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 .
DETAILED ACTION
This Office action is in response to the Request for Continued Examination (RCE) filed on Feb. 19, 2026.
Response to Arguments
Applicant filed an RCE for consideration of IDS references without submitting amendments or argument. After reviewing the entire record, including the newly cited references, the Examiner has determined that the claims are unpatentable under 35 USC 103 for the reasons discussed below.
Claim Rejections - 35 USC § 103
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 1-7, 10, 12-15, 18-23, 25, 27, and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0104120 (hereinafter “Arrizza”) cited in Applicant’s filed IDS forms, in view of US 2005/0144043 (hereinafter “Holland”).
In the following claim analysis, Applicant’s claim language is in bold text and Examiner’s explanations are enclosed in square brackets.
As to claim 1, Arrizza discloses An infusion pump (Arrizza, ¶ 24, the present disclosure describes a system and method for providing updates to medical devices or medical devices systems, such as medication administrating devices like medical infusion devices or infusion pumps) comprising:
a processor (Arrizza, ¶ 76, The MCU of the application subsystem 118 includes a CPU, and also provides control of the pumping action, as well as the user interface devices); and non-transitory memory storing computer-readable instructions that, when executed by the processor (Arrizza, ¶ 75, The application subsystem 118 has access to flash storage 122 for storing installed software and configuration files; ¶ 76, FIG. 11 is an infusion device physical/subsystem block diagram illustrating the physical arrangement of some features of the infusion pump communication subsystem 116 and application subsystem 118. Both subsystems have access to RAM and flash memory), cause the infusion pump to:
receive, via a wireless communication interface and from a remote server, configuration information for the infusion pump (Arrizza, ¶ 27, In the example of an infusion pump, an update to the device configuration may include updates to a customized drug library, which may include but is not limited to defaults, ranges (hard and/or soft limits) of acceptable pump configuration parameters like dose, rate, and volume; device-specific settings; acceptable ranges of monitored values, etc; ¶ 53, The communication subsystem 16 receives the update message and in response, downloads the update files), the configuration information comprising medication administration information indicating at least one parameter to control operation of the infusion pump (Arrizza, ¶ 27, These two types of update processes include updates to the operational software of the medical device, and updates to the device configuration… an update to the device configuration may include updates to a customized drug library, which may include but is not limited to defaults, ranges (hard and/or soft limits) of acceptable pump configuration parameters like dose, rate, and volume; device-specific settings; acceptable ranges of monitored values); and
determine an appropriate time for the infusion pump to activate the configuration information (Arrizza, ¶ 40, the system waits until such time that the updates can be installed; ¶ 63, the installation of new configuration is successful); and
activate the configuration information such that the infusion pump operates based on the at least one parameter (Arrizza, Fig. 8, ¶ 63, If the installation of new configuration is successful (the right side of FIG. 8), the new configuration becomes the active configuration [i.e., the configuration information is activated], and the former configuration is deactivated and becomes the previous configuration), during the clinically appropriate time for the infusion pump to activate the configuration information (Arrizza, the system waits until such time that the updates can be installed; ¶ 63, the installation of new configuration is successful), wherein the clinically appropriate time is after the infusion pump completes a power-up (Arrizza, ¶ 54, During a normal shutdown of the medical device … the updates will be installed, and the medical device 10 will shutdown; ¶ 41, steps 2-10 through 2-20 can be performed in the background while the medical device is operating in its normal manner [after the infusion pump completes a power-up]).
Although Arrizza discloses determine an appropriate time for the infusion pump to activate the configuration information and activate the configuration information, but Arrizza does expressly disclose determining a clinically appropriate time for the infusion pump to activate the configuration information. However, Holland teaches determine a clinically appropriate time for the infusion pump to activate the configuration information (Holland, ¶ 113, The Download Drug Library 132 proceeds to block 248 where it determines if a specific trigger event has occurred. For instance, the trigger event could be a completed infusion, a stopped infusion, a determination that the device is in a configurable mode [It is noted that Holland determines whether a predetermined operation condition has occurred before activation of the configuration, thereby determining a clinically appropriate time for activation.]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the techniques by Arrizza with the method taught by Holland. The modification would be obvious because one of ordinary skill in the art would be motivated to implement an integrated system for maximizing patient safety and caregiver productivity for medication delivery when updating a new drug library at the medical device to replace an existing drug library/configuration, during execution of a medication order (Holland, ¶ ¶ 2 and 16).
Claim 18 recites substantially similar subject matter to that of claim 1. Therefore, claim 25 is rejected based on the same rationale as claim 1.
As to claim 2, the rejection of claim 1 is incorporated. Arrizza as modified further discloses The infusion pump of claim 1, wherein the medication administration information is provided by at least one of a customer, a hospital, an administrator, a nurse, a physician, or a pharmacy (Arrizza, ¶ 34, The server 12 could be located in the hospital, at a location away from the hospital, at a manufacturer's facility, in another hospital, or anywhere else, as desired).
Claim 19 recites substantially similar subject matter to that of claim 2. Therefore, claim 19 is rejected based on the same rationale as claim 2.
As to claim 3, the rejection of claim 1 is incorporated. Arrizza as modified further discloses The infusion pump of claim 1, wherein the configuration information comprises information including a parameter characterizing operation of the infusion pump (Arrizza, ¶ 27, an update to the device configuration may include updates to a customized drug library, which may include … device-specific settings; acceptable ranges of monitored values).
Claim 20 recites substantially similar subject matter to that of claim 3. Therefore, claim 20 is rejected based on the same rationale as claim 3.
As to claim 4, the rejection of claim 1 is incorporated. Arrizza as modified further discloses The infusion pump of claim 1, wherein the configuration information comprises a patient treatment parameter (Arrizza, ¶ 27, an update to the device configuration may include updates to a customized drug library, which may include but is not limited to defaults, ranges (hard and/or soft limits) of acceptable pump configuration parameters like dose, rate, and volume).
Claim 21 recites substantially similar subject matter to that of claim 4. Therefore, claim 21 is rejected based on the same rationale as claim 4.
As to claim 5, the rejection of claim 1 is incorporated. Arrizza as modified further discloses The infusion pump of claim 1, wherein the computer-readable instructions, when executed by the processor, cause the infusion pump to: monitor a performance parameter of the infusion pump (Arrizza, ¶ 27, an update to the device configuration may include updates to a customized drug library, which may include … acceptable ranges of monitored values).
Claim 22 recites substantially similar subject matter to that of claim 5. Therefore, claim 22 is rejected based on the same rationale as claim 5.
As to claim 6, the rejection of claim 5 is incorporated. Arrizza as modified further discloses The infusion pump of claim 5, wherein the computer-readable instructions, when executed by the processor, cause the infusion pump to: provide data indicative of the performance parameter of the infusion pump (Arrizza, ¶ 27, an update to the device configuration may include updates to a customized drug library, which may include … ranges (hard and/or soft limits) of acceptable pump configuration parameters like dose, rate, and volume; device-specific settings; acceptable ranges of monitored values; ¶ 24, It is sometimes desirable to update the software running on a medical device to improve the performance, address problems, add features, or otherwise modify the operation of the medical device. For medical devices using a customized drug library, it is also sometimes desirable to update the drug library).
Claim 23 recites substantially similar subject matter to that of claim 6. Therefore, claim 23 is rejected based on the same rationale as claim 6.
As to claim 7, the rejection of claim 5 is incorporated. Roberts as modified further discloses The infusion pump of claim 5, wherein the performance parameter comprises a number of hours of operation of the infusion pump, a threshold for an alert related to operation of the infusion pump, a performance requirement of the infusion pump, data indicative of a status of the infusion pump, or patient information (Arrizza, ¶ 27, an update to the device configuration may include updates to a customized drug library, which may include but is not limited to defaults, ranges (hard and/or soft limits) of acceptable pump configuration parameters like dose, rate, and volume; device-specific settings; acceptable ranges of monitored values, etc.).
As to claim 10, the rejection of claim 1 is incorporated. Arrizza as modified further discloses The infusion pump of claim 1, wherein the computer-readable instructions, when executed by the processor, cause the infusion pump to: overwrite the configuration information for the infusion pump (Holland, ¶ 25, During execution of a medication order, the medical device caches an updated drug library in a cache memory and, upon occurrence of a triggering event, replaces an existing drug library in the primary memory of the device with the updated library). The motivation to combine the references is the same as set forth in the rejection of claim 1.
Claim 27 recites substantially similar subject matter to that of claim 10. Therefore, claim 27 is rejected based on the same rationale as claim 10.
As to claim 12, the rejection of claim 1 is incorporated. Arrizza as modified further discloses The infusion pump of claim 1, wherein the infusion pump is a syringe pump (Holland, ¶ 74, the term "medical device" includes without limitation a device that acts upon a cassette, reservoir, vial, syringe), a patient controlled infusion pump (Holland, ¶ 74, the term "medical device" includes … infusion pump, a patient controlled analgesia (PCA) or pain management medication pump), a volumetric infusion pump, or a peristaltic pump. The motivation to combine the references is the same as set forth in the rejection of claim 1.
Claim 29 recites substantially similar subject matter to that of claim 12. Therefore, claim 29 is rejected based on the same rationale as claim 12.
As to claim 13, the rejection of claim 1 is incorporated. Arrizza as modified further discloses The infusion pump of claim 1, wherein the computer-readable instructions, when executed by the processor, cause the infusion pump to: receive, via the infusion pump, a user input comprising a selection to view or modify a parameter regarding operation of the infusion pump (Holland, ¶ 83, The input device 32 enters this drug ID at step 144. The input device 32 processes the drug ID to select the correct task from the task list, then displays a task screen 143B (FIG. 11), and transmits a request (dispense ID) based upon the entered drug ID); and render, for display, at least a portion of the user selection (Holland, ¶ 91, the caregiver 114 selects the "yes" soft key 187B on the medical device 14 to confirm the delivery data … Once the caregiver 114 confirms the delivery data at the medical device 14, the medical device 14 then executes the delivery program code and begins infusion at step 198). The motivation to combine the references is the same as set forth in the rejection of claim 1.
Claim 30 recites substantially similar subject matter to that of claim 13. Therefore, claim 30 is rejected based on the same rationale as claim 13.
As to claim 14, the rejection of claim 1 is incorporated. Arrizza as modified further discloses The infusion pump of claim 1, wherein the computer-readable instructions, when executed by the processor, cause the infusion pump to: determine whether to activate the configuration information at the determined time (Holland, ¶ 111, The Download Drug Library 132 program is designed to cache in a cache memory 126A a new database or drug library at medical device 14 while maintaining an existing older version database or drug library in its primary memory 126. This allows the medical device to operate or deliver an infusion based on the older version of the drug library without disruption until a trigger event occurs [a determination factor], at which time the new drug library replaces the older version in the primary memory 126). The motivation to combine the references is the same as set forth in the rejection of claim 1.
As to claim 15, the rejection of claim 1 is incorporated. Arrizza as modified further discloses The infusion pump of claim 1, wherein the computer-readable instructions, when executed by the processor, cause the infusion pump to: display, on a display of the infusion pump, a message comprising a prompt for whether to activate the configuration information now or at a later time (Holland, ¶ 91, With reference to FIGS. 5, 5A and 15, the medical device 14 displays an order dose confirmation screen 187A (FIG. 15) which prompts the caregiver 114 to confirm the delivery data [the configuration information]. As shown, the caregiver 114 selects the "yes" soft key 187B on the medical device 14 to confirm the delivery data and the "no" soft key 187C to cancel the delivery. The caregiver 114 confirms the delivery data at the medical device 14 at step 188. Once the caregiver 114 confirms the delivery data at the medical device 14, the medical device 14 then executes the delivery program code and begins infusion at step 198).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the techniques by Roberts with the method taught by Holland including that the computer-readable instructions, when executed by the processor, cause the infusion pump to: display, on a display of the infusion pump, a message comprising a prompt for whether to activate the configuration information now or at a later time. The modification would be obvious because one of ordinary skill in the art would be motivated to implement a delivery program that sends a patient-specific rule set generated from any rule based adjudication at the MMU 12, including hard and soft dosage limits for each drug being administered and asks user’s confirmation of the delivery data at the medical device via a user interface (Holland, ¶ ¶ 90-91).
As to claim 31, the rejection of claim 1 is incorporated. Arrizza as modified further discloses The infusion system of claim 1, wherein the non-transitory memory storing computer-readable instructions, when executed by the processor, cause the infusion system to: send, via the wireless communication interface, information about the operation status of the infusion pump to a remote infusion pump tracking system (Arrizza, ¶ 40, the server will be able to track the status if each medical device in the system).
Claim 32 recites substantially similar subject matter to that of claim 31. Therefore, claim 32 is rejected based on the same rationale as claim 31.
Claims 8 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Arrizza, in view of Holland, and further in view of (hereinafter “Roberts”) in view of US 2009/0156991 (hereinafter “Roberts”).
As to claim 8, the rejection of claim 1 is incorporated. Arrizza does not appear to explicitly disclose The infusion pump of claim 1, wherein the computer-readable instructions, when executed by the processor, cause the infusion pump to: provide, to a remote device, data characterizing treatment of the patient or one or more physiological measurements of the patient. However, Roberts teaches The infusion pump of claim 1, wherein the computer-readable instructions, when executed by the processor, cause the infusion pump to: provide, to a remote device, data characterizing treatment of the patient (Roberts, the medical device 5608 transmits a message 5644 indicating the success or failure of receipt of the therapy order message 5642. The medical device server 5606 and operations web service 5604 relay the message 5644 back to the order trigger application 5602) or one or more physiological measurements of the patient (Roberts, ¶ 119, A status receipt module 604 receives a status of a patient from a first medical device … the status receipt module 604 can receive a status of a patient from a medical device associated with that patient. The status of the patient may include the heart or breath rate or regularity, an indication by the patient that he is experiencing pain, the blood glucose level of the patient).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the techniques by Arrizza as modified with the method taught by Roberts. The modification would be obvious because one of ordinary skill in the art would be motivated to track changed parameters in a medical infusion pump by establishing a communication session between a medical infusion pump and a medical device server, and communicating an original parameter value, an updated parameter value, and a final parameter value from the medical infusion pump to the medical device server (Roberts, ¶ 8).
Claim 24 recites substantially similar subject matter to that of claim 8. Therefore, claim 24 is rejected based on the same rationale as claim 8.
Claims 11 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Arrizza in view of Holland, and further in view of JP 2013179973 (hereinafter “Kamimura”).
As to claim 11, the rejection of claim 1 is incorporated. Arrizza as modified does not appear to explicitly disclose The infusion pump of claim 1, wherein the configuration information includes syringe compatibility information, and wherein the computer-readable instructions, when executed by the processor, cause the infusion pump to: determine that a syringe is compatible with the infusion pump based on the syringe compatibility information. However, in an analogous art to the claimed invention in the field of Managing medical devices, Kamimura teaches The infusion pump of claim 1, wherein the configuration information includes syringe compatibility information, and wherein the computer-readable instructions, when executed by the processor, cause the infusion pump to: determine that a syringe is compatible with the infusion pump based on the syringe compatibility information (JP 2013179973, Fig. 19-21 and their associated paragraphs, it is determined whether or not the syringe 300 is already stored as being compatible with the syringe pump 200 … Specifically, the determination is made with reference to the “syringe information storage unit 222” in FIG. In the “syringe information storage unit 222”, identification symbol information of the syringe 300 that can be used for the syringe pump 200).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the techniques by Roberts as modified with the method taught by Kamimura including that the configuration information includes syringe compatibility information, and wherein the computer-readable instructions, when executed by the processor, cause the infusion pump to: determine that a syringe is compatible with the infusion pump based on the syringe compatibility information. The modification would be obvious because one of ordinary skill in the art would be motivated to determine rapidly whether a medical device equipment is suitable for using to the medical device even when the device equipment is not stored to be usable on each medical device (Kamimura, Abstract).
Therefore, Arrizza as modified teaches after activation of the configuration information, infuse a fluid from the syringe into a patient (Holland, ¶ 155, The caregiver 114 enters or scans the machine-readable indicia 102 on the drug container 100 and the machine-readable indicia 92, 96 on the particular channel of the medical device or infusion pump 14 to be used for the infusion; ¶ 74, the term "medical device" includes without limitation a device that acts upon a cassette, reservoir, vial, syringe, or tubing to convey medication or fluid to or from a patient (for example, an enteral pump, infusion pump). The motivation to combine the references is the same as set forth in the rejection of claim 1.
Claim 28 recites substantially similar subject matter to that of claim 11. Therefore, claim 28 is rejected based on the same rationale as claim 11.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Arrizza in view of Holland, and further in view of US 2010/0313105 (hereinafter “Nekoomaram”).
As to claim 16, the rejection of claim 1 is incorporated. Arrizza as modified does not appear to explicitly disclose The infusion pump of claim 1, wherein the computer-readable instructions, when executed by the processor, cause the infusion pump to: receive, via the wireless communication interface and while the infusion pump is administering the infusion to the patient, an update to executable code for the infusion pump. However, in an analogous art to the claimed invention in the field of managing data updating, Nekoomaram teaches The infusion pump of claim 1, wherein the computer-readable instructions, when executed by the processor, cause the infusion pump to: receive, via the wireless communication interface and while the infusion pump is administering the infusion to the patient, an update to executable code for the infusion pump (Nekoomaram, ¶ 57, the upgraded version of the software for the device 201 may correspond to a critical update for the device 201; ¶ 101, a desired software version for the identified device 201 is determined (803)); and after the infusion pump has completed administering the infusion to the patient, activate the updated executable code for the infusion pump (Nekoomaram, Fig. 8, para. 102, the desired version of the software of the device 201 is executed [activated] by a microprocessor of the identified device 201 (805)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the techniques by Arrizza as modified with the method taught by Nekoomaram including activating the updated executable code for the infusion pump. The modification would be obvious because one of ordinary skill in the art would be motivated to automatically update a medical device and recover from a failure to upgrade the medical device (Nekoomaram, Abstract).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Arrizza in view of Holland, and further in view of US 10,453,157 (hereinafter “Kamen”).
As to claim 17, the rejection of claim 1 is incorporated. Arrizza as modified does not appear to explicitly disclose The infusion pump of claim 1, wherein the configuration information comprises dose error reduction software. However, in an analogous art to the claimed invention in the field of managing medical devices, Kamen teaches The infusion pump of claim 1, wherein the configuration information comprises dose error reduction software (Kamen, col.31, ln. 63-65, the facility services 8 and/or the drug adverse event network 9 may also include a Drug Error Reduction System (“DERS”)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the techniques by Arrizza as modified with the method taught by Kamen including dose error reduction software. The modification would be obvious because one of ordinary skill in the art would be motivated to implement an effective monitoring system that monitors and intercedes at any phase of the medication ordering and administration process to help minimize any of adverse events that could result from the treatment (Kamen, col. 23, ln. 29-32).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAXIN WU whose telephone number is (571) 270-7721. The examiner can normally be reached on M-F (7 am - 11:30 am; 1:30- 5 pm).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Wei Mui can be reached at (571) 272-3708. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAXIN WU/ Primary Examiner, Art Unit 2191
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