DETAILED ACTION
Applicant's response, filed 16 June 2025, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Status of the Claims
Claims 1-20 are pending.
Claims 1-20 are rejected.
Claim 11 is objected to.
Priority
Claims 1-20 are given the benefit of priority to Foreign Application No. PCT/JP2018/045937, filed 13 December 2018.
Drawings
The drawings were received 14 June 2021. These drawings are acceptable.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10 September 2021 and 14 September 2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
New ground for objection was necessitated by amendment to the claims, received 16 June 2025. Claim 11 is objected to because of the following informalities:
“a possibility-of-being-use status” should be “a possibility-of-being-used status” to maintain consistency throughout the entire claimed invention.
Appropriate correction is required.
Response to Arguments
Regarding 35 USC § 112(f): Applicant’s arguments, see page 8 lines 16-20, filed 16 June 2025, with respect to claims 1 and 3-10 have been fully considered and are persuasive. The interpretation of the claims under 35 USC § 112(f) has been withdrawn in view of the amendments to the claims, filed 16 June 2025.
Regarding 35 USC § 101: Applicant’s arguments, see page 8 line 22 to page 11 line 8, filed 16 June 2025, with respect to claims 1-20 have been fully considered and are persuasive. The amendments to the claims direct the claimed invention to patent eligible subject matter under 35 U.S.C. §101 because amended claims 1-20, satisfy Step 2A Prong One and/or Step 2A Prong Two of the analysis set forth in the subject matter eligibility analysis. The rejection of claims 1-20 under 35 USC § 101 has been withdrawn in view of the amendments to the claims, filed 16 June 2025.
Regarding 35 U.S.C. § 103: Applicant's arguments, filed 16 June 2025, have been fully considered but are not persuasive.
Applicant argues, see page 13 lines 5-9, that neither one of Showalter's SAC segment and ORC segment include: "a reserved-for-use status indicating that the sample container cannot be assigned to another examination", "a possibility-of-being-used status that indicates that there is a possibility that the sample container is being used during the examination" and "an unreserved status that indicates that the sample container is available to be assigned to another examination", recited in claim 1.
However, the Examiner argues that Showalter teaches automatic status updates (OUL) initiated by ORC segments which encompass the following statuses as claimed in the instant application:
a "reserved-for-use status" (ORC-5 attribute field “Order (HD) is on hold” at para. [0077]; this status is interpreted as a sample container is required (i.e. reserved) for the order that is on hold);
a "possibility-of-being-used status" (ORC-5 attribute field "In Process" (IP) status at para. [0077]; this status is interpreted as a possibility that a sample container is used for an order that is in-process);
an "unreserved status” (ORC-5 attribute field "Error, order unable to complete" (ER) at para. [0077]; this status is interpreted as a sample container is not required (i.e., unreserved) because an order was not completed); and
a “used status” (ORC-5 attribute field “Order is Completed” (CM) status at para. [0077]; this status is interpreted as a sample container was used for the completed order).
Applicant further argues, see page 13 lines 10-17, that Showalter's "OML message applies to new orders and may not be used to cancel or modify existing orders." Hence, the SAC and ORC segments in Showalter's OML message are being provided when a new order for testing is being requested. Showalter does not disclose or suggest "acquire... information indicating that the sample container has been moved when the status is the reserved-for-use status" and "acquire...information regarding the completion of the examination when the status is the reserved-for-use status (emphasis added)" recited in claim 1.
The Examiner argues that Showalter further teaches that it is assumed that the order status (ORC-5) always reflects the status as it is known to the sending application at the time the message is sent and that only the filler can originate the value in this field, thus, this field is only valid in the ORL (Automatic Test Ordering) and OUL (Automatic Status Updates) messages (at para. [0077]). Showalter further teaches that the ORC-6 attribute field is an optional field that enables the status update (OUL) and allows the sending application to determine the amount of information to be returned from the filler via one or more OUL messages (at para. [0078]).
Showalter further teaches that the ORC segment is a required field in an OML message and if an order detail segment is present, the ORC segment is also mandatory in Unsolicited Laboratory Observation (OUL) messages (at para. [0079]).
Additionally, Showalter further teaches the status results message, or Automatic Status Updates (Unsolicited Laboratory Observation or OUL) message is also a unidirectional message. However, the OUL is generated by the laboratory instrument and received by the LIS to notify the LIS of the specimen status. The OUL message is a response status message that combines the original order request from the LIS with a status update relating to that order request (emphasis added) (at para. [0095]).
Note that this indicates the Automatic Status Update (OUL) is initiated in response to acquiring information regarding the various statuses as specified by the ORC segment when an order detail segment is present.
Therefore, the rejection to claims 1-20 under 35 U.S.C. § 103 is maintained with modifications as necessitated by amendment of the claims, filed 16 June 2025.
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 (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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Eisenberg et al. (United States Patent Application Publication No.: 2010/0127067 A1) in view of Showalter et al. (United States Patent Application Publication No.: US 2005/0159982 A1).
Independent claim 1 recites a medical information processing apparatus for managing a status of a sample container having identification information, comprising:
a server including a processor configured to:
acquire, from a wireless access point in a location where an examination is to be performed, information regarding the examination to be performed;
associate the information regarding the examination with the identification information of the sample container;
store, in a memory, a status of the sample container that is a reserved-for-use status indicating that the sample container cannot be assigned to another examination;
acquire, from the wireless access point, information indicating that the sample container has been moved when the status is the reserved-for-use status;
in response to acquiring the information indicating that the sample container has been moved, update, in the memory, the status from the reserved-for-use status to a possibility-of-being-used status that indicates that there is a possibility that the sample container is being used during the examination;
acquire, from the wireless access point, information regarding a completion of the examination when the status is the reserved-for-use status; and
in response to acquiring the information regarding the completion of the examination, update, in the memory, the status from the reserved-for-use status to an unreserved status that indicates that the sample container is available to be assigned to another examination.
Independent claim 11 recites a medical information management method for managing a status of a sample container having identification information, comprising:
acquiring, from a wireless access point in a location where an examination is to be performed, information regarding the examination to be performed;
associating the information regarding the examination with the identification information of the sample container;
storing, in a memory, the status of the sample container that is a reserved-for-use status indicating that the sample container cannot be assigned to another examination;
acquiring, from the wireless access point, information indicating that the sample container has been moved when the status is the reserved-for-use status;
in response to acquiring the information indicating that the sample container has been moved, updating, in the memory, the status from the reserved-for-use status to a possibility-of-being-use status that indicates that there is a possibility that the sample container is being been used during the examination;
acquiring, from the wireless access point, information regarding a completion of the examination when the status is the reserved-for-use status; and
in response to acquiring the information regarding the completion of the examination, updating, in the memory, the status from the reserved-for-use status to an unreserved status that indicates that the sample container is available to be assigned to another examination.
Dependent claim 2 further recites the medical information processing apparatus according to claim 1, wherein: the status of the sample container includes a used status in which the sample container has been used in an associated examination.
Dependent claim 3 further recites the medical information processing apparatus according to claim 2, wherein: the processor is configured to: update, in the memory, the status of the sample container to the reserved-for-use status when the information regarding the examination becomes associated with the identification information of the sample container.
Dependent claim 4 further recites the medical information processing apparatus according to claim 3, wherein: the processor is configured to: update, in the memory, the status of the sample container based on a distance between the sample container and a reader for the identification information.
Dependent claim 5 further recites the medical information processing apparatus according to claim 4, wherein: the processor is configured to: update, in the memory, the reserved-for-use status to another status when the distance between the sample container and the reader for the identification information changes.
Dependent claim 6 further recites the medical information processing apparatus according to claim 1, wherein: the processor is configured to: notify a user upon acquiring information regarding a completion of the examination when the status is the possibility-of-being-used status.
Dependent claim 7 further recites the medical information processing apparatus according to claim 5, wherein: the processor is configured to: update, in the memory, the status of the sample container from the reserved-for-use status to the possibility-of-being-used status when a tray for placing the sample container and the sample container become separated from each other; and when the tray and the sample container become close to each other after the status stored in the memory is updated to the possibility-of-being-used status, update the status of the sample container from the possibility-of-being-used status to the used status.
Dependent claim 8 further recites the medical information processing apparatus according to claim 7, wherein: the processor is configured to: notify a user upon acquiring information regarding a completion of the examination when the status stored in the memory is updated to the possibility-of-being-used status; and not notify the user upon acquiring the information regarding the completion of the examination when the status stored in the memory is updated to the used status.
Dependent claim 9 further recites the medical information processing apparatus according to claim 5, wherein: the processor is configured to: update, in the memory, the status of the sample container from the reserved-for-use status to the possibility-of-being-used status when a tray for placing the sample container and the sample container become separated from each other; and notify a user when the tray and a sample container not associated with the examination become close to each other after the status stored in the memory is updated to the possibility-of-being-used status.
Dependent claim 10 further recites the medical information processing apparatus according to claim 1, wherein: the processor is configured to: associate the information regarding the examination with the identification information of the sample container when the status stored in the memory is updated to the unreserved status.
Dependent claim 12 further recites the medical information management method according to claim 11, wherein: the status of the sample container includes a used status in which the sample container has been used in an associated examination.
Dependent claim 13 further recites the medical information management method according to claim 12, comprising: updating, in the memory, the status of the sample container to the reserved-for-use status when the information regarding the examination becomes associated with the identification information of the sample container.
Dependent claim 14 further recites the medical information management method according to claim 13, comprising: updating, in the memory, the status of the sample container based on a distance between the sample container and a reader for the identification information.
Dependent claim 15 further recites the medical information management method according to claim 14, comprising: updating, in the memory, the reserved-for-use status to another status when the distance between the sample container and the reader for the identification information changes.
Dependent claim 16 further recites the medical information management method according to claim 11, comprising: notifying a user upon acquiring the information regarding the completion of the examination when the status stored in the memory is updated to the possibility-of-being-used status.
Dependent claim 17 further recites the medical information management method according to claim 15, comprising: updating, in the memory, the status of the sample container from the reserved-for-use status to the possibility-of-being-used status when a tray for placing the sample container and the sample container become separated from each other; and when the tray and the sample container become close to each other after the status stored in the memory is updated to the possibility-of- being-used status, updating, in the memory, the status of the sample container from the possibility-of-being-used status to the used status.
Dependent claim 18 further recites the medical information management method according to claim 17, comprising: notifying a user upon acquiring the information regarding the completion of the examination when the status stored in the memory is updated to the possibility-of-being-used status; and not notifying the user upon acquiring the information regarding the completion of the examination when the status stored in the memory is updated to the used status.
Dependent claim 19 further recites the medical information management method according to claim 15, comprising: updating, in the memory, the status of the sample container from the reserved-for-use status to the possibility-of-being-used status when a tray for placing the sample container and the sample container become separated from each other; and notifying a user when the tray and a sample container not associated with the examination become close to each other after the status stored in the memory is updated to the possibility-of- being-used status.
Dependent claim 20 further recites the medical information management method according to claim 11, comprising: associating the information regarding the examination with the identification information of the sample container when the status stored in the memory is updated to the unreserved status.
Eisenberg et al. shows a print device for specimen tracking and management (Title) including techniques described for using radio-frequency identification (RFID) tags to track patient specimens throughout the collection and analysis of patient specimens, and a series of RFID tags may be used to track the specimens starting with the collection of a patient's tissue specimen at a surgery or examination room, through the process of preparing the specimens at a laboratory, to a specialist's office where the specimens are analyzed, and eventually into storage where the left-over specimen materials may be archived (Abstract);
With regard to independent claims 1 and 11, Eisenberg et al shows techniques for using radio-frequency identification (RFID) tags to manage patient-specific material throughout the entire process of collection, preparation, and analysis of anatomic pathology specimens, and series of RFID tags may be used to manage the patient-specific material starting with the collection of specimens from a patient at a hospital, through processing the specimens at a laboratory facility, to analysis of the specimens by a pathologist, and eventually into storage where materials may be archived (Abstract and para. [0005]); and a specimen management system includes RFID stations deployed throughout an institution, and possibly multiple institutions, to track and manage the patient-specific material throughout the entire process, and the RFID stations may maintain one or more databases to store patient records, where each patient record includes patient information and unique identifiers for the RFID tags associated with the anatomic pathology specimens for the patient, moreover, the specimen management system may interface with other systems, such as patient management systems and laboratory information systems used during the process (para. [0006]). Eisenberg et al. further shows network environment 2 may utilize RFID readers to read and program the RFID tags as the specimens travel from the examination location or surgery 12 to a laboratory 16, to a pathologist 24, and finally to an archive 30, and at each different location within in the process, RFID stations at those locations read the RFID tag associated with the specimen to update a status and record timestamps within the RFID tag itself, a database of specimen management system 4, or both (para. [0051]); the RFID tags of the bottles may be interrogated at different locations during the process of transferring the bottles 14 from rooms 12 to laboratory 16, and at laboratory 16, information may be read from the bottles 14 by an RFID reader associated with specimen management system 4, for example, the RFID reader may be used to check the bottles 14 into laboratory 16 by updating status information for the patient's record within SMS 4 to reflect that the bottles for the patient are now located in laboratory 16 (para. [0054]).
Eisenberg et al. further shows RFID stations 42 typically include RFID readers 48A-48N coupled to antennas 44A-44N ("antennas 44") for interrogating the RFID tags fixed to articles and programming the RFID tags as desired; SMS 4 may use other RFID readers, such as handheld RFID readers, doorway mounted or corridor RFID readers associated with examination and procedure rooms, intelligent storage locations having built-in RFID readers, and the like (para. [0064]).
Eisenberg et al. further shows a specimen management system (SMS) may in part provide an RFID inventory management system to manage inventory of incoming bottles, blocks, slides, and other articles. The healthcare facility may include "smart" storage areas (e.g., shelves, vertical files, carts, bins, cabinets, boxes or other locations) that are RFID-enabled. The smart storage areas may be equipped with one or more antennas for interrogating RFID tags to aid in determining in real-time which articles are located at each of the storage areas. The antennas may be positioned in various ways, such as on top or bottom of a storage area, at the back of a storage area, or supported vertically, interspersed among the articles. The antennas can be retrofitted to existing storage areas or built into a storage area and purchased as a unit (para. [0069]).
Eisenberg et al. further shows SMS 4 typically includes a plurality of software modules executing on one or more servers, e.g., web servers, application servers and/or database servers, to perform the functions described herein. The software modules include instructions executable by a programmable processor and may be stored in a computer-readable storage medium, such as memory or a disk. SMS database 41 may be deployed across one or more database servers, and may be a relational database, multidimensional database, object-oriented database, associative database, a series of flat files or other suitable data storage mechanism (para. [0071]).
With regard to claims 2, 3, 12, and 13, Eisenberg et al. further shows a method comprises collecting one or more tissue specimens from a patient at a surgical location within a medical facility, programming, at the surgical location, radio frequency identification (RFID) tags associated with a set of anatomical pathology specimen containers that contain the one or more tissue specimens, associating identifiers of the RFID tags with a patient record associated with the patient in a first information management system, receiving one or more of the set of anatomical pathology specimen containers at a laboratory, interrogating, at the laboratory, at least on RFID tag of the anatomical pathology specimen containers to obtain identification information, retrieving information for the patient from the first information management system using the identification information, and storing the patient information in a laboratory information system (para. [0015]); a system comprises a radio frequency identification (RFID) station within a surgery room for collecting one or more tissue specimens from a patient, the RFID station within the surgery room configured to program RFID tags associated with a set of anatomical pathology specimen containers that contain the one or more tissue specimens and associate identifiers of the RFID tags with a patient record associated with the patient in a first information management system, and an RFID station within a laboratory for receiving one or more of the set of anatomical pathology specimen containers and processing the tissue specimens, the RFID station within the laboratory configured to interrogate at least one RFID tag of the anatomical pathology specimen containers to obtain identification information, retrieve information for the patient from the first information management system using the identification information, and store the patient information in a laboratory information system (para. [0016]).
With regard to claims 4-10, and 14-20, Eisenberg et al. further shows in another embodiment, a method comprises configuring a set of one or more rules within a specimen management system to define a route for an anatomical pathology specimen container having a radio frequency identification (RFID) tag, wherein the route includes two or more expected locations having RFID readers, and wherein the set of rules includes an expected time period for the anatomical pathology specimen container to travel between two of the expected locations on the route, and the method further comprises interrogating the RFID tag of the anatomical pathology specimen container with an RFID reader upon receiving the anatomical pathology specimen container at a location, and storing a timestamp to the specimen management system to indicate the time and location of the anatomical pathology specimen container based on the interrogation (para. [0017]); in yet another embodiment, a system comprises a specimen management system having a set of one or more rules, wherein the specimen management system presents a user interface to configure the set of rules to define a route for an anatomical pathology specimen container having a radio frequency identification (RFID) tag, wherein the route includes at least two locations within a medical facility, and the system further comprises an RFID station at each of the locations to interrogate the RFID tag of the anatomical pathology specimen container at the respective location, wherein the specimen management system applies the rules to automatically provide an alert upon determining, based on the interrogation of the RFIG tag at one or more of the locations, that shipment of the anatomical pathology specimen container within the medical facility fails to comply with the route defined by the set of rules (para. [0018]); and in another embodiment, a method comprises configuring a set of one or more rules within a specimen management system to define an expected sequence of actions to be performed with respect to a type of tissue specimen, interrogating, at different locations within a medical facility, to retrieve information from a radio frequency identification (RFID) tag of an anatomical pathology specimen container that contains a tissue specimen corresponding to the type of tissue specimen, storing the information for each of the interrogations to a patient record associated with the tissue specimen within the specimen management system, and providing an alert when the specimen management system determines, based on the information, that one or more actions within the expected sequence of actions has failed to occur (para. [0021]). Eisenberg et al. further shows network environment 2 may utilize RFID readers to read and program the RFID tags as the specimens travel from the examination location or surgery 12 to a laboratory 16, to a pathologist 24, and finally to an archive 30, and at each different location within in the process, RFID stations at those locations read the RFID tag associated with the specimen to update a status and record timestamps within the RFID tag itself, a database of specimen management system 4, or both (para. [0051]); the RFID tags of the bottles may be interrogated at different locations during the process of transferring the bottles 14 from rooms 12 to laboratory 16, and at laboratory 16, information may be read from the bottles 14 by an RFID reader associated with specimen management system 4, for example, the RFID reader may be used to check the bottles 14 into laboratory 16 by updating status information for the patient's record within SMS 4 to reflect that the bottles for the patient are now located in laboratory 16 (para. [0054]). Eisenberg et al. further shows RFID stations 42 may be positioned at a variety of locations along the collection and processing process within the healthcare facility. For example, RFID stations 42 may be located within patient intake 8, examination or surgery rooms 12, laboratory 16, pathologist offices 24, or archive 30, for example, a user 52 at examination or surgery room 12 may print and encode labels having RFID tags for bottles 14 using an RFID printer/encoder (not shown) at RFID station 42A, and user 52 may record collection of specimens and program the RFID tags on the bottles 14 by placing bottles 14 containing the specimens on or near an RFID station, e.g., RFID station 42A, and interacting with client computing device SOB, and in particular, upon sensing and interrogating the RFID tags adhered to or embedded within the bottles 14, SMS 4 may record the unique identifiers for the RFID tags within database 41 (para. [0065]); as one example, the administrator may configure a set of one or more rules to define a route for each type of anatomical pathology specimen container used within the health care facility, that is, the route may specify two or more different locations within the facility at which the container is expected to be interrogated (i.e., sensed or programmed), for example, the administrator may configure one or more rules to specify an expected route for bottles 14 as surgery 12[Wingdings font/0xE0]laboratory 16[Wingdings font/0xE0]archive 30 (para. [0074]).
Eisenberg et al. does not show (explicitly) updating the status of a sample container to a reserved-for-use status, possibility-of-being-used status, used status, or unreserved status (claims 1-3, 5-13, and 15-20).
Showalter et al. shows a laboratory instrumentation information management and control network (Title); an interface point network (IPN) and a method for communication with a laboratory information system using an IPN, and the use of bar code and RFID labels for tracking samples and in maintaining sample data (Abstract); an attribute field which is an optional field that is used to specify the status of an order; and messages used in communications (para. [0295]).
With regard to claims 1-3, 5-13, and 15-20, Showalter et al. shows a method for communication with a laboratory information system using an IPN, and the use of bar code and RFID labels for tracking samples and in maintaining sample data (Abstract); information may be encoded in said radio frequency identification label and may include at least one of patient information, test information, and batch information used to identify at least one other element and said element from a same batch, information may be read from said radio frequency identification label, information may be written to said radio frequency identification label, the information may include test information about at least one test performed in an anatomical pathology laboratory, the element may be sample and the method may also comprise: reading said test information from said radio frequency identification label in connection with a test to be performed as a step in laboratory processing prior to performing said test for verification that said step is to be performed, the method may also include: encoding said radio frequency identification label with additional information about said test, said additional information including at least one of: time, date, test parameters, filename, and test results, and the method may also include: determining a location of said element in said laboratory in accordance with said electromagnetic response signal (para. [0013]). Showalter et al. further shows the ordering message, or Automatic Test Ordering (OML) message, is a unidirectional message used to send accessioning information and test orders from the LIS to the laboratory instrument, the OML message typically includes a plurality of key message segments that include a Message Header (MSH) segment, a Patient Identification (PID) segment, a Patient Visit (PVl) segment, a Specimen and Container (SAC) segment for information relating to the tissue sample, a Common Order (ORC) segment for adding new test orders (para. [0072]); the ORC segment is used to transmit fields that are common to all requested services and includes six (6) segment attribute fields: an Order Control (ORC-1) attribute field, a Placed Order (ORC-2) attribute field, a Filled Order (ORC-3) attribute field, a Placer Group (ORC-4) attribute field, an Order Status (ORC-5) attribute field and a Response Flag (ORC-6) attribute field (para. [0074]); the ORC-5 attribute field is an optional field that is used to specify the status of an order, but that does not initiate any action, and the ORC-5 attribute field includes five (5) possible values: an "Identifier" (ID) value, an "In Process" (IP) value, an "Order is completed" (CM) value, an "Error, order unable to complete" (ER) value and an "Order (HD) is on hold" value (para. [0077]); and an embodiment may store the unique slide identifier in fields ORC-2, 3, and/or 4 of messages used in communications, and the unique slide identifier may be used with the bar code and/or RFID identifiers (para. [0295]).
Showalter further teaches automatic status updates (OUL) initiated by ORC segments which encompass the following statuses as claimed in the instant application:
a "reserved-for-use status" (ORC-5 attribute field “Order (HD) is on hold” at para. [0077]; this status is interpreted as a sample container is required (i.e. reserved) for the order that is on hold);
a "possibility-of-being-used status" (ORC-5 attribute field "In Process" (IP) status at para. [0077]; this status is interpreted as a possibility that a sample container is used for an order that is in-process);
an "unreserved status” (ORC-5 attribute field "Error, order unable to complete" (ER) at para. [0077]; this status is interpreted as a sample container is not required (i.e., unreserved) because an order was not completed); and
a “used status” (ORC-5 attribute field “Order is Completed” (CM) status at para. [0077]; this status is interpreted as a sample container was used for the completed order).
Showalter further teaches that it is assumed that the order status (ORC-5) always reflects the status as it is known to the sending application at the time the message is sent and that only the filler can originate the value in this field, thus, this field is only valid in the ORL (Automatic Test Ordering) and OUL (Automatic Status Updates) messages (at para. [0077]). Showalter further teaches that the ORC-6 attribute field is an optional field that enables the status update (OUL) and allows the sending application to determine the amount of information to be returned from the filler via one or more OUL messages (at para. [0078]).
Showalter further teaches that the ORC segment is a required field in an OML message and if an order detail segment is present, the ORC segment is also mandatory in Unsolicited Laboratory Observation (OUL) messages (at para. [0079]).
Showalter further teaches the status results message, or Automatic Status Updates (Unsolicited Laboratory Observation or OUL) message is also a unidirectional message. However, the OUL is generated by the laboratory instrument and received by the LIS to notify the LIS of the specimen status. The OUL message is a response status message that combines the original order request from the LIS with a status update relating to that order request (at para. [0095]).
Note that this indicates the Automatic Status Update (OUL) is initiated in response to acquiring information regarding the various statuses as specified by the ORC segment when an order detail segment is present.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system and method shown by Eisenberg et al. by incorporating messaging signals in communication with RFID identifiers to set and change the status of a patient sample according to Showalter et al. One of ordinary skill in the art would have been motivated to combine the methods of Eisenberg et al. with Showalter et al. in order to use messaging signals in communication with RFID identifiers to set and change the status of a patient sample. This modification would have had a reasonable expectation of success because both Eisenberg et al. and Showalter et al. show methods of using radio-frequency identification (RFID) tags to track and manage patient specimens throughout the collection and analysis of patient specimens.
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 LEAH E SEXTON whose telephone number is (571)272-3057. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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/L.E.S./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687