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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of claims 1-12 in the reply filed on 1/6/2026 is acknowledged.
Claims 13-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/6/2026.
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.
Claim(s) 1, 8 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bereczki (WO2012102842A1) in view of Arthurs (US 20180110531) and further in view of Farr (US 20090216234).
With respect to claims 1 and 10-12, Bereczki teaches a tool set for percutaneous extraforaminotomy (e.g., see fig. 8), comprising: a stylet member (e.g., 13) comprising an elongated probe (e.g., guide wire/guide pin, see para. 57, 98), a guide pipe (tubular body 13) into which the probe is insertable and from which the probe is separable (see para. 57), and a hub body (14) mounted to the guide pipe, wherein the stylet member reaches a target point for resection of transforaminal ligament during the percutaneous extraforaminotomy (see para. 57 and note that this device is capable of performing this function if one so desires); a trocar (25) comprising a needle (body of 28), a needle tip with a cutting end (e.g., 29) (see fig. 3c) and a first handle (21) serving to apply a force to the needle in accordance with an angle of percutaneous entry to a spinal facet joint (see fig. 3c and para. 64), wherein the trocar reaches the target point for resection of the transforaminal ligament under guidance of the guide pipe of the stylet member and drills a hole in the transforaminal ligament (see para. 98 and note that the stylus- guide pin and 13- are used in the placement of cannula 1, which then guides 25 to the site), during the percutaneous extraforaminotomy (see para. 98-99, 102); a cannula (1) comprising a sleeve (8) formed to have a greater diameter than the trocar and having an axial through-hole (e.g., at 4) into which the trocar is insertable (see fig. 8 and also para. 36, 98-100, 102), the cannula including a fixation shaft (e.g., 4) located in a central portion of the cannula to insert and fix one end of the sleeve (see fig. 1a, para. 43), and a handle (2) having a seating portion (e.g., for a hand) formed on a rear surface thereof (see fig. 1a); wherein the cannula reaches the target point for resection of the transforaminal ligament under the guidance of the trocar during the percutaneous extraforaminotomy (see para. 102 and note that this device is capable of performing this function if one so desires).
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Bereczki does not appear to teach the stylet member including a cap mounted to the probe, and the hub body mounted to the guide pipe and coupled to the cap; the trocar comprising a needle having a groove formed in a predetermined portion thereof and a needle tip with a pointed front end, and a first handle inserted into the needle and serving to apply a force to the needle in accordance with an angle of percutaneous entry to a spinal facet joint; and a curette comprising a rod which is inserted into the sleeve of the cannula, a resection tip provided at a front end of the rod and serving to peel off the transforaminal ligament at the target point for resection of the transforaminal ligament, scrape the residue of the transforaminal ligament and push the residue resected primarily, into the intervertebral foramen, and a second handle which is seated on the seating portion of the cannula; wherein the resection tip of the curette has a central concave portion to scrape the transforaminal ligament surrounding the intervertebral foramen, and a round-shaped rim portion formed at a periphery of the concave portion; wherein the resection tip has a straight section in such a manner as to come into close contact with an inner surface of the gradient of the tapered portion, and is inserted into and protrudes from the tapered portion of the sleeve, and there is little or no gap between the end of the resection tip and the tapered portion; and wherein a rim portion formed at the resection tip of the curette has a rounded end.
Arthurs, also drawn to a percutaneous tool set (see abstract), teaches cooperative tool attachments and locking members, including a nested (stylet) member (e.g. 3, 4, see fig. 10a-10c) including a cap (e.g., 44) mounted to a probe (4) (see fig. 7), and the hub body (35) mounted to the guide pipe (e.g., 3) (see fig. 6a) and coupled to the cap (see fig. 10a-10c); a trocar (e.g. 1) comprising a needle (11) having a groove (18) formed in a predetermined portion thereof (see para. 38) and a needle tip with a pointed front end (15) (see para. 37), and a first handle (12) inserted into the needle (via pin 17) and serving to apply a force to the needle in accordance with an angle of percutaneous entry to a spinal facet joint (see para. 38) in order to provide known tool connection and locking components that a) prevents a nested tool (e.g., probe) from sliding too far within its counterpart (e.g., guide pipe) and b) locks two components (e.g., needle and handle) together to provide stable connection between the elements when imparting a force on the tool (see para. 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Bereczki wherein the stylet member including a cap mounted to the probe, and the hub body mounted to the guide pipe and coupled to the cap; the trocar comprising a needle having a groove formed in a predetermined portion thereof and a needle tip with a pointed front end, and a first handle inserted into the needle and serving to apply a force to the needle in accordance with an angle of percutaneous entry to a spinal facet joint, in view of Arthurs, in order to provide known tool connection and locking components that a) prevents a nested tool from sliding too far within its counterpart and b) locks two components together to provide stable connection between the elements when imparting a force.
Farr, also drawn to spinal surgical tools (see abstract), teaches a curette (500) comprising a rod (504) which is inserted into the sleeve of the cannula (18) (see para. 125), a resection tip (506) provided at a front end of the rod and serving to peel off the transforaminal ligament at the target point for resection of the transforaminal ligament, scrape the residue of the transforaminal ligament and push the residue resected primarily, into the intervertebral foramen (see para. 124 and note that this device is capable of performing this function if one so desires), and a second handle (502) which is seated on the seating portion of the cannula (see fig. 17 and para. 128, note that tool 700 is similar to 500 and this figure depicts an example of how such a tool is located within the cannula); wherein the resection tip of the curette has a central concave portion (e.g., 508, see para. 124) to scrape the transforaminal ligament surrounding the intervertebral foramen, and a round-shaped rim portion (e.g. 510) formed at a periphery of the concave portion (see fig. 20b-20c, para. 124); wherein the resection tip has a straight section (portion of 504 attached to 506, see fig. 20a) in such a manner as to come into close contact with an inner surface of the gradient of the tapered portion, and is inserted into and protrudes from the tapered portion of the sleeve, and there is little or no gap between the end of the resection tip and the tapered portion (see fig. 20a); and wherein a rim portion formed at the resection tip of the curette has a rounded end (see fig. 19) in order to provide a known instrument used with tools that perform spinal procedures, including foraminotomies (see para. 117).
It would have been obvious to one of ordinary skill in the art before the effective fling date of to modify Bereczki to include a curette comprising a rod which is inserted into the sleeve of the cannula, a resection tip provided at a front end of the rod and serving to peel off the transforaminal ligament at the target point for resection of the transforaminal ligament, scrape the residue of the transforaminal ligament and push the residue resected primarily, into the intervertebral foramen, and a second handle which is seated on the seating portion of the cannula; wherein the resection tip of the curette has a central concave portion to scrape the transforaminal ligament surrounding the intervertebral foramen, and a round-shaped rim portion formed at a periphery of the concave portion; wherein the resection tip has a straight section in such a manner as to come into close contact with an inner surface of the gradient of the tapered portion, and is inserted into and protrudes from the tapered portion of the sleeve, and there is little or no gap between the end of the resection tip and the tapered portion; and wherein a rim portion formed at the resection tip of the curette has a rounded end, in view of Farr, in order to provide a known instrument used with tools that perform spinal procedures, including foraminotomies.
As for claim 8, Bereczki, as modified by Arthurs and Farr, further teaches the tool set of claim 1, wherein a predetermined section at a front-end side of the sleeve of the cannula consists of a tapered portion (e.g., bevel) with a gradient (see fig. 8 above).
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bereczki (WO2012102842A1), Arthurs (US 20180110531) and Farr (US 20090216234), as applied to claim 1 above, in view of Hill (US 1248492).
As for claims 2-4, Bereczki, as modified by Arthurs and Farr, further teaches a beveled tip at the end of the guide pipe (see fig. 8 above) but does not appear to teach wherein the end of the probe of the stylet member has a bevel cut formed in an inclined shape and a curved portion formed by machining a lower portion opposite to the bevel cut in a round shape; and wherein a plurality of grooves are formed in an outer circumferential surface of each of the cap of the stylet member and the hub body; and wherein the stylet member has a handle configured by coupling a locking lever mounted to the cap to a locking groove formed in the hub body.
Hill, also drawn to surgical tools (see abstract, fig. 7), teaches wherein the end of the probe of the stylet member has a bevel cut formed in an inclined shape and a curved portion formed by machining a lower portion opposite to the bevel cut in a round shape (see col. 2 lines 74-81, fig. 7); and wherein a plurality of grooves (e.g., 24, 21, spaces between 15 and 12, see fig. 4 or outer surface of 13, see fig. 5) are formed in an outer circumferential surface of each of the cap of the stylet member and the hub body; and wherein the stylet member has a handle (e.g., 18) configured by coupling a locking lever (e.g., 19) mounted to the cap to a locking groove (e.g., 21) formed in the hub body, in order to provide appropriate and known gripping and locking elements on the handles of a probe and hub body which allow secure retraction and extension of the stylet members (see fig. 2 and col. 1 lines 27-32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Bereczki, as modified by Arthurs and Farr, wherein the end of the probe of the stylet member and the end of the guide pipe each have a bevel cut formed in an inclined shape and a curved portion formed by machining a lower portion opposite to the bevel cut in a round shape; and wherein a plurality of grooves are formed in an outer circumferential surface of each of the cap of the stylet member and the hub body; and wherein the stylet member has a handle configured by coupling a locking lever mounted to the cap to a locking groove formed in the hub body, in view of Hill, in order to provide appropriate and known gripping and locking elements on the handles of a probe and hub body which allow secure retraction and extension of the stylet members.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bereczki (WO2012102842A1), Arthurs (US 20180110531) and Farr (US 20090216234), as applied to claim 8 above, in view of Scanlan (US 20070066987).
As for claim 9, Bereczki, as modified by Arthurs and Farr, does not teach coupling protrusions provided on both sides of the second handle of the curette in such a manner as to be inserted into coupling grooves of the seating portion.
Scanlan, also drawn to surgical tools, teaches mating coupling grooves and protrusions between a tool and a seating portion of a handle in which the tool is inserted into (see fig. 3, note 50, 160, 130, 120) in order to provide known secure locking between both tools (see para. 19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Bereczki, as modified by Arthurs and Farr, to include coupling protrusions provided on both sides of the second handle of the curette in such a manner as to be inserted into coupling grooves of the seating portion, in view of Scanlan, in order to provide known secure locking between both tools.
Reasons for Allowance
The following is a statement of reasons for the indication of allowable subject matter:
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1. In particular, none of the cited references teach or suggest wherein the first handle of the trocar comprises: a body having a lengthwise groove formed in the central portion thereof and an accommodation space formed in a one-side surface thereof to have a predetermined depth; a stepped portion formed at a rear end of the body and serving to provide a gripping force to a surgical operator; a shaft inserted into the accommodation space; and a lever having a pressing portion formed in a round shape to provide a pressing force while coming into contact with the groove of the needle, wherein the shaft is inserted into a center of the pressing portion and is rotated within the accommodation space to lock and unlock the needle, as required by claims 5-7.
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.”
Allowable Subject Matter
Claims 5-7 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20060089633; US 4573448; US 20100185161.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA ROSE E CARTER/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773