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 .
Amendment Entered
In response to the amendment filed on January 22nd, 2026, amended claims 13, 20-21, 24, 31, 35, 45, and 47 are entered. Claims 24-25, 28-32, 35, and 43-47 remain withdrawn from consideration. Claims 13-14 and 17-21 are currently under examination.
Response to Arguments
Applicant's remarks and amendments with respect to the drawing objections have been fully considered. The objections are withdrawn in view of the filing of the replacement sheets.
Applicant's remarks and amendments with respect to the claim interpretations have been fully considered. The interpretations are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant's arguments, filed on January 22nd, 2026, with respect to the rejections under 35 U.S.C. 101 have been fully considered but they are not persuasive. The rejections are maintained, and further clarified, in view of the amendment.
At Pg. 12 of the Reply, Applicant argues “Applicant respectfully submits that the claims as amended integrate any alleged judicial exception into a practical application…[t]he present claims provide a clear improvement in the technical field of medical monitoring”. Examiner respectfully disagrees. Although the Applicant has amended the claim to further specify the abstract idea, the abstract idea is still not integrated into practical application. The additional elements of a “sensor device”, an “accelerometer”, and a “gyroscope” detect the physical signal exploited in the abstract idea, but they do not constitute a particular machine (i.e., both are recited at a high level of generality). Further, the judicial exception is not applied or used in a meaningful way beyond generally linking its use to a particular technological environment. Additionally, there are no additional elements which apply or use the judicial exception to affect a particular treatment or transform a particular article to a different state or thing. Recitation of the “computing device”, “communication port”, “processor”, and “memory” merely indicates that a computer or equivalent hardware is used as a tool for executing the abstract idea(s), and the claimed system does not reflect an improvement in the functioning of the computer.
The current claims do not have any limitations drawn to performing any decisions, procedures, or steps in response to the determination output by the abstract idea. Although the claims recite a “display device” that is configured for outputting the blood pressure measurement, the “display device” is not part of the abstract idea and is considered data-outputting, categorized under insignificant, extra-solution activity. “As explained by the Supreme Court, the addition of insignificant extra-solution activity does not amount to an inventive concept, particularly when the activity is well-understood or conventional. Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978)” MPEP 2106.05(g). Therefore, there is nothing outside of the abstract idea that shows integration into practical application or significantly more.
At Pg. 13 of the Reply, Applicant cites a portion of the previous Office Action and argues “Applicant respectfully submits that neither this former version of the limitation, nor the rest of claim 13, merely recite formulae. Instead, they provide a clear solution in the field of non-invasive medical monitoring…[i]t is respectfully submitted that the amended claims do not recite any judicial exceptions. In accordance with the USPTO's own examples presented in the Memo, the amended claims may include techniques and/or activities that involve or rely upon mathematical concepts, but they do not describe any specific mathematical calculations or formulas”. Examiner respectfully disagrees.
The step of “determin[ing] a vibration feature exclusively from the vibration signal, determin[ing] a blood pressure measurement from the vibration feature such that the blood pressure measurement is obtained exclusively from the detected myocardial vibrations, and generat[ing] a human-readable format of the blood pressure measurement” recites an abstract idea in the form of a mental processes, as consistent with Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind, see Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016). Determining blood pressure measurement based on chest vibrations are assessments that may be performed by a human. This applies for all claims dependent on claim 13.
The claims recite mental processes performed on a computer control system. The “Federal Circuit has explained, ‘[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.’ Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015).” MPEP 2106.04(a)(2) III. Thus, the use of the “computing device” including a “processor” and “memory” does not prevent identification of the abstract idea as a mental process. There is no time limit recited for performing the steps. The claimed steps can be performed via pen and paper or in a person’s mind with no time limit. The computer is merely utilized as a tool to perform the mental steps.
At Pg. 14 of the Reply, Applicant argues “[a]s decided in the US Supreme Court decision in Diamond V. Diehr, 450 U.S. 175 (1981), ‘In determining the eligibility of respondents' claimed process for patent protection under § 101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis.’ This is reiterated in the Memo, which similarly states that Examiners ‘should only make a rejection when it is more likely than not that the claim is ineligible under 35 U.S.C. 101.’ Applicant respectfully submits that the Examiner's approach of rejecting the entirety of claim 13 based on a single limitation departs from the standards provided by both the US Supreme Court and the USPTO”. Examiner respectfully disagrees.
The currently claimed limitations lack the specificity of those in Diamond v. Diehr, 450 U.S. 175 (198). Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter. The Examiner would further like to clarify that the Examiner is not asserting that the whole claim is an abstract idea. Rather, the Examiner is arguing that the abstract idea is only coupled with limitations that are insufficient in showing integration into practical application or amounting to significantly more than the abstract idea itself.
At Pgs. 14-15 of the Reply, Applicant maintains that the claims reflect an improvement, arguing “[a]s an example, the claimed invention improves, among other aspects, medical monitoring techniques. Conventional approaches to blood pressure measurement and monitoring are not suitable for continuous remote health monitoring applications. They can be invasive, involve complicated equipment setups that add inconveniences and reduce freedom of movement, and may require another person to administer the measurement or process the results. Accordingly, a significant goal of the claimed invention is to improve medical monitoring techniques by providing for non-invasive techniques. Such techniques may be particularly well suited to remote applications such as telehealth monitoring, military applications, spaceflight missions, or other scenarios where health professionals may not be physically present or accessible and where maintaining health states can be particularly critical. Applicant respectfully submits that such improved techniques would be apparent to those of ordinary skill in the art”. Examiner respectfully disagrees.
“The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification).” MPEP 2106.05(a). “That is, the claim must include the components or steps of the invention that provide the improvement described in the specification.” Id.
“[I]n McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea.” MPEP 2106.05 (a). There is no improvement to a computer or other technology. Unlike McRO, the claimed system invokes a computer as a tool to perform a mathematical concept and/or mental process.
The processor, units, and memory perform the same with or without the claimed abstract idea. Therefore, it is unclear how the abstract idea can improve the standard functions of the additional elements.
The Examiner would like to clarify that the claimed steps do not improve the functioning of the data acquisition or the signal exchange. “It is important to note, the judicial exception alone cannot provide the improvement.” MPEP 2106.05(a). The data acquisition and signal exchange appear to perform the same with or without the abstract idea. Therefore, any improvement resides solely within the abstract idea.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive. The rejections are maintained, and further clarified, in view of the amendment.
At Pgs. 16-17 of the Reply, Applicant argues that the previously cited art does not teach, disclose, or suggest the newly added limitations of independent claim 13. Examiner respectfully disagrees. Kale, the previously cited primary reference, clearly teaches the newly added limitations of independent claim 13.
Regarding the newly added limitation of “the sensor device for detecting myocardial vibrations at a single point at a surface of a chest of the subject and transmitting a vibration signal associated with the detected myocardial vibrations”, Kale teaches a transducer array 102, equivalent to the sensor device, which may be implemented as a single transducer which would then detect vibrations at a single point (transducer array 102 may be implemented as a single transducer; [0038]) and applied to the patient’s chest (transducer array 102 may be applied to a patient's torso (i.e., chest, abdomen, back, ribcage, etc.); [0038]) for detecting myocardial vibrations (Examiner’s Note: The definition of “myocardial” is “relating to the muscular tissue of the heart”. Therefore, the transducer 102 placed on the chest of the subject would be measuring vibrations related to the muscular tissue of the heart) and transmitting a vibration signal associated with the detected myocardial vibrations (transducer array 102 may be operative to capture or acquire sonic energy, vibrational energy, or both within frequency ranges that are medically or diagnostically relevant as well as to direct or transmit signals representative of such sonic energy or vibrational energy to another component of system 100 for processing or analysis; [0038]).
Regarding the newly added limitation of “a blood pressure measurement from the vibration feature such that the blood pressure measurement is obtained exclusively from the detected myocardial vibrations”, Kale clearly teaches a system of measuring hemodynamic parameters (equivalent to the claimed “blood pressure measurement”), by employing cardiac time intervals (equivalent to the claimed “vibration feature”) calculated from source separated individual cardio-pulmonary signals isolated from vibrations captured on the chest wall (equivalent to the claimed “detected myocardial vibrations”) ([0026]). Kale teaches a method of measuring systolic blood pressure (SBP) and diastolic blood pressure (DBP) using the formula X=A1+A2*(S1S2/S2S1), where X=SBP or DBP, and where A1 and A2 again denote predetermined numerical constants, and S1S2 and S2S1 may be cardiac time intervals or a ratio of cardiac intervals ([0054]). The blood pressure equation taught by Kale only requires 4 variables: A1, A2, S1S2, and S2S1. A1 and A2 are mathematical constants that do not change in value and are being used as proportionality constants in the equation. Therefore, the only actual variables are S1S2 and S2S1, which are cardiac time intervals, equivalent to the vibration features determined from the vibration signal. Examiner would further like to note that even [0018] of the Applicant’s Specification recites wherein “the vibration feature may include determining any one or more of jerk, amplitude, frequency, phase, and a cardiac time interval from a linear acceleration component or rotational velocity component of the vibration signal”. Therefore, a “cardiac time interval” would qualify as a vibration feature determined exclusively from the vibration signal, and since Kale utilizes an equation to measure blood pressure using only constants and vibration features, Kale clearly teaches the newly added limitation of “a blood pressure measurement from the vibration feature such that the blood pressure measurement is obtained exclusively from the detected myocardial vibrations”.
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 13-14 and 17-21 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. Each of Claims 13-14 and 17-21 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 13-14 and 17-21 recite a system for non-invasive blood pressure measurement of a subject. Thus, the claims are directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 13-14 and 17-21 recites at least one step or instruction for non-invasive blood pressure measurement of a subject, which is grouped as a mental process under the 2019 PEG. The claimed steps of determining and generating can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
Accordingly, each of Claims 13-14 and 17-21 recites an abstract idea.
Specifically, Claim 13 recites the abstract idea of: “determine a vibration feature exclusively from the vibration signal, determine a blood pressure measurement from the vibration feature such that the blood pressure measurement is obtained exclusively from the detected myocardial vibrations, and generate a human-readable format of the blood pressure measurement”.
Further, dependent Claims 14 and 17-21 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the abstract idea steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claim 13 (and its dependent Claims 14 and 17-21) is not integrated into a practical application under 2019 PEG because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: “sensor device”, “accelerometer”, “gyroscope”, “computing device”, “communication port”, “processor”, “memory”, and “display device” are generically recited elements in independent Claim 13 (and its dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claim 13 (and its dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., “computing device” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 13 (and its dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 13 (and its dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 13-14 and 17-21 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “sensor device”, “accelerometer”, “gyroscope”, “computing device”, “communication port”, “processor”, “memory”, and “display device” as recited in independent Claim 13 and its dependent claims. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks and/or categorized as data-gathering or data-outputting elements. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93. The steps of detecting, transmitting, receiving, storing, and outputting are categorized as extra-solution activity in the forms of data-gathering and data-outputting.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
Applicant’s specification (e.g. paragraphs [0179-0196]) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. determining, generating) that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Applicant’s Background in the specification; and
The non-patent literature of record in the application.
Accordingly, in light of Applicant’s specification, the claimed term “computing device” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the computing device. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 13-14 and 17-21 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the system of Claims 13-14 and 17-21 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 13-14 and 17-21 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 13 (and its dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 13-14 and 17-21 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 13-14 and 17-21 amounts to significantly more than the abstract idea itself. Accordingly, Claims 13-14 and 17-21 are not patent eligible and rejected under 35 U.S.C. 101.
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 13-14 and 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kale et al (U.S. Publication No. 2017/0188978; cited by Applicant; previously cited) in view of NPL Yang et al (Yang, C., & Tavassolian, N. (2017). Combined seismo-and gyro-cardiography: A more comprehensive evaluation of heart-induced chest vibrations. IEEE journal of biomedical and health informatics, 22(5), 1466-1475.; cited by Applicant; previously cited).
Regarding Claim 13, Kale discloses a system for non-invasive blood pressure measurement of a subject (A system and method for monitoring and diagnosing heart conditions; Abstract), the system comprising:
a sensor device (transducer array 102) including an accelerometer (transducer array 102 may be embodied in or comprise a sonic or an ultrasonic transducer 102 a, an accelerometer transducer 102 b; [0038]), the sensor device for detecting myocardial vibrations at a single point (transducer array 102 may be implemented as a single transducer in some implementations where hardware and processing capabilities are suitable for using a single transducer component as opposed to an array of components disposed at different locations relative to the environment 101; [0038]) at a surface of a chest of the subject and transmitting a vibration signal associated with the detected myocardial vibrations (transducer array 102 may be applied to a patient's torso (i.e., chest, abdomen, back, ribcage, etc.) in or proximate to auditory environment 101 from which relevant sound and other vibrations may emanate…transducer array 102 may be embodied in or comprise a sonic or an ultrasonic transducer 102 a, an accelerometer transducer 102 b…transducer array 102 may be operative to capture or acquire sonic energy, vibrational energy, or both within frequency ranges that are medically or diagnostically relevant as well as to direct or transmit signals representative of such sonic energy or vibrational energy to another component of system 100 for processing or analysis; [0038]; Examiner’s Note: The definition of “myocardial” is “relating to the muscular tissue of the heart”. Therefore, the accelerometer transducer 102 placed on the chest of the subject would be measuring vibrations related to the muscular tissue of the heart);
a computing device communicatively connected to the sensor device via a data communication link (As illustrated in FIGS. 1A and 1B, reference numeral 103 represents a wearable microprocessor-based hardware component having, in some instances, digital signal processing capabilities, an application processor, an analog to digital frontend, data storage, an input mechanism such as buttons or a touch-sensitive display, and wireless connectivity to other components of system 100, such as via Bluetooth™, Bluetooth™ low energy, some other near field communication transceiver, Wi-Fi, Ethernet, or USB. The individual hardware elements (reference numeral 112) of wearable component 103 are generally well known in the art, and so details have been omitted from the drawings for clarity. In some implementations, some or all of the functionality described below with reference to wearable component 103 may be executed by a remote processing component 105; [0039]), the computing device including:
a communication port for receiving the vibration signal from the sensor device via the data communication link (wearable component 103 may generally comprise a signal processing module operative (e.g., integrated with hardware 112) to capture or otherwise to receive sensor data from transducer array 102; [0040]);
a processor configured to determine a vibration feature exclusively from the vibration signal (FIG. 3 illustrates individual streams identified by a system and method of capturing multi-channel vibration signals; [0045]; reference numeral 405 in FIG. 4 indicates certain vibration changes during a cardiac cycle as captured by an accelerometer transducer, and reference numeral 406 indicates the different valve opening and closing events as captured by the accelerometer sensor; [0047]; FIG. 6 illustrates the source separation of heart valve opening and closing signals 600, wherein: 601 indicates a vibration signal for mitral valve closing, 602 indicates a vibration signal for the tricuspid valve closing, 603 indicates a vibration signal for the aortic valve closing, 604 indicates a vibration signal for the pulmonic valve closing, 605 indicates a composite vibration signal captured by a particular transducer, and 606 indicates an EKG signal captured by the system. Similarly, 607 indicates a vibration signal for the aortic valve opening, and 608 indicates a vibration signal for the pulmonic valve opening; [0050]), determine a blood pressure measurement from the vibration feature (a system and method of measuring hemodynamic parameters may employ cardiac time intervals (described below) calculated from source separated individual cardio-pulmonary signals isolated from composite vibrations captured on the chest wall…the disclosed implementations may be operative with respect to various hemodynamic measurements, such as: systolic blood pressure; diastolic blood pressure; pulmonary arterial blood pressure; [0026]; Examiner’s Note: As recited in [0018] of the Applicant’s Specification, “the vibration feature may include determining any one or more of jerk, amplitude, frequency, phase, and a cardiac time interval from a linear acceleration component or rotational velocity component of the vibration signal”. Therefore, a “cardiac time interval” would qualify as a vibration feature determined exclusively from the vibration signal, and Kale clearly teaches a system of measuring hemodynamic parameters, including blood pressure, by employing cardiac time intervals calculated from source separated individual cardio-pulmonary signals isolated from composite vibrations captured on the chest wall) such that the blood pressure measurement is obtained exclusively from the detected myocardial vibrations (a method of measuring a parameter indicative of systolic blood pressure (SBP) and diastolic blood pressure (DBP) may generally comprise using the formula X=A1+A2*(S1S2/S2S1), where X=SBP or DBP, and where A1 and A2 again denote predetermined numerical constants, and S1S2 and S2S1 may be cardiac time intervals or a ratio of cardiac intervals. The numerical values of A1 and A2 in the formula above may be set, by way of example, according to empirical data such as illustrated in FIG. 8 (A1=−191.46, A2=769.23); [0054]; S1S2 or M1A2 (or closure of Mitral valve to Closure of Aortic valve), S2S1 or A2M1 (or closure of aortic valve to closure of the mitral valve of the next heart cycle); [0051]; Examiner’s Note: The blood pressure equation taught by Kale only requires 4 variables: A1, A2, S1S2, and S2S1. A1 and A2 are mathematical constants that do not change in value and are being used as proportionality constants in this equation. Therefore, the only actual variables are S1S2 and S2S1, which are cardiac time intervals, equivalent to the vibration features determined from the vibration signal), and generate a human-readable format of the blood pressure measurement (During use of system 100, a user may be enabled to see individual streams, composite signals, or both, as well as other information related to or derived from different cardio-pulmonary signals displayed by a suitable hardware. In one embodiment, visualization may be provided by a display associated with wearable component 103; [0043]);
a memory for storing the blood pressure measurement (suitable hardware 112 resident at or incorporated in wearable component 103 may save or store data (received from transducer array 102) to memory (not shown in FIG. 1) and may communicate some or all of same to other components of system 100; [0041]); and
a display device for outputting the blood pressure measurement in the human-readable format (During use of system 100, a user may be enabled to see individual streams, composite signals, or both, as well as other information related to or derived from different cardio-pulmonary signals displayed by a suitable hardware. In one embodiment, visualization may be provided by a display associated with wearable component 103; [0043]).
Kale fails to teach wherein the sensor device further includes a gyroscope.
In a similar technical field, NPL Yang teaches wherein the sensor device includes an accelerometer and a gyroscope (The strap is tightened to make a firm contact between the sensor and the chest wall. The sensor node consists of a 3-axis MEMS accelerometer (Kionix KXRB5-2042, Kionix, Inc.) and a 3-axis MEMS gyroscope (Invensense MPU9150, Invensense, Inc.). The SCG and GCG sensors share the same coordinate system; Page 1468).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the gyroscopic teachings of NPL Yang into the invention of Kale because incorporating gyroscopic signals yield a higher motion artifact rejection level compared to using accelerometer readings alone (NPL Yang Page 1467).
Regarding Claim 14, Kale discloses wherein the processor is further configured to identify vibrational pulses V1 and V2 from vibrational cardiography (VCG) data, the VCG data derived from the vibration signal, and determine the vibration feature from the vibrational pulses V1 and V2 (the two major audible heart sounds in a normal cardiac cycle are the first and second heart sound, S1 and S2, respectively. S1 occurs at the onset of the ventricular contraction during the closure of the mitral and tricuspid-valves. It generally contains a series of low-frequency vibrations, and is usually the longest and loudest heart sound. Audible sub-components of S1 may be associated with the closure of each of the two mitral and tricuspid valves. S2 is generally heard at the end of the ventricular systole, during the closure of the aortic and pulmonic valves…these vibrations usually precede the onset of the QRS complex, except in instances of short P-R intervals. Unless the P-R interval is prolonged, S4 is normally inaudible, although some small, insignificant vibrations may be recorded at low frequency ranges. Significant (i.e., abnormal) vibrations have greater amplitude and pitch, and constitute the audible, and clinically meaningful, S4, which may be readily recorded, even at medium frequency ranges; [0035-0036]; FIG. 3 illustrates individual streams identified by a system and method of capturing multi-channel vibration signals; [0045]; reference numeral 405 in FIG. 4 indicates certain vibration changes during a cardiac cycle as captured by an accelerometer transducer, and reference numeral 406 indicates the different valve opening and closing events as captured by the accelerometer sensor; [0047]; FIG. 6 illustrates the source separation of heart valve opening and closing signals 600, wherein: 601 indicates a vibration signal for mitral valve closing, 602 indicates a vibration signal for the tricuspid valve closing, 603 indicates a vibration signal for the aortic valve closing, 604 indicates a vibration signal for the pulmonic valve closing, 605 indicates a composite vibration signal captured by a particular transducer, and 606 indicates an EKG signal captured by the system. Similarly, 607 indicates a vibration signal for the aortic valve opening, and 608 indicates a vibration signal for the pulmonic valve opening; [0050]).
Regarding Claim 17, Kale discloses wherein determining the blood pressure measurement by the processor includes determining maxima, minima, or mean of a central aortic or left ventricular pressure waveform for each cardiac cycle in real-time (FIG. 3 illustrates individual streams identified by a system and method of capturing multi-channel vibration signals; [0045]; reference numeral 405 in FIG. 4 indicates certain vibration changes during a cardiac cycle as captured by an accelerometer transducer, and reference numeral 406 indicates the different valve opening and closing events as captured by the accelerometer sensor; [0047]; FIG. 6 illustrates the source separation of heart valve opening and closing signals 600, wherein: 601 indicates a vibration signal for mitral valve closing, 602 indicates a vibration signal for the tricuspid valve closing, 603 indicates a vibration signal for the aortic valve closing, 604 indicates a vibration signal for the pulmonic valve closing, 605 indicates a composite vibration signal captured by a particular transducer, and 606 indicates an EKG signal captured by the system. Similarly, 607 indicates a vibration signal for the aortic valve opening, and 608 indicates a vibration signal for the pulmonic valve opening; [0050]; FIG. 6 illustrates one representation of cardiac time intervals estimated from source separated heart valve signals. In an embodiment, extracted individual valve vibration objects may be aligned into a signal for each of the four heart valves across multiple heart beats…the time reference or registration comes from annotation of the simultaneously recorded ECG signal's Q or R wave. For instance, isovolumic contraction time (IVCT or the Mitral Valve Closure to Aortic Valve Opening period), isovolumic relaxation times (IVRT or Aortic Valve Closer to Mitral Valve Opening period), pre-ejection period (PEP or Q to Aortic Opening period), electomechanical delay (EMD) or Electromechanical activation time (EMAT) or Q to Mitral Closing period), left ventricular ejection time (LVET or Aortic valve opening to Aortic Valve Closure period), S1S2 or M1A2 (or closure of Mitral valve to Closure of Aortic valve), S2S1 or A2M1 (or closure of aortic valve to closure of the mitral valve of the next heart cycle), along with similar time intervals for the tricuspid and pulmonary valve, are examples of such time features; [0050-0051]).
Regarding Claim 18, although Kale discloses wherein the vibration signal includes a linear acceleration component (an accelerometer transducer 102 b, or other electromagnetic hardware component such as an EKG sensor or the like. In use, transducer array 102 may be operative to capture or acquire sonic energy, vibrational energy, or both within frequency ranges that are medically or diagnostically relevant as well as to direct or transmit signals representative of such sonic energy or vibrational energy to another component of system 100 for processing or analysis; [0038]; Examiner’s Note: Accelerometers measure linear acceleration), Kale fails to teach wherein the vibration signal includes a rotational velocity component.
NPL Yang teaches wherein the vibration signal includes a linear acceleration component and a rotational velocity component (Our research focuses on the infrasonic components of the vibration in both linear and rotational aspects…the chest mechanical vibrations are coupled into both linear and rotational kinetic energies of the chest wall; Page 1468).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the rotational component teachings of NPL Yang into the invention of Kale because incorporating rotational components yield a higher motion artifact rejection level compared to using linear components alone (NPL Yang Page 1467).
Regarding Claim 19, Kale fails to teach wherein the vibration signal includes six orthogonal motion signals.
NPL Yang teaches wherein the vibration signal includes six orthogonal motion signals (The sensor node consists of a 3-axis MEMS accelerometer (Kionix KXRB5-2042, Kionix, Inc.) and a 3-axis MEMS gyroscope (Invensense MPU9150, Invensense, Inc.); Page 1468).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the 6-axis teachings of NPL Yang into the invention of Kale because incorporating additional 3-axis rotational signals from a gyroscope yield a higher motion artifact rejection level compared to using 3-axis linear signals from an accelerometer alone (NPL Yang Page 1467).
Regarding Claim 20, Kale fails to teach wherein determining the vibration feature by the processor includes quantifying a fraction of energy of stroke volume converted to vibration.
NPL Yang teaches wherein determining the vibration feature by the processor includes quantifying a fraction of energy of stroke volume converted to vibration (more than 60% of the kinetic energy of the waveform recorded from a chest wall IMU sensor is in the form of rotation rather than the 3-axis linear acceleration…a mechanical coupling model that includes both the rotational and linear kinetic movements will be able to draw connections between SCG and GCG signals and potentially explain the intersubject differences…our experiments have indicated that the rotational kinetic energy waveform can be used to generate annotation timing envelopes for IM and AC indices in the SCG signal. We also reported a higher motion artifact rejection level for the gyroscope signal (GCG) compared to accelerometer readings (SCG). Representative gyroscope recordings from our device are illustrated in Fig. 1(b); Page 1467).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the kinetic energy teachings of NPL Yang into the invention of Kale because quantifying rotational kinetic energy signals from a gyroscope yield a higher motion artifact rejection level compared to merely quantifying linear kinetic energy signals from an accelerometer alone (NPL Yang Page 1467).
Regarding Claim 21, Kale discloses wherein determining the vibration feature by the processor includes determining any one or more of jerk, amplitude, frequency, phase, or a cardiac time interval from a linear acceleration component or rotational velocity component of the vibration signal (the two major audible heart sounds in a normal cardiac cycle are the first and second heart sound, S1 and S2, respectively. S1 occurs at the onset of the ventricular contraction during the closure of the mitral and tricuspid-valves. It generally contains a series of low-frequency vibrations, and is usually the longest and loudest heart sound…these vibrations usually precede the onset of the QRS complex, except in instances of short P-R intervals. Unless the P-R interval is prolonged, S4 is normally inaudible, although some small, insignificant vibrations may be recorded at low frequency ranges. Significant (i.e., abnormal) vibrations have greater amplitude and pitch, and constitute the audible, and clinically meaningful, S4, which may be readily recorded, even at medium frequency ranges; [0035-0036]; FIG. 3 illustrates individual streams identified by a system and method of capturing multi-channel vibration signals; [0045]; reference numeral 405 in FIG. 4 indicates certain vibration changes during a cardiac cycle as captured by an accelerometer transducer, and reference numeral 406 indicates the different valve opening and closing events as captured by the accelerometer sensor; [0047]; FIG. 6 illustrates the source separation of heart valve opening and closing signals 600, wherein: 601 indicates a vibration signal for mitral valve closing, 602 indicates a vibration signal for the tricuspid valve closing, 603 indicates a vibration signal for the aortic valve closing, 604 indicates a vibration signal for the pulmonic valve closing, 605 indicates a composite vibration signal captured by a particular transducer, and 606 indicates an EKG signal captured by the system. Similarly, 607 indicates a vibration signal for the aortic valve opening, and 608 indicates a vibration signal for the pulmonic valve opening; [0050]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791
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