DETAILED ACTION
This action is in response to Applicant’s amendment filed on August 25, 2026.
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 .
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.
Claim 22 is 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 22 states “further comprising a rasp couplable to the hollow elongate tube”. Claim 21 however claims a removable tip. A review of the disclosure would indicate that the removable tip and rasp and one in the same. Thus, the use of “further comprising” is unclear since that phrase implies a separate element. Clarification 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.
Claim(s) 21- is/are rejected under 35 U.S.C. 103 as being unpatentable over Lechmann et al. (U.S. Publication No. 2008/0071284) in view of Henniges et al. (U.S. Publication No. 2007/0233146).
Lechdiscloses a bone graft delivery system, comprising: a hollow elongate tube (10) configured to receive a bone graft material; a syringe device (30) operatively coupled to the hollow elongate tube, wherein the syringe device is configured to advance the bone graft material from the hollow elongate tube. In the matter of the guide, handle element 20 is considered a guide removably coupled to the hollow elongate tube (Figure 6, paragraph 28). The guide has claimed has not inherent structure and thus any structure capable of performing the function of, “be tracked by a navigation system” is satisfactory for anticipation. In the instant case the guide (20) is configured to be tracked by a navigation system since the guide is configured in a way, i.e. perpendicular there to and capable of receiving a sensor array via a clamp, to satisfy the functional limitation. A removable tip (1) is attached to the hollow elongate tube.
Lechman fails to disclose that the syringe device has a trigger to induce flow of the bone graft material. Henniges et al. teaches a bone graft delivery system (10), comprising: a hollow elongate tube (18) configured to receive a bone graft material; a trigger (86) operatively coupled to the hollow elongate tube, wherein the trigger is configured to advance the bone graft material from the hollow elongate tube and induce a flow of the bone graft material to a treatment location (paragraph 82). Such is a known alternative to manually pushing an injection system. (paragraph 80). It would have been obvious to one skilled in the art at to construct the device of Lechman with a trigger device for moving bone graft material in view of Henniges et al. since such was a known alternative at the time of filing.
Regarding claim 22, Lechman discloses that the tip one has unsmooth surfaces that can be used as a rasp (Figure 6).
Regarding claim 23, Lechman fails to disclose a sheath for receing the hollow elongate tube. Henniges further teaches a sheath (16) for receiving the hollow elongate tube (18) to enter a target site without creating major trauma (paragraph 54). It would have been obvious to one skilled in the art to construct the device of Lechman with a sheath for receiving the hollow elongate tube in view of Henniges in order to provide a path to the target site without creating major trauma.
Regarding claim 24, wherein the removable tip is selected from a plurality of removable tips, each of the plurality of removable tips configured for use at a different anatomical location, the Examiner is taking official notice that such would have been obvious since providing a kit with different sized implants for different parts of the spine takes only routine skill in the art.
Regarding claim 26, Lechmann et al. discloses a method for delivering bone graft material (40) to a treatment location, comprising: visualizing a guide of a bone graft delivery system (It is noted that visualizing by the surgeon is inherent since the surgeon look to see what they are doing), the bone graft delivery system comprising a bone graft delivery device (30), an elongate tube (10) loaded with a bone graft material (as the syringe 30 is depressed, bone graft material is loaded into the tube 10), and a rasp (1) couplable to the elongate tube (element 1 is considered capable of use as a rasp); and monitoring a position of the bone graft delivery device relative to the treatment location (it is noted that as a surgeion handles the device, “monitoring it” is an inherent process).
Lechman fails to disclose that the syringe device has a trigger to induce flow of the bone graft material. Henniges et al. teaches a bone graft delivery system (10), comprising: a hollow elongate tube (18) configured to receive a bone graft material; a trigger (86) operatively coupled to the hollow elongate tube, wherein the trigger is configured to advance the bone graft material from the hollow elongate tube and induce a flow of the bone graft material to a treatment location (paragraph 82). Such is a known alternative to manually pushing an injection system. (paragraph 80). It would have been obvious to one skilled in the art at to construct the device of Lechman with a trigger device for moving bone graft material in view of Henniges et al. since such was a known alternative at the time of filing.
Regarding claim 27, Lechman et al. discloses that the bone graft material is flowable (paragraph 29).
Regarding claim 28, Lechman et al. discloses that the rasp comprises a surface suitable for scraping bone (as seen in the figures 1-6, the element 1 has a roughened surface suitable for scraping).
Regarding claim 30, Lechman et al. discloses that the elongate tube comprises a lumen extending therethrough, wherein the bone graft material is loaded within the lumen (Figure 4, as the material 40 is moved from the syringe, it is loaded into the lumen).
Regarding claim 32, Lechman et al. discloses that the method further comprising advancing the bone graft material to the treatment location when the bone graft delivery device is positioned at the treatment location (paragraph 26, “After the intervertebral prosthesis 1 has been positioned in the intervertebral space, the handle 20 is removed and, as shown in FIG. 3, replaced by a conveying unit for the flowable osteocementum 30.”).
Claim(s) 29, 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lechmann et al. (U.S. Publication No. 2008/0071284) in view of Henniges et al. (U.S. Publication No. 2007/0233146) and further in view of Dicorleto et al. (U.S. Patent No. 8961500).
Regarding claim 29, Lechman et al. discloses the claimed invention except visualizing the guide of the bone graft delivery device comprises visualizing the guide with a navigation system. Dicorleto et al. teaches a surgical instrument (30) having an elongate tool (104) and a guide (100) removably coupled thereto. The instrument and the guide is configured to be visualized by a navigation system (paragraph 13). The guide includes tacking markers (68). This allows a computer assisted system to track in real time position of a body part and the instrument (paragraph 5). It would have been obvious to one skilled in the art to construct the device of Lechmann et al. with a guide that can be visualized by a navigations system in view of Dicorleto so that a computer assisted system could track the instrument and body in real time.
Regarding claim 31, Lechmann et al. in view of Dicorleto further makes obvious that monitoring the position of the bone graft delivery device relative to the treatment location comprises tracking the position of the guide as the bone graft delivery device is advanced toward the treatment location. The teaching of “track in real time” is considered monitoring.
Claim(s) 33-37, 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lechmann et al. (U.S. Publication No. 2008/0071284 in view of Dicorleto et al. (U.S. Patent No. 8961500).
Lechmann et al. discloses a method for delivering bone graft material to a treatment location, comprising: providing a bone graft delivery system comprising a bone graft delivery device (Figure 3, 4) comprising an elongate tube (30) loaded with a bone graft material (40) and a trigger configured to induce a flow of bone graft material to the treatment location (the syringe plunger figure 3, Lechmann et al. can be considered a trigger since depressing it will trigger the bone graft material to flow); coupling a tip (10) configured for use at the treatment location to the elongate tube; and advancing the bone graft material to the treatment location when the bone graft delivery device is positioned at the treatment location (paragraph 26, “After the intervertebral prosthesis 1 has been positioned in the intervertebral space, the handle 20 is removed and, as shown in FIG. 3, replaced by a conveying unit for the flowable osteocementum 30.”).
Lechmann fails to disclose a guide and advancing the bone graft delivery device towards the treatment location while visualizing the guide with a navigation system. Dicorleto et al. teaches a surgical instrument (30) having an elongate tool (104) and a guide (100) removably coupled thereto. The instrument and the guide is configured to be tracked by a navigation system (paragraph 13). The guide includes tacking markers (68). This allows a computer assisted system to track in real time position of a body part and the instrument (paragraph 5). It would have been obvious to one skilled in the art to construct the device of Lechmann et al. with a guide that can be tracked by a navigations system in view of Dicorleto so that a computer assisted system could track the instrument and body in real time.
Regarding 34, coupling a tip configured for use at the treatment location comprises selecting the tip from a plurality of tips, each of the plurality of tips configured for use at a different anatomical location. The Examiner is taking official notice that such would have been obvious to one skilled in the art since providing a kit with differing length tips (i.e. tubes) allows for the device to reach different parts of the spine.
Regarding claim 35, Lechmann et al. in view of Dicorleto further makes obvious advancing the bone graft delivery device towards the treatment location while visualizing the guide with a navigation system comprises monitoring a position of the bone graft delivery device relative to the treatment location. The teaching of “track in real time” is considered monitoring.
Regarding claim 36, Lechmann et al. in view of Dicorleto further makes obvious monitoring the position of the bone graft delivery device relative to the treatment location comprises tracking the position of the bone graft delivery device as the bone graft delivery device is advanced toward the treatment location (paragraph 5, Dicorleto et al.)
Regarding claim 37, advancing the bone graft material to the treatment location when the bone graft delivery device is positioned at the treatment location comprises actuating an actuation mechanism to deliver a flow of bone graft material to the treatment location (Lechmann et al., paragraph 26, “After the intervertebral prosthesis 1 has been positioned in the intervertebral space, the handle 20 is removed and, as shown in FIG. 3, replaced by a conveying unit for the flowable osteocementum 30.”).
Regarding 39, the bone graft delivery device further comprises a rasp (element 1, Lechmann et al.) couplable to the elongate tube.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-24, 26-32 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding claim 33, Applicant has not pointed to any supposed errors for the Examiner considering the syringe plunger a trigger since it triggers flow of the material. As such the consideration for claim 33 stands.
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 ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW YANG/Primary Examiner, Art Unit 3775
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