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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 22 Jan 2026 and 10 Mar 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Response to Arguments
Applicant’s arguments, see pg. 5, filed 22 Jan 2026, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections of 01 Oct 2025 have been withdrawn in view of the amended claims.
Applicant's arguments, see pg. 5-7, filed 22 Jan 2026, with respect to the prior art rejection have been fully considered but they are not persuasive.
Regarding independent claim 11, Applicant argues, see pg. 6, that Aljuri, a previously presented prior art under 35 U.S.C. 103 rejection to claim 16, does not disclose the new limitation “the carriage configured to couple to the imaging probe to allow translation and rotation of the imaging probe relative to the base and relative to the sheath, wherein the imaging probe is removable from the sheath” in claim 11. However, the Examiner respectfully disagrees. First, a broadest reasonable interpretation of “the carriage configured to couple to the imaging probe” includes Aljuri’s “fixed support” coupled to TRUS probe 460 in at least Fig. 49-50. Further, the intended use “to allow translation and rotation of the imaging probe relative to the base and relative to the sheath” is capable by Aljuri’s fixed support when the locking knob on the fixed support (see Fig. 49 of Aljuri) is not locked to allow the translation as well as the rotation of TRUS probe relative to the stiff sheath and the fixed support. Specifically, each of Aljuri’s stiff sheath and fixed support comprises an opening to respectively allow TRUS probe to translate and rotate: the opening of the stiff sheath and the opening of the fixed support that are aligned at where TRUS probe enters the stiff sheath (see Fig. 49-50). Second, Johnson, a prior art previously presented under 35 U.S.C. 102 rejection to claim 11, discloses the imaging probe (Fig. 2-3: ultrasound probe 12) is removable from the sheath (Fig. 1, 3: ultrasound probe 12 decoupled from probe tip assembly 10). See the 35 U.S.C. 103 rejection to at least claim 11 below.
Applicant's arguments, see pg. 7, filed 22 Jan 2026, with respect to the Double Patenting Rejections have been fully considered but they are not persuasive at least for the reasons explained above for the prior art rejection. See the Double Patenting Rejections below.
Applicant's arguments, see pg. 8, filed 22 Jan 2026, with respect to the new claims 24-25 have been fully considered but they are not persuasive at least for the reasons explained above for the prior art rejection. See the 35 U.S.C. 103 rejections to the new claims 24-25 below.
Status of Claims
Claims 11-25 are currently under examination. Claims 24-25 have been newly added and no claims have been further cancelled nor withdrawn since the Non-Final Office Action of 01 Oct 2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 originally recited the limitation “a stiff sheath, the stiff sheath comprising an internal channel sized to receive the imaging probe”, but claim 11 now has been amended to recite “a sheath comprising an internal channel sized to receive the imaging probe” instead. The amended claim is now broader than the originally presented claimed invention and the narrower scope of the written description of the instant application. See MPEP 2163.II.A.2. In particular, the original specification does not disclose a sheath other than a stiff sheath. Additionally, the amended claim also recites the new limitation ”translation and rotation of the imaging probe … relative to the sheath”, which according to [0020]-[0021] of the original specification of the instant application, is enabled by the sheath being stiff. See MPEP 2163.05.I.A. Therefore, the amended claim omits an element which applicant describes as an essential or critical feature of the invention originally disclosed does not comply with the written description requirement. Furthermore, the instant application is a continuation application to parent application 17/247,922 (now US Patent No. 11751846), and the originally presented claims of 30 Dec 2020 in the parent application explicitly recited “a stiff sheath”. Exclusion of a sheath being stiff in the system claim 11 of the instant continuation application fails to comply with the original claims of the parent application for the benefit of earlier priority date. See MPEP 2163.II.3(b): “Akeva LLC v. Nike, Inc., 817 Fed. Appx. 1005, 1012-13, 2020 USPQ2d 10797 (Fed. Cir. 2020) (The court found that the continuation patents were not entitled to the benefit of an earlier filing date because the continuation patents removed a disclaimer that the invention did not cover shoes with conventional fixed rear soles that was present in the earlier filed patents) … if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as lacking adequate written description, or in the case of a priority or benefit claim under 35 U.S.C. 119, 120, 365, or 386, the priority or benefit claim must be denied.” Claims 12-25 inherit the deficiency by the nature of their dependency on claim 11.
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 Examiner relied on the copy previously provided in the Non-Final Office Action of 01 Oct 2025) – hereinafter referred to as Aljuri.
Regarding claim 11, 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 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 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 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 sheath (Fig. 1, 3: ultrasound probe 12 decoupled from probe tip assembly 10).
Johnson does not explicitly disclose:
an arm configured to couple to a proximal end of the sheath; and
a 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 sheath.
In the same field of endoscopic ultrasound imaging, Aljuri, however, teaches:
an arm (Fig. 51B: arm 442) configured to couple to a proximal end of the sheath (Fig. 51B: arm 442 coupled to a proximal end of sheath 458; [00424]: locking arm for fixing stiff sheath); and
a carriage (Fig. 49-50: fixed support; Fig. 14D1: fixed support connected to arm 444) configured to couple to the imaging probe (Fig 49-50: TRUS Probe 460; [00418]: TRUS probe 460 images treatment site) to allow translation and rotation of the imaging probe relative to the carriage and relative to the 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; and [00420]: axial movement of the TRUS probe provided by linkage 430 results in axial movement of the distal end of the TRUS probe in relation to the distal end of the 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 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]).
Regarding claim 12, Johnson in view of Aljuri 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 sheath when the imaging probe has been inserted into the sheath and the imaging probe is drawn proximally away from a distal end of the 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 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 sheath when the imaging probe has been inserted into the sheath and the imaging probe is advanced distally toward a distal end of the 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 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 discloses all limitations of claim 14, as discussed above, and Johnson further discloses:
wherein the sheath comprises a reference structure (Fig. 12: tabs 60) that orients the 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 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 (Fig. 51A and [00422]-[00423]: docking structure 467) corresponding to a reference structure, the engagement structure configured to receive the sheath (Fig. 51A and [00423]: protrusion 461 of stiff sheath 458 engaging with docking structure 467) 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 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 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 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 24, Johnson in view of Aljuri discloses all limitations of claim 11, as discussed above, and Aljuri further teaches (also see claim 11 above):
a common base (Fig. 13A: base 440), the common base comprising the arm and the carriage (Fig. 13A: arm 442 and fixed support connected to arm 444 all connected to base 440).
Regarding claim 25, Johnson in view of Aljuri discloses all limitations of claim 11, as discussed above, and Aljuri further teaches (also see claim 11 above):
wherein the arm (Fig. 14D1, 51A-B: arm 442) is configured to move independently from the carriage (Fig. 49-50: “fixed” support; Fig. 14D1: fixed support connected to arm 444; [00206]: arm 442 is movable – thus arm 442 is movable while “fixed” support is “fixed”).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Aljuri, 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 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 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 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 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 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 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, 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, as applied to claim 11 above, and further in view of Law.
Regarding claim 23, Johnson in view of Aljuri discloses all limitations of claim 11, as discussed above, and Johnson does not disclose:
wherein the sheath and the imaging probe are sized and arranged to pump fluid with a reciprocating motion of the imaging probe in the 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 and Aljuri, 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; an arm configured to couple to a proximal end of the sheath; and a 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 sheath, wherein the imaging probe is removable from the sheath.
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 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 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, however, teaches:
an arm (Fig. 51B: arm 442) configured to couple to a proximal end of the sheath (Fig. 51B: arm 442 coupled to a proximal end of sheath 458; [00424]: locking arm for fixing stiff sheath); and
a carriage (Fig. 49-50: fixed support; Fig. 14D1: fixed support connected to arm 444) configured to couple to the imaging probe (Fig 49-50: TRUS Probe 460; [00418]: TRUS probe 460 images treatment site) to allow translation and rotation of the imaging probe relative to the carriage and relative to the 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; and [00420]: axial movement of the TRUS probe provided by linkage 430 results in axial movement of the distal end of the TRUS probe in relation to the distal end of the 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 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]).
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; an arm configured to couple to a proximal end of the sheath; and a 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 sheath, wherein the imaging probe is removable from the sheath.
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 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, however, teaches:
an arm (Fig. 51B: arm 442) configured to couple to a proximal end of the sheath (Fig. 51B: arm 442 coupled to a proximal end of sheath 458; [00424]: locking arm for fixing stiff sheath); and
a carriage (Fig. 49-50: fixed support; Fig. 14D1: fixed support connected to arm 444) configured to couple to the imaging probe (Fig 49-50: TRUS Probe 460; [00418]: TRUS probe 460 images treatment site) to allow translation and rotation of the imaging probe relative to the carriage and relative to the 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; and [00420]: axial movement of the TRUS probe provided by linkage 430 results in axial movement of the distal end of the TRUS probe in relation to the distal end of the 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 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]).
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, 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; an arm configured to couple to a proximal end of the sheath; and a 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 sheath.
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, however, teaches:
an arm (Fig. 51B: arm 442) configured to couple to a proximal end of the sheath (Fig. 51B: arm 442 coupled to a proximal end of sheath 458; [00424]: locking arm for fixing stiff sheath); and
a carriage (Fig. 49-50: fixed support; Fig. 14D1: fixed support connected to arm 444) configured to couple to the imaging probe (Fig 49-50: TRUS Probe 460; [00418]: TRUS probe 460 images treatment site) to allow translation and rotation of the imaging probe relative to the carriage and relative to the 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; and [00420]: axial movement of the TRUS probe provided by linkage 430 results in axial movement of the distal end of the TRUS probe in relation to the distal end of the 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 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]).
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; an arm configured to couple to a proximal end of the sheath; and a 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 sheath.
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, however, teaches:
an arm (Fig. 51B: arm 442) configured to couple to a proximal end of the sheath (Fig. 51B: arm 442 coupled to a proximal end of sheath 458; [00424]: locking arm for fixing stiff sheath); and
a carriage (Fig. 49-50: fixed support; Fig. 14D1: fixed support connected to arm 444) configured to couple to the imaging probe (Fig 49-50: TRUS Probe 460; [00418]: TRUS probe 460 images treatment site) to allow translation and rotation of the imaging probe relative to the carriage and relative to the 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; and [00420]: axial movement of the TRUS probe provided by linkage 430 results in axial movement of the distal end of the TRUS probe in relation to the distal end of the 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 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]).
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;
14 + Johnson + Aljuri
1 + Johnson + Aljuri;
16 + Johnson + Aljuri
12
2 + Johnson + Aljuri
2 + Johnson + Aljuri
13
3 + Johnson + Aljuri
3 + Johnson + Aljuri
14
14 + Johnson + Aljuri
16 + Johnson + Aljuri
15
1 + Johnson + Aljuri;
14 + Johnson + Aljuri
1 + Johnson + Aljuri;
16 + Johnson + Aljuri
16
1 + Johnson + Aljuri;
14 + Johnson + Aljuri
1 + Johnson + Aljuri;
16 + Johnson + Aljuri
17
15 + Johnson + Aljuri
17 + Johnson + Aljuri
18
16 + Johnson + Aljuri
18 + Johnson + Aljuri
19
17 + Johnson + Aljuri
19 + Johnson + Aljuri
20
18 + Johnson + Aljuri
20 + Johnson + Aljuri
21
18 + Johnson + Aljuri
20 + Johnson + Aljuri
22
20 + Johnson + Aljuri
22 + Johnson + Aljuri
23
1 + Johnson + Aljuri;
14 + Johnson + Aljuri
1 + Johnson + Aljuri;
16 + Johnson + Aljuri
24
1 + Johnson + Aljuri;
14 + Johnson + Aljuri
1 + Johnson + Aljuri;
16 + Johnson + Aljuri
25
1 + Johnson + Aljuri;
14 + Johnson + Aljuri
1 + Johnson + Aljuri;
16 + Johnson + Aljuri
.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
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/Y.C./Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
5/7/26
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