DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicant
2. This communication is in response to the communication filed 7/10/2025. Claims 1-20 are currently pending.
Claim Rejections - 35 USC § 101
3. 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.
3.1. Claims 1-20 are rejected under 35 U.S.C. § 101 because while the claims (1) are to a statutory category (i.e., process, machine, manufacture or composition of matter, the claims (2A1) recite an abstract idea (i.e., a law of nature, a natural phenomenon); (2A2) do not recite additional elements that integrate the abstract idea into a practical application; and (2B) are not directed to significantly more than the abstract idea itself.
In regard to (1), the claims are to a statutory category (i.e., statutory categories including a process, machine, manufacture or composition of matter). In particular, independent claims 1 and 13, and their respective dependent claims are directed, in part, to a system and method for managing a patient at risk of cardiac arrhythmia.
In regard to (2A1), the claims, as a whole, recite and are directed to an abstract idea because the claims include one or more limitations that correspond to an abstract idea including mental processes and/or certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. For example, independent claims 1 and 13, as a whole, are directed to managing a patient at risk of cardiac arrhythmia by, inter alia, obtaining physiological information from a patient, determining arrhythmia risk for the patient based on the patient information, initiating or adjusting arrhythmia management for the patient based on the risk, generating a recommendation for the patient, etc. which are human activities and/or interactions and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. The dependent claims include all of the limitations of their respective independent claims and thus are directed to the same abstract idea identified for the independent claims but further describe the elements and/or recite field of use limitations.
Furthermore, the claims are also directed to an abstract idea because the claims, except for certain limitations (* identified below in bold), under the broadest reasonable interpretation, can be reasonably and practically performed in the human mind and/or with pen and paper using observation, evaluation, judgment and/or opinion. That is, other than reciting the certain additional elements, nothing in the claims precludes the limitations from being practically performed in the mind and/or with pen and paper. For example, a person is capable of reasonably and practically performing the steps of the process (e.g., determining a patient’s arrhythmia risk, generating a recommendation for the patient, etc.), as set forth below, using observation, evaluation, judgment and/or opinion.
CLAIM 1:
A medical-device system for managing a patient at a risk of cardiac arrhythmia, the system comprising:
a risk stratifier circuit configured to, in an absence of prior and present atrial arrhythmia, determine a composite arrhythmia risk of the patient developing a future atrial arrhythmia using a trained computational model and physiological information sensed from the patient; and
a controller circuit configured to, based at least in part on the determined composite arrhythmia risk, automatically initiate or adjust an arrhythmia management process or to generate a recommendation on a user interface for initiating or adjusting the arrhythmia management process.
CLAIM 2
The medical-device system of claim 1, wherein the controller circuit is configured to generate the recommendation for initiating or adjusting the arrhythmia management process including a recommendation for initiating or titrating antiarrhythmic or anticoagulation medication based on the determined composite arrhythmia risk.
CLAIM 3
The medical-device system of claim 2, wherein the determined composite arrhythmia risk is represented by a numerical risk score, wherein the recommendation for initiating or titrating the antiarrhythmic or
anticoagulation medication includes a recommendation for initiating or increasing dosage of the antiarrhythmic or anticoagulation medication when the numerical risk score is above a threshold, and a recommendation for withholding or decreasing the dosage of the antiarrhythmic or anticoagulation medication when numerical risk score is below the threshold.
CLAIM 4
The medical-device system of claim 1, wherein the controller circuit is configured to automatically initiate or adjust the arrhythmia management process including to automatically initiate or titrate drug infusion dosage of a drug pump associated with the patient based on the determined composite arrhythmia risk.
CLAIM 5
The medical-device system of claim 1, wherein the controller circuit is configured to automatically initiate or adjust the arrhythmia management process including to automatically initiate or adjust an electrostimulation therapy via an ambulatory medical device associated with the patient based on the determined composite arrhythmia risk.
CLAIM 6
The medical-device system of claim 1, wherein the controller circuit is configured to generate the recommendation for initiating or adjusting the arrhythmia management process including a recommendation for patient candidacy for receiving an ambulatory cardiac monitoring or therapy device based on the determined composite arrhythmia risk.
CLAIM 7
The medical-device system of claim 1, further comprising sensing circuitry operatively coupled to one or more sensors and configured to collect the physiological information, wherein the controller circuit is configured to automatically initiate or adjust the arrhythmia management process including to automatically adjust collection of the physiological information via the sensing circuitry based on the determined composite arrhythmia risk.
CLAIM 8
The medical-device system of claim 7, wherein the one or more sensors includes at least one of: a cardiac electrical activity sensor; a heart sound or cardiac acceleration sensor; a cardiac or thoracic impedance sensor; or a respiratory sensor.
CLAIM 9
The medical-device system of claim 7, wherein to automatically adjust the collection of physiological information includes to selectively activate or deactivate at least one sensor to acquire the physiological information based on the determined composite arrhythmia risk.
CLAIM 10
The medical-device system of claim 7, wherein to automatically adjust the collection of physiological information includes to adjust a data acquisition duration or a data acquisition frequency based on the determined composite arrhythmia risk.
CLAIM 11
The medical-device system of claim 1, wherein the trained computational model include a trained machine-learning model.
CLAIM 12
The medical-device system of claim 1, wherein the risk stratifier circuit is configured to determine the composite arrhythmia risk further using one or more of patient demographic information or patient medical history information.
CLAIM 13
A method of managing a patient at a risk of cardiac arrhythmia via a medical-device system, the method comprising:
receiving physiological information sensed from the patient;
in an absence of prior and present atrial arrhythmia, determining a composite risk of the patient developing a future atrial arrhythmia using a trained computational model and the received physiological information; and
based at least in part on the determined composite arrhythmia risk, automatically initiating or adjusting, or generating a recommendation on a user interface for initiating or titrating, an arrhythmia management process via a controller circuit.
CLAIM 14
The method of claim 13, wherein the recommendation for initiating or titrating the arrhythmia management process includes a recommendation for initiating or titrating antiarrhythmic or anticoagulation medication based on the determined composite arrhythmia risk.
CLAIM 15
The method of claim 14, wherein the determined composite arrhythmia risk is represented by a numerical risk score, wherein the recommendation for initiating or titrating the antiarrhythmic or anticoagulation medication includes a recommendation for initiating or increasing dosage of the antiarrhythmic or anticoagulation medication when the numerical risk score is above a threshold, and a recommendation for withholding or decreasing the dosage of the antiarrhythmic or anticoagulation medication when numerical risk score is below the threshold.
CLAIM 16
The method of claim 13, wherein automatically initiating or adjusting the arrhythmia management process includes automatically initiating or titrating drug infusion dosage via a drug pump associated with the patient based on the determined composite arrhythmia risk.
CLAIM 17
The method of claim 13, wherein automatically initiating or adjusting the arrhythmia management process includes automatically initiating or adjusting an electrostimulation therapy via an ambulatory medical device associated with the patient based on the determined composite arrhythmia risk.
CLAIM 18
The method of claim 13, wherein the recommendation for initiating or titrating the arrhythmia management process includes a recommendation for patient candidacy for receiving an ambulatory cardiac monitoring or therapy device based on the determined composite arrhythmia risk.
CLAIM 19
The method of claim 13, further comprising collecting the physiological information using sensing circuitry operatively coupled to one or more sensors, wherein automatically initiating or adjusting the arrhythmia management process includes automatically adjusting collection of the physiological information based on the determined composite arrhythmia risk.
CLAIM 20
The method of claim 19, wherein automatically adjusting collection of the physiological information includes, based on the determined composite arrhythmia risk, automatically selecting at least one active sensor, or adjusting a data acquisition duration or a data acquisition frequency, for acquiring the physiological information.
* The limitations that are in bold are considered “additional elements” that are further analyzed below in subsequent steps of the 101 analysis. The limitations that are not in bold are abstract and/or can be reasonably and practically performed in the human mind and/or with pen paper.
In regard to (2A2), the claims do not recite additional elements that integrate the abstract idea into a practical application. The additional elements in the claims (i.e., * identified above in bold) do not integrate the abstract idea into a practical application because the additional elements merely add insignificant extra-solution activity to the abstract idea; merely link the use of the judicial exception to a particular technological environment or field of use; and/or simply append technologies and functions, specified at a high level of generality, to the abstract idea (i.e., the additional elements do not amount to more than a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer).
Here, the additional elements (e.g., medical device system, risk stratifier circuit, controller circuit, etc.) are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the abstract idea using generic computer technologies. Moreover, the claims recite “circuit configured to”, “via a medical device system”, etc. devoid of any meaningful technological improvement details and thus, further evidence the additional elements are merely being used to leverage generic technologies to automate what otherwise could be done manually. Accordingly, the 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.
Furthermore, the additional elements do not recite improvements to the functioning of a computer, or to any other technology or technical field—the additional elements merely recite general purpose computer technology; the additional elements do not recite applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition—there is no actual administration of a particular treatment; the additional elements do not recite applying the judicial exception with, or by use of, a particular machine—the additional elements merely recite general purpose computer technology; the additional elements do not recite limitations effecting a transformation or reduction of a particular article to a different state or thing—the additional elements do not recite transformation such as a rubber mold process; the additional elements do not recite applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment—the additional elements merely leverage general purpose computer technology to link the abstract idea to a technological environment.
In regard to (2B), the claims, individually, as a whole and in combination with one another, do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of (A) a generic computer structure(s) that serves to perform computer functions that serve to merely link the abstract idea to a particular technological environment (i.e., computers); and/or (B) functions that are well-understood, routine, and conventional activities previously known to the pertinent industry. Here, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements fall under (A), that is, the additional elements amount to no more than mere instructions to apply the exception using generic computer technologies. Mere instructions to apply an exception using generic computer technologies cannot provide an inventive concept.
Moreover, paragraphs [0101]-[0103] of applicant's specification (US 2025/0339079) recites that the system/method is implemented using a machine, such as, a personal computer, a tablet, a personal digital assistant, a mobile telephone, etc. which are well-known general purpose or generic-type computers and/or technologies. The use of generic computer components recited at a high level of generality to process information through an unspecified processor/computer does not impose any meaningful limit on the computer implementation of the abstract idea. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Furthermore, the additional elements are merely well-known general purpose computers, components and/or technologies that receive, transmit, store, display, generate and otherwise process information which are akin to functions that courts consider well-understood, routine, and conventional activities previously known to the pertinent industry, such as, performing repetitive calculations; receiving or transmitting data over a network; electronic recordkeeping; retrieving and storing information in memory; and sorting information (See, for example, MPEP § 2106).
Therefore, the claims are not patent-eligible under 35 U.S.C. § 101.
Double Patenting
4. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
4.1. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-7, 14 and 18 of U.S. Patent No. 12,369,838 and obviousness via a secondary reference. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined application claim(s) is/are either anticipated by, or would have been obvious over, the reference claim(s) because all of the limitations of claims 1-20 of instant pending patent application 19/265817 correspond to limitations recited in claims 1, 6-7, 14 and 18 of U.S. Patent No. 12,369,838 and obviousness via a secondary reference. The difference between the instant application claims and the patent claims lies in the fact that the patent claim includes more elements and is thus more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). As such, because instant application claims are anticipated by the patent claims, the instant application claims are not patentably distinct from the patent claims. Moreover, any claim limitation differences are not substantively significant and/or are obvious under a broad and reasonable interpretation, as detailed in the comparison chart below.
PENDING CLAIMS (19/265817)
US PATENT 12,369,838
CLAIM 1
A medical-device system for managing a patient at a risk of cardiac arrhythmia, the system comprising:
a risk stratifier circuit configured to, in an absence of prior and present atrial arrhythmia, determine a composite arrhythmia risk of the patient developing a future atrial arrhythmia using a trained computational model and physiological information sensed from the patient; and
a controller circuit configured to, based at least in part on the determined composite arrhythmia risk, automatically initiate or adjust an arrhythmia management process or to generate a recommendation on a user interface for initiating or adjusting the arrhythmia management process.
CLAIM 1
A medical-device system for monitoring a patient at a risk of cardiac arrhythmia, comprising:
a risk stratifier circuit configured to, in an absence of prior and present atrial arrhythmia, determine a composite risk of the patient developing a future atrial arrhythmia using a trained machine-learning model and a plurality of features of physiological information sensed via multiple sensors associated with the patient; and
an arrhythmia monitor circuit configured to adjust an arrhythmia monitoring parameter including to selectively activate or deactivate one or more of the multiple sensors to acquire or process sensor data based at least in part on the composite risk, and to detect an atrial arrhythmia event using the adjusted arrhythmia monitoring parameter.
CLAIM 2
The medical-device system of claim 1, wherein the controller circuit is configured to generate the recommendation for initiating or adjusting the arrhythmia management process including a recommendation for initiating or titrating antiarrhythmic or anticoagulation medication based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 3
The medical-device system of claim 2, wherein the determined composite arrhythmia risk is represented by a numerical risk score, wherein the recommendation for initiating or titrating the antiarrhythmic or anticoagulation medication includes a recommendation for initiating or increasing dosage of the antiarrhythmic or anticoagulation medication when the numerical risk score is above a threshold, and a recommendation for withholding or decreasing the dosage of the antiarrhythmic or anticoagulation medication when numerical risk score is below the threshold.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 4
The medical-device system of claim 1, wherein the controller circuit is configured to automatically initiate or adjust the arrhythmia management process including to automatically initiate or titrate drug infusion dosage of a drug pump associated with the patient based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 5
The medical-device system of claim 1, wherein the controller circuit is configured to automatically initiate or adjust the arrhythmia management process including to automatically initiate or adjust an electrostimulation therapy via an ambulatory medical device associated with the patient based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 6
The medical-device system of claim 1, wherein the controller circuit is configured to generate the recommendation for initiating or adjusting the arrhythmia management process including a recommendation for patient candidacy for receiving an ambulatory cardiac monitoring or therapy device based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 7
The medical-device system of claim 1, further comprising sensing circuitry operatively coupled to one or more sensors and configured to collect the physiological information, wherein the controller circuit is configured to automatically initiate or adjust the arrhythmia management process including to automatically adjust collection of the physiological information via the sensing circuitry based on the determined composite arrhythmia risk.
CLAIM 1
A medical-device system for monitoring a patient at a risk of cardiac arrhythmia, comprising:
a risk stratifier circuit configured to, in an absence of prior and present atrial arrhythmia, determine a composite risk of the patient developing a future atrial arrhythmia using a trained machine-learning model and a plurality of features of physiological information sensed via multiple sensors associated with the patient; and
an arrhythmia monitor circuit configured to adjust an arrhythmia monitoring parameter including to selectively activate or deactivate one or more of the multiple sensors to acquire or process sensor data based at least in part on the composite risk, and to detect an atrial arrhythmia event using the adjusted arrhythmia monitoring parameter.
CLAIM 8
The medical-device system of claim 7, wherein the one or more sensors includes at least one of: a cardiac electrical activity sensor; a heart sound or cardiac acceleration sensor; a cardiac or thoracic impedance sensor; or a respiratory sensor.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 9
The medical-device system of claim 7, wherein to automatically adjust the collection of physiological information includes to selectively activate or deactivate at least one sensor to acquire the physiological information based on the determined composite arrhythmia risk.
CLAIM 1
A medical-device system for monitoring a patient at a risk of cardiac arrhythmia, comprising:
a risk stratifier circuit configured to, in an absence of prior and present atrial arrhythmia, determine a composite risk of the patient developing a future atrial arrhythmia using a trained machine-learning model and a plurality of features of physiological information sensed via multiple sensors associated with the patient; and
an arrhythmia monitor circuit configured to adjust an arrhythmia monitoring parameter including to selectively activate or deactivate one or more of the multiple sensors to acquire or process sensor data based at least in part on the composite risk, and to detect an atrial arrhythmia event using the adjusted arrhythmia monitoring parameter.
CLAIM 10
The medical-device system of claim 7, wherein to automatically adjust the collection of physiological information includes to adjust a data acquisition duration or a data acquisition frequency based on the determined composite arrhythmia risk.
CLAIM 6
The medical-device system of claim 5, wherein to adjust the data acquisition plan includes to increase a data acquisition duration in response to the composite risk exceeding a risk threshold.
CLAIM 7
The medical-device system of claim 5, wherein to adjust the data acquisition plan includes to increase a data acquisition frequency in response to the composite risk exceeding a risk threshold.
CLAIM 11
The medical-device system of claim 1, wherein the trained computational model include a trained machine-learning model.
CLAIM 1
A medical-device system for monitoring a patient at a risk of cardiac arrhythmia, comprising:
a risk stratifier circuit configured to, in an absence of prior and present atrial arrhythmia, determine a composite risk of the patient developing a future atrial arrhythmia using a trained machine-learning model and a plurality of features of physiological information sensed via multiple sensors associated with the patient; and
an arrhythmia monitor circuit configured to adjust an arrhythmia monitoring parameter including to selectively activate or deactivate one or more of the multiple sensors to acquire or process sensor data based at least in part on the composite risk, and to detect an atrial arrhythmia event using the adjusted arrhythmia monitoring parameter.
CLAIM 12
The medical-device system of claim 1, wherein the risk stratifier circuit is configured to determine the composite arrhythmia risk further using one or more of patient demographic information or patient medical history information.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 13
A method of managing a patient at a risk of cardiac arrhythmia via a medical-device system, the method comprising:
receiving physiological information sensed from the patient;
in an absence of prior and present atrial arrhythmia, determining a composite risk of the patient developing a future atrial arrhythmia using a trained computational model and the received physiological information; and
based at least in part on the determined composite arrhythmia risk, automatically initiating or adjusting, or generating a recommendation on a user interface for initiating or titrating, an arrhythmia management process via a controller circuit.
CLAIM 14
A method of monitoring a patient at a risk of cardiac arrhythmia, the method comprising:
receiving physiological information sensed via multiple sensors associated with the patient;
in an absence of prior and present atrial arrhythmia, determining a composite risk of the
patient developing a future atrial arrhythmia using a trained machine-learning model and a plurality of features of the received physiological information;
via an arrhythmia monitor circuit, adjusting an arrhythmia monitoring parameter including selectively activating or deactivate one or more of the multiple sensors to acquire or process sensor data based at least in part on the composite risk; and
detecting an atrial arrhythmia event using the adjusted arrhythmia monitoring parameter.
CLAIM 14
The method of claim 13, wherein the recommendation for initiating or titrating the arrhythmia management process includes a recommendation for initiating or titrating antiarrhythmic or anticoagulation medication based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 15
The method of claim 14, wherein the determined composite arrhythmia risk is represented by a numerical risk score, wherein the recommendation for initiating or titrating the antiarrhythmic or anticoagulation medication includes a recommendation for initiating or increasing dosage of the antiarrhythmic or anticoagulation medication when the numerical risk score is above a threshold, and a recommendation for withholding or decreasing the dosage of the antiarrhythmic or anticoagulation medication when numerical risk score is below the threshold.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 16
The method of claim 13, wherein automatically initiating or adjusting the arrhythmia management process includes automatically initiating or titrating drug infusion dosage via a drug pump associated with the patient based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 17
The method of claim 13, wherein automatically initiating or adjusting the arrhythmia management process includes automatically initiating or adjusting an electrostimulation therapy via an ambulatory medical device associated with the patient based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 18
The method of claim 13, wherein the recommendation for initiating or titrating the arrhythmia management process includes a recommendation for patient candidacy for receiving an ambulatory cardiac monitoring or therapy device based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 19
The method of claim 13, further comprising collecting the physiological information using sensing circuitry operatively coupled to one or more sensors, wherein automatically initiating or adjusting the arrhythmia management process includes automatically adjusting collection of the physiological information based on the determined composite arrhythmia risk.
CLAIM 14
A method of monitoring a patient at a risk of cardiac arrhythmia, the method comprising:
receiving physiological information sensed via multiple sensors associated with the patient;
in an absence of prior and present atrial arrhythmia, determining a composite risk of the
patient developing a future atrial arrhythmia using a trained machine-learning model and a plurality of features of the received physiological information;
via an arrhythmia monitor circuit, adjusting an arrhythmia monitoring parameter including selectively activating or deactivate one or more of the multiple sensors to acquire or process sensor data based at least in part on the composite risk; and
detecting an atrial arrhythmia event using the adjusted arrhythmia monitoring parameter.
CLAIM 20
The method of claim 19, wherein automatically adjusting collection of the physiological information includes, based on the determined composite arrhythmia risk, automatically selecting at least one active sensor, or adjusting a data acquisition duration or a data acquisition frequency, for acquiring the physiological information.
CLAIM 18
The method of claim 17, wherein adjusting the data acquisition plan includes increasing a data acquisition duration or a data acquisition frequency in response to the composite risk exceeding a risk threshold.
4.2. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-10, 12 and 14 of U.S. Patent No. 11,602,398 and obviousness via a secondary reference. Although the claims at issue are not identical, they are not patentably distinct from each other because the examined application claim(s) is/are either anticipated by, or would have been obvious over, the reference claim(s) because all of the limitations of claims 1-20 of instant pending patent application 19/265817 correspond to limitations recited in claims 1, 9-10, 12 and 14 of U.S. Patent No. 11,602,298 and obviousness via a secondary reference. The difference between the instant application claims and the patent claims lies in the fact that the patent claim includes more elements and is thus more specific. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the instant application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). As such, because instant application claims are anticipated by the patent claims, the instant application claims are not patentably distinct from the patent claims. Moreover, any claim limitation differences are not substantively significant and/or are obvious under a broad and reasonable interpretation, as detailed in the comparison chart below.
PENDING CLAIMS (19/265817)
US PATENT 11,602,298
CLAIM 1
A medical-device system for managing a patient at a risk of cardiac arrhythmia, the system comprising:
a risk stratifier circuit configured to, in an absence of prior and present atrial arrhythmia, determine a composite arrhythmia risk of the patient developing a future atrial arrhythmia using a trained computational model and physiological information sensed from the patient; and
a controller circuit configured to, based at least in part on the determined composite arrhythmia risk, automatically initiate or adjust an arrhythmia management process or to generate a recommendation on a user interface for initiating or adjusting the arrhythmia management process.
CLAIM 1
A system for assessing a cardiac arrhythmia risk of a patient, the system comprising:
an arrhythmia predictor circuit configured to:
receive physiologic information sensed from the patient including two or more of heart sounds (HS) information, thoracic impedance information, or respiration information; and
in an absence of prior and present atrial tachyarrhythmia, determine a composite atrial arrhythmia risk of the patient developing a future atrial tachyarrhythmia, the determination including applying a trained machine-learning model to a plurality of signal metrics obtained from two or more of the HS information, the thoracic impedance information, or the respiration information.
CLAIM 9
The system of claim 1, comprising a therapy circuit configured to generate or adjust a therapy according to the composite atrial arrhythmia risk.
CLAIM 2
The medical-device system of claim 1, wherein the controller circuit is configured to generate the recommendation for initiating or adjusting the arrhythmia management process including a recommendation for initiating or titrating antiarrhythmic or anticoagulation medication based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 3
The medical-device system of claim 2, wherein the determined composite arrhythmia risk is represented by a numerical risk score, wherein the recommendation for initiating or titrating the antiarrhythmic or anticoagulation medication includes a recommendation for initiating or increasing dosage of the antiarrhythmic or anticoagulation medication when the numerical risk score is above a threshold, and a recommendation for withholding or decreasing the dosage of the antiarrhythmic or anticoagulation medication when numerical risk score is below the threshold.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 4
The medical-device system of claim 1, wherein the controller circuit is configured to automatically initiate or adjust the arrhythmia management process including to automatically initiate or titrate drug infusion dosage of a drug pump associated with the patient based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 5
The medical-device system of claim 1, wherein the controller circuit is configured to automatically initiate or adjust the arrhythmia management process including to automatically initiate or adjust an electrostimulation therapy via an ambulatory medical device associated with the patient based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 6
The medical-device system of claim 1, wherein the controller circuit is configured to generate the recommendation for initiating or adjusting the arrhythmia management process including a recommendation for patient candidacy for receiving an ambulatory cardiac monitoring or therapy device based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 7
The medical-device system of claim 1, further comprising sensing circuitry operatively coupled to one or more sensors and configured to collect the physiological information, wherein the controller circuit is configured to automatically initiate or adjust the arrhythmia management process including to automatically adjust collection of the physiological information via the sensing circuitry based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 8
The medical-device system of claim 7, wherein the one or more sensors includes at least one of: a cardiac electrical activity sensor; a heart sound or cardiac acceleration sensor; a cardiac or thoracic impedance sensor; or a respiratory sensor.
CLAIM 1
A system for assessing a cardiac arrhythmia risk of a patient, the system comprising:
an arrhythmia predictor circuit configured to:
receive physiologic information sensed from the patient including two or more of heart sounds (HS) information, thoracic impedance information, or respiration information; and
in an absence of prior and present atrial tachyarrhythmia, determine a composite atrial arrhythmia risk of the patient developing a future atrial tachyarrhythmia, the determination including applying a trained machine-learning model to a plurality of signal metrics obtained from two or more of the HS information, the thoracic impedance information, or the respiration information.
CLAIM 9
The medical-device system of claim 7, wherein to automatically adjust the collection of physiological information includes to selectively activate or deactivate at least one sensor to acquire the physiological information based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 10
The medical-device system of claim 7, wherein to automatically adjust the collection of physiological information includes to adjust a data acquisition duration or a data acquisition frequency based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 11
The medical-device system of claim 1, wherein the trained computational model include a trained machine-learning model.
CLAIM 1
A system for assessing a cardiac arrhythmia risk of a patient, the system comprising:
an arrhythmia predictor circuit configured to:
receive physiologic information sensed from the patient including two or more of heart sounds (HS) information, thoracic impedance information, or respiration information; and
in an absence of prior and present atrial tachyarrhythmia, determine a composite atrial arrhythmia risk of the patient developing a future atrial tachyarrhythmia, the determination including applying a trained machine-learning model to a plurality of signal metrics obtained from two or more of the HS information, the thoracic impedance information, or the respiration information.
CLAIM 12
The medical-device system of claim 1, wherein the risk stratifier circuit is configured to determine the composite arrhythmia risk further using one or more of patient demographic information or patient medical history information.
CLAIM 10
The system of claim 1, wherein the arrhythmia predictor circuit is configured to determine the composite atrial arrhythmia risk further using patient demographic information or patient medical history information.
CLAIM 13
A method of managing a patient at a risk of cardiac arrhythmia via a medical-device system, the method comprising:
receiving physiological information sensed from the patient;
in an absence of prior and present atrial arrhythmia, determining a composite risk of the patient developing a future atrial arrhythmia using a trained computational model and the received physiological information; and
based at least in part on the determined composite arrhythmia risk, automatically initiating or adjusting, or generating a recommendation on a user interface for initiating or titrating, an arrhythmia management process via a controller circuit.
CLAIM 12
A method of assessing a cardiac arrhythmia risk of a patient, the method comprising, via an arrhythmia predictor circuit of a medical-device system:
receiving physiologic information sensed from the patient including two or more of heart sounds (HS) information, thoracic impedance information, or respiration information; and
in an absence of prior and present atrial tachyarrhythmia, determining a composite atrial arrhythmia risk of the patient developing a future atrial tachyarrhythmia, the determination including applying a trained machine-learning model to a plurality of signal metrics obtained from two or more of the HS information, the thoracic impedance information, or the respiration information.
CLAIM 14
The method of claim 12, comprising generating or adjusting a therapy according to the composite atrial arrhythmia risk.
CLAIM 14
The method of claim 13, wherein the recommendation for initiating or titrating the arrhythmia management process includes a recommendation for initiating or titrating antiarrhythmic or anticoagulation medication based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 15
The method of claim 14, wherein the determined composite arrhythmia risk is represented by a numerical risk score, wherein the recommendation for initiating or titrating the antiarrhythmic or anticoagulation medication includes a recommendation for initiating or increasing dosage of the antiarrhythmic or anticoagulation medication when the numerical risk score is above a threshold, and a recommendation for withholding or decreasing the dosage of the antiarrhythmic or anticoagulation medication when numerical risk score is below the threshold.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 16
The method of claim 13, wherein automatically initiating or adjusting the arrhythmia management process includes automatically initiating or titrating drug infusion dosage via a drug pump associated with the patient based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 17
The method of claim 13, wherein automatically initiating or adjusting the arrhythmia management process includes automatically initiating or adjusting an electrostimulation therapy via an ambulatory medical device associated with the patient based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 18
The method of claim 13, wherein the recommendation for initiating or titrating the arrhythmia management process includes a recommendation for patient candidacy for receiving an ambulatory cardiac monitoring or therapy device based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 19
The method of claim 13, further comprising collecting the physiological information using sensing circuitry operatively coupled to one or more sensors, wherein automatically initiating or adjusting the arrhythmia management process includes automatically adjusting collection of the physiological information based on the determined composite arrhythmia risk.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
CLAIM 20
The method of claim 19, wherein automatically adjusting collection of the physiological information includes, based on the determined composite arrhythmia risk, automatically selecting at least one active sensor, or adjusting a data acquisition duration or a data acquisition frequency, for acquiring the physiological information.
It is submitted that his feature would be rendered obvious via a secondary reference and thus, is rejected under double patenting.
Conclusion
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Tomaszewski whose telephone number is (313)446-4863. The examiner can normally be reached M-F 5:30 am - 2:30 pm.
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/MICHAEL TOMASZEWSKI/Primary Examiner, Art Unit 3681
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