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 amendment filed October 29th, 2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed October 29th, 2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 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 Therefore, the rejection has been withdrawn.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 newly found prior art that teaches the newly disclosed claim limitations.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 15, the claim recites “a balloon” in lines 2-3 and it is unclear if this is the same balloon as recited in claim 1, from which clam 15 depends, or is a different balloon. For examination purposes, these are the same balloon and the limitation will be interpreted as “the balloon”.
Claim 16 is also rejected by virtue of its dependency on claim 15.
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 1-9, 11, 15-19 & 47 are rejected under 35 U.S.C. 103 as being unpatentable over Mayse et al. (U.S. Pub. No. 20130310822, previously cited), herein referred to as “Mayse” in view of Mayse et al. (U.S. Pub. No. 20110152855), herein referred to as “Mayse 2” and further in view of Brannan et al. (U.S. Pub. No. 20160184013, previously cited), herein referred to as “Brannan”.
Regarding claim 1, Mayse discloses a system for treating target tissue located at a first location along an anatomic lumen (Abstract: A pulmonary treatment system includes a compact configuration for delivery to a first airway of a patient. An energy delivery system of the pulmonary treatment system delivers energy to target tissue in or along an airway wall of the first airway to reduce airway resistance in a second airway distal to the first airway), the system comprising:
a catheter (pulmonary treatment system 2100) including a distal end portion configured for deployment in the anatomic lumen ([0203]: pulmonary treatment system 2100 is configured to be positioned at a treatment site within an airway of a patient to deliver energy to target tissue);
an expansion device (expandable member 2140) coupled to the distal end portion of the catheter ([0203]: the pulmonary treatment system 2100 includes a thermodynamically cooled treatment wand 2110, an electrode 2120, and an expandable member 2140), the expansion device including a balloon having a balloon membrane (see Fig. 7 that shows that expandable member 2140 is a balloon comprising a balloon membrane), a ridge (treatment wand 2110) in a deployed configuration ([0203]: FIG. 7 illustrates the pulmonary treatment system 2100 in a fully deployed state, in which the expandable member 2140 is fully inflated and the treatment wand 2110 extends circumferentially around a portion of the expandable member 2140; [0205]: The expandable member 2140 conforms to the shape of the treatment wand 2110 and holds the treatment wand 2110 in close appositional contact with the airway wall between adjacent cartilage rings 28),
wherein the expansion device in the deployed configuration is configured to occlude the anatomic lumen at a second location, different from the first location, along the anatomic lumen and the ridge is configured to compress at least one of a plurality of blood vessels adjacent the anatomic lumen to reduce blood flow to the target tissue at the first location ([0056]: positioning an energy delivery system at a treatment site in a first airway and delivering energy from the energy delivery system to occlude at least one bronchial artery that extends along the first airway; [0205]: The expandable member 2140 conforms to the shape of the treatment wand 2110 and holds the treatment wand 2110 in close appositional contact with the airway wall between adjacent cartilage rings 28; [0251]: delivering energy from the pulmonary treatment system 2110 may occlude at least one bronchial artery 130' within the zone of ablation 117. It is believed that occluding a bronchial artery that extends along a first airway may reduce inflammation in a second airway that is a higher generation airway of the first airway; see bronchial arteries 130 & 130’ in Figs. 15 & 16 and wherein if the device is in close appositional contact with the airway wall between adjacent cartilage rings, then the structure is capable of compressing at least one of a plurality of blood vessels adjacent the anatomic lumen to reduce blood flow to the target tissue at the first location).
While Mayse discloses a balloon, a balloon membrane, and a ridge, Mayse fails to disclose the balloon membrane forming a ridge.
However, Mayse 2 discloses a balloon (balloon 720, Fig. 37) having a balloon membrane (membrane of balloon 720, see Fig. 37), the balloon membrane forming a ridge in a deployed configuration (ablation assembly 780, see Fig. 37 where this is formed in the balloon membrane). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the balloon membrane and ridge of Mayse to be a balloon membrane forming a ridge, as taught by Mayse 2, for the purpose of enabling the inflation pressure to be increased to increase the force applied to an airway wall and to help seat the ridge and allow positioning between cartilaginous rings (Mayse 2: [0225]-[0226]).
But Mayse fails to disclose a control system comprising at least one processor, the control system configured to: identify the first location along the anatomic lumen where the target tissue is located; and determine the second location, different from the first location, along the anatomic lumen for occluding the anatomic lumen and compressing the at least one of the plurality of blood vessels adjacent the anatomic lumen to reduce blood flow to the target tissue at the first location.
However, Brannan discloses a system for treating target tissue located at a first location along an anatomic lumen (Abstract: A system and method enabling the receipt of image data of a patient, identification of one or more locations within the image data depicting symptoms of COPD, analyzing airways and vasculature proximate the identified locations; planning a pathway to the one or more locations, navigating an extended working channel to one of the locations, positioning a microwave ablation catheter proximate the location, and energizing the microwave ablation catheter to treat the locations), comprising: a control system (computing device 48) comprising at least one processor ([0059]: a computing device 48 including software and/or hardware), the control system configured to:
identify the first location along the anatomic lumen where the target tissue is located ([0062]: computing device 48 utilizes computed tomographic (CT) image data for generating and viewing a three-dimensional model of the patient's “P's” airways, enables the identification of a target 50 on the three-dimensional model (automatically, semi-automatically, or manually), and allows for determining a pathway through the patient's “P's” airways to the target 50); and
determine the second location, different from the first location, along the anatomic lumen for occluding the anatomic lumen and compressing the at least one of the plurality of blood vessels adjacent the anatomic lumen to reduce blood flow to the target tissue at the first location ([0062]: computing device 48 utilizes computed tomographic (CT) image data for generating and viewing a three-dimensional model of the patient's “P's” airways, enables the identification of a target 50 on the three-dimensional model (automatically, semi-automatically, or manually), and allows for determining a pathway through the patient's “P's” airways to the target 50; [0045]: the EWC 12 would be navigated proximate the desired location here near alveolus 11. Once approximately located and proximal balloon 14 is expanded, the microwave ablation catheter 16a, which may be formed as part of a balloon catheter 20 can be extended from the EWC 12; [0042]: Proximal and distal balloons 14 and 21 expand to effectively seal airway 10a from other portions of airway 10 … By moving the treatment zone 32 to a location sufficiently removed from blood vessel 30, and identifying an appropriate power and duration for treatment the blood vessel 28 can be effectively sealed; [0052]: By careful analysis of the vasculature and its interaction with the hypodense areas, determinations can be made as to the identity of vasculature that might be affected by treatment using microwave ablation. This analysis can identify locations where a blood vessel is to be sealed creating a shunt preventing the blood from continuing circulate through the blood vessel; wherein the navigation to an area proximate to the desired location (the second location) is seen as identifying the second location since the planning phase requires identifying the target & the airway leading to the target (which comprises the first and second locations).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the system of Mayse to include the controller of Brannan for the purpose of enabling the accurate placement of the microwave ablation catheters to achieve the desired treatments and to allow the clinician to identify the hypodense areas to target, the vasculature around that hypodense area to either target for sealing and coagulation, or to avoid, the adjustment of power and durations of microwave ablation settings as well as other parameters to identify how a predicted ablation zone will impact the tissue (both directly treated and distal of the treatment locations) (Brannan: [0047], [0063]).
Regarding claim 2, Mayse discloses wherein the expansion device in the deployed configuration is configured to dilate the anatomic lumen and reduce a distance between a wall of the anatomic lumen and the at least one of the plurality of blood vessels ([0402]: The various embodiments and aspects described above can be combined to provide further embodiments and aspects; [0343]: To treat a bronchial tree of a human, the diameter of the expandable member 4040 can be in a range of about 10 mm to about 20 mm. For enhanced treatment flexibility, the inflated expandable member 4040 diameter may be in a range of about 7 mm to about 25 mm; wherein a device of this diameter would be capable of performing the claimed limitation).
Regarding claim 3, Mayse discloses wherein the expansion device in the deployed configuration is configured to reduce a diameter of the at least one of the plurality of blood vessels ([0402]: The various embodiments and aspects described above can be combined to provide further embodiments and aspects; [0343]: To treat a bronchial tree of a human, the diameter of the expandable member 4040 can be in a range of about 10 mm to about 20 mm. For enhanced treatment flexibility, the inflated expandable member 4040 diameter may be in a range of about 7 mm to about 25 mm; wherein a device of this diameter would be capable of performing the claimed limitation).
Regarding claim 4, Mayse discloses wherein the anatomic lumen is an airway ([0056]: positioning an energy delivery system at a treatment site in a first airway); the target tissue includes parenchymal tissue ([0032]: deliver energy to alter targeted tissue of the bronchial tree; wherein this includes parenchymal tissue); and the plurality of blood vessels includes a bronchial artery ([0056]: delivering energy from the energy delivery system to occlude at least one bronchial artery that extends along the first airway).
Regarding claim 5, Mayse discloses wherein the expansion device in the deployed configuration is configured to dilate the airway by between approximately 10 and 50 percent ([0402]: The various embodiments and aspects described above can be combined to provide further embodiments and aspects; [0343]: To treat a bronchial tree of a human, the diameter of the expandable member 4040 can be in a range of about 10 mm to about 20 mm. For enhanced treatment flexibility, the inflated expandable member 4040 diameter may be in a range of about 7 mm to about 25 mm; wherein a device of this diameter would be capable of performing the claimed limitation).
Regarding claim 6, Mayse discloses wherein the plurality of blood vessels further includes a pulmonary artery ([0402]: The various embodiments and aspects described above can be combined to provide further embodiments and aspects; [0343]: To treat a bronchial tree of a human, the diameter of the expandable member 4040 can be in a range of about 10 mm to about 20 mm. For enhanced treatment flexibility, the inflated expandable member 4040 diameter may be in a range of about 7 mm to about 25 mm; [0189]: A main pulmonary artery 30 originates at a right ventricle of the heart and passes in front of a lung root 24. At the lung root 24, the artery 30 branches into a left and a right pulmonary artery, which in turn branch to form a network of branching blood vessels. These blood vessels can extend alongside airways of a bronchial tree 27; wherein a device of this diameter would be capable of performing the claimed limitation & see Figs. 15 & 16 for the location of the device relative pulmonary artery 30).
Regarding claim 7, Mayse discloses wherein the expansion device in the deployed configuration is configured to result in dilation of the airway by between approximately 50 and 100 percent ([0402]: The various embodiments and aspects described above can be combined to provide further embodiments and aspects; [0343]: To treat a bronchial tree of a human, the diameter of the expandable member 4040 can be in a range of about 10 mm to about 20 mm. For enhanced treatment flexibility, the inflated expandable member 4040 diameter may be in a range of about 7 mm to about 25 mm; wherein a device of this diameter would be capable of performing the claimed limitation).
Regarding claim 8, Mayse discloses wherein the system further comprises a heating system at the distal end portion of the catheter, the heating system configured to heat the expansion device to further occlude the anatomic lumen and the at least one of the plurality of blood vessels ([0056]: positioning an energy delivery system at a treatment site in a first airway and delivering energy from the energy delivery system to occlude at least one bronchial artery that extends along the first airway; [0081]: The energy delivery portion can be configured to generate heat energy at a power density ranging from 0.3 to 1.0 W/mm.sup.2 in an airway wall of the airway. The energy delivery portion can be configured to generate heat energy at a power density ranging from 0.48 to 0.64 W/mm.sup.2 in an airway wall of the airway).
Regarding claim 9, Mayse discloses wherein the heating system is at the distal end portion of the catheter and wherein the heating system includes at least one of a resistive heating member, an RF heat source, a microwave heat source, an ultrasound heat source, or a laser heat source ([0056]: positioning an energy delivery system at a treatment site in a first airway and delivering energy from the energy delivery system to occlude at least one bronchial artery that extends along the first airway; [0081]: The energy delivery portion can be configured to generate heat energy at a power density ranging from 0.3 to 1.0 W/mm.sup.2 in an airway wall of the airway. The energy delivery portion can be configured to generate heat energy at a power density ranging from 0.48 to 0.64 W/mm.sup.2 in an airway wall of the airway; [0221]: The internal power supply can supply energy to the electrode 2120 and can be an energy generator, such as a radiofrequency (RF) electrical generator. RF energy can be outputted at a desired frequency).
Regarding claim 11, Mayse discloses a liquid source configured to provide liquid to fill the balloon to expand the balloon to the deployed configuration ([0205]: the expandable member is supplied with a fluid for expansion via an elongate member 2150).
Regarding claim 15, Mayse discloses wherein the heating system includes two radio-frequency electrodes and wherein at least one of the radio-frequency electrodes is coupled to a balloon ([0049]: The energy delivery system can include a radio frequency electrode. The energy delivery cooling system includes an expandable member. The pulmonary treatment system can include a plurality of electrodes. The plurality of electrodes can extend around the expandable member in a spiral pattern).
Regarding claim 16, Mayse discloses wherein the heating system includes the two radio- frequency electrodes coupled to the catheter ([0049]: The energy delivery system can include a radio frequency electrode. The energy delivery cooling system includes an expandable member. The pulmonary treatment system can include a plurality of electrodes. The plurality of electrodes can extend around the expandable member in a spiral pattern).
Regarding claim 17, Mayse discloses wherein the balloon includes a reinforcement member and wherein the reinforcement member is configured to support an inflation of the balloon ([0402]: The various embodiments and aspects described above can be combined to provide further embodiments and aspects; [0289]: the electrode can be deployed by inflating the electrode or activating a shape memory material in the electrode; see Figs. 28A-E).
Regarding claim 18, Mayse discloses wherein the reinforcement member includes a braid or a metallic coating ([0402]: The various embodiments and aspects described above can be combined to provide further embodiments and aspects; [0289]: the electrode can be deployed by inflating the electrode or activating a shape memory material in the electrode; see Figs. 28A-E and wherein an electrode disposed on a balloon is seen as a metallic coating).
Regarding claim 19, Mayse discloses wherein the expansion device includes an expandable ring (liquid coolant supply channel 4010, Figs. 55-58; where this is seen as an expandable ring; [0402]: The various embodiments and aspects described above can be combined to provide further embodiments and aspects; [0335]: FIGS. 55-58 illustrate the collapsibility of the pulmonary treatment system 4000. In this example, the liquid coolant supply channel 4010 is a flexible conduit and the electrode 4020 is a conductive epoxy applied to an outside surface of the conduit).
Regarding claim 47, Mayse discloses wherein the balloon membrane defines an interior cavity, and wherein the interior cavity is configured to span the anatomic lumen in the deployed configuration (see Fig. 8 where the interior of balloon 2140 defines an interior cavity and the interior cavity spans the anatomic lumen shown in Fig. 8).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mayse in view of Mayse 2 and Brannan as applied to claim 1 above, and further in view of Danek et al. (U.S. Pat. No. 6411852, previously cited), herein referred to as “Danek”.
Regarding claim 12, Mayse in view of Mayse 2 and Brannan fails to disclose wherein the heating system is further configured to heat the liquid.
However, Danek discloses wherein the heating system is further configured to heat the liquid (Col. 10, lines 43-47: The electrodes 128 may be used as resistance heaters by application of an electric current to the electrodes. Alternatively, radio frequency or microwave energy may be applied to the electrodes 128 to heat a fluid within the balloon 126). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the heating system of Mayse in view of Mayse 2 and Brannan to be the heating system of Danek for the purpose of enabling the energy applied to be applied indirectly to the airway wall through the fluid and the balloon and for enabling conductive heating of the airway tissue (Danek: Col. 10, lines 47-53).
Regarding claim 13, Mayse in view of Mayse 2, Brannan and Danek discloses wherein the liquid is heated by the heating system at a distal end portion of the catheter after being released into the balloon (Danek: Col. 10, lines 43-47: The electrodes 128 may be used as resistance heaters by application of an electric current to the electrodes. Alternatively, radio frequency or microwave energy may be applied to the electrodes 128 to heat a fluid within the balloon 126).
Claims 20 & 46 are rejected under 35 U.S.C. 103 as being unpatentable over Mayse in view of Mayse 2 and Brannan as applied to claim 1 above, and further in view of Rajagopalan et al. (WO 2014197632, cited in IDS), herein referred to as “Rajagopalan”.
Regarding claim 20, Mayse discloses wherein the control system is further configured to ([0219]: The control portion 2200 may include, without limitation, one or more processors): regulate the heating system ([0220]: The control portion 2200 can also be programmed to control the amount of energy delivered from a power source to the energy emitter to injure targeted tissue and promote the formation of scar tissue).
But Mayse fails to disclose wherein the control system is configured to expand the expansion device.
However, Rajagopalan discloses wherein the control system is configured to expand the expansion device ([0133]: The system can further comprise a balloon, and the controller can be constructed and arranged to control the diameter of the balloon; [0333]: Controller 310 can be configured to modify one or more tissue treatment parameters, such as a parameter selected from the group consisting of: temperature of an ablative fluid to be delivered directly to tissue or to an expandable reservoir such as a balloon; type of ablative fluid to be delivered; rate of ablative fluid to be delivered; volume of ablative fluid to be delivered).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the system of Mayse in view of Mayse 2 and Brannan to include the control system of Rajagopalan for the purpose of the control system enabling an operator to initiate, modify and cease treatment of target tissue by the various components of the system (Rajagopalan: [0333]).
Regarding claim 46, Mayse in view of Mayse 2, Brannan and Rajagopalan disclose wherein the expanding of the expansion device is based on a distance between a wall of the anatomic lumen and the at least one of the plurality of blood vessels, an amount of compression of the at least one of the plurality of blood vessels, a diameter of the anatomic lumen, or an amount of blood flow (Rajagopalan: [0133]: The system can further comprise a balloon, and the controller can be constructed and arranged to control the diameter of the balloon; [0210]: the expandable elements expand to be larger than the diameter of the luminal wall tissue into which the expandable element has been placed, such as to improve the quality of the apposition of the expandable element against the uneven surface of the tissue).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571) 272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794