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 .
The current application has the effective filing date of 10/27/2022 according to the priority chain on the record.
Response to Restriction Election
Applicant’s election of Group I: claims 1-18 in the reply filed on 12/03/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Non-elected Group II: claims 19 and 20 are withdrawn from consideration.
Claim Objections
Claim 2 is objected to because of the following informalities: claim 2 “energy delivered device” should be amended to “energy delivery device”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 1-4, 10-11 and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Washburn, II et al. US 2017/0265879 A1 (hereinafter “Washburn”, cited in Applicant’s IDS).
Regarding claim 1, Washburn teaches a medical system (Figs. 23-24: 1600), comprising:
a sheath (outer sheath 1601) with at least one lumen (evacuation hypotube 1653), wherein the at least one lumen (1653) is configured to be coupled to a suction source ([0194] “The clot evacuation hypotube 1653 may be connected to a suction tube 1673 exiting the handpiece 1664 for providing suction to the evacuation hypotube 1653. The suction tube 1673 may be connected to a wall suction port, a syringe, or any other suitable means of providing suction.”);
an irrigation device (inherent, see [0193]), wherein the irrigation device includes at least one irrigation lumen (irrigation hypotubes 1655) configured to be coupled to an irrigation source ([0193] and Fig. 24B); and
a medical device (Fig.24B-24C: visualization element 1654), wherein the medical device (1654) includes a handle (handpiece 1604) and a shaft (outer sheath 1601, or elongate body 1602), wherein the shaft (1601, 1602) includes a working channel (1653) with a distal opening (distal opening shown in Fig. 24B-24C) at a distal end (distal end 1608) of the shaft (1601), wherein the distal end (1608) of the shaft further includes one or more illumination devices (1654 is the same as visualization element 1628 according to [0193] “a visualization element 1654 (e.g., 1.73 mm OD), which may be the same or similar to the visualization element 1628 disposed within the optical introducer 160.” Since 1628 comprises an illumination source according to [0188], then 1654 also comprises an illumination device) and one or more visualization devices (camera/image sensor 1629; see Fig. 24A and [0188]);
wherein the medical device (1654) is configured to be positioned within the sheath (1601) during delivery of the sheath (1601) to a treatment site and during an application of energy to one or more objects to break up the one or more objects to form one or more particles or dust (this is an intended use of system 1600; described with respect to analogous embodiments in [0106] “inner hypotube 1128 comprising the visualization elements (such as the visualization sensor and lens) may be vibrated to break up and remove clots that may be lodged in the lumen 1138” and [0108: last sentence] “The use of features which assist in breaking up clots that may be lodged within the aspiration lumen, can help the user avoid having to remove the device to clear the clots in mid-procedure, requiring the user to reintroduce the device and relocate the target tissue.”); and
wherein the irrigation device (see [0193], irrigation hypotubes 1655) is configured to be positioned within the sheath (1601) and deliver irrigation fluid while suction is applied to the treatment site through the sheath during a removal of one or more particles or dust from the treatment site (see [0193] “…If more than one irrigation hypotube 1655 is provided, one may be configured to provide irrigation primarily to the blood clot and/or near the distal end of the evacuation hypotube 1653 to assist in removing the clot…”).
Regarding claim 2, Washburn teaches the medical system of claim 1, further comprising a laser fiber or another energy delivered device. (see rejection to claim 1, medical device, i.e. visualization element 1654 is the same as 1628, in which [0188] “The visualization element 1628 may include illumination elements within the hypotube, such as fiber optics or LEDs…”)
Regarding claim 3, Washburn teaches the medical system of claim 2, wherein the laser fiber or the another energy delivery device is delivered through the working channel (1653) of the medical device. (see Figs. 24B visualization element 1654 which comprises said fiber optic or LED is delivered through working channel 1653)
Regarding claim 4, Washburn teaches the medical system of claim 2, wherein the laser fiber or the another energy delivery device is coupled to or integrated within the shaft (outer sheath 1601, or elongate body 1602) of the medical device. (as shown in Fig. 24B)
Regarding claim 10, Washburn teaches the medical system of claim 1, wherein the sheath (1601) includes an additional lumen (see Figs. 24B-24C: sheath 1601 comprises a plurality of lumen including at least two 1655, a second 1655 is taken to encompass “additional lumen” in this claim), wherein the additional lumen (1655) is at least partially separated from the lumen of the sheath (as shown in Figs. 24B-24C, the two 1655 are separate from one another).
Regarding claim 11, Washburn teaches the medical system of claim 10, wherein the additional lumen (second 1655) is configured to movably receive the irrigation device while the shaft (1601) of the medical device (1654) is positioned within the lumen (first 1655) of the sheath. ([0194] “The handpiece 1664 may also comprise irrigation lines, including a clot irrigation line 1675 and lens irrigation line 1676, connected to the irrigation hypotubes 1655 and exiting the handpiece 1664 to join a supply means for providing irrigation”)
Regarding claim 13, Washburn teaches the medical system of claim 1, wherein a distal portion (1608) of the shaft (1601) of the medical device includes an articulation section (atraumatic tip 1640), and wherein the handle (1604) of the medical device includes a deflection lever (tabs 1603) that is configured to be manipulated to control a position of the articulation section of the shaft. (As shown in Fig. 24F [0196], also see [0186] “The outer sheath 1601 may or may not be a peel-away sheath. If peel-away, the outer sheath 1601 may comprise tabs 1603 for bisecting the outer sheath 1601 along its circumference”)
Regarding claim 14, Washburn teaches the medical system of claim 1, wherein the handle (1604) is coupled to an umbilicus (cable 1605) configured to couple the handle (1604) to one or more of an irrigation source, a suction source, a display, or a power source. (as shown in Fig. 23 and see [0187] “The handpiece 1604 may include a cable 1605, such as a USB cable, extending from the handpiece 1604 for transferring data and/or for powering the device”)
Regarding claim 15, Washburn teaches the medical system of claim 1, wherein the treatment site is a kidney, and wherein the one or more objects are kidney stones. (This claim is treated as an intended use or functional language of the claim, it is the Examiner’s position that device 1600 can be adapted for use in a kidney, and to break up kidney stones, see [0101] which discusses breaking up a blot, also see [0106])
Regarding claim 16, Washburn teaches medical system (Figs. 23-24: 1600) comprising:
a sheath (outer sheath 1601) with at least one lumen (evacuation hypotube 1653), wherein the at least one lumen (1653) is configured to be coupled to a suction source ([0194] “The clot evacuation hypotube 1653 may be connected to a suction tube 1673 exiting the handpiece 1664 for providing suction to the evacuation hypotube 1653. The suction tube 1673 may be connected to a wall suction port, a syringe, or any other suitable means of providing suction.”);
an irrigation device (inherent, see [0193] irrigation lumen 1655), wherein the irrigation device includes at least one irrigation lumen (irrigation hypotubes 1655) configured to be coupled to an irrigation source ([0102] fluid source), and wherein the irrigation device (1655) includes a shape that is substantially complementary to an interior surface of the at least one lumen (1138) of the sheath (1102) in order to retain or maintain a position of the irrigation device (1655) within the sheath (1601) with at least a portion of the irrigation device abutting an inner wall of the at least one lumen of the sheath (as shown in Figs. 24B-24C, lumen 1655 abutts the other lumens within 1601); and
a medical device (visualization element 1654), wherein the medical device includes a handle (handpiece 1604) and a shaft (outer sheath 1601, or elongate body 1602), wherein the handle (1604) includes a deflection lever (tabs 1603),
wherein the shaft (outer sheath 1601, or elongate body 1602) includes a working channel (1653) with a distal opening (distal opening shown in Fig. 24B-24C) at a distal end (distal end 1608) of the shaft (1601), and wherein a portion of the shaft includes an articulation section (atraumatic tip 1640) controlled by the deflection lever (1603; as shown in Fig. 24F [0196], also see [0186] “The outer sheath 1601 may or may not be a peel-away sheath. If peel-away, the outer sheath 1601 may comprise tabs 1603 for bisecting the outer sheath 1601 along its circumference”);
wherein the medical device (1654) is configured to be positioned within the sheath (1601) during delivery of the sheath (1601) to a treatment site and during an application of energy to one or more objects to break up the one or more objects to form one or more particles or dust (this is an intended use of system 1600; described with respect to analogous embodiments in [0106] “inner hypotube 1128 comprising the visualization elements (such as the visualization sensor and lens) may be vibrated to break up and remove clots that may be lodged in the lumen 1138” and [0108: last sentence] “The use of features which assist in breaking up clots that may be lodged within the aspiration lumen, can help the user avoid having to remove the device to clear the clots in mid-procedure, requiring the user to reintroduce the device and relocate the target tissue.”); and
wherein the irrigation device (see [0193], irrigation hypotubes 1655) is configured to be positioned within the sheath (1601) and deliver irrigation fluid while suction is applied to the treatment site through the sheath during a removal of one or more particles or dust from the treatment site (see [0193] “…If more than one irrigation hypotube 1655 is provided, one may be configured to provide irrigation primarily to the blood clot and/or near the distal end of the evacuation hypotube 1653 to assist in removing the clot…”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Washburn as applied to claim 1 above, and further in view of Palais et al. US 6,613,026 B1.
Regarding claim 5, Washburn teaches the medical system of claim 1, comprising an irrigation device (irrigation lumens 1655 as shown in Figs. 24B and 24C); but wherein the irrigation device includes a closed distal end and a plurality of holes arranged on a distal portion of the irrigation device. Palais, another prior art reference in the analogous art, discloses a device for injecting fluid into tissue utilizing laterally directed fluid ports to increase fluid retention in the tissue (see Abstract). As shown in Fig. 1A-1B, catheter 12 has a shaft 14 comprising a sheath 28 and a fluid lumen 24; the lumen 24 has a closed distal end and a plurality of ports 26 dispersed radially (see col.4, ll.12-19). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Washburn’s irrigation port so as to include the plurality of ports dispersed radially in view of Palais, the motivation for doing so is because multiple ports would increase flow rate and increase tissue penetration of the irrigating and/or aspirating fluids. (Palais: col.2, ll.63-col.3, ll.6, col.6, ll.39-49)
Regarding claim 6, Washburn in view of Palais discloses the medical system of claim 5, wherein the plurality of holes (ports 26) are arranged in at least one row of holes (see Palais: Figs.1B-2 illustrating at least two rows of ports 26; and col.4, ll.20-30).
Regarding claim 7, Washburn in view of Palais discloses medical system of claim 6, wherein the at least one row of holes includes at least two rows of holes arranged on opposing sides of the distal portion of the irrigation device (see Palais: Fig. 5-a cross-sectional view which illustrates two rows of port 25 along axis on opposing sides), wherein the plurality of holes are formed via laser cutting (this limitation is a product by process limitation, i.e. holes formed via laser cutting; see MPEP 2113 product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Since Washburn in view of Palais teaches a plurality of holes i.e. ports 26, as discussed in claim 5 rejection above, it is sufficient to meet this claim).
Claims 8, 12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Washburn as applied to claims 1 and 16 above and further in view of Sotak et al. US 2017/0042519 A1 (hereinafter “Sotak”).
Regarding claim 8, Washburn discloses the medical system of claim 1, comprising an irrigation device (see [0193] and Fig. 24B-24C: irrigation hypotubes 1655); but does not teach wherein the irrigation device includes a crescent cross-sectional shape with an open distal end. Sotak, another prior art reference in analogous field, discloses a catheter shaft 402 comprising a first lumen for delivering a guidewire and a second lumen adapted to delivery fluid, wherein “[t]he second lumen 406 may have a circular cross section or a non-circular cross-sectional shape, such as a crescent-like cross-sectional shape.” (See [0197] and as shown in Fig. 4:405 or Fig.5:506) It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Washburn’s irrigation lumen so as to comprise a crescent cross-sectional shape in view of Sotak; the motivation for doing so is because this is a known alternative shape to a circular cross section (Sotak: [0197]), and provides the additional advantage to accommodate or abut a second circular lumen as shown Sotak: Fig. 4: 404 and 406 and Fig. 5:506 and 504.
Regarding claim 12, Washburn teaches medical system of claim 10, comprising a plurality of lumen for irrigation and aspiration (first and second lumen 1655, [0193]). But does not disclose wherein the additional lumen includes a sliver shape formed by a first wall with a first radius of curvature and a second wall with a second radius of curvature that is greater than the first radius of curvature. Sotak, another prior art reference in analogous field, discloses a catheter shaft 402 comprising a first lumen for delivering a guidewire and a second lumen adapted to delivery fluid, wherein “[t]he second lumen 406 may have a circular cross section or a non-circular cross-sectional shape, such as a crescent-like cross-sectional shape.” (See [0197] and as shown in Fig. 4:405 or Fig.5:506) It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Washburn’s irrigation/aspiration lumen so as to includes a sliver shape formed by a first wall with a first radius of curvature and a second wall with a second radius of curvature that is greater than the first radius of curvature shape (e.g. crescent-like shape) in view of Sotak; the motivation for doing so is because this is a known alternative shape to a circular cross section (Sotak: [0197]), and provides the additional advantage to accommodate or abut a second circular lumen as shown Sotak: Fig. 4: 404 and 406 and Fig. 5:506 and 504.
Regarding claim 17, this claim is rejected by Washburn in view of Sotak, based on the same rationale as discussed to claim 8 above.
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Washburn as applied to claims 1 and 18 above, and further in view of Trudell US 2004/0044329 A1.
Regarding claim 9, Washburn medical system of claim 1, wherein the irrigation device are straight lumens, Washburn does not teach wherein the irrigation device includes at least one helical section. Trudell, another prior art reference in the analogous art, teaches a catheter comprising a fluid delivery lumen 150 that has alternating straight and helical sections ([0047]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Washburn’s irrigation lumen such that it has alternating straight and helical sections in view of Trudell, the motivation for doing so because the helical section can be oriented parallel or at an angle with respect to the long axis of the catheter and to provide flexibility along the lumen (Trudell: [0047]).
Regarding claim 18, this claim is rejected by Washburn in view of Trudell, based on the same rationale as discussed to claim 9 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
January 7, 2026