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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 02/04/2026. As directed by the amendment: Claims 1-2 have been amended, claims 6 and 14 have been cancelled, and no claims have been added. Claims 10-13 and 15-20 were previously withdrawn due to a Restriction Requirement. Thus, claims 1-5, 7-9, and 21 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see pages 7-8, filed 02/04/2026, with respect to 35 U.S.C. 112(b) and 112(a) have been fully considered and are persuasive. The amendments to the claim obviate the rejections of record. The rejection of the has been withdrawn.
Applicant's arguments, see pages 8-13, filed 02/04/2026, regarding 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant later argues on pages 9-10 that “The claim further requires that information is displayed while maintaining integrity of information from each of the first device and the WCD, in accordance with a regulated device compliance rule applicable to the first device and the WCD based on their respective classifications. These operations are machine- executed and system-level functions performed within a regulated wearable health monitoring environment and cannot be practically performed by the human mind… Such operations cannot be performed by the human mind as they require real-time, machine-level verification of device interoperability and automated enforcement of regulated compliance rules. This verification process of interoperability and enforcement of regulated compliance rules are performed in order to preserve integrity of information received from multiple medical devices.”
Examiner disagrees because the reception of data is data gathering (insignificant extra-solution activity) and the claim requires device interoperability, and device classification which can all be performed in the mind. Further, these steps can be implemented in the “remote computing device”, which is a generic computing system used to implement this abstract idea.
Applicant then argues on pages 10-11 that “the determination of interoperability recited in the claim is not a subjective judgment, but a system-level technical determination performed by a remote computing device to verify that the first device can properly communicate, exchange data, and operate within the wearable health monitoring system. Such interoperability cannot be assessed by the human mind alone and requires evaluation of device-specific data, communication protocols, and system compatibility. Further, confirmation of interoperability is a required technical condition that governs
whether information from the first device is displayed in accordance with a regulated device
compliance rule based on classification assigned to the first device. These steps are performed
within a wearable health monitoring system and require coordinated operation of a remote
computing device, a display, and device-specific compliance enforcement mechanisms.”
Examiner disagrees because determining from the received information whether the device is a regulated medical device can be done by a human because a human can verify if the first device can communicate and exchange data. Examiner argues that such a classification of regulated or non-regulated device can be made by a human through the analysis and evaluation of the data provided. Examiner argues that such a classification is occurring in a generic computing system used to implement this abstract idea.
Applicant then argues on page 11-12 that “McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299 (Fed. Cir. 2016), claims are not abstract when they use specific rules to automate a process that would otherwise be performed manually, especially when that automation results in improvements in a technical field. Similarly, amended claim 1 recites a structured process in which interoperability is determined by a remote computing device and used to control whether information from the first device is displayed while preserving its integrity… The sequence of steps involving interoperability simplifies what would otherwise be a complex and unreliable manual process of verifying device compatibility and safe integration within a regulated medical system. The use of a computing device to determine interoperability and to condition system behavior based on that determination cannot be performed in the human mind, particularly in the context of real-time and safety-critical medical monitoring.” Examiner disagrees because McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299 (Fed. Cir. 2016) does not recite an abstract idea whereas the instant claim contains a mental process of determining interoperability and whether the device is a regulated medical device. Further, these steps can be implemented in the “computing device”, which is a generic computing system used to implement this abstract idea.
Applicant then argues on pages 12-13 that “the practical application of the claimed features of amended claim 1 lies in the use of displaying information in accordance with the compliance rules upon interoperability confirmation while maintaining integrity of the system as a technical control mechanism. The claimed method requires determining whether a first device is interoperable with the wearable health monitoring system and enables displaying information from the device only upon confirming such interoperability. The interoperability control directly governs system behavior in a safety-critical medical environment and cannot be executed without technical compatibility verification. See paragraph [31] of the specification.
Additionally, the claimed features represent steps more than a mere presentation of information. The claimed outcomes result from a multi-stage technical process in which the remote computing device determines interoperability, determines regulatory status, identifies regulatory classification, and then enforces display of information based on those determinations, including integrity maintenance of information from multiple sources.
The claimed steps collectively ensure that only interoperable devices are permitted to contribute data to the wearable health monitoring system and that such data is handled in compliance with regulatory requirements while maintaining the integrity of the system. These actions are not practicable by a human alone and require coordinated operation of hardware and software within a regulated medical system.”
Examiner disagrees since the processing of data on a microcontroller unit is merely performing this process on a generic computer structure. The transmitting of signals is simply a generic computer function performed by a generic computer structure, wherein implementing the abstract idea with a generic computer is not enough to show integration into a practical application or significantly more than the abstract idea itself. The transmission of data to and from the sensor systems and the displaying of data acquired from the processed abstract idea is merely data gathering and displaying, which are insignificant extra-solution activity.
Therefore, the rejections of record are maintained.
Applicant’s arguments, see pages 13-17, filed 02/04/2026, with respect to 35 U.S.C. 103 have been fully considered and are persuasive. The amendments obviate the rejection of record. The rejection of the claims has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7-9 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the term “information” in lines 16-17 is the same or different than the “information” of line 3.
Regarding claim 1 line 18, it is unclear where the classification of the WCD is coming from as no classification was made to the WCD in the claim.
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 1-5, 7-9 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each of independent claim 1 recites a step determining, by the remote computing device, from the received information that the first device is interoperable with the wearable health monitoring system,
determining, by the remote computing device, from the received information whether the first device is a regulated medical device,
identifying…a classification of the regulated medical device as a Class I, Class II, or Class III regulated medical device, which is a mental process. This judicial exception is not integrated into a practical application because the generically recited computer elements (ie. a remote computing device, first device), determining values, and determining regulation of the device do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are to receiving data, processing data, and determine regulation of the device, which are all well-understood, routine, and conventional computer functions. See MPEP § 2106.05(d).
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 1 is directed to a method and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claim 1, the following step is an abstract idea:
“determining, by the remote computing device, from the received information that the first device is interoperable with the wearable health monitoring system,
determining, by the remote computing device, from the received information whether the first device is a regulated medical device,
identifying…a classification of the regulated medical device as a Class I, Class II, or Class III regulated medical device”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could analyze interoperability of a first device with the system from information and determining if the device is regulated. Examiner notes that the FDA identifies these devices based on the classification definitions on the following website (“Classify your Medical Device”, https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device, FDA, 2020), thereby showing that these devices are evaluated by humans.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claim 1, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a remote computing device”, “display”, “a first device”, and “a wearable health monitoring system comprising a WCD” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “regulatory compliance rules”, “health parameter data”, “classification”, “display”, “Class I-III regulated medical device”, and “received information” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a remote computing device”, “display”, “a first device”, and “a wearable health monitoring system comprising a WCD” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “regulatory compliance rules”, “health parameter data”, “classification”, “display”, “Class I-III regulated medical device”, and “received information” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
The additional elements of claim 1, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the remote computing device and first device, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The wearable cardioverter defibrillator is a well-understood, and routine structure, which is taught by Jorgenson (US 20170367591) which shows the WCD connected to sensors (Abstract).
Dependent claims 2-5, 7-9 and 21 do not integrate the abstract idea into a practical application
and do not add significantly more to the abstract idea of claim 1. The dependent claim limitations are directed to the data processing (claims 2-3, 5, 7-8) and to generic structure/computing components (claims 4, 9, and 21), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1-5, 7-9 and 21 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Conclusion
Claims 1-5, 7-9, and 21 are overcome the prior art but are still rejected under 35 U.S.C. 101.
The following is a statement of reasons for the indication of the claims overcoming the prior art:
The first device, removably attached to a WCD, that has information received by the remote computing device for determining interoperability with the WCD for determining whether the first device is a regulated medical device, determining a classification, and responsive to the classification, displaying on a display, information from the first device in accordance to a regulated device compliance rule upon confirming the first device is interoperable with the WCD are not conventionally relied upon in wearable cardioverter defibrillators and are therefore allowable over the prior art.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Volosin et al. (US 20190282178)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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