DETAILED ACTION
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.
Claim(s) 1-5 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shapira (US 6358252).
Regarding claim 1, Shapira discloses a surgical bur (Fig. 2) including: a shaft (30, Fig. 2) extending along an axis; a cutting part or bur 38 provided on the shaft at one end in an axial direction of the shaft; a liquid flow generation part in the form of a spiral cutting blade formed on an outer peripheral surface of the shaft at a position close to bur 38, the liquid flow generation part having at least one of a convex part projecting outward in a radial direction of the shaft or a concave part or portion recessed inward in the radial direction of the shaft and being configured to generate liquid flow when the shaft is rotated around the axis (col. 6, lines 42-67, cols. 7-9 and col. 10, lines 1-17).
Regarding claim 2, Shapira discloses the liquid flow generation part includes a spiral blade or protrusion formed spirally around the outer peripheral surface of the shaft centering on the axis, and protruding outward from the outer peripheral surface of the shaft (Fig. 2, col. 6, lines 42-67, cols. 7-9 and col. 10, lines 1-17).
Regarding claim 3, the spiral protrusion has a lower protruding height in the radial direction toward a position closer to the cutting part (Fig. 2 where the spiral cutting blade 59 terminates, col. 6, lines 42-67, cols. 7-9 and col. 10, lines 1-17).
Regarding claim 4, a maximum outer diameter dimension of the spiral protrusion is smaller than a maximum outer diameter dimension of the cutting part as the spiral blade approaches its termination on shaft 30 (Fig. 2, col. 6, lines 42-67, cols. 7-9 and col. 10, lines 1-17).
Regarding claim 5, Shapira discloses a surgical system (Fig. 1), including the surgical bur according to claim 1 and a handpiece having a longitudinal tubular support that exposes the cutting part and the liquid flow generation part at the tip and rotationally supports the shaft; and a rotation control device that rotationally drives the shaft of the surgical bur supported by the tubular support; and a perfusion fluid device that supplies perfusion fluid towards the cutting part and the liquid flow generation part of the surgical bur (Fig. 1, col. 6, lines 42-67, cols. 7-9 and col. 10, lines 1-17).
Regarding claim 9, Shapira discloses a method for operating the surgical system according to claim 5, the method including the steps of: supplying the perfusion fluid towards the cutting area by the surgical bur using the perfusion fluid device while inserting the tip of the longitudinal tubular support of the handpiece supporting the surgical bur into the affected area; and rotationally driving the surgical bur with the rotation control device while the cutting part and the liquid flow generation part are placed in the liquid perfusion fluid accumulated in the affected area, generating a flow of the perfusion fluid by the liquid flow generation part (Fig. 1, col. 6, lines 42-67, cols. 7-9 and col. 10, lines 1-17).
Regarding claim 10, Shapira discloses the method steps of a liquid flow directing the perfusion fluid around the cutting part along the shaft towards the liquid flow generation part with the rotation control device rotating the surgical bur (Fig. 1, col. 6, lines 42-67, cols. 7-9 and col. 10, lines 1-17).
Regarding claim 11, Shapira discloses the method steps of directing the perfusion fluid around the cutting part towards a side further to the shaft with the rotation control device rotating the surgical bur (Fig. 1, col. 6, lines 42-67, cols. 7-9 and col. 10, lines 1-17).
Claim(s) 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomas et al. (US 5925056).
Regarding claim 1, Thomas et al. disclose a surgical cutting device or “bur” (Fig. 27) including: a shaft (164, Fig. 27) extending along an axis; a cutting head or part (168) provided on the shaft at one end in an axial direction of the shaft; a liquid flow generation part in the form of threads 166 formed on an outer peripheral surface of the shaft at a position close to cutting head 168, the liquid flow generation part having at least one of a convex (protruding) part projecting outward in a radial direction of the shaft or a concave (depressed) part or portion recessed inward in the radial direction of the shaft and being configured to generate liquid flow when the shaft is rotated around the axis (col. 5, lines 65-67, cols. 6-8 and col. 9, lines 1-37). The preamble of the claim recites a surgical bur but the body of the claim recites a cutting part which is interpreted to mean any cutting device (MPEP 2111.02).
Regarding claim 2, Thomas et al. disclose the liquid flow generation part includes threads (helical or spiral) 166 formed around the outer peripheral surface of the shaft centering on the axis, and protruding outward from the outer peripheral surface of the shaft (Fig. 27, col. 5, lines 65-67, cols. 6-8 and col. 9, lines 1-37).
Regarding claim 3, the spiral protrusion (thread crest) has a lower protruding height in the radial direction toward a position closer to the cutting part (Fig. 27 where the thread 166 terminates, col. 5, lines 65-67, cols. 6-8 and col. 9, lines 1-37).
Regarding claim 4, a maximum outer diameter dimension (thread crest) of the spiral protrusion is smaller than a maximum outer diameter dimension of the cutting part as the thread turn approaches its termination on shaft 164 (Fig. 27, col. 5, lines 65-67, cols. 6-8 and col. 9, lines 1-37).
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 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (US 5925056) in view of Furlong et al. (US 9028424).
Regarding claims 5-11, Thomas et al. disclose the cutting tool to be capable of being used in an endoscopic surgical procedure but do not describe details of the endoscope including: (1) irrigation of the surgical site along with aspiration; and (2) an optical device for visualizing the surgical site during cutting. See previous discussion of Thomas et al. with respect to claims 1-4.
Regarding claims 5-11, Furlong et al. disclose a system and method for cutting tissue including the steps of: supplying the perfusion or irrigation fluid towards the cutting area by the surgical bur using the perfusion fluid device while inserting the tip of the longitudinal tubular support of the handpiece supporting the surgical bur into the affected area; and rotationally driving the surgical bur with the rotation control device while the cutting part and the liquid flow generation part are placed in the liquid perfusion fluid accumulated in the affected area, generating a flow of the perfusion fluid by the liquid flow generation part (Fig. 4A and 15, col. 16, lines 1-67, cols. 27-34 and col. 35, lines 1-40).
Regarding claims 6 and 8, Furlong et al. disclose supplying irrigation fluid to the surgical cutting assembly via an irrigation fluid channel defined with the endoscope or sheath wherein the face of the tip of the sheath includes a light source allowing a user to view an image of the area being cut (Fig. 4A, col. 16, lines 1-67, cols. 27-34 and col. 35, lines 1-40).
Regarding claim 7, Furlong et al. disclose an irrigation channel and a suction conduit in the endoscope (Fig. 4B, col. 16, lines 1-67, cols. 27-34 and col. 35, lines 1-40).
Therefore, it would have been obvious to one of ordinary skill in the art to have utilized the Thomas et al. cutting device during an endoscopic procedure with an endoscopic sheath having irrigation fluid delivery and aspiration along with visualization of the surgical site, as taught by Furlong et al., for effective visualization and removal of diseased tissue.
Regarding claim 9, the combination of Thomas et al. and Furlong et al. discloses a method including the steps of: supplying the perfusion fluid towards the cutting area by the surgical bur using the perfusion fluid device while inserting the tip of the longitudinal tubular support of the handpiece supporting the surgical bur into the affected area; and rotationally driving the surgical bur with the rotation control device while the cutting part and the liquid flow generation part are placed in the liquid perfusion fluid accumulated in the affected area, generating a flow of the perfusion fluid by the liquid flow generation part.
Regarding claim 10, the combination of Thomas et al. and Furlong et al. discloses a method including the steps of discloses the method steps of a liquid flow directing the perfusion fluid around the cutting part along the shaft towards the liquid flow generation part with the rotation control device rotating the surgical bur.
Regarding claim 11, the combination of Thomas et al. and Furlong et al. discloses a method including the steps of directing the perfusion fluid around the cutting part towards a side further to the shaft with the rotation control device rotating the surgical bur.
Response to Arguments
Applicant's arguments have been fully considered by the Examiner. The amendments to the Drawings and the Specification have been entered by the Examiner. Applicant’s amendment of claim 5 overcomes the rejections under 35 USC 112(b) made in the previous office action.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(1) over Shapira (US 6358252) are not persuasive for the following reasons.
Shapira discloses all elements of Applicant’s claimed invention as discussed in this office action. Contrary to Applicant’s arguments, Shapira discloses passing irrigation or perfusion fluid through passage 50 in hollow shaft 29 and a second passage 53 which enables flow of fluid or perfusion away from the cutting part or bur by application of a vacuum (Fig. 2, col. 6 lines 42-67, col. 7 and col. 8, lines 11-37). Applicant argues features of Applicant’s invention which are not claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims MPEP 2145 (VI).
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(1) over Thomas et al. (US 5925056) are not persuasive for the following reasons.
Thomas et al. disclose all elements of Applicant’s claimed invention. Thomas et al. disclose “The main shaft can be a straight cylindrical shaft or can be threaded similar to a screw which serves to move displaced emulsified disk material from the tip of the cutting device.” Interpreted to mean, “away from the cutting tip.” Thomas et al. also disclose normal irrigation (or perfusion) and suction can be used to thoroughly flush the surgical site (col. 2, lines 28-67, col. 3 and col. 4, lines 1- 44). Applicant’s invention in claim 1 only requires “the liquid flow generation part to be configured to generate liquid flow of a perfusion fluid away from a vicinity of the cutting part when the shaft is rotated around the axis.” Based on the disclosure of Thomas et al., the threaded or “liquid flow generation part” moves liquid away from the cutting part when used in conjunction with irrigation and suction. The perfusion fluid and/or structure that provides the perfusion fluid is not positively recited in claim 1. Furlong et al. disclose the use of an endoscope assembly for providing irrigation and flushing wherein the endoscope has an instrument channel for receiving a surgical cutting assembly. The combination of Thomas and Furlong et al. discloses all elements of the claimed invention when irrigation and aspiration are provided along with cutting to clear a surgical site.
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 Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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July 10, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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