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 .
Drawings
The drawings are objected to because the “third well” label 72 (Fig. 2-8, 13-21, 31) and 202 (Fig. 22, 26) does not correspond to the description of the “third well” as recited in claims 2, 6, 12, and 16. The “third well” with labels 72 or 202 correspond with the second end of the channel paired with the air vent. However, the claim set and paragraphs 0010, 0014, 0018, and 0022, refer to the additional well within the second channel of a channel network. This results in two different parts of the device being labeled as a “third well” leading to confusion as so which part is which.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The abstract of the disclosure is objected to because it exceeds 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
In paragraphs 0080-0081, 0091, 0096, and 0101 a part of a “third well” (with labels 72 and 202) is described as being the well associated with the second end of the channel paired with the air vent. However, the claim set and paragraphs 0010, 0014, 0018, and 0022, refer to the additional well within the second channel of a channel network. This results in two different parts of the device being labeled as a “third well” leading to confusion as so which part is which.
Appropriate correction is required.
Claim Objections
Claims 2, 19 and 23 objected to because of the following informalities:
Claim 2 recites the limitation "a third port" in line 6 of the claim. Examiner believes this is meant to recite “a third loading port” as recited later in the same line of the same claim and will be examined as such. Examiner recommends amending the claim to add the limitation of “loading” to the claim.
claim 19 recited the limitation “in communication with channel at a location” in line 9 of the claim. The recitation is missing the work “the” or “said” before “channel.”
Claim 23 recites the limitation “wherein the channel is first channel” in line 1 of the claim. This recitation is missing the word “a” before “first channel.”
Appropriate correction is required.
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.
Claims 3-5 and 11-25 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites a plurality of elements, “a channel,” “a first well,” “a first loading port,” “a second well,” “a second loading port” throughout the claim. Examiner notes these are features of the second channel network but when first recited in claim 3 have the same name as the equivalent part of the first channel network. This leads to confusion as to if the part is in the first or second channel. Examiner recommends amending the claim elements to have a qualifier such as “of the second channel network” or an equivalent thereof to all repeated elements.
Claims 4-5 are rejected based on their dependence to claim 3.
Claim 4 recites the limitations “an air outlet” in line 3 of the claim. Examiner notes this feature of the second channel network but when first recited in claim 4 has the same name as the equivalent part of the first channel network. This leads to confusion as to if the part is in the first or second channel. Examiner recommends amending the claim elements to have a qualifier such as “of the second channel network” or an equivalent thereof to the repeated element.
Claim 5, recites the limitations “the air outlet” in line 2 of the claim. Examiner notes this feature of the second channel network but when first recited in claim 5 has the same name as the equivalent part of the first channel network. This leads to confusion as to if the part is in the first or second channel. Examiner recommends amending the claim elements to have a qualifier such as “of the second channel network” or an equivalent thereof to the repeated element.
Claim 5 recites the limitation "the air outlet" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. While claim 1 recites “an air outlet” this is the air outlet of the first channel and Examiner believes the air outlet recited in claim 5 is a secondary air outlet associated with a secondary channel and will be examined as such. Examiner recommends amending the claim to recite “an air outlet of the second channel” or an equivalent thereof.
Claim 11 recites the limitation “the second loading port” in line 15 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 11 previously recites “a loading port” in line 6 of the same claim. Examiner believes “the second loading port” is equivalent to “a loading port” and will be examined as such. Examiner recommends amending the claims to “the loading port” or an equivalent thereof.
Claims 12-18 are rejected based on their dependence to claim 11.
Claim 13-14 recites a plurality of elements, “a channel,” “a first well,” “a loading port,” “a second well,” and “an air outlet” (claim 14) throughout the claim. Examiner notes these are features of the second channel network but when first recited in claim 3 have the same name as the equivalent part of the first channel network. This leads to confusion as to if the part is in the first or second channel. Examiner recommends amending the claim elements to have a qualifier such as “of the second channel network” or an equivalent thereof to all repeated elements.
Claim 15 is rejected based on its dependence to claim 13.
Claim 15 recites the limitation "the air outlet" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. While claim 11 recites “an air outlet” this is the air outlet of the first channel and Examiner believes the air outlet recited in claim 15 is a secondary air outlet associated with a secondary channel and will be examined as such. Examiner recommends amending the claim to recite “an air outlet of the second channel” or an equivalent thereof.
Claim 19 recites the limitation "the second well" in lines 8, 13, and 16-17 and “the first well” in line 14 of the claim. There is insufficient antecedent basis for this limitation in the claim as only “a well” is previously recited in the claim. Examiner believes “the second well” and “the first well” is equivalent to “a well” and will be examined as such. Examiner recommends amending the claims to “the well” or an equivalent thereof.
Claims 20-25 are rejected based on their dependence to claim 19.
Claim 20-21 recites a plurality of elements, “a channel,” “a well,” “a first loading port,” “a second loading port” and “an air outlet” (claim 21) throughout the claim. Examiner notes these are features of the second channel network but when first recited in claim 3 have the same name as the equivalent part of the first channel network. This leads to confusion as to if the part is in the first or second channel. Examiner recommends amending the claim elements to have a qualifier such as “of the second channel network” or an equivalent thereof to all repeated elements.
Claim 22 is rejected based on its dependence to claim 20.
Claim 22 recites the limitation "the air outlet" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. While claim 19 recites “an air outlet” this is the air outlet of the first channel and Examiner believes the air outlet recited in claim 22 is a secondary air outlet associated with a secondary channel and will be examined as such. Examiner recommends amending the claim to recite “an air outlet of the second channel” or an equivalent thereof.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-5, 11, 13-15, and 19-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trietsch, et. al. (US 20180169656 A1).
Regarding claim 1, Trietsch teaches a microfluidic system for analysis of fluid contents, like assays, reactions, or cultures of biochemical particles (Abstract, par. 0002) (a microfluidic device for profiling biochemical samples). Trietsch teaches the microfluidic system comprises a microfluidic plate 1 with a series of microfluidic networks (channel network) wherein each network is formed through support structure 8 (cartridge) driven by a capillary pressure barrier (par. 0014-0015, 0051-0052) (a cartridge defining a channel network). Each network comprises a first 3A, second 3B, and third 3C inlet (Fig. 2; par. 0144). The inlets are fluidically connected by microfluidic channels 35, 36, 37 (Fig. 4c; par. 0149) that span parallel to the horizontal surface (par. 0027) with inlet 3C on a first end (a first end) of the channel and 3A on an opposite end of the channel (a second opposite end) (Fig. 4c) (the channel network including: a channel having first and second opposite ends). Trietsch teaches each inlet is accompanied a two-part reservoir 24, 25 (well) with the inlet 3A-C (loading port) located between the reservoir and channel 35-37 (Fig. 4d).
Trietsch teaches the reservoirs 24, 25 above the inlets 3A-C are configured to hold fluid (par. 0154) (having a dimension to pin the… fluid) until a dispensing part 29 is received by an opening 9 between reservoirs 24, 25 (Fig. 4d; par. 0159) such that when a dispensing part 29, like a pipette tip, injects a fluid, the fluid can move into the microfluidic network by capillary force (par. 0164) (having sufficient dimension to allow the first fluid to flow into the channel).
This means the reservoirs 24, 25 (a first well) and inlet 3C (a first loading port) combination at a first side (the first end) of the channel network (a first well adjacent the first end of the channel) can receive a fluid sample from a dispensing part 29 (the first well adapted for receiving a first fluid therein). Wherein the fluid sample overcomes capillary barrier pressure to move through inlet 3C to fill connected channel 37 (Fig. 4c; 4d; par. 0164) (a first loading port extending between the first well and the channel, the first loading port having a sufficient dimension to allow the first fluid to flow into the channel).
Trietsch teaches this reservoirs 24, 25 inlet 3A-C combination is repeated such that there is a second reservoir and inlet combination in the middle of the channel network as seen by reservoirs 24, 25 (a second well) connect to inlet 3B (a second loading port) (Fig. 4c-d) (a second well disposed between the first and second ends of the channel, the second well adapted for receiving a second fluid therein). As stated above, Trietsch teaches the reservoirs 24, 25 above the inlets 3A-C are configured to hold fluid (par. 0154) until a dispensing part 29 is received by an opening 9 between reservoirs 24, 25 (Fig. 4d; par. 0159). Therefore, inlet 3B (second loading port) can hold back any fluids within connected reservoirs 24, 25 (second well) unless actuated by a dispensing part (a second loading port extending between the second well and the channel, the second loading port having a dimension to pin the second fluid in the second well).
Trietsch teaches the use of a vent to regulate pressure within the microfluidic network (par. 0034) and wherein an inlet can additionally be used as a vent (par. 0148). Therefore, final reservoirs 24, 25 inlet 3A combination (an air outlet) can be used to vent the microfluidic network with the environment (par. 0165) (an air outlet adjacent to the second end of the channel, the air outlet allowing an interior of the channel to communicate with an environment external of the cartridge).
Trietsch teaches once the fluid (first fluid) is injected into the container, capillary forces can draw the fluid through the channel network from the reservoirs 24, 25 (the first well) inlet 3C (first loading port) combination (par. 0164) (capillary action causes the first fluid received in the first well to flow into the channel through the first loading port and toward the air outlet). Trietsch further teaches once the fluid sample is injected into the inlet 3C (the first well) and the sample fluid flows into the channel network (at least a portion of the first fluid flowing through the channel), channel 37 that extends to channel 36 connects inlet 3C (the first inlet) to reservoirs 24, 25 combined with inlet 3B (the second well and the second loading port) (Fig. 4c), and while fluid flow from the reservoirs to the network channel is prohibited until actuation, there is no physical barrier to prevent passive diffusion of the fluid sample through inlet 3B to connected reservoirs 24, 25 (at least a portion of the first fluid flowing through the channel flows into the second well through the second loading port).
Regarding claim 3, Trietsch teaches the microfluidic system comprises a plate with a series of microfluidic networks wherein each network is driven by a capillary pressure barrier (par. 0014-0015, 0051-0052) (wherein the channel network is a first channel network and wherein the cartridge further includes a second channel network). Each network comprises a first 3A, second 3B, and third 3C inlet (Fig. 2; par. 0144). The inlets are fluidically connected by microfluidic channels 35, 36, 37 (Fig. 4c; par. 0149) that span parallel to the horizontal surface (par. 0027) with inlet 3C on a first end of the channel and 3A on an opposite end of the channel (Fig. 4c) (the second channel network defined by: a channel having first and second opposite ends). Trietsch teaches each inlet is accompanied a two-part reservoir 24, 25 (wells) with the inlet 3A-C (loading ports) located between the reservoir and channel 35-37 (Fig. 4d).
As seen in Figures 2-3, the networks are repeated in columns and rows mimicking 384 well plate to create 96 structurally microfluidic networks (par. 0144).
Examiner notes, for the sake of clarity and keeping the rejection of record clear and concise, the limitations of claim 3 are repeated from claim 1, but located in a second channel network distinctly separated from the first channel network. Since Trietsch teaches all claim limitations in the first channel network and that the device comprises multiple channel networks, the claim limitations are met for the second channel network. A simplified list of the parts are as follows with each part having the same functional abilities regarding fluid flow as previously outlined (see claim 1 above):
reservoirs 24, 25 (first well) and inlet 3C (first loading port) combination connected to channel 37 at a furthermost end (a first well adjacent the first end of the channel of the second channel network, the first well of the second channel network adapted for receiving a third fluid therein) (a first loading port extending between the first well of the second channel network and the channel of the second channel network, the first loading port of the second channel network having a sufficient dimension to allow the third fluid to flow into the channel of the second channel network)
reservoirs 24, 25 (second well) and inlet 3B (second loading port) combination connected to channel 36 in a middle section (a second well disposed between the first and second ends of the channel of the second channel network, the second well of the second channel network adapted for receiving a fourth fluid therein) (a second loading port extending between the second well of the second channel network and the channel of the second channel network, the second loading port of the second channel network having a dimension to pin the fourth fluid in the second well of the second channel network).
Regarding claim 4, Examiner notes, for the sake of clarity and keeping the rejection of record clear and concise, the limitations of claim 4 are repeated from claim 1, but located in a second channel network distinctly separated from the first channel network. Since Trietsch teaches all claim limitations in the first channel network and that the device comprises multiple channel networks, the claim limitations are met for the second channel network. A simplified list of the parts are as follows with each part having the same functional abilities as previously supported (see claim 1 above).
Trietsch teaches the channel network the use of a vent to regulate pressure within the microfluidic network (par. 0034) and wherein an inlet can additionally be used as a vent (par. 0148). Therefore, final reservoirs 24, 25 inlet 3A combination can be used to vent the microfluidic network with the environment (par. 0165) (an air outlet adjacent to the second end of the second channel network, the air outlet of the second channel network allowing an interior of the channel of the second channel network to communicate with an environment external of the cartridge).
Examiner notes the following limitations are drawn to the functional limitation if the channel within the microfluidic device. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims. Further, all structural limitation (outlined above) are present and therefore the device should be able to perform such functional operations because the same structural elements are present.
Trietsch teaches once the fluid is injected into the container, capillary forces can draw the fluid through the channel network (par. 0164) (capillary action causes the third fluid received in the first well of the second channel network to flow into the channel of the second channel network through the first loading port of the second channel network and toward the air outlet of the second channel network). Trietsch further teaches one the fluid sample is injected into the inlet 3C and the sample fluid flows into the channel network, channel 37 that extends to channel 36 connects inlet 3C to reservoirs 24, 25 in combination with inlet 3B (Fig. 4c), and while fluid flow from the reservoirs to the network channel is prohibited until actuation, there is no physical barrier to prevent passive diffusion of the fluid sample through inlet 3B to connected reservoirs 24, 25 (at least a portion of the third fluid flowing through the channel of the second channel network flows into the second well of the second channel network through the second loading port of the second channel network).
Regarding claim 5, Examiner notes, for the sake of clarity and keeping the rejection of record clear and concise, the limitations of claim 5 are related to the limitations from claim 1 but located in a second channel network distinctly separated from the first channel network. Since Trietsch teaches all claim limitations in the first channel network and that the device comprises multiple channel networks, the claim limitations are met for the second channel network. A simplified list of the parts are as follows with each part having the same functional abilities as previously supported (see claim 1 above).
Trietsch teaches the channel network the use of a vent to regulate pressure within the microfluidic network (par. 0034) and wherein an inlet can additionally be used as a vent (par. 0148). Therefore, final reservoirs 24, 25 inlet 3A combination can be used to vent the microfluidic network with the environment (par. 0165) (wherein the channel of the second channel network communicates with the air outlet adjacent to the second end of the channel of the second channel network, the air outlet allowing an interior of the channel of the second channel network to communicate with an environment external of the cartridge).
Examiner notes the following limitations are drawn to the functional limitation if the channel within the microfluidic device. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims. Further, all structural limitation (outlined above) are present and therefore the device should be able to perform such functional operations because the same structural elements are present.
Trietsch teaches once the fluid is injected into the container, capillary forces can draw the fluid through the channel network (par. 0164) (capillary action causes the third fluid received in the first well of the second channel network to flow into the channel of the second channel network through the first loading port of the second channel network and toward the air outlet). Trietsch further teaches one the fluid sample is injected into the inlet 3C and the sample fluid flows into the channel network, channel 37 that extends to channel 36 connects inlet 3C to reservoirs 24, 25 in combination with inlet 3B (Fig. 4c), and while fluid flow from the reservoirs to the network channel is prohibited until actuation, there is no physical barrier to prevent passive diffusion of the fluid sample through inlet 3B to connected reservoirs 24, 25 (and at least a portion of the third fluid flowing through the channel of the second channel network flows into the second well of the second channel network through the second loading port of the second channel network).
Regarding claim 11, Trietsch teaches a microfluidic system for analysis of fluid contents, like assays, reactions, or cultures of biochemical particles (Abstract, par. 0002) (a microfluidic device for profiling biochemical samples). Trietsch teaches the microfluidic system comprises a plate with a series of microfluidic networks wherein each network is driven by a capillary pressure barrier (par. 0014-0015, 0051-0052) (a cartridge defining a channel network). Each network comprises a first 3A, second 3B, and third 3C inlet (Fig. 2; par. 0144). The inlets are fluidically connected by microfluidic channels 35, 36, 37 (Fig. 4c; par. 0149) that span parallel to the horizontal surface (par. 0027) with inlet 3C on a first end of the channel and 3A on an opposite end of the channel (Fig. 4c) (the channel network including: a channel having first and second opposite ends). Trietsch teaches each inlet is accompanied a two-part reservoir 24, 25 (well) with the inlet 3A-C (loading port) located between the reservoir and channel 35-37 (Fig. 4d).
Trietsch teaches the reservoirs 24, 25 above the inlets 3A-C are configured to hold fluid (par. 0154) (having a dimension to pin the… fluid) until a dispensing part 29 is received by an opening 9 between reservoirs 24, 25 (Fig. 4d; par. 0159) such that when a dispensing part 29, like a pipette tip, injects a fluid, the fluid can move into the microfluidic network by capillary force (par. 0164) (having sufficient dimension to allow the first fluid to flow into the channel).
This means the reservoirs 24, 25 (first well) and inlet 3C (first loading port) combination at a first side of the channel network (a first well adjacent the first end of the channel) can receive a fluid sample from a dispensing part 29 (the first well adapted for receiving a first fluid therein). Wherein the fluid sample overcomes capillary barrier pressure to move through inlet 3C to fill connected channel 37 (Fig. 4c; 4d; par. 0164).
Trietsch teaches this reservoirs 24, 25 inlet 3A-C combination is repeated such that there is a second reservoir and inlet combination in the middle of the channel network as seen by reservoirs 24, 25 (a second well) connect to inlet 3B (a loading port) (Fig. 4c-d) (a second well in communication with the channel through a loading port at a location between the first and second ends of the channel, the second well adapted for receiving a second fluid therein). As stated above, Trietsch teaches the reservoirs 24, 25 above the inlets 3A-C are configured to hold fluid (par. 0154) until a dispensing part 29 is received by an opening 9 between reservoirs 24, 25 (Fig. 4d; par. 0159). Therefore, inlet 3B (second loading port) can hold back any fluids within connected reservoirs 24, 25 (second well) unless actuated by a dispensing part (the second loading port having a dimension to pin the second fluid in the second well).
Trietsch teaches the use of a vent to regulate pressure within the microfluidic network (par. 0034) and wherein an inlet can additionally be used as a vent (par. 0148). Therefore, final reservoirs 24, 25 inlet 3A combination can be used to vent the microfluidic network with the environment (par. 0165) (an air outlet adjacent to the second end of the channel, the air outlet allowing an interior of the channel to communicate with an environment external of the cartridge).
Trietsch teaches once the fluid is injected into the container, capillary forces can draw the fluid through the channel network (par. 0164) (capillary action causes the first fluid received in the first well to flow into the channel through the first loading port and toward the air outlet). Trietsch further teaches one the fluid sample is injected into the inlet 3C and the sample fluid flows into the channel network, channel 37 that extends to channel 36 connects inlet 3C to reservoirs 24, 25 in combination with inlet 3B (Fig. 4c), and while fluid flow from the reservoirs to the network channel is prohibited until actuation, there is no physical barrier to prevent passive diffusion of the fluid sample through inlet 3B to connected reservoirs 24, 25 (at least a portion of the first fluid flowing through the channel flows into the second well through the second loading port).
Regarding claim 13, Trietsch teaches the microfluidic system comprises a plate with a series of microfluidic networks wherein each network is driven by a capillary pressure barrier (par. 0014-0015, 0051-0052) (wherein the channel network is a first channel network and wherein the cartridge further includes a second channel network). Each network comprises a first 3A, second 3B, and third 3C inlet (Fig. 2; par. 0144). The inlets are fluidically connected by microfluidic channels 35, 36, 37 (Fig. 4c; par. 0149) that span parallel to the horizontal surface (par. 0027) with inlet 3C on a first end of the channel and 3A on an opposite end of the channel (Fig. 4c) (the second channel network defined by: a channel having first and second opposite ends). Trietsch teaches each inlet is accompanied a two-part reservoir 24, 25 (wells) with the inlet 3A-C (loading ports) located between the reservoir and channel 35-37 (Fig. 4d).
As seen in Figures 2-3, the networks are repeated in columns and rows mimicking 384 well plate to create 96 structurally microfluidic networks (par. 0144).
Examiner notes, for the sake of clarity and keeping the rejection of record clear and concise, the limitations of claim 13 are repeated from claim 11, but located in a second channel network distinctly separated from the first channel network. Since Trietsch teaches all claim limitations in the first channel network and that the device comprises multiple channel networks, the claim limitations are met for the second channel network. A simplified list of the parts are as follows with each part having the same functional abilities regarding fluid flow as previously outlined (see claim 11 above):
reservoirs 24, 25 (first well) and inlet 3C (loading port) combination connected to channel 37 (a first well communicating with the channel of the second channel network at a location adjacent the first end of the channel of the second channel network, the first well of the second channel network adapted for receiving a third fluid therein)
reservoirs 24, 25 (second well) and inlet 3B (loading port) combination connected to channel 36 (a second well communicating with the channel of the second channel network through a loading port at a location between the first and second ends of the channel of the second channel network, the second well of the second channel network adapted for receiving a fourth fluid therein)
inlet 3B (loading port) can hold back any fluids within connected reservoirs 24, 25 (second well) unless actuated by a dispensing part (wherein the loading port of the second channel network has a dimension to pin the fourth fluid in the second well of the second channel network).
Regarding claim 14, Examiner notes, for the sake of clarity and keeping the rejection of record clear and concise, the limitations of claim 14 are repeated from claim 11, but located in a second channel network distinctly separated from the first channel network. Since Trietsch teaches all claim limitations in the first channel network and that the device comprises multiple channel networks, the claim limitations are met for the second channel network. A simplified list of the parts are as follows with each part having the same functional abilities as previously supported (see claim 11 above).
Trietsch teaches the channel network the use of a vent to regulate pressure within the microfluidic network (par. 0034) and wherein an inlet can additionally be used as a vent (par. 0148). Therefore, final reservoirs 24, 25 inlet 3A combination can be used to vent the microfluidic network with the environment (par. 0165) (an air outlet in communication with the channel of the second channel network at a location adjacent to the second end of the second channel network, the air outlet of the second channel network allowing an interior of the channel of the second channel network to communicate with an environment external of the cartridge).
Examiner notes the following limitations are drawn to the functional limitation if the channel within the microfluidic device. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims. Further, all structural limitation (outlined above) are present and therefore the device should be able to perform such functional operations because the same structural elements are present.
Trietsch teaches once the fluid is injected into the container, capillary forces can draw the fluid through the channel network (par. 0164) (capillary action causes the third fluid received in the first well of the second channel network to flow into the channel of the second channel network toward the air outlet of the second channel network). Trietsch further teaches one the fluid sample is injected into the inlet 3C and the sample fluid flows into the channel network, channel 37 that extends to channel 36 connects inlet 3C to reservoirs 24, 25 in combination with inlet 3B (Fig. 4c), and while fluid flow from the reservoirs to the network channel is prohibited until actuation, there is no physical barrier to prevent passive diffusion of the fluid sample through inlet 3B to connected reservoirs 24, 25 (at least a portion of the third fluid flowing through the channel of the second channel network flows into the second well of the second channel network through the loading port of the second channel network).
Regarding claim 15, Examiner notes, for the sake of clarity and keeping the rejection of record clear and concise, the limitations of claim 15 are related to the limitations from claim 11 but located in a second channel network distinctly separated from the first channel network. Since Trietsch teaches all claim limitations in the first channel network and that the device comprises multiple channel networks, the claim limitations are met for the second channel network. A simplified list of the parts are as follows with each part having the same functional abilities as previously supported (see claim 11 above).
Trietsch teaches the channel network the use of a vent to regulate pressure within the microfluidic network (par. 0034) and wherein an inlet can additionally be used as a vent (par. 0148). Therefore, final reservoirs 24, 25 inlet 3A combination can be used to vent the microfluidic network with the environment (par. 0165) (wherein the channel of the second channel network communicates with the air outlet at a location adjacent to the second end of the channel of the second channel network, the air outlet allowing an interior of the channel of the second channel network to communicate with an environment external of the cartridge).
Examiner notes the following limitations are drawn to the functional limitation if the channel within the microfluidic device. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims. Further, all structural limitation (outlined above) are present and therefore the device should be able to perform such functional operations because the same structural elements are present.
Trietsch teaches once the fluid is injected into the container, capillary forces can draw the fluid through the channel network (par. 0164) (capillary action causes the third fluid received in the first well of the second channel network to flow into the channel of the second channel network toward the air outlet). Trietsch further teaches one the fluid sample is injected into the inlet 3C and the sample fluid flows into the channel network, channel 37 that extends to channel 36 connects inlet 3C to reservoirs 24, 25 in combination with inlet 3B (Fig. 4c), and while fluid flow from the reservoirs to the network channel is prohibited until actuation, there is no physical barrier to prevent passive diffusion of the fluid sample through inlet 3B to connected reservoirs 24, 25 (at least a portion of the third fluid flowing through the channel of the second channel network flows into the second well of the second channel network through the loading port of the second channel network).
Regarding claim 19, Trietsch teaches a microfluidic system for analysis of fluid contents, like assays, reactions, or cultures of biochemical particles (Abstract, par. 0002) (a microfluidic device for profiling biochemical samples). Trietsch teaches the microfluidic system comprises a plate with a series of microfluidic networks wherein each network is driven by a capillary pressure barrier (par. 0014-0015, 0051-0052) (a cartridge defining a channel network). Each network comprises a first 3A, second 3B, and third 3C inlet (Fig. 2; par. 0144). The inlets are fluidically connected by microfluidic channels 35, 36, 37 (Fig. 4c; par. 0149) that span parallel to the horizontal surface (par. 0027) with inlet 3C on a first end of the channel and 3A on an opposite end of the channel (Fig. 4c) (the channel network including: a channel having first and second opposite ends). Trietsch teaches each inlet is accompanied a two-part reservoir 24, 25 (well) with the inlet 3A-C (loading port) located between the reservoir and channel 35-37 (Fig. 4d).
Trietsch teaches the reservoirs 24, 25 above the inlets 3A-C are configured to hold fluid (par. 0154) (having a dimension to pin the… fluid) until a dispensing part 29 is received by an opening 9 between reservoirs 24, 25 (Fig. 4d; par. 0159) such that when a dispensing part 29, like a pipette tip, injects a fluid, the fluid can move into the microfluidic network by capillary force (par. 0164) (having sufficient dimension to allow the first fluid to flow into the channel).
This means the reservoirs 24, 25 (well) and inlet 3C (loading port) combination at a first side of the channel network can receive a fluid sample from a dispensing part 29. Wherein the fluid sample overcomes capillary barrier pressure to move through inlet 3C to fill connected channel 37 (Fig. 4c; 4d; par. 0164) (a first loading port extending between the first well and the channel, the first loading port having a sufficient dimension to allow the first fluid to flow into the channel).
Trietsch teaches this reservoirs 24, 25 inlet 3A-C combination is repeated such that there is a second reservoir and inlet combination in the middle of the channel network as seen by reservoirs 24, 25 (a well) connect to inlet 3B (a second loading port) (Fig. 4c-d) (a well in communication with the channel through a second loading port and located between the first loading port and the second end of the channel, the second well adapted for receiving a second fluid therein). As stated above, Trietsch teaches the reservoirs 24, 25 above the inlets 3A-C are configured to hold fluid (par. 0154) until a dispensing part 29 is received by an opening 9 between reservoirs 24, 25 (Fig. 4d; par. 0159). Therefore, inlet 3B (second loading port) can hold back any fluids within connected reservoirs 24, 25 (second well) unless actuated by a dispensing part (the second loading port has a dimension to pin the second fluid in the second well).
Trietsch teaches the use of a vent to regulate pressure within the microfluidic network (par. 0034) and wherein an inlet can additionally be used as a vent (par. 0148). Therefore, final reservoirs 24, 25 inlet 3A combination can be used to vent the microfluidic network with the environment (par. 0165) (an air outlet adjacent to the second end of the channel, the air outlet allowing an interior of the channel to communicate with an environment external of the cartridge).
Trietsch teaches once the fluid is injected into the container, capillary forces can draw the fluid through the channel network (par. 0164) (capillary action causes the first fluid received in the first well to flow into the channel through the first loading port and toward the air outlet). Trietsch further teaches one the fluid sample is injected into the inlet 3C and the sample fluid flows into the channel network, channel 37 that extends to channel 36 connects inlet 3C to reservoirs 24, 25 in combination with inlet 3B (Fig. 4c), and while fluid flow from the reservoirs to the network channel is prohibited until actuation, there is no physical barrier to prevent passive diffusion of the fluid sample through inlet 3B to connected reservoirs 24, 25 (at least a portion of the first fluid flowing through the channel flows into the second well through the second loading port).
Regarding claim 20, Trietsch teaches the microfluidic system comprises a plate with a series of microfluidic networks wherein each network is driven by a capillary pressure barrier (par. 0014-0015, 0051-0052) (wherein the channel network is a first channel network and wherein the cartridge further includes a second channel network). Each network comprises a first 3A, second 3B, and third 3C inlet (Fig. 2; par. 0144). The inlets are fluidically connected by microfluidic channels 35, 36, 37 (Fig. 4c; par. 0149) that span parallel to the horizontal surface (par. 0027) with inlet 3C on a first end of the channel and 3A on an opposite end of the channel (Fig. 4c) (the second channel network defined by: a channel having first and second opposite ends). Trietsch teaches each inlet is accompanied a two-part reservoir 24, 25 (wells) with the inlet 3A-C (loading ports) located between the reservoir and channel 35-37 (Fig. 4d).
As seen in Figures 2-3, the networks are repeated in columns and rows mimicking 384 well plate to create 96 structurally microfluidic networks (par. 0144).
Examiner notes, for the sake of clarity and keeping the rejection of record clear and concise, the limitations of claim 20 are repeated from claim 19, but located in a second channel network distinctly separated from the first channel network. Since Trietsch teaches all claim limitations in the first channel network and that the device comprises multiple channel networks, the claim limitations are met for the second channel network. A simplified list of the parts are as follows with each part having the same functional abilities regarding fluid flow as previously outlined (see claim 19 above):
reservoirs 24, 25 (well) and inlet 3C (first loading port) combination connected to channel 37 (a first loading port in communication with the channel of the second channel network, the first loading port of the second channel network configured to allow introduction of a third fluid into the channel of the second channel network)
reservoirs 24, 25 (well) and inlet 3B (second loading port) combination connected to channel 36 (a well in communication with the channel of the second channel network through a second loading port and located between the first loading port of the second channel network and the second end of the channel of the second channel network, the well of the second channel network adapted for receiving a fourth fluid therein).
inlet 3B (second loading port) can hold back any fluids within connected reservoirs 24, 25 unless actuated by a dispensing part (wherein the second loading port of the second channel network has a dimension to pin the fourth fluid in the second well of the second channel network).
Regarding claim 21, Examiner notes, for the sake of clarity and keeping the rejection of record clear and concise, the limitations of claim 21 are repeated from or related to the limitations from claim 19 but located in a second channel network distinctly separated from the first channel network. Since Trietsch teaches all claim limitations in the first channel network and that the device comprises multiple channel networks, the claim limitations are met for the second channel network. A simplified list of the parts are as follows with each part having the same functional abilities as previously supported (see claim 19 above).
Trietsch teaches the channel network the use of a vent to regulate pressure within the microfluidic network (par. 0034) and wherein an inlet can additionally be used as a vent (par. 0148). Therefore, final reservoirs 24, 25 inlet 3A combination can be used to vent the microfluidic network with the environment (par. 0165) (wherein the second channel network further includes an air outlet in communication with the channel of the second channel network at a location adjacent to the second end of the second channel network, the air outlet of the second channel network allowing an interior of the channel of the second channel network to communicate with an environment external of the cartridge).
Regarding claim 22, Examiner notes, for the sake of clarity and keeping the rejection of record clear and concise, the limitations of claim 22 are related to the limitations from claim 19 but located in a second channel network distinctly separated from the first channel network. Since Trietsch teaches all claim limitations in the first channel network and that the device comprises multiple channel networks, the claim limitations are met for the second channel network. A simplified list of the parts are as follows with each part having the same functional abilities as previously supported (see claim 19 above).
Trietsch teaches the channel network the use of a vent to regulate pressure within the microfluidic network (par. 0034) and wherein an inlet can additionally be used as a vent (par. 0148). Therefore, final reservoirs 24, 25 inlet 3A combination can be used to vent the microfluidic network with the environment (par. 0165) (wherein the second channel network further includes an air outlet in communication with the channel of the second channel network at a location adjacent to the second end of the second channel network, the air outlet of the second channel network allowing an interior of the channel of the second channel network to communicate with an environment external of the cartridge).
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 2, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Trietsch, et. al. (US 20180169656 A1) in view of Reed, et. al. (US 20150273469 A1).
Regarding claim 2, Trietsch teaches the limitations as applied to claim 1 (see above). Trietsch teaches a microfluidic device with a plurality of networks resulting in a device with a plurality of channels. Trietsch teaches wherein each network comprises an inlet is accompanied a two-part reservoir 24, 25 (well) with the inlet 3A-C (loading port) located between the reservoir and channel 35-37 (Fig. 4d) (a… loading port extending between the… well and the… channel).
Trietsch teaches the channel networks run parallel to one another creating column networks that are then repeated in rows (Fig. 2-3). Therefore, when looking at two parallel network channels, there are:
-two channels each with a first and second side (wherein the channel is a first channel, the air outlet is a first air outlet) (a second channel having first and second opposite ends)
-each channel has a reservoir 24, 25 and inlet combination 3C at a first end configured to hold fluid (par. 0154) until a dispensing part 29 is received by an opening 9 between reservoirs 24, 25 (Fig. 4d; par. 0159) such that when a dispensing part 29, like a pipette tip, injects a fluid, the fluid can move through the microfluidic network by capillary force (par. 0164) (a third well adjacent the first end of the second channel, the third well adapted for receiving a third fluid therein) (a third port extending between the third well and the second channel, the third loading port having a sufficient dimension to allow the third fluid to flow into the second channel)
-a reservoir 24, 25 and inlet combination 3B in the middle of the channel (a fourth loading port extending between… the second channel)
-a reservoir 24, 25 and inlet combination 3A at the second end that can serve as a vent (Fig. 2-3, 4c; par. 0165) (a second air outlet adjacent to the second end of the second channel, the second air outlet allowing an interior of the second channel to communicate with an environment external of the cartridge)
Examiner notes the following limitations are drawn to the functional limitation if the channel within the microfluidic device. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims. Further, all structural limitation (outlined above) are present and therefore the device should be able to perform such functional operations because the same structural elements are present.
Trietsch teaches once the fluid is injected into the container, capillary forces can draw the fluid through the channel network (par. 0164) (capillary action causes the third fluid received in the third well to flow into the second channel through the third loading port and toward the second air outlet). Trietsch further teaches one the fluid sample is injected into the inlet 3C and the sample fluid flows into the channel network, channel 37 that extends to channel 36 connects inlet 3C to reservoirs 24, 25 in combination with inlet 3B (Fig. 4c), and while fluid flow from the reservoirs to the network channel is prohibited until actuation, there is no physical barrier to prevent passive diffusion of the fluid sample through inlet 3B to connected reservoirs 24, 25 (at least a portion of the third fluid flowing through the second channel flows into the…. well through the fourth loading port). However, Trietsch teaches wherein one inlet corresponds with one channel (Fig. 4c) and the middle well and port of each channel network are not fluidically connected.
Trietsch is silent to the fourth loading port extending between the second well and the second channel and a portion of the third fluid flowing through the second channel flows into the second well through the fourth loading port. In other words, Trietsch teach two second wells each with a loading port, and not a singular second well with two loading ports (a second and fourth loading ports) that fluidically connect the parallel channel networks.
Reed teaches a microplate (cartridge) with a series of microfluidic channels connecting wells (Abstract). Reed teaches the microplate comprises an input layer 404 the input layer comprising an assay input port 402 (Fig. 20-21; par. 0384-0385). The assay input port 402 fluidically connected to a plurality of microfluidic channels 406, specifically a middle portion of the plurality of microfluidic channels (Fig. 20, 23a; par. 0386) (the fourth loading port extending between the second well and the second channel). A modification of Figure 23a is provided below to show a first end (see the vertical arrow) and a second end (see the horizontal arrow) and label 418 specifically shows the lowermost portion of assay input port 402 wherein input port fluidically connects the multiple channels at a middle portion of the multiple channels (a portion of the third fluid flowing through the second channel flows into the second well through the fourth loading port). Reed teaches this fluidically connected design allows for rapid filling of multiple areas with the same fluid creating groupings 407(par. 0382-0383) creating a high-density analysis system (par. 0198) which ultimately increases device throughput.
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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 parallel channel networks, specifically the middle well and port combination (second well) of Trietsch to include an additional port (a second loading port and a fourth loading port) to fluidically connect the channel networks as taught by Reed because it allows for fluid filling based on grouping (Reed, par. 0382-0383) creating a high-density analysis system for increased device throughput (Reed, par. 0198) with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 10, Trietsch teaches the microfluidic system comprises a microfluidic plate 1 with a rectangular shape comprising at least two ends (Fig. 1-3) (wherein the cartridge includes: first and second ends).
Trietsch is silent to the microfluidic device further comprising a frame having first and second sides and first and second ends; a first connector connected to the cartridge adjacent the first end of the cartridge, the first connector removably connectable to the first side of the frame; and a second connector connected to the cartridge adjacent the second end of the cartridge, the second connector removably connectable to the second side of the frame.
Reed teaches a microplate (cartridge) with a series of microfluidic channels connecting wells (Abstract). Reed teaches the microplate 20 comprises a main body 28 that is planar and rectangular in shape; wherein the microplate can be installed with a skirt portion 30 (frame) the skirt portion have a corresponding rectangular shape of the microplate 20 meaning the frames will inherently have four sides and a first and second ends (Fig. 2; par. 0207) (further comprising a frame having first and second sides and first and second ends). Reed teaches the addition of a skirt portion 30 provides additional rigidity to the microplate and improved handling capabilities of the microplate during use (par. 0207).
Reed teaches microplate (cartridge) further comprises alignment features 58, wherein the alignment features can take many forms with the purpose of interfacing the microplate with corresponding features (Fig. 2; par. 0218). Reed teaches skirt portion 30 also facilitates alignment of the microplate with other devices (par. 0207).
When looking at Figure 2, an alignment feature taking the shape of a protrusion on the lower left and right ends of the microplate 20 (a first connector connected to the cartridge adjacent the first end of the cartridge, the first connector removably connectable to the first side of the frame) (a second connector connected to the cartridge adjacent the second end of the cartridge, the second connector removably connectable to the second side of the frame). Reed teaches alignment features help attached the microplate to other device features (par. 0218).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the microplate of Trietsch to further include a skirt portion as a frame with alignment and connecting features to attached the microplate to the skirt/frame as taught by Reed because the addition of a skirt/frame provides additional rigidity to the microplate and improved handling capabilities of the microplate during use (Reed, par. 0207) with alignment features to improve the connection (Reed, par. 0218) with reasonable expectation of success. MPEP 2143(I)(G).
Regarding claim 12, Trietsch teaches the limitations as applied to claim 1 (see above). Trietsch teaches a microfluidic device with a plurality of networks resulting in a device with a plurality of channels. Trietsch teaches wherein each network comprises an inlet is accompanied a two-part reservoir 24, 25 (well) with the inlet 3A-C (loading port) located between the reservoir and channel 35-37 (Fig. 4d) (a… loading port extending between the… well and the… channel).
Trietsch teaches the channel networks run parallel to one another creating column networks that are then repeated in rows (Fig. 2-3). Therefore, when looking at two parallel network channels, there are:
-two channels each with a first and second side (wherein the channel is a first channel) (a second channel having first and second opposite ends)
-each channel has a reservoir 24, 25 and inlet combination 3C at a first end configured to hold fluid (par. 0154) until a dispensing part 29 is received by an opening 9 between reservoirs 24, 25 (Fig. 4d; par. 0159) such that when a dispensing part 29, like a pipette tip, injects a fluid, the fluid can move through the microfluidic network by capillary force (par. 0164) (the loading port is a first loading port) (a third well communicating the first end of the second channel, the third well adapted for receiving a third fluid therein)
-a reservoir 24, 25 and inlet combination 3 in the middle of the channel (a fourth loading port extending between… the second channel)
-a reservoir 24, 25 and inlet combination 3A at the second end that can serve as a vent (Fig. 2-3, 4c; par. 0165) (he air outlet is a first air outlet) (a second air outlet adjacent to the second end of the second channel, the second air outlet allowing an interior of the second channel to communicate with an environment external of the cartridge)
Examiner notes the following limitations are drawn to the functional limitation if the channel within the microfluidic device. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims. Further, all structural limitation (outlined above) are present and therefore the device should be able to perform such functional operations because the same structural elements are present.
Trietsch teaches once the fluid is injected into the container, capillary forces can draw the fluid through the channel network (par. 0164) (capillary action causes the third fluid received in the third well to flow into the second channel through the third loading port and toward the second air outlet). Trietsch further teaches one the fluid sample is injected into the inlet 3C and the sample fluid flows into the channel network, channel 37 that extends to channel 36 connects inlet 3C to reservoirs 24, 25 in combination with inlet 3B (Fig. 4c), and while fluid flow from the reservoirs to the network channel is prohibited until actuation, there is no physical barrier to prevent passive diffusion of the fluid sample through inlet 3B to connected reservoirs 24, 25 (at least a portion of the third fluid flowing through the second channel flows into the…. well through the second loading port). However, Trietsch teaches wherein one inlet corresponds with one channel (Fig. 4c) and the middle well and port of each channel network are not fluidically connected.
Trietsch is silent to a second loading port extending between the second well and the second channel and a portion of the third fluid flowing through the second channel flows into the second well through the second loading port. In other words, Trietsch teach two second wells each with a loading port, and not a singular second well with two loading ports that fluidically connect the parallel channel networks.
Reed teaches a microplate (cartridge) with a series of microfluidic channels connecting wells (Abstract). Reed teaches the microplate comprises an input layer 404 the input layer comprising an assay input port 402 (Fig. 20-21; par. 0384-0385). The assay input port 402 fluidically connected to a plurality of microfluidic channels 406, specifically a middle portion of the plurality of microfluidic channels (Fig. 20, 23a; par. 0386) (the fourth loading port extending between the second well and the second channel). A modification of Figure 23a is provided below to show a first end (see the vertical arrow) and a second end (see the horizontal arrow) and label 418 specifically shows the lowermost portion of assay input port 402 wherein input port fluidically connects the multiple channels at a middle portion of the multiple channels (a portion of the third fluid flowing through the second channel flows into the second well through the second loading port). Reed teaches this fluidically connected design allows for rapid filling of multiple areas with the same fluid creating groupings 407(par. 0382-0383) creating a high-density analysis system (par. 0198) which ultimately increases device throughput.
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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 parallel channel networks, specifically the middle well and port combination (second well) of Trietsch to include an additional port (a second loading port) to fluidically connect the channel networks as taught by Reed because it allows for fluid filling based on grouping (Reed, par. 0382-0383) creating a high-density analysis system for increased device throughput (Reed, par. 0198) with reasonable expectation of success. MPEP 2143(I)(G).
Claims 6, 7, 9, 16, 17, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Trietsch, et. al. (US 20180169656 A1) in view of Liu, et. al. (US 20230256438 A1).
Regarding claim 6, Trietsch teaches the limitations as applied to claim 1 (see above). Trietsch teaches a microfluidic device with a plurality of networks resulting in a device with a plurality of channels. Trietsch teaches wherein each inlet is accompanied a two-part reservoir 24, 25 (well) with the inlet 3A-C (loading port) located between the reservoir and channel 35-37 (Fig. 4d) (a… loading port extending between the… well and the… channel). Trietsch teaches the reservoirs 24, 25 above the inlets 3A-C are configured to hold fluid (par. 0154) until a dispensing part 29 is received by an opening 9 between reservoirs 24, 25 (Fig. 4d; par. 0159) such that when a dispensing part 29, like a pipette tip, injects a fluid, the fluid can move through the microfluidic network by capillary force (par. 0164) (the… loading port having a dimension to pin the… fluid in the… well). However, Trietsch teaches wherein one inlet corresponds with one channel (Fig. 4c) (wherein the channel is first channel).
Trietsch is silent to the channel network further includes: a second channel having first and second opposite ends; a third well disposed between the first and second ends of the second channel, the third well adapted for receiving a third fluid therein; and a third loading port extending between the third well and the second channel, the third loading port having a dimension to pin the third fluid in the third well; and wherein: the first loading port communicates with the second channel adjacent the first end of the second channel.
Liu teaches a microfluidic cartridge with a first inlet leading to a biochip through a channel (Abstract). Liu teaches an embodiment of the microfluidic cartridge comprising an inlet port 270 (first well) with a first opening 242 (first loading port) with a channel 216 leading to a biochip 260 and terminating in an outlet port 278 (air outlet) (Fig. 6, 7; par. 0084-0085). Between inlet port 270 and biochip 260, Liu teaches the channel branches into sub-channels each subchannel provided with a respective sample injection port 248 (Fig. 6-7; par. 0084). These sub-channels begin their branch at an inlet side and converge again at the outlet side (the channel network further includes: a second channel having first and second opposite ends) wherein the sample inlet 248 is between the inlet port 270 and outlet port 278 (Fig. 6) (a third well disposed between the first and second ends of the second channel, the third well adapted for receiving a third fluid therein) (wherein: the first loading port communicates with the second channel adjacent the first end of the second channel). Liu teaches the addition of a plurality of additional wells (a third well) allows for a plurality of samples to be analyzed simultaneously or a plurality of targets of interest within the same sample to be analyzed simultaneously (par. 0084) increasing device throughput.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the first well and first loading port and channel of the microfluidic device of Trietsch to have the first well and first loading port branch to at least two channels to accommodate a third well and third loading port as taught by Liu because the branched channels allow for additional samples or additional reagents to be analyzed increasing throughput of the microfluidic device (Liu, par. 0084) with reasonable expectation of success. MPEP 2143(I)(G).
Examiner notes the loading port and well combination and the fluid pinning ability of the well as taught by Trietsch are understood to apply to additional branched channels and inlets provided by Liu. Liu is provided to teach that branching channels from a first inlet to accommodate at least one additional inlet along at least one additional channel is known in the art as a technique to increase throughput. Therefore, the configuration and ability of the wells and loading ports are taught by Trietsch, and those structural elements are then multiplied as taught by Liu.
Regarding claim 7, modified Trietsch in view of Liu teaches wherein the sub-channels accommodating a plurality of sample inlets 248 converge at a second outlet in to reach shared outlet 278 (Liu, Fig. 6; par. 0084). Modified Trietsch teaches an inlet can additionally be used as a vent or an outlet (Trietsch, par. 0148) (wherein the air outlet communicates with the second end of the second channel).
Regarding claim 9, modified Trietsch in view of Liu teaches the branched sub-channels are symmetrical in length (Fig. 6-7) (wherein a length of the first channel between the first loading port and the second loading port is generally equal to a length of the second channel between the first loading port and the third loading port).
Regarding claim 16, Trietsch teaches the limitations as applied to claim 1 (see above). Trietsch teaches a microfluidic device with a plurality of networks resulting in a device with a plurality of channels. Trietsch teaches wherein each inlet is accompanied a two-part reservoir 24, 25 (well) with the inlet 3A-C (loading port) located between the reservoir and channel 35-37 (Fig. 4d) (a… well in communication with the… channel through a… loading port). Trietsch teaches the reservoirs 24, 25 above the inlets 3A-C are configured to hold fluid (par. 0154) until a dispensing part 29 is received by an opening 9 between reservoirs 24, 25 (Fig. 4d; par. 0159). However, Trietsch teaches wherein one inlet corresponds with one channel (Fig. 4c) (wherein the channel is first channel and the loading port is a first loading port).
Trietsch is silent to the channel network further includes: a second channel having first and second opposite ends; a third well at a location between the first and second ends of the second channel, the third well adapted for receiving a third fluid therein; and wherein: the first well in communication with the second channel at a location adjacent the first end of the second channel.
Liu teaches a microfluidic cartridge with a first inlet leading to a biochip through a channel (Abstract). Liu teaches an embodiment of the microfluidic cartridge comprising an inlet port 270 (first well) with a first opening 242 (first loading port) with a channel 216 leading to a biochip 260 and terminating in an outlet port 278 (air outlet) (Fig. 6, 7; par. 0084-0085). Between inlet port 270 and biochip 260, Liu teaches the channel branches into sub-channels each subchannel provided with a respective sample injection port 248 (Fig. 6-7; par. 0084). These sub-channels begin their branch at an inlet side and converge again at the outlet side (the channel network further includes: a second channel having first and second opposite ends) wherein the sample inlet 248 is between the inlet port 270 and outlet port 278 (Fig. 6) (a third well… at a location between the first and second ends of the second channel, the third well adapted for receiving a third fluid therein) (wherein: the first well in communication with the second channel at a location adjacent the first end of the second channel). Liu teaches the addition of a plurality of additional wells allows for a plurality of samples to be analyzed simultaneously or a plurality of targets of interest within the same sample to be analyzed simultaneously (par. 0084) increasing device throughput.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the first well and first loading port and channel of the microfluidic device of Trietsch to have the first well and first loading port branch to at least two channels to accommodate additional wells with loading ports as taught by Liu because the branched channels allow for additional samples or additional reagents to be analyzed increasing throughput of the microfluidic device (Liu, par. 0084) with reasonable expectation of success. MPEP 2143(I)(G).
Examiner notes the loading port and well combination as taught by Trietsch are understood to apply to additional branched channels and inlets provided by Liu. Liu is provided to teach that branching channels from a first inlet to accommodate at least one additional inlet along at least one additional channel is known in the art as a technique to increase throughput. Therefore, the configuration and ability of the wells and loading ports are taught by Trietsch, and those structural elements are then multiplied as taught by Liu.
Regarding claim 17, modified Trietsch in view of Liu teaches wherein the sub-channels accommodating a plurality of sample inlet 248 converge at a second outlet in to reach shared outlet 278 (Liu, Fig. 6; par. 0084). Modified Trietsch teaches an inlet can additionally be used as a vent or an outlet (Trietsch, par. 0148) (wherein the air outlet communicates with the second end of the second channel).
Regarding claim 23, Trietsch teaches the limitations as applied to claim 1 (see above). Trietsch teaches a microfluidic device with a plurality of networks resulting in a device with a plurality of channels. Trietsch teaches wherein each inlet is accompanied a two-part reservoir 24, 25 (well) with the inlet 3A-C (loading port) located between the reservoir and channel 35-37 (Fig. 4d) (a… well in communication with the… channel through a… loading port). However, Trietsch teaches wherein one inlet corresponds with one channel (Fig. 4c) (wherein the channel is first channel).
Trietsch is silent to the channel network further includes: a second channel having first and second opposite ends, the second channel in communication with the first loading port; a second well at a location between the first loading port and the second end of the second channel, the second well adapted for receiving a third fluid therein.
Liu teaches a microfluidic cartridge with a first inlet leading to a biochip through a channel (Abstract). Liu teaches an embodiment of the microfluidic cartridge comprising an inlet port 270 (first well) with a first opening 242 (first loading port) with a channel 216 leading to a biochip 260 and terminating in an outlet port 278 (air outlet) (Fig. 6, 7; par. 0084-0085). Between inlet port 270 and biochip 260, Liu teaches the channel branches into sub-channels each subchannel provided with a respective sample injection port 248 (Fig. 6-7; par. 0084). These sub-channels begin their branch at an inlet side and converge again at the outlet side (the channel network further includes: a second channel having first and second opposite ends) wherein the sample inlet 248 is between the inlet port 270 and outlet port 278 (Fig. 6) (a second well at a location between the first loading port and the second end of the second channel, the second well adapted for receiving a third fluid therein) (the second channel in communication with the first loading port). Liu teaches the addition of a plurality of additional wells allows for a plurality of samples to be analyzed simultaneously or a plurality of targets of interest within the same sample to be analyzed simultaneously (par. 0084) increasing device throughput.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the first well and first loading port and channel of the microfluidic device of Trietsch to have the first well and first loading port branch to at least two channels to accommodate additional wells with loading ports as taught by Liu because the branched channels allow for additional samples or additional reagents to be analyzed increasing throughput of the microfluidic device (Liu, par. 0084) with reasonable expectation of success. MPEP 2143(I)(G).
Examiner notes the loading port and well combination as taught by Trietsch are understood to apply to additional branched channels and inlets provided by Liu. Liu is provided to teach that branching channels from a first inlet to accommodate at least one additional inlet along at least one additional channel is known in the art as a technique to increase throughput. Therefore, the configuration and ability of the wells and loading ports are taught by Trietsch, and those structural elements are then multiplied as taught by Liu.
Regarding claim 24, modified Trietsch in view of Liu teaches wherein the sub-channels accommodating a plurality of sample inlet 248 converge at a second outlet in to reach shared outlet 278 (Liu, Fig. 6; par. 0084). Modified Trietsch teaches an inlet can additionally be used as a vent or an outlet (Trietsch, par. 0148) (wherein the air outlet is in communication with the communication with the second channel at a location adjacent the second end of the second channel).
Claims 8, 18, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Trietsch, et. al. (US 20180169656 A1) in view of Liu, et. al. (US 20230256438 A1) as applied to claims 6, 16, and 23 (respectively) in further view of Shartle, et. al. (US 20200030797 A1).
Regarding claim 8, modified Trietsch teaches an inlet at a second end can additionally be used as a vent or an outlet (Trietsch, par. 0148) (wherein the air outlet is a first air outlet) (the… air outlet allowing an interior of the… channel to communicate with an environment external of the cartridge). Modified Trietsch in view of Liu teaches wherein the sub-channels accommodating a plurality of sample inlets 248 branch from an inlet port 270 at a first end (Liu, Fig. 6; par. 0084). Modified Trietsch teaches once the fluid is injected into the container, capillary forces can draw the fluid through all channels of the network (par. 0164) (capillary action causes the… fluid received in the… channel to flow into the… channel through the first loading port and toward the… air outlet)
Modified Trietsch is silent to the channel network further includes a second air outlet adjacent to the second end of the second channel.
Shartle teaches a microfluid device for analysis of a biofluid with a microfluidic channel between an opening on either side of the microchannel. (Abstract). Shartle teaches an embodiment of the microfluidic device comprising a first substrate layer 510 with a first opening 530 on a first end and a plurality of second openings 540 on an opposite end, the two opening connected by a set of microfluidic channels 520 than branch from the first opening 530 and each lead to a respective section opening 540 (Fig. 5A-5B; par. 0092). Shartle teaches the set of second openings can be configured to vent gas as well (par. 0098) (the channel network further includes a second air outlet adjacent to the second end of the second channel, the second air outlet allowing an interior of the second channel to communicate with an environment external of the cartridge). Shartle further teaches the fluid can move through the channels by capillary action moving the fluid from a first opening at one end to the second openings at a second end (Fig. 5A-5B; par. 0103) (capillary action causes the first fluid received in the second channel to flow into the second channel through the first loading port and toward the second air outlet). Shartle teaches providing second openings at the end of each respective branched channels allows for each branched/sub-channel to be independently vented from one another (par. 0098).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the singular outlet of the branched and then converged sub-channels of modified Trietsch to instead have an air outlet at a second end of each branched sub-channel as taught by Shartle because providing second openings at the end of each respective branched channels allows for each branched/sub-channel to be independently vented from one another (Shartle, par. 0098) with reasonable expectation of success. MPEP 2143(I)(G).
Examiner notes the loading port and well combination and the capillary action of the channel as taught by Trietsch are understood to apply to additional branched channels and inlets provided by Liu and additional air outlets of Shartle. Liu is provided to teach that branching channels from a first inlet to accommodate at least one additional inlet along at least one additional channel is known in the art as a technique to increase throughput. Each sub-channel and further be independently vented by providing an opening/air vent at a second end as provided by Shartle. Therefore, the configuration and ability of the wells and loading ports and capillary action of the channels are taught by Trietsch, and those structural elements are then multiplied as taught by Liu and Shartle.
Regarding claim 18, modified Trietsch teaches an inlet at a second end can additionally be used as a vent or an outlet (Trietsch, par. 0148) (the… air outlet allowing an interior of the… channel to communicate with an environment external of the cartridge). Modified Trietsch in view of Liu teaches wherein the sub-channels accommodating a plurality of sample inlets 248 branch from an inlet port 270 at a first end (Liu, Fig. 6; par. 0084). Modified Trietsch teaches once the fluid is injected into the container, capillary forces can draw the fluid through all channels of the network (par. 0164).
Modified Trietsch is silent to the channel network further includes a second air outlet in communication with the second channel at a location adjacent to the second end of the second channel.
Shartle teaches a microfluid device for analysis of a biofluid with a microfluidic channel between an opening on either side of the microchannel. (Abstract). Shartle teaches an embodiment of the microfluidic device comprising a first substrate layer 510 with a first opening 530 on a first end and a plurality of second openings 540 on an opposite end, the two opening connected by a set of microfluidic channels 520 than branch from the first opening 530 and each lead to a respective section opening 540 (Fig. 5A-5B; par. 0092). Shartle teaches the set of second openings can be configured to vent gas as well (par. 0098) (the channel network further includes a second air outlet in communication with the second channel at a location adjacent to the second end of the second channel, the second air outlet allowing an interior of the second channel to communicate with an environment external of the cartridge). Shartle further teaches the fluid can move through the channels by capillary action moving the fluid from a first opening at one end to the second openings at a second end (Fig. 5A-5B; par. 0103) (capillary action causes the first fluid received in the second channel to flow into the second channel toward the second air outlet). Shartle teaches providing second openings at the end of each respective branched channels allows for each branched/sub-channel to be independently vented from one another (par. 0098).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the singular outlet of the branched and then converged sub-channels of modified Trietsch to instead have an air outlet at a second end of each branched sub-channel as taught by Shartle because providing second openings at the end of each respective branched channels allows for each branched/sub-channel to be independently vented from one another (Shartle, par. 0098) with reasonable expectation of success. MPEP 2143(I)(G).
Examiner notes the loading port and well combination and the capillary action of the channel as taught by Trietsch are understood to apply to additional branched channels and inlets provided by Liu and additional air outlets of Shartle. Liu is provided to teach that branching channels from a first inlet to accommodate at least one additional inlet along at least one additional channel is known in the art as a technique to increase throughput. Each sub-channel and further be independently vented by providing an opening/air vent at a second end as provided by Shartle. Therefore, the configuration and ability of the wells and loading ports and capillary action of the channels are taught by Trietsch, and those structural elements are then multiplied as taught by Liu and Shartle.
Regarding claim 25, modified Trietsch teaches an inlet at a second end can additionally be used as a vent or an outlet (Trietsch, par. 0148) (wherein the air outlet is a first air outlet) (the… air outlet allowing an interior of the… channel to communicate with an environment external of the cartridge). Modified Trietsch in view of Liu teaches wherein the sub-channels accommodating a plurality of sample inlets 248 branch from an inlet port 270 at a first end (Liu, Fig. 6; par. 0084). Modified Trietsch teaches once the fluid is injected into the container, capillary forces can draw the fluid through all channels of the network (par. 0164) (capillary action causes the… fluid received in the… channel to flow into the… channel through the first loading port and toward the… air outlet)
Modified Trietsch is silent to the channel network further includes a second air outlet in communication with the second channel at a location adjacent to the second end of the second channel, the second air outlet allowing an interior of the second channel to communicate with an environment external of the cartridge.
Shartle teaches a microfluid device for analysis of a biofluid with a microfluidic channel between an opening on either side of the microchannel. (Abstract). Shartle teaches an embodiment of the microfluidic device comprising a first substrate layer 510 with a first opening 530 on a first end and a plurality of second openings 540 on an opposite end, the two opening connected by a set of microfluidic channels 520 than branch from the first opening 530 and each lead to a respective section opening 540 (Fig. 5A-5B; par. 0092). Shartle teaches the set of second openings can be configured to vent gas as well (par. 0098) (the channel network further includes a second air outlet in communication with the second channel at a location adjacent to the second end of the second channel, the second air outlet allowing an interior of the second channel to communicate with an environment external of the cartridge). Shartle teaches providing second openings at the end of each respective branched channels allows for each branched/sub-channel to be independently vented from one another (par. 0098).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the singular outlet of the branched and then converged sub-channels of modified Trietsch to instead have an air outlet at a second end of each branched sub-channel as taught by Shartle because providing second openings at the end of each respective branched channels allows for each branched/sub-channel to be independently vented from one another (Shartle, par. 0098) with reasonable expectation of success. MPEP 2143(I)(G).
Examiner notes the loading port and well combination and the capillary action of the channel as taught by Trietsch are understood to apply to additional branched channels and inlets provided by Liu and additional air outlets of Shartle. Liu is provided to teach that branching channels from a first inlet to accommodate at least one additional inlet along at least one additional channel is known in the art as a technique to increase throughput. Each sub-channel and further be independently vented by providing an opening/air vent at a second end as provided by Shartle. Therefore, the configuration and ability of the wells and loading ports and capillary action of the channels are taught by Trietsch, and those structural elements are then multiplied as taught by Liu and Shartle.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Beebe, et. al. (US 20210379587 A1): Beebe teaches a microfluidic device for detection a target in a biological sample (Abstract) wherein the microfluidic device comprises a series of channel networks wherein each channel comprises a series of wells along the channel (Fig. 2).
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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