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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/15/2026 has been entered.
Status of the Claims
The status of the claims as of the response filed 4/15/2026 is as follows: claims 15-20 remain withdrawn from consideration. Claims 1 and 9 are currently amended. Claim 2-8, 10, 12, and 14 is are as previously presented. Claims 11 and 13 are original. Claims 1-14 are currently pending in the application and have been considered below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/23/2026 is in compliance with the provisions of 37 CFR 1.97 and is being considered by the examiner.
Response to Amendment
Rejection Under 35 USC 112(a)
Claims 1 and 9 have been amended to sufficiently align with the subject matter disclosed in the specification such that the corresponding 35 USC 112(a) rejections are withdrawn.
Rejection Under 35 USC 102
The amendments made to the claims introduce limitations that are not fully addressed in the previous Office action, and thus the corresponding 35 USC 102 rejections are withdrawn. However, Examiner will consider the amended claims in light of an updated prior art search and address their patentability with respect to prior art below.
Response to Arguments
Rejection Under 35 USC 102
On pages 9-10 of the response filed 4/15/2026 Applicant argues that Rosinko does not sufficiently teach the claimed “advisory statement regarding an operational status” as in the independent claims. Applicant’s arguments are fully considered, and are found persuasive. Though Examiner maintains that Rosinko teaches the presentation of a statement regarding an operational status of the infusion pump when it displays unlocked editable operational controls of the pump as in Fig. 31 & [0355], Examiner concedes that this data is not explicitly advisory in nature. However, Examiner submits that this feature does not render the claims non-obvious, as explained in the new grounds of rejection below.
On page 11 Applicant argues that “Rosinko does not teach this specific data flow architecture where collected physiological data provides updated clinical information to a protocol unit in real time, and the controller controls the pumping mechanism in accordance with operational parameters provided by that protocol unit.” Applicant’s arguments are fully considered, but are not persuasive. Examiner submits that Rosinko does adequately teach the limitation at issue. Para. [0090] notes that continuously collected physiological sensor data (i.e. real-time data) about the user is used to adjust operation of the therapy protocol by the system (i.e. acting as a protocol unit) determining appropriate dosage and type of medicament to administer to the user (e.g. within/compliant with the preset operating limits of the pump as in [0417]-[0418]), and sending a signal to therapy delivery module to initiate the adjusted medicament delivery to the subject via the infusion pump. As described in [0086]-[0087], the controller controls the physical operation of the pumping device to deliver the indicated medication and dosage to the patient based on their physiological measurements, such that the computerized system of Rosinko satisfies each of the functional elements of the instant claims via computerized control means making decisions about and then implementing pump operational adjustments based on physiological sensor data collected in real-time.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5-7 and 12-13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 5-7 depend on claim 2, which depends on claim 1. However, the subject matter recited in claims 5-7 is already recited in parent claim 1, such that these claims do not further limit the subject matter of claims 1 and 2. Similarly, claims 12-13 depend on claims 9, 10, and 11, but merely restate limitations that are already recited in parent claim 9 such that they do not further limit the subject matter of claims 9-11. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Rosinko et al. (US 20220080120 A1) in view of Gupta et al. (US 20210151146 A1).
Claim 1
Rosinko teaches a communication system for connecting a user in communication with a computerized device (Rosinko Fig. 6, [0084]-[0088], noting communication hardware that allows a user to control a computerized medical device like an AMD with an insulin pump) which comprises:
a computer including a controller, wherein the controller is connected to a pumping mechanism in the computerized device and controls the pumping mechanism in accordance with operational parameters provided by a protocol unit (Rosinko Fig. 6, [0084]-[0088], [0090], noting control and computing module (i.e. a controller) connected to one or more infusion pumps (i.e. pumping mechanisms) and used to control operational parameters of the pumps in accordance with desired settings entered or modified at a user interface, i.e. operational parameters provided by a protocol unit; see also [0417]-[0418], noting normal and minimum operating parameters embodied on the AMD);
instructions for a first communication between the user and the computer, initiated by the user of the device, wherein the first communication includes instructions from the user to the controller for a specified operation of the computerized device in compliance with a protocol that is clinically incorporated for use in the computer (Rosinko Fig. 31, [0236], [0241], [0353], noting a user may initiate a therapy change input or request at a user interface to change therapy parameters or operational settings of the AMD; see also [0417]-[0418], noting the AMD can check for compliance with normal and minimum operating parameters embodied on the AMD, considered equivalent to the first communication including instructions from the user to the controller for a specified operation of the computerized device in compliance with a protocol that is clinically incorporated for use in the computer), and further wherein a request is made from the controller back to the user for a validating response from the user together with a first prearranged signal for validating subsequent identification of the user (Rosinko Fig. 31, [0242]-[0245], [0252], [0355], noting the system prompts a user for an interaction that confirms the setting change, e.g. a gesture, biometric identifier, passcode, etc. See specifically the example in [0355], where if a requested setting change is protected by a passcode, the AMD will prompt a user to input the required user-generated passcode (i.e. request a validating response together with a first prearranged passcode signal that validates identification of the user));
instructions for a second communication, initiated by the controller specifically in response to the first communication, wherein the second communication includes an (Rosinko Fig. 31, [0355], noting after the user has provided the passcode (i.e. the first prearranged signal), the system presents the unlocked parameter control elements to the verified user and may prompt the user to provide a second gesture to confirm the changes made. The presentation of the unlocked parameter control elements is considered to be a second communication initiated by the controller specifically in response to the first communication, and these control elements are also considered equivalent to a statement regarding an operational status of the computerized device for compliance with the protocol (such as the normal or minimum operating parameters as in [0417]-[0418]) because they present the user with information about how the AMD is currently operating and a range of options for modifying operation in a manner that would allow compliance with the present normal and minimum operating parameters. Further, prompting for a second confirmation is considered a request for reconfirming the response and operational confirmation from the user together with a second prearranged signal for identifying the user because the confirmation interactions are described in [0243]-[0245] as including user-specific inputs like complex gestures, alphanumeric sequences, biometric data, etc. that act as user-specific identifiers),
wherein a monitor is connected with the user for collecting data pertinent to a physical characteristic of the user and the controller uses the collected data for compliant execution and control of the protocol (Rosinko [0090], noting a subject sensor collects physiological data about the user which is used to adjust operation of the therapy protocol), and
wherein when the collected data is noncompliant with the protocol, the controller executes an alarm message that is transmitted immediately to both the user and designated clinical personnel (Rosinko [0372]-[0373], [0377]-[0380], [0383]-[0384], noting if an alarm condition is met (such as data from the subject sensor meeting a threshold of a preset alarm profile), an alarm may be sent to the user interface of the AMD (i.e. to the user) as well as to other remote devices (i.e. to clinical personnel)),
wherein the controller uses the collected data from the monitor for compliant execution and control of the protocol, wherein the collected data provides updated clinical information to the protocol unit in real time, and the computer controls the pumping mechanism in accordance with the operational parameters provided by the protocol unit (Rosinko [0090], noting collected physiological sensor data about the user is used to adjust operation of the therapy protocol by determining appropriate dosage and type of medicament to administer to the user (e.g. within/compliant with the preset operating limits of the pump as in [0417]-[0418]), and the system sends a signal to therapy delivery module to initiate the adjusted medicament delivery to the subject via the infusion pump, i.e. by controlling operation of the pumping mechanism in accordance with the adjusted operational parameters); and
an order from the user to execute the instructions from the user to the controller for the specified operation of the computerized device (Rosinko [0252], [0355], noting in response to a user’s confirmation (i.e. an order from the user to execute the instructions from the user to the controller for the specified operation of the computerized device), the desired operational changes are implemented by the AMD).
In summary, Rosinko teaches a system that permits user programming of an infusion pump via sequential prompts for user input and corresponding parameter confirmations. Though this reference contemplates displaying unlocked parameter control elements that relay information related to operational status of the infusion pump (e.g. current settings that may be changed by the user), it fails to explicitly disclose that the communicated information is advisory in nature. However, Gupta teaches an analogous infusion pump programming system that includes functionality for displaying warnings or alerts (i.e. advisory statements) to a user if input operational parameters do not comply with clinical guidelines, protocols, rules, limits, etc. so that the user may modify them or provide an override confirmation (Gupta [0032]-[0037]). 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 second communication of Rosinko (which displays adjustable operating parameters of the pump to a user for modification prior to confirmation) to further include an advisory alert or warning if the input operational parameters will result in non-compliance with established clinical protocols, guidelines, or other rules as in Gupta in order to inform the user of potentially dangerous pump programming inputs so that a fail-safe against incorrect administration of medication is provided (as suggested by Gupta [0006] & [0033]).
Claim 9
Rosinko teaches a communication system for operating a computerized device in accordance with instructions from a user (Rosinko Fig. 6, [0084]-[0088], noting communication hardware that allows a user to control a computerized medical device like an AMD with an insulin pump) which comprises:
a computer connected with the device, wherein the computer is connected to a pumping mechanism in the computerized device and controls the pumping mechanism in accordance with operational parameters provided by a protocol unit (Rosinko Fig. 6, [0084]-[0088], [0090], noting control and computing module (i.e. a controller) connected to one or more infusion pumps (i.e. pumping mechanisms) and used to control operational parameters of the pumps in accordance with desired settings entered or modified at a user interface, i.e. operational parameters provided by a protocol unit; see also [0417]-[0418], noting normal and minimum operating parameters embodied on the AMD);
an interface unit mounted on the computer and adapted for communication applications with the user (Rosinko Fig. 6, [0088], noting user interface module is part of the AMD (i.e. is mounted on the computer module 610) and is adapted for communicating with a user via input and outputs);
a receiver included in the interface unit for receiving instructions for a first communication between the user and the computer, initiated by the user of the device, wherein the first communication includes instructions from the user to the computer for a specified operation of the computerized device in compliance with a protocol that is clinically incorporated for use in the computer (Rosinko Fig. 31, [0236], [0241], [0353], noting a user may initiate a therapy change input or request at the user interface (i.e. receiver) to change therapy parameters or operational settings of the AMD; see also [0417]-[0418], noting the AMD can check for compliance with normal and minimum operating parameters embodied on the AMD, considered equivalent to the first communication including instructions from the user to the controller for a specified operation of the computerized device in compliance with a protocol that is clinically incorporated for use in the computer), and further wherein a request is made from the computer back to the user for an operational confirmation from the user together with a first prearranged signal for validating subsequent identification of the user (Rosinko Fig. 31, [0242]-[0245], [0252], [0355], noting the system prompts a user for an interaction that confirms the setting change, e.g. a gesture, biometric identifier, passcode, etc. See specifically the example in [0355], where if a requested setting change is protected by a passcode, the AMD will prompt a user to input the required user-generated passcode (i.e. request a validating response together with a first prearranged passcode signal that validates identification of the user)); and
a transmitter included in the interface unit for transmitting instructions for a second communication, initiated by the computer in response to the first communication, wherein the second communication includes an (Rosinko Fig. 31, [0355], noting after the user has provided the passcode (i.e. the first prearranged signal), the system presents the unlocked parameter control elements to the verified user and may prompt the user to provide a second gesture to confirm the changes made. The presentation of the unlocked parameter control elements is considered to be a second communication initiated by the computer specifically in response to the first communication, and these control elements are also considered equivalent to a statement regarding an operational status of the computerized device for compliance with the protocol (such as the normal or minimum operating parameters as in [0417]-[0418]) because they present the user with information about how the AMD is currently operating and a range of options for modifying operation in a manner that would allow compliance with the present normal and minimum operating parameters. Further, prompting for a second confirmation is considered a request for reconfirming the response and operational confirmation from the user together with a second prearranged signal for identifying the user because the confirmation interactions are described in [0243]-[0245] as including user-specific inputs like complex gestures, alphanumeric sequences, biometric data, etc. that act as user-specific identifiers);
wherein a monitor is connected with the user for collecting data pertinent to a physical characteristic of the user and the computer uses the collected data for compliant execution and control of the protocol (Rosinko [0090], noting a subject sensor collects physiological data about the user which is used to adjust operation of the therapy protocol), and
wherein when the collected data is noncompliant with the protocol, the computer executes an alarm message that is transmitted immediately to both the user and designated clinical personnel (Rosinko [0372]-[0373], [0377]-[0380], [0383]-[0384], noting if an alarm condition is met (such as data from the subject sensor meeting a threshold of a preset alarm profile), an alarm may be sent to the user interface of the AMD (i.e. to the user) as well as to other remote devices (i.e. to designated clinical)), and
wherein the computer uses the collected data from the monitor for compliant execution and control of the protocol, wherein the collected data provides updated clinical information to the protocol unit in real time, and the computer controls the pumping mechanism in accordance with the operational parameters provided by the protocol unit (Rosinko [0090], noting collected physiological sensor data about the user is used to adjust operation of the therapy protocol by determining appropriate dosage and type of medicament to administer to the user (e.g. within/compliant with the preset operating limits of the pump as in [0417]-[0418]), and the system sends a signal to therapy delivery module to initiate the adjusted medicament delivery to the subject via the infusion pump, i.e. by controlling operation of the pumping mechanism in accordance with the adjusted operational parameters); and
an order from the user to execute the instructions from the user to the computer for the specified operation of the computerized device (Rosinko [0252], [0355], noting in response to a user’s confirmation (i.e. an order from the user to execute the instructions from the user to the controller for the specified operation of the computerized device), the desired operational changes are implemented by the AMD).
In summary, Rosinko teaches a system that permits user programming of an infusion pump via sequential prompts for user input and corresponding parameter confirmations. Though this reference contemplates displaying unlocked parameter control elements that relay information related to operational status of the infusion pump (e.g. current settings that may be changed by the user), it fails to explicitly disclose that the communicated information is advisory in nature. However, Gupta teaches an analogous infusion pump programming system that includes functionality for displaying warnings or alerts (i.e. advisory statements) to a user if input operational parameters do not comply with clinical guidelines, protocols, rules, limits, etc. so that the user may modify them or provide an override confirmation (Gupta [0032]-[0037]). 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 second communication of Rosinko (which displays adjustable operating parameters of the pump to a user for modification prior to confirmation) to further include an advisory alert or warning if the input operational parameters will result in non-compliance with established clinical protocols, guidelines, or other rules as in Gupta in order to inform the user of potentially dangerous pump programming inputs so that a fail-safe against incorrect administration of medication is provided (as suggested by Gupta [0006] & [0033]).
Claims 2 and 10
Rosinko in view of Gupta teaches the system of claim 1, and the combination further teaches wherein the computerized device is an infusion pump (Rosinko [0087], noting the controlled medical device includes an infusion pump), and instructions from the user include time, dosage and medication changes for the protocol clinically established in the medium for execution and control by the computer (Rosinko [0243], noting the therapy changes may include different hormone medications, different amounts of medication, rate of delivery of medications, thresholds for when medications are delivered, etc., considered equivalent to time, dosage, and medication changes for an infusion protocol).
Claim 10 recites substantially similar subject matter as claim 2 and is also rejected as above.
Claim 3
Rosinko in view of Gupta teaches the system of claim 2, and the combination further teaches wherein the first communication is initiated, and the instructions and validating response from the user are accomplished, in a manner selected from the group consisting of audio, visual, and tactile signals from the user (Rosinko [0088], [0243], noting the user interface for modifying operational parameters can include visual and touchscreen modalities).
Claim 4
Rosinko in view of Gupta teaches the system of claim 2, and the combination further teaches wherein the second communication is initiated, and the advisory statement and request for a revalidating response are accomplished in a manner selected from the group consisting of vibrations, light variations, visual presentations and sound sequences from the device (Rosinko [0088], noting outputs of the system (i.e. the second communication, the advisory statement and any requests) are communicated to a user via at least visual signals from the user interface of the AMD).
Claim 11
Rosinko in view of Gupta teaches the system of claim 10, and the combination further teaches wherein the first communication is initiated, and the instructions and validating response from the user are accomplished, in a manner selected from the group consisting of audio, visual, and tactile signals from the user (Rosinko [0088], [0243], noting the user interface for modifying operational parameters can include visual and touchscreen modalities), and wherein the second communication is initiated, and the advisory statement and request for a revalidating response are accomplished in a manner selected from the group consisting of vibrations, light variations, visual presentations and sound sequences from the device (Rosinko [0088], noting outputs of the system (i.e. the second communication, the advisory statement and any requests) are communicated to a user via at least visual signals from the user interface of the AMD).
Claim 5
Rosinko in view of Gupta teaches the system of claim 2, and the combination further teaches wherein the computerized device further comprises a monitor connected with the user for collecting data pertinent to a physical characteristic of the user in accordance with the protocol for execution and control by the computer (Rosinko [0090], noting a subject sensor collects physiological data about the user which is used to adjust operation of the therapy protocol).
Claim 6
Rosinko in view of Gupta teaches the system of claim 5, and the combination further teaches wherein the computerized device executes an alarm message when data collected by the monitor is noncompliant with the protocol (Rosinko [0372]-[0373], [0377]-[0380], [0383]-[0384], noting if an alarm condition is met (such as data from the subject sensor meeting a threshold of a preset alarm profile), an alarm may be sent to the user interface of the AMD as well as to other remote devices).
Claim 12
Rosinko in view of Gupta teaches the system of claim 11, and the combination further teaches wherein the computerized device further comprises a monitor connected with the user for collecting data pertinent to a physical characteristic of the user in accordance with the protocol for execution and control by the computer (Rosinko [0090], noting a subject sensor collects physiological data about the user which is used to adjust operation of the therapy protocol), and wherein the computer-controlled device executes an alarm message when data collected by the monitor is noncompliant with the protocol (Rosinko [0372]-[0373], [0377]-[0380], [0383]-[0384], noting if an alarm condition is met (such as data from the subject sensor meeting a threshold of a preset alarm profile), an alarm may be sent to the user interface of the AMD as well as to other remote devices).
Claims 7 and 13
Rosinko in view of Gupta teaches the system of claim 6, and the combination further teaches wherein the alarm message is transmitted immediately to the user and to designated clinical personnel (Rosinko [0372]-[0373], [0377]-[0380], [0383]-[0384], noting the alarm may be sent to the user interface of the AMD (i.e. to the user) as well as to other remote devices (i.e. to designated clinical personnel)).
Claim 13 recites substantially similar subject matter as claim 7 and is also rejected as above.
Claims 8 and 14
Rosinko in view of Gupta teaches the system of claim 1, and the combination further teaches wherein the first communication and the second communication are initiated, in sequence, independently of one another (Rosinko Fig. 31, noting steps 3108 (representing the first communication from the user) and 3128-3130 (representing the second communication) are initiated in a sequence and independently of each other).
Claim 14 recites substantially similar subject matter as claim 8 and is also rejected as above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Welsch et al. (US 20160228633 A1) describes a system for displaying sequential confirmation and authorization prompts to a user responsive to a desired infusion pump programming input. Condurso et al. (US 20060047538 A1) describes a system for managing infusion therapy by monitoring patient physiological signals, ensuring compliance with institutional rules/guidelines, and providing alerts and confirmation prompts to users. Workman (US 20240374811 A1) describes a system for presenting a workflow to a user to resolve deviations in input infusion device operational data as compared to stored programming data.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A HRANEK whose telephone number is (571)272-1679. The examiner can normally be reached M-F 8:00-4:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached on 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN A HRANEK/Primary Examiner, Art Unit 3684
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