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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 4, 6, 9-10, 14-15, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Selkee et al., (US 20200345262; hereinafter Selkee) in view of Sliwa et al., (US 20170367756; hereinafter Sliwa), Olson et al., (US 20190021620; hereinafter Olson) and Townley et al., (US 20190239954; hereinafter Townley).
Regarding claim 1, Selkee (Figures 1 and 6A) discloses a surgical instrument comprising: (a) a sheath ([0059]: guiding sheath) configured to be inserted into a target area ([0059]); and (b) an energy catheter (10) disposed within the sheath (guiding sheath), wherein the energy catheter (10) includes: (i) a shaft (14) extending along a longitudinal axis, and (ii) an elongate, expandable end effector (100) extending distally from the shaft (14) and configured to selectively expand radially outwardly from a non-expanded state to an expanded state ([0027]), wherein the end effector (100) includes at least one energy member (1/3) comprising: (A) at least one flexible wire (600), and (B) a plurality of electrodes (37) disposed along the at least one flexible wire (600), ([0028], [0043]); wherein the energy catheter (10) is selectively translatable relative to the sheath (guiding sheath) between a proximal retracted position in which the end effector (100) is housed coaxially within the sheath (guiding sheath) to thereby prevent the end effector (100) from radially expanding from the non-expanded state to the expanded state, and a distal extended position in which the end effector (100) is exposed from the sheath (guiding sheath) to thereby permit the end effector (100) to expand from the non-expanded state to the expanded state for contacting target tissue ([0059]), wherein when the end effector (100) is in the expanded state, the end effector (100) has a width and a length greater than the width (as shown in Figure 1), and wherein the at least one energy member (1/3) includes a plurality of loop- shaped energy members (1/3) that overlap each other and include a first loop-shaped energy member (1) and a second loop-shaped energy member (2), each of the first and second loop-shaped energy members (1/3) includes a pair of outwardly splayed segments (1A-1B, 3A-3B) coupled to a distal end of the shaft (14), and one (1B) of the pair of outwardly splayed segments (1A-1B) of the first loop-shaped energy member (1) is coupled to the distal end of the shaft (14) at a location between the locations at which the pair of outwardly splayed segments (3A-3B) of the second loop-shaped energy member (3) are coupled to the distal end of the shaft (14), ([0043]).
Selkee (Figures 1 and 6A) further discloses wherein the at least one support wire (600) is a resiliently biased material ([0043], [0046]: Nitinol), but fails to disclose wherein each of the plurality of cylindrically-shaped electrodes is electrically coupled to an RF generator via the at least one support wire. However, Sliwa (Figure 2) teaches a surgical instrument (300) comprising electrically active splines/support wires (306, 308) which may electrically couple cylindrical electrodes (318, 322), respectively, to an RF generator (electrical source), ([0033]-[0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Selkee to include each of the plurality of cylindrically-shaped electrodes being electrically coupled to an RF generator via the at least one support wire, as taught by Sliwa, because the modification would reduce the bulk of the device by removing the need for lead wires that extend to the cylindrical electrodes (Sliwa; [0033][0034]) while maintaining individual electrode arm control by enabling independent electrical activation of different support arms (Sliwa; [0033]-[0034]).
Selkee (Figures 1 and 6A) further discloses that the plurality of electrodes (37) are cylindrically-shaped electrodes ([0028], [0043]), but Selkee/Sliwa fails to teach that each of the plurality of cylindrically-shaped electrodes has (i) an outer conductive surface, and (ii) an electrically insulative layer applied partially over of the outer conductive surface. However, Olson (Figures 5 and 8-9) teaches a surgical instrument comprising a plurality of cylindrically-shaped electrodes (42), each having (i) an outer conductive surface (54), and (ii) an electrically insulative layer (56) applied partially over of the outer conductive surface ([0064], [0071]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Selkee/Sliwa to include each of the plurality of cylindrically-shaped electrodes having (i) an outer conductive surface, and (ii) an electrically insulative layer applied partially over of the outer conductive surface, as taught by Olson, because the modification would create a seal between the outer conductive surface and the target area to aid in reception of the localization signal by the partially-masked electrode; thereby improving signal quality and magnitude (Olson; [0064], [0071]).
Selkee/Sliwa/Olson fails to teach that the sheath is configured to be inserted into a nasal cavity of a patient’s head such that the end effector is configured to contact tissue in the nasal cavity of the patient’s head in the expanded state. However, Townley (Figures 2 and 4) teach a surgical instrument comprising a sheath ([0053]: introducer sheath) configured to be inserted into a nasal cavity of a patient's head such that the end effector (212) is configured to contact tissue in the nasal cavity of the patient’s head in the expanded state ([0042]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Selkee/Sliwa/Olson such that the sheath is configured to be inserted into a nasal cavity of a patient’s head such that the end effector is configured to contact tissue in the nasal cavity of the patient’s head in the expanded state, as taught by Townley, because the modification would provide application of energy to disrupt the parasympathetic motor sensory function in the nasal region, for example to treat rhinitis ([0030]).
Regarding claim 4, Selkee (Figures 1 and 6A) further discloses wherein the end effector (100) is configured to resiliently expand radially from the non-expanded state to the expanded state in response to the energy catheter (10) translating from the proximal retracted position to the distal extended position ([0059]).
Regarding claim 6, Selkee/Sliwa/Olson/Townley further teaches wherein the electrically insulative layer (Olson; 56) extends coaxially about the outer conductive surface (Olson; 54) of each of the plurality of cylindrically-shaped electrodes (Olson; 42), (Olson; [0064], [0077]).
Regarding claim 9, Selkee/Sliwa/Olson/Townley further teaches wherein the electrically insulative layer (Olson; 56) includes an electrically insulative coating (Olson; [0064], [0077]).
Regarding claim 10, Selkee (Figures 1 and 6A) further discloses wherein at least one electrode (37) of the plurality of electrodes (37) is selectively removable from the at least one flexible wire (600), ([0052]: the electrodes 37 are ring electrodes mounted on the splines, including corresponding flexible wires 600, simply using glue or the like; therefore, the electrodes 37 may be selectively removed by unmounting as desired).
Regarding claim 14, Selkee (Figures 1 and 6A) further discloses wherein the plurality of loop-shaped energy members (1/3) are positioned about the longitudinal axis ([0028], [0043]).
Regarding claim 15, Selkee (Figures 1 and 6A) further discloses wherein the at least one energy member (1/3) includes at least one angled energy member ([0028], [0043]).
Regarding claim 21, Selkee (Figures 1 and 6A) further discloses wherein each of the plurality of loop-shaped energy members (1/3) extends along a respective plane, and each respective plane is parallel to the longitudinal axis, as shown in Figure 1, ([0028], [0043]).
Regarding claim 22, Selkee (Figures 1 and 6A) further discloses wherein each respective plane is laterally offset from the longitudinal axis, as shown in Figure 1, ([0028], [0043]).
Claim(s) 16, 18, and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Selkee in view of Sliwa and Olson.
Regarding claim 16, Selkee (Figures 1 and 6A) discloses a surgical instrument comprising: a sheath ([0059]: guiding sheath); and an energy catheter (10) disposed within the sheath (guiding sheath), wherein the energy catheter (10) extends along a longitudinal axis and includes an expandable end effector (100) configured to selectively expand radially outwardly from a non-expanded state to an expanded state ([0027]), wherein the end effector (100) includes at least one energy member (1/3) comprising: at least one flexible wire (600), and a plurality of electrodes (37) disposed along the at least one flexible wire (600), ([0028], [0043]), wherein the energy catheter (10) is selectively translatable relative to the sheath (guiding sheath) between a proximal retracted position in which the end effector (100) is housed coaxially within the sheath (guiding sheath) to thereby prevent the end effector (100) from radially expanding from the non-expanded state to the expanded state, and a distal extended position in which the end effector (100) is exposed from the sheath (guiding sheath) to thereby permit the end effector (100) to expand from the non-expanded state to the expanded state for contacting tissue ([0059]), and wherein the at least one energy member (1/3) includes a first loop-shaped energy member (1) and a second loop-shaped energy member (3), each of the first and second loop-shaped energy members (1/3) includes a pair of outwardly splayed segments (1A-1B, 3A-3B) coupled to a distal end of the shaft (14), and one (1B) of the pair of outwardly splayed segments (1A-1B) of the first loop-shaped energy member (1) is coupled to the distal end of the shaft (14) at a location between the locations at which the pair of outwardly splayed segments (3A-3B) of the second loop-shaped energy member (3) are coupled to the distal end of the shaft (14), ([0043]).
Selkee (Figures 1 and 6A) further discloses wherein the at least one support wire (600) is a resiliently biased material ([0043], [0046]: Nitinol), but fails to disclose wherein each of the plurality of cylindrically-shaped electrodes is electrically coupled to an RF generator via the at least one support wire. However, Sliwa (Figure 2) teaches a surgical instrument (300) comprising electrically active splines/support wires (306, 308) which may electrically couple cylindrical electrodes (318, 322), respectively, to an RF generator (electrical source), ([0033]-[0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Selkee to include each of the plurality of cylindrically-shaped electrodes being electrically coupled to an RF generator via the at least one support wire, as taught by Sliwa, because the modification would reduce the bulk of the device by removing the need for lead wires that extend to the cylindrical electrodes (Sliwa; [0033][0034]) while maintaining individual electrode arm control by enabling independent electrical activation of different support arms (Sliwa; [0033]-[0034]).
Selkee further discloses that the plurality of electrodes (37) are cylindrically-shaped electrodes ([0028], [0043]), but Selkee/Sliwa fails to teach that each of the plurality of cylindrically-shaped electrodes includes (i) an electrically conductive outer surface, and (ii) an electrically insulative layer applied partially over the outer surface of the electrically conductive body. However, Olson (Figures 5 and 8-9) teaches a surgical instrument comprising a plurality of cylindrically-shaped electrodes (42), each having (i) an outer conductive surface (54), and (ii) an electrically insulative layer (56) applied partially over of the outer conductive surface ([0064], [0071]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Selkee/Sliwa to include each of the plurality of cylindrically-shaped electrodes including (i) an electrically conductive outer surface, and (ii) an electrically insulative layer applied partially over the outer surface of the electrically conductive body, as taught by Olson, because the modification would create a seal between the outer conductive surface and the target area to aid in reception of the localization signal by the partially-masked electrode; thereby improving signal quality and magnitude (Olson; [0064], [0071]).
Regarding claim 18, Selkee/Sliwa/Olson further teaches wherein the electrically insulative layer (Olson; 56) includes an electrically insulative coating (Olson; [0064], [0077]).
Regarding claim 23, Selkee (Figures 1 and 6A) further discloses wherein each of the first loop-shaped energy member (1) and the second loop-shaped energy member (3) extends along a respective plane, and each respective plane is parallel to the longitudinal axis, as shown in Figure 1, ([0028], [0043]).
Regarding claim 24, Selkee (Figures 1 and 6A) further discloses wherein each respective plane is laterally offset from the longitudinal axis, as shown in Figure 1, ([0028], [0043]).
Response to Arguments
Applicant’s arguments filed 01/16/2026, with regard to the newly amended claim limitations, 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 reference Sliwa, which teaches a surgical instrument (300) comprising electrically active splines/support wires which may electrically couple cylindrical electrodes, respectively, to an RF generator, thereby reducing the bulk of the device by removing the need for lead wires that extend to the cylindrical electrodes while maintaining individual electrode arm control by enabling independent electrical activation of different support arms (Sliwa; [0033]-[0034]). Therefore, the Selkee/Sliwa/Olson/Townley combination teaches the invention as claimed at least in amended claim 1 and the Selkee/Sliwa/Olson combination teaches the invention as claimed at least in amended claim 16.
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.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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