DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/25/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 06/25/2026. As directed by the amendment: Claims 1-4 and 7 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 Claims 10-13 and 15-20 were previously withdrawn due to a Restriction Requirement.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, filed 06/25/2026, with respect to 35 U.S.C. 112(b) 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 The rejection of the has been withdrawn.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 8-12, filed 06/25/2026, regarding 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant later argues on pages 9- that “Therefore, responsive to the classification of the device, the remote computing device controls a display device to display information while maintaining integrity under the regulated device compliance rules for the medical device and thus, a treatment is provided to the patient wearing the medical device by analyzing the displayed information as recited in amended independent claim 1 and its dependent claims are directed to a system for treatment.
In particular, the information displayed on the display device while abiding the compliance rules of the information source device is used to provide treatment to the patient wearing the medical device. Implementation of Applicant's claimed technology constitutes a particular treatment or prophylaxis for a medical condition/event, which has been held to be patentable subject matter. See, e.g., Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1066-68 (Fed. Cir. 2011). See also Vanda Pharm. Inc. v. West-Ward Pharm. Int'l Ltd., 887 F.3d 1117, 1135 (Fed. Cir. 2018) (holding claims to the practical application of the natural relationships between iloperidone, CYP2D6 metabolism, and QTec prolongation to treat schizophrenia, not merely the recognition of those relationships, to be patent eligible at Mayo/Alice step 1 (USPTO Step 2A)), and USPTO Vanda Memorandum.”
Examiner disagrees because Applicant fails to recite specific treatments that are displayed and individualized for each user. Looking at Example 49 of the July 2024 SME Examples, claim 1 is patent ineligible because “Although this limitation indicates that a treatment is to be administered, it does not provide any information as to how the patient is to be treated or what the treatment is, but instead covers any possible treatment that a medical professional decides to administer to the patient. As such, there are no meaningful constraints on the administering step such that the particular treatment or prophylaxis consideration would apply because it is not limited to any particular manner or type of treatment.” The instant claims suffer the same issue as “treatment” covers any possible treatment. Furthermore, the claims are directed to the interoperability of the devices, so the treatment has an insignificant relationship to the judicial exception to a particular technological environment or field of use.
Applicant then argues on page 11 that “claim 1 achieves a concrete technological improvement in the field of displaying information of a wearable medical/non-medical device. Accordingly, Applicant has shown teachings in the specification that describe a practical implementation and how regulatory compliance is improved and maintained by determining interoperability of the devices or sensors with the wearable health monitoring system, classifying the devices or sensors as a regulated or non-regulated device, and thus controlling an display device to display information from individual devices or sensors based on the determined interoperability and medical device regulations in accordance with the respective classification of each device or sensor to maintain integrity and compliance rules. Further, the displayed information abiding the compliance rule is analyzed and used to provide treatment to a patient. Accordingly, Applicant has established a clear nexus between the claim language and the practical implementation of the alleged judicial exception, along with the improvements to the technology.”
Examiner disagrees because such a classification is occurring in a generic computing system used to implement this abstract idea. The controlling of a display is simply the displaying of data necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity. Applicant fails to recite specific treatments that are displayed and individualized for each user.
Applicant then argues on page 12 that “the Examiner has acknowledged on page 9 of the Office Action that the cited prior arts fail to disclose or suggest the claimed combination of limitations, and furthermore, no prior-art rejection is listed for the claims in the instant office action. This further supports that claim 1 embodies an inventive concept under Step 2B.”
Examiner disagrees, 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." Intellectual Ventures | v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188-89, 209 USPQ at 9). Although the instant claims are not directed to an art rejection, novelty of the claims has no effect on patent eligibility.
Therefore, the rejections of record are maintained.
Claim Objections
Claim 7 is objected to because of the following informalities: Examiner suggests clarifying if the displaying in accordance to the non-regulated device rule is done for the second information or the third information. Examiner notes that based on the limitations of claim 7, the phrase “second information” of line 13 should be amended to recite “third information”. Appropriate correction is required.
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.
Claim 1 recites the limitation "the received information" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, it is unclear if the “confirmation” of interoperability of line 21 is the same or different than the “determining” of interoperability of lines 9-10.
Regarding claim 1, it is unclear what “maintaining integrity” means for the first and second information. The specification and claim do not clarify if the claim is directed to preventing modification, preventing corruption, or preserving data. The phrase “integrity” is therefore ambiguous.
Claim 21 recites the limitation "the information" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-5, 7-9 and 21 are rejected for being dependent on rejected claim 1.
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.
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 “first and second 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)];
- “wherein a treatment is provided to a patient associated with the WCD based on the displayed first information and the displayed second information” is nominal or insignificant relationship to the judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.04(d)(2). Similar to the nominal connection of aspirin administration and the prevention of ketoacidosis (because aspirin does not treat or prevent ketoacidosis), treatment has no bearing on the interoperability of the device, and is a nominal relationship.
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 “first and second 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)];
- “wherein a treatment is provided to a patient associated with the WCD based on the displayed first information and the displayed second information” is nominal or insignificant relationship to the judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.04(d)(2). Similar to the nominal connection of aspirin administration and the prevention of ketoacidosis (because aspirin does not treat or prevent ketoacidosis), treatment has no bearing on the interoperability of the device, and is a nominal relationship.
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.
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
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