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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-9, 21-29, and 31, drawn to a computing device, method, and non-transitory computer-readable medium for classifying and determining episodes to change rules applied by a medical device.
Group II, claim 30, drawn to a system using an electrocardiogram of a patient to detect a health event and determine a change in health event risk.
During a telephone conversation with Ashley Preston on July 2, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-9, 21-29, and 31. Affirmation of this election must be made by applicant in replying to this Office action. Claim 30 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 31, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character not mentioned in the description: 344 in Fig. 7. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 and 21-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-9 are directed to a computing device for classifying episodes using a computational algorithm, which is an abstract idea. Claims 21-29 are directed to a method for classifying episodes using a computational algorithm. Claim 30 is directed to a system for detecting health data and adjusting rules using a computational algorithm. Claim 31 is directed to a non-transitory computer readable medium for classifying episodes using a computational algorithm. Claims 1-9 and 21-31 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a machine.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] – apply a second set of rules to episode data wirelessly received from a medical device for each of a plurality of episodes via the communication circuitry;
[B1] - classify each episode of the plurality of episodes as one of a plurality of classifications based on the application of the second set of rules to the episode data, wherein at least one of the plurality of classifications comprises a classification for which transmission of the episode data from the medical device to the computing device was unnecessary, wherein the classification of unnecessary corresponds to at least one of non-life threatening, not requiring a medical response, or a false positive;
[C1] - determine that an amount of the plurality of episodes classified as the classification for which transmission of the episode data from the medical device to the computing device was unnecessary satisfies at least one criterion.
These elements [A1]-[E1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] – communication circuitry;
[B2] – processing circuitry;
[C2] – memory comprising program instructions;
[D2] – the episode data stored by the medical device for the episodes in response to detecting a health event based on application of a first set of rules by the medical device to sensed data sensed by the medical device;
[E2] - transmit a communication via the communication circuitry to initiate a change to the first set of rules applied by the medical device based on the determination.
These elements [A2]-[E2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the element [A2-C2] are merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Also, the elements [D2-E2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering and communication at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation [D2] does not qualify as significantly more because this limitation merely describes the nature of the episode data and does not incorporate the generic medical device as part of the claimed invention. Also, the recitation [D2] is merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements or simply displaying the results of the algorithm that uses conventional, routine, and well-known elements. In particular, the data acquirer is nothing more than a temperature sensor detecting temperature at the wrist and a temperature sensor detecting environmental or ambient temperature.
Further, the elements [A2-C2] do not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Claims 2-9 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exception:
Claim 8: “a cloud-based health monitoring system”.
This claim limitation does not integrate the exception into a practical application. This limitation from claim 8 is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of storage) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) 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, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
The analysis of claim 21 is as follows:
Step 1: Claim 21 is drawn to a process.
Step 2A – Prong One: Claim 21 recites an abstract idea. In particular, claim 21 recites the following limitations:
[A1] - applying, by processing circuitry of the computing device, a second set of rules to episode data received from the medical device for each of a plurality of episodes, the episode data stored by the medical device for the episodes in response to detecting a health event based on application of a first set of rules by the medical device to sensed data sensed by the medical device;
[B1] - classifying, by the processing circuitry, each episode of the plurality of episodes as one of a plurality of classifications based on the application of the second set of rules to the episode data, wherein at least one of the plurality of classifications comprises a classification for which transmission of the episode data from the medical device to the computing device was unnecessary, wherein the classification of unnecessary corresponds to at least one of non-life threatening, not requiring a medical response, or a false positive;
[C1] - determining, by the processing circuitry, that an amount of the plurality of episodes classified as the classification for which transmission of the episode data from the medical device to the computing device was unnecessary satisfies at least one criterion.
These elements [A1]-[E1] of claim 21 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 21 recites the following limitations that are beyond the judicial exception:
[A2] – method of controlling the operation of a computing device configured to communicate with a medical device configured to store episode data for episodes in response to detecting a health event of a patient;
[B2] – the episode data stored by the medical device for the episodes in response to detecting a health event based on application of a first set of rules by the medical device to sensed data sensed by the medical device;
[C2] - transmitting, by the processing circuitry and via communication circuitry of the computing device, a communication to initiate a change to the first set of rules applied by the medical device based on the determination.
These elements [A2]-[C2] of claim 21 do not integrate the exception into a practical application of the exception. In particular, the element [A2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Furthermore, the elements [B2-C2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering and communication at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 21 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitations [A2-C2] do not qualify as significantly more because this limitation merely describes the nature of the episode data and does not incorporate the generic medical device as part of the claimed invention. Also, the recitations [A2-C2] are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the medical device is no more than a generic computer device with intended use for medical purposes.
Further, the element [A2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Claims 22-29 depend from claim 21, and recite the same abstract idea as claim 21. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 22: “implantable medical device”; and
Claim 23: “insertable cardiac monitor”.
Claims 22-23 do not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the “implantable medical device” and “insertable cardiac monitor” are nothing more than well-known sensors used to gather medical and cardiac data. Such devices are conventional as evidenced by:
U.S. Patent Application Publication No. US 20170311836 A1 (Sweeny, Michael) discloses that implantable cardiac devices and ECGs are conventional ([0020], [0042]);
Also, this limitation from claims 22-23 is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of display) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) 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, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim 30 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim 30 is directed to a system for determining health changes and adjusting rules using a computational algorithm, which is an abstract idea. Claim 30 does not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 30 is as follows:
Step 1: Claim 30 is drawn to a machine.
Step 2A – Prong One: Claim 30 recites an abstract idea. In particular, claim 30 recites the following limitations:
[A1] - detect an acute health event of the patient based on application of a set of rules to a first set of the parameter data;
[B1] - determine that a risk of the acute health event is changed based on a second set of the parameter data; and
[C1] - adjust at least one of a sensitivity or specificity of the set of rules based on the determination that the risk of the acute health event is changed.
These elements [A1-C1] of claim 30 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 30 recites the following limitations that are beyond the judicial exception:
[A2] - a medical device configured to sense parameter data of a patient, including at least an electrocardiogram of the patient; and
[B2] – processing circuitry.
These elements [A2-B2] of claim 30 do not integrate the exception into a practical application of the exception. In particular, the element [A2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the element [B2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Step 2B: Claim 30 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation [A2] does not qualify as significantly more because this limitation merely describes the nature of the senser parameter data gathered by the medical device and does not incorporate an electrocardiogram device as part of the claimed invention. Also, the recitation [A2] is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, medical device is nothing more than a device for gathering an electrocardiogram of a patient. Such devices are conventional as evidenced by Sweeny (as provided above with respect to the rejection of claim 30)
Further, the element [B2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
The analysis of claim 31 is as follows:
Step 1: Claim 31 is drawn to a machine.
Step 2A – Prong One: Claim 31 recites an abstract idea. In particular, claim 31 recites the following limitations:
[A1] - apply a second set of rules to episode data wirelessly received from a medical device for each of a plurality of episodes via the communication circuitry;
[B1] - classify each episode of the plurality of episodes as one of a plurality of classifications based on the application of the second set of rules to the episode data, wherein at least one of the plurality of classifications comprises a classification for which transmission of the episode data from the medical device to the computing device was unnecessary, wherein the classification of unnecessary corresponds to at least one of non-life threatening, not requiring a medical response, or a false positive; and
[C1] - determine that an amount of the plurality of episodes classified as the classification for which transmission of the episode data from the medical device to the computing device was unnecessary satisfies at least one criterion.
These elements [A1-C1] of claim 31 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 31 recites the following limitations that are beyond the judicial exception:
[A2] - A non-transitory computer-readable medium storing instructions that when executed cause processing circuitry; and
[B2] - the episode data stored by the medical device for the episodes in response to detecting a health event based on application of a first set of rules by the medical device to sensed data sensed by the medical device; and
[C2] - transmit a communication via the communication circuitry to initiate a change to the first set of rules applied by the medical device based on the determination.
These elements [A2-C2] of claim 31 do not integrate the exception into a practical application of the exception. In particular, the elements [A2] is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Also, the elements [B2-C2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering or communication at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 31 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation [B2] does not qualify as significantly more because this limitation merely describes the nature of the episode data and does not incorporate the generic medical device as part of the claimed invention.
Further, the element [A2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
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 21-29 and 31 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 21 recites the limitation "the operation" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites “episode data” in line 5. It is unclear if this is meant to be the same as “detecting a health event” as recited in line 3, or if these are different health events. Further clarification is required.
Claim 21 recites “detecting a health event” in line 6. It is unclear if this is meant to be the same as “detecting a health event” as recited in line 3, or if these are different health events. Further clarification is required.
Claim 31 recites the limitation "the communication circuitry" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the computing device" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, 9, 21-23, 25-29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over US 20100262030 A1 (Kim et al.) in view of US 20190232067 A1 (Mahajan et al.).
Regarding claim 1, Kim teaches a computing device ([0031] “external device 110”) comprising:
communication circuitry ([0031] “the system 100 also includes an external device 110 that communicates with the IMD 108 via a wireless connection 112”);
processing circuitry ([0012] “an implant controller, coupled to the sensing circuit, the implant controller including: an arrhythmia detection module, the arrhythmia detection module adapted to detect a tachyarrhythmia based on a heart rate obtained from the at least one cardiac signal; and an arrhythmia discriminator module, the arrhythmia discriminator module adapted to create a first classification of a tachyarrhythmia as either ventricular tachycardia (VT) or supraventricular tachycardia (SVT)”; [0035] “implant controller circuit 304”); and
memory comprising program instructions that, when executed by the processing circuitry ([0031] “the external device 110 can include a monitoring or reporting unit optionally coupled to a computer, communications, or other network.”; Claim 18 recites a machine-readable medium), cause the processing circuitry to:
apply a second set of rules to episode data wirelessly received from a medical device for each of a plurality of episodes via the communication circuitry, the episode data stored by the medical device for the episodes in response to detecting a health event based on application of a first set of rules by the medical device to sensed data sensed by the medical device ([0031] “the system 100 also includes an external device 110 that communicates with the IMD 108 via a wireless connection 112, where the wireless connection 112 employs wireless signals such as radio frequency (RF), inductive, or other telemetry signals.”; [0035] “The sensing circuit 302 provides sensed atrial and ventricular signals to the implant controller circuit 304. In some examples, a heart rate change module 320 uses the signals provided by the sensing circuit 302 to determine if the tachyarrhythmia is sudden onset. Additionally, in other examples, a heart rate comparison module 322 uses the signals provided by the sensing circuit 302 to determine if the tachyarrhythmia has a 1:1 atrial-to-ventricular rate. In the controller 304, an arrhythmia detection module 306 uses the signals provided by the sensing circuit 302 to detect an arrhythmia, and an arrhythmia discrimination module 308 classifies the arrhythmia as either ventricular (VT) or supraventricular (SVT) in origin by performing searches for certain patterns of atrial and ventricular signals using the pattern search module 316”);
classify each episode of the plurality of episodes as one of a plurality of classifications based on the application of the second set of rules to the episode data, wherein at least one of the plurality of classifications comprises a classification for which transmission of the episode data from the medical device to the computing device was unnecessary, wherein the classification of unnecessary corresponds to at least one of nonlife threatening, not requiring a medical response, or a false positive ([0045] “If VTCount is greater than or equal to a given threshold value (e.g., one), then the tachyarrhythmia is classified as VT. Otherwise, the tachyarrhythmia is classified as SVT.”; [0052] “SVT classification … false positives”; SVT is not a life-threatening arrhythmia);
determine that an amount of the plurality of episodes classified as the classification for which transmission of the episode data from the medical device to the computing device was unnecessary satisfies at least one criterion ([0052] “Specificity generally refers to the ability of the detection scheme to avoid improper classifications. Specificity can be expressed with the function: specificity=(true negatives)/(true negatives+false positives). Thus, a higher specificity generally reflects more accurate classification of true negatives or reduction of false positives”) and
transmit a communication via the communication circuitry to initiate a change to the first set of rules applied by the medical device based on the determination ([0052] “if the tachyarrhythmia is initially classified as SVT, then the FCC threshold value is adaptively lowered in response to the initial classification as SVT. In certain examples, a low threshold is initially established and if the initial classification is SVT, then the threshold is maintained. In either case, the lowered threshold improves the specificity of classifying a tachyarrhythmia as VT because it makes it more likely that the morphology analysis will result in an SVT classification … In one example, the FCC threshold is adaptively lowered to 0.6 from an initial value (e.g., 0.94) to improve the specificity of classifying the arrhythmia as VT”; [0053] “After the FCC threshold value has been adjusted, at 414, a morphology analysis is performed. This yields a secondary tachyarrhythmia classification as VT or SVT. This secondary tachyarrhythmia classification (which has been influenced by the initial tachyarrhythmia classification) can then be used in an algorithm that controls evaluation and delivery of appropriate anti-tachyarrhythmia therapy”).
Kim does not explicitly teach a computing device comprising processing circuitry.
However,
Mahajan teaches a computing device comprising processing circuitry ([0019] “an external device that may include one or more of the user interface, the memory circuit, and the episode management circuit. The external device may be configured to receive the arrhythmia episode from the medical device communicatively coupled to the external device.”; [0023] “the external device that may be configured to program the medical device to deliver therapy to treat arrhythmia.”; [0055] “the external system 125 may include an external data processor configured to analyze the physiologic or functional signals received by the AMD 110, and to confirm or reject the detection of the medical events”; [0082]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Kim to include the processing circuitry within the computing device. One would have been motivated to make this modification because using a device to reduce false positives leads to fewer unnecessary treatments and improves battery life and longevity of the medical device, and transmission of medical device data to a separate device for processing also allows the medical device to be reprogramed based on detected medical events, as suggested by Mahajan [0006, 0055].
Regarding claim 2, Kim teaches the computing device of claim 1.
Kim does not teach wherein the second set of rules comprises a machine learning model.
However,
Mahajan teaches wherein the second set of rules comprises a machine learning model ([0055] “machine-learning algorithms, may be implemented in the external data processor to process the data retrospectively to detect cardia arrhythmia”; [0031]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Kim to include a machine learning model. One would have been motivated to make this modification because machine learning algorithms may be used to detect cardiac arrhythmia retrospectively in an external data processor, as suggested by Mahajan [0055].
Regarding claim 3, Kim teaches the computing device of claim 1, wherein the plurality of episodes comprises a plurality of ventricular tachyarrhythmia episodes ([0010] “ventricular tachyarrhythmia (VT)”).
Regarding claim 4, Kim teaches the computing device of claim 3, wherein the classification for which transmission of the episode data from the medical device to the computing device was unnecessary comprises at least one of noise, oversensing, or supraventricular tachycardia ([0010] “supraventricular tachyarrhythmia (SVT)”; [0052] “SVT classification”).
Regarding claim 5, Kim teaches the computing device of claim 1, wherein the transmitted communication comprises an instruction to the medical device to initiate the change to the first set of rules ([0031]; [0050]; [0052] “if the tachyarrhythmia is initially classified as SVT, then the FCC threshold value is adaptively lowered in response to the initial classification as SVT”; [0053] “After the FCC threshold value has been adjusted, at 414, a morphology analysis is performed. This yields a secondary tachyarrhythmia classification as VT or SVT. This secondary tachyarrhythmia classification (which has been influenced by the initial tachyarrhythmia classification) can then be used in an algorithm that controls evaluation and delivery of appropriate anti-tachyarrhythmia therapy.”).
Regarding claim 6, Kim teaches the computing device of claim 5, wherein the instruction comprises a changed value for at least one rule of the first set of rules ([0052] “In one example, the FCC threshold is adaptively lowered to 0.6 from an initial value (e.g., 0.94) to improve the specificity of classifying the arrhythmia as VT”).
Regarding claim 7, Kim teaches the computing device of claim 5, wherein the instruction comprises an instruction to select a different version of the first set of rules ([0052] “In one example, the FCC threshold is adaptively lowered to 0.6 from an initial value (e.g., 0.94) to improve the specificity of classifying the arrhythmia as VT”).
Regarding claim 9, Kim teaches the computing device of claim 1, wherein to initiate the change to the first set of rules, the processing circuitry is configured to initiate a change to at least one of a number of cardiac intervals threshold, a heart rate threshold, a criterion for detecting R-waves, or a noise rejection setting ([0007] “a rate or interval-based rhythm discriminator classifies a tachyarrhythmia as a supraventricular tachyarrhythmia (SVT) when: (1) the heart rate or ventricular rate is unstable, or (2) the tachyarrhythmia exhibits a gradual onset and is stable (stability can be determined from the beat-to-beat variability in heart rate or depolarization intervals)”; [0035] “a heart rate change module 320”; [0047]; [0054]).
Regarding claim 21, Kim teaches a method of controlling the operation of a computing device configured to communicate with a medical device configured to store episode data for episodes in response to detecting a health event of a patient ([0031] “a system 100 that uses an implantable medical device (IMD) 108’; “the external device 110 can include a monitoring or reporting unit optionally coupled to a computer, communications, or other network.”), the method comprising:
applying, by processing circuitry, a second set of rules to episode data received from the medical device for each of a plurality of episodes, the episode data stored by the medical device for the episodes in response to detecting a health event based on application of a first set of rules by the medical device to sensed data sensed by the medical device ([0031] “the system 100 also includes an external device 110 that communicates with the IMD 108 via a wireless connection 112, where the wireless connection 112 employs wireless signals such as radio frequency (RF), inductive, or other telemetry signals.”; [0035] “The sensing circuit 302 provides sensed atrial and ventricular signals to the implant controller circuit 304. In some examples, a heart rate change module 320 uses the signals provided by the sensing circuit 302 to determine if the tachyarrhythmia is sudden onset. Additionally, in other examples, a heart rate comparison module 322 uses the signals provided by the sensing circuit 302 to determine if the tachyarrhythmia has a 1:1 atrial-to-ventricular rate. In the controller 304, an arrhythmia detection module 306 uses the signals provided by the sensing circuit 302 to detect an arrhythmia, and an arrhythmia discrimination module 308 classifies the arrhythmia as either ventricular (VT) or supraventricular (SVT) in origin by performing searches for certain patterns of atrial and ventricular signals using the pattern search module 316”);
classifying, by the processing circuitry, each episode of the plurality of episodes as one of a plurality of classifications based on the application of the second set of rules to the episode data, wherein at least one of the plurality of classifications comprises a classification for which transmission of the episode data from the medical device to the computing device was unnecessary, wherein the classification of unnecessary corresponds to at least one of non-life threatening, not requiring a medical response, or a false positive ([0045] “If VTCount is greater than or equal to a given threshold value (e.g., one), then the tachyarrhythmia is classified as VT. Otherwise, the tachyarrhythmia is classified as SVT.”; [0052] “SVT classification … false positives”; SVT is not a life-threatening arrhythmia);
determining, by the processing circuitry, that an amount of the plurality of episodes classified as the classification for which transmission of the episode data from the medical device to the computing device was unnecessary satisfies at least one criterion ([0052] “Specificity generally refers to the ability of the detection scheme to avoid improper classifications. Specificity can be expressed with the function: specificity=(true negatives)/(true negatives+false positives). Thus, a higher specificity generally reflects more accurate classification of true negatives or reduction of false positives”); and
transmitting, by the processing circuitry and via communication circuitry of the computing device, a communication to initiate a change to the first set of rules applied by the medical device based on the determination ([0052] “if the tachyarrhythmia is initially classified as SVT, then the FCC threshold value is adaptively lowered in response to the initial classification as SVT. In certain examples, a low threshold is initially established and if the initial classification is SVT, then the threshold is maintained. In either case, the lowered threshold improves the specificity of classifying a tachyarrhythmia as VT because it makes it more likely that the morphology analysis will result in an SVT classification … In one example, the FCC threshold is adaptively lowered to 0.6 from an initial value (e.g., 0.94) to improve the specificity of classifying the arrhythmia as VT”; [0053] “After the FCC threshold value has been adjusted, at 414, a morphology analysis is performed. This yields a secondary tachyarrhythmia classification as VT or SVT. This secondary tachyarrhythmia classification (which has been influenced by the initial tachyarrhythmia classification) can then be used in an algorithm that controls evaluation and delivery of appropriate anti-tachyarrhythmia therapy”).
Kim does not explicitly teach processing circuitry of the computing device.
However,
Mahajan teaches processing circuitry of the computing device ([0019] “an external device that may include one or more of the user interface, the memory circuit, and the episode management circuit. The external device may be configured to receive the arrhythmia episode from the medical device communicatively coupled to the external device.”; [0023] “the external device that may be configured to program the medical device to deliver therapy to treat arrhythmia.”; [0055] “the external system 125 may include an external data processor configured to analyze the physiologic or functional signals received by the AMD 110, and to confirm or reject the detection of the medical events”; [0082]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Kim to include the processing circuitry within the computing device. One would have been motivated to make this modification because using a device to reduce false positives leads to fewer unnecessary treatments and improves battery life and longevity of the medical device, and transmission of medical device data to a separate device for processing also allows the medical device to be reprogramed based on detected medical events, as suggested by Mahajan [0006, 0055].
Regarding claim 22, Kim teaches the method of claim 21, wherein the medical device comprises an implantable medical device ([0031] “implantable medical device (IMD) 108”).
Regarding claim 23, Kim teaches the method of claim 22, wherein the implantable medical device comprises an insertable cardiac monitor ([0031] “IMD 108 includes an electronics unit coupled by electrodes to a heart 104 of a patient 102”; “Examples of IMD 108 include, without limitation, a pacer, a defibrillator, a cardiac resynchronization therapy (CRT) device, or a combination of such devices”).
Regarding claim 25, Kim teaches the method of claim 21, wherein the plurality of episodes comprises a plurality of ventricular tachyarrhythmia episodes ([0010] “ventricular tachyarrhythmia (VT”).
Regarding claim 26, Kim teaches the method of claim 25, wherein the classification for which transmission of the episode data from the medical device to the computing device was unnecessary comprises at least one of noise, oversensing, or supraventricular tachycardia ([0010] “supraventricular tachyarrhythmia (SVT)”; [0052] “SVT classification”).
Regarding claim 27, Kim teaches the method of claim 21, wherein initiating the change to the first set of rules comprises transmitting, by the processing circuitry and via the communication circuitry of the computing device, an instruction from the computing device to the medical device ([0053] “After the FCC threshold value has been adjusted, at 414, a morphology analysis is performed. This yields a secondary tachyarrhythmia classification as VT or SVT. This secondary tachyarrhythmia classification (which has been influenced by the initial tachyarrhythmia classification) can then be used in an algorithm that controls evaluation and delivery of appropriate anti-tachyarrhythmia therapy.”).
Regarding claim 28, Kim teaches the method of claim 27, wherein the instruction comprises a changed value for at least one rule of the first set of rules ([0052] “if the tachyarrhythmia is initially classified as SVT, then the FCC threshold value is adaptively lowered in response to the initial classification as SVT … In one example, the FCC threshold is adaptively lowered to 0.6 from an initial value (e.g., 0.94) to improve the specificity of classifying the arrhythmia as VT.”).
Regarding claim 29, Kim teaches the method of claim 27, wherein the instruction comprises an instruction to select a different version of the first set of rules ([0052] “if the tachyarrhythmia is initially classified as SVT, then the FCC threshold value is adaptively lowered in response to the initial classification as SVT … In one example, the FCC threshold is adaptively lowered to 0.6 from an initial value (e.g., 0.94) to improve the specificity of classifying the arrhythmia as VT.”).
Regarding claim 31, Kim teaches a non-transitory computer-readable medium storing instructions that when executed cause processing circuitry to ([0031] “the external device 110 can include a monitoring or reporting unit optionally coupled to a computer, communications, or other network.”; [0035] “implant controller circuit 304”; Claim 18 recites a machine-readable medium):
apply a second set of rules to episode data wirelessly received from a medical device for each of a plurality of episodes via the communication circuitry, the episode data stored by the medical device for the episodes in response to detecting a health event based on application of a first set of rules by the medical device to sensed data sensed by the medical device ([0031] “the system 100 also includes an external device 110 that communicates with the IMD 108 via a wireless connection 112, where the wireless connection 112 employs wireless signals such as radio frequency (RF), inductive, or other telemetry signals.”; [0035] “The sensing circuit 302 provides sensed atrial and ventricular signals to the implant controller circuit 304. In some examples, a heart rate change module 320 uses the signals provided by the sensing circuit 302 to determine if the tachyarrhythmia is sudden onset. Additionally, in other examples, a heart rate comparison module 322 uses the signals provided by the sensing circuit 302 to determine if the tachyarrhythmia has a 1:1 atrial-to-ventricular rate. In the controller 304, an arrhythmia detection module 306 uses the signals provided by the sensing circuit 302 to detect an arrhythmia, and an arrhythmia discrimination module 308 classifies the arrhythmia as either ventricular (VT) or supraventricular (SVT) in origin by performing searches for certain patterns of atrial and ventricular signals using the pattern search module 316”);
classify each episode of the plurality of episodes as one of a plurality of classifications based on the application of the second set of rules to the episode data, wherein at least one of the plurality of classifications comprises a classification for which transmission of the episode data from the medical device to the computing device was unnecessary, wherein the classification of unnecessary corresponds to at least one of non-life threatening, not requiring a medical response, or a false positive ([0045] “If VTCount is greater than or equal to a given threshold value (e.g., one), then the tachyarrhythmia is classified as VT. Otherwise, the tachyarrhythmia is classified as SVT.”; [0052] “SVT classification … false positives”; SVT is not a life-threatening arrhythmia);
determine that an amount of the plurality of episodes classified as the classification for which transmission of the episode data from the medical device to the computing device was unnecessary satisfies at least one criterion ([0052] “Specificity generally refers to the ability of the detection scheme to avoid improper classifications. Specificity can be expressed with the function: specificity=(true negatives)/(true negatives+false positives). Thus, a higher specificity generally reflects more accurate classification of true negatives or reduction of false positives”); and
transmit a communication via the communication circuitry to initiate a change to the first set of rules applied by the medical device based on the determination ([0052] “if the tachyarrhythmia is initially classified as SVT, then the FCC threshold value is adaptively lowered in response to the initial classification as SVT. In certain examples, a low threshold is initially established and if the initial classification is SVT, then the threshold is maintained. In either case, the lowered threshold improves the specificity of classifying a tachyarrhythmia as VT because it makes it more likely that the morphology analysis will result in an SVT classification … In one example, the FCC threshold is adaptively lowered to 0.6 from an initial value (e.g., 0.94) to improve the specificity of classifying the arrhythmia as VT”; [0053] “After the FCC threshold value has been adjusted, at 414, a morphology analysis is performed. This yields a secondary tachyarrhythmia classification as VT or SVT. This secondary tachyarrhythmia classification (which has been influenced by the initial tachyarrhythmia classification) can then be used in an algorithm that controls evaluation and delivery of appropriate anti-tachyarrhythmia therapy”).
Kim does not explicitly teach transmission of the episode data to from the medical device to the computing device.
However,
Mahajan teaches teach transmission of the episode data to from the medical device to the computing device. ([0019] “an external device that may include one or more of the user interface, the memory circuit, and the episode management circuit. The external device may be configured to receive the arrhythmia episode from the medical device communicatively coupled to the external device.”; [0023] “the external device that may be configured to program the medical device to deliver therapy to treat arrhythmia.”; [0055] “the external system 125 may include an external data processor configured to analyze the physiologic or functional signals received by the AMD 110, and to confirm or reject the detection of the medical events”; [0082]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by Kim to include the processing circuitry with a external computing device that receives data from medical device. One would have been motivated to make this modification because using a device to reduce false positives leads to fewer unnecessary treatments and improves battery life and longevity of the medical device, and transmission of medical device data to a separate device for processing also allows the medical device to be reprogramed based on detected medical events, as suggested by Mahajan [0006, 0055].
Claims 8 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over US 20100262030 A1 (Kim et al.) in view of US 20190232067 A1 (Mahajan et al.), further in view of US 20200352466 A1 (Chakravarthy et al.).
Regarding claim 8, Kim teaches the computing device of claim 1, wherein the transmitted communication comprises a request to change the first set of rules from the computing device to a health monitoring system to initiate the change to the first set of rules ([0031]; [0050]; [0052] “if the tachyarrhythmia is initially classified as SVT, then the FCC threshold value is adaptively lowered in response to the initial classification as SVT”; [0053] “After the FCC threshold value has been adjusted, at 414, a morphology analysis is performed. This yields a secondary tachyarrhythmia classification as VT or SVT. This secondary tachyarrhythmia classification (which has been influenced by the initial tachyarrhythmia classification) can then be used in an algorithm that controls evaluation and delivery of appropriate anti-tachyarrhythmia therapy.”).
Kim does not explicitly teach a cloud-based health monitoring system.
However,
Chakravarthy teaches a cloud-based health monitoring system ([0060] “computing device 400 may be a cloud computing system distributed across a plurality of devices.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Kim to include a cloud-based system. One would have been motivated to make this modification because cloud systems can be used to distribute information across a plurality of devices, as suggested by Chakravarthy [0060].
Regarding claim 24, Kim teaches the method of claim 21.
Kim does not teach wherein the second set of rules comprises an artificial intelligence algorithm.
However,
Chakravarthy teaches wherein the second set of rules comprises an artificial intelligence algorithm ([0025] “artificial intelligence (AI) algorithms”; [0028] “AI methods for arrhythmia detection may provide a flexible platform to develop arrhythmia detection and classification algorithms with different objectives (e.g., detect atrial fibrillation (AF), exclude cardiac episodes that exhibit no arrhythmia, etc.)”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the device taught by Kim to include an artificial intelligence algorithm. One would have been motivated to make this modification because AI provides a flexible platform to develop arrhythmia classification algorithms with difference objectives, as suggested by Chakravarthy [0028].
Conclusion
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/EVELYN GRACE PARK/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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