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 .
DETAILED ACTION
Status of Claims
Claims 1-13 and 15-21 are pending and have been examined.
Priority
This application, Serial No. 17/778,177 (PGPub: US2024/0183848) was filed 12/15/2022. This application is a 371 of PCT/CN2021/098865 filed 06/08/2021.
Information Disclosure Statements
The Information Disclosure Statement filed 11/07/2022 has been considered by the Examiner.
Claim Objections
Claim 17 is objected to because of the following informalities:
Claim 17 at line 8 should remove the word “are” before “at least partially overlap”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-2 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Higashino et al., (EP 1867385, published 12/19/2007, hereinafter “Higashino”).
Higashino teaches throughout the publication a first substrate for a microfluidic chip (paragraph 0025 and see Figure 4), comprising:
a first injection port configured to receive a first fluid (bottom right side pump 11);
a first reacting region, wherein a first upstream end of the first reacting region is communicated with the first injection port through a flow channel (detection section 22a, paragraph 0088);
a second injection port configured to receive a second fluid (reservoir section 17a, paragraph 0079);
a second reacting region, wherein an upstream end of the second reacting region is communicated with the second injection port through a flow channel, and a downstream end of the second reacting region is communicated with a second upstream end of the first reacting region through a flow channel (see flow path 15g and paragraph 0088);
a fluid backflow prevention region between the second reacting region and the first reacting region, wherein an upstream end of the fluid backflow prevention region is communicated with the downstream end of the second reacting region through a flow channel, and a downstream end of the fluid backflow prevention region is communicated with the second upstream end of the first reacting region through a flow channel (paragraph 0092, reverse flow prevention section 16 present at upstream end of 22a); and
an exit port communicated with a downstream end of the first reacting region through a flow channel (waste liquid reservoir section 23).
Regarding claim 2, Higashino teaches the substrate wherein the fluid backflow prevention region comprises: a switching valve on the flow channel between the downstream end of the second reacting region and the second upstream end of the first reacting region (paragraph 0092).
Regarding claim 16, Higashino teaches the substrate further comprising a waste liquid region between the first reacting region and the exit port, wherein an upstream end of the waste liquid region is communicated with the downstream end of the first reacting region through a flow channel, and the exit port is at a downstream end of the waste liquid region (Figure 4, see channel region between section 22a and 23).
Claim(s) 1-2 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ririe et al. (US 2013/0137172, Pub Date: 05/30/2013, hereinafter “Ririe”).
Regarding claim 1, Ririe teaches throughout the publication a first substrate for a microfluidic chip (paragraph 0044, plastic film 10; see Figures 1 and 3 and paragraph 0053), comprising:
a first injection port configured to receive a first fluid (channel 38);
a first reacting region, wherein a first upstream end of the first reacting region is communicated with the first injection port through a flow channel (blister 58);
a second injection port configured to receive a second fluid (input 41);
a second reacting region, wherein an upstream end of the second reacting region is communicated with the second injection port through a flow channel, and a downstream end of the second reacting region is communicated with a second upstream end of the first reacting region through a flow channel (blister 46);
a fluid backflow prevention region between the second reacting region and the first reacting region, wherein an upstream end of the fluid backflow prevention region is communicated with the downstream end of the second reacting region through a flow channel a downstream end of the fluid backflow prevention region is communicated with the second upstream end of the first reacting region through a flow channel (see valve 57 in Figure 1 and 3); and
and an exit port communicated with a downstream end of the first reacting region through a flow channel (channel 52).
Regarding claim 2, Ririe teaches the substrate wherein the fluid backflow prevention region comprises: a switching valve on the flow channel between the downstream end of the second reacting region and the second upstream end of the first reacting region (paragraphs 0046-0047 and valve 57 in Figure 3).
Regarding claim 16, Ririe teaches the substrate further comprising a waste liquid region between the first reacting region and the exit port, wherein an upstream end of the waste liquid region is communicated with the downstream end of the first reacting region through a flow channel, and the exit port is at a downstream end of the waste liquid region (Figure 3, see channel region between blister 58 and channel 52).
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.
Claim(s) 1, 3-7, 10-12 and 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Hunan et al., (CN 208399514U, 01/18/2019, IDS, translation provided by Applicant) in view of Dongguan et al., (CN 209624608, 11/12/2019, IDS, translation provided by Applicant).
Regarding claim 1, Hunan teaches throughout the publication a first substrate for a microfluidic chip (Figure 4, underlying chip 2; see paragraphs 0035-0044), comprising:
a first injection port configured to receive a first fluid (sample inlet 10);
a first reacting region, wherein a first upstream end of the first reacting region is communicated with the first injection port through a flow channel (reaction detection reservoir 14);
a second reacting region, and a downstream end of the second reacting region is communicated with a second upstream end of the first reacting region through a flow channel (reagent filling reservoir 8);
a fluid backflow prevention region between the second reacting region and the first reacting region, wherein an upstream end of the fluid backflow prevention region is communicated with the downstream end of the second reacting region through a flow channel and a downstream end of the fluid backflow prevention region is communicated with the second upstream end of the first reacting region through a flow channel; (buffer channel 9), and
an exit port communicated with a downstream end of the first reacting region through a flow channel (waste reservoir 17). However, Hunan does not specifically teach a second injection port that is in communication with an upstream end of the second reaction region.
Dongguan throughout the publication a microfluidic immune chip (paragraph 0008) and more specifically teaches a secondary input port and channel for flowing reagents (See Figure 1, upstream end of channel 2).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the substrate of Hunan, a second injection port and channel connecting to downstream components as taught by Dongguan because ports are well-known in the art to be incorporated on microfluidic chips for fluid introduction and since Dongguan teaches the input channels are beneficial so that necessary reagents can enter the chip for subsequent reactions.
Regarding claim 3, Hunan teaches the substrate wherein the fluid backflow prevention region comprises: a first flow channel extending in a serpentine shape, wherein the first flow channel comprises a plurality of first flow channel subsegments parallel to each other in a plane defined by the first substrate, wherein the plurality of first flow channel subsegments are communicated end to end in sequence through at least one first connection part (See Figure 4, serpentine channel 9).
Regarding claims 4-5, Hunan teaches the substrate further comprising: a first mixing region between the first injection port and the first reacting region, wherein an upstream end of the first mixing region is communicated with the first injection port through a flow channel, and a downstream end of the first mixing region is communicated with the first upstream end of the first reacting region through a flow channel, wherein the first mixing region comprises: a second flow channel extending in a serpentine shape, wherein the second flow channel comprises a plurality of second flow channel subsegments parallel to each other in the plane defined by the first substrate, wherein the plurality of second flow channel subsegments are communicated end to end in sequence through at least one second connection part (see Figure 4, serpentine channel 13).
Regarding claims 6-7, Hunan in view of Dongguan teach the substrate as described above incorporating a port and channel connected to the upstream end of the chamber 8 of Hunan (interpreted as the claimed second reaction region). Although the references do not specifically teach that the channel connecting the chamber and input port is a serpentine mixing channel, Hunan teaches, as seen in Figure 4, that serpentine mixing channels are beneficial for fluid flow and increasing mixing area. Therefore it would have been prima facie obvious to one having ordinary skill in the art to incorporate a serpentine connecting channel as taught by Hunan as the channel between the second port and second reaction region of Hunan in view of Donnguan for flow enhancement between components on the device.
Regarding claim 10, Hunan teaches the substrate wherein a first axis is a straight-line passing through the downstream end of the first reacting region and a midpoint of the first upstream end and the second upstream end of the first reacting region, wherein the first reacting region comprises a first section closer to the first upstream end or the second upstream end of the first reacting region and a second section closer to the downstream end of the first reacting region, wherein an orthographic projection of the first section on a surface of the first substrate is an arch (see Figure 4, chamber 14). While Hunan does not explicitly teach that a distance between at least one edge of an orthographic projection of the second section on the surface of the first substrate and the first axis gradually decreases along a fluid flow direction, such modifications would be obvious to one skilled in the art as a matter of engineering and design choice.
Regarding claim 11, Hunan teaches the first substrate wherein a second axis is a straight-line passing through the upstream end of the second reacting region and the downstream end of the second reacting region, wherein the second reacting region comprises a third section closer to the upstream end of the second reacting region and a fourth section closer to the downstream end of the second reacting region, wherein an orthographic projection of the third section on a surface of the first substrate is an arch (see Figure 4, chamber 8). While Hunan does not explicitly teach that a distance between at least one edge of an orthographic projection of the fourth section on the surface of the first substrate and the second axis gradually decreases along a fluid flow direction, such modifications would be obvious to one skilled in the art as a matter of engineering and design choice.
Regarding claim 12, Hunan in view of Dongguan teaches the first substrate comprising: a first branch comprising the first injection port, the first mixing region, and a flow channel between the first injection port, the first mixing region and the first upstream end of the first reacting region, and a second branch comprising the second injection port, the second mixing region, the fluid backflow prevention region, the second reacting region, and a flow channel between the second injection port, the second mixing region, the second reacting region, the fluid backflow prevention region and the second upstream end of the first reacting region (see Figure 4). Although the references do not specifically teach that a first axis is a straight-line passing through the downstream end of the first reacting region and a midpoint of the first upstream end and the second upstream end of the first reacting region, the first injection port and the second injection port are symmetrically distributed with respect to the first axis, and the first branch and the second branch are respectively located on two sides of the first axis, such modifications would be obvious to one skilled in the art as a matter of engineering and design choice.
Regarding claim 15, although Hunan in view of Dongguan do not specifically teach that a length of the flow channel between the first injection port and the upstream end of the first mixing region is substantially equal to a length of the flow channel between the downstream end of the first mixing region and the first upstream end of the first reacting region, it has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value for a result effective variable. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the specific limitations recited in instant claim 15 are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the microfluidics art.
Regarding claim 16, Hunan teaches the substrate further comprising a waste liquid region between the first reacting region and the exit port, wherein an upstream end of the waste liquid region is communicated with the downstream end of the first reacting region through a flow channel, and the exit port is at a downstream end of the waste liquid region (see channel between region 14 and exit 19).
Regarding claim 17, Hunan in view of Dongguan teaches a microfluidic chip, comprising: the first substrate according to claim 1 (See above), and a second substrate assembled with the first substrate (Hunan, cover on chip 1, paragraph 0040), wherein the second substrate comprises: a first sample region pre-stored with a capture antibody, and a second sample region pre-stored with a fluorescent antibody (Hunan, paragraphs 0042-0044; as the claim does not specify when the second substrate is prestored with reagents or at which point in manufacture/assay reaction, Hunan is interpreted as reading on the limitations since once assembled, the reagents are technically stored and utilized within the components on both sides of the substrate), wherein orthographic projections of the first sample region and the second sample region on the first substrate are at least partially overlap with orthographic projections of the first reacting region and the second reacting region on the first substrate, respectively (Hunan, see Figure 1).
Regarding claim 18, Hunan teaches the chip wherein the first substrate comprises a plastic-based material and the second substrate comprises a glass-based material (paragraph 0017).
Regarding claim 19-21, Hunan in view of Dongguan teaches a method for processing a sample by using the microfluidic chip according to claim 17 (See above), comprising: adding the first fluid through the first injection port, such that the first fluid reacts with the capture antibody in the first reacting region to generate a first product; adding a cleaning liquid through the first injection port, and adjusting a pressure in the flow channel or letting a waste liquid to flow out by the exit port, such that excess impurity in the first substrate is washed away; and adding the second fluid through the second injection port, such that the second fluid reacts in the second reacting region and provides the fluorescent antibody to the first reacting region, and the fluorescent antibody reacts with the first product in the first reacting region to generate a double antibody sandwich compound, wherein after the fluorescent antibody reacts with the first product in the first reacting region to generate the double antibody sandwich compound, the method further comprises: adding a buffer liquid through the first injection port, and adjusting the pressure in the flow channel or letting the waste liquid to flow out by the exit port, such that an unreacted fluorescent antibody is washed away, wherein after the unreacted fluorescent antibody is washed away, the method further comprises: performing an optical signal detection on the double antibody sandwich compound to determine an antigen content in the sample (See Hunan, paragraphs 36-44 and 0048-0049; Dongguan, paragraphs 0051-0054 and 0065).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Higashino et al., (EP 1867385, published 12/19/2007, hereinafter “Higashino”) as applied to claim 1 above.
Regarding claim 10, Higashino teaches the substrate as described above and also teaches that a first axis is a straight-line passing through the downstream end of the first reacting region and a midpoint of the first upstream end and the second upstream end of the first reacting region, wherein the first reacting region comprises a first section closer to the first upstream end or the second upstream end of the first reacting region and a second section closer to the downstream end of the first reacting region (see Figure 4, structure of section 22a). While Ririe does not explicitly teach an orthographic projection of the first section on a surface of the first substrate is an arch and that a distance between at least one edge of an orthographic projection of the second section on the surface of the first substrate and the first axis gradually decreases along a fluid flow direction, such modifications would be obvious to one skilled in the art as a matter of engineering and design choice.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ririe et al. (US 2013/0137172, Pub Date: 05/30/2013, hereinafter “Ririe”) as applied to claim 1 above.
Regarding claim 10, Ririe teaches the substrate as described above and also teaches that a first axis is a straight-line passing through the downstream end of the first reacting region and a midpoint of the first upstream end and the second upstream end of the first reacting region, wherein the first reacting region comprises a first section closer to the first upstream end or the second upstream end of the first reacting region and a second section closer to the downstream end of the first reacting region and an orthographic projection of the first section on a surface of the first substrate is an arch (see Figure 3, structure of section 58 ). While Ririe does not explicitly teach that a distance between at least one edge of an orthographic projection of the second section on the surface of the first substrate and the first axis gradually decreases along a fluid flow direction, such modifications would be obvious to one skilled in the art as a matter of engineering and design choice.
Allowable Subject Matter
Claims 8-9 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art fails to teach the limitations of claim 8 and more specifically, a first mixing region comprising a first groove, wherein the first groove comprises a first stage at the first or second upstream end of the first reaction region, wherein the first stage a surface of a non-functional region of the first substrate have the claimed structural configurations of claim 8.
Conclusion
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677