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 Amendment
This action is in response to Applicant’s remarks, filed on 6/1/2026. The amendments to claim(s) 1-2, 5, 10-11 and 14 have been entered. Claim(s) 9 is/are cancelled by Applicant and therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b). Corresponding rejections of claim(s) 9 from the prior office action are withdrawn as moot in light of the Applicant’s cancellation. No new claim(s) have been entered. Claims 15-22 were previously withdrawn by Applicant. Accordingly, claim(s) 1-8 and 10-14 remain pending for examination on the merits.
Response to Arguments
Applicant’s arguments, see p. 6-11, with respect to claim(s) 1-22 have been fully considered.
After review of the Applicant’s remarks regarding the objections to claim(s) 1, 10 and 14, Examiner respectfully agrees with Applicant and the prior objections to the claims are withdrawn. Regarding the rejection(s) under 35 U.S.C. § 112, Examiner respectfully agrees with the remarks and the prior rejections under 35 U.S.C. §112 have been withdrawn.
New grounds of rejection are made in view of the following: new amendments provided by Applicant and attached remarks; updated search and review of pertinent, eligible prior art; and/or different interpretation of the previously applied references. Regarding the rejection of claim(s) 1-8 and 10-14 under 35 U.S.C. § 102 and 35 U.S.C. §103, Applicant provides the following:
Claim Rejections Under 35 U.S.C. §§ 102(a)(1) and 103
Claims 1-8 were rejected under 35 U.S.C. § 102(a)(1) as allegedly being anticipated by U.S. Patent Application Publication No. 2017/0360401 to Rothberg et al. ("Rothberg"). Claims 9 and 10-14 were rejected under 35 U.S.C. § 103 as allegedly being unpatentable over Rothberg in view of U.S. Patent Application Publication No. 2017/0105701 to Pelissier et al. ("Pelissier"). Applicant respectfully disagrees with the rejection of Claims 1-14. However, solely to expedite prosecution, Applicant has amended Claims 1 and 10.
Independent Claim 1
Claim 1 is amended to include the features of Claim 9, which has been cancelled. For example, Claim 1 now recites a method comprising, inter alia, "establishing an interface through which the skilled resource can transmit instructional feedback to the local user and control at least one probe setting of the medical device."
First, Applicant and Office both agree that Rothberg fails to teach "permitting control of at least one attribute of the medical device by the skilled resource." The Office turns to Pelissier to supplement this deficiency. However, Pelissier also fails to teach "establishing an interface through which the skilled resource can ... control at least one probe setting of the medical device," as presently claimed.
The Present Application states that in some embodiments of the method of the present claims, an experienced user can "control aspects of the probe 120 [...] For example, the experienced user can remotely control or adjust features and/or settings such as mode selection, measurements (such as volume or velocity), calculations, adjustments to presets, brightness, scan settings (such as gain, scan depth, size/zoom, color, focus, or position), image and video capture, image freeze, annotation and capture tools, power settings, software settings, tool selection, share and data transfer settings and controls, and/or various other features and controls as may be implemented for a given medical device."2
In contrast, Pelissier discloses an "apparatus and method for providing remote expert feedback to an operator of an ultrasound imaging machine."3 Pelissier discloses that "a patient imaging device 104 captures patient images showing probe 103 and patient P."4 FIG. 3 of Pelissier is reproduced below for reference.
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FIG. 3
Thus, as seen in FIG. 3 and described in Pelissier's specification, the patient imagingdevice 104 and probe 103 are distinct elements. Furthermore, patient imaging device 104 is explicitly a "video camera, web camera, security camera, or the like,"5 and/or “a tablet, laptop or cellular telephone equipped with a camera."6
The Office Action alleges that the features of original Claim 9 are taught by Pelissier because Pelissier discloses that "patient imaging device 104 is adjustable (for example has adjustable pan and/or zoom) and remote interface device 118 includes controls that allow the expert to remotely adjust patient imaging device 104 to obtain a clear view of the procedure or a view that can best help the user to see and understand how to best conduct a scan."7
However, Pelissier only discloses that the expert can remotely control certain settings of the patient imaging device 104, which is distinct from the probe 103. Pelissier does not disclose the expert remotely controlling the probe itself, as presently claimed.
Furthermore, Pelissier provides no teaching, suggestion, or motivation to alter its design to arrive at the claimed feature. Pelissier's is explicit that an objective of its design is for a remote user to provide feedback (only).8 Pelissier repeatedly teaches that the remote user is there to provide feedback to the user, and not that the remote user controls the device. The only device in Pelissier taught to be remotely controllable is imaging device 104, and this feature is explicitly explained to further the above objective, i.e. by enabling the expert "to obtain a clear view of the procedure or a view that can best help the user to see and understand how to best conduct a scan."9 Lastly, Pelissier's stated need for "systems that can work effectively with relatively low- bandwidth data connections"10 would discourage and teach away from any design comprising "establishing an interface through which the skilled resource can ... control at least one probe setting of the medical device," as presently claimed.
For at least these reasons, Applicant respectfully submits that Claim 1 is patentable over the cited references, whether considered alone or in combination. Thus, reconsideration and withdrawal of the rejection of Claim 1 are respectfully requested.
Examiner respectfully disagrees with Applicant; the prior rejections under 35 U.S.C. §102 over Rothberg have been withdrawn, and are replaced with new rejections under 35 U.S.C. §102 over Pelissier. Applicant argued "However, Pelissier also fails to teach "establishing an interface through which the skilled resource can ... control at least one probe setting of the medical device," as presently claimed" as recited in Applicant's independent claim 1 and claim 10. Specifically, Applicant asserts that “Pelissier only discloses that the expert can remotely control certain settings of the patient imaging device 104, which is distinct from the probe 103. Pelissier does not disclose the expert remotely controlling the probe itself,”. As shown in the new rejection provided, Pelissier indeed teaches these limitations. Specifically, Pelissier provides the transmission of feedback from an expert to a local user of an ultrasound probe, based on the expert’s review of ultrasound imaging data and video of the ultrasound examination taking place [see claim 1 rejection]. Regarding the feedback, Pelissier discloses the following:
“The expert may, for example, use system 100 to provide feedback on how to capture a high quality image. This feedback may include adjustments to the type or amount of acoustic coupling used, gross positioning, fine positioning, or imaging parameters.”
Pelissier [0062] (emphasis added)
As provided by Pelissier, the ‘feedback’ from the remote expert to the local user of the ultrasound probe may be adjustments to imaging parameters of the ultrasound probe. Pelissier clearly discloses the independent claim language, providing instructional feedback and an adjustment of imaging parameters (i.e., a probe setting). Accordingly, each of the elements of the independent claims is taught by the prior art.
Examiner respectfully notes that Applicant’s arguments only address independent claim(s) 1 and 10, and no remarks regarding the subject matter of the dependent claim(s) have been presented. Accordingly, the rejections to dependent claims 2-8 and 11-14 are modified to address Applicant’s amendments and the new rejection to independent claim(s) 1 and 10 and are sustained. The rejections of claim(s) 1-8 and 10-14 under 35 U.S.C. § 102 and 35 U.S.C. § 103 are maintained.
Claim Objections
Claim 11 is objected to because of informalities. The claim recites the limitation “the establishing the interface further comprising remote source transmitting feedback to the device operator” which is grammatically improper. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 and 10-14 is/are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by Pelissier et al. (US20170105701A1, 2017-04-20; hereinafter “Pelissier”) as provided by Applicant.
Regarding claim 1, Pelissier teaches a method for providing remote guidance from a skilled resource to a local user during a medical procedure on a patient for enhancing quality of the medical procedure performed by the local user (“A method for providing positional feedback to an operator performing an ultrasound scan of a patient” [clm 25]; “System 100 comprises apparatus 100A at a location where a user performs an ultrasound scan on a patient and apparatus 100B at a remote location. An expert may use apparatus 100B to review information about an ultrasound procedure in real time as the ultrasound procedure is being performed at apparatus 100A and to provide real time feedback to a user of apparatus 100A.” [0061]; [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11]), the method comprising:
transmitting information, representative of the medical procedure being performed by the local user, to the skilled resource, wherein the local user performs the medical procedure using a medical device (“acquiring ultrasound image data from an probe at a first location; […] transmitting the ultrasound image data and the video stream to a second location that is remote from the first location;” [clm 25]; “System 100 comprises apparatus 100A at a location where a user performs an ultrasound scan on a patient and apparatus 100B at a remote location.” [0061]; “local user interface device 102 is operable to transmit the ultrasound imaging data and the video stream data through data communication network 106 to remote apparatus 100B […] This is preferably done in real time as a user is performing an ultrasound scan using probe 103.” [0074]; The operator performs an ultrasound scan on a patient using an ultrasound probe transmitting ultrasound waves and measuring reflected ultrasound echoes, generating ultrasound imaging data which is transferred to remote apparatus (i.e., skilled resource) for an expert to remotely view and adjust the ultrasound scan [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11]);
establishing an interface through which the skilled resource can transmit instructional feedback to the local user and control at least one probe setting of the medical device (“A method for providing positional feedback to an operator performing an ultrasound scan of a patient, […] receiving input through the graphical interface of a positional correction;” [clm 25]; “The expert may, for example, use system 100 to provide feedback on how to capture a high quality image. This feedback may include adjustments to the type or amount of acoustic coupling used, gross positioning, fine positioning, or imaging parameters.” [0062]; “When remote feedback is desired apparatus 100A is caused to transmit one or both of the ultrasound imaging data and the video stream through a data communication network 106 to remote apparatus 100B.” [0070]; “patient imaging device 104 is adjustable (for example has adjustable pan and/or zoom) and remote interface device 118 includes controls that allow the expert to remotely adjust patient imaging device 104 to obtain a clear view of the procedure or a view that can best help the user to see and understand how to best conduct a scan” [0074]; An expert may use apparatus 100B to monitor an ultrasound procedure in real time as it is being performed by a user at apparatus 100A, wherein the expert provides real time feedback (e.g., adjustments to imaging parameters) to a user of apparatus 100A [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11; see fig. 1 reproduced below]); and
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An expert remotely located at apparatus 100B may monitor an ultrasound exam performed at apparatus 100A in real-time, wherein expert may provide feedback to adjust ultrasound probe and capture a high-quality image (Pelissier [fig. 1])
conveying the feedback to the local user via a communication interface (“transmitting the positional correction from the second location to the first location; outputting the positional correction to a device at the first location.” [clm 25]; “The expert may, for example, use system 100 to provide feedback on how to capture a high quality image. This feedback may include adjustments to the type or amount of acoustic coupling used, gross positioning, fine positioning, or imaging parameters.” [0062]; “If the remote expert considers that the user's technique for performing the ultrasound scan could be improved then the remote expert may provide feedback to the user by way of remote user interface 118” [0076]; “the expert at remote interface 118 to select messages for transmission to the user, the selected feedback is transmitted back through network 106 to local user interface device 102 and displayed to the user.” [0097]; The expert selects feedback to provide to the user at the local interface where the ultrasound examination is performed, wherein the feedback is transmitted across the network in real-time [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11]).
Regarding claim 2, Pelissier teaches the method of Claim 1,
Pelissier further teaching wherein the establishing the interface comprises establishing the interface through which the skilled resource can indicate at least one suggested position or movement of the medical device (“receiving input through the graphical interface of a positional correction; transmitting the positional correction from the second location to the first location; outputting the positional correction to a device at the first location.” [clm 25]; “The remote interface is configured to display the ultrasound imaging data and the patient images and receive input from a positional feedback selector. The positional feedback selector includes controls for triggering transmission of predefined messages to the local user interface. […] This positional feedback is transmitted back to the local user interface and displayed in real-time.” [0022]; “The predetermined messages can include messages to change the position of probe 103.” [0080]; “the expert may annotate the frozen frame to show a desired change in position and/or orientation of probe 103.” [0132]; The expert may generate feedback to adjust the position and orientation of the probe for the user to instruct the user how to perform ultrasound scan [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11], [see claim 1 rejection]).
Regarding claim 3, Pelissier teaches the method of Claim 1,
Pelissier further teaching wherein the transmitting information comprises sending a video feed to the skilled resource of the local user performing the medical procedure (“acquiring a video stream depicting the probe and the patient; transmitting the ultrasound image data and the video stream to a second location that is remote from the first location;” [clm 25]; “The patient images may comprise a video stream. […] Imaging device 104 may, for example, comprise a suitable video camera, web camera, security camera or the like.” [0067]; “When remote feedback is desired apparatus 100A is caused to transmit one or both of the ultrasound imaging data and the video stream through a data communication network 106 to remote apparatus 100B.” [0070]; “local user interface device 102 is operable to transmit the ultrasound imaging data and the video stream data through data communication network 106 to remote apparatus 100B which includes remote interface 118. The remote expert can then use remote interface device 118 to view one or both of the ultrasound imaging data and the patient image data. This is preferably done in real time as a user is performing an ultrasound scan using probe 103.” [0074]; The expert may review a real-time video feed of the ultrasound examination when considering feedback to transmit to the ultrasound operator [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11], [see claim 1 rejection]).
Regarding claim 4, Pelissier teaches the method of Claim 3,
Pelissier further teaching wherein the video feed is a live video feed (“An expert may use apparatus 100B to review information about an ultrasound procedure in real time as the ultrasound procedure is being performed at apparatus 100A and to provide real time feedback to a user of apparatus 100A.” [0061]; “local user interface device 102 is operable to transmit the ultrasound imaging data and the video stream data through data communication network 106 to remote apparatus 100B which includes remote interface 118. The remote expert can then use remote interface device 118 to view one or both of the ultrasound imaging data and the patient image data. This is preferably done in real time as a user is performing an ultrasound scan using probe 103.” [0074]; [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11], [see claim 3 rejection]).
Regarding claim 5, Pelissier teaches the method of Claim 1,
Pelissier further teaching wherein the establishing the interface comprises the skilled resource overlaying notation over the information transmitted to the skilled resource (“the expert may annotate the frozen frame to show a desired change in position and/or orientation of probe 103” [0132]; “Remote interface 118 may automatically generate and send to apparatus 100A a freeze message containing an identifier of the frozen frame (e.g. a frame number). Upon receipt of the freeze message apparatus 100A may retrieve the selected frame and display it instead of or in addition to the video stream (e.g. on display 102A). […] For example, the frozen image may be displayed together with a particular icon or symbol or overlaid with a particular color or the like.” [0133]; “Some embodiments provide an annotation feature that may be used by an expert to annotate images (e.g. frames from the ultrasound imaging data generated by ultrasound imaging apparatus 101 and/or the video stream from patient imaging device 104).” [0142]; [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11], [see claim 1 rejection]).
Regarding claim 6, Pelissier teaches the method of Claim 1,
Pelissier further teaching wherein the conveying the feedback comprises providing visual feedback to the local user using a first communication device (“local user interface device 102 may comprise a general purpose device such as a tablet computer, a smart phone, a laptop computer, a personal computer, a computer workstation or the like.” [0065]; “The remote expert may drag and drop the icon onto the display of an ultrasound image stream or video stream at remote interface 118. In a preferred embodiment, the local user interface 102 is updated with the position of the icon in real time as the icon is applied by the expert.” [0072]; “Whatever mechanism is used by the expert at remote interface 118 to select messages for transmission to the user, the selected feedback is transmitted back through network 106 to local user interface device 102 and displayed to the user.” [0097]; The local user interface device (i.e., first communication device) receives feedback from the network and displays the feedback to the user [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11], [see claim 1 rejection]).
Regarding claim 7, Pelissier teaches the method of Claim 1,
Pelissier further teaching wherein the skilled resource comprises a skilled user of the medical device (“An ultrasound system may provide features that allow a person at a remote site (e.g. an expert ultrasound user) to review the actions of a person using an ultrasound system and provide feedback.” [0060]; “The expert may, for example, use system 100 to provide feedback on how to capture a high quality image. This feedback may include adjustments to the type or amount of acoustic coupling used, gross positioning, fine positioning, or imaging parameters.” [0062]; [0061-0090, 0147-168], [fig. 1-2, 7-8, 11], [see claim 1 rejection]).
Regarding claim 10, Pelissier teaches a method for enhancing a device operator's use of a medical device via feedback from a remote source during a medical procedure (“A method for providing positional feedback to an operator performing an ultrasound scan of a patient” [clm 25]; “System 100 comprises apparatus 100A at a location where a user performs an ultrasound scan on a patient and apparatus 100B at a remote location. An expert may use apparatus 100B to review information about an ultrasound procedure in real time as the ultrasound procedure is being performed at apparatus 100A and to provide real time feedback to a user of apparatus 100A.” [0061]; [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11]), the method comprising:
performing the medical procedure using the medical device (“acquiring ultrasound image data from an probe at a first location;” [clm 25]; “System 100 comprises apparatus 100A at a location where a user performs an ultrasound scan on a patient and apparatus 100B at a remote location.” [0061]; “local user interface device 102 is operable to transmit the ultrasound imaging data and the video stream data through data communication network 106 to remote apparatus 100B […] This is preferably done in real time as a user is performing an ultrasound scan using probe 103.” [0074]; [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11], [see claim 1 rejection]);
transmitting a video, via a shared application, of the medical procedure from a video-enabled device of the device operator to a remote device of the remote source (“acquiring a video stream depicting the probe and the patient; […] transmitting the ultrasound image data and the video stream to a second location that is remote from the first location;” [clm 25]; “When remote feedback is desired apparatus 100A is caused to transmit one or both of the ultrasound imaging data and the video stream through a data communication network 106 to remote apparatus 100B.” [0070]; “local user interface device 102 is operable to transmit the ultrasound imaging data and the video stream data through data communication network 106 to remote apparatus 100B […] This is preferably done in real time as a user is performing an ultrasound scan using probe 103.” [0074]; [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11], [see claim 1 rejection]); and
the shared application establishing an interface for instructional sharing by the remote source, viewing of the video by the remote source, and controlling an operation or attribute of the medical device by the remote source (“A method for providing positional feedback to an operator performing an ultrasound scan of a patient, […] receiving input through the graphical interface of a positional correction;” [clm 25]; “The expert may, for example, use system 100 to provide feedback on how to capture a high quality image. This feedback may include adjustments to the type or amount of acoustic coupling used, gross positioning, fine positioning, or imaging parameters.” [0062]; “patient imaging device 104 is adjustable (for example has adjustable pan and/or zoom) and remote interface device 118 includes controls that allow the expert to remotely adjust patient imaging device 104 to obtain a clear view of the procedure or a view that can best help the user to see and understand how to best conduct a scan” [0074]; “If the remote expert considers that the user's technique for performing the ultrasound scan could be improved then the remote expert may provide feedback to the user by way of remote user interface 118” [0076]; “the expert at remote interface 118 to select messages for transmission to the user, the selected feedback is transmitted back through network 106 to local user interface device 102 and displayed to the user.” [0097]; [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11], [see claim 1 rejection]).
Regarding claim 11, Pelissier teaches the method of Claim 10,
Pelissier further teaching the establishing the interface further comprising remote source transmitting feedback to the device operator (“A method for providing positional feedback to an operator performing an ultrasound scan of a patient, […] receiving input through the graphical interface of a positional correction;” [clm 25]; “The expert may, for example, use system 100 to provide feedback on how to capture a high quality image. This feedback may include adjustments to the type or amount of acoustic coupling used, gross positioning, fine positioning, or imaging parameters.” [0062]; “patient imaging device 104 is adjustable (for example has adjustable pan and/or zoom) and remote interface device 118 includes controls that allow the expert to remotely adjust patient imaging device 104 to obtain a clear view of the procedure or a view that can best help the user to see and understand how to best conduct a scan” [0074]; “If the remote expert considers that the user's technique for performing the ultrasound scan could be improved then the remote expert may provide feedback to the user by way of remote user interface 118” [0076]; “the expert at remote interface 118 to select messages for transmission to the user, the selected feedback is transmitted back through network 106 to local user interface device 102 and displayed to the user.” [0097]; [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11], [see claim 1 rejection]).
Regarding claim 12, Pelissier teaches the method of Claim 11,
Pelissier further teaching further comprising conveying the feedback to the device operator via a communication interface (“A method for providing positional feedback to an operator performing an ultrasound scan of a patient, […] receiving input through the graphical interface of a positional correction;” [clm 25]; “The expert may, for example, use system 100 to provide feedback on how to capture a high quality image. This feedback may include adjustments to the type or amount of acoustic coupling used, gross positioning, fine positioning, or imaging parameters.” [0062]; “patient imaging device 104 is adjustable (for example has adjustable pan and/or zoom) and remote interface device 118 includes controls that allow the expert to remotely adjust patient imaging device 104 to obtain a clear view of the procedure or a view that can best help the user to see and understand how to best conduct a scan” [0074]; “If the remote expert considers that the user's technique for performing the ultrasound scan could be improved then the remote expert may provide feedback to the user by way of remote user interface 118” [0076]; “the expert at remote interface 118 to select messages for transmission to the user, the selected feedback is transmitted back through network 106 to local user interface device 102 and displayed to the user.” [0097]; [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11], [see claim 1 rejection]).
Regarding claim 13, Pelissier teaches the method of Claim 10,
Pelissier further teaching wherein the establishing the interface comprises, in response to a signal from the remote source, generating haptic feedback via the medical device to allow the remote source to communicate with the medical device operator (“If the monitored motion does not correspond to the message received from remote interface 118 then a warning signal may be provided to the user. The warning signal may, for example, comprise a sound, tactile feedback or the like. For example, probe 103 may be controlled to deliver a vibration or other haptic feedback to a user if the user moves the probe 103 in the wrong way.” [0112]; “the tactile feedback is provided by transducers such as piezoelectric transducers and/or heaters on a housing of probe 103 that may be selectively actuated to change the texture, temperature and/or vibration patterns sensed by a user holding probe 103 in a manner that maps intuitively to suggested movements.” [0116]; The probe may provide tactile cues to the user based on the suggestions/instructions provided by the remote located expert [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11]).
Regarding claim 14, Pelissier teaches the method of Claim 13,
Pelissier further teaching wherein the medical device contains an accelerometer (“providing an accelerometer in probe 103 and monitoring one or more outputs of the accelerometer to detect and/or measure inclination of and/or rotations of the probe 103;” [0110]; [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11]),
the remote source has a second medical device that contains an accelerometer (“In some embodiments remote interface 118 includes a demonstration device which can be positioned like probe 103 and is equipped with a position sensor. The demonstration device may be a probe 103 or a replica of probe 103 for example.” [0076]; The demonstration device (i.e., second medical device) manipulated by remote expert may be the same type of probe used by the local user, wherein the demonstration device probe possesses an accelerometer as a position sensor [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11]), and
the remote source can manipulate the second medical device, wherein when the medical device operator has oriented the medical device in the same way as the remote source, the medical device operator receives haptic feedback in their medical device (“The expert may manipulate the demonstration device to demonstrate a particular technique while the position and orientation of the demonstration device is tracked. The tracked position and orientation of the demonstration device may be transmitted to apparatus 100A which may generate an animation showing the user of apparatus 100A how the expert is manipulating the demonstration device.” [0076]; “the tactile feedback is provided by transducers such as piezoelectric transducers and/or heaters on a housing of probe 103 that may be selectively actuated to change the texture, temperature and/or vibration patterns sensed by a user holding probe 103 in a manner that maps intuitively to suggested movements.” [0116]; The tracked position and orientation of demonstration device may be transmitted to the apparatus for the local user, wherein the manipulations of the local user may be guided by tactile feedback [0061-0090, 0147-0168], [fig. 1-2, 7-8, 11], [see claim 13 rejection]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being obvious over Pelissier as applied to claim 1 above, in view of Rothberg et al. (US20170360401A1, 2017-12-21; hereinafter “Rothberg”).
Regarding claim 8, Pelissier teaches the method of Claim 1,
but Pelissier fails to teach wherein the skilled resource comprises an artificial intelligence.
However, in the same field of endeavor, Rothberg teaches a method for providing remote guidance from a skilled resource to a local user during a medical procedure on a patient for enhancing quality of the medical procedure performed by the local user (“A method, comprising: […] generating, using the ultrasound image, a guidance plan for how to guide an operator of the ultrasound device to capture an ultrasound image of the subject containing the target anatomical view” [clm 20]; “techniques for guiding an operator to use an ultrasound device” [abst]; “The disclosure provides techniques for instructing an operator of an ultrasound device how to position the ultrasound device on a subject to capture a medically relevant ultrasound image. […] The guidance may be provided via a software application (hereinafter “App”) installed on a computing device of the operator (such as: a mobile device, a smartphone or smart-device, tablet, etc.)” [0144]; “the App may be executed on a cloud and communicated to the operator through the smart device. […] the execution of the App may be at a local or a remote device” [0146]; [0140-0180], [fig. 1, 5A-5B, 15A-15B, 9]);
Rothberg further teaching wherein the skilled resource comprises an artificial intelligence (“Example automated image processing techniques include machine learning techniques such as deep learning techniques. […] the convolutional neural network may be trained with a set of ultrasound images labeled with the particular anatomical view depicted in the ultrasound image” [0149]; “the computing device may identify the initial position of the ultrasound device on the subject at least in part by: identifying an anatomical view contained in the ultrasound image (e.g., using deep learning techniques) and map the identified anatomical view to a position on the subject” [0229]; “Aspects of the technology described herein relate to the application of automated image processing techniques to analyze images, such as ultrasound images and non-acoustic images. In some embodiments, the automated image processing techniques may comprise machine learning techniques such as deep learning techniques.” [0257]; Deep learning techniques (i.e., artificial intelligence) may be applied to analyze both ultrasound image data and non-acoustic images, and to determine operator instructions [0144-0153, 0171-0174, 0225-0244, 0257-0315], [fig. 1, 3A-3B, 5A-5B, 9-11, 15A-15B]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to combine the method for providing remote guidance taught by Pelissier wherein the skilled resource comprises an artificial intelligence as taught by Rothberg. It can be difficult to properly capture and analyse ultrasound images. The successful use of ultrasound is dependent on highly-skilled technicians to perform the scans and experienced physicians to interpret them. It typically takes several years of training for a technician to become proficient (Pelissier [0003]). Trained ultrasound technicians are not universally accessible. Ultrasound could be used to improve care for more patients, especially in rural and low-resource settings, if less-skilled operators were able to perform ultrasound examinations quickly and accurately (Pelissier [0007]). Furthermore, holding the ultrasound device a few inches too high or too low on the subject may make the difference between capturing a medically relevant ultrasound image and capturing a medically irrelevant ultrasound image. As a result, non-expert operators of an ultrasound device may have considerable trouble capturing medically relevant ultrasound images of a subject (Rothberg [0004]). The technology improvements described may enable, among other capabilities, focused diagnosis, early detection and treatment of conditions by an ultrasound system (Rothberg [0209]), and may increase the effectiveness of remote feedback, thus helping inexperienced ultrasound users to capture accurate images in less time, ultimately leading to improved patient care and reduced costs (Pelissier [0032]).
Conclusion
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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JAMES FRANKLIN MCDONALD III
Examiner
Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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