within prior art conditions. The retention of liquid in the chamber will depend on the properties of the fluid (including surface tension), the pressure within the chamber, and the overall volume of the chamber. Per MPEP 2144.05(II)(A), optimization within prior art conditions supports a case of prima facie obviousness. As the specification does not explicitly disclose the criticality of the angle, and as Shkolnikov et al teaches the desirability of an acute angle, the exact angle between a wall of the measurement chamber and a longitudinal centreline would have been obvious to one of ordinary skill in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ismagilov et al (WO 2015084458 A2) teaches a microfluidic device having a fluidic layer, a sealing layer, and a layer having various reagent inlets.
McFarland et al (US 20220325240 A1) teaches microfluidic cartridges composed of several layers, and which is designed for use with fluidic components and cartridge interfaces.
Solomon (US 20220266212 A1) teaches microfluidic devices with chambers having a variety of shapes and cross-sections.
Zhang et al (US 20210164587 A1) teaches a microfluidic device composed of a base layer, a fluidic layer, a cover layer, and an inlet interface.
Lee et al (WO 2018071541 A1, cited on the IDS provided 21 June 2024) teaches a microfluidic chip with a detection chamber, sealing layers, and a plurality of conduits.
Taylor et al (US 20160175835 A1) teaches a microfluidic cartridge with a variety of layers and fluidic layers, as well as a plurality of holes through various sealing layers.
Kayyem et al (US 20160129437 A1) teaches a microfluidic cartridge with a variety of layers including fluidic layers, as well as a plurality of holes through various sealing layers. Zenhausern et al (US 20130323737 A1) teaches a microfluidic cartridge having chambers with a variety of shapes and configurations.
Park et al (US 20080112854 A1) teaches a layered microfluidic device where chambers are composed out of the thickness of various layers.
Karp et al (US 20040238052 A1) teaches a layered microfluidic device where various microfluidic components (such as conduits, chambers, sealing elements, and inlets) are distributed across different flow layers.
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/ALISON CLAIRE GERHARD/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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