DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-19 are pending.
This action is Non-Final.
Drawings
The drawings are objected to because
Figure 1A has stray lead lines and a stray “10” near 106
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 3-6, 8, 10-11 13, 18-19 are objected to because of the following informalities: abbreviations should be defined prior to usage for clarity: claim 10 “ECG, PPG, ICG”. Claim terminology should be clear and consistent: Claims 1, 3-6, 8, 13, 18, 19 “the blood pressure signal” should read “the at least one blood pressure related signal”; Claim 1, 3-6, 10, 12, 18-19 “the pulse related signal” should read “the at least one pulse related signal”; Claims 8 and 19 “the pressure sensor” should read “ the at least one pressure sensor”; Claim 11 “the motion sensor” should read “the at least one motion sensor”; Claim 19 “the pulse sensor” should read “the at least one pulse sensor”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-10, 14-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the motion related signal". There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "the correlation". There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 7, the limitations “The method according to claim 1, wherein the correlation score is determined using a correlation function, configured to be applied to one or more of the obtained signals, or any parameters derived therefrom” renders the claim indefinite. There are no steps of determining or obtaining from claim 1, which the claim depends from. This makes the metes and bounds of the claim indefinite. For examination purposes, the limitations are interpreted as being intended results and do not further limit any active process claimed.
Regarding claim 8, the limitations “The method according to claim 1, wherein the correlation score indicative of the validity of the blood pressure signal is determined by: pairing and comparing one or more features of the signals obtained from the pressure sensor and one or more features of the signals obtained from the pulse-related sensors; and determining an agreement value between pairs of signals, wherein the correlation score is determined based on the agreement value” renders the claim indefinite. There are no steps of determining or obtaining from claim 1, which the claim depends from. This makes the metes and bounds of the claim indefinite. For examination purposes, the limitations are interpreted as being intended results and do not further limit any active process claimed.
Claim 8 recites the limitation "the pulse-related sensors". There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the pulse related sensor". There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 14, the limitations “an ambulatory subject, the device comprising:
a wearable body comprising a pressure sensor(s) configured to be worn by the subject;
a pulse-related sensor(s) associated with the wearable body; and
a processor configured to execute the method according to claim 1” renders the claim indefinite. Claim 14 depends directly from claim 1 but refers to a subject which is not clear if this is the same or different from claim 1, and then further limits “the subject”; refers to sensors which are not clear if these are the same or different from claim 1 . Claim 16-17 are also not clear which structure is being further limited, that of claim 1 or claim 14. For these reasons, the metes and bounds of the claim are unclear, which renders the claim indefinite.
Regarding claim 18, the limitations “a method for determining quality or validity of a blood pressure signal from a pressure sensor, obtained from a non-static subject, the method comprising:
receiving at least one blood pressure related signal from at least one pressure sensor;
receiving at least one pulse related signal from at least one pulse sensor;
calculating a correlation score between the blood pressure signal and the pulse related signal, wherein a correlation score above a predetermined threshold is indicative of the quality and/or validity of said blood pressure signal” renders the claim indefinite. The terms from the preamble and the claim are intermingled such that it is not clear when reference is being made to a body of the claim limitation or the preamble limitation for further limitations.
The dependent claims are rejected for depending on a rejected claim.
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 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
Claim 1
calculating a correlation score between the blood pressure signal and the pulse related signal, said correlation score is indicative of quality and/or validity of the blood pressure signal (mathematical concepts and/or mental processes)
calculating blood pressure if the correlation score is above a predetermined threshold (contingent, mathematical concepts and/or mental processes)
Claim 18
calculating a correlation score between the blood pressure signal and the pulse related signal, wherein a correlation score above a predetermined threshold is indicative of the quality and/or validity of said blood pressure signal (mathematical concepts and/or mental processes)
Claim 19
calculating a quality score based on integration of data derived from the pulse related signal and data derived from the blood pressure related signal, said quality score is indicative of quality of the blood pressure related signal (mathematical concepts and/or mental processes);
calculating blood pressure based on combined data obtained from the pressure sensor and the pulse sensor, if the quality score is above a predetermined threshold (contingent, mathematical concepts and/or mental processes)
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
Claim 1
receiving at least one blood pressure related signal from at least one pressure sensor comprised in a wearable device (insignificant pre-solution activities, data gathering)
receiving at least one pulse related signal from at least one pulse sensor (insignificant pre-solution activities, data gathering)
Claim 14
a wearable body comprising a pressure sensor(s) configured to be worn by the subject (insignificant pre-solution activities, data gathering)
a pulse-related sensor(s) associated with the wearable body (insignificant pre-solution activities, data gathering); and
a processor configured to execute the method according to claim 1 (computer structures used as a tool for implementing an exception)
Claim 18
receiving at least one blood pressure related signal from at least one pressure sensor (insignificant pre-solution activities, data gathering);
receiving at least one pulse related signal from at least one pulse sensor (insignificant pre-solution activities, data gathering);
Claim 19
receiving at least one blood pressure related signal from at least one pressure sensor (insignificant pre-solution activities, data gathering);
receiving at least one pulse related signal from at least one pulse sensor (insignificant pre-solution activities, data gathering)
These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination, they do not add significantly more to the exception. Analyzing the additional claim limitations individually, the additional limitation that are not directed to the abstract idea are the same as those identified in step 2A above. Such limitations related to the sensors are recognized by the courts as routine data gathering in order to input data to the mathematical algorithm/mental process, and thus, do not add a meaningful limitation to the method/system as it would be routinely used by those of ordinary skill in the art in order to apply the mathematical algorithm/mental process. In addition, these sensor structures are known from US 2018/0184920, US 2019/0239759, US 2019/0388035, and in general are generic sensors producing the expected data signals. The method does not contain any computing structure, such that the steps can all be analog/mental processing of the data gathered which further supports that the claims are directed to a judicial exception without significantly more. The computer structures cited above are claimed as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The additional limitations recited in the dependent claims are merely directed further details of the exception (A more specific abstraction is still an abstraction). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. (US 2019/0239759) in view of Rabinovich et al. (Rabinovich, US 2018/0184920).
Regarding claim 1, Watson a method for continuous, non-invasive blood pressure measurement of subject while being active, the method comprising:
receiving at least one blood pressure related signal (see at least Figures 4-7, [0039], [0041] any pressure monitoring device);
receiving at least one pulse related signal from at least one pulse sensor (see at least Figures 4-7 pleth signal);
calculating a correlation score between the blood pressure signal and the pulse related signal, said correlation score is indicative of quality and/or validity of the blood pressure signal (see at least Figures 4-7, processes to determine algorithmic result of comparing the data for confidence in data correlation); and
calculating blood pressure if the correlation score is above a predetermined threshold (contingent limitation bears no patentable weight, see also Figure 4).
However, the limitation of at least one pressure sensor comprised in a wearable device is not directly taught.
Rabinovich teaches a related system for monitoring blood pressure (see title) and teaches that a wearable device can include pressure sensor, motion sensor, and pulse related sensors, which reasonably teaches at least one pressure sensor comprised in a wearable device (see at least Figure 4, [0017]-[0018], [0073]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including different sensors in a wearable in order to analyze a multitude of user data while being worn.
Regarding claim 2, the limitations are met by Watson in view of Rabinovich, where Rabinovich teaches further comprising receiving a motion related signal from at least one motion sensor (see at least [0073]-[0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including different sensors in a wearable in order to analyze a multitude of user data while being worn.
Regarding claim 3, the limitations are met by Watson in view of Rabinovich, where Watson teaches further comprising a step of synchronizing the receiving of the blood pressure signal, the pulse- related signal and/or the motion related signal (see at least Figures 3-7, data is time synchronized).
Regarding claim 4, the limitations are met by Watson in view of Rabinovich, where Watson teaches preprocessing the blood pressure signal and/or the pulse related signal prior to calculating the correlation (see at least [0034]).
Regarding claim 5, the limitations are met by Watson in view of Rabinovich, where Watson teaches wherein the preprocessing comprises one or more feature selection and/or onset detection in the blood pressure signal and/or the pulse related signal (see at least [0034]).
Regarding claim 6, the limitations are met by Watson in view of Rabinovich, where Watson teaches wherein the preprocessing comprises motion cancelation or motion compensation algorithms applied to the blood pressure signal and/or the pulse related signal (see at least [0034]).
Regarding claim 7, the limitations are met by Watson in view of Rabinovich, where Watson teaches wherein the correlation score is determined using a correlation function, configured to be applied to one or more of the obtained signals, or any parameters derived therefrom (intended results, see at least Figures 4-7).
Regarding claim 8, the limitations are met by Watson in view of Rabinovich, where Watson teaches wherein the correlation score indicative of the validity of the blood pressure signal is determined by: pairing and comparing one or more features of the signals obtained from the pressure sensor and one or more features of the signals obtained from the pulse-related sensors; and determining an agreement value between pairs of signals, wherein the correlation score is determined based on the agreement value (intended results, see at least Figures 4-7).
Regarding claim 9, the limitations are met by Watson in view of Rabinovich, where Watson teaches wherein the agreement value is determined based on metrics applied to each of the signal pairs, or on a plurality of signal pairs over a designated time frame (intended results, see at least Figures 4-7).
Regarding claim 10, the limitations are met by Watson in view of Rabinovich, where Watson teaches wherein the pulse related sensor comprises ECG, PPG, ICG, phonocardiography, or any combinations thereof (see at least Figures 4-7 pleth signal, [0025]).
Regarding claim 11, the limitations are met by Watson in view of Rabinovich, where Rabinovich teaches wherein the motion sensor comprises accelerometer, gyroscope, magnetometer, Inertial measurement Unit (IMU) or any combination thereof (see at least [0073]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including different sensors in a wearable in order to analyze a multitude of user data while being worn.
Regarding claim 12, the limitations are met by Watson in view of Rabinovich, where Watson teaches wherein the pulse relate signal is selected from: continues pulse rate, heart rate, onset of pulse beat(s), separation of pulse beat(s) to segments, blood flow velocity (see at least [0032], [0035]).
Regarding claim 13, the limitations are met by Watson in view of Rabinovich, where Watson teaches wherein the blood pressure signal is associated with a blood pressure waveform (see at least Figure 3).
Regarding claim 14, the limitations are met by Watson in view of Rabinovich, where the combination teaches a device for continuous, non-invasive blood pressure measurement of an ambulatory subject (see rejection of claim 1), the device comprising:
a wearable body comprising a pressure sensor(s) configured to be worn by the subject (see Rabinovich Figure 4, [0017]-[0018], [0073]);
a pulse-related sensor(s) associated with the wearable body (see Rabinovich Figure 4, [0017]-[0018], [0073]); and
a processor (see Rabinovich Figure 4, [0017]-[0018], [0073]) configured to execute the method according to claim 1 (see rejection of claim 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including different sensors in a wearable in order to analyze a multitude of user data while being worn.
Regarding claim 15, the limitations are met by Watson in view of Rabinovich, where Rabinovich teaches further comprising a motion related sensor(s) (see at least [0073]-[0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including different sensors in a wearable in order to analyze a multitude of user data while being worn.
Regarding claim 16, the limitations are met by Watson in view of Rabinovich, where Rabinovich teaches wherein the pulse-related sensor is comprised within the wearable body (see at least Figure 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including different sensors in a wearable in order to analyze a multitude of user data while being worn.
Regarding claim 17, the limitations are met by Watson in view of Rabinovich, where Rabinovich teaches wherein the pulse-related sensor is functionally associated with the wearable body (see at least Figures 1 and 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including different sensors in a wearable in order to analyze a multitude of user data while being worn.
Regarding claim 18, Watson teaches a method for determining quality or validity of a blood pressure signal from a pressure sensor, obtained from a non-static subject, the method comprising:
receiving at least one blood pressure related signal (see at least Figures 4-7, [0039], [0041] any pressure monitoring device);
receiving at least one pulse related signal from at least one pulse sensor (see at least Figures 4-7 pleth signal);
calculating a correlation score between the blood pressure signal and the pulse related signal, wherein a correlation score above a predetermined threshold is indicative of the quality and/or validity of said blood pressure signal (see at least Figures 4-7, processes to determine algorithmic result of comparing the data for confidence in data correlation).
However, the limitation of at least one pressure sensor is not directly taught.
Rabinovich teaches a related system for monitoring blood pressure (see title) and teaches that a wearable device can include pressure sensor, motion sensor, and pulse related sensors, which reasonably teaches at least one pressure sensor (see at least Figure 4, [0017]-[0018], [0073]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including different sensors in a wearable in order to analyze a multitude of user data while being worn.
Regarding claim 19, Watson teaches a method for continuous, non-invasive blood pressure measurement of a non- static subject, the method comprising:
receiving at least one blood pressure related signal (see at least Figures 4-7, [0039], [0041] any pressure monitoring device);
receiving at least one pulse related signal from at least one pulse sensor (see at least Figures 4-7 pleth signal);
calculating a quality score based on integration of data derived from the pulse related signal and data derived from the blood pressure related signal, said quality score is indicative of quality of the blood pressure related signal (see at least Figures 4-7, processes to determine algorithmic result of comparing the data for confidence in data correlation); and
calculating blood pressure based on combined data obtained from the pressure sensor and the pulse sensor, if the quality score is above a predetermined threshold (contingent limitation bears no patentable weight, see also Figure 4).
However, the limitation of at least one pressure sensor is not directly taught.
Rabinovich teaches a related system for monitoring blood pressure (see title) and teaches that a wearable device can include pressure sensor, motion sensor, and pulse related sensors, which reasonably teaches at least one pressure sensor (see at least Figure 4, [0017]-[0018], [0073]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of including different sensors in a wearable in order to analyze a multitude of user data while being worn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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/MICHAEL R BLOCH/ Primary Examiner, Art Unit 3791
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