DETAILED ACTION
Notices to Applicant
This communication is a First Action Non-Final on the merits. Claims 1-20 as filed 01/07/2025, are currently pending and have been considered below.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application claims priority to U.S. Provisional Application Serial No. 63/368,993, filed 07/21/2022, and is a 371 of PCT/US/2023/070421 files 07/18/2023.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, U.S. Provisional Application Serial No. 63/368,993, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The U.S. Provisional Application Serial No. 63/368,993 fails to provide support for essential elements of the claims, including but limited to measurement hardware in communication with the processor and configured to measure properties of a specimen and a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations. The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. See MPEP 37 CFR 1.57(b), 608.01(p).
Claim Objections
Claims 2 and 17 are objected to because of the following informalities:
Claim 2 recites “determining a customized number of samples required to achieve a desired accuracy comprises” – the claim should read, “determining the customized number of samples required to achieve a desired accuracy comprises.”
Claim 17 recites “wherein determining an optimal number of samples required to achieve a desired accuracy” – the claim should read, “wherein determining the optimal number of samples required to achieve a desired accuracy.” to maintain antecedent basis with claim 16, that introduces the element in the claim from which claim 17 depends.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-7 and 12 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "a user” twice, in lines 2 and 3, respectively. As a result, it is unclear as to whether each recitation of “a user” is the same or different claim element. Claim 7 also recites “a user” such that it is unclear as to which “a user” element it is referring to. As a result, claims 6 and 7 fail to maintain proper antecedent basis for this element in the claims.
Claim 12 recites the limitation "the stored mean and standard deviation.” There is insufficient antecedent basis for this limitation in the claim.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Claims 1-7 are drawn to a clinical diagnostic analyzer for conducting customized automated crossover studies comprising a processor and memory, which is within the four statutory categories (i.e. machine).
Independent Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites (additional elements bolded):
1. A clinical diagnostic analyzer for conducting customized automated crossover studies, comprising:
a processor;
measurement hardware in communication with the processor and configured to measure properties of a specimen;
a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations comprising:
determining a customized number of samples required to achieve a desired accuracy for a new lot of quality control material;
analyzing, over a period of time, a number of QC specimens corresponding to the customized number of samples;
storing a result for each of the analyzed QC specimens, and loading and testing an analyte from a patient specimen using the stored results.
The claim data, as drafted, is a machine that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through rules or instructions but for the recitation of generic computer components. That is, other than reciting “a processor; measurement hardware in communication with the processor and configured to measure properties of a specimen; a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations,” nothing in the claim precludes the steps from management of personal behavior or interactions between people through rules or instructions. For example, but for the above bolded language, determining a customized number of samples required to achieve a desired accuracy for a new lot of quality control material; analyzing, over a period of time, a number of QC specimens corresponding to the customized number of samples; storing a result for each of the analyzed QC specimens, and testing an analyte from a patient specimen using the stored results in the context of this claim encompasses the rules or instructions for managing behaviors for conducting customized crossover studies. If a claim limitation, under its broadest reasonable interpretation, covers rules or instructions for managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Further, the limitations of determining a customized number of samples required to achieve a desired accuracy for a new lot of quality control material; and analyzing, over a period of time, a number of QC specimens corresponding to the customized number of samples cover performance of the limitations in the mind but for the recitation of generic computer components, such that they falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea(s).
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements, for example, “a processor; measurement hardware in communication with the processor and configured to measure properties of a specimen; a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations,” to perform the claim limitations. The elements in each of these steps are recited at a high-level of generality (i.e., any controller, microcontroller, or microprocessor knowing in the art, hard drives, solid state memory, and combinations thereof and interface circuitry to allow communication to and from a network, each as they relate to general purpose computer components and measurement hardware comprising a sample receptacle configured to receive one or more samples, within vials to extract analytes, from any desired specimen vial, and external turntables, loaders, or other mechanisms to facilitate loading and unloading of samples (Application Specification [0030], [0031], [0033], [0036]) As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer or other machinery in its ordinary capacity, or merely uses a computer or other machinery in its ordinary capacity as a tool to perform an abstract idea. See MPEP 2106.05(f)(2). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the above bolded additional elements, for example, “a processor; measurement hardware in communication with the processor and configured to measure properties of a specimen; a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using a generic computer component. (i.e., any controller, microcontroller, or microprocessor knowing in the art, hard drives, solid state memory, and combinations thereof and interface circuitry to allow communication to and from a network, each as they relate to general purpose computer components and measurement hardware comprising a sample receptacle configured to receive one or more samples, within vials to extract analytes, from any desired specimen vial, and external turntables, loaders, or other mechanisms to facilitate loading and unloading of samples (Application Specification [0030], [0031], [0033], [0036]) Mere instructions to apply an exception using a generic computer component or other machinery in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f)(2). The claim is not patent eligible.
Dependent claims 2-7 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Dependent claims 6 and 7 recite the additional element of “an input panel and display operable to present information and data from the processor to a user and to accept input and selection from a user,” and “presenting a prompt on the input panel and display,” and “accept an input from the user,” which amounts to mere instructions to apply the abstract idea using generic computer components or other machinery in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f)(2); (Application Specification [0030], [0031], [0033]) Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claims 8-11 are drawn to a system clinical diagnostic analyzer for conducting customized automated crossover studies, which is within the four statutory categories (i.e. machine).
Independent Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 8 recites (additional elements bolded):
8. A system for conducting customized automated crossover studies, comprising:
a server comprising a processor, a memory and a database;
a plurality of clinical diagnostic analyzers in communication with the server, wherein each of the plurality of clinical diagnostic analyzers comprises:
a processor;
measurement hardware in communication with the processor and configured to measure properties of a specimen;
a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations comprising:
loading a specimen from a new lot of quality control material into the measurement hardware;
wherein the memory of the server has stored thereon executable instructions that, when executed by the server processor, cause the server to perform operations comprising: determining a customized number of samples required to achieve a desired accuracy for a new lot of quality control material;
analyzing, over a period of time, a number of QC specimens corresponding to the customized number of samples, storing a result for each of the analyzed QC specimens; and
loading and testing an analyte from a patient specimen using the stored results.
The claim data, as drafted, is a machine that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through rules or instructions but for the recitation of generic computer components. That is, other than reciting “a server comprising a processor, a memory and a database,” “wherein the memory of the server has stored thereon executable instructions that, when executed by the server processor, cause the server to perform operations,” “a plurality of clinical diagnostic analyzers in communication with the server, wherein each of the plurality of clinical diagnostic analyzers comprises: a processor; measurement hardware in communication with the processor and configured to measure properties of a specimen; a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations,” nothing in the claim precludes the steps from management of personal behavior or interactions between people through rules or instructions. For example, but for the above bolded language, loading a specimen from a new lot of quality control material; determining a customized number of samples required to achieve a desired accuracy for a new lot of quality control material; analyzing, over a period of time, a number of QC specimens corresponding to the customized number of samples, storing a result for each of the analyzed QC specimens; and testing an analyte from a patient specimen using the stored results in the context of this claim encompasses the rules or instructions for managing behaviors for conducting customized crossover studies. If a claim limitation, under its broadest reasonable interpretation, covers rules or instructions for managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Further, the limitations of determining a customized number of samples required to achieve a desired accuracy for a new lot of quality control material and analyzing, over a period of time, a number of QC specimens corresponding to the customized number of samples cover performance of the limitations in the mind but for the recitation of generic computer components, such that they falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea(s).
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements, for example, “a server comprising a processor, a memory and a database,” “wherein the memory of the server has stored thereon executable instructions that, when executed by the server processor, cause the server to perform operations,” “a plurality of clinical diagnostic analyzers in communication with the server, wherein each of the plurality of clinical diagnostic analyzers comprises: a processor; measurement hardware in communication with the processor and configured to measure properties of a specimen; a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations,” to perform the claim limitations. The elements in each of these steps are recited at a high-level of generality (i.e., any server, server system, computer, or computer system known in the art; any controller, microcontroller, or microprocessor knowing in the art; hard drives, solid state memory, and combinations thereof and interface circuitry to allow communication to and from a network, each as they relate to general purpose computer components and measurement hardware comprising a sample receptacle configured to receive one or more samples, within vials to extract analytes, from any desired specimen vial, and external turntables, loaders, or other mechanisms to facilitate loading and unloading of samples (Application Specification [0030], [0031], [0033], [0036]). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer or other machinery in its ordinary capacity, or merely uses a computer or other machinery in its ordinary capacity as a tool to perform an abstract idea. See MPEP 2106.05(f)(2). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the above bolded additional elements, for example, “a server comprising a processor, a memory and a database,” “wherein the memory of the server has stored thereon executable instructions that, when executed by the server processor, cause the server to perform operations,” “a plurality of clinical diagnostic analyzers in communication with the server, wherein each of the plurality of clinical diagnostic analyzers comprises: a processor; measurement hardware in communication with the processor and configured to measure properties of a specimen; a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using a generic computer component. (i.e., any server, server system, computer, or computer system known in the art; any controller, microcontroller, or microprocessor knowing in the art; hard drives, solid state memory, and combinations thereof and interface circuitry to allow communication to and from a network, each as they relate to general purpose computer components and measurement hardware comprising a sample receptacle configured to receive one or more samples, within vials to extract analytes, from any desired specimen vial, and external turntables, loaders, or other mechanisms to facilitate loading and unloading of samples (Application Specification [0030], [0031], [0033], [0036]). Mere instructions to apply an exception using a generic computer component or other machinery in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f)(2). The claim is not patent eligible.
Dependent claims 9-11 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Dependent claim 11 recites the additional element of “an input panel and display,” to “present a prompt on the input panel and display,” and “accept an input from the user,” which amounts to mere instructions to apply the abstract idea using generic computer components or other machinery in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f)(2); (Application Specification [0030], [0031], [0033]) Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claims 12-15 are drawn to a clinical diagnostic analyzer for conducting customized automated crossover studies comprising a processor and memory, which is within the four statutory categories (i.e. machine).
Independent Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 12 recites (additional elements bolded):
12. A method for conducting customized automated crossover studies, comprising:
determining a customized number of samples required to achieve a desired accuracy for a new lot of quality control material;
loading a specimen from a new lot of quality control material into measurement hardware of a clinical diagnostic analyzer;
analyzing the specimen to obtain a data value corresponding to an attribute of the specimen;
obtaining and storing data values from a number of QC samples corresponding to the customized number of samples;
storing the obtained data values for each specimen;
loading and testing an analyte from a patient specimen using the stored mean and standard deviation.
The claim data, as drafted, is a machine that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through rules or instructions but for the recitation of generic computer components. That is, other than reciting “measurement hardware of a clinical diagnostic analyzer,” nothing in the claim precludes the steps from management of personal behavior or interactions between people through rules or instructions. For example, but for the above bolded language, determining a customized number of samples required to achieve a desired accuracy for a new lot of quality control material; loading a specimen from a new lot of quality control material; analyzing the specimen to obtain a data value corresponding to an attribute of the specimen; obtaining and storing data values from a number of QC samples corresponding to the customized number of samples; storing the obtained data values for each specimen; loading and testing an analyte from a patient specimen using the stored mean and standard deviation in the context of this claim encompasses the rules or instructions for managing behaviors for conducting customized crossover studies. If a claim limitation, under its broadest reasonable interpretation, covers rules or instructions for managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Further, the limitations of determining a customized number of samples required to achieve a desired accuracy for a new lot of quality control material; and analyzing, over a period of time, a number of QC specimens corresponding to the customized number of samples cover performance of the limitations in the mind but for the recitation of generic computer components, such that they falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea(s).
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements, for example, “measurement hardware of a clinical diagnostic analyzer,” to perform the claim limitations. The elements in each of these steps are recited at a high-level of generality (i.e., measurement hardware comprising a sample receptacle configured to receive one or more samples, within vials to extract analytes, from any desired specimen vial, and external turntables, loaders, or other mechanisms to facilitate loading and unloading of samples (Application Specification [0036]) As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer or other machinery in its ordinary capacity, or merely uses a computer or other machinery in its ordinary capacity as a tool to perform an abstract idea. See MPEP 2106.05(f)(2). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the above bolded additional elements, for example, “measurement hardware of a clinical diagnostic analyzer,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using a generic computer component. (i.e. measurement hardware comprising a sample receptacle configured to receive one or more samples, within vials to extract analytes, from any desired specimen vial, and external turntables, loaders, or other mechanisms to facilitate loading and unloading of samples (Application Specification [0036]) Mere instructions to apply an exception using a generic computer component or other machinery in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f)(2). The claim is not patent eligible.
Dependent claims 13-15 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claims 16-20 are drawn to a clinical diagnostic analyzer for conducting customized automated crossover studies comprising a processor and memory, which is within the four statutory categories (i.e. machine).
Independent Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 16 recites (additional elements bolded):
16 A clinical diagnostic analyzer for conducting crossover studies, comprising:
a processor;
measurement hardware in communication with the processor and configured to measure properties of a specimen;
a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations comprising:
determining an optimal number of samples required to achieve a desired accuracy for a lot of quality control material;
analyzing, over a period of time, a number of QC specimens corresponding to the optimal number of samples; and
loading and testing an analyte from a patient specimen.
The claim data, as drafted, is a machine that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through rules or instructions but for the recitation of generic computer components. That is, other than reciting “a processor; measurement hardware in communication with the processor and configured to measure properties of a specimen; a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations,” nothing in the claim precludes the steps from management of personal behavior or interactions between people through rules or instructions. For example, but for the above bolded language, determining an optimal number of samples required to achieve a desired accuracy for a lot of quality control material; analyzing, over a period of time, a number of QC specimens corresponding to the optimal number of samples; and testing an analyte from a patient specimen in the context of this claim encompasses the rules or instructions for managing behaviors for conducting customized crossover studies. If a claim limitation, under its broadest reasonable interpretation, covers rules or instructions for managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Further, the limitations of determining a customized number of samples required to achieve a desired accuracy for a new lot of quality control material; and analyzing, over a period of time, a number of QC specimens corresponding to the customized number of samples cover performance of the limitations in the mind but for the recitation of generic computer components, such that they falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea(s).
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements, for example, “a processor; measurement hardware in communication with the processor and configured to measure properties of a specimen; a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations,” to perform the claim limitations. The elements in each of these steps are recited at a high-level of generality (i.e., any controller, microcontroller, or microprocessor knowing in the art, hard drives, solid state memory, and combinations thereof and interface circuitry to allow communication to and from a network, each as they relate to general purpose computer components and measurement hardware comprising a sample receptacle configured to receive one or more samples, within vials to extract analytes, from any desired specimen vial, and external turntables, loaders, or other mechanisms to facilitate loading and unloading of samples (Application Specification [0030], [0031], [0033], [0036]) As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer or other machinery in its ordinary capacity, or merely uses a computer or other machinery in its ordinary capacity as a tool to perform an abstract idea. See MPEP 2106.05(f)(2). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the above bolded additional elements, for example, “a processor; measurement hardware in communication with the processor and configured to measure properties of a specimen; a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using a generic computer component. (i.e., any controller, microcontroller, or microprocessor knowing in the art, hard drives, solid state memory, and combinations thereof and interface circuitry to allow communication to and from a network, each as they relate to general purpose computer components and measurement hardware comprising a sample receptacle configured to receive one or more samples, within vials to extract analytes, from any desired specimen vial, and external turntables, loaders, or other mechanisms to facilitate loading and unloading of samples (Application Specification [0030], [0031], [0033], [0036]) Mere instructions to apply an exception using a generic computer component or other machinery in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f)(2). The claim is not patent eligible.
Dependent claims 17-20 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2022/0199206 A1 (hereinafter “Yundt-Pacheco et al.”) in view of U.S. 2019/0303361 A1 (hereinafter “Ashida et al.”).
RE: Claim 1 Yundt-Pacheco et al. teaches the claimed:
1. A clinical diagnostic analyzer for conducting customized automated crossover studies, comprising: a processor; measurement hardware in communication with the processor and configured to measure properties of a specimen; a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations comprising ((Yundt-Pacheco et al., [0013], [0038], [0040]) (the system and method of the present invention employ one or more clinical diagnostic analyzers to conduct a virtual crossover study for a new lot of quality control material by relying on data associated with the new lot of material gathered from a peer group of similar laboratories that are already using the new lot of quality control material and have already gathered data from that new lot of material; a detailed view of a single clinical diagnostic analyzer 110a of the system of FIG. 1 is depicted. Clinical diagnostic analyzer 110a preferably comprises a processor 124, a memory device 126, measurement hardware 128, and an input panel/display; Measurement hardware preferably includes a sample receptacle configured to receive one or more samples or specimens into the analyzer for testing));
determining a … number of samples to achieve a desired accuracy for a new lot of quality control material ((Yundt-Pacheco et al., [0044], [0088]) (clinical diagnostic analyzer known in the art. Preferably, analyzer is configured to test quality control materials having known properties to allow users to determine the accuracy of the analyzer and to provide assurance to users that the analyzer is operating within allowable tolerances; the virtual crossover study continues for a target number of analyses (Nr)- Nr, the target number of analyses, or study size, is preferably initially set to ten so that ten analyses of the new lot of control material are conducted in the crossover study. In alternative embodiments, N r may be greater than ten. In a preferred embodiment, the target number of analyses (N r) ; is preset at ten in the clinical diagnostic analyzer. In alternative embodiments, the operator may be prompted by the analyzer to enter a desired target number CNr)- In further embodiments, the target number (N r) is obtained by the clinical diagnostic analyzer from the server, the database, or other source));
analyzing, over a period of time, a number of QC specimens corresponding to the customized number of samples ((Yundt-Pacheco et al., [0044], [0088]) (clinical diagnostic analyzer known in the art. Preferably, analyzer is configured to test quality control materials having known properties to allow users to determine the accuracy of the analyzer and to provide assurance to users that the analyzer is operating within allowable tolerances; the virtual crossover study continues for a target number of analyses (Nr)- Nr, the target number of analyses, or study size, is preferably initially set to ten so that ten analyses of the new lot of control material are conducted in the crossover study. In alternative embodiments, N r may be greater than ten. In a preferred embodiment, the target number of analyses (N r) ; is preset at ten in the clinical diagnostic analyzer. In alternative embodiments, the operator may be prompted by the analyzer to enter a desired target number CNr)- In further embodiments, the target number (N r) is obtained by the clinical diagnostic analyzer from the server, the database, or other source));
storing a result for each of the analyzed QC specimens, and loading and testing an analyte from a patient specimen using the stored results ((Yundt-Pacheco et al., [0036]) (the database may contain instructions or programming for execution by a processor on a clinical diagnostic analyzer, or for execution on the server, or may store data related to the number of samples processed, the frequency of testing, the results of analysis performed on the analyzer, as well as data relating to the samples themselves, such as tracking information, lot numbers, sample size, sample weight, percentage of sample remaining, and the like)).
Yundt-Pacheco et al. fails to explicitly teach, but Ashida et al. teaches the claimed:
determining a customized number of samples required to achieve a desired accuracy for a new lot of quality control material ((Ashida et al., [0007], [0012], [0076], [0078]) (all the determination results acquired by the generating apparatus may be used as a statistical population to calculate the ratio. For example, the ratio may be calculated for each population using a predetermined group as a statistical population. The predetermined group may be at least one group selected from the groups including the reagent lot, a predetermined number of samples, each sample analyzer, each facility in which the sample analyzer is installed, each apparatus model, each country, prefecture, or region, and a person in charge of an examination; The index is not limited insofar as it is a value that can be precision controlled using the ratio. It is preferable that the index is a value calculated by statistical processing from a plurality of determination results. More preferably, it is a value calculated by statistical processing from a plurality of determination results collected before measurement of the sample. It is preferable that the index has already been calculated when the ratio is calculated. The index may vary depending on the number of cumulative samples up to the point of generating the index. The index may be updated, for example, when the reagent lot or the like is changed))
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the determining a customized number of samples based on a determined index related to a ratio as a statistical calculation including a predetermined number of samples as taught by Ashida et al. within the method and system for performing a virtual crossover study on quality control materials as taught by Yundt-Pacheco et al. with the motivation of managing accuracy as quality control information is gathered and improve the appropriateness of the quality control index (Ashida et al,, [0015], [0076])).
RE: Claim 2 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
2. The clinical diagnostic analyzer of claim 1, wherein determining a customized number of samples required to achieve a desired accuracy comprises: estimating a historical relationship between the clinical diagnostic analyzer and a peer group ((Yundt-Pacheco et al., [0014]) (a virtual crossover study can be instigated on a new lot of quality control material by using data from a peer group with respect to prior lot numbers of quality control material and with respect to the new lot number as collected by the peer group)).
RE: Claim 3 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
3. The clinical diagnostic analyzer of claim 2, further comprising estimating new control means based on the estimated historical relationship ((Yundt-Pacheco et al., [0013]) (Using a Bayesian approach, an estimate for the lab mean of the new lot of control material is generated using peer statistics from the new lot of control material prior to the evaluation by the lab of the new lot of control material; Lab data for the new lot of control is incorporated in a weighted fashion to update the estimate of the lab mean for the new lot of control material, which is further used to estimate the SD of the new lot of control material)).
RE: Claim 4 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
4. The clinical diagnostic analyzer of claim 3, further comprising: calculating a confidence factor based on the estimated historical relationship ((Ashida, [0078]) (The index may be updated, for example, when the reagent lot or the like is changed. The index also may be updated when the treatment method of the subject is changed. The plurality of determination results also may originate from the same facility or from a plurality of facilities. For example, at least one selected from the upper limit value and the lower limit value of the confidence interval can be cited as an index. A value obtained by considering the average value, the standard deviation, the variance and the like of the ratio in the statistical population also may be used as an index)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the confidence interval for determining a customized number of samples based on a determined index related to a ratio as a statistical calculation including a predetermined number of samples as taught by Ashida et al. within the method and system for performing a virtual crossover study on quality control materials as taught by Yundt-Pacheco et al. with the motivation of managing accuracy as quality control information is gathered and improve the appropriateness of the quality control index (Ashida et al,, [0015], [0076])).
RE: Claim 5 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
5. The clinical diagnostic analyzer of claim 3, further comprising: determining a variation of the new control means ((Yundt-Pacheco et al., [0061], [0063], [0085]-]0088]) (CVold is the coefficient of variation from the prior lot of quality control material; With the bias (D) calculated, an initial prediction of the mean for the new lot of control material (Lxnew) is calculated by adjusting the peer group mean (Gxnew) to account for the bias (D))).
RE: Claim 6 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
6. The clinical diagnostic analyzer of claim 1, further comprising an input panel and display operable to present information and data from the processor to a user and to accept input and selections from a user ((Yundt-Pacheco et al., [0042]) (Input panel/display 130 is in communication with the processor and is operable to present controls to facilitate operation of the analyzer, as well as to present prompts and instructions to an user, and to receive input commands and/or data from the user)).
RE: Claim 7 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
7. The clinical diagnostic analyzer of claim 6, wherein the memory device includes instructions, that when executed, further cause the clinical diagnostic analyzer to perform operations comprising: presenting a prompt on the input panel and display to a user to load a QC sample into the measurement hardware; and accept an input from the user indicating that the analyte has been loaded ((Yundt-Pacheco et al., [0043]) (Looking to FIGS. 3A, 3B, 3C, and 3D, for
example, the input panel/display may present prompts to a user to load one a QC specimens and press a READY button once completed (FIG. 3A), to begin a virtual crossover study (FIG. 3B), to load a patient specimen (FIG. 3C) or to select a lot of material to use for a study, store data, or run an analysis (FIG. 3D). It should be understood that the clinical diagnostic analyzer 100a may have multiple programs and functions available, a menu or selection prompt is preferably presented to guide a user through the operation of the analyzer and the selection of desired functions and operations)).
RE: Claim 8 Yundt-Pacheco et al. teaches the claimed:
8. A system for conducting customized automated crossover studies, comprising: a server comprising a processor, a memory and a database; a plurality of clinical diagnostic analyzers in communication with the server ((Yundt-Pacheco et al., [0029]) (a clinical diagnostic system in accordance with an exemplary embodiment of the present invention is depicted generally by the numeral 100. The system 100 generally includes a plurality of clinical diagnostic analyzers 110a, 110b, 110c, 110n and a server 112 in communication with a database 114. The plurality of clinical diagnostic analyzers 110a, 110b, 110c, 110n are in communication with network 116, which facilitates the transmission of instructions, information, and data between each clinical diagnostic analyzer 110a, 110b, 110c, 110n and the server 112, as well as between each of the clinical diagnostic analyzers 110a, 110b, 110c, 110n and any of the other diagnostic analyzers, or between any combination of clinical diagnostic analyzers and/or the server));
wherein each of the plurality of clinical diagnostic analyzers comprises: a processor; measurement hardware in communication with the processor and configured to measure properties of a specimen; a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations comprising ((Yundt-Pacheco et al., [0013], [0038], [0040]) (the system and method of the present invention employ one or more clinical diagnostic analyzers to conduct a virtual crossover study for a new lot of quality control material by relying on data associated with the new lot of material gathered from a peer group of similar laboratories that are already using the new lot of quality control material and have already gathered data from that new lot of material; a detailed view of a single clinical diagnostic analyzer 110a of the system of FIG. 1 is depicted. Clinical diagnostic analyzer 110a preferably comprises a processor 124, a memory device 126, measurement hardware 128, and an input panel/display; Measurement hardware preferably includes a sample receptacle configured to receive one or more samples or specimens into the analyzer for testing));
loading a specimen from a new lot of quality control material into the measurement hardware ((Yundt-Pacheco et al., [0040]) (such as sampling as commanding the measurement hardware to load test specimens or to perform a test on a loaded sample, or instructing or prompting an user to perform specific operations such as replacing a test sample, beginning a test, or viewing collected data));
wherein the memory of the server has stored thereon executable instructions that, when executed by the server processor, cause the server to perform operations comprising determining a … number of samples required to achieve a desired accuracy for a new lot of quality control material ((Yundt-Pacheco et al., [0044], [0088]) (clinical diagnostic analyzer known in the art. Preferably, analyzer is configured to test quality control materials having known properties to allow users to determine the accuracy of the analyzer and to provide assurance to users that the analyzer is operating within allowable tolerances; the virtual crossover study continues for a target number of analyses (Nr)- Nr, the target number of analyses, or study size, is preferably initially set to ten so that ten analyses of the new lot of control material are conducted in the crossover study. In alternative embodiments, N r may be greater than ten. In a preferred embodiment, the target number of analyses (N r) ; is preset at ten in the clinical diagnostic analyzer. In alternative embodiments, the operator may be prompted by the analyzer to enter a desired target number CNr)- In further embodiments, the target number (N r) is obtained by the clinical diagnostic analyzer from the server, the database, or other source));
analyzing, over a period of time, a number of QC specimens corresponding to the customized number of samples ((Yundt-Pacheco et al., [0044], [0088]) (clinical diagnostic analyzer known in the art. Preferably, analyzer is configured to test quality control materials having known properties to allow users to determine the accuracy of the analyzer and to provide assurance to users that the analyzer is operating within allowable tolerances; the virtual crossover study continues for a target number of analyses (Nr)- Nr, the target number of analyses, or study size, is preferably initially set to ten so that ten analyses of the new lot of control material are conducted in the crossover study. In alternative embodiments, N r may be greater than ten. In a preferred embodiment, the target number of analyses (N r) ; is preset at ten in the clinical diagnostic analyzer. In alternative embodiments, the operator may be prompted by the analyzer to enter a desired target number CNr)- In further embodiments, the target number (N r) is obtained by the clinical diagnostic analyzer from the server, the database, or other source));
storing a result for each of the analyzed QC specimens; and loading and testing an analyte from a patient specimen using the stored results ((Yundt-Pacheco et al., [0036]) (the database may contain instructions or programming for execution by a processor on a clinical diagnostic analyzer, or for execution on the server, or may store data related to the number of samples processed, the frequency of testing, the results of analysis performed on the analyzer, as well as data relating to the samples themselves, such as tracking information, lot numbers, sample size, sample weight, percentage of sample remaining, and the like)).
Yundt-Pacheco et al. fails to explicitly teach, but Ashida et al. teaches the claimed:
determining a customized number of samples required to achieve a desired accuracy for a new lot of quality control material ((Ashida et al., [0007], [0012], [0076], [0078]) (all the determination results acquired by the generating apparatus may be used as a statistical population to calculate the ratio. For example, the ratio may be calculated for each population using a predetermined group as a statistical population. The predetermined group may be at least one group selected from the groups including the reagent lot, a predetermined number of samples, each sample analyzer, each facility in which the sample analyzer is installed, each apparatus model, each country, prefecture, or region, and a person in charge of an examination; The index is not limited insofar as it is a value that can be precision controlled using the ratio. It is preferable that the index is a value calculated by statistical processing from a plurality of determination results. More preferably, it is a value calculated by statistical processing from a plurality of determination results collected before measurement of the sample. It is preferable that the index has already been calculated when the ratio is calculated. The index may vary depending on the number of cumulative samples up to the point of generating the index. The index may be updated, for example, when the reagent lot or the like is changed))
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the determining a customized number of samples based on a determined index related to a ratio as a statistical calculation including a predetermined number of samples as taught by Ashida et al. within the method and system for performing a virtual crossover study on quality control materials as taught by Yundt-Pacheco et al. with the motivation of managing accuracy as quality control information is gathered and improve the appropriateness of the quality control index (Ashida et al,, [0015], [0076])).
RE: Claim 9 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
9. The system of claim 8, wherein the server memory includes instructions, that when executed, further cause the server to perform operations comprising: estimating a historical relationship between the clinical diagnostic analyzer and a peer group ((Yundt-Pacheco et al., [0014]) (a virtual crossover study can be instigated on a new lot of quality control material by using data from a peer group with respect to prior lot numbers of quality control material and with respect to the new lot number as collected by the peer group)).
RE: Claim 10 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
10 The system of claim 8, wherein the server memory includes instructions, that when executed, further cause the server to perform operations comprising: prompting a user of one or more of the plurality of clinical diagnostic analyzers to load and test an analyte from a patient specimen ((Yundt-Pacheco et al., [0043]) (Looking to FIGS. 3A, 3B, 3C, and 3D, for example, the input panel/display may present prompts to a user to load one a QC specimens and press a READY button once completed (FIG. 3A), to begin a virtual crossover study (FIG. 3B), to load a patient specimen (FIG. 3C) or to select a lot of material to use for a study, store data, or run an analysis (FIG. 3D). It should be understood that the clinical diagnostic analyzer 100a may have multiple programs and functions available, a menu or selection prompt is preferably presented to guide a user through the operation of the analyzer and the selection of desired functions and operations)).
RE: Claim 11 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
11. The system of claim 8, wherein each of the plurality of clinical diagnostic analyzers comprises an input panel and display, and wherein the server memory includes instructions, that when executed, further cause the server to perform operations comprising: transmitting an instruction to at least one of the plurality of clinical diagnostic analyzers to present a prompt on the input panel and display to a user to load an analyte into the measurement hardware; and accept an input from the user of the at least one of the plurality of clinical diagnostic analyzers indicating that the analyte has been loaded ((Yundt-Pacheco et al., [0043]) (Looking to FIGS. 3A, 3B, 3C, and 3D, for example, the input panel/display may present prompts to a user to load one a QC specimens and press a READY button once completed (FIG. 3A), to begin a virtual crossover study (FIG. 3B), to load a patient specimen (FIG. 3C) or to select a lot of material to use for a study, store data, or run an analysis (FIG. 3D). It should be understood that the clinical diagnostic analyzer 100a may have multiple programs and functions available, a menu or selection prompt is preferably presented to guide a user through the operation of the analyzer and the selection of desired functions and operations)).
RE: Claim 12 Yundt-Pacheco et al. teaches the claimed:
12. A method for conducting customized automated crossover studies, comprising: determining a … number of samples required to achieve a desired accuracy for a new lot of quality control material ((Yundt-Pacheco et al., [0044], [0088]) (clinical diagnostic analyzer known in the art. Preferably, analyzer is configured to test quality control materials having known properties to allow users to determine the accuracy of the analyzer and to provide assurance to users that the analyzer is operating within allowable tolerances; the virtual crossover study continues for a target number of analyses (Nr)- Nr, the target number of analyses, or study size, is preferably initially set to ten so that ten analyses of the new lot of control material are conducted in the crossover study. In alternative embodiments, N r may be greater than ten. In a preferred embodiment, the target number of analyses (N r) ; is preset at ten in the clinical diagnostic analyzer. In alternative embodiments, the operator may be prompted by the analyzer to enter a desired target number CNr)- In further embodiments, the target number (N r) is obtained by the clinical diagnostic analyzer from the server, the database, or other source));
loading a specimen from a new lot of quality control material into measurement hardware of a clinical diagnostic analyzer (( Yundt-Pacheco et al., [0040]) (such as sampling as commanding the measurement hardware to load test specimens or to perform a test on a loaded sample, or instructing or prompting an user to perform specific operations such as replacing a test sample, beginning a test, or viewing collected data));
analyzing the specimen to obtain a data value corresponding to an attribute of the specimen ((Yundt-Pacheco et al., [0039]) (cause the clinical diagnostic analyzer to perform desired steps, such as sampling as commanding the measurement hardware to load test specimens or to perform a test on a loaded sample, or instructing or prompting an user to perform specific operations such as replacing a test sample, beginning a test, or viewing collected data. The processor 124 may also execute instructions to receive data from the measurement hardware 128 and to perform one or more analyses on the received data, and to display test results or other information on the input panel/display panel 130));
obtaining and storing data values from a number of QC samples corresponding to the customized number of samples; storing the obtained data values for each specimen; loading and testing an analyte from a patient specimen using the stored mean and standard deviation ((Yundt-Pacheco et al., [0046], [0041]) (the database may contain instructions or programming for execution by a processor on a clinical diagnostic analyzer, or for execution on the server, or may store data related to the number of samples processed, the frequency of testing, the results of analysis performed on the analyzer, as well as data relating to the samples themselves, such as tracking information, lot numbers, sample size, sample weight, percentage of sample remaining, and the like; The analyzer 110a preferably allows information relating to the QC materials to be entered by an user, including statistical information such as a mean or standard deviation for the lot of material. In other embodiments, the information may be obtained over a network or from a server using, for example a QR code on the sample vial or container to uniquely identify the sample or lot)).
Yundt-Pacheco et al. fails to explicitly teach, but Ashida et al. teaches the claimed:
determining a customized number of samples required to achieve a desired accuracy for a new lot of quality control material ((Ashida et al., [0007], [0012], [0076], [0078]) (all the determination results acquired by the generating apparatus may be used as a statistical population to calculate the ratio. For example, the ratio may be calculated for each population using a predetermined group as a statistical population. The predetermined group may be at least one group selected from the groups including the reagent lot, a predetermined number of samples, each sample analyzer, each facility in which the sample analyzer is installed, each apparatus model, each country, prefecture, or region, and a person in charge of an examination; The index is not limited insofar as it is a value that can be precision controlled using the ratio. It is preferable that the index is a value calculated by statistical processing from a plurality of determination results. More preferably, it is a value calculated by statistical processing from a plurality of determination results collected before measurement of the sample. It is preferable that the index has already been calculated when the ratio is calculated. The index may vary depending on the number of cumulative samples up to the point of generating the index. The index may be updated, for example, when the reagent lot or the like is changed))
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the determining a customized number of samples based on a determined index related to a ratio as a statistical calculation including a predetermined number of samples as taught by Ashida et al. within the method and system for performing a virtual crossover study on quality control materials as taught by Yundt-Pacheco et al. with the motivation of managing accuracy as quality control information is gathered and improve the appropriateness of the quality control index (Ashida et al,, [0015], [0076])).
RE: Claim 13 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
13. The method of claim 12, further comprising: estimating a historical relationship between the clinical diagnostic analyzer and a peer group ((Yundt-Pacheco et al., [0014]) (a virtual crossover study can be instigated on a new lot of quality control material by using data from a peer group with respect to prior lot numbers of quality control material and with respect to the new lot number as collected by the peer group)).
RE: Claim 14 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
14. The method of claim 12, further comprising: estimating new control means based on the estimated historical relationship ((Yundt-Pacheco et al., [0013]) (Using a Bayesian approach, an estimate for the lab mean of the new lot of control material is generated using peer statistics from the new lot of control material prior to the evaluation by the lab of the new lot of control material; Lab data for the new lot of control is incorporated in a weighted fashion to update the estimate of the lab mean for the new lot of control material, which is further used to estimate the SD of the new lot of control material)).
RE: Claim 15 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
15. The method of claim 12, further comprising: calculating a confidence factor based on the estimated historical relationship ((Ashida, [0078]) (The index may be updated, for example, when the reagent lot or the like is changed. The index also may be updated when the treatment method of the subject is changed. The plurality of determination results also may originate from the same facility or from a plurality of facilities. For example, at least one selected from the upper limit value and the lower limit value of the confidence interval can be cited as an index. A value obtained by considering the average value, the standard deviation, the variance and the like of the ratio in the statistical population also may be used as an index)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the confidence interval for determining a customized number of samples based on a determined index related to a ratio as a statistical calculation including a predetermined number of samples as taught by Ashida et al. within the method and system for performing a virtual crossover study on quality control materials as taught by Yundt-Pacheco et al. with the motivation of managing accuracy as quality control information is gathered and improve the appropriateness of the quality control index (Ashida et al,, [0015], [0076])).
RE: Claim 16 Yundt-Pacheco et al. teaches the claimed:
16 A clinical diagnostic analyzer for conducting crossover studies, comprising a processor; measurement hardware in communication with the processor and configured to measure properties of a specimen; a memory device having stored thereon executable instructions that, when executed by the processor, cause the clinical diagnostic analyzer to perform operations comprising: determining an … number of samples required to achieve a desired accuracy for a lot of quality control material ((Yundt-Pacheco et al., (0013], [0038], [0040], [0044], [0088]) (the system and method of the present invention employ one or more clinical diagnostic analyzers to conduct a virtual crossover study for a new lot of quality control material by relying on data associated with the new lot of material gathered from a peer group of similar laboratories that are already using the new lot of quality control material and have already gathered data from that new lot of material; a detailed view of a single clinical diagnostic analyzer 110a of the system of FIG. 1 is depicted. Clinical diagnostic analyzer 110a preferably comprises a processor 124, a memory device 126, measurement hardware 128, and an input panel/display; Measurement hardware preferably includes a sample receptacle configured to receive one or more samples or specimens into the analyzer for testing clinical diagnostic analyzer known in the art. Preferably, analyzer is configured to test quality control materials having known properties to allow users to determine the accuracy of the analyzer and to provide assurance to users that the analyzer is operating within allowable tolerances; the virtual crossover study continues for a target number of analyses (Nr)- Nr, the target number of analyses, or study size, is preferably initially set to ten so that ten analyses of the new lot of control material are conducted in the crossover study. In alternative embodiments, N r may be greater than ten. In a preferred embodiment, the target number of analyses (N r) ; is preset at ten in the clinical diagnostic analyzer. In alternative embodiments, the operator may be prompted by the analyzer to enter a desired target number CNr)- In further embodiments, the target number (N r) is obtained by the clinical diagnostic analyzer from the server, the database, or other source));
analyzing, over a period of time, a number of QC specimens corresponding to the optimal number of samples; and ((Yundt-Pacheco et al., [0044], [0088]) (clinical diagnostic analyzer known in the art. Preferably, analyzer is configured to test quality control materials having known properties to allow users to determine the accuracy of the analyzer and to provide assurance to users that the analyzer is operating within allowable tolerances; the virtual crossover study continues for a target number of analyses (Nr)- Nr, the target number of analyses, or study size, is preferably initially set to ten so that ten analyses of the new lot of control material are conducted in the crossover study. In alternative embodiments, N r may be greater than ten. In a preferred embodiment, the target number of analyses (N r) ; is preset at ten in the clinical diagnostic analyzer. In alternative embodiments, the operator may be prompted by the analyzer to enter a desired target number CNr)- In further embodiments, the target number (N r) is obtained by the clinical diagnostic analyzer from the server, the database, or other source)); and
loading and testing an analyte from a patient specimen ((Yundt-Pacheco et al., [0040]) (such as sampling as commanding the measurement hardware to load test specimens or to perform a test on a loaded sample, or instructing or prompting an user to perform specific operations such as replacing a test sample, beginning a test, or viewing collected data)).
Yundt-Pacheco et al. fails to explicitly teach, but Ashida et al. teaches the claimed:
determining a customized number of samples required to achieve a desired accuracy for a new lot of quality control material ((Ashida et al., [0007], [0012], [0076], [0078]) (all the determination results acquired by the generating apparatus may be used as a statistical population to calculate the ratio. For example, the ratio may be calculated for each population using a predetermined group as a statistical population. The predetermined group may be at least one group selected from the groups including the reagent lot, a predetermined number of samples, each sample analyzer, each facility in which the sample analyzer is installed, each apparatus model, each country, prefecture, or region, and a person in charge of an examination; The index is not limited insofar as it is a value that can be precision controlled using the ratio. It is preferable that the index is a value calculated by statistical processing from a plurality of determination results. More preferably, it is a value calculated by statistical processing from a plurality of determination results collected before measurement of the sample. It is preferable that the index has already been calculated when the ratio is calculated. The index may vary depending on the number of cumulative samples up to the point of generating the index. The index may be updated, for example, when the reagent lot or the like is changed))
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the determining an optimal number of samples based on a determined index related to a ratio as a statistical calculation including a predetermined number of samples as taught by Ashida et al. within the method and system for performing a virtual crossover study on quality control materials as taught by Yundt-Pacheco et al. with the motivation of managing accuracy as quality control information is gathered and improve the appropriateness of the quality control index (Ashida et al,, [0015], [0076])).
RE: Claim 17 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
17. The clinical diagnostic analyzer of claim 16, wherein determining an optimal number of samples required to achieve a desired accuracy comprises: estimating a historical relationship between the clinical diagnostic analyzer and a peer group ((Yundt-Pacheco et al., [0014]) (a virtual crossover study can be instigated on a new lot of quality control material by using data from a peer group with respect to prior lot numbers of quality control material and with respect to the new lot number as collected by the peer group)).
RE: Claim 18 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
18 The clinical diagnostic analyzer of claim 17, further comprising estimating new control means based on the estimated historical relationship ((Yundt-Pacheco et al., [0013]) (Using a Bayesian approach, an estimate for the lab mean of the new lot of control material is generated using peer statistics from the new lot of control material prior to the evaluation by the lab of the new lot of control material; Lab data for the new lot of control is incorporated in a weighted fashion to update the estimate of the lab mean for the new lot of control material, which is further used to estimate the SD of the new lot of control material)).
RE: Claim 19 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
19. The clinical diagnostic analyzer of claim 18, further comprising: calculating a confidence factor based on the estimated historical relationship ((Ashida, [0078]) (The index may be updated, for example, when the reagent lot or the like is changed. The index also may be updated when the treatment method of the subject is changed. The plurality of determination results also may originate from the same facility or from a plurality of facilities. For example, at least one selected from the upper limit value and the lower limit value of the confidence interval can be cited as an index. A value obtained by considering the average value, the standard deviation, the variance and the like of the ratio in the statistical population also may be used as an index)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the confidence interval for determining a customized number of samples based on a determined index related to a ratio as a statistical calculation including a predetermined number of samples as taught by Ashida et al. within the method and system for performing a virtual crossover study on quality control materials as taught by Yundt-Pacheco et al. with the motivation of managing accuracy as quality control information is gathered and improve the appropriateness of the quality control index (Ashida et al,, [0015], [0076])).
RE: Claim 20 Yundt-Pacheco et al. and Ashida et al. teach the claimed:
20. The clinical diagnostic analyzer of claim 18, further comprising: determining a variation of the new control means ((Yundt-Pacheco et al. [0061], [0063], [0085]-]0088]) (CVold is the coefficient of variation from the prior lot of quality control material; With the bias (D) calculated, an initial prediction of the mean for the new lot of control material (Lxnew) is calculated by adjusting the peer group mean (Gxnew) to account for the bias (D))).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. 2020/0401653 A1 teaches quality control monitoring of laboratory analyzers and determining a standard deviation of differences among pairs of multiple test results (Abstract); and
U.S. 2016/0034653 A1 teaches system to recover from large out-of-control conclusion in a clinical diagnostic process using rules as to whether to accept or reject test results (Abstract)
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/A.M.B./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682
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