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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP21194466.5, filed on 09/02/2021.
Information Disclosure Statement
The information disclosure statement(s) filed 03/01/2024 has/have been considered by the Examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract recites, “The present invention relates to…” which constitutes implied phraseology and should be avoided. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 2-3, 6, and 14 is objected to because of the following informalities:
Claims 2-3 and 6 includes the symbol, (Δt), which should be removed. Appropriate correction is required.
Claim 14 does not include a wherein clause (“The method according to claim 1, applied to a measurement of a subject during a sleep cycle”). Examiner interprets claim 14 to refer to the method of claim 14 to be applied. 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 non-statutory subject matter (abstract ideas) without significantly more.
Step 1):
Claims 1-14 recite a method of synchronizing output signals from a plurality of sensors, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Claims 15 recite a system of synchronizing output signals from a plurality of sensors, which satisfies the 4 statutory categories (process, machine, manufacture, or composition of matter) of patent-eligible subject matter.
Step 2a) Prong One:
Independent claim 1 recites:
A method of synchronizing output signals from a plurality of sensors each measuring a heart rate derivable physiological signal of a subject, comprising the steps of:
providing a first output signal acquired by means of a first sensor configured to measure a heartbeat derivable physiological signal of a subject;
providing a second output signal acquired by means of a second sensor configured to measure a heartbeat derivable physiological signal of the subject, wherein each of the first and second sensor comprises an independent clock for associating the first and second output signals with a respective time domain, the method further comprising the steps of:
determining a first heart rate sequence signal from the first output signal;
determining a second heart rate sequence signal from the second output signal;
identifying timings of at least one heart rate event in the respective first and second heart rate sequence signals; and
determining a first time domain transformation for the time domain of the second output signal to the time domain of the first output signal by means of a model fitted to the timings of the at least one heart rate event in the respective first and second heart rate sequence signals,
providing a first additional physiological signal captured by means of the first sensor which is different from the first output signal;
providing a second additional physiological signal captured by means of the second sensor which is different from the second output signal;
applying model parameters of said model to said first and second additional physiological signals to synchronize said first and second additional physiological signals.
Independent claim 15 recites:
A system for synchronizing sensor output signals comprising:
at least a first and a second sensor each configured to measure a heartbeat derivable physiological signal of a subject and to provide a first and second output signal, respectively, wherein each sensor comprises an independent clock for associating the first and second output signals with a respective time domain;
and a processing unit configured to:
receive the first and second output signals;
determine a first heart rate sequence signal from the first output signal;
determine a second heart rate sequence signal from the second output signal;
identify timings of at least one heart rate event in the respective first and second heart rate sequence signals; and
determine a first time domain transformation for the time domain of the second output signal to the time domain of the first output signal by means of a model fitted to the timings of the at least one heart rate event in the respective first and second heart rate sequence signals;
wherein the first sensor is configured to capture a first additional physiological signal which is different from the first output signal, the second sensor is configured to capture a second additional physiological signal which is different from the first output signal, and the processing unit is configured to
apply model parameters of said model to said first and second additional physiological signals to synchronize said first and second additional physiological signals.
Independent claims 1 and 15 are all directed to MENTAL PROCESSES, where nothing in the claim elements precludes the steps from practically being performed in the human mind or by a human using pen and paper. In the instant case, a person could mentally receive data by observing and memorizing data, or by writing the value on a piece of paper. A person could then mentally determine and identify mentally observing and analyzing to conclude something.
Claims 1 and 15 can also be directed MATHEMATICAL CONCEPTS, which includes application of model parameters which use mathematical concepts of linear modeling to manipulate data, of which can also be calculated by use of pen and paper.
Dependent claims 2-14 contain no additional elements that integrate the abstract ideas into practical application, or amount to significantly more than the abstract idea itself. Dependent claims 2-14 only further define the abstract ideas (mental processes), and do not amount to significantly more than the abstract idea itself. Dependent claim 6 further defines the mathematical model of claim 1 by a mathematical equation. Accordingly, the dependent claims are also directed to non-statutory subject matter.
Step 2a) Prong Two:
This judicial exception is not integrated into a practical application because mere instruction to implement on a computer, or merely using a computer as a tool to perform the abstract idea, adding insignificant extra solution activity, and/or generally linking the use of the abstract idea to a technological environment or field of use is not considered integration into a practical application. The Court defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
judicial exception is not integrated into a practical application because claims 1-15 do not disclose using the result of the mental process steps (i.e. receiving and determining), for prophylactic treatment of a particular medical condition under MPEP 2106.05(e). In the instant case, there is no specific treatment in the form of stimulation/pacing pulses, drug therapy, or other forms of treatment that is ultimately used to treat a particular condition as a result of the mental process steps/mathematical concepts as outlined above. There is no specific treatment delivered to treat a particular condition that is specified in the claims, but is only directed to a form of simple data analysis. Accordingly, claims 1-15 do not disclose using the result of the mental processes/mathematical concepts steps for prophylactic treatment of a particular medical condition under MPEP 2106.05(e).
This judicial exception is not integrated into a practical application because claims 1-15 do not provide improvements to the functioning of a computer or to any the technical field under MPEP 2106.05(a). Specifically, the claims recite the elements of an ECG and PPG sensor, of which are considered well-understood, routine and conventional in the art. The claims further recite a processing unit; however, this has not been described with sufficient detail to constitute an improvement in the tech field. As such, these features merely define the field of use for the current invention by generally linking mental processes/mathematical concepts to generic computer elements as a tool to execute the abstract ideas. By failing to explain how these elements are different from conventional computer elements, it is reasonable that the broadest reasonable interpretation of the additional elements is just a conventional computer performing generic functions (e.g., data analysis). Conventional computer elements performing basic data analysis is directed to the components of a system amounting to merely field of use type limitations and/or extra solution activity to implement the abstract idea as identified above, and merely including instructions to implement abstract ideas on a computer does not integrate the judicial exception into practical application, see MPEP 2106.04(d) Integration of a Judicial Exception into a Practical Application.
Additional elements further include steps of providing first-fourth/additional output signals, which can be considered pre-solution activity as a data-gathering step by administering the treatments to gather physiological signal data for data analysis. As such, these additional elements are merely nominal or tangential additions to the claims as they do not impose any meaningful limits on the claim, see MPEP 2106.05(g) Insignificant Extra-Solution Activity.
Accordingly, dependent claims 2-14 do not recite additional elements which practically integrate the judicial exception(s) of the current invention.
Step 2b)
Step 2B in the analysis requires us to determine whether the claims do significantly more than
simply describe that abstract method. Mayo, 132 S. Ct. at 1297. We must examine the limitations of the
claims to determine whether the claims contain an "inventive concept" to "transform" the claimed
abstract idea into patent-eligible subject matter. Alice, 134 S. Ct. at 2357 (quoting Mayo, 132 S. Ct. at
1294, 1298). The transformation of an abstract idea into patent-eligible subject matter "requires 'more
than simply stat[ing] the [abstract idea] while adding the words 'apply it."' Id. (quoting Mayo, 132 S. Ct.
at 1294) (alterations in original). "A claim that recites an abstract idea must include 'additional features'
to ensure 'that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].'" Id.
(quoting Mayo, 132 S. Ct. at 1297) (alterations in original). Those "additional features" must be more
than "well-understood, routine, conventional activity." Mayo, 132 S. Ct. at 1298.
The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited ECG and PPG sensor, in addition to the “processor” is/are recognized as generic computer interfaces and generic computers (or computer components), because the claims do not describe these features as having distinguishing element(s) over their generic counterparts, which are well-understood, routine and conventional activities previously known in the industry, as shown in the reference as taught by Rogers (US 20200129077 A1), which teaches two sensor system synchronized (abstract – “Provided are apparatuses and methods for non-invasively measuring a blood pressure of a mammal subject. The apparatus includes a first sensor system and a second sensor system time-synchronized to each other”) comprising an ECG and PPG sensor (paragraph 0014 – “In one embodiment, the first sensor system is an electrocardiography (ECG) sensor system, and the second sensor system is a photoplethysmography (PPG) sensor system”), and a processing unit (figure 1, microcontroller 190).
Additionally, Tomlinson (US 20210275110 A1) similarly teaches a system for measuring and synchronizing physiological signals (paragraph 0002 – “The present invention relates in general to systems for synchronizing the operation of various medical equipment and fitness devices to a user or patient cardiac cycle, and in particular to synchronizing ECG and PPG systems to the cardiac cycle”), comprising ECG and PPG sensors (paragraph 0062 – “Another objective of the present system is to employ the best placement for each of the ECG and PPG sensors on the body”) and a processing unit (calibration device, paragraph 0011)
Thus, the present claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. When looked at individually and as a whole, the claim limitations are determined to be an abstract idea without "significantly more," and thus claims 1-15 are not patent eligible under 35 USC § 101.
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.
Claim(s) 1-5, 7-10, 14-15 is/are rejected under 35 U.S.C. 102(a1/a2) as being anticipated by Lambein (EP3865059A1 – hereinafter Lambein).
Re. claim 1, Lambein teaches a method of synchronizing output signals from a plurality of sensors each measuring a heart rate derivable physiological signal of a subject (paragraph 0001 – “The present invention generally relates to time-synchronizing or aligning an electrocardiogram signal, abbreviated ECG signal, with a photoplethysmography signal, abbreviated PPG signal”), comprising the steps of:
providing a first output signal acquired by means of a first sensor configured to measure a heartbeat derivable physiological signal of a subject (paragraph 0041 – “In step 101, the ECG signal is obtained by an ECG monitoring system, for example a Holter monitoring system”);
providing a second output signal acquired by means of a second sensor configured to measure a heartbeat derivable physiological signal of the subject (paragraph 0041 – “In step 102, the PPG signal is obtained by a PPG sensor, for example a pulse oximeter or smart device with camera, like for instance a smart wristband or smartwatch“),
wherein each of the first and second sensor comprises an independent clock for associating the first and second output signals with a respective time domain (paragraph 0044 teaches respective time domains for ECG and PPG signals – “…the time base used by the PPG sensor that records the PPG signal in step 102… the time base used by the ECG monitoring system…”), the method further comprising the steps of:
determining a first heart rate sequence signal from the first output signal (figure 3 shows ECG and PPG signals over time); determining a second heart rate sequence signal from the second output signal (figure 3 shows ECG and PPG signals over time);
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identifying timings of at least one heart rate event in the respective first and second heart rate sequence signals (paragraph 0044 – “…Fig. 3 is cut out of a recorded PPG signal, an algorithm that detects peaks or local maxima in the PPG signal piece 300 shall detect 25 PPG beats and output… a peak detection algorithm that detects local maxima in the ECG signal piece 350…”);
and determining a first-time domain transformation for the time domain of the second output signal to the time domain of the first output signal by means of a model fitted to the timings of the at least one heart rate event in the respective first and second heart rate sequence signals (paragraphs 0047-0048 describe linear regression modeling on PPG and ECG signals pieces, also shown in figure 4),
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providing a first additional physiological signal captured by means of the first sensor which is different from the first output signal (paragraph 0049 synchronizes ECG and PPG measurements for many hours to create additional signals, respectively; paragraph 0049 – “…long (many hours) simultaneously recorded ECG-PPG measurements”; paragraph 0001 – “…the invention relates to the synchronization of an ECG signal and PPG signal that are semi-simultaneously recorded, for applications wherein the ECG signal and PPG signal are the result of long recordings, typically many hours”);
providing a second additional physiological signal captured by means of the second sensor which is different from the second output signal (paragraph 0049 synchronizes ECG and PPG measurements for many hours to create additional signals, respectively; paragraph 0049 – “…long (many hours) simultaneously recorded ECG-PPG measurements”; paragraph 0001 – “…the invention relates to the synchronization of an ECG signal and PPG signal that are semi-simultaneously recorded, for applications wherein the ECG signal and PPG signal are the result of long recordings, typically many hours”)
applying model parameters of said model to said first and second additional physiological signals to synchronize said first and second additional physiological signals (paragraphs 0047-0049 teaches synchronization of ECG and PPG signals using linear regression modeling).
Re. claim 2, Lambein further teaches wherein the step of determining a first-time domain transformation comprises the steps of identifying a first-time difference between the timing of a first heart rate event in the first heart rate sequence signal and the timing of a corresponding first heart rate event in the second heart rate sequence signal (paragraph 0044 – “The total distance d between the PPG peak time vector [301, ..., 315] and the ECG peak time vector [351, ..., 365] is determined as the sum of the absolute time differences between all pairs of matching ECG-PPG peaks”),
and forming the model based on the first-time difference (paragraph 0047 – “The linear regression is applied with weights 1/do such that best matching tuples with higher minimal distance do between PPG and ECG peak time vectors get a lower weight in the linear model 400”).
Re. claim 3, Lambein further teaches wherein the method further comprises a step of resampling the second output signal based on the first-time domain transformation (paragraph 0037 – “…generating a vector of PPG peak times for peaks in the PPG signal piece; -selecting different offsets o; -cutting different ECG signal pieces out of the ECG signal by applying the different offsets o in the ECG signal…”; paragraph 0045 – “The best synchronization is determined by testing different offsets o and selecting the offset oo which has the minimal distance between two vectors, one vector with ECG peaks (which varies with the offset o and thus with the location y) and one vector with PPG peaks (which remains constant at location x)”).
Re. claim 4, Lambein further teaches wherein the first heart rate sequence signal is based on a portion of the first output signal and the second heart rate sequence signal is based on a portion of the second output signal (figure 3 shows ECG and PPG signals over portions of time).
Re. claim 5, Lambein further teaches wherein the method further comprises a step of resampling the second output signal based on the first-time domain transformation (paragraph 0037 – “…generating a vector of PPG peak times for peaks in the PPG signal piece; -selecting different offsets o; -cutting different ECG signal pieces out of the ECG signal by applying the different offsets o in the ECG signal…”; paragraph 0045 – “The best synchronization is determined by testing different offsets o and selecting the offset oo which has the minimal distance between two vectors, one vector with ECG peaks (which varies with the offset o and thus with the location y) and one vector with PPG peaks (which remains constant at location x)”).
Re. claim 7, Lambein further teaches wherein at least one of the first and second sensors providing the first and second output signals is a body-worn sensor (paragraph 0019 – “…contact PPG sensor…”; paragraph 0020 – “The ECG signal is obtained by an ECG monitoring system, for example a Holter monitoring system”, which are known to attach electrodes to the body).
Re. claim 8, Lambein further teaches wherein said body-worn sensor is configured to be worn on the chest, the head, and/or a leg of a subject (paragraph 0020 – “The ECG signal is obtained by an ECG monitoring system, for example a Holter monitoring system”, which are known to attach electrodes to the body).
Re. claim 9, Lambein further teaches wherein at least one of the sensors providing an output signal is an ECG-measuring sensor (paragraph 0020 – “The ECG signal is obtained by an ECG monitoring system, for example a Holter monitoring system”).
Re. claim 10, Lambein further teaches wherein at least one of the sensors providing an output signal is a PPG-measuring sensor (paragraph 0041 – “In step 102, the PPG signal is obtained by a PPG sensor, for example a pulse oximeter or smart device with camera, like for instance a smart wristband or smartwatch“).
Re. claim 14, Lambein further teaches the method applied to a measurement of a subject during a sleep cycle (Lambein teaches providing ECG and PPG signals during sleep, paragraph 0034 – “…synchronizing a PPG signal with an ECG signal according to the invention, as defined by claim 7, the annotations comprise one or more of the following… non-rhythm clinical annotations comprising: sleep apnea”; paragraph 0035 – “…improved ECG-PPG annotation mapping may be used to detect insufficient quality on the ECG, insufficient quality on the PPG, impossibility or insufficient quality in the mapping between ECG and PPG, as well as other non-rhythm clinical annotations, like for instance sleep apnea”).
Re. claim 15, Lambein teaches a system for synchronizing sensor output signals (paragraph 0001 – “The present invention generally relates to time-synchronizing or aligning an electrocardiogram signal, abbreviated ECG signal, with a photoplethysmography signal, abbreviated PPG signal”) comprising:
at least a first and a second sensor each configured to measure a heartbeat derivable physiological signal of a subject and to provide a first and second output signal, respectively (paragraph 0041 – “In step 101, the ECG signal is obtained by an ECG monitoring system, for example a Holter monitoring system… “In step 102, the PPG signal is obtained by a PPG sensor, for example a pulse oximeter or smart device with camera, like for instance a smart wristband or smartwatch“),
wherein each sensor comprises an independent clock for associating the first and second output signals with a respective time domain (paragraph 0044 teaches respective time domains for ECG and PPG signals – “…the time base used by the PPG sensor that records the PPG signal in step 102… the time base used by the ECG monitoring system…”);
and a processing unit (paragraph 0036 – “…the controller comprising at least one processor and at least one memory including computer program code, the at least one memory and computer program code being configured to, with the at least one processor, cause the controller to perform”) configured to:
receive the first and second output signals and determine a first heart rate sequence signal from the first output signal (figure 3 shows ECG and PPG signals over time); determine a second heart rate sequence signal the second output signal (figure 3 shows ECG and PPG signals over time);
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identify timings of at least one heart rate event in the respective first and second heart rate sequence signals (paragraph 0044 – “…Fig. 3 is cut out of a recorded PPG signal, an algorithm that detects peaks or local maxima in the PPG signal piece 300 shall detect 25 PPG beats and output… a peak detection algorithm that detects local maxima in the ECG signal piece 350…”);
and determine a first time domain transformation for the time domain of the second output signal to the time domain of the first output signal by means of a model fitted to the timings of the at least one heart rate event in the respective first and second heart rate sequence signals (paragraphs 0047-0048 describe linear regression modeling on PPG and ECG signals pieces, also shown in figure 4),
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wherein the first sensor is configured to capture a first additional physiological signal which is different from the first output signal (paragraph 0049 synchronizes ECG and PPG measurements for many hours to create additional signals, respectively; paragraph 0049 – “…long (many hours) simultaneously recorded ECG-PPG measurements”; paragraph 0001 – “…the invention relates to the synchronization of an ECG signal and PPG signal that are semi-simultaneously recorded, for applications wherein the ECG signal and PPG signal are the result of long recordings, typically many hours”),
the second sensor is configured to capture a second additional physiological signal which is different from the first output signal (paragraph 0049 synchronizes ECG and PPG measurements for many hours to create additional signals, respectively; paragraph 0049 – “…long (many hours) simultaneously recorded ECG-PPG measurements”; paragraph 0001 – “…the invention relates to the synchronization of an ECG signal and PPG signal that are semi-simultaneously recorded, for applications wherein the ECG signal and PPG signal are the result of long recordings, typically many hours”),
and the processing unit is configured to apply model parameters of said model to said first and second additional physiological signals to synchronize said first and second additional physiological signals (paragraphs 0047-0049 teaches synchronization of ECG and PPG signals using linear regression modeling).
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.
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lambein (EP3865059A1 – hereinafter Lambein).
Re. claim 11-13, Lambein teaches determining a time domain transformation for the time domains of the second output signal to the time domain of the first output signal by means of a model fitted to the timings of the at least one heart rate event in the respective first and second heart rate sequence signals as stated above in claim 1, but does not explicitly teach providing a third and fourth output signal each acquired by means of a respective third and fourth sensor measuring a heart rate derivable physiological signal of a subject, and determining a second and a third time domain transformation for the time domains of the third and fourth output signals to the time domain of the first output signal by means of respective models fitted to the timings of heartbeats in the respective first and third heart rate sequence signals and first and fourth heart rate sequence signals, respectively;
wherein two of the first, second, third, and fourth sensors are ECG-measuring sensors;
and wherein two of the first, second, third, and fourth sensors are PPG-measuring sensors.
However, it is held that “…mere duplication of parts has no patentable significance unless a new and unexpected result is produced”, as per in re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), see 2144.04. VI. B. Duplication of Parts. In the instant case, duplicating the ECG and PPG sensors to sense third and fourth output signals and determine their domain transformations to the time domain of the first output would not change operation of the device, nor produce any unexpected results in determining time domain transformations as well as synchronizing additional physiological signals.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lambein, specifically the providing output signals, to try duplicating the ECG and PPG sensors to provide third and fourth output signals, since such modification would still predictably result in determining time domain transformations as well as synchronizing additional physiological signals.
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not reasonably anticipate and/or render obvious to the linear model described as A+Bt2, wherein A represents an initial time offset between the first and second heart rate sequence signals, B represents a clock drift of the clock of the second sensor based on the first and second time differences, and t2 is the time instant of the time domain of the second output signal. As claimed in claim 6.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796