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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/23/2021 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-24 are pending with claims 1-24 being examined. Claims 25-55 are canceled.
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.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
As to line 2 of claim 21, “the cloud” lacks antecedent basis.
Appropriate action is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The instant rejection reflects the Guidance published in the Federal Register notice titled 2019 Revised Patent Subject Matter Eligibility Guidelines (Vol. 84, No. 4, Monday January 7, 2019 at 50) and the October 2019 Updated Subject Matter Eligibility Guidance (hereinafter both referred to as the “Guidance”).
Framework with which to Evaluate Subject Matter Eligibility:
(1) Are the claims directed to a process, machine, manufacture or composition of matter;
(2A) Are the claims directed to a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea (Prong One); If the claims are directed to a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
(2B) If the claims are directed to a judicial exception and do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
With regard to (1), the instant claims recite “a method for molecular diagnostics comprising a microfluidic cartridge, inserting the microfluidic cartridge into a diagnostic system, detecting the microfluidic cartridge and initiating a sample protocol, wherein initiating the sample testing protocol comprises: reading a computer readable code, receiving a sample test protocol from a computer system based on the computer readable code, and performing the sample protocol, identifying a detection chamber or imaging chamber on the microfluidic device, capturing image data of the patient sample at one or more points during incubation period based on the sample test protocol, performing image analysis on the captured image data; and outputting a diagnostic result based on the image analysis, the sample collection device further comprises a computer readable code, and wherein the sample collection device computer readable code is read and linked to a patient sample or patient reference number, wherein the microfluidic cartridge computer readable code is further linked to test quality information, wherein the diagnostic results are stored in the cloud”, and therefore the answer is "yes".
With regard to (2A), Prong One, under the broadest reasonable interpretation (BRI), the instant claims recite claim steps directed to the judicial exception that is an abstract idea of the type that is in the grouping of “mental process” or “mathematical concepts” (See MPEP 2106.04(a)(2) subsections (I) and (III)) because said operations could be performed in the mind. Mental operations and mathematical concepts in the instant claims are recited as: “a diagnostic system, detecting the microfluidic cartridge and initiating a sample protocol, wherein initiating the sample testing protocol comprises: reading a computer readable code, receiving a sample test protocol from a computer system based on the computer readable code, and performing the sample protocol, identifying a detection chamber or imaging chamber on the microfluidic device, capturing image data of the patient sample at one or more points during incubation period based on the sample test protocol, performing image analysis on the captured image data; and outputting a diagnostic result based on the image analysis, the sample collection device further comprises a computer readable code, and wherein the sample collection device computer readable code is read and linked to a patient sample or patient reference number, wherein the microfluidic cartridge computer readable code is further linked to test quality information, wherein the diagnostic results are stored in the cloud”.
In summary, the claim(s) recite(s) “a method for molecular diagnostics comprising a microfluidic cartridge, inserting the microfluidic cartridge into a diagnostic system, detecting the microfluidic cartridge and initiating a sample protocol, wherein initiating the sample testing protocol comprises: reading a computer readable code, receiving a sample test protocol from a computer system based on the computer readable code, and performing the sample protocol, identifying a detection chamber or imaging chamber on the microfluidic device, capturing image data of the patient sample at one or more points during incubation period based on the sample test protocol, performing image analysis on the captured image data; and outputting a diagnostic result based on the image analysis, the sample collection device further comprises a computer readable code, and wherein the sample collection device computer readable code is read and linked to a patient sample or patient reference number, wherein the microfluidic cartridge computer readable code is further linked to test quality information, wherein the diagnostic results are stored in the cloud” which is a step that can be performed using a computer which uses mathematical algorithms/formulas as a form of an abstract idea.
Said recited judicial exception steps are directed to using a computer which uses mathematical algorithms/formulas for reading, storing and analyzing information, which under the BRI, cover performance of the limitations in the mind and mathematical concepts, as said steps under said interpretation would involve a making a mental comparison and mental correlation or mathematical correlation. Thus, if a claim, under its BRI, covers performance of the limitation in the mind, but for the recitation of generic computer elements, then it falls within the “mental processes” grouping of abstract ideas (see MPEP 2106.04(a)(2)(III)(C)).
Because the claims are directed to abstract ideas, they must further be analyzed under Prong Two to determine if said judicial exceptions are integrated into a practical application as determined by further assessment of the “additional steps” recited in the claims. With respect to Prong Two, the additional elements and the rationale pertaining to why the additional elements are not integrated, are as follows:
(a) The claims recite mathematical process (judicial exception) which are not integrated into a practical application because the method describes “detecting the microfluidic cartridge and initiating a sample protocol, wherein initiating the sample testing protocol comprises: reading a computer readable code, receiving a sample test protocol from a computer system based on the computer readable code, and performing the sample protocol, identifying a detection chamber or imaging chamber on the microfluidic device, capturing image data of the patient sample at one or more points during incubation period based on the sample test protocol, performing image analysis on the captured image data; and outputting a diagnostic result based on the image analysis, the sample collection device further comprises a computer readable code, and wherein the sample collection device computer readable code is read and linked to a patient sample or patient reference number, wherein the microfluidic cartridge computer readable code is further linked to test quality information, wherein the diagnostic results are stored in the cloud” In summary, the claim(s) recite(s) “a method for molecular diagnostics comprising a microfluidic cartridge, inserting the microfluidic cartridge into a diagnostic system, detecting the microfluidic cartridge and initiating a sample protocol, wherein initiating the sample testing protocol comprises: reading a computer readable code, receiving a sample test protocol from a computer system based on the computer readable code, and performing the sample protocol, identifying a detection chamber or imaging chamber on the microfluidic device, capturing image data of the patient sample at one or more points during incubation period based on the sample test protocol, performing image analysis on the captured image data; and outputting a diagnostic result based on the image analysis, the sample collection device further comprises a computer readable code, and wherein the sample collection device computer readable code is read and linked to a patient sample or patient reference number, wherein the microfluidic cartridge computer readable code is further linked to test quality information, wherein the diagnostic results are stored in the cloud”, a mathematical process, but the method for diagnostics does not describe a resultant action/step that is taken by reading a computer readable code, receiving a sample test protocol from a computer system based on the computer readable code, performing the sampling test protocol, performing image analysis on the captured image data and outputting a diagnostic result based on the image analysis, and therefore the method does not add a meaningful limitation to the abstract idea;
(b) Although the claims recite “initiating a sample protocol, wherein initiating the sample testing protocol comprises: reading a computer readable code, receiving a sample test protocol from a computer system based on the computer readable code, and performing the sample protocol, identifying a detection chamber or imaging chamber on the microfluidic device, capturing image data of the patient sample at one or more points during incubation period based on the sample test protocol, performing image analysis on the captured image data; and outputting a diagnostic result based on the image analysis, the sample collection device further comprises a computer readable code, and wherein the sample collection device computer readable code is read and linked to a patient sample or patient reference number, wherein the microfluidic cartridge computer readable code is further linked to test quality information, wherein the diagnostic results are stored in the cloud”, the claims do not apply the exception, as the claim does not transform the diagnostic system to a different state or thing beyond its ordinary purpose (See MPEP 2106.05(f) and MPEP 2106.05(c));
(c) A sample testing protocol that includes a computer readable code and a computer system is recited at a high level of generality (as a generic and well-known structure) such that it is no more than mere instructions to apply the exception using a generic computer/diagnostic system (see MPEP 2106.04(a)(2)(III)(C) and MPEP 2106.05(d));
(d) The claims include “diagnostic results are stored in the cloud”, which is recited at a high level of generality (i.e., generic computer and processor performing generic computer functions) such that the recitations amount to no more than instructions to apply the judicial exceptions on said generic computer (See MPEP 2106.05(f)).
As such, the additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea.
Because the claims fail under (2A), the claims are further evaluated under (2B). The claims herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception under (2B) because, as discussed above with regard to integration of the recited abstract idea into a practical application, the additional elements herein amount to no more than a diagnostic system that includes a computer system, a computer readable code and cloud storage, which do not provide an inventive concept as a generic diagnostic system with a computer and cloud storage is well-understood, routine and conventional. Further, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because (1) the computer system and the cloud storage are being used in their ordinary capacity and are merely tools to execute the abstract idea (See MPEP 2106.05(d)), (2) the additional claim elements of capturing image data, performing image analysis on the captured image data, and outputting a diagnostic result based on the image analysis, whether considered individually or as a whole, do not meaningfully limit the judicial exception (See MPEP 2106.05(e)), (3) the claims recite insignificant extra-solution activity because the activity of using a computer system to read a computer readable code and store results in a cloud storage is not inventive since all diagnostic systems have a computer system and storage that are used to control the processing (See MPEP 2106.05(g)).
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the features represent an abstract idea. Dependent claims 19 and 21 amount to no more than a computer system that reads a computer readable code, performs a sampling testing protocol and stores diagnostic results on a storage cloud, which is an intangible abstract idea or mathematical concept, and similarly does not integrate the exception into a practical application or include additional elements that amount to significantly more. The instant claims do not include an inventive concept.
Thus, in light of the above considerations the claims remain non-statutory, and are thus not patent eligible under 35 U.S.C. 101.
Step 1: Claims 1-24 are directed towards a method for molecular diagnostics..
Step 2A, Prong One: Claim 1 recites the abstract idea, “detecting the microfluidic cartridge…”, initiating a sample test protocol…”, “reading a computer readable code…”, “receiving a sample test protocol from a computer system…”, “performing the sample test protocol…”, “identifying a detection chamber…”, “capturing image data…”, “performing image analysis…”, “outputting diagnostic results…”.
Abstract human reasoning or a generic computer is required to detect the microfluidic cartridge, initiate a sample test protocol, read a computer readable code, receive a sample test protocol from a computer system, perform the sample test protocol, identify a detection chamber, capture image data, perform image analysis and output diagnostic results.
Claim 19 recites the abstract idea “computer readable code is read and linked to a patient sample…”.
Abstract human reasoning or a generic computer is required to read a computer readable code and link to a patient sample.
Claim 21 recites the abstract idea, “results are stored in the cloud…”.
Abstract human reasoning or a generic computer is required to store results in the cloud storage.
Step 2A, Prong Two: These judicial exceptions are not integrated into a practical application because upon evaluating the sample testing protocol, performing image analysis and outputting a diagnostic result based on the image analysis, reading the sample test protocol and storing diagnostic results in a storage cloud, nothing further is performed with the abstract evaluation.
Step 2B: Claim 1 recites the elements “detecting the microfluidic cartridge…”, initiating a sample test protocol…”, “reading a computer readable code…”, “receiving a sample test protocol from a computer system…”, “performing the sample test protocol…”, “identifying a detection chamber…”, “capturing image data…”, “performing image analysis…”, “outputting diagnostic results…”.
Claim 19 recites the element “computer readable code is read and linked to a patient sample…”.
Claim 21 recites “results are stored in the cloud…”.
These elements are interpreted as extra-solution activity which are incidental to the primary process and are mere instructions for performing the sample test protocol, which is not considered significantly more than the abstract idea (see MPEP § 2106.05(g), Insignificant Extra-Solution Activity).
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.
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 1-2, 4, 6-9, 11, 13-14, 16-20 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Williams (translation of ES 2893587 T3; hereinafter “Williams”) in view of Ker (US 20170014822 A1; hereinafter “Ker”), further in view of Galen et al. (US 2019005354 A1; hereinafter “Galen”).
Regarding claim 1, Williams teaches a method for molecular diagnostics (Williams; [0011]), the method comprising:
receiving a patient sample in a collection device (Williams; [0324] and fig. 4. 996); coupling the collection device to a microfluidic cartridge (Williams; fig. 1B and fig. 4. 994, 996); detecting the microfluidic cartridge (Williams; [0024]) and initiating a sample testing protocol (Williams; [0016]-[0117]), wherein initiating the sample testing protocol comprises;
reading a computer readable code (Williams; [0016] “processor receives data from a barcode”) located on the microfluidic cartridge (Williams; [0010] and fig. 23);
receiving a sample test protocol from a computer system based on the computer readable code (Williams; [0085]); and
performing the sample test protocol (Williams; [0305] “the one or more labels containing human and machine readable information pertaining to the analysis to be performed”).
Williams fails to teach dispensing the patient sample into the microfluidic cartridge using capillary action; inserting the microfluidic cartridge into a diagnostic system.
However, Ker teaches the analogous art of a microfluidic cartridge (Ker; Title) wherein dispensing of the patient sample into the microfluidic cartridge is performed using capillary action (Ker; [0016]); inserting the microfluidic cartridge into a diagnostic system (Ker; [0011]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Williams’ method for molecular diagnostics that includes a microfluidic cartridge to dispense the patient sample into the microfluidic cartridge using capillary action and inserting the microfluidic cartridge into a diagnostic system as taught by Ker because Ker teaches a microfluidic cartridge (Ker; Title) wherein dispensing of the patient sample into the microfluidic cartridge is performed using capillary action (Ker; [0016]); inserting the microfluidic cartridge into a diagnostic system (Ker; [0011]).
The modification would allow to place a small amount of the patient’s sample on the microfluidic cartridge.
Williams fails to teach identifying a detection chamber or imaging chamber on the microfluidics device; capturing image data of the patient sample in the detection chamber or imaging chamber at one or more time points during an incubation period based on the sample test protocol; performing image analysis on the captured image data; and outputting a diagnostic result based on the image analysis.
However, Galen teaches the analogous art of a diagnostics system and method (Galen; Title) that includes an optical image device, (Galen; fig. 3A. 330), wherein the optical image device includes an imaging area (Galen; fig. 3B, 312, and [0046]); capturing image data of the patient sample in the detection chamber or imaging chamber at one or more time points during an incubation period (Galen; [0058]) based on the sample test protocol (Galen; [0121] “patient sample analysis of a reader”, “the reader can then identify the analysis to be performed on the sample based on a cartridge feature…”); performing image analysis on the captured image data (Galen; fig. 4. 414); and outputting a diagnostic result based on the image analysis (Galen; [0121] “sample analysis data is then output”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Williams’ method for molecular diagnostics that includes a microfluidic cartridge to identify a detection chamber or imaging chamber on the microfluidics device; capturing image data of the patient sample in the detection chamber or imaging chamber at one or more time points during an incubation period based on the sample test protocol; performing image analysis on the captured image data; and outputting a diagnostic result based on the image analysis as taught by Galen because Galen teaches a diagnostics system and method (Galen; Title) that includes an optical image device, (Galen; fig. 3A. 330), wherein the optical image device includes an imaging area (Galen; fig. 3B, 312, 314, 316, 318 and [0046]); capturing image data of the patient sample in the detection chamber or imaging chamber at one or more time points during an incubation period (Galen; [0058]) based on the sample test protocol (Galen; [0121] “patient sample analysis of a reader”, “the reader can then identify the analysis to be performed on the sample based on a cartridge feature…”); performing image analysis on the captured image data (Galen; fig. 4. 414); and outputting a diagnostic result based on the image analysis (Galen; [0121] “sample analysis data is then output”).
The modification allows the sample to be optically analyzed by taking multiple images of the sample to evaluate the bands (Galen; [0058]).
Regarding claim 2, modified Williams teaches the method of claim 1 (see above), wherein the microfluidic cartridge comprises a sensor (Williams; [0161], [0226] “sensors”) having a sensor surface (Williams; fig. 49. 1011), and optionally wherein the sensor surface comprises a cartridge surface, an immobilization surface or a porous paper matrix (Williams; [0160] “the microfluidic cartridge has sensors positioned in the microfluidic cartridge”).
Regarding claim 4, modified Williams teaches the method of claim 1 (see above) to include an imaging area (chamber) (see above).
Modified Williams fails to teach wherein the detection chamber or imaging chamber comprises one or more regions of interest.
However, Galen teaches the analogous art of a diagnostics system and method (Galen; Title) that includes an imaging area (chamber) (Galen; fig. 3B, 312) 314, 316, 318 and [0046]), wherein the imaging area (chamber) comprises one or more regions of interest (Galen; fig. 3B, 312, 314, 316, 318 and [0046]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Williams’ imaging area to include one or more regions of interest as taught by Galen because Galen teaches a diagnostics system and method (Galen; Title) that includes an imaging area (chamber) (Galen; fig. 3B, 312) 314, 316, 318 and [0046]), wherein the imaging area (chamber) comprises one or more regions of interest (Galen; fig. 3B, 312, 314, 316, 318 and [0046]).
The modification allows to identify the components in the sample and their relative proportions (Galen; [0046]).
Regarding claim 6, modified Williams teaches the method of claim 1 (see above), wherein the sample testing protocol comprises one or more test parameters selected from assay conditions, assay temperature, incubation time, image capture parameters, illumination sources, optical filters or any combination thereof (Williams; [0022] “heating functions can be controlled by the processor”).
Regarding claim 7, modified Williams teaches the method of claim 6 (see above) to include test parameters (see above).
Modified Williams fails to teach the test parameters that include image capture parameters wherein the image capture parameters comprise fluorescent, luminescent or colorimetric, and wherein the captured image data is fluorescent data, colorimetric data, wavelength data, bioluminescent data or chemiluminescent data.
However, Galen teaches the analogous art of a diagnostics system and method (Galen; Title) that includes fluorescence parameters and imaging the electrophoresis testing (Galen; [0046], [0135]) and fig. 3A. 310, 330), wherein the image capture parameters comprise fluorescent data (Galen; [0135]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Williams test parameters to include fluorescence parameters, and wherein the captured image data is fluorescent data as taught by Galen because Galen teaches a diagnostics system and method (Galen; Title) that includes fluorescence parameters and imaging the electrophoresis testing (Galen; [0046], [0135]) and fig. 3A. 310, 330), wherein the image capture parameters comprise fluorescent data (Galen; [0135]).
The modification allows to make it easier to determine the position of the marker (Galen; [0135]).
Regarding claim 8, Modified Williams teaches the method of claim 1 (see above), wherein the sample testing protocol comprises the use of one or more reagents (Williams; [0022]-[0023]) and wherein the one or more reagents are added to the patient sample to create a reaction sample (Williams; [0057], [0088]).
Regarding claim 9, modified Williams teaches the method of claim 8 (see above), wherein the one or more reagents comprises probes or primers, and wherein the probes or primers are stored in a liquid medium or immobilized to the sensor surface (Williams; [0112] “mixture of PCR reagents comprising a fluorogenic hybridization probe”).
Regarding claim 11, modified Williams teaches the method of claim 8 (see above) wherein the one or more reagents comprises a freeze-dried master mix comprising antibodies, enzymes or gold nanoparticles, and wherein the antibodies, enzymes or gold nanoparticles facilitate a change in the captured image data (Williams; [0112], [0305]).
Regarding claim 13, modified Williams teaches the method of claim 8 (see above), wherein the one or more reagents comprises a colorimetric reagent (Williams ; [0088], [0271] “fluorogenic hybridization probe”) and/or a hydrogen peroxide reagent, and wherein the colorimetric reagent and/or hydrogen peroxide reagent are stored on the microfluidic cartridge in one or more reagent storage compartments (Williams; [0163] “plurality of fluorescent dyes at a plurality of different locations in a microfluidic cartridge”).
Regarding claim 14, modified Williams teaches the method of claim 1 (see above), wherein the testing protocol further comprises inactivating the sample in the microfluidic cartridge, and wherein the inactivation comprises chemical, physical or thermal inactivation (Williams; [0387] “target organisms are lysed by heating the collection solution”).
Williams teaches the organisms can be any organism that employs deoxyribonucleic acid (DNA or ribonuncleic acid (RNA) polynucleotides.
It is well known in that heating a are lysed which it is known in the art that heating DNA or RNA in a sample inactivates the nucleic acids.
Regarding claim 16, modified Williams teaches the method of claim 14 (see above) to include physical inactivation of the sample (see above).
Modified Williams fails to teach wherein physical inactivation comprises sonication.
However, Galen teaches the analogous art of a diagnostics system and method (Galen; Title) that includes lysing a sample (inactivating) (Galen; [0051]), wherein physical inactivation comprises sonication (Galen; [0051] “mechanical lysing can be used such as by sonication”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Williams’ physical inactivation of the sample wherein physical inactivation comprises sonication as taught by Galen because Galen teaches a diagnostics system and method (Galen; Title) that includes lysing a sample (inactivating) (Galen; [0051]), wherein physical inactivation comprises sonication (Galen; [0051] “mechanical lysing can be used such as by sonication”).
The modification allows to achieve adequate lysing of the cells of the blood sample in preparation for analysis of the sample (Galen; [0051]).
Regarding claim 17, modified Williams teaches the method of claim 1 (see above), wherein the testing protocol further comprises performing multiplexed detection (Williams; Abstract) of different targets by passing the sample into different detection chambers (Williams; [0156] “the microfluidic cartridge contains multiple sample lanes in parallel and can detect and analyze PCR amplification products in each lane separately”), optionally wherein each of said detection chambers comprises a different (Williams; [0397] “lyophilization chamber has PCR reagents/enzymes”, and [0261] “PCR chamber includes a liquid”).
Regarding claim 18, modified Williams teaches the method of claim 1 (see above), wherein the computer system comprises a processor (Williams; [0016]), storage (Williams; [0021]) and computer readable code (Williams; [0085]), and wherein the computer readable code includes one or more sample testing protocols (Williams; [0085]).
Regarding claim 19, modified Williams teaches the method of claim 1 (see above), wherein the sample collection device further comprises a computer readable code (Williams; [0085] “a label with a combination of reagents for which type of sample preparation”), and wherein the sample collection device computer readable code is read and linked to a patient sample or patient reference number (Williams; [0319]) to facilitate tracking of the patient sample (Williams; [0031]), and wherein optionally the computer readable code is used as a token to communicate with an external database (Williams; [0020]).
Regarding claim 20, modified Williams teaches the method of claim 1 (see above), wherein the microfluidic cartridge computer readable code is further linked to test quality information including but not limited to a cartridge serial number to facilitate automate processing of the patient sample (Williams; [0085]).
Regarding claim 22, Williams teaches the method of claim 2 (see above), wherein the microfluidic cartridge comprises two wire leads capable of receiving a voltage differential in order to move charged particles inside the device reversibly (Williams; [0259] teaches the PCR reaction zone is controlled by passing currents through microfabricated heaters, the heating can be controlled by turning the current on and off with a variable pulse width modulation (PWM).
It is well known in the art that pulse width modulation (PWM) controls the average voltage delivered in a reversible manner.
It is also well known in the art that (PWM) are designed with only two wire leads for their main connections, (positive and negative).
Regarding claim 23, modified Williams teaches the method of claim 2 (see above), wherein the microfluidic cartridge comprises two wire leads capable of receiving a voltage differential in order to heat, lyse particles, or for flow control by manipulating temperature or voltage sensitive materials (Williams; [0378] “rear main panel 180 can be wired to the motor control and two lysis heater plates”).
Williams does not explicitly teach the microfluidic cartridge comprises two wire leads. However, it would have been obvious to have two wire leads in order to complete the path for current flow with one live wire and one neutral wire.
Regarding claim 24, modified Williams teaches the method of claim 2 (see above), wherein the diagnostic device contains electrical connectors that mate with leads of an external device to detect the presence of the microfluidic cartridge (Williamson; [0344] “the microfluidic PCR has individual heaters and sensors that are electrically connected to a printed circuit board using aluminum wire links”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Williams (translation of ES 2893587 T3; hereinafter “Williams”) in view of Ker (US 20170014822 A1; hereinafter “Ker”), further in view of Galen et al. (US 2019005354 A1; hereinafter “Galen”) and Rutter (US 20100267049 A1; hereinafter “Rutter).
Regarding claim 3, modified Williams teaches the method of claim 2 (see above) to include a sensor (see above).
Modified Williams fails to teach the sensor surface comprises an immobilization surface, and wherein the immobilization surface contains agarose, gelatin, alginate, optical fiber, plastic surface or paper matrices.
However, Rutter teaches the analogous art of a diagnostic device and related method (Rutter; Title) that includes a sensor (Rutter; fig. 2A. 111), wherein the sensor surface comprises an immobilization surface (Rutter; fig. 3A. 300, and [0110] “test strip may be used in cartridge 111” and fig. 3A. 302 “substrate”), and wherein the immobilization surface contains agarose, gelatin, alginate, optical fiber, plastic surface or paper matrices (Rutter; 0118]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Williams’ sensor wherein the sensor surface comprises an immobilization surface, and wherein the immobilization surface contains agarose, gelatin, alginate, optical fiber, plastic surface or paper matrices as taught by Rutter because Rutter teaches a diagnostic device and related method (Rutter; Title) that includes a sensor (Rutter; fig. 2A. 111), wherein the sensor surface comprises an immobilization surface (Rutter; fig. 3A. 300, and [0110] “test strip may be used in cartridge 111” and fig. 3A. 302 “substrate”), and wherein the immobilization surface contains agarose, gelatin, alginate, optical fiber, plastic surface or paper matrices (Rutter; 0118]).
The modification allows for fluid applied on the test strip to flow to other strips (Rutter; 0118]).
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Williams (translation of ES 2893587 T3; hereinafter “Williams”) in view of Ker (US 20170014822 A1; hereinafter “Ker”) as applied to claim 1, further in view of
Stein et al. (US 20140080119 A1; hereinafter “Stein”).
Regarding claim 5, modified Williams teaches the method of claim 1 (see above) to include a microfluidic cartridge (see above).
Modified Williams fails to teach the microfluidic cartridge contains pillars, a porous matrix or membrane for separation by size exclusion of particles larger than viral particles.
However, Stein teaches the analogous art of a molecular net used for diagnosis (Stein; [0016]) that includes a device (cartridge) (Stein; fig. 8B. 808 [0393]) wherein the cartridge contains the molecular net (Stein; fig. 8B. 814) a porous matrix (Stein; [0238]) or membrane for separation by size exclusion of particles larger than viral particles (Stein; [0097], [0408] [1224]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Williams’ microfluidic cartridge to contain pillars, a porous matrix or membrane for separation by size exclusion of particles larger than viral particles as taught by Stein because Stein teaches a molecular net used for diagnosis (Stein; [0016]) that includes a device (cartridge) (Stein; fig. 8B. 808 [0393]) wherein the cartridge contains the molecular net (Stein; fig. 8B. 814) a porous matrix (Stein; [0238]) or membrane for separation by size exclusion of particles larger than viral particles (Stein; [0097], [0408] [1224]).
The modification allows to have filters of increasingly smaller pore size to select for viruses Stein; [0408]).
Regarding claim 15, modified Williams teaches the method of claim 14 (see above) to include chemical inactivation (see above).
Modified Williams fails to teach the chemical inactivation comprises incubation with a detergent and/or chelating agent.
However, Stein teaches the analogous art of a molecular net used for diagnosis (Stein; [0016]) that includes a device (cartridge) for analyzing biological samples (Stein; [0091]) wherein the sample is incubated with a chelating agent (Stein; [0561] “samples were spiked with EDTA and incubated”).
It is well known in the art that adding a chelating agent to a biological sample inhibits certain enzymes which could lead to inactivation of the biological sample.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Williams’ chemical inactivation to include incubation with a detergent and/or chelating agent as taught by Stein because Stein teaches a molecular net used for diagnosis (Stein; [0016]) that includes a device (cartridge) for analyzing biological samples (Stein; [0091]) wherein the sample is incubated with a chelating agent (Stein; [0561] “samples were spiked with EDTA and incubated”).
The modification allows to evaluate fluorescence in the sample (Stein; [0561]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Williams (translation of ES 2893587 T3; hereinafter “Williams”) in view of Ker (US 20170014822 A1; hereinafter “Ker”) as applied to claim 1, further in view of Emeric et al (US 20130189794 A1; hereinafter “Emeric”).
Regarding claim 10, modified Williamson teaches the method of claim 8 (see above) to include one or more reagents (see above).
Modified Williamson fails to teach wherein the one or more reagents comprises capture antibodies, and wherein the capture antibodies are stored in a liquid medium or immobilized to the sensor surface.
However, Emeric teaches the analogous art of a cartridge (Emeric; Abstract) for analyzing molecules (proteins) (Emeric; [077]) that includes one or more reagents that are added to the sample (Emeric; [0024], [0100]), wherein the one or more reagents comprises capture antibodies (Emeric; [0024]), and wherein the capture antibodies are stored in a liquid medium or immobilized to the sensor surface.
Emeric does not teach the capture antibodies are stored in a liquid medium or immobilized to the sensor surface.
It would have been obvious to have the capture antibodies stored in a liquid medium to have the capture antibodies ready to use.
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Williamsons one or more reagents to include capture antibodies as taught by Emeric because Emeric teaches a cartridge (Emeric; Abstract) for analyzing molecules (proteins) (Emeric; [077]) that includes one or more reagents that are added to the sample (Emeric; [0024], [0100]), wherein the one or more reagents comprises capture antibodies (Emeric; [0021], [0024]).
The modification allows to the antibody to bind with the analyte in the sample (Emeric; [0024]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Williams (translation of ES 2893587 T3; hereinafter “Williams”) in view of Ker (US 20170014822 A1; hereinafter “Ker”) as applied to claim 1, further in view of Cho et al. (US 20090286327 A1; hereinafter “Cho”).
Regarding claim 12, modified Williams teaches the method of claim 11 (see above) to include a freeze-dried master mix (see above).
Williams fails to teach wherein the freeze-dried master mix is mixed with the patient sample by passing the patient sample through a microfluidic channel in the microfluidic cartridge containing the freeze-dried master mix thereby creating a reaction sample by mixing of the patient sample with the freeze-dried master mix.
However, Cho teaches in the analogous art of analyzing a sample (Cho; 0010), in a microfluidic structure suitable for blood testing (Cho. [0044]) and a lyophilized reagent that can include a mixture with enzymes and small molecules (Cho; [0014]-[0017]), wherein the lyophilized reagent is loaded in a microfluidic chamber (Cho; [0026]), and the patient blood is mixed with the reagents including the lyophilized reagent in the chamber walls (Cho; [0044] “reagent which is suitable for reaction”).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Williams freeze-dried master mix wherein the freeze-dried master mix is mixed with the patient sample by passing the patient sample through a microfluidic channel in the microfluidic cartridge containing the freeze-dried master mix thereby creating a reaction sample by mixing of the patient sample with the freeze-dried master mix as taught by Cho because Cho teaches a sample (Cho; 0010), in a microfluidic structure suitable for blood testing (Cho. [0044]) and a lyophilized reagent that can include a mixture with enzymes and small molecules (Cho; [0014]-[0017]), wherein the lyophilized reagent is loaded in a microfluidic chamber (Cho; [0026]), and the patient blood is mixed with the reagents including the lyophilized reagent in the chamber walls (Cho; [0044] “reagent which is suitable for reaction”).
The modification allows for detecting a target material contained in the sample (Cho; [0044]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Williams (translation of ES 2893587 T3; hereinafter “Williams”) in view of Ker (US 20170014822 A1; hereinafter “Ker”) as applied to claim 1, further in view of Nielsen et al. (US 20150136604 A1; hereinafter “Nielsen”).
Regarding claim 21, modified Williams teaches the method of claim 1 (see above), wherein the diagnostic results further comprise an associated reference number, one or more quality information features, such as batch number, expiry date, lot number (Williams; [0017], [0085] “batch”), or successful analysis threshold (Williams; [0122], [0317]), and one or more operator information features, such as operator ID (Williams; [0319] “patient identification and user”), and optionally wherein the test results are matched with an external database for patient identification (Williams; [0017], [0085]).
Modified Williams fails to teach the diagnostic results are stored in the cloud.
However, Nielsen teaches the analogous art of a sample cartridge that includes microfluidic channels (Nielsen; [0011]), and an electronic device (Nielsen; fig. 19. 1905 and [0322]) configured to run various diagnostic tests (Nielsen; [0318]) fig. 19), wherein the analysis system can be used for cloud computing (Nielsen; [0348]) and store data remotely (Nielsen; [0350]).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Williams diagnostic test results to be stored in the clouds as taught by Nielsen because Nielsen teaches a sample cartridge that includes microfluidic channels (Nielsen; [0011]), and an electronic device (Nielsen; fig. 19. 1905 and [0322]) configured to run various diagnostic tests (Nielsen; [0318]) fig. 19), wherein the analysis system can be used for cloud computing (Nielsen; [0348]) and store data remotely (Nielsen; [0350]).
The modification allows to permit the device to store information remotely and retrieve information when required Nielsen; [0350]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
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, Charles Capozzi can be reached at (571) 270-3638. 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.
/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
Prosecution Insights