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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. IN202011028207, filed on July 2, 2020.
Response to Amendment
In the amendment filed on March 16, 2026, the following has occurred: claim(s) 1-3, 5-8, 15-17 have been amended. Now, claim(s) 1-24 are pending.
Notice to Applicant
The rejections under 35 U.S.C. 101 rejection(s) have been withdrawn based on the amendments to the claims. When the claim limitations are considered together as an ordered combination of “a thin point-of-care device”, “transmit, to the medical device, an instruction to cause two or more user-selectable user interface elements to be displayed on the display of the medical device, without affecting the one or more clinical operations of the medical device, wherein the two or more user-selectable user interface elements are unrelated to the one or more clinical operations of the medical device;” and “perform the one or more automated actions to be performed based on the selected one of the two or more user-selectable user interface elements received via the separate messaging channel”. These claimed limitations provide a technical improvement by integrating the abstract idea into a practical application by improving methods of operating medical and network devices, which further improve medical and computer technologies (See Specification in Paragraph [0004]).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 6-7, 10-11, 15-16, and 19-20, 22-24 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being unpatentable over Holland et al. (U.S. Patent Pre-Grant Publication No. 2007/0083344).
As per independent claim 1, Holland discloses a system configured to facilitate transmission of messages between one or more medical devices and one or more hospital servers, the system comprising:
a medical device configured to perform one or more clinical operations (See Paragraph [0052]: The medication management system (MMS) 10 of the present invention includes a medication management unit (MMU) 12 and a medical device 14, typically operating in conjunction with one or more information systems or components of a hospital environment, which the Examiner is interpreting medical device to encompass a medical device configured to perform one or more clinical operations), wherein the medical device includes a display and one or more input devices (See Paragraph [0064]: The pump style medical device 14 includes a user interface means 86, display 88, first channel 90, and first channel machine readable indicator, which the Examiner is interpreting the user interface means and display to encompass a display and one or more input devices ([0056]: As the input device 32 communicates directly with the medical device 14 or may be integrated wholly or in part with the medical device));
a hospital server configured to transmit instructions to perform one or more of the clinical operations to the medical device (See Paragraph [0060]: The MMU 12 can consist of a collection of MMU specific applications running on distinct servers in order to avoid a single point of failure, address availability requirements, and handle a high volume of requests, which the Examiner is interpreting to encompass a hospital server configured to transmit instructions to perform one or more of the clinical operations to the medical device), and transmit instructions to display one or more user interface elements on the display of the medical device (See Paragraph [0076]: The medical device can display a channel selection screen and a screen to select the clinical care area (CCA), which the Examiner is interpreting a channel screen and a screen to select the CCA to encompass the claimed portion); and
wherein the medical device is further configured to, in addition to being configured to perform the one or more clinical operations, operate as a thin point-of-care device that creates a separate messaging channel (See Paragraphs [0049], [0056], [0060], [0063]-[0064], [0113]: Delivery information input device 32 also communicates with the MMU 12 to assist in processing drug orders for delivery through the MMU, and the Monitor Lines program acquires ongoing updates of status, events and alarms for each channel or line for a medical device that supports multiple drug delivery channels or lines, which the Examiner is interpreting the communication between the delivery information device and MMU to encompass a separate messaging channel that allows the hospital server as Paragraph [0113] describes that the indicator can be transmitted directly to an MMU located in the area or indirectly through another route, including the medical device which the Examiner is interpreting a route to encompass a separate messaging channel, and interpreting the medical device to encompass a thin point-of-care device as the Applicant’s Specification in Paragraph [0057] discloses “In example (2), the infusion pump operates as a-18- "thin" point-of-care device that relays information between the hospital server and the user at the infusion pump, without affecting the clinical operations of the infusion pump or accessing any data specific to the infusion pump.”) configured to transmit unregulated message requests that are unrelated to the one or more clinical operations of the medical device and distinct from communications used by the hospital server to transmit the instructions to perform the one or more clinical operations (See Paragraphs [0107]-[0108]: Once the physical location of the medical device is determined by the MMU, a report physical location message is sent from the MMU to the computer, which the Examiner is interpreting a report physical location message to encompass the claimed portion as the Applicant’s Specification describes the unregulated message request in Paragraph [0067] as “At block 506, the server determines that a second condition for transmitting an unregulated message request to the medical device is satisfied. For example, the second condition may include one or more of (i) detecting that the medical device is within a threshold level of proximity with a patient not associated with the medical device, (ii) detecting that an ongoing infusion therapy at the medical device has been ordered to be discontinued, (iii) detecting that the medical device has entered a clinical care area not associated with the medical device, (iv) detecting that a medication bag associated with an ongoing infusion therapy at the medical device has reached a threshold level of volume, and (v) detecting that the medical device needs to be moved to a specific location. Additionally, the unregulated message request may be a type of communication is not regulated by the governing entity (e.g., due to the nature of the communication not being related to the clinical operations of the medical device).”), wherein the thin point-of-care device is configured to relay information between the hospital server and a user physically present in the vicinity of the medical device (See Figs. 4A, 12, and Paragraphs [0064], [0067], [0076], [0112]-[0114], [0125]: The medical device can display a channel selection screen and a screen to select the clinical care area (CCA), and the caregiver 114 enters or selects the CCA at step 166 using scroll and select/enter keys on the user interface means, which the Examiner is interpreting the caregiver to be in the vicinity of the medical device as the interface is available physically as [0112] describes that the caregiver machine readable indicator and medication machine readable indicator may also be equipped with a transmitter/receiver chip), without affecting the clinical operations of the medical device (See Paragraphs [0107]-[0108]: Once the physical location of the medical device is determined by the MMU, a report physical location message is sent from the MMU to the computer, which the Examiner is interpreting a report physical location message to encompass without affecting the clinical operations of the medical device), wherein the separate messaging channel allows the hospital server (See Paragraphs [0049], [0056], [0060], [0063]-[0064]: Delivery information input device 32 also communicates with the MMU 12 to assist in processing drug orders for delivery through the MMU, and the Monitor Lines program acquires ongoing updates of status, events and alarms for each channel or line for a medical device that supports multiple drug delivery channels or lines, which the Examiner is interpreting the communication between the delivery information device and MMU to encompass a separate messaging channel that allows the hospital server, and interpreting the medical device to encompass a thin point-of-care device as the Applicant’s Specification in Paragraph [0057] discloses “In example (2), the infusion pump operates as a-18- "thin" point-of-care device that relays information between the hospital server and the user at the infusion pump, without affecting the clinical operations of the infusion pump or accessing any data specific to the infusion pump.”) to (1) initiate presentation of user-selectable options at the medical device (See Figs. 4A, 12, and Paragraphs [0067], [0076] [0125]: The medical device 14 is turned on at step 164 the medical device 14 displays a start up screen 163A (FIG. 12) on the display 88 of the medical device, which the Examiner is interpreting the selection screen to encompass initiate presentation of user-selectable options at the medical device), (2) receive one or more selections of the user-selectable options made by a user physically present in the vicinity of the medical device (See Figs. 4A, 12, and Paragraphs [0064], [0067], [0076] [0125]: The caregiver 114 enters or selects the CCA at step 166 using scroll and select/enter keys on the user interface means, which the Examiner is interpreting the caregiver to be in the vicinity of the medical device as the interface is available physically), and (3) perform one or more automated actions based on the one or more selections received via the separate messaging channel (See Figs. 5, 5A, and 15 Paragraphs [0077]-[0080]: 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, which the Examiner is interpreting the infusion to encompass one or more automated actions),
wherein the hospital server is further configured to:
transmit, to the medical device, an instruction to cause two or more user-selectable user interface elements to be displayed on the display of the medical device, without affecting the one or more clinical operations of the medical device, wherein the two or more user-selectable user interface elements are unrelated to the one or more clinical operations of the medical device (See Paragraph [0076]: The medical device can display a channel selection screen and a screen to select the clinical care area (CCA), which the Examiner is interpreting a channel screen and a screen to select the CCA to encompass the two or more user-selectable user interface elements are unrelated to the one or more clinical operations of the medical device);
receive an indication from the medical device that the user physically present in the vicinity of the medical device has selected, via the one or more input devices of the medical device, one of the two or more user-selectable user interface elements previously displayed according to the instruction transmitted from the hospital server to the medical device via the separate messaging channel (See Figs. 4A, 12, and Paragraphs [0064], [0067], [0076] [0125]: The medical device can display a channel selection screen and a screen to select the clinical care area (CCA), and the caregiver 114 enters or selects the CCA at step 166 using scroll and select/enter keys on the user interface means, which the Examiner is interpreting the caregiver to be in the vicinity of the medical device as the interface is available physically, and the Examiner is interpreting a channel screen to encompass one of the two or more user-selectable user interface elements previously displayed according to the instruction transmitted from the hospital server to the medical device via the separate messaging channel), wherein the medical device is configured to transmit the indication to the hospital server without changing one or more clinical operations being performed by the medical device (See Paragraphs [0060], [0107]-[0108]: Once the physical location of the medical device is determined by the MMU, a report physical location message is sent from the MMU to the computer, which the Examiner is interpreting a report physical location message to encompass without affecting the clinical operations of the medical device); and
perform the one or more automated actions to be performed based on the selected one of the two or more user-selectable user interface elements received via the separate messaging channel (See Figs. 5, 5A, and 15 Paragraphs [0077]-[0080]: 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, which the Examiner is interpreting the infusion to encompass one or more automated actions.)
Claim(s) 6 and 15 mirror claim 1 only within different statutory categories, and are rejected for similar reason(s) as claim 1.
As per claim 2, Holland discloses the system of claim 1 as described above. Holland further teaches the hospital server is further configured to detect an order for an infusion therapy based on one or more parameters, wherein the one or more parameters indicate at least a medication to be infused and a concentration at which the medication is to be infused (See Paragraphs [0098]: The drug library includes drug and device related information, which may include but is not limited to drug name, drug class, drug concentration, drug amount, drug units, diluent amount, diluent units, dosing units, delivery dose or rate, medication parameters or limits, device/infuser settings and/or modes, CCA designations and constraints, and 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, at which time the new drug library replaces the older version in the primary memory, which the Examiner is interpreting
operate or deliver an infusion to encompass detect an order for an infusion therapy based on one or more parameters.)
Claim(s) 7 and 16 mirror claim 2 only within different statutory categories, and is rejected for the same reason as claim 2.
As per claim 10, Holland discloses the server of claim 6 as described above. Holland further teaches wherein further configured to detect that an ongoing infusion therapy at the medical device has been ordered to be discontinued, wherein the two or more user-selectable user interface elements comprise a user interface element that indicates that the ongoing infusion therapy is to be discontinued (See Figs. 2, 4A, 5, 5A, 20 and Paragraphs [0082]-[0083], [0090]-[0091]: When the infusion is to end at step 228, the Process Drug Order 46 program can remotely stop the infusion by sending a stop order 226 to the medical device 14, which triggers the medical device to end infusion, which the Examiner is interpreting a stop order to encompass detect that an ongoing infusion therapy at the medical device has been ordered to be discontinued, and interpreting the Process Drug Order 128 program sends infusion change events and infusion time events in a delivery event log message to encompass a user interface element that indicates that the ongoing infusion therapy is to be discontinued.)
Claim(s) 19 mirrors claim 10 only within a different statutory category, and is rejected for the same reason as claim 10.
As per claim 11, Holland discloses the server of claims 6 and 10 as described above. Holland further teaches wherein the medical device is configured to output the user interface element that indicates that the ongoing infusion therapy is to be discontinued on a display of the medical device without actually discontinuing the ongoing infusion therapy and while the ongoing infusion therapy is still ongoing (See Figs. 2, 4A, 5, 5A, 20 and Paragraphs [0090]-[0091]: The Process Drug Order 46 program can remotely stop the infusion by sending a stop order 226 to the medical device 14, which triggers the medical device to end infusion at step 228, in most cases, the MMU 12 requires the caregiver to confirm the start or stop of execution, which the Examiner is interpreting the ability for a caregiver to confirm the start of execution to encompass a display of the medical device without actually discontinuing the ongoing infusion therapy and while the ongoing infusion therapy is still ongoing.)
Claim(s) 20 mirrors claim 11 only within a different statutory category, and is rejected for the same reason as claim 11.
As per claim 22, Holland discloses the system of claim 1 as described above. Holland further teaches wherein the one or more automated actions comprise causing one or more database entries to be created or updated in a hospital database based on the selected one of the two or more user-selectable user interface elements previously displayed according to the instruction transmitted from the hospital server to the medical device via the separate messaging channel (See Paragraphs [0060], [0101]-[0103]: The MMU and the corresponding Download Drug Library 132 program include recording the history of the download, verify the correct download, notification to the caregiver of a change of library, and a preliminary note on the medical device 14 display stating that the drug library will be changed after any current infusion, which the Examiner is interpreting recording the history of the download to encompass one or more database entries to be created or updated in a hospital database.)
Claim(s) 23-24 mirrors claim 20 only within different statutory categories, and are rejected for the same reason as claim 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 (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.
Claims 3-5, 8-9, 12 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Holland et al. (U.S. Patent Pre-Grant Publication No. 2007/0083344) in view of Miodownik et al (U.S. Patent Pre-Grant Publication No. 2006/0089539) in further view of Graves et al. (U.S. Patent Pre-Grant Publication No. 2006/0236373)
As per claim 3, Holland discloses the system of claim 1 as described above. Holland may not explicitly teach wherein the hospital server is further configured to detect that the medical device is within a threshold level of proximity with a patient not associated with the medical device, wherein the two or more user-selectable user interface elements comprise a user interface element that, when selected by the user at the medical device, indicates to the hospital server that the patient is to be associated with the medical device, wherein the hospital server is further configured to update a hospital database to indicate that the patient is associated with the medical device.
Miodownik teaches a system […] wherein the two or more user-selectable user interface elements comprise a user interface element that, when selected by the user at the medical device, indicates to the hospital server that the patient is to be associated with the medical device (See Paragraph [0072]: The caregiver generates association data using the ID readers whenever the caregiver administers a change to the patient location, equipment or medication, which the Examiner is interpreting to encompass wherein the two or more user interface elements comprise a user interface element that, when selected by the user at the medical device, indicates to the hospital server that the patient is to be associated with the medical device), wherein the hospital server is further configured to update a hospital database to indicate that the patient is associated with the medical device (See Paragraph [0081]: The ID reader is used by the caregiver to read an ID structure attached to equipment that the caregiver is currently attached to equipment that the caregiver is currently attaching to the patient, the server uses this information to associate the equipment with the patient, which the Examiner is interpreting to encompass wherein the hospital server is further configured to update a hospital database to indicate that the patient is associated with the medical device.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Holland to include the two or more user-selectable user interface elements comprise a user interface element that, when selected by the user at the medical device, indicates to the hospital server that the patient is to be associated with the medical device, wherein the hospital server is further configured to update a hospital database to indicate that the patient is associated with the medical device as taught by Miodownik. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Holland with Miodownik with the motivation of increasing medical facility efficiency (See Background of the Invention of Miodownik in Paragraph [0002]).
While Holland/Miodownik discloses the system as described above, Holland/Miodownik may not explicitly teach wherein the hospital server is further configured to detect that the medical device is within a threshold level of proximity with a patient not associated with the medical device, […].
Graves discloses a system wherein the hospital server is further configured to detect that the medical device is within a threshold level of proximity with a patient not associated with the medical device, […] (See Paragraph [0076]: A tag of a patient interacts with the detector of a terminal allowing the controller to learn of the relative proximity of each patient to terminal, which the Examiner is interpreting the relative proximity of each patient to terminal encompasses detect that the medical device is within a threshold level of proximity with a patient not associated with the medical device.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Holland/Miodownik to include the hospital server is further configured to detect that the medical device is within a threshold level of proximity with a patient not associated with the medical device as taught by Graves. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Holland/Miodownik with Graves with the motivation of improving communications (See Background of Graves in Paragraph [0006]).
Claims 8 and 17 mirror claim 3 only within different statutory categories, and are rejected for similar reasons as claim 3.
As per claim 4, Holland discloses the system of claim 1 and Holland/Miodownik/Graves discloses the system of claim 3 as described above. Holland may not explicitly teach wherein the medical device, in response to the selection by the user at the medical device, is configured to transmit the indication to the hospital server without changing one or more clinical operations being performed by the medical device.
Miodownik teaches a system wherein the medical device, in response to the selection by the user at the medical device, is configured to transmit the indication to the hospital server without changing one or more clinical operations being performed by the medical device (See Paragraph [0081]: The ID reader is used by the caregiver to read an ID structure attached to equipment that the caregiver is currently attached to equipment that the caregiver is currently attaching to the patient, the server uses this information to associate the equipment with the patient, which the Examiner is interpreting to encompass the claimed portion as the patient is associated with the equipment as the initial step.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Holland to include the medical device, in response to the selection by the user at the medical device, is configured to transmit the indication to the hospital server without changing one or more clinical operations being performed by the medical device as taught by Miodownik. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Holland with Miodownik with the motivation of increasing medical facility efficiency (See Background of the Invention of Miodownik in Paragraph [0002]).
Claim(s) 9 mirrors claim 4 only within a different statutory category, and is rejected for the same reasons as claim 4.
As per claim 5, Holland discloses the system of claim 1 as described above. Holland may not explicitly teach wherein the hospital server is further configured to detect that the medical device has entered a clinical care area not associated with the medical device, wherein the two or more user-selectable user interface elements comprise a user interface element that, when selected by the user at the medical device, indicates to the hospital server that the medical device is to be associated with the clinical care area, wherein the hospital server is further configured to update a hospital database to indicate that the medical device is associated with the clinical care area.
Miodownik teaches a system […], wherein the two or more user-selectable user interface elements comprise a user interface element that, when selected by the user at the medical device, indicates to the hospital server that the medical device is to be associated with the clinical care area (See Paragraph [0072]: The caregiver generates association data using the ID readers whenever the caregiver administers a change to the patient location, equipment or medication, which the Examiner is interpreting to encompass wherein the two or more user interface elements comprise a user interface element that, when selected by the user at the medical device, indicates to the hospital server that the medical device is to be associated with the clinical care area), wherein the hospital server is further configured to update a hospital database to indicate that the medical device is associated with the clinical care area (See Paragraph [0081]: The ID reader is used by the caregiver to read an ID structure attached to equipment that the caregiver is currently attached to equipment that the caregiver is currently attaching to the patient, the server uses this information to associate the equipment with the patient, which the Examiner is interpreting to encompass wherein the hospital server is further configured to update the hospital database to indicate that the medical device is associated with the clinical care area.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Holland to include the two or more user interface elements comprise a user interface element that, when selected by the user at the medical device, indicates to the hospital server that the medical device is to be associated with the clinical care area, wherein the hospital server is further configured to update a hospital database to indicate that the medical device is associated with the clinical care area as taught by Miodownik. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Holland with Miodownik with the motivation of increasing medical facility efficiency (See Background of the Invention of Miodownik in Paragraph [0002]).
While Holland/Miodownik discloses the system as described above, Holland/Miodownik may not explicitly teach wherein the hospital server is further configured to detect that the medical device has entered a clinical care area not associated with the medical device, […].
Graves discloses a system wherein the hospital server is further configured to detect that the medical device has entered a clinical care area not associated with the medical device (See Paragraphs [0138] and [0144]-[0147]: An overall "location-awareness area" is used in a hospital that allows for the absolute location of tagged clinicians and equipment to be detected, calculated, and tracked, which the Examiner is interpreting to encompass claimed portion as determining that the second condition is satisfied comprises detecting that the medical device has entered a clinical care area not associated with the medical device as the location-awareness area could identify if a medical device has entered a clinical care area not associated with the medical device as the equipment is tracked), […].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the system of Holland/Miodownik to include the hospital server is further configured to detect that the medical device has entered a clinical care area not associated with the medical device as taught by Graves. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Holland/Miodownik with Graves with the motivation of improving communications (See Background of Graves in Paragraph [0006]).
Claim(s) 12 mirrors claim 5 only within different a statutory category, and is rejected for the same reason as claim 5.
As per claim 18, Holland discloses the method of claim 15 and Holland/Miodownik/Graves discloses the method of claim 17 as described above. Holland may not explicitly teach wherein the medical device, in response to the selection by the user at the medical device, is configured to output, without changing one or more clinical operations being performed by the medical device, an indication that the patient is to be associated with the medical device.
Macoviak teaches a method wherein the medical device, in response to the selection by the user at the medical device, is configured to output, without changing one or more clinical operations being performed by the medical device, an indication that the patient is to be associated with the medical device (See Paragraphs [0081], [0127]: The ID reader is used by the caregiver to read an ID structure attached to equipment that the caregiver is currently attached to equipment that the caregiver is currently attaching to the patient, the server uses this information to associate the equipment with the patient and the wireless held PDAs are equipped with screens to display text and video data, text entry interfaces, speakers, audio sensors, video sensors, and ID readers, which the Examiner is interpreting to encompass the claimed portion as the patient is associated with the equipment as the initial step.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Holland to include the medical device, in response to the selection by the user at the medical device, is configured to output, without changing one or more clinical operations being performed by the medical device, an indication that the patient is to be associated with the medical device as taught by Miodownik. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Holland with Miodownik with the motivation of increasing medical facility efficiency (See Background of the Invention of Miodownik in Paragraph [0002]).
Claims 13, 21 are rejected under 35 U.S.C.103 as being unpatentable over Holland et al. (U.S. Patent Pre-Grant Publication No. 2007/0083344) in view of Simpson et al. (U.S. Patent Pre-Grant Publication No. 2014/0288947).
As per claim 13, Holland discloses the server of claim 6 as described above. Holland may not explicitly teach further configured to detect that a medication bag associated with an ongoing infusion therapy at the medical device has reached a threshold level of volume, wherein the two or more user-selectable user interface elements comprise a user interface element that indicates a location of another bag associated with the ongoing infusion therapy.
Simpson teaches a server further configured to detect that a medication bag associated with an ongoing infusion therapy at the medical device has reached a threshold level of volume (See Paragraphs [0297]-[0298]: Modification include identifying the volume of an infusion bag, which the Examiner is interpreting to encompass the claimed portion as the volume of the infusion bag can be identified so a threshold could be identified), wherein the two or more user-selectable user interface elements comprise a user interface element that indicates a location of another bag associated with the ongoing infusion therapy (See Paragraph [0307]: A message can be displayed to request that the physician contact the pharmacy, which the Examiner is interpreting the message to contact the pharmacy to encompass the two or more user interface elements comprises a user interface element indicates a location of another bag associated with the ongoing infusion therapy as the pharmacy would be identified to possess bags.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the server of Holland to include detect that a medication bag associated with an ongoing infusion therapy at the medical device has reached a threshold level of volume, wherein the two or more user-selectable user interface elements comprise a user interface element that indicates a location of another bag associated with the ongoing infusion therapy as taught by Simpson. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Holland with Simpson with the motivation of improving clinician workflow, and making delivery of care easier (See Detailed Description of Simpson in Paragraph [0156]).
As per claim 21, Holland discloses the system of claim 1 as described above. Holland may not explicitly teach wherein the medical device is configured to process both regulated and unregulated message requests and perform tasks corresponding to the regulated and unregulated message requests.
Simpson teaches a system wherein the medical device is configured to process both regulated and unregulated message requests and perform tasks corresponding to the regulated and unregulated message requests (See Paragraphs [0158], [0311], [0433]-[0435]: Messages can be sent to the one or more electronic computing devices to display numerous hospital-definable alerts and alarms, and the infusion system includes a messages module for communicating with entities throughout the patient care system, the messages are sent in response to a status information output provided by the medication administration module, and the messages relate to the status information output and can provide alerts, alarms, reminders or other messages appropriate in assisting the clinician with medication administration, and the second server causes the digital assistant to display a list of actions, which the Examiner is interpreting the messages to encompass regulated message requests ([0311]) and the actions taken to identify flow rate modifications to encompass perform tasks corresponding to the regulated message requests, and the display a list of actions to encompass the unregulated message request and perform tasks corresponding to the unregulated messages when combined with Miodownik described below as the Specification in Paragraph [0067] discloses that the unregulated message request can be “Additionally, the unregulated message request may be a type of communication is not regulated by the governing entity (e.g., due to the nature of the communication not being related to the clinical operations of the medical device). The unregulated message request may be an instruction to cause one or more indications to be output via the output devices of the medical device. For example, the one or more indications can include one or more visual or voice/audio messages to be output via the output devices of the medical device, and/or one or more user interface elements to be displayed on the display of the medical device.”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the server of Holland to include the medical device is configured to process both regulated and unregulated message requests and perform tasks corresponding to the regulated and unregulated message requests as taught by Simpson. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Holland with Simpson with the motivation of improving clinician workflow, and making delivery of care easier (See Detailed Description of Simpson in Paragraph [0156]).
Claims 14 are rejected under 35 U.S.C. 103 as being unpatentable over Holland et al. (U.S. Patent Pre-Grant Publication No. 2007/0083344) in view of Miodownik et al (U.S. Patent Pre-Grant Publication No. 2006/0089539).
As per claim 14, Holland discloses the server of claim 6 as described above. Holland may not explicitly teach further configured to detect that the medical device needs to be moved to a specific location, wherein the two or more user-selectable user interface elements comprise a user interface element that provides an instruction to move the medical device to the specific location.
Miodownik teaches a system further configured to detect that the medical device needs to be moved to a specific location (See Paragraph [0105]: The equipment ID is currently associated with this patient, the message indicates that the equipment is being removed from use with this patient, which the Examiner is interpreting to encompass the claimed portion as the equipment is being disassociated with the patient and could be taken to inventory (See Paragraph [0101])), wherein the two or more user-selectable user interface elements comprise a user interface element that provides an instruction to move the medical device to the specific location (See Paragraph [0105]: The message indicates that the equipment is being removed from use with the patient, which the Examiner is interpreting to encompass the claimed portion.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the server of Holland to include further configured to detect that the medical device needs to be moved to a specific location, wherein the two or more user interface elements comprise a user interface element that provides an instruction to move the medical device to the specific location as taught by Miodownik. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Holland with Miodownik with the motivation of increasing medical facility efficiency (See Background of the Invention of Miodownik in Paragraph [0002]).
Response to Arguments
In the Remarks filed on March 16, 2026, the Applicant argues that the newly amended and/or added claims overcome the Claim Objection(s), 35 U.S.C. 102 rejection(s), and 35 U.S.C. 103 rejection(s). The Examiner acknowledges that the newly added and/or amended claims overcome the Claim Objection(s). However, the Examiner does not acknowledge that the newly added and/or amended claims overcome the 35 U.S.C. 102 rejection(s) and 35 U.S.C. 103 rejection(s).
The Applicant argues that:
(1) Office Action relies on Holland's delivery-information communications, channel-selection screen, clinical-care-area selection screen, and infusion execution. However, those disclosures concern communications used to configure, control, or carry out clinical operations. They do not disclose a separate messaging channel for transmitting unregulated message requests unrelated to clinical operations, as now recited in the claims. Further, paragraph [0076] of Holland provides that ''when the medical device 14 is turned on at step 164 the medical device 14 displays a start up screen'' and the ''medical device 14 then displays a clinical care area selection screen." Thus, CCA selection of Holland is not selection of ''user interface elements previously displayed according to the instruction transmitted from the hospital server to the medical device via the separate messaging channel," as recited in the amended claims. At least for these reasons, Applicant respectfully submits that Claims 1, 6, and 15 are patentably distinct from the cited references and requests that the rejection of Claims 1, 6, and 15 under 35 U.S.C. §§ 102 and 103 be withdrawn and the claims be allowed;
(2) Applicant has not addressed all the issues of the dependent claims, Applicant respectfully submits that Applicant does not necessarily agree with the characterization and assessments of the dependent claims made by the Examiner, and Applicant believes that each claim is patentable on its own merits. Applicant respectfully submits that the dependent claims incorporate by reference all the limitations of the claim to which they refer and include their own patentable features and are therefore in condition for allowance. Therefore, Applicant respectfully requests the withdrawal of all claim rejections and prompts allowance of the claims.
In response to argument (1), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains Holland’s teachings in Paragraphs [0107]-[0108] as once the physical location of the medical device is determined by the MMU, a report physical location message is sent from the MMU to the computer, which the Examiner is interpreting a report physical location message to encompass the claimed portion as the Applicant’s Specification describes the unregulated message request in Paragraph [0067] as “At block 506, the server determines that a second condition for transmitting an unregulated message request to the medical device is satisfied. For example, the second condition may include one or more of (i) detecting that the medical device is within a threshold level of proximity with a patient not associated with the medical device, (ii) detecting that an ongoing infusion therapy at the medical device has been ordered to be discontinued, (iii) detecting that the medical device has entered a clinical care area not associated with the medical device, (iv) detecting that a medication bag associated with an ongoing infusion therapy at the medical device has reached a threshold level of volume, and (v) detecting that the medical device needs to be moved to a specific location. Additionally, the unregulated message request may be a type of communication is not regulated by the governing entity (e.g., due to the nature of the communication not being related to the clinical operations of the medical device).” Holland further describes in Paragraph [0113] that the indicator can be transmitted directly to an MMU located in the area or indirectly through another route, including the medical device which the Examiner is interpreting a route to encompass a separate messaging channel The 35 U.S.C. 102 rejection(s) stand.
In response to argument (2), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains the 35 U.S.C. 102 and 103 rejection(s) on the dependent claims as described above in the 35 U.S.C. 102 and 103 rejection(s). The 35 U.S.C. 102 and 35 U.S.C. 103 rejection(s) stand.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/Bennett Stephen Erickson/Primary Examiner, Art Unit 3683
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