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 .
Claim Status: Claims 1-19 are pending.
Claims 6-11 and 15 appear to avoid the prior art but remain rejected under section 101 below. They will be re-evaluated in light of the prior art based on whether or how the claims are amended.
Claim Objections
Claim 8 is objected to because of the following informalities: “at least one acoustic” should be corrected to “at least one acoustic sensor”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) a method.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, Claim 1 is directed towards a method.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the judicial exception relied upon by the instantly claimed invention is an abstract idea, and the limitation that sets forth or describes the abstract idea is: the step of measuring the at least one auscultation data signal provides collected data that is provided to an algorithm for detection of one or more medical issues.
The reason that the above limitations are abstract idea is because they are directed to mental process (observation, evaluation, judgment, opinion).
Please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016)
The steps of data collection and usage carried out in Applicant's claims are akin to a mental process because they are the type of calculations that could theoretically be carried out mentally, but are merely implemented using generic collection technology. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claim recites additional elements “disposing a wearable on a user”, “measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable”, and “the step of measuring the at least one auscultation data signal provides collected data”; however, these additional elements do not integrate the judicial exception into a practical application, because gathering data amounts to insignificant extra-solution activity.
The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Gathering and analyzing information using conventional techniques and displaying the result, TIJ Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
It is further noted that merely collecting the necessary data using known, generic sensors (or other data gathering components) only amounts to insignificant extrasolution activity; see MPEP § 2106.05(g). Applicant's claimed invention does not affect/change the functionality of the technology being used. Rather, Applicant's claimed invention uses the claimed technology for its standard, well-known purpose, e.g. known sensors are used to collect data which they are known to be capable of collecting, known generic processing circuitry is used to perform data calculations/ comparisons, etc. Applicant's invention does not result in improved performance of the sensors, the processing circuitry, etc.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the claim recites additional elements “disposing a wearable on a user”, “measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable”, and “the step of measuring the at least one auscultation data signal provides collected data”. The additional elements do not amount to significantly more than the judicial exception, because it is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (See MPEP 2106.05(d)) and Berkheimer Memo.
Gavriely (US6168568B1) discloses that the use of various sensors which transform the acoustic signals of the body into electric voltages is well known in the art (col. 1, lines 40-49).
Rimmer (US 2024/0057963) discloses known wearable devices for carrying out a form of electronic auscultations (para. [0004], [0005]).
Therefore, the claim is not patent eligible.
With regards to the instantly rejected dependent claims 2-15, these claims when analyzed as a whole are also held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to a judicial exception and/or do not add significantly more to the judicial exception. Therefore, the claim(s) is/are not patent eligible.
Claims 16-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. The claim(s) recite(s) a method.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04.
The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, Claim 16 is directed towards a method.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the judicial exception relied upon by the instantly claimed invention is an abstract idea, and the limitation that sets forth or describes the abstract idea is: the step of measuring the at least one auscultation data signal provides collected data that is provided to an algorithm for detection of one or more medical issues.
The reason that the above limitations are abstract idea is because they are directed to mental process (observation, evaluation, judgment, opinion).
Please see the following analogous types of data manipulations that courts have found to be abstract ideas (all taken from MPEP § 2106.04):
collecting information, analyzing it, and displaying certain results of the collection and analysis, Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1351-52, 119 USPQ2d 1739, 1740 (Fed. Cir. 2016)
The steps of data collection and usage carried out in Applicant's claims are akin to a mental process because they are the type of calculations that could theoretically be carried out mentally, but are merely implemented using generic collection technology. The 2019 revised§ 101 guidance makes clear that the "mental process" category of abstract ideas does not only apply to steps actually carried out mentally; it also applies to the types of processes that could be carried out mentally, but are instead carried out using generic processing/collection technology.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
No, the claim recites additional elements “disposing a wearable on a user”, “measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable”, “the step of measuring the at least one auscultation data signal provides collected data”, “wherein the device performs real-time, continuous monitoring measured in whole days without a need for removal form the user”, and “the at least one auscultation signals are detected and recorded directly from a surface of the user”; however, these additional elements do not integrate the judicial exception into a practical application, because gathering data amounts to insignificant extra-solution activity.
The following are relevant examples of similar limitations which courts have found not to constitute improvements to computers or improvements to other technology or technical field:
Gathering and analyzing information using conventional techniques and displaying the result, TIJ Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48.
It is further noted that merely collecting the necessary data using known, generic sensors (or other data gathering components) only amounts to insignificant extrasolution activity; see MPEP § 2106.05(g). Applicant's claimed invention does not affect/change the functionality of the technology being used. Rather, Applicant's claimed invention uses the claimed technology for its standard, well-known purpose, e.g. known sensors are used to collect data which they are known to be capable of collecting, known generic processing circuitry is used to perform data calculations/ comparisons, etc. Applicant's invention does not result in improved performance of the sensors, the processing circuitry, etc.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No, the claim recites additional elements “disposing a wearable on a user”, “measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable”, “the step of measuring the at least one auscultation data signal provides collected data”, “wherein the device performs real-time, continuous monitoring measured in whole days without a need for removal form the user”, and “the at least one auscultation signals are detected and recorded directly from a surface of the user”. The additional elements do not amount to significantly more than the judicial exception, because it is simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (See MPEP 2106.05(d)) and Berkheimer Memo.
Gavriely (US 6168568B1) discloses that the use of various sensors which transform the acoustic signals of the body into electric voltages is well known in the art (col. 1, lines 40-49).
Rimmer (US 2024/0057963) discloses known wearable devices for carrying out a form of electronic auscultations (para. [0004], [0005]).
Therefore, the claim is not patent eligible.
With regards to the instantly rejected dependent claims 17-19, these claims when analyzed as a whole are also held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to a judicial exception and/or do not add significantly more to the judicial exception. Therefore, the claim(s) is/are not patent eligible.
Claim Rejections - 35 USC § 102
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 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, 12, 13, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song (US 2013/0237863 A1).
Re Claim 1, Song discloses a method for measuring at least one auscultation data signal from at least one acoustic sensor disposed on a user having a need to measure or monitor the at least one auscultation data signal, the method comprising:
disposing a wearable on a user (fig. 1, para. [0038], an external patch 16 with acoustic sensors 18 and 20); and
measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable (para. [0038], external patch 16 is placed so that acoustic sensors 18 and 20 are located over spaces between the ribs. This also allows for better capture of the heart sounds), wherein the step of measuring the at least one auscultation data signal provides collected data that is provided to an algorithm for detection of one or more medical issues (para. [0030]-[0033], correlation between heart and/or lung sounds are used to monitor pulmonary hypertension, including progression and treatment.).
Re Claim 2, Song discloses that the collected data is sent to a healthcare provider to assess the user’s control of an illness, to provide suggestions to adjust medication dosage, or to suggest different medication to the user (para. [0093], Programmer 24 may provide an alert to patient 12 indicating the need to check in with his or her physician regarding treatment of pulmonary hypertension. The physician may in turn start patient 12 on medicine to treat the pulmonary hypertension. In some examples, the indication of pulmonary hypertension may be provided to a drug pump. The drug pump may provide a dose of medication to patient 12 based on the level of pulmonary hypertension present; para. [0094], In some examples, the indication of a need for heart failure treatment may be provided to a physician via programmer 24. The physician may manually change one or more treatment parameters.).
Re Claim 3, Song discloses that the at least one auscultation data signal includes sounds from one or more organs (para. [0095], acoustic sensors collect heart signals).
Re Claim 4, Song discloses that the one or more organs includes the heart (para. [0095], acoustic sensors collect heart signals).
Re Claim 12, Song discloses that the device performs real-time, continuous monitoring measured in whole days without a need for removal from the user (para. [0030], the use of an external patch may allow for a patient to be monitored continuously or at regular intervals without the need for invasive procedures to determine pulmonary arterial blood pressure).
Re Claim 13, Song discloses that the at least one auscultation data signals are detected and recorded directly from a surface of the user between a waist and a base of a neck of the user (para. [0038], fig. 1, External patch 16 is placed on patient 12 over sternum 22 so that acoustic sensor 18 over the right side of the heart 14 and acoustic sensor 20 is over the left side of heart 14.).
Re Claim 16, Song discloses a method for measuring at least one auscultation data signal from at least one acoustic sensor disposed on a user having a need to measure or monitor the at least one auscultation data signal, the method comprising:
disposing a wearable on a user (fig. 1, para. [0038], an external patch 16 with acoustic sensors 18 and 20); and
measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable (para. [0038], external patch 16 is placed so that acoustic sensors 18 and 20 are located over spaces between the ribs. This also allows for better capture of the heart sounds),
wherein the step of measuring the at least one auscultation data signal provides collected data that is provided to an algorithm for detection of one or more medical issues (para. [0030]-[0033], correlation between heart and/or lung sounds are used to monitor pulmonary hypertension, including progression and treatment.),
wherein the device performs real-time, continuous monitoring measured in whole days without a need for removal from the user (para. [0030], the use of an external patch may allow for a patient to be monitored continuously or at regular intervals without the need for invasive procedures to determine pulmonary arterial blood pressure); and
the at least one auscultation data signals are detected and recorded directly from a surface of the user (para. [0038], fig. 1, External patch 16 is placed on patient 12 over sternum 22 so that acoustic sensor 18 over the right side of the heart 14 and acoustic sensor 20 is over the left side of heart 14.).
Re Claim 17, Song discloses that the at least one auscultation data signals includes sounds from at least one organ (para. [0095], acoustic sensors collect heart signals).
Re Claim 18, Song discloses that the organ is the heart (para. [0095], acoustic sensors collect heart signals).
Claims 1, 5, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bang et al. (WO 2020/243463A1).
Examiner note: These grounds of rejection are given in order to address dependent claim 5 which is not rejected with Song.
Re Claim 1, Bang discloses a method for measuring at least one auscultation data signal from at least one acoustic sensor disposed on a user having a need to measure or monitor the at least one auscultation data signal, the method comprising:
disposing a wearable on a user; and measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable (fig. 3, para. [095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal -related auscultation, and/or proximate a joint for orthopedic-related auscultation),
wherein the step of measuring the at least one auscultation data signal provides collected data that is provided to an algorithm for detection of one or more medical issues (para. [0050], The diagnostic system can include a phonocardiogram to detect changes in heart sounds (e.g. SI, S2, S3, S4) and/or lung sounds; para. [0051], heart failure; para. [0095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal -related auscultation, and/or proximate a joint for orthopedic-related auscultation, such as to provide data complementary to data provided by implantable device 100 and/or otherwise improve the diagnosis provided by system 10).
Re Claim 5, Bang discloses that the at least one auscultation data signals include sounds from a joint of the user (para. [095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal -related auscultation, and/or proximate a joint for orthopedic-related auscultation).
Re Claim 16, Bang discloses a method for measuring at least one auscultation data signal from at least one acoustic sensor disposed on a user having a need to measure or monitor the at least one auscultation data signal, the method comprising:
disposing a wearable on a user; and measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable (fig. 3, para. [095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal -related auscultation, and/or proximate a joint for orthopedic-related auscultation),
wherein the step of measuring the at least one auscultation data signal provides collected data that is provided to an algorithm for detection of one or more medical issues (para. [050], The diagnostic system can include a phonocardiogram to detect changes in heart sounds (e.g. SI, S2, S3, S4) and/or lung sounds; para. [0051], heart failure; para. [0095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal -related auscultation, and/or proximate a joint for orthopedic-related auscultation, such as to provide data complementary to data provided by implantable device 100 and/or otherwise improve the diagnosis provided by system 10),
wherein the device performs real-time, continuous monitoring measured in whole days without a need for removal from the user (para. [050], [063], The diagnostic system can be configured to provide continuous and/or long-term monitoring of the patient, such as to aid in providing an accurate diagnosis; para. [094]); and
the at least one auscultation data signals are detected and recorded directly from a surface of the user (para. [094], [095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal -related auscultation, and/or proximate a joint for orthopedic-related auscultation).
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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Song (US 2013/0237863 A1) in view of Sullivan (WO 2008/148172).
Re Claim 14, Song discloses the claimed invention substantially as set forth in claim 1.
Song is silent regarding the at least one acoustic sensor is embedded in a protective layer that facilitates sound transfer through a housing of the device.
Sullivan discloses a sensor automatically provides for auscultation and discloses that the at least one acoustic sensor is embedded in a protective layer that facilitates sound transfer through a housing of the device (page 4, abstract, a sound vibration sensing element in the form of a PVDF membrane. An impedance matching layer on top of the membrane transmits fine breath sounds through to the membrane as the latex does not weaken or attenuate the fine breath sounds but transmits them to the PVDF membrane).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Song, to configure the at least one acoustic sensor to be embedded in a protective layer that facilitates sound transfer through a housing of the device, as taught by Sullivan, for the purpose of transmitting fine sounds through the sensor without attenuating them significantly (page 4).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Song (US 2013/0237863 A1) in view of Bang et al. (WO 2020/243463A1)
Re Claim 19, Song discloses the claimed invention substantially as set forth in claims 16, 17, and 18.
Song is silent regarding wherein the at least one auscultation data signals includes sounds from a joint of the user.
However, Bang discloses disposing a wearable on a user; and measuring the at least one auscultation data signal of the user with at least one sensor disposed in the wearable (fig. 3, para. [095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal -related auscultation, and/or proximate a joint for orthopedic-related auscultation) and discloses that the at least one auscultation data signals includes sounds from a joint of the user (para. [095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal-related auscultation, and/or proximate a joint for orthopedic-related auscultation).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Song, by configuring the at least one auscultation data signals to include sounds from a joint of the user, as taught by Bang, for the purpose of providing data complementary to heart sound data to improve the diagnosis (para. [0095], external device 200 can comprise a device configured to be positioned proximate the abdominal region to provide gastrointestinal-related auscultation, and/or proximate a joint for orthopedic-related auscultation, such as to provide data complementary to data provided by implantable device 100 and/or otherwise improve the diagnosis provided by system 10; para. [050], The diagnostic system can include a phonocardiogram to detect changes in heart sounds (e.g. SI, S2, S3, S4) and/or lung sounds; para. [0051], heart failure).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, March 7, 2026Examiner, Art Unit 3792