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 .
This Office Action is in response to the amendments dated March 9, 2026.
Claims 1-19 and 22 are pending.
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 present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1-6, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US PGPUB 2020/0214664 – “Zhao”) in view of Moore et al. (US Patent 11,129,586 – “Moore”).
Regarding Claim 1, Zhao discloses:
A system (Zhao FIG. 2, system 200) comprising:
an elongate flexible instrument (Zhao FIG. 2, catheter 202) including
an imaging device (Zhao FIG. 2, image capture probe 226; Zhao paragraph [0047], “the image capture probe 226 may be a sensor probe for use with a imaging technology such as ultrasound”) disposed at a distal end portion of the elongate flexible instrument, the imaging device including a multi-directional imaging array (Zhao FIG.10a, imaging probe 606; Zhao paragraph [0066], “A side-imaging probe generates images of the tissue at a radial distance from the axis of rotation, including tissue located outside of the anatomic passageways. In other embodiments, a forward-looking ultrasound probe may be used to image tissue distal of the imaging transducer.”) and
a localization sensor within the elongate flexible instrument (Zhao FIG. 2, position sensor system 220 and shape sensor system 222; Zhao paragraph [0067], “The position and orientation of the distal end portion 610 may be tracked, as described above, using sensor systems (e.g., position sensor system 220 and/or the shape sensor system 222) interfaced with a tracking system (e.g., tracking system 206).; and
a controller (Zhao FIG. 1, control system 116) comprising one or more processors (Zhao paragraph [0037], “one or more computer processors, which may include the processors of a control system 116”) configured to:
receive orientation data for the distal end portion of the elongate flexible instrument from the localization sensor (Zhao paragraph [0037], “The catheter system 202 optionally includes a sensor system which includes a position sensor system 220 (e.g., an electromagnetic (EM) sensor system) and/or a shape sensor system 222 for determining the position, orientation, speed, pose, and/or shape of the catheter tip at distal end 218 and/or of one or more segments 224 along the body 216”);
based on the orientation data, select a portion of the transducer elements of the multi-directional imaging array to produce a selected imaging plane (Zhao FIG. 10a, imaging probe 606; Zhao paragraph [0066], “the imaging probe is an ultrasound probe. The ultrasound probe may be a side-imaging probe including a rotating ultrasound transducer for imaging in a direction generally perpendicular to the axis of rotation of the transducer.”; Zhao FIG. 10b, image along plane 612 from Zhao FIG. 10a); and
display an image in the selected imaging plane, the image generated by imaging data from the multi-directional imaging array of the imaging device (Zhao FIG. 10b; Zhao paragraph [0068], “FIG. 10b illustrates an image 650 generated by the ultrasound probe 606 in the imaging plane 612 shown in FIG. 10a.”).
Zhao does not explicitly disclose that the multi-directional imaging array is an array of transducer elements, and that a portion of the transducer elements are selected based on the orientation of the distal end of the imaging device.
Moore teaches an array of transducer elements (Moore FIG. 1, array of ultrasound transducers 30), and that a portion of the transducer elements are selected based on the orientation of the distal end of the imaging device (Moore FIG. 7, left ultrasound array 100L and right ultrasound array 100R1; Moore col. 17 lines 6-9, “the processor circuit 805 may select the ultrasound transducer array 100L1 as a candidate on the left side, and the ultrasound transducer array 100R1 as a candidate on the right side of the upper airway 105”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Moore’s array of transducer elements, from which a subset can be selected for use, with the system disclosed by Zhao. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a system that 1) captures a best field of view and 2) if combined, creates a composite image of an area of interest in a perspective volumetric ultrasound image data set for identifying specific patient structures (see Moore col. 17 lines 10-15).
Regarding Claim 2, Zhao in view of Moore teaches the features of Claim 1, as described above.
Zhao further discloses wherein the imaging device includes an ultrasound imaging device (Zhao FIG. 2, image capture probe 226; Zhao paragraph [0047], “the image capture probe 226 may be a sensor probe for use with an imaging technology such as ultrasound”).
Regarding Claim 3, Zhao in view of Moore teaches the features of Claim 1, as described above.
Zhao further discloses wherein the localization sensor includes an optical fiber shape sensor (Zhao FIG. 2, shape sensor system 222; Zhao paragraph [0039], “The optical fiber of the shape sensor system 222 forms a fiber optic bend sensor for determining the shape of the catheter system 202.“).
Regarding Claim 4, Zhao in view of Moore teaches the features of Claim 1, as described above.
Zhao further discloses wherein the localization sensor includes an electromagnetic sensor (Zhao paragraph [0037], “The catheter system 202 optionally includes a sensor system which includes a position sensor system 220 (e.g., an electromagnetic (EM) sensor system)”).
Regarding Claim 5, Zhao in view of Moore teaches the features of Claim 1, as described above.
Zhao further discloses wherein the multi-directional imaging array includes a forward-facing imaging array (Zhao paragraph [0066], “a forward-looking ultrasound probe may be used to image tissue distal of the imaging transducer”).
Regarding Claim 6, Zhao in view of Moore teaches the features of Claim 1, as described above.
Zhao further discloses wherein the multi-directional imaging array includes a first linear transducer set and a second linear transducer set extending orthogonally to the first linear transducer set (Zhao FIG.10a, imaging probe 606; Zhao paragraph [0066], “A side-imaging probe generates images of the tissue at a radial distance from the axis of rotation, including tissue located outside of the anatomic passageways. In other embodiments, a forward-looking ultrasound probe may be used to image tissue distal of the imaging transducer.”).
Regarding Claim 13, Zhao in view of Moore teaches the features of Claim 1, as described above.
Zhao further discloses wherein the one or more processors are further configured to adjust a pose of the distal end portion of the elongate flexible instrument prior to conducting an interventional treatment with an interventional tool extended through an aperture in a distal face of the elongate flexible instrument (Zhao FIG. 4, showing interventional tool 310 extending from flexible body 309 and passing through passageway wall 306 to target structure 302; Zhao paragraph [0053], “The navigation planning module generates or allows the clinician to select a planned deployment location within an anatomical passageway for parking a distal end of the interventional instrument to conduct the interventional procedure.”).
Regarding Claim 14, Zhao in view of Moore teaches the features of Claim 1, as described above.
Zhao further discloses wherein the one or more processors are further configured to register the image in the selected imaging plane to a pre-operative anatomic model (Zhao paragraph [0031], “the display system 111 may display a virtual visualization image in which the actual location of the interventional instrument is registered (e.g., dynamically referenced) with preoperative or concurrent images from the modeled anatomy to present the surgeon S with a virtual image of the internal interventional site at the location of the tip of the interventional instrument”).
Regarding Claim 15, Zhao in view of Moore teaches the features of Claim 1, as described above.
Zhao further discloses wherein the one or more processors are further configured to receive pose data for the distal end portion of the elongate flexible instrument from the localization sensor, the pose data including the orientation data (Zhao FIG. 2, flexible body 216; Zhao paragraph [0037], “catheter system 202 optionally includes a sensor system which includes a position sensor system 220 (e.g., an electromagnetic (EM) sensor system) and/or a shape sensor system 222 for determining the position, orientation, speed, pose, and/or shape of the catheter tip at distal end 218 and/or of one or more segments 224 along the body 216”).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US PGPUB 2020/0214664 – “Zhao”) in view of Moore et al. (US Patent 11,129,586 – “Moore”) and Stigall et al. (US PGPUB 2015/0305710 – “Stigall”).
Regarding Claim 7, Zhao in view of Moore teaches the features of Claim 1, as described above.
Zhao in view of Moore does not explicitly teach wherein the multi-directional imaging array includes a radial transducer array.
Stigall teaches wherein the multi-directional imaging array includes a radial transducer array (Stigall FIG. 5, radial array of ultrasound echo transducers 210).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Stigall’s radial array of ultrasound transducers with the ultrasound transducers taught by Zhao in view of Moore. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an ultrasound probe that attaches to a flex circuit in order to optimize flexibility of the endoscope (see Stigall paragraph [0036]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US PGPUB 2020/0214664 – “Zhao”) in view of Moore et al. (US Patent 11,129,586 – “Moore”) and Ikuma et al. (US PGPUB 2009/0175518 – “Ikuma”).
Regarding Claim 8, Zhao in view of Moore teaches the features of Claim 1, as described above.
Zhao in view of Moore does not explicitly teach wherein selecting the portion of the transducer elements of the multi-directional imaging array to produce the selected imaging plane includes: selectively activating the portion of the transducer elements of the multi-directional imaging array, based on the orientation data; and generating the imaging data in the selected imaging plane with the selectively activated portion of the transducer elements of the multi-directional imaging array.
Ikuma teaches wherein selecting the portion of the transducer elements of the multi-directional imaging array to produce the selected imaging plane includes: selectively activating the portion of the transducer elements of the multi-directional imaging array, based on the orientation data; and generating the imaging data in the selected imaging plane with the selectively activated portion of the transducer elements of the multi-directional imaging array (Ikuma paragraph [0119], “ultrasound observation apparatus 4 reselects the plurality of ultrasound transducers 29a which make a contribution to forming the ultrasound beam, and then transmits further excitation signals. As a result, a 12 o'clock direction in the rectangular ultrasound tomographic image is determined by which ultrasound transducers 29a the ultrasound observation apparatus 4 selects as the 12 o'clock direction to transmit the excitation signals”;. See also Ikuma FIG.29, showing optical image when insertion shape detecting coils 2 and 4 (e.g., detection coils 32 shown in Ikuma FIG. 1) are selected.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Ikuma’s selective use of different ultrasound transducers with the system taught by Zhao in view of Moore. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a system that keeps a generated image in a 12 o’clock orientation relative to movement of the insertion portion of the endoscope (see Okuma FIG. 29).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US PGPUB 2020/0214664 – “Zhao”) in view of Moore et al. (US Patent 11,129,586 – “Moore”), Ikuma et al. (US PGPUB 2009/0175518 – “Ikuma”), and Stigall et al. (US PGPUB 2015/0305710 – “Stigall”).
Regarding Claim 9, Zhao in view of Moore and Ikuma teaches the features of Claim 8, as described above.
Ikuma further teaches wherein the selectively activated set of transducer elements of the multi-directional imaging array includes a first subset of transducer elements and a second subset of transducer elements (Ikuma FIG. 1, showing multiple ultrasound transducers 29a radially positioned around rigid portion 21 of ultrasound endoscope 2).
Although Ikuma teaches different subsets of transducer elements, Zhao in view of Moore and Ikuma does not explicitly teach wherein the first and second subsets of transducer elements are separated from each other on opposite sides of a channel opening on a distal face of the elongate flexible instrument.
Stigall teaches wherein the first and second subsets of transducer elements are separated from each other on opposite sides of a channel opening on a distal face of the elongate flexible instrument (see Examiner-annotated Stigall FIG 6. below, showing opposing first and second subsets of transducer elements in region 600 of ultrasound scanner assembly 110 shown in Stigall FIG. 1).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute Stigall’s radial array of ultrasound transducers for the ultrasound transducers taught by Moore and/or Ikuma in the system taught by Zhao in view of Moore and Ikuma. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an ultrasound probe that attaches to a flex circuit in order to optimize flexibility of the endoscope (see Stigall paragraph [0037]).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US PGPUB 2020/0214664 – “Zhao”) in view of Moore et al. (US Patent 11,129,586 – “Moore”) and Kumata (US PGPUB 2020/0205777 – “Kumata”).
Regarding Claim 10, Zhao in view of Moore teaches the features of Claim 1, as described above.
Zhao in view of Moore does not explicitly teach wherein the one or more processors are further configured to: capture a plurality of images with the multi-directional imaging array and select an image of the plurality of images that is in the selected imaging plane, based on the orientation data.
Kumata teaches wherein the one or more processors are further configured to: capture a plurality of images with the multi-directional imaging array and select an image of the plurality of images that is in the selected imaging plane, based on the orientation data (Kumata FIG. 2, curvature portion 212 of ultrasound endoscope 2 shown in Kumata FIG. 1, and ultrasound transducer 7; Kumata paragraph [0005], “an ultrasound endoscope includes: a distal end portion that is provided on a distal end of an insertion portion to be inserted into a subject; a curvature portion that is connected to a proximal end side of the distal end portion in the insertion portion, and is capable of being curved in two directions orthogonal to each other”; Examiner interprets Kumata’s system that aims the ultrasound transducer in orthogonal planes as teaching an imaging array that captures a plurality of images based on the orientation of the endoscope).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Kumata’s positionable transducer with the system taught by Zhao in view of Moore. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope capable of targeting specific areas of interest with ultrasound energy.
Regarding Claim 11, Zhao in view of Moore teaches the features of Claim 1, as described above.
Zhao in view of Moore does not explicitly teach wherein the selected imaging plane has a parallel orientation to a longitudinal axis of an anatomic passageway in which the elongate flexible instrument extends.
Kumata teaches wherein the selected imaging plane has a parallel orientation to a longitudinal axis of an anatomic passageway in which the elongate flexible instrument extends (Kumata FIG. 2, curvature portion 212 of ultrasound endoscope 2 shown in Kumata FIG. 1, and ultrasound transducer 7; Kumata paragraph [0005], “an ultrasound endoscope includes: a distal end portion that is provided on a distal end of an insertion portion to be inserted into a subject; a curvature portion that is connected to a proximal end side of the distal end portion in the insertion portion, and is capable of being curved in two directions orthogonal to each other”; Examiner interprets Kumata’s system that aims the ultrasound transducer in orthogonal planes as teaching an imaging array that captures a images of an area of interest that are parallel to the longitudinal axis of the passageway in which the elongate flexible instrument extends).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Kumata’s positionable transducer with the system taught by Zhao in view of Moore. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope capable of targeting specific areas of interest with ultrasound energy.
Regarding Claim 12, Zhao in view of Moore teaches the features of Claim 1, as described above.
Zhao in view of Moore does not explicitly teach wherein the selected imaging plane has a parallel orientation to a longitudinal axis of a portion of the elongate flexible instrument proximal of the distal end portion.
Kumata teaches wherein the selected imaging plane has a parallel orientation to a longitudinal axis of a portion of the elongate flexible instrument proximal of the distal end portion (Kumata FIG. 2, curvature portion 212 of ultrasound endoscope 2 shown in Kumata FIG. 1, and ultrasound transducer 7; Kumata paragraph [0005], “an ultrasound endoscope includes: a distal end portion that is provided on a distal end of an insertion portion to be inserted into a subject; a curvature portion that is connected to a proximal end side of the distal end portion in the insertion portion, and is capable of being curved in two directions orthogonal to each other”; Examiner interprets Kumata’s system that aims the ultrasound transducer in orthogonal planes as teaching an imaging array that captures a images of an area of interest that are parallel to the elongate flexible instrument).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Kumata’s positionable transducer with the system taught by Zhao in view of Moore. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope capable of targeting specific areas of interest with ultrasound energy.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US PGPUB 2020/0214664 – “Zhao”) in view of Moore et al. (US Patent 11,129,586 – “Moore”) and Vrba et al. (US PGPUB 2019/0069949 – “Vrba”).
Regarding Claim 16, Zhao in view of Moore teaches the features of Claim 1, as described above.
Zhao in view of Moore does not explicitly teach wherein the one or more processors are further configured to display at least one guidance marker to guide motion of the distal end portion of the elongate flexible instrument into an apposition position.
Vrba teaches wherein the one or more processors are further configured to display at least one guidance marker to guide motion of the distal end portion of the elongate flexible instrument into an apposition position (Vrba FIG. 42A, radiopaque marker bands 4210; Vrba paragraph [0014], “radiopaque markers are located at a distal end of the neuromodulation system to aid in delivery and alignment of the neuromodulation system”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Vrba’s markers with the system taught by Zhao in view of Moore. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an ultrasound treatment system that uses known markers on the treatment catheter to guide the treatment catheter to the target site (see also Vrba paragraph [0636]).
Regarding Claim 17, Zhao in view of Moore and Vrba teaches the features of Claim 16, as described above.
Vrba further teaches wherein the at least one guidance marker includes an extension marker (Vrba paragraph [0540], “In some embodiments, one or more of the transducers are radiopaque or the ultrasound catheter comprises separate radiopaque markers to facilitate assessment of positioning.”) for guiding an extension of the distal end portion and an apposition marker (Vrba paragraph [0540], “the sensing or visualization apparatus may comprise angiographic markers that define margins of the blood vessel”) for guiding bending the distal end portion into the apposition position.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Vrba’s catheter markers and angiographic markers with the system taught by Zhao in view of Moore and Vrba. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a system that uses redundant markers (catheter markers and angiographic markers) to ensure proper positioning of an ultrasound catheter.
Claims 18-19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US PGPUB 2020/0214664 – “Zhao”) in view of Algawi et al. (US PGPUB 2021/0196315 – “Algawi”) and Moore et al. (US Patent 11,129,586 – “ Moore”).
Regarding Claim 18, Zhao discloses:
A method comprising:
receiving orientation data for a distal end portion of the elongate flexible instrument from the localization sensor extending within the elongate flexible instrument (Zhao paragraph [0037], “The catheter system 202 optionally includes a sensor system which includes a position sensor system 220 (e.g., an electromagnetic (EM) sensor system) and/or a shape sensor system 222 for determining the position, orientation, speed, pose, and/or shape of the catheter tip at distal end 218 and/or of one or more segments 224 along the body 216”);
based on the orientation data, selecting transducer elements disposed at a distal end of the elongate flexible instrument to produce a selected imaging plane (Zhao FIG. 10a, imaging probe 606; Zhao paragraph [0066], “the imaging probe is an ultrasound probe. The ultrasound probe may be a side-imaging probe including a rotating ultrasound transducer for imaging in a direction generally perpendicular to the axis of rotation of the transducer.”; Zhao FIG. 10b, image along plane 612 from Zhao FIG. 10a); and
displaying an image in the selected imaging plane, the image generated by imaging data from the multi-directional imaging array of the imaging device (Zhao FIG. 10b; Zhao paragraph [0068], “FIG. 10b illustrates an image 650 generated by the ultrasound probe 606 in the imaging plane 612 shown in FIG. 10a.”).
Zhao does not explicitly disclose the localization sensor extending within the elongate flexible instrument.
Algawi teaches the localization sensor extending within the elongate flexible instrument (Algawi FIG. 1, position sensor 50 within probe 39; Algawi paragraph [0014], “position sensor, which is attached to an inner wall of a distal end of the cannula”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Algawi’s inner position sensor with the method taught by Zhao. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that positions a transducer in a manner that minimizes the size of the cannula used to create the image.
Zhao in view of Algawi does not explicitly teach based on the orientation data, selecting a portion of transducer elements to produce a selected imaging plane.
Moore teaches based on the orientation data, selecting a portion of transducer elements to produce a selected imaging plane (elements (Moore FIG. 1, array of ultrasound transducers 30; Moore FIG. 7, left ultrasound array 100L and right ultrasound array 100R1; Moore col. 17 lines 6-9, “the processor circuit 805 may select the ultrasound transducer array 100L1 as a candidate on the left side, and the ultrasound transducer array 100R1 as a candidate on the right side of the upper airway 105”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Moore’s array of transducer elements, from which a subset can be selected for use, with the method taught by Zhao in view of Algawi A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a system that 1) captures a best field of view and 2) if combined, creates a composite image of an area of interest in a perspective volumetric ultrasound image data set for identifying specific patient structures (see Moore col. 17 lines 10-15).
Regarding Claim 19, Zhao in view of Algawi and Moore teaches the features of Claim 18, as described above.
Moore further teaches receiving ultrasound imaging data from the multi-directional imaging array (Moore col. 12 lines 42-67, “FIG. 7A is a perspective view of a patient's 15 head and neck with right ultrasound transducer array 100R1 and left ultrasound transducer array 100L separated from one another on opposing sides of the upper airway 105. The ultrasound transducer arrays 100R1 and 100L are separated from one another so that the transmitted ultrasound beams generated therefrom travel in directions which intersect one another. In other words, in some embodiments according to the invention, the first and second ultrasound transducer arrays 100R1 and 100L are decoupled from one another so that they may be positioned independently to provide acceptable imaging of the upper airway 105.”).
Regarding Claim 22, Zhao in view of Algawi and Moore teaches the features of Claim 18, as described above.
Zhao further discloses wherein the localization sensor includes an optical fiber shape sensor (Zhao FIG. 2, shape sensor system 222; Zhao paragraph [0039], “The optical fiber of the shape sensor system 222 forms a fiber optic bend sensor for determining the shape of the catheter system 202.“).
Response to Arguments
Applicant’s arguments, see page 6, filed March 9, 2026, with respect to the objection to Claims 1, 8, and 18 have been fully considered and are persuasive in view of the present amendments. The objection to Claims 1, 8, and 18 has been withdrawn.
Applicant’s arguments, see page 6, filed March 9, 2026, with respect to the rejection of Claims 1 and 18 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of Claims 1 and 18 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see pages 7-8, filed March 9, 2026, with respect to the rejection(s) of claim(s) 1-6, 13-16, 18-19 and 22 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection under 35 U.S.C. 103 is made in view of Moore et al. (US Patent 11,129,586 – “Moore”).
More specifically, Applicant argues that Zhao et al. (US PGPUB 2020/0214664 – “Zhao”) fails to explicitly disclose the newly-claimed feature of the imaging device including a multi-directional imaging array of transducer elements. Examiner agrees. However, newly-cited Moore teaches an array of transducer elements (Moore FIG. 1, array of ultrasound transducers 30), and that a portion of the transducer elements are selected based on the orientation of the distal end of the imaging device (Moore FIG. 7, left ultrasound array 100L and right ultrasound array 100R1; Moore col. 17 lines 6-9, “the processor circuit 805 may select the ultrasound transducer array 100L1 as a candidate on the left side, and the ultrasound transducer array 100R1 as a candidate on the right side of the upper airway 105”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Moore’s array of transducer elements, from which a subset can be selected for use, with the system disclosed by Zhao. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a system that 1) captures a best field of view and 2) if combined, creates a composite image of an area of interest in a perspective volumetric ultrasound image data set for identifying specific patient structures (see Moore col. 17 lines 10-15).
As such, all pending Claims 1-19 and 22 stand rejected under 35 U.S.C. 103.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
5/15/26
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