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 .
Acknowledgement of Amendment
The following office action is in response to the applicant’s amendment filed on 02/06/2026. Claims 1-2, and 4-20 are pending. Claim 3 has been cancelled. Claims 14-20 are withdrawn from consideration as they are drawn to a non-elected invention. Claims 1-2, and 4-13 are rejected under 35 U.S.C. 103 for the reasons stated in the Response to Arguments and 35 U.S.C. 103 sections below.
Election/Restrictions
Applicant’s election without traverse of Group I corresponding to claims 1-13 in the reply filed on 08/13/2024 is acknowledged.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/13/2024.
Response to Arguments
Applicant’s arguments, see Remarks page 7, filed 10/23/2025, with respect to the examiner’s note been fully considered and are persuasive.
In the Examiner's Note section of the Office Action, the Examiner comments that the scanning surface will be interpreted as a flexible membrane which attaches to the biological tissue and allows for movement of the transducer. Respectfully, this interpretation by the Examiner is inaccurate. The scanning surface is never portrayed as a component that "attaches" to the biological tissue. Instead, it gets pressed against the biological tissue by means of an operator of the imaging device. Although it may seem like a trivial distinction, it is important from an operability point of view for the imaging device to be easily moveable and to not be physically attached to a patient. Although the present application provides for a coupling agent, such as a gel or lotion, this is simply used to act as a temporary "acoustic bridge" for enhanced imaging.
The examiner respectfully acknowledges that the scanning surface is pressed against the biological tissue by means of an operator of the imaging device such that is it easily moveable along the patient. Furthermore, the examiner recognizes that the present application provides for a coupling agent, such as a gel or lotion, this is simply used to act as a temporary "acoustic bridge" for enhanced imaging.
Additionally, the Applicant notes that the Examiner also notes that the "electronics module" is being interpreted to be an analog- to-digital converter. Respectfully, this limited interpretation by the Examiner does not make sense. The electronics module is discussed in various paragraphs of the description. Paragraph [0102], for example, provides for the electronics module to include a beamformer "configured to receive the converted digital signals and transmit the digital signals to the computing device". The electronics module may also include an amplifier and filter, which may be separate from a standard analog-to-digital converter. As such, Applicant respectfully submits that the Examiner's limited interpretation of the term seems unsupported.
The examiner recognizes that an analog-to-digital converter is one of many devices which can be included within the electronics module. The examiner acknowledges that paragraph [0102] provides for the electronics module to include a beamformer "configured to receive the converted digital signals and transmit the digital signals to the computing device". Additionally, the examiner recognizes that the electronics module may also include an amplifier and filter, which may be separate from a standard analog-to-digital converter.
Applicant’s arguments, see Remarks page 7-13, filed 02/06/2026, with respect to the rejection of the claims under 35 U.S.C. 102 and 35 U.S.C. 103 have been fully considered and are persuasive.
. Claim(s) 1-5, 9-10, and 12-13 is/are rejected under 35 U.S.C. 102 as being anticipated by Saberi et al. US 2017/0311923 Al "Saberi". Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saberi et al. US 2017/0311923 Al "Saberi" as applied to claim 1 above, and further in view of Zhang et al. US 2016/0166234 Al "Zhang". Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saberi et al. US 2017/0311923 Al "Saberi" as applied to claim 1 above, and further in view of Wang US 2018/0256130 Al "Wang". Claim(s)-7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saberi et al. US 2017/0311923 Al "Saberi" as applied to claim 1 above, and further in view of Wang US 2018/0256130 Al "Wang" and Chiang et al. US 2019/0336101 Al "Chiang".
Applicant respectfully traverses the rejections. While Applicant traverses the rejections, characterization of the cited art and the claimed subject matter, and/or implicit or explicit potential for reliance on official notice. Applicant amended the claims to expedite prosecution and canceled claim 3 without prejudice or disclaimer. For at least the following reasons, Applicant respectfully submits that the cited references do not teach every limitation of each claim and that the claims are allowable.
The Examiner has fully considered the Applicant's previously submitted arguments, and conceded that none of the previously cited references, either considered individually or in combination, disclose or suggest all the features of previously submitted claim 1. And the previous rejection of claim 1 has consequently been withdrawn. Notwithstanding, the Examiner has now asserted new grounds of rejection based on Saberi. While the Applicant does not agree that Saberi discloses all features of the previously presented claim, the Applicant has amended claim 1 in order to clarify and emphasize the distinctions over Saberi and thereby to advance prosecution.
The applicant notes that Saberi is directed to a wearable ultrasound system and method. As described in its abstract, Saberi provides an ultrasound system including: a housing including a handle region and a membrane; an ultrasound transducer; a reservoir; a rotational actuator; and an electronics module.
Importantly, Saberi therefore claims to provide a wearable ultrasound system for capturing images which includes, amongst other components, an ultrasound transducer and a rotational actuator.
The Applicant submits that the assembly described in Saberi has a very specific application and associated limitations as it is specifically designed to be a low-cost, compact, and/or wearable ultrasound system (paragraph [0020], Saberi).
Saberi's inventive concept therefore seems to rest on image acquisition by rotation of a transducer assembly.
Although, admittedly, Saberi does share certain high-level similarities with the claimed invention in that both relate to portable ultrasound imaging systems, Saberi neither discloses nor renders obvious the specific combination of structural and functional features recited in amended claim 1.
Amended claim 1 of the present application expressly requires a linear scanning element and a drive system configured to automatically move the scanning element linearly along a scanning surface, wherein image data is captured as the scanning element is moved along that scanning surface. Saberi, by contrast, is expressly directed to embodiments employing a rotational actuator and a rotational scanning modality. The imaging approach in Saberi is therefore fundamentally different in both structure and operation. The present application relies on an imaging device having a translational, linear acquisition architecture capable of capturing image data during a single automated linear scan, whereas Saberi relies on rotational movement of the transducer assembly.
The examiner acknowledges that the transducer assembly of Saberi performs image acquisition by performing a rotation. Specifically, the ultrasound system 100 includes a first actuator to provide rotation of the transducer support relative to a first axis 101 and a second actuator which provides rotation about a second axis 102 (See [0019]). However, in a second variation, “the actuator includes a linear actuator configured to translate the transducer (e.g., substantially tangent the user’s tissue, substantially normal the central beam axis, substantially parallel the central beam axis, along an axis at an oblique angle to the central beam axis, etc.). For example, the linear actuator can produce radial transducer motion toward and away from one or more axes (e.g., second axis 102, such as described below” [0027]. Therefore, it appears that Saberi includes a linear actuator to translate the transducer substantially tangent the user’s tissue (i.e. a linear scanning element).
The Applicant submits that Saberi is completely silent on, and does not disclose, a linear scanning element that is automatically driven along a scanning surface forming part of the enclosure. Any passing mention in Saberi of alternate actuator types does not disclose a linear transducer element arranged and operated to acquire a complete three-dimensional image of tissue in a single automated linear pass. A rotational actuator is not a linear drive system, and a rotational sweep cannot reasonably be construed as the claimed linear automated scan recited in amended claim 1. Accordingly, Saberi does not teach the claimed linear drive configuration or the associated mode of image acquisition as claimed in claim 1.
The examiner respectfully disagrees that Saberi is completely silent on, and does not disclose, a linear scanning element that is automatically driven along a scanning surface forming part of the enclosure (see [0019] above and FIG. 1A). Furthermore, Saberi discloses “Additionally or alternatively, the transducer 110 can be coupled to an actuator (e.g., linear actuator) that can adjust the position of the transducer in one or more directions, to adjust a focal length or position of the transducer 110 in relation to a tissue body. The linear actuator can translationally couple the transducer 110 (e.g., to the housing), enabling control of the transducer position along a translation axis (e.g., first axis 101, second axis 102, central beam axis 103, longitudinal axis, etc.)” [0030]. The examiner acknowledges that a rotational actuator is not a linear drive system and that a rotational sweep cannot reasonably be construed as the claimed linear automated scan, however, Saberi also discloses an embodiment where a linear actuator is used (see paragraphs cited above). Therefore, Saberi includes a linear actuator to perform linear scanning. Furthermore, the examiner notes that claim 1, as written does not include a limitation to specify that linear transducer element is arranged and operated to acquire “a complete three-dimensional image of tissue in a single automated linear pass”. If this is a feature that the Applicant intends to include within claim 1, the examiner would recommend amending the claim as such, while also noting where support for “a complete three-dimensional image of tissue in a single automated linear pass” can be found within the Applicant’s disclosure.
Furthermore, amended claim 1 requires that the enclosure is configured to house the scanning element, the drive system, the electronics module, and the computing device, and that the electronics module transmits image data to an integrated computing device via a computing device interface, where the computing device operatively receives the image data and presents it to an operator in processed form. In other words, the computing device is not external to the portable imaging device, but forms part of the same integrated enclosure that houses the scanning and drive components.
The applicant argues that Saberi does not disclose such structural integration. Rather, Saberi, particularly in paragraph [0069], provides for an interface between the system and a controller configured to receive inputs from a user or other operator of the system. Saberi further explains that this interface may be implemented via a web-based platform, controller device platform, mobile device application platform, and/or any other suitable platform that allows a user or other entity to communicate with the system (e.g., over a wireless and/or wired connection) to initiate, terminate, or restart a scanning protocol. Saberi further contemplates transmission of scanning data to a processing system (e.g., a cloud-computing system, remote server, etc.).
Paragraph [0073] of Saberi additionally describes post-processing of acquired data and expressly indicates that real-time ultrasound imaging and display are not required. This paragraph further discusses implementation of required electronics on a small PCB, consistent with Saberi's stated objective of providing a compact, low-cost, wearable scanner.
Taken together, these disclosures of Saberi indicate a separation between the imaging hardware and the processing/display hardware. Saberi is therefore silent on, and does not suggest, an on-board computing device integrated within the same enclosure that houses the scanning element and drive system, and configured to present processed image data to the operator in real time while the device is being held over the patient.
In other words, there is no teaching in Saberi that the computing device is structurally integrated within the same enclosure such that the operator holding the portable imaging device is able to view processed image data in real time on a computing device forming part of the imaging device itself.
Accordingly, Saberi does not disclose all the features of amended claim 1 arranged as claimed, and the rejection under 35 U.S.C. §102 should be withdrawn.
The examiner respectfully acknowledges that Saberi is silent on, and does not suggest, an on-board computing device integrated within the same enclosure that houses the scanning element and drive system, and configured to present processed image data to the operator in real time while the device is being held over the patient. Rather paragraphs [0069] and [0073] suggest a separation between the imaging hardware and the processing/display hardware.
Therefore, the examiner agrees that there is no teaching in Saberi that the computing device is structurally integrated within the same enclosure such that the operator holding the portable imaging device is able to view the processed image data in real time on a computing device forming part of the imaging device itself.
Thus, the rejection of claim 1 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Poland US 2021/0315541 A1 “Poland” as discussed in the 35 U.S.C. 103 section below.
Moreover, the Applicant also submits that the subject matter of amended claim 1 would not have been obvious to a person of ordinary skill in the art. Replacing Saberi's rotational scanning architecture to the presently claimed linear, automatically driven scanning element is not a routine design alternative. The two configurations involve materially different mechanical configurations, motion control strategies, transducer arrangements, and image acquisition techniques. Saberi provides no teaching, suggestion, or motivation to abandon its rotational actuator system in favour of a linear translational drive configured to perform an automated linear scan along a defined scanning surface forming part of the enclosure, nor does it provide any reasoned expectation of success for doing so.
Likewise, Saberi does not provide any teaching or suggestion to integrate the computing device within the same enclosure that houses the scanning element and drive system. Integrating processing and display functionality into the handheld imaging enclosure introduces significant technical considerations/challenges relating to power management, thermal dissipation, mechanical packaging, signal integrity, and real-time image processing. Saberi neither addresses these challenges nor provides any indication that such integration was contemplated. There is also no reason why a person looking at Sabri would consider modifying Saberi to arrive at the imaging device of the present application. As mentioned above, Saberi is directed to a small, low-cost imaging scanner that is configured to be worn (attached to) a patient.
It should further be appreciated that Saberi's overall structural configuration would have to be fundamentally altered in order to accommodate the linear scanning element and drive system as recited in amended claim 1. As is evident from Saberi's figures, the transducer assembly is positioned within a curved cupping region and/or window designed to conform to the anatomy of the patient. The rotational actuator operates within this curved geometry.
Adapting Saberi to include a linear scanning element configured to move linearly along a defined scanning surface forming part of the enclosure would not be a simple substitution of motion type. Rather, it would require redesign of the cupping region, the scanning window, and the internal mechanical architecture to provide a substantially linear guide path. The curved geometry disclosed in Saberi is structurally incompatible with a linear translational scan extending along a scanning surface as presently claimed.
While the examiner respectfully disagrees that Saberi does not disclose an embodiment in which linear scanning is performed (see [0027], [0030]), the examiner recognizes that Saberi does not provide any teaching or suggestion to integrate the computing device within the same enclosure that houses the scanning element and drive system. The examiner acknowledges that integrating processing and display functionality into the handheld imaging enclosure introduces significant technical considerations/challenges relating to power management, thermal dissipation, mechanical packaging, signal integrity, and real-time image processing. Saberi neither addresses these challenges not provides any indication that such integration was contemplated.
The examiner does not necessarily agree that Saberi’s overall structural configuration would have to be fundamentally altered in order to accommodate the linear scanning element and drive system to be fundamentally altered in order to accommodate the linear scanning element and drive system as recited in amended claim 1 (see Saberi: [0027], [0030]). The examiner respectfully notes that while the transducer assembly may be positioned within a curved cupping region and/or window designed to conform to the anatomy of the patient, this does not necessarily mean that a linear scan within the curved cupping region (i.e. substantially tangent to the user’s tissue) cannot be performed.
The Applicant submits that the specific combination of (i) a linear scanning element automatically driven along a scanning surface forming part of the enclosure, and (ii) an integrated computing device housed within the same enclosure and configured to present processed image data to the operator, is neither disclosed nor suggested by Saberi.
Replacing Saberi's rotational scanner with a linear scanning architecture and, in addition, integrating a computing device within the same enclosure would not constitute a routine design modification. Rather, it would require a fundamental reconfiguration of Saberi's mechanical layout, spatial constraints, and overall system architecture. Saberi is expressly directed to a compact, low-cost, wearable imaging system, with electronics configured to support that objective. In contrast, the presently claimed device employs a comparatively larger linear scanning element specifically configured to enable acquisition of a complete 3D image of the tissue in a single automated linear scan (a capability acknowledged by the Examiner on page 9 of the Office Action). Saberi, by comparison, contemplates rotational scanning and envisages multiple scans, and does not aim to achieve single-pass volumetric acquisition through linear translation.
There is no teaching, suggestion, or motivation in Saberi that would lead a person of ordinary skill in the art to abandon Saberi's rotational, curved, wearable configuration in favour of a linear translational architecture integrated with an on-board computing and display device. Any assertion that Saberi renders the presently claimed combination obvious can only be derived from knowledge of the Applicant's disclosure and would therefore require impermissible hindsight reconstruction.
For at least these reasons, Saberi neither anticipates nor renders obvious amended claim 1.
It is therefore submitted that none of the cited references, either considered individually or in combination, disclose or suggest all the features of the presently presented claim 1. Accordingly, the Applicant respectfully requests that the rejection of amened Claim 1 be withdrawn.
The examiner respectfully acknowledges that Saberi does not teach the specific combination of (i) a linear scanning element automatically driven along a scanning surface forming part of the enclosure, and (ii) an integrated computing device housed within the same enclosure and configured to present processed image data to the operator.
The examiner does not necessarily agree that replacing Saberi’s rotational scanner with a linear scanning architecture would not constitute a routine design modification (i.e. since Saberi includes an embodiment which uses a linear actuator, see [0027], [0030]), the examiner agrees that performing this substitution, in addition to, integrating a computing device within the same enclosure would not constitute a routine design modification. Rather, it would require a fundamental reconfiguration of Saberi's mechanical layout, spatial constraints, and overall system architecture. Saberi is expressly directed to a compact, low-cost, wearable imaging system, with electronics configured to support that objective. While the Applicant notes that the presently claimed device employs a comparatively larger linear scanning element specifically configured to enable acquisition of a complete 3D image of the tissue in a single automated linear scan, the examiner notes that claim 1 does not include a limitation expressing that a complete 3D image of the tissue in a single automated linear scan is obtained. Should the Applicant desire to claim this feature, the examiner would again recommend amending the claim as such and noting where support can be found for this feature in the Applicant’s disclosure. That being said, the examiner acknowledges that Saberi, by comparison, contemplates rotational scanning and envisages multiple scans, and does not aim to achieve single-pass volumetric acquisition through linear translation.
Dependent Claims
Although Applicant has not addressed all the issues of the dependent claims, Applicant respectfully submits that Applicant does not necessarily agree with the characterization and assessments of the dependent claims made by the Examiner, and Applicant believes that each claim is patentable on its own merits. Applicant respectfully submits that the dependent claims incorporate by reference all the limitations of the claim to which they refer and include their own patentable features and are therefore in condition for allowance. Therefore, Applicant respectfully requests the withdrawal of all claim rejections and prompts allowance of the claims.
The examiner respectfully notes that the dependent claims (i.e. claims 2, and 4-13) are subject to the reasoning provided with respect to claim 1 above. Thus, claims 2, and 4-13 are subject to the new ground(s) of rejection made in view of Poland US 2021/0315541 A1 “Poland” as stated in the 35 U.S.C. 103 section below.
Request to Rejoin Withdrawn Claims
The Applicant respectfully requests that the Examiner rejoin claims 14-20. The Applicant respectfully submits that the withdrawn claims are allowable for at least similar reasons as the pending claims as well as for the unique features recited therein.
The examiner respectfully notes that claims 14-20 are directed to a method for imaging and evaluating tissue (i.e. claims 14-18) and a system for imaging and evaluating tissue (i.e. claims 19-20). These claims require the technical features of “performing computer-assisted diagnosis (CAD) on the image data by machine learning or artificial intelligent processing to identify a presence of one or more abnormalities in the image data”; “based on the one or more abnormalities in the image data, making a diagnosis on the server computer”; “determining that the diagnosis is made within an acceptable confidence factor and sending the diagnosis to the portable imaging device”; […] “updating a machine learning model or an artificial intelligence model with one or more data point from the diagnosis” which are not required by the portable imaging device of claims 1-13.
Thus, the examiner respectfully maintains that since claims 14-20 require different features than that of claim 1-13 (i.e. elected by the Applicant on 08/13/2024 without traverse), the restriction is maintained. Therefore claims 1-20 are not rejoined.
Examiner’s Note
Regarding claim 1, the claim includes the phrase “a scanning element” which is described in the specification when it states “In the present embodiment, the scanning element (102) includes an ultrasound probe, commonly referred to as a transducer, having a piezoelectric crystal acting as a transmitter and detector” [Page 11, Lines 1-2]. Therefore, the examiner will be interpreting the scanning element to be an ultrasound probe/transducer.
Furthermore, claim 1 recites “a scanning surface” which is described in the specification when it states “The scanning surface may include a substantially planar mesh membrane configured to, in use, be pressed against a surface of the biological tissue so as to compress the tissue and enable the capturing of image data of a larger area of biological tissue. In use the biological tissue and/or mesh membrane may be coated with a coupling agent, such as ultrasound gel or lotion. The mesh membrane may be manufactured from a mesh material providing sufficient structural integrity so that the scanning surface may compress the biological tissue during use, as required” [Page 3, Line 35-Page 4, Line 4] and “The scanning surface may be optically translucent so that placement of the device at a desired location of the biological tissue is possible” [Page 9, Line 38-Page 10, Line 1]. Therefore, the examiner will be interpreting the scanning surface to be a flexible membrane which contacts biological tissue and allows for movement of the transducer.
Furthermore, claim 1 recites “an electronics module” which is described in the specification when it states “The electronics module (104) includes an analog front end (108) that serves as an interface between the scanning element and other digital components of the imaging device (100). The analog front end (108) is configured to receive the image data, in the form of an analog signal, from the scanning element (102) and amplify, filter and convert the analog signals into a digital format, by means of an analog-to-digital converter, readable by the digital components” [Page 11, Lines 16-20]. Therefore, the examiner will be interpreting the electronics module to be a device which includes, among other processing components, an analog-to-digital converter.
Furthermore, claim 1 recites “a computing device interface” which is described in the specification when it states “The computing device interface may be a standard connector, such as a USB connector” [Page 10, Lines 17-18]. Therefore, the examiner will be interpreting the computing device interface to be a connector.
Furthermore, claim 1 recites “a computing device” which is described in the specification when it states “The computing device 106 includes a controller (116) configured to send control instructions to components of the device, such as the scanning element (102) and/or a drive system […] In some embodiments, the computing device (106) may include a user interface (118) which enables the operator to interact with the computing device and thereby control operation of the device” [Page 13, Lines 9-17] and “The computing device may be a tablet computer or a smart phone, for example” [Page 10, Lines 18-19]. Therefore, the examiner will be interpreting the computing device to be a tablet computer (i.e. containing a processor) with a user interface for controlling the device.
Regarding claim 13, this claim includes the phrase “communications interface” which is described in the specification when it states “Data transferred via the communications interface may be in the form of signals, which may be electronic, electromagnetic, optical, radio, or other types of signal. The communications interface may be configured for connection to wireless communication channels (e.g., a Bluetooth network, wireless local area network (e.g., using Wi-Fi), etc.) and may include an associated wireless transfer element, such as an antenna and associated circuitry. It should be appreciated that the computing device 106 may be configured to communicate with the components of the device, of the server, through Wi-Fi, Bluetooth, Ethernet, a serial port and a variety of other interfaces to ultimately connect devices” [Page 12, Lines 24-34]. Therefore, the examiner will be interpreting the communications interface to be a series of ports used for wired or wireless transfer of data between devices.
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, the claim has been amended to recite: “[…] a linear scanning element […] a scanning surface configured to provide a surface service as an interface between the scanning element and the biological tissue; a drive system configured to automatically move the scanning element […]; an electronics module in data communication with the scanning element […] an integrated computing device […], wherein the computing device operatively receives […] wherein the enclosure is configured to house the scanning element, the drive system, the electronics module and the computing device”. However to avoid potential antecedent basis issues, the examiner would recommend updating all instances of “the scanning element” to “the linear scanning element” and all instances of “the computing device” to “the integrated computing device”.
Appropriate correction 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.
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) 1-2, 4-5, 9-10, and 12-13 is/are rejected under 35 U.S.C. 103 as being anticipated by Saberi et al. US 2017/0311923 A1 “Saberi” and further in view of Poland US 2021/0315541 A1 “Poland”.
Regarding claim 1, Saberi teaches “A portable imaging device for imaging biological tissue, comprising:” (“As shown in FIGS. 1A-1B and 2A-2B, an embodiment of an ultrasound system 100 can include: a scanner assembly including a transducer 110, preferably coupled to a shaft of an actuator by way of a transducer support, wherein the actuator provides rotation of the transducer support relative to a first axis 101 and/or translation of the transducer support; a housing 120 coupled to the transducer that preferably provides rotation of the transducer about a second axis 102 by way of a second actuator, wherein the first axis 101 is different from the second axis 102; a reservoir 130 of coupling medium surrounding a scanning portion of the transducer 110; a window 140, such as a membrane forming a boundary of the reservoir; a positioning portion 150, preferably configured to interface with the window for reliable and repeatable positioning of the scanner assembly relative to the body region of the user; and an electronics subsystem 160 configured to facilitate actuation of the transducer and acquisition of scanning data from the body region of the user” [0019]. As shown in FIG. 9A, the housing 120 is included within a positioning portion 150 (i.e. a brassiere). Therefore, the ultrasound system 100 (i.e. including the housing 120) represents a portable imaging device for imaging biological tissue (i.e. a breast).);
“an enclosure configured to interface with biological tissue” (See housing 120 in combination with the reservoir 130, window 140 and positioning portion 150 in FIG. 1A; and “Additionally or alternatively, the housing 120 and/or any other suitable portion of the system 100 can be configured to provide scanning paths with non-rotational axes of symmetry” [0050]; “The reservoir 130 of coupling medium is configured to surround a scanning portion of the transducer 110, and functions to provide a fluid (e.g., a material with sufficiently low viscosity) that has a high degree of acoustic transparency to provide proper scanning” [0051]; “In relation to the reservoir, the system 100 also preferably includes a window 140 (e.g., rigid or flexible membrane, aperture, etc.), which can optionally be configured to conform to a body region of a user during operation and/or form a boundary of the reservoir. The window is preferably positioned proximal to the cupping region 122 of the housing 120 described above in order to form a boundary of the reservoir, and is preferably retained against a skin surface (or other body surface) of the user in a manner that provides coupling between the ultrasound beam of the transducer 110 and the body of the user, more preferably without producing air gaps or bubbles at the interface between the system and the user (e.g., by defining a concavity configured to accept a user's breast” [0053]. As shown in FIG. 1A, the housing 120 contacts the tissue via the reservoir 130/window 140/positioning portion 150. Therefore, the housing 120 represents an enclosure configured to interface with biological tissue.).
“a linear scanning element including an ultrasound transducer configured to capture image data of the biological tissue of a subject” (See 110 in FIG. 1A and “The scanner assembly includes a transducer 110 coupled to a shaft of an actuator by way of a transducer support, wherein the actuator provides rotation of the transducer support relative to a first axis 101, wherein the transducer 110 functions to emit acoustic waves toward a tissue region of a user, and/or detect signals from the tissue region of the user resulting from interactions between the acoustic waves and the tissue region” [0023]; “In a second variation, the actuator includes a linear actuator configured to translate the transducer (e.g., substantially tangent the user's tissue, substantially normal the central beam axis, substantially parallel the central beam axis, along an axis at an oblique angle to the central beam axis, etc.). For example, the linear actuator can produce radial transducer motion toward and away from one or more axes (e.g., second axis 102, such as described below)” [0027]. Therefore, since the transducer 110 is coupled to a shaft of an actuator and the actuator may include a linear actuator configured to translate the transducer (e.g. substantially tangent the user’s tissue) the transducer 110 represents a linear scanning element including an ultrasound transducer configured to capture image data of the biological tissue of a subject.);
“a scanning surface configured to provide a surface serving as an interface between the scanning element and the biological tissue” (See [0051] and [0053] above. Therefore, since the system 100 includes a window 140 to conform to the body region of a user during operation and/or form a boundary or the reservoir (i.e. 130), the portable imaging device includes a scanning surface configured to provide a surface serving as an interface between the scanning element and the biological tissue.);
“a drive system configured to automatically move the scanning element linearly along the scanning surface, wherein the scanning element is configured to capture the image data as the scanning element is moved along the scanning surface by the drive system” (See [0027] above and “The actuator 114 is preferably a motor powered and/or controlled by elements of the electronics subsystem 160 described below, but can alternatively comprise any other suitable actuator that provides rotation of the transducer 110 about one or more axes and/or translation of the transducer 110 along one or more axes” [0029]; “In addition, volumetric ultrasound images can be acquired by automatically moving the transducer over the surface of the tissue (e.g., in a predefined scan pattern), which can be programmed and controlled electronically. […] The automation of the scan mechanism can enable hands-free operation of the scanner, which can reduce or eliminate operator error, resulting in repeatable imaging of tissue” [0074]. Therefore, since the actuator 114 provides rotation to the transducer support (i.e. shaft/coupler 112) in order to produce motion of the transducer 110 with a desired scanning behavior (i.e. predefined scan pattern/substantially tangent to user’s tissue) and volumetric ultrasound images are acquired by automatically moving the transducer over the surface of the tissue, the device includes a drive system (i.e. actuator 114 connected to the shaft/coupler 112) configured to automatically move the scanning element (i.e. transducer 110) along the scanning surface (i.e. the reservoir 130/window 140), wherein the scanning element is configured to capture the image data (i.e. volumetric images, for example) as the scanning element (i.e. transducer 110) is moved along the scanning surface i.e. the reservoir 130/window 140) by the drive system (i.e. actuator 114 connected to the shaft/coupler 112).);
“an electronics module in data communication with the scanning element and with a computing device interface, the electronics module being configured to receive the image data of the scanning element and to transmit the image data to […] computing device via the computing device interface” (See [0019] and “The electronics subsystem 160 is configured to facilitate actuation of the transducer and/or portions of the housing by one or more actuators and to facilitate acquisition of scanning data from the body region of the user. As such, the electronics subsystem 160 can include one or more of: analog front end (AFE) circuitry, field programmable gate array (FPGA) circuitry, microcontrollers, memory, a linking interface (e.g., wired linking interface 161, such as shown in FIG. 5, wireless linking interface), a power management subsystem, a battery (e.g., non-rechargeable battery, rechargeable battery) interfacing with the power management subsystem, and any other suitable electronics” [0063]; “The system 100 can, however, include any other suitable elements or interface with any other suitable elements that facilitate scanning and/or processing of scanning data. For instance, the system 100 can include or otherwise communicate with computing systems (e.g., cloud computing systems, remote servers, etc.) configured for image processing of data produced by the system 100” [0065].
As shown in FIG. 1A, the electronics subsystem 160 interfaces with an external processing system, such as a mobile computing device (See [0021]), via the wireless linking interface, (See 161 in FIG. 5). Therefore, the electronics subsystem 160 represents an electronics module in data communication with the scanning element (i.e. transducer 110) and with a computing device interface (i.e. mobile computing device, see [0021]; and/or external processing system, such as cloud computing system or remote server, see FIG. 1A), the electronics module being configured to receive the image data of the scanning element and to transmit the image data to a computing device via the computing device interface (i.e. via the wireless linking interface (i.e. 161 in FIG. 5).);
“wherein the computing device operatively receives the image data and presents it to an operator in a processed form” (“Thus, use of a mobile computing device and application can facilitate transfer of image data produced during scanning to a processing system (e.g., cloud computing system, remote server, etc.) for processing and reconstruction of 2D, 3D, and/or 4D (i.e., including time aspects) ultrasound images. Processing can additionally or alternatively include implementation of machine learning techniques to facilitate analysis and/or computer-aided detection of tumors and other tissue abnormalities over time” [0021]. Therefore, the computing device (i.e. processing system, e.g. cloud computing system, remote server) operatively received the image data (i.e. from the electronics module 160) and presents it to an operator in a processed form (i.e. reconstruction of 2D, 3D and/or 4D ultrasound images).).
“wherein the scanning surface forms part of the enclosure, and wherein the enclosure is configured to house the scanning element, the driving system, and the electronics module” (See FIG. 1A and “Furthermore, the electronics subsystem 160 is preferably contained within the housing 120” [0064]. As shown in FIG. 1A, the scanning surface (i.e. reservoir in combination with the window 140) is part of the enclosure (i.e. housing 120). Additionally, housing 120 houses the scanning element (i.e. transducer 110), the driving system (i.e. actuator 114 in combination with the shaft/coupler 112), and the electronics module (i.e. electronics subsystem 160).
However, Saberi does not teach that the computing device is “an integrated computing device” or that the enclosure is configured to house “the computing device”.
Poland is within the same field of endeavor as the claimed invention because it involves a handheld medical scanning device (see FIGS. 1A and 1B).
Poland teaches that the computing device is “an integrated computing device” and that the enclosure is configured to house “the computing device” (“Turning now to FIGS. 1A and 1B, shown therein are various diagrammatic views of a handheld medical scanning device 102, according to aspects of the present disclosure. As illustrated, the handheld medical scanning device 102 may include an imaging element 110, a display 112, a reference mark 116, and a housing 118. The housing 118 may have a length 120, width 121, and depth 122. The display 112 and the imaging element 110 may be disposed on top and bottom faces of the handheld medical scanning device 102, respectively, and may be wholly or partially disposed within the housing 118” [0028]; “A user may issue touch-based instructions on the display 112 to switch between various screens and a home screen, in order to zoom in on one or more regions of an image, e.g., an ultrasound image, which may comprise a 3D ultrasound image” [0040].
In this case, since the display 112 displays an ultrasound image (i.e. which the user can zoom in on, see [0040]), the display 112 represents an integrated computing device which operatively receives the image data (i.e. transmitted from an electronics module in data communication with the scanning element, i.e. imaging element 110) and presents it to an operator in a processed form. Furthermore, as shown in FIG. 1A, the display 112 is disposed within the housing 118 (i.e. enclosure configured to interface with biological tissue). Therefore, the display 112 represents an integrated computing device which is housed within the enclosure.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the portable imaging device of Saberi such that the computing device is an integrated computing device and the enclosure houses the integrated computing device as disclosed in Poland in order to allow a user to easily view ultrasound images without having to look to a separate device. Integrating a computing device (i.e. display) into the same enclosure as a scanning element (i.e. imagine element 110) is one of a finite number of techniques which can be used to allow a user to simultaneously view images of patient tissue the location/position of the scanning element, without having to look in separate locations, with a reasonable expectation of success. Thus, modifying the portable imaging device of Saberi such that the computing device is an integrated computing device and the enclosure houses the integrated computing device as disclosed in Poland would yield the predictable result of allowing a user to easily view ultrasound images without having to look to a separate device.
Regarding claim 2, Saberi in view of Poland discloses all features of the claimed invention as discussed with respect to claim 1 above, and Saberi further teaches “wherein the computing device is in data communication with the electronics module via the computing device interface” (“The system 100 can, however, include any other suitable elements or interface with any other suitable elements that facilitate scanning and/or processing of scanning data. For instance, the system 100 can include or otherwise communicate with computing systems (e.g., cloud computing systems, remote servers, etc.) configured for image processing of data produced by the system 100” [0065]; “As a result, all the required electronics (e.g., analog transmit and receive electronics, low-cost FPGA and microcontroller for digital signal processing and I/O operations, etc.) can be integrated in a small PCB” [0073]. Therefore, since the system 100 can include any other suitable elements that facilitate scanning and/or processing of scanning data obtained by the transducer 110 and all the required electronics (i.e. including microcontroller for digital signal processing and I/O operations) can be integrated in a small PCB, the computing device is an integral computing device in data communication with the electronics module (i.e. electronics subsystem 160) via the computing device interface (i.e. wired or wireless connection, see [0065]).
Regarding claim 4, Saberi in view of Poland discloses all features of the claimed invention as discussed with respect to claim 1 above, and Saberi further teaches “wherein the computing device includes a processor for processing the image data to be presented to the operator in a processed form” (See [0021] as discussed with respect to claim 1 above. Therefore, since the mobile computing device includes a processing system for processing and reconstructing 2D, 3D, and/or 4D ultrasound images, the computing device includes a processor for processing the image data to be presented to the operator in a processed form.).
Regarding claim 5, Saberi in view of Poland discloses all features of the claimed invention as discussed with respect to claim 4 above, and Saberi further teaches “wherein the image data in the processed form includes three-dimensional ultrasound images of the biological tissue based on the image data captured by the scanning element” (See [0021] as discussed in claim 1 above. Therefore, since the mobile computing device receives image data produced during scanning (i.e. by system 100, see FIG. 1A), and includes a processing system for processing and reconstructing 2D, 3D and/or 4D ultrasound images, the image data in the processed form includes three-dimensional ultrasound images (i.e. 3D ultrasound images) of the biological tissue based on the image data captured by the scanning element (i.e. transducer 110).).
Regarding claim 9, Saberi in view of Poland discloses all features of the claimed invention as discussed with respect to claim 1 above, and Saberi further teaches “wherein the electronics module includes an analog front end configured to receive the image data as an output from the scanning element and filter, amplify and/or convert the image data from an analog to digital format” (See [0063] as discussed with respect to claim 1 above. Therefore, the electronics module (i.e. electronics subsystem 160) includes an analog front end (i.e. analog front end (AFE) circuitry) configured to receive the image data as an output from the scanning element (i.e. transducer 110) and filter, amplify and/or convert the image data from an analog to digital format.).
Regarding claim 10, Saberi in view of Poland discloses all features of the claimed invention as discussed with respect to claim 1 above, and Saberi further teaches “wherein the electronics module includes a digital beamformer and, wherein the digital beamformer is an ultrasound beamformer configured to transmit and receive ultrasound waves of the scanning element for improving image data quality” (“Furthermore, variations of a transducer 110 with multiple transducing elements can provide different focal lengths at each scan line and/or can enable beamforming and/or beam steering (e.g., by statically and/or dynamically offsetting the ultrasound phase and/or amplitude emitted from each element). Additionally or alternatively, implementation of a wideband transducer with one or more transducing elements can provide pulse echo data at different frequencies along each scan line, in order to improve axial and/or lateral resolution signal-to-noise ratios (SNRs) at different depths of the tissue body” [0023]. Therefore, in order for the multiple transducing elements of transducer 110 to provide different focal lengths and/or enable beamforming to improve axial and/or lateral resolution signal-to-noise ratios (SNRs) at different depths of the tissue body, the electronics module must include a digital beamformer, and wherein the digital beamformer is an ultrasound beamformer configured to transmit and receive ultrasound waves of the scanning element (i.e. transducer 110) for improving image data quality (i.e. improves SNR at different depths of the tissue body).).
Regarding claim 12, Saberi in view of Poland discloses all features of the claimed invention as discussed with respect to claim 1 above, and Saberi further teaches “including a controller arranged to control the drive system so as to move the scanning element continuously through a range or pre-selected positions to capture the image data, wherein the image data is two-dimensional ultrasound image data” (See [0021], [0027] and [0074] as discussed with respect to claim 1 above. In order for the transducer 110 to move automatically over the surface of the tissue in a predefined scan pattern (see [0074]) corresponding to a desired scanning behavior (see [0027]), the portable imaging device must include a controller arranged to control the drive system (i.e. actuator 114 in combination with shaft/coupler 112) so as to move the scanning element (i.e. transducer 110) continuously through a range or pre-selected positions (i.e. predefined scan pattern) to capture the image data, wherein the image data is two-dimensional ultrasound image data (see [0021]: reconstruction of 2D ultrasound images).).
Regarding claim 13, Saberi in view of Poland discloses all features of the claimed invention as discussed with respect to claim 1 above, and Saberi further teaches “wherein the computing device includes a communications interface for operation of the computing device in a networked environment so as to enable transfer of data between the computing device and one or both of the portable imaging device and a server computer” (See [0021] and [0063] as discussed with respect to claim 1 above. Therefore, the computing device (i.e. cloud computing system, remote server, mobile computing device) includes a communications interface (i.e. wired connection or wireless connection) for operation of the computing device in a networked environment (i.e. linking interface) so as to enable transfer of data between the computing device and one or both of the portable imaging device (i.e. system 100) and a server computer (i.e. mobile computing device).).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saberi et al. US 2017/0311923 A1 “Saberi” in view of Poland US 2021/0315541 A1 “Poland” as applied to claim 1 above, and further in view of Zhang et al. US 2016/0166234 A1 “Zhang”.
Regarding claim 6, Saberi in view of Poland discloses all features of the claimed invention as discussed with respect to claim 1 above, and Saberi further teaches “wherein the scanning surface includes a […] membrane configured to be pressed against a surface of the biological tissue to compress the biological tissue and enable the capture of the image data of a larger area of the biological tissue” (See [0051] and [0053] as discussed in claim 1 above. Therefore, the scanning surface (i.e. reservoir 130 in combination with the window 140) includes a membrane configured to be pressed against a surface of the biological tissue to compress the biological tissue and enable the capture of the image data of a larger area of the biological tissue (i.e. such as a breast).).
Saberi in view of Poland do not teach that the scanning surface includes a “planar mesh”.
Zhang is within the same field of endeavor as the claimed invention because it includes performing an ultrasound scan on compressed breast tissue (see Zhang: [0047]).
Zhang teaches, that the scanning surface includes a “planar mesh” (“In the depicted example, the frame 250 of the paddle 152 includes an open or cutout region 252 in which a mesh material (not shown in FIG. 5), such as a polyester mesh material, may be secured. The mesh material, when so attached may be stretched or taut, may be relaxed or slack, or may be neither stretched or slack (i.e. have substantially zero tension). Thus, the paddle 152 formed from the frame 250 and a mesh material may be formed and applied to patient so as to achieve the desired degree of compression of the breast tissue undergoing imaging” [0050] and “In embodiments employing a mesh compression paddle 152, the mesh structure allows passage of the acoustic gel or lotion to facilitate acoustic coupling of the probe 160 through the paddle 152 and with the breast tissue: [0045]. Therefore, the scanning surface (i.e. of the compression paddle 152) includes a substantially planar mesh.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the scanning surface (i.e. reservoir 130 in combination with the window 140) of Saberi so as to include a planar mesh membrane (i.e. the polyester mesh material) of Zhang so as to facilitate acoustic coupling between the probe and the breast tissue and to achieve a desired degree of compression of the breast tissue (see Zhang: [0050] and [0045]). A substantially planar mesh, like the mesh structure described in Zhang, is one of a finite number of structures which can be used to conform the shape of a biological tissue with a reasonable expectation of success. Modifying the scanning surface (i.e. reservoir 130 in combination with the window 140) of Saberi so as to include the substantially planar mesh membrane (i.e. polyester mesh material) of Zhang would yield the predictable result of facilitating acoustic coupling between the ultrasound probe and the breast tissue and to achieve a desired degree of compression of the breast tissue.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saberi et al. US 2017/0311923 A1 “Saberi” in view of Poland US 2021/0315541 A1 “Poland” as applied to claim 1 above, and further in view of Wang US 2018/0256130 A1 “Wang”.
Regarding claim 7, Saberi in view of Poland discloses all features of the claimed invention as discussed with respect to claim 1 above. However, the combination does not teach “including an optically translucent view panel, configured to provide the operator of the portable imaging device with an unobstructed view of the surface of the biological tissue, and thereby enable the operator to position the portable imaging device at a desired position with reference to the biological tissue to be scanned”.
Wang is within a related field of endeavor to the claimed invention because it involves a breast ultrasound scanning device which allows a technician/operator to observe the “wetting of the breast” to achieve good positioning and contact with the breast (see [0044]).
Wang teaches “including an optically translucent view panel, configured to provide the operator of the portable imaging device with an unobstructed view of the surface of the biological tissue, and thereby enable the operator to position the portable imaging device at a desired position with reference to the biological tissue to be scanned” (“The top cover 107 of housing 102 can be made of a transparent material to allow the operator to visually guide the positioning of pod 101 onto the patient’s breast” [0038] and “FIGS. 5E and 5F are top views illustrating further aspects of a breast ultrasound scanning device and related methods according to some embodiments. These FIGS. illustrate aspects of a view that could be observed by an operator during placement of pod 101 (as shown in FIGS. 1-3) on a patient’s breast. The technician/operator can observe the extent of the “wetting of the breast” to achieve good positioning and contact with the breast. […] A good contact would show that the wet area has no air bubbles. A good positioning would show that the wet area is indeed the desired parts of breast to be scanned. The view might be observed through a window or transparent/translucent portions of the scanning pod e.g. as shown in FIG. 3 […] FIG. 5E illustrates a poorly positioned pod since it includes a “crescent moon” region 530 as well as an air bubble 532. […] FIG. 5F shows a view that might be observed when there are no longer any pod positioning issues or air bubbles that can deteriorate and image, and a high-quality ultrasonic image can be obtained” [0044]. Therefore, since the technician/operator can view the breast through a window or transparent/translucent portions of the scanning pod (see FIG. 3), the device includes an optically translucent view panel, configured to provide the operator of the portable imaging device with an unobstructed view of the surface of the biological tissue (i.e. the breast) and thereby enable the operator to position the portable imaging device at a desired position with reference to the biological tissue to be scanned (i.e. the desired parts of the breast to be scanned).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the portable imaging device of Saberi in view of Poland so as to include the optically translucent view panel (i.e. window or transparent/translucent portion) as disclosed in Wang in order to allow a technician to ensure that there is good contact and positioning between the pod (i.e. containing the ultrasound transducer 110, see FIG. 5E) and the breast such that a high-quality ultrasonic image can be obtained. When there is poor positioning/contact between an ultrasound transducer and the tissue being observed (i.e. the breast, for example), the image quality of ultrasound images declines. A window or transparent/translucent portion is one of a finite number of devices which can be used to ensure good contact/positioning between an ultrasound transducer and a tissue with a reasonable expectation of success. Therefore, modifying the portable imaging device of Saberi to include the optically translucent view panel of Wang would yield the predictable result of allowing a technician to ensure proper contact/positioning between the ultrasound transducer and the tissue (i.e. breast) such that high quality ultrasound images are obtained.
Regarding claim 8, Saberi in view of Poland discloses all features of the claimed invention as discussed with respect to claim 1 above. However, the combination does not teach “including a video capturing device in data communication with the computing device which enables real-time display of the biological tissue on a display of the computing device, and thereby enables the operator to position the portable imaging device at a desired position with reference to the biological tissue being scanned”.
Wang teaches “including a video capturing device in data communication with the computing device which enables real-time display of the biological tissue on a display of the computing device, and thereby enables the operator to position the portable imaging device at a desired position with reference to the biological tissue being scanned” (“According to some embodiments, a wide-angle camera 108 is located on the top cover 107 or elsewhere within pod 101, preferably in the center, to further aid the operator in the positioning of the scanning pod 101 on the patient's breast. This camera 108 is particularly beneficial for prone type of ABUS systems described in more detail below, since the operator does not have a good view of the breast while the patient is being positioned face down” [0038]; “Display 630 can be used to show the operator live view from an internal camera (e.g. camera 108 shown in FIGS. 1 and 2), compression information (e.g. from sensor 120 shown in FIGS. 1-3), and/or images of additional scans by hand-held transducer 640 on areas of axilla and under the nipple or other areas” [0045]. Therefore, since the camera 108 is used to show the operator live view(s) from an internal camera 108 to further aid the operator in positioning the scanning pod 101 on the patient’s breast, the portable imaging device includes a video capturing device in data communication with the computing device which enables real-time display of the biological tissue on a display of the computing device, and thereby enables the operator to position the portable imaging device at a desired position with reference to the biological tissue being scanned.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the enclosure of Saberi in view of Poland such that it further includes a video capturing device (i.e. camera 108) as disclosed in Wang in order to allow an operator to view live images when positioning the enclosure relative to the patient, thereby facilitating proper positioning. Including a video camera (i.e. camera 108, for example) within an enclosure (i.e. housing) is one of a finite number of techniques which can be used to ensure proper placement of the enclosure relative to a patient with a reasonable expectation of success. Thus, modifying the enclosure of Saberi such that it further includes a video capturing device (i.e. camera 108) as disclosed in Wang would yield the predictable result of allowing an operator to properly position the enclosure relative to the patient being examined.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saberi et al. US 2017/0311923 A1 “Saberi” in view of Poland US 2021/0315541 A1 “Poland” as applied to claim 1 above, and further in view of Wang US 2018/0256130 A1 “Wang” and Chiang et al. US 2019/0336101 A1 “Chiang”.
Regarding claim 11, Saberi in view of Poland discloses all features of the claimed invention as discussed with respect to claim 1 above. However, the combination does not teach “including a pair of handles for manually carrying or moving the portable imaging device, wherein at least one of the pair of handles has a switch mechanism incorporated therein for controlling image data capture of the scanning element”.
Wang teaches “including a pair of handles for manually carrying or moving the portable imaging device, wherein at least one of the pair of handles has a switch mechanism incorporated therein [ …]” (“FIG. 1 is a perspective view showing some aspects of a breast ultrasound scanning device and related methods, according to some embodiments. The apparatus of FIG. 1 includes an ultrasound scanning pod 101 which has an outer housing 102. A rotating ultrasonic transducer 110, mounted on or integrated with a rotating template 115, is provided inside housing 102 and is driven by a driving mechanism. […] The pod 101 can be positioned over the patient’s breast by the operator using the attached handles 105 and 106. According to some embodiments, a locking mechanism and a pressure gauge 120 are installed on the supporting arm 103 so that the scanning pod 101 can be locked in place using locking button 150 once satisfactory positioning and contact have been achieved” [0038]. As shown in FIG. 1, the locking button 150 is located on the handle 106. Therefore, the device includes a pair of handles for manually carrying or moving the portable imaging device, wherein at least one of the pair of handles has a switch mechanism incorporated therein.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Saberi in view of Poland so as to include a pair of handles and the switch mechanism (i.e. button 150) of Wang in order to allow a user to easily position the device relative to the tissue of the patient and control the operation thereof once the device is properly positioned relative to the patient’s tissue. A pair of handles is one of a finite number of devices which can be used to control the positioning of an ultrasound transducer with a reasonable expectation of success. Furthermore, one of ordinary skill would have been motivated to incorporate the button to switch between the connected transducers (i.e. thus controlling image data capture of the scanning element, see [0149]) of Chiang into the button on handle 106 of Wang in order to facilitate the capture of high-quality ultrasound images once the device (i.e. pod 101 containing the transducer 110, see FIG. 5F) is in good contact/position with the breast (See Wang: [0044] and FIG. 5F).
Saberi in view of Poland and Wang does not teach that the switch mechanism is “for controlling image data capture of the scanning element”.
Chiang is within the same field of endeavor as the claimed invention because it involves a portable ultrasound system (see [Title]).
Chiang teaches “ the switch mechanism is “for controlling image data capture of the scanning element” (“In some applications, it is necessary to switch among different types of transducers during one ultrasound scanning session. In this case, it is more convenient to have multiple transducers connected to the same ultrasound system and the operator can quickly switch among these connected transducers by hitting a button on the operator console, without having to physically detach and re-attach the transducers, which takes a longer time” [0149]. Therefore, the device includes a switch mechanism (i.e. button) for controlling image data capture of the scanning element (i.e. transducer).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the button 150 of Wang such that it is also used for controlling image data capture of the scanning element (i.e. transducer) as disclosed in Chiang in order to allow a user to easily control when image data capture is performed. Modifying the button 150 of Wang such that it is also used for controlling image data capture of the scanning elements as disclosed in Chiang would yield the predictable result of allowing a user to more easily control when data capture is performed with the transducer (i.e. scanning element.).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SEBASTIAN whose telephone number is (571)272-6190. The examiner can normally be reached Mon.- Fri. 7:30-4:30 (Alternate Fridays Off).
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797