DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
2. 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.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Regarding the terms "computer-readable storage medium" in claim 9, the broadest reasonable interpretation of a claim drawn to a computer readable medium, as presented in the claim, covers both forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent (see MPEP 2111.01). Because the broadest reasonable interpretation covers a signal per se, a rejection under 35 USC 101 is appropriate as covering non-statutory subject matter. See 1351 OG 212, Feb 23 2010.
The Examiner suggests that the Applicant replaces “computer-readable storage medium” in claim 9 with "non- transitory computer-readable storage medium."
Claim Rejections - 35 USC § 102
3. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
4. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lesher (US Pat. Pub. 2017/0285624).
In regards to claim 1, Lesher teaches a computer-implemented method for facilitating maintenance of a medical analyzer device (Lesher abstract and paragraphs [0009]-[0010] and [0037] teach a computer-implemented method for facilitating maintenance of a medical diagnostic analyzer device by reviewing a quality control measurement value of the diagnostic analyzer device), the method comprising:
obtaining a plurality of measurement results associated with a plurality of quality control (QC) measurements performed by a plurality of medical analyzer devices (Lesher abstract and paragraph [0009] teach obtaining a plurality of quality control (QC) measurements from both a target diagnostic analyzer and a plurality of peer group diagnostic analyzers) on a plurality of predefined QC samples, wherein each QC sample is associated with a predefined target range (Lesher paragraphs [0034]-[0035] teach a plurality of predefined QC samples to verify the operation of the diagnostic analyzers, where each QC sample has predefined levels or amounts (range) of constituents) and wherein each medical analyzer device is associated with a peer group of medical analyzer devices (Lesher paragraph [0010] teaches where each target diagnostic analyzer is associated with a peer group of diagnostic analyzer devices);
for each medical analyzer device:
evaluating the obtained measurement results against measurement results of the associated peer group in order to identify a deviation of at least one QC measurement parameter (Lesher paragraphs [0009], [0032] and [0050] teach evaluating a quality control measurement from each target diagnostic analyzer in comparison to statistical criteria associated with the plurality of quality control measurement values received from the plurality of peer group diagnostic analyzers);
if a deviation above a predefined threshold is identified (Lesher paragraphs [0032] and [0045] teach identifying a deviation above a predefined threshold (including peer group established upper and lower limits) to identify issues with the QC measurement to prompt a troubleshooting phase):
obtaining an action log of the medical analyzer device, the action log comprising data indicative of any previously transmitted maintenance actions associated with the medical analyzer device (Lesher paragraph [0098] teaches obtaining a maintenance history log of the target diagnostic analyzer based on the determined rule violations of QC measurements deviating above a threshold);
obtaining at least one suggested maintenance action for the medical analyzer device associated with the identified deviation based on a type of QC measurement parameter that is associated with the identified deviation, wherein obtaining the at least one maintenance action further comprises identifying a parameter group of the type of QC measurement parameter that is associated with the identified deviation, and obtaining at least one suggested maintenance action based on the identified parameter group (Lesher paragraphs [0086]-[0089] teach obtaining at least one suggested maintenance action for the medical analyzer device associated with the identified deviation based on a type of QC measurement parameter (such as red blood cell (RBC) type parameters), wherein obtaining the at least one maintenance action further comprises a parameter group (such as a group of RBC and flow cytometer (FCM) parameters, or only the RBC parameters, or only the FCM parameters), and obtaining at least one suggested maintenance action (such as performing a cleaning operation, checking the pressure of a measurement unit, or rinsing a flowcell) based on the identified parameter group having a failing deviation above a threshold);
selecting a maintenance action for the medical analyzer device associated with the identified deviation from the at least one suggested maintenance action based on the obtained action log (Lesher paragraph [0063] teaches selecting a maintenance action based on which rules (deviations) were flagged, and paragraph [0098] teaches selecting an instruction for servicing the target diagnostic analyzer based on the maintenance action log history); and
transmitting, to a device for managing the medical analyzer device associated with the identified deviation, data indicative of an instruction to execute the selected maintenance action for the medical analyzer device (Lesher paragraphs [0079]-[0080] and [0090] teach transmitting each selected instruction to a central computer for managing the target diagnostic device associated with the identified deviation)).
In regards to claim 2, Lesher teaches the method wherein each QC measurement parameter is associated with a parameter group out of a set of predefined parameter groups (Lesher paragraph [0087] teaches where each QC measurement parameter (such as MCV (mean corpuscular volume)) is associated with a parameter group (such as an RBC parameter group) out of a set of predefined parameter groups (RBC or FCM parameter groups)), and wherein the set of predefined parameter groups is formed based on one or more hardware and/or software components of the medical analyzer devices being associated with the performance of the QC measurement (Lesher paragraph [0087] teaches where the predefined parameter groups are formed based on hardware components (such as an RBC detector or flow cytometer) of the analyzer devices being associated with the performance of the QC measurement).
In regards to claim 3, Lesher teaches the method wherein the at least one suggested maintenance action comprises a plurality of suggested maintenance actions arranged in a sequential order (Lesher Fig. 7C and paragraph [0022] teaches a sequential order of instructions for performing maintenance), and wherein the selected maintenance action is a first maintenance action in accordance with the sequential order (Lesher paragraph [0080] teaches selecting a first maintenance action in accordance with the sequential order), the method further comprising:
if a deviation above the predefined threshold is identified (Lesher paragraphs [0071]-[0072] teach checking for rule violations (such as rule 1) in which a given QC measurement is beyond the total allowable error threshold):
checking the obtained action log in order to identify an entry in the action log corresponding to a transmission of the first maintenance action (Lesher paragraph [0098] teaches checking the maintenance history action log in the determination of the next instruction, including the transmission of the first maintenance action);
if the entry in the action log corresponding to the transmission of the first maintenance action is identified and if the deviation above the predefined threshold is identified at a point in time after the entry in the action log corresponding to the transmission of the first maintenance action (Lesher paragraph [0081] teaches identifying a confirmation that the first maintenance operation instruction was performed, and paragraph [0084] teaches re-running a QC measurement after transmission of the first maintenance action to determine if there are still issues detected, and if so):
transmitting, to the device for managing the medical analyzer device associated with the identified deviation, data indicative of an instruction to execute a second maintenance action of the plurality of suggested maintenance actions for the medical analyzer device, the second action being a subsequent maintenance action relative to the first maintenance action in accordance with the sequential order (Lesher paragraphs [0085]-[0088] teach that if another rule violation (deviation) is detected, transmitting a second maintenance instruction (such as checking the pressure of a measurement unit) after the performance of the first maintenance action (such as cleaning the flow passages in the target diagnostic analyzer)) .
In regards to claim 4, Lesher teaches the method further comprising:
obtaining a maintenance log of the medical analyzer device, the maintenance log comprising data indicative of historical maintenance actions performed on the medical analyzer device prior to a point in time defined by a timing of the obtained measurement results of the medical analyzer device (Lesher paragraph [0098] teaches obtaining a maintenance history log of the diagnostic analyzer device; Lesher Fig. 16 and paragraphs [0127]-[0128] teach where the maintenance log includes an "S" indication that a servicing was carried out, and includes maintenance carried out prior to a time of obtained further measurement results of the diagnostic analyzer device (as a continuous calibration verification certificate over time is generated));
after transmitting data indicative of the selected maintenance action for the medical analyzer device (Lesher paragraphs [0080] and [0090] teach transmitting instructions indicative of a selected maintenance action for the target diagnostic analyzer):
checking the obtained maintenance log in order to identify an entry in the maintenance log corresponding to an execution of the selected maintenance action (Lesher paragraphs [0081] teach confirming (checking) that an execution of the selected maintenance action has occurred);
if the entry in the maintenance log corresponding to the execution of the selected maintenance action is not identified within a predefined time period (Lesher paragraphs [0078] and [0081] teach identifying if the entry in the maintenance log corresponding to the execution of the selected maintenance action has or has not been been carried out by the operator over a predetermined time period);
transmitting, to the device for managing the medical analyzer device associated with the identified deviation, data indicative of a reminder of the selected maintenance action for the medical analyzer device (Lesher paragraphs [0077]-[0078] teach that if the maintenance action has not been carried out yet within the predefined time period, then a central server may repeat a communication of a rule violation as a reminder for the selected maintenance instruction action for an operator to access).
In regards to claim 5, Lesher teaches the method wherein the measurement results of the peer group comprise information about an average measurement value for each QC measurement associated with the peer group (Lesher paragraphs [0032] and [0051] teach where the measurement results of the peer group comprise information about a mean (average) measurement value for each QC measurement associated with the peer group), the method further comprising:
updating the average measurement value for each QC measurement of the peer group based on at least a portion of the obtained plurality of measurements (Lesher paragraph [0065] teaches updating the statistical criteria (including the mean) for each QC measurement of the peer group based on at least a portion of newly obtained measured QC measurements).
In regards to claim 6, Lesher teaches the method wherein the predefined threshold comprises a first predefined threshold (Lesher paragraph [0032] teaches where the predefined threshold comprises upper and lower limits for assessing whether a quality control measurement is normal), and wherein the step of evaluating the obtained measurement results comprises:
comparing the obtained measurement results with the average measurement value for each QC measurement of the associated peer group (Lesher paragraph [0009] teaches comparing the obtained measurement results with a statistical value for each QC measurement of a peer group of the plurality of diagnostic analyzers, and paragraphs [0069], [0097], and [0129] teach where the statistical value for comparison includes the group mean value); and
determining that a deviation is identified if the comparison indicates a difference above the first predefined threshold (Lesher paragraph [0069] teaches identifying a deviation if the comparison indicates a difference above the upper and lower limits of the predefined threshold).
In regards to claim 7, Lesher teaches the method wherein the obtained measurement results comprise information about an evolution over time of the measurement results for each of the plurality of medical analyzer devices and wherein the predefined threshold comprises a second predefined threshold (Lesher paragraph [0069] teaches obtaining measurement results comprising an aging evolution over time of the measurement results for each of the plurality of diagnostic analyzer devices, and comprising a second predefined threshold of upper and lower limits that track to the aging measurements of the group mean), and wherein the evaluating the obtained measurement results comprises:
comparing the measurement results for each QC measurement parameter for a most recent time period with an evolution over time of the average measurement value for each corresponding QC measurement of the associated peer group during the most recent time period (Lesher paragraph [0009] teaches comparing the obtained measurement results with a statistical value for each QC measurement of a peer group of the plurality of diagnostic analyzers, and paragraphs [0065] and [0069] teach where the statistical criteria (including the average mean) may be updated to reflect the newly inserted (most recent time period) QC measurement); and
determining that a deviation is identified if the comparison indicates a difference above the second predefined threshold value during the most recent time period (Lesher paragraph [0069] teaches identifying a deviation if the comparison indicates a difference above the upper and lower limits of the continually updated predefined threshold, including the second predefined threshold during the most recent time period).
In regards to claim 8, Lesher teaches the method wherein the obtained measurement results comprise information about an evolution over time of the measurement results for the plurality of medical analyzer devices (Lesher paragraph [0069] teaches obtaining measurement results comprising an aging evolution over time of the measurement results for the plurality of diagnostic analyzer devices), and wherein the step of evaluating the obtained measurement results comprises:
comparing the measurement results for each QC measurement parameter for a most recent time period with an evolution over time of the average measurement value for each corresponding QC measurement during the most recent time period (Lesher paragraph [0009] teaches comparing the obtained measurement results with a statistical value for each QC measurement of a peer group of the plurality of diagnostic analyzers, and paragraphs [0065] and [0069] teach where the statistical criteria (including the average mean) may be updated to reflect the newly inserted (most recent time period) QC measurement);
determining that a deviation is identified if the comparison indicates an increasing difference over time during the most recent time period (Lesher paragraph [0097] teaches determining a deviation issue when the mean values associated with the last QC measurement is shifting away (i.e., increasing in difference over time) from the group mean value).
In regards to claim 9, Lesher teaches a computer-readable storage medium storing one or more programs configured to be executed by one or more processors of a processing system, the one or more programs comprising instructions for performing the method according to claim 1 (Lesher paragraphs [0010] and [0039] teach a non-transitory computer-readable storage medium storing program instruction code for performing the method).
In regards to claim 10, Lesher teaches an apparatus for facilitating maintenance of a medical analyzer device, the apparatus comprising control circuitry configured to (Lesher paragraphs [0001] and [0009] teach a system (apparatus) for facilitating maintenance of a medical diagnostic analyzer device by reviewing a quality control measurement value of the diagnostic analyzer device, where the system comprises a central server (control circuitry)):
obtain a plurality of measurement results associated with a plurality of quality control (QC) measurements performed by a plurality of medical analyzer devices (Lesher abstract and paragraph [0009] teach obtaining a plurality of quality control (QC) measurements from both a target diagnostic analyzer and a plurality of peer group diagnostic analyzers) on a plurality of predefined QC samples, wherein each QC sample is associated with a predefined target range (Lesher paragraphs [0034]-[0035] teach a plurality of predefined QC samples to verify the operation of the diagnostic analyzers, where each QC sample has predefined levels or amounts (range) of constituents) and wherein each medical analyzer device is associated with a peer group of medical analyzer devices (Lesher paragraph [0009] teaches where each target diagnostic analyzer is associated with a peer group of diagnostic analyzer devices);
for each medical analyzer device:
evaluate the obtained measurement results against the measurement results of the associated peer group in order to identify a deviation of at least one QC measurement parameter (Lesher paragraphs [0009], [0032] and [0050] teach evaluating a quality control measurement from each target diagnostic analyzer in comparison to statistical criteria associated with the plurality of quality control measurement values received from the plurality of peer group diagnostic analyzers);
if a deviation above a predefined threshold is identified Lesher paragraphs [0032] and [0045] teach identifying a deviation above a predefined threshold (including peer group established upper and lower limits) to identify issues with the QC measurement to prompt a troubleshooting phase):
obtain an action log of the medical analyzer device, the action log comprising data indicative of any previously transmitted maintenance actions associated with the medical analyzer device (Lesher paragraph [0098] teaches obtaining a maintenance history log of the target diagnostic analyzer based on the determined rule violations of QC measurements deviating above a threshold); obtain at least one suggested maintenance action for the medical analyzer device associated with the identified deviation based on a type of QC measurement parameter that is associated with the identified deviation, wherein the control circuitry configured to obtain the at least one maintenance action is further configured to identify a parameter group of the type of QC measurement parameter that is associated with the identified deviation, and obtain at least one suggested maintenance action based on the identified parameter group (Lesher paragraphs [0086]-[0089] teach obtaining at least one suggested maintenance action for the medical analyzer device associated with the identified deviation based on a type of QC measurement parameter (such as red blood cell (RBC) type parameters), wherein obtaining the at least one maintenance action further comprises a parameter group (such as a group of RBC and flow cytometer (FCM) parameters, or only the RBC parameters, or only the FCM parameters), and obtaining at least one suggested maintenance action (such as performing a cleaning operation, checking the pressure of a measurement unit, or rinsing a flowcell) based on the identified parameter group having a failing deviation above a threshold);
select a maintenance action for the medical analyzer device associated with the identified deviation from the at least one suggested maintenance action based on the obtained action log (Lesher paragraph [0063] teaches selecting a maintenance action based on which rules (deviations) were flagged, and paragraph [0098] teaches selecting an instruction for servicing the target diagnostic analyzer based on the maintenance action log history); and
transmit, to a device for managing the medical analyzer device associated with the identified deviation, data indicative of an instruction to execute the selected maintenance action for the medical analyzer device (Lesher paragraphs [0079]-[0080] and [0090] teach transmitting each selected instruction to a central computer for managing the target diagnostic device associated with the identified deviation)).
In regards to claim 11, Lesher teaches the apparatus wherein the device for managing the medical analyzer device is configured to monitor and control one or more medical analyzer devices connected to the device (Lesher paragraphs [0009] teaches where the central server device for managing the target diagnostic analyzer is configured to monitor and control a plurality of connected peer medical analyzer devices that also provide quality control measurements).
In regards to claim 12, Lesher teaches the apparatus wherein the device for managing the medical analyzer device is associated with a geographical location comprising one or more medical analyzer devices (Lesher paragraphs [0002] and [0037] teach the apparatus where the central server device for managing the medical analyzer device is associated with a geographical location such as a laboratory or hospital comprising one or more medical analyzer devices).
In regards to claim 13, Lesher teaches a remote server comprising the apparatus (Lesher paragraph [0009] and Fig. 1 Item 155 teach a remote central server comprising the apparatus for monitoring and facilitating maintenance of a medical analyzer device).
In regards to claim 14, Lesher teaches a cloud environment comprising one or more remote servers (Lesher Fig. 1 Item 102 teaches a cloud environment comprising a remote central server 155).
Pertinent Art
5. Applicants are directed to consider additional pertinent prior art included on the Notice of References Cited (PTOL 892) attached herewith. The Examiner has pointed out particular references contained in the prior art of record within the body of this action for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply. Applicant, in preparing the response, should consider fully the entire reference as potentially teaching all or part of the claimed invention, as well as the context of the of the passage as taught by the prior art or disclosed by the Examiner. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
A. Baruah et al. (US Pat. Pub. 2016/0203283) discloses System and Method for Facilitating Diagnostic and Maintenance of a Medical Device.
B. Junker at al. (US Pat. Pub. 2021/0193305) discloses System of Medical Devices.
C. Martin et al. (US Pat. Pub. 2022/0020489) discloses Inferring a Condition of a Medical Analyzer.
D. Kwan et al. (US Pat. Pub. 2024/0161919) discloses Maintenance Systems and Methods for Medical Devices.
Conclusion
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL D LEE whose telephone number is (571)270-1598. The examiner can normally be reached on M to F, 9:30 am to 6 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 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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/PAUL D LEE/Primary Examiner, Art Unit 2857 7/16/2026
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