DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 20, 2026 has been entered.
Currently, claims 1-11, 15-17 and 19-21 are pending with claims 12-14 and 18 cancelled, claims 20-21 newly added, and claims 1, 10 and 17 amended. The following is a complete response to the July 20, 2026 communication.
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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9, 15, 16 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Fleury et al. (US Pat. Pub. 2015/0265331 A1) further in view of Desrochers (US Pat. Pub. 2011/0184398 A1), Waldstreicher et al. (US Pat. Pub. 2019/0201089 A1) and Fuqua (US Pat. No. 4,738,666).
Regarding claim 1, Fleury provides for a catheter comprising an elongated shaft configured to house a line and a lumen (treatment device 300 with line 310 and lumen 306),
a balloon connected to a distal end of the elongated shaft, the balloon being sized to expand to a diameter to press against and internal wall of a bronchus of an airway (balloon 304),
wherein the catheter is sized to fit within a working channel of a bronchoscope such that at least a portion of the balloon or the injection tube is configured to be delivered to or near the target site by advancing the distal end of the elongated shaft distally beyond the working channel of the bronchoscope into the airway (see [0024] providing for the medical device 300 to be used with a bronchoscope and with tissue 102 being described as airway tissue throughout).
While Fleury provides for the above features of the medical device, Fleury fails to specifically provide that the line is a delivery line configured to receive and deliver refrigerant to or near a target site in an airway, that the lumen is an exhaust lumen configured to guide refrigerant exhaust away from the target site, and for an injection tube extending into the balloon and in fluid communication with the delivery line and configured to spray the refrigerant into the balloon through which the refrigerant is allowed thermal communication with the target site to impart cryogenic thermal injury to neural fibers positioned outward from the internal wall of the bronchus..
Desrochers provides for a similar medical device as that of Fleury for the delivery of a refrigerant to a balloon at the distal end of a catheter. Desrochers specifically discloses an elongated shaft configured to house a delivery line and a lumen (tube 12 having the return lumen 22’ and the delivery line 20) and a balloon connected to a distal end of the elongated shaft (516), wherein the delivery line configured to receive and deliver refrigerant to or near a target site in an airway (via 20/520 proximal to the helical portion as in figures 8A-D being an delivery tube for the delivery of refrigerant within 516), wherein the exhaust lumen is configured to guide refrigerant exhaust away from the target site (via the lumen 20’ being a return lumen), and for an injection tube extending into the balloon (portion of 520 being an injection tube) in fluid communication with the delivery line and configured to spray the refrigerant into the balloon through which the refrigerant is allowed thermal communication with the target site (see the spray of the cryogen as in figures 8A-8D and with [0050] disclosing that such is a spray).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the delivery line, injection tube and return lumen arrangement of Desrochers in place of the respective structures in Fleury to provide for an exemplary manner of delivering and removing a spray of refrigerant within a balloon for treatment of the body. Desrochers provides that the embodiment in figure 8 with the helical injection tube provides for targeted dispersion of the cooling along the length of the balloon. The Examiner is further of the position that the combined arrangement would readily provide for the requirement in claim 1 of “configured to spray … to impart cryogenic thermal injury to neural fibers positioned outward from the internal wall of the bronchus” given that such is a functional recitation of the intended use of the device that fails to structurally distinguish the claimed invention over the prior art combination of Fleury in view of Desrochers.
Fleury, while contemplating non-limiting locations of treatment with its device including a respiratory airway, renal nerves, bladder tissue, and for the treatment of various airway-related diseases including COPD, asthma, chronic cough, bronchitis and other bronchial diseases (see [0021]), fails to provide for a specific diameter of the balloon to be “to a diameter of at least 9 mm to press against an internal wall of a bronchus”. Desrochers fails to cure this deficiency in Fleury.
Waldestreicher contemplates a variety of sizes for an expandable device for treatment tissue within an airway including the bronchus including for similar diseases as contemplated in Fleury (see the Abstract). Waldestreicher then provides that for treatments within the bronchus, it is desirable to utilized an energy delivery body of various sized including one that is at least 9 mm (see [0407] providing for 9 mm -12 mm in diameter or 12 mm – 16 mm in diameter). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a balloon with an expanded size of at least 9 mm to the combined device in view of the teaching of Waldestreicher so as to provide a device for treating at least one of the various diseases alternatively contemplated in [0021] of Fleury. Fleury, readily contemplates the use and treatment of a variety of locations within the body with Waldestreicher supporting that the change in size of an expandable member for treatment within the body is generally known to be selected to provide for a suitable size at a desired location. Further, it has been held that such a change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
None of Fleury, Desrochers or Waldestreicher provide for the claimed balloon protector assembly positioned over at least a portion of the balloon wherein the balloon is configured to be unsheathed from the balloon protector assembly as the balloon enters a working channel of a bronchoscope. Fuqua provides for an exemplary balloon protector assembly that is configured to be positioned over at least a portion of an expandable portion of a medical catheter (sheath 60 disposed over the expandable catheter 14), wherein the balloon protector assembly is configured to removed from the expandable portion of the catheter via manual activation by the user (see col. 5; 18-28). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a removable balloon protector assembly as in Fuqua to the combined arrangement of Fleury, Desrochers and Waldestreicher to provide for an exemplary manner of maintaining an expandable portion of a medical catheter, including a balloon, in a reduced diameter arrangement when inserting the device into a introducer lumen.
The Examiner further notes that the recitation of “the balloon is configured to be unsheathed from the balloon protector assembly as the balloon enters a working channel of a bronchoscope” is a functional recitation of the intended use of the balloon and/or balloon protector assembly, where the combined arrangement set forth above in view of the teaching of Fuqua is capable of being drawn proximally as the balloon enters into a working channel of a bronchoscope to as to unsheathe the balloon. It is well established that a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 2, Fleury provides that the balloon has a deflated configuration and an inflated configuration, the balloon is at the deflated configuration when the balloon is being delivered toward or retracted from the target site (via the balloon 304 being deflated when inserted through the bronchoscope or two maneuver the balloon within the body; and for such to have an inflated configuration when filled with refrigerant), and the balloon is configured to appose the internal wall of the airway at the inflated configuration (the balloon 304 is capable of such; see for example 304 apposing the wall of 102 as in figure 3).
Regarding claim 3, Fleury provides that the balloon is configured to partially occlude a portion of the airway where the balloon apposes the internal wall when the balloon is at the inflated configuration (the balloon 304 of Fleury would be capable of providing for partial apposition).
Regarding claim 4, Fleury provides that the balloon is configured to completely occlude a portion of the airway where the balloon apposes the internal wall when the balloon is at the inflated configuration (the balloon 304 of Fleury would be capable of providing for complete occlusion).
Regarding claim 5, Fleury provides that the balloon is configured to at least partially retract within the elongated shaft when the balloon is at the deflated configuration, and at least partially extend beyond the elongated shaft when the balloon is at the inflated configuration (see [0024] with the undeployed positioned within the tubular member, and then a partially deployed position with the balloon outside of the tubular member).
Regarding claim 6, in view of the combination with Desrochers in the rejection of claim 1 above, the combined treatment device would further provide that the injection tube is configured to at least partially retract within the elongated shaft when the injection tube is being delivered toward or retracted from the target site (via the injection tube being formed by the portion 520 defined in the rejection capable of being inserted/retracted within the device in view of the teaching as in [0024]), and the injection tube is configured to extend at least partially beyond the distal end of the elongated shaft when spraying the refrigerant into the balloon (via the injection tube being formed by the portion 520 defined in the rejection capable of being extending from the device in view of the teaching as in [0024] when the balloon is inflated and refrigerant is sprayed on the balloon).
Regarding claim 7, in view of the combination in the rejection of claim 1 above, the combined device with the injection tube of Desrochers further provides that the injection tube has a plurality of openings located in select positions along a length of the injection tube through which the refrigerant is sprayed into the balloon (see [0050] and figures 8A-D providing for the openings to spray the refrigerant in multiple directions).
Regarding claim 8, in view of the reliance upon Desrochers to teach the inclusion of a plurality of openings on the injection tube, neither Fleury nor Desrochers specifically provides that at least one of the openings include a nozzle or an orifice through which the refrigerant undergoes expansion and pressure drop when sprayed into the balloon. Desrochers provides, however, with respect to generic embodiments of its device, that an injection tube includes Joule-Thompson device to provide for expansion and pressure drop into the expansion chamber (see [0003]). Therefore, it is the Examiner’s position that it would have been further obvious to one of ordinary skill in the art at the time of filing to have provided at least one of the openings in the embodiment in figures 8A-D of Desrochers per the combination with a Joule-Thompson opening to provide for the disclosed cryogenic cooling effect set forth in [0003] of Desrochers. The Examiner is of the position that the use of an expansion orifice represents one of a known number of manners to provide for the use of a cryogenic balloon within the art to provide for a spray within the balloon as depicted in figure 8A-D, with such being readily known and appreciated by one of ordinary skill as capable of providing the disclosed cooling already contemplated in Desrochers.
Regarding claim 9, in view of the combination in the rejection of claim 1 above, the combined arrangement of Fleury and Desrochers provides that the delivery line is located within the exhaust lumen (via the structural arrangement of the return lumen 22’ and the delivery line 20 in Desrochers).
Regarding claim 15, in view of the combination with Waldstreicher in the rejection of claim 1 above, Waldstreicher contemplates values of 10-15 mm when in an inflated state (per the disclosure in [0407]).
Regarding claim 16, the Examiner is further of the position that the combined arrangement as in the rejection of claim 1 above would readily provide for the requirement in claim 16 of “the balloon and injection tube are configured to impart the cryogenic thermal injury to neural fibers positioned at least 1 mm from the internal wall of the bronchus” given that such is a functional recitation of the intended use of the device that fails to structurally distinguish the claimed invention over the prior art combination of Fleury in view of Desrochers.
Regarding claim 21, in view of the combination with Fuqua above, the Examiner is of the position that the balloon protection system in the form of the sheath 60 would be formed of a material that has an inherent stiffness with such being imparted on the elongated shaft of the device 300.
Claims 10, 11, 17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fleury et al. (US Pat. Pub. 2015/0265331 A1) further in view of Desrochers (US Pat. Pub. 2011/0184398 A1) and Fuqua (US Pat. No. 4,738,666).
Regarding claim 10, Fleury provides for a system for delivering refrigerant, the system comprising: a catheter comprising an elongated shaft having a distal end and configured to house a line and a lumen (treatment device 300 with line 310 and lumen 306),
and a cooling assembly at the distal end of the elongated shaft, the cooling assembly comprising a balloon connected to a distal end of the elongated shaft (balloon 304),
wherein the catheter is sized to fit within a lumen of a bronchoscope such that the balloon and the injection tube are configured to be delivered to or near the target site in the bronchus of an airway by inserting the lumen of the bronchoscope in the airway (see [0024] providing for the medical device 300 to be used with a bronchoscope and with tissue 102 being described as airway tissue throughout).
While Fleury provides for the above features of the medical device, Fleury fails to specifically provide that the line is a delivery line configured to receive and deliver refrigerant to or near a target site in a bronchus of an airway, that the lumen is an exhaust lumen configured to guide refrigerant exhaust away from the target site, and for an injection tube in fluid communication with the delivery line and configured to spray the refrigerant into the balloon through which the refrigerant is allowed thermal communication with the target site so as to be configured to impart cryogenic thermal injury to neural fibers positioned outward from the inner wall of the bronchus..
Desrochers provides for a similar medical device as that of Fleury for the delivery of a refrigerant to a cooling assembly including a balloon at the distal end of a catheter. Desrochers specifically discloses an elongated shaft is configured to house a delivery line and a lumen (tube 12 having the return lumen 22’ and the delivery line 20) and a balloon connected to a distal end of the elongated shaft (516), wherein the delivery line configured to receive and deliver refrigerant to or near a target site in a bronchus of an airway (via 20/520 proximal to the helical portion as in figures 8A-D being an delivery tube for the delivery of refrigerant within 516), wherein the exhaust lumen is configured to guide refrigerant exhaust away from the target site (via the lumen 20’ being a return lumen), and for an injection tube (portion of 520 being an injection tube) in fluid communication with the delivery line and configured to spray the refrigerant into the balloon through which the refrigerant is allowed thermal communication with the target site (see the spray of the cryogen as in figures 8A-8D and with [0050] disclosing that such is a spray).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the delivery line, injection tube and return lumen arrangement of Desrochers in place of the respective structures in Fleury to provide for an exemplary manner of delivering and removing a spray of refrigerant within a balloon for treatment of the body. Desrochers provides that the embodiment in figure 8 with the helical injection tube provides for targeted dispersion of the cooling along the length of the balloon. The Examiner is further of the position that the combined arrangement would readily provide for the requirement in claim 10 of “configured to impart cryogenic thermal injury to neural fibers positioned outward from the internal wall of the bronchus” given that such is a functional recitation of the intended use of the device that fails to structurally distinguish the claimed invention over the prior art combination of Fleury in view of Desrochers.
None of Fleury or Desrochers provide for the claimed balloon protector assembly positioned over at least a portion of the balloon wherein the balloon is configured to be unsheathed from the balloon protector assembly as the balloon enters a working channel of a bronchoscope. Fuqua provides for an exemplary balloon protector assembly that is configured to be positioned over at least a portion of an expandable portion of a medical catheter (sheath 60 disposed over the expandable catheter 14), wherein the balloon protector assembly is configured to removed from the expandable portion of the catheter via manual activation by the user (see col. 5; 18-28). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a removable balloon protector assembly as in Fuqua to the combined arrangement of Fleury and Desrochers to provide for an exemplary manner of maintaining an expandable portion of a medical catheter, including a balloon, in a reduced diameter arrangement when inserting the device into a introducer lumen.
The Examiner further notes that the recitation of “the balloon is configured to be unsheathed from the balloon protector assembly as the balloon enters a working channel of a bronchoscope” is a functional recitation of the intended use of the balloon and/or balloon protector assembly, where the combined arrangement set forth above in view of the teaching of Fuqua is capable of being drawn proximally as the balloon enters into a working channel of a bronchoscope to as to unsheath the balloon. It is well established that a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 11, Fleury further provides that the bronchoscope is configured to provide real-time visualization of at least a portion of the catheter when the catheter moves within the airway with the bronchoscope (see [0024] providing for a bronchoscope for visualization).
Regarding claim 17, Fleury provides that where the balloon is in a delivery state, the balloon is configured to be at least partially retracted into the elongated shaft (with a delivery state considered a point where the balloon is partially delivered from the tubular member, the ballon would be partially restricted as claimed; see [0024] describing the delivery of the balloon).
Regarding claim 19, Fleury further provides that the catheter comprises a handle at a proximal portion of the elongated shaft (see [0024] providing for a handle) and for the handle to be configured to be attached at a proximal portion of the bronchoscope (via the functional capability of the device of Fleury to be inserted through a bronchoscope such that the handle of [0024] would then be structurally attached to the proximal end of the bronchoscope.
Regarding claim 20, in view of the rejection of claim 10 above, Fleury further provides for the bronchoscope (100 as in [0024] is a bronchoscope) with a channel formed therein defining the lumen of the bronchoscope (as shown in the figures with the channel for the passage of the device 300 therethrough).
Response to Arguments
Applicant’s arguments, see pages 7-9 of the Remarks filed July 20, 2026, with respect to the rejections of claims 1 and 10 under 35 U.S.C. 103 based on prior combinations of Fleury, Descrochers, Waldstreicher and/or Aklog have been fully considered and are persuasive. As noted by Applicant, the Examiner reiterates the agreement as set in the interview on July 10, 2026 that the submitted amendments in each of independent claims 1 and 10 would define over the prior combination with Aklog reference (as applied to now-cancelled dependent claim 18) given that the Aklog reference contemplates for the relied upon sleeve 3260 is configured to be removed by processes within the body as in [0109]) and it is not clear that such a sleeve as per Aklog would be functionally capable of providing the added functionality of the balloon protector system as in each of independent claims 1 and 10. Therefore, the prior grounds of rejection under 35 U.S.C. 103 have been withdrawn based on the submitted amendments to each of claims 1 and 10. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-9, 15, 16 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Fleury et al. (US Pat. Pub. 2015/0265331 A1) further in view of Desrochers (US Pat. Pub. 2011/0184398 A1), Waldstreicher et al. (US Pat. Pub. 2019/0201089 A1) and Fuqua (US Pat. No. 4,738,666).
Claims 10, 11, 17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fleury et al. (US Pat. Pub. 2015/0265331 A1) further in view of Desrochers (US Pat. Pub. 2011/0184398 A1) and Fuqua (US Pat. No. 4,738,666).
It is the Examiner’s position that the newly cited combinations of references under 35 U.S.C. 103 readily provide for a proper prima facie obviousness rejection for each of the pending claims for at least the reasoning set forth in the Action above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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