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 .
Prosecution Reopened
In view of the appeal brief filed on May 21st, 2026, PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/ELIZABETH HOUSTON/ Supervisory Patent Examiner, Art Unit 3771
Response to Arguments
One of Applicant’s arguments, see Appeal Brief, filed May 21st, 2026, with respect to the rejection of claims 250-256 and 258-269 under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gutierrez et al. (Pub. No. 2010/0082021) in view of Sinelnikov et al. (Pub. No. 2016/0374710).
The rejection of claims 250-256 and 258-269 under 103 over Eisner et al. in view of Sinelnikov et al. and Harrah et al. (Pub. No. 2017/0215965) has been withdrawn in light of Applicant’s arguments made in the Appeal Brief filed on May 21st, 2026; specifically, Applicant argued in Point 6 that the Final Rejection dated October 23rd, 2026 did not explain how one of ordinary skill in the art could combine the teachings of Eisner et al. and Harrah et al. to allow multiple instruments to be inserted into a single irrigation lumen and introduced out of different irrigation ports, nor how the modification would result in the nozzle of Eisner et al. only partly residing within the distal section of the outer tube 1706. Upon further view, Examiner agrees with these arguments.
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.
Claim(s) 250, 252-256, 258-259, 263, and 269 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez et al. (Pub. No. 2010/0082021) in view of Sinelnikov et al. (Pub. No. 2016/0374710).
Regarding claim 250, Gutierrez et al. discloses a catheter (100; FIGs. 1-4; [0013]), comprising:
a handle portion ([0013] the proximal end of 100, not shown);
a flexible tube portion (102) coupled to the handle portion ([0013] 102 is coupled to the proximal end of 100), the flexible tube portion comprising one vacuum lumen (114; the claim language only requires the structure of a lumen be capable of aspiration, and 114 is capable of acting as a vacuum lumen) through which a kidney stone can be removed (FIG. 3: 114 is capable of removing kidney stones) and one irrigation lumen (118; the claim language only requires the structure of a lumen be capable of irrigation, and 118 is capable of acting as a irrigation lumen) extending along a length of the flexible tube portion ([0014] 118 extends from the proximal end to the distal opening 122) through which an irrigation fluid can be supplied ([0014] 118 is capable of having irrigation fluid supplied through 118); and
a nozzle (104) inserted partially within a distal end opening of the flexible tube portion (FIG. 2: 104 is partially inserted within 122) and capping the irrigation lumen (FIGs. 1-2: 104 caps 118), the nozzle comprising
a distal facing wall (FIGs. 1-2: the distal and side walls of 104) extending across and covering a distal portion of the one irrigation lumen (FIG. 2: 104 covers the distal opening of 118), the distal facing wall having apertures forming a plurality of irrigation ports (130) all of which are in fluid communication with the one irrigation lumen ([0014] 130 are in fluid communication with 118) and each of the apertures forming the irrigation ports are sized so as to provide a constriction on the flow of irrigation fluid out from the distal opening of the one irrigation lumen and through the apertures forming the irrigation ports ([0018] 130 reduces the flow of fluid into and out of 118), wherein each of the irrigation ports opens in both a distal-facing and lateral-facing direction (FIG. 4: 130 are tapered to face both distally and laterally).
Gutierrez et al. does not disclose a plurality of pull wires running from a distal section of the flexible tube portion to one or more wire pull members on the handle portion, wherein pulling on one or more of the pull wires using the one or more wire pull members causes the distal section of the flexible tube portion to bend in one or more directions.
Sinelnikov et al. teaches in the same field of endeavor of catheters, and discloses a catheter ([0213] ablation catheter) with a plurality of pull wires running from a distal section of the flexible tube portion to one or more wire pull members on the handle portion ([0213] ablation catheter can be controllably deflected by pull wires connected to the distal region 368, running up the lumens in the shaft to the proximal region to a deflection actuator 369 on the handle 370; see FIG. 17), wherein pulling on the one or more pull wires using the wire pull members causes the distal section of the flexible tube portion to bend in one or more directions ([0213] pulling on the pull wires with 369 causes 368 to bend back and forth, as shown in FIG. 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the catheter of Gutierrez et al. to have a plurality of pull wires running from a tube portion distal section to one or more wire pull members on the handle portion, wherein pulling on the one or more pull wires using the wire pull members causes the tube portion distal section to bend in one or more directions, as taught by Sinelnikov et al., for the purpose of being able to control the angle at which the catheter is bent (Sinelnikov et al. [0213]).
Regarding claim 252, Gutierrez et al. as modified further discloses the irrigation lumen is fixed with respect to the vacuum lumen ([0014] since 108 and 110 cannot move relative to each other and 108 forms 114 while 108 and 110 collectively form 118, 114 and 118 are fixed relative to each other).
Regarding claim 253, Gutierrez et al. discloses a catheter (100; FIGs. 1-4; [0013]) for removal of kidney stones, comprising:
a handle portion ([0013] the proximal end of 100, not shown );
a flexible tube portion (102) coupled to the handle portion, the flexible tube portion comprising a vacuum lumen (114; the claim language only requires the structure of a lumen be capable of aspiration, and 114 is capable of acting as a vacuum lumen) and an irrigation lumen (118; the claim language only requires the structure of a lumen be capable of irrigation, and 118 is capable of acting as a irrigation lumen); and
a nozzle (104) inserted partially within a distal end opening of the flexible tube portion (FIG. 2: 104 is partially inserted within 122), the nozzle comprising
nozzle channels (FIG. 2: depths of 130) in communication with the irrigation lumen ([0014] 130 are in fluid communication with 118) such that the nozzle channels partially seal the irrigation lumen to constrict a flow path of irrigation stream through the irrigation lumen so as to alter the flow of the irrigation stream from the irrigation lumen through the nozzle channels ([0018] 130 reduces the flow of fluid into and out of 118), and
a distal nozzle face (FIG. 2: distal and side surface of 130) on which a plurality of irrigation ports (FIG. 2: openings of 130) are spaced apart from each other and in fluid communication with the nozzle channels ([0014] the openings of 130 are in fluid communication with the depths of 130), and an aspiration port (126) in communication with the vacuum lumen (FIG. 2: 126 is in communication with 114), wherein the aspiration port of the nozzle has an opening larger than an opening of any one of the plurality of irrigation ports of the nozzle (FIG. 4: 126 is larger than any 130), and wherein the irrigation ports of the nozzle are positioned such that each of the irrigation ports opens in a distal-facing and lateral-facing direction (FIG. 2: 130 are both distally and laterally facing).
Gutierrez et al. does not disclose a plurality of pull wires running from a tube portion distal section to one or more wire pull members on the handle portion, wherein pulling on one or more of the pull wires using the one or more wire pull members causes the distal section of the flexible tube portion to bend in one or more directions.
Sinelnikov et al. teaches in the same field of endeavor of catheters, and discloses a catheter ([0213] ablation catheter) with a plurality of pull wires running from a distal section of the flexible tube portion to one or more wire pull members on the handle portion ([0213] ablation catheter can be controllably deflected by pull wires connected to the distal region 368, running up the lumens in the shaft to the proximal region to a deflection actuator 369 on the handle 370; see FIG. 17), wherein pulling on the one or more pull wires using the wire pull members causes the distal section of the flexible tube portion to bend in one or more directions ([0213] pulling on the pull wires with 369 causes 368 to bend back and forth, as shown in FIG. 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the catheter of Gutierrez et al. to have a plurality of pull wires running from a tube portion distal section to one or more wire pull members on the handle portion, wherein pulling on the one or more pull wires using the wire pull members causes the tube portion distal section to bend in one or more directions, as taught by Sinelnikov et al., for the purpose of being able to control the angle at which the catheter is bent (Sinelnikov et al. [0213]).
Regarding claim 254, Gutierrez et al. further discloses at least some of the plurality of irrigation ports are configured to create an irrigation stream that extends radially outward from a longitudinal axis of the catheter (FIG. 2: the fluid coming out of 100 goes radially outward from the longitudinal axis of 100).
Regarding claim 255, Gutierrez et al. further discloses all of the plurality of irrigation ports are configured to create an irrigation stream that extends radially outward away from the longitudinal axis of the catheter (FIG. 2: the fluid coming out of 100 goes radially outward from the longitudinal axis of 100).
Regarding claim 256, Gutierrez et al. further discloses the plurality of irrigation ports are configured to create an irrigation stream that diverges away from a longitudinal axis of the catheter (FIG. 2: the fluid coming out of 100 goes radially outward from the longitudinal axis of 100).
Regarding claim 258, Gutierrez et al. further discloses the plurality of irrigation ports are configured to produce laminar flow ([0020] the flow can be kept continuous and unchanged).
Regarding claim 259, Gutierrez et al. further discloses the plurality of irrigation ports are configured to produce turbulent flow ([0016] the flow can be staggered to create turbulent flow).
Regarding claim 263, Gutierrez et al. as modified by Sinelnikov et al. further discloses each of the pull wires extends through a wall of the flexible tube portion (Sinelnikov et al. [0213] the pull wires pass through lumens in the shaft; see FIG. 17).
Regarding claim 269, Gutierrez et al. as modified further discloses the distal facing wall of the nozzle extends orthogonal to a longitudinal axis of the irrigation lumen (FIG. 2: the distal surface of 104 extends orthogonal to 118).
Claim(s) 251 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez et al. in view of Sinelnikov et al., and in further view of Bonutti et al. (Pub. No. 2013/0253387).
Regarding claim 251, Gutierrez et al. as modified by Sinelnikov et al. discloses the invention as claimed in claim 250, as discussed above. Gutierrez et al. does not disclose the catheter system is configured to allow kidney stone transport through the vacuum lumen when the distal portion is bent to form a curve in the range of about 100 degrees to about 200 degrees.
Bonutti et al. teaches in the same field of endeavor of methods for treating kidney stones ([0174]) and discloses a catheter ([0173] an effector) where the distal portion of the catheter is bent to form a curve in the range of about 100 to 200 degrees ([0173] an effector may be made of a variety of materials, such as shape memory material, which allow for a change in the angle between 0 and 180 degrees in either direction, and a total potential change in angle of 360 degrees). Bonutti et al. teaches the catheter (effector) may be cannulated to allow for irrigation and/or suction ([0167]). Therefore, bending the distal portion in the claimed range would not affect stone transport through the vacuum lumen.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have further modified the catheter in Gutierrez et al. to be capable of having the distal portion of the catheter is bent to an angle in the range of about 100 degrees to about 200 degrees, as taught by Bonutti et al, for the purpose of providing a greater range of motion within the kidney to reach any targeted areas (Bonutti et al. [0173]).
Claim(s) 260-262 and 264-268 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez et al. in view of Sinelnikov et al., and in further view of Eisner et al. (Pub. No. 2017/0319776).
Regarding claims 260-262, Gutierrez et al. as modified by Sinelnikov et al. discloses the invention as claimed in claim 250, as discussed above. The modified reference is silent regarding the vacuum lumen has an inner diameter greater than 2 mm, less than 2.5 mm, and about 2.5 mm.
Eisner et al. discloses a vacuum lumen ([0020] first lumen) with an inner diameter between 0.17 and 2.67 mm ([0020] the diameter of the first lumen is 0.5 to 8 Fr, or 0.17-2.67 mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the inner diameter of vacuum lumen of Gutierrez et al. to be sized between 0.17 and 2.67 mm, as taught by Eisner et al., for the purpose of being properly sized to be introduced into the body and to then suction up fluid and debris (Eisner et al. [0019]).
Regarding claims 264-267, Gutierrez et al. as modified by Sinelnikov et al. discloses the invention as claimed in claim 250, as discussed above. The modified reference is silent regarding a direct visualization device configured to be movable within the vacuum lumen and removed from within the vacuum lumen prior to stone transport through the vacuum lumen. Gutierrez et al. does disclose that a hysteroscope (116; [0013]; FIGs. 1-4) can be introduced into the body via the lumen (114).
Eisner et al. discloses directing cameras through a vacuum lumen ([0093] cameras can be put through the first and second passageways; [0175] 1704 accommodates viewing instruments) for the purpose of providing a real-time visual of the surgical site ([0093]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the catheter of Gutierrez et al. to include a direct visualization device, as taught Eisner et al., for the purpose of providing a real-time visual of the surgical site. The modification would replace the hysteroscope with the cameras, which would allow the cameras to move within the vacuum lumen and be interchanged with the hysteroscope as desired.
Regarding claims 268, Gutierrez et al. as modified discloses the invention as claimed in claim 265, as discussed above. The modified reference is silent regarding the apertures that form the irrigation ports have a diameter of 0.001 to 0.1 inches.
Eisner et al. further discloses apertures that form irrigation ports have a diameter of 0.001 to 0.1 inches ([0177] 1744 can from a combined cross-sectional area of 0.7131 square millimeters, or 0.0011 square inches, which would make the diameter of each 1744 equal to 0.048 inches).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the apertures of Gutierrez et al. to have a diameter of 0.048, as taught by Eisner et al., since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patently distinct from the prior art device. In this case, the device of Gutierrez et al. would not operate differently with the claimed aperture diameters.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
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/JRM/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights