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 .
Response to Amendment
The amendments under 37 CFR 1.132 filed 02/19/2026 is insufficient to overcome the rejection of claim 46 based upon being rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US PGPUB: 2019/0388133) in view of Eversull et al (US PGPUB: 2007/0015964), further in view of Daniels (US 4655746 A) and Harshman (US 20160310210 A1) as set forth in the last Office action because: Sharma teaches wherein the first occlusion balloon is spaced apart from the second occlusion balloon by a selected distance (Fig. 11) to define a first treatment space between the first occlusion balloon and the second occlusion balloon (Fig 11B; treatment site located between the two balloons) ([0373] In the embodiments depicted in FIGS. 11A, 11B, the catheters 1145a, 1145b include a proximal first inflatable balloon 1147 and a distal second inflatable balloon 1148 positioned proximate the distal end of the body 1146 with a plurality of infusion ports 1149 located on the body 1146 between the two balloons 1147, 1148); a controller configured to control operating parameters of the heating mechanism ([0376] “the supply of liquid and electrical current, and therefore delivery of vapor, is controlled by a microprocessor”) based on the selected distance ([0293] each treatment dose delivered to the gastrointestinal tract comprises the following parameters: 1-15 cm of contiguous or non-contiguous small intestine mucosa is treated; at least 50% of a circumference of a small intestine is treated; energy in a range of 5-25 J/cm.sup.2; delivery period of 1-60 seconds; delivery rate of 5-2,500 cal/sec; total dose of 5-40 cal/gm of tissue to be ablated; target tissue temperature between 60° C. and 110° C.; vapor temperature between 99° C. and 110° C.; and pressure in the gastrointestinal tract less than 5 atm, and preferably less than 1 atm) (Parameters include selected distance of the small intestine).
Acknowledgement is made to newly added claims 64-65. Currently claims 46-65 are pending.
Response to Arguments
Applicant's arguments filed 02/19/2026 have been fully considered but they are not persuasive.
Applicant argues that there is no teaching in Sharma of spacing a first occlusion balloon from a second occlusion balloon by a selected distance and that Sharma also fails to teach controlling the operating parameters of a heating element based on the selected distance. However, Examiner respectfully disagrees. Sharma teaches two occlusion balloons being set a preferred distance to control the length of the ablation zone between the two ([0387] In this way, a distance between the distal and proximal balloons 1410, 1412 may be adjusted before or during an ablation procedure, thereby adjusting a length of a coagulation/ablation zone 1420. In some embodiments, the length of the zone 1420 ranges from 4 cm to 6 cm). Further, Sharma teaches controlling parameters of the heating element based on a selected distance ([0376] the supply of liquid and electrical current, and therefore delivery of vapor, is controlled by a microprocessor) ([0293] each treatment dose delivered to the gastrointestinal tract comprises the following parameters: 1-15 cm of contiguous or non-contiguous small intestine mucosa is treated; at least 50% of a circumference of a small intestine is treated; energy in a range of 5-25 J/cm.sup.2; delivery period of 1-60 seconds; delivery rate of 5-2,500 cal/sec; total dose of 5-40 cal/gm of tissue to be ablated; target tissue temperature between 60° C. and 110° C.; vapor temperature between 99° C. and 110° C.; and pressure in the gastrointestinal tract less than 5 atm, and preferably less than 1 atm) (Parameters include selected distance of the small intestine). The selected distance of 1-15 cm in the small intestine is treated with specific control parameters.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 46-55 and 59-63 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US PGPUB: 2019/0388133) in view of Eversull et al (US PGPUB: 2007/0015964), further in view of Daniels (US 4655746 A) and Harshman (US 20160310210 A1).
Regarding independent claim 46, Sharma discloses a single-use probe (Fig. 11A-11B, 12A-12C) for performing a medical procedure in a gastrointestinal tract of a patient (at least [0050], [0291], [0338], [0377]), comprising:
a handle (1210) coupled to an elongated shaft (1146) having a central axis (Fig. 11) and configured for trans- esophageal introduction into a patient's small intestine (at least [0012], [0047], [0060], [0108], [0287], [0291], [0293], [0377] discusses inserting the device into the esophagus and small intestine)
a plurality of occlusion balloons (1147, 1148) including a first occlusion balloon (1147) and a second occlusion balloon (1148), the plurality of occlusion balloons located at the working end (Fig. 11B), wherein the first occlusion balloon is spaced apart from the second occlusion balloon by a selected distance (Fig. 14A) ([0387] In this way, a distance between the distal and proximal balloons 1410, 1412 may be adjusted before or during an ablation procedure, thereby adjusting a length of a coagulation/ablation zone 1420. In some embodiments, the length of the zone 1420 ranges from 4 cm to 6 cm) to define a first treatment space between the first occlusion balloon and the second occlusion balloon (Fig 11B; treatment site located between the two balloons) ([0373] In the embodiments depicted in FIGS. 11A, 11B, the catheters 1145a, 1145b include a proximal first inflatable balloon 1147 and a distal second inflatable balloon 1148 positioned proximate the distal end of the body 1146 with a plurality of infusion ports 1149 located on the body 1146 between the two balloons 1147, 1148);
at least one inflation channel (1155, 1156) in the elongated shaft (Fig. 11B) for expanding the plurality of occlusion balloons ([0374]); and
a fluid source in communication with a flow channel (1157; [0374]-[0376]) in the single-use probe having an outlet (1149) between the first occlusion balloon and the second occlusion balloon (Fig. 11B);
a heating mechanism (1150) configured to convert a fluid flow in the flow channel to a vapor media ([0376]); and
a controller configured to control operating parameters of the heating mechanism ([0376] “the supply of liquid and electrical current, and therefore delivery of vapor, is controlled by a microprocessor”) based on the selected distance ([0293] each treatment dose delivered to the gastrointestinal tract comprises the following parameters: 1-15 cm of contiguous or non-contiguous small intestine mucosa is treated; at least 50% of a circumference of a small intestine is treated; energy in a range of 5-25 J/cm.sup.2; delivery period of 1-60 seconds; delivery rate of 5-2,500 cal/sec; total dose of 5-40 cal/gm of tissue to be ablated; target tissue temperature between 60° C. and 110° C.; vapor temperature between 99° C. and 110° C.; and pressure in the gastrointestinal tract less than 5 atm, and preferably less than 1 atm) (Parameters include selected distance of the small intestine).
Sharma does not explicitly disclose an image sensor and at least one light emitter at the distal end of the elongated shaft; the elongated shaft configured to be flexible; and a plurality of pull wires in the elongated shaft for articulating a working end of the elongated shaft.
However, Eversull discloses a probe (Fig. 1A-1C) comprising a balloon (50) on a flexible elongated shaft (12; [0076]). An image sensor (64) and a light emitter (68) are located on the distal end of the shaft (Fig. 1B; [0101]-[0103]). The flexible elongated shaft comprises a plurality of pull wires (22) for articulating the working end of the shaft ([0077]-[0079]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Sharma to incorporate an image sensor; the at least one light emitter at the distal end of the elongated shaft the elongated shaft configured to be flexible; and a plurality of pull wires in the elongated shaft for articulating a working end of the elongated shaft of Eversull. This configuration provides the benefit of improved visualization and control for minimally invasive procedures ([0003]-[0004], [0077]), thereby improving the efficiency of the device.
Further, the combination fails to teach where the plurality of occlusion balloons are axially advanceable from the working end independently to the image sensor.
However, Daniels teaches where the plurality of occlusion balloons are axially advanceable from the working end ([15] As part of the positioning procedure, the catheter may be used to deliver a contrast agent for purposes of tissue imaging. The second catheter is then threaded through the first catheter and into the vessel until its balloon is positioned adjacent the other end of the segment. Inflating the two balloons isolates the vessel segment).
Further, Harshman teaches where the occlusion balloons move independently to the image sensor (Fig 5-7; [0104] Visualization of the electrode and balloon can be performed by moving the camera independently of the electrode and balloon. For example, the user can hold the handle of catheter assembly fixed, and then axially move the camera towards the electrode and the balloon without disturbing their position).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the combination system to incorporate teachings of Daniels and Harshman of balloons being movable axially relative to a delivery sheath. Harshman also teaches the presence of the image sensor within the delivery sheath, such that the balloon/catheter can move independently of the image sensor & delivery sheath. It would have been obvious to modify Sharma to incorporate this delivery sheath of Harshman having the image sensor thereon such that the occlusion balloons of Sharma are capable of moving axially relative to a working end and independently of the image sensor. Doing so allows for independent imaging of the axial placement of occlusion balloons from an outer perspective.
Regarding dependent claim 47, in view of the combination of claim 46, Sharma further discloses wherein the selected distance is 5 cm to 40 cm ([0248], [0375]).
Regarding dependent claim 48, in view of the combination of claim 46, Eversull further discloses wherein the handle carries a first grip (32) and a second grip (32) for actuating the plurality of pull wires to articulate the working end (0079] “The 30 may include one or more steering controls 32 that may be actuated to steer the distal end 16 of the catheter 12.”).
Regarding dependent claim 49, in view of the combination of claim 46, Sharma further discloses wherein each of the plurality of occlusion balloons has an independent inflation channel (1155, 1156) connected thereto ([0374]; Fig. 11B).
Regarding dependent claim 50, in view of the combination of claim 46, Sharma further discloses wherein the controller is operatively coupled to an inflation source for controlling inflation and deflation at least the first occlusion balloon and the second occlusion balloon ([0376]).
Regarding dependent claim 51, in view of the combination of claim 46, Sharma further discloses wherein the heating mechanism is carried in the handle ([0376], [0378] portion of heating mechanism, i.e., wires for carrying electric current, are carried in the handle).
Regarding dependent claim 52, in view of the combination of claim 46, Sharma further discloses further comprising at least a first actuator button (3-way valve 1240) on the handle configured to actuate the fluid source and the heating mechanism ([0384]-[0385]).
Regarding dependent claim 53, in view of the combination of claim 46, Sharma further discloses wherein the fluid source and the heating mechanism are controlled by the controller ([0384]- [0385]) to deliver energy from the vapor media to tissue between 10 calories/sec and 100 calories/sec ([0014], [0026], [0352], [0384]- [0385], claim 5).
Regarding dependent claim 54, in view of the combination of claim 53, Sharma further discloses wherein energy delivered to tissue is between 20 calories/sec and 50 calories/sec ([0014], [0026], [0352], [0384]-[0385], claim 5).
Regarding dependent claim 55, in view of the combination of claim 46, Sharma further discloses further comprising a negative pressure source coupled to a channel in the elongated shaft having an outlet in the working end ([0374] inflation channel with outlet capable of receiving suction, i.e. negative pressure).
Regarding dependent claim 59, in view of the combination of claim 46, Eversull further discloses further comprising at least a second actuator button on the handle for adjusting parameters of the at least one light emitter and for operation of the image sensor ([0103] source 70 coupled to handle).
Regarding independent claim 60, Sharma discloses a method of using the single-use probe of claim 46 (see rejection of claim 46 above) comprising:
introducing the elongated shaft (1146) in a trans-esophageal approach into a duodenum of the patient (at least [0012], [0047], [0060], [0108], [0287], [0290], [0291], [0293],[0296], [0377], [0419]; Fig. 11C; Fig. 23B);
positioning the working end in a targeted location in the duodenum under endoscopic vision ([0269], [0377]);
expanding the plurality of occlusion balloons under endoscopic vision ([0269], [0377]); and
actuating the fluid source and the heating mechanism to deliver the vapor media to tissue in the duodenum between the plurality of occlusion balloons ([0377]).
Sharma does not explicitly disclose the device is delivered to the target by viewing images from the image sensor and actuating the plurality of pull wires to articulate the working end.
However, Eversull discloses the device is delivered to the target by viewing images from the image sensor ([0101]-[0103]) and actuating the plurality of pull wires to articulate the working end ([0077]-[0079]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Sharma to incorporate viewing images from the image sensor and actuating the plurality of pull wires to articulate the working end of Eversull. This configuration provides the benefit of improved visualization and control for minimally invasive procedures ([0003]-[0004], [0077]), thereby improving the efficiency of the device.
Regarding dependent claim 61, in view of the combination of claim 60, Sharma further discloses wherein delivering the vapor media comprises applying energy to tissue between 10 calories/sec and 100 calories/sec ([0014], [0026], [0352], [0384]-[0385], claim 5).
Regarding dependent claim 62, in view of the combination of claim 61, while Sharma discloses the depth is dependent on the parameters of the system ([0248]) and as such contemplates an ablation depth of less than 0.8 mm, Sharma does not explicitly wherein applying energy ablates tissue to a depth of less than 0.8 mm. However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have used the system of Sharma to ablate tissue to a depth less than 0.8mm because Sharma discloses it is known to adjust the parameters f a system to produce the predictable result of a desired ablation depth.
Regarding dependent claim 63, in view of the combination of claim 60, Sharma further discloses wherein delivering the vapor media comprises applying energy to tissue between 20 calories/sec and 50 calories/sec ([0014], [0026], [0352], [0384]-[0385], claim 5).
Claims 56-58 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US PGPUB: 2019/0388133) in view of Eversull et al (US PGPUB: 2007/0015964), further in view of Daniels (US 4655746 A) and Harshman (US 20160310210 A1), further in view of Knowlton (US Patent No.: 6,427,089).
Regarding dependent claims 56-58, in view of the combination of claim 46, Sharma does not explicitly disclose wherein at least one of the plurality of occlusion balloons carries a sensor for sensing tissue contact with a balloon surface (claim 56); wherein the sensor is adapted to provide a signal to an operator relating to tissue contact of the balloon surface to tissue (claim 57); and wherein the sensor is an electrical sensor adapted to sense at least one of capacitance, impedance and phase angle (claim 58).
However, Knowlton discloses a balloon (Fig. 2A: 14) comprising a sensor (26) for sensing tissue contact with the balloon surface by measuring impedance to inform the operator the degree of contact with the tissue (Col. 14, Line 59 - Col. 15, Line 5). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Sharma to incorporate wherein at least one of the plurality of occlusion balloons carries a sensor for sensing tissue contact with a balloon surface; wherein the sensor is adapted to provide a signal to an operator relating to tissue contact of the balloon surface to tissue; and wherein the sensor is an electrical sensor adapted to sense at least one of capacitance, impedance and phase angle of Knowlton. This configuration provides the benefit of the ability to predict the depth and extend of the ablation to thereby improve the performance of the treatment and regulate the delivery of energy (Col. 15, lines 1-5 & Lines 45-48). Further, Knowlton discloses these contact sensors for monitoring tissue contact are known in the art (Col. 14, Line 59 - Col. 15, Line 5). Examiner notes the remainder of the limitations of claim 58 (i.e. the capacitance and phase angle) are in the alternative.
Claims 64-65 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US PGPUB: 2019/0388133) in view of Eversull et al (US PGPUB: 2007/0015964), further in view of Daniels (US 4655746 A) and Harshman (US 20160310210 A1), further in view of Forman (US 6685672 B1)
Regarding dependent claim 64, in view of the combination of claim 46, Sharma does not explicitly disclose wherein the plurality of occlusion balloons further comprises a third occlusion balloon spaced apart from the second occlusion balloon by a selected distance to define a second treatment space between the second occlusion balloon and the third occlusion balloon.
However, Forman teaches wherein the plurality of occlusion balloons further comprises a third occlusion balloon spaced apart from the second occlusion balloon (Fig 1; balloons 20/22/24 and second treatment space 32) by a selected distance (Fig 1; [30] In the embodiments where the balloons are a fixed distance apart, there are preferably 1 cm agent delivery segments of shaft between the balloons) to define a second treatment space between the second occlusion balloon and the third occlusion balloon (Fig 1; treatment space 32). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system of Sharma to incorporate wherein the plurality of occlusion balloons further comprises a third occlusion balloon spaced apart from the second occlusion balloon by a selected distance to define a second treatment space between the second occlusion balloon and the third occlusion balloon. Doing so would allow a second treatment site to be located further down for a more selective treatment based on the target site (Forman; [19] Agents can then be infused or collected via the orifices 28 in the first and/or second agent delivery segment 30/32 the agent delivery pocket 8).
Regarding dependent claim 65, in view of the combination of claim 64, Sharma teaches wherein the controller is configured to control operating parameters of the heating mechanism ([0376] “the supply of liquid and electrical current, and therefore delivery of vapor, is controlled by a microprocessor”) ([0293] each treatment dose delivered to the gastrointestinal tract comprises the following parameters: 1-15 cm of contiguous or non-contiguous small intestine mucosa is treated; at least 50% of a circumference of a small intestine is treated; energy in a range of 5-25 J/cm.sup.2; delivery period of 1-60 seconds; delivery rate of 5-2,500 cal/sec; total dose of 5-40 cal/gm of tissue to be ablated; target tissue temperature between 60° C. and 110° C.; vapor temperature between 99° C. and 110° C.; and pressure in the gastrointestinal tract less than 5 atm, and preferably less than 1 atm) (Parameters include selected distance of the small intestine) to selectively deliver vapor media ([0274] Delivery of the ablative agent is controlled by a controller 15 and treatment is controlled by a treating physician via the controller 15. The controller 15 includes at least one processor 23 in data communication with the saline pump 14 and a catheter connection port 21 in fluid communication with the saline pump 14) to the first treatment space or the second treatment space (Fig 11B; treatment site located between the two balloons) ([0373] In the embodiments depicted in FIGS. 11A, 11B, the catheters 1145a, 1145b include a proximal first inflatable balloon 1147 and a distal second inflatable balloon 1148 positioned proximate the distal end of the body 1146 with a plurality of infusion ports 1149 located on the body 1146 between the two balloons 1147, 1148).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794