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 .
Response to Amendment
The Amendment filed 11/10/2025 has been entered. Claims 1, 5, 6, 8, 12 and 18 have been amended. Claims 1-20 are still pending in the application. Applicant's amendments to the specification has overcome the specification rejection previously set forth in the Non-Final Office Action mailed 08/15/2025. The previous drawing objection and 35 USC 112(b) rejections found in the Non-Final Office Action mailed 08/15/2025 appear to have been overcome and are withdrawn accordingly.
Response to Arguments
Applicant’s arguments with respect to claims 1 , 8, and 18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a flushing component” in claim 8;
“a solution collection component” in claim 16.
“a bearing component” in claim 18.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-2, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (“Microfluidic Surface Plasmon Resonance Sensors: From Principles to Point-of-Care Applications”, 2016)(hereinafter, “Wang”) in view of Baker et al. (US Pub 2019/0124930 A1)(hereinafter, “Baker”).
Regarding claim 1, Wang teaches a method for testing whole blood specimen using fluidic
diffraction chip (discloses LSPR/LSPR sensors integrated with microfluidics for biomolecular detection, microfluidic plasmonic sensing, inject sample into diffraction chip with protrusions grafted with antibody, sections 3.1-3.3) comprises:
injecting a whole blood sample into a diffraction chip (discloses delivery of biological samples through microfluidic channels to the plasmonic sensing area, section 3.2. Droplet-Based SPR Sensor); wherein the diffraction chip comprises a chip layer having a diffraction area, wherein the diffraction area comprises a plurality of protrusions and is grafted with an antibody that specifically binds to the test target(discloses metal nanostructure arrays functionalized with antibodies, section 3.1. Flow-through SPR Sensor); wherein the material of the chip layer is selected from the group consisting of polydimethylsiloxane (PDMS), polymethyl methacrylate (PMMA), and polyethylene terephthalate (PET) (discloses PDMS and PMMA, section 3.3. Microfluidic Surface Plasmon Resonance Sensor for Point-of-Care (POC) Diagnostics);
rinsing the diffraction chip (discloses washing steps, section 3.3. Microfluidic Surface Plasmon Resonance Sensor for Point-of-Care (POC) Diagnostics);
emitting a laser light source vertically (vertical emission is implied, as standard LSPR transmittance measurement is normal-incidence,) through the diffraction area of the diffraction chip (discloses absorbance/transmittance in the visible range, section 3.1. Flow-through SPR Sensor), wherein the wavelength range of the laser light source is 400 nm to 700 nm (“the material for microfluidic cell must have low absorbance at wavelength 450–700 nm, as in this region most nanoparticles absorb light”, section 3.1. Flow-through SPR Sensor); and receiving a laser diffraction signal (discloses monitoring light transmitted or reflected through/at the LSPR sensor surface, section 3.1. Flow-through SPR Sensor) on the opposite surface of the laser light source (discloses detecting the signal on the side opposite to the light incidence, section 2.4. Localized Surface Plasmon Resonance Sensor), and the quantity of a measured target being calculated (discloses the measured optical signal shift in absorption/transmittance is proportional to analyte concentration, section 2.4. Localized Surface Plasmon Resonance Sensor) by the attenuation of the laser diffraction signal(discloses that changes in the optical signal reflect the analyte quantity, “resulting in a shift of the absorption spectrum”, section 2.4. Localized Surface Plasmon Resonance Sensor).
Wang fails to disclose the power density of the laser light source passing through the diffraction chip is 2 mW/
c
m
2
to 2000 mW/
c
m
2
.
Baker teaches the energy range of the laser light source is 2 mW/
c
m
2
to 2000 mW/
c
m
2
(“a 405 nm diode laser having a nominal output power of 10 mW was used, in place of a high power 405 nm diode laser. The 10 mW laser has an adjustable beam size, and the size was adjusted to provide a laser power density in the range of 2-4 mW/
c
m
2
”, [0047]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to utilizing a laser power density between 2 and 4 mW/
c
m
2
of Baker to Wang to simplify the experimental configuration by removing the need for a power-reducing beamsplitter ([0047]), thereby optimizing laser power management and reducing system complexity.
Regarding claim 2, Wang teach further comprising drying the diffraction chip (discloses controlling evaporation, inherently discloses the drying step, section 3.2. Droplet-Based SPR Sensor).
Regarding claim 7, Wang teaches wherein the attenuation of the laser diffraction signal is proportional to the quantity of the tested target (discloses SPR signals change due to analyte binding, the quantitative relationship between signal change (resonance shift) and target concentration is implied, section 2.4. Localized Surface Plasmon Resonance Sensor).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (“Microfluidic Surface Plasmon Resonance Sensors: From Principles to Point-of-Care Applications”, 2016)(hereinafter, “Wang”) in view of Baker et al. (US Pub 2019/0124930 A1)(hereinafter, “Baker”), further in view of Nagrath et al. ( WO 2010080978 A2)(hereinafter, “Nagrath”).
Regarding claim 3, Wang in view of Baker teach wherein the whole blood sample passes through the diffraction chip ( discloses delivery of biological samples through microfluidic channels to the plasmonic sensing area, section 3.2. Droplet-Based SPR Sensor).
Wang in view of Baker fail to disclose wherein the whole blood sample at a flow rate ranging from 1 ml/hr to 12 ml/hr.
Nagrath teaches wherein the whole blood sample at a flow rate ranging from 1 ml/hr to 12 ml/hr (“the whole blood sample at a whole blood sample flow rate of 30 μL/min, the whole blood sample at a whole blood sample flow rate of 50 μL/min”, discloses 1.8 ml/hr to 3 ml/hr, [00010]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to incorporate the whole blood sample flow rate range of Nagrath to Wang in view of Baker to reduce noise and interference from blood components, thereby improving capture purity ([00007] and [00021]).
Regarding claim 4, Wang in view of Baker teach wherein the whole blood sample passes through the diffraction chip ( discloses delivery of biological samples through microfluidic channels to the plasmonic sensing area, section 3.2. Droplet-Based SPR Sensor).
Wang in view of Baker fail to disclose wherein the whole blood sample at a flow rate ranging from 1 ml/hr to 3 ml/hr.
Nagrath teaches wherein the whole blood sample at a flow rate ranging from 1 ml/hr to 3 ml/hr (“the whole blood sample at a whole blood sample flow rate of 30 μL/min, the whole blood sample at a whole blood sample flow rate of 50 μL/min”, discloses 1.8 ml/hr to 3 ml/hr, [00010]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to incorporate the whole blood sample flow rate range of Nagrath to Wang in view of Baker to reduce noise and interference from blood components, thereby improving capture purity ([00007] and [00021]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (“Microfluidic Surface Plasmon Resonance Sensors: From Principles to Point-of-Care Applications”, 2016)(hereinafter, “Wang”) in view of Baker et al. (US Pub 2019/0124930 A1)(hereinafter, “Baker”), further in view of Nagrath et al. ( WO 2010080978 A2)(hereinafter, “Nagrath”), in view of Tao et al. (US Pub 2012/0029045 A1) (hereinafter, “Tao ”).
Regarding claim 5, Wang in view of Baker, further in view of Nagrath teach the diffraction chip (inherently discloses the light interacting with nanostructures for biosensing, section 2.4. Localized Surface Plasmon Resonance Sensor ) but fail to teach wherein the wavelength range of the laser light source is 500 nm to 575 nm , and the laser power density range is between 10 mW/
c
m
2
to 100 mW/
c
m
2
.
Tao teaches the wavelength range of the laser light source is 500 nm to 575 nm (discloses a KTP laser (pulsed Nd:YAG laser, 532 nm), [0032]), and the laser power density range is between 10 mW/
c
m
2
to 100 mW/
c
m
2
( discloses a power density in the range of about 60 mW/
c
m
2
to 100 mW/
c
m
2
).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate the 532nm KTP laser of Tao to Wang in view of Baker, further in view of Nagrath to enhance signal clarity, thereby enhance detection sensitivity ([0032]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (“Microfluidic Surface Plasmon Resonance Sensors: From Principles to Point-of-Care Applications”, 2016)(hereinafter, “Wang”) in view of Baker et al. (US Pub 2019/0124930 A1)(hereinafter, “Baker”), further in view of Nagrath et al. ( WO 2010080978 A2)(hereinafter, “Nagrath”), further in view of Zimmerley et al. (US Pub 2020/0009556 A1) (hereinafter, “Zimmerley ”), further in view of Meuler et al. (US Pub 2017/0045284 A1)(hereinafter, “Meuler”).
Regarding claim 6, Wang teaches the diffraction chip (inherently discloses the light interacting with nanostructures for biosensing, section 2.4. Localized Surface Plasmon Resonance Sensor).
Wang in view of Baker, further in view of Nagrath fail to teach wherein the diffraction chip further comprises: an upper cover, which comprises an input port injecting the whole blood sample into the diffraction chip; and an output port exporting the whole blood sample from the diffraction chip; and an adhesive layer, bonding the upper cover and the chip layer, with a thickness of 200 μm to 500 μm, wherein the adhesive layer has a hollow block for the whole blood sample to pass through the diffraction chip, and the hollow block comprises: an injection channel connected to the input port to introduce the whole blood sample into the diffraction area; a diffusion area connecting the injection channel and the vertical line of the diffusion area overlapping the vertical line of the diffusion area; and an outflow channel connected to the diffusion area and connected to the output port to make the whole blood sample flow out of the diffusion area.
Zimmerley teaches comprises: an upper cover (upper substrate 41/310, the top fluidic layer, [0085]), which comprises an input port (inlet ends of the microfluidic channels 138/438, where the sample is introduced into the flow cell, [0084-0086]) injecting the whole blood sample into the diffraction chip; and an output port (outlet of microfluidic channels 138/438, where the fluid exits after passing through the sensing region (wells), [0084-0086]) exporting the whole blood sample from the diffraction chip;
an adhesive layer(adhesive layers 134/146, [0087]), bonding the upper cover and the chip layer (figure 3), wherein the adhesive layer has a hollow block (discloses laser-cut microfluidic channels 138/438 through the adhesive layer/interposer, [0089]) for the whole blood sample to pass through the diffraction chip (used for fluid transport through the device, [0089]), and the hollow block comprises:
an injection channel connected to the input port to introduce the whole blood sample into the diffraction area (teaches the microfluidic channels 138 structured to deliver the fluid (e.g., blood), [0084]);
a diffusion area (functionalized wells 314/324, binding zone where interaction occurs, [0081]) connecting the injection channel and the vertical line of the diffusion area overlapping the vertical line (discloses a stacked chip structure with layers aligned vertically, layered stack 41, 43, 42 with channels and wells aligned, [0086] ) of the diffusion area; and
an outflow channel (microfluidic channels 438, [0086]) connected to the diffusion area and connected to the output port to make the whole blood sample flow out of the diffusion area (discloses microfluidic channels 438 that pass through adhesive layers and base layer and are fluidly connected to wells 414 and 424, [0086]).
Meuler teaches an adhesive layer (the adhesive layer 205, [0065]) with a thickness of 200 μm to 500 μm (discloses the adhesive layer 205 about 225 micrometers”, [0065]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate a diffraction chip design comprising an upper cover; a chip layer; an adhesive layer; an injection channel; a diffusion area; and an outflow channel of Zimmerley and an adhesive layer thickness range of Meuler to Wang in view of Baker, further in view of Nagrath to reduce background fluorescence noise, thereby improving measurement accuracy and detection fidelity ([0087-0090]).
Claims 8-9, and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (“Microfluidic Surface Plasmon Resonance Sensors: From Principles to Point-of-Care Applications”, 2016)(hereinafter, “Wang”) in view of Baker et al. (US Pub 2019/0124930 A1)(hereinafter, “Baker”), further in view of Wawro et al. (US Pub 2014/0056559 A1)(hereinafter, “Wawro”).
Regarding claim 8, Wang teaches a system for testing whole blood specimen using diffraction
chip (discloses LSPR/LSPR sensors integrated with microfluidics for biomolecular detection, microfluidic plasmonic sensing, inject sample into diffraction chip with protrusions grafted with antibody, sections 3.1-3.3) comprises:
a sample injection component for passing a whole blood sample through a diffraction chip (discloses delivery of biological samples through microfluidic channels to the plasmonic sensing area, section 3.2. Droplet-Based SPR Sensor); wherein the diffraction chip comprises a chip layer having a diffraction area, wherein the diffraction area comprises a plurality of protrusions and is grafted with an antibody that specifically binds to the test target(discloses metal nanostructure arrays functionalized with antibodies, section 3.1. Flow-through SPR Sensor); wherein the material of the chip layer is selected from the group consisting of polydimethylsiloxane (PDMS), polymethyl methacrylate (PMMA), and polyethylene terephthalate (PET) (discloses PDMS and PMMA, section 3.3. Microfluidic Surface Plasmon Resonance Sensor for Point-of-Care (POC) Diagnostics);
a flushing component for flushing the diffraction chip (discloses the need for sample preparation and purification before interaction with SPR sensor, section 3.3. Microfluidic Surface Plasmon Resonance Sensor for Point-of-Care (POC) Diagnostics);
a laser transmitter being disposed above a fixing component (discloses the light source used for exciting the SPR, inherently implies that a light source is used to illuminate the sensor, section 3.3. Microfluidic Surface Plasmon Resonance Sensor for Point-of-Care (POC) Diagnostics), is used for emitting a laser light source through the diffraction chip (discloses absorbance/transmittance in the visible range, section 3.1. Flow-through SPR Sensor), wherein the wavelength range of the laser light source is 400 nm to 700 nm (“the material for microfluidic cell must have low absorbance at wavelength 450–700 nm, as in this region most nanoparticles absorb light”, section 3.1. Flow-through SPR Sensor).
a laser receiver being disposed below the fixing component and on the opposite side of the laser transmitter, for receiving a laser diffraction signal(discloses detect changes in light intensity after it interacts with a surface, section 3.2. Droplet-Based SPR Sensor); wherein the laser receiver and the center of the laser transmitter are located on the same axis (section 3.1. Flow-through SPR Sensor).
Wang fails to teach the energy range of the laser light source is 2 mW/
c
m
2
to 2000 mW/
c
m
2
; a processor receiving the laser diffraction signal and calculating the quantity of a test target according to the attenuation of the laser diffraction signal; and a bearing component being arranged on the fixing component and between the laser transmitter and the laser receiving unit for placing the diffraction chip.
Baker teaches the energy range of the laser light source is 2 mW/
c
m
2
to 2000 mW/
c
m
2
(“a 405 nm diode laser having a nominal output power of 10 mW was used, in place of a high power 405 nm diode laser. The 10 mW laser has an adjustable beam size, and the size was adjusted to provide a laser power density in the range of 2-4 mW/
c
m
2
”, [0047]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to utilizing a laser power density between 2 and 4 mW/
c
m
2
of Baker to Wang to simplify the experimental configuration by removing the need for a power-reducing beamsplitter ([0047]), thereby optimizing laser power management and reducing system complexity.
Wawro teaches a processor (detection unit, [0079]) receiving the laser diffraction signal and calculating the quantity of a test target according to the attenuation of the laser diffraction signal (discloses the detection unit measures the intensity of the reflected signal, the power meter measures the attenuation or changes in intensity of the laser light, “to monitor the intensity of the reflected signal 36 using a fixed wavelength laser source, the detection unit may be an optical power meter, such as a Newport 835 optical power meter”, [0079]); and a bearing component being arranged on the fixing component and between the laser transmitter and the laser receiving unit for placing the diffraction chip (discloses the concept of arranging and placing optical components like the waveguide grating and detection unit for proper alignment, [0079]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate a detection unit of Wawro to Wang in view of Baker to improve sensitivity and accuracy ([0090]).
Regarding claim 9, Wang teach further comprising a drying component for drying the diffraction chip (discloses controlling evaporation, inherently discloses the drying step, section 3.2. Droplet-Based SPR Sensor).
Regarding claim 13, Wang teaches wherein the attenuation of the laser diffraction signal is proportional to the quantity of the tested target (discloses SPR signals change due to analyte binding, the quantitative relationship between signal change (resonance shift) and target concentration is implied, section 2.4. Localized Surface Plasmon Resonance Sensor).
Regarding claim 14, Wang teaches wherein the sample injection component comprises a sample chamber, a syringe pump, an injection channel and an injection joint, wherein the syringe pump of the sample injection component controls the whole blood sample in the sample chamber to flow through the injection channel (“microfluidics reduces the reaction volume and offers an automatic way to deliver the sample, wash, and regenerate the surface”, section 4 conclusions), and the injection joint is set on the injection channel and connected to one of the input ports of the diffraction chip (“the automatic operation of mixing sample and reagent, cleaning and washing, and facilitating sensing”, section 3.3. Microfluidic Surface Plasmon Resonance Sensor for Point-of-Care (POC) Diagnostics).
Regarding claim 15, Wang teaches wherein the flushing component comprises a flushing solution chamber, a syringe pump and a flushing channel, wherein the syringe pump of the flushing component injects a flushing liquid of the flushing solution chamber into the flushing channel, and the flushing channel communicates with the injection channel (“the automatic operation of mixing sample and reagent, cleaning and washing, and facilitating sensing”, section 3.3. Microfluidic Surface Plasmon Resonance Sensor for Point-of-Care (POC) Diagnostics).
Regarding claim 16, Wang teaches further comprises a solution collection component, the solution collection component comprising a collection tank, an export channel and an export joint, wherein two ends of the export channel are connected to the collection tank and the export joint is connected, and the export joint is used for connecting with an output port of the diffraction chip (discloses fluid management and waste handling through microfluidic systems, (“the automatic operation of mixing sample and reagent, cleaning and washing, and facilitating sensing”, section 3.3. Microfluidic Surface Plasmon Resonance Sensor for Point-of-Care (POC) Diagnostics).
Regarding claim 17, Wang teaches further comprising a drying component for drying the diffraction chip (discloses controlling evaporation, inherently discloses the drying step, section 3.2. Droplet-Based SPR Sensor).
Regarding claim 18, Wang teaches a sample injection component including a sample chamber, a syringe pump, an injection channel and an injection joint, wherein the syringe pump controls a whole blood sample in the sample chamber to flow through the injection channel (“microfluidics reduces the reaction volume and offers an automatic way to deliver the sample, wash, and regenerate the surface”, section 4 conclusions), and the injection joint is set on the injection channel and connected to one of the input ports of the diffraction chip (“the automatic operation of mixing sample and reagent, cleaning and washing, and facilitating sensing”, section 3.3. Microfluidic Surface Plasmon Resonance Sensor for Point-of-Care (POC) Diagnostics);
a flushing component including a flushing solution chamber, a syringe pump and a flushing channel, wherein the syringe pump injects a flushing liquid of the flushing solution chamber into the flushing channel, and the flushing channel communicates with the injection channel (“the automatic operation of mixing sample and reagent, cleaning and washing, and facilitating sensing”, section 3.3. Microfluidic Surface Plasmon Resonance Sensor for Point-of-Care (POC) Diagnostics);
a laser receiver being disposed below the fixing component and on the opposite side of the laser transmitter, for receiving a laser diffraction signal (discloses detect changes in light intensity after it interacts with a surface, section 3.2. Droplet-Based SPR Sensor); wherein the laser receiver and the center of the laser transmitter are located on the same axis (section 3.1. Flow-through SPR Sensor).
Wang fails to teach a processor receiving the laser diffraction signal and calculating the quantity of a test target according to the attenuation of the laser diffraction signal; and a bearing component being arranged on the fixing component and between the laser transmitter and the laser receiving unit for placing the diffraction chip.
Wawro teaches a processor (detection unit, [0079]) receiving the laser diffraction signal and calculating the quantity of a test target according to the attenuation of the laser diffraction signal (discloses the detection unit measures the intensity of the reflected signal, the power meter measures the attenuation or changes in intensity of the laser light, “to monitor the intensity of the reflected signal 36 using a fixed wavelength laser source, the detection unit may be an optical power meter, such as a Newport 835 optical power meter”, [0079]); and a bearing component being arranged on the fixing component and between the laser transmitter and the laser receiving unit for placing the diffraction chip (discloses the concept of arranging and placing optical components like the waveguide grating and detection unit for proper alignment, [0079]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate a detection unit of Wawro to Wang in view of Baker to improve sensitivity and accuracy ([0090]).
Regarding claim 19, Wang teaches a solution collection component, the solution collection component comprising a collection tank, an export channel and an export joint, wherein two ends of the export channel are connected to the collection tank and the export joint is connected, and the export joint is used for connecting with an output port of the diffraction chip (discloses fluid management and waste handling through microfluidic systems, (“the automatic operation of mixing sample and reagent, cleaning and washing, and facilitating sensing”, section 3.3. Microfluidic Surface Plasmon Resonance Sensor for Point-of-Care (POC) Diagnostics).
Regarding claim 20, Wang teaches further comprising a drying component for drying the diffraction chip (discloses controlling evaporation, inherently discloses the drying step, section 3.2. Droplet-Based SPR Sensor).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (“Microfluidic Surface Plasmon Resonance Sensors: From Principles to Point-of-Care Applications”, 2016)(hereinafter, “Wang”) in view of Baker et al. (US Pub 2019/0124930 A1)(hereinafter, “Baker”), further in view of Wawro et al. (US Pub 2014/0056559 A1)(hereinafter, “Wawro”), further in view of Nagrath et al. ( WO 2010080978 A2)(hereinafter, “Nagrath”).
Regarding claim 10, Wang in view of Baker teach wherein the sample injection component injects the whole blood sample ( discloses delivery of biological samples through microfluidic channels to the plasmonic sensing area, section 3.2. Droplet-Based SPR Sensor),
Wang in view of Baker, further in view of Wawro fail to disclose the whole blood sample at a flow rate ranging from 1 ml/hr to 12 ml/hr.
Nagrath teaches the whole blood sample at a flow rate ranging from 1 ml/hr to 3 ml/hr (“the whole blood sample at a whole blood sample flow rate of 30 μL/min, the whole blood sample at a whole blood sample flow rate of 50 μL/min”, discloses 1.8 ml/hr to 3 ml/hr, [00010]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to incorporate the whole blood sample flow rate range of Nagrath to Wang in view of Baker to reduce noise and interference from blood components, thereby improving capture purity ([00007] and [00021]).
Regarding claim 11, Wang in view of Baker teach wherein the sample injection component injects the whole blood sample ( discloses delivery of biological samples through microfluidic channels to the plasmonic sensing area, section 3.2. Droplet-Based SPR Sensor).
Wang in view of Baker, further in view of Wawro fail to disclose the whole blood sample at a flow rate ranging from 1 ml/hr to 7 ml/hr.
Nagrath teaches the whole blood sample at a flow rate ranging from 1 ml/hr to 7 ml/hr (“the whole blood sample at a whole blood sample flow rate of 30 μL/min, the whole blood sample at a whole blood sample flow rate of 50 μL/min”, discloses 1.8 ml/hr to 3 ml/hr, [00010]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to incorporate the whole blood sample flow rate range of Nagrath to Wang in view of Baker to reduce noise and interference from blood components, thereby improving capture purity ([00007] and [00021]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (“Microfluidic Surface Plasmon Resonance Sensors: From Principles to Point-of-Care Applications”, 2016)(hereinafter, “Wang”) in view of Baker et al. (US Pub 2019/0124930 A1)(hereinafter, “Baker”), further in view of Wawro et al. (US Pub 2014/0056559 A1)(hereinafter, “Wawro”), further in view of Nagrath et al. ( WO 2010080978 A2)(hereinafter, “Nagrath”), further in view of Zimmerley et al. (US Pub 2020/0009556 A1) (hereinafter, “Zimmerley ”), further in view of Meuler et al. (US Pub 2017/0045284 A1)(hereinafter, “Meuler”).
Regarding claim 12, Wang teaches the diffraction chip (inherently discloses the light interacting with nanostructures for biosensing, section 2.4. Localized Surface Plasmon Resonance Sensor).
Wang in view of Baker, further in view of Nagrath fail to teach wherein the diffraction chip further comprises: an upper cover, which comprises an input port injecting the whole blood sample into the diffraction chip; and an output port exporting the whole blood sample from the diffraction chip; and an adhesive layer, bonding the upper cover and the chip layer, with a thickness of 200 μm to 500 μm, wherein the adhesive layer has a hollow block for the whole blood sample to pass through the diffraction chip, and the hollow block comprises: an injection channel connected to the input port to introduce the whole blood sample into the diffraction area; a diffusion area connecting the injection channel and the vertical line of the diffusion area overlapping the vertical line of the diffusion area; and an outflow channel connected to the diffusion area and connected to the output port to make the whole blood sample flow out of the diffusion area.
Zimmerley teaches comprises: an upper cover (upper substrate 41/310, the top fluidic layer, [0085]), which comprises an input port (inlet ends of the microfluidic channels 138/438, where the sample is introduced into the flow cell, [0084-0086]) injecting the whole blood sample into the diffraction chip; and an output port (outlet of microfluidic channels 138/438, where the fluid exits after passing through the sensing region (wells), [0084-0086]) exporting the whole blood sample from the diffraction chip;
an adhesive layer(adhesive layers 134/146, [0087]), bonding the upper cover and the chip layer (figure 3), wherein the adhesive layer has a hollow block (discloses laser-cut microfluidic channels 138/438 through the adhesive layer/interposer, [0089]) for the whole blood sample to pass through the diffraction chip (used for fluid transport through the device, [0089]), and the hollow block comprises:
an injection channel connected to the input port to introduce the whole blood sample into the diffraction area (teaches the microfluidic channels 138 structured to deliver the fluid (e.g., blood), [0084]);
a diffusion area (functionalized wells 314/324, binding zone where interaction occurs, [0081]) connecting the injection channel and the vertical line of the diffusion area overlapping the vertical line (discloses a stacked chip structure with layers aligned vertically, layered stack 41, 43, 42 with channels and wells aligned, [0086] ) of the diffusion area; and
an outflow channel (microfluidic channels 438, [0086]) connected to the diffusion area and connected to the output port to make the whole blood sample flow out of the diffusion area (discloses microfluidic channels 438 that pass through adhesive layers and base layer and are fluidly connected to wells 414 and 424, [0086]).
Meuler teaches an adhesive layer (the adhesive layer 205, [0065]) with a thickness of 200 μm to 500 μm (discloses the adhesive layer 205 about 225 micrometers”, [0065]).
It would have been obvious to one of ordinary skill in the art before the earliest effective filing date to integrate a diffraction chip design comprising an upper cover; a chip layer; an adhesive layer; an injection channel; a diffusion area; and an outflow channel of Zimmerley and an adhesive layer thickness range of Meuler to Wang in view of Baker, further in view of Nagrath to reduce background fluorescence noise, thereby improving measurement accuracy and detection fidelity ([0087-0090]).
Conclusion
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/C.X./Examiner, Art Unit 2877
/Kara E. Geisel/Supervisory Patent Examiner, Art Unit 2877