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 Rejections - 35 USC § 112
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.
Claim 12 is 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. Claim 12 does not specify which claim it depends upon. 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. For the purposes of examination, claim 12 will be assumed to depend from claim 1.
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.
Claim(s) 1-3, 5-12, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US 20170312165 A1), hereinafter Johnson, in view of Patil et al. (US 20170333006 A1), hereinafter Patil.
Regarding claim 1, Johnson discloses a computer-implemented method of determining a tissue property of a body part ([0159]: “A controller 1206 of the compression system controls its operation”, [0058]), the method comprising: controlling a shell cuff apparatus to apply a plurality of different pressures to the body part ([0029]: “fastening one or more compression elements of a wearable compression device around the body part… tighten or loosen the one or more compression elements fastened around the body part”), wherein the shell cuff apparatus at least partially encloses the body part (Fig 3, wherein the device encloses the leg), and wherein the shell cuff apparatus comprises a hard shell portion placed at least partially around the body part ([0145]: “the system and method may include a rigid or semi-rigid compression plate 316, 716, 716′, 716″ that is pulled into the appendage or body part, such as the lower leg, and released via an attached drive train mechanism, locally compressing the area under the compression plate. The compression plate facilitates and allows selective pressure to be applied to specific vascular, muscular or lymph regions.”) and an inflatable cuff surrounding the hard shell portion that is inflated and/or deflated to apply the plurality of different pressures to the body part via the hard shell portion ([0144]: “The compression straps may have inflatable zones or be entirely inflatable to pad the straps and/or may be constructed fully or partially of an inelastic material in order to efficiently transmit the compressive forces to the body part.”, [0145]: “, each zone of the compression plate can be associated with its own compression strap,”, wherein the compression straps may inflate and wherein the compression plate (the hard shell) are covered by at least one strap); obtaining circumference measurements of the body part, or changes in the circumference of the body part, as the plurality of different pressures are applied to the body part ([0161]: “using a strain gauge to measure the change in the circumference and volume of the body part”); obtaining a pressure measurements of the different pressures applied to the body part ([0024]: “a sensor configured to measure a magnitude of pressure applied to the body part by the device”);
While Johnson discloses obtaining circumference measurements, they fail to specifically disclose obtain a radius measurements of a radius of the body part, or changes in the radius of the body part. Johnson further fails to disclose determining the tissue property of the body part from the radius measurements and the pressure measurements.
Patil discloses determining obtaining radius measurements of the body part, or changes in the radius of the body part ([0017]: “which captures the change in diameter of an artery caused due to pulsatile nature of blood”, [0039]: “This change in elastic property is manifested in diameter change of the artery. Based on the echoes obtained due to wall motion, successive signal frames are analyzed, and the distension waveform of the artery is computed as the difference between the near and far wall movements”), and a tissue property of the body part from the radius measurements and the pressure measurements ([0051]: “As the change in diameter and the pressure associated with artery of interest are available, other arterial compliance measures such as Elastic modulus”, wherein the elastic modulus is a tissue property).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the method disclosed by Johnson to include the determination of a tissue property of the body part from the radius measurements and the pressure measurements as disclosed by Patil in order to allow for non-invasive determination of arterial parameters (Patil [0006]).
Regarding claim 2, Johnson further discloses wherein the pressure measurements are obtained using a sensor pad positioned on the inside of the hard shell portion ([0139]: “The pressure sensor, force sensor, or strain gauge can be positioned against the skin or against the stocking and under the base plate”).
Regarding claim 3, Johnson further discloses ([0139]: “an integrated strain gauge, pressure sensor, and/or force sensor can be provided to provide real time feedback of compression level in the mechanical compression system”)
Regarding claim 5, Johnson further discloses obtaining the radius measurement comprises using one or more radius sensors (table 1 gauges).
Regarding claim 6, Johnson further discloses wherein the radius sensor is a sensor configured to measure the deformation of the hard shell portion (table 1 gauges, wherein the gauge is integrated into the compression plate chassis).
Regarding claim 7, Johnson further discloses wherein the radius sensor is configured or arranged such that deformation of the hard shell changes one or more electrical properties of the radius sensor ([0140]: “strain gauge,”).
Regarding claim 8, Johnson further discloses wherein the radius sensor is a strain gauge ([0140]: “strain gauge”).
Regarding claim 9, Johnson further discloses wherein the radius measurements are obtained from measurements of the pressure in the inflatable cuff ([0073]: “an interface pressure between the wearable compression mechanism and the body part”), and the measurements of the rate of fluid into and out of the cuff ([0191]: “, the sequence, rate and delivered degree of compression force may be adjusted for use in combination with compression device”).
Regarding claim 10, Johnson further discloses wherein the radius measurements are obtained from measurements of the pressure in the inflatable cuff ([0140]: “real time feedback from various system sensors and/or measurements (e.g. strain gauge, pressure sensor, force sensor, heart rate sensor, blood pressure sensor, impedance sensor, clot formation detection, blood flow measurements, ultrasound sensor, wound size measurement, temperature sensor, gas sensor, blood chemistry, posture sensor, accelerometer, etc.)”), pressure measurements obtained using the sensor pad ([0140]), a friction factor for the hard shell portion ([0140]: “Sequential compression may also be enhanced by passive (friction) or active (multiple servos/motors/zones) means”), and the length of the hard shell portion ([0235]).
Regarding claim 11, Patil discloses wherein the step of determining the tissue property of the body part from the radius measurements and the pressure measurements comprises using a function that relates changes in the radius of the body part to one or more tissue properties and the pressure applied to the body part ([0051-0052]).
Regarding claim 12, Patil discloses wherein the step of determining the tissue property comprises evaluating, using the obtained radius measurements:
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([0047-0051], eq (1) including the diameter and cross section, eq (2) including the pressure, and formulas for elastic modulus, arterial distensibility, arterial compliance, and stiffness index).
Regarding claim 14, Johnson discloses a device for determining a tissue property of a body part ([0159]: “A controller 1206 of the compression system controls its operation”), comprising a processor configured to: output a control signal to a shell cuff apparatus to apply a plurality of different pressures to the body part ([0029]: “fastening one or more compression elements of a wearable compression device around the body part… tighten or loosen the one or more compression elements fastened around the body part”), wherein the shell cuff apparatus at least partially encloses the body part (Fig 3, wherein the device encloses the leg), and wherein the shell cuff apparatus comprises a hard shell portion placed at least partially around the body part ([0145]: “the system and method may include a rigid or semi-rigid compression plate 316, 716, 716′, 716″ that is pulled into the appendage or body part, such as the lower leg, and released via an attached drive train mechanism, locally compressing the area under the compression plate. The compression plate facilitates and allows selective pressure to be applied to specific vascular, muscular or lymph regions.”) and an inflatable cuff surrounding the hard shell portion that is inflated and/or deflated to apply the plurality of different pressures to the body part via the hard shell portion ([0144]: “The compression straps may have inflatable zones or be entirely inflatable to pad the straps and/or may be constructed fully or partially of an inelastic material in order to efficiently transmit the compressive forces to the body part.”, [0145]: “, each zone of the compression plate can be associated with its own compression strap,”); obtain a circumference measurements of a circumference of the body part, or changes in the radius of the body part, as the plurality of different pressures are applied to the body part ([0161]: “using a strain gauge to measure the change in the circumference and volume of the body part”); obtaining a pressure measurements of the different pressures applied to the body part ([0024]: “a sensor configured to measure a magnitude of pressure applied to the body part by the device”);
While Johnson discloses obtaining circumference measurements, they fail to specifically disclose obtain a radius measurements of a radius of the body part, or changes in the radius of the body part. Johnson further fails to disclose determining the tissue property of the body part from the radius measurements and the pressure measurements.
Patil discloses determining obtaining radius measurements of the body part, or changes in the radius of the body part ([0017]: “which captures the change in diameter of an artery caused due to pulsatile nature of blood”, [0039]: “This change in elastic property is manifested in diameter change of the artery. Based on the echoes obtained due to wall motion, successive signal frames are analyzed, and the distension waveform of the artery is computed as the difference between the near and far wall movements”), and a tissue property of the body part from the radius measurements and the pressure measurements ([0051]: “As the change in diameter and the pressure associated with artery of interest are available, other arterial compliance measures such as Elastic modulus”, wherein the elastic modulus is a tissue property).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the method disclosed by Johnson to include the determination of a tissue property of the body part from the radius measurements and the pressure measurements as disclosed by Patil in order to allow for non-invasive determination of arterial parameters (Patil [0006]).
Regarding claim 15, Johnson further discloses a shell cuff apparatus configured to at least partially encloses the body part (Fig 3, wherein the device encloses the leg), and wherein the shell cuff apparatus comprises a hard shell portion placed at least partially around the body part ([0145]: “the system and method may include a rigid or semi-rigid compression plate 316, 716, 716′, 716″ that is pulled into the appendage or body part, such as the lower leg, and released via an attached drive train mechanism, locally compressing the area under the compression plate. The compression plate facilitates and allows selective pressure to be applied to specific vascular, muscular or lymph regions.”) and an inflatable cuff surrounding the hard shell portion that is inflated and/or deflated to apply the plurality of different pressures to the body part via the hard shell portion ([0144]: “The compression straps may have inflatable zones or be entirely inflatable to pad the straps and/or may be constructed fully or partially of an inelastic material in order to efficiently transmit the compressive forces to the body part.”, [0145]: “, each zone of the compression plate can be associated with its own compression strap,”); and one or more sensors for providing the radius measurements and the pressure measurements ([0136]: “, active feedback is provided via wearable sensor(s) (e.g., pressure, force and/or strain sensors)”).
Regarding claim 16, Johnson further discloses a non-transitory computer-readable medium that stores therein a computer program product, which executed on a processor, causes the method of claim 1 to be performed ([0118]: “an electronic control board 308 with processor(s) and memory,”).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Patil in further view of Pfeiffer et al (US 20220257130 A1, as cited by applicant’s IDS filed 04/03/2024).
Regarding claim 4, Johnson as modified by Patil discloses the method as claimed in claim 3. Johnson further discloses determining a total length of the hard shell portion ([0123]: “Sizing of the stocking can be determined by measurement of the length and circumference of the lower leg or body part to be compressed.”), but fails to disclose determining a pressure measurement as a function of a cuff pressure sensor measurement and a corresponding radius measurement.
Patil further discloses determining a pressure measurement as a function of a cuff pressure sensor measurement ([0048] and eq 2) and a corresponding radius measurement ([0047] and eq 1).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the method disclosed by Johnson to include the measurements disclosed by Patil in order to obtain a more robust data set.
Johnson as modified by Patil fails to disclose determining a coefficient of friction of the hard shell.
Pfeiffer discloses determining a coefficient of friction of a hard shell portion ([0035]: “allows for a friction coefficient of less than 0.5, preferably of less than 0.3, more preferably of less than 0.2”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the method disclosed by Johnson as modified by Patil to include the coefficient of friction as disclosed by Pfeiffer in order to obtain a more robust data set.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Patil in further view of Russel (US 20030135124 A1).
Regarding claim 13, Johnson in view of Patil discloses a computer-implemented method of determining a measurement of a physiological characteristic of a subject, the method comprising: determining a tissue property of a body part of the subject according to the method of claim 1 (see rejection above), but fails to disclose using the determined property to calibrate pressure measurements by a sensor pad positioned inside the hard shell portion; and determining a measurement of the physiological characteristic using the calibrated measurements.
Russel discloses using a determined property to calibrate pressure measurements by a sensor pad positioned inside the hard shell portion ([0137]: “Calibration Phase-I occlusive cuff determination (OCD) processes determine arterial blood pressure and radius. Spatial, time-domain (Td) calibration processes determine radial displacement values at low monitoring cuff pressure, whereby elasticity moduli can be computed for flow relationships and blood pressure monitoring.”); and determining a measurement of the physiological characteristic using the calibrated measurements ([0137]: “Frequency domain (Fd) processes initiate blood flow monitoring, calibrate a pressure gradient sampling interval to assure equivalence between Td elasticity and Fd flow-based elasticity parameters, and recalibrate (OCD) systolic blood pressure”, wherein the physiological characteristic is systolic blood pressure).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the method disclosed by Johnson as modified by Patil to include the calibration disclosed by Russel in order to improve the accuracy of detecting a physiological characteristic (Russel [0137]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhu et al. (US 20160007884 A1) -discloses radius measurements
Oser et al. (US 6375620 B1) – discloses use of strain gauge to determine circumference of a body part
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAVYA SHOBANA BALAJI whose telephone number is (703)756-5368. The examiner can normally be reached Monday - Friday 8:30 - 5:30 ET.
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/KAVYA SHOBANA BALAJI/ Examiner, Art Unit 3791
/DANIEL L CERIONI/ Primary Examiner, Art Unit 3791