DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of delivery device (species 1, Fig. 2); implant species s, Fig. 50A in the reply filed on May 26, 2026 is acknowledged. Claims 1-17 have been examined on the merits in this office action.
Claim Objections
Claim 3 is objected to because of the following informalities. It appears claim 3 should depend on 2 instead of itself. For examination, it is assumed that claim 3 depends on claim 2.
Appropriate correction is required.
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 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11141144 in view of Winslow et al. (US 20070016196 A1).
The patented claims disclose all elements of the claimed invention except for a fixation device.
Winslow et al. disclose an inter-cervical facet implant to distract a facet joint wherein a fixation device is used to secure the implant to the adjacent bone (Fig. 11 and paras [0059], [0061], [0065], [0071]-[0072] and [0077]).
It would have been obvious to one of ordinary skill in the art to have provided an implant in combination with a fixation device as taught by Winslow et al. for the predictable result of secure engagement of the implant with adjacent bone for spinal fixation.
Claims 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11141144 and Winslow et al. (US 20070016196 A1) further in view of Lipovsek et al. (US 4736738).
The combination of the patented claims and Winslow et al. discloses all elements of the claimed invention except for providing the various instruments in a kit configuration.
It is well known to provide the instruments used for spinal surgery in a kit configuration for ease of access to instruments that are specifically adapted for use in a specific procedure, as evidenced by Lipovsek et al. (col. 2, lines 26-34).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided the various instrumentation of the system of the combination of the patented claims and Winslow et al., in a kit configuration, as taught by Lipovsek et al., for ease of access to instruments that are specifically adapted for use in a specific procedure.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10149673 in view of Winslow et al. (US 20070016196 A1).
The patented claims disclose all elements of the claimed invention except for a fixation device.
Winslow et al. disclose an inter-cervical facet implant to distract a facet joint wherein a fixation device is used to secure the implant to the adjacent bone (Fig. 11 and paras [0059], [0061], [0065], [0071]-[0072] and [0077]).
It would have been obvious to one of ordinary skill in the art to have provided an implant in combination with a fixation device as taught by Winslow et al. for the predictable result of secure engagement of the implant with adjacent bone for spinal fixation.
Claims 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10149673 and Winslow et al. (US 20070016196 A1) further in view of Lipovsek et al. (US 4736738).
The combination of the patented claims and Winslow et al. discloses all elements of the claimed invention except for providing the various instruments in a kit configuration.
It is well known to provide the instruments used for spinal surgery in a kit for ease of access to instruments that are specifically adapted for use in a specific procedure, as evidenced by Lipovsek et al. (col. 2, lines 26-34).
Therefore it would have been obvious to one of ordinary skill in the art to have provided the various instrumentation of the system of the combination of the patented claims and Winslow et al. in a kit configuration, as taught by Lipovsek et al., for ease of access to instruments that are specifically adapted for use in a specific procedure.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-20 of copending Application No. 17/477,847 (issued but not printed as of the date of preparation of this Office Action) in view of Winslow et al. (US 20070016196 A1).
The patented claims disclose all elements of the claimed invention except for a fixation device.
Winslow et al. disclose an inter-cervical facet implant to distract a facet joint wherein a fixation device is used to secure the implant to the adjacent bone (Fig. 11 and paras [0059], [0061], [0065], [0071]-[0072] and [0077]).
It would have been obvious to one of ordinary skill in the art to have provided an implant of the issued claims in combination with a fixation device as taught by Winslow et al. for the predictable result of secure engagement of the implant with adjacent bone for spinal fixation.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 9 and 10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Winslow et al. (US 20070016196 A1) and Heinz (US 7776045) in view of Steffee (US 5716415).
Winslow et al. disclose a facet joint distraction system including: a spinal implant (800, Fig. 11); and a fixation device (840, Fig. 11) wherein the implant is used to distracting a facet joint in a cervical spine (paras [0071]-[0078]).
Winslow et al. disclose all elements of the claimed invention except for: (1) a driver assembly including a first tubular shaft; a pair of implant holder arms positioned on a distal end of the first tubular shaft, the arms configured to hold a spinal implant; and (2) a delivery device including a second tubular shaft; and a pair of tines extending from a distal end of the second tubular shaft, the tines adapted to penetrate a facet joint, wherein the second tubular shaft is adapted to slidably receive the driver assembly.
Heinz discloses a distractor or delivery device including a pair of distraction members or tines 42, 44 to facilitate access and viewing of vertebrae during a surgical procedure (Figs. 1 and 11-15, col. 2, lines 27-67, cols. 3-8 and col. 9, lines 1-28).
It would have been obvious to one of ordinary skill in the art to have utilized a distractor or delivery device, as taught by Heinz, to provide access to the specific joint, for insertion of the Winslow et al. implant, to enable viewing of the vertebrae.
The combination of Winslow et al. and Heinz discloses all elements of the claimed invention except for a driver assembly including a first tubular shaft; a pair of implant holder arms positioned on a distal end of the first tubular shaft, the arms configured to hold a spinal implant.
Steffee discloses an instrument for holding and delivering a wedge shaped implant (Fig. 4, col. 2, lines 26-67, cols. 3-7 and col. 8, lines 1-48).
Therefore, it would have been obvious to one of ordinary skill in the art to have utilized the driver assembly of Steffee in the system of the combination of Winslow et al. and Heinz for the predictable result of secure engagement with an implant for proper insertion of the implant in a prepared surgical site.
The method steps of claim 10 are rendered obvious by the above discussion. The system of the combination of Winslow et al. and Heinz is fully capable of being used in a cervical facet joint based on the disclosure of Winslow et al. that their apparatus finds application in both open and minimally invasive procedures including endoscopic and arthroscopic procedures, including joint repair and spinal stabilization and spinal fusion, wherein access to the surgical site is achieved through a cannula or small incision.
Claims 2-7 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Winslow et al. (US 20070016196 A1), Heinz (US 7776045) and Steffee (US 5716415), further in view of Martz et al. (US 2005/0038511 A1).
The combination of Winslow et al., Heinz and Steffee discloses all elements of the claimed invention except for various instrumentation used during implant insertion.
Martz et al. teach the use of a chisel (Fig. 30a) and a decorticator (Fig. 86c) with an abrasive end for preparing bone to receive an implant. Each of the instruments has a shaft that is capable of being received in the delivery device of Branch et al.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have utilized bone preparation instruments, as taught by Martz et al., to prepare bone when utilizing the implant and delivery device of the combination of Winslow et al., Heinz and Steffee because it was well known to use bone preparation instruments to prepare a site for receipt of an implant so that the bone surfaces conform to the implant surfaces and to remove any diseased or damaged bone.
Claim 8 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Winslow et al. (US 20070016196 A1), Heinz (US 7776045) and Steffee (US 5716415) further in view of Melkent (US 20080161810 A1).
The combination of Winslow et al., Heinz, Steffee and Melkent discloses all elements of the claimed invention except for an implant having teeth on the surface contacting the upper spinous process of the facet joint.
Melkent discloses a type of facet joint implant with a fixation member wherein both the upper and lower surfaces have teeth to promote bone growth and adhesion of the implant to the surrounding bone (Fig. 2 and para [0035]).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided teeth on both surfaces to promote bone growth and adhesion, as taught by Melkent.
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Winslow et al. (US 20070016196 A1), Heinz (US 7776045) and Steffee (US 5716415), in view of Lipovsek et al. (US 4736738).
The combination of Winslow et al., Heinz and Steffee discloses all elements of the claimed invention except for providing the various instruments in a kit configuration.
It is well known to provide the instruments used for spinal surgery in a kit configuration for ease of access to instruments that are specifically adapted for use in a specific procedure, as evidenced by Lipovsek et al. (col. 2, lines 26-34).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided the various instrumentation of the system of the combination of Winslow et al., Heinz and Steffee, as taught by Lipovsek et al., for ease of access to instruments that are specifically adapted for use in a specific procedure.
Claims 12-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Winslow et al. (US 20070016196 A1), Heinz (US 7776045), Steffee (US 5716415) and Lipovsek et al. (US 4736738), as applied to claim 11, further in view of Martz et al. (US 2005/0038511 A1).
The combination of Winslow et al., Heinz, Steffee, and Lipovsek et al. discloses all elements of the claimed invention except for various instrumentation used during implant insertion..
Martz et al. teach the use of a chisel (Fig. 30a) and a decorticator (Fig. 86c) with an abrasive end for preparing bone to receive an implant. Each of the instruments has a shaft that is capable of being received in the delivery device of Heinz.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have utilized bone preparation instruments, as taught by Martz et al., to prepare bone when utilizing the implant and delivery device of the combination of Winslow et al., Heinz, Steffee and Lipovsek et al. because it was well known to use bone preparation instruments to prepare a site for receipt of an implant so that the bone surfaces conform to the implant surfaces and to remove any diseased or damaged bone.
Conclusion
Conflicting claims are found in related applications 19/028821; 17/592,579 and 17/828,115 which are pending and not issued as patents. Double-patenting rejections based on the referenced applications is dependent on the final scope of claims in the instant application and the referenced applications.
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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July 22, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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