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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/18/2026 has been entered. Claims 1, 3-14, and 17-20 remain pending in the application.
Response to Amendment
Claims 1, 3-14, and 17-20 remain pending in the application in response to the applicant’s amendments to the rejections previously set forth in the Final Office Action mailed 12/17/2025.
Response to Arguments
Applicant’s arguments filed 03/17/2026 with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Given the amendments to claim 1, reference to Kristiansen is being relied upon to teach dependent claims 4, 9, 12-14, 20 more-consistently with the instant claim language, as shown below.
Given the amendments to claim 1, reference to Zhang is being relied upon to teach dependent claims 3, 5, and 10-11 more-consistently with the instant claim language, as shown below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4, 6-9, 12-14, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Perrey et al. (US 20200113542 A1, published April 16, 2020) in view of Kristiansen (US 20070167768 A1, published July 19, 2007), Poland et al. (US 20230101257 A1, publishedMarch30, 2023), from IDS, Patil et al. (US 20210128114 A1, published May 6, 2021), and Bai et al. (EP 4006832 A1, published June 1, 2022), hereinafter referred to as Perrey, Kristiansen, Poland, Patil, and Bai, respectively.
Regarding claim 1, Perrey teaches an ultrasound apparatus (Fig. 1B, ultrasound system 100) for scanning an anatomical region of interest, the apparatus comprising:
a plurality of transducers provided in the housing and positioned in a geometrical arrangement for scanning the anatomical region of interest, the plurality of transducers configured to emit a plurality of ultrasound waves and receive a plurality of echoes produced by the plurality of ultrasound waves (Fig. 1B, transducer elements within ultrasound probe 126 (housing); see para. 0032- “The transducer elements 124 emit pulsed ultrasonic signals into a body (e.g., patient) or volume…The echoes are delayed in time and/or frequency according to a depth or movement, and are received by the transducer elements 124 within the transducer array of the probe 126. The ultrasonic signals may be used for imaging…”);
at least one processor (Fig. 1B, includes controller 102) configured to:
process the plurality of echoes using a machine learning model to identify an anatomical landmark (Fig. 3, input 304 image data (plurality of echoes) into detection framework302(machine learning model) to indicate and display target plane/structure 306 (anatomical structure); see para. 0054 "The detection framework 302 may be an artificial intelligence and machine learning framework that includes one or more algorithms and models, such as one or more of the learning algorithm 107, anatomical structure model 108, and models 109 discussed above with reference to FIG. 1A.");
in response to identifying the anatomical landmark, determine an offset for the housing (Fig. 3, guidance on where/how to move probe 306 as offset for housing; see para. 0048 " the method at 208 may additionally include direction or guidance on how to move the probe [housing] to the determined reference position and/or anatomical landmarks to look for in the determined reference position. This guidance and/or direction may be displayed to the user via the display in the form of a dialog box or pop up screen, in one example.");
display a user instruction on the display to shift the housing by the offset (see para. 0048 " the method at 208 may additionally include direction or guidance on how to move the probe [housing] to the determined reference position and/or anatomical landmarks to look for in the determined reference position. This guidance and/or direction may be displayed to the user via the display in the form of a dialog box or pop-up screen, in one example.").
Perrey teaches a plurality of transducers in housing (Fig. 1B, transducer elements 124 within ultrasound probe 126 (housing)), but does not explicitly teach where the transducers are arranged in a non-linear pattern.
Whereas, Kristiansen, in an analogous field of endeavor, teaches
a housing adapted to be fixed in place over the anatomical region of interest (Fig. 1; see para. 0072 – “The apparatus 3 for the bladder monitoring measurement is arranged in the belt, based on a plurality of individual ultrasound transducer arrays 4 that are of the phased-array type.”);
scanning the anatomical region of interest while the housing is fixed in place over the anatomical region of interest (see para. 0077 – “FIG. 4 shows two scan planes 8A,8B which are transmitted from two arbitrarily selected individual transducer arrays 4 from a bladder monitoring apparatus comprising seven individual transducer arrays.”);
wherein the geometrical arrangement is an unstructured grid in which the transducers are arranged in a non-linear pattern and each transducer of the plurality of transducers is configured to generate a 2D ultrasound image based on the plurality of echoes (see para. 0075 – “An enlarged section of the apparatus of FIG. 1 is shown in FIG. 2, where there are seven independent transducer arrays 4 which are positioned equidistantly on a closed curve…”; see para. 0064 – “FIG. 4 shows two two-dimensional scan planes, viewed from a point on the said axis away from the abdominal surface, where the scan planes are transmitted from two arbitrary selected individual transducer arrays of a bladder volume monitoring apparatus that comprises seven individual transducer arrays,”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a plurality of transducers, as disclosed in Perrey, by having the transducers arranged in a non-linear pattern, as disclosed in Kristiansen. One of ordinary skill in the art would have been motivated to make this modification in order to monitor measurements from different positions on the abdominal surface and not from only a single position, as taught in Kristiansen (see para 0046).
Perrey in view of Kristiansen teaches a display, but does not explicitly teach where the display is provided on the housing.
Whereas, Poland, in an analogous field of endeavor, teaches a display provided on the housing (Fig. 3A, display assembly 310 of handheld ultrasound system 300).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a display, as disclosed in Perrey in view of Kristiansen, by having the display provided on the housing, as disclosed in Poland. One of ordinary skill in the art would have been motivated to make this modification in order to allow simultaneous scanning and viewing, as taught in Poland (see para. 0039).
Perrey in view of Kristiansen and Poland teaches a plurality of transducers, but does not explicitly teach categorizing the plurality of transducers into one or more included transducers and one or more excluded transducers based on the plurality of echoes.
Whereas, Patil, in the same field of endeavor, teaches categorize the plurality of transducers into one or more included transducers and one or more excluded transducers based on the plurality of echoes, wherein the one or more included transducers provide relevant data for identifying a likelihood of a condition affecting the anatomical region of interest (see para. 0045 "For example, the parameter adjustment processor 160 of the signal processor 132 may receive the locations of any image artifacts 250, 260, obstructing anatomical structures 220, and/or deficient anatomical structures from the enhancement detection processor 150. The parameter adjustment processor 160 may be operable to adjust the transmit and receive beamforming parameters, such as a number and position of activated and deactivated transducer elements [included and excluded transducers] based on the received locations [echoes]."); and
generate an included dataset that includes only echoes of the plurality of echoes from the one or more included transducers (see para. 0046 "At step 312, the ultrasound system 100 may acquire a next ultrasound image 202. For example, the ultrasound system 100 may be operable to acquire a next ultrasound image based on the beamformer parameters adjusted by the parameter adjustment processor 160.").
Perrey in view of Kristiansen, Poland, and Patil teaches generating an included dataset that includes only echoes of the plurality of echoes from the one or more included transducers, but does not explicitly teach processing the included dataset using a machine learning model to identify the likelihood of the condition affecting the anatomical region of interest.
Whereas, Bai, in an analogous field of endeavor, teaches processing the included dataset using a machine learning model to identify the likelihood of the condition affecting the anatomical region of interest (see para. 0105 "The method 300 comprises a step 340 of processing groups of regions of interest, using a machine-learning method, to generate a predictive indicator that indicates a likelihood that the group of regions of interest contains a lesion [condition affecting ROI] in the individual.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified generating an included dataset that includes only echoes of the plurality of echoes from the one or more included transducers, as disclosed in Perrey in view of Kristiansen, Poland, and Patil, by also identifying a likelihood of a condition affecting the anatomical region of interest in the dataset via a machine learning model, as disclosed in Bai. One of ordinary skill in the art would have been motivated to make this modification in order to facilitate a fully automated mechanism for identifying potential lesions, as well as adopting existing and well-developed mechanisms for identifying potential lesions in ultrasound images for improved reliability, as taught in Bai (see para. 0017).
Furthermore, regarding claim 4, Kristiansen further teaches wherein each of the plurality of transducers comprises a 1-D array of elements (see para. 0042 – “In a preferred embodiment of the present invention, the said at least two individual transducer arrays may be one-dimensional transducer arrays of the phased-array kind.”).
Furthermore, regarding claim 6, Perrey further teaches wherein the geometrical arrangement covers an area larger than the anatomical region of interest (see para. 0061 "For example, the detection framework (detection framework 302 shown in FIG. 3) may include one or more anatomical structure specific image and/or scan plane detection models configured to identify scan planes and/or anatomical structures in a specific anatomical structure (e.g., for fetal heart detection). The anatomical structure may be an organ (e.g., heart, kidney, bladder, lung, brain, and/or the like), skeletal structure (e.g., bone, skull, and/or the like), vascular structure (e.g., artery, vein, and/or the like), region of body (e.g., head, torso, and/or the like), and/or the like." Where the transducer elements of the probe is configured to image at least the area of the anatomical region of interest).
Furthermore, regarding claim 7, Perrey further teaches wherein the anatomical region of interest has an area between 25 cm2 and 400 cm2 (see para. 0061 "For example, the detection framework (detection framework 302 shown in FIG. 3) may include one or more anatomical structure specific image and/or scan plane detection models configured to identify scan planes and/or anatomical structures in a specific anatomical structure (e.g., for fetal heart detection). The anatomical structure may be an organ (e.g., heart, kidney, bladder, lung, brain, and/or the like), skeletal structure (e.g., bone, skull, and/or the like), vascular structure (e.g., artery, vein, and/or the like), region of body (e.g., head, torso, and/or the like), and/or the like." Areas of these anatomical structures can be between 25 cm2 and 400 cm2).
Furthermore, regarding claim 8, Perrey further teaches wherein the anatomical region of interest is selected from the group consisting of trachea, bronchi, bronchioles, alveoli, pleurae and pleural cavity (see para. 0061 "For example, the detection framework (detection framework 302 shown in FIG. 3) may include one or more anatomical structure specific image and/or scan plane detection models configured to identify scan planes and/or anatomical structures in a specific anatomical structure (e.g., for fetal heart detection). The anatomical structure may be an organ (e.g., heart, kidney, bladder, lung [which includes trachea, bronchi, bronchioles, alveoli, pleurae, and pleural cavity],…”).
Furthermore, regarding claim 9, Kristiansen further teaches wherein the geometrical arrangement is a 1-D geometrical arrangement (see para. 0042 – “In a preferred embodiment of the present invention, the said at least two individual transducer arrays may be one-dimensional transducer arrays of the phased-array kind.”).
Furthermore, regarding claim 12, Kristiansen further teaches a stick-to-skin adhesive provided on the housing for fixing the housing in place over the anatomical region of interest (see para. 0054 – “In an alternative embodiment of the apparatus of the present invention the at least two individual transducer arrays are held in place on the abdominal surface, of the individual being monitored, using adhesive means.”). One of ordinary skill in the art would have been motivated to make this modification in order to have the arrays held in a stable position, where movement or minor contact will not displace the individual transducer arrays, as could be the case with the portable fixture, as taught in Kristiansen (see para. 0054).
Furthermore, regarding claim 13, Kristiansen further teaches a coupling gel provided on the housing for acoustically coupling the plurality of transducers (see para. 0059 – “It is well known within the art, that it is preferred to use a form of ultrasound transmission gel or similar means for coupling the ultrasonic transducers, such as the individual transducer arrays described in the present invention, to the body…”). One of ordinary skill in the art would have been motivated to make this modification in order to increasing the transmission and reception efficiency of ultrasound signals to and from the body, as taught in Kristiansen (see para. 0059).
Furthermore, regarding claim 14, Kristiansen further teaches wherein the at least one processor is configured to individually control the plurality of transducers (see para. 0085 – “The apparatus according to the present invention may advantageously comprise electronic circuits for controlling the individual transducer arrays, including excitation of these as well as data collection from the received signals.”).
Furthermore, regarding claim 17, Bai further teaches when the likelihood exceeds a threshold percentage, the at least one processor transmits an indication to the display (see para. 0126 "In some examples, in response to determining that at least one of the groups of regions of interest contains a lesion, e.g. if a predicted likelihood exceeds some threshold, step 350 may comprise identifying a position of the identified lesion with respect to a displayed ultrasound image of the patient...").
Furthermore, regarding claim 18, Perrey further teaches wherein the at least one processor is provided within the housing (see para. 0043 "For example, display 138 and user interface 142 may be integrated into an exterior surface of the handheld ultrasound imaging device [housing], which may further contain controller 102, beamformer processor 130, RF processor 132, and memory 106.").
Furthermore, regarding claim 19, Perrey further teaches wherein the at least one processor is provided external to the housing (see para. 0043 "For example, display 138 and user interface 142 may be integrated into an exterior surface of the handheld ultrasound imaging device [external device], which may further contain controller 102, beamformer processor 130, RF processor 132, and memory 106 [processors external to ultrasound probe 106 (housing)]. Probe 106 may comprise a handheld probe in electronic communication with the handheld ultrasound imaging device to collect raw ultrasound data.").
Furthermore, regarding claim 20, Kristiansen further teaches wherein each of the plurality of transducers comprises at least one element, and the elements are selected from the group consisting of: crystal, ceramic with piezoelectric properties, and MEMS (see para. 0073 – “…the individual transducer array is composed of multiple piezoelectric crystals…”).
The motivation for claims 4, 9, 14, 17, and 20 was shown previously in claim 1.
Claims 3, 5, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Perrey in view of Kristiansen, Poland, Patil, and Bai, in further view of Zhang et al. (CN 110974304 A, published April 10, 2020), hereinafter referred to as Zhang.
Regarding claim 3, Perrey in view of Kristiansen, Poland, Patil, and Bai teaches all of the elements disclosed in claim 1 above.
Perrey in view of Kristiansen, Poland, Patil, and Bai teaches a plurality of transducers, but does not explicitly teach where the transducers are annular transducers.
Whereas, Zhang, in an analogous field of endeavor, teaches wherein each of the plurality of transducers comprises one or more annular element (see pg. 8, para. 10 – “As shown in FIG. 4 a flexible wearable multi-array-element imaging transducer structure schematic diagram, flexible wearing-type array of multi-array-element imaging transducer can be in various forms, such as…annular array…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the transducers, in Perrey in view of Kristiansen, Poland, Patil, and Bai, by having the transducers as annular transducers, as disclosed in Zhang. One of ordinary skill in the art would have been motivated to make this modification in order for each transducer to perform dynamic focused beam steering.
Furthermore, regarding claim 5, Zhang further teaches wherein each of the plurality of transducers comprises a 2-D array of elements (see pg. 8, para. 10 – “As shown in FIG. 4 a flexible wearable multi-array-element imaging transducer structure schematic diagram, flexible wearing-type array of multi-array-element imaging transducer can be in various forms, such as…area array [2D array of elements]…”).
Furthermore, regarding claim 10, Zhang further teaches wherein the geometrical arrangement is a 2-D geometrical arrangement (see pg. 8, para. 10 – “As shown in FIG. 4 a flexible wearable multi-array-element imaging transducer structure schematic diagram, flexible wearing-type array of multi-array-element imaging transducer can be in various forms, such as…area array [2D array of elements]…”).
Furthermore, regarding claim 11, Zhang further teaches wherein the housing is flexible (see pg. 8, para. 10 – “As shown in FIG. 4 a flexible wearable multi-array-element imaging transducer structure [housing] schematic diagram…”). One of ordinary skill in the art would have been motivated to make this modification in order to perform more accurate imaging, as taught in Zhang (see pg. 3, para. 1).
The motivation for claims 5 and 10 was shown previously in claim 3.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Haddad (US 20020099290 A1, published July 25, 2002) discloses a plurality of transducer elements arranged in a dense array in a semi-circular pattern on a cylindrical surface surrounding the target (Fig. 2D).
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/N.C./Examiner, Art Unit 3798
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