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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10 Jul 2026 has been entered.
Response to Arguments
Applicant’s arguments, see pg. 4, filed 10 Jul 2026, with respect to the 35 U.S.C. 112(a) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(a) rejections of 12 May 2026 have been withdrawn in view of the amended claims.
Applicant’s arguments, see pg. 4-6, filed 10 Jul 2026, with respect to the 35 U.S.C. 103 rejections have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument. See the 35 U.S.C. 103 rejections with a new prior art presented below.
Applicant’s arguments, see pg. 6, filed 10 Jul 2026, with respect to the Double Patenting rejections have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument. See the Double Patenting rejections with a new prior art presented below.
Status of Claims
Claims 11-25 are currently under examination. No claim has been cancelled, added, nor withdrawn since the Final Office Action of 12 May 2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “one or more motors to provide rotational movement to the imaging probe about an elongate axis of the imaging probe” in claim 11 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 11 is objected to because of the following informality:
“the base comprising one or more motors” should read “the base further comprising one or more motors” (claim 11).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 24 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 recites the limitation “a common base, the common base comprising the arm and the carriage”. It is unclear whether the “common base” recited in the limitation is the same or different from newly recited “base” recited in claim 11, to which claim 24 depends. For the purposes of the examination, “common base” in the limitation is being given a broadest reasonable interpretation to be the same as the “base” in claim 11 in light of the specification of the instant application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11-17, 22, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US PG Pub No. 2014/0243677) – hereinafter referred to as Johnson – in view of Aljuri et al. (WIPO Pub No. WO2015/035249, provided by the Applicant in the IDS of 06 Dec 2024 and the copy relied on previously provided in the Non-Final Office Action of 01 Oct 2025) – hereinafter referred to as Aljuri – and ACMIT Gmbh (AT 519168, a machine translation relied upon attached to this Office action) – hereinafter referred to as ACMIT.
Regarding claims 11 and 24, Johnson discloses an imaging system (at least Fig. 3) to image tissue of a patient ([0040]: probe tip assembly 10 and ultrasound probe 12 used in conjunction and ultrasound probe 12 is used to generate diagnostic images of a tissue) comprising:
an imaging probe (Fig. 2-3: ultrasound probe 12; [0040]: probe 12 used to generate diagnostic images) configured to be inserted in the patient ([0023]: probe introduced in a sterile manner into a patient);
a stiff sheath (Fig. 1, 3: probe tip assembly 10; [0042]: body 22 of assembly 10 formed of rigid plastic) comprising an internal channel sized to receive the imaging probe (Fig. 3 and [0042]: body 22 of assembly 10 defines or surrounds a cavity for receiving at least a portion of the probe 12 therein);
a seal (Fig. 4: mechanism 28; [0044]: mechanism 28 seals assembly 10 and probe 12) configured to decrease leakage of fluid from an interior of the stiff sheath ([0046]: mechanism 28 creates a compression seal to the probe tip sealing surface in order to retain the fluid within the probe tip assembly 10);
a fluid removal line (Fig. 1, 4: tubing 32a,b, ports 30 a,b, vent 34) configured to remove fluid from the internal channel ([0053]: fluid flows through tubes 32 a,b via ports 30 a,b into cavity of assembly 10 then exits via vent 34 at distal end 22b of assembly 10; [0047]: one of ports 30a,b is an outlet port from the cavity of the probe tip assembly 10),
the fluid removal line extending to one or more openings (Fig. 1: vent 34) within and located on an upper side of the internal channel to receive air bubbles (Fig. 1: vent 34 would be on "upper side" when assembly 10 is rotated 180 deg; [0048]: air vent 34 located at or near distal end 22b of assembly 10 in the form of a valve, a threaded screw, or any other means through which only air can flow; [0053]: air is forced out of vent 34),
the one or more openings (Fig. 1: vent 34) configured to be located near a distal tip of the imaging probe when the imaging probe is inserted into the stiff sheath (Fig. 1 and [0048]: air vent 34 located at or near distal end 22b of assembly 10 in the form of a valve, a threaded screw, or any other means through which only air can flow; Fig. 3 and [0053]: closure of vent 34 to create airless environment surrounding transducer 14 of probe 12).
wherein the imaging probe (Fig. 2-3: ultrasound probe 12) is removable from the stiff sheath (Fig. 1, 3: ultrasound probe 12 decoupled from probe tip assembly 10).
Johnson does not explicitly disclose:
a base comprising an arm and a carriage,
the arm configured to couple to a proximal end of the stiff sheath,
the carriage configured to couple to the imaging probe to allow translation and rotation of the imaging probe relative to the carriage and relative to the stiff sheath, and
the base comprising one or more motors to provide rotational movement to the imaging probe about an elongate axis of the imaging probe.
In the same field of endoscopic ultrasound imaging, Aljuri, however, teaches:
a base (Fig. 49-50: fixed support) comprising an arm and a carriage (see annotated Fig. 50 below):
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the arm (see annotated Fig. 50 above) configured to couple to a proximal end of the stiff sheath (see annotated Fig. 50 above: “arm” at proximal end of stiff sheath); and
the carriage (see annotated Fig. 50 above) configured to couple to the imaging probe to allow translation and rotation of the imaging probe relative to the carriage and relative to the stiff sheath (Fig. 49-50: TRUS probe can be translated as well as rotated about sheath and fixed support as the probe fits into the openings of both the sheath and the fixed support - the opening of the stiff sheath and the opening of the fixed support that are aligned at where TRUS probe enters the stiff sheath).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson’s imaging system to include Aljuri’s arm and carriage. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., coupling the sheath to a base comprising an arm and a carriage, as disclosed by Aljuri), and the combination would have yielded a reasonable expectation of success since both Johnson and Aljuri are directed to an endoscopic ultrasound imaging in which an ultrasound probe is movable relative to a stiff sheath. The motivation for the combination would have been to allow “positioning and fixating the sheath, such that a plurality of instruments and instrument delivery systems can be interchanged without the frame of reference changing”, as taught by Aljuri ([00422]).
In the same field of endoscopic ultrasound imaging, ACMIT further teaches:
a base (Fig. 1-5: motor unit 7) comprising one or more motors (Fig. 3-4: electric motor 18) to provide rotational movement to the imaging probe (Fig. 1-5: ultrasonic probe 2) about an elongate axis of the imaging probe ([15]: motor arranged in the motor unit causes a rotation of the ultrasound probe about the longitudinal axis of the same).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson’s imaging system to include ACMIT’s motor for rotational movement of the imaging probe. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing a base with a motor for rotational movement of the ultrasound probe, as disclosed by ACMIT), and the combination would have yielded a reasonable expectation of success since both Johnson and ACMIT are directed to an endoscopic ultrasound imaging. The motivation for the combination would have been to automate the “rotation of the ultrasound probe about its longitudinal axis in order to rotate and/or scan the probe relative to the organ to be examined … to form a three-dimensional image (of the organ to be examined)”, as taught by ACMIT ([06]).
Regarding claim 12, Johnson in view of Aljuri and ACMIT discloses all limitations of claim 11, as discussed above, and Johnson further discloses:
wherein the seal (Fig. 4: mechanism 28; [0044]: mechanism 28 seals assembly 10 and probe 12) is configured to inhibit air from entering the interior of the stiff sheath when the imaging probe has been inserted into the stiff sheath and the imaging probe is drawn proximally away from a distal end of the stiff sheath ([0046]: mechanism 28 creates a wiper seal to or with the shaft 20 to eliminate fluid (e.g., water) ingress into the probe housing 16 internals and also creates a compression seal to the probe tip sealing surface in order to retain the fluid within the probe tip assembly 10).
Regarding claim 13, Johnson in view of Aljuri and ACMIT discloses all limitations of claim 11, as discussed above, and Johnson further discloses:
wherein the seal (Fig. 4: mechanism 28; [0044]: mechanism 28 seals assembly 10 and probe 12) is configured to inhibit liquid from exiting the interior of the stiff sheath when the imaging probe has been inserted into the stiff sheath and the imaging probe is advanced distally toward a distal end of the stiff sheath ([0046]: mechanism 28 creates a compression seal to the probe tip sealing surface in order to retain the fluid within the probe tip assembly 10).
Regarding claim 14, Johnson in view of Aljuri and ACMIT discloses all limitations of claim 11, as discussed above, and Johnson further discloses:
wherein the one or more openings (Fig. 1: vent 34) are located along an upper interior surface of the internal channel (Fig. 1: vent 34 would be on "upper side" when assembly 10 is rotated 180 deg; [0048]: air vent 34 located at or near distal end 22b of assembly 10 in the form of a valve, a threaded screw, or any other means through which only air can flow).
Regarding claim 15, Johnson in view of Aljuri and ACMIT discloses all limitations of claim 14, as discussed above, and Johnson further discloses:
wherein the stiff sheath comprises a reference structure (Fig. 12: tabs 60) that orients the stiff sheath with the one or more openings along the upper interior surface ([0051]-[0052]: tabs 60 of assembly 10 aligns assembly 10 correctly relative to the resting position of transducer 14 of probe 12 and acoustic window 24 of assembly 10 overlays transducer 14, thus the assembly 10 including vent 34 would be oriented as shown in Fig. 7).
Regarding claim 16, Johnson in view of Aljuri and ACMIT discloses all limitations of claim 15, as discussed above, and Aljuri further teaches (also see claim 11 above):
wherein the arm comprises an engagement structure (see annotated Fig. 50 above in claim 11: side walls of “arm”) corresponding to a reference structure, the engagement structure configured to receive the stiff sheath (see annotated Fig. 50 above: side walls of “arm” receiving proximal end of stiff sheath) with one or more openings (Fig. 49: opening) oriented along the upper interior surface (Fig. 49-50: opening would be on “upper” interior surface when stiff sheath is rotated 180 deg).
Regarding claim 17, Johnson in view of Aljuri and ACMIT discloses all limitations of claim 11, as discussed above, and Johnson further discloses:
a flexible coupling (Fig. 5-6: compressible tube drape 36) coupled to the seal (Fig. 5-6: mechanism 28 coupled to drape 36; [0049]: drape 36 at most proximal end of probe tip assembly 10).
Regarding claim 22, Johnson in view of Aljuri and ACMIT discloses all limitations of claim 11, as discussed above, and Johnson further discloses:
an imaging probe assembly (Fig. 1, 4: tubing 32a,b and ports 30 a,b) configured to replace air in the stiff sheath with an acoustic medium ([0047]: one of ports 30a,b is an inlet port into the cavity of the probe tip assembly 10 and tubing 32a or b connected to a fixed or variable volume supply 33 of fluid pumped into probe tip assembly 10),
wherein the imaging probe assembly comprises the imaging probe (Fig. 2-3: ultrasound probe 12; [0040]: probe 12 used to generate diagnostic images).
Regarding claim 25, Johnson in view of Aljuri and ACMIT discloses all limitations of claim 11, as discussed above, and Aljuri further teaches (also see claim 11 above):
wherein the arm (see annotated Fig. 50 above in claim 11) is configured to move independently from the carriage (Fig. 49-50: arm and carriage are connected to fixed support but the carriage is movable while the arm is fixed to the fixed support to hold sheath; Fig. 14D1: fixed support connected to arm 444; [00206]: arm 444 is movable – thus arm of the base is moved by arm 444 while the carriage of the base is movable independently on its own along the fixed support).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Aljuri and ACMIT, as applied to claim 17 above, and further in view of Chaluisan et al. (US PG Pub No. 2018/0161604, provided by the Applicant in the IDS of 06 Dec 2024) – hereinafter referred to as Chaluisan.
Regarding claim 18, Johnson in view of Aljuri and ACMIT discloses all limitations of claim 17, as discussed above, and Johnson does not disclose:
wherein the flexible coupling comprises a first end portion configured to engage the stiff sheath at a first location, and a second end portion configured to engage the imaging probe at a second location of the flexible coupling.
In the same field of ultrasound imaging, Chaluisan, however, teaches:
a flexible coupling (Fig. 5: grooved regions 470, 472) comprising a first end portion configured to engage with a sheath at a first location (Fig. 1, 5 and [0048]-[0049]: sealing members 474, 476 allow transducer assembly 406 to move in (towards cap 42) with respect to the bolus assembly 434, thereby allowing relatively easy insertion of transducer shaft 406), and
a second end portion to engage the imaging probe at a second location of the flexible coupling (Fig. 1, 5 and [0048]-[0049]: sealing members 474, 476 allow transducer assembly 406 to move out (away from cap 42) with respect to the bolus assembly 434, thereby allowing relatively easy insertion of transducer shaft 406).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson’s imaging system to include Chaluisan’s flexible coupling configured to couple with a sheath and an ultrasound probe at different locations. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., arranging flexible coupling to couple with a sheath and an ultrasound probe at different locations, as disclosed by Chaluisan), and the combination would have yielded a reasonable expectation of success since both Johnson and Chaluisan are directed to an ultrasound imaging in which an ultrasound probe is movable relative to a sheath. The motivation for the combination would have been to “allow the transducer assemblies to move in/out of, to easily rotate within, and to move angularly with respect to the bolus assemblies 234, 334, 434 (a sheath), thereby allowing for relatively easy insertion and removal of the transducer shafts 206, 306, 406, without allowing fluid (e.g., water) to pass therethrough”, as taught by Chaluisan ([0049]).
Regarding claim 19, Johnson in view of Aljuri, ACMIT, and Chaluisan discloses all limitations of claim 18, as discussed above, and Chaluisan further teaches (also see claim 18 above):
wherein a distance between the first location and the second location (Fig. 1, 5 and [0049]: transducer assembly 406 moved in (towards cap 42) with respect to the bolus assembly 434 v. transducer assembly 406 moved out (away from cap 42) with respect to the bolus) decreases when the imaging probe is advanced into the internal channel and the distance increases when the imaging probe is retracted from the internal channel (Fig. 1, 5 and [0049]: transducer assembly 406 moved in (towards cap 42) with respect to the bolus assembly 434 v. transducer assembly 406 moved out (away from cap 42) with respect to the bolus).
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Aljuri, ACMIT, and Chaluisan, as applied to claim 18 above, and further in view of Law et al. (US Patent No. 5762066, provided by the Applicant in the IDS of 06 Dec 2024) – hereinafter referred to as Law.
Regarding claim 20, Johnson in view of Aljuri, ACMIT, and Chaluisan discloses all limitations of claim 18, as discussed above, and Johnson does not disclose:
wherein the flexible coupling comprises an internal volume of fluid and
wherein the internal volume increases when the imaging probe is advanced into the stiff sheath and the internal volume decreases when the imaging probe is retracted away from a distal end of the internal channel.
In the same field of endoscopic ultrasound imaging, Law, however, teaches:
a coupling comprising an internal volume of fluid (Col 17, lines 20-30: total volume of fluid in fluid reservoir 36) and
wherein the internal volume increases when the imaging probe is advanced into the sheath and the internal volume decreases when the imaging probe is retracted away from a distal end of the internal channel (Col. 17, lines 31-46: when transducer member 28 moves proximally past sliding seals 42, fluid flows between distal region 30 and reservoir 36, where the total of the two volumes remains constant and fluid is pumped through the recirculating system).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson’s imaging system to include Law’s fluid reservoir within a sheath. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., arranging the internal volume of fluid within the sheath, as disclosed by Law), and the combination would have yielded a reasonable expectation of success since both Johnson and Law are directed to an endoscopic ultrasound imaging in which an ultrasound probe is movable relative to a sheath. The motivation for the combination would have been to provide a recirculating fluid system in coupling the ultrasound probe within a sheath to a target tissue (Col 17, lines 31-46 of Law), and minimize refilling of the coupling fluid from an external source into the sheath.
Regarding claim 21, Johnson in view of Aljuri, ACMIT, Chaluisan, and Law discloses all limitations of claim 20, as discussed above, and Johnson further discloses:
wherein the flexible coupling (Fig. 5-6: compressible tube drape 36) comprises a balloon or a bellows (Fig. 5-6 and [0049]: compressible tube drape 36, like a "bellows").
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Aljuri and ACMIT, as applied to claim 11 above, and further in view of Law.
Regarding claim 23, Johnson in view of Aljuri and ACMIT discloses all limitations of claim 11, as discussed above, and Johnson does not disclose:
wherein the stiff sheath and the imaging probe are sized and arranged to pump fluid with a reciprocating motion of the imaging probe in the stiff sheath.
In the same field of endoscopic ultrasound imaging, Law, however, teaches:
a sheath (probe housing 11) and an imaging probe (transducer member 28) are sized and arranged to pump fluid with a reciprocating motion of the imaging probe in the sheath (Col 17, lines 20-46: linear motion of transducer member 28 allows fluid flow from fluid reservoir 36 to distal region 30 and vice versa).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Johnson’s imaging system to include Law’s arrangement of imaging probe within the sheath in a closed system. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., arranging the sheath and the imaging probe in a closed system, as disclosed by Law), and the combination would have yielded a reasonable expectation of success since both Johnson and Law are directed to an endoscopic ultrasound imaging in which an ultrasound probe is movable relative to a sheath. The motivation for the combination would have been to provide a recirculating fluid system in coupling the ultrasound probe within a sheath to a target tissue (Col 17, lines 31-46 of Law), and minimize refilling of the coupling fluid from an external source into the sheath.
Double Patenting
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 14-18, and 20 of U.S. Patent No. 11751846 – hereinafter referred to as ‘846 – in view of Johnson, Aljuri, and ACMIT, respectively.
Regarding claim 11 of instant application, patented claim 1 of ‘846 recites an imaging system to image tissue of a patient, comprising: an imaging probe to be inserted into the patient; a stiff sheath, the stiff sheath comprising an internal channel sized to receive the imaging probe …; a proximal seal to decrease leakage of fluid from an interior of the stiff sheath; …
Patented claim 1 of ‘846 does not recite a fluid removal line to remove fluid from the internal channel, the line extending to one or more openings within and located on an upper side of the internal channel to receive air bubbles, the one or more openings configured to be located near a distal tip of the imaging probe when the imaging probe is inserted into the stiff sheath; a base comprising an arm and a carriage, the arm configured to couple to a proximal end of the stiff sheath, the carriage configured to couple to the imaging probe to allow translation and rotation of the imaging probe relative to the carriage and relative to the stiff sheath, wherein the imaging probe is removable from the stiff sheath, and the base comprising one or more motors to provide rotational movement to the imaging probe about an elongate axis of the imaging probe.
In the same field of endoscopic ultrasound imaging, Johnson, however, teaches:
a fluid removal line (Fig. 1, 4: tubing 32a,b, ports 30 a,b, vent 34) to remove fluid from the internal channel ([0053]: fluid flows through tubes 32 a,b via ports 30 a,b into cavity of assembly 10 then exits via vent 34 at distal end 22b of assembly 10; [0047]: one of ports 30a,b is an outlet port from the cavity of the probe tip assembly 10),
the line extending to one or more openings (Fig. 1: vent 34) within and located on an upper side of the internal channel to receive air bubbles (Fig. 1: vent 34 would be on "upper side" when assembly 10 is rotated 180 deg; [0048]: air vent 34 located at or near distal end 22b of assembly 10 in the form of a valve, a threaded screw, or any other means through which only air can flow; [0053]: air is forced out of vent 34),
the one or more openings (Fig. 1: vent 34) configured to be located near a distal tip of the imaging probe when the imaging probe is inserted into the stiff sheath (Fig. 1 and [0048]: air vent 34 located at or near distal end 22b of assembly 10 in the form of a valve, a threaded screw, or any other means through which only air can flow; Fig. 3 and [0053]: closure of vent 34 to create airless environment surrounding transducer 14 of probe 12); and
wherein the imaging probe (Fig. 2-3: ultrasound probe 12) is removable from the stiff sheath (Fig. 1, 3: ultrasound probe 12 decoupled from probe tip assembly 10).
Therefore, 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 imaging system of claim 1 of ‘846 to include Johnson’s fluid removal line and removable imaging probe. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., adding a fluid removal line and configuring the imaging probe be removable from the stiff sheath, as disclosed by Johnson), and the combination would have yielded a reasonable expectation of success since both ‘846 and Johnson are directed to an endoscopic ultrasound imaging in which an ultrasound probe is movable relative to a sheath. The motivation for the combination would have been to remove air and even fluid from the cavity between the stiff sheath and the imaging probe ([0053] of Johnson).
In the same field of endoscopic ultrasound imaging, Aljuri also teaches:
a base (Fig. 49-50: fixed support) comprising an arm and a carriage (see annotated Fig. 50 below):
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the arm (see annotated Fig. 50 above) configured to couple to a proximal end of the stiff sheath (see annotated Fig. 50 above: “arm” at proximal end of stiff sheath); and
the carriage (see annotated Fig. 50 above) configured to couple to the imaging probe to allow translation and rotation of the imaging probe relative to the carriage and relative to the stiff sheath (Fig. 49-50: TRUS probe can be translated as well as rotated about sheath and fixed support as the probe fits into the openings of both the sheath and the fixed support - the opening of the stiff sheath and the opening of the fixed support that are aligned at where TRUS probe enters the stiff sheath).
Therefore, 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 imaging system of claim 1 of ‘846 to include Aljuri’s arm and carriage. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., coupling the sheath to a base comprising an arm and a carriage, as disclosed by Aljuri), and the combination would have yielded a reasonable expectation of success since both ‘846 and Aljuri are directed to an endoscopic ultrasound imaging in which an ultrasound probe is movable relative to a stiff sheath. The motivation for the combination would have been to allow “positioning and fixating the sheath, such that a plurality of instruments and instrument delivery systems can be interchanged without the frame of reference changing”, as taught by Aljuri ([00422]).
In the same field of endoscopic ultrasound imaging, ACMIT further teaches:
a base (Fig. 1-5: motor unit 7) comprising one or more motors (Fig. 3-4: electric motor 18) to provide rotational movement to the imaging probe (Fig. 1-5: ultrasonic probe 2) about an elongate axis of the imaging probe ([15]: motor arranged in the motor unit causes a rotation of the ultrasound probe about the longitudinal axis of the same).
Therefore, 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 imaging system of claim 1 of ‘846 to include ACMIT’s motor for rotational movement of the imaging probe. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing a base with a motor for rotational movement of the ultrasound probe, as disclosed by ACMIT), and the combination would have yielded a reasonable expectation of success since both ‘846 and ACMIT are directed to an endoscopic ultrasound imaging. The motivation for the combination would have been to automate the “rotation of the ultrasound probe about its longitudinal axis in order to rotate and/or scan the probe relative to the organ to be examined … to form a three-dimensional image (of the organ to be examined)”, as taught by ACMIT ([06]).
Regarding claim 11 of instant application, patented claim 14 of ‘846 additionally recites an imaging system to image tissue of a patient, comprising: an imaging probe to be inserted into the patient; a stiff sheath, the stiff sheath comprising an internal channel sized to receive the imaging probe …; a proximal seal to decrease leakage of fluid from an interior of the stiff sheath; …; a line to remove fluid from the internal channel, the line extending to one or more openings within the internal channel, wherein the one or more openings are located on an upper side of the internal channel to receive air bubbles.
Patented claim 14 of ‘846 does not recite the one or more openings configured to be located near a distal tip of the imaging probe when the imaging probe is inserted into the stiff sheath; a base comprising an arm and a carriage, the arm configured to couple to a proximal end of the stiff sheath, the carriage configured to couple to the imaging probe to allow translation and rotation of the imaging probe relative to the carriage and relative to the stiff sheath, wherein the imaging probe is removable from the stiff sheath, and the base comprising one or more motors to provide rotational movement to the imaging probe about an elongate axis of the imaging probe.
In the same field of endoscopic ultrasound imaging, Johnson, however, teaches:
one or more openings (Fig. 1: vent 34) configured to be located near a distal tip of the imaging probe when the imaging probe is inserted into the stiff sheath (Fig. 1 and [0048]: air vent 34 located at or near distal end 22b of assembly 10 in the form of a valve, a threaded screw, or any other means through which only air can flow; Fig. 3 and [0053]: closure of vent 34 to create airless environment surrounding transducer 14 of probe 12); and
wherein the imaging probe (Fig. 2-3: ultrasound probe 12) is removable from the stiff sheath (Fig. 1, 3: ultrasound probe 12 decoupled from probe tip assembly 10).
Therefore, 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 imaging system of claim 14 of ‘846 to include Johnson’s opening near a distal tip of an imaging probe and removable imaging probe. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., adding an opening near a distal tip of the imaging probe and configuring the imaging probe be removable from the sheath, as disclosed by Johnson), and the combination would have yielded a reasonable expectation of success since both ‘846 and Johnson are directed to an endoscopic ultrasound imaging in which an ultrasound probe is movable relative to a sheath. The motivation for the combination would have been to remove air and even fluid from the cavity between the stiff sheath and the imaging probe ([0053] of Johnson).
In the same field of endoscopic ultrasound imaging, Aljuri also teaches:
a base (Fig. 49-50: fixed support) comprising an arm and a carriage (see annotated Fig. 50 below):
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the arm (see annotated Fig. 50 above) configured to couple to a proximal end of the stiff sheath (see annotated Fig. 50 above: “arm” at proximal end of stiff sheath); and
the carriage (see annotated Fig. 50 above) configured to couple to the imaging probe to allow translation and rotation of the imaging probe relative to the carriage and relative to the stiff sheath (Fig. 49-50: TRUS probe can be translated as well as rotated about sheath and fixed support as the probe fits into the openings of both the sheath and the fixed support - the opening of the stiff sheath and the opening of the fixed support that are aligned at where TRUS probe enters the stiff sheath).
Therefore, 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 imaging system of claim 1 of ‘846 to include Aljuri’s arm and carriage. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., coupling the sheath to a base comprising an arm and a carriage, as disclosed by Aljuri), and the combination would have yielded a reasonable expectation of success since both ‘846 and Aljuri are directed to an endoscopic ultrasound imaging in which an ultrasound probe is movable relative to a stiff sheath. The motivation for the combination would have been to allow “positioning and fixating the sheath, such that a plurality of instruments and instrument delivery systems can be interchanged without the frame of reference changing”, as taught by Aljuri ([00422]).
In the same field of endoscopic ultrasound imaging, ACMIT further teaches:
a base (Fig. 1-5: motor unit 7) comprising one or more motors (Fig. 3-4: electric motor 18) to provide rotational movement to the imaging probe (Fig. 1-5: ultrasonic probe 2) about an elongate axis of the imaging probe ([15]: motor arranged in the motor unit causes a rotation of the ultrasound probe about the longitudinal axis of the same).
Therefore, 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 imaging system of claim 1 of ‘846 to include ACMIT’s motor for rotational movement of the imaging probe. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing a base with a motor for rotational movement of the ultrasound probe, as disclosed by ACMIT), and the combination would have yielded a reasonable expectation of success since both ‘846 and ACMIT are directed to an endoscopic ultrasound imaging. The motivation for the combination would have been to automate the “rotation of the ultrasound probe about its longitudinal axis in order to rotate and/or scan the probe relative to the organ to be examined … to form a three-dimensional image (of the organ to be examined)”, as taught by ACMIT ([06]).
Claims 11-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 16-20, and 22 of U.S. Patent No. 12082973 – hereinafter referred to as ‘973 – in view of Johnson, Aljuri, and ACMIT, respectively.
Regarding claim 11 of the instant application, patented claim 1 of ‘973 recites an imaging system to image tissue of a patient, comprising: an imaging probe … the imaging probe configured to be inserted into the patient; a stiff sheath, the stiff sheath comprising an internal channel sized to receive the imaging probe, …; a proximal seal … to decrease leakage of fluid from an interior of the stiff sheath; … wherein the imaging probe is removable from the stiff sheath …
Patented claim 1 of ‘973 does not recite a fluid removal line to remove fluid from the internal channel, the line extending to one or more openings within and located on an upper side of the internal channel to receive air bubbles, the one or more openings configured to be located near a distal tip of the imaging probe when the imaging probe is inserted into the stiff sheath; a base comprising an arm and a carriage, the arm configured to couple to a proximal end of the stiff sheath, the carriage configured to couple to the imaging probe to allow translation and rotation of the imaging probe relative to the carriage and relative to the stiff sheath, wherein the imaging probe is removable from the stiff sheath, and the base comprising one or more motors to provide rotational movement to the imaging probe about an elongate axis of the imaging probe.
Johnson in the same field of endoscopic ultrasound imaging, however, teaches:
a fluid removal line (Fig. 1, 4: tubing 32a,b, ports 30 a,b, vent 34) to remove fluid from the internal channel ([0053]: fluid flows through tubes 32 a,b via ports 30 a,b into cavity of assembly 10 then exits via vent 34 at distal end 22b of assembly 10; [0047]: one of ports 30a,b is an outlet port from the cavity of the probe tip assembly 10),
the line extending to one or more openings (Fig. 1: vent 34) within and located on an upper side of the internal channel to receive air bubbles (Fig. 1: vent 34 would be on "upper side" when assembly 10 is rotated 180 deg; [0048]: air vent 34 located at or near distal end 22b of assembly 10 in the form of a valve, a threaded screw, or any other means through which only air can flow; [0053]: air is forced out of vent 34),
the one or more openings (Fig. 1: vent 34) configured to be located near a distal tip of the imaging probe when the imaging probe is inserted into the stiff sheath (Fig. 1 and [0048]: air vent 34 located at or near distal end 22b of assembly 10 in the form of a valve, a threaded screw, or any other means through which only air can flow; Fig. 3 and [0053]: closure of vent 34 to create airless environment surrounding transducer 14 of probe 12).
Therefore, 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 imaging system of claim 1 of ‘973 to include Johnson’s fluid removal line. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., adding a fluid removal line, as disclosed by Johnson), and the combination would have yielded a reasonable expectation of success since both ‘973 and Johnson are directed to an endoscopic ultrasound imaging in which an ultrasound probe is movable relative to a sheath. The motivation for the combination would have been to remove air and even fluid from the cavity between the stiff sheath and the imaging probe ([0053] of Johnson).
In the same field of endoscopic ultrasound imaging, Aljuri also teaches:
a base (Fig. 49-50: fixed support) comprising an arm and a carriage (see annotated Fig. 50 below):
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the arm (see annotated Fig. 50 above) configured to couple to a proximal end of the stiff sheath (see annotated Fig. 50 above: “arm” at proximal end of stiff sheath); and
the carriage (see annotated Fig. 50 above) configured to couple to the imaging probe to allow translation and rotation of the imaging probe relative to the carriage and relative to the stiff sheath (Fig. 49-50: TRUS probe can be translated as well as rotated about sheath and fixed support as the probe fits into the openings of both the sheath and the fixed support - the opening of the stiff sheath and the opening of the fixed support that are aligned at where TRUS probe enters the stiff sheath).
Therefore, 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 imaging system of claim 1 of ‘846 to include Aljuri’s arm and carriage. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., coupling the sheath to a base comprising an arm and a carriage, as disclosed by Aljuri), and the combination would have yielded a reasonable expectation of success since both ‘846 and Aljuri are directed to an endoscopic ultrasound imaging in which an ultrasound probe is movable relative to a stiff sheath. The motivation for the combination would have been to allow “positioning and fixating the sheath, such that a plurality of instruments and instrument delivery systems can be interchanged without the frame of reference changing”, as taught by Aljuri ([00422]).
In the same field of endoscopic ultrasound imaging, ACMIT further teaches:
a base (Fig. 1-5: motor unit 7) comprising one or more motors (Fig. 3-4: electric motor 18) to provide rotational movement to the imaging probe (Fig. 1-5: ultrasonic probe 2) about an elongate axis of the imaging probe ([15]: motor arranged in the motor unit causes a rotation of the ultrasound probe about the longitudinal axis of the same).
Therefore, 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 imaging system of claim 1 of ‘846 to include ACMIT’s motor for rotational movement of the imaging probe. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing a base with a motor for rotational movement of the ultrasound probe, as disclosed by ACMIT), and the combination would have yielded a reasonable expectation of success since both ‘846 and ACMIT are directed to an endoscopic ultrasound imaging. The motivation for the combination would have been to automate the “rotation of the ultrasound probe about its longitudinal axis in order to rotate and/or scan the probe relative to the organ to be examined … to form a three-dimensional image (of the organ to be examined)”, as taught by ACMIT ([06]).
Regarding claim 11 of instant application, patented claim 16 of ‘973 additionally recites an imaging system to image tissue of a patient, comprising: an imaging probe … the imaging probe configured to be inserted into the patient; a stiff sheath, the stiff sheath comprising an internal channel sized to receive the imaging probe, …; a proximal seal … to decrease leakage of fluid from an interior of the stiff sheath; … wherein the imaging probe is removable from the stiff sheath; … a line to remove fluid from the internal channel, the line extending to one or more openings within the internal channel; and wherein the one or more openings are located on an upper side of the internal channel to receive air bubbles.
Patented claim 16 of ‘973 does not recite the one or more openings configured to be located near a distal tip of the imaging probe when the imaging probe is inserted into the stiff sheath; a base comprising an arm and a carriage, the arm configured to couple to a proximal end of the stiff sheath, the carriage configured to couple to the imaging probe to allow translation and rotation of the imaging probe relative to the carriage and relative to the stiff sheath, wherein the imaging probe is removable from the stiff sheath, and the base comprising one or more motors to provide rotational movement to the imaging probe about an elongate axis of the imaging probe.
Johnson in the same field of endoscopic ultrasound imaging, however, teaches:
one or more openings (Fig. 1: vent 34) configured to be located near a distal tip of the imaging probe when the imaging probe is inserted into the stiff sheath (Fig. 1 and [0048]: air vent 34 located at or near distal end 22b of assembly 10 in the form of a valve, a threaded screw, or any other means through which only air can flow; Fig. 3 and [0053]: closure of vent 34 to create airless environment surrounding transducer 14 of probe 12).
Therefore, 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 imaging system of claim 16 of ‘973 to include Johnson’s opening near a distal tip of an imaging probe. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., adding an opening near a distal tip of the imaging probe, as disclosed by Johnson), and the combination would have yielded a reasonable expectation of success since both ‘973 and Johnson are directed to an endoscopic ultrasound imaging in which an ultrasound probe is movable relative to a sheath. The motivation for the combination would have been to remove air and even fluid from the cavity between the stiff sheath and the imaging probe ([0053] of Johnson).
In the same field of endoscopic ultrasound imaging, Aljuri also teaches:
a base (Fig. 49-50: fixed support) comprising an arm and a carriage (see annotated Fig. 50 below):
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the arm (see annotated Fig. 50 above) configured to couple to a proximal end of the stiff sheath (see annotated Fig. 50 above: “arm” at proximal end of stiff sheath); and
the carriage (see annotated Fig. 50 above) configured to couple to the imaging probe to allow translation and rotation of the imaging probe relative to the carriage and relative to the stiff sheath (Fig. 49-50: TRUS probe can be translated as well as rotated about sheath and fixed support as the probe fits into the openings of both the sheath and the fixed support - the opening of the stiff sheath and the opening of the fixed support that are aligned at where TRUS probe enters the stiff sheath).
Therefore, 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 imaging system of claim 1 of ‘846 to include Aljuri’s arm and carriage. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., coupling the sheath to a base comprising an arm and a carriage, as disclosed by Aljuri), and the combination would have yielded a reasonable expectation of success since both ‘846 and Aljuri are directed to an endoscopic ultrasound imaging in which an ultrasound probe is movable relative to a stiff sheath. The motivation for the combination would have been to allow “positioning and fixating the sheath, such that a plurality of instruments and instrument delivery systems can be interchanged without the frame of reference changing”, as taught by Aljuri ([00422]).
In the same field of endoscopic ultrasound imaging, ACMIT further teaches:
a base (Fig. 1-5: motor unit 7) comprising one or more motors (Fig. 3-4: electric motor 18) to provide rotational movement to the imaging probe (Fig. 1-5: ultrasonic probe 2) about an elongate axis of the imaging probe ([15]: motor arranged in the motor unit causes a rotation of the ultrasound probe about the longitudinal axis of the same).
Therefore, 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 imaging system of claim 1 of ‘846 to include ACMIT’s motor for rotational movement of the imaging probe. One of ordinary skill in the art would have combined the elements as claimed by known methods (i.e., providing a base with a motor for rotational movement of the ultrasound probe, as disclosed by ACMIT), and the combination would have yielded a reasonable expectation of success since both ‘846 and ACMIT are directed to an endoscopic ultrasound imaging. The motivation for the combination would have been to automate the “rotation of the ultrasound probe about its longitudinal axis in order to rotate and/or scan the probe relative to the organ to be examined … to form a three-dimensional image (of the organ to be examined)”, as taught by ACMIT ([06]).
The following is the mapping between the claims of instant application and the claims of ‘846 and ‘973, respectively:
Claims of Instant Application
Claims of ‘846
Claims of ‘973
11
1 + Johnson + Aljuri + ACMIT;
14 + Johnson + Aljuri + ACMIT
1 + Johnson + Aljuri+ ACMIT;
16 + Johnson + Aljuri+ ACMIT
12
2 + Johnson + Aljuri+ ACMIT
2 + Johnson + Aljuri+ ACMIT
13
3 + Johnson + Aljuri + ACMIT
3 + Johnson + Aljuri+ ACMIT
14
14 + Johnson + Aljuri+ ACMIT
16 + Johnson + Aljuri+ ACMIT
15
1 + Johnson + Aljuri+ ACMIT;
14 + Johnson + Aljuri+ ACMIT
1 + Johnson + Aljuri+ ACMIT;
16 + Johnson + Aljuri+ ACMIT
16
1 + Johnson + Aljuri+ ACMIT;
14 + Johnson + Aljuri+ ACMIT
1 + Johnson + Aljuri+ ACMIT;
16 + Johnson + Aljuri+ ACMIT
17
15 + Johnson + Aljuri+ ACMIT
17 + Johnson + Aljuri+ ACMIT
18
16 + Johnson + Aljuri+ ACMIT
18 + Johnson + Aljuri+ ACMIT
19
17 + Johnson + Aljuri+ ACMIT
19 + Johnson + Aljuri+ ACMIT
20
18 + Johnson + Aljuri+ ACMIT
20 + Johnson + Aljuri+ ACMIT
21
18 + Johnson + Aljuri+ ACMIT
20 + Johnson + Aljuri+ ACMIT
22
20 + Johnson + Aljuri+ ACMIT
22 + Johnson + Aljuri+ ACMIT
23
1 + Johnson + Aljuri+ ACMIT;
14 + Johnson + Aljuri+ ACMIT
1 + Johnson + Aljuri+ ACMIT;
16 + Johnson + Aljuri+ ACMIT
24
1 + Johnson + Aljuri+ ACMIT;
14 + Johnson + Aljuri+ ACMIT
1 + Johnson + Aljuri+ ACMIT;
16 + Johnson + Aljuri+ ACMIT
25
1 + Johnson + Aljuri+ ACMIT;
14 + Johnson + Aljuri+ ACMIT
1 + Johnson + Aljuri+ ACMIT;
16 + Johnson + Aljuri+ ACMIT
.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Salcudean et al. (US PG Pub No. 2009/0143679) discloses a base comprising a motor to provide a rotataionl movement to an imaging probe about an elongate axis of the probe (see at least Fig. 1-2: rotation motor 120 of rotation assembly 14).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Y.C./Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
07/28/2026
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