Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s amendment and remark filed on 07/28/26 have been entered. Claims 12-13 are cancelled. Claims 1-11 and 14-20 are pending and examined herein. Applicant’s amendment and remark have overcome each and every objection and 112(b) rejection set forth in Office Action mailed on 07/28/26.
Status of Objection and Rejection
The specification objection is withdrawn in view of Applicant’s amendment.
The rejection of claims 2, 9, and 20 under 112(b) is withdrawn in light of Applicant’s amendment.
The rejection of claims 12-13 is obviated by Applicant’s cancellation.
The rejection of claims 1-4, 11, 15, and 18-19 under 102(a)(1) in view of Niemz is maintained.
The rejection for claim 1-6, 11, 16, and 20 under 102(a)(1) in view of Ahn is withdrawn in light of Applicant’s amendment. Upon further consideration, new ground of rejection is made in view of Ball.
Claim Objections
Claim(s) 15-16 is/are objected to because of the following informalities: “a lower surface of the check valve” should be “[[a]]the lower surface of the check valve”. Appropriate correction is required.
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.
Claim(s) 1-4, 11, 15, and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Niemz (US 20130267016 A1) as cited in previous Office Action.
Regarding claim 1, Niemz discloses a polymerase chain reaction (cartridge assembly 100, Fig. 10) comprising;
a base substrate (top member 125A, Fig. 12; substrate 181, Fig. 14A);
at least one reaction unit (reaction pouch 114, Fig. 11) each formed as a closed structure on the base substrate by an elastic sealing film (thin film patch 136, Fig. 14A), wherein the elastic sealing film is fused to the base substrate (In that regard, the flexible reaction pouch is formed by thin film patch 136 whose peripheral edge 138 is affixed to the bottom surface 183…by thermal bonding…or adhesive, para. [0076]), wherein each of the at least one reaction unit has a corresponding inlet (121N, Figure 11);
a first flow channel connecting the corresponding inlet to the at least one reaction unit (Fluid conduit 121, Figure 11); and
a check valve formed between the sample pretreatment reaction tank and the PCR reaction tank to prevent the DNA or the PCR mixture from flowing backward (Check Valve 117 IN; Fig. 11),
wherein the check valve is positioned within a check valve depression (Empty spaces within valve 17, Fig. 1), such that a fluid introduced though an injection hole or a fluid inlet hole moves toward the check valve depression (Fig. 1), causing the check valve to float and allowing the fluid to move into the reaction unit (Fig. 2),
wherein the check valve is configured to be pressed downward when a backflow phenomenon occurs, thereby blocking a fluid inlet hole and preventing a fluid and reactants within the at least one reaction unit from flowing reversely outside (The passive one-way valves 117IN and 117OUT may be any suitable passive one-way valve provided it is position in a suitable orientation that allows fluid to flow in the desired direction. In some embodiments, however, the valve is small, simple and low-cost. One exemplary valve is a one-way passive ball-and-spring valve (e.g., CCPI2510014S, the Lee Company, Westbrook, Conn.) which can be press-fit into the fluid conduits to complete the pathways to and/or from the reaction pouches and the pump pouches. Para. [0097]),
wherein the check valve has a lower surface configured to come into contact with a surface around the fluid inlet hole (see annotated figure below) when the check valve is pressed downward (Downward force coming from the spring of ball-and-spring valve 17).
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Regarding claim 2, Niemz discloses the claimed invention as discussed above in claim 1. Niemz discloses the apparatus is a real-time polymerase chain reaction (PCR) analysis plate (Abstract).
Regarding claim 3, Niemz discloses the claimed invention as discussed above in claim 1. Niemz discloses the at least on reaction unit is a polymerase chain reaction (PCR) reaction unit (For amplification, contents of reaction pouch 114…para. [0088]).
Regarding claim 4, Niemz discloses the claimed invention as discussed above in claim 1. Niemz discloses the corresponding inlet, the first flow channel, and the at least one reaction unit form a closed line (conduit 121, entry 121N, and reaction pouch 114 are connected to each other fluidly, Fig. 11).
Regarding claim 11, Niemz discloses the claimed invention as discussed above in claim 1. Niemz discloses the apparatus comprises at least one heating block (heating block 191, Fig. 11) positioned on an upper surface of the at least one reaction unit, wherein the at least one heating block provides temperature condition suitable for inducing polymerase chain reaction (PCR) and applies pressure on the at least one reaction unit, promoting homogenous mixing of a PCR mixture by moving the injected solution (Contents of the reaction pouch 114 are heated by the heating surface 191 of the unit 165, thereby initiating amplification of the sample in the reaction pouch. Para. [0090]).
Regarding claim 15, Niemz discloses the claimed invention as discussed above in claim 1. Niemz discloses the check valve is formed of an elastic material (the inlet valve and outlet valve were fabricated from rigid PEEK™ (Zeus, Inc.) plastic tubing, para. [0104]) and opens by pressure of injecting the solution into the first flow channel (para. [0104]);
an upper surface of the check valve (interpreted to be the conical exterior housing of the ball-and-spring, para. [0097]) comes into contact with an inner side of the elastic sealing film and is in the shape of a cone; and
the lower surface of the check valve is implemented as a smooth mirror surface and comes into contact with a surface of a solution injection hole in the base substrate (the ball of the ball-and-spring valve in which the ball is a smooth mirror surface due to its spherical shape).
Regarding claim 18, Niemz discloses the claimed invention as discussed above in claim 1. Niemz discloses one or more pairs of primers or a primer/probe (The present system is adapted to apply isothermal nucleic acid amplification methods…An example of isothermal nucleic acid amplification includes the loop-mediated isothermal amplification (LAMP). LAMP uses four to six oligonucleotide primers that recognize multiple sequences in a target DNA…para.[0049]), which is a dried material (reagent 154, Fig. 11), is applied to a portion adjacent (reagent chamber 154, Fig. 11) to the corresponding inlet of the at least one reaction unit; and
when the solution is injected, as air inside the first flow channel and the at least one reaction unit is compressed (The system T also includes a fluid pump pouch 118 in direct pressure contact with the reaction pouch 114. para. [0070]), the solution is mixed with the dried material (After the reaction pouch of the cartridge assembly is heated to the selected reaction temperature, a sample is injected into the inlet 113…The sample enters the fluid conduit 148 and into reagent chamber 154 with reagent 153… para. [0089]), and the elastic sealing film is stretched and forms a convex shape (See 114 of Fig. 11).
The rest of the limitation regarding “the solution is a target nucleic acid solution, and when an operation of pressing the convex surface of the elastic sealing film with a pressing block is repeatedly performed, the injected solution moves into the at least one reaction unit, and the solution becomes homogeneous” is intended use recitation. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Moreover, Niemz discloses the solution is a target nucleic acid solution (para. [0055]), and when an operation of pressing the convex surface of the elastic sealing film with a pressing block is repeatedly performed, the injected solution moves into the at least one reaction unit, and the solution becomes homogenous (As a result of the compression, the contents of the reaction pouch 114 are expressed or otherwise displaced into the fluid conduit 122 via the one-way passive outlet check valve 117OUT and pass into the detection chamber 116. Para. [0090]).
Regarding claim 19, Niemz discloses the claimed invention as discussed above in claim 18. As discussed above, the limitation regarding the target nucleic acid solution is an intended use recitation as the solution is not recited as part of the claimed device. Furthermore, Niemz discloses the target nucleic acid solution contains polymerases (para. [0050]).
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.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niemz in view of Daub (US 2012/0276582 A1) as cited in the previous Office Action.
Regarding claim 14, Niemz discloses the claimed invention as discussed above in claim 1. Niemz discloses the apparatus comprises an outlet of the at least one reaction unit (conduit 122, Fig. 11);
a lateral flow analysis unit (detection chamber 116, Fig. 11) connected to the outlet of the at least one reaction unit, wherein the lateral flow analysis unit comprises a lateral flow analysis module (test strip 119, Fig. 11) with a fixed nucleic acid probe (para. [0052]), and wherein the lateral flow analysis unit is formed as a closed structure on the base substrate by the elastic sealing film (para. [0082]); and
a check valve between the outlet of the at least one reaction unit and an inlet of the lateral flow analysis unit (check valve 117 OUT, Fig. 11).
However, Niemz does not explicitly teach a shut-off valve provided between the reaction unit and analysis unit.
Daub et. al. (hereinafter Daub) teaches an inlet and outlet channels with an inlet and outlet valves (Paragraph 19; Figure 2, inlet valve 22 and outlet valve 23).
Niemz and Daub are both considered analogous to the claimed invention because they are in the same field of PCR biochip device. Therefore, it would have been obvious to someone ordinary skill in the art before the effective filing date of the claimed invention to have modified Niemz to utilize the shutoff valve of Daub in place of or in addition to the check valve of Niemz to derive a PCR microchip with an isolation valve between the reaction unit and a flow channel unit connected to the inlet of the reaction unit. Doing so will provide a “controllable closures at the ends” of flow channels (Daub, Paragraph 19) and allow the users greater flexibility to determine when to flush out the PCR solution “after the desired number of PCR cycles has been reached” (Daub, Paragraph 34).
Claims 1-6, 11, 16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahn et. al (KR 10-2010-0020394 A; hereinafter Ahn) in view of Ball (A simple check valve for microfluidic point of care diagnostics, 2017) as cited in the previous Office Action.
Regarding claim 1, Ahn teaches an apparatus (100, Drawing 1) comprising;
a base substrate (thin glass chip 102, Description of the Invention, Paragraph 33; Drawing 1);
at least one reaction unit (“a sample pretreatment reaction tank”, Claim 2; Drawing 1, reaction tank 120) each formed as a closed structure on the base substrate by an elastic sealing film (PDMS chip 101, Drawing 1), wherein the elastic sealing film is fused to the base substrate (And said sample pretreatment reactor, said PCR reactor and said check valve are formed by one PDMS chip and one thin film glass chip bonded to one surface of said PDMS chip, Claim 2), wherein each of the at least one reaction unit has a corresponding inlet (121 and 141, Drawing 1);
a first flow channel connecting the corresponding inlet to the at least one reaction unit (serpentine channel 122 and 142, Drawing 1); and
a check valve that prevents backflow of solution injected into the at least one reaction unit and first flow channel through the corresponding inlet (Abstract; Drawing 1, check valve 160),
wherein the check valve is positioned within a check valve depression (Chamber 165 and 166, Drawing 6), such that a fluid introduced through an injection hole or a fluid inlet hole moves toward the check valve depression (Drawing 6a), causing the check valve to float and allowing the fluid to move into the reaction unit (Drawing 6b).
Ahn does not disclose the check valve is configured to be pressed downward when a backflow phenomenon occurs, thereby blocking a fluid inlet hole and preventing a fluid and reactants within the at least one reaction unit from flowing reversely outside and wherein the check valve has a lower surface configured to come into contact with a surface around the fluid inlet hole when the check valve is pressed.
Analogous art Ball discloses a PCR microfluidic device (Fig. S3) comprising:
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an orthoplanar spring valve (Fig. 1), wherein the check valve is configured to be pressed downward when a backflow phenomenon occurs, thereby blocking a fluid inlet hole and preventing a fluid and reactants within the at least one reaction unit from flowing reversely outside (an orthoplanar spring that applies a small, adjustable amount of force to an elastomer pad seal situated atop a fluid supply hole (Fig. 1). Introduction, para. 3) and wherein the check valve has a lower surface configured to come into contact with a surface around the fluid inlet hole when the check valve is pressed (Annular boss; The bottom of the valve housing features a central inlet hole and a concentric raised annular boss. The raised boss enhances the valve’s seal by distributing the restoring force generated by the spring over a smaller surface area on the base of the elastomer. Device design and fabrication, para. 1).
Both Ahn and Ball disclose similar microfluidic devices It would have been obvious to one of ordinary skill in the art for DNA polymerase. Furthermore, Ahn discloses the embodiment is not limited to what is being shown in prior arts and is open to modification. It would have been obvious to one of ordinary skilled in the art before the effective filing date to have incorporated the Orthoplanar spring valve of Ball to the device of Ahn to derive the claimed invention as Ball’s valve are specifically designed and tested for PoC microfluidic diagnostic where robust sealing and passive fluid manipulation is required (Here we pre-stress valve springs by placing a separate, soft elastomeric disc at the center of the spring while controlling the valve housing geometry. This innovation permits manufacture of robustly sealing check valves with springs patterned from flat sheets of thermoplastics rather than from photopolymers. Our improved designs open the door for integrating this elegant class of check valves into point-of-care microfluidic diagnostics where robust sealing and passive fluid manipulation are required. Introduction, para. 3).
Regarding claim 2, Modified Ahn discloses the claimed invention as discussed above in claim 1. Ahn discloses the apparatus is a real-time PCR analysis plate (Abstract).
Regarding claim 3, Modified Ahn discloses the claimed invention as discussed above in claim 1. Ahn discloses the at least one reaction unit is a PCR reaction unit (PCR reactor 140, Drawing 1; Abstract).
Regarding claim 4, Modified Ahn discloses the claimed invention as discussed above in claim 1. Ahn discloses the corresponding inlet, the first flow channel, and the at least one reaction unit form a closed line (And said sample pretreatment reactor, said PCR reactor and said check valve are formed by one PDMS chip and one thin film glass chip bonded to one surface of said PDMS chip, Claim 2).
Regarding claim 5, Modified Ahn discloses the claimed invention as discussed above in claim 4. Ahn discloses the closed line formed by the elastic sealing film has a thickness of 0.5 mm to 2 mm (height and width of the channel 122 of the sample pretreatment reaction tank 120 according to the present invention are preferably 150 μm and 600 μm, paragraph 44).
Regarding claim 6, Modified Ahn discloses the claimed invention as discussed above in claim 4. Ahn discloses the closed line is formed by the elastic sealing film is formed to be inflated to a height of 2 mm or less above the base substrate (height and width of the channel 122 of the sample pretreatment reaction tank 120 according to the present invention are preferably 150 μm and 600 μm, paragraph 44).
Regarding claim 11, Modified Ahn discloses the claimed invention as discussed above in claim 1. Ahn discloses at least one heating block positioned on an upper surface of the at least one reaction unit (heating unit 180, Drawing 1, paragraph 20), wherein the at least one heating block provides temperature conditions suitable for inducing polymerase chain reaction and applies pressure on the at least one reaction unit, promoting homogenous mixing of a PCR mixture by moving the injected solution (a heating unit 180 that adjusts the temperatures of the sample pretreatment reaction tank 120 and the PCR reaction tank 140 for an efficient experiment, paragraph 32; also paragraph 80).
Regarding claim 16, Modified Ahn discloses the claimed invention as discussed above in claim 1. Ball, after incorporation, discloses the check valve is formed of an elastic material (We addressed this need by laser patterning a thermoplastic film into an orthoplanar spring that applies a small, adjustable amount of force to an elastomer pad seal situated atop a fluid supply hole (Fig. 1). Introduction, para. 3) and opens by pressure of injecting the solution into the first flow channel (We placed two check valves in series to create a finger-operated pump…The pump consisted of an inlet hole (at valve 1), a deformable air chamber (the two eyes, covered with clear silicone and connected via channels cut in an adhesive layer) flanked by two laser-engraved check valves (valves 1 and 2), and a distensible air chamber covered in a soft grey silicone (the throat pouch). To operate the pump, we first pressed on the two eyes simultaneously, increasing pressure in the pumping chamber. Since valve 1 seals passively against backflow, air was pushed through valve 2 into the distensible air chamber. Staged delivery of on-board reagents and finger-actuated pumping, para. 3; Fig. 4A);
an upper surface of the check valve comes into contact with an inner side of the elastic sealing film that is in a shape of a two-tier cylinder (the combination of the elastomeric disc and planar spring, Fig. 1) having projections formed on an upper surface and allows a solution to permeate in which the top diameter (the diameter of the elastomer disc) is smaller than a bottom diameter (Diameter of the planar spring); and
the lower surface of the check valve comes is implemented as a smooth mirror surface and comes into contact with a surface of a solution injection hole (annular boss around the injection hole).
Neither Ahn nor Ball explicitly discloses the diameter of the top has to be no more than half of the diameter of the bottom. Ball discloses elastomer disc diameter can be directly varied in order to alter the valve opening pressure (Valve parameters with less impact on opening pressure included inlet hole diameter, elastomer stiffness (durometer), and elastomer thickness. Using the scheme presented in Fig. 1A–B, we tested valves with inlet holes ranging between 0.25 mm and 1.5 mm in diameter and observed little effect on valve opening pressure. It is possible that varying the inner diameter of the annular boss featured in either the laser-engraved or machined valve housings (Fig 1C–F) could influence valve opening pressure. Valve performance and impact of valve design parameters on opening pressure, para. 2). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filign date to derive the claimed parametric constrain between the diameter of the elastomer disc and orthoplanar spring. The parameters would have been a direct results of varying elastomer disc diameter to set a desired valve opening pressure.
Regarding claim 20, Modified Niemz discloses the claimed invention as discussed above in claim 18. Niemz does not disclose the one or more pairs primer are labeled with at least one of fluorescent material, a chemiluminescent material, or gold nanoparticles.
Analogous art Ball discloses a PCR microfluidic device (Fig. 5). For RT-LAMP detection of West Niles virus comprising reagents for QUASR RT-LAMP detection comprising labeled primer and the probes (Quenching probes were added at 1.5× the concentration of the corresponding fluorescently labeled primer. RT-LAMP detection of West Nile virus, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of Niemz by incorporating a dry mixture containing quenching probes and fluorescently labeled primer in a dried state as taught by Ball because doing so allows for the device to be capable of conducting RT-LAMP amplification while also allowing long term storage of the PCR mixture in the device (RT-LAMP detection of West Nile virus).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahn in view of Ball as discussed above in claim 1, and further in view of Daub (US 2012/0276582 A1) as cited in IDS.
Regarding claims 7-8, Modified Ahn discloses the claimed invention as discussed above in claim 1. Ahn discloses the at least one reaction unit comprises a first reaction unit and a second reaction unit spaced apart from each other (reaction unit 120 and 140, Drawing 1);
the first reaction unit and the second reaction unit are each formed as closed structures on the base substrate by the elastic sealing film (And said sample pretreatment reactor, said PCR reactor and said check valve are formed by one PDMS chip and one thin film glass chip bonded to one surface of said PDMS chip, Claim 2);
the apparatus comprises a second flow channel (flow path 168 and/or 169, Drawing 1) connecting the first reaction unit to the second reaction unit; and
the apparatus comprises a check valve to control a flow of solution between the first reaction unit and the second reaction unit through the second flow channel (check valve 160a, Drawing 1).
Ball, after incorporation teaches the second PCR unit is formed of a plurality of second PCR sub-units having second inlets and further includes the second flow channel unit which starts at an outlet of the first PCR unit and is branched off at a branching point into a plurality of flow channels connected in parallel to the inlets of the plurality of the second PCR sub-units (Middle image in Fig. S3).
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the apparatus comprises a check valve to control a flow of solution between the first reaction unit and the second reaction unit through the second flow channel (check valve 160a, Drawing 1).
However, Ahn does not explicitly teach a shut-off valve provided between the reaction unit and a flow channel unit connected to the inlet of the reaction unit.
Daub et. al. (hereinafter Daub) teaches an inlet and outlet channels with an inlet and outlet valves (reads on instantly claimed shut-off valve provided between the reaction unit and a flow channel unit connected to the inlet of the reaction unit; Paragraph 19; Figure 2, inlet valve 22 and outlet valve 23).
Ahn, Ball, and Daub are both considered analogous to the claimed invention because they are in the same field of PCR biochip device. Therefore, it would have been obvious to someone ordinary skill in the art before the effective filing date of the claimed invention to have modified Ahn to utilize the shutoff valve of Daub in place of or in addition to the check valve of Ahn to derive a PCR microchip with an isolation valve between the reaction unit and a flow channel unit connected to the inlet of the reaction unit. Doing so will provide a “controllable closures at the ends” of flow channels (Daub, Paragraph 19) and allow the users greater flexibility to determine when to flush out the PCR solution “after the desired number of PCR cycles has been reached” (Daub, Paragraph 34).
Regarding claim 9, Modified Ahn discloses the claimed invention as discussed above in claim 8. Ahn discloses the second reaction unit comprises a mixture for a DNA polymerase reaction (Table 2), but does not disclose the unit comprises a labeled primer having the ability to complementarily bind to a 5’ position of a single strand of amplified DNA, which is a dried material, and a probe of a hybridization having nucleic acid sequences complementary to single-helix DNA synthesized by the labeled primer and are fixed in a solid state.
Analogous art Ball discloses a PCR microfluidic device (Fig. 5). For RT-LAMP detection of West Niles virus comprising reagents for QUASR RT-LAMP detection comprising labeled primer and the probes (Quenching probes were added at 1.5× the concentration of the corresponding fluorescently labeled primer. RT-LAMP detection of West Nile virus, first paragraph). Furthermore, Ball discloses the device is manufactured by first adding mixtures containing the reaction mixture to the microfluidic channel before allowing them to air dry (Mixtures containing 5 μL per reaction of a proprietary stabilization mixture from Biomatrica (San Diego, CA), dNTPs, oligonucleotides, and enzymes were added to channels and allowed to air dry. RT-LAMP detection of West Nile virus, paragraph 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device of Modified Ahn by incorporating a dry mixture containing quenching probes and fluorescently labeled primer in a dried state as taught by Ball because doing so allows for the device to be capable of conducting RT-LAMP amplification while also allowing long term storage of the PCR mixture in the device (RT-LAMP detection of West Nile virus).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ahn in view of Daub and Ball as applied to claim 7 above, and further in view of Battrell (US 8222023 B2) as cited in previous Office Action.
Regarding claim 10, Modified Ahn discloses the claimed invention as discussed above in claim 7. Neither Ahn, Ball, nor Daub explicitly teaches that the shut-off valve open in such a way that the sealing film is stretched due to pressure of a solution entering through the inlet and the solution exits through the outlet; and when an upper portion of the sealing film is pressed with a valve compression unit and the sealing film having elasticity comes into close contact with the base substrate, the inlet and outlet are closed as all the solution in an inner space of the shut-off valve is drained.
Analogous art Battrell teaches a pneumatic on-off valve (reads on instantly claimed shut-off valve and valve compression unit; Col. 31, Line 44-63; Figure 7A, 7B, and 7C). Said valve has an elastomeric diaphragm mounted above an inlet and outlet via to control the fluid flow (reads on instantly claimed stretchable sealing film; Col. 31, Line 44-63; Figure 7A, 7B, and 7C). When the diaphragm is pulled up, fluid flows over the dam from inlet to outlet (reads on instantly claimed sealing film is stretched due to pressure of a solution entering through the inlet; dam reads as a component of the claimed valve; Col. 31, Line 44-63; Figure 7B). “When the diaphragm is pressurized, fluid flow is cut off” (reads on instantly claimed valve is closed due to a compression unit; Col 31, Line 44-63; Figure 7C).
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Modified 7B and 7C of Battrell
Ahn, Daub, Ball, and Battrell are considered analogous to the claimed invention because they are in the same field of PCR device. Therefore, it would have been obvious to someone ordinary skill in the art before the effective filing date of the claimed invention to have modified Ahn to utilize the valve of Daub and valve of Battrell to derive a device with an on-off valve that can open and close based on chamber pressure difference. Doing so allows the operator flexibility and greater control over the precise amount of solution entering each assay/sample well and to mitigate damage by stopping flow if contaminants were accidentally introduced (Col. 31 Line 50-56 and Col. 32 Line 10-20).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Ahn in view of Ball as discussed above in claim 1, and further in view of Travi (WO 2018071296 A1) and Daub.
Regarding claim 14, Ahn teaches the invention discussed in claim 1. Ahn teaches the apparatus comprising an outlet of the at least one reaction unit (121 or 141, Drawings 1-2). However, Ahn teaches neither a lateral flow analysis unit or a shut-off valve configured to control a flow in the second flow channel connecting the outlet of the reaction unit and the inlet of the lateral flow analysis unit.
Analogous art Travi teaches a lateral flow assay strip/unit (lateral flow strip 995, Fig. 9B) formed as a closed structure on the base substrate (the unlabeled base substrate in Fig. 9B), wherein the strip is connected to the outlet of reaction unit (amplification chamber 994 and mixing chamber 993 for mixing the amplification product with dilution buffer; Fig. 9B; para. [0059]), wherein the lateral flow analysis unit comprises a lateral flow analysis module with a fixed nucleic acid probe (para. [0095]). While Travi discloses using check valve/one-way valve between chambers/reservoirs. Travi does not explicitly disclose using a shut-off valve between the reaction unit and an inlet of the lateral flow analysis unit.
Daub et. al. (hereinafter Daub) teaches an inlet and outlet channels with an inlet and outlet valves (reads on instantly claimed shut-off valve provided between the reaction unit and a flow channel unit connected to the inlet of the reaction unit; Paragraph 19; Figure 2, inlet valve 22 and outlet valve 23).
Ahn, Ball, Travi, and Daub are both considered analogous to the claimed invention because they are in the same field of PCR biochip device. Therefore, it would have been obvious to someone ordinary skill in the art before the effective filing date of the claimed invention to have attempted to incorporate a lateral flow strip/unit directly connected to the PCR reactor of the device of Ahn to derive the claimed invention. It is Examiner’s position that “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice” as Travi discloses the lateral flow unit may be either integrally formed or detachably formed/connected to the PCR reactor unit (…connected by fluid channels (507) to the lateral flow device output 509 that can be either attached to, or on the device itself. Para. [0049]). Furthermore, regarding the limitation of having a shut-off valve between the outlet of the at least one reaction unit and an inlet of the lateral flow analysis unit, it would have been obvious to someone ordinary skill in the art before the effective filing date of the claimed invention to have incorporate a shut-off valve between the lateral flow unit and reactor unit in the device of Modified Ahn (after incorporation with Travi) to derive a PCR microchip with an isolation valve between the reaction unit and a lateral flow unit connected to the outlet of the reaction unit. Doing so will provide a “controllable closures at the ends” of flow channels (Daub, Paragraph 19) and allow the users greater flexibility to determine when to flush out the PCR solution “after the desired number of PCR cycles has been reached” (Daub, Paragraph 34).
Response to Arguments
Applicant's arguments filed 07/28/26 have been fully considered but they are not persuasive.
Applicant’s arguments, see pages 9-11, filed 07/28/26, with respect to the rejection(s) of claim(s) 1-6, 11-13, 16, and 17 under Ahn have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Ball. Examiner believes the orthoplanar spring check valve overlaps with Applicant’s claimed check valve.
Regarding Applicant’s arguments with respect to the 102 rejection of Niemz, Applicant argues that Niemz does not teach the newly recited limitation regarding the check valve (Page 12-14). Examiner respectfully disagrees.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a sealing interface between the lower surface of the check valve and the surface around the fluid inlet hole) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim language simply recites “check valve has a lower surface configured to come into contact with a surface around the fluid inlet hole”. Under broadest reasonable interpretation, the limitation simply requires a lower surface to come into contact (without necessarily forming a seal interface) with the inlet, which is a function the ball-and-spring valve achieved when the spring of the valve presses the ball against the hole, effectively closing the fluidic circuit.
In addition, Applicant argues that the check valve is configured to be pressed downward when backflow occurs, which is not taught by the ball-and-spring valve. Examiner also disagrees. When backflow occurs, the pressure that pushing the ball away from the inlet is decreasing. As a result, this creates a force imbalance that allows the spring to outpush against the flow coming from the injection hole. Hence the spring would have effectively “pressed” the ball downward and closes the hole. Therefore, the function cited in the amended limitation is also being performed by the ball-and-spring valve of Niemz.
Therefore, for the reasons above, the rejection of claims in view of Niemz is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 5712707698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.H./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758
