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 .
Preliminary Amendments
Applicant’s preliminary amendments filed on January 10, 2024 and September 10, 2024 are acknowledged. Claims 1, 3-4, 6-9, 12-16, 18-24, and 26 are currently pending.
Claim objections
Claim 1 preamble recites "loading aqueous liquids" (plural) and "an aqueous liquid" (singular) in line 3. It is suggested to be consistent and use them either plural or singular throughout the claims referring to the same aqueous liquid.
Claim 1 recites the limitation "aqueous liquid" in line. It is suggested to be "the aqueous liquid” in all places.
Claim 23 recites the limitation "aqueous liquid" in line. It is suggested to be "the aqueous liquid” in both places.
Appropriate amendments are requested.
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(s) 1, 3-4, 6-9, 12-16, 18-24, and 26 is/are 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation "the electrodes" in line 9. There is insufficient antecedent of this limitation and it is unclear what these electrodes are.
Claim 1 recites the limitation "at least two of the electrodes" in line 11. It is suggested to be "the at least two electrodes.”
Dependent claim(s) 3-4, 6-9, 12-16, 18-24, and 26 is/are rejected based on rejected claim 1.
Claim 7 recites the limitation that at least of the four sections is "switched off" to separate the defined reservoir from the inlet port. It is unclear how to switch off a section.
Claim 12 recites the limitation "a" in line . It is unclear whether it is the same one in claim 1 and suggested to be "the .”
Claim 14 recites the limitation "the delivery path" in line . There is insufficient antecedent of this limitation and it is suggested to be "an delivery path.”
Dependent claim(s) 15 is/are rejected based on rejected claim 14.
Claim 15 recites the limitation "a" in line . It is unclear whether it is the same one in claim 14 and suggested to be "the .”
Claim 21 recites the limitation "the source liquid" in line . It is unclear whether it is the same one as “the aqueous liquid” and suggested to be "the.”
Dependent claim(s) 22 is/are rejected based on rejected claim 21.
Claim 22 recites the limitation "the virtual calibration structures" in line. It is unclear and suggested to be "the .”
Claim 23 recites the limitation “The method of claim 1” but repeats the same limitations of claim 1. It is suggested to be “The method” and delete “of claim 1.”
Claim 23 recites the limitation "a" in line. It is unclear whether it is the same one in claim 1 and suggested to be "the aqueous liquid.”
Claim 23 recites the limitation "the source liquid" in line. It is unclear whether it is the same one in claim 1 suggested to be "the.”
Claim 23 recites the limitation "the electrodes" in line . There is insufficient antecedent of this limitation and it is unclear what these electrodes are.
Claim 23 recites the limitation "at least two of the electrodes" in line 1. It is unclear and suggested to be "the at least two electrodes.”
Claim 23 recites the limitation "switching off" the virtual calibration structure in line. It is unclear how to switch off the virtual calibration structures.
Claim 23 recites the limitation "the virtual calibration structures" in lines 18. It is suggested to be "the one or more virtual calibration structures.”
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 6-9, 12, 14, and 18-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walton (US 2020/0269249).
Regarding claim 1, Walton teaches a method for loading aqueous liquids from an external source into a planar EWoD device (Fig. 1; ¶1: loading fluid into such a microfluidic device; EWOD) having an array of electrodes (Fig. 1: EWOD device; ¶6: a plurality of array element electrodes 12, e.g., 12A, 12B), the method comprising;
a. taking an EWoD device having an inlet port (Fig. 5(a); ¶111: fluid well 62) containing an aqueous liquid (Fig. 5(b); ¶113: the dispensing end 64 of a pipette in the fluid well),
b. actuating reservoir electrodes in an activation pattern (Fig. 6(a); ¶148: a second group of one or more of the array elements are actuated) to form a defined reservoir of aqueous liquid on the device (Fig. 6(d); ¶147: the target region 70), wherein the defined reservoir is separated from the inlet port by at least two electrodes so as not to overlap the inlet port (Fig. 6(d): indicating the target region 70 separated from the dispensing end 64, by at least two array elements, and does not overlap the inlet port), the activation pattern defines a volume of aqueous liquid held in the defined reservoir (¶147: the fluid was loaded in to the device and moved into the first region 70);
c. actuating specific path electrodes on the device from the inlet port to form a virtual path for aqueous liquid entry over the electrodes onto the device (Fig. 6(c); ¶148: the dispensed fluid loads into the second region 72 of the microfluidic device since the array element(s) of the second region 72 are actuated), wherein the virtual path is narrower than the defined reservoir (Fig. 8; ¶181: narrower width of region 72 than the width of the target region 70); and
d. switching off at least two of the electrodes in the virtual path (¶152: then cease actuation of the second group of array elements defining the second region 72) to separate the defined volume of aqueous liquid in the defined reservoir from the inlet port (Fig. 6(d): separated from the inlet port; ¶152: the fluid was loaded in to the device and moved into the first region 70), thereby preventing back-flow of the aqueous liquid from the defined reservoir to the inlet port (this limitation is functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Since the fluid of the first region 70 has moved away from pipette tip, it would prevent the back-flow to the inlet port).
Regarding claim 3, Walton teaches wherein the number of electrodes activated to form the width of the virtual path is less than half the number forming the width of the defined reservoir (Fig. 10: the width of region 72a, i.e., the width of the virtual path, is less than half of the width of the defined reservoir, i.e., the width of the first target region 70, which suggests the number of the electrode elements actuated for the region 72a would be half less than that of the region 70, in the direction of the width).
Regarding claim 6, Walton teaches wherein the virtual path comprises a cruciform shape (Fig. 8: the region 72 and region 70 comprise a cruciform shape).
Regarding claim 7, Walton teaches wherein the virtual path comprises four sections of different widths (Fig. 10: the sections of 72a, 72b, and 70a; since the edge 76 moves toward right and expands during transition region 72b, which contains at least two sections of different width), at least one of which is switched off to separate the defined reservoir from the inlet port (¶152: then cease actuation of the second group of array elements defining the second region 72 for the loaded fluid to move into the first region 70).
Regarding claim 8, Walton teaches wherein electrodes in the virtual path are pulsed off and on and off (Fig. 13; ¶215: to split the droplet in the second region 82 into two disconnected droplets; ¶152: then cease actuation of the second group of array elements defining the second region 72; thus, the actuation would be off and on and off to continuously generate more droplets).
Regarding claim 9, Walton wherein the inlet port comprises a hole in the surface of the planar EWoD device (Fig. 5(a): aperture 66) and the array of electrodes are formed on the surface of the planar EWoD device (Fig. 1: electrodes 12A, 12B) opposing the inlet port (Fig. 6(a): applied electrodes).
Regarding claim 12, Walton teaches wherein the aqueous liquid in the inlet port is loaded from an external source in the form of a pipette (Fig. 5(b); ¶113: dispensing end 64 of a pipette).
Regarding claim 14, Walton teaches wherein the delivery path is formed by actuating between 10-500 electrodes arranged in an elongated pattern (Fig. 6(c): indicating 24 array elements, i.e., electrodes, of an elongated shape forming the delivery path).
Regarding claim 18, Walton teaches wherein multiple on-chip reservoirs are formed using a single inlet port (Fig. 6: one inlet port with the aperture 66) by actuating different virtual paths (¶12: the splitting of droplets; and thus the split droplets would form multiple reservoirs in actuated different virtual paths).
Regarding claim 19, Walton teaches wherein multiple inlet ports (Fig. 3; ¶17: a plurality of ports 9; ¶25: a plurality of fluid wells, each fluid well associated with a respective aperture) and virtual paths are used to combine reagents into one or more on-chip reservoirs (¶12: the merging of droplets and the mixing together of droplets of different materials).
Regarding claim 20, Walton teaches wherein multiple reservoirs are formed in parallel from multiple inlet ports (Fig. 3; ¶17: a plurality of ports 9; ¶25: a plurality of fluid wells, each fluid well associated with a respective aperture; here, the formed defined reservoirs along the path after the loading through the ports or the fluid wells would be in parallel).
Regarding claim 21, Walton teaches wherein the method comprises temporarily actuating electrodes on an opposing side of the defined reservoir to the source liquid (¶152: then cease actuation of the second group of array elements defining the second region 72; here the array elements defining the second region 72 is on the opposing side of the first target region 70) to form one or more virtual calibration structures which are the last areas last to fill, such that when the temporarily actuated electrodes are switched off the liquid becomes part of the defined reservoir, thereby accurately controlling the liquid area in the defined reservoir (Fig. 10; ¶191: when enough working fluid has been introduced to the chamber, further notification may be provided to indicate that a user may safely stop loading working fluid and withdraw the fluid application; here, when the working fluid arrive at the right end of the target region 70, which is deemed to be the virtual calibration structure and the last area to fill, it is indicated that enough working fluid that has been introduced).
Further, limitation “such that when the temporarily actuated electrodes are switched off the liquid becomes part of the defined reservoir, thereby accurately controlling the liquid area in the defined reservoir” is functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 22, Walton teaches wherein the virtual calibration structures are elongated protrusions (Fig. 10: the edge 76 would move toward right and fulfill the region 70) and there are two or three elongated protrusions per reservoir (Fig. 10: indicating the edge 76 would expand to three elongated protrusions of the region 70, i.e., top, bottom, and right).
Regarding claim 23, Walton teaches the method according to of claim 1 (as described in claim 1) comprising
a. taking an EWoD device having an inlet port (Fig. 5(a); ¶111: fluid well 62) containing an aqueous liquid (Fig. 5(b); ¶113: the dispensing end 64 of a pipette in the fluid well),
b. actuating reservoir electrodes to form a defined reservoir of aqueous liquid on the device (Fig. 6(a); ¶148: a second group of one or more of the array elements are actuated; Fig. 6(d); ¶147: the target region 70), wherein the defined reservoir is separated from the inlet port by at least two electrodes so as not to overlap the inlet port (Fig. 6(d): indicating the target region 70 separated from the dispensing end 64 and does not overlap the inlet port) and the defined reservoir includes electrodes on an opposing side of the defined reservoir to the source liquid (Fig. 1: electrodes 12A, 12B; Fig. 6(a): applied electrodes) to form one or more virtual calibration structures which are the last areas last to fill (Fig. 10; ¶191: when enough working fluid has been introduced to the chamber, further notification may be provided to indicate that a user may safely stop loading working fluid and withdraw the fluid application; here, when the working fluid arrive at the right end of the target region 70, which is deemed to be the virtual calibration structure and the last area to fill, it is indicated that enough working fluid that has been introduced);
c. actuating specific path electrodes on the device from the inlet port to form a virtual path for aqueous liquid entry over the electrodes onto the device (Fig. 6(c); ¶148: the dispensed fluid loads into the second region 72 of the microfluidic device since the array element(s) of the second region 72 are actuated), wherein the virtual path is narrower than the defined reservoir (Fig. 8; ¶181: narrower width of region 72 than the width of the target region 70) and forms a cruciform shape (Fig. 8: the region 72 and region 70 comprise a cruciform shape);
d. switching off at least two of the electrodes in the virtual path (¶152: then cease actuation of the second group of array elements defining the second region 72) to separate the defined reservoir from remaining cruciform shape and hence the inlet port (Fig. 6(d); ¶152: the fluid was loaded in to the device and moved into the first region 70), thereby preventing back-flow of the aqueous liquid from the defined reservoir to the inlet port (this limitation is functional limitation in apparatus claims. MPEP 2114 (II). It does not differentiate the claimed apparatus from a prior art apparatus because the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Since the fluid of the first region 70 has moved away from pipette tip, it would prevent the back-flow to the inlet port); and
e. switching off the virtual calibration structures (¶191: when enough working fluid has been introduced to the chamber, further notification may be provided to indicate that a user may safely stop loading working fluid and withdraw the fluid application).
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim(s) 4, 13, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walton.
Regarding claim 3, Walton discloses all limitations of claim 3, but fails to teach wherein the number of electrodes activated to form the width of the virtual path is less than one quarter the number forming the width of the defined reservoir
However, Walton teaches the array element electrodes 48 are arranged in an array 50, having X by Y array elements where X and Y may be any integer (Fig. 2; ¶10). From Fig. 10, the width of the virtual path (Fig. 10: the width of section 72a) is about one third of the width of the target region (Fig. 10: the width of region 70).
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 Walton by adjusting the number of electrode of the virtual path in the direction of width less than one quarter of that of the defined reservoir as claimed because the width of the virtual path is about one third of the width of the target region (Fig. 10) and in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Regarding claim 13, Walton discloses all limitations of claim 1, but fails to teach wherein the electrode actuation to form the virtual path occurs for a period of greater than 1 second.
However, Walton teaches The method may comprise applying a time varying actuation pattern to the array elements of the EWOD device, so that the boundary between the first part and the second part moves away from the aperture as the flow edge of working fluid moves away from the aperture (¶62). The pattern of actuated array elements may be controlled based on a sensed position of fluid in the microfluidic device, e.g., by applying a predetermined time-varying actuation pattern (¶84), rendering the time of period a result-effective variable to arrive a desirable position.
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 Walton by adjusting the time of period for electrode actuation as claimed, i.e., greater than 1 second, because the time of period is a result-effective variable and can be optimized through routine experimentation to arrive a desirable position. MPEP 2144.05 (II)(B).
Regarding claim 15, Walton discloses all limitations of claim 1, and further discloses the delivery path is in an elongated pattern by 4 electrode wide (Fig. 6(c)). Walton fails to teach wherein the delivery path having 22 to 35 electrodes long.
However, Walton teaches the array element electrodes 48 are arranged in an array 50, having X by Y array elements where X and Y may be any integer (Fig. 2; ¶10). The loading of the working fluid is controlled from the initial contact with the second region 72, along the loading process with an appropriate rate, and then to the desired position (Fig. 10; ¶191). Thus, the delivery length between the aperture to the desired position is a result-effective variable to obtain sufficient working fluid and would pass an appropriate length having a certain number of the electrode elements.
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 Walton by adjusting the delivery length having 22 to 35 electrodes long as claimed because the delivery length is a result-effective variable and can be optimized through routine experimentation to load the desired volume of the working fluid. MPEP 2144.05 (II)(B). As a result, the optimized appropriate delivery length would correspond to a certain appropriate number of electrodes in its length, and thus the claimed number of the electrodes would be achievable by optimization through routine experimentation.
Regarding claim 16, Walton discloses all limitations of claim 1, but fails to teach wherein the defined reservoir is an on-chip reservoir formed 20-100 electrodes away from the inlet port.
However, Walton teaches the array element electrodes 48 are arranged in an array 50, having X by Y array elements where X and Y may be any integer (Fig. 2; ¶10). The loading of the working fluid is controlled from the initial contact with the second region 72, along the loading process with an appropriate rate, and then to the desired position (Fig. 10; ¶191). Thus, the delivery length between the aperture to the desired position is a result-effective variable to obtain sufficient working fluid and would pass an appropriate length having a certain number of the electrode elements.
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 Walton by adjusting the length between the reservoir and the aperture of the inlet port as claimed because it is a delivery length that is a result-effective variable and can be optimized through routine experimentation to load the desired volume of the working fluid. MPEP 2144.05 (II)(B). As a result, the optimized appropriate delivery length would correspond to a certain appropriate number of electrodes in its length, and the claimed number of the electrodes would be achievable by optimization through routine experimentation.
Claim(s) 24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walton in view of Kolar (US 6,989,234).
Regarding claim 24, Walton discloses all limitations of claim 1, and further discloses wherein the EWoD device includes:
a first substrate (Fig. 2; ¶10: lower substrate 44) having a matrix of electrodes (Fig. 2: a plurality of array element electrodes 48 arranged in an electrode or element array 50) ,wherein each of the matrix of electrodes is coupled to a thin film transistor (¶10: thin-film transistors TFTs), and wherein the matrix of electrodes (Fig. 1: e.g., electrodes 12A, 12B) are overcoated with a functional coating comprising:
a dielectric layer in contact with the matrix of electrodes (Fig. 1; ¶7: insulator layer 22), and
a hydrophobic layer (Fig. 1; ¶7: a first hydrophobic coating 24);
a second substrate (Fig. 1; ¶7: top substrate 16) comprising a top electrode (Fig. 1; ¶7: reference electrode 30);
a spacer (Fig. 1; ¶6: spacer 18) disposed between the first substrate and the second substrate and defining an electrokinetic workspace; and
a voltage source operatively coupled to the matrix of electrodes (Fig. 1: indicating voltages are applied; thus there must be a voltage source coupled to the electrodes to apply the voltages).
Walton does not disclose a conformal layer in contact with the dielectric layer, and the hydrophobic layer in contact with the conformal layer.
However, Kolar teaches a droplet actuating apparatus (Fig. 1A: 10; col. 5, ll. 30-31), including a lower substrate, the first planar body 22, that is a dielectric material (Fig. 1A; col. 5, ll. 41-45). A droplet-contacting surface 20A of first plane 20 is hydrophobized by providing a hydrophobic film or layer 24 (col. 5, ll. 50-52). Alternatively, first plane 20 can be treated with a parylene coating 26 such as Parylene C coating prior to applying hydrophobic layer 24 (Fig. 1A; col. 5, ll. 60-62).
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 Walton by incorporating a parylene coating between the dielectric layer and the hydrophobic layer as taught by Kolar because it provides an alternative way to coat the dielectric layer with a hydrophobic surface (Fig. 1A; col. 5). Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Regarding claim 26, Walton discloses all limitations of claim 1, but fails to teach wherein a subset of the reservoirs contain nucleic acid templates and a subset contain a cell-free system having components for protein expression.
However, Kolar teaches the apparatus for droplet actuation may be applied to in situ synthesis in the field of biological, chemical, and biochemical assaying of samples, e.g., nucleic acids, proteins, for use in sample detection, monitoring and analysis (col. 1, ll. 14-15, 23-28).
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 Walton by incorporating nucleic acid templates in a subset of the reservoirs and proteins in another subset as taught by Kolar because the droplet actuation apparatus has been well-known in those applications, and the parallel reservoirs through multiple inlet ports would provide various application in different path of the apparatus. Here, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP 2143(I)(A).
Conclusion
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/C. SUN/Primary Examiner, Art Unit 1795