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 decorticator species i, Fig. 81A; access chisel species a20 (Fig. 67); and guide tube species b3 (Fig. 81A) in the reply filed on March 27, 2026 is acknowledged. The traversal is on the ground(s) that Figs. 91A-D are not directed to a distinct species. Upon further consideration of Applicant’s disclosure, the Examiner finds Applicant’s arguments to be persuasive. Claims 21-29 and 31-40 have been examined on the merits in this Office Action.
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.
Claim 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12,144,513.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the only difference between the claim of the present application and the patented claim is that the patented claim includes more elements and is thus more specific. Thus, the invention of the patented claim is in effect a “species” of the “generic” invention of the claim of the present application. 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 claim of the present application is anticipated by the patented claim, it is not patentably distinct from the patented claim.
Claims 28-29, 31 and 32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 14, 16 and 17 of U.S. Patent No. 12,144,513.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the only difference between the claims of the present application and the patented claims is that the patented claims include more elements and are thus more specific. Thus, the invention of the patented claims is in effect a “species” of the “generic” invention of the claims of the present application. 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 claims of the present application are anticipated by the patented claims, they are not patentably distinct from the patented claims.
Claim 27 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 12,144,513 in view of McCormack et al. (US 8623054).
The patented claim discloses all elements of the claimed invention except for the guide tube having a cutout or scallop feature configured to further expose the decortication tool to decorticate areas outside of or adjacent to the spinal facet joint.
McCormack et al. disclose a guide tube 104 to have a cutout or scallop feature (defined by anchoring forks 112) configured to expose the decortication tool received therein to decorticate areas outside of or adjacent to the spinal facet joint (Figs. 2 and 4 and col. 18, lines 5-32).
It would have been obvious to one of ordinary skill in the art to have provided a cutout or scallop feature in the guide tube of the patented claim, as taught by McCormack et al., to expose the decortication tool received therein to decorticate areas outside of or adjacent to the spinal facet joint.
Claim 34 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 14, 16 and 17 of U.S. Patent No. 12,144,513 in view of Schifano et al. (US 10321945).
Each of the patented claims disclose all elements of pending claim 34 except for providing the elements in a kit configuration.
It is well known to provide surgical implements in a kit configuration for ease of access by the surgeon during a surgical procedure, as disclosed by Schifano et al. (col. 11, lines 4-19).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided the various elements of the patented claims in a kit configuration, as taught by Schifano et al., for ease of access by the attending surgeon.
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) 21-26, 28-29, 31 and 35-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCormack et al. (US 20090312763 A1).
Regarding claim 21 and 35, McCormack et al. disclose an apparatus including: a delivery device or guide tube 104 having a hard stop in the form of anchoring forks 112 and a cutout or scallop feature defined by anchoring forks 112 that exposes a decortication tool to bone (Fig. 4); a decortication tool 106 that is slidably and rotatably received within guide tube 104 to decorticate bone (Fig. 4 and paras [0191]-[0195]).
Regarding claims 22 and 36, anchoring forks 112 with serrations or teeth function as a hard stop to prevent over insertion of the guide tube when a scope is inserted through the guide tube 104 for correct positioning of its distal end (Fig. 2 and para [0195]).
Regarding claims 23 and 37, the end of guide tube 104 is curved and tapered between anchoring forks 112 which is configured to provide a visualization landmark to aid in positioning the distal end of the guide tube using an endoscope (Fig. 2 and paras [0192]-[0195]).
Regarding claim 24, guide tube 104 defines a working cannula that is hollow (interpreted to mean a center hole) which allows a variety of instruments to be inserted through the cannula (Fig. 4 and paras [0192]-[0199]).
Regarding claim 25, guide tube 104 is hollow and has a center or visualization hole which in conjunction with the tapered distal end of the guide tube is configured to or capable of providing visualization of a landmark such as a bony feature (Fig. 2 and paras [0192]-[0195]).
Regarding claims 26, 28 and 38, McCormack et al. disclose the access chisel 108 to have a lumen 131 or control feature which may be used for advancing a scope along with the chisel to prevent the chisel from advancing into a facet joint (para [0197]).
Regarding claims 29 and 39, McCormack et al. disclose the chisel to have a hard stop feature (the bevel leading to the tubular shaft 808, Fig. 94A).
Regarding claim 31, McCormack et al. disclose the access chisel to have a tip or tongue 1030 with a roughened surface or anti-backout feature to aid in anchoring or docking the chisel in the facet joint (Fig. 122 and para [0309]).
Claim(s) 21-26, 28-29, 31-32 and 35-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCormack et al. (US 8623054).
Regarding claims 21 and 35, McCormack et al. disclose an apparatus including: a delivery device or guide tube 104 having a hard stop in the form of anchoring forks 112 and a cutout or scallop feature that exposes a decortication tool to bone (Fig. 4); and a decortication tool 106 that is slidably and rotatably received within guide tube 104 to decorticate bone (Fig. 4, cols. 18-19 and col. 20, lines 1-39).
Regarding claim 22, anchoring forks 112 with serrations or teeth function as a hard stop to prevent over insertion of the guide tube when a scope is inserted through the guide tube 104 for correct positioning of its distal end (Fig. 2, cols. 18-19 and col. 20, lines 1-39).
Regarding claim 23, the end of guide tube 104 is curved and tapered between anchoring forks 112 which is configured to provide a visualization landmark to aid in positioning the distal end of the guide tube using an endoscope (Fig. 2, cols. 18-19 and col. 20, lines 1-39).
Regarding claim 24, guide tube 104 defines a working cannula that is hollow (interpreted to mean a center hole) which allows a variety of instruments to be inserted through the cannula (Fig. 4, cols. 18-19 and col. 20, lines 1-39).
Regarding claim 25, guide tube 104 is hollow and has a center or visualization hole which in conjunction with the tapered distal end of the guide tube is configured to or capable of providing visualization of a landmark such as a bony feature (Fig. 2, cols. 18-19 and col. 20, lines 1-39).
Regarding claims 28 and 35, McCormack et al. further disclose an access chisel that has a tubular shaft 108 (Figs. 1, 94A and 149).
Regarding claims 26, 29, 38 and 39, McCormack et al. disclose the chisel to have a control feature in the form of a hard stop (the bevel leading to the tube 808, Fig. 94A) which prevents the access chisel from advancing into the spinal canal.
Regarding claim 31, McCormack et al. disclose the control feature of the access chisel to include an anti-backout feature in the form of ridges 2033 for holding the chisel in place (Fig. 149 and col. 61, lines 46-61).
Regarding claim 32, McCormack et al. disclose an embodiment wherein the access chisel 2209 has a control feature in the form of a notch 2217 in the chamfered tip (Figs. 171-174, col. 69, lines 48-67, col. 70 and col. 71, lines 1-27).
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 33, 34 and 40 rejected under 35 U.S.C. 103 as being unpatentable over McCormack et al. (US 20090312763 A1) in view of Schifano et al. (US 10321945).
McCormack et al. disclose all elements of the claimed invention except for providing the various elements in a kit configuration.
It is well known to provide surgical implements in a kit configuration for ease of access by the surgeon during a surgical procedure, as disclosed by Schifano et al. (col. 11, lines 4-19).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided the various elements of the McCormack et al. system in a kit configuration, as taught by Schifano et al., for ease of access by the attending surgeon.
Claims 33, 34 and 40 rejected under 35 U.S.C. 103 as being unpatentable over McCormack et al. (US 8623054) in view of Schifano et al. (US 10321945).
McCormack et al. disclose all elements of the claimed invention except for providing the various elements in a kit configuration.
It is well known to provide surgical implements in a kit configuration for ease of access by the surgeon during a surgical procedure, as disclosed by Schifano et al. (col. 11, lines 4-19).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided the various elements of the McCormack et al. system in a kit configuration, as taught by Schifano et al., for ease of access by the attending surgeon.
Conclusion
Non application of prior art to claim 27 indicates allowable subject matter provided the double-patenting rejections made in this office action are overcome.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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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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June 13, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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