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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/28/2025, 11/25/2025, & 07/14/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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, the:
Claims 1 & 13 limitation of "a groove is recessed from an area of the top surface that is adjacent to the at least one side surface, the detection electrode is disposed in the groove, and the groove defined on a part of the top surface has an opening defined on the at least one side surface.".
Claim 3 limitation "the first notch, the second notch, the one of the at least one second side plate that corresponds to the second notch, and the second region together define the groove".
Claim 19 in lines 6-7 recites the limitation "at least one side surface, connected to each of the top surface and the bottom surface, wherein the groove penetrates one of the at least one side surface;" & in line 11 recites the limitation "wherein the groove comprises a plane and a side wall".
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
Claim 2 objected to because of the following informalities:
Claim 2 in line 2 recites the limitation "the four side surfaces". There is insufficient antecedent basis for this limitation in the claim. “number of the at least one side surface is four” could be interpreted differently from “the four side surfaces”.
Note: the first instance of an element should be in the form “a [unique descriptive terminology]” and successive references to that element should be in the form “the [unique descriptive terminology]” where [unique descriptive terminology] is the same throughout the claims. This is necessary because similarly phrased elements can be patentably distinct. Otherwise, the claim would likely raise 35 U.S.C § 112(b) antecedent basis issues.
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 1-20 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.
Regarding “Failure to particularly point out & distinctly claim [indefinite]”:
Claims 1 & 13 in lines 6-9 & lines 9-12 (respectively) recites the limitation "a groove is recessed from an area of the top surface that is adjacent to the at least one side surface, the detection electrode is disposed in the groove, and the groove defined on a part of the top surface has an opening defined on the at least one side surface.". A notch or a groove (Fig. 3-78) is a region in which the material has been removed (or made without), there cannot be an opening in the groove or the notch just as there cannot be an opening in an open space (the notch or the groove is an absence in the housing without at least one side surface). For the purposes of examination, there is considered to be a groove bounded by 2 orthogonal surfaces.
Claim 3 & 14 in lines 1-2 (both claims) recites the limitation "wherein the housing further comprises a first housing and a second housing". A housing encloses a device(s) such as circuitry, a second housing would be a separate enclosure which would house a different device; the invention (as supported by instant application’s Fig. 4) is one housing made up of multiple parts. For the purposes of examination, there is considered to be one housing.
Claim 3 in lines 7-9 recites the limitation "the first notch, the second notch, the one of the at least one second side plate that corresponds to the second notch, and the second region together define the groove". Notch and groove are both typically interpreted as recessed areas in a structure; it is not clear how two recessed areas (notches) create one recessed area (the groove). For the purposes of examination, the notches are considered to be one groove.
Claim 5 in lines 2-3 recites the limitation "a third housing, comprising a mounting plate and at least one third side plate disposed around mounting plate,". A housing encloses a device such as circuitry, a third housing would be a separate enclosure which would house a different device; the invention (as supported by instant application’s Fig. 4) is one housing made up of multiple parts. For the purposes of examination, there is considered to be one housing.
Claim 19 in lines 6-7 recites the limitation "at least one side surface, connected to each of the top surface and the bottom surface, wherein the groove penetrates one of the at least one side surface;" & in line 11 recites the limitation "wherein the groove comprises a plane and a side wall". A groove is an absence of material which is bounded by 2 to 3 surfaces, but it is not clear how a plane and a side wall can penetrate a surface to create an absence of material. “Penetrate” means that an structure goes through a surface, if the structure is an absence of material then that would be a hole not a groove. For the purposes of examination, there is considered to be a groove bounded by 2 orthogonal surfaces.
Regarding ‘rejected for inheriting the rejected limitation(s) of a parent claim without rectifying the issue(s) for which the parent claim was rejected’:
Claims 4-11, 15-18, & 20 in line 1 (for each claim) recites the limitation "The detection assembly as claimed in claim 3[4][5]", "The detection assembly as claimed in claim 14[15][16]", & "The detection assembly as claimed in claim 19" (respectively).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200232981 A1 (Johnson) in view of US 20220196584 A1 (Lutz).
Regarding claim 1, Johnson teaches a detection assembly (Fig. 1A-104: “cartridge”, assembly/(“cartridge” with interior components)) for a medical detection device (Abstract: “Provided are point of care sensor systems that include portable readers and disposable cartridges for receiving and analyzing samples.”, medical/(“point of care”)), the detection assembly comprising: a housing (FIG. 2A-200: “cartridge”), comprising a top surface (Fig. 2A-230, para 0047: “Components of cartridge 200 include top and bottom plates 230 and 232”, top surface/(top plate) see annotated Fig. 2A below), a bottom surface(Fig. 2A-232, para 0047: “Components of cartridge 200 include top and bottom plates 230 and 232”, bottom surface/(bottom plate)), at least one side surface (Fig. 2A-238: “airline plate”, airline plate has side surfaces), a fluid inlet(Fig. 2A-246: “sample inlet port”, fluid inlet/(“inlet port”)), … , wherein the at least one side surface is connected to each of the top surface and the bottom surface, and a cavity (para 0048: “may include a sample inlet port 246 and a waste chamber 244.”, top and side surfaces define a cavity and additionally there are “chambers”) is defined within the housing; and a detection electrode (Fig. 7A-710a: “electrodes”, para 0114: “Components of sensing assembly 700 on base sheet 702 can include working electrodes 710a-710e, counter electrodes 711a-711e, reference electrodes 712a-712e,”); wherein each of the fluid inlet and the fluid outlet is communicated with the cavity (para 0051: “A sample chamber 204 may be connected to sample line 206 that pulls the sample from the sample inlet port 204 and into other components of cartridge 200”, any inlet or outlet (as taught by Lutz) are connected to cavities/(chambers or reservoirs)), …
Johnson does not as explicitly teach … and a fluid outlet … a groove is recessed from an area of the top surface that is adjacent to the at least one side surface, the detection electrode is disposed in the groove, and the groove defined on a part of the top surface has an opening defined on the at least one side surface.
Lutz teaches … and a fluid outlet (para 0027: “A sensor assembly may comprise a plurality of physically separated fluidic conduits”) … a groove (Fig. 2B, region in which 14 is installed) is recessed from an area of the top surface (Fig. 2B, region around 14 is recessed) that is adjacent to the at least one side surface (Fig. 2B, has a side surface), the detection electrode is disposed in the groove, and the groove defined on a part (the top surface inherently has a part) of the top surface has an opening (Fig. 2B-14, recessed area is an opening) defined on the at least one side surface (Fig. 2A-11A: “electrodes” & Fig. 2B-14: “electrical contact elements”, para 0059: “The electrical contact elements 14 are used to establish electrical connection between the sensors of the sensor assembly 1 and the IVD analyzer. In the embodiment as shown in FIG. 1, the electrodes 11A, 12A, 13A formed on a first substrate 10A are connected to the corresponding electrical contact elements 14 via electrically conducting pathways printed onto the substrate 10A”, electrodes or contacts are on the groove to enable electrical connections).
It would have been obvious to one of ordinary skill in the relevant art before the effective filing date of the claimed invention to have modified the device taught by Johnson with the teachings of Lutz. One would have combined the “Point of Care Sensor Systems” of Johnson with the “Sensor Assembly” with outlets and with electrodes with electrical contacts of Lutz. The outlets would enable the system to separate waste (see Lutz para 0058: “The first fluidic conduit 2 and the reference fluidic conduit 4 converge and lead into a common fluidic outlet 8, through which the fluid is transferred out of the sensor assembly 1 and back into the fluid system of the IVD analyzer, where it can be wasted (not shown).”) and the electrical contacts enable connection to an analysis system (see Lutz para 0025: “These electrical contact elements are required to establish electrical connection with the IVD analyzer”)
PNG
media_image1.png
610
862
media_image1.png
Greyscale
Regarding claim 2, Johnson in view of Lutz teaches the detection assembly as claimed in claim 1,
Johnson further teaches wherein the top surface and the bottom surface are arranged in parallel (Fig. 2A-232 & Fig. 2A-230, when assembled 230 and 232 are parallel), the number of the at least one side surface is four (Fig. 2A-238: “airline plate”, the airline plate has four sides), the four side surfaces are sequentially connected to each other (there is necessarily a sequence which corresponds to the connected four sides), … , a width of the groove (Fig. 1A-106: “small portion”, small portion provides electrical interface) is smaller than a width of the top surface (inherently has a width), and a width of the opening (Fig. 1A-106: “small portion”, small portion provides electrical interface) is smaller than a width of the one of the four side surfaces (Fig. 1A-106a, recessed opening is smaller than the width of the top surface); the groove comprises a plane (Fig. 1A-106a) and a side wall (Fig. 1A-106a, has a side wall), and the plane and the side wall match with the top surface (Fig. 1A-106a, groove with plane and side wall), the plane is parallel to each of the top surface and the bottom surface (Fig. 1A-106a, plane with the groove is parallel to the top and bottom surfaces), the side wall is perpendicular to the plane and is connected to each of the top surface and the plane (Fig. 2A-238: “airline plate”, has sides which are perpendicular to the plane), and the detection electrode is disposed on the plane (para 0042: “Interface portion 106b includes conductive traces 109.”).
Lutz teaches the groove and the opening are defined on an area (Fig. 2B-14, area around 14) where the top surface is connected to one of the four side surfaces (Fig. 2B, para 0061: “A spacer 20C is arranged in between the two opposite substrates 20A, 20B, where the spacer 20C comprises recesses that form fluidic conduits 2, 3, 4,”, top surface/(substrate 20B))
Regarding claim 3, Johnson in view of Lutz teaches the detection assembly as claimed in claim 1,
Johnson further teaches wherein the housing further comprises a first housing (by interpretation, Fig. 2A above, 1 housing made of multiple parts) and a second housing (by interpretation, Fig. 2A above, 1 housing made of multiple parts), the top surface is a surface (Fig. 2A above) of the first housing facing away from the second housing (Fig. 2A-232 & Fig. 2A-230, 232 and 230 for the top and bottom parts of the housing); the detection assembly further comprises a circuit board (Fig. 9B the board has electric circuits) with a first region (inherently has first region) and a second region (inherently has a second region), and the detection electrode is disposed on the second region (Fig. 7C-716 & Fig. 7C-710, para 0114: “Components of sensing assembly 700 on base sheet 702 can include working electrodes 710a-710e, counter electrodes 711a-711e, reference electrodes 712a-712e,”, electrodes are connected to the circuits); the second housing comprises a base (Fig. 7C-702: base sheet) and at least one first side plate (Fig. 2A-230 & Fig. 2A-238, there is a base connected to sides) disposed around the base, a bottom end (side plate inherently has a bottom end) of the at least one first side plate is connected to an edge of base (Fig. 2A, sides 238 are connected to base 230), a first notch (Fig 1A-106, the notches are considered to be one groove) is defined on a top end (Fig. 1A, end with 106) of one of the at least one first side plate away from the base (Fig. 2A-232, the housing has notch on the top), an accommodating chamber (para 0048: “may include a sample inlet port 246 and a waste chamber 244.”, top and side surfaces define a cavity and additionally there are “chambers”) is defined by the base and the at least one first side plate, the bottom surface is a surface (bottom surface inherently has a surface) of the base facing away from the first housing, and the at least one side surface is an outer surface (side surface inherently has an outer surface) of the at least one first side plate facing away from the accommodating chamber (Fig. 2A an accommodating chamber is formed by the parts of the housing); and the first housing cooperates with the at least one first side plate to cover the accommodating chamber (Fig. 2A, chamber is covered by housing), the circuit board is disposed between the base and the first housing (Fig. 2A-234, electric circuits are in between the housing components), the first region is located within the accommodating chamber (para 0004: “Aspects of the description herein include cartridges, systems, and methods that provide dissolution and mixing of lyophilized reagents in a sample, ensuring repeatable and precise measurements.”, system has an accommodating chamber/(contains liquids)), and the second region is an area of the circuit board that is outside the accommodating chamber and corresponds to the groove, to form the plane of the groove (Fig. 2A-234, there is a region with electric circuitry and which connects to electrodes or electrical contacts).
Regarding claim 4, Johnson in view of Lutz teaches the detection assembly as claimed in claim 3,
Johnson further teaches wherein the first housing comprises a cover (Fig. 2A, housing includes a cover) and at least one second side plate (Fig. 2A, housing includes a cover and sides) disposed around the cover, a top end (second side plate inherently has a top end) of the at least one second side plate is connected to an edge (inherent to cover) of the cover (Fig. 2A, components 232 and 238 and 230 form and a housing with cover and sides and a base), the top surface is a surface (top surface inherently has a surface) of the cover away from the second housing (Fig. 2A, second housing is the bottom part of the cartridge), a second notch (Fig 1A-106, the notches are considered to be one groove) is defined on an area (cover inherently has an area) of the cover that is close to the first notch, one of the at least one second side plate that corresponds to the second notch extends along a contour (notch inherently has a contour) of the second notch (first notch and the second notch are necessary parts of the groove); the first notch, the second notch, the one of the at least one second side plate that corresponds to the second notch, and the second region together define the groove (Fig. 1A-106, para 0040: “the reader 102 may be configured to interface with only a small portion 106 of the cartridge 104, for example to provide an electrical interface to sensor electrodes and vacuum and/or pressure lines to move fluids and open/close valves.”, groove/(“small portion”)),
Lutz further teaches the one of the at least one second side plate that corresponds to the second notch forms the side wall of the groove (Fig. 2B, there is a groove).
Regarding claim 5, Johnson in view of Lutz teaches the detection assembly as claimed in claim 4,
Johnson further teaches further comprising: a third housing (by interpretation, Fig. 2A above, 1 housing made of multiple parts), comprising a mounting plate (Fig. 2A, device is in an enclosure which has a mounting plate inherently) and at least one third side plate disposed around mounting plate, a bottom end (third plate inherently has a bottom end) of each of the at least one third side plate is connected to an edge (mounting plate inherently has an edge) of the mounting plate, each of the mounting plate and the at least one third side plate is disposed within the accommodating chamber, a top end (third side plate inherently has a top end) of the at least one third side plate is connected to the top end of the at least one first side plate, the circuit board is disposed on the mounting plate and is located between the mounting plate and the first housing (Fig. 2A, housings are attached to the device which they enclose so there is necessarily a mounting plate); a third notch (Fig. 3-106, the notches are considered to be one groove) is defined on one of the at least one third side plate that corresponds to the first notch, and the third notch has a shape matching with a shape of the first notch (Fig. 1A, at least by interpretation a groove is necessarily comprised of notches).
Regarding claim 6, Johnson in view of Lutz teaches the detection assembly as claimed in claim 5,
Johnson further teaches wherein a raised rib (known to POSITA for holding together by a fixing member/(screw or bolt) has a raised rib at least in order to prevent relative rotation) is disposed on an edge (known to POSITA for fixing components) of the mounting plate that is close to the at least one third side plate and is disposed around a periphery of the circuit board (inherent to circuit board to inherently have a periphery) to limit the circuit board (Fig. 2A, the sides fit together so there must be a raised rib, without some sort of rib the top and bottom parts wouldn’t hold together).
Regarding claim 7, Johnson in view of Lutz teaches the detection assembly as claimed in claim 5,
Johnson further teaches further comprising: a fixing member (known to POSITA, fixing member/(screw or bolt)); wherein a first through hole (known to POSITA, components held together by fixing member have through holes) is defined on the cover of the first housing, a second through hole (known to POSITA, through holes) is defined on the circuit board, a third through hole (known to POSITA, through holes) is defined on the mounting plate, a fourth through hole (known to POSITA, through holes) is defined on the base, and the fixing member penetrates through the fourth through hole, the third through hole, the second through hole, and the first through hole, to fix the first housing, the circuit board, and the second housing to each other (Fig. 2A, components are attached together and so require fixing members such as screws, the circuitry must be attached to a mounting board).
Regarding claim 8, Johnson in view of Lutz teaches the detection assembly as claimed in claim 4,
Johnson further teaches wherein the fluid inlet and the fluid outlet are defined on the bottom surface (Fig. 4B: “pneumatic ports”, para 0090: “Turning to FIG. 4B, a simplified schematic diagram of a layer 405 is depicted. Layer 405 includes pneumatic ports 450,”, due to structure of the board fluids have to enter and leave through the bottom surface).
Regarding claim 9, Johnson in view of Lutz teaches the detection assembly as claimed in claim 4,
Johnson further teaches wherein a height (inherently has a height) of the at least one second side plate is greater than or equal to one-fourth of a height (inherently has a height) of the at least one first side plate and is smaller than or equal to three-fourths of the height of the at least one first side plate (see MPEP 2144.05(II)(A): "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”, these proportions would be determined by the available hardware and routine experimentation on the part of a POSITA ).
Regarding claim 10, Johnson in view of Lutz teaches the detection assembly as claimed in claim 3,
Johnson further teaches wherein the second region is in shape of a rectangle (Fig. 2A, regions and the enclosed regions are square or rectangular in shape) or a square (Fig. 2A, regions and the enclosed regions are square or rectangular in shape).
Regarding claim 11, Johnson in view of Lutz teaches the detection assembly as claimed in claim 3,
Johnson further teaches wherein the at least one first side plate and the base are connected in one piece (Fig. 2A, para 0106: “Aspects of the cartridge and fluid delivery system described herein include multi-layer microfluidic layers including a monolithic membrane layer and liquid and pneumatic chambers and channels on both sides of the monolithic membrane layer.”, when the parts are connected they become one piece i.e. a cartridge).
Regarding claim 12, Johnson in view of Lutz teaches the detection assembly as claimed in claim 1,
Lutz further teaches wherein the groove is in shape of a cuboid (Fig. 2B, groove is either cuboid or a cube) or a cube (Fig. 2B, groove is either cuboid or a cube).
Regarding claim 13, Johnson teaches a medical detection device, comprising: a device body, comprising a slot (Fig. 1A-102: “reader”, para 040: “FIG. 1A is a simplified schematic showing an example of a point-of care system 100, including a reader 102 and a cartridge 104 inserted in the reader 102”, reader must have a slot for the cartridge to make contact) and a contact electrode (reader must have contact electrode in order to share information with a cartridge), wherein the slot is configured to receive a detection assembly (Fig. 1A-102: “reader”, device body/(“reader”)); when the detection assembly is inserted into the medical detection device (Fig. 1A-104: “cartridge”, detection assembly/(“cartridge”)), the contact electrode is in contact with a detection electrode (inherent to electrical information processing devices to have contacts on both the cartridge and the reader) of the detection assembly (Fig. 7A-710a: “electrodes”, para 0114: “Components of sensing assembly 700 on base sheet 702 can include working electrodes 710a-710e, counter electrodes 711a-711e, reference electrodes 712a-712e,”); wherein the detection assembly comprises: a housing (FIG. 2A-200: “cartridge”), comprising a top surface (Fig. 2A-230, para 0047: “Components of cartridge 200 include top and bottom plates 230 and 232”, top surface/(top plate)), a bottom surface (Fig. 2A-232, para 0047: “Components of cartridge 200 include top and bottom plates 230 and 232”, bottom surface/(bottom plate)), at least one side surface (Fig. 2A-238: “airline plate”, airline plate has side surfaces), a fluid inlet (Fig. 2A-246: “sample inlet port”, fluid inlet/(“inlet port”)), … , wherein the at least one side surface is connected to each of the top surface and the bottom surface, and a cavity (para 0048: “may include a sample inlet port 246 and a waste chamber 244.”, top and side surfaces define a cavity and additionally there are “chambers” and “reservoir”) is defined within the housing; and the detection electrode (Fig. 7A-710a: “electrodes”, para 0114: “Components of sensing assembly 700 on base sheet 702 can include working electrodes 710a-710e, counter electrodes 711a-711e, reference electrodes 712a-712e,”); wherein each of the fluid inlet and the fluid outlet is communicated with the cavity (para 0051: “A sample chamber 204 may be connected to sample line 206 that pulls the sample from the sample inlet port 204 and into other components of cartridge 200”, any inlet or outlet (as taught by Lutz) are connected to cavities/(chambers or reservoirs)),
Johnson does not as explicitly teach … and a fluid outlet … a groove is recessed from an area of the top surface that is adjacent to the at least one side surface, the detection electrode is disposed in the groove, and the groove defined on a part of the top surface has an opening defined on the at least one side surface.
Lutz teaches … and a fluid outlet (para 0027: “A sensor assembly may comprise a plurality of physically separated fluidic conduits”) … a groove (Fig. 2B, region in which 14 is installed) is recessed from an area of the top surface (Fig. 2B, region around 14 is recessed) that is adjacent to the at least one side surface, the detection electrode is disposed in the groove, and the groove defined on a part (the top surface inherently has a part) of the top surface has an opening (Fig. 2B-14, recessed area is an opening) defined on the at least one side surface (Fig. 2A-11A: “electrodes” & Fig. 2B-14: “electrical contact elements”, para 0059: “The electrical contact elements 14 are used to establish electrical connection between the sensors of the sensor assembly 1 and the IVD analyzer. In the embodiment as shown in FIG. 1, the electrodes 11A, 12A, 13A formed on a first substrate 10A are connected to the corresponding electrical contact elements 14 via electrically conducting pathways printed onto the substrate 10A”, electrodes or contacts are on the groove to enable electrical connections).
It would have been obvious to one of ordinary skill in the relevant art before the effective filing date of the claimed invention to have modified the device taught by Johnson with the teachings of Lutz. One would have combined the “Point of Care Sensor Systems” of Johnson with the “Sensor Assembly” with outlets and with electrodes with electrical contacts of Lutz. The outlets would enable the system to separate waste (see Lutz para 0058: “The first fluidic conduit 2 and the reference fluidic conduit 4 converge and lead into a common fluidic outlet 8, through which the fluid is transferred out of the sensor assembly 1 and back into the fluid system of the IVD analyzer, where it can be wasted (not shown).”) and the electrical contacts enable connection to an analysis system (see Lutz para 0025: “These electrical contact elements are required to establish electrical connection with the IVD analyzer”)
Regarding claim 14, Johnson in view of Lutz teaches the medical detection device as claimed in claim 13,
Johnson further teaches wherein the housing further comprises a first housing (by interpretation, Fig. 2A above, 1 housing made of multiple parts) and a second housing(by interpretation, Fig. 2A above, 1 housing made of multiple parts), the top surface is a surface (Fig. 2A above) of the first housing facing away from the second housing (Fig. 2A-232 & Fig. 2A-230, 232 and 230 for the top and bottom parts of the housing); the detection assembly further comprises a circuit board (Fig. 9B the board has electric circuits) with a first region (inherently has first region) and a second region (inherently has a second region), and the detection electrode is disposed on the second region (Fig. 7C-716 & Fig. 7C-710, para 0114: “Components of sensing assembly 700 on base sheet 702 can include working electrodes 710a-710e, counter electrodes 711a-711e, reference electrodes 712a-712e,”, electrodes are connected to the circuits); the second housing comprises a base (Fig. 7C-702: base sheet) and at least one first side plate (Fig. 2A-230 & Fig. 2A-238, there is a base connected to sides) disposed around the base, a bottom end (side plate inherently has a bottom end) of the at least one first side plate is connected to an edge of base (Fig. 2A, sides 238 are connected to base 230), a first notch (Fig 1A-106, the notches are considered to be one groove) is defined on a top end (Fig. 1A, end with 106) of one of the at least one first side plate away from the base(Fig. 2A-232, the housing has notch on the top), an accommodating chamber (para 0048: “may include a sample inlet port 246 and a waste chamber 244.”, top and side surfaces define a cavity and additionally there are “chambers”) is defined by the base and the at least one first side plate, the bottom surface is a surface (bottom surface inherently has a surface) of the base facing away from the first housing, and the at least one side surface is a surface (side surface inherently has an outer surface) of the at least one first side plate facing away from the accommodating chamber (Fig. 2A an accommodating chamber is formed by the parts of the housing); and the first housing cooperates with the at least one first side plate to cover the accommodating chamber(Fig. 2A, chamber is covered by housing), the circuit board is disposed between the base and the first housing (Fig. 2A-234, electric circuits are in between the housing components), the first region is located within the accommodating chamber (para 0004: “Aspects of the description herein include cartridges, systems, and methods that provide dissolution and mixing of lyophilized reagents in a sample, ensuring repeatable and precise measurements.”, system has an accommodating chamber/(contains liquids)), and the second region is an area of the circuit board that is outside the accommodating chamber and corresponds to the groove, to form the plane of the groove(Fig. 2A-234, there is a region with electric circuitry and which connects to electrodes or electrical contacts).
Regarding claim 15, Johnson in view of Lutz teaches the medical detection device as claimed in claim 14,
Johnson further teaches wherein the first housing comprises a cover (Fig. 2A, housing includes a cover) and at least one second side plate (Fig. 2A, housing includes a cover and sides) disposed around the cover, a top end (second side plate inherently has a top end) of the at least one second side plate is connected to an edge (inherent to cover) of the cover (Fig. 2A, components 232 and 238 and 230 form and a housing with cover and sides and a base), the top surface is a surface (top surface inherently has a surface) of the cover away from the second housing (Fig. 2A, second housing is the bottom part of the cartridge), a second notch (Fig 1A-106, the notches are considered to be one groove) is defined on an area (cover inherently has an area) of the cover that is close to the first notch, one of the at least one second side plate that corresponds to the second notch extends along a contour (notch inherently has a contour) of the second notch (first notch and the second notch are necessary parts of the groove);
Lutz further teaches the first notch, the second notch, the one of the at least one second side plate that corresponds to the second notch, and the second region together define the groove, the one of the at least one second side plate that corresponds to the second notch forms the side wall of the groove(Fig. 2B, there is a groove).
Regarding claim 16, Johnson in view of Lutz teaches the medical detection device as claimed in claim 15,
Johnson further teaches wherein the detection assembly further comprises: a third housing (by interpretation, Fig. 2A above, 1 housing made of multiple parts), comprising a mounting plate (Fig. 2A, device is in an enclosure which has a mounting plate inherently) and at least one third side plate disposed around mounting plate, a bottom end (third plate inherently has a bottom end) of each of the at least one third side plate is connected to an edge (mounting plate inherently has an edge) of the mounting plate, each of the mounting plate and the at least one third side plate is disposed within the accommodating chamber, a top end (third side plate inherently has a top end) of the at least one third side plate is connected to the top end of the at least one first side plate, the circuit board is disposed on the mounting plate and is located between the mounting plate and the first housing (Fig. 2A, housings are attached to the device which they enclose so there is necessarily a mounting plate); a third notch (Fig. 3-106, the notches are considered to be one groove) is defined on one of the at least one third side plate that corresponds to the first notch, and the third notch has a shape matching with a shape of the first notch(Fig. 1A, groove is necessarily comprised of notches).
Regarding claim 17, Johnson in view of Lutz teaches the medical detection device as claimed in claim 16,
Johnson further teaches wherein the detection assembly further comprises: a fixing member (known to POSITA, fixing member/(screw or bolt)); wherein a first through hole (known to POSITA, components held together by fixing member have through holes) is defined on the cover of the first housing, a second through hole (known to POSITA, through holes) is defined on the circuit board, a third through hole (known to POSITA, through holes) is defined on the mounting plate, a fourth through hole (known to POSITA, through holes) is defined on the base, and the fixing member penetrates through the fourth through hole, the third through hole, the second through hole, and the first through hole, to fix the first housing, the circuit board, and the second housing to each other (Fig. 2A, components are attached together and so require fixing members such as screws, the circuitry must be attached to a mounting board).
Regarding claim 18, Johnson in view of Lutz teaches the medical detection device as claimed in claim 15,
Johnson further teaches wherein the fluid inlet and the fluid outlet are defined on the bottom surface (Fig. 4B: “pneumatic ports”, para 0090: “Turning to FIG. 4B, a simplified schematic diagram of a layer 405 is depicted. Layer 405 includes pneumatic ports 450,”, due to structure of the board fluids have to enter and leave through the bottom surface).
Regarding claim 19, Johnson teaches a detection assembly for a medical detection device, the detection assembly comprising: a housing (FIG. 2A-200: “cartridge”), comprising: a bottom surface (Fig. 2A-232, para 0047: “Components of cartridge 200 include top and bottom plates 230 and 232”, bottom surface/(bottom plate)); a top surface (Fig. 2A-230, para 0047: “Components of cartridge 200 include top and bottom plates 230 and 232”, top surface/(top plate)), … ; at least one side surface (Fig. 2A-238: “airline plate”, airline plate has side surfaces), connected to each of the top surface and the bottom surface, wherein the groove penetrates one of the at least one side surface; a cavity (para 0048: “may include a sample inlet port 246 and a waste chamber 244.”, top and side surfaces define a cavity and additionally there are “chambers” and “reservoir”), spaced apart from the groove; and a fluid inlet (Fig. 2A-246: “sample inlet port”, fluid inlet/(“inlet port”)) … , each being communicated with the cavity(para 0051: “A sample chamber 204 may be connected to sample line 206 that pulls the sample from the sample inlet port 204 and into other components of cartridge 200”, any inlet or outlet (as taught by Lutz) are connected to cavities/(chambers or reservoirs)); and a detection electrode(Fig. 7A-710a: “electrodes”, para 0114: “Components of sensing assembly 700 on base sheet 702 can include working electrodes 710a-710e, counter electrodes 711a-711e, reference electrodes 712a-712e,”), accommodated in the groove without extending out of the groove (Fig.1A, electrical contact elements are within the groove); wherein the groove comprises a plane (groove inherently has a plane) and a side wall (groove inherently has side walls), the plane and the side wall match with the top surface (Fig. 1A-106a, groove with plane and side wall), the side wall is connected to each of the top surface and the plane(Fig. 2A-238: “airline plate”, has sides which are perpendicular to the plane), and the plane is spaced apart from the bottom surface(Fig. 2A, planes and surfaces are space apart).
Johnson does not as explicitly teach disposed in opposite to the bottom surface, wherein a groove is recessed from the top surface toward the bottom surface … and a fluid outlet.
Lutz teaches disposed in opposite to the bottom surface, wherein a groove is recessed from the top surface toward the bottom surface(Fig. 2A-11A: “electrodes” & Fig. 2B-14: “electrical contact elements”, para 0059: “The electrical contact elements 14 are used to establish electrical connection between the sensors of the sensor assembly 1 and the IVD analyzer. In the embodiment as shown in FIG. 1, the electrodes 11A, 12A, 13A formed on a first substrate 10A are connected to the corresponding electrical contact elements 14 via electrically conducting pathways printed onto the substrate 10A”, electrodes or contacts are on the groove to enable electrical connections) … and a fluid outlet(para 0027: “A sensor assembly may comprise a plurality of physically separated fluidic conduits”)
It would have been obvious to one of ordinary skill in the relevant art before the effective filing date of the claimed invention to have modified the device taught by Johnson with the teachings of Lutz. One would have combined the “Point of Care Sensor Systems” of Johnson with the “Sensor Assembly” with outlets and with electrodes with electrical contacts of Lutz. The outlets would enable the system to separate waste (see Lutz para 0058: “The first fluidic conduit 2 and the reference fluidic conduit 4 converge and lead into a common fluidic outlet 8, through which the fluid is transferred out of the sensor assembly 1 and back into the fluid system of the IVD analyzer, where it can be wasted (not shown).”) and the electrical contacts enable connection to an analysis system (see Lutz para 0025: “These electrical contact elements are required to establish electrical connection with the IVD analyzer”)
Regarding claim 20, Johnson in view of Lutz teaches the detection assembly as claimed in claim 19,
Johnson further teaches wherein the groove comprises a plane (groove inherently has a plane) and three side walls (groove inherently has side walls), and the opening is defined by the plane and the three side walls(Fig. 2A, the opening creates a groove with a plane and three side walls).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 5336388 A "Analyte And PH Measuring Sensor Assembly And Method" (Leader) is relevant to the Applicant's disclosure, see Fig. 2b.
US 10350593 B2 "Chip Device For Monitoring And Regulating Fluid Flow, And Methods Of Manufacture Thereof" (Shmilovich) is relevant to the Applicant's disclosure, see Fig. 1A.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN WALTER BRAUNLICH whose telephone number is (571)272-3178. The examiner can normally be reached Monday-Friday 7:30 am-5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Huy Phan can be reached at (571) 272-7924. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARTIN WALTER BRAUNLICH/Examiner, Art Unit 2858
/HUY Q PHAN/Supervisory Patent Examiner, Art Unit 2858
Prosecution Insights