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 .
Applicant’s amendments and comments, received December 15, 2025, have been fully considered by the examiner. The arguments directed towards the Drawing Objection and the 35 USC 112 rejection are deemed persuasive, and those issues are deemed obviated. The following is a complete response to the December 15, 2025 communication.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4-10, 14, 15, 17-19 and 21-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ingle et al (6,139,569).
Regarding claim 1, Ingle et al provide a treatment device comprising an elongate shaft (23) having proximal and distal ends with a handle (25) attached to the proximal end and an elongate treatment element (22) attached to the distal end of the shaft. A flexible joint (27) is provided such that the elongate treatment may be provided parallel to the elongate shaft. The elongate element has a front tissue contacting surface (24) and a back surface, and two rows of bipolar RF electrodes (26 – Figure 5D) positioned on the front tissue contacting surface and protruding outward from an outer surface of the front tissue contact surface (Figure 5E and col. 7, lines 41-423). Ingle et al do not disclose the use of the device to treat nasal tissue. However, it is inherently capable of such a use given the size of the treatment probe (e.g. 5mm by 10mm as disclosed at col. 7, lines 4-10). The two rows of bipolar electrodes (Figure 5F) comprise multiple bipolar pairs (pairs 1 through 6) wherein each bipolar pair has a separate controlled electrode channel to allow for independent operation of each bipolar pair with temperature feedback. See, for example, column 9, lines 25-60.
Regarding claim 2, Ingle et al teach that the back surface may narrow along the length as seen in Figure 17C, for example. Regarding claim 4, the surface (22) is insulative and is interposed between the electrodes (Figures 5D and 5E, for example). Regarding claim 5, there is a cable (28) connected to the handle with an adaptor coupled to the proximal end of the cable for connecting to an RF generator (Figure 5B). Regarding claim 6, Ingle et al provide a cooling mechanism to cool tissue being treated (Abstract, for example). Regarding claim 7, the treatment element is wider than the shaft (Figures 5B and 5C, for example). Regarding claims 8 and 9, Ingle et al disclose the use of thermocouples (31) for measuring tissue temperature and controlling the delivery of energy. See Figure 5G, for example. Regarding claim 10, the back surface may comprise a shallow, curved surface as seen in Figures 17B and 17C.
Regarding claim 14, Ingle et al provide a system for treating tissue comprising a treatment device comprising an elongate shaft, a handle and an elongate treatment element having two rows if bipolar RF electrode protruding outward from the outer surface of the tissue-contact area as addressed with respect to claim 1 above. There is also a cable attached to the handle with an adaptor for connecting to an RF energy source (Figure 5B), an RF generator (33 – Figure 6A) and a control system (35,37 – Figure 6A) for controlling energy delivery to the electrodes. There is inherently an outlet on the RF generator for receiving the adaptor/plug of the cable. The two rows of electrodes comprise electrode pairs with each pair having a separate, controlled channel as addressed with respect to claim 1 above.
Regarding claim 15, the treatment element is a separate piece attached to the shaft by flexible joint (27). Regarding claim 17, given the size of the treatment element it is inherently configured to be inserted into a nostril. Regarding claim 18, Ingle et al provide heat sensors (31) coupled with the contact surface to measure tissue temperature. Regarding claim 19, there is a control system to control the delivery of energy based on sensed temperature (col. 10, lines 10-23, for example).
Regarding claim 21, Ingle et al provide a device for treating tissue comprising an elongate shaft (23), a handle (25) and a treatment element (22) disposed on the elongate shaft. The treatment element includes two rows of bipolar RF electrodes (26) and an expandable section (92 – Figures 17B and 17C) configured to expand from a collapsed to an expanded configuration with the two rows of electrodes disposed on an outer surface of the expandable section (Figures 17B and 17C, for example). As asserted previously, the examiner maintains the treatment element is sized such that it is configured for use in a nasal cavity.
Regarding claims 22-24, see Figures 5C, 5D and 5F.
Regarding claim 25, Ingle et al again provide a treatment device comprising an elongate shaft, a handle, a treatment element having an expandable section and a first row and second row of bipolar RF electrodes disposed on an outer surface of the treatment element (Figures 5E and 17A) as addressed with respect to claim 21 above.
Regarding claims 26-28, see again Figures 5C, 5D and 5F and Figure 17A.
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 11-13, 20, 29-33 and 35-39 are rejected under 35 U.S.C. 103 as being unpatentable over Ingle et al (569) in view of the teaching of Hissong (6,361,531).
Regarding claims 11, 12 and 20, Ingle et al fail to expressly disclose the shaft of the device is flexible or the specific length of the shaft.
Hissong discloses a structurally similar device comprising a handle, an elongate shaft and a treatment element having an array of treatment devices (e.g. transducers) on the treatment element. In particular, Hissong specifically teach that it is advantageous to provide the shaft (20) as a malleable member to provide flexibility in adjusting the location of the treatment element (col. 10, lines 46-67, for example). The specific length of the shaft would be an obvious design consideration for one of ordinary skill in the art and selected for the particular procedure being performed.
To have provided the Ingle et al device with a flexible/malleable shaft to afford flexibility in providing the treatment element to a tissue site would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Hissong fairly teach it is known to provide a malleable shaft on a similarly constructed treatment probe.
Regarding claims 13, 29 and 33, Ingle et al provide a handle but fail to expressly disclose providing a button or input control to control the delivery of energy to tissue. The examiner maintains that it is generally well-known to provide activation buttons on handles of electrosurgical devices.
Hissong provides a similarly constructed probe as addressed previously, and specifically teach that it is known to provide input controls in the form of buttons (42) to control the delivery of energy to the transducers. To have provided the Ingle et al device with an input control (e.g. buttons) on the handle to control the delivery of energy to the electrodes during the procedure would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Hissong fairly teaches it is known to provide such an input control on a similarly constructed energy delivery probe.
Regarding claims 30-32, 35, 36 and 39, see discussion of earlier claims (e.g. claims 26-28) which discuss such an arrangement of bipolar electrodes on the Ingle et al device. Regarding claims 37 and 38, the use of more than one treatment element to treat multiple locations simultaneously is deemed an obvious consideration for one of ordinary skill in the art.
Response to Arguments
Applicant's arguments filed December 15, 2025 have been fully considered but they are not persuasive.
Applicant asserts that Ingle does not teach that each electrode pair has its own electrical channel and therefore Ingle can not anticipate the claims. The examiner disagrees.
As clearly shown in Figure 5F, each pair of bipolar electrodes (numbered 1 through 6) are capable of being independently actuated and controlled with temperature feedback (as discussed at column 9, lines 25-60). To activate bipolar pair number 1, the leads of column 1 and row 1 are connected in a singular channel that allows for the activation of just that bipolar pair. Similarly, activation of row 1 and column 2 will independently activate the channel for bipolar pair 2. Each bipolar pair of electrodes has a specific connection (i.e. channel) that allows for the independent activation of that bipolar pair and energy is delivered in accordance with temperature feedback (col. 9, lines 30-32). As such, the examiner maintains that Ingle et al continue to anticipate the claims as amended.
Applicant has not substantively argued the obviousness rejections other than to assert that the secondary reference (i.e. Hissong) fails to cure the alleged deficiencies of the Ingle device. As asserted above, the examiner maintains the Ingle device anticipates the claims as outlined in the above rejections.
Further, it is noted that independent claims 21, 25, 29 and 33 do not include the specific recitation of the bipolar electrode pairs having a separated controlled electrical channel, and applicant has asserted that Ingle fails to disclose the electrodes on an outer surface of the at least one expandable section. The examiner disagrees. The entirety of the distal end of the device may be deemed “the expandable section”, and the electrodes are clearly disposed on an outer surface of that expandable section. The claims do not require the electrodes to be on any specific portion or surface of the expandable section, and the examiner maintains the Ingle references continues to anticipate this language.
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 MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/February 16, 2026