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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cooper (WO 2018/031786 as cited by IDS filed 8/14/25).
Regarding claim 1, Cooper discloses a method of operating an apparatus for analyzing biological samples, the apparatus comprising:
a receptacle (cartridge 600 is inserted into the analyzer 200);
a measurement unit (analyzer 200 has an optical based detector) configured to bring a biological sample into operational interaction with at least a first sensor of one or more sensors of a replaceable sensor module received by said receptacle (The cartridge is placed within the analyzer), to obtain a measurement result responsive to the interaction between at least the first sensor and the biological sample and to output the obtained measurement result; (optical analyzer detects cartridge sample and outputs a result; para 33-37); wherein the receptacle is adapted to receive the replaceable sensor module and wherein the replaceable sensor module comprises a writeable memory (this limitation does not further structurally limit the instant claims. The receptacle is structurally capable of receiving the replaceable sensor module. The cartridge is the sensor module having a sensor and a writable memory such as an RFID tag or chip, para 33-36);
a control unit (analyzer has a processor, para 33-36,43; further comprising a RFID reader/writer controller) configured to control operation of the measurement unit (para 43);
a data exchange interface (database/memory of control unit) configured to receive data from the writable memory and to forward data to the replaceable sensor module for storage in the writable memory (para 43); and
a communications interface (para 40-43; communication interface having a wireless interface; communication module 305) for communicating with a remote host system (central server; para 41); wherein the method comprises performing the following steps by the control unit:
a) receiving, from the remote host system (analyzer receives information from the central server, para 41)) via said communications interface, one or more healthcare facility-specific operational parameters associated with the sensor module (para 43; receiving information from server regarding first batch of information, second batch of information regarding the sensor module or any other information related to the test cartridge through the communication interface; para 43-44; the batch information on the RFID reader/writer includes an initial time stamp for a development time of the biological sample on a lateral flow strip. The RFID can also include information that the analyzer can use to perform computations such as identifying the assay type, finding the concentration of the target molecules, and interpreting the results. this information is broadly interpreted as a healthcare facility-specific operational parameter because the batch information is specific to the testing facility and relates to the patient for what tests are being performed, para. 44, 51. Applicant has not claimed specific healthcare facility-specific operational parameters);
b) causing writing, via said data exchange interface, the received one or more healthcare facility-specific operational parameters to the writable memory (para 43; receiving/writing information from server regarding first batch of information, second batch of information regarding the sensor module or any other information related to the test cartridge through the communication interface; para 43-44; the batch information on the RFID reader/writer includes an initial time stamp for a development time of the biological sample on a lateral flow strip. The RFID can also include information that the analyzer can use to perform computations such as identifying the assay type, finding the concentration of the target molecules, and interpreting the results. this information is broadly interpreted as a healthcare facility-specific operational parameter because the batch information is specific to the testing facility and relates to the patient for what tests are being performed, para. 44, 51. The information is written on the RFID tag. Applicant has not claimed specific healthcare facility-specific operational parameters); and
c) controlling operation of the measurement unit in accordance with the received one or more customer operational parameters by performing acts comprising determining whether to perform one or more measurements using the replaceable sensor module based on the received one or more customer-specific operational parameters (para 43; receiving information from server regarding first batch of information, second batch of information regarding the sensor module or any other information related to the test cartridge through the communication interface; para 43-44; the batch information on the RFID reader/writer includes an initial time stamp for a development time of the biological sample on a lateral flow strip. The RFID can also include information that the analyzer can use to perform computations such as identifying the assay type, finding the concentration of the target molecules, and interpreting the results. this information is broadly interpreted as a healthcare facility-specific operational parameter because the batch information is specific to the testing facility and relates to the patient for what tests are being performed, para. 44, 51. Applicant has not claimed specific healthcare facility-specific operational parameters; Para,95-96; determining whether to perform is a operational decision to not run a test or not).
Regarding claim 2, the method according to claim 1; wherein causing writing the received one or more operational parameters to the writable memory comprises causing writing a time stamp to the writable memory (abstract), the time stamp being associated with the one or more healthcare facility-specific operational parameters (abstract; para 43-44).
Regarding claim 3, the method according to claim 1; wherein receiving the one or more healthcare facility-specific parameters comprises:
receiving, via the data exchange interface, a module identifier from the writable memory of the sensor module received by the receptacle (barcode associated with the test cartridge);
communicating, via the communications interface, the read module identifier to the remote host system (reading a barcode and identifying condition parameters for analyzer);
receiving, from the remote host system via the communications interface, one or more operational parameters associated with the communicated module identifier (receiving condition parameters to the analyzer to be carried out; para 43-44).
Regarding claim 4, the method according to claim 3; wherein communicating the read module identifier further comprises communicating a time stamp indicative of a time of reading the module identifier from the writable memory (44-45, 91).
Regarding claim 5, the method according to claim 1; wherein receiving the one or more customer specific operational parameters comprises:
communicating, via the communications interface, an analyzer identifier to the remote host system, the analyzer identifier identifying the apparatus for analyzing biological samples (para 43-45);
receiving, from the remote host system via the communications interface, one or more healthcare facility-specific operational parameters associated with the communicated analyzer identifier (para 40-45, batch information for analyzer processing of test cartridge; see above for healthcare facility-specific operational parameters).
Regarding claim 6, the method according to claim 1; comprising performing the following by the control unit:
upon start-up of the apparatus, receiving information, via the data exchange interface, from the writable memory of a sensor module received by the receptacle (para 39-45);
determining, based on the received information, whether or not the replaceable sensor module has previously been used (para 48);
responsive to determining that the replaceable sensor module has not previously been used, performing steps a) through c); otherwise controlling operation of the measurement unit in accordance with one or more previously stored operational parameters read from the writable memory via the data exchange interface (para 43-48).
Regarding claim 7, the method according to claim 1; comprising performing the following by the control unit:
upon start-up of the apparatus, determining whether or not communication with the remote host system can be established via the communications interface (para 40-45);
responsive to determining that communication with the remote host system can be established, performing steps a) through c); otherwise controlling operation of the measurement unit in accordance with one or more previously stored operational parameters read from the writable memory via the data exchange interface (para 40-48).
Regarding claim 8, the method according to claim 1; comprising performing the following by the control unit:
controlling the measurement unit to perform one or more quality control measurements (para 43-45);
responsive to a result of the one or more quality control measurements, obtaining one or more modified operational parameters associated with the sensor module received by the receptacle (first and second batch parameters received, para 40-45);
causing writing, via said data exchange interface, the one or more modified operational parameters to the writable memory (batch parameters are written and read to processor); and
controlling operation of the measurement unit in accordance with the one or more modified operational parameters (analyzer carries out batch parameters).
Regarding claim 9, the method according to claim 1; comprising causing, by the control unit responsive to operation of the measurement unit, writing usage data to the writable memory via the data exchange interface, the usage data being indicative of one or more usage parameters (para 40-45).
Regarding claim 10, the method according to claim 1; wherein the method comprises writing one or more operational parameters to the writable memory of the replaceable sensor module, wherein the one ore more operational parameters written to the memory of the replaceable sensor module, wherein the one or more operational include one or more parameters chosen from:
a lock/unlock flag indicative of whether the control unit is to allow measurements to be performed with the replaceable sensor module;
one or more feature lock/unlock flags indicative of whether the control unit is to lock or unlock one or more selected features of the apparatus with the replaceable sensor module received by the receptacle;
one or more usage restriction parameters restricting usage of the replaceable sensor module to one or more locations and/or operators and/or health care facilities;
one or more start-up parameters indicative of a required start-up configuration of the apparatus with the replaceable sensor module received by the receptacle (para 91, elapsed time of cartridge insertion for analysis run time);
one or more measurement parameters indicative of a required measurement configuration of the apparatus with the replaceable sensor module received by the receptacle (para 91, elapsed time of cartridge insertion for analysis run time).
Regarding claim 11, the method according to claim 1; comprising:
maintaining, in a data storage of the apparatus, a local cache of one or more cached operational parameters;
responsive to determining that the sensor module has not previously been used and that communication with the remote host system cannot be established, causing writing, via said data exchange interface, the cached operational parameters to the writable memory (para 44-45); and controlling operation of the measurement unit in accordance with the cached one or more operational parameters (para 43-48).
Regarding claim 12, the method according to claim 11; comprising, responsive to determining that communication with the remote host system can again be established:
receiving, from the remote host system via said communications interface, one or more updated operational parameters associated with the sensor module; causing writing, via said data exchange interface, the received one or more updated operational parameters to the writable memory; and controlling operation of the measurement unit in accordance with the received one or more updated operational parameters (para 43-48).
Regarding claim 13, Cooper discloses an apparatus for analyzing biological samples, the apparatus comprising:
a receptacle for receiving a replaceable sensor module, the replaceable sensor module comprising one or more sensors and a writable memory (cartridge 600 is inserted into the analyzer 200; cartridge is the replaceable sensor module having a sensor and a writable memory such as an RFID tag or chip, para 33-36);
a measurement unit (optical measurement detector which is part of the analyzer 200) configured to bring a biological sample into operational interaction with at least a first sensor of the one or more sensors of a sensor module received by said receptacle, to obtain a measurement result responsive to the interaction between at least the first sensor and the biological sample and to output the obtained measurement result (para 67);
a control unit (analyzer 200 having processor; para 43) configured to control operation of the measurement unit;
a data exchange interface ((database/memory of control unit; para 43) configured to receive data from the writable memory and to forward data to the replaceable sensor module for storage in the writable memory; and
a communications interface (para 43; communication module) for communicating with a remote host system; wherein the control unit is configured to perform the method of claim 1.
Regarding claim 14, a system for analyzing biological samples, the system comprising: the apparatus of claim 13; a replaceable sensor module comprising one or more sensors and a writable memory (test cartridge is inserted into analyzer 200 for testing of a sample); and a remote host system (remoted server sending batch parameter information, para. 43-45) configured to send one or more operational parameters associated with the replaceable sensor module to the apparatus.
Regarding claim 15, Cooper discloses a host system comprising: a communications interface (communication module 305) for communicating with one or more apparatuses for analyzing biological samples;
a data processing unit; and
a database (remote server) comprising data (batch parameter information regarding test cartridge parameters and analyzer parameters) indicative of one or more healthcare facility-specific operational parameters and/or of one or more module-specific operational parameters ((para 43; receiving information from server regarding first batch of information, second batch of information regarding the sensor module or any other information related to the test cartridge through the communication interface; para 43-44; the batch information on the RFID reader/writer includes an initial time stamp for a development time of the biological sample on a lateral flow strip. The RFID can also include information that the analyzer can use to perform computations such as identifying the assay type, finding the concentration of the target molecules, and interpreting the results. this information is broadly interpreted as a healthcare facility-specific operational parameter because the batch information is specific to the testing facility and relates to the patient for what tests are being performed, para. 44, 51. Applicant has not claimed specific healthcare facility-specific operational parameters); wherein the data processing unit is configured to programmed with instructions which, when executed:
retrieve from the database, responsive to receipt of a module identifier of a replaceable sensor module and an analyzer identifier from an apparatus for analyzing biological samples via the communications interface, the one or more healthcare facility-specific operational parameters and/or the one or more module-specific operational parameters, and forward the retrieved one or more healthcare facility-specific operational parameters and/or the one or more module-specific operational parameters to the apparatus for analyzing biological samples via the communications interface ((para 43; receiving information from server regarding first batch of information, second batch of information regarding the sensor module or any other information related to the test cartridge through the communication interface; para 43-44; the batch information on the RFID reader/writer includes an initial time stamp for a development time of the biological sample on a lateral flow strip. The RFID can also include information that the analyzer can use to perform computations such as identifying the assay type, finding the concentration of the target molecules, and interpreting the results. this information is broadly interpreted as a healthcare facility-specific operational parameter because the batch information is specific to the testing facility and relates to the patient for what tests are being performed, para. 44, 51. Applicant has not claimed specific healthcare facility-specific operational parameters).
Regarding claim 16, the host system according to claim 15; wherein the data processing unit is further configured to programmed with instructions which, when executed:
receive usage data from the apparatus, the usage data being indicative of one or more usage parameters of the apparatus, store the received usage data in the database; determine the one or more healthcare facility-specific operational parameters and/or the one or more module-specific operational parameters based on the stored usage data (para 43; receiving information from server regarding first batch of information, second batch of information regarding the sensor module or any other information related to the test cartridge through the communication interface; para 43-44; the batch information on the RFID reader/writer includes an initial time stamp for a development time of the biological sample on a lateral flow strip. The RFID can also include information that the analyzer can use to perform computations such as identifying the assay type, finding the concentration of the target molecules, and interpreting the results. this information is broadly interpreted as a healthcare facility-specific operational parameter because the batch information is specific to the testing facility and relates to the patient for what tests are being performed, para. 44, 51. Applicant has not claimed specific healthcare facility-specific operational parameters).
Regarding claim 17, the method according to claim 1, wherein the method comprises writing one or more operational parameters to the writeable memory of the replaceable sensor module, wherein the one or more operational parameters written to the memory of the replaceable sensor module comprise one or more usage restriction parameters restricting usage of the replaceable sensor module to one or more locations and/or operators and/or healthcare facilities (para 43; receiving information from server regarding first batch of information, second batch of information regarding the sensor module or any other information related to the test cartridge through the communication interface; para 43-44; the batch information on the RFID reader/writer includes an initial time stamp for a development time of the biological sample on a lateral flow strip. The RFID can also include information that the analyzer can use to perform computations such as identifying the assay type, finding the concentration of the target molecules, and interpreting the results. this information is broadly interpreted as a healthcare facility-specific operational parameter because the batch information is specific to the testing facility and relates to the patient for what tests are being performed, para. 44, 51. Applicant has not claimed specific healthcare facility-specific operational parameters).
Response to Arguments
Applicant's arguments filed 7/22/26 have been fully considered but they are not persuasive. Applicant argues, “However, without conceding that "customer-specific" was properly interpreted as being broad enough to encompass patient information, the applicant submits that the interpretation relied on in the Office Action cannot justify maintaining the rejection of claim 1, since patient information is clearly not "healthcare facility-specific," as is recited in amended claim 1.” Cooper in para 43 discloses receiving information from server regarding first batch of information, second batch of information regarding the sensor module or any other information related to the test cartridge through the communication interface; para 43-44; the batch information on the RFID reader/writer includes an initial time stamp for a development time of the biological sample on a lateral flow strip. The RFID can also include information that the analyzer can use to perform computations such as identifying the assay type, finding the concentration of the target molecules, and interpreting the results. This information is broadly interpreted as a healthcare facility-specific operational parameter because the batch information is specific to the testing facility and relates to the patient for what tests are being performed, para. 44, 51. Applicant has not claimed specific healthcare facility-specific operational parameters that are used in the computations, time stamp values, patient information, equations and messages.
Regarding claim 15, Applicant argues, “In rejecting claim 15, the Office Action asserted that retrieving healthcare facility-specific and/or module specific operational parameters from a database in response to receipt of a module identifier and/or a customer identifier was taught in paragraphs 43-48 of Cooper, and also asserted that reciting a data processing unit "configured to" retrieve such information from a database was an intended use limitation which did not structurally limit the claim.10 However, as set forth below, neither of these assertions can justify treating amended claim 15 as anticipated by either Cooper or Glavina.”
Cooper in para 43 discloses receiving information from server regarding first batch of information, second batch of information regarding the sensor module or any other information related to the test cartridge through the communication interface; para 43-44; the batch information on the RFID reader/writer includes an initial time stamp for a development time of the biological sample on a lateral flow strip. The RFID can also include information that the analyzer can use to perform computations such as identifying the assay type, finding the concentration of the target molecules, and interpreting the results. This information is broadly interpreted as a healthcare facility-specific operational parameter because the batch information is specific to the testing facility and relates to the patient for what tests are being performed, para. 44, 51. Applicant has not claimed specific healthcare facility-specific operational parameters that are used in the computations, time stamp values, patient information, equations and messages.
Conclusion
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 SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday-Friday 8-5.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758
