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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/02/2025 has been entered.
Priority
Acknowledgement is made to Applicant’s claim to priority to U.S. Provisional App. No. 63/407,769 filed September 19, 2022.
Status of Claims
This Office Action is responsive to the claims filed on 08/26/2025. Claims 1, 4, 6, 9, 10, 12, and 15 have been amended. Claim 3 has been canceled. Claim 16 is newly presented. Claims 1, 2, and 4-16 are presently pending in this 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.
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 9-11 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 10, line 4 recites the claim limitation “a dimension of the diaphragm of a patient” which is indefinite because it is unclear if “a dimension” and “a patient” are the same dimension and patient recited in claims 9 and 1; OR different dimensions and patients. For the purpose of examination, this is understood to mean the dimension and patient are the same as previously recited; OR different dimensions and patients.
Claim 11, line 3 recite the limitation "the dimension of the diaphragm". There is insufficient antecedent basis for this limitation in the claim. It is further unclear if the dimension is the thickness, apparent thickness, or estimated thickness as described in claims 1 and 8; OR if the dimension refers to a different dimension of the diaphragm. For the purpose of examination, this is understood to mean the thickness, apparent thickness, or estimated thickness as recited in claims 1 and 8; OR a different dimension of the diaphragm.
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.
Claims 1, 2, 5, 7, 12, 13, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (CN-114680929-A; Translation of CN-114680929-A relied upon herein) in view of Cerofolini (US 20110257531 A1).
Regarding claim 1, Huang teaches a diaphragm imaging device (Abstract; Pg. 5, Para 2; ultrasonic measuring system for measuring diaphragm, Fig. 1), and at least one electronic controller (Pg. 5, Para 2; a processor 130) comprising: at least one electronic processor programmed to perform a diaphragm imaging method (Pg. 5, Para 2 and 6; a processor 130; the image characteristic of the diaphragm… automatically acquire the target M line of the diaphragm region of the testee) including:
receiving ultrasound imaging data of a diaphragm of a patient (Pg. 5, Para 5 and 6; ultrasonic imaging model excitation ultrasonic probe 110 to the testee tissue emitting ultrasonic beam and receiving the echo of the beam ultrasonic by the testee tissue; testee tissue comprises diaphragm), the ultrasound imaging data being acquired by an associated ultrasound imaging probe (Pg. 5, Para 3; ultrasonic probe 110) with the probe at a plurality of different observable probe angles (Pg. 8, Para 6; multiple anatomical M lines of the diaphragm region of the automatic acquire Referring to FIG. 5, wherein the diaphragm region of the arc line arbitrarily selecting several point through the selected several point as the tangent of the diaphragm region of the arc line…; Fig. 5 shows each arc line is taken at a different angle.);
for each observable probe angle (Pg. 9, Para 6; obtain the plurality of M image diaphragm region, wherein each M image diaphragm region corresponding to a target M line), determining a corresponding apparent thickness of the diaphragm of the patient from the received ultrasound data acquired at that observable probe angle (Pg. 9, Para 4-7; based on the M image of the target M line, the obtain parameter of the diaphragm region of the testee; wherein the measuring parameter is… diaphragm region thickness; Pg. 10, Para 8; wherein the M image diaphragm region can be one, or two or more than two); and
estimating a thickness of the diaphragm of the patient based at least on the apparent thicknesses (Pg. 10, Para 9-Pg. 11, Para 1; For example, the average value of the maximum value and the minimum value is the thickness of the diaphragm region of the testee)
Huang does not explicitly teach estimating a thickness by fitting a plurality of data pairs each comprising one of the determined apparent thicknesses (dj) and its corresponding observable probe angle (pobs) to an expected relationship between apparent thickness and observable probe angle.
Cerofolini, however, teaches estimating a thickness (Paragraph [0071]; measurement of the thickness of the biological tissue 2 according to a line of sight oriented along the axis) by fitting a plurality of data pairs (Pararaph [0073]; thickness of the biological tissue 2 is calculated by the time interval between the reception of the first echo and the reception of the second echo… sequentially orienting the line of sight according to different angles) each comprising one of the determined apparent thicknesses (Paragraph [0073]; thickness of the biological tissue 2 is calculated by the time interval between the reception of the first echo and the reception of the second echo, which are relevant to the same ultrasonic pulse emitted along a line of sight) and its corresponding observable probe angle (Paragraph [0073]; sequentially orienting the line of sight according to different angles, Figs. 1 and 2) to an expected relationship between apparent thickness and observable probe angle (Paragraph [0074]; iteration of measurements according to different angles and by comparisons of the measured intensity values the orientation of the line of sight having the maximum intensity of the first echo is defined; Paragraph [0077]; the aim is to find the maximum value of the first echo according to subsequent orientations 31, 32, 33 by increasing from time to time the angle of the line of sight but keeping it on a single first plane; Finding the maximum intensity is considered to read on the claimed limitation of fitting an expected relationship between apparent thickness and observable probe angle as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the thickness estimation of Huang such that to include fitting a plurality of data pairs each comprising one of the determined apparent thicknesses and its corresponding observable probe angle to an expected relationship between apparent thickness and observable probe angle as taught by Cerofolini because it would allow the measurement of the thickness to be taken along an axis perpendicular to the surface of the biological tissue even when the probe is not perfectly perpendicular to the surface of the biological tissue (paragraph [0019]).
Regarding claim 2, together Huang and Cerofolini teach all of the limitations of claim 1 as noted above.
Huang does not teach estimating the thickness of the diaphragm of the patient as the smallest apparent thickness of the determined apparent thicknesses.
Cerofolini, however, further teaches a method of estimating a thickness of a tissue of the patient (Paragraph [0071]; measurement of the thickness of the biological tissue 2 according to a line of sight oriented along the axis) as the smallest apparent thickness of the determined apparent thicknesses (Paragraph [0080]; value acquired at the second-last step on such first plane 3 is defined as the maximum value on such first plane; Paragraph [0082]; the process is repeated in order to find the maximum value even on the second plane 4, corresponding to the maximum value on the whole volume insonificated by the probe; Paragraph [0085]; As the maximum value of the first echo corresponds to the point showing the smallest distance between the surface plane of the biological tissue).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Huang to have performed the steps of estimating the thickness of the diaphragm of the patient as the smallest apparent thickness of the determined apparent thicknesses as further taught by Cerofolini because such point is necessarily arranged along the axis perpendicular to the surface of the biological tissue passing through the point of origin of the lines of sight and therefore would provide the real measurement of the thickness of the biological tissue (Paragraph [0085] and [0018]).
Regarding claim 5, together Huang and Cerofolini teach all of the limitations of claim 1 as noted above.
Huang further teaches the observable angle is measured during the receiving by: determining a position of a surface of the diaphragm of the patient from ultrasound imaging data of the dimension of a diaphragm of a patient (Pg. 7, Para 6; M line intersects with the diaphragm region of the arc line at the intersection point, through the intersection point as the tangent line of the diaphragm region of the arc line; The intersection point at the tangent to the arc line of the diaphragm is understood to be a position of a surface from ultrasound imaging data of the dimension of a diaphragm of a patient as understood in its broadest reasonable interpretation); and
calculating an inclination angle of the associated ultrasound imaging probe from the determined position of the surface of the diaphragm (Pg. 7, Para 6-7; processor automatically acquire the included angle between several M lines and the diaphragm region of the testee).
Regarding claim 7, together Huang and Cerofolini teach all of the limitations of claim 1 as noted above.
Huang further teaches method further includes performing a corrective action based on the estimated thickness of the diaphragm (Pg. 7, Para 6-7; determining the target M line by the M line of the first preset condition of the included angle satisfy wherein the first preset condition is the included angle clinical satisfy), the corrective action comprising: displaying, on a display device, a representation of the calculated inclination angle (Pg. 8, Para 4-11; automatic acquiring tissue in the image of the diaphragm area capable of presenting the substantially contour; Fig. 5 shows the M-lines at different angles which are considered to be representations of the calculated inclination angle as understood in its broadest reasonable interpretation).
Regarding claim 12, together Huang and Cerofolini teach all of the limitations of claim 5 as noted above.
Huang further teaches calculating an inclination angle of the associated ultrasound imaging device (Pg. 7, Para 6; processor automatically acquire the included angle between several M lines and the diaphragm region of the testee; The angles of the M lines are considered to be inclination angle of the associated ultrasound imaging device as understood in its broadest reasonable interpretation in view of the rejection under 35 USC 112(b) as noted above) includes: calculating the inclination angle using one or more sensors (Pg. 7, Para 5; the direction of the M line is the direction of the sound beam emission. In one embodiment, using a convex array probe; The ultrasound probe is considered to be a sensor as understood in its broadest reasonable interpretation).
Regarding claim 13, together Huang and Cerofolini teach all of the limitations of claim 1 as noted above.
Huang further teaches calculating a diaphragm thickness metric based on the received ultrasound imaging data of the diaphragm of the patient (Pg. 9, Para 4-7; based on the M image of the target M line, the obtain parameter of the diaphragm region of the testee; wherein the measuring parameter is… diaphragm region thickness; Pg. 10, Para 9-Pg. 11, Para 1; For example, the average value of the maximum value and the minimum value is the thickness of the diaphragm region of the testee); and
displaying, on a display device (Pg. 6, Para 2; display 140), a representation of the calculated diaphragm thickness metric (Pg. 6, Para 2; displaying and outputting various detection results. The result comprises various patterns or measurement parameters of the intermediate process, which can be graphically presented to the operator or the subject by means of graphics, images, characters, numbers or charts).
Regarding claim 15, Huang teaches a diaphragm imaging device (Abstract; Pg. 5, Para 2; ultrasonic measuring system for measuring diaphragm, Fig. 1), and at least one electronic controller (Pg. 5, Para 2; a processor 130) comprising: at least one electronic processor programmed to perform a diaphragm imaging method (Pg. 5, Para 2 and 6; a processor 130; the image characteristic of the diaphragm… automatically acquire the target M line of the diaphragm region of the testee) including:
receiving ultrasound imaging data of a diaphragm of a patient (Pg. 5, Para 5 and 6; ultrasonic imaging model excitation ultrasonic probe 110 to the testee tissue emitting ultrasonic beam and receiving the echo of the beam ultrasonic by the testee tissue; testee tissue comprises diaphragm), the ultrasound imaging data being acquired by an associated ultrasound imaging probe (Pg. 5, Para 3; ultrasonic probe 110) with the probe at a plurality of different observable probe angles (Pg. 8, Para 6; multiple anatomical M lines of the diaphragm region of the automatic acquire Referring to FIG. 5, wherein the diaphragm region of the arc line arbitrarily selecting several point through the selected several point as the tangent of the diaphragm region of the arc line…; Fig. 5 shows each arc line is taken at a different angle.);
for each observable probe angle (Pg. 9, Para 6; obtain the plurality of M image diaphragm region, wherein each M image diaphragm region corresponding to a target M line), determining a corresponding apparent thickness of the diaphragm of the patient from the received ultrasound data acquired at that observable probe angle (Pg. 9, Para 4-7; based on the M image of the target M line, the obtain parameter of the diaphragm region of the testee; wherein the measuring parameter is… diaphragm region thickness; Pg. 10, Para 8; wherein the M image diaphragm region can be one, or two or more than two); and
estimating a thickness of the diaphragm of the patient based at least on the apparent thicknesses (Pg. 10, Para 9-Pg. 11, Para 1; For example, the average value of the maximum value and the minimum value is the thickness of the diaphragm region of the testee).
Huang does not teach estimating the thickness of the diaphragm of the patient as the smallest apparent thickness of the determined apparent thicknesses.
Cerofolini, however, further teaches a method of estimating a thickness of a tissue of the patient (Paragraph [0071]; measurement of the thickness of the biological tissue 2 according to a line of sight oriented along the axis) as the smallest apparent thickness of the determined apparent thicknesses (Paragraph [0080]; value acquired at the second-last step on such first plane 3 is defined as the maximum value on such first plane; Paragraph [0082]; the process is repeated in order to find the maximum value even on the second plane 4, corresponding to the maximum value on the whole volume insonificated by the probe; Paragraph [0085]; As the maximum value of the first echo corresponds to the point showing the smallest distance between the surface plane of the biological tissue).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Huang to have performed the steps of estimating the thickness of the diaphragm of the patient as the smallest apparent thickness of the determined apparent thicknesses as further taught by Cerofolini because such point is necessarily arranged along the axis perpendicular to the surface of the biological tissue passing through the point of origin of the lines of sight and therefore would provide the real measurement of the thickness of the biological tissue (Paragraph [0085] and [0018]).
Regarding claim 16, together Huang and Cerofolini teach all of the limitations of claim 1 as noted above.
Huang does not explicitly teach an external sensor measuring the different observable probe angles (Gobs) respective to a surface of skin of the patient.
Cerofolini however further teaches an external sensor (Paragraphs [0088] and [0039]-[0042]; means for processing the reception signals and means for orienting one or more lines of sight, along which the emission of the pulses and/or the reception of the echoes is focused, according to different angles with respect to an axis perpendicular to the emitting surface of the probe; Paragraph [0101]; the transducer array can be oscillated by means of motors according to two axes perpendicular to each other and perpendicular to the direction of propagation of the ultrasound beam; The motor and orienting means for getting the orientation is considered to read on the claimed limitation as understood in its broadest reasonable interpretation) measuring the different observable probe angles (Gobs) respective to a surface of skin of the patient (Paragraph [0018]; iteratively orienting the line of sight according to different angles with respect to an axis perpendicular to the emitting surface, which generally is coincident with the longitudinal axis of the probe, till an orientation is found coinciding with the axis perpendicular to the surface of the biological tissue).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Huang in view of Cerofolini to include an external sensor measuring the different observable probe angles (Gobs) respective to a surface of skin of the patient because it would have allowed the device to orient the line of sight along at least a plane perpendicular to the emitting surface of the probe, thereby allowing accurate measurement of the thickness.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Cerofolini as applied to claim 1 above, and further in view of Govari (US 20180008229).
Regarding claim 4, together Huang and Cerofolini teach all of the limitations of claim 1 as noted above.
Huang and Cerofolini do not explicitly teach the expected relationship between the corresponding apparent thickness and each observable probe angle is an equation), and the unknown fitted parameters are thickness of the diaphragm of the patient and a reference angle.
Govari teaches an expected relationship between the corresponding apparent thickness (Paragraph [0051]; tissue thickness T_54′, Fig. 3) and each observable probe angle (Paragraph [0051]; appropriate angle theta (θ), Fig. 3) is an equation (Paragraph [0051]; multiplying the tissue thickness T_54′ by the cosine of the appropriate angle theta (θ);
T
54
=
T
54
'
*
cos
θ
; Fig. 3), and the unknown fitted parameters are thickness of the diaphragm of the patient (Paragraph [0051]; calculated tissue thickness T_54, Fig. 3) and a reference angle (Paragraph [0047]; force signal 21 typically includes both the magnitude and direction of the force; Paragraph [0050]; processor is configured to determine, based on the directionality of the force signal, the portion of the tissue from which the ultrasound signals were received; The direction used to determine the angle theta is considered to be a reference angle as understood in its broadest reasonable interpretation).
Together Huang and Govari do not explicitly teach the equation
d
I
=
d
D
sin
β
o
b
s
-
β
r
e
f
as explicitly claimed. The arrangement as described in Govari, however, is geometrically equivalent to the claimed equation. See below Fig. A. The angle β as described in Applicant specification and illustrated in Fig. 4 of the drawings has been drawn below (β, dashed arc) in the arrangement of Govari. One of ordinary skill in the in the art would recognize the angle β is the complement to the angle θ (θ, arc with no dash) as shown below. Furthermore one of ordinary skill in the art would recognize the equation of
T
54
=
T
54
'
*
cos
θ
as described by Govari can be rewritten in the form of β using a trigonometric transformation, yielding the equation
T
54
=
T
54
'
*
sin
β
.
Rearranging the equation such that the apparent thickness is written as an expression of the actual thickness yields the equation
T
54
'
=
T
54
sin
β
. This equation is equivalent to the claimed equation.
PNG
media_image1.png
609
650
media_image1.png
Greyscale
Figure A: Adapted from Govari, Fig. 3
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the device of Huang in view of Govari such that the expected relationship between the corresponding apparent thickness and each observable probe angle is an equation and the unknown fitted parameters are thickness of the diaphragm of the patient and a reference angle as taught by Govari because it would allow ensuring the correct thickness of the tissue which would allow determining the recommended treatment parameters (Govari, Paragraph [0053]), such as properly assess the timing and use of a respiratory device (Huang, Pg. 2, Para 2-4). It further would have been obvious to have substituted the equation of Govari with the claimed equation of
d
I
=
d
D
sin
β
o
b
s
-
β
r
e
f
because the equation would have been suitable equivalent of the equation of Govari for the same purpose of determining the thickness of a tissue wall.
Claims 6, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Cerofolini as applied to claim 1 above, and further in view of Hiuga (JP-2015054007-A).
Regarding claim 6, Huang and Cerofolini teaches all of the limitations of claim 5 as noted above.
Huang further teaches determining the position of a surface of the diaphragm from the acquired ultrasound imaging data of the dimension of a diaphragm of a patient (Pg. 7, Para 6; M line intersects with the diaphragm region of the arc line at the intersection point, through the intersection point as the tangent line of the diaphragm region of the arc line; The intersection point at the tangent to the arc line of the diaphragm is understood to be a position of a surface from ultrasound imaging data of the dimension of a diaphragm of a patient as understood in its broadest reasonable interpretation).
Huang does not explicitly teach that determining a position of a surface of the diaphragm of the patient from ultrasound imaging data of the dimension of a diaphragm of a patient includes: acquiring ultrasound imaging data of the dimension of a diaphragm of a patient based on a plurality of different orientations of the associated ultrasound imaging device relative to skin of the patient.
Hiuga, however, teaches a imaging device (Pg. 2, Para 3; ultrasonic measurement device) comprising: at least one electronic processor (Pg. 5, Para 2; processing unit 120) programmed to estimate a thickness of a muscle layer of the patient (Pg. 2, Para 3; perform image diagnosis of the surface layer of a subject, such as measurement of the thickness of a muscle layer), and further acquiring ultrasound imaging data of the dimension of the muscle layer of the patient based on a plurality of different orientations of the associated ultrasound imaging device relative to skin of the patient (Pg. 2, Para 7; Pg. 3, Para 1 and 6; when measuring the thickness… when an attitude deviation of the ultrasonic probe occurs, it is required to detect the attitude deviation of the ultrasonic probe and notify the measurer attitude shift is detected; the amount of tilt and the tilt direction are visualized and a warning is displayed on the display unit; Pg. 13, Para 9; detecting posture deviation of the probe posture of the ultrasonic probe with respect to the surface of the measurement target is performed; Pg. 14, Para 1; detect the posture deviation of the ultrasonic probe based on the difference in luminance between the two ultrasonic images).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Huang in view of Cerofolini to have further included performed steps of acquiring ultrasound imaging data of the dimension of the muscle layer of the patient based on a plurality of different orientations of the associated ultrasound imaging device relative to skin of the patient as taught by Hiuga because it would have allowed detection when the tilt of the probe is out of alignment with target structure and thus allow the operator to adjust the posture of the probe and prevent slipping which reduces the ability to obtain a correct measurement (Hiuga, pg. 2, Para 6).
Regarding claim 8, together Huang and Cerofolini teaches all of the limitations of claim 1 as noted above.
Huang does not teach performing a corrective action based on the estimated thickness of the diaphragm, the corrective action comprising: providing, via the associated ultrasound imaging device, tactile feedback for an operator of the associated ultrasound imaging device.
Hiuga, however, teaches a imaging device (Pg. 2, Para 3; ultrasonic measurement device) comprising: at least one electronic processor (Pg. 5, Para 2; processing unit 120) programmed to estimate a thickness of a muscle layer of the patient (Pg. 2, Para 3; perform image diagnosis of the surface layer of a subject, such as measurement of the thickness of a muscle layer), and further performing a corrective action (Pg. 13, para 9; notification information for notifying the detected posture deviation of the ultrasonic probe is output) based on the estimated thickness of the diaphragm, the corrective action comprising: providing, via the associated ultrasound imaging device, tactile feedback for an operator of the associated ultrasound imaging device (Pg. 13, Para 10; notification information is information representing the posture deviation of the probe posture of the ultrasonic probe. Furthermore, the notification information may be vibration data that notifies the posture deviation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Huang in view of Cerofolini to have included performing a corrective action based on the estimated thickness of the diaphragm, the corrective action comprising: providing, via the associated ultrasound imaging device, tactile feedback for an operator of the associated ultrasound imaging device as taught by Hiuga because it would have allowed the operator to detect when there is a deviation in the posture of the ultrasonic probe (Pg. 13, Para 9 and 10) and further allow the operator to adjust the posture of the probe and prevent slipping which reduces the ability to obtain a correct measurement (Hiuga, pg. 2, Para 6).
Regarding claim 9, together Huang, Cerofolini, and Hiuga teaches all of the limitations of claim 8 as noted above.
Huang further teaches the corrective action comprises: determining a position of a surface of the diaphragm of the patient from ultrasound imaging data of the dimension of a diaphragm of a patient (Pg. 7, Para 6; M line intersects with the diaphragm region of the arc line at the intersection point, through the intersection point as the tangent line of the diaphragm region of the arc line; The intersection point at the tangent to the arc line of the diaphragm is understood to be a position of a surface from ultrasound imaging data of the dimension of a diaphragm of a patient as understood in its broadest reasonable interpretation); and
determining a standard inclination angle of the associated ultrasound imaging device from the determined position of the surface of the diaphragm at which the associated ultrasound imaging device is able to image the surface of the diaphragm of the patient (Pg. 7, Para 6-8; acquire the included angle between several M lines and the diaphragm region of the testee; processor automatically recognizes the diaphragm region).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Cerofolini and Hiuga as applied to claim 9 above, and further in view of Akkaraju (US 20210041558).
Regarding claim 10, together Huang, Cerofolini, and Hiuga teach all of the limitations of claim 9 as noted above. Huang further teaches:
determining a position of a surface of the diaphragm of the patient from ultrasound imaging data of the dimension of a diaphragm of a patient (Pg. 7, Para 6; M line intersects with the diaphragm region of the arc line at the intersection point, through the intersection point as the tangent line of the diaphragm region of the arc line; The intersection point at the tangent to the arc line of the diaphragm is understood to be a position of a surface from ultrasound imaging data of the dimension of a diaphragm of a patient as understood in its broadest reasonable interpretation);
calculating an inclination angle of the associated ultrasound imaging probe from the determined position of the surface of the diaphragm (Pg. 7, Para 6-7; processor automatically acquire the included angle between several M lines and the diaphragm region of the testee); and
determining a difference between the calculated inclination angle and the standard inclination angle (Pg. 8. Paras 2 and 4; computing a first included angle, a second included angle and a difference value of 90 degrees).
Together Huang and Hiuga do not explicitly teach providing the tactile feedback until the calculated inclination angle matches the standard inclination angle.
Akkaraju, however, teaches an ultrasonic probe (Paragraph [0006]; ultrasonic probe, Fig. 1B) which provides the tactile feedback (Paragraph [0006]; configured to provide haptic feedback with regard to operating conditions, for example, by varying the intensity of feedback until the user attains optimal orientation) until the calculated inclination angle matches the standard inclination angle (Paragraph [0074]; the ultrasound probe will vary the intensity of the haptic feedback based on the orientation of the probe, with peak intensity indicating correct alignment, Figs. 9A and 9B; the achievement of correct alignment is considered to read on the claimed limitation of matching the calculated inclination angle and the standard inclination angle as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Huang in view of Cerofolini and Hiuga such that the tactile feedback is provided until the calculated inclination angle matches the standard inclination angle as taught by Akkaraju because it would have provided a convenient additional way to provide information to the user without reducing screen real estate or requiring extra input from the user, or warning the user of critical information (Akkaraju, Paragraphs [0074]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Cerofolini as applied to claim 1 above, and further in view of Kruger (US 20200163650).
Regarding claim 11, together Huang and Cerofolini teaches all of the limitations of claim 1 as noted above.
Huang further teaches an ultrasound probe (Pg. 5, Para 5 and 6; ultrasonic imaging model excitation ultrasonic probe 110) configured to acquire the ultrasound imaging data of the dimension of the diaphragm of the patient (Pg. 5, Para 5 and 6; receiving the echo of the beam ultrasonic by the testee tissue; testee tissue comprises diaphragm; Pg. 9, Para 4-7; based on the M image of the target M line, the obtain parameter of the diaphragm region of the testee).
Huang does not teach wherein the ultrasound probe includes an actuator disposed on a portion of the ultrasound probe and configured to move the ultrasound probe relative to skin of the patient.
Kruger, however, teaches an ultrasound probe (Paragraph [0039]; sensor 100 includes one or more ultrasound transducers) including an actuator (Paragraph [0042] and [0043]; example sensor 100 includes a low-friction, high-speed pneumatic actuator) disposed on a portion of the ultrasound probe (Paragraphs [0042] and [0043]; the pneumatic actuator may be located within the reservoir. The ultrasound and associated electronics may be integrated with the sensor body to provide a wireless solution; Fig. 2A) and configured to move the ultrasound probe relative to skin of the patient (Paragraph [0043] The sensor head moves within the fluid reservoir parallel to the acoustic window; guide rail may also be rotated or translated in order to adjust the angle of the sensor head relative to the surface of the skin).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the ultrasound probe of Huang in view of Cerofolini to have included an actuator disposed on a portion of the ultrasound probe and configured to move the ultrasound probe relative to skin of the patient as taught by Kruger because it would have allowed the processing device to provide control and monitoring of spatial orientation of the probe (Kruger, Paragraph [0039]) and further allow obtaining perpendicular images, slightly off perpendicular images to minimize reflections or capture images across multiple planes in order to measure vessel/flow trajectory or build 3D images of a segment of tissue (Kruger, Paragraph [0047]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Huang in view of Cerofolini as applied to claim 1 above, and further in view of Raymondos (US 20240123226).
Regarding claim 14, together Huang and Cerofolini teaches all of the limitations of claim 1 as noted above.
Huang further teaches receiving the ultrasound imaging data of a dimension of a diaphragm of occurs during inspiration and expiration (Pg. 9, Para 3; first predetermined period of time is at least one of motion period diaphragms of the diaphragm, the motion period of the diaphragm corresponding to the respiratory cycle).
Huang does not teach a mechanical ventilator configured to deliver mechanical ventilation therapy to the patient, wherein receiving the ultrasound imaging data occurs while the patient undergoes mechanical ventilation therapy with the mechanical ventilator; and the method further includes:
controlling an associated mechanical ventilator to adjust one or more parameters of the mechanical ventilation therapy delivered to the patient based on the calculated diaphragm thickness metric.
Raymondos, however, teaches a mechanical ventilator (Paragraph [0226]; ventilator 11, Fig. 2) configured to deliver mechanical ventilation therapy to the patient (Paragraph [0226]; air delivery unit 18 through which air can be suctioned from the environment via a port 19 and can be fed by means of a breathing mask 13 into the airways of the living being 1 via an air line 12, Fig. 2), wherein receiving the ultrasound imaging data occurs while the patient undergoes mechanical ventilation therapy with the mechanical ventilator (Paragraph [0078]; ultrasound measurements of movements and thickening of the diaphragm); and the method further includes:
controlling an associated mechanical ventilator to adjust one or more parameters of the mechanical ventilation therapy delivered to the patient based on the calculated diaphragm thickness metric (Paragraph [0078]; thickening of the diaphragm can provide an indirect indication of the diaphragmatic force; Paragraph [0078]; diaphragmatic force is advantageous in particular for the feedback for controlling the training stimulations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the device of Huang in view of Cerofolini to have further included a mechanical ventilator configured to deliver mechanical ventilation therapy to the patient, wherein receiving the ultrasound imaging data occurs while the patient undergoes mechanical ventilation therapy with the mechanical ventilator; and the method further includes: controlling an associated mechanical ventilator to adjust one or more parameters of the mechanical ventilation therapy delivered to the patient based on the calculated diaphragm thickness metric as taught by Raymondos. This would allow supporting the spontaneous respiration of a patient (Raymondos, Paragraph [0005]) and furthermore the controlling of the respirator based on the diaphragm thickness can ensure the diaphragm doesn’t further weaken and result in muscle atrophy thereby preventing diaphragm collapse (Raymondos, Paragraph [0140]).
Response to Arguments
Claim Objections
Examiner acknowledges the amendments and arguments to the claims and withdraws all previous objections to the claims.
Claim Rejections under – 35 U.S.C. § 112(b)
Examiner acknowledges the remarks and amendments to the claims and withdraws rejections of claim 9 under 35 USC 112(b).
Examiner points arguments and amendments fail to address rejections under 35 USC 112(b) regarding the recitation of “a dimension” and “a patient” in claim 10 as being unclear; and “the dimension” as lacking proper antecedent basis in claims 11.
Rejections of claims 10-11 under 35 USC 112(b) are maintained.
Claim Rejections under – 35 U.S.C. § 102 and 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 102 and 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Conclusion
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
3/5/26