DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 16, 28, 29, and 31 are objected to because of the following informalities:
Claim 16, line 9: “a flexible” should be replaced with –the flexible–;
Claim 16, line 20: both instances of “the vascular” should be replaced with –a vascular–;
Claim 28, line 1: “a vascular” should be replaced with –the vascular–;
Claim 29, line 1: “a vascular” should be replaced with –the vascular–; and
Claim 31, line 2: “a vascular” should be replaced with –the vascular–.
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.
Claim 18 is 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 18 recites “the first pulsations” on line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the recitation will be interpreted to be “the pulsations”.
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.
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.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0263411 A1 (Stockmann) (previously cited) in view of US 2013/0023777 A1 (Tokko)
With regards to claim 16, Stockmann teaches a measuring device for continuously, non-invasively determining at least one cardiovascular parameter on an extremity containing an artery (Fig. 1 and ¶¶ [0120], [0124], [0128] depict a blood pressure measuring apparatus which is capable of being used for continuous and non-invasive blood pressure monitoring; see ¶ [0142] which depicts a cuff-based blood pressure measuring device for continuously determining a blood pressure), the measuring device comprising: a recording element configured to be attached to the extremity and to at least partially enclose the extremity (Fig. 1 and ¶¶ [0124], [0128] depict an initialization and measuring unit 3 comprising a cuff); wherein the measuring device includes a component configured to measure pulsations that occur due to volume flow in the artery (¶ [0127] disclose a measurement sensor 31 comprising an optical sensor, acoustic sensor, electromagnetic sensor, a tonometric measurement sensor, or a patch or compression stocking with integrated strain sensors; also see ¶¶ [0102]-[0104]; ¶ [0146] depicts, during an oscillometric measurement M, determining an oscillating signal component posc); and wherein the measuring device has a first control unit (Fig. 1 and ¶ [0122] depict control and memory unit 2 for the execution of all blood pressure measurements and the programs) including at least the following elements: a signal detection unit configured to record the pulsations that occur due to the volume flow in the artery (Figs. 4-5 and ¶¶ [0142]-[0143], [0146] depict, during an oscillometric measurement M, determining an oscillating signal component posc); a measuring unit configured to determine the at least one cardiovascular parameter by using a vascular control technique (¶ [0146] discloses using the amplitude curve of posc to determine the mean arterial blood pressure as well as diastolic and systolic blood pressure; the Examiner notes that “vascular control technique” is not understood by one of ordinary skill in the art to have a specific meaning. Additionally, the specification does not clearly redefine the term. Therefore, the limitation is being given its broadest reasonable interpretation (i.e., any technique in which vasculature is controlled); ¶¶ [0145]-[0146] of Stockmann discloses measuring the parameters by applying pressure to the vasculature); and wherein the component configured to measure the pulsations that occur due to the volume flow in the artery comprises a photoplethysmographic system having at least one light source and at least one light detector for measuring the pulsations (¶ [0127] depicts the measurement sensor 31 being a PPG sensor which necessarily includes at least one light source and at least one light detector for measuring pulsations; ¶ [0124] indicates the sensor 31 is used to detect the pressure) during an interpolation phase of the measuring device while the pressure in the flexible, fluid-filled bladder is reduced to a minimum (¶¶ [0147]-[0150] disclose the determination of coefficients of the person-specific transfer functions Hk; ¶¶ [0153]-[0154] disclose determining the transfer function Hk that allows for determining the arterial pulse wave signal on the basis of the oscillating signal component posc(t) from a low-pressure plateau measurement with constant cuff pressure; ¶ [0156] discloses a validation V is intended for example to determine whether a previously defined constant counter pressure for the low-pressure plateau measurements is suitable for the patient/user, or whether this must be increased slightly in order to be able to measure a reliable pulse wave signal in the oscillating signal component of the cuff, thereby indicating that the low-pressure plateau is a minimum pressure).
Stockmann is silent regarding a flexible, fluid-filled bladder supported on the recording element and acting on the extremity; an actuator positioned in or on the recording element, wherein the actuator is configured to vary a pressure in the flexible, fluid-filled bladder, wherein the flexible, fluid-filled bladder has a pressure sensor in contact with the fluid in the flexible, fluid-filled bladder, the pressure sensor configured to continuously measure an absolute value of the pressure; the signal detection unit is configured to record the absolute value of the pressure; a second control unit for the actuator configured to vary the pressure in the flexible, fluid filled bladder, wherein the recording element, the flexible, fluid-filled bladder, the component configured to measure the pulsations that occur due to the volume flow in the artery, and the actuator are integrated in a housing configured to be worn on the body.
In the same field of endeavor of blood pressure measurement, Tokko teaches a measuring device (Figs. 1-2 and ¶¶ [0031], [0035] depict an electronic sphygmomanometer) comprising: a flexible, fluid-filled bladder supported on the recording element and acting on the extremity (Fig. 2 and ¶ [0036] depict an airbladder 21 supported on the cuff 20; ¶ [0033] depict the measurement site being the wrist); an actuator positioned in or on the recording element (Fig. 1 depicts a main body unit 10 positioned on the cuff 20; Fig. 2 depicts the main body unit 10 comprising the adjustment unit 50; ¶ [0044] depicts the adjustment unit 50 being an actuator and air cylinder), wherein the actuator is configured to vary a pressure in the flexible, fluid-filled bladder (¶ [0044] depicts an actuator for driving an air cylinder for adjusting a pressure inside the cuff 20), wherein the flexible, fluid-filled bladder has a pressure sensor in contact with the fluid in the flexible, fluid-filled bladder (Fig. 2 and ¶¶ [0040], [0043] depict a pressure sensor 32 in fluidic contact with the air in the air bladder), the pressure sensor configured to continuously measure an absolute value of the pressure (¶ [0043] discloses a pressure sensor 32 being a capacitance pressure sensor, which necessarily provides an absolute value of pressure); the signal detection unit is configured to record the absolute value of the pressure (¶ [0043] discloses the CPU 100 detects pressure by converting the signal from the pressure sensor and the oscillation circuit 33 into a pressure; ¶ [0038] discloses a memory for storing measurement results); a second control unit for the actuator configured to vary the pressure in the flexible, fluid filled bladder (¶ [0044] discloses a pump drive circuit 53; ¶ [0074] discloses a cuff pressure control unit 1011 that variably controls the cuff pressure Pc by controlling the pump drive circuit 53), wherein the recording element, the flexible, fluid-filled bladder, the component configured to measure the pulsations that occur due to the volume flow in the artery, and the actuator are integrated in a housing configured to be worn on the body (Fig. 1 depict the elements of the device being integrated in a housing comprising multiple parts). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Stockmann to incorporate a flexible, fluid-filled bladder supported on the recording element and acting on the extremity; an actuator positioned in or on the recording element, wherein the actuator is configured to vary a pressure in the flexible, fluid-filled bladder, wherein the flexible, fluid-filled bladder has a pressure sensor in contact with the fluid in the flexible, fluid-filled bladder, the pressure sensor configured to continuously measure an absolute value of the pressure; the signal detection unit is configured to record the absolute value of the pressure; a measuring unit configured to determine the at least one cardiovascular parameter by using the vascular control technique or the vascular unloading technique to determine the at least one cardiovascular parameter; a second control unit for the actuator configured to vary the pressure in the flexible, fluid filled bladder, wherein the recording element, the flexible, fluid-filled bladder, the component configured to measure the pulsations that occur due to the volume flow in the artery, and the actuator are integrated in a housing configured to be worn on the body as taught by Tokko. Because the above elements of Tokko and the components of Stockman are both capable of measuring a blood pressure in at least an oscillometric mode, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to provide a sphygmomanometer that is capable of measuring blood pressure based on change in arterial volume without giving rise to an increase device size (¶ [0009] of Tokko).
With regards to claim 17, the above combination teaches or suggests the first control unit has at least two different operating modes: a measurement phase and the interpolation phase (Figs. 4-5 and ¶¶ [0143]-[0144] of Stockmann discloses an oscillometric measurement M and an initialization I).
With regards to claim 18, the above combination teaches or suggests the pressure sensor is further configured to measure the first pulsations that occur due to the volume flow in the artery (¶ [0043] of Tokko discloses an oscillation frequency signal determined from the pressure sensor)
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Stockmann in view of Tokko, as applied to claim 16 above, and further in view of US 2019/0099095 A1 (Zhang) (previously cited).
With regards to claim 21, the above combination teaches or suggests the measurements positions include fingers (¶ [0105]). However, the above combination is silent regarding whether the housing is configured to be worn on a finger of a hand.
In the same field of endeavor of monitoring blood pressure measurements, Zhang teaches a unit is configured to be worn on a finger of a hand (Figs. 1-2 and ¶¶ [0047]-[0048] of Zhang depict a finger blood pressure cuff 100). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the housing of the above combination to incorporate that the housing is configured to be worn on a finger of a hand of a body as taught by Zhang. The motivation would have been to make the blood pressure cuff less bulky, easier to use, more portable, more compact, less obtrusive, and more comfortable to the user (¶ [0045] of Zhang).
Claims 22, 24 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0263411 A1 (Stockmann) (previously cited) in view of US 2013/0060152 A1 (Baron) (previously cited) and US 2013/0023777 A1 (Tokko)
With regards to claim 22, Stockmann teaches a method for continuously, non-invasively determining at least one cardiovascular parameter on an extremity containing an artery with a measuring device (¶ [0011] discloses a method for operating a blood pressure measuring apparatus; ¶ [0142] which depicts a cuff-based blood pressure measuring method for continuously determining a blood pressure), wherein the extremity is at least partially enclosed by a flexible, fluid-filled bladder of a recording element (Fig. 1 and ¶¶ [0124], [0128] depict an initialization and measuring unit 3 comprising the a cuff); wherein a pressure sensor generates a pressure signal (¶ [0127] disclose a measurement sensor 31 comprising an optical sensor, acoustic sensor, electromagnetic sensor, a tonometric measurement sensor, or a patch or compression stocking with integrated strain sensors; also see ¶¶ [0102]-[0104]; ¶ [0146] depicts, during an oscillometric measurement M, determining an oscillating signal component posc); the method comprising: varying a pressure in the flexible, fluid-filled bladder (¶¶ [0145]-[0146] disclose a complete oscillometric measurement M is performed for initialization, in which the cuff pressure is pumped to a peak value which is at least 20 mmHg above the expected systolic blood pressure); measuring an absolute value of the pressure in the flexible, fluid-filled bladder in a measurement phase during the variation (¶¶ [0145]-[0147], [0150] disclose inflating and deflating the cuff pressure and determining an oscillating pressure signal posc and a non-oscillating cuff pressure pcuff during the inflation and/or deflation processes); measuring first pulsations generated by a volume flow in the artery during the measurement phase (¶¶ [0146]-[0147], [0150] depict determining oscillating pressure signal posc which includes first pulsations); determining the at least one cardiovascular parameter from the absolute value and the first pulsations (¶¶ [0146]-[0147] discloses the pcuff and amplitude curve of posc is used to determine the mean arterial blood pressure as well as diastolic and systolic blood pressure), wherein a vascular control technique or a vascular unloading technique is used to determine the at least one cardiovascular parameter (¶ [0146] discloses using the amplitude curve of posc to determine the mean arterial blood pressure as well as diastolic and systolic blood pressure; the Examiner notes that “vascular control technique” is not understood by one of ordinary skill in the art to have a specific meaning. Additionally, the specification does not clearly redefine the term. Therefore, the limitation is being given its broadest reasonable interpretation (i.e., any technique in which vasculature is controlled); ¶¶ [0145]-[0146] of Stockmann discloses measuring the parameters by applying pressure to the vasculature); and subsequently, in an interpolation phase (Figs. 4-5 and ¶ [0144] depict low-pressure plateau measurements pM): reducing the pressure in the flexible, fluid-filled bladder to a minimum (¶ [0156] discloses a validation V is intended for example to determine whether a previously defined constant counter pressure for the low-pressure plateau measurements is suitable for the patient/user, or whether this must be increased slightly in order to be able to measure a reliable pulse wave signal in the oscillating signal component of the cuff, thereby indicating that the low-pressure plateau is a minimum pressure), measuring second pulsations generated by the volume flow in the artery during the interpolation phase (¶ [0154] discloses determination of an oscillating signal component posc(t) during the low-pressure plateau measurement with constant cuff pressure).
Stockmann is silent regarding a pressure sensor, which generates a pressure signal pc(t), is arranged in the flexible, fluid-filled bladder.
In the same field of endeavor of blood pressure measurement, Baron teaches pressure sensor, which generates a pressure signal, is arranged in the flexible, fluid-filled bladder, (Fig. 6 and ¶ [0068] disclose a transducer 840 for measuring the pressure in the bladder 848). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Stockmann to incorporate a pressure sensor, which generates a pressure signal pc(t), is arranged in the flexible, fluid-filled bladder as taught by Baron. The motivation would have been to provide high fidelity pulse waveform detection (¶ [0031] of Baron). Additionally or alternatively, it would have been the simple substitution of one known equivalent location for a pressure sensor of a cuff for another to obtain predictable results.
The above combination is silent regarding varying, by an actuator, a pressure in the flexible, fluid-filled bladder; measuring second pulsations with a photoplethysmographic system having at least one light source and at least one light detector; and wherein the recording element, the flexible, fluid-filled bladder, the photoplethysmographic system, and the actuator are integrated in a unit configured to be worn on the body.
In the same field of endeavor of blood pressure measurement, Tokko teaches varying, by an actuator, a pressure in flexible, fluid-filled bladder (¶ [0044] depicts an actuator for driving an air cylinder for adjusting a pressure inside the cuff 20), measuring second pulsations with a photoplethysmographic system having at least one light source and at least one light detector (¶¶ [0036]-[0037] depict an arterial volume sensor 70 comprising a light emitting element 71 and a light receiving element 72; Fig. 3 and ¶ [0050] depict arterial volume V pulsations); and wherein the recording element, the flexible, fluid-filled bladder, the photoplethysmographic system, and the actuator are integrated in a unit configured to be worn on the body (Fig. 1 depict the elements of the sphygmomanometer 1 being integrated in a unit; Fig. 2 depicts the sphygmomanometer including a cuff 20, air bladder 21, arterial volume sensor 70, and a adjustment unit 50; ¶ [0044] discloses the adjustment unit may include an air cylinder and an actuator). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate varying, by an actuator, a pressure in the flexible, fluid-filled bladder; measuring second pulsations with a photoplethysmographic system having at least one light source and at least one light detector; and wherein the recording element, the flexible, fluid-filled bladder, the photoplethysmographic system, and the actuator are integrated in a unit configured to be worn on the body as taught by Tokko. Because the above elements of Tokko and the components of Stockman are both capable of measuring a blood pressure in at least an oscillometric mode, it would have been the simple substitution of one known equivalent element for another to obtain predictable results. Additionally or alternatively, the motivation would have been to provide a sphygmomanometer that is capable of measuring blood pressure based on change in arterial volume without giving rise to an increase device size (¶ [0009] of Tokko).
With regards to claim 24, the above combination teaches or suggests a restart of the measurement phase is initiated as a function of the calculated error of the at least one cardiovascular parameter (Fig. 21 and ¶ [0242] of Stockmann discloses an iterative process in which the coefficients of the mapping rule are adjusted until the deviation or error e between the calculated and the measured oscillating signal component reaches or falls below a predefined minimum error e).
With regards to claim 28, the Examiner notes that “vascular control technique” is not understood by one of ordinary skill in the art to have a specific meaning. Additionally, the specification does not clearly redefine the term. Therefore, the limitation is being given its broadest reasonable interpretation (i.e., any technique in which vasculature is controlled).
The above combination teaches or suggests a vascular control technique is used to determine the at least one cardiovascular parameter (¶¶ [0145]-[0146] of Stockmann discloses measuring the parameters by applying pressure to the vasculature).
With regards to claim 30, the above combination teaches or suggests an oscillometric method is used to determine the at least one cardiovascular parameter (¶¶ [0145]-[0146] of Stockmann).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Stockmann in view of Baron and Tokko, as applied to claim 22 above, and further in view of US 2019/0343407 A1 (Huijbregts) (previously cited)
With regards to claim 25, the above combination is silent regarding a restart of the measurement phase is initiated after a specifiable period of time has elapsed.
In the same field of endeavor of recalibrating blood pressure measurements, Huijbregts teaches a restart of the measurement phase is initiated after a specifiable period of time has elapsed (¶ [0116] discloses recalibrating periodically (e.g., every few minutes or every hours)). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate a restart of the measurement phase is initiated after a specifiable period of time has elapsed as taught by Huijbregts. The motivation would have been to account for drift over time, thereby providing a more accurate analysis of the blood pressure.
Claims 29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Stockmann in view of Baron and Tokko, as applied to claim 22 above, and further in view of US 2002/0026121 A1 (Kan)
With regards to claim 29, the above combination is silent regarding whether a vascular unloading technique is used to determine the at least one cardiovascular parameter.
In the same field of endeavor of monitoring blood pressure, Kan teaches using a vascular unloading technique to determine at least one cardiovascular parameter (Fig. 9 and ¶ [0061] a volume compensation method for determine a blood pressure wave). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate using a vascular unloading technique to determine at least one cardiovascular parameter as taught by Kan. Because both the methods of Kan and Stockmann are capable of determining blood pressure parameters, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 31, the above combination is silent regarding whether first the oscillometric method and then the vascular control technique or the vascular unloading technique is carried out to determine the at least one cardiovascular parameter.
In the same field of endeavor of monitoring blood pressure, Kan teaches first the oscillometric method and then the vascular control technique or the vascular unloading technique is carried out to determine the at least one cardiovascular parameter
(Fig. 9 and ¶¶ [0060]-[0061] depict first determining SBP, MBP, and DBP using an oscillometric method then using a volume compensation method for determine a blood pressure wave). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate first the oscillometric method and then the vascular control technique or the vascular unloading technique is carried out to determine the at least one cardiovascular parameter as taught by Kan. Because both the methods of Kan and Stockmann are capable of determining blood pressure parameters, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
Response to Arguments
Specification Objection
In view of the amendment to the abstract filed 01/28/2026, the objection to the specification was withdrawn.
Claim Objections
There are new grounds of claim objections necessitated by the claim amendment filed 01/28/2026.
Rejections under 35 U.S.C. §112
In view of the amendments filed 01/28/2026, the rejections under 35 U.S.C. §112(a) were withdrawn.
There are new grounds of rejections under 35 U.S.C. §112(b) necessitated by the claim amendment filed 01/28/2026.
Rejections under 35 U.S.C. §103
There are new grounds of rejections under 35 U.S.C. §103 necessitated by the claim amendments filed 01/28/2026. To the extent the arguments are applicable to the current prior art rejections, the examiner makes the following comments.
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive.
On page 9 of the response filed 01/28/2026, the Applicant asserts:
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These arguments are not persuasive.
First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the use of the at least one cardiovascular parameter during the interpolation phase) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In this case, neither claims 16 or 22 require the use of the at least one cardiovascular parameter during the interpolation phase.
Second, the Examiner asserts that “vascular control technique” is not understood by one of ordinary skill in the art to have a specific meaning. Additionally, the specification does not clearly redefine the term. Therefore, the limitation is being given its broadest reasonable interpretation (i.e., any technique in which vasculature is controlled). ¶¶ [0145]-[0146] of Stockmann discloses measuring the parameters by applying pressure to the vasculature, which amounts to a “vascular control technique”. Therefore, Stockmann teaches the determination of at least one cardiovascular parameter using a vascular control technique.
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 SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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