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 .
Status of Claims
Claims 1-18 are pending in the application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The instant specification does not appear to provide proper antecedent basis for there being both a counter/reference electrode (5) shared by all the electrochemical cells (claim 1) and a shared counter electrode (6) and shared reference electrode (7) (claim 4). On page 3 lines 10-14 it describes a first preferred embodiment where there is a shared counter/reference electrode, and on page 3 lines 15-19 it describes a second preferred embodiment where the biosensor comprises two shared electrodes, a counter and reference electrode.
Additionally, page 6 lines 3-23 describes Figure 1 which shows a shared counter/reference electrode 5, and page 6 lines 27-34 to page7 lines 1-10 describes Figure 2 that has the reference electrode 6 and counter electrode 7.
Page 7 lines 14-16 recites “As it can be observed in Figures 1 and 2, the fact that all electrochemical cells share counter/reference electrode (two-electrode cells) or a common counter and reference electrodes (three-electrode cells),” which appears to indicate that the these are two separate embodiments.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, a biosensor system that one counter/reference electrode (5) and further comprising a shared counter electrode (6) and shared reference electrode (7) (the counter/reference electrode described in claim 1 and the shared counter electrode and shared reference electrode described in claim 4) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Objections
Claims 2-18 are objected to because of the following informalities:
Claims 2-18 currently recite “System according to” where this should be amended to recite “The system according to” such that it is clear it is referring back to the system.
Claim 6 recites “or shared counter electrode and a shared reference electrode (6, 7)” on line 4 where it is suggested to amend this claim to recite “or a shared counter electrode and a shared reference electrode (6, 7)”
Further, it is suggested to amend line 5 to recite “wherein a part of each of the connection tracks (4)”
Claim 9 recites “the microfluid channels (9) on lines 3-4, where it is suggested that it should be changed to “the microfluidic
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 1-18 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 1 recites “the electrochemical detection” 11 where there is insufficient antecedent basis for this limitation. No electrochemical detection has been recited prior, and it is therefore unclear what line 11 is referring to.
Claims 2-18 are rejected by virtue of being dependent on a rejected claim.
Claim 2 recites “an electrochemical cell” on lines 5-6, where it is unclear if the electrochemical cell is the same or different from the electrochemical cells recited prior.
For examination, it will be interpreted that they are the same.
Claims 9, 11-15, and 17 are rejected by virtue of being dependent on a rejected claim.
Claim 4 recites “further comprising a shared counter electrode (6) and a shared reference electrode (7)” on lines 1-2, where it is unclear if the shared counter electrode and shared reference electrode of claim 4 are the same or different from the one counter/reference electrode (5) shared by all the electrochemical cells as described on line 6. Is the one counter/reference electrode (5) being broken up into separate electrodes?
Claim 5 is rejected by virtue of being dependent on a rejected claim.
Claim 5 recites “and a shared reference electrode” on line 5, where it is unclear if this shared reference electrode is the same or different from the shared reference electrode recited on line 2 of claim 5.
For examination, it will be interpreted that they are the same shared reference electrode.
Claim 7 recites “wherein the counter (6), reference (7), or shared counter/reference (5)” on lines 2-3, where it is unclear what counter (6) and what reference (7) electrodes are being referred to, as there is only a shared counter/reference electrode 5 in claim 1.
It is noted that claim 7 was originally dependent on claim 1 or 4, where it is now only dependent on claim 1. Claim 4 describes a shared counter electrode (6) and shared reference electrode (7).
Claim 8 recites “the chip substrate (30)” on lines 1-2 where there is insufficient antecedent basis for this limitation, as no chip substrate has been recited prior.
Claim 9 recites “the shared counter and reference electrodes (6,7)” on lines 4-5 where there is insufficient antecedent basis for this limitation, as no shared counter and reference electrodes have been recited prior.
For examination, it will be interpreted that claim 9 is referring to the shared counter/reference electrode, as that is what is currently present.
Further, please see instant Figure 4B and page 8 of the instant specification, which shows and describes the fluidic channels and their relation to the counter/reference electrode 5.
Claim 12 recites “the top part (20) of the cartridge” on line 1, where there is insufficient antecedent basis for this limitation, as no top part of the cartridge has been recited prior.
Line 5 further recites “the spring-loaded contacts (16)” where there is insufficient antecedent basis for this limitation, as no spring-loaded contacts have been recited prior.
Claim 13 recites “with antibodies or DNA strands to carry out affinity assays.” on lines 2-3, where it is unclear if the antibodies or DNA strands are the same or different from the biocomponents described on line 2 of claim 2.
As the fluidic component of claim 2 is described to have microfluidic channels (9) including biocomponents, and claim 13 describes where the microfluidic channels (9) are provided with antibodies or DNA strands, it will be interpreted that the antibodies or DNA strands are the biocomponents.
Claim 14 recites “wherein functionalized magnetic particles are applied to the microfluidic component (8)” on lines 1-2, where it is unclear if the functionalized magnetic particles are the same or different from the biocomponents described on line 2 of claim 2.
As the fluidic 99
Line 3 recites “the biological reaction”, where there is insufficient antecedent basis for this limitation, as no biological reaction has been recited prior.
Claim 15 is rejected by virtue of being dependent on a rejected claim.
Claim 15 recites “trapping magnetic nanoparticles in the microfluidic channels (9).” on line 2, where it is unclear if these magnetic nanoparticles are the same or different from the functionalized magnetic particles that are applied to the microfluidic component described in claim 14.
Claim 18 recites “the multiplexed biosensor” on line 3, where it is unclear what multiplexed biosensor is being referred to. While claim 1 does describe a biosensor system for multiplexed detection of biomarkers, this is a biosensor system and it is not seen where a multiplexed biosensor is described specifically.
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.
Claim(s) 1-3, 6-7, 9-10, 13, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fukuda (US-2011/0042237-A1), herein Fukuda 2011, in view of Li (US-2005/0252777-A1), Fukuda (US-2018/0057851-A1), herein Fukuda 2018, and Ramon Azcon (US-2012/0309108-A1).
Regarding claim 1, Fukuda 2011 teaches a biosensor system for multiplexed detection of biomarkers, the system comprising:
an array of at least two electrochemical cells (measuring portions: confluent portion 15, first independent portion 16a and second independent portion 16b), adapted to be individually addressable ([0046], [0054], [0061], Figure 1),
a working electrode (working electrodes 20a, 20b, 20c) in each electrochemical cell (15, 16a, 16b) ([0046], Figure 1),
a fluidic component (insulating film 3ii) ([0062], Figure 1), and
While Fukuda 2011 does teach where the reference electrode belt 40 extends over the three measuring portions and that a belt-shaped counter electrode belt 30 (Fukuda 2011; [0061], Figure 1), this is not one counter/reference electrode.
In the analogous art of electrochemical sensors, Li teaches where electrochemical sensors require two electrodes (working and counter/reference electrodes) or three electrodes (working, counter, and reference electrodes) for detection measurements (Li; [0008]).
Examiner finds that the prior art contained a device/method/product (i.e., electrochemical sensor device) which differed from the claimed device by the substitution of component(s) (i.e., a three electrode construction) with other component(s) (i.e., a two electrode construction), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., the working, reference, and counter electrode configuration for a working and reference/counter electrode configuration), and the results of the substitution (i.e., detecting measurements) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the three electrode configuration of reference Fukuda 2011 with the two electrode configuration of reference Li, since the result would have been predictable.
The reference electrode belt and counter electrode belt of Fukuda 2011 will now be a single reference/counter electrode belt.
Fukuda 2011 teaches where the insulating film 3ii is formed of an insulating material, and provides polyimide or the like (Fukuda 2011; [0062]), however polyimide is understood to not be a porous material.
In the analogous art of biosensors, Fukuda 2018 teaches an insulation substrate (Fukuda; [0041]).
Specifically, Fukuda 2018 teaches where the insulation substrate can be formed of materials that include resin, glass, ceramics, paper, and rubber, where listed plastics include polyimide resin (Fukuda 2018; [0042]).
Examiner finds that the prior art contained a device/method/product (i.e., electrochemical sensor device) which differed from the claimed device by the substitution of component(s) (i.e., an insulating film formed of polyimide) with other component(s) (i.e., the material of the insulating film to be paper), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., material of the insulating film to be paper instead of polyimide), and the results of the substitution (i.e., insulation) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the polyimide insulating film of reference Fukuda 2011 with the paper material of Fukuda 2018, since the result would have been predictable.
Fukuda 2011 does not teach a cartridge configured to align and put in contact the array and the fluidic component for the electrochemical detection of biological samples.
In the analogous art of multi-electrode chips, Ramon Azcon teaches support plates (Ramon Azcon; abstract, [0021]).
Specifically, Ramon Azcon teaches where a tetra-electrode chip 10 has four microelectrodes 11a-d, which is then inserted into the groove 21 of a single-duct cell 20, where it is then secured between support plates 23, 24 by screws 25 and nuts 26 (Ramon Azcon; [0044], [0046], [0047], Figure 1).
It would have been obvious to one skilled in the art to modify the device of modified Fukuda 2011 such that all components are fixed between two support plates as taught by Ramon Azcon, because Ramon Azcon teaches that by fixing components between two support plates it prevents fluid leakage from the chambers and uncontrolled mixing (Ramon Azcon; [0021]).
Regarding claim 2, modified Fukuda 2011 teaches system according to claim 1. The insulating film 3ii of Fukuda 2011 has been modified by Fukuda 2018 to instead be made of paper, where it is seen in Figure 1 of Fukuda 2011 that there are cutouts in film 3ii that are channels isolated from each other. Further the film 3ii is couplable with the measurement locations 15, 16a, 16b where each microfluidic channel is placed over one of the measurement locations 15, 16a, 16b.
It is further described by [0085] and [0086] of Fukuda 2011 that a sensor substrate for generating a current measured by each of the working electrodes is immobilized on the protrusion portions 51 and base 50 of the working electrodes 20, where in one example an antibody is used as the sensor substrate. It is understood that when the insulating film 3ii is placed on the electrode substrate 3 seen in Fukuda 2011, the antibodies on the electrodes will be in the cutouts (microfluidic channels) of insulating film 3ii.
Regarding claim 3, modified Fukuda 2011 teaches system according to claim 1. Fukuda 2011 further teaches wherein the working electrodes (20a-c) are aligned in a longitudinal straight direction (Fukuda 2011; see Figure 1).
The reference electrode belt 40 and counter electrode belt 30 are now a single reference/counter electrode belt as taught by Li, where this electrode is a straight track in the same location as the electrode belts seen in Figure 1 of Fukuda 2011. The working electrodes 20a-c seen in Figure 1 of Fukuda 2011 will be adjacent to one side of the reference/counter electrode belt.
Regarding claim 6, modified Fukuda 2011 teaches system according to claim 1. Fukuda 2011 further teaches further comprising a set of connection pads (working electrode pads 21a-c), and a set of connection tracks (lead wires 22a-c) connecting the working electrodes (20a-c) with the connection pads (21a-c) (Fukuda 2011; [0060], Figures 1, 3).
The limitation “wherein a part of each connection tracks (4) is parallel to the shared counter and shared reference electrodes.” is not required because the claim only requires a set of connection tracks that connects the working electrodes, the shared counter/reference electrode, or a shared counter electrode and shared reference electrode with the connection pads. And since the connection tracks connect to the working electrodes to the pads, the limitation “wherein a part of each connection tracks (4) is parallel to the shared counter and shared reference electrodes.” is not required.
Regarding claim 7, modified Fukuda 2011 teaches system according to claim 1. Fukuda 2011 further teaches further comprising a chip substrate (electrode substrate 3) (Fukuda 2011; [0060], Figure 1).
Fukuda 2011 has been modified by Li such that there will now be a single reference/counter electrode belt, where this electrode belt and the working electrodes 20a-c are placed on the upper surface 3i of electrode substrate 3 (Fukuda 2011; [0060]).
Fukuda 2011 has further been modified such that all components of the device 1 (including the electrode substrate 3) are now sandwiched between the two support plates of Ramon Azcon.
Regarding claim 9, modified Fukuda 2011 teaches system according to claim 2. The insulating film 3ii of Fukuda 2011 has been modified to now be made of paper as taught by Fukuda 2018, where it is seen in Figure 1 of Fukuda 2011 that the cutouts in film 3ii are the microfluidic channels that are in the form of straight strips that will be transversally arranged with respect to the belt counter/reference electrode.
Regarding claim 10, modified Fukuda 2011 teaches system according to claim 1. Ramon Azcon further teaches wherein the cartridge (support plates 23, 24) has top and bottom parts and clamping structures (screws 25 and nuts 26) adapted to attach and press the top and bottom parts of the cartridge (support plates 23, 24) to keep the array and the fluidic component in close and stable contact (Ramon Azcon; [0021], [0047], [0049], Figure 2b).
Regarding claim 13, modified Fukuda 2011 teaches system according to claim 2. Fukuda 2011 further teaches protrusion portions 51 and base 50 of the working electrode 20 can have a sensor substance such as an antibody (Fukuda 2011; [0085], [0086]). The insulating film 3ii (now paper as taught by Fukuda 2018) when placed on the electrode substrate 3, the antibodies on the electrodes will be in the cutouts (microfluidic channels) of insulating film 3ii.
The limitation “to carry out affinity assays” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Fukuda 2011 and the apparatus of modified Fukuda 2011 is capable of carrying out affinity assays. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Fukuda 2011 (see MPEP §2114).
As the device is being utilized as a high-sensitivity biosensor device when a biochemical interaction arises between analyte and sensor substance, the device is capable of carrying out affinity assays (Fukuda 2011; [0089]).
Regarding claim 16, modified Fukuda 2011 teaches system according to claim. Fukuda 2018 teaches paper (to replace the material of the insulating film 3ii), which is made of cellulose.
Claim(s) 1-3, 6-7, 9-10, 13, 16 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Fukuda (US-2011/0042237-A1), herein Fukuda 2011, in view of Li (US-2005/0252777-A1), Fukuda (US-2018/0057851-A1), herein Fukuda 2018, and Hongo (EP-154200-A1).
Regarding claim 1, Fukuda 2011 teaches a biosensor system for multiplexed detection of biomarkers, the system comprising:
an array of at least two electrochemical cells (measuring portions: confluent portion 15, first independent portion 16a and second independent portion 16b), adapted to be individually addressable ([0046], [0054], [0061], Figure 1),
a working electrode (working electrodes 20a, 20b, 20c) in each electrochemical cell (15, 16a, 16b) ([0046], Figure 1),
a fluidic component (insulating film 3ii) ([0062], Figure 1), and
While Fukuda 2011 does teach where the reference electrode belt 40 extends over the three measuring portions and that a belt-shaped counter electrode belt 30 (Fukuda 2011; [0061], Figure 1), this is not one counter/reference electrode.
In the analogous art of electrochemical sensors, Li teaches where electrochemical sensors require two electrodes (working and counter/reference electrodes) or three electrodes (working, counter, and reference electrodes) for detection measurements (Li; [0008]).
Examiner finds that the prior art contained a device/method/product (i.e., electrochemical sensor device) which differed from the claimed device by the substitution of component(s) (i.e., a three electrode construction) with other component(s) (i.e., a two electrode construction), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., the working, reference, and counter electrode configuration for a working and reference/counter electrode configuration), and the results of the substitution (i.e., detecting measurements) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the three electrode configuration of reference Fukuda 2011 with the two electrode configuration of reference Li, since the result would have been predictable.
The reference electrode belt and counter electrode belt of Fukuda 2011 will now be a single reference/counter electrode belt.
Fukuda 2011 teaches where the insulating film 3ii is formed of an insulating material, and provides polyimide or the like (Fukuda 2011; [0062]), however polyimide is understood to not be a porous material.
In the analogous art of biosensors, Fukuda 2018 teaches an insulation substrate (Fukuda; [0041]).
Specifically, Fukuda 2018 teaches where the insulation substrate can be formed of materials that include resin, glass, ceramics, paper, and rubber, where listed plastics include polyimide resin (Fukuda 2018; [0042]).
Examiner finds that the prior art contained a device/method/product (i.e., electrochemical sensor device) which differed from the claimed device by the substitution of component(s) (i.e., an insulating film formed of polyimide) with other component(s) (i.e., the material of the insulating film to be paper), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., material of the insulating film to be paper instead of polyimide), and the results of the substitution (i.e., insulation) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the polyimide insulating film of reference Fukuda 2011 with the paper material of Fukuda 2018, since the result would have been predictable.
Fukuda 2011 does not teach a cartridge configured to align and put in contact the array and the fluidic component for the electrochemical detection of biological samples.
In the analogous art of apparatuses that has highly uniform electrochemical reaction characteristic, Hongo teaches a cassette (Hongo; [0005], [0238]).
Specifically, Hongo teaches a cassette 703 that comprises a cassette top cover 711 and cassette bottom cover 712 that have inner surfaces that oppose each other and are fixed when packing 713 and substrate 714 are between them (Hongo; [0238], Figure 36). Figure 41 shows a plan view of substrate 714 that has 3-electrode systems 761 and pads 762 and 763 (Hongo; [0260]). [0261] describes where packing 713 and substrate 714 are positioned to the cassette top cover 711 and cassette bottom cover 712 and are fixed between them, a channel is formed by groove 758 and surface of substrate 714 and the 3-electrode systems 761 are exposed to the surface of the channel, and that in this state sealing between packing 713 and substrate 714 is held. Additionally, there are screws 770a to 770d that are inserted into threaded holes 747a-747d and 727a-727d to threadably attach the top cover 711 and bottom cover 712 (Hongo; [0265], Figure 42). Figure 45 shows a cross sectional view of the channel of cassette 703 where there is nozzle 707 and nozzle 708 inserted into insertion holes 722 and 723 and pressed against the introduction port 752 and delivery port 753 of packing 713, further see Figure 45 where there is an arrow coming into introduction port 752 and an arrow exiting from delivery port 753.
It would have been obvious to one skilled in the art to modify the device of modified Fukuda 2011 such that the components are fixed between top and bottom covers as taught by Hongo because Hongo teaches that the top and bottom create a state of sealing between a component that has a groove and a flat substrate (Hongo; [0261]).
Regarding claim 2, modified Fukuda 2011 teaches system according to claim 1. The insulating film 3ii of Fukuda 2011 has been modified by Fukuda 2018 to instead be made of paper, where it is seen in Figure 1 of Fukuda 2011 that there are cutouts in film 3ii that are channels isolated from each other. Further the film 3ii is couplable with the measurement locations 15, 16a, 16b where each microfluidic channel is placed over one of the measurement locations 15, 16a, 16b.
It is further described by [0085] and [0086] of Fukuda 2011 that a sensor substrate for generating a current measured by each of the working electrodes is immobilized on the protrusion portions 51 and base 50 of the working electrodes 20, where in one example an antibody is used as the sensor substrate. It is understood that when the insulating film 3ii is placed on the electrode substrate 3 seen in Fukuda 2011, the antibodies on the electrodes will be in the cutouts (microfluidic channels) of insulating film 3ii.
Regarding claim 3, modified Fukuda 2011 teaches system according to claim 1. Fukuda 2011 further teaches wherein the working electrodes (20a-c) are aligned in a longitudinal straight direction (Fukuda 2011; see Figure 1).
The reference electrode belt 40 and counter electrode belt 30 are now a single reference/counter electrode belt as taught by Li, where this electrode is a straight track in the same location as the electrode belts seen in Figure 1 of Fukuda 2011. The working electrodes 20a-c seen in Figure 1 of Fukuda 2011 will be adjacent to one side of the reference/counter electrode belt.
Regarding claim 6, modified Fukuda 2011 teaches system according to claim 1. Fukuda 2011 further teaches further comprising a set of connection pads (working electrode pads 21a-c), and a set of connection tracks (lead wires 22a-c) connecting the working electrodes (20a-c) with the connection pads (21a-c) (Fukuda 2011; [0060], Figures 1, 3).
The limitation “wherein a part of each connection tracks (4) is parallel to the shared counter and shared reference electrodes.” is not required because the claim only requires a set of connection tracks that connects the working electrodes, the shared counter/reference electrode, or a shared counter electrode and shared reference electrode with the connection pads. And since the connection tracks connect to the working electrodes to the pads, the limitation “wherein a part of each connection tracks (4) is parallel to the shared counter and shared reference electrodes.” is not required.
Regarding claim 7, modified Fukuda 2011 teaches system according to claim 1. Fukuda 2011 further teaches further comprising a chip substrate (electrode substrate 3) (Fukuda 2011; [0060], Figure 1).
Fukuda 2011 has been modified by Li such that there will now be a single reference/counter electrode belt, where this electrode belt and the working electrodes 20a-c are placed on the upper surface 3i of electrode substrate 3 (Fukuda 2011; [0060]).
Fukuda 2011 has further been modified such that all components of the device 1 (including the electrode substrate 3) are now sandwiched between the top and bottom covers of Hongo.
Regarding claim 9, modified Fukuda 2011 teaches system according to claim 2. The insulating film 3ii of Fukuda 2011 has been modified to now be made of paper as taught by Fukuda 2018, where it is seen in Figure 1 of Fukuda 2011 that the cutouts in film 3ii are the microfluidic channels that are in the form of straight strips that will be transversally arranged with respect to the belt counter/reference electrode.
Regarding claim 10, modified Fukuda 2011 teaches system according to claim 1. Hongo further teaches wherein the cartridge (711 and 712) has top and bottom parts and clamping structures (screws 770a-770d) adapted to attach and press the top and bottom parts of the cartridge (711 and 712) to keep the array and the fluidic component in close and stable contact (Hongo; [0238], [0265], Figure 42).
Regarding claim 13, modified Fukuda 2011 teaches system according to claim 2. Fukuda 2011 further teaches protrusion portions 51 and base 50 of the working electrode 20 can have a sensor substance such as an antibody (Fukuda 2011; [0085], [0086]). The insulating film 3ii (now paper as taught by Fukuda 2018) when placed on the electrode substrate 3, the antibodies on the electrodes will be in the cutouts (microfluidic channels) of insulating film 3ii.
The limitation “to carry out affinity assays” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Fukuda 2011 and the apparatus of modified Fukuda 2011 is capable of carrying out affinity assays. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Fukuda 2011 (see MPEP §2114).
As the device is being utilized as a high-sensitivity biosensor device when a biochemical interaction arises between analyte and sensor substance, the device is capable of carrying out affinity assays (Fukuda 2011; [0089]).
Regarding claim 16, modified Fukuda 2011 teaches system according to claim. Fukuda 2018 teaches paper (to replace the material of the insulating film 3ii), which is made of cellulose.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fukuda (US-2011/0042237-A1), herein Fukuda 2011, Li (US-2005/0252777-A1), Fukuda (US-2018/0057851-A1), herein Fukuda 2018, and Ramon Azcon (US-2012/0309108-A1), and in further view of Yang (US-2005/0196776-A1).
Regarding claim 8, modified Fukuda 2011 teaches system according to claim 6.
Fukuda 2011 further teaches wherein the chip substrate (electrode substrate 3) is rectangular and the connection pads (21a-c) are grouped in a reticular matrix arrangement (Fukuda 2011; [0060], [0169] see substrate was cut into a rectangle, Figure 1).
While it appears that the working electrode pads 21a-c are on a long side of the rectangular electrode substrate 3 seen in Figure 1 of Fukuda 2011, one skilled in the art would find it obvious to rearrange the location of the components such that the electrode pads 21a-c are on the short side as rearranging the components would not modify the operation of the device (see MPEP 2144.04 VI.C.).
Fukuda 2011 further teaches where the device 1 has the working electrode pads 21, counter electrode pad 32, reference electrode pad 42 (which will be a single counter/reference electrode pad as the counter electrode belt and reference electrode belt have been modified by Li to be a single counter/reference electrode belt) are connected to a voltage-applying device such as a potentiostat (Fukuda 2011; [0126]).
Fukuda 2011 does not teach wherein the system further comprises spring-loaded contacts (16) connected with the connection pads (3).
In the same problem solving area of electrodes being electrically coupled to an interface to a sample analysis system, Yang teaches spring loaded probes (Yang; abstract, [0063]).
Specifically, Yang teaches a sample array 10 having electrode sets, where the electrode sets are coupled to contact pads 402 (Yang; [0060]). When analyzing the samples in the sample array 10, the sample array 10 is disposed on analysis instrumentation that couples the contact pads 402 to corresponding connections 410 on the analysis instrumentation, where the corresponding connections can be spring contacts or spring loaded probes that connect with the contact pads 402 (Yang; [0063]).
It would have been obvious to one skilled in the art to modify the potentiostat of Fukuda 2011 such that it has the spring loaded probes as taught by Yang because Yang teaches that the spring probes are advantageous due to the long life cycle associated with such a connection (Yang; [0066]).
The spring loaded probes in the potentiostat connected with the working electrode pads will be part of the biosensor system.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fukuda (US-2011/0042237-A1), herein Fukuda 2011, Li (US-2005/0252777-A1), Fukuda (US-2018/0057851-A1), herein Fukuda 2018, and Ramon Azcon (US-2012/0309108-A1), and in further view of Zhang (US-2004/0096991-A1).
Regarding claim 11, modified Fukuda 2011 teaches system according to claim 2. Fukuda 2011 does not teach further comprising an absorbent pad (11) in contact and partially overlapping the microfluidic channels (9) of the fluidic component (8).
In the analogous art of electrosensors for electrochemical detection, Zhang teaches an absorbent material used as a waste reservoir that is placed at the end of the sensor assembly (Zhang; abstract, [0020]).
Specifically, Zhang teaches a device that includes a base strip having a working electrode, reference electrode, and auxiliary electrode on a plastic substrate, a cover casing, an application zone, a detection zone, a wicking member that carries liquid from application zone to detection zone by capillary action, and an absorbent sink placed in partial contact with the wicking member at the end of the flow path to absorb any excess fluid from the detection zone (Zhang; [0116], Figures 1, 2). [0147] of Zhang further describes that the absorbent material is a pad that absorbs and retains any excess fluid at the leading end of the lateral flow path, and serves as a waste fluid reservoir.
It would have been obvious to one skilled in the art to modify the device of modified Fukuda 2011 to have an absorbent pad as taught by Zhang because Zhang teaches that the absorbent pad absorbs and retains any excess fluid in a device for electrochemical measurement (Zhang; [0116], [0147]).
Claim(s) 11 is/are alternatively rejected and claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fukuda (US-2011/0042237-A1), herein Fukuda 2011, Li (US-2005/0252777-A1), Fukuda (US-2018/0057851-A1), herein Fukuda 2018, and Hongo (EP-154200-A1), and in further view of Zhang (US-2004/0096991-A1).
Regarding claim 11, modified Fukuda 2011 teaches system according to claim 2. Fukuda 2011 does not teach further comprising an absorbent pad (11) in contact and partially overlapping the microfluidic channels (9) of the fluidic component (8).
In the analogous art of electrosensors for electrochemical detection, Zhang teaches an absorbent material used as a waste reservoir that is placed at the end of the sensor assembly (Zhang; abstract, [0020]).
Specifically, Zhang teaches a device that includes a base strip having a working electrode, reference electrode, and auxiliary electrode on a plastic substrate, a cover casing, an application zone, a detection zone, a wicking member that carries liquid from application zone to detection zone by capillary action, and an absorbent sink placed in partial contact with the wicking member at the end of the flow path to absorb any excess fluid from the detection zone (Zhang; [0116], Figures 1, 2). [0147] of Zhang further describes that the absorbent material is a pad that absorbs and retains any excess fluid at the leading end of the lateral flow path, and serves as a waste fluid reservoir.
It would have been obvious to one skilled in the art to modify the device of modified Fukuda 2011 to have an absorbent pad as taught by Zhang because Zhang teaches that the absorbent pad absorbs and retains any excess fluid in a device for electrochemical measurement (Zhang; [0116], [0147]).
Regarding claim 12, modified Fukuda 2011 teaches system according to claim 11. The device of Fukuda 2011 is sandwiched between the top and bottom covers of Hongo. As there are two inflow tubes of Fukuda 2011 seen in Figure 1, there will be two nozzle insertion holes 722 in the top cassette cover 711. The nozzle insertion holes (sample access window) is placed over the first and second inflow portions (first window) of the channel substrate of Fukuda 2011. Further the top cassette cover 711 of Hongo has electric connector ports 724 and 725, which are connector windows. Nozzle insertion hole 723 seen in Figure 42 of Hongo will be over where the absorbent pad is located.
The limitations “serves as a sink area evaporation window”, “for receiving the spring-loaded contacts (16).” are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Fukuda 2011 and the top cassette cover of Hongo is capable of serving as a sink area evaporation window and capable of receiving spring-loaded contacts. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Fukuda 2011 (see MPEP §2114).
Further, please note that the spring-loaded contacts have not been positively recited in the claim, and are therefore not a part of the device. Additionally, please see 112(b) section supra, where “the spring-loaded contacts” lacks antecedent basis.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fukuda (US-2011/0042237-A1), herein Fukuda 2011, Li (US-2005/0252777-A1), Fukuda (US-2018/0057851-A1), herein Fukuda 2018, and Ramon Azcon (US-2012/0309108-A1), and in further view of Ochoteco Vaquero (US-2012/0181173-A1) and Abbott (US-2006/0252031-A1).
Regarding claim 14, modified Fukuda 2011 teaches system according to claim 2. Fukuda 2011 does teach where a sensor substance generates a current that can be measured with each of the working electrodes 20 by an interaction with an analyte, where an antibody is used as the sensor substance and the analyte can be a nucleic acid (Fukuda 2011; [0085], [0086], [0087]). However, Fukuda 2011 does not teach wherein functionalized magnetic particles are applied to the microfluidic component (8) for the biological reaction.
In the analogous art of electrochemical sensors for the detection of analytes, Ochoteco Vaquero teaches magnetic nanoparticles functionalized with a biological compound and a magnet located below a substrate (Ochoteco Vaquero; abstract, [0020]).
Specifically, Ochoteco Vaquero teaches where an electrochemical sensor has a magnet 6 coupled below the substrate, and that functionalized magnetic nanoparticles are captured due to the effect of the magnet, and that the magnetic nanoparticles react with certain analytes to allow for their quantification by means of an electrochemical signal (Ochoteco Vaquero; [0056], [0057], [0059]). [0059] describes that the biological compound on the magnetic nanoparticles may be antibodies.
It would have been obvious to one skilled in the art to modify the electrochemical device of modified Fukuda 2011 such that it has a magnet and functionalized magnetic particles as taught by Ochoteco Vaquero because it is taught by Abbott that an advantage of magnetic bead-based assays is the rapid mass transport of the target to a surface-immobilized binding group by virtue of the mobility of the binding group located on a bead as opposed to a macroscopic (immobile) surface (Abbott; [0241]).
Regarding claim 15, modified Fukuda 2011 teaches system according to claim 14. Ochoteco Vaquero further teaches further comprising magnets arranged for trapping magnetic nanoparticles in the microfluidic channels, see claim 14 supra.
There will be a magnet under each of the working electrodes 20a-c of Fukuda 2011.
Further, the limitation “for trapping magnetic nanoparticles in the microfluidic channels (9).” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Fukuda 2011 and the apparatus of modified Fukuda 2011 is capable of trapping magnetic nanoparticles. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Fukuda 2011 (see MPEP §2114).
Further, the magnetic nanoparticles have not been positively recited in the claim, and are therefore not a part of the system. It is noted that claim 14 describes magnetic particles, which is unclear if they are meant to be the same as the magnetic nanoparticles in claim 15.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fukuda (US-2011/0042237-A1), herein Fukuda 2011, Li (US-2005/0252777-A1), Fukuda (US-2018/0057851-A1), herein Fukuda 2018, and Ramon Azcon (US-2012/0309108-A1), and in further view of Jackson (US-2009/0042313-A1).
Regarding claim 17, modified Fukuda 2011 teaches system according to claim 2.
The insulating film 3ii of Fukuda 2011 has cutouts seen in Figure 1, where the material for the insulating film 3ii is now paper as taught by Fukuda 2018. Fukuda 2011 does not teach wherein the microfluidic channels are isolated from each other by means of hydrophobic barriers.
In the same problem solving area of creating channels formed on a substrate, Jackson teaches where a substrate has a primary assay reagent conduit that comprises filter paper and can comprise alternatively the following: multiple channels formed in paper by impregnation with polymers to form water impermeable regions, formation of strips of water permeable material within a sheet of material by cutting regions from a sheet to form multiple channels (Jackson; [0042]).
Examiner finds that the prior art contained a device/method/product (i.e., film substrate) which differed from the claimed device by the substitution of component(s) (i.e., a channel formed by cutting out pieces) with other component(s) (i.e., channel being formed by hydrophobic barriers), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., channels formed by cutting out components for channels formed by impregnation with polymers that form water impermeable regions), and the results of the substitution (i.e., channel formation) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the method of channel formation from being cutting out substrate as taught by Fukuda 2011 to be instead impregnating the substrate with polymers that form water impermeable regions as taught by Jackson, since the result would have been predictable.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fukuda (US-2011/0042237-A1), herein Fukuda 2011, Li (US-2005/0252777-A1), Fukuda (US-2018/0057851-A1), herein Fukuda 2018, and Ramon Azcon (US-2012/0309108-A1), and as evidenced by Nemiroski (US-2016/0117463-A1).
Regarding claim 18, modified Fukuda 2011 teaches system according to claim 1. Fukuda further teaches comprising instrumentation to carry out the electrochemical detection (Fukuda 2011; [0126] see working electrode pads, counter electrode pad 32, and reference electrode pad 42 are connected to a voltage-applying device such as a potentiostat, where the reference electrode and counter electrode have been modified by Li to be a reference/counter electrode belt that will have a single pad).
The limitation “by chronoamperometry of the multiplexed biosensor.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Fukuda 2011 and the apparatus of modified Fukuda 2011 is capable of chronoamperometry. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Fukuda 2011 (see MPEP §2114).
It is evidenced by Nemiroski that electrochemical measurements may utilize a potentiostat and two or three electrodes, and that the potentiostat can be programmed to perform chronoamperometry (Nemiroski; [0047], [0064]).
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hodko (US-2019/0361313-A1) teaches an electrophoretic chip comprising a non-conductive substrate, an electrode structure for conducting current through the chip, a dielectric ink insulator layer, and a molecule capturing matrix spotted on and covering an addressable location (Hodko; abstract, Figures 1a-b, 3a-c).
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796