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
Claims 5-6 are cancelled, and claims 1-4 and 7-16 remain pending in the application in response to the applicant’s amendments to the rejections previously set forth in the Non-Final Office Action mailed 04/08/2026.
Response to Arguments
Applicant’s arguments filed 07/08/2026 with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Given the amendments to claim 1, reference to Costa is being relied upon to teach dependent claims 2, 11-12, and 16 more-consistently with the instant claim language, as shown below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 9, 11-12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Costa (US 20110055447 A1, published March 3, 2011) in view of Liu (US 20160213398 A1, published July 28, 2016), from IDS, hereinafter referred to as Costa and Liu, respectively.
Regarding claim 1, Costa teaches an ultrasound system (Fig. 1), comprising:
a case configured to removably hold a handheld computer (Fig. 1; see para. 0032-0033 – “In the embodiment of FIG. 1, the hand held device is a smartphone, in particular an iPhone 100, being a smartphone device manufactured by Apple, Inc. The iPhone 100 [handheld computer] is releasably held within a docking assembly 101 [case].”), the case comprising:
a posterior opening configured to align with a camera of the handheld computer (see para. 0032-0033 – “In the embodiment of FIG. 1, the hand held device is a smartphone, in particular an iPhone 100, being a smartphone device manufactured by Apple, Inc. The iPhone 100 [handheld computer] is releasably held within a docking assembly 101 [case].”; see para. 0103 – “In order for camera functionality to continue to be provided a camera lens must remain unobscured.” Where the case must have an opening aligned with the iPhone’s camera for the camera lens to remain unobscured);
an anterior opening configured to align with a display of the handheld computer (Fig. 2 and 6; see para. 0032-0033 – “In the embodiment of FIG. 1, the hand held device is a smartphone, in particular an iPhone 100, being a smartphone device manufactured by Apple, Inc. The iPhone 100 [handheld computer] is releasably held within a docking assembly 101 [case].”; see para. 0078 – “The hand held device includes a user interface 517. In the case of the preferred iPhone, this is a touch screen and associated software. The touch screen is the display screen 516.” Where the case must have an opening aligned with the iPhone’s display for the touchscreen display to be utilized); and
a rechargeable battery positioned in the case opposite of the anterior opening (Fig. 2; see para. 0036 – “The iPhone includes as standard a connector enabling it to be connected to external devices, to a docking cradle and to a battery charging facility.”; see para 0051 – “The primary dock [of docking assembly 101, case] includes a secondary battery 203. The battery 203 may be a fixed part of the dock or it may be removable.”);
a probe head coupled to the case, the probe head coupling to the handheld computer when the handheld computer is held in the case (Fig. 1, probe unit 105 (probe head) connected to device 100 (handheld computer) and docking assembly 101 (case); see para. 0053 – “FIG. 3 shows a further view of the partially exploded dock assembly [case]. It can be seen that the dock incorporates a connector 102, on the inside of the dock. This is adapted to connect to the standard connector 301 provided on the hand held device 100 [handheld computer]. This connection provides a data connection between the hand held device and dock and the probe [probe head] attached to the dock.”).
Costa teaches a probe head (Fig. 1, probe unit 105) with an ultrasound transducer (Fig. 1, ultrasonic transducer 106), but does not explicitly teach where the probe head includes an array of transducers, and the probe head is connected to a needle-guide holder and a needle guide.
Whereas, Liu, in an analogous field of endeavor, teaches the probe head including an array of transducers and a needle-guide holder; and a needle guide coupled to the needle-guide holder (Fig. 3, probe head 21, where it is inherent and known in the art for a handheld probe to include an array of transducers; see para. 0015 "In this embodiment the needle positioning aid element 40 includes a body 41 [needle guide holder] fixed on the ultrasound detection device 20 [probe head] and a positioning aid support portion 42 [needle guide] at one side of the body 41 remote from the ultrasound detection device 20.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe head, as disclosed in Costa, by having a needle holder connected to the probe head, as disclosed in Liu. One of ordinary skill in the art would have been motivated to make this modification in order to perform blood vessel puncturing operation while the user is directly looking at the blood vessel image, thereby improving operation precision and reliability, as taught in Liu (see para. 0020).
Furthermore, regarding claim 2, Costa further teaches wherein the probe head is removable from the case, further comprising a secondary probe head configured to be coupled to the case (Fig. 6; see para. 0066 – “Physical connection of the probe unit 502 [probe head] to the dock assembly 501 [case] is via probe connector 530. communications cable 510 and dock probe connector 511. The connectors may be fixed connections or they may be plug and socket connections.” So a second probe head can be connected to the case).
Furthermore, regarding claim 9, Liu further teaches wherein the probe head is coupled to the case via a joint to permit the probe head to articulate about the joint when moving the probe head over a skin surface of a patient (Fig. 1, probe head 20 connected to display 30 (case) via joint (hinges 23 and 31)).
Furthermore, regarding claim 11, Costa further teaches wherein the case further comprises one or more side buttons to switch among various functions or modes of the portable ultrasound system (Fig. 2; see para. 0048 – “The docking assembly also includes a supplementary user interface 108. This allows for additional or more convenient control to that provided by the user interface of the iPhone.”).
Furthermore, regarding claim 12, Costa further teaches wherein the probe head includes a wireless module configured to communicate information from the probe head to the handheld computer (see para. 0039 – “In a further embodiment, the connector 102 is absent, and the data connection from the docking system [case] to the hand held device [handheld computer] is provided by wireless connection.”; see para. 0041 – “In other embodiments, data connection to the probe unit [probe head] may be provided by a wireless connection.”).
Furthermore, regarding claim 16, Costa further teaches wherein the handheld computer is a smartphone including one or more programs or modules, the one or more programs or modules driving the array of ultrasonic transducers and processing reflected ultrasound signals into ultrasound images for the display (see para. 0059 – “The transducer is driven by transmit/receive electronics 606. These electronics provide the appropriate electrical signals to drive the transducer, and receive the electrical signals returned from the transducer.”; see para. 0073 – “The scanline data is passed to the iPhone. The iPhone has an iPhone processor which runs an ultrasound software application 515.”).
The motivation for claim 9 was shown previously in claim 1.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Costa in view of Liu, as applied to claim 1, and in further view of Hagy et al. (US 20140275990 A1, published September 19, 2014), hereinafter referred to as Hagy.
Regarding claim 3, Costa in view of Liu teaches all of the elements disclosed in claim 1 above.
Costa in view of Liu teaches a camera of the handheld computer (Costa: see para. 0032 – “In the embodiment of FIG. 1, the hand held device is a smartphone, in particular an iPhone 100 [handheld computer], being a smartphone device manufactured by Apple, Inc.”; see para. 0103 – “In order for camera functionality to continue to be provided a camera lens must remain unobscured.”), but does not explicitly teach where the camera is configured to capture graphical data and textual data including technical details of a needle.
Whereas, Hagy, in an analogous field of endeavor, teaches wherein the camera of the handheld computer is configured to capture graphical data and textual data including technical details of a needle to be used with the ultrasound system (Fig. 2A; see para. 0040 "As the needle assembly passes an optical sensor located, for example, on the post 204, it can be read by the sensor (with rotation of the assembly, if necessary) and the information can be sent to the processor.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a camera of a handheld computer, as disclosed in Costa in view of Liu, by having the camera configured to capture graphical data and textual data including technical details of a needle, as disclosed in Hagy. One of ordinary skill in the art would have been motivated to make this modification in order to accurately determine a characteristic distance of the probe assembly, for instance the distance from the center of the target to the tip of the probe, which can then be used to accurately correlate the location of the probe tip as determined by the probe detection system with the actual location of the probe tip in the subdermal environment, as taught in Hagy (see para. 0029).
Furthermore, regarding claim 4, Hagy further teaches wherein the textual data is obtained from one-dimensional or two-dimensional barcodes (see para. 0040 "For example, in one embodiment the tag may be an optical tag, and can utilize optical methods including, without limitation, QR- or Bar-code, color coding, etc. By way of example, a bar code can be printed on the target, the needle hub, the syringe, or any other suitable component of the probe assembly.").
The motivation for claim 4 was shown previously in claim 3.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Costa in view of Liu, as applied to claim 1 above, and in further view of Bonutti et al. (US 20210353785 A1, published November18, 2021 with a priority date of April 15, 2020), hereinafter referred to as Bonutti.
Regarding claim 7, Costa in view of Liu teaches all of the elements disclosed in claim 1 above.
Costa in view of Liu teaches a case, but does not explicitly teach where the case includes a knob.
Whereas, Bonutti, in an analogous field of endeavor, teaches wherein the case further comprises a handle selected from the group consisting of a knob, one or more finger loops, and an adjustable strap (Fig. 2; see para. 0037 "The UVC device may be part or integrally formed with another device attachable to the phone/tablet or phone/tablet case 111, such as a grip and/or stand device 113 (e.g., a POPSOCKET device sold by PopSockets) [knob]...").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a case, as disclosed in Costa in view of Liu, by having the case include a knob, as disclosed in Bonutti. One of ordinary skill in the art would have been motivated to make this modification in order to facilitate holding the phone in the user's hand or propping the phone on a surface, as taught in Bonutti (see para. 0037).
Furthermore, regarding claim 8, Bonutti further teaches wherein the handle is a knob configured to reside in a compartment in the case and extend out of the case when ready for use (Fig. 2; see para. 0037 "The UVC device may be part or integrally formed with another device attachable to the phone/tablet or phone/tablet case 111, such as a grip and/or stand device 113 (e.g., a POPSOCKET device sold by PopSockets) [knob]...").
The motivation for claim 8 was shown previously in claim 7.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Costa in view of Liu, as applied to claim 1 above, and in further view of Hopkins (US 20110320143 A1, published December29, 2011), hereinafter referred to as Hopkins.
Regarding claim 10, Costa in view of Liu teaches all of the elements disclosed in claim 1 above, and
Costa further teaches wherein the case further comprises a button (Fig. 2; see para. 0048 – “The docking assembly also includes a supplementary user interface 108 [button]. This allows for additional or more convenient control to that provided by the user interface of the iPhone.”).
Costa in view of Liu teaches a button on a case, but does not explicitly teach where the button is configured to switch between longitudinal and transverse scanning.
Whereas, Hopkins, in an analogous field of endeavor, teaches wherein the case further comprises a button configured to switch between longitudinal and transverse scanning when the array of ultrasonic transducers is a 2-dimensional ("2D") array of ultrasonic transducers (Fig. 1, probe switch 12 as button; see para. 0019 "The piezoelectric element may consist of a number of elements as used in a phased array..." where a 2D array of ultrasound transducers is known in the art; see para. 0037 "Pressing the probe switch 12 or the START button on the monitor screen starts the transverse scan...After having obtained the transverse scan, the sagittal scan can then be obtained manually when the operator rotates the probe 90° to the previous scan and repeats the process of scanning [pressing probe switch 12 again]
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a button on a case, as disclosed in Costa in view of Liu, by having the button configured to switch between longitudinal and transverse scanning, as disclosed in Hopkins. One of ordinary skill in the art would have been motivated to make this modification in order to calculate for the bladder volume using the transverse and sagittal frame images stored showing the bladder with the maximum area, as taught in Hopkins (see para. 0038).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Costa in view of Liu, as applied to claim 1, and in further view of Ikeda et al. (US 20150223774 A1, published August 13, 2015), hereinafter referred to as Ikeda.
Regarding claim 13, Costa in view of Liu teaches all of the elements disclosed in claim 1 above.
Costa in view of Liu teaches a probe, but does not explicitly teach where the probe includes magnetic sensors.
Whereas, Ikeda, in an analogous field of endeavor, teaches wherein the probe head includes an array of magnetic sensors configured to detect changes in a magnetic field to assist with guidance of a magnetized needle (Fig. 9 and 11; see para. 0065 "The position/direction analyzing unit 58 and the coordinate conversion unit 59 specifies the guideline of the puncture needle 28 and the position of the needlepoint by converting the moving distance and the moving direction of the puncture needle 28 into the 3-dimensional positional coordinate based on the detected signals from the first magnet sensor 36 and the second magnet sensor 70.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a probe, as disclosed in Costa in view of Liu, by including to the probe magnetic sensors, as disclosed in Ikeda. One of ordinary skill in the art would have been motivated to make this modification in order to improve the accuracy of needle placement, as taught in Ikeda (see para. 0062-0063).
Furthermore, regarding claim 14, Ikeda further teaches wherein the array of magnetic sensors is configured to convert magnetic signals from the needle into electronic signals, and wherein the handheld computer is configured to process the electronic signals into distance and orientation information for an iconographic representation of the needle on the display during the on-screen guidance (Fig. 9 and 11; see para. 0065 "The position/direction analyzing unit 58 and the coordinate conversion unit 59 specifies the guideline of the puncture needle 28 and the position of the needlepoint by converting the moving distance and the moving direction of the puncture needle 28 into the 3-dimensional positional coordinate based on the detected signals from the first magnet sensor 36 and the second magnet sensor 70. Then the coordinate conversion unit 59 transmits the guideline of the puncture needle 28 and the positional information of the needlepoint to the composition unit 52. The composition unit 52 displays the guideline of the puncture needle and the position of the needlepoint on the image display unit 56 based on the received positional information.").
The motivation for claim 14 was shown previously in claim 13.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Costa in view of Liu and Ikeda, as applied to claim 14 above, and in further view of Swan et al. (US 20200390416 A1), from IDS, hereinafter referred to as Swan.
Regarding claim 15, Costa in view of Liu and Ikeda teaches all of the elements disclosed in claim 14 above.
Costa in view of Liu and Ikeda teaches a screen displaying a needle within an ultrasound image (Liu: see para. 0020 ...display images detected by the probe head 21 to allow the user to directly and intuitively judge the blood vessel position. Then the puncturing needle 11 can be positioned via the aid of the needle positioning aid element 40 to perform blood vessel puncturing operation while the user is directly looking at the blood vessel image..."), but does not explicitly teach notifying if the needle is not expected to intersect with a cross section of an anatomical target in accordance with the distance and orientation information.
Whereas, Swan, in an analogous field of endeavor, teaches wherein the handheld computer is configured to generate notifications selected from haptic feedback, visual notifications on the display screen, and aural notifications through a speaker of the handheld computer if the needle is not expected to intersect with a cross section of an anatomical target in accordance with the distance and orientation information (Fig. 7; see para. 0045 "At step 740, the ultrasound imaging system may determine one or more high-confidence areas for where an inserted needle may intersect the first plane. The determining may be based on the ultrasound image and information regarding the out of plane needle insertion. At step 750, the ultrasound imaging system may display one or more on-screen markers corresponding to the one or more high-confidence areas in conjunction with the plurality of ultrasound images on the display.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified teaches a screen displaying a needle within an ultrasound image, as disclosed in Costa in view of Liu and Ikeda, by also notifying if the needle is not expected to intersect with a cross section of an anatomical target in accordance with the distance and orientation information, as disclosed in Swan. One of ordinary skill in the art would have been motivated to make this modification in order to provide providing additional feedback to the operator on not only where the needle should intersect the ultrasound image plane, but also where it could intersect, as taught in Swan (see para. 0047).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Damjanovic (US 20140343406 A1, published November 20, 2014) discloses a main body portion attached to an ultrasound probe, an adjustable arm member attached to the main body member, and a needle mount attached to the arm member.
Ogle et al. (U S5817024 A, published October 6, 1998) discloses a transducer array mounted in a hand-held enclosure, with an integrated circuit transceiver connected to the elements of the array for the reception of echo signals. A digital beamformer is located in the hand-held enclosure for forming ultrasonic scanlines from the echo signals received by the elements of the array.
Mauldin, Jr. et al. (US 20180153513 A1, published June 7, 2018) discloses a display can be connected to housing via a pivot, which can allow a rotatable display to rotate about at least one rotational axis; and a cover comprises a sleeve, which is being used to house a needle. The sleeve can be configured to control the angle of a needle to be inserted at the target region (Fig. 7).
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 Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.C./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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