DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is in reply to an application filed on 11/17/2025. Claims 1-20 are currently pending and have been examined.
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 1-3, 6-14, 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over White, et al. (US 2004/0176984 A1) in view of Alwan (US 2020/0265933 A1).
With regards to claim 1, White teaches an electronic medical record system (see at least figure 2) comprising: a database stored in a memory device, the database configured to store a medication order to an electronic medical record (“EMR”) of a patient (see at least ¶ 0031, doctor’s IV medication infusion pump order stored electronically in HIMS [electronic medical record of a patient]), the medication order including a medication order identifier and a patient identifier of the patient (see at least ¶ 0037, patient and medication identification verified electronically) and the EMR of the patient including the patient identifier (see at least ¶ 0025, patient ID in the HIMS); a clinician device including a user interface for accessing the EMR of the patient (see at least ¶ 0037, hand held communication unit); and a server communicatively coupled to the database and the clinician device (see at least figure 2), the server including a memory storing machine-readable code or instructions, that when executed by a processor of the server (see at least ¶ 0046), cause the server to: receive, while an infusion pump is administering a medication to a patient, an identifier message including at least two of a device identifier of the infusion pump, a patient identifier of the patient, and a medication order identifier of a medication being administered by the infusion pump (see at least ¶ 0042-0043, while IV pump is operating pump operation information is transmitted to HIMS including medication name, patient ID, pump ID),
White does not explicitly teach …use contents from the identifier message to determine an association is to be created between the EMR of the patient and the infusion pump, transmit a prompt message to the clinician device indicative of the association, receive a response message from the clinician device, responsive to the response message indicating that association can be created, create the association between the EMR of the patient and the infusion pump, receive after the association between the EMR of the patient and the infusion pump, infusion pump data from the infusion pump, the infusion pump data including the device identifier, and store the infusion pump data to the EMR of the patient based on the created association between the EMR of the patient and the infusion pump, transmit a prompt message to the clinician device indicative of the association, receive a response message from the clinician device, responsive to the response message indicating that association can be created, create the association between the EMR of the patient and the infusion pump, receive after the association between the EMR of the patient and the infusion pump, infusion pump data from the infusion pump, the infusion pump data including the device identifier, and store the infusion pump data to the EMR of the patient based on the created association between the EMR of the patient and the infusion pump. Alwan teaches …use contents from the identifier message to determine an association is to be created between the EMR of the patient and the infusion pump, transmit a prompt message to the clinician device indicative of the association, receive a response message from the clinician device, responsive to the response message indicating that association can be created, create the association between the EMR of the patient and the infusion pump, receive after the association between the EMR of the patient and the infusion pump, infusion pump data from the infusion pump, the infusion pump data including the device identifier, and store the infusion pump data to the EMR of the patient based on the created association between the EMR of the patient and the infusion pump (see at least ¶ 0041, At step 224, the server 110 may associate the health care device 102 from which the set of parameters was received with the patient that is identified by the correlated order. Alternatively, or in addition, the server 110 may provide an indication of the patient to the healthcare device 102 and the healthcare device 102 may present the indication of the patient to the healthcare professional that programmed the healthcare device 102. The healthcare professional may confirm that the indicated patient corresponds to the patient receiving healthcare from the healthcare device 102, such as by pressing a confirmation button on a keypad. The confirmation may be provided to the server 110 and upon receiving the confirmation the server 110 may store an association between an identifier of the healthcare device 102 and an identifier of the patient in the data store 114. In this manner, the server 110 may identify any subsequent data items received from the healthcare device 102 as corresponding to the associated patient). It would have been obvious to one of ordinary skill in the art at the time of invention to combine the patient device association system of Alwan with the patient infusion pump method of White with the motivation of patient device association to assist with providing healthcare to patients (Alwan, ¶ 0004).
Claim 12 recites similar limitations regarding the method of the system and is rejected for the same reasons.
With regards to claim 2, White teaches the electronic medical record system of claim 1, wherein the identifier message is generated by scanning at least one of alpha-numeric characters, barcodes, or quick-response (“QR”) codes corresponding to the at least two of the device identifier of the infusion pump, the patient identifier, and the medication order identifier (see at least ¶ 0037, barcode).
Claim 13 recites similar limitations regarding the method of the system and is rejected for the same reasons.
With regards to claim 3, Alwan teaches the electronic medical record system of claim 1, wherein the server is further configured to: receive first infusion pump data before the association between the EMR of the patient and the infusion pump; and store the first infusion pump data to an unassociated record after determining that there is no association between the device identifier and any patient identifiers or medication order identifiers (see at least ¶ 0042, if the server 110 receives a communication from the healthcare device 102 indicating that the indicated patient is not the patient receiving healthcare from the healthcare device 102, the server 110 may store an indication that the patient is not associated with the healthcare device 102). It would have been obvious to one of ordinary skill in the art at the time of invention to combine the patient device association system of Alwan with the patient infusion pump method of White with the motivation of patient device association to assist with providing healthcare to patients (Alwan, ¶ 0004).
Claim 14 recites similar limitations regarding the method of the system and is rejected for the same reasons.
With regards to claim 6, Alwan teaches the electronic medical record system of claim 3, wherein the server is further configured to index the unassociated record by the device identifier (see at least ¶ 0046). It would have been obvious to one of ordinary skill in the art at the time of invention to combine the patient device association system of Alwan with the patient infusion pump method of White with the motivation of patient device association to assist with providing healthcare to patients (Alwan, ¶ 0004).
Claim 16 recites similar limitations regarding the method of the system and is rejected for the same reasons.
With regards to claim 7, White teaches the electronic medical record system of claim 1, wherein the server is further configured to create the association between the EMR of the patient and the infusion pump by matching the patient identifier or the medication order identifier of the identifier message to the medication order identifier or the patient identifier of a medication order (see at least ¶ 0047, 0049).
Claim 20 recites similar limitations regarding the method of the system and is rejected for the same reasons.
With regards to claim 8, White teaches the electronic medical record system of claim 1, wherein the infusion pump data further includes at least one of an infusion rate, a dose, a total volume infused, a time remaining for an infusion therapy, a medication concentration, rate change, a volume remaining within a medication container, a medication name, titration information, bolus information, a care area identifier, a timestamp when the infusion pump data was generated, an alarm condition, an alert condition, or an event (see at least ¶ 0029).
Claim 18 recites similar limitations regarding the method of the system and is rejected for the same reasons.
With regards to claim 9, White teaches the electronic medical record system of claim 1, wherein the identifier message is received from at least one of the infusion pump or a computer-on-wheels (see at least ¶ 0043).
With regards to claim 10, White teaches the electronic medical record system of claim 1, wherein the EMR of the patient is stored in conjunction with EMRs of other patients (see at least ¶ 0025).
With regards to claim 11, White teaches the electronic medical record system of claim 1, wherein the infusion pump includes at least one of a syringe pump, a linear peristaltic pump, a large volume pump (“LVP”), an ambulatory pump, or a multi-channel pump (see at least ¶ 0012).
With regards to claim 17, White teaches the medication order further includes at least one of a medication name, a volume to be infused, a medication concentration, or a medication delivery rate (see at least ¶ 0050).
Claims 4, 5, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over White, et al. (US 2004/0176984 A1) in view of Alwan (US 2020/0265933 A1) in further view of Gejdos, et al. (US 2009/0150176 A1).
With regards to claim 4, White does not explicitly teach the electronic medical record system of claim 3, wherein the server is further configured to after the association between the EMR of the patient and the infusion pump is created: transmit a second prompt message to the clinician device indicative of the first infusion pump data located at the unassociated record; receive a second response message from the clinician device; and responsive to the response message indicating that the first infusion pump data is to be imported, store the first infusion pump data to the EMR of the patient. Gejdos teaches the electronic medical record system of claim 3, wherein the server is further configured to after the association between the EMR of the patient and the infusion pump is created: transmit a second prompt message to the clinician device indicative of the first infusion pump data located at the unassociated record; receive a second response message from the clinician device; and responsive to the response message indicating that the first infusion pump data is to be imported, store the first infusion pump data to the EMR of the patient (see at least ¶ 0006, a database for storing healthcare maintenance (HCM) device pump data; figure 3, ¶ 0049-0050, message is delivered to physician’s computer to assign data points to a patient, user assigns data to a patient). It would have been obvious to one of ordinary skill in the art at the time of invention to combine the patient data association system of Gejdos with the patient infusion pump method of White with the motivation of correct assignment of patient data (Gejdos, ¶ 0005, 0007).
Claim 15 recites similar limitations regarding the method of the system and is rejected for the same reasons.
With regards to claim 5, Gejdos teaches the electronic medical record system of claim 4, wherein the second response message includes information indicative of a time window for the first infusion pump data that is to be imported from the unassociated record, and wherein the server is further configured to select the first infusion pump data from the unassociated record that corresponds to the time window for storage to the EMR of the patient (see at least figure 11, ¶ 0064). ). It would have been obvious to one of ordinary skill in the art at the time of invention to combine the patient data association system of Gejdos with the patient infusion pump method of White with the motivation of correct assignment of patient data (Gejdos, ¶ 0005, 0007).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over White, et al. (US 2004/0176984 A1) in view of Alwan (US 2020/0265933 A1) in further view of Simpson, et al. (US 2015/0356255 A1).
With regards to claim 19, White teaches the method of claim 12, wherein the medication order is received in at least one …message from a pharmacy server (see at least ¶ 0032-0033).
White does not explicitly teach …HL7. Simpson teaches …HL7 (see at least Abstract). It would have been obvious to one of ordinary skill in the art at the time of invention to combine the HL7 messaging system of Simpson with the patient infusion pump method of White with the motivation of efficiency in patient data management (Simpson, ¶ 0002).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kelly, et al. (US 2017/0165413 A1) which discloses methods, computer systems and computer readable media cause an infusion pump to provide visual confirmation of line checks. In embodiments, an indication is provided that one or more infusions need a line check. A selection of on the one or more infusion is received. Information corresponding to the selection of the one of the one or more infusions is received from an electronic medical record (EMR) and communicated to a corresponding infusion pump. The infusion pump then provides a visual indication of the line check.
Zaleski (US 2004/0181314 A1) which discloses a system and user interface according to invention principles supports concurrently managing and maintaining multiple medical devices (e.g., infusion pumps) and processing and displaying the data produced by the medical devices within a Healthcare enterprise. An information system supports a plurality of network connected infusion pumps. The system includes an acquisition processor for acquiring fluid infusion related data from a plurality of concurrently operating infusion pumps. A data processor processes the acquired fluid infusion related data to provide data suitable for presentation in a single display image identifying the plurality of concurrently operating infusion pumps together with status information identifying status of individual pumps of the plurality of concurrently operating infusion pumps.
P. Frisch, S. Miodownik, P. Booth, P. Carragee and R. M. Dowling, "Patient centric identification and association," 2009 Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Minneapolis, MN, USA, 2009, pp. 1722-1725, doi: 10.1109/IEMBS.2009.5333558 which discloses increased technological complexity of medical devices and systems coupled with increased workloads and reduced staffing, have created difficulties and discontinuities in the management of patient information. These issues have directly impacted and contributed to a rise in equipment-related errors, patient dissatisfaction, a potential for patient injury and resulting overall increased concern for patient safety. In response these concerns a variety of new devices, systems and applications have been developed to share information, provide cross checks along with verified delivery of critical information to the point of care. These applications include biomedical information systems, medication administration, sample collection, and electronic medical records. The deployment of these new integrated and networked devices, systems and applications are dependent on an accurate and consistent patient identification and association methodology which dynamically manages the relationship between patients, staff and equipment. Since the association information is common to many applications and utilizes a variety of technologies, (i.e. active and passive radio frequency identification (RFID), barcodes, etc.) an institutional approach is necessary to mange these processes in a consistent manor utilizing a common set of identification hardware. Implementation of a “Patient Centric Identification and Association Platform” represents a significant advance in the management of clinical patient information. The implementation of a Biomedical Device Information Network at Memorial Sloan-Kettering Cancer Center (MSKCC) integrates the identification and association of patients with devices and care providers and provides the methodologies to manage alarms, providing the ability to filter low priority or nuisance alarms. This implementation enables critical information to be distributed directly to care providers utilizing dedicated communications devices. Patient Centric Identification and Association is the enabling technology providing precise identification and association establishing an enhanced environment of care, increased patient safety, and a clear proactive response to the regulatory requirements of the Joint Commission (JCAHO) national patient safety initiatives.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joey Burgess whose telephone number is (571)270-5547. The examiner can normally be reached Monday through Friday 9-6.
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/JOSEPH D BURGESS/ Primary Examiner, Art Unit 3685
