Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Response to Amendment
In the amendment dated 29 December 2025, the following occurred: Claim 1, 3, 4, and 20 have been amended.
Claims 1-20 are pending.
Priority
This application claims priority to U.S. Provisional Patent Application No. 63/676,307 dated 26 July 2024.
Information Disclosure Statement
The Information Disclosure Statement(s) (lDS) submitted on 30 December 2025 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(3) because following figure(s) contain text that is smaller than the permissible limit of 1/8”:
Fig. 2 (text in the boxes on right side of drawing).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite methods for monitoring compliance with patient protocols, which are within a statutory category.
Step 2A1
The limitations of receiving or accessing one or more hospital or physician orders for each patient of a set of patients within a healthcare location; determining a patient care protocol for each of the hospital or physician orders for each patient, wherein each patient care protocol comprises: one or more steps to be performed by a caregiver, one or more timers associated with the one or more steps, and one or more compliance indicators for each of the one or more steps, wherein the compliance indicators each include a proximity indicator indicating that a patient of the set of patients is within a predetermined distance of the caregiver and a time-stamped image providing visual confirmation of compliance of a step of the patient care protocol; displaying a time-ordered list of the patient care protocols for the set of patients, with a countdown time associated with each patient care protocol in the time-ordered list; [accessing] radio frequency (RF) signal [information] from a device of the patient of the set of patients and determining a proximity of the patient relative to the caregiver based on the received RF signal; determining an expiry of a timer associated with a patient care protocol for the patient of the set of patients; sending an alert to the caregiver to perform the patient care protocol based on the expiry of the timer and determined proximity of the patient; confirming compliance with each step of the patient care protocol of the time-ordered list of patient care protocols based on receipt of the proximity indicator and the time-stamped image, the proximity indicator associated with the patient care protocol, the determined proximity of the patient based on the received RF signal, and one or more times associated with the one or more steps; and outputting an indication that all or some of the one or more steps of the patient care protocol have been completed based on the confirmed compliance, as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components (discussed at Step 2A2).
That is, other than reciting a system implemented by (Claim 1) a mobile computing device having one or more processors and a user interface or (Claim 20) a mobile computing device having a processor, the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the mobile device, this claim encompasses a person determining care protocols, displaying them, and confirming compliance with them in the manner described in the identified abstract idea, supra. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional element(s) of (Claim 1) a mobile computing device having one or more processors and a user interface or (Claim 20) a mobile computing device having a processor that implements the identified abstract idea. The mobile computing device having a processor(s) and/or user interface is not exclusively described by the applicant and is disclosed to encompass a generic laptop computer, tablet, or smartphone (see Spec. Para. 0019, 0045, 0058, 0093). These generic computer components are recited at a high-level of generality (i.e., a generic computer performing generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. The Examiner notes that a mobile device, such as a cell phone (i.e., a smartphone), has been held by the courts to be a generic computing component. See United Services Automobile Association v. PNC Bank, N.A., 139 F.4th 1332, 1334, 1337 (Fed. Cir. 2025) (finding that claims confined to a “personal mobile device, like a cell phone” do not render eligible an otherwise ineligible claim because a “mobile device is a piece of generic hardware”). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim further recites the additional element of receiving a radio frequency (RF) signal from a device of the patient. The receipt of a radio frequency (RF) signal from a device of the patient merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
Step 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element(s) of using (Claim 1) a mobile computing device having one or more processors and a user interface or (Claim 20) a mobile computing device having a processor to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of receiving a radio frequency (RF) signal from a device of the patient were determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. For completeness, the Examiner also notes that the prior art of record indicates that tracking patient location using radio frequency information is well-understood, routine, and conventional in the art (see US 2018/0369039 to Bhimavarapu et al. at Para. 0122; US 2017/0032093 to Norton et al. at Para. 0042; US 2014/0184408 to Herbst et al. at Para. 0043; US 2012001669 to Sievenpiper et al. at Para. 0026). Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
Claims 2-19 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2, 3, 4, 5, 6, 7 merely describe(s) the proximity data and/or how it is used, which further defines the abstract idea.
Claim(s) 2, 3, 4, 6 also includes the additional element of a mobile/remote device, a caregiver device, and /or a patient-worn device. The mobile/remote device and caregiver-worn device are presumed to be the mobile device of Claim 1 per the 112(b) interpretation, supra, and do not provide an inventive concept for the reasons noted with respect to Claim 1. The patient-worn device generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
Claim(s) 8, 11 merely describe(s) how the patient care protocol is arrived at, which further defines the abstract idea.
Claim 11 recites the additional element of a database, which is interpreted to be part of the generic computer of Claim 1 and doesn’t not provide a provide a practical application or significantly more for the reasons noted above.
Claim(s) 9, 10 merely describe(s) the content of the care protocol, which further defines the abstract idea.
Claim(s) 12 merely describe(s) the data gathered that is used to arrive at the protocol, which further defines the abstract idea.
Claim(s) 13 merely describe(s) identifying additional data, which further defines the abstract idea.
Claim(s) 14, 15, 16 merely describe(s) what data is displayed/outputted, which further defines the abstract idea.
Claim(s) 14, 15 also includes the additional elements of on a user interface of a mobile device and a remote device. The user interface of a mobile device is presumed to be the interface of the mobile device of Claim 1 per the 112(b) interpretation, supra, and do not provide an inventive concept for the reasons noted with respect to Claim 1. The remote device generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
Claim(s) 17 merely describe(s) the image, which further defines the abstract idea.
Claim(s) 18, 19 merely describe(s) how compliance is identified, which further defines the abstract idea.
Claim 19 recites using a trained machine learning agent to identify data. This represents mere instructions to implement the abstract idea on a generic computer. Implementing an abstract idea using a generic computer or components thereof does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. This has been re-evaluated under the “significantly more” analysis and determined to be insufficient to provide significantly more. MPEP 2106.05(I) indicates that mere instructions to implement the abstract idea on a generic computer and/or confining the use of the abstract idea to a particular technological environment or field of use cannot provide significantly more.
Response to Arguments
Drawings
Regarding the drawing objection(s), the Applicant has submitted replacement drawings; however, the text height issues are still present in Figure 2 and the objection is maintained.
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-20, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
The instant claims, as amended, recite "determining a location…; determining an expiry of a timer…and; and sending an alert…” which are clearly not "methods of organizing human activity." […] Moreover, the claims do not recite any other judicial exception (e.g., abstract ideas, laws of nature and natural phenomena).
Regarding (a), the Examiner respectfully disagrees. The identified abstract idea represents a series of rule of instructions for a person or persons to follow, with or without the aid of a computer. All the limitations argued by the Applicant falls within this characterization.
In rejecting the claims under 35 U.S.C. §101, the Office Action ignores the claims' technological core: the operation of a caregiver-held mobile device that uses RF signals from a patient device to determine patient-to-caregiver proximity, combines that sensor input with timer expiry and time-stamped imaging, and generates alerts conditioned on proximity, and automatically verifies compliance step-by-step before outputting completion indications.
Regarding (b), the Examiner respectfully disagrees. The Examiner has not ignored anything. Each and every portion of the claim has been addressed. Specifically, the handheld mobile device is a generic computing component. Further, the RF signals merely represent data that the claim is comparing.
Claim 1 improves mobile device functionality by automating protocol verification using specific sensor fusion (RF proximity and time-stamped imaging and timers) rather than manual attestation. That is an improvement to device operation, not an instruction for human behavior.
Regarding (c), the Examiner respectfully submits that there is no physical improvement to the computer within the meaning of Enfish. The functionality surrounding the RF signal is merely the comparison of data and represents part of the rules or instructions for a person to follow, i.e., part of the certain methods of organizing human activity. The actually receipt/transmission of RF signals was analyzed as an additional element and was found to generally link the claim to a particular technological environment as well as being well-understood, routine, and conventional. There is no improvement to the mobile device that is achieved by collecting and comparing RF signal proximity.
The instant claim recite a specific technological improvement to protocol verification, validating caregiver proximity and visual confirmation at the moment a timed step should occur, using precise, device-implemented mechanisms (e.g., RF proximity determination, time-stamped imaging, and countdown-based alerting).
Regarding (d), the Examiner respectfully submits that these features represent the identified abstract idea. They are the manipulation of data that represents the rules or instructions. An improved abstract idea is still an abstract idea; the abstract idea cannot provide the improvement. Regarding Thales, the Examiner submits that the sensors in Thales rendered the claims eligible because the represent a non-routine, non-conventional arrangement of known parts. Applicant has not pointed to nor can the Examiner locate anything in the record that indicates that the arrangement of the mobile device (or sensors) is non-routine or non-conventional.
verification is part of the abstract idea. Any improvement present in the claim is an improvement to the abstract idea. An improved abstract idea is still an abstract idea. Further, whether or not the identified abstract idea is well-understood, routine, conventional (i.e., is novel) is not the test for significantly more.
The Office Action itself recognizes that the prior art "fails to expressly teach or suggest" the combination of these particular features (e.g., determining protocols with steps, timers, compliance indicators including proximity indicators and time-stamped images, time-ordered display with countdown, RF reception to determine patient location/proximity, automatic confirmation based on the sensor fusion, and output of completion) further underscoring that the claim's focus is a technical mechanism for protocol verification, not human organization per se.
Regarding (e), the Examiner respectfully disagrees. MPEP 2106.05(I) states: “As made clear by the courts, the novelty of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter (internal quotations omitted, emphasis original).” That the claims do not have an art rejection is immaterial to the subject matter eligibility analysis.
Thus, the claims generally recite receiving sensor inputs and reacting to the sensor inputs by sending an signal (e.g., an alert to the caregiver) in a manner similar to eligible subject matter of Example 25 of the 2014 Interim Eligibility Guidance.
Regarding (f), the Examiner respectfully disagrees. Example 25 is an illustrative example of the application of the holding of Diamond v. Diehr to a hypothetical claim set. The claims in Diamond v. Diehr and Example 25 we found to be eligible because opening a rubber molding machine at the correct time based on the application of the Arrhenius equation (the abstract idea) resulted in a practical application of the abstract idea; it was an improvement to “another technology,” i.e., the rubber molding machine. See MPEP 2106.04(d)(1), 2106.05(a). Here there is no other technology recited in the claim. The claim is confined to one or more computers. There is no indication that these computers are physically improved, nor is there any indication that another technology is improved.
The claims recite a technical solution to the technical problem of locating a patient, determining that a timer associated with a patient care protocol has expired, and sending an alert to the caregiver. (See Applicant's Specification, paragraph [0089].)
Regarding (g), the Examiner respectfully disagrees and submits that there is no technological problem present. Spec. Para. 0089 describes what the invention does; it does not describe any technical problem.
Further, the instant claims do not merely recite "received RF" in the abstract, but require: [the features of the claim].
Regarding (h), the Examiner respectfully submits that the comparison of RF (and other) data is part of the abstract idea while the receipt/transmission of the RF signal(s) was analyzed as an additional element. This additional element was determined to be insufficient to provide a practical application.
These sensor-conditioned control actions integrate the alleged concept into a practical application.
Regarding (i), the Examiner respectfully disagrees for the reasons noted in the response to argument (h).
The claim further requires a time-stamped image to provide visual confirmation of compliance for each step of the protocol. The time stamp is not decorative; it is an algorithmic constraint used in the verification logic: compliance is confirmed only when the image time stamp aligns with the step's timer and the RF-derived proximity.
Regarding (j), inasmuch as the Examiner understands the nuances of what Applicant is arguing, the Examiner respectfully disagrees. Comparing data (the image timestamp data and RF data) is part of the abstract idea; it is part of the rules or instructions. The Examiner never stated that the time stamp is decorative.
This is not correct. That analysis conflates the presence of an individual technology (RF proximity) with the claimed ordered combination and specific use of that technology in multi-sensor verification.
Regarding (k), the Examiner respectfully submits that this is correct. The abstract idea was identified and any additional elements (the computer and RF signal features) were analyzed and found not to provide a practical application. There is nothing in the disclosure that indicates that the combination of additional elements provides a practical application by any measure in MPEP 2106.04, nor would a person having skill in the art recognize the combination to provide a practical application.
This is akin to Diehr, in which using a mathematical relationship in conjunction with repeated sensor measurements and timing controls to cure rubber was patent-eligible because it improved an industrial process. See Diamondv. Diehr, 450 U.S. 175, 187-88 (1981). The instant claim similarly use timing and sensor fusion to improve the technical process of protocol verification performed by the mobile computing system.
Regarding (l), the Examiner respectfully disagrees. The Claimed invention is unlike Diehr because there is no improvement to another technology. The only “other” technology in the claim is the RF functionality. This is not improved by application of the abstract idea.
The Examiner cannot suggest a path forward with respect to the lack of subject matter eligibility.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Experton et al. (U.S. Pre-Grant Patent Publication No. 2018/0233225) which discloses a system for managing electronic records where the health records are transferred from the patient device to a provider device and the transfer includes the GPS location of the parties.
Dirghangi et al. (U.S. Pre-Grant Patent Publication No. 2019/0320898) which discloses a system for coordinating information from multiple medical data sources for an associated medical examination.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON S TIEDEMAN whose telephone number is (571)272-4594. The examiner can normally be reached 7:00am-4:00pm, off alternate Fridays.
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/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683