DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The IDS’ filed on 02/21/23, 09/19/23, and 05/15/25 have been considered.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 77 (figure 16). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 39 is objected to because of the following informalities:
Claim 39, line 5 states, “executed the selection …” This appears to be a minor grammatical informality. It will be construed that the claim should state, “execute the selection …”
Appropriate correction is required.
Examiner’s Note - 35 USC § 101
Claims 25-42 qualify as eligible subject matter under 35 U.S.C. 101.
Independent claim 25 discloses the following limitations:
a plurality of specimen analyzers configured to count a first set of cells of a predetermined type contained in a patient specimen, the plurality of specimen analyzers each including a controller, wherein the controllers of the plurality of specimen analyzers include a first controller and at least one second controller
each of the specimen analyzers comprises a measurement sample preparator configured to prepare a first measurement sample containing the patient specimen and a second measurement sample containing a quality control sample, which contains a second set of cells of the predetermined type at a predetermined concentration
each of the specimen analyzers comprises an optical detector configured to convert a first set of light from the first set of cells optically interrogated while flowing through a flow cell into a first set of cell signals and convert a second set of light from the second set of cells optically interrogated while flowing through the flow cell into a second set of cell signals
Under step 2A, prong two of the 101 eligibility analysis, the above limitations, when considered as a whole, are indicative of integration into a practical application because they apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)). In this case, the particular machine is the plurality of specimen analyzers. Here, the plurality of specimen analyzers were described in enough detail such that they were considered to be more than simply a general linking of the use of any judicial exception to a particular technological environment or field of use under MPEP 2106.05(h)).
Independent claim 33 discloses the following limitations:
a plurality of specimen analyzers configured to count a first set of cells of a predetermined type contained in a patient specimen, the plurality of specimen analyzers each including a controller
each of the specimen analyzers comprises a measurement sample preparator configured to prepare a first measurement sample containing the patient specimen and a second measurement sample containing a quality control sample, which contains a second set of cells of the predetermined type at a predetermined concentration
each of the specimen analyzers comprises an optical detector configured to convert a first set of light from the first set of cells optically interrogated while flowing through a flow cell into a first set of cell signals and to convert a second set of light from the second set of cells optically interrogated while flowing through the flow cell into a second set of cell signals
Under step 2A, prong two of the 101 eligibility analysis, the above limitations, when considered as a whole, are indicative of integration into a practical application because they apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)). In this case, the particular machine is the plurality of specimen analyzers. Here, the plurality of specimen analyzers were described in enough detail such that they were considered to be more than simply a general linking of the use of any judicial exception to a particular technological environment or field of use under MPEP 2106.05(h)).
Independent claims 25 and 33 are therefore not directed to a judicial exception. They qualify as eligible subject matter under 35 U.S.C. 101.
All other claims depend on independent claims 25 and 33. They also qualify as eligible subject matter under 35 U.S.C. 101 as a result of their dependency.
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.
Claim(s) 25-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glavina et al (US PgPub 20160356800) in view of Nagai et al (US PgPub 20160282377).
With respect to claim 25, Glavina et al discloses:
A blood specimen analysis system (paragraphs 0002-0003 state, “The technical character of the present invention relates to systems and methods of determining quality compliance for a set of biological sample testing devices, e.g., single-use blood test cartridges, used with one or more test instruments at the point-of-care … Point-of-care (POC) sample analysis systems …”)
a plurality of specimen analyzers, the plurality of specimen analyzers each including a controller, wherein the controllers of the plurality of specimen analyzers include a first controller and at least one second controller (figure 4, references 305; paragraph 0043 states, “The reading apparatus 102 may include a micro-processor …” Figure 4 shows multiple specimen analyzer, each one including a micro-processor that can be broadly interpreted as a “controller.”)
each of the specimen analyzers comprises a measurement sample preparator configured to prepare a first measurement sample containing the patient specimen and a second measurement sample containing a quality control sample, which contains a second set of cells of the predetermined type at a predetermined concentration (Paragraph 0037 states, “The disposable device 103 may include, for example, a port 108 for receiving a patient sample.” Paragraph 0078 states, “Measurement of quality control samples may be useful in detecting systematic errors that affect all test results in a predictable manner.” Glavina et al teaches both patient samples and control samples.)
With respect to claim 25, Glavina et al differs from the claimed invention in that it does not explicitly disclose:
configured to count a first set of cells of a predetermined type contained in a patient specimen
each of the specimen analyzers comprises an optical detector configured to convert a first set of light from the first set of cells optically interrogated while flowing through a flow cell into a first set of cell signals and convert a second set of light from the second set of cells optically interrogated while flowing through the flow cell into a second set of cell signals
each of the controllers programmed to, in response to receipt of the first set of cell signals, count the optically interrogated first set of cells to obtain a first cell count and, in response to receipt of the second set of cell signals, count the optically interrogated second set of cells to obtain a second cell count, wherein each of the controllers is configurable with preset calculation rules for determining a target value and a limit value, wherein the target value is indicative of a desired count that the second cell count is expected to be, and the limit value is indicative of a statistical range within which the second cell count is expected to fall
wherein the first controller is reconfigured with a selection from the preset calculation rules to interpret the second cell count counted by the first controller or the at least one second controller or interpret the second cell count counted by at least some of the controllers to determine a set of the target value and the limit value, and the first controller is further programmed to deliver the determined set of target value and limit value to the at least one second controller for adoption of the determined set of target value and limit value by a respective one of the at least one second controller
wherein each of the controllers is programmed to run a quality control operation for assurance of a quality of measurement by its specimen analyzer, the quality control operation including evaluating the second cell count with the determined set of target value and limit value
With respect to claim 25, Nagai et al discloses:
configured to count a first set of cells of a predetermined type contained in a patient specimen (paragraph 0023 states, “The first through third embodiments described below apply the present invention in an apparatus which performs examination and analysis of blood by detecting the red blood cells and the like contained in a blood sample, and counting each blood cell.”)
each of the specimen analyzers comprises an optical detector configured to convert a first set of light from the first set of cells optically interrogated while flowing through a flow cell into a first set of cell signals and convert a second set of light from the second set of cells optically interrogated while flowing through the flow cell into a second set of cell signals (figure 1, reference 72; paragraph 0032 states, “The measuring part 70 has a resistance detector 71, optical detector 72 …”)
each of the controllers programmed to, in response to receipt of the first set of cell signals, count the optically interrogated first set of cells to obtain a first cell count and, in response to receipt of the second set of cell signals, count the optically interrogated second set of cells to obtain a second cell count, wherein each of the controllers is configurable with preset calculation rules for determining a target value and a limit value, wherein the target value is indicative of a desired count that the second cell count is expected to be, and the limit value is indicative of a statistical range within which the second cell count is expected to fall (obvious in view of combination; Glavina discloses multiple specimen analyzers. Furthermore, paragraph 0017 of Glavina states, “and determine a compliance status of the set of sample testing cartridges at the data manager based on whether the quality control test data is within range of predetermined cartridge test target values.” Glavina further discloses many instances of target values throughout is disclosure. Nagai teaches principle of cell counting.)
wherein the first controller is reconfigured with a selection from the preset calculation rules to interpret the second cell count counted by the first controller or the at least one second controller or interpret the second cell count counted by at least some of the controllers to determine a set of the target value and the limit value, and the first controller is further programmed to deliver the determined set of target value and limit value to the at least one second controller for adoption of the determined set of target value and limit value by a respective one of the at least one second controller (obvious in view of combination; paragraph 0020 of Glavina states, “The data manager is configured to determine a compliance status of the set of sample testing cartridges based on whether the quality control test data is within range of predetermined cartridge test target values, store the determined compliance status for the set of sample testing cartridges in a data table, and transmit the data table to each of the plurality of analyzers.” Glavina suggests communication of compliance between multiple controllers. Nagai teaches principle of cell count.)
wherein each of the controllers is programmed to run a quality control operation for assurance of a quality of measurement by its specimen analyzer, the quality control operation including evaluating the second cell count with the determined set of target value and limit value (obvious in view of combination; Glavina teaches quality control all throughout its disclosure; there are over 450 instances of “quality control” mentioned. For example, paragraph 0007 states, “To achieve the goal of quality control …” Nagai teaches principle of cell count.)
With respect to claim 25, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Nagai et al into the invention of Glavina et al. The motivation for the skilled artisan in doing so is to gain the benefit of successfully measuring specimen samples.
With respect to claim 26, Glavina et al, as modified, discloses:
wherein the preset calculation rules include a first rule executed to determine the set of target value and limit value individually for each of the specimen analyzers and a second rule executed to determine one set of the target value and the limit value in common for the plurality of the specimen analyzers (Glavina paragraphs 0082-0083 state “The control samples and corresponding thresholds or target values can be selected by the data manager 315 or a primary user. For example, the data manager 315 can be configured to automatically select control samples and corresponding thresholds or target values based on control samples that ship with each manufacturing lot of devices … Optionally, the primary user can be a point-of-care coordinator who operates the data manager to manually select or input control samples … The thresholds or target values can be selected by the data manager or the primary user for each IQCP, each type of device 310, each manufacturing lot of devices 310, each instrument 305 or a subset of instruments 305, etc.” Glavina discloses flexibility and broad variations in how it assigns its target values. In view of such broad teachings, the claimed limitation is one obvious implementation among many different options.)
With respect to claim 27, Glavina et al, as modified, discloses:
wherein the second rule includes a third rule executed to interpret the second cell count obtained from one of the specimen analyzers to determine the set of target value and limit value in common for the plurality of specimen analyzers, and a fourth rule executed to interpret the second cell count obtained by at least some of the plurality of specimen analyzers to determine the set of target value and limit value in common for the plurality of specimen analyzers (obvious in view of broad and flexible target value teachings of Glavina. As discussed above, Nagai teaches principle of cell count, and various implementations of cell count interpretation would be obvious in view of the combination of Glavina and Nagai.)
With respect to claim 28, Glavina et al, as modified, discloses:
wherein the first controller is programmed to determine the set of target value and limit value individually for each of the plurality of specimen analyzers (obvious in view of broad and diverse target value teachings of Glavina, as discussed above, such as in paragraphs 0082-0083)
With respect to claim 29, Glavina et al, as modified, discloses:
wherein the first controller is programmed to interpret the second cell count from one of the plurality of specimen analyzers to determine the set of target value and limit value specifically for said one of the plurality of specimen analyzers (obvious in view of combination; as discussed above, Nagai teaches cell count, while Glavina teaches target value and limit value, as well as a plurality of specimen analyzers.)
With respect to claim 30, Glavina et al, as modified discloses:
wherein the first controller is programmed to determine the set of target value and limit value in common for the plurality of specimen analyzers (obvious in view of broad and diverse target value teachings of Glavina, as discussed above)
With respect to claim 31, Glavina et al, as modified, discloses:
wherein the first controller is programmed to interpret the second cell count obtained from a respective one of the plurality of specimen analyzers to determine the set of target value and limit value (obvious in view of combination; Nagai teaches cell count. Glavina discloses target and limit values.)
With respect to claim 32, Glavina et al, as modified, discloses:
wherein the first controller is programmed to interpret the second cell counts obtained from at least some of the plurality of specimen analyzers to determine the set of target value and limit value (obvious in view of combination; Nagai teaches cell count. Glavina discloses target and limit values.)
With respect to claim 33, Glavina et al discloses:
A blood specimen analysis system (paragraphs 0002-0003)
a plurality of specimen analyzers, the plurality of specimen analyzers each including a controller (figure 4, references 305; paragraph 0043)
a computer operably connected to each of the controllers of the plurality of specimen analyzers (figures 1, 4 and paragraph 0060)
each of the specimen analyzers comprises a measurement sample preparator configured to prepare a first measurement sample containing the patient specimen and a second measurement sample containing a quality control sample, which contains a second set of cells of the predetermined type at a predetermined concentration (paragraphs 0037 and 0078)
With respect to claim 33, Glavina et al differs from the claimed invention in that it does not explicitly disclose:
configured to count a first set of cells of a predetermined type contained in a patient specimen
each of the specimen analyzers comprises an optical detector configured to convert a first set of light from the first set of cells optically interrogated while flowing through a flow cell into a first set of cell signals and to convert a second set of light from the second set of cells optically interrogated while flowing through the flow cell into a second set of cell signals
each of the controllers programmed to, in response to receipt of the first set of cell signals, count the optically interrogated first set of cells to obtain a first cell count and, in response to receipt of the second set of cell signals, count the optically interrogated second set of cells to obtain a second cell count
the computer is programable with a selection of preset calculation rules to interpret the second cell count to determine a set of target value and limit value and to transmit the determined set of target value and limit value to each of the controllers, wherein the target value is indicative of a desired count that the second cell count is expected to be, the limit value is indicative of a statistical range within which the second cell count is expected to fall
each of the controllers is programmed to run a quality control operation for assurance of a quality of measurement by its specimen analyzer, the quality control operation including evaluating the second cell count with the determined set of target value and limit value
With respect to claim 33, Nagai et al discloses:
configured to count a first set of cells of a predetermined type contained in a patient specimen (see rejection of claim 25 above)
each of the specimen analyzers comprises an optical detector configured to convert a first set of light from the first set of cells optically interrogated while flowing through a flow cell into a first set of cell signals and to convert a second set of light from the second set of cells optically interrogated while flowing through the flow cell into a second set of cell signals (see rejection of claim 25 above)
each of the controllers programmed to, in response to receipt of the first set of cell signals, count the optically interrogated first set of cells to obtain a first cell count and, in response to receipt of the second set of cell signals, count the optically interrogated second set of cells to obtain a second cell count (see rejection of claim 25 above)
the computer is programable with a selection of preset calculation rules to interpret the second cell count to determine a set of target value and limit value and to transmit the determined set of target value and limit value to each of the controllers, wherein the target value is indicative of a desired count that the second cell count is expected to be, the limit value is indicative of a statistical range within which the second cell count is expected to fall (see rejection of claim 25 above)
each of the controllers is programmed to run a quality control operation for assurance of a quality of measurement by its specimen analyzer, the quality control operation including evaluating the second cell count with the determined set of target value and limit value (see rejection of claim 25 above)
With respect to claim 33, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Nagai et al into the invention of Glavina et al. The motivation for the skilled artisan in doing so is to gain the benefit of successfully measuring specimen samples.
With respect to claim 34, Glavina et al, as modified, discloses:
wherein the computer is programmed to execute the selection of the preset calculation rules on the second cell count obtained from each of the plurality of specimen analyzers to determine the set of target value and limit value (obvious in view of broad and diverse target value teachings of Glavina et al, as discussed above and the cell count principles of Nagai et al)
With respect to claim 35, Glavina et al, as modified, discloses:
wherein the computer is programmed to select one calculation rule from the preset calculation rules and execute the selected one calculation rule to determine the set of target value and limit value (obvious in view of broad and diverse teachings of Glavina et al, as discussed above)
With respect to claim 36, Glavina et al, as modified, discloses:
wherein the preset calculation rules include a first rule executed to determine the set of target value and limit value individually for each of the plurality of specimen analyzers and a second rule executed to determine one set of the target value and the limit value in common for the plurality of specimen analyzers (see rejection of claim 26 above)
With respect to claim 37, Glavina et al, as modified, discloses:
wherein the second rule includes a third rule executed to interpret the second cell count obtained from one of the plurality of specimen analyzers to determine the set of target value and limit value in common for the plurality of specimen analyzers, and a fourth rule executed to interpret the second cell count obtained from at least some of the plurality of specimen analyzers to determine the set of target value and limit in common for the plurality of specimen analyzers (see rejection of claim 27 above)
With respect to claim 38, Glavina et al, as modified, discloses:
wherein the computer is programmed to determine the set of target value and limit value individually for each of the plurality of specimen analyzers (see rejection of claim 28 above)
With respect to claim 39, Glavina et al, as modified, discloses:
wherein the controllers are divided into a first group including at least one controller and a second group including at least one controller which does not belong in the first group (obvious in view of broad and diverse teachings of Glavina et al, as discussed above)
the computer is programmed to:
execute the selection of the preset calculation rules on the second cell count obtained from the at least one controller in the first group to determine the set of target value and limit value for the first group (obvious in view of broad and diverse teachings of Glavina et al, as discussed above)
execute the selection of the present calculation rules on the second cell count obtained from the at least one controller in the second group to determine the set of target value and limit value for the second group (obvious in view of broad and diverse teachings of Glavina et al, as discussed above)
With respect to claim 40, Glavina et al, as modified, discloses:
wherein the computer is programmed to determine the set of target value and limit value in common for the plurality of specimen analyzers (obvious in view of broad and diverse teachings of Glavina et al, as discussed above)
With respect to claim 41, Glavina et al, as modified, discloses:
wherein the computer is programmed to execute the selection of the preset calculation rules on the second cell count obtained from one of the controllers to determine the set of target value and limit value for the plurality of specimen analyzers (obvious in view of combination; Glavina et al teaches target value and limit value. Nagai teaches cell count.)
With respect to claim 42, Glavina et al, as modified, discloses:
wherein a respective one of the controllers is programmed to transmit to the computer a plurality of the second cell counts obtained by its specimen analyzer (obvious in view of combination; Nagai teaches cell counts.)
the computer is programmed to execute the selection of the present calculation rules on the plurality of second cell counts to determine the set of target value and limit value individually for the respective one of the controllers (obvious in view of combination; Nagai teaches target value and limit value.)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kato (US PgPub 20220065882) discloses a method for displaying calibration curve and analyzer.
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/LEONARD S LIANG/ Examiner, Art Unit 2857 01/09/26