18579273
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 01, 2026 has been entered.
Response to Amendment
The Amendment filed August April 01, 2026 has been entered. Claims 1, 14, 22, 28, 30, 37, 41, 44, 47-48, 54, 58, and 65-69 remain pending in the application.
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.
Claims 41, 44, 47-48, 54 and 65 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 41 recites the limitation, “a user-specific information”. There is insufficient antecedent basis for this limitation in the claim. “a user-specific information” is already recited in claim 1.
Dependent claims 44, 47-48, 54 and 65 are rejected based on their dependency to a rejected base claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 41, 44, 47 and 54 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 41, 44, 47, and 54 merely repeat subject matter already recited in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 14, 28, 30, 37, 41, 44, 47-48, 54, 58, and 65-69 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Niehaus et al. (US 2017/0245769 A1) (“Niehaus”).
Regarding claims 1 and 66-68, Niehaus discloses A system for determining a blood pressure (BP) of a plurality of users, the system comprising (Abstract and entire document and [0067], [0114 – 0115] discussing plurality of users),
for each respective user of the plurality of users, a signal module and a wearable device configured to be worn on a wrist of the respective user (FIG. 2-5 and associated paragraphs, see at least [0079]);
wherein the wearable device comprises a pulsatility sensing unit including an optical measuring sensor configured to measure pulsatility signals at the respective user's wrist when the wearable device is worn, and a motion sensor measuring a motion signal representative of movement of the respective user (FIG. 2-5 and associated paragraphs, see at least [0079], [0112], [0126]);
wherein the signal module comprises a controlling processor including a triggering processor comprising a firmware portion or a hardware portion configured to initiate a pulsatility measurement according to a trigger parameter such that, following initiation, the pulsatility sensing unit measures a plurality of pulsatility signals at the respective user's wrist during a predetermined measurement time period, and to end the pulsatility measurement upon expiration of the predetermined measurement time period (FIG. 2-5 and associated paragraphs, see at least [0102], [0109] processor, memory, see further [0130], trigger based on step count to measure during a time period, the measurement has a start and end point);
wherein the trigger parameter comprises an activity level of the respective user calculated from the motion signal, the triggering processor controlling the pulsatility sensing unit such that the pulsatility measurement is initiated once a resting interval of the respective user exceeds a threshold duration after activity (FIG. 2-5 and associated paragraphs, see at least [0102], [0109] processor, memory, see further [0130], trigger based on step count to measure during a time period, the measurement has a start and end point);
wherein the signal module further comprises a processing processor comprising a firmware portion or a hardware portion being configured for processing the plurality of pulsatility signals to obtain pulsatility signal data for the respective user (FIG. 2-5 and associated paragraphs, see at least [0102], [0109] processor, memory);
wherein the system is configured to input, for each respective user of the plurality of users, user-specific information comprising one or more reference blood pressure measurements of the respective user, each reference blood pressure measurement being measured independently from measurement performed with the pulsatility sensing unit, or simultaneously with measurement performed with the pulsatility sensing unit (FIG. 2-5 and associated paragraphs, see at least [0110 – 0112] discussing reference data);
wherein the system further comprises an external service module, comprising one or a plurality of remote servers or computers and remote from the wearable device and from the signal module (FIG. 2-5 and associated paragraphs, see at least [0082], [0097]);
the signal module further comprising a communication processor including a long range communication link, wherein the communication processor comprises a firmware portion or a hardware portion configured to remotely transmit said pulsatility signal data from the signal module to the external service module via the long range communication link (FIG. 2-5 and associated paragraphs, see at least [0082], [0097], [0117]);
wherein the external service module includes a database storage system configured for storing in a database, for each respective user of the plurality of users, the transmitted pulsatility signal data obtained from the wearable device of that respective user (FIG. 2-5 and associated paragraphs, see at least [0082], [0097]);
wherein the database storage system is further configured to store, as user-specific information, the one or more reference blood pressure measurements in the database corresponding to the set of pulsatility signal data of the respective user (FIG. 2-5 and associated paragraphs, see at least [0110 – 0112] discussing reference data);
wherein the external service module further includes a calculating processor configured to calculate a BP value for each respective user of the plurality of users, based on the transmitted pulsatility signal data stored in the database for that respective user and further based on the user- specific information comprising the one or more reference blood pressure measurements of that respective user (FIG. 2-5 and associated paragraphs, see at least [0102], [0109 - 0112];); and
wherein the calculating processor is further configured to calculate the BP value for each respective user of the plurality of users based on the plurality of pulsatility signal data stored in the database for that respective user, or based on a subset of said plurality of pulsatility signal data comprising more than one pulsatility signal data (FIG. 2-5 and associated paragraphs, see at least [0102], [0109 - 0112];); and
wherein the system further comprises a display interface configured for displaying the calculated BP value (FIG. 2-5 and associated paragraphs, see at least [0082 – 0085]).
Regarding claim 14, Niehaus discloses The system according to claim 11, wherein the trigger parameter comprises a user-related behavioral information (FIG. 2-5 and associated paragraphs, see at least [0102], [0109] processor, memory, see further [0130], trigger based on step count to measure during a time period, the measurement has a start and end point).
Regarding claim 28, Niehaus discloses The system according to claim 1, wherein the signal module is remote from the wearable device and the signal module cooperates with the wearable device via a first short range communication link (FIG. 2-5 and associated paragraphs, see at least [0082], [0097], [0117]); and
wherein the signal module comprises a first short range data buffer adapted to store the measured pulsatility signals at the respective user’s wrist (FIG. 2-5 and associated paragraphs, see at least [0082], [0097], [0117]); and/or
wherein the wearable device comprises a long range data buffer adapted to store the pulsatility signal data (FIG. 2-5 and associated paragraphs, see at least [0082], [0097], [0117]; [0123]).
Regarding claim 30, Niehaus discloses The system according to claim 1, wherein the communication module is comprised in a portable gateway device (FIG. 2-5 and associated paragraphs, see at least [0082], [0097], [0117]; [0123]).
Regarding claim 37, Niehaus discloses The system according to claim 1, wherein the database storage system is configured for storing in the database any one of: the pulsatility signal data for each of the plurality of users, the trigger parameter for each pulsatility signal data, or the triggering input for each pulsatility signal data ([0077], [0105], [0123]).
Regarding claim 41, Niehaus discloses The system according to claim 1, configured for inputting a user-specific information for each of the plurality of users (FIG. 2-5 and associated paragraphs, see at least [0110 – 0112] discussing reference data).
Regarding claim 44, Niehaus discloses The system according to claim 41, wherein said user-specific information comprises one or a plurality of reference BP measurements of the respective user, each measured independently from to the measurement performed with the pulsatility sensing unit; or wherein said one or a plurality of reference BP measurements is measured simultaneously with the measurement performed with the pulsatility sensing unit (FIG. 2-5 and associated paragraphs, see at least [0110 – 0112] discussing reference data).
Regarding claim 47, Niehaus discloses The system according to claim 41, wherein the database storage system is configured for storing said user-specific information in the database ([0077], [0105], [0123]).
Regarding claim 48, Niehaus discloses The system according to claim 41, wherein the portable gateway device is configured for introducing said user-specific information in the database (FIG. 2-5 and associated paragraphs, see at least [0082], [0097], [0117]; [0123]).
Regarding claim 54, Niehaus discloses The system according to claim 41, wherein the calculating module is configured for calculating the BP value of a user by further using said user-specific information (FIG. 2-5 and associated paragraphs, see at least [0110 – 0112] discussing reference data).
Regarding claim 58, Niehaus discloses The system according to claim 1, wherein the calculating module is further configured for calculating other physiological parameters including any one of: systolic BP, diastolic BP or mean arterial pressure, pulse pressure, central pulse wave velocity, peripheral pulse wave velocity, arterial stiffness, aortic pulse transit time, augmentation index, stroke volume, stroke volume variations, pulse pressure variations, cardiac output, systemic vascular resistance, venous pressure, systemic hemodynamic parameters, pulmonary hemodynamic parameters, cerebral hemodynamic parameters, heart rate, heart rate variability, inter-beat intervals, arrhythmias detection, ejection duration, SpO2, SpHb, SpMet, SpCO, respiratory rate, tidal volume, apnea detection, sleep quality, sleep scoring, sleep analysis, bed time, sleep duration, rem sleep time, light sleep time, deep sleep time, time to get up, time to sleep, sleep efficiency, minutes awake after sleep onset, snoring duration, stress indexes, and general cardiovascular or health indexes ([0102 – 0103] and [-109 – 0112]).
Regarding claim 65, Niehaus discloses The system according to claim 41, wherein the calculating module is configured for calculating the BP value of the plurality of users according to a calculating technique, based on the pulsatility signal data, or the trigger parameter for each pulsatility signal data, or the triggering input for each pulsatility signal data, or the user-specific information, stored in the database of the database storage system from the plurality of users; wherein the calculating module is configured for calculating the BP and for training the calculating technique ([0153]).
Regarding claim 69, Niehaus discloses The system according to claim 1, wherein the triggering processor is further configured to calculate, based on the motion signal, an intense exercise time period, the intense exercise time period corresponding to the user performing an activity with an intensity being above a given intensity level; and wherein the triggering processor controls the pulsatility sensing unit such that the pulsatility measurement is initiated once the resting interval exceeds the threshold duration after activity and predetermined resting period after said intense exercise ([0068], “some implementations provide a device that can automatically detect that a user has recently engaged in a physical activity that may cause blood pressure to temporally fluctuate, and automatically instructs the user to delay taking a blood pressure measurement until the effect of the activity subsides” motion sensor senses activity above a threshold level, that would cause bp to fluctuate, and the measurement is resumed after threshold waiting time for the effect to subsidize).
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Niehaus in view of DeBusschere et al. (US 2016/0338599 A1) (“DeBusschere”).
Regarding claim 22, Niehaus discloses The system according to claim 1, Niehaus fails to disclose wherein the processing module is configured to perform a pre-processing step on the measured pulsatility signals at the respective user’s wrist to obtain said pulsatility signals; and wherein said pre-processing step comprises a lossless compression of the measured pulsatility signals at the respective user’s wrist, and executing an ensemble averaging algorithm on the measured pulsatility signals at the respective user’s wrist.
However, in the same field of endeavor, DeBusschere teaches wherein the processing module is configured to perform a pre-processing step on the measured pulsatility signals at the respective user’s wrist to obtain said pulsatility signals; and wherein said pre-processing step comprises a lossless compression of the measured pulsatility signals at the respective user’s wrist, and executing an ensemble averaging algorithm on the measured pulsatility signals at the respective user’s wrist (Para. [0045], “This pulse-wave velocity is a measure of a patient's cardiovascular health. The signal-to-noise ratio of the signals from sensor 106-3 can be improved through synchronization with the other sensors to perform correlation techniques such as ensemble averaging and artifact rejection techniques such as motion compensation.”).
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 system as taught by Niehaus to include wherein the processing module is configured to perform a pre-processing step on the measured pulsatility signals at the respective user’s wrist to obtain said pulsatility signals; and wherein said pre-processing step comprises a lossless compression of the measured pulsatility signals at the respective user’s wrist, and executing an ensemble averaging algorithm on the measured pulsatility signals at the respective user’s wrist as taught by DeBusschere in order to improve the signal-to-noise ratio (Para. [0045], “The signal-to-noise ratio of the signals from sensor 106-3 can be improved through synchronization with the other sensors to perform correlation techniques such as ensemble averaging and artifact rejection techniques such as motion compensation.”).
Response to Arguments
Applicant’s arguments with respect to claims 1, 14, 22, 28, 30, 37, 41, 44, 47-48, 54, 58, and 65-69 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH A TOMBERS/ Examiner, Art Unit 3791
Prosecution Insights