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
This action is in response to the amendment filed on 7/6/2026. In the amendment, claims 1, 3, 8, 13, and 15 have been amended, claim 12 has been cancelled, and claim 21 has been added.
Claim Rejections - 35 USC § 103
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.
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 1-5, 15-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Sakurai et al. (US Pat. No. 5,391,144) in view of Stulen (US Pub. No. 2009/0030438 A1).
Regarding claim 1, Sakurai et al. disclose a surgical instrument (Figs. 92 & 93), comprising: a handle assembly (proximal portion of instrument; shown in generic assembly of Fig. 1 as ‘1a’ or ‘1b); an elongated body (portion of instrument shown in Figs. 92 & 93) extending distally from the handle assembly, the elongated body defining a longitudinal axis and comprising: a first tube 118 (Figs. 92 & 93); a waveguide 3 (Figs. 92 & 93) positioned within the first tube 118; and an inflow conduit 259 (Figs. 92 & 93) between the first tube 118 and the waveguide 3 (Figs. 92 & 93); a blade 4 (Figs. 92 & 93) coupled to a distal end of the waveguide 3 and configured to oscillate with respect to the first tube for treating tissue, the blade comprising: a blade lumen 68 (Figs. 92 & 93) traversing at least a portion of the blade; a blade inlet 260 (Figs. 92 & 93) placing the blade lumen in fluid communication with the inflow conduit (column 38, line 32 to column 39, line 14); and a blade outlet (distal end of lumen 68 of blade 4) in fluid communication with the blade lumen 68 and providing an opening at a distal end of the blade 4 (column 38, line 32 to column 39, line 14), wherein the blade outlet is configured to facilitate an outflow of fluid from a distal end of the blade lumen (since no source of fluid is positively claimed as part of the invention, the outlet (i.e. opening) of Sakurai et al.’s device is considered to be capable of facilitating an outflow of fluid if a source of fluid were delivered therethrough). Sakurai et al. fails to further disclose wherein the blade outlet has an angled surface disposed at a non-zero angle with respect to a surface of the blade lumen.
However, Stulen teaches an ultrasonic blade having an open distal end wherein the distal end opening has an angled surface disposed at a non-zero angle with respect to a surface of the blade in order to provide a surface that allows fluid that comes in contact with it during a cutting procedure to converge causing a convergent jet of fluid mist in order to increase visibility at the surgical site (Fig. 14A; paragraph [0092]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the blade outlet of Sakurai et al. to have an angled surface disposed at a non-zero angle with respect to a surface of the blade, as suggested and taught by Stulen, for the purpose of reducing divergent fluid mist that occurs during an ultrasonic surgical cutting procedure, thereby increasing visibility at the surgical site for the operator to have a more successful procedure.
Regarding claim 2, Sakurai et al. as modified by Stulen meets the limitation ‘wherein a distal end of the blade outlet has a larger diameter than a proximal end of the blade outlet’ (conical shape - Fig. 14A), as suggested and taught by Stulen - see rejection of claim 1 above.
Regarding claim 3, Sakurai et al. as modified by Stulen meets the limitation ‘wherein the blade outlet is configured to expel the cooling fluid from the blade as a mist or a vapor’ (paragraph [0092]), as suggested and taught by Stulen - see rejection of claim 1 above.
Regarding claim 4, Sakurai et al. further disclose wherein the surgical instrument is coupled to a fluid control system (column 38, line 32 to column 39, line 14) configured to pump cooling fluid through the blade lumen 68 and out of the blade through the blade outlet when the instrument is deactivated (the fluid control system associated with the lumen 68 is capable of performing this function if intended; it is noted that since this is not a process/method claim, the intended use of the fluid control system is not required by the prior art, rather, the structure/element merely needs to be capable of performing this function if programmed to do so).
Regarding claim 5, Sakurai et al. further disclose wherein the inflow conduit 259 is defined by an annulus formed between the waveguide 3 and the first tube 118 (column 38, line 32 to column 39, line 14).
Regarding claim 15, Sakurai et al. disclose a surgical instrument (Figs. 92 & 93), comprising: a tube 118 (Figs. 92 & 93); a waveguide 3 (Figs. 92 & 93) positioned within the tube 118, the waveguide 3 and the tube 118 defining an inflow conduit 259 (Figs. 92 & 93) therebetween; and an ultrasonic blade 4 (Figs. 92 & 93) coupled to a distal end of the waveguide 3 and configured to oscillate with respect to the tube 118 for treating tissue, the ultrasonic blade 4 comprising: a blade lumen 68 (Figs. 92 & 93) traversing at least a portion of the ultrasonic blade 4 and in fluid communication with the inflow conduit 260 (column 38, line 32 to column 39, line 14); and a blade outlet (distal end of blade lumen 68) in fluid communication with the blade lumen 68 and providing an opening at a distal end of the ultrasonic blade 4 (column 38, line 32 to column 39, line 14), wherein the blade outlet is configured to facilitate an outflow of fluid from a distal end of the blade lumen (since no source of fluid is positively claimed as part of the invention, the outlet (i.e. opening) of Sakurai et al.’s device is considered to be capable of facilitating an outflow of fluid if a source of fluid were delivered therethrough). Sakurai et al. fails to further disclose wherein the blade outlet has an angled surface disposed at a non-zero angle with respect to a surface of the blade lumen.
However, Stulen teaches an ultrasonic blade having an open distal end wherein the distal end opening has an angled surface disposed at a non-zero angle with respect to a surface of the blade in order to provide a surface that allows fluid that comes in contact with it during a cutting procedure to converge causing a convergent jet of fluid mist in order to increase visibility at the surgical site (Fig. 14A; paragraph [0092]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the blade outlet of Sakurai et al. to have an angled surface disposed at a non-zero angle with respect to a surface of the blade, as suggested and taught by Stulen, for the purpose of reducing divergent fluid mist that occurs during an ultrasonic surgical cutting procedure, thereby increasing visibility at the surgical site for the operator to have a more successful procedure.
Regarding claim 16, Sakurai et al. as modified by Stulen meets the limitation ‘wherein a distal end of the blade outlet has a larger diameter than a proximal end of the blade outlet’ (conical shape - Fig. 14A), as suggested and taught by Stulen - see rejection of claim 1 above.
Regarding claim 17, Sakurai et al. as modified by Stulen meets the limitation ‘wherein the blade outlet is configured to expel the cooling fluid from the blade as a mist or a vapor’ (paragraph [0092]), as suggested and taught by Stulen - see rejection of claim 1 above.
Regarding claim 18, Sakurai et al. further disclose wherein the surgical instrument is coupled to a fluid control system (column 38, line 32 to column 39, line 14) configured to pump cooling fluid through the blade lumen 68 and out of the blade through the blade outlet when the instrument is deactivated (the fluid control system associated with the lumen 68 is capable of performing this function if intended; it is noted that since this is not a process/method claim, the intended use of the fluid control system is not required by the prior art, rather, the structure/element merely needs to be capable of performing this function if programmed to do so).
Regarding claim 19, Sakurai et al. further disclose wherein the inflow conduit 259 is defined by an annulus formed between the waveguide 3 and the first tube 118 (column 38, line 32 to column 39, line 14).
Regarding claim 21, Stulen et al.’s teaching and suggestion of an angled surface is disposed at an angle θ to an inner surface of the blade lumen, wherein the angle θ is in a range of 0o to 45o (Fig. 14A; paragraph [0092]).
Allowable Subject Matter
Claims 8-11, 13, & 14 are allowed.
The following is an examiner’s statement of reasons for allowance: claim 8 has been amended to include the previously indicated allowable subject matter from prior claim 12 (see Reasons for Allowance section of Non-Final Rejection mailed on 4/27/2026 for reasons for indicating allowable subject matter).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 6, 7, & 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claims 7 and 20, although Sakurai et al. has a microtube positioned within the fluid conduit 259, it does not meet the limitation ‘wherein the inflow conduit comprises one or more polyimide microtubes’ since claims 1 and 15 require the inflow conduit to be in fluid communication with the blade lumen. Since the microtube 243 of Sakurai et al. (Fig. 93) is not in fluid communication with the blade lumen, in cannot read on the inflow conduit and therefore does not meet the claim limitation read as a whole. Regarding claim 6, Sakurai et al. as modified fails to further disclose, teach, or suggest wherein the elongated body further comprises a second tube, wherein the second tube is disposed within the first tube, and wherein the inflow conduit is defined between the first tube and the second tube. Although there is a microtube 243 disposed within the first tube/elongated body 118, the inflow conduit 259 would not be defined between the first tube 118 and the microtube 243 (seen in Fig. 93).
Response to Arguments
Applicant's arguments filed 7/6/2026 have been fully considered but they are not persuasive. Applicant argues that Sakurai et al.’s fluid outlet is not capable of performing the function of ‘facilitating an outflow of fluid from a distal end of the blade lumen’ since the intended use of the outlet in Sakurai et al.’s system is to be connected to a suction pump to utilize the outlet as a means to remove emulsified tissue. However, the structural requirements in claims 1 and 15 never positively recited a source of fluid to be attached to/communicating with the blade outlet, rather just the structure of the outlet is claimed with a functional statement of the outlet to be capable of facilitating outflow of fluid. Without the presence of the fluid source, all the structure that is being claimed is an outlet which needs to be capable of receiving a source of fluid and dispensing it therethrough. Sakurai et al.’s outlet, when the instrument is not attached to the suction source, is an outlet structure that is capable of receiving fluid therethrough and delivering it from the outlet. Since the outlet is capable of drawing tissue in and removing it, it is considered to be an open system where it can communicate with some source at its proximal end. If an irrigation/fluid source were to be attached to that proximal end, the fluid would have a path to move through the instrument and out the outlet. Without the positive recitation of a fluid source, these arguments will not be found persuasive since the structure of Sakurai et al.’s outlet has the capability of facilitating an outflow of fluid as recited.
Conclusion
THIS ACTION IS MADE FINAL. 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 ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 August 27, 2026
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