DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 04/22/26 have been fully considered but they are not persuasive.
The applicant’s core argument is, “As discussed in paragraphs 51 and 57 of the specification, there are three options to generate a target value and a limit value: a first option is to calculate the values from the specimen analyzers measuring a control specimen; a second option is to adopt the values specified by a user; and the third option is to adopt the values provided by a manufacture of the control specimen … It is respectfully submitted that Glavina only discloses the second and third options and does not disclose the first option.”
The examiner respectfully disagrees. While Glavina does disclose the second and third options, Glavina also teaches, discloses, or suggests the first option.
Paragraph 0077 of Glavina states, “The configuration manager 325 can be used to establish ranges and control rules that define how much change in assay performance is allowed … Westgard rules are one such example that employ limits calculated from the mean value and standard deviation …” (emphasis mine).
Paragraph 0084 of Glavina states, “The quality control rules are a decision criterion for judging whether an analytical run is in-control or out-of-control … utilizing one or more of the following …” Here, Glavina proceeds to list various mathematical standards.
It is clear that Glavina’s broad teachings are not limited to user-specified values and manufacturer-provided values. Glavina discloses calculated mathematical values.
Since the premise of the applicant’s core argument is that Glavina lacks what it apparently teaches, the applicant’s arguments are not persuasive.
Information Disclosure Statement
The IDS filed on 02/04/26 has been considered.
Drawings
In view of the Specification amendments of 04/22/26, the drawings of 02/21/23 are accepted.
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 34, 36-37, 39, and 41-42 are 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 34 discloses, “the selected one of the preset calculation rules …” However, claim 34 depends on claim 33, and the phrase “a selection of present calculation rules” was cancelled in the latest amendment. The claim therefore lacks antecedent basis.
Similarly, claims 36-37, 39, and 41-42 also disclose some variation of “the rules …” The claims now lack antecedent basis, due to the 04/22/26 amendment of claim 33. For the purposes of examination, the examiner will interpret claim 33 to state, “the computer is programmed with a selection of present calculation rules …”
Examiner’s Note - 35 USC § 101
For similar reasons, as discussed in the previous action, claims 25-28, 30-34, and 36-42 qualify as eligible subject matter 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.
Claim(s) 25-28, 30-34, and 36-42 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 lights 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 lights 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 is 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 programmed to run a quality control operation that evaluates the second cell count with reference to 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 programmed to interpret the second cell count from a respective one of at least one of the controllers to determine a reference set of the target value and the limit value, and the first controller is further programmed to deliver the reference set of target value and limit value to a respective one of the at least one second controller for adoption of the reference set of target value and limit value by the respective one of the at least one second controller
wherein each of the controllers is programmed to run the quality control operation that includes evaluating the second cell count with reference to the reference 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 lights 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 lights 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 is 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 (paragraphs 0023 and 0054 of Nagai teach cell counting; the limitation is obvious, in view of applying Nagai’s principles of cell counting to the measured samples of Glavina et al.)
wherein each of the controllers is programmed to run a quality control operation that evaluates the second cell count with reference to 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 programmed to interpret the second cell count from a respective one of at least one of the controllers to determine a reference set of the target value and the limit value, and the first controller is further programmed to deliver the reference set of target value and limit value to a respective one of the at least one second controller for adoption of the reference set of target value and limit value by the 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. Paragraph 101 also states, “the evaluation may include comparing the quality control test results with the thresholds or target values for the control samples …” Nagai teaches principle of cell count.)
wherein each of the controllers is programmed to run the quality control operation that includes evaluating the second cell count with reference to the reference 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 …” Furthermore, please note Glavina paragraphs 0077 and 0084, which disclose specific criterion for quality control that depend on specific calculated values. 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 controllers are programable with preset calculation rules that include a first rule under which each controller determines a set of target value and limit value for corresponding one of the plurality of specimen analyzers and a second rule under which the first controller determines the reference set of target value and 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. Please also note paragraphs 0077 and 0084 of Glavina for more discussion of quality control rules. 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 under which the first controller interprets the second cell count from a corresponding specimen analyzer to determine the reference set of target value and limit value in common for the plurality of specimen analyzers, and a fourth rule under which the first controller interprets the second cell count from a respective of at least some of the plurality of specimen analyzers to determine the reference 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 reference 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 30, Glavina et al, as modified discloses:
wherein the first controller is programmed to determine the reference 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 from one of the plurality of specimen analyzers to determine the reference set of target value and limit value in common for the plurality of specimen analyzers (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 from at least some of the plurality of specimen analyzers to determine the reference set of target value and limit value in common for the plurality of specimen analyzers (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 is 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 programmed 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 deliver the set of target value and limit value to each of the controllers for adoption of the set of target value and limit value by each of the controllers, 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
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 reference to the 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 is 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 programmed 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 deliver the set of target value and limit value to each of the controllers for adoption of the set of target value and limit value by each of the controllers, 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 (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 reference to the 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 selected one of the preset calculation rules on the second cell count from each of the plurality of specimen analyzers 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 et al, as discussed above and the cell count principles of Nagai et al)
With respect to claim 36, Glavina et al, as modified, discloses:
wherein the preset calculation rules include a first rule under which the computer determines the set of target value and limit value individually for each of the plurality of specimen analyzers and a second rule under which the computer determines the 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 under which the computer interprets the second cell count 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 under which the computer interprets the second cell count obtained from a respective one of 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 selected one of the preset calculation rules on the second cell count 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 selected one 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 selected one of the preset calculation rules on the second cell count from one of the controllers to determine the set of target value and limit value in common 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 selected one 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.
Kowata (US PgPub 20070027648) discloses clinical testing information processing apparatus, clinical testing information processing method, and analyzing system.
Yamada (US PgPub 20100104169) discloses a specimen processing system and blood cell image classifying apparatus.
Fujimoto et al (US PgPub 20190346466) discloses a quality control method, quality control system, management apparatus, analyzer, and quality control abnormality determination method.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEONARD S LIANG whose telephone number is (571)272-2148. The examiner can normally be reached M-F 10:00 AM - 7 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ARLEEN M VAZQUEZ can be reached at (571)272-2619. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEONARD S LIANG/ Examiner, Art Unit 2857 06/28/26
/ARLEEN M VAZQUEZ/ Supervisory Patent Examiner, Art Unit 2857
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