Prosecution Insights
Last updated: April 19, 2026
Application No. 18/709,184

POST-SERVICE STATE VALIDATOR FOR MEDICAL DEVICES

Final Rejection §101§103
Filed
May 10, 2024
Examiner
EL-BATHY, IBRAHIM N
Art Unit
3628
Tech Center
3600 — Transportation & Electronic Commerce
Assignee
Koninklijke Philips N V
OA Round
2 (Final)
51%
Grant Probability
Moderate
3-4
OA Rounds
3y 2m
To Grant
99%
With Interview

Examiner Intelligence

Grants 51% of resolved cases
51%
Career Allow Rate
138 granted / 269 resolved
-0.7% vs TC avg
Strong +50% interview lift
Without
With
+50.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
55 currently pending
Career history
324
Total Applications
across all art units

Statute-Specific Performance

§101
43.2%
+3.2% vs TC avg
§103
37.2%
-2.8% vs TC avg
§102
8.3%
-31.7% vs TC avg
§112
8.6%
-31.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 269 resolved cases

Office Action

§101 §103
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Status of Claims Office Action is in response to the Applicant's amendments and remarks filed11/4/2025. Claims 1-20 are presently pending and presented for examination. Response to Remarks/Arguments In regards to rejection under 35 U.S.C. § 101: Applicant’s arguments, filed 11/4/2025, with respect to claims 1-20 have been fully considered and are not persuasive. In regards to Applicant’s arguments that “These limitations are not rules for human interactions or "managing interactions between people"; they are technology-focused steps that configure, control, and validate the state of a particular machine (a medical device) at a specific lifecycle moment (post-service), in order to ensure safe and correct technical operation before returning the device to patient-facing functionality… Properly understood, claim 1 is directed to improving the functioning, safety, and security posture of a medical device via a specific device-implemented validation protocol tied to device modes and service-session boundaries. It is not an abstract business or human-organization method. Even if a judicial exception were implicated, which for the above-reasons it should not, the claim integrates any such exception into a practical application. The claim's additional elements integrate the alleged abstract idea into a practical application because they (a) are "tied to" a particular machine (the medical device and its processor, memory, and display) and (b) effect an improvement to the functioning of that machine by enforcing a validation process at a defined operational boundary (end of a service-mode session) before returning to patient-facing operation. This reduces risk of misconfiguration or unsafe operation and addresses concrete technical states. The guidance instructs that Step 2A Prong Two asks whether additional elements integrate a judicial exception into a practical application: The claim then requires further analysis in Step 2A Prong Two, to determine whether any additional elements in the claim integrate the abstract idea into a practical application, see MPEP §2106.04(d)… Even if the claim were found to recite an abstract idea, the additional elements-particularly the ordered combination of (i) dual, device-side operating and service modes; (ii) a validation process performed "at an end of a servicing session ... performed using the service mode" to determine an incorrect operating state; and (iii) a device-side SE display of the validation result supply an inventive concept… Furthermore, the claim is not managing human relationships or business practices; it configures and controls a medical device's operating lifecycle. The "service engineer" reference simply identifies the machine's human operator at the point of validation display; it does not convert the claim into a human-organization method. The proper inquiry focuses on whether the additional elements integrate any exception into a practical application and/or recite an inventive concept, not whether the hardware could be off- the-shelf. Here, the recited elements are arranged in a specific way to solve a device-operation problem at a particular lifecycle boundary, satisfying MPEP §2106.04(d) and § 2106.05(a)-(e)”, (see remarks , pg. 7-10). Examiner respectfully disagrees, the current claims are not statutory because they are directed towards an abstract idea without significantly more. The claims recite method for providing medical diagnostics for a medical a device, which is a method of managing interactions between people, which falls into the methods of organizing human activity grouping as for example an individual may obtain possession of a medical tool, then observe/analyze whether it is in an incorrect operating state, then record/communicate this status to a database/server. The computing elements such as “computer readable medium, electronic processor, medical device, display device of claim 1; electronic device, electronic processor, computer readable medium, medical device, display device of claim 16; medical device, user interface, display device of claim 20” are recited at a high level of generality and are generically recited computer elements. The generically recited computer elements amount to simply implementing the abstract idea on a computer. The combination of these additional elements are additional elements do no more than generally link the use of the judicial exception to a particular technological environment or field of use. Also, with respect to technological improvement "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). Accordingly, in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, elements being analyzed for significantly more are mere generic computer components being implemented to implement the abstract idea on a computer. Response to Prior Art Arguments In regards to rejection under 35 U.S.C. § 103: Applicant’s arguments, filed 11/4/2025, with respect to claims 1-20 have been fully considered and are not persuasive. In regards to Applicant’s arguments that “None of this teaches a device- side "operating mode" that provides medical diagnostic/treatment functionality, or a device- side "service mode" for servicing the device. Jensen is not operating the medical device in a patient-facing operating mode; instead, it surfaces fleet status and maintenance operations across devices. See, e.g., FIGS. 4-11 and corresponding description of the browser-based remote maintenance UI “, (see Remarks, pg. 10-11). Examiner respectfully disagrees, Examiner’s interpretation of “operating mode” as mentioned in the claims “provide an operating mode for a medical device to provide medical diagnostic and/or medical treatment functionality” is shown by ¶53-¶54 of Jensen as it states with emphasis “the medical devices 102, 104 send maintenance information (e.g., configuration and usage information) to the server device 112. This maintenance information can be used to determine a current state of the medical devices 102, 104. The information can also be used to manage maintenance and upgrading of the medical devices 102, 104. For example, as described further below, the medical devices 102, 104 report usage information and current firmware/software configurations to the server device 112”, while ¶39-¶43 shows one of the current states as in operating modes as it states “medical device 102 is able to operate within one or more workflows. A workflow is a series of one or more tasks that a user of the medical device 102 performs. When the medical device 102 operates within a workflow, the medical device 102 provides functionality suitable for assisting the user in performing the workflow. When the medical device 102 operates within different workflows, the medical device 102 provides different functionality”. In regards to Applicant’s arguments that “Claim 1 includes a timing requirement, namely "perform a validation process at an end of a servicing session ... performed using the service mode", which is not taught or suggested in the prior art. This is a specific timing and mode-dependent trigger.”, (see Remarks, pg. 13). Examiner respectfully disagrees, the claim language stating at an end of a servicing session is not interpreted as a defined time which then triggers a validation process, the interpretation of the limitation is performing validation process after use of the tool which is presented by ¶52 of Danielson, as Danielson observes the quality of the tool. In regards to Applicant’s arguments that “Claim 1 further recites that, in response to the validation process determining the device is in "an incorrect operating state," the device displays to a service engineer (SE) an indication of that incorrect operating state. This element is not taught or suggested by the cited art”, (see Remarks, pg. 14). Examiner respectfully disagrees, ¶52 of Danielson, shows incorrect operating state if the tools accuracy falls outside the determined threshold such as “a QC sample may understood as a substance or sample having a measurable property that is carefully controlled such that when a medical analyzer devices performs a measurement on the QC sample to verify its operational accuracy, there is an associated target range (e.g. target value±tolerance value) that the measurement result within which the result should fall in order to fulfil the associated quality requirements”. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites method for providing medical diagnostics for a medical a device. Step 2A – Prong 1 Independent Claims 1, 16 and 20 as a whole recite a method of organizing human activity. The limitations from exemplary Claim 1 reciting “provide an operating mode to provide medical diagnostic and/or medical treatment functionality; provide a service mode that provides service functions for servicing; and perform a validation process at an end of a servicing session of the performed using the service mode to determine whether is in an incorrect operating state; and display, operable by a service engineer (SE) and in response to determining the is in the incorrect operating state, an indication that is in the incorrect operating state” is a method of managing interactions between people, which falls into the certain methods of organizing human activity grouping. The mere recitation of a generic computer (computer readable medium, electronic processor, medical device, display device of claim 1; electronic device, electronic processor, computer readable medium, medical device, display device of claim 16; medical device, user interface, display device of claim 20) does not take the claim out of the methods of organizing human activity grouping. Thus, the claim recites an abstract idea. Step 2A - Prong 2: Claims 1-20 and their underlining limitations, steps, features and terms, are further inspected by the Examiner under the current examining guidelines, and found, both individually and as a whole, not to include additional elements that are sufficient to integrate the abstract idea into a practical application. The limitations are directed to limitations referenced in MPEP 2106.05 that are not enough to integrate the abstract idea into a practical application. Limitations that are not enough include, as a non-limiting or non-exclusive examples, such as: (i) adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions, (ii) insignificant extra solution activity, and/or (iii) generally linking the use of the judicial exception to a particular technological environment or field of use. This judicial exception is not integrated into a practical application because the claim recites the additional elements of (computer readable medium, electronic processor, medical device, display device of claim 1; electronic device, electronic processor, computer readable medium, medical device, display device of claim 16; medical device, user interface, display device of claim 20). The computer readable medium, electronic processor, medical device, display device of claim 1; electronic device, electronic processor, computer readable medium, medical device, display device of claim 16; medical device, user interface, display device of claim 20, are recited at a high level of generality and are generically recited computer elements. The generically recited computer elements amount to simply implementing the abstract idea on a computer. The combination of these additional elements are additional elements do no more than generally link the use of the judicial exception to a particular technological environment or field of use. Accordingly, in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as discussed above, the additional elements do no more than generally link the use of the judicial exception to a particular technological environment or field of use. Thus, even when viewed as an ordered combination, nothing in the claims add significantly more (i.e. an inventive concept) to the abstract idea. The claims are ineligible. Dependent claims 2-15 and 17-19 are also directed to same grouping of methods of organizing human activity. The additional elements of the computer readable medium in claims 2-15; medical device in claims 2-6, 9-16 and 17-19; interface of claim 2-3, 8; device in claims 4, 7; button of claim 7; central remote server of claim 10; software in claims 11-12, are additional elements do no more than generally link the use of the judicial exception to a particular technological environment or field of use. Accordingly, in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-7, 10 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen et al (US Patent Application Publication No. 20150371198 - hereinafter Jensen) in view of Danielson et al (US Patent Application Publication No. 20240321439 - hereinafter Danielson). Re. claim 1, Jensen teaches: A non-transitory computer readable medium storing: instructions readable and executable by at least one electronic processor to provide an operating mode for a medical device to provide medical diagnostic and/or medical treatment functionality; [Jensen; ¶53-¶54 shows medical device providing server with diagnostics that get evaluated by the service device such as “the medical devices 102, 104 send maintenance information (e.g., configuration and usage information) to the server device 112. This maintenance information can be used to determine a current state of the medical devices 102, 104. The information can also be used to manage maintenance and upgrading of the medical devices 102, 104. For example, as described further below, the medical devices 102, 104 report usage information and current firmware/software configurations to the server device 112”. while ¶39-¶43 shows one of the current states as in operating modes as it states “medical device 102 is able to operate within one or more workflows. A workflow is a series of one or more tasks that a user of the medical device 102 performs. When the medical device 102 operates within a workflow, the medical device 102 provides functionality suitable for assisting the user in performing the workflow. When the medical device 102 operates within different workflows, the medical device 102 provides different functionality”]. instructions readable and executable by the at least one electronic processor to provide a service mode for the medical device that provides service functions for servicing the medical device; and [Jensen; ¶53-¶55] Jensen doesn’t teach, Danielson teaches: instructions readable and executable by the at least one electronic processor to: perform a validation process at an end of a servicing session of the medical device performed using the service mode to determine whether the medical device is in an incorrect operating state; and [Danielson; ¶52 shows verification process performed to make sure the device operation falls within an acceptable range such as “obtaining S101 a plurality of measurements results associated with a plurality of quality control (QC) measurements performed by a plurality of medical analyzer devices on a plurality of predefined QC samples (may also be referred to as control substance, QC specimen or QC samples). In more detail, a QC sample may understood as a substance or sample having a measurable property that is carefully controlled such that when a medical analyzer devices performs a measurement on the QC sample to verify its operational accuracy, there is an associated target range (e.g. target value±tolerance value) that the measurement result within which the result should fall in order to fulfil the associated quality requirements”]. display, on a display device operable by a service engineer (SE) and in response to determining the medical device is in the incorrect operating state, an indication that the medical device is in the incorrect operating state. [Danielson; ¶92 shows the use of communication interface. Then, ¶80-¶89 shows determining and indicating a device falls outside the threshold such as “for each medical analyzer device 110, the control circuitry 202 is configured to evaluate the obtained measurement results against the measurement results of the associated peer group in order to identify a deviation of at least one QC measurement parameter. Then, if a deviation above a predefined threshold is identified, the control circuitry 202 is further configured to obtain an action log(s) of the deviating medical analyzer device(s) 110. The action log(s) comprise(s) data indicative of any previously transmitted maintenance actions associated with the medical analyzer device(s) 110”]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the process of Jensen by including limitation(s) as taught by Danielson to include the above features in the invention of Jensen. One would be motivated to modify Jensen with the teachings of Danielson since “predefined parameter groups may be formed based on one or more hardware and/or software components of the medical analyzer enabling an efficient and accurate identification of specific component(s) that may be failing”. [Danielson; ¶37]. Re. claim 2, Jensen in view of Danielson teaches medium of claim 1. Jensen teaches: wherein the operating mode is provided on an operating mode user interface (UI) for the medical device that provides operational functions for operating the medical device. [Jensen; ¶49] Re. claim 3, Jensen in view of Danielson teaches medium of claim 1. Jensen teaches: wherein the service mode is provided on a service mode user interface (UI) for the medical device that provides service functions for servicing the medical device. [Jensen; ¶49 and ¶53-¶55] Re. claim 4, Jensen in view of Danielson teaches medium of claim 1. Jensen doesn’t teach, Danielson teaches: wherein the validation process includes: determining a state of the medical device by analyzing device data generated by the medical device. [Danielson; ¶52 shows verification process performed to make sure the device operation falls within an acceptable range such as “obtaining S101 a plurality of measurements results associated with a plurality of quality control (QC) measurements performed by a plurality of medical analyzer devices on a plurality of predefined QC samples (may also be referred to as control substance, QC specimen or QC samples). In more detail, a QC sample may understood as a substance or sample having a measurable property that is carefully controlled such that when a medical analyzer devices performs a measurement on the QC sample to verify its operational accuracy, there is an associated target range (e.g. target value±tolerance value) that the measurement result within which the result should fall in order to fulfil the associated quality requirements”]. Please see motivation to combine Jensen in view of Danielson presented in claim 1 above. Re. claim 5, Jensen in view of Danielson teaches medium of claim 1. Jensen doesn’t teach, Danielson teaches: wherein the validation process includes: determining a state of the medical device by analyzing a record of operations performed during the servicing session. [Danielson; ¶27-¶28 and ¶52 shows an action log that is analyzed such as “the control circuitry is configured to, if the deviation above the predefined threshold is identified, check the obtained action log in order to identify an entry in the action log corresponding to a transmission of the first maintenance action. Then, if the entry in the action log corresponding to the transmission of the first maintenance action is identified and if the deviation above the predefined threshold is identified at a point in time after the entry in the action log corresponding to the transmission of the first maintenance action, the control circuitry is further configured to transmit, to the device for managing the medical analyzer device associated with the identified deviation, data indicative of an instruction to execute a second maintenance action of the plurality of suggested maintenance actions for the medical analyzer device”]. Please see motivation to combine Jensen in view of Danielson presented in claim 1 above. Re. claim 6, Jensen in view of Danielson teaches medium of claim 1. Jensen doesn’t teach, Danielson teaches: wherein the validation process includes: determining a most-recent correct operational state of the medical device; and comparing a current state of the medical device with the most-recent correct operational state of the medical device. [Danielson; ¶27-¶28 and ¶52 shows an action log that is analyzed such as “the control circuitry is configured to, if the deviation above the predefined threshold is identified, check the obtained action log in order to identify an entry in the action log corresponding to a transmission of the first maintenance action. Then, if the entry in the action log corresponding to the transmission of the first maintenance action is identified and if the deviation above the predefined threshold is identified at a point in time after the entry in the action log corresponding to the transmission of the first maintenance action, the control circuitry is further configured to transmit, to the device for managing the medical analyzer device associated with the identified deviation, data indicative of an instruction to execute a second maintenance action of the plurality of suggested maintenance actions for the medical analyzer device”]. Please see motivation to combine Jensen in view of Danielson presented in claim 1 above. Re. claim 7, Jensen in view of Danielson teaches medium of claim 1. Jensen teaches: wherein the instructions further include: providing a button selectable by the SE via at least one user input device to perform the validation process. [Jensen; ¶74 provides a button for device upgrade such as “a firmware upgrade module 434 is provided that allows the technician to select which devices to upgrade. For example, a checkbox is associated with each device listed, and the technician can select the checkboxes associated with the desired devices to upgrade. Upon selection, the “Approve Upgrade” button is selected to schedule the selected medical devices for firmware upgrades”]. Re. claim 10, Jensen in view of Danielson teaches medium of claim 1. Jensen doesn’t teach, Danielson teaches: wherein the validation process is performed on a central remote server operable by a manufacturer of the medical device. [Danielson; ¶33-¶34 and ¶52]. Please see motivation to combine Jensen in view of Danielson presented in claim 1 above. Re. claim 16, Device of claim 16 substantially mirrors the medium of claim 1. Re. claim 17, Jensen in view of Danielson teaches device of claim 16. Jensen doesn’t teach, Danielson teaches: wherein the validation process includes: determining a state of the medical device with by analyzing device data automatically generated by the medical device. [Danielson; ¶52 shows verification process performed to make sure the device operation falls within an acceptable range such as “obtaining S101 a plurality of measurements results associated with a plurality of quality control (QC) measurements performed by a plurality of medical analyzer devices on a plurality of predefined QC samples (may also be referred to as control substance, QC specimen or QC samples). In more detail, a QC sample may understood as a substance or sample having a measurable property that is carefully controlled such that when a medical analyzer devices performs a measurement on the QC sample to verify its operational accuracy, there is an associated target range (e.g. target value±tolerance value) that the measurement result within which the result should fall in order to fulfil the associated quality requirements”]. Please see motivation to combine Jensen in view of Danielson presented in claim 16 above. Re. claim 18, Device of claim 18 substantially mirrors the medium of claim 5. Re. claim 19, Device of claim 19 substantially mirrors the medium of claim 6. Re. claim 20, Device of claim 20 substantially mirrors the medium of claim 1. Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen in view of Danielson in view of Liang et al (US Patent Application Publication No. 20210335479 - hereinafter Liang). Re. claim 8, Jensen in view of Danielson teaches medium of claim 1. Jensen doesn’t teach, Liang teaches: wherein the instructions further include: automatically performing the validation process responsive to an input to the service mode user interface indicating that the servicing session is completed. [Liang; ¶32]. It would have been obvious to one of ordinary skill in the art before the effective filing date to include limitation(s) as taught by Liang in the system of Jensen, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Re. claim 9, Jensen in view of Danielson teaches medium of claim 1. Jensen doesn’t teach, Liang teaches: wherein the instructions further include: automatically performing the validation process responsive to the medical device entering the operating mode after the servicing session is completed. [Liang; ¶32]. It would have been obvious to one of ordinary skill in the art before the effective filing date to include limitation(s) as taught by Liang in the system of Jensen, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen in view of Danielson in view of Khilnani et al (US Patent Application Publication No. 20110214186 - hereinafter Khilnani). Re. claim 11, Jensen in view of Danielson teaches medium of claim 1. Jensen doesn’t teach, Khilnani teaches: wherein the validation process includes detecting the incorrect operating state comprising anti-virus software of the medical device failing to update virus signatures. [Khilnani; ¶32-¶38]. It would have been obvious to one of ordinary skill in the art before the effective filing date to include limitation(s) as taught by Khilnani in the system of Jensen, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Re. claim 12, Jensen in view of Danielson teaches medium of claim 1. Jensen doesn’t teach, Khilnani teaches: wherein the validation process includes detecting the incorrect operating state comprising software whitelisting of the medical device being deactivated or left in an unsupported or insecure configuration setting. [Khilnani; ¶32-¶38]. It would have been obvious to one of ordinary skill in the art before the effective filing date to include limitation(s) as taught by Khilnani in the system of Jensen, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Re. claim 13, Jensen in view of Danielson teaches medium of claim 1. Jensen doesn’t teach, Khilnani teaches: wherein the validation process includes detecting the incorrect operating state comprising an incorrectly configured or deactivated firewall of the medical device. [Khilnani; ¶32-¶38]. It would have been obvious to one of ordinary skill in the art before the effective filing date to include limitation(s) as taught by Khilnani in the system of Jensen, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Re. claim 14, Jensen in view of Danielson teaches medium of claim 1. Jensen doesn’t teach, Khilnani teaches: wherein the validation process includes detecting the incorrect operating state comprising a configuration of the medical device that is not compatible with operating the medical device to provide the medical diagnostic and/or medical treatment functionality. [Khilnani; ¶32-¶38]. It would have been obvious to one of ordinary skill in the art before the effective filing date to include limitation(s) as taught by Khilnani in the system of Jensen, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Jensen in view of Danielson in view of Eberspach et al (US Patent Application Publication No. 20230213610 - hereinafter Eberspach). Re. claim 15, Jensen in view of Danielson teaches medium of claim 1. Jensen doesn’t teach, Eberspach teaches: wherein the validation process includes detecting the incorrect operating state comprising a missing component of the medical device. [Eberspach; ¶407]. It would have been obvious to one of ordinary skill in the art before the effective filing date to include limitation(s) as taught by Eberspach in the system of Jensen, since the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM EL-BATHY whose telephone number is (571)272-7545. The examiner can normally be reached Monday - Friday 9am - 7pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nathan Uber can be reached at 571-270-3923. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /IBRAHIM N EL-BATHY/Primary Examiner, Art Unit 3628
Read full office action

Prosecution Timeline

May 10, 2024
Application Filed
Jul 31, 2025
Non-Final Rejection — §101, §103
Nov 04, 2025
Response Filed
Feb 13, 2026
Final Rejection — §101, §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
51%
Grant Probability
99%
With Interview (+50.5%)
3y 2m
Median Time to Grant
Moderate
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