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 .
Response to Arguments
Regarding 35 U.S.C. 101
Examiner notes that the previously set forth 101 rejections are withdrawn in view of the amendments to the claims.
Regarding 35 U.S.C. 112
Examiner notes that the previously set forth 112(b) rejections are withdrawn in view of the amendments to the claims, however, new 112(a) and 112(b) rejections are necessitated by amendment.
Regarding prior art
Applicant's arguments filed 07/16/2026 have been fully considered but they are not persuasive. For example, applicant argues “Yang with the remaining references does not teach or suggest ‘providing at least one data acquisition and/or data processing parameter to an ultrasound patch…. Wherein the at least one data acquisition and/or data processing parameter comprises a correction factor applied when determining a diaphragm thickness metric using the ultrasound patch.’ Claim 1 (as amended). While Yang suggest utilizing bladder imaging techniques to inform downstream bladder monitoring processes, the combination including Yang does not contemplate providing a ‘correction factor’ to an ultrasound patch for diaphragm imaging, as claimed. Id. Similarly, the remaining references do not teach or suggest ‘providing’ a correction factor for application ‘ when determining a diaphgram thickness metric using the ultrasound patch’ (REMARKS pg. 11). Examiner respectfully disagrees in that the correction factor when determining a diaphragm thickness metric using the ultrasound patch is considered extremely broad and that the beam-steering taught by Yang would read on such a correction factor as “when determining a diaphragm thickness metric using the ultrasound patch” merely defines a timing of when the correction factor is applied, but does not require any specific diaphragm thickness metric determination using the correction factor. Nonetheless, it is noted that Liu teaches the features of providing a correction factor to an ultrasound transducer for diaphragm imaging as noted below and when applied to the teachings of Yang would read on the claimed invention.
Applicant’s arguments that the Office cannot modify Yang as proposed as doing so would change its principle of operation (related to bladder monitoring). MPEP 2143.01 (VI). Here, the Office suggests adding core functions of Applicant’s claims to an unrelated imaging system, which would change Yang’s principle of operations, e.g. related to the alleged predicted scan lines, the target position, and adding diaphragm thickness correction factor that is unrelated to bladder imaging (REMARKS pg. 11-12). Examiner respectfully disagrees in that while a majority of Yang is directed toward bladder monitoring, the disclosure suggests the use of the system for any organ and presents the bladder as merely an example of the organ for which monitoring occurs (see for example [0024] and [0039] disclosing identification of an organ (e.g. a bladder)). A person having ordinary skill in the art would have recognized the benefit of using the system of Yang on other organs such as the diaphragm to perform continuous monitoring of such organs accordingly, furthermore, regarding applicant’s arguments with respect to adding diaphragm thickness correction factor, examiner notes that the claim does not specifically require any specific diaphragm thickness correction factors, but rather recites application of a correction factor which is applied when diaphragm thickness is measured. Such a limitation merely refers to a timing of when the correction factor is applied, but does not recite any specific nature of the correction factor which is not precluded from being merely a beam-steering or other customized setting taught by Yang. Nonetheless, examiner notes that providing parameters including a diaphragm thickness correction factor are considered to be taught by Liu as noted below. Specifically Liu teaches determining a target M-line and providing the M-line to the ultrasound transducer to acquire an M-line image from which diaphragm thickness parameters are acquired. Such a Target M-line is considered a “diaphragm thickness” correction factor.
For at least these reasons, applicant’s arguments that the Office cannot modify Yang as proposed are not found persuasive.
Applicant’s arguments against the cited prior art are therefore not found persuasive.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-18 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 11, and 15 recite the limitation “an ultrasound imaging probe configured to identify a target position on a patient”. Examiner notes that the limitation “configured to identify a target position on a patient” is understood to be a computer implemented function and while there appears to be support that a user or an algorithm may determine/indicate/identify a target position (see for example [0088] and [0092]), there is no such disclosure of an ultrasound imaging probe performing such identification. Thus the limitation as a whole lacks sufficient written description such that a person having ordinary skill in the art would have recognized the inventor had possession of the claimed invention at the original time of filing and the limitation therefore constitutes new matter.
Claim Rejections - 35 USC § 112(b)
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 1-18 and 20 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.
Claims 1, 11, and 15 recite the limitation “an ultrasound imaging probe configured to identify a target position on a patient”. Examiner notes that identifying a target position is understood to be a computer-implemented function and the limitation is unclear as to how a probe is configured to identify a target position on a patient and whether applicant intends for the/a processor to use the probe to identify a target position or if the claim merely intends to recite a capability of the use of the ultrasound imaging probe or if the ultrasound imaging probe includes some form of processor which is configured to identify a target position. For examination purposes, it has been intended to mean that the ultrasound probe is merely used to identify a target position on a patient, however, clarification is required.
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.
Claims 1-6, 9-12, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 20190357836 A1), hereinafter Yang in view of WIPO Liu et al. (WO 2022073306 A1), hereinafter Liu.
Regarding claims 1, 11, and 15,
Yang discloses an ultrasound imaging system (at least fig. 1 (100) and corresponding disclosure in at least [0020]), comprising:
At least one electronic processor (at least fig. 1 (120 and 300) and corresponding disclosure in at least [0021] and [0028] and/or fig. 4 (410) and corresponding disclosure in at least [0047]) programmed to:
Receive ultrasound images of a target tissue of a patient (P) acquired using an ultrasound imaging probe (at least fig. 1 (110) and corresponding disclosure in at least [0021]) configured to identify a target position of the patient (at least fig. 7 (730) and corresponding disclosure in at least [0067] and see also at least fig. 8A);
Provide at least one data acquisition and/or data processing parameter to an ultrasound patch (at least fig. 1 (200) and corresponding disclosure in a least [0025]) configured to replace the ultrasound imaging probe based on at least one ultrasound image of the target tissue acquired by the ultrasound imaging probe at the target position during the ultrasound imaging, wherein the at least one data acquiring and/or data processing parameter comprises a correction factor applied when determining a target tissue thickness metric using the ultrasound patch; (at least fig. 7 (730) and corresponding disclosure in at least [0070] which discloses scanning system 100 may provide guidance, based on image 910, to increase penetration depth and widen the steering angles for predicted signals 920 from sensors (e.g., ultrasound transducers 460). See also [0034] which discloses scanning system 100 may provide customization settings to patch 200 prior to attachment of patch 200 to the patient (e.g., based on scan data from probe 110 and default properties of patch 200 and [0017] which discloses customization settings for a patch may change physical properties, such as adjusting steering angles and beam intensities of sensors in the patch, and/or logical properties, such as adjusting how raw sensor data from the patch is interpreted. Examiner note that such adjustment of steering angles/beam intensities are considered a correction factor and would be applied in any case including when determining a thickness metric using the ultrasound patch);
Monitor the target tissue of the patient including acquiring tissue data of the target tissue of the patient using the ultrasound patch (200) comprising at least one ultrasound transducer (at least fig. 4 (460) and corresponding disclosure in at least [0047]) placed at the target position on the patient (see at least fig. 8A) and using the at least one data acquisition and/or data processing parameter ([0033] which discloses scanning system 100 may associate positive readings from one or more sensor combinations with a different bladder volume percentage (e.g., 25%, 55%, 80%, etc.) or volume amount (e.g., 100 cubic centimeters (cm.sup.3), 150 cm.sup.3, 300 cm.sup.3, etc.), See also [0027] which discloses scanning system 100 may receive sensor readings from patch 200 during an initial configuration period and provide customization instructions to patch 200. In one implementation, customization instructions may correlate particular combinations of sensor readings from patch 200 with corresponding bladder volume levels (e.g., based on the sensor readings and scan data from scanning system 100) and [0028] which discloses notification device 300 may include a device to process signals transmitted from patch 200 and provide audible, visible, or tactile notifications to a patient).
Yang fails to explicitly teach the target tissue is a diaphragm of the patient.
Nonetheless, Liu teaches at least one electronic processor (at least fig. 1 (130) and corresponding disclosure in at least pg. 13) programmed to provide at least one data acquisition and/or data processing parameter to an ultrasound transducer, based on at least one ultrasound image of the diaphragm acquired at a target position using an ultrasound imaging probe, wherein the at least one data acquisition and/or data processing parameter comprises a correction factor applied when determining a diaphragm thickness metric using the ultrasound transducer(pg. 14 first paragraph which discloses the processor 130 identifies the diaphragm region of the subject from the image of the subject's tissue according to the image features of the diaphragm. The processor 130 automatically acquires the target M-line of the subject's diaphragm region. The processor 130 acquires an M image of the target M-line based on the acquired target M-line. The processor determines the position of the target M-line according to several anatomical M-lines and pg. 16 which discloses The processor calculates the sum of the differences between the third included angle, the fourth included angle and 90 degrees, respectively, and the difference and the anatomical M-line satisfying the first preset condition are determined as the target M-line and pg. 17 which discloses the measurement parameters of the diaphragm muscle area include at least one of the movement amplitude of the diaphragm muscle area, the movement speed of the diaphragm muscle area, the thickness of the diaphragm muscle area, the thickening rate of the diaphragm muscle area, and the strain rate of the diaphragm muscle area. The target M-line is thus considered a correction factor applied when determining thickness parameters of the diaphragm accordingly) and monitor a diaphragm of a patient including acquiring tissue data of the patient using the ultrasound patch comprising at least one ultrasound transducer placed at a target position on a patient and using the at least one data acquisition and/or data processing parameter (pg. 14 which discloses the processor acquires an M image of the target M-line based on the acquired target M-line and abstract which discloses automatically acquiring a target M line of the diaphragm region of the testee and an M image thereof).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Yang to further include the diaphragm as a target tissue as taught by Liu in order to provide additional monitoring capabilities to the ultrasound patch of Yang accordingly. Such a modification would allow for providing the ultrasound patch to monitor other anatomical regions including the diaphragm thereby enhancing the capabilities of the system of Yang accordingly. Additionally/alternatively, such a modification amounts to merely a simple substitution of one known target tissue for another yielding predictable results with respect to long-term monitoring of organs, thereby rendering the claim obvious (MPEP 2143).
Additionally, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have provided the data acquisition parameter(s) of Liu to the ultrasound patch of Yang when monitoring the diaphragm in order to allow for enhanced evaluation of the diaphragm accordingly such that measurement parameters including movement speed, thickness, thickening and strain rate may be acquired for additional diagnostic purposes of the diaphragm.
Examiner notes that in the modified system by including a target tissue which is the diaphragm, that the processor would function to receive ultrasound images of a diaphragm of a patient acquired using the ultrasound probe configured to identify a target position on the patient and provide the at least one data acquisition and/or data processing parameter to the ultrasound patch based on the at least one ultrasound image of the diaphragm accordingly.
Examiner notes that the modified system includes a non-transitory computer readable medium (630 and [0062]) storing instructions executable by the at least one electronic processor to perform an ultrasound monitoring method of claim 1 and would perform the method of claim 11 each having corresponding method steps.
Regarding claim 2,
Yang further discloses wherein the ultrasound patch is configured to acquire the tissue data comprising ultrasound data collected along one or more ultrasound patch scanlines, and the ultrasound monitoring method further includes:
displaying the at least one ultrasound image on a display device (at least fig. 9A-9B (910) and corresponding disclosure in at least [0070]); and
overlaying a predicted target scanline annotation on the displayed at least one ultrasound image (at least fig. 9 (920) and corresponding disclosure in at least [0070]) ;
wherein the predicted target scanline annotation indicates a predicted location of a scanline of the ultrasound patch when the ultrasound patch is placed at the target position on the patient ([0070] which discloses scanning system may provide guidance, based on image 910, to increase penetration depth and widen the steering angles for predicted signals 920 from sensors (e.g. ultrasound transducers 460).
Regarding claim 3,
Yang, as modified, teaches the elements of claim 1 as previously stated. Yang further teaches the at least one ultrasound image includes a time sequence of ultrasound images ([0068] Base unit 120 may receive B-mode ultrasound images from probe 110 and apply noise reduction and/or other pre-processing techniques to remove speckle and background noise from the image), and the ultrasound monitoring method further includes:
Receiving respiration data from the patient time synchronized with the at least one ultrasound image ([0026] which discloses patch 200 may provide useful health information such as heart rate, respiratory rate, activity…. As well as bladder volume)
Displaying an ultrasound image on a display device (see at least figs. 9A-9B), and
Overlaying first and second markers on the displayed at least one acquired ultrasound image (see at least figs. 9A-9B (920) and corresponding disclosure in at least [0070]).
Yang, as currently modified, fails to explicitly teach the ultrasound monitoring method further includes: receiving respiration data from the patient time synchronized with the acquisition of the at least one ultrasound image of the diaphragm of the patient; selecting, from the time sequence of ultrasound images and based on the respiration data, at least one target phase ultrasound image acquired at a target respiration phase; displaying the at least one target phase ultrasound image on a display device; and overlaying first and second markers on the displayed at least one acquired ultrasound image; wherein the first and second markers indicate predicted boundaries of an image of the diaphragm in the displayed at least one target phase ultrasound image when the ultrasound patch is placed at the target position on the patient.
Liu further teaches wherein the ultrasound monitoring method includes:
Receiving respiration data from the patient time synchronized with the acquisition of at least one ultrasound image of the diaphragm of the patient (pg. 24 second full paragraph which discloses the preset physiological signal of the subject is obtained, fifth full paragraph which discloses preset physiological signals include at least one of the following: breathing frequency, breathing volume, spontaneous breathing tidal volume, heart rate, oxygen saturation, arterial blood gas index, blood pressure, systolic blood pressure, hemoglobin, body temperature, Coma index and metabolic index.;
Selecting, from the time sequence of ultrasound images and based on the respiration data, at least one target phase ultrasound images acquired at a target respiration phase (see at least fig. 13. Examiner notes that in displaying an ultrasound image from the time sequence of images that such an image is necessarily selected and is based on any other collected data (e.g. the respiration data). Furthermore, a target respiration phase is broadly recited and it is noted that the ultrasound image that is displayed is considered to be acquired at a target respiration phase in its broadest reasonable interpretation);
Displaying the at least one target phase ultrasound image on a display device (see at least fig. 13); and
Overlaying first and second markers on the displayed at least one target phase ultrasound image (see at least fig. 13);
Wherein the first and second markers indicate predicted boundaries of an image of the diaphragm in the displayed at least one target phase ultrasound image (see at least fig. 13 and corresponding disclosure in at least pg. 31 first paragraph and pg. 30 last full paragraph which discloses each motion track edge area corresponding area includes an upper edge area corresponding area and a lower edge area corresponding area and pg. 21 first full paragraph which discloses The second type of mark is displayed on the corresponding area of the diaphragm area, and the position of the second type of mark is dynamically updated to describe the movement track of the area corresponding to the edge area of the diaphragm in the M image).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Yang, as currently modified, to include selecting and displaying at least one target image, and overlay first and second markers as taught by Liu in order to provide additional monitoring capabilities to the ultrasound patch of Yang accordingly. Such a modification would allow for providing the ultrasound patch to monitor other anatomical regions including the diaphragm which would allow for the assessing a state of the patient’s diaphragm to help doctors predict the timing of weaning from breathing equipment (pg. 2 Background) thereby enhancing the capabilities of the system of Yang accordingly.
Examiner notes that in the modified system, the first and second markers indicate predicted boundaries of an image of the diaphragm in the displayed at least one target phase ultrasound image in any instance including when the ultrasound patch is placed at the target position on the patient.
Regarding claim 4,
Yang, as modified, teaches the elements of claim 3 as previously stated. Yang, as modified, further teaches wherein the monitoring method further includes: determining a predicted target phase scanline annotation indicating a position of an ultrasound scanline of the ultrasound patch in the at least one ultrasound image when the ultrasound patch is placed at the target position on the patient (Yang at least fig. 9A-9B (920) and corresponding disclosure in at least [0070]).
Examiner notes that in the modified system the position of the scanline is in the at least one target phase ultrasound image.
Alternatively, Liu further teaches determining a predicted target phase scanline annotation indicating a position of an ultrasound scanline in at least one ultrasound image when the ultrasound transducer is placed at a target position on the patient (pg. 16 third full paragraph which discloses the processor calculates the difference sum of the first included angle, the second included angle and 90 degrees, respectively, and the difference sum and at least one M line satisfying the first preset condition is determined as at least one target M line).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Yang, as currently modified, to include determining a predicted target phase scanline annotation as taught by Liu in order to provide for performing accurate measurements of the diaphragm accordingly. Such a modification would ensure that the scan line is perpendicular to the upper and lower edges of the diaphragm area and the measured thickness of the diaphragm area will be more accurate (Liu pg. 16 fifth full paragraph)
Regarding claim 5,
Yang, as modified, teaches the elements of claim 4 as previously stated. Yang, as modified, further teaches, wherein the predicted target phase scanline annotation comprises a line or strip portion (see at least figs. 9A-9B (920)) of the at least one ultrasound image having maximum cross-correlation with an ultrasound scanline acquired by the ultrasound patch placed at the target position on the patient (Yang at least fig. 9A-9B (920) and corresponding disclosure in at least [0070]. Examiner notes that the scanlines have a maximum cross-correction with an ultrasound scanline acquire by the patch in its broadest reasonable interpretation).
Alternatively, Liu further teaches the predicted target phase scanline annotation comprising a line or strip portion of the at least one target phase ultrasound image having maximum cross-correlation with an ultrasound scanline acquired by the ultrasound transducer placed at the target position on the patient (pg. 16 which discloses the first preset condition is that the sum of the difference between the first included angle, the second included angle and 90 degrees is close to 0 degrees, thus having a maximum cross-correlation with an ultrasound scanline (i.e. 90 degrees))
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Yang, as currently modified, to include determining a predicted target phase scanline annotation as taught by Liu in order to provide for performing accurate measurements of the diaphragm accordingly. Such a modification would ensure that the scan line is perpendicular to the upper and lower edges of the diaphragm area and the measured thickness of the diaphragm area will be more accurate (Liu pg. 16 fifth full paragraph)
Regarding claim 6,
Yang, as modified, teaches the elements of claim 4 as previously stated. Yang, as currently modified, fails to explicitly teach wherein the monitoring of the diaphram includes determining a diaphragm thickness metric from the tissue data of the diaphragm of the patient acquired using the ultrasound patch, and the at least one data acquisition and/or data processing parameter comprises a correction factor computed from the angle between the scanline annotation and the first and second markers.
Liu further teaches wherein the monitoring of the diaphragm includes determining a diaphragm thickness metric from the tissue data of the diaphragm of the patient using an ultrasound transducer (pg. 17 which discloses the measurement parameters of the diaphragm muscle area include at least one of… the thickness of the diaphragm muscle area) and at least one data acquisition and/or data processing parameter comprises the correction factor computed from an angle between the scanline annotation and the first and second markers (pg. 16 which discloses the first preset condition is that the sum of the difference between the first included angle, the second included angle and 90 degrees is close to 0. At this time, it can be considered that the M line is perpendicular to the upper and lower edges of the diaphragm area, and the measured thickness of the diaphragm area will be more accurate. Examiner notes that applying the target M line as the M line for acquiring the diaphragm area that a correction factor (i.e. correction factor of the M line) is necessarily determined and applied).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Yang, as currently modified, to include determining a thickness metric, and the correction factor as taught by Liu in order to provide an accurate measurement parameter for providing the operator with more comprehensive and accurate reference information, so as to make a more accurate assessment on whether to withdraw the breathing apparatus from the subject (Liu pg. 22).
Regarding claim 9,
Yang further teaches wherein the determined at least one data acquisition and/or data processing parameter includes at least one data acquisition parameter, and the ultrasound monitoring method includes: acquiring the tissue data of the target tissue of the patient using the ultrasound patch with at least one setting of the ultrasound patch set equal to the determined at least one data acquisition parameter ([0044] which discloses Patch programming logic 346 may program characteristics of RF signals, such as the carrier frequency, acoustic intensity, steering angel (for an array transducer), pulse repeating frequency (PRF), signal bias, gain level, pre-processing method, etc. Patch programming logic 346 may identify customization settings for patch 200 based on, for example, patient information (e.g., size, weight, gender, etc.) and bladder characteristics (e.g., from bladder characteristics unit 320). In one implementation, using patch communication interface 342, patch programming logic 346 may remotely adjust parameters of patch 200 to best cover dimensions of a patient's bladder and [0048] which discloses For example, a center frequency for ultrasound transducers 460 may be adjusted based on patient information (e.g., lower frequency for heavier patient); steering angles for ultrasound transducers 460 may be adjusted to modify a patch field of view based on patient dimensions (e.g., use a narrower field of view for smaller patient); or the rate of monitoring (or PRF) may be adjusted to account for different patient conditions (e.g., increase rate of monitoring depending on type of urinary incontinence). Examiner notes that the tissue data is acquired with the set characteristics equal to the determined characteristic(s) (i.e. the at least one data acquisition parameter)).
Examiner notes that in the modified system the target tissue is the diaphragm and the acquiring the tissue data would be from the diaphragm of the patient using the ultrasound patch accordingly.
Regarding claim 10,
Yang further teaches wherein the ultrasound monitoring method further comprises: electronically transferring at least one data acquisition parameter from the at least one electronic processor to the ultrasound patch ([0048] which discloses as described above in connection with patch programming logic 346, for example, patch 200 may be programmed by scanning system 100 to adjust the characteristics of ultrasound transducers 460 and/or other aspects of patch 200. For example, a center frequency for ultrasound transducers 460 may be adjusted based on patient information (e.g., lower frequency for heavier patient); steering angles for ultrasound transducers 460 may be adjusted to modify a patch field of view based on patient dimensions (e.g., use a narrower field of view for smaller patient); or the rate of monitoring (or PRF) may be adjusted to account for different patient conditions (e.g., increase rate of monitoring depending on type of urinary incontinence).
Regarding claim 12,
Yang further teaches further comprising adhering a patch holder to the patient at the target position on the patient; wherein the placing of the ultrasound patch at the target position on the patient includes placing the ultrasound patch in the patch holder adhered to the patient patch ([0018] which discloses 200 may be include certain disposable components (e.g., a two-sided adhesive, an adhesive frame, etc.,) that permit removal and re-attachment of patch 200 to the patient and [0025] which discloses bladder monitoring patch 200 (also referred to as a “wearable bladder monitoring device,” or simply as “patch 200”) may be attached to a patient using an adhesive, embedding in a garment, integrating with a belt, or another positioning mechanism).
Regarding claim 16,
Yang further teaches further including: an ultrasound patch (200) comprising at least one ultrasound transducer (460) placed at the target position on a patient.
Regarding claim 17,
Yang further teaches further including the ultrasound imaging probe (110).
Regarding claim 19,
Yang teaches the elements of claim 15 as previously stated. Yang fails to explicitly teach wherein the target tissue is a thoracic diaphragm.
Liu teaches receiving ultrasound images of a diaphragm of a patient acquired using an ultrasound imaging probe positioned at a target position on the patient (pg. 2 which discloses obtaining an image of the subject's tissue according to the echo signal of the first ultrasonic wave; Identifying the subject's diaphragm region from the image of the subject's tissue according to the image features of the diaphragm);
Determining at least one data acquisition and/or data processing parameter based on the at least one ultrasound image of the diaphragm acquired by the ultrasound imaging probe determine the ultrasound imaging (pg. 2 which discloses automatically acquiring the target M-line of the subjects diaphragm region in the image of the subject’s tissue);
And monitoring the thoracic diaphragm of the patient including acquiring tissue data of the thoracic diaphragm of the patient using an ultrasound transducer using the at least one data acquisition and/or data processing parameter (pg. 2 which discloses based on the target M-line, obtaining an M-image along the target M-line within a first predetermined time period).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Yang such that the target tissue is the diaphragm in order to provide additional monitoring capabilities to the ultrasound patch of Yang accordingly. Such a modification would allow for providing the ultrasound patch to monitor other anatomical regions including the diaphragm which would allow for the assessing a state of the patient’s diaphragm to help doctors predict the timing of weaning from breathing equipment (pg. 2 Background) thereby enhancing the capabilities of the system of Yang accordingly. Furthermore, such a modification amounts to merely a simple substitution of one known target tissue in ultrasound imaging for another yielding predictable results with respect to anatomical monitoring thereby rendering the claim obvious.
Claims 7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yang and Liu, as applied to claims 3 and 15 above, and further in view of WIPO Kruecker et al. (WO 2022268761 A1), hereinafter Kruecker
Regarding claim 7,
Yang, as modified, teaches the elements of claim 3 as previously stated. Liu further teaches a ventilator providing mechanical ventilation therapy to a patient (pg. 24 third full paragraph). Yang, as modified, fails to explicitly teach wherein the received respiration data comprises one or more ventilator waveforms received from a mechanical ventilator providing mechanical ventilation therapy to the patient (P).
Nonetheless, Kruecker teaches received respiration data comprises one or more ventilator waveforms received from a mechanical ventilator providing mechanical ventilation therapy to a patient ([0043] which discloses lung injury monitoring system determines a ventilation phase of the ventilator. The ventilation phase of the ventilator, such as what point along the respiratory cycle the ventilator is operator, when the ultrasound image was received. The system may monitor the respiratory phase and/or ventilation phase using a signal (thus one or more waveforms) from the ventilator).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the respiration data of Yang, as currently modified, to include one or more ventilator waveforms as taught by Kruecker in order to monitor the ventilation phase of the ventilator of Liu such that the phase of the ultrasound image may be determined with respect to the ventilator accordingly. Such a modification would enhance the respiration data and time synchronization of the ultrasound images.
Regarding claim 20,
Yang, as modified, teaches the elements of claim 15 as previously stated. Liu, as applied to claim 15 above, further teaches providing mechanical ventilation therapy to a patient (pg. 24 third full paragraph). Yang, as currently modified, fails to explicitly teach further including: a mechanical ventilator configured to provide mechanical ventilation therapy to the patient (P); wherein the at least one electronic processor is further programmed to: receive one or more ventilator waveforms from the mechanical ventilator; identify at least one phase of a breathing cycle of the patient from the ventilator waveforms and the acquired ultrasound images; determine a position of the diaphragm of the patient from the identified at least one phase of the breathing cycle.
Kruecker, in a similar field of endeavor involving ultrasound imaging, teaches an ultrasound imaging system (at least fig. 2 (200) and corresponding disclosure in at least [0039]) comprising:
at least one electronic processor (at least fig. 2 (220) and corresponding disclosure in at least [0083]) programmed to:
receive ultrasound images of a target tissue of a patient (P) acquired using an ultrasound imaging probe positioned at a target position on the patient (at least fig. 1 (108) and corresponding disclosure in at least [0042])
A mechanical ventilator (at least fig. 2 (270) and corresponding disclosure in at least [0039]) providing mechanical ventilation therapy to the patient (P) ([0039] which discloses utilized to ventilate a patient);
Wherein the at least one electronic processor is further programed to:
receive one or more ventilator waveforms from the mechanical ventilator ([0043] which discloses the system may monitor the respiratory phase and/or ventilation phase using a signal from the ventilator, and may determine that an ultrasound image is more properly obtained, or a received ultrasound image is more properly used, when the respiratory phase and/or ventilation phase is at a desirable stage for the subsequent analyses described or otherwise envisioned herein);
Identify at least one phase of a breathing cycle of the patient from the ventilator waveforms and the acquired ultrasound images ([0014] which discloses labeling the received ultrasound image as an inspiratory or expiratory image based on the determined ventilation phase of the ventilator [0043] which discloses the system may determine the ventilation phase of the ventilator, such as what point along the respiratory cycle the patient and/or ventilator is operating, when the ultrasound image was obtained or received);
Determine a position of a target tissue of the patient from the identified at least one phase of the breathing cycle (at least fig. 4 (404) and corresponding disclosure in at least [0058] and [0012] which discloses determining from the determined ventilation phase of the ventilator that full expiration of the patient’s lungs has been reached, identifying a pleural line in a received ultrasound image after full expiration of the patient’s lungs has been reached).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Yang, as currently modified, to include a mechanical ventilator and receiving ventilator waveforms, identifying a phase of the breathing cycle and determining a position of the target tissue as taught by Kruecker in order to provide additional capabilities of the system of Yang. Such a modification would allow for analyzing ultrasound images of the lungs for a patient on a ventilator and would allow for monitoring of a patient’s lungs during ventilation (Kruecker Abstract) thus enhancing the capabilities of the monitoring of Yang, as currently modified, accordingly.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yang and Liu as applied to claim 1 above and further in view of Dhatt (US 20230043371 A1), hereinafter Dhatt.
Regarding claim 8,
Yang, as modified, teaches the elements of claim 1 as previously stated. Yang further teaches wherein the monitoring method further comprises:
Receiving initial ultrasound images of the patient (P) acquired using the ultrasound imaging probe, wherein the initial ultrasound images are acquired at a plurality of different positions of the ultrasound imaging probe on the patient (at least fig. 7 (710) and corresponding disclosure in at least [0067] and [0069] which discloses scanning system 100 may guide a technician to position probe 110 over placement location 820, so that placement location 820 can be marked (e.g., with a sticker, pen, marker, stencil, etc.) by the technician. Placement location 820 may be indicated to a technician by text (e.g. text 124) on screen 122, an audible tone, or another indication, when probe 110 is positioned over placement location 820. In another implementation, scanning system 100 may guide a technician to position probe 110 over two or more different placement locations for use of multiple patches 200.);
Determining an ultrasound imaging probe position at which each initial ultrasound images is acquired using ultrasound imaging probe position tracking data (scanning system 100 may guide a technician to position probe 110 over placement location 820, so that placement location 820 can be marked (e.g., with a sticker, pen, marker, stencil, etc.) by the technician. Placement location 820 may be indicated to a technician by text (e.g. text 124) on screen 122, an audible tone, or another indication, when probe 110 is positioned over placement location 820. In another implementation, scanning system 100 may guide a technician to position probe 110 over two or more different placement locations for use of multiple patches 200. Examiner notes that such guidance requires determining an ultrasound imaging probe position at which each initial ultrasound image is acquired using ultrasound imaging probe position tracking data)
Selecting one of the initial ultrasound images that optimally images the target tissue of the patient ([0069] which discloses Based on the B-mode ultrasound images and/or 3D renderings generated therefrom, scanning system 100 may identify an optimal placement location 820 for patch 200 and placement location 820 may be indicated to a technician by text (e.g. text 124) on screen 122, an audible tone, or another indication, when probe 110 is positioned over placement location 820); and
Determining the target position on the patient as the ultrasound imaging probe position at which the selected one of the initial ultrasound images is acquired ([0069] which discloses Based on the B-mode ultrasound images and/or 3D renderings generated therefrom, scanning system 100 may identify an optimal placement location 820 for patch 200 and placement location 820 may be indicated to a technician by text (e.g. text 124) on screen 122, an audible tone, or another indication, when probe 110 is positioned over placement location 820).
Yang fails to explicitly teach the ultrasound imaging probe position tracking data received from an inertial measurement unit (IMU) attached to the ultrasound imaging probe.
Dhatt, in a similar field of endeavor involving ultrasound imaging determining an ultrasound imaging probe position at which each initial ultrasound images is acquired ([0038] which discloses the position of the probe 116 can be estimated using simultaneous localization and mapping (SLAM) and [0040] which discloses the system can denote the current position of the probe 116 as an indication on a map of a membrane, thus the current position (i.e. for each ultrasound image) is determined) using ultrasound imaging probe position tracking data received from an inertial measurement unit (IMU) (at least fig. 1 (118) and corresponding disclosure in at least [0024]) attached to an ultrasound imaging probe (at least fig. 1 (116) and corresponding disclosure in at least [0024])
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Yang to include using ultrasound imaging probe position tracking data received from an inertial measurement unit attached to the ultrasound imaging probe in order to provide for a simultaneously localization and mapping algorithm with provides an improved accuracy of a position estimate of the probe (Dhatt [0038]). Furthermore, such a modification would allow for further guidance such as navigating to a part of the patient’s body that was previously imaged (Dhatt [0039]). Additionally/alternatively such a modification amounts to merely a combination of prior art elements according to known techniques yielding predictable results with respect to ultrasound probe guidance thereby rendering the claim obvious (MPEP 2143).
Claims 13 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Yang and Liu as applied to claims 11 and 17 above and further in view of Puleo et al. (US 20210015454 A1), hereinafter Puleo.
Regarding claim 13,
Yang, as modified, teaches the elements of claim 11 as previously stated. Yang further teaches wherein the probe holder is an adhesive, a garment, a belt, or other position mechanism ([0025]). Yang fails to explicitly teach wherein the ultrasound imaging is performed with the ultrasound imaging probe attached to the patch holder, the adhering of the patch holder to the patient at the target position of the patient includes removing a protection sheet from the patch holder to expose adhesive of the patch holder, and the method further includes detaching the ultrasound imaging probe from the patch holder adhered to the skin of the patient.
Puleo, in a similar field of endeavor involving ultrasound imaging, teaches wherein ultrasound imaging is performed with an ultrasound imaging probe attached to a patch holder, adhering a patch holder to the patient at the target position of the patient includes removing a protection sheet from the patch holder to expose adhesive of the patch holder ([0053] which discloses the neuromodulation positioning patch 16 may also include a release layer (i.e. protection sheet) that, during storage covers the application layer to maintain the adhesive 99 and the coupling gel 98. The release layer, when present is removed prior to application of the neuromodulation positioning patch), and the method further includes detaching the ultrasound imaging probe from the patch holder adhered to the skin of the patient ([0048] which discloses after completion of the acquisition of image data, the dock 40 and the ultrasound imaging probe 28 may be removed from the neuromodulation positioning patch 16 so that the subject may continuously wear only the less complex and expensive components of the system 10 that may be readily replaced if damaged).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Yang, as currently modified, to include imaging with the ultrasound imaging probe attached to a patch holder, adhering the patch holder including removing a protection sheet, and detaching the ultrasound imaging probe from the patch holder as taught by Puleo in order to facilitate identification of a desired position and positioning of the patch at the desired position (Puleo [0025]). Furthermore, removing the ultrasound imaging probe would allow for imaging for determining the desired position to be determined and the probe to be removed from the patch holder so that the subject may continuously wear the patch upon removal of the ultrasound probe (Puleo [0048]).
Regarding claim 18,
Yang, as modified, teaches the elements of claim 17 as previously stated. Yang further teaches further including: a patch holder configured for attachment to the patient (P) at the target position on the patient ([0018] which discloses 200 may be include certain disposable components (e.g., a two-sided adhesive, an adhesive frame, etc.,) that permit removal and re-attachment of patch 200 to the patient and [0025] which discloses bladder monitoring patch 200 (also referred to as a “wearable bladder monitoring device,” or simply as “patch 200”) may be attached to a patient using an adhesive, embedding in a garment, integrating with a belt, or another positioning mechanism).
Yang fails to explicitly teach the patch holder configured to receive the ultrasound probe.
Puleo, in a similar field of endeavor involving ultrasound imaging, teaches a patch holder (at least fig. 2 (16) and corresponding disclosure in at least [0035]) configured for attachment to the patient (P) at the target position on the patient and configured to receive an ultrasound probe ([0035] which discloses neuromodulation positioning patch 16 applied to a subject and configured to receive an imaging probe 28).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Yang, as currently modified, to include a patch holder as taught by Puleo in order to facilitate identification of a desired position and positioning of the patch at the desired position (Puleo [0025]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Yang and Liu as applied to claim 11 above and further in view of Halmann (US 20190065489 A1), hereinafter Halmann.
Regarding claim 14,
Yang, as modified, teaches the elements of claim 11 as previously stated.
Yang further teaches adjusting a position of the ultrasound patch ([0073] which discloses scanning system 100 may provide instructions for adjusting a patch 200 position on the patient and/or replacing patch 200 with another patch having different pre-configured settings)
Yang fails to explicitly teach determining a shift in a position of the patient.
Halmann teaches determining a shift in a position of the patient (P) ([0044] which discloses the probe movement condition the patch probe movement condition may be detected by the patch probe unassignment module 150 analyzing the superficial area of the acquired ultrasound image data and comparing sequential frames using cross-correlation algorithms to detect ultrasound probe motion and [0045] which discloses indication is a patch probe movement condition detected by the signal processor 132, 160 one or both of applying cross-correlation algorithms that compare a superficial area of the acquired ultrasound image data in sequential frames to determine if the ultrasound patch probe 104a, 104b has moved relative to a skin surface of the patient, and analyzing motion sensor data received from motion sensors attached to the ultrasound patch probe 104a, 104b and the patient to determine if the ultrasound patch probe 104a, 104b has moved relative to a skin surface of the patient. Examiner notes that such relative movement by analyzing ultrasound image data determines a shift in position as does the motion sensor data from motion sensors attached to the patient).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Yang to include determining a shift in a position of the patient in order to identify when patch has moved relative to the skin surface and is no longer acquiring ultrasound image data of the appropriate patient anatomy (Halmann [0033]).
It would have been further obvious to a person having ordinary skill in the art before the effective filing date to have modified Yang, as currently modified, to adjust the position of the patch based on the determined shift of Halmann in order to reposition the probe relative to the patient in order to reestablish acquiring ultrasound image data of the appropriate patient anatomy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zhao (US 20230277159 A1) teaches at least one electronic processor (at least fig. 1 (112) and corresponding disclosure in at least [0068]) programmed to provide at least one data acquisition and/or data processing parameter to an ultrasound patch ([0070] which discloses transmitter can be programmed to transmit spatially or temporally encoded pulses. In some configurations beam steering may be used. The receiver can be programmed to implement a suitable detection sequence for the imaging task at hand) and monitoring a diaphragm of a patient including acquiring tissue data of the patient using the ultrasound patch comprising at least one ultrasound transducer placed at a target position on a patient and using the at least one data acquisition and/or data processing parameter ([0089] which discloses the on-person wearable ultrasound system can provide high-resolution (up to 200 microns), long-term (>48 hours) and may provide for continuous imaging of diverse internal tissues and organs, including blood vessels, muscle, heart, gastrointestinal tract, diaphragm, and the like. See also [0152] which discloses the adjustable BAUS systems’ capability of simultaneous multi-window imaging of multi-organ correlations was demonstrated including diaphragm-heart-jugular vein, stomach-bladder, and muscle-brachial artery correlations in daily activity).
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.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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