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 tool assembly species f, Fig. 136 and implant species 14, Fig. 50A in the reply filed on May 26, 2026 is acknowledged. Claims 1-12 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.
Claims 1-3 and 5-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11272964.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the only difference between claims of the present application and the patented claims is that the patented claims are 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. All of the structural elements of the pending claims are present in the patented claims defined with either identical or equivalent language.
Claims 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of US Patent No. 11272964 in view of Lipovsek et al. (US 4736738).
The patented claims disclose 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 such as spinal fusion 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).
It would have been obvious to one of ordinary skill in the art to have provided the various instrumentation of the system of the patented claims 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 1-3 and 5-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10226285.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the only difference between claims of the present application and the patented claims is that the patented claims are 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. All of the structural elements of the pending claims are present in the patented claims defined with either identical or equivalent language.
Claims 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of US Patent No. 10226285 in view of Lipovsek et al. (US 4736738).
The patented claims disclose 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 such as spinal fusion 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).
It would have been obvious to one of ordinary skill in the art to have provided the various instrumentation of the system of the patented claims 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 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 17/592579.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the claims of the present application and the claims of the copending application is that the claims of the copending application include more elements and are thus more specific. Thus the invention of the claims of the copending application 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 claims of the copending application, they are not patentably distinct from the claims of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-4, 7 and 10-12 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.
In claim 1, the recitation “wherein the implant engagement feature is adjacent the distal end of the driver assembly” renders the claim vague and indefinite because it is unclear which portion of the driver assembly defines the implant engagement feature.
In claim 1, the recitation “wherein when the handle acts on the proximal part of the internal actuator to release the implant from the implant engagement feature, the internal actuator distally displaces within the lumen of the elongated body to act upon the implant” renders the claim vague and indefinite because the functional recitation is not supported by interaction of claimed structure.
In claim 10, the preamble recites “an implant” and the body of the claim recites “the monolithic spinal facet joint implant.” It is suggested that Applicant use consistent description to avoid confusion.
In claims 7 and 12, the term “end face” is confusing. At least the elected implant species (Fig. 50A) does not have an “end face” at one end. It is suggested that Applicant amend the claim to remove “end face” to avoid confusion.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-9 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Zdeblick et al. (US 5782919).
Regarding claims 1, 5 and 6, Zdeblick discloses a system for delivery of a spinal implant to a spinal joint space including: an elongated shaft portion or tubular body 52 having a proximal portion defining a proximal end and a distal portion defining a distal end, the elongated body defining a lumen; an internal actuator 51 extending through the lumen and an implant engagement feature or implant engagement portion in the form of two features or prongs extending in a spaced apart parallel configuration that are configured to receive or capable of receiving at least a portion of a proximal face of the facet joint implant 30; and a device or handle at the proximal part of actuator 51 that enables rotation of the actuator 51 for implant placement and subsequent release (Figs. 9-10, col. 5, lines 13-67, cols. 6-10 and col. 11, lines 1-33).
Regarding the recitation “facet joint implant,” implant 30 is a spinal implant or facet joint implant because it can be placed in a facet joint of a patient (see for e.g. use of a threaded implant in a facet joint, Fisher et al. (US 20080234758)). Specific structure is not recited in the claim to distinguish over the Zdeblick et al. implant.
Regarding claim 3, the recitation “spinal joint space is a cervical facet joint” is intended use and the Zdeblick et al. implant is fully capable of being used in a cervical facet joint, depending on the anatomical characteristics of a patient.
Regarding claims 4 and 9, the Zdeblick et al. implant is inserted into intervertebral space or a spinal joint to distract and restore the normal angular relationship of the vertebrae adjacent the intervertebral space (see abstract).
Regarding claim 7, implant 30 has a proximal end face, a distal end face, a first surface and a second surface (defined by truncated side walls 22) and teeth defined by peaks of threads 18 (Figs. 2, 8 and 10).
Regarding claim 8, the Zdeblick et al. driver assembly is fully capable of being used to deliver an implant into a cervical facet joint (MPEP 2114 (II)).
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 negatived by the manner in which the invention was made.
Claims 10-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zdeblick et al. (US 5782919) in view of Lipovsek et al. (US 4736738).
See previous discussion for Zdeblick et al. Regarding claim 15, Zdeblick et al. disclose the use of an outer sleeve or guide tube 76 that provides a working channel for a laparoscopic-type approach (col. 9, lines 45-65). Zdeblick et al. disclose all elements of the claimed invention except for providing the various instruments in a kit configuration.
It is well known to provide instruments used for spinal surgery such as spinal fusion in a kit for ease of access to the various instruments that are specifically adapted for use in the surgical procedure, as evidenced by Lipovsek et al. (col. 2, lines 26-34).
It would have been obvious to one of ordinary skill in the art to have provided the various instrumentation of Zdeblick 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.
Conclusion
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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August 7, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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