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 .
Election/Restrictions
Applicant's election with traverse of Group 1, Species of figure 5A in the reply filed on 10/15/2025 is acknowledged. The traversal is on the ground(s) that the examiner does not provide reasonable example of the apparatus being used in a materially different process from the process and that there is no search burden. Applicant’s arguments with respect to the group restriction is persuasive and the restriction between the apparatus and the method has been withdrawn. With respect to the species restriction the election was made without traverse but the applicant elected a species of figure 5A which was not previously in a species restriction as the specification did not list it as an alternative cannula lock and was treated as a generic lock but further review and applicant’s arguments are persuasive and figure 5A shows a species of a ball and cam design. The proper groups should be Species 1: Figure 5A, Species 2: 5B, Species 3: Figures 5C-D, Species 4: Figures 5E-G, and species 5; Figures 5H-I. Claims 1, 12 and 27 are still generic.
Claim 3 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/15/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation "the locking knob" in line 1. There is insufficient antecedent basis for this limitation in the claim. The locking knob is claimed in claim 8 such that claim 9 should depend from claim 8.
Claim 11 recites the limitation "the lock mandrel" in line 2. There is insufficient antecedent basis for this limitation in the claim. The lock mandrel is claimed in claim 8 such that claim 9 should depend from claim 8.
Claim Rejections - 35 USC § 102
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 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, 2, 4, 5, 11-14 and 27-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baynham (US Pub 2014/0094822).
With respect to claim 1, Baynham discloses a surgical bone tap (See figures 24 and 25 below) comprising:(a) a cannulated shaft (fig 24, 416) having threads (paragraph 39) on a distal end (bottom);(b) a cannulated handle (fig 24, 402) attached to a proximal end of the cannulated shaft and forming a central passage (fig 24, passage for 420) extending through the cannulated handle and the cannulated shaft, the cannulated shaft being fixed to the cannulated handle such that there is no relative rotation there between (Fig 24); and(c) a cannula lock (fig 25, 418) configured to selectively move between (i) a locked position (shown in figure 25) where a guidewire(fig 24, 420) positioned in the central passage is engaged and cannot move axially with respect to the central passage, and (ii) an unlocked position (figure 25 arrow shows unlocking of lock) where the guidewire is disengaged and can move axially with respect to the central passage. With respect to claim 2, Baynham discloses wherein the cannula lock is continuous with the cannulated handle (fig 25). With respect to claim 4, Baynham discloses wherein the cannula lock is formed on a proximal end of the cannulated handle (fig 25 the lock is on and in the proximal end of the handle). With respect to claim 5, Baynham discloses wherein the cannula lock includes an impingement member (fig 25, 428) which moves at least partially into the central passage to engage the guidewire when in the locked position. With respect to claim 11, Baynham discloses wherein the handle includes a guide cap (See fig 25 below) threaded (by a screw) onto a proximal end of the lock mandrel (See fig 25 below), the guide cap including a guide aperture having an opening of greater diameter than that of the central passage, but tapering to a diameter substantially the same as that of the central passage (fig 25, the aperture is shown tapering to the width of the central passage.
With respect to claim 12, Baynham discloses a cannulated surgical instrument (see figures 24 and 25 below) comprising:(a) a cannulated shaft (fig 24, 416); (b) a cannulated driver (fig 24, 402) attached to a proximal end of the cannulated shaft and forming a central passage (for 420) extending through the cannulated driver and the cannulated shaft, the cannulated shaft being fixable to the cannulated driver such that there is no relative rotation there between (fig 24);and (c) a cannula lock (fig 24, 418) configured to selectively move between (i) a locked position (as shown in figure 25) where a guidewire positioned in the central passage is engaged and cannot move axially with respect to the central passage, and (ii) an unlocked position (fig 25 arrow shows how the device is unlocked) where the guidewire is disengaged and can move axially with respect to the central passage. With respect to claim 13, Baynham discloses wherein the cannulated driver is either (i) a manually operated handle, or (ii) a powered cannulated drill (fig 24 shows a manually operated handle). With respect to claim 14, Baynham discloses wherein the surgical instrument is one of (i) a tap, (ii) an awl, (iii) a screw driver, or (iv) a drill and drill bit (paragraph 39).
With respect to claim 27, Baynham discloses a method of selectively fixing a guidewire in a cannulated surgical instrument (See figs 24 and 25 below), the method comprising the steps of:(a) providing the cannulated surgical instrument (fig 24) comprising:(i) a cannulated shaft (fig 24, 416) ;(ii) a cannulated handle (fig 24, 402) attached to a proximal end of the cannulated shaft and forming a central passage (for 420) extending through the cannulated handle and the cannulated shaft, the cannulated shaft being fixed to the cannulated handle (fig 24) such that there is no relative rotation there between; and(iii) a cannula lock(fig 24, 418) configured to selectively move between (1) a locked position (as shown in figure 25) where a guidewire positioned in the central passage is engaged and cannot move axially with respect to the central passage, and (2) an unlocked position (arrow in fig 25 shows moving to the unlocked position) where the guidewire is disengaged and can move axially with respect to the central passage (paragraph 42) ;(b) with the cannula lock in the unlocked position, inserting a guidewire through the central passage (paragraph 42, open position allows for linear motion of the wire in the tool);(c) moving the cannula lock to the lock position and performing a step in a surgical procedure;(d) moving the cannula lock to the unlocked position (paragraph 43) and withdrawing the surgical instrument such that the central passage slides over the stationary guidewire (paragraph 40, wire left while tool is removed to allow the wire to be used for other parts of the procedure). With respect to claim 28, Baynham discloses wherein the surgical instrument is a bone tap and a distal end of the guidewire is first positioned in a bone aperture and then a proximal end of the guidewire is inserted into the central passage (paragraph 34). With respect to claim 29, Baynham discloses wherein the cannula lock is in the locked position while the bone tap is advanced into the bone aperture (paragraph 35, wire is locked to prevent movement with insertion). With respect to claim 30, Baynham discloses wherein after fully tapping the bone aperture, the cannula lock is placed in the unlocked position and the bone tap is withdrawn while leaving the guidewire inside the bone aperture (paragraph 40). With respect to claim 31, Baynham discloses wherein a cannulated bone screw is inserted over the guidewire and once the bone screw begins threaded engagement with the bone aperture, the guidewire is withdrawn from the bone aperture and bone screw (paragraph 40, wire removed after the screw insertion process).
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Claim(s) 1, 2, 4-9, 12-14 and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ramsay et al. (US pub 2014/0277164).
With respect to claim 1, Ramsay et al. discloses a surgical bone tap (see figures 5A-D) comprising:(a) a cannulated shaft (fig 5A, 500) having threads (See fig 5A below) on a distal end;(b) a cannulated handle (fig 1, 528) attached to a proximal end of the cannulated shaft and forming a central passage (for 540) extending through the cannulated handle and the cannulated shaft, the cannulated shaft being fixed to the cannulated handle such that there is no relative rotation there between (fixed by 514); and(c) a cannula lock (fig 5, 544) configured to selectively move between (i) a locked position (fig 5C) where a guidewire positioned in the central passage is engaged and cannot move axially with respect to the central passage, and (ii) an unlocked position (fig 5D) where the guidewire is disengaged and can move axially with respect to the central passage. With respect to claim 2, Ramsay et al. discloses wherein the cannula lock is continuous (fig 5B-D) with the cannulated handle. With respect to claim 4, Ramsay et al. discloses wherein the cannula lock is formed on a proximal end of the cannulated handle (fig 5C). With respect to claim 5, Ramsay et al. discloses wherein the cannula lock includes an impingement member (fig 5C, 554) which moves at least partially into the central passage to engage the guidewire when in the locked position. With respect to claim 6, Ramsay et al. discloses wherein the impingement member is a ball (fig 5C, 552). With respect to claim 7, Ramsay et al. discloses wherein the cannula lock includes a cam surface (fig 5C-D, 558) moving the ball between the locked (fig 5C) and unlocked position (fig 5D). With respect to claim 8, Ramsay et al. discloses wherein the cannula lock includes (i) a lock mandrel (fig 5C, 542) connected to the handle and (ii) a locking knob (fig 5C, 550) having internal threads (see fig 5C below) which travels on the lock mandrel. With respect to claim 9, Ramsay et al. discloses wherein the cam surface is positioned on the locking knob (see fig 5C below).
With respect to claim 12, Ramsay et al. discloses a cannulated surgical instrument (See fig 5A-D) comprising:(a) a cannulated shaft (fig 5A, 500);(b) a cannulated driver (fig 5A, 528) attached to a proximal end of the cannulated shaft and forming a central passage (for 540) extending through the cannulated driver and the cannulated shaft, the cannulated shaft being fixable to the cannulated driver such that there is no relative rotation there between (fixed by 514); and (c) a cannula lock (fig 5A, 544) configured to selectively move between (i) a locked position (fig 5C) where a guidewire positioned in the central passage is engaged and cannot move axially with respect to the central passage, and (ii) an unlocked position (fig 5D) where the guidewire is disengaged and can move axially with respect to the central passage. With respect to claim 13, Ramsay et al. discloses wherein the cannulated driver is either (i) a manually operated handle, or (ii) a powered cannulated drill (fig 5 shows a manual driver). With respect to claim 14, Ramsay et al. discloses wherein the surgical instrument is one of (i) a tap, (ii) an awl, (iii) a screw driver, or (iv) a drill and drill bit (abstract).
With respect to claim 27, Ramsay discloses a method (see figures 5A-D below) of selectively fixing a guidewire (fig 5, 402) in a cannulated surgical instrument (fig 5, 510), the method comprising the steps of:(a) providing the cannulated surgical instrument (fig 5A)comprising:(i) a cannulated shaft (fig 5A, 506) ;(ii) a cannulated handle (fig 5A, 528) attached to a proximal end of the cannulated shaft and forming a central passage (for 502) extending through the cannulated handle and the cannulated shaft, the cannulated shaft being fixed to the cannulated handle such that there is no relative rotation there between (fig 5A); and(iii) a cannula lock (fig 5, 544) configured to selectively move between (1) a locked position (fig 5C) where a guidewire positioned in the central passage is engaged and cannot move axially with respect to the central passage, and (2) an unlocked position (fig 5D) where the guidewire is disengaged and can move axially with respect to the central passage;(b) with the cannula lock in the unlocked position, inserting a guidewire through the central passage (paragraph 102) ;(c) moving the cannula lock to the lock position and performing a step in a surgical procedure (paragraph 101);(d) moving the cannula lock to the unlocked position and withdrawing the surgical instrument such that the central passage slides over the stationary guidewire (paragraph 102, release position).
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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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramsay et al (US pub 2014/0277164) in view of Baynham (US Pub 2014/0094822).
With respect to claim Ramsay discloses the claimed invention except for the lock mandrel is connected to the handle by way of external threads on the lock mandrel engaging internal threads in the handle.
Baynham discloses a lock mandrel (Fig 25, 424) is connected to the handle by way of external threads (fig 25) on the lock mandrel engaging internal threads (fig 25, 426) in the handle to aid the user in determining the depth of insertion during operation of the device.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Ramsay to include the lock mandrel is connected to the handle by way of external threads on the lock mandrel engaging internal threads in the handle in view of Baynham in order to aid the user in determining the depth of insertion during operation of the device
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramsay et al (US pub 2014/0277164) in view of Suchomel et al. (US Pub 2021/0244424).
With respect to claim 15, Ramsay discloses the claimed invention with a manual driver (fig 5) to drill the hole (abstract) and does not disclose the driver is powered.
Suchomel discloses a driver being powered (paragraph 3) to drill the hole (paragraph 3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the manual driver of Ramsay with the powered driver in view of Suchomel because manual driver and the powered driver are mere functional equivalents, and because such a substitution of one for the other would have achieved the same predicable result of drilling the hole.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baynham (US pub 2014/0094822) in view of Suchomel et al. (US Pub 2021/0244424).
With respect to claim 15, Baynham discloses the claimed invention with a manual driver (fig 24, 402) to drill the hole (paragraph 35) and does not disclose the driver is powered.
Suchomel discloses a driver being powered (paragraph 3) to drill the hole (paragraph 3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the manual driver of Baynham with the powered driver in view of Suchomel because manual driver and the powered driver are mere functional equivalents, and because such a substitution of one for the other would have achieved the same predicable result of drilling the hole.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20060133889 A1 discloses a cannula lock with an impingement member
US 20200289170 A1 discloses a cannula lock with an impingement member
US 20130310842 A1 discloses a cannula lock with an impingement member
US 20090275994 A1 discloses a cannula lock with an impingement member
US 20190083271 A1 discloses a cannula lock with an impingement member that is a ball
US 9855087 B2 discloses a cannula lock with an impingement member
US 9526553 B2 discloses a cannula lock with an impingement member
US 6827722 B1 discloses a cannula lock with an impingement member
US 6024749 A discloses a cannula lock with an impingement member
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773