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
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 – 6, 11, 13 – 17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rowlandson et al. (US Pub. No. 20130056535), hereinafter referred to as Rowlandson.
As to claim 1, Rowlandson discloses the maintenance method for an analyzer (medical device performing medical test, Fig. 1, medical device 24) that is not communicably connected to a network outside of a facility (device isolated from hospital/EMR network, only receives info via barcode, Fig. 2, medical device 24 with scanner 74), the maintenance method comprising:
presenting, by a terminal (mobile computer such as tablet, smartphone, or EMR terminal, Fig. 1, mobile computer 12; Fig. 2, EMR terminal/mobile device 62) that is communicably connected to the network outside of the facility (connected to hospital EMR/computer network, Fig. 1, data connection 22 to EMR 20), information about a process to be executed by the analyzer (patient/test/order information encoded in barcode, Fig. 2, bar code file 72 generated by EMR system 52 and displayed on terminal 12/62);
reading, by the analyzer, the information presented by the terminal (barcode scanner imports patient/test/order data from displayed barcode, Fig. 1, barcode scanner 30; Fig. 2, scanner 74 reading barcode 76); and
executing, by the analyzer, the process indicated by the information read by the analyzer (performing the requested medical test using received barcode data, Fig. 3, step 112, medical device 24).
As to claim 2, Rowlandson discloses the maintenance method of claim 1, wherein the presenting includes displaying an optically readable information code including the information (barcode displayed on mobile computer, Fig. 1, barcode 16 on display 14).
As to claim 3, Rowlandson discloses the maintenance method of claim 1, wherein the information includes a set of a plurality of the processes (multiple barcodes sequentially presented for multiple processes, Fig. 1, bar code file 36; Fig. 2, bar code 72).
As to claim 4, Rowlandson discloses the maintenance method of claim 1, wherein the information includes order information indicating an order of execution of a plurality of the processes (order number encoded in barcode by EMR system, Fig. 2, EMR system 52 generating barcode file 72), and the executing includes executing, by the analyzer, the plurality of the processes according to the order of execution indicated by the order information read by the analyzer (medical device performs ordered test using received order number, Fig. 3, step 112 medical device 24).
As to claim 5, Rowlandson discloses the maintenance method of claim 1, wherein the process includes a process that cannot be executed in a user mode of the analyzer and that can be executed in a service mode (barcode order/authorization enables restricted medical procedure, Fig. 2, EMR system 52 providing order number to device 24).
As to claim 6, Rowlandson discloses the maintenance method of claim 1, wherein the information includes an ID for identifying a command corresponding to the process (barcode encodes patient/test/order identifiers, Fig. 1, bar code file 36; Fig. 3, step 106), and the executing includes executing, by the analyzer (medical device executes procedure based on received identifiers, Fig. 3, step 112 medical device 24), the process corresponding to the ID included in the information read by the analyzer (barcode encodes patient/test/order ID used by analyzer to identify process, Fig. 1, bar code file 36; Fig. 3, step 106).
As to claim 11, Rowlandson discloses the maintenance method of claim 10, further comprising transmitting information from the management device to the terminal, the information indicating the processes the input of which has been received (EMR system 20/52 transmits barcode file 36/72 back to mobile computer 12 containing process/order info, Fig. 1–2), wherein the presenting includes displaying, by the terminal, the information code that allows reading of the information indicating the processes the input of which has been received (mobile computer 12 presents barcode 16/72 on display 14 for analyzer to scan, Fig. 1, Fig. 2).
As to claim 13, Rowlandson discloses the maintenance method of claim 1, wherein the analyzer is not connected to the Internet (medical device 24 is isolated from outside networks and communicates only via barcode/indirect links, Fig. 2, gateway-controlled connection).
As to claim 14, Rowlandson discloses the maintenance method of claim 1, wherein the terminal is connected via a mobile communication network to the Internet (mobile computer connected wirelessly via RF/cellular communication platforms to EMR network, Fig. 1, data connection 22 between mobile computer 12 and computer network 20).
As to claim 15, Rowlandson discloses the maintenance method of claim 1, wherein the terminal is a smartphone or a tablet terminal (mobile computer exemplified as smartphone or tablet computer, Fig. 1, mobile computer 12).
As to claim 16, Rowlandson discloses a system comprising: an analyzer that is not communicably connected to a network outside of a facility (medical device isolated from EMR system, Fig. 2, medical device 24 not directly connected to EMR server 52); and a terminal that is communicably connected to the network outside of the facility (mobile computer connected to EMR system, Fig. 1, mobile computer 12 with data connection 22), wherein the terminal is configured to present information about a process to be executed by the analyzer (barcode presented on display 14 of mobile computer 12, Fig. 1, barcode 16); the analyzer is configured to read the information presented by the terminal (barcode scanner 30/74 reads barcode from terminal display, Fig. 1 and Fig. 2); and execute the process indicated by the information read by the analyzer (medical device 24 executes medical test, Fig. 3, step 112).
As to claim 17, Rowlandson discloses the system of claim 16, wherein the terminal is communicably connected to a management device via the network, the terminal is configured to obtain the information about the process to be executed by the analyzer (mobile computer 12 communicatively connected to hospital EMR system 20, which provides test/order information, Fig. 1, data connection 22; Fig. 2, EMR system server 52).
As to claim 20, Rowlandson discloses the system of claim 16, wherein the terminal is connected via a mobile communication network to the Internet (mobile computer connected by wireless/cellular data connection to EMR system, Fig. 1, data connection 22 between mobile computer 12 and computer network 20).
Claim Rejections - 35 USC § 103
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 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 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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Rowlandson et al. (US Pub. No. 20130056535), hereinafter referred to as Rowlandson in view of Faenger (US Pub. No. 20110295502).
As to claim 7, Rowlandson discloses the maintenance method of claim 1, wherein the information includes the executing includes determining (comparison of mobile computer/analyzer ID encoded in barcode, Fig. 2, barcode 72 with mobile computer identification), by the analyzer, whether or not the ID included in the information read by the analyzer and an ID stored in the analyzer match (device verifies encoded ID with stored ID, Fig. 3, step 106), and executing, by the analyzer, the process when the IDs match (mobile computer ID encoded in barcode compared by analyzer, Fig. 2, barcode 72 with mobile computer identification; Fig. 3, step 106).
Faenger discloses, what Rowlandson lacks, an ID of the analyzer (an ID of the analyzer, barcode 308, fig. 3).
Rowlandson and Faenger are analogous art because they are from the same field of endeavor, namely medical/diagnostic analyzers and associated data transfer systems using barcodes and optically readable codes for secure device communication.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having the teachings of Rowlandson and Faenger before him or her, to modify the barcode information structure of Rowlandson to include the explicit device ID field disclosed by Faenger because Faenger teaches that encoding a device/analyzer identifier directly into a displayed barcode allows the receiving device to verify which analyzer produced or is authorized for the process (barcode 308, Fig. 3 and para. [0066]–[0068]). This complements Rowlandson’s teaching of barcodes carrying order/test information by ensuring the analyzer’s identity is also encoded for security and traceability.
The suggestion/motivation for doing so would have been to improve security, ensure proper device-to-system association, and prevent unauthorized analyzers from executing maintenance/test processes. Faenger expressly teaches that encoding device identity in barcodes enables reliable device pairing and authentication.
Therefore, it would have been obvious to combine Faenger with Rowlandson to obtain the invention as specified in the instant claim.
Claim Rejections - 35 USC § 103
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 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 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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Rowlandson et al. (US Pub. No. 20130056535), hereinafter referred to as Rowlandson in view of DeSoto et al. (US Pub. No. 20130219479), hereinafter referred to as DeSoto.
As to claim 8, Rowlandson discloses the maintenance method of claim 2, the executing includes determining, by the analyzer (device uses encoded timing/order data to validate process authorization, Fig. 2, EMR system 52 generating barcode file 72), whether or not the information code is valid (authorization/order validation logic, Fig. 2, barcode 72; Fig. 3, step 106), on the basis of the date-and-time information included in the information code (order number/time-based compliance information encoded, Fig. 2, barcode file 72 generated by EMR system 52), and executing, by the analyzer, the process when the information code is valid (order number and timestamp information encoded in barcode for compliance, Fig. 2, EMR system 52 generating barcode file 72).
DeSoto discloses, what Rowlandson lacks, wherein the information code includes date-and-time information indicating a date and a time of issuance and/or an expiration of validity period of the information code (The time stamp may indicate a period of validity of the QR code, para. 0028).
Rowlandson and DeSoto are analogous art because they are from the same problem-solving area, namely secure data transfer and device maintenance systems using optically readable codes (barcodes/QR codes) for process initiation and authentication.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having the teachings of Rowlandson and DeSoto before him or her, to modify the barcode information presented by the terminal in Rowlandson to include the timestamp and validity period of DeSoto because DeSoto explicitly teaches encoding time-of-issuance and validity windows in QR codes to prevent replay or stale code usage (DeSoto, para. [0028]).
The suggestion/motivation for doing so would have been to increase security, compliance, and reliability by preventing reuse of expired codes and ensuring process execution occurs only within an authorized timeframe.
Therefore, it would have been obvious to combine DeSoto with Rowlandson to obtain the invention as specified in the instant claim.
Claim Rejections - 35 USC § 103
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 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 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.
Claims 9, 10, 12, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Rowlandson et al. (US Pub. No. 20130056535), hereinafter referred to as Rowlandson in view of Atkinson (WO 2024168167).
As to claim 9, Rowlandson discloses, wherein the executing includes displaying, a message by the analyzer without executing the process by the analyzer (barcode displayed on mobile computer, Fig. 1, barcode 16 on display 14; analyzer scans code with scanner 30, Fig. 1; medical device 24 executes process, Fig. 3, step 112). However, Rowlandson does not disclose that the analyzer displays a message when the information code is not valid.
Atkinson discloses that when a QR code is invalid or expired, the device provides an error notification or display message to the user (displaying invalid test results, para. 0032).
Rowlandson and Atkinson are analogous art because they are from the same field of endeavor or address the same problem-solving area, namely medical/diagnostic analyzers with barcode-based data transfer and control.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having the teachings of Rowlandson and Atkinson before him or her, to modify the analyzer of Rowlandson to include Atkinson’s error message functionality when codes are invalid.
The suggestion/motivation for doing so would have been to improve usability and compliance by alerting users to invalid or expired codes, preventing unauthorized or failed maintenance/test operations (displaying invalid test results, para. 0032 - 0034).
Therefore, it would have been obvious to combine Atkinson with Rowlandson to obtain the invention as specified in claim 9.
As to claim 10, Rowlandson discloses transmitting the information from the terminal to a management device that is not communicably connected to the analyzer (terminal transmits data to EMR system 20 over data connection 22, Fig. 1, mobile computer 12 to EMR 20) and that is communicably connected to the terminal, the information having been read from said information code (barcode file 36 generated by EMR system and transmitted to mobile computer 12, Fig. 1); and
receiving, by the management device, input of one or more of the processes corresponding to the information having been transmitted (EMR system 20 processes received test order and encodes order number into barcode file 36, Fig. 2, EMR system 52).
However, Rowlandson does not explicitly disclose the analyzer displaying its own barcode for export.
Atkinson discloses, what Rowlandson lacks, displaying, by the analyzer, an information code that allows reading of information stored in the analyzer (device generates and displays QR code for data export, para. [0056]–[0060]);
reading said information code by the terminal (matrix code such as a QR code, para. [0060]);
Rowlandson and Atkinson are analogous art because they are from the same field of endeavor or address the same problem-solving area, namely medical/diagnostic analyzers using barcode systems for secure offline communication and data export.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having the teachings of Rowlandson and Atkinson before him or her, to modify the analyzer of Rowlandson to include Atkinson’s teaching of displaying a barcode on the analyzer itself for data export.
The suggestion/motivation for doing so would have been to provide a standardized, network-independent way to transmit analyzer results and configuration data in facilities where direct network connections are not possible (Atkinson, para. [0056]–[0060]).
Therefore, it would have been obvious to combine Atkinson with Rowlandson to obtain the invention as specified in claim 10.
As to claim 12, Rowlandson discloses transmitting quality/test result data from the analyzer to the terminal/EMR (test result data transmitted, Fig. 3, step 114, medical device 24). However, Rowlandson does not wherein the executing includes displaying, by the analyzer, the information code that allows reading of quality control-related information obtained by the analyzer after the process is executed by the analyzer, the maintenance method further comprising: reading said information code by the terminal; and transmitting, to the management device, the information having been read from said information code.
Atkinson discloses that a diagnostic device can generate and display barcodes containing not only test results but also QC-related and operational information for subsequent scanning and transfer (QC and operational data encoded in displayed barcode, para. [0072]–[0075]).
Rowlandson and Atkinson are analogous art because they are from the same field of endeavor or address the same problem-solving area, namely medical analyzers that transfer test and QC information using barcode displays for offline interoperability.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having the teachings of Rowlandson and Atkinson before him or her, to modify the analyzer of Rowlandson to include Atkinson’s disclosure of barcodes containing QC information displayed after execution.
The suggestion/motivation for doing so would have been to enable efficient QC data transfer and validation without requiring network connectivity, improving traceability and compliance (Atkinson, para. [0072]–[0075]).
Therefore, it would have been obvious to combine Atkinson with Rowlandson to obtain the invention as specified in claim 12.
Claims 18 and 19 recite the corresponding limitation of claims 10 and 12. Therefore, they are rejected accordingly.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Biasi et al. (Pub. No. 20220223283) -- A system for electronic patient care includes a gateway and a medical device. The gateway is configured to provide at least one of a routing functionality, a medical device software update, and a web service.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUANITO C BORROMEO whose telephone number is (571)270-1720. The examiner can normally be reached on Monday - Friday 9 - 5.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Henry Tsai can be reached on 5712724176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.C.B/ Assistant Examiner, Art Unit 2184
/HENRY TSAI/Supervisory Patent Examiner, Art Unit 2184