DETAILED CORRESPONDENCE
Summary
This is the initial Office Action based on the DANIELS application filed with the Office on 7 April 2024.
Claims 1-28 are currently pending and have been fully considered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application does not claim any domestic or foreign priority. Thus, the effective filing date of the application is 7 April 2024.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: driving electrodes 1210, recited at [0110] of the specification as filed. 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 214, shown in Figure 2; 802, 804, 806, 808, 810, and 812, shown in Figure 8; 1602, 1604, 1606, and 1608, shown in Figure 16; 1702, 1704, 1706 and 1708, shown in Figure 17; and 1810 and 1818, shown in Figure 18. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: at [0062] of the specification as filed, a drain is designated by two different reference numbers, 706 and 708.
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.
Claims 1-13, 15, 17 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by a US Patent Application Publication to Merz, et al. (US 2011/0036913 A1; hereinafter, “Merz”).
Regarding Claim 1, Merz discloses a packaged semiconductor sensor (an electrochemical sensor; [0034]), comprising:
a semiconductor die having a top surface and a bottom surface, with at least two bond pads and at least one detection area located at the top surface (a semiconductor die 30 having a bottom surface and a top surface with a pH sensor element 34 and electrical contacts 31a, b; Fig. 2f; [0041]);
a support member having a top side and a bottom side, and having a detection window provided as an opening in the support member from the top side to the bottom side, wherein the opening in the support member and a detection area located at the top surface of the semiconductor die define a sample well for receiving a sample to be tested by the packaged semiconductor sensor, and at least two conductive traces provided on the bottom side of the support member (an interposer substrate 20 having a top side 26 and bottom side 23 with a liquid access opening 25 therethrough, the sensor element 34 facing into the opening 25 forming a well, the bottom side having electrical contacts 21a, b; Figs. 2a, 2f; [0037], [0041]);
a z-axis conductive adhesive for bonding and electrically connecting a respective one of the bond pads to a corresponding one of the conductive traces (an anisotropic conductive adhesive connecting the contacts 21a, 31a and 21b, 31b; [0041]); and
a sealing member for sealing the bottom side of the support member with the top surface of the die to seal the sample well (a sealing compound applied to the interface between the die 30 and an inside wall 33 of the opening 25; Fig. 2f; [0041]).
Regarding Claim 2, Merz discloses the packaged semiconductor of claim 1, wherein the z-axis conductive adhesive also forms the sealing member (the sealing compound 32 may be provided by the same anisotropic adhesive used to connect the contacts 21 a, 21 b to the die 30; [0041]).
Regarding Claim 3, Merz discloses the packaged semiconductor of claim 1, where the sealing member comprises at least one of an epoxy, glue, pressure sensitive adhesive and gasket (the sealing compound 32 is formed from a pressure sensitive adhesive; [0041]).
Regarding Claim 4, Merz discloses the packaged semiconductor of claim 1, where the z-axis conductive adhesive comprises at least one of a anisotropically conductive epoxy, anisotropically conductive glue, and anisotropically conductive pressure sensitive adhesive film (the adhesive comprises an anisotropically conductive pressure sensitive adhesive film or paste; [0041]).
Regarding Claim 5, Merz discloses the packaged semiconductor of claim 1, where the support member is one of a flex circuit having an etched metal pattern forming the conductive traces, a plastic substrate having printed conductive ink forming the conductive traces, and rigid circuit board having at least one of etched metal and the printed conductive ink forming the conductive traces (a substrate 20 is small thin plastic substrate with contacts 21a, 21b formed by deposition of patterned foil to the surface 23; [0037]).
Regarding Claim 6, Merz discloses a sensor card assembly (an electrochemical sensor; [0034]) comprising:
a bare die semiconductor sensor with a top surface including two or more bond pads and at least one detection area (a semiconductor die 30 having a bottom surface and a top surface with a pH sensor element 34 and electrical contacts 31a, 3b; Fig. 2f; Para. [0041]);
a support member having at least a corresponding number of conductive traces as the bond pads on the bare die, the conductive traces provided on a bottom side of the support member, the support member having a detection window through-hole aligning with a detection area of the bare die (an interposer substrate 20 having a top side 26 and bottom side 23 with a liquid access opening 25 therethrough, the sensor element 34 facing into the opening 25 forming a well, the bottom side having electrical contacts 21a, b; Figs. 2a, 2f; [0037], [0041]);
a conductive adhesive applied between each said two or more bond pads of the bare die and corresponding conductive trace of the support member, wherein the conductive epoxy provides an electrical connection between a respective bond pad and a corresponding conductive trace (an anisotropic conductive adhesive connecting the contacts 21a, 31a and 21b, 31b; [0041]).
Regarding Claim 7, Merz discloses the sensor card assembly of claim 6, wherein the conductive adhesive comprises a z-axis conductive adhesive and provides both the electrical connection and mechanical attachment, and the respective bond pad and the corresponding conductive trace are electrically connected by the z-axis conductive adhesive (the adhesive providing mechanical and electrical connection between the die contacts 31a, 31b and substrate contacts 21a, 21b; [0041]).
Regarding Claim 8, Merz discloses the sensor card assembly of claim 7, wherein the z-axis conductive adhesive comprises an anisotropic conductive adhesive material that allows for conductivity primarily in the z-axis direction (the anisotropic conductive adhesive connecting the contacts 31a, 21a, and 31a, 31b in the z-axis; Fig. 2f; [0041]).
Regarding Claim 9, Merz discloses the sensor card assembly of claim 6, wherein the support member is fabricated from a flexible substrate material and the conductive traces are formed on the flexible substrate through at least one of an additive manufacturing process and a subtractive manufacturing process (the substrate 20 is small thin plastic substrate with contacts 21 a, 21 b formed by deposition of patterned foil to the surface 23; [0037]).
Regarding Claim 10, Merz discloses the sensor card assembly of claim 6, wherein the detection window through-hole and the detection area collectively define a sample well for receiving a fluid sample to be analyzed (the liquid access opening 25 and pH sensor element 34 defining a sample well; Fig. 2f; [0041]).
Regarding Claim 11, Merz discloses the sensor card assembly of claim 10, further comprising a sealing member integrated with the z-axis conductive epoxy that seals the sample well (a sealing compound applied to the interface between the die 30 and an inside wall 33 of the opening 25 adjacent to the contacts and therefore the conductive adhesive; Fig. 2f; [0041]).
Regarding Claim 12, Merz discloses the sensor card assembly of claim 11, where the sealing member is composed of the z-axis conductive epoxy (the sealing compound 32 may be provided by the same anisotropic adhesive used to connect the contacts 21 a, 21 b to the die 30; [0041 ]).
Regarding Claim 13, Merz discloses the sensor card assembly of claim 11, where the sealing member is composed of a nonconductive adhesive that seals the detection area and detection window through-hole to form the sample well and provide a barrier to protect the z-axis conductive adhesive from contacting a fluid disposed in the sample well (the sealing compound may be provided by a separate non-conducting adhesive, the compound applied between the interface of the die 30 and the walls of the opening 25 to seal the contacts from direct contact with an analyte; [0041]).
Regarding Claim 15, Merz discloses the sensor card assembly of claim 6, wherein each bond pad of the bare die is aligned with the electrically connected to a respective conductive trace via the z-axis conductive epoxy without the need for wire bonding (an anisotropic conductive adhesive connecting the contacts 21a, 31a and 21b, 31b; [0041])
Regarding Claim 17, Merz discloses a sensor card assembly configured for enhanced fluid sample analysis (an electrochemical sensor; [0034]), comprising:
a sensor element with a detection area and a plurality of bond pads on a top surface (a semiconductor die 30 having a bottom surface and a top surface with a pH sensor element 34 and electrical contacts 31a, b; Fig. 2f; [0041]);
a support member featuring a top side and a bottom side providing conductive traces corresponding to the bond pads (an interposer substrate 20 having a top side 26 and bottom side 23 with electrical contacts 21a, b; Figs. 2a, 2f; [0037], [0041]);
a z-axis conductive adhesive provided between each of the plurality of bond pads and a corresponding conductive trace for selective electrical connection in a z-axis direction (an anisotropic conductive adhesive connecting the contacts 21a, 31a and 21b, 31b; [0041]); and
a detection window through-hole on the top side of the support member aligned with the detection area of the sensor element to form a sample well (the substrate 20 having a liquid access opening 25 therethrough, the sensor element 34 facing into the opening 25 forming a well; Fig. 2f; [0041]).
Regarding Claim 23, Merz discloses the sensor card assembly configured of claim 17, wherein the z-axis conductive adhesive is further defined to have an anisotropic conductivity profile that prevents lateral electrical connectivity, ensuring precise signal transmission from the detection area (the anisotropic conductive adhesive connecting the contacts 31a, 21a, and 31a, 31b in the z-axis; Fig. 2f; [0041]).
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.
Claims 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Merz in view of a US Patent Application Publication to Diagmetrics Inc. (US 2023/0333038 A1; hereinafter “Diagmetrics”).
Regarding Claim 14, Merz discloses the sensor card assembly of claim 6. Merz fails to explicitly disclose further comprising at least one liquid detection feature integrated into the top surface of the support member to monitor presence of a fluid sample.
Diagmetrics teaches a mask based diagnostic device (abstract) further comprising at least one liquid detection feature integrated into the top surface of the support member to monitor presence of a fluid sample (an exhaled breath condensate, EBC, testing device includes a biosensor 202 and a fluid detector 306, the fluid detector detects when EBC is flowing through a fluid conductor 304 to the biosensor; [0088], [0089]).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Merz to include at least one liquid detection feature integrated into the top surface of the support member to monitor presence of a fluid sample as taught by Diagmetrics. The motivation being to provide a portable and recyclable diagnostics device (Diagmetrics [0012]).
Regarding Claim 18, Merz discloses the sensor card assembly configured of claim 17.
Merz fails to explicitly disclose further comprising liquid detection features formed on the top side and operative to indicate a fluid sample presence and flow characteristics.
Diagmetrics teaches a mask based diagnostics device (Abstract) further comprising liquid detection features formed on the top side and operative to indicate a fluid sample presence and flow characteristics (an exhaled breath condensate, EBC, testing device includes a biosensor 202 and a fluid detector 306, the fluid detector detects when EBC is flowing through a fluid conductor 304 to the biosensor; [0088], [0089]).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Merz to include liquid detection features formed on the top side and operative to indicate a fluid sample presence and flow characteristics as taught by Diagmetrics. The motivation being to provide a portable and recyclable diagnostics device (Diagmetrics, [0012]).
Claims 16 and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Merz in view of a US Patent Application Publication to Agilome, Inc. (US 2017/0102358; hereinafter, “Agilome”).
Regarding Claim 16, Merz discloses the sensor card assembly of claim 6.
Merz fails to explicitly disclose further comprising an accumulator in fluid communication with the sensor areas, the accumulator for applying an electrostatic field to the fluid sample for aligning target biomarkers within a fluid sample, wherein the accumulator facilitates enhanced detection by modulating orientation and proximity of target biomarkers to the sensor areas.
Agilome teaches chemically sensitive field effect transistors (abstract) further comprising an accumulator in fluid communication with the sensor areas, the accumulator for applying an electrostatic field to the fluid sample for aligning target biomarkers within a fluid sample, wherein the accumulator facilitates enhanced detection by modulating orientation and proximity of target biomarkers to the sensor areas (a Chemically-sensitive FET 1 has a well 38 for containing a fluid with microbeads 60 having a target analyte, the FET 1 includes an electric field generator 70 for creating an electric field to draw beads 60 into the well; [0248], [0320]-[0323]).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Merz to include an accumulator in fluid communication with the sensor areas, the accumulator for applying an electrostatic field to the fluid sample for aligning target biomarkers within a fluid sample, wherein the accumulator facilitates enhanced detection by modulating orientation and proximity of target biomarkers to the sensor areas as taught by Agilome. The motivation being to provide a portable and easily mass manufactured sensor (Agilome, [0020], [0022]).
Regarding Claim 25, Merz discloses the sensor card assembly configured of claim 17.
Merz fails to explicitly disclose further comprising an accumulator in fluid communication with the sensor areas, the accumulator for applying an electrostatic field to the fluid sample for aligning target biomarkers within a fluid sample, wherein the accumulator facilitates enhanced detection by modulating orientation and proximity of target biomarkers to the sensor areas.
Agilome teaches chemically sensitive field effect transistors (abstract) further comprising an accumulator in fluid communication with the sensor areas, the accumulator for applying an electrostatic field to the fluid sample for aligning target biomarkers within a fluid sample, wherein the accumulator facilitates enhanced detection by modulating orientation and proximity of target biomarkers to the sensor areas (a Chemically-sensitive FET 1 has a well 38 for containing a fluid with microbeads 60 having a target analyte, the FET 1 includes an electric field generator 70 for creating an electric field to draw beads 60 into the well; [0248], [0320]-[0323]).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Merz to include an accumulator in fluid communication with the sensor areas, the accumulator for applying an electrostatic field to the fluid sample for aligning target biomarkers within a fluid sample, wherein the accumulator facilitates enhanced detection by modulating orientation and proximity of target biomarkers to the sensor areas as taught by Agilome. The motivation being to provide a portable and easily mass manufactured sensor (Agilome, [0020], [0022]).
Regarding claim 26, an integrated biosensor card and bare die sensor assembly for targeted biomarker detection (an electrochemical sensor; [0034]), comprising:
a semiconductor die having a top surface with a least one sensor device having at least one sensor area and bond pads associated with each said at least one sensor device (a semiconductor die 30 having a bottom surface and a top surface with a pH sensor element 34 and electrical contacts 31a, b; Fig. 2f; [0041]); and
a support member having a bottom side with conductive traces corresponding to the bond pads (an interposer substrate 20 having a top side 26 and bottom side 23 with a liquid access opening 25 therethrough, the sensor element 34 facing into the opening 25 forming a well, the bottom side having electrical contacts 21a, b; Figs. 2a, 2f; [0037], [0041]).
Merz fails to explicitly disclose further comprising an accumulator in fluid communication with the sensor areas, the accumulator for applying an electrostatic field to a fluid sample for aligning target biomarkers within a fluid sample, wherein the accumulator facilitates enhanced detection by modulating the orientation and proximity of target biomarkers to the sensor areas.
Agilome teaches chemically sensitive field effect transistors (abstract) further comprising an accumulator in fluid communication with the sensor areas, the accumulator for applying an electrostatic field to the fluid sample for aligning target biomarkers within a fluid sample, wherein the accumulator facilitates enhanced detection by modulating orientation and proximity of target biomarkers to the sensor areas (a Chemically-sensitive FET 1 has a well 38 for containing a fluid with microbeads 60 having a target analyte, the FET 1 includes an electric field generator 70 for creating an electric field to draw beads 60 into the well; [0248], [0320]-[0323]).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Merz to include an accumulator in fluid communication with the sensor areas, the accumulator for applying an electrostatic field to the fluid sample for aligning target biomarkers within a fluid sample, wherein the accumulator facilitates enhanced detection by modulating orientation and proximity of target biomarkers to the sensor areas as taught by Agilome. The motivation being to provide a portable and easily mass manufactured sensor (Agilome, [0020], [0022]).
Regarding claim 27, Merz discloses a z-axis conductive adhesive providing selective electrical connection between the bond pads and the conductive traces, while preventing lateral electrical shorting (an anisotropic conductive adhesive connecting the contacts 21a, 31a and 21b, 31b; [0041]).
Regarding claim 28, Merz discloses a detection window formed in the support member and aligned with the sensor areas to define at least one individually accessible sample well (an interposer substrate 20 having a top side 26 and bottom side 23 with a liquid access opening 25 therethrough, the sensor element 34 facing into the opening 25 forming a well, the bottom side having electrical contacts 21a, b; Figs. 2a, 2f; [0037], [0041]).
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Merz in view of a US Patent Application Publication to Daniels (US 2021/0325279 A1; hereinafter, “Daniels”).
Regarding Claim 19, Merz discloses the sensor card assembly configured of claim 17.
Merz fails to explicitly disclose further comprising at least one of hydrophilic and hydrophobic patterns formed on at least one of the top side and the top surface to control flow and positioning of a fluid sample over the detection area.
Daniels teaches a mask based testing system (abstract) further comprising at least one of hydrophilic and hydrophobic patterns formed on at least one of the top side and the top surface to control flow and positioning of a fluid sample over the detection area (a wearable electronic breath chemistry sensor having a breath collector on a top side of a flexcircuit, said breath collector including a hydrophobic field and hydrophilic channels leading into an aperture over a breath sensor; Figs. 5-7; [0206]).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Merz to include at least one of hydrophilic and hydrophobic patterns formed on at least one of the top side and the top surface to control flow and positioning of a fluid sample over the detection area as taught by Daniels. The motivation being to provide a low-cost, scalable, accurate, and easy-to-use testing system (Daniels, [0015]).
Regarding Claim 20, modified Merz discloses the sensor card assembly configured of claim 19.
Merz fails to explicitly disclose wherein the at least one hydrophilic and hydrophobic patterns are arranged to create microchannels that direct the fluid sample towards the detection area.
Daniels teaches the testing system (abstract) wherein the at least one hydrophilic and hydrophobic patterns are arranged to create microchannels that direct the fluid sample towards the detection area (the hydrophobic field and hydrophilic channels direct droplets to an aperture over the breath sensor; Figs. 5-7).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Merz such that the at least one hydrophilic and hydrophobic patterns are arranged to create microchannels that direct the fluid sample towards the detection area as taught by Daniels. The motivation being to provide a low-cost, scalable, accurate, and easy-to-use testing system (Daniels, [0015]).
Regarding Claim 21, modified Merz discloses the sensor card assembly configured of claim 19.
Merz fails to explicitly disclose where the hydrophobic patterns are located around a periphery of the detection area to contain the fluid sample.
Daniels teaches the testing system (abstract) where the hydrophobic patterns are located around a periphery of the detection area to contain the fluid sample (the hydrophobic field surround a periphery of the sensor; Figs. 5-7).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Merz such that the hydrophobic patterns are located around a periphery of the detection area to contain the fluid sample as taught by Daniels. The motivation being to provide a low-cost, scalable, accurate, and easy-to-use testing system (Daniels, [0015]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Merz in view of Daniels as applied to claim 19 above, and further in view of a US Patent Application Publication to Lea, et al. (US 2008/0269075 A1; hereinafter, “Lea”).
Regarding Claim 22, modified Merz discloses the sensor card assembly configured of claim 19.
Merz fails to explicitly disclose further comprising a microstructured surface on the detection area that includes a combination of hydrophilic and hydrophobic regions designed to modulate sample volume and fluid dynamics for optimizing surface wetting properties of the detection area.
Daniels fails to explicitly disclose further comprising a microstructured surface on the detection area that includes a combination of hydrophilic and hydrophobic regions designed to modulate sample volume and fluid dynamics for optimizing surface wetting properties of the detection area.
Lea teaches an assay device (abstract) further comprising a microstructured surface on the detection area that includes a combination of hydrophilic and hydrophobic regions designed to modulate sample volume and fluid dynamics for optimizing surface wetting properties of the detection area (a reading area 16 of an assay device has a polymer planar surface modified to have hydrophobic and hydrophilic sites; [0038]-[0040]).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Merz to include a microstructured surface on the detection area that includes a combination of hydrophilic and hydrophobic regions designed to modulate sample volume and fluid dynamics for optimizing surface wetting properties of the detection area as taught by Lea. The motivation being to optimize the sensitivity of the sensor (Lea, [0014]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Merz in view of a US Patent Application Publication to Grolltex Inc. (US 203/0296558 A1; hereinafter, “Grolltex”).
Regarding Claim 24, Merz discloses the sensor card assembly configured of claim 17.
Merz fails to explicitly disclose wherein the support member is designed to facilitate quick-release engagement with a data processing unit via a mechanical and electrical connector interface, allowing for rapid interchangeability of the sensor card assembly.
Grolltex teaches (a biosensor 510 having contact pads for quick connection with a dongle 520 for electrical communication with a computing device such as a smartphone; Figs. 5, 6; [0078]-[0079], [0083]).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Merz such that the support member is designed to facilitate quick-release engagement with a data processing unit via a mechanical and electrical connector interface, allowing for rapid interchangeability of the sensor card assembly as taught by Grolltex. The motivation being to reduce user workflow and provide for passive sample preparation (Grolltex, [0087]).
Interview with the Examiner
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN C BALL whose telephone number is (571)270-5119. The examiner can normally be reached M - F, 9 am - 5:30 pm.
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/J. Christopher Ball/ Primary Examiner, Art Unit 1795