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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 7-8, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halmann et al. (US 2019/0328361 A1, Oct. 31, 2019) (hereinafter “Halmann”) in view of Pagoulatos et al. (US 2021/0272679 A1, Sep. 2, 2021) (hereinafter “Pagoulatos”).
Regarding claim 1: Halmann discloses a handheld ultrasound device (at least the probe of figure 3 is “handheld”) comprising a transducer cover having a contact area to be in contact with a user's body and located on one end of the handheld ultrasound device ([0038], housing 300); a contact part whose outer surface is located on at least a portion of the contact area ([0038], face surface 302); an ultrasound transducer unit including N number (N is a natural number of 1 or more) of ultrasound transducers each configured to irradiate an ultrasound signal through the outer surface of the contact part and receive the reflected ultrasound signal ([0028]-[0030], elements 104; [0038], elements 104 are inside housing 300 and transmit through housing surface face 302); a movement speed sensing unit configured to sense a movement speed of the contact area in contact with the body and generate movement speed information ([0049]); and a controller configured to output a control signal to control the ultrasound transducer unit and generate ultrasound images based on the received ultrasound signals ([0030], processor 116).
Halmann is silent on a communication unit configured to transmit the ultrasound images to an external device.
Pagoulatos, in the same field of endeavor, discloses a handheld ultrasound device ([0024]-[0025], [0071]; claim 1) operatively coupled to an ultrasound probe (probe 118); a controller configured to output a control signal to control the ultrasound transducer unit and generate ultrasound images based on the received ultrasound signals (processor 116; [0028]); and a communication unit configured to transmit the ultrasound images to an external device (figs. 1 and 6, network 102/602 and image recognition module 120/620; [0029]-[0030]). Pagoulatos further discloses providing image acquisition guidance to the user by providing feedback according to the probe position/motion (claim 1, [0047], [0052]). Pagoulatos further teaches that previous systems require expert training to acquire suitable images, while the disclosed system allows such determinations to be made by the artificial intelligence image recognition module (“external device”), which may also provide the user guidance ([0002]-[0004]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date to modify the device of Halmann by providing the artificial intelligence image recognition module (“external device”) of Pagoulatos in order to allow a non-expert to acquire a suitable image using AI image recognition and guidance.
With respect to the handheld ultrasound device being configured to detect a breast mass, it is noted that the particular body part/tissue which is examined using the ultrasound device is considered to be the intended use of the device in the absence of any structural limitations which would differentiate between the claimed device and the device of Halmann and Pagoulatos. Applicant is reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the ultrasound device of Halmann and Pagoulatos is considered to be capable of imaging any tissue.
Regarding claim 2: Halmann and Pagoulatos disclose the handheld ultrasound device of Claim 1, further comprising: an output unit configured to output information corresponding to the movement speed information (Halmann – [0075]; Pagoulatos – [0053]).
Regarding claim 3: Halmann and Pagoulatos disclose the handheld ultrasound device of claim 2 wherein the output unit includes at least one of: a display part configured to output an image or text corresponding to the movement speed information (Halmann – [0075]; Pagoulatos – visual feedback elements 420, [0053]). Pagoulatos further discloses a light indicator (visual feedback elements 420, [0053], [0056]); a haptic feedback (“vibration”) indicator (haptic feedback indicator 440, [0056]); and a speaker unit configured to output a sound corresponding to the movement speed information (audible feedback element 430, [0053], [0056]).
Regarding claim 7: Halmann as modified by Pagoulatos discloses the handheld ultrasound device of claim 1 wherein the communication unit transmits the movement speed information to the external device (Pagoulatos transfers the probe position and motion information, which would include the speed information of Halmann, to the “external device” - figs. 1 and 6, network 102/602 and image recognition module 120/620; [0029]-[0030]).
Regarding claim 8: Halmann and Pagoulatos disclose the handheld ultrasound device of claim 1 wherein the movement speed sensing unit includes at least one of a speed calculator that calculates a speed of the handheld ultrasound device based on a change in the received ultrasound signal, an acceleration sensor, or an optical sensor (Halmann – [0049]; Pagoulatos – [0059]).
Regarding claim 15: Halmann and Pagoulatos disclose the handheld ultrasound device of claim 1. Pagoulatos further discloses wherein the external device includes at least one of a smartphone, a personal computer, or a tablet PC connected to the handheld ultrasound device (fig. 6, user computer devices 630 which is illustrated as a laptop computer; [0066], [0088], [0102]).
Regarding claim 16: Halmann and Pagoulatos disclose the handheld ultrasound device of claim 1. Pagoulatos further discloses wherein the external device includes an Al cloud server connected to a plurality of handheld ultrasound devices (fig. 6, ultrasound devices 610; [0066], [0071]).
Regarding claim 17: Halmann and Pagoulatos disclose the handheld ultrasound device of claim 1. Pagoulatos further discloses wherein the external device includes a medical device connected to a plurality of handheld ultrasound devices (fig. 6 – in the absence of any description of what constitutes a “medical device”; any element of system 600 could be considered a “medical device” because the elements are all devices which are used for a medical purpose).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halmann and Pagoulatos as applied to claim 3 above, and further in view of Pelissier et al. (US 2017/0105701 A1, Apr. 20, 2017) (hereinafter “Pelissier”).
Regarding claim 4: Halmann and Pagoulatos disclose the handheld ultrasound device of claim 3, comprising a light indicator which varies in color according to whether the probe motion is suitable (Pagoulatos – [0058]). Halmann further discloses a visual indicator, which may be a light, that changes color based on whether the probe speed is within a predefined range (Halmann – [0074]). Halmann and Pagoulatos are silent on the light indicator being an LED.
Pelissier, in the same field of endeavor, discloses a handheld ultrasound device with an LED light indicator for providing feedback on probe motion ([0105], [0107], fig. 10B, 101-6).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the indicator of Halmann and Pagoulatos as an LED as taught by Pelissier because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halmann and Pagoulatos as applied to claim 3 above, and further in view of Shoudy (US 2019/0076120 A1, Mar. 14, 2019) (hereinafter “Shoudy”).
Regarding claim 5: Halmann and Pagoulatos disclose the handheld ultrasound device of claim 3. Halmann further discloses providing feedback depending on whether or not the movement speed of the probe is within a predetermined normal range ([0071], [0075]) while Pagoulatos further discloses providing haptic (vibration) feedback for probe positioning guidance ([0051], [0053], [0056]). However, Halmann and Pagoulatos are silent on wherein the vibrator outputs a vibration after adjusting an interval, an intensity, or a pattern of vibration to be output depending on whether or not the movement speed is within a predetermined normal range.
Shoudy, in the same field of endeavor, discloses providing haptic (vibration) feedback including adjusting an interval, an intensity, or a pattern of vibration to be output to guide the movement speed of the ultrasound probe ([0040] – “…to guide a speed of movement of the ultrasound probe 14 by the operator, a repetition rate of the vibration pattern may vary or modulate”). Shoudy further teaches that, as tactile sense perception of the operator is already used for moving the ultrasound probe, such that the operator is not looking at the ultrasound probe, but rather is visually focused on the workstation and the live ultrasound image, use of the vibration actuators in the ultrasound probe for probe positioning may take advantage of an underutilized sense perception ([0034]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the movement speed guidance of Halmann and Pagoulatos as haptic (vibration) feedback as taught by Shoudy in order to provide feedback that can be sensed while the operator is viewing the live image and not looking at the probe.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halmann and Pagoulatos as applied to claim 3 above, and further in view of Laviola et al. (US 2019/0251327 A1, Aug. 15, 2019) (hereinafter “Laviola”).
Regarding claim 6: Halmann and Pagoulatos disclose the handheld ultrasound device of claim 3 including providing feedback based on whether or not the movement speed is within a predetermined normal range (Halmann - [0071], [0075]) and a speaker providing audible feedback for probe guidance (Pagoulatos – [0051], [0053], [0056]). However, Halmann and Pagoulatos are silent on wherein the speaker unit outputs a sound after adjusting at least one of an interval, a volume, and a type of sound to be output depending on whether or not the movement speed is within a predetermined normal range.
Laviola, in the same field of endeavor, discloses providing an audible feedback based on the moving velocity of the ultrasound probe which changes in pitch as the ultrasound probe velocity changes ([0049]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the probe movement speed guidance of Halmann and Pagoulatos as a variable audio feedback as taught by Laviola in order to allow the user to receive the feedback even if they are viewing the patient or another area of the display.
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halmann and Pagoulatos as applied to claim 1 above, and further in view of El-Aklouk et al. (US 2010/0324418 A1, Dec. 23, 2010) (hereinafter “El-Aklouk”).
Regarding claim 9: Halmann and Pagoulatos disclose the handheld ultrasound device of claim 1, but are generally silent regarding the particular structure or operation of the ultrasound transducer elements.
It is noted that “wherein the control signal is independent of a cross-sectional size of each of the N number of ultrasound transducers and a spacing between the N number of ultrasound transducers” does not appear to be a structural limitation on the ultrasound device. According to the disclosure, this feature is a result of independently operating the ultrasound transducer elements. In the absence of any structural limitations regarding the control signal being “independent of a cross-sectional size of each of the N number of ultrasound transducers and a spacing between the N number of ultrasound transducers,” it will be assumed that independent operation of the transducer elements is sufficient to achieve the claimed result.
El-Aklouk, in the same field of endeavor, discloses a limited-element ultrasound transducer array where each element may be individually controlled (“firing”) ([0086]-[0088]). El-Aklouk further discloses that the transducer array is advantageous for handheld ultrasound systems due to reduced size, weight, and cost ([0107]) while the reduced array size provides a good image width for lest cost and complexity ([0062]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the ultrasound device of Halmann and Pagoulatos using the transducer array of El-Aklouk in order to gain the advantages of reduced size, weight, cost, and complexity in view of the further teachings of El-Aklouk.
Regarding claim 19: Halmann and Pagoulatos disclose the handheld ultrasound device of claim 1, but are generally silent regarding the particular structure or operation of the ultrasound transducer elements.
El-Aklouk, in the same field of endeavor, discloses a limited-element ultrasound transducer array comprising as few as one transducer element ([0053]), where the figures show eight transducer elements (figs. 4-8). El-Aklouk further discloses that the transducer array is advantageous for handheld ultrasound systems due to reduced size, weight, and cost ([0107]) while the reduced array size provides a good image width for lest cost and complexity ([0062]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the ultrasound device of Halmann and Pagoulatos using the transducer array of El-Aklouk in order to gain the advantages of reduced size, weight, cost, and complexity in view of the further teachings of El-Aklouk.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halmann and Pagoulatos as applied to claim 1 above, and further in view of Murakami et al. (JP 2015062453 A, Apr. 09, 2015) (hereinafter “Murakami”).
Regarding claim 10: Halmann and Pagoulatos disclose the handheld ultrasound device of claim 1, but are generally silent regarding the particular structure or operation of the ultrasound transducer elements.
Murakami, in the same field of endeavor, discloses an ultrasound transducer array comprising N number of ultrasound transducers are arranged in a zigzag pattern in two rows, wherein the N is a natural number between 3 and 10 ([0006] – n is an integer of 2 or more, which substantially overlaps with the claimed range of 3-10 with K rows is between 1 and n-1, which is inclusive of 2 rows; figs. 4-7; [0009]-[0023]; [0031]). Murakami further discloses that this arrangement improves the resolution of the image without reducing element size ([0005], [0007]), where a reduction in element size increases cost and manufacturing load ([0002]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the ultrasound device of Halmann and Pagoulatos using the transducer array of Murakami in order to provide a higher resolution ultrasound image without an associated increase in cost or manufacturing load in view of the further teachings of Murakami.
Regarding claim 11: Halmann, Pagoulatos, and Murakami disclose the handheld ultrasound device of claim 10. Murakami further discloses wherein first and third ultrasound transducers among the N number of ultrasound transducers are arranged in a first row and a second ultrasound transducer is arranged in a second row and between the first and third ultrasound transducers (figs. 4-7; [0009]-[0023]; [0031]). With respect to the limitation “and the second ultrasound transducer measures a blind spot at edges of the first and third ultrasound transducers,” it is unclear what it means to “measure a blind spot” in terms of a structural limitation on the ultrasound device. However, since the transducer array of Murakami meets the claimed structure, it is assumed that it is capable of performing the claimed function.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halmann and Pagoulatos as applied to claim 1 above, and further in view of Noguchi et al. (US 2020/0170624 A1, Jun. 4, 2020) (hereinafter “Noguchi”).
Regarding claims 12-14: Halmann and Pagoulatos disclose the handheld ultrasound device of claim 1, but are silent on wherein the external device is configured to detect a breast mass based on the received ultrasound images and visually distinguish the detected breast mass in a specific shape; wherein the external device utilizes a pre-trained artificial intelligence neural network to detect the breast mass; and wherein the external device is configured to display at least one of a size, a depth and a presence probability of the detected breast mass.
Noguchi, in the same field of endeavor, discloses an automated lesion detection system configured to detect a breast mass based on the received ultrasound images and visually distinguish the detected breast mass in a specific shape (fig. 6, [0073], lesion 205 “visually distinguish[ed] in a specific shape), which utilizes a pre-trained artificial intelligence neural network to detect a breast mass ([0067] - lesion detector 122 uses machine learning, where a neural network is given as an example of “machine learning” in [0085] – “…a machine learning algorithm such as logistic regression, support vector machine, random forest, and neural network.”); display at least one of a size, a depth and a presence probability of the detected breast mass (fig. 10; [0085] – analysis results include lesion size, lesion aspect ratio, and border shape, the lesion images, and the like; [0092], [0095] – analysis results are output in the analysis result display field 1030 as shown in fig. 10). Noguchi further discloses that these processes allow the user to view the detection result and the analysis result, making a high-quality diagnosis possible ([0089]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the external device of Halmann and Pagoulatos to perform the lesion detection and display functions of Noguchi in order to provide a high-quality diagnosis result.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halmann and Pagoulatos as applied to claim 1 above, and further in view of Yoo et al. (US 2011/0079082 A1, Apr. 7, 2011) (hereinafter “Yoo”).
Regarding claim 18: Halmann and Pagoulatos disclose the handheld ultrasound device of claim 1, including acquiring an extended field of view (panoramic) image (Halmann – [0026]). However, Halmann and Pagoulatos are silent on wherein the controller detects an axial movement along a vertical direction while the contact area moves in contact with the breast in a horizontal direction, and generates the ultrasound image by correcting the received ultrasound signals based on the detected axial movement.
Yoo, in the same field of endeavor, discloses a method device for acquiring an extended field of view (panoramic) image where the controller detects an axial movement along a vertical direction while the contact area moves in contact with the breast in a horizontal direction, and generates the ultrasound image by correcting the received ultrasound signals based on the detected axial movement ([0029]-[0032] – displacement vectors between T plane, S plane, and C plane are calculated and used to correct alignment between successive image frames; where figs. 3-5 show the relation of the planes as being both vertical and horizontal and the movement directions including “up”, “down”, “left” and “right” which encompasses “axial” movement). Yoo further discloses that without alignment of acquired frames the resultant image will have geometric distortions ([0002]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to perform the alignment correction of Yoo on the acquired images of Halmann and Pagoulatos in order to prevent geometric distortions in the resultant image.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Flannery et al. (WO 2025/068084 A1, Apr. 03, 2025) – discloses every limitation of at least claim 1.
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/CAROLYN A PEHLKE/ Primary Examiner, Art Unit 3799