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 .
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Rontal (US 20060069343 A1).
Regarding claim 1, Rontal teaches a method of operating a medical device (para. [0040]: " The method of the present invention broadly involves treatment of a body tissue or bodily implant or prosthesis having a biofilm coating on its surface by irrigating the surface with a flow of fluid and suctioning the excess fluid off while imparting energy to the biofilm directly or through the fluid to reduce or change the biofilm."), comprising: positioning a distal end of a medical device at a target area (para. [0011]: "[0011] A preferred embodiment of the apparatus for practicing the present invention, which will subsequently be described in detail, comprises an elongated tube or barrel, adapted to be introduced to the human body through the nasal passages or otherwise, so that its distal end is in proximity to a biofilm-lined sinus to be treated."), the medical device including a first lumen (Fig. 3; 20) and a second lumen (Fig. 3; 22), wherein the second lumen is in fluid communication with a port (claim 14; "second port") and the port is proximal of the distal end of the medical device (claim 14: "a second port at the proximal end of the tube for applying a suction force to the second lumen to suction fluid from the cavity."); supplying fluid through the first lumen (claim 14: "a first port for introducing fluid containing biofilm treatment reducing agents."); and applying suction through the second lumen (claim 14: "a second port at the proximal end of the tube for applying a suction force to the second lumen to suction fluid from the cavity.").
Regarding claim 2, Rontal teaches the method of claim 1 (see above), wherein the medical device includes a tube (Fig. 3; tube 14), wherein the first lumen (Fig. 3; 20) extends from the proximal end to the distal end of the tube (para. [0069]: " As is best seen in the cross section of FIG. 2, the irrigating fluid may pass through a lumen 20 which is concentric about the tube 14 along its length and return through a larger lumen 22." Along the length means the first lumen 20 traverses from the proximal to distal ends of the tube), with the first lumen (Fig. 3; 20) having a distal opening (Fig. 3; see arrow pointing to distal opening on annotated Fig. 3 below) on a distalmost face of the distal end of the tube (the opening is on the concentric to the distal end of the tube 14 (Fig. 2 and 3)).
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Regarding claim 3, Rontal teaches the method of claim 2 (see above), wherein the tube (Fig. 2 and 3; 14) includes an outermost wall surrounding each of the first lumen and the second lumen (see annotated figure below).
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Regarding claim 4, Rontal teaches the method of claim 1 (see above), wherein a distal portion of the medical device has a curved configuration at the target area (Fig. 1 shows curvature at the distal end 16 of the device. 26 appears to be pointing to the bent or curved section of the tube 14), and wherein, after applying the suction (para. [0011]: " A second lumen is connected to a vacuum source at the proximal end so as to create a suction at the distal end to remove excess fluid along with debris…"; claim 14: "a second lumen for suctioning fluid from the body."), at least a portion of the fluid enters the second lumen (Fig. 3 shows the fluid entering lumen 22) along a curved fluid path adjacent to the tube (The curve is shown in Fig. 1; Since the vacuum source is at the proximal end and creates a vacuum at the distal end (as disclosed in para. [0011]), it is implied that the fluid travels through the curved portion of the tubing when traveling from the distal end to the proximal end).
Claims 1, 5, 6, 9, and 10 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Schaaf (US 20110202039 A1).
Regarding claim 1, Schaff teaches A method of operating a medical device (abstract: "The invention relates to a method for removing kidney stones and to an endoscope for performing said method."), comprising: positioning a distal end of a medical device (Fig. 1, endoscope; the end towards 6 on figure 1 is the distal end) at a target area (para. [0006]: "In accordance with the invention, the endoscope is first of all introduced into a region of the ureter or of the renal calyx that is positioned in the direction of introduction in front of the kidney stone(s)."; the kidney is the target), the medical device including a first lumen (para. [0009]: "rinsing lumen") and a second lumen (para. [0009]: "suction lumen"), wherein the second lumen is in fluid communication with a port (para. [0022]: "lumen exit 24") and the port is proximal of the distal end of the medical device (para. [0022]: "A A tool or--as in the invention--a rinsing probe or jetting lance may be attached to a working lumen exit 24. In the illustrated embodiment, this rinsing probe is attached via a Y piece 26 with luer lock couplings, wherein a rinsing line 30 leading to a rinsing reservoir 28 is connected to the axial connection of the Y piece 26, and a suction line 32 that is connected to a suction or vacuum pump is connected to the inclined connection. This Y piece 26 is attached to the rinsing probe introduced into the working lumen 8"; 24 is proximal (Fig. 1; away from 6) the distal end (towards 6)); supplying fluid (para. [0023]: "rinsing fluid") through the first lumen (para. [0009]: "rinsing lumen"); and applying suction through the second lumen (para. [0009]: "suction lumen").
Regarding claim 5, Schaff teaches the method of claim 1 (see above), wherein the suction is applied after supplying the fluid. (para. [0023]: "The kidney stones 40 that are often to be found at places of the renal calyx which are very difficult to access are then swirled up by the rinsing probe with rinsing fluid and are suctioned into an access region 42 that is easy to access by means of the vacuum pump 34 that is actuated simultaneously or triggered after the rinsing process.").
Regarding claim 6, Schaff teaches the method of claim 1 (see above), wherein the fluid is supplied simultaneously with applying the suction (para. [0023]: "The kidney stones 40 that are often to be found at places of the renal calyx which are very difficult to access are then swirled up by the rinsing probe with rinsing fluid and are suctioned into an access region 42 that is easy to access by means of the vacuum pump 34 that is actuated simultaneously or triggered after the rinsing process."; Schaff discloses that both rinsing and suction can be done simultaneously or suction can be applied after rinsing).
Regarding claim 9, Schaff teaches the method of claim 1 (see above), wherein the target area is within a kidney (para. [0023]: " In accordance with the schematic illustration in FIG. 2, the catheter probe 2 is introduced by means of the control means through the ureter 36 into the renal calyx 38, and subsequently the renal calyx 38 and the portion of the ureter 36 opening therein are sealed against the bladder by the expanding of the balloon 12.”; The renal calyx is in the kidney. Further, the method is for removing kidney stones).
Regarding claim 10, Schaff teaches the method of claim 1 (see above), wherein positioning the distal end of the medical device at the target area includes advancing the distal end through a urinary bladder, ureter, and into a calyx of a kidney (para. [0023]: " In accordance with the schematic illustration in FIG. 2, the catheter probe 2 is introduced by means of the control means through the ureter 36 into the renal calyx 38, and subsequently the renal calyx 38 and the portion of the ureter 36 opening therein are sealed against the bladder by the expanding of the balloon 12. The kidney stones 40 that are often to be found at places of the renal calyx which are very difficult to access are then swirled up by the rinsing probe with rinsing fluid and are suctioned into an access region 42 that is easy to access by means of the vacuum pump 34 that is actuated simultaneously or triggered after the rinsing process.").
Claims 1 is rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Gist (US 20050261705 A1).
Regarding claim 1, Gist teaches a method of operating a medical device (para. [0002]: “The present invention relates to medical devices for retrieving objects from within a body. More particularly, the invention is a device to remove kidney stones that includes means for providing irrigation and suction.”), comprising: positioning a distal end (Fig. 2A; towards 224) of a medical device at a target area (a location of kidney stones), the medical device including a first lumen (Fig. 2D; Fluid conduit 116a that has irrigation pump 118 on it) and a second lumen (116 that does not have irrigation pump 118 on it (below 116a)), wherein the second lumen is in fluid communication (“fluid conduit” 116 implies fluid communication) with a port (see annotated Fig. 2D, which shows an arrow pointing to the port) and the port is proximal of the distal end of the medical device (the entire Fig. 2D can be considered the distal end of the medical device, and it is proximal to the most distal end where the retrieval basket is located); supplying fluid through the first lumen (para. [0036]: “…an electrically operated irrigation pump 118 is contained within the handle 100, the pump 118 being inline in one of the fluid conduits 116a”); and applying suction through the second lumen (para. [0033]: “Providing the handle 100 with a pair of fluid conduits 116 allows for one of the fluid conduits 116 to be connected to a fluid source, while the other is connected to a suction source, thereby allowing irrigation and suction to be selectively applied to the retrieval basket assembly 200.”)
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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 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Rontal (US 20060069343 A1), in view of Preiss et al. (US 20150196361 A1, "Preiss").
Regarding claim 7 and 8, Rontal teaches the method of claim 3 (see above). However, Rontal does not expressly disclose extending a tool through the first lumen and distal to the distal end of the tube; and actuating the tool to break up an object at the target area.
Preiss, concerned with the common problem of removing unwanted debris from biological cavities and passages, discloses a method of fragmenting and aspirating material from body lumen. Preiss discloses extending a tool through the first lumen and distal to the distal end of the tube (para. [0034]: "Thus, an optical fiber advanced through the device 100 under action of the wheel or roller 102 will exit the distal end of tube 120 and enter the lumen 39 which constitutes the fiber lumen as shown in FIGS. 3 and 5."); and actuating the tool to break up an object at the target area (para. [0034]: " Now to be discussed is the operation and structure of the mechanisms 100 and 200 which are utilized to control and advance the position of the optical fiber…Thus, an optical fiber advanced through the device 100 under action of the wheel or roller 102 will exit the distal end of tube 120 and enter the lumen 39 which constitutes the fiber lumen as shown in FIGS. 3 and 5."; para. [0004] discloses that the optical fiber is used to break apart stones."; para. [0013] mentions that the operator unit controls the optical fiber (actuation).)(claim 7). Further, Preiss discloses wherein the suction is applied before actuating the tool (para. [0033]: " The locking switch 34 may be designed in any number of desired default orientations: always off so that no vacuum is in operation unless actuated; always on so that the vacuum is always on unless the operator disengages the operation; and a mode in which the vacuum is turned on any time the laser is activated so that aspiration occurs while fragmenting stones."; para. [0033] discloses an "always on" mode where the vacuum is always on unless disengaged. Thus, the aspiration would occur before actuation of the laser (activation).).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Rontal to further include actuating a tool to break up an object and applying suction before actuation of the tool, as disclosed by Rontal. Rontal discloses where an optical fiber is extended and from lumen and used to break up stones. One of ordinary skill would recognize that it would have been an obvious improvement to the method of Rontal to further include a laser fiber to break up the target to enhance the method of Rontal. This would improve the method of Rontal by increasing the efficacy of debris removal and types of debris that could be removed. Further, Rontal proves that applying suction before actuating the laser tool is an effective method for removing kidney stones. It would have been obvious for one of ordinary skill in the art to also apply suction before actuating the tool since doing so would yield the predictable to effect of debris removal.
Claims 11, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Rontal (US 20060069343 A1), in view of Irby III (US 20140275762 A1, “Irby”).
Regarding claim 11, Rontal teaches A method of operating a medical device (para. [0040]: " The method of the present invention broadly involves treatment of a body tissue or bodily implant or prosthesis having a biofilm coating on its surface by irrigating the surface with a flow of fluid and suctioning the excess fluid off while imparting energy to the biofilm directly or through the fluid to reduce or change the biofilm."), comprising: positioning a distal end of a medical device at a target area (para. [0011]: "A preferred embodiment of the apparatus for practicing the present invention, which will subsequently be described in detail, comprises an elongated tube or barrel, adapted to be introduced to the human body through the nasal passages or otherwise, so that its distal end is in proximity to a biofilm-lined sinus to be treated."), the medical device including a tube (Fig. 3; tube 14) defining a first lumen (Fig. 3; 20) and a second lumen (Fig. 3; 22), wherein the medical device includes a tube (Fig. 3; tube 14), wherein the first lumen (Fig. 3; 20) extends from the proximal end to the distal end of the tube (para. [0069]: " As is best seen in the cross section of FIG. 2, the irrigating fluid may pass through a lumen 20 which is concentric about the tube 14 along its length and return through a larger lumen 22." Along the length means the first lumen 20 traverses from the proximal to distal ends of the tube), with the first lumen (Fig. 3; 20) having a distal opening (Fig. 3; see arrow pointing to distal opening on annotated Fig. 3 below) on a distalmost face of the distal end of the tube (the opening is on the concentric to the distal end of the tube 14 (Fig. 2 and 3); supplying fluid through the first lumen (claim 14: "a first port for introducing fluid containing biofilm treatment reducing agents."); and applying suction through the second lumen (claim 14: "a second port at the proximal end of the tube for applying a suction force to the second lumen to suction fluid from the cavity."). However, Rontal does not disclose wherein the second lumen terminates at a port proximal to the distal end of the tube.
Irby, concerned with the common problem of removing unwanted debris from biological cavities and passages, discloses a method of removing debris (kidney stone). Irby discloses wherein the second lumen terminates at a port proximal to the distal end of the tube (Fig. 1; para. [0031]: "The interior of the elongate member 12 includes a longitudinally extending conduit 18 (represented by the dashed lines in FIG. 1) that extends from a port 20 located towards the proximal portion 16 of the elongate member 12 and an opening 22 disposed at the distal portion 14 of the elongate member 12. The conduit is configured to provide communication between the port and the opening.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Rontal to further include where the second lumen terminates before the distal end of the tube, as disclosed by Irby. One would recognize that configuring the lumen in this manner would improve the efficacy of delivering irrigation for removing debris. Further, Irby’s configuration would improve the method of Rontal to include more types of debris the method would be able to remove, such as kidney stones. Lastly, as disclosed by Irby, the configuration of Irby’s device would be effective for delivering the device to the kidney for delivery of treatment. Thus, it would have been obvious to combine the method and device of Rontal to include the method and device as disclosed by Irby.
Regarding claim 14 and 15, Rontal, in combination with Irby, discloses the method of claim 11 (see above). However, Rontal does not expressly disclose extending a laser fiber through the first lumen and distal to the distal end of the tube through the distal opening; aiming the laser fiber at an object at the target area; and actuating the laser fiber to break up the object; and wherein the object is a kidney stone.
Irby discloses extending a laser fiber through the first lumen (para. [0034]: "The diameter D2 (or width) of the conduit 18 is desirably large enough to allow for irrigation as well as the insertion of a guide wire or laser fiber.") and distal to the distal end of the tube through the distal opening (para. [0022]: "passing a laser fiber through the ureteroscope so that the laser fiber is in close proximity to the stone; activating the laser fiber to fragment the stone."; para. [0052]: " With the laser fiber in direct contact with the stone, the laser is activated and fired at standard energy settings (typically 6-10 Hz at 600-800 mJ)." The laser fiber being in "direct contact with the stone" implies the laser fiber must be going through an opening at the distal end of conduit 18 so the laser fiber can contact the stone); aiming the laser fiber at an object at the target area (para. [0022]: "the stone"); and actuating the laser fiber to break up the object (para. [0022]: "activating the laser fiber to fragment the stone.")(claim 14); and wherein the object is a kidney stone (above; para. [0024]: " Aspects of the present invention may provide advantages over currently available treatment methods for the treatment of kidneys stones. In particular, the availability to surgically treat patients suffering from kidney stones as a non-hospital, truly outpatient procedure may help minimize patient pain and suffering as well as significantly reduce costs typically associated with the surgical treatment of kidney stones.")(claim 15).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and device for performing the method of Rontal to include the laser fiber and actuation to break up a kidney stone, as disclosed by Irby. One of ordinary skill would recognize that a laser would be effective to break up debris, and would make it easier to remove debris. Further, it would have been obvious to try the method of Rontal with a kidney stone as a target. A kidney stone is a type of debris, and the method of Rontal is effective for breaking up debris. It would have been obvious to try different types of debris with an expectation that the method would be effective in breaking up a kidney stone. Therefore, one of ordinary skill in the art would have found it obvious to combine the methods of Irby with the methods of Rontal to enhance the method of Rontal.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Rontal (US 20060069343 A1), Irby III (US 20140275762 A1, “Irby”), and Schaaf (US 20110202039 A1).
Regarding claim 12, Rontal, in combination with Irby, discloses the method of claim 11 (see above). Rontal further discloses wherein, after applying the suction (para. [0011]: " A second lumen is connected to a vacuum source at the proximal end so as to create a suction at the distal end to remove excess fluid along with debris…"; claim 14: "a second lumen for suctioning fluid from the body."), at least a portion of the fluid enters the second lumen (Fig. 3 shows the fluid entering lumen 22) along a curved fluid path adjacent to the tube (The curve is shown in Fig. 1; Since the vacuum source is at the proximal end and creates a vacuum at the distal end (as disclosed in para. [0011]), it is implied that the fluid travels through the curved portion of the tubing when traveling from the distal end to the proximal end). However, Rontal does not expressly disclose wherein the suction is applied after supplying the fluid.
Schaaf, concerned with the common problem of removing unwanted debris from biological cavities and passages, discloses a method of removing debris (kidney stone). Schaff discloses wherein the suction is applied after supplying the fluid (para. [0023]: "The kidney stones 40 that are often to be found at places of the renal calyx which are very difficult to access are then swirled up by the rinsing probe with rinsing fluid and are suctioned into an access region 42 that is easy to access by means of the vacuum pump 34 that is actuated simultaneously or triggered after the rinsing process."; “triggered after the rinsing process” means the suction is applied after the fluid.).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Rontal to include suction applied after supplying fluid. One of ordinary skill would recognize that the method of Schaaf is effective for removing unwanted debris, and that supplying suction after fluid would accomplish the removal of debris. Therefore, since Schaff discloses this step in a method of removing debris, one of ordinary skill would have found it obvious to include this step in the method of Rontal.
Regarding claim 13, Rontal, in combination with Irby, discloses the method of claim 11 (see above). However, Rontal does not expressly disclose wherein the fluid is supplied simultaneously with applying the suction.
Schaaf discloses wherein the fluid is supplied simultaneously with applying the suction. (para. [0023]: "The kidney stones 40 that are often to be found at places of the renal calyx which are very difficult to access are then swirled up by the rinsing probe with rinsing fluid and are suctioned into an access region 42 that is easy to access by means of the vacuum pump 34 that is actuated simultaneously or triggered after the rinsing process.")
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Rontal to include simultaneous suction and fluid supply, as disclosed by Schaaf. One of ordinary skill would recognize that the method of Schaaf is effective for removing unwanted debris, and that simultaneous suction and fluid would accomplish the removal of debris. Further, since Schaff discloses both suction after fluid release and simultaneous suction and fluid release, it would have been obvious for one of ordinary skill in the art to try both options to see which is most effective for removing debris. Therefore, since Schaff discloses this step in a method of removing debris, one of ordinary skill would have found it obvious to include this step in the method of Rontal.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Rontal (US 20060069343 A1), Irby III (US 20140275762 A1, “Irby”), and Gist (US 20050261705 A1).
Regarding claims 14-16, Rontal, in combination with Irby, discloses the method of claim 11 (see above). As detailed above, Irby discloses the deficiencies of Rontal (see 103 rejection above) for claims 14 and 15. However, Irby does not expressly disclose wherein the fluid is supplied after actuating the laser fiber (Irby does not specify when the irrigation fluid is applied)(claim 16).
Gist, concerned with the common problem of removing unwanted debris from biological cavities and passages, discloses a method of removing debris (kidney stones). Gist discloses extending a laser fiber (Fig. 2B; fiber optic 300) through the first lumen (central conduit 114) and distal to the distal end of the tube through the distal opening (para. [0032]: “extended until a distal end 304 of the fiber optic 300 emerges from the distal end of the elongated member 220”); aiming the laser fiber at an object at the target area (para. [0032]: “where the fiber optic 300 is used to apply laser impulses to a stone captured in the region of the basket 230”); and actuating the laser fiber to break up the object (para. [0032]: “where the fiber optic 300 is used to apply laser impulses to a stone captured in the region of the basket 230”)(claim 14); wherein the object is a kidney stone (para. [0032]: “stone”; para. [0002]: “…a device to remove kidney stones…”) (claim 15); wherein the fluid is supplied after actuating the laser fiber (para. [0032]: "where the fiber optic 300 is used to apply laser impulses to a stone captured in the region of the basket 230. Removal of the fiber optic 300 facilitates application of irrigation and suction through the retrieval basket assembly 200.") (claim 16).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and device for performing the method of Rontal to include the laser fiber and actuation to break up a kidney stone, as well as supplying fluid after the actuation of the laser fiber, as disclosed by Gist. One of ordinary skill would recognize that a laser would be effective to break up debris, and including a laser would make it easier to remove debris. Further, it would have been obvious to try the method of Rontal with a kidney stone as a target. A kidney stone is a type of debris, and the method of Rontal is effective for breaking up debris. It would have been obvious to try different types of debris with an expectation that the method would be effective in breaking up a kidney stone. Lastly, Gist demonstrates that applying fluid irrigation would successfully remove the debris, and therefore, it is obvious to include step in the method of Rontal to effectively remove lasered debris. Therefore, one of ordinary skill in the art would have found it obvious to combine the methods of Gist with the methods of Rontal to enhance the method of Rontal.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Rontal (US 20060069343 A1), Irby III (US 20140275762 A1, “Irby”), and Schaaf (US 20110202039 A1).
Regarding claim 17, Rontal teaches A method of operating a medical device (para. [0040]: " The method of the present invention broadly involves treatment of a body tissue or bodily implant or prosthesis having a biofilm coating on its surface by irrigating the surface with a flow of fluid and suctioning the excess fluid off while imparting energy to the biofilm directly or through the fluid to reduce or change the biofilm."), comprising: positioning a distal end of a medical device at a target area (para. [0011]: "[0011] A preferred embodiment of the apparatus for practicing the present invention, which will subsequently be described in detail, comprises an elongated tube or barrel, adapted to be introduced to the human body through the nasal passages or otherwise, so that its distal end is in proximity to a biofilm-lined sinus to be treated."), the medical device including a tube (Fig. 3; tube 14) defining a first lumen (Fig. 3; 20) and a second lumen (Fig. 3; 22), wherein the first lumen (Fig. 3; 20) extends from the proximal end to a distal opening of a distal end of the tube (para. [0069]: " As is best seen in the cross section of FIG. 2, the irrigating fluid may pass through a lumen 20 which is concentric about the tube 14 along its length and return through a larger lumen 22." Along the length means the first lumen 20 traverses from the proximal to distal ends of the tube); supplying fluid through the first lumen (claim 14: "a first port for introducing fluid containing biofilm treatment reducing agents."); and applying suction through the second lumen (claim 14: "a second port at the proximal end of the tube for applying a suction force to the second lumen to suction fluid from the cavity."). However, Rontal does not expressly teach wherein the second lumen terminates at a port proximal to the distal end of the tube; and wherein the suction is applied after supplying the fluid.
Irby, concerned with the common problem of removing unwanted debris from biological cavities and passages, discloses a method of removing debris (kidney stone). Irby discloses wherein the second lumen terminates at a port proximal to the distal end of the tube (Fig. 1; para. [0031]: "The interior of the elongate member 12 includes a longitudinally extending conduit 18 (represented by the dashed lines in FIG. 1) that extends from a port 20 located towards the proximal portion 16 of the elongate member 12 and an opening 22 disposed at the distal portion 14 of the elongate member 12. The conduit is configured to provide communication between the port and the opening.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Rontal to further include where the second lumen terminates before the distal end of the tube, as disclosed by Irby. One would recognize that configuring the lumen in this manner would improve the efficacy of delivering irrigation for removing debris. Further, Irby’s configuration would improve the method of Rontal to include more types of debris the method would be able to remove, such as kidney stones. Lastly, as disclosed by Irby, the configuration of Irby’s device would be effective for delivering the device to the kidney for delivery of treatment. Thus, it would have been obvious to combine the method and device of Rontal to include the method and device as disclosed by Irby.
Irby, however, does not expressly disclose wherein the suction is applied after supplying the fluid. Schaaf, concerned with the common problem of removing unwanted debris from biological cavities and passages, discloses a method of removing debris (kidney stone). Schaff discloses wherein the suction is applied after supplying the fluid (para. [0023]: "The kidney stones 40 that are often to be found at places of the renal calyx which are very difficult to access are then swirled up by the rinsing probe with rinsing fluid and are suctioned into an access region 42 that is easy to access by means of the vacuum pump 34 that is actuated simultaneously or triggered after the rinsing process."; “triggered after the rinsing process” means the suction is applied after the fluid.).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Rontal to include suction applied after supplying fluid. One of ordinary skill would recognize that the method of Schaaf is effective for removing unwanted debris, and that supplying suction after fluid would accomplish the removal of debris. Therefore, since Schaff discloses this step in a method of removing debris, one of ordinary skill would have found it obvious to include this step in the method of Rontal.
Regarding claim 18, Rontal, in combination with Irby and Schaaf, discloses the method of claim 17 (see above). Rontal further discloses wherein an outermost wall of the tube surrounds both the first lumen and the second lumen (Fig. 2; As detailed in the rejection of claim 3, there is an outermost wall in that surrounds the first lumen (20). The first lumen (20) and second lumen (22) are concentric in Fig. 2; Therefore, the outermost wall of the first lumen (20) would surround both the first and second lumen).
Regarding claim 19, Rontal, in combination with Irby and Schaaf, discloses the method of claim 17 (see above). Rontal further discloses wherein at least a portion of the fluid supplied to the target area enters the port. (claim 15: "a first port for introducing fluid containing biofilm treatment reducing agents into the proximal end of the first lumen; a second port at the proximal end of the tube for applying a suction force to the second lumen to suction fluid from the cavity.").
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Rontal (US 20060069343 A1), Irby III (US 20140275762 A1, “Irby”), Schaaf (US 20110202039 A1), and Gist (US 20050261705 A1).
Regarding claim 20, Rontal, in combination with Irby and Schaff, discloses the method of claim 18 (see 103 rejection above). Irby further discloses extending a laser fiber through the first lumen (para. [0034]: "The diameter D2 (or width) of the conduit 18 is desirably large enough to allow for irrigation as well as the insertion of a guide wire or laser fiber.") and distal to the distal end of the tube through the distal opening (para. [0022]: "passing a laser fiber through the ureteroscope so that the laser fiber is in close proximity to the stone; activating the laser fiber to fragment the stone."; para. [0052]: " With the laser fiber in direct contact with the stone, the laser is activated and fired at standard energy settings (typically 6-10 Hz at 600-800 mJ)." The laser fiber being in "direct contact with the stone" implies the laser fiber must be going through an opening at the distal end of conduit 18 so the laser fiber can contact the stone); aiming the laser fiber at an object at the target area (para. [0022]: "the stone"); and actuating the laser fiber to break up the object (para. [0022]: "activating the laser fiber to fragment the stone."); wherein the object is a kidney stone (para. [0024]: "Aspects of the present invention may provide advantages over currently available treatment methods for the treatment of kidneys stones. In particular, the availability to surgically treat patients suffering from kidney stones as a non-hospital, truly outpatient procedure may help minimize patient pain and suffering as well as significantly reduce costs typically associated with the surgical treatment of kidney stones."). However, Irby does not expressly disclose that the laser is extended through a first lumen before supplying fluid and applying suction.
Gist, in the same field of endeavor as Irby of removing kidney stones, discloses extending a laser fiber through the first lumen before supplying the fluid and applying the suction (para. [0032]: "where the fiber optic 300 is used to apply laser impulses to a stone captured in the region of the basket 230. Removal of the fiber optic 300 facilitates application of irrigation and suction through the retrieval basket assembly 200."; the retraction of the fiber optic after using the laser is what triggers the fluid and suction, so the laser is extended and used before irrigation and suction.).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method and device for performing the method of Rontal to include the laser fiber and actuation to break up a kidney stone, as disclosed by Irby, as well as extending the laser fiber before irrigation and suction application, as disclosed by Gist. One of ordinary skill would recognize that a laser would be effective to break up debris, and would make it easier to remove debris. Further, it would have been obvious to try the method of Rontal with a kidney stone as a target. A kidney stone is a type of debris, and the method of Rontal is effective for breaking up debris. It would have been obvious to try different types of debris with an expectation that the method would be effective in breaking up a kidney stone. Lastly, it would have been obvious to extend the laser fiber and apply the laser before applying fluid and suction as a method of retrieving the debris since Gist demonstrates that doing so is effective for clearing kidney stones. Therefore, one of ordinary skill in the art would have found it obvious to combine the methods of Irby and Gist with the methods of Rontal to enhance the method of Rontal.
Conclusion
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/O.L.M./Examiner, Art Unit 3796
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