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
In response to the amendment filed on 4/28/2025, no claims have been cancelled, and no claims have been newly added, thus claims 1-15 are pending.
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 1-2, 5-11, 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018080487 A1 Mirza et al. (hereinafter Mirza) in view of US 20130197553 Ng et al. (hereinafter Ng).
Regarding claim 1, Mirza discloses a system, comprising:
a cannulated trocar (10, Fig. 1) comprising a trocar handle (15, 16, Fig. 1-2, paragraph 57) and defining a slot therein (14, Fig. 1, paragraph 54);
a cutter comprising a cutting blade (70) at a distal end of a blade shaft (74) (paragraph 66, Fig. 10, cutting instrument, such as a surgical knife 70, is mounted at the leading end 72 of an elongate hollow tubular member 74, within the cannula 10) and a blade clamp configured to clamp the cutter to a surgical scope (paragraph 67-68, Fig. 10-11, leading end 84 of the endoscope 82 positioned closely to the cutting instrument or cutting blade 70 through use of lever 66 on locking device 60).
Mirza is silent on an elongated shim comprising a shim handle, the elongated shim configured to fit within a proximal aperture of the cannulated trocar and below the cutter so to cause the cutting blade to be exposed from the slot when positioned therein.
However, Ng teaches a cutting device for cutting tissue (abstract, paragraph 10) that comprises a cannulated trocar (3, 3100, Fig. 2, 7) having a slot (31, 3110, Fig. 2, 7), and an elongated shim (6, Fig. 8a) comprising a shim handle (7) (paragraph 87, Fig. 8a, support rod holder 7 supporting the support rod 6), the elongated shim configured to fit within a proximal aperture of the cannulated trocar (paragraph 70, 87, Fig. 8a, housing 10 of sleeve 3 comprises a movable cutter holder 8 and a movable support rod holder 7) and below the cutter (2, 3000, Fig. 5, 8a) so to cause the cutting blade to be exposed from the slot when positioned therein (paragraph 70-72, Fig. 6, 11, 13-15, when in position, the support rod 6, 3201 is inserted fully into the sleeve 3, 3100, (shown below cutter 2), this will force the cutting blade 13, 3001 to protrude through the slit 31, 3110 and pierce through the tissue).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Mirza with the teachings of Ng in order to retract the cutting blade to prevent any unnecessary damage to the surrounding tissues as disclosed by Ng (paragraph 72).
Regarding claim 2, the combination of Mirza and Ng teaches the limitations of claim 1, and Mirza further discloses wherein the cannulated trocar comprises an elongated body having the slot defined therein (elongated body 11 having the slot 14 defined therein, Fig. 1).
Regarding claim 5, the combination of Mirza and Ng teaches the limitations of claim 1, and Mirza further discloses wherein the blade shaft extends between the blade clamp and the cutting blade (as seen in Fig. 11, paragraph 67, tubular member 74 with hub end positioned within locking device 60, and blade end 72 with blade 70).
Regarding claim 6, the combination of Mirza and Ng teaches the limitations of claim 5, and Ng teaches wherein the cutting blade has a blunt distal end (paragraph 86, Fig. 14, the blade edge of the cutting blade is pointing away from the first end of the sleeve, i.e. the end with the tapered shape 1, 3002, and points towards the second end from where the cutter rod is inserted).
Regarding claim 7, the combination of Mirza and Ng teaches the limitations of claim 6, and Ng teaches wherein the cutting blade has a sharp proximal end (paragraph 86, Fig. 14, the blade edge of the cutting blade is pointing away from the first end of the sleeve, i.e. the end with the tapered shape 1, 3002, and points towards the second end from where the cutter rod is inserted).
Regarding claim 8, the combination of Mirza and Ng teaches the limitations of claim 1, and Ng teaches wherein the elongated shim comprises an elongated shim body coupled to the shim handle (as seen in Fig. 8a, elongated shim 6 has an elongated shim body coupled to the shim handle 7).
Regarding claim 9, the combination of Mirza and Ng teaches the limitations of claim 8, and Ng teaches wherein the elongated shim body is relatively flat with grooves defined therein (paragraph 103, as seen in Fig. 15, the support rod 6 having a first end 61 comprises a groove 62 at the opposite end).
Regarding claim 10, the combination of Mirza and Ng teaches the limitations of claim 1, and Ng teaches wherein when the elongated shim is not positioned within the cannulated trocar along with the cutter, the cutting blade remains within the slot of the cannulated trocar (paragraph 70-72, As long as the support rod 6, 3201 is not fully inserted into the sleeve the cutting blade 13, 3001 will not protrude through the slit 31, 3110 of the sleeve 3, 3100).
Regarding claim 11, the combination of Mirza and Ng teaches the limitations of claim 1, and modified Mirza further teaches a method comprising using the system of claim 1 to perform a surgical procedure (abstract, paragraph 1, 15, 133-144).
Regarding claim 13, the combination of Mirza and Ng teaches the limitations of claim 11, and Mirza discloses wherein the step of using the system comprises:
coupling a surgical scope to the blade clamp of the cutter (paragraph 67-68, Fig. 10-12, lever 66 of locking device 60 is pivoted forwardly into the locking position, thereby causing the endoscope 82 to be clamped to the tubular member 74 mounting the cutting instrument or cutting blade 70);
inserting a distal end of the cutter into the proximal aperture of the cannulated trocar that has been positioned within a mammalian body (paragraph 69-70, Fig. 10-12, elongate tubular element 74, which mounts the knife or cutting element 70 at the leading end 72, is introduced into the patient towards the surgical site through slotted cannula 10); and
advancing the distal end of the cutter to a tissue of interest within the mammalian body (paragraph 71, the cutting instrument can be inserted through the cannula 10 into the operating site).
Regarding claim 14, the combination of Mirza and Ng teaches the limitations of claim 13, and Ng teaches further comprising:
inserting the shim into the cannulated trocar to cause the cutting blade to extend through the slot of the cannulated trocar (paragraph 70-72, when in position, the support rod 6, 3201 is inserted fully into the sleeve 3, 3100, this will force the cutting blade 13, 3001 to protrude through the slit 31, 3110 of the sleeve 3, 3100).
Regarding claim 15, the combination of Mirza and Ng teaches the limitations of claim 14, and Mirza discloses further comprising:
retracting the cutter so that the cutting blade can cut the tissue of interest (paragraph 148, engaging the cutting surface of the cutting tool with the target tissue and pulling the cutting tool back towards the proximal end of the cannula (for cutting tools with a backward facing cutting surface)).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Mirza in view of Ng as applied to claim 1 above, and further in view of US 20030028179 Piskun.
Regarding claim 3, the combination of Mirza and Ng teaches the limitations of claim 1.
The combination is silent on wherein the elongated body has a curvature.
However, Piskun teaches using trocars in laparoscopic procedures (abstract) that comprises a cannulated trocar (7, Fig. 2a) wherein the elongated body of the trocar has a curvature (as seen in Fig. 2a, paragraph 45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Mirza with Ng with the teachings of Piskun in order to provide ease of insertion into target tissue and provide increased work space between the hands of the surgeon as disclosed by Piskun (abstract).
Regarding claim 4, the combination of Mirza, Ng and Piskun teaches the limitations of claim 3, and Piskun teaches wherein the curvature curves upward (the direction of the curve is relative to the positioning of the trocar with the surgeon).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mirza in view of Ng as applied to claim 11 above, and further in view of US 20180042631 Garlock et al. (hereinafter Garlock).
Regarding claim 12, the combination of Mirza and Ng teaches the limitations of claim 11.
The combination is silent on wherein the surgical procedure comprises a gastrocnemius recession.
However, Garlock teaches surgical systems and methods for performing endoscopic release procedures including gastrocnemius release procedures (abstract, paragraph 4, 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Mirza with Ng with the teachings of Garlock to alleviate heel pain through endoscopic procedures without causing substantial trauma to the patient.
Conclusion
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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