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 Arguments
Claims 1-113, 115-116, 120, 123, and 127 are cancelled. Claims 134-136 are new. Claims 114, 117-119, 121-122, 124-126, 128-136 are pending in this action.
Specification
Applicant’s arguments, filed 02/23/2026, with respect to the objection to the Specification have been fully considered and are persuasive. The specification objection of 10/22/2025 has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments, filed 02/23/2026, with respect to the 35 USC § 103 rejections have been fully considered and are persuasive in view of the amendments. The 35 USC § 103 rejections of 10/22/2025 has been withdrawn.
Claim Rejections - 35 USC § 101
Applicant's arguments filed 02/23/2026 have been fully considered but they are not persuasive. As stated in the rejection below, claim 114 is directed to abstract ideas (mental processes), where nothing in the claim elements precludes the steps from practically being performed in the human mind or by a human using pen and paper (i.e. analyze, identify, determine), which as stated below can be performed in the mind but for the recitation of generic computer elements. Since there is no treatment delivered to treat a particular condition in the claims, nor any additional elements that integrate the abstract ideas into practical application, or amount to significantly more than the abstract idea (mental processes) itself, claim 114, and subsequently 117-119, 121-122, 124-126, 128-136 are directed abstract ideas without significantly more. Additional elements of a wearable garment, a plurality of ECG electrodes, and at least one non-ECG physiological sensor and controller as stated in the claims as well as a remote server, memory and a processor are well-understood, routine and conventional elements and merely define the field of use for the current invention by generally linking mental processes to generic computer elements as a tool to execute the abstract ideas, and merely appending abstract ideas, or mental processes, to be performed on generic computer elements and/or well-understood, routine and conventional elements in the art is not considered practical application. Regarding the amendment, “…wherein the output comprises an indication that the patient shows no cardiotoxicity risk or an indication that the patient shows a cardiotoxicity risk”, this is merely defining the additional element of “…generate an output…” as an additional post-solution activity step that is merely performed after the primary step of determining cardiotoxicity status, and does not add any meaningful limitation to the claim, and is further not considered practical application. As such, these additional elements are merely nominal or tangential additions to the claims as they do not impose any meaningful limits on the claim, specifically on practicing the abstract ideas, see MPEP 2106.05(g) Insignificant Extra-Solution Activity.
Ultimately, the system of claims 114, 117-119, 121-122, 124-126, 128-136 are directed to abstract ideas, specifically mental processes, which can be performed by a human or by a human with pen and paper, but for the recitation of generic computer elements using well-understood, routine and conventional additional elements to perform the abstract ideas, or mental processes, thus merely defining the field of use of the abstract ideas, which does not amount to significantly more than the abstract ideas, and does not include practical treatment application as a result of the cardiotoxicity status to treat a particular condition. Thus, the present claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. When looked at individually and as a whole, the claim limitations are determined to be an abstract idea without significantly more, and therefore claims 114, 117-119, 121-122, 124-126, 128-136 are not patent eligible under 35 USC § 101.
Information Disclosure Statement
The information disclosure statement(s) filed January 09, 2024 and January 29, 2024 has/have been considered by the Examiner.
Claim Objections
Claims 121-122 are objected to because of the following informalities:
Claims 121-122 depend on claim 120 which has been CANCELED. Appropriate correction is required.
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 114, 117-119, 121-122, 124-126, 128-136 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter (abstract ideas) without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Step 1):
Claims 114, 117-119, 121-122, 124-126, 128-136 are directed to a system, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Step 2a) Prong One:
Independent claim 114 recites:
114. A wearable cardiotoxicity monitoring system for monitoring cardiotoxicity biosignal markers in oncology patients, comprising: a wearable cardiotoxicity monitoring device configured for long-term, continuous wear by a patient, comprising a garment configured to be worn around the patient's torso; a plurality of externally applied biosignal sensors configured to sense one or more biosignals from the patient, the plurality of externally applied biosignal sensors comprising a plurality of ECG electrodes configured to sense one or more electrical signals indicative of ECG activity from a skin surface of the patient, and at least one non-ECG physiological sensor configured to sense a non-ECG biosignal of the patient, wherein at least a portion of the plurality of applied biosignal sensors are configured to be removably mounted into the garment, and a controller operationally coupled to the plurality of externally applied biosignal sensors, the controller configured to transmit biosignal-based data based on the one or more sensed biosignals to a remote server, wherein the biosignal-based data comprises an ECG of the patient; and the remote server in communication with the wearable cardiotoxicity monitoring device, comprising a memory implemented in a non-transitory media, and a processor in communication with the memory, the processor configured to receive the biosignal-based data from the wearable cardiotoxicity monitoring device; analyze the biosignal-based data from the wearable cardiotoxicity monitoring device to identify at least one cardiotoxicity biosignal marker associated with heart failure caused by at least one of chemotherapy cardiotoxicity or radiation therapy cardiotoxicity, wherein the at least one cardiotoxicity biosignal marker comprises at least a QT interval duration derived from the ECG of the patient; determine a current status of cardiotoxicity in the patient based on the at least one cardiotoxicity biosignal marker at least by identifying whether the QT interval duration transgresses at least one predetermined QT interval duration threshold, wherein the at least one predetermined QT interval duration threshold is based on a gender of the patient; and generate an output based on whether the QT interval duration transgresses the at least one predetermined QT interval duration threshold, wherein the output comprises an indication that the patient shows no cardiotoxicity risk or an indication that the patient shows a cardiotoxicity risk.
Independent claim 114 is directed to MENTAL PROCESSES in the analyze, identify and determine steps, where nothing in the claim elements precludes the steps from practically being performed in the human mind or by a human using pen and paper. In the instant case, a person could mentally analyze biosignals by mentally examining and study the signals to extract, transform or conclude something form the signal. A person could mentally identify by observing data (i.e. biosignal markers) and mentally indicate or designate something. A person could then mentally determine something (i.e. cardiotoxicity status) by mentally ascertaining or deliberating as a result of observing something, such as biosignal data.
Dependent claims 117-119, 121-122, 124-126, 128-136 contain no additional elements that integrate the abstract ideas into practical application, or amount to significantly more than the abstract idea itself. Dependent claims 117-119, 121-122, 124-126, 128-136 further define the abstract ideas (mental processes) in identifying and determining, and do not amount to significantly more than the abstract idea itself. Dependent claims 125, 128, 130, 133-135 are all further directed to mental processes (i.e. analyzing, identifying and determining). Accordingly, the dependent claims 117-119, 121-122, 124-126, 128-136 are also directed to non-statutory subject matter.
Step 2a) Prong Two:
This judicial exception is not integrated into a practical application because mere instruction to implement on a computer, or merely using a computer as a tool to perform the abstract idea, adding insignificant extra solution activity, and/or generally linking the use of the abstract idea to a technological environment or field of use is not considered integration into a practical application. The Court defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
This judicial exception is not integrated into a practical application because claims 114, 117-119, 121-122, 124-126, 128-136 do not disclose using the result of the mental process steps (i.e. identify and determine), for prophylactic treatment of a particular medical condition under MPEP 2106.05(e). In the instant case, there is no specific treatment in the form of stimulation/pacing pulses, drug therapy, or other forms of treatment that is ultimately used to treat a particular condition as a result of the mental process steps of identifying one cardiotoxicity biosignal marker, and determining a current status of cardiotoxicity. There is no specific treatment delivered to a patient to treat a particular condition that is specified in the claims, but is only directed to a form of simple data transmission (i.e. outputting or generating an output), which is considered an insignificant extra-solution activity as a form of data to be manipulated, see MPEP 2106.05(g) Insignificant Extra-Solution Activity. Furthermore, the added limitation of, “…wherein the output comprises an indication that the patient shows no cardiotoxicity risk or an indication that the patient shows a cardiotoxicity risk” in claim 114 is merely defining the additional element of “…generate an output…” as an additional post-solution activity step that is merely performed after the primary step of determining cardiotoxicity status, and does not add any meaningful limitation to the claim. As such, these additional elements are merely nominal or tangential additions to the claims as they do not impose any meaningful limits on the claim, see MPEP 2106.05(g) Insignificant Extra-Solution Activity. Accordingly, claims 114, 117-119, 121-122, 124-126, 128-136 do not disclose using the result of the mental processes steps for prophylactic treatment of a particular medical condition under MPEP 2106.05(e).
This judicial exception is not integrated into a practical application because claims 114, 117-119, 121-122, 124-126, 128-136 do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Specifically, the claims recite the additional elements of a wearable garment, a plurality of ECG electrodes, and at least one non-ECG physiological sensor and controller, of which are well-understood, routine and conventional in the art. Additional elements further include a remote server, memory and a processor, but these elements have not been described with sufficient detail to constitute an improvement in the tech field, and as such these features merely define the field of use for the current invention by generally linking mental processes to generic computer elements as a tool to execute the abstract ideas (mental processes). By failing to explain how these elements are different from conventional computer elements, it is reasonable that the broadest reasonable interpretation of the additional elements is just a conventional computer performing generic functions (e.g., data analysis and data transfer). Conventional computer elements performing basic data analysis is directed to the components of a system amounting to merely field of use type limitations and/or extra solution activity to implement the abstract idea as identified above, and merely including instructions to implement abstract ideas on a computer does not integrate the judicial exception into practical application, see MPEP 2106.04(d) Integration of a Judicial Exception into a Practical Application.
Accordingly, dependent claims 117-119, 121-122, 124-126, 128-136 do not recite additional elements which practically integrate the judicial exception(s) of the current invention.
Step 2b)
Step 2B in the analysis requires us to determine whether the claims do significantly more than
simply describe that abstract method. Mayo, 132 S. Ct. at 1297. We must examine the limitations of the
claims to determine whether the claims contain an "inventive concept" to "transform" the claimed
abstract idea into patent-eligible subject matter. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at
1294, 1298). The transformation of an abstract idea into patent-eligible subject matter "requires 'more
than simply stat[ing] the [abstract idea] while adding the words 'apply it."' Id. (quoting Mayo, 132 S. Ct.
at 1294) (alterations in original). "A claim that recites an abstract idea must include 'additional features'
to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].'" Id.
(quoting Mayo, 132 S. Ct. at 1297) (alterations in original). Those "additional features" must be more
than "well-understood, routine, conventional activity." Mayo, 132 S. Ct. at 1298.
The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited wearable cardiotoxicity monitoring device, ECG electrodes, at least one non-ECG physiological sensor and controller are well-understood, routine and conventional in the art, while the server, memory and processor is/are recognized as generic computer interfaces and generic computers (or computer components), because the claims do not describe these features as having distinguishing element(s) over their generic counterparts, which are well-understood, routine and conventional activities previously known in the industry.
As shown in the reference as taught by Wen (US 20200057050 A1 – hereinafter Wen) Wen teaches a wearable cardiotoxicity monitoring system (Wen paragraph 0062 – “In an example, the AMD 202 can include an implantable medical device (IMD), a subcutaneous or leadless medical device, a wearable or external medical device”; paragraph 0063 – “The AMD 202 can include one or more sensors configured to receive physiologic information of a patient 201. The received physiologic information may include sensor measurements indicative of particular medical conditions, patient signs or symptoms, or other physiologic responses to immunotherapy toxicity (e.g., respiratory, cardiovascular…”), and further includes ECG electrodes (Wen paragraph 0067), respiration sensor (Wen paragraph 0063), controller for data transmission (Wen paragraph 0086), as well as the server (Wen paragraph 0096) with memory and processor (Wen paragraph 0097), while also generating an output (Wen paragraph 0014).
Additionally, Tran (US 20070276270 A1 – hereinafter Tran) similarly teaches wearable system for monitoring toxicity markers (Tran figures 6A-6B; paragraph 0487) comprising a respiration sensor (Tran paragraph 0062), server with memory and processor (Tran paragraphs 0186, 0235), ECG electrodes (Tran paragraph 0341), control for transmitting data (Tran paragraph 0055) as well as generation of an output based on data (Tran paragraph 0208).
Thus, the present claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. When looked at individually and as a whole, the claim limitations are determined to be an abstract idea without significantly more, and thus claims 114, 117-119, 121-122, 124-126, 128-136 are not patent eligible under 35 USC § 101.
Allowable Subject Matter
Claims 114, 117-119, 121-122, 124-126, 128-136 are allowed over the prior art.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record, including the previously cited combination of Weinstein (US 20210244282 A1 – hereinafter Weinstein) in view of Wen (US 20200057050 A1 – hereinafter Wen) does not anticipate and/or render obvious to claim 114 in its entirety, including at least to the wearable cardiotoxicity monitoring system for monitoring cardiotoxicity biosignal markers in oncology patients, comprising a processor configured to determine a current status of cardiotoxicity in the patient based on the at least one cardiotoxicity biosignal marker at least by identifying whether the QT interval duration transgresses at least one predetermined QT interval duration threshold, wherein the at least one predetermined QT interval duration threshold is based on a gender of the patient; and generate an output based on whether the QT interval duration transgresses the at least one predetermined QT interval duration threshold, wherein the output comprises an indication that the patient shows no cardiotoxicity risk or an indication that the patient shows a cardiotoxicity risk, among the other limitations as claimed in claim 114. Dependent claims 117-119, 121-122, 124-126, 128-136 are further allowed for the same reasons.
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 Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796