DETAILED ACTION
Applicant’s amendments and remarks, filed December 16, 2025, are fully acknowledged by the Examiner. Currently, claims 1-11, 15-19 are pending with claims 15-19 newly added, claims 12-14 cancelled, and claims 1-3, 7 and 10 amended. The following is a complete response to the December 16, 2025 communication.
The Examiner notes newly added claim 19 is missing the claim’s status identifier. Please see MPEP 714 with respect to the manner of indicating claims including those newly presented.
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 1-11, 15, 16 and 19 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 Waldstreicher et al. (US Pat. Pub. 2019/0201089 A1).
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)
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 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 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.
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 10 mm in an expanded state”. 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 10 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 10 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)
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 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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Fleury et al. (US Pat. Pub. 2015/0265331 A1) in view of Desrochers (US Pat. Pub. 2011/0184398 A1) and Waldstreicher et al. (US Pat. Pub. 2019/0201089 A1) as applied to claim 1 above, and further in view of Aklog et al. (WO 2022/204008 A1).
Regarding claim 18, none of Fleury, Desrochers or Waldestreicher provide for the claimed balloon protector assembly positioned over at least a portion of the balloon when the balloon is in a delivery state, and wherein the balloon is configured to be unsheathed from the balloon protector assembly at the target site to move to an expanded state. Aklog discloses a similar balloon catheter device as that of Fleury and specifically contemplates the use of a balloon protector assembly positioned over at least a portion of the balloon when the balloon is in a delivery state (sleeve 3260 as in [0109] positioned over the balloons 3220 and 3230). Aklog further provides that the balloon is configured to be unsheathed from the balloon protector assembly at a target site so as to move to an expanded state (see [0109]).
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 protector assembly as in Aklog to the combined arrangement of Fleury, Desrochers and Waldestreicher to provide for a manner of holding the balloon in a deflated state during introduction of the device into the body. Such would provide for the balloon to have a reduced diameter in the deflated state, and for the balloon to be protected from abrasions, cuts, and/or tears during passage of the balloon/catheter through the bronchoscope.
Response to Arguments
Applicant’s arguments, see pages 6-9 of the Remarks filed December 16, 2025, with respect to the rejections of independent claims 1 and 10 under 35 U.S.C. 103 as unpatentable over the combination of Fleury and Desrochers have been fully considered and are persuasive. Specifically, neither Fleury nor Desrochers provide for a) the newly added limitation in claim 1 of “the balloon being sized to expand to a diameter of at least 9 mm to press against an internal wall of a bronchus” or b) the newly added limitation in claim 10 of “ a balloon having a diameter of at least 10 mm in an expanded state”. Applicant’s remarks in the second paragraph on page 8 of the Remarks further address this deficiency. Therefore, the prior rejections based on the Fleury and Desrochers combination have been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-11, 15, 16 and 19 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 Waldstreicher et al. (US Pat. Pub. 2019/0201089 A1).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Fleury et al. (US Pat. Pub. 2015/0265331 A1) in view of Desrochers (US Pat. Pub. 2011/0184398 A1) and Waldstreicher et al. (US Pat. Pub. 2019/0201089 A1) as applied to claim 1 above, and further in view of Aklog et al. (WO 2022/204008 A1).
For the sake of completeness, the Examiner notes that Applicant has argued with respect to the Desrochers reference that “Desrochers does not disclose both a delivery line and an injection tube” and points to the requirement in claim 1 of “an injection tube extending into the balloon and in fluid communication with the delivery line”. Applicant contends on page 8 that the delivery line and injection tube are “distinct in position and function, and they are in fluid communication with each other”, that the Examiner’s rejection improperly relies upon two structures (20 and 520) that are the same structure in differing embodiments and that “Fleury and Desrochers fail to disclose a delivery line and an injection tube as claimed.”
This is not persuasive.
The Examiner notes, as a preliminary matter, that claim 1 presently requires an elongated shaft “configured to house a delivery line … wherein the delivery line is configured to receive and deliver refrigerant to or near a target site in a bronchus of an airway” as well as “an injection tube extending into the balloon and in fluid communication with the delivery line, wherein the injection tube is configured to spray the refrigerant into the balloon …”.
The Examiner is of the position that, while Applicant contends that the delivery line and injection tube are “distinct in position and function”, that nothing in the claim precludes the interpretation for the delivery line and injection tube to be formed from different portions of the same structure as presently relied upon in the rejection of claim 1 above. Thus, the Examiner has relied upon the teaching in Desrochers of the delivery line configured to receive and deliver refrigerant to or near a target site in an airway in the form of the structure of 20/520 proximal to the helical portion as in figures 8A-D being an delivery tube for the delivery of refrigerant, and for the injection tube extending into the balloon as the distal portion of 520 distal to the above-defined delivery line. This structure forming the injection tube is indeed in fluid communication with the delivery line via the continuation of the lumen from the proximal portion of 520 defining the delivery line to and through the distal portion of 520 defining the injection tube.
The Examiner finds that the above interpretation of the Desrochers reference readily provides for the structural and functional requirements of each of the delivery line and injection tube as presently recited in claim 1. If Applicant desires a narrower interpretation that either structurally or functionally defines over this interpretation of the structure of Desrochers, language to such an effect should be added to the claims. Further, while it appears that Applicant’s arguments allege that each of the delivery line and injection tube are desired to be interpreted as separate structure, such is simply not reflected in the current claim language.
Applicant further argues on page 9 of the Remarks with respect to the combination of Fleury and Desrochers that neither provide for the injection tube functioning “to impart cryogenic thermal injury to neural fibers positioned outward from the internal wall of the bronchus”. Applicant contends that the Fleury reference “is not configured to treat the bronchus, and is instead focused on creating necrosis that results in scar tissue sufficient to occlude an airway”. Applicant further alleges that Desrochers fails to cure this deficiency in Fleury given that such “is void of any reference to nerves or neural structures”.
This is not persuasive.
The Examiner notes that the argued-for limitation above is set forth within a functional recitation of the intended use of the injection tube in the form of “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”. It is well established that such 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. In the instant case, the at-issue functional recitations fails to structurally define the claimed catheter, and more particularly the claimed injection tube, from the combined structure of Fleury, Desrochers and Waldestreicher in the rejection of claim 1 above.
To this end, it appears from Applicant’s own disclosure that the modulation of neural fibers is much more dependent upon one or both of the length of cryotherapy and the number of cycles of cryotherapy performed at a target location (see paragraphs [0045] and [0050]) rather than the structure of the injection tube. Said differently, [0050] readily contemplates that “[t]he distance from the bronchial lumen and size of the ablation can depend, at least in part, on the duration of ablation and the number of cycles of ablation”. As such, the Examiner fails to find that the claimed functional language noted above results in a structural different between the claimed invention and the prior art combination of Fleury, Desrochers and Waldestreicher when, at the very least, the combination readily functions to spray refrigerant within the balloon and can function to do so for a desired duration and number of cycles so as to effectively freeze tissue up to a desired depth within the target treatment site.
Substantially similar rationale as argued-for with respect to claim 1 is equally applicable to the new grounds of rejection set forth with respect to independent claim 10 in the Action above.
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 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