DETAILED ACTION
This action is in response to the initial filing filed on January 28, 2025. Claims 1-20 were filed. A preliminary amendment was filed on January 28, 2025. Claim 4 has been cancelled. Claims 1, 3, 7-8, 10, 12-14, and 16-20 have been amended. Claim 21 has been added. Claims 1-3 and 5-21 have been examined and are currently pending.
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 .
Inventorship
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.
Information Disclosure Statement
The Information Disclosure Statements filed 1/28/2025 and 5/22/2025 have been considered. Initialed copies of the Form 1449 are enclosed herewith.
Claim Objections
Claim 7 is objected to because of the following informalities: Dependent claim 7 recites “the flow” in line 2 lacks antecedent basis. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: Dependent claim 9 recites the term “if” which implies the claim is optional. Replace the term “if” with “when”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Dependent claim 14 recites the term “if” which implies the claim is optional. Replace the term “if” with “when”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: Dependent claim 15 recites the term “if” which implies the claim is optional. Replace the term “if” with “when”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: Dependent claim 16 recites the term “if” which implies the claim is optional. Replace the term “if” with “when”. Appropriate correction is required.
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 5-6 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. Dependent claim 5 is dependent upon cancelled claim 4. 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
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.
Claim(s) 1-3, 5-8, and 10-21 are rejected under 35 U.S.C. 103 as being unpatentable over Van Zon et al. US Publication 20240021282 A1 in view of Bates US Publication 20190221310 A1.
Claims 1, 19, and 20:
As per claims 1, 19, and 20, Van Zon teaches a method, apparatus, and non-transitory computer readable medium comprising:
initialising a treatment program wrapper in a software environment (paragraphs 0104 “Referring to FIG. 11, the computer system 1100 includes a set of software instructions that can be executed to cause the computer system 1100 to perform any of the methods or computer-based functions disclosed herein. The computer system 1100 may operate as a standalone device or may be connected, for example, using a network 1101, to other computer systems or peripheral devices. In embodiments, a computer system 1100 performs logical processing based on digital signals received via an analog-to-digital converter.”);
initialising a treatment program using the treatment program wrapper, wherein the treatment program wrapper provides runtime execution context to the treatment program and isolates the treatment program from the software environment (paragraphs 0002 and 0041-0042 “According to an aspect of the present disclosure, a system for treating a patient in a medical procedure includes a computer and a medical apparatus. The computer includes a memory that stores instructions and a processor that executes the instructions. The medical apparatus is configured to apply a medical treatment to the patient when instructed to apply the medical treatment by the computer. When executed by the processor, the instructions cause the system to perform a process that includes obtaining medical data of the patient indicative of a medical condition to be treated, and selecting an algorithm and applying the algorithm to the medical data to identify the medical treatment to remedy the medical condition. The process executed by the system also includes determining whether the system can be authorized to apply the medical treatment to the patient and, when the system can be authorized to apply the medical treatment to the patient, instructing the medical apparatus to apply the medical treatment to the patient. The medical apparatus applies the medical treatment to the patient based on the computer instructing the medical apparatus to apply the medical treatment to the patient.”);
executing a personalised therapeutic process of the treatment program to output personalised therapeutic data (paragraph 0036 “As an example use of the medical treatment system in FIG. 1, an automated clinical decision making (ACDM) system may analyze a patient's vital characteristics combined with the patient's current health status. When the analysis indicates that the patient urgently needs medication, the control system 160 may be alerted by the alerting system 170 and may determine that the patient should be treated with a specific dose of a specific drug. The medical treatment system in FIG. 1 may automatically retrieve and administer the specified dose of the specified compound via IV using one or more of the therapeutic device(s) 110, and the entire episode is recorded in the EMR system 140.”);
routing the personalised therapeutic data to a clinician portal using a clinician interface mechanism of the treatment program wrapper (paragraphs 0043 and 0033 “The alerting system 170 may include one or more networked communications sources and distributed receivers such as mobile devices that interact over an electronic communications network. For example, the alerting system 170 may include an automated source of alerts that are sent to one or more clinicians via applications installed on mobile devices. The alerting system 170 may present alerts to the clinicians and may prompt one or more clinician(s) to respond to the alerts by entering answers and/or by travelling to patients who are the subjects of the alerts. The alerts may be sent to the alerting system 170 from the therapeutic device(s) 110 based on triggers such as to alert that the therapeutic device(s) 110 are failing or anticipating failing. The alerts may be automatically sent to the alerting system 170 from the diagnostic device(s) 120 based on triggers such as to alert that a monitored health condition of a patient is deteriorating.” and “At S240, the method of FIG. 2 includes determining whether the system that performs the method of FIG. 2 can be authorized to perform an action identified at S230 based on the medical data obtained at S210. The determining at S240 may involve a lookup table of authorized clinical actions. The authorization that is the subject of S240 may be determined after obtaining the medical data of the patient at S210 without further instructions from a clinician.”);
Van Zon does not teach and outputting the personalised therapeutic instruction to a user interface based on the personalised therapeutic data. However, Bates teaches a System and Method for Automated Diagnosis and Treatment and further teaches, “Diagnostic results and treatment suggestions provided by the automated healthcare system 100 are accessible by the doctor for review, confirmation, or even modification if the doctor has different opinion.” (paragraph 0037), and “At step 710, the treatment module generates one or more treatment schemes based on the chosen one or more diagnostic results, the received patient information including symptom inputs, electronic health record (EHR) of the patient, and retrieved reference information. The generated one or more treatment schemes are presented to the doctor for review. The treatment schemes may be a drug prescription, a physical therapy, a drug injection, a surgical operation, a physical exercise, a chiropractic treatment, an alternative medicine such as acupuncture or hypnosis, or a combination thereof.” (paragraph 0079). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Van Zon to include outputting the personalised therapeutic instruction to a user interface based on the personalised therapeutic data as taught by Bates in order to inform the clinical or doctor regarding a recommended action or treatment.
Claim 2:
As per claim 2, Van Zon and Bates teach the method of claim 1 as described above and Van Zon further teaches wherein the steps of initialising the treatment program, executing the personalised therapeutic process, routing the personalised therapeutic data and outputting the personalised therapeutic instruction are performed by the treatment program wrapper (paragraphs 0033, 0036, and 0041-0043).
Claim 3:
As per claim 3, Van Zon and Bates teach the method of claim 1 as described above and Bates further teaches wherein the method further comprises:
receiving the personalised therapeutic instruction from the clinician interface mechanism (paragraph 0037). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Van Zon to include receiving the personalised therapeutic instruction from the clinician interface mechanism as taught by Bates in order to receive a clinician’s input or directive.
Claim 5:
As per claim 5, Van Zon and Bates teach the method of clam 4 as described above and Van Zon further teaches wherein the method comprises:
routing the personalised therapeutic instruction to the clinician interface mechanism of the computer program wrapper (paragraphs 0043 and 0033).
Claim 6:
As per claim 6, Van Zon and Bates teach the method of claim 5 as described above and Bates further teaches further comprising:
receiving an approved personalised therapeutic instruction from the clinician interface mechanism (paragraphs 0081 and 0084). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Van Zon to include receiving an approved personalised therapeutic instruction from the clinician interface mechanism as taught by Bates in order to receive a clinician’s input or directive.
wherein outputting the personalised therapeutic instruction comprises outputting the approved personalised therapeutic instruction (paragraphs 0081 and 0084). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Van Zon to include wherein outputting the personalised therapeutic instruction comprises outputting the approved personalised therapeutic instruction as taught by Bates in order to display the clinician’s decision.
Claim 7:
As per claim 7, Van Zon and Bates teach the method of claim 1 as described above and Van Zon further teaches wherein the wrapper isolates the treatment program by controlling the flow of input data and output data to and from the treatment program respectively using one or more input interfaces and one or more output interfaces (paragraph 0109).
Claim 8:
As per claim 8, Van Zon and Bates teach the method of claim 1 as described above and Van Zon further teaches wherein the wrapper provides runtime execution context by configuring an underlying device, virtualised environment, platform, operating system and/or the software environment (paragraphs 0105).
Claim 10:
As per claim 10, Van Zon and Bates teach the method of claim 1 as described above and Van Zon further teaches further comprising:
initiating and/or monitoring workflow events using the treatment program wrapper (paragraphs 0022, 0036, and 0040);
and communicating a detected workflow event to the treatment program, wherein executing the process of the treatment program comprises executing the process of the treatment program in response to the detected workflow event (paragraphs 0022, 0036, and 0041-0042).
Claim 11:
As per claim 11, Van Zon and Bates teach the method of claim 10 as described above and Van Zon further teaches wherein the workflow event comprises one or more of:
a patient or clinician completing a task or failing to complete a task;
a patient accepting, rejecting or requesting a deferral to a personalised therapeutic instruction;
patient requesting a clinician consultation;
an event time being reached;
receipt of input data (paragraph 0040);
a change in automation state;
a patient being offline for a threshold time;
and a fault report.
Claim 12:
As per claim 12, Van Zon and Bates teach the method of claim 10 as described above and Van Zon further teaches comprising:
retrieving a time reference using the treatment program wrapper (paragraphs 0040-0042);
and initiating and/or monitoring the workflow events using the time reference (paragraphs 0040-0042);
and/or providing the time reference to the treatment program (paragraphs 0040-0042).
Claim 13:
As per claim 13, Van Zon and Bates teach the method of claim 1 as described above and Van Zon further teaches further comprising:
changing an automation state of the treatment program using the wrapper, in response to one or more of (paragraphs 0040-0042):
receiving a request to change the automation state from the clinician interface mechanism;
receiving a request to change the automation state from the treatment program (paragraphs 0040-0042);
and an event time being reached.
Claim 14:
As per claim 14, Van Zon and Bates teach the method of claim 1 as described above and Van Zon further teaches further comprising:
validating, with the treatment program wrapper, input data from an input data source against one or more expected values (paragraph 0032);
and executing the process of the treatment program using the input data if the validation is successful (paragraph 0032).
Claim 15:
As per claim 15, Van Zon and Bates teach the method of claim 14 as described above and Van Zon further teaches wherein if the validation is unsuccessful, the method further comprises:
generating a log message (paragraph 0032);
initiating an adverse event workflow (paragraph 0032);
or terminating the treatment program and preventing further execution (paragraph 0032).
Claim 16:
As per claim 16, Van Zon and Bates teach the method of claim 1 as described above and Van Zon further teaches comprising:
performing one or more safety checks on the personalised therapeutic instruction (paragraph 0032);
and outputting the personalised therapeutic instruction to the user interface if the personalised therapeutic instruction satisfies the one or more safety checks (paragraph 0032);
or performing one or more safety actions if the personalised therapeutic instruction does not satisfy the one or more safety checks (paragraph 0032).
Claim 17:
As per claim 17, Van Zon and Bates teach the method of claim 1 as described above and Van Zon further teaches wherein the personalised therapeutic instruction comprises:
an instruction to change the treatment therapy (paragraph 0042);
an instruction to change a dosage amount and/or a dosage timing of the treatment therapy (paragraph 0042);
an instruction to undertake or change a level or particular activity of cognitive behavioural therapy (paragraph 0042);
provision of a new or updated prescription (paragraph 0042);
an instruction to suspend or terminate the treatment therapy (paragraph 0061);
an instruction to commence, or change a frequency of, physiological measurements (paragraphs 0042 and 0061);
and an instruction to seek immediate medical attention (paragraph 0033).
Claim 18:
As per claim 18, Van Zon and Bates teach the method of claim 1 as described above and Van Zon further teaches wherein the wrapper and the treatment program form a container image for a container engine (paragraphs 0035 and 0074).
Claim 21:
As per claim 21, Van Zon and Bates teach the method of claim 1 as described above and Van Zon further teaches comprising conducting the treatment therapy on a patient in accordance with the personalised therapeutic instruction (paragraphs 0036 and 0044).
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Van Zon and Bates as applied to claim 8 above, and further in view of Chaturvedi et al. US Publication 20130311222 A1 in view of Richards et al. US Publication 20170265076 A1.
Claim 9:
As per claim 9, Van Zon and Bates teach the method of claim 8 as described above but do not teach further comprising:
comparing a performance of the underlying device, virtualised environment, platform, operating system and/or the software environment against requirements of a service level agreement. However, Chaturvedi teaches a Social Networking System for Organization Management and further teaches, “For example, the organization management platform retrieves the service level agreements defined for each of the organizational groups from a database management system of the organization management platform. The organization management platform compares the performance of the tasks by the employees in each of the organizational groups in accordance with the service level agreements defined for each organizational group. In an example, if the service level agreement defines a required reduction in the number of errors of a software code, the organization management platform determines weekly progress in the reduction of the number of errors achieved by the particular organizational group and compares the determined reduction with the service level agreement.” (paragraph 0056). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Van Zon to include comparing a performance of the underlying device, virtualised environment, platform, operating system and/or the software environment against requirements of a service level agreement as taught by Chaturvedi in order to measure progress or the lack of progress with respect to the service level agreement.
Charturvedi does not teach and generating a warning, failing to initialise the treatment program and/or terminating the treatment program if the requirements of the service level agreement are not satisfied. However, Richards teaches a System and Method for an Automated System for Continuous Observation, Audit and Control of User Activities as they occur within a Mobile Network and further teaches, “Referring now to FIG. 20, there is illustrated the manner in which the system may be used to ensure service-level agreement compliance. Various service-level agreement (SLA) parameters are monitored in real-time at step 2002 and a determination is made 2004 whether all parameters are met. When inquiry step 2004 determines that certain parameters are not met, an alert/flag is generated at step 2006.” (paragraph 0124). Therefore, it would have been obvious to one of ordinary skilled in the art at the time of filing to modify Van Zon to include generating a warning, failing to initialise the treatment program and/or terminating the treatment program if the requirements of the service level agreement are not satisfied as taught by Richards in order to indicate an issue(s) with the service being provided.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Prince et al. US Publication 20240285225 A1 Automated Allergy Office System and Method
Prince discloses an automated allergy office system and method provides a medical professional with a new allergy treatment plan to administer to a patient. The automated allergy office system comprises a smart phone or a tablet computer to select a test site on the patient's skin that is clear. A multiple test applicator is in cooperative engagement with a fluid tray and delivers a small amount of a first allergen to a first test site on the patient's skin as a small amount of a second allergen is delivered to a second test site on the patient's skin. The allergy condition of the patient is detected as a wheal forms at the first test site after fifteen minutes. The elements of the treatment plan are retrieved from a database for treating the patient's allergy condition.
Rajput et al. US Publication 20230395235 A1 System and Method for Delivering Personalized Cognitive Intervention
Rajput discloses a computational personalized cognitive therapeutic system for treating patients with Mild Cognitive Impairment, Alzheimer's Disease, dementia and related conditions is described. The system includes a patient clinical database, a data aggregation layer and data pre-processor module, a digital cognitive therapy delivery module, a cognitive analytics engine, and a personalised cognitive platform configured to personalize a personalised cognitive digital therapy model. The personalised cognitive digital therapy model defines specific digital treatments to be delivered to the patient using the digital cognitive therapy delivery module each with a different mechanism of action. A range of digital cognitive biomarkers are collected along with behavioural and physiological biomarkers from wearable and medical devices which are processed by the cognitive analytics engine and uses AI/ML methods which are configured to estimate metrics and generate alerts. The metrics are used to assess treatment progress and then personalize the personalised cognitive digital therapy model for the patient including adjustment of digital therapies and medication. Alerts may be generated if adverse side effects are observed. This process is iteratively repeated to provide improved treatment over time.
Van Zon US Publication 20220270747 A1 Automated Clinical Decision Disambiguation
Van Zon discloses a method for allocating and activating healthcare resources includes receiving an automated clinical decision from an automated clinical decision-making (ACDM) engine, determining that an action based on the automated clinical decision should performed during a time-critical period, identifying a clinician available within the time-critical period, determining a rank of the clinician relative to the automated clinical decision for the patient condition, and selecting the action to be performed by the at least one clinician or based on the automated clinical decision. The selection operation is performed based on the rank within the time-critical period, and all or a portion of the aforementioned operations are automatically performed using at least one machine-implemented algorithm.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW L HAMILTON whose telephone number is (571)270-1837. The examiner can normally be reached Monday-Thursday 9:30-5:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marc Jimenez can be reached at (571)272-4530. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW L HAMILTON/Primary Examiner, Art Unit 3681