DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 2nd, 2025, has been entered.
Response to Amendment
The claims filed on July 2nd, 2025, have been entered. Claims 1-14 and 23-27 remain pending in the Application. Claims 21-22 have been canceled by the Applicant. The claim amendments overcome the previous claim objections and 112(b) rejections.
Response to Arguments
The rejection of claims 1-14 and 23-27 under 103 over Bonneau et al. (Pub. No. 2016/0235478) in view of Hussein et al. (U.S. Patent No. 4,445,892), Furtmueller et al. (W.O. App 2010/034040), and Nguyen (Pub. No. 2018/0360482) has been withdrawn in light of Applicant’s amendment made July 2nd, 2025; specifically, Bonneau et al. does not teach the balloon, when in the expanded state, has an outer diameter that is approximately equivalent to an inner diameter of the sheath such that the balloon, when in the expanded state, is configured to slidingly contact an inner surface of the sheath.
Applicant’s arguments with respect to claim(s) 1-14 and 23-27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is noted that Applicant argues that the newly added claim limitation are not taught by the cited references; however, as discussed below, the newly added reference Hoganson (U.S. Patent No. 11,160,956) teaches said limitation.
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) 1-6, 11-14, and 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonneau et al. (Pub. No. 2016/0235478) in view of Hussein et al. (U.S. Patent No. 4,445,892) and Hoganson (U.S. Patent No. 11,160,956).
Regarding claim 1, Bonneau et al. discloses a combination access and removal device for use in percutaneous nephrolithotomy to remove a kidney stone from a patient ([0046] kidney stone removal system 10; see FIGs. 1A-3B), the device comprising:
a balloon configured to dilate a portion of a percutaneous nephrolithotomy access route from an external location on the patient to a location within a kidney of the patient ([0046] inflation balloon 24, which [0037] describes as being used to remove kidney stones from kidneys, requiring a route from a location within a kidney to an external location; see FIGs. 2A-2B);
an elongated shaft extending through a central lumen defined by the balloon and attached thereto ([0059] wall protection member shaft 42, which FIGs. 2A-B illustrate passes through 24);
a basket apparatus connected to the elongated shaft distal of the balloon ([0048] basket 20, which FIGs. 2A-B illustrate is at the distal end of 42) and configured to capture a kidney stone or fragment or both ([0048] 20 is used to trap kidney stones), wherein the basket apparatus is configured to deploy when the balloon is in a deflated state ([0080] and FIGs. 5A-5F); and
wherein the elongated shaft, the balloon, and the basket apparatus are configured to be deployed and operated concurrently as an integrated unit (FIGs. 4A-5F: in multiple methods, 20, 24, and 42 deploy and operate simultaneously as one device 10).
Bonneau et al. does not discloses a sheath configured to be extended over the balloon to provide a port extending along the percutaneous nephrolithotomy access route to provide secondary instrument access to the kidney including when the elongated shaft is located within the port with the balloon in a deflated state; the sheath extendable over the high-pressure balloon while maintaining the balloon in an expanded state sufficient for dilating the portion of the access route, and the balloon configured to be received through the port; wherein in the expanded state, the balloon has an outer diameter that is approximately equivalent to an inner diameter of the sheath such that the balloon is configured to slidingly contact the sheath and is configured to hold open the access route and permit movement of the sheath thereover; and the balloon is a high-pressure balloon. Bonneau et al. does disclose the balloon may be advanced through a catheter ([0076]).
Hussein et al. teaches in the same filed of endeavor of inflatable medical devices and discloses a sheath (C6:L1-3: outer tube 120; see FIGs. 4-5) configured to be extended over an inflatable balloon (C6:L31-36: second balloon 136; see FIGs. 4-5) to provide a port (C6:L36-38: fluid channel 146; see FIGs. 4-5) extending along the percutaneous nephrolithotomy access route to provide secondary instrument access to the kidney including when the shaft is located within the port with the balloon in a deflated state (C6:L47-53: when 136 is deflated, a clear space in 146 allows for use of stem 164; see FIG. 4) the sheath extendable over the balloon while maintaining the balloon in an expanded state sufficient for dilating the portion of the access route (C5:L66-C6:L30: 120 can go over 136 while 136 is expanded), and the balloon configured to be received through the port (FIGs. 4-5: 136 can be received through 146).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device in Bonneau et al. to include a sheath configured to be extended over the inflatable balloon to provide a port extending along the percutaneous nephrolithotomy access route to provide secondary instrument access to the kidney including when the shaft is located within the port with the balloon in a deflated state, as taught by Hussein et al., for the purpose of sealing off an operating area and allowing secondary tools to operate in the area (Hussein et al. C6:L10-17 and 28-30).
Hoganson discloses an expandable balloon (36; FIG. 2C) which is advanced through a sheath (10) and, in an expanded state (FIG. 2C), the outer diameter of the balloon can be equal to the internal diameter of the sheath (C4:L63-C5:L3) such that the balloon is configured to slidingly contact an inner surface of the sheath (C5:L29-37: while 36 is inflated, 36 can be threaded over a guidewire 40 before 33 and 10 are fed over 36 and into the target area) and is configured to hold open the portion of the access route and permit movement of the sheath thereover (C5:L29-37: 36 is inflated to allow threading of 40 before 10 is moved, where 10 can then be moved) for the purpose of creating a smooth and removable transition between the tools being used in the procedure and the sheath being used to deploy the tools.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the balloon of Bonneau et al. to have the same diameter as the sheath and to slidably contact the sheath while inflated, which would mean that in the expanded state, the balloon is configured to hold open the access route and permit movement of the sheath thereover, for the purpose of creating a smooth and removable transition between the tools being used in the procedure and the sheath being used to deploy the tools.
Regarding claim 2, Bonneau et al. further discloses the device is configured to allow for entry of the basket apparatus through a distal end of the port without removal of the balloon ([0048] does not mention the balloon is removed during entry of the basket).
Regarding claim 3, Bonneau et al. further discloses the basket apparatus is configured to be collapsible within the distal end of the shaft ([0048] basket goes from collapsed in the inner shaft to expanded).
Regarding claim 4, Bonneau et al. further discloses a basket actuator located at a proximal end of the shaft ([0057] retention member slider 32; see FIG. 1A), the basket actuator being configured to deploy the basket apparatus when the shaft is located within the port ([0057] retention member slider 32 can retract 20 back into the inner shaft).
Regarding claim 5, Bonneau et al. further discloses the basket apparatus is configured to be capable of withstanding lithotripsy via the secondary instrument and remain safely removable ([0048] basket 20 is made of nitinol, which [0036] of the Spec discloses has this property).
Regarding claim 6, Bonneau et al. further discloses the basket apparatus is configured to break non-traumatically when struck by the secondary instrument ([0048] basket 20 is made of nitinol, which [0036] of the Spec discloses has this property).
Regarding claim 11, Bonneau et al. further discloses the shaft a longitudinal lumen ([0052] a small inner shaft is within the outer shaft 16; see FIG. 2A) and further comprising a basket manipulation member ([0052] the small inner shaft) configured to extend through the lumen of the shaft and connecting to the basket apparatus at a distal end of the basket manipulation member, to permit removal of a kidney stone, fragment, or both via the lumen of the shaft ([0052] the small inner shaft extends through 16 and connects the basket to the rest of the device to allow capturing of a kidney stone).
Regarding claim 12, Bonneau et al. further discloses the basket manipulation member is configured to provide a first position wherein the basket apparatus is near the distal end of the shaft ([0052] the small inner shaft has an initial position with 20 inside the distal end); and a second position wherein the basket apparatus extends outward the distal end of the shaft ([0052] the small inner shaft has a position where 20 is advanced out and expanded to capture stones).
Regarding claim 13, Bonneau et al. further discloses an extension actuator located at a proximal end of the shaft ([0053] handle extension 14 advances and retracts one or more of the shafts), the extension actuator being configured to extend the basket manipulation member from the first position to the second position ([0053] 14 can advance the small inner shaft from the first position to the second position).
Regarding claim 14, Bonneau et al. discloses a combination access and removal device for use in percutaneous nephrolithotomy to remove a kidney stone from a patient ([0046] kidney stone removal system 10; see FIGs. 1A-3B), the device comprising:
a balloon configured to dilate a portion of a percutaneous nephrolithotomy access route from an external location on the patient to a location within a kidney of the patient ([0046] inflation balloon 24, which [0037] describes as being used to remove kidney stones from kidneys, requiring a route from a location within a kidney to an external location; see FIGs. 2A-2B), wherein the balloon is configured to be inflated with a non-gaseous medium ([0054] balloon is inflated a balloon inflation fluid such as saline, water, or contrast agent);
an elongated shaft extending through a central lumen defined by the balloon and attached thereto ([0059] wall protection member shaft 42, which FIGs. 2A-B illustrate passes through 24);
a basket apparatus fixed to a distally of the ballon on a distal end of the shaft and configured to capture a kidney stone or fragment or both ([0048] basket 20, which FIGs. 2A-B illustrate is at the distal end of 42, and which is used to trap kidney stones), wherein the balloon and the basket apparatus are deployable together on the elongated shaft (FIGs. 2A-2B: both 20 and 24 are deployed together with 42), wherein the basket apparatus is configured to allow for deployment and retrieval of the basket through a distal end of a port without removal of the balloon ([0048] does not mention the balloon is removed during entry of the basket).
Bonneau et al. does not discloses a sheath configured to be extended over the balloon to provide a port extending along the percutaneous nephrolithotomy access route to provide secondary instrument access to the kidney including when the elongated shaft is located within the port with the balloon in a deflated state; when in an expanded state, the balloon has an outer diameter that is approximately equivalent to an inner diameter of the sheath such that the balloon is configured to slidingly contact an inner surface of the sheath, the sheath extendable over the high-pressure balloon while maintaining the balloon in an expanded state sufficient for dilating the access route; and the balloon is a high-pressure balloon. Bonneau et al. does disclose the balloon may be advanced through a catheter ([0076]).
Hussein et al. teaches in the same filed of endeavor of inflatable medical devices and discloses a sheath (C6:L1-3: outer tube 120; see FIGs. 4-5) configured to be extended over an inflatable balloon (C6:L31-36: second balloon 136; see FIGs. 4-5) to provide a port (C6:L36-38: fluid channel 146; see FIGs. 4-5) extending along the percutaneous nephrolithotomy access route to provide secondary instrument access to the kidney including when the shaft is located within the port with the balloon in a deflated state (C6:L47-53: when 136 is deflated, a clear space in 146 allows for use of stem 164; see FIG. 4) the sheath extendable over the balloon while maintaining the balloon in an expanded state sufficient for dilating the portion of the access route (C5:L66-C6:L30: 120 can go over 136 while 136 is expanded).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the device in Bonneau et al. to include a sheath configured to be extended over the inflatable balloon to provide a port extending along the percutaneous nephrolithotomy access route to provide secondary instrument access to the kidney including when the shaft is located within the port with the balloon in a deflated state, as taught by Hussein et al., for the purpose of sealing off an operating area and allowing secondary tools to operate in the area (Hussein et al. C6:L10-17 and 28-30).
Hoganson discloses an expandable balloon (36; FIG. 2C) which is advanced through a sheath (10) and, in an expanded state (FIG. 2C), the outer diameter of the balloon can be equal to the internal diameter of the sheath (C4:L63-C5:L3) such that the balloon is configured to slidingly contact an inner surface of the sheath (C5:L29-37: while 36 is inflated, 36 can be threaded over a guidewire 40 before 33 and 10 are fed over 36 and into the target area) and is configured to hold open the portion of the access route and permit movement of the sheath thereover (C5:L29-37: 36 is inflated to allow threading of 40 before 10 is moved, where 10 can then be moved) for the purpose of creating a smooth and removable transition between the tools being used in the procedure and the sheath being used to deploy the tools.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the balloon of Bonneau et al. to have the same diameter as the sheath and to slidably contact the sheath while inflated, which would mean that in the expanded state, the balloon is configured to hold open the access route and permit movement of the sheath thereover, for the purpose of creating a smooth and removable transition between the tools being used in the procedure and the sheath being used to deploy the tools.
Regarding claim 23, Bonneau et al. as modified further discloses the device is configured to allow for entry of the basket apparatus through a distal end of the port without removal of the balloon ([0048] does not mention the balloon is removed during entry of the basket).
Regarding claim 24, Bonneau et al. as modified further discloses the basket apparatus is configured to be collapsible within the distal end of the shaft (FIGs. 4A-E illustrate the method of using 10, and FIG. 4E shows 20 collapsing within the distal end of the shaft).
Regarding claim 25, Bonneau et al. as modified further discloses the shaft includes a longitudinal lumen ([0076] 42 is hollow and contains inner shaft 44; FIGs. 4A-E) and further comprising a basket manipulation member (44) configured to extend through the longitudinal lumen of the shaft and connecting to the basket apparatus at a distal end of the basket manipulation member, to permit removal of a kidney stone, fragment, or both via the longitudinal lumen of the shaft ([0077]).
Regarding claim 26, Bonneau et al. as modified by Hussein et al. further discloses a secondary instrument (164; C6:L47-53; FIG. 4) configured to be deployed when the balloon is in a deflated state (C6:L47-53: when 136 is deflated, a clear space in 146 allows for use of stem 164; FIG. 4).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonneau et al. in view of Hussein et al. and Hoganson, and in further view of Adams et al. (Pub. No. 2014/0180326).
Regarding claim 7, Bonneau et al. as modified discloses the invention as claimed in claim 1. Bonneau et al. does not disclose the balloon has a length of at least 12 centimeters.
Adams et al. teaches in the same field of endeavor of medical devices, and discloses a balloon ([0026] balloon 410) with a length of at least 12 centimeters ([0026] 410 has a length of 6-12 cm).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have further modified the balloon in Bonneau et al. to have a length of at least 12 centimeters, as taught by Adams et al., for the purpose of extending over the aorta from one side of aorta to the other side to protect the left renal vein from being pinched or compressed (Adams et al. [0026]).
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonneau et al. in view of Hussein et al. and Hoganson, and in further view of Erbey, II et al. (Pub. No. 2019/0105465).
Regarding claim 8, Bonneau et al. as modified discloses the invention as claimed in claim 1. Bonneau et al. does not disclose the balloon has a length of no more than 14 centimeters.
Erbey, II et al. teaches in the same field of endeavor of medical devices deployed within kidneys, and discloses a balloon ([0353] inflatable balloon 350; see FIG. 38B) with a length of no more than 14 centimeters ([0513] inflatable balloon catheter has a length of 5 cm).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have further modified the balloon in Bonneau et al. to have a length of no more than 14 centimeters, as taught by Erbey, II et al., for the purpose of fitting within the renal pelvis (Erbey, II et al. [0353]).
Regarding claim 9, Bonneau et al. as modified discloses the invention as claimed in claim 1. Bonneau et al. does not disclose the balloon in an inflated state has an outer diameter of at least 10 millimeters.
Erbey, II et al. teaches in the same field of endeavor of medical devices deployed within kidneys, and discloses a balloon ([0353] inflatable balloon 350; see FIG. 38B) with an outer diameter of at least 10 millimeters ([0353] 350 has a diameter of 10-30 mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have further modified the balloon in Bonneau et al. to have an outer diameter of at least 10 millimeters, as taught by Erbey, II et al., for the purpose of fitting within the renal pelvis (Erbey, II et al. [0353]).
Regarding claim 10, Bonneau et al. as modified discloses the invention as claimed in claim 1. Bonneau et al. does not disclose the balloon in an inflated state has an outer diameter of no greater than 12 millimeters.
Erbey, II et al. teaches in the same field of endeavor of medical devices deployed within kidneys, and discloses a balloon ([0353] inflatable balloon 350; see FIG. 38B) with an outer diameter of no greater than 12 millimeters ([0353] 350 has a diameter of 10-30 mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have further modified the balloon in Bonneau et al. to have an outer diameter of no more than 12 millimeters, as taught by Erbey, II et al., for the purpose of fitting within the renal pelvis (Erbey, II et al. [0353]).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonneau et al. in view of Hussein et al. and Hoganson, and in further view of Chang et al. (Pub. No. 2010/0174308).
Regarding claim 27, Bonneau et al. as modified discloses the invention as claimed in claim 1, as discussed above. Bonneau et al. does not disclose a lubricious coating on an interior surface of the sheath, wherein the lubricious coating enables concurrent dilation and instrument access through the sheath while the high-pressure balloon maintains the access route.
Chang et al. teaches a sheath (902; FIG. 9A) that has an inner surface with a lubricious coating ([0196]) for the purpose of facilitating passage of devices through the lumen of the sheath.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the sheath of Hussein et al. to include a lubricious coating, for the purpose of speeding up procedures by allowing the balloon to be partially inflated before leaving the sheath without getting stuck. This modification would enable concurrent dilation and instrument access through the sheath while the high-pressure balloon maintains the access route, as the coating would help speed up the passage of devices, including secondary instruments, through the sheath.
Conclusion
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/JRM/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771