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
The Amendment filed 02/18/26 has been entered. Claims 1 and 14-17 been amended, and new claim 18. Claims 1-11 and 14-18 are addressed in the following office action
Claim Objections
Claim 14 objected to because of the following informalities: In line 1, “cross-sectional” should read “cross-section”. Appropriate correction is required.
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 1, 3, 5-7, 9-11, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Cole (US 2015/0305767), cited in previous office action, in view of Anderson et al. (US 6,086,543).
Regarding claim 1, an invention relating to surgical punch, Cole discloses (Figs. 1a, 1c, 1e) a cutting tool (10) capable of removing a portion of soft tissue from a target tissue layer interfacing an anterior chamber of an eye, thereby creating a tubeless channel through the target tissue layer enabling excessive fluid to be drained from inside the anterior chamber of the eye through the tubeless channel, the cutting tool adapted for an ab interno procedure [i.e. the distal end of the tool is of a structure and size, cutting edge with 0.5 mm diameter, that it can be introduced into the anterior chamber of the eye through an incision made in the cornea] (Par. 0025) and comprising: a proximal side (see annotated figure below); and a distal side (see annotated figure below), the distal side configured to be introduced into the anterior chamber, the distal side comprising: an elongated round body [i.e. tubular cylinder] extending along a longitudinal axis [i.e. central axis] and having a uniform outer cross-section at a proximal side (see annotated figure below) thereof (Par. 0025 & 0029), a cutting portion (45) at a distal side (see annotated figure below) of the elongated round body, the cutting portion comprising an outer cross-section smaller than said uniform outer cross-section of the elongated body and continuously decreasing in the distal direction [i.e. the bevel has a smaller diameter that tapers towards the distal most end], the cutting portion being open and having a cutting edge (33) at a distal most end of the cutting portion, the cutting edge is of a substantially circular shape oriented in a perpendicular direction to the longitudinal axis (Fig. 1d; Par. 0025-0026), the cutting edge configured, when the cutting tool is advanced distally into the target tissue layer, to cut and remove the portion of soft tissue, and a chamber [i.e. bore] extending proximally along the longitudinal axis inside the cutting tool from said open distal end (33) of the cutting portion (Par. 0025 & 0036-0037). However, Cole fails to disclose wherein a diameter of a cross-section of the chamber continuously decreases from the cutting edge to a first location located proximal to the cutting edge, the diameter of the cross-section of the chamber remains substantially constant or increases from the first location to a second location located proximal to the first location.
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In the analogous art of surgical cutters, Anderson teaches (Fig. 5A) wherein a diameter of a cross-section of a chamber continuously decreases from a cutting edge to a first location located proximal to the cutting edge [i.e. conical distal tip (507A)], the diameter of the cross-section of the chamber remains substantially constant or increases from the first location to a second location located proximal to the first location (see annotated figure below & Col. 10, lines 27-34).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cole to have wherein a diameter of a cross-section of the chamber continuously decreases from the cutting edge to a first location located proximal to the cutting edge, the diameter of the cross-section of the chamber remains substantially constant or increases from the first location to a second location located proximal to the first location. Doing so would provide a sharpened conical distal tip highly effective in cutting through tissue and encouraging tissue to enter the center axial lumen (Col. 6, lines 65-67 & Col. 7, lines 1-2), as taught by Anderson.
Regarding claim 3, Cole, as modified by Anderson, discloses the cutting tool according to claim 1. Cole further discloses wherein said cross-section of the chamber is proximal to said distal side of the chamber (Fig. 1c; Par. 0005 & 0025).
Regarding claim 5, Cole, as modified by Anderson, discloses the cutting tool according to claim 1. Cole further discloses wherein said removed soft tissue portion is substantially cylindrical with a cross-section equal to a cross section of the cutting edge (Par. 0035-0037).
Regarding claim 6, Cole, as modified by Anderson, discloses the cutting tool according to claim 1. Cole further discloses wherein said removed soft tissue portion has a length of up to 1.5mm (Par. 0036-0037).
Regarding claim 7, Cole, as modified by Anderson, discloses the cutting tool according to claim 1. Cole further discloses wherein said chamber has a length of up to 1.5mm (Par. 0041).
Regarding claim 9, Cole, as modified by Anderson, discloses the cutting tool according to claim 1. Cole discloses further comprising an outer protective shaft (3 & 19) surrounding a proximal portion of the elongated round body (Fig. 2), the protective shaft forms as a stopping part (see annotated figure below) for the cutting tool in the distal direction such that a distal side of the protective shaft is stuck to an inner side wall of the target tissue layer when the cutting tool is advanced distally, ab interno inside the anterior chamber, into the target tissue layer (Figs. 7-8; Par. 0031 & 0039-0041).
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Regarding claim 10, Cole, as modified by Anderson, discloses the cutting tool according to claim 1. Cole discloses further wherein said cutting portion is rotated in addition to being advanced distally to cut and remove the portion of the soft tissue layer (Par. 0037).
Regarding claim 11, Cole, as modified by Anderson, discloses the cutting tool according to claim 1. Cole discloses (Fig. 1a) further comprising a handle (17), at a proximal side, for gripping and handling the cutting tool (Par. 0030).
Regarding claim 14, Cole, as modified by Anderson, discloses the cutting tool according to claim 1. Cole further discloses wherein a diameter of said uniform outer cross-sectional of the elongated round body is about 0.2mm to about 0.5mm (Par. 0006).
Regarding claim 15, Cole, as modified by Anderson, discloses the cutting tool according to claim 1. Cole further discloses wherein a diameter of inner surface of said chamber is about 0.1mm to about 0.2mm (Par. 0025).
Regarding claim 16, Cole, as modified by Anderson, discloses the cutting tool according to claim 9. Cole further discloses wherein said outer protective shaft has an outer cross-section diameter of about 0.5mm (Par. 0022 & 0025).
Regarding claim 17, Cole, as modified by Anderson, discloses the cutting tool according to claim 16. Cole further discloses wherein said outer protective shaft has an outer cross-section diameter that is substantially constant (Par. 0022).
Regarding claim 18, Cole, as modified by Anderson, discloses the cutting tool according to claim 1. Cole further discloses wherein the chamber having dimensions enabling storing of the removed soft tissue portion inside the chamber (Fig. 6).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Cole (US 2015/0305767), in view of Anderson et al. (US 6,086,543), as applied to claim 1 above, and further in view of Sullivan et al. (US 2013/0046316), cited in previous office action.
Regarding claim 2, Cole, as modified by Anderson, discloses the cutting tool according to claim 1. Cole fails to further disclose wherein said cross-section of the chamber increases continuously towards a proximal of the chamber.
In the analogous art of tissue cutting device, Sullivan teaches wherein said cross-section of the chamber [i.e. lumen] increases continuously towards a proximal of the chamber (Par. 0102).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cole, in view of Anderson, to have wherein said cross-section of the chamber increases continuously towards a proximal of the chamber. Doing so would reduce the risk of clogging (Par. 0102), as taught by Sullivan.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Cole (US 2015/0305767), in view of Anderson et al. (US 6,086,543), as applied to claim 1 above, and further in view of Ginggen et al. (WO 2016/077759), cited in previous office action.
Regarding claim 4, Cole, as modified by Anderson, discloses the cutting tool according to claim 3. Cole fails to disclose wherein said diameter of the cutting edge is between about 0.1mm to about 0.2mm.
In the analogous art of follicular extraction device, Ginggen teaches wherein said diameter of the cutting edge is between about 0.1mm to about 0.2mm (Pg. 7, lines 14-26 & Pg. 33, lines 4-24).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cole, in view of Anderson, to have wherein said diameter of the cutting edge is between about 0.1mm to about 0.2mm. Doing so would facilitate the removal of tissue from the treatment area and/or the needles themselves and may limit the need for clearing using a pressure generating source (Pg. 33, lines 22-24), as taught by Ginggen.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Cole (US 2015/0305767), in view of Anderson et al. (US 6,086,543), as applied to claim 1 above, and further in view of Umar et al. (US 2014/0031839), cited in previous office action.
Regarding claim 8, Cole, as modified by Anderson, discloses the cutting tool according to claim 1. Cole fails to further disclose wherein an inner surface of the chamber is coated with a friction-lowering composition.
In the analogous art of follicular extraction device, Umar teaches wherein an inner surface of the chamber is coated with a friction-lowering composition (Par. 0026).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cole, in view of Anderson, to have wherein an inner surface of the chamber is coated with a friction-lowering composition. Doing so would reduce the twisting of the upper portion of the follicle which has been partially or wholly dislodged from its surrounding tissue attachments. This serves to further reduce the transection rate (Par. 0026), as taught by Umar.
Response to Arguments
Applicant’s arguments, see page 6, filed 02/18/26, with respect to claims 14-17 have been fully considered and are persuasive. The 35 USC § 112 rejection of claims 14-17 has been withdrawn.
Applicant’s remaining arguments, with respect to the prior art rejections of claims under 35 USC § 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of newly cited prior art.
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 Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 May 2, 2026
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