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/Restrictions
Applicant's election with traverse of Invention I and Subspecies 1AA and 2A in the reply filed on August 28, 2026 is acknowledged.
Applicant’s election with traverse of Invention I is acknowledged. The traversal of Invention I is on the grounds that the claims share overlapping technical features, disclosure, and search fields and that the Office has not established a sufficient search burden. Examiner respectfully disagrees. As discussed in the “Requirement for Restriction/Election” filed on 07/28/2026, Invention I, which encompasses claims 1-8, Invention II which encompasses claims 9-17, and Invention III which encompasses claims 18-20, recite different features that make the inventions independent or distinct from each other. Invention I is distinct from Invention II or Invention III because it can be practiced with another materially different product or by another materially different process of using the product, one that does not require features that Invention II and Invention III require. For these reasons, the Restriction requirement is maintained.
Applicant’s election with traverse of Species 1A and 2A is acknowledged. During a telephone conversation with the attorney on record on 09/09/2026 a provisional election was made with traverse to elect subspecies 1AA: cardiac rhythm device from species 1A. Affirmation of this election must be made by applicant in replying to this Office action.
The traversal of Subspecies 1AA and 2A is on the grounds that the claims encompass the elected invention and elected species. Examiner respectfully disagrees. As discussed in the “Requirement for Restriction/Election” the species are independent and distinct due to their mutually exclusive characteristics. In addition, a requirement for restriction is permissible if there is a patentable difference between the species as claimed and there would be a serious search and/or examination burden on the examiner if restriction is not required, see MPEP 808.01(a). For these reasons, the Election of Species requirement of Species 1 and 2 is maintained.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim 7 is 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.
In re claim 7, the limitation “activate the at least one other physiologic sensor in response to the measured intensity of the S3 heart sound exceeding the PH detection threshold intensity; and generate the indication of PH using both the sensed heart sound signal and the at least one other sensed physiological signal” is unclear. Specifically, it is unclear how both the heart sound signal and one other sensed physiological signal are used to generation an indication of PH when, In re claim 1, PH is already indicated from the S3 heart sound exceeding the PH detection threshold. For examination purposes, as best understood, the limitation “generate the indication of PH using both the sensed heart sound signal and the at least one other sensed physiological signal” will be interpreted to mean that while PH can be indicated from S3 exceeding the PH detection threshold alone, is S3 exceeds the detection threshold, it may be helpful to also use a secondary signal to confirm that the patient is experiencing PH and not another disorder.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-8 do not include additional elements that integrate the exception into a practical application of the exception 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, p. 50, January 7, 2019).
Step 1: Independent claim 1 is directed to a device for indicating pulmonary hypertension. Thus, they are directed to statutory categories of invention (Step 1: YES).
Step 2A, Prong 1:
Claim 1 recites the following claim limitations which are directed to abstract ideas, specifically mental processes (see MPEP 2106.04(a)(2)):
In re claim 1:
“produce an indication of pulmonary hypertension (PH) when the measured intensity of the S3 heart sound exceeds a PH detection threshold intensity” (fall under one of observation, evaluation, judgement, or opinion and mathematical concepts, i.e. judgement)
This limitation is drawn to an abstract idea because it is, under its broadest reasonable interpretation, mere steps that are capable of being mentally performed or with a pen and paper. For example, detecting a change in the activity level of a patient are a matter of observation, evaluation, judgement, and opinion recognized by the courts as mental processes. Additionally, this limitation is drawn to an abstract idea because it is an observation.
Step 2A, Prong 2:
Claim 1 recites the following additional elements:
In re claim 1, “the device comprising:
an activity sensor configured to produce an activity signal representative of activity level of a patient (generic component for data gathering)
a heart sound sensor configured to produce a heart sound signal (generic component for data gathering)
a control circuit operatively coupled to the activity sensor and the heart sound sensor (generic computer components)
detect a change in activity level of the patient using the activity signal (pre-solution activity)
enable sensing of the heart sound signal in response to detecting the change in activity level (pre-solution activity)
measure intensity of an S3 heart sound in the sensed heart sound signal (insignificant extra-solution activity)
The above limitations do not integrate the exception into a practical application of the exception because the elements are directed to mere data gathering, generic computer components, and insignificant extra-solution activity.
The limitations “produce an activity signal representative of activity level”, “produce a heart sound signal”, “detect a change in activity level”, and “enable sensing of the heart sound sensor” are directed towards pre-solution activity (see MPEP 2106.05(g)) since they’re used to obtain information about the user (i.e. mere data gathering).
The limitation “a control circuit” is merely directed towards a generically recited computer element which does not improve the function of a computer, or any other technology or technical field. In other words, the computer components are being used as a tool to carry out the system’s functions (see MPEP 2106.05(a)).
Additionally, the limitation “measure intensity of the S3 heart sound” is directed to insignificant post-solution activity (see MPEP 2106.05(g)), as it is just determining a parameter of the sensed signal.
The judicial exception does not integrate the claims as a whole into a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A, Prong 2, the additional elements in the claim amount to no more than insignificant extra-solution activity, mere data gathering, and generically recited computer elements.
The limitations directed to an “activity sensor” and a “heart sound sensor” are well known, routine, and conventional as evidenced by the references below; see Su et al. (US 2016/0113618) which teaches a system for monitoring acoustic signals that detects a medical condition [0004] such as pulmonary hypertension or heart failure [0042]. The system can use acoustic sensors to sense heart sounds of a patient [0042] and an activity sensor to detect movement, footfalls, or posture [0063]. Additionally, Zhang et al. (US 2012/0296228) teaches a system that allows a medical device to detect heart sounds to aid in cardiac resynchronization therapy [0006]. The medical device includes a heart sound sensor and an activity sensor [0055].
Thus, none of the claims 1-8 amount to significantly more than the abstract idea itself. Accordingly, claims 1-8 are not patent eligible and are rejected under 35 U.S.C. 101 as being directed to abstract ideas in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al., MPEP 2106.04(a)(2), MPEP 2106.04(d)(2), and MPEP 2106.05(g).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. (US 2013/0237863).
In re claim 1, Song discloses an ambulatory medical device (fig 2), the device comprising:
an activity sensor [0077] configured to produce an activity signal representative of activity level of a patient [0077];
a heart sound sensor ([0092]: “acoustic sensor”) configured to produce a heart sound signal ([0092]: “monitor both heart sounds”); and
a control circuit operatively coupled to the activity sensor and the heart sound sensor ([0077]: “processor”), wherein the control circuit is configured to:
detect a change in activity level of the patient using the activity signal ([0098]: “acoustic sensors 18 and 20 may be activated at a certain time of day or when patient activity is below a certain level”);
enable sensing of the heart sound signal in response to detecting the change in activity level ([0077]): last sentence);
measure intensity of an S3 heart sound in the sensed heart sound signal ([0092]: “heart sound parameters may include… S3”; [0098]: “amplitude of heart sound S3”); and
produce an indication of pulmonary hypertension (PH) when the measured intensity of the S3 heart sound exceeds a PH detection threshold intensity ([0092]: “pulmonary hypertension signatures may include changes in… heart sound frequency changes”; [0098]: “processor 54 then determines if a patient 12 has pulmonary hypertension induce heart failure”, “processor 54 may compare the current amplitude of heart sound S3 to the previous amplitude of heart sound S3”).
In re claim 4, Song discloses including:
a communication circuit configured to communicate information wirelessly with a second device (fig 3); and
wherein the control circuit is configured to send a message to the second device indicative of PH in response to the measured intensity of the S3 heart sound exceeding the PH detection threshold intensity ([0090; fig 9: 96; fig 4).
In re claim 6, Song discloses wherein the control circuit is configured to activate the at least one other physiologic sensor in response to the measured intensity of the S3 heart sound exceeding the PH detection threshold intensity ([0041]: programmer can determine if the patient has pulmonary hypertension using the heart sound signals and then can use both heart sound signals and other signals to determine if the patient has pulmonary hypertension induced heart failure; [0093]).
Claim Rejections - 35 USC § 103
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 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (US 2013/0237863), herein after referred to as “Song”, in view of An et al. (US 2018/0008228), herein after referred to as “An (8228)”.
In re claim 2, Song discloses wherein the control circuit is configured to:
detect activity of the patient using the activity signal [0077]; and
enable the sensing of the heart sound signal in response to detecting the activity is below a predetermined threshold [0077].
Song lacks
detect exercise of the patient using the activity signal; and
enable the sensing of the heart sound signal in response to detecting the exercise.
An (8228) teaches a system for efficiently collecting heart sound data by controlling the operation of the heart sound sensor using physiologic information [0006]. Physiologic information, such as activity level, can be used to trigger heart sound detection [0025]. The heart sound sensor can be triggered when a period of activity is detected [0025].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Song by enabling the sensing of the heart sound signal during exercise, or activity, as taught by An (8228), as sensing the heart sounds only during desired periods would allow for more efficient heart sound detection as it would allow for increasing the processing capability of the medical devices [0016].
In re claim 3, Song discloses wherein the control circuit is configured to:
detect an activity level of the patient using the activity signal [0077]; and
enable the sensing of the heart sound signal in response to detecting the level of activity is below a threshold value [0077].
Song lacks
detect an increase in ambulatory activity of the patient using the activity signal; and
enable the sensing of the heart sound signal in response to detecting the increase in ambulatory activity.
An (8228) teaches that heart sound detection can be enabled while the patient is walking [0025].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Song by detecting when the patient is walking and enabling sensing of the heart sounds as taught by An (8228), as one may want to sense the heart sounds during different activities and one of ordinary skill would be able to select the type of activity or inactivity, they wanted to sense heart sounds during.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (US 2013/0237863), herein after referred to as “Song”, in view of An et al. (US 2017/0281095), herein after referred to as “An (1095)”.
In re claim 5, Song discloses including:
at least one other physiologic sensor configured to produce at least one other sensed physiological signal that includes physiological information of the patient [0063, 0072]; and
wherein the control circuit is configured to:
detect heart failure (HF) of the patient using the at least one other sensed physiological signal ([0072]: last sentence); and
Song lacks
change at least one of sensitivity of the HF detection and specificity of the HF detection by the control circuit in response to the measured intensity of the S3 heart sound exceeding the PH detection threshold intensity.
An (1095) teaches an ambulatory medical device [0042] that senses heart sounds [0050], including the intensity of the S3 heart sound [0050] and uses the sensed signals to detect whether a patient has a disease such as pulmonary hypertension [0052] or heart failure [0064]. A detector circuit is used to detect diseases, such as heart failure, by looking at a signal metric or detection algorithm [0064]. The specificity and sensitivity of the detection algorithms used to detect disease can be selected based on whether there is a high or low cardiac risk [0064].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Song by changing the sensitivity and specificity of the disease detection algorithms as taught by An (1095), would allow for changing the sensitivity and specificity of the heart failure detection which would allow for more accurate heart failure readings to be determined.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al. (US 2013/0237863), herein after referred to as “Song”, in view of An et al. (US 2017/0281095), herein after referred to as “An (1095)”, in view of An et al. (US 2018/0008228), herein after referred to as “An (8228)”.
In re claim 7, Song lacks including:
at least one other physiologic sensor configured to produce at least one other sensed physiological signal that includes physiological information of the patient; and
wherein the control circuit is configured to:
activate the at least one other physiologic sensor in response to the measured intensity of the S3 heart sound exceeding the PH detection threshold intensity; and
generate the indication of PH using both the sensed heart sound signal and the at least one other sensed physiological signal.
An (1095) teaches using one or more physiological signals to detect physiological information of a patient [0049]. The physiological signals can both be used to detect a pulmonary disease such as pulmonary hypertension [0056] and generate a composite health status indicator [0052] which is presented to the user [0069].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Song by using another physiological sensor and by using both the heart sound signal and the other physiological signal to indicate a pulmonary disease such as hypertension as taught by An (1095), as using multiple signal types would provide more information indicating that the disease the patient has is pulmonary hypertension instead of a different pulmonary disease.
An (8228) teaches a system for enabling more efficient monitoring of heart sound information [0016]. The heart sound sensing can be enabled depending on the patient’s activity or inactivity levels or depending on other physiologic information [0025]. Additionally, detecting one heart sound that exceeds a threshold condition can be used to trigger detection of another heart sound [0024].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the proposed combination by activating sensing of another parameter after a threshold condition is met as taught by An (8228), as activating another physiologic sensor only when S3 is detected to be above a threshold would allow for the medical device to be more energy efficient and save processing power [0016] by allowing detection of pulmonary hypertension to occur using multiple sensors only when a first condition is met.
In re claim 8, Song lacks wherein the at least one other physiologic sensor includes at least one of:
a cardiac signal sensor configured to produce a sensed cardiac signal including heart rate information of the patient,
a temperature sensor configured to produce temperature information of the patient, or
a lung sound sensor configured to produce a sensed lung sound signal including lung sounds of the patient; and
wherein the control circuit is configured to generate the indication of PH using both of the measured intensity of the S3 heart sound and the at least one of the heart rate information, the temperature information, or a lung sound of the patient.
An (1095) teaches wherein the physiological sensors can be a cardiac signal that measures heart rate [0044] and wherein the indication of PH is determined using more than one physiological signal such as heart sound signals and cardiac signals [0052, 0056].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Song by using a cardiac signal sensor that detects heart rate and using both heart rate and the S3 heart sound to detect pulmonary hypertension as taught by An (1095), as using multiple signal types would allow for a more accurate assessment of which disease a patient has and both heart sounds and heart rate can be used to determine pulmonary hypertension.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
An et al. (US 2017/0281095) teaches measuring the intensity of S3 heart sounds [0050] and detecting disease based on a change in signal metrics [0061], such as heart sounds [0077], compared to a baseline and determining whether the change exceeds a specific threshold [0061].
Nagale et al. (US 2018/0153477) teaches a system that detects multiple physiological signals in a patient for detecting stroke (abstract). The physiological signals can include pulmonary signals, such as heart sound signals [0052]. Initially, one physiological signal is sensed and if a predetermined condition is satisfied from the sensed signal, another sensor can be used to perform other assessments [0079, 0080].
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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