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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-39 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11583416. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claims 21-39 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12144745. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claim Rejections - 35 USC § 102
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) 26-28, 30, 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lechmann et al. (U.S. Publication No. 2008/0071284).
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).
Regarding claim 27, the bone graft material is flowable (paragraph 29).
Regarding claim 28, 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, 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, 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 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, 23, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henniges et al. (U.S. Publication No. 2007/0233146) in view of Dicorleto et al. (U.S. Patent No. 8961500).
Henniges et al. discloses 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 (paragraph 82). Henniges et al. fails to disclose a guide removably couplable to the hollow elongate tube, wherein the guide is configured to be tracked by 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 Henniges 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 claim 23, Dicorleto further teaches that the guide comprises a sheath (Figure 4). The combination would then yield that the sheath is configured to receive the hollow elongate tube of Henniges et al.
Regarding 25, Henniges et al. the trigger is configured to induce a flow of the bone graft material to a treatment location (paragraph 82).
Claim(s) 21, 22, 24, 29, 31, 33-39 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 bone graft delivery system (Figure 3, 4), comprising: a hollow elongate tube (10) configured to receive a bone graft material (40); a trigger (syringed plunger is considered a trigger since depressing it initiates the cement being moved) operatively coupled to the hollow elongate tube, wherein the trigger is configured to advance the bone graft material from the hollow elongate tube (paragraph 26). Lechmann et al. fails to disclose a guide removably couplable to the hollow elongate tube, wherein the guide is configured to be tracked by 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 claim 22, Lechmann et al. further discloses a rasp (1) couplable to the hollow elongate tube, wherein the rasp comprises a surface suitable for scraping bone.
Regarding claim 24. The bone graft delivery system of claim 21, further comprising a removable tip (1) coupled to the hollow elongate tube. Regarding 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.
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.
Regarding claim 33, Lechmann et al. discloses a method for delivering bone graft material to a treatment location, comprising: providing a bone graft delivery system comprsing a bone graft delivery device (Figure 3, 4) comprising an elongate tube (30) loaded with a bone graft material (40); 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 claim 38, the actuation mechanism is a trigger. The syringe plunger (figure 3, Lechmann et al.) can be considered a trigger since depressing it will trigger the bone graft material to flow.
Regarding 39, the bone graft delivery device further comprises a rasp (element 1, Lechmann et al.) couplable to the elongate tube.
Conclusion
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