DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 26, 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claims 1, 7 and 14, the recitation “rigid” seeks to introduce new matter. Applicant’s disclosure, as originally filed, does not describe the material of construction of the driver assembly and/or the implant engagement features.
Appropriate correction is required.
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 1-17 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 claims 1, 7 and 14, the qualifier “rigid” renders the claims vague and indefinite because Applicant’s disclosure does not describe the material of construction (for e.g. type of material and properties thereof) of the implant engagement portions of the delivery assembly to understand the scope of the term in the context of Applicant’s invention.
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 1-13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Zdeblick et al. (US 5782919).
Regarding claims 1, 7 and 8, Zdeblick discloses a system for delivery of a spinal implant to a spinal joint space including: an elongated shaft portion or tubular body 50 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 portion extending from and integral with the distal portion of the elongated body including opposing first and second prongs or engagement portions 54 that extend in parallel in a spaced apart configuration (Fig. 9) wherein prongs 54 are configured to receive or capable of receiving at least a portion of a monolithic spinal implant or facet joint implant 30; and a device or handle at the proximal part of actuator 51 that enables rotation of the actuator 51 and facilitates implant placement (Figs. 9-10, col. 5, lines 13-67, cols. 6-10 and col. 11, lines 1-33).
Regarding the term “rigid portions (claim 1)” and “rigid features (claim 7), the first and second prongs or engagement portions or features are individually rigid or stiff in order to enable gripping implant 30.
Regarding claims 2 and 9, implant 30 is a spinal implant or facet joint implant because it can be placed in a suitably 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 implant.
Regarding claims 3 and 10, 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 claims 4 and 11, 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 method claims 5, 6, 12 and 13, the Zdeblick et al. implant is used to insert an implant into an intervertebral space or spinal joint to distract and restore the normal angular relationship of the vertebrae adjacent the intervertebral space (see abstract).
Claims 1-2, 4-5, 7-9 and 11-13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Bagby (US 4501269).
Regarding claims 1, 7 and 8, Bagby discloses a system for delivery of a spinal implant to a spinal joint space including: an elongated shaft portion or tubular body 20 having a proximal portion and a distal portion, the shaft defining a lumen; an internal actuator 19 extending through the lumen, actuator 19 having proximal and distal parts; and an implant engagement portion 28 extending from and integral the distal end of tubular body 20 including prongs 21 that extend in parallel (Fig. 6) wherein prongs 21 are configured to receive or capable of receiving at least a portion of a monolithic spinal implant or facet joint implant 10; and a handle 18 coupled with the proximal part of the internal actuator 19 (Figs. 1-6, col. 3, lines 28-68, col. 4 and col. 5, lines 1-39).
Regarding the term “rigid portions (claim 1)” and “rigid features (claim 7), the first and second prongs 21 or engagement portions or features are individually rigid or stiff in order to enable gripping implant 30.
Regarding claims 2 and 9, basket 10 is a spinal implant or facet joint implant. No specific structure is recited in the claim to distinguish over the Bagby implant.
Regarding claims 4 and 11, the recitation “spinal joint space is a cervical facet joint” is intended use and the Bagby implant is fully capable of being used in a cervical facet joint, depending on the anatomical characteristics of a patient (see for e.g. Fig. 7 of Carl et al. (US 20060036323)).
Regarding method claims 5, 12 and 13, the Bagby implant is used to insert an implant into an intervertebral space or spinal joint to distract and restore the normal angular relationship of the vertebrae adjacent the intervertebral space (see abstract).
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 14-17 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).
Zdeblick et al. disclose all elements of the claimed invention except for providing the various instruments in a kit configuration. Regarding claim 15, Zdeblick et al. disclose the use of an outer sleeve 76 that operates as a working channel for a laparoscopic approach (col. 9, lines 45-65). See previous discussion for claims 1-13.
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.
Claims 14 and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bagby (US 4501269) in view of in view of Lipovsek et al. (US 4736738).
Bagby discloses all elements of the claimed invention except for providing the various instruments in a kit configuration. See previous discussion for claims 7-9 and 11-13.
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 Bagby 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.
Claim 15 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bagby (US 4501269) and Zdeblick et al. (US 5782919) further in view of Lipovsek et al. (US 4736738).
Bagby discloses all elements of the claimed invention except for a guide tube.
Regarding claim 15, Zdeblick et al. disclose the use of an outer sleeve 76 that operates as a working channel for a laparoscopic approach (col. 9, lines 45-65).
It would have been obvious to have utilized the guide tube of Zdeblick et al. to introduce the Bagby implant to facilitate insertion in a minimally invasive manner.
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).
Therefore, it would have been obvious to one of ordinary skill in the art to have provided the various instrumentation of the combination of Bagby and 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.
Response to Arguments
Applicant's arguments filed have been fully considered but are not persuasive for the following reasons.
Regarding the rejections under 35 USC 102(b) over Zdeblick et al., “rigid” does not imply lack of motion between the implant engagement portions 54.
Regarding the rejections under 35 USC 102(b) over Bagby, “rigid” does not imply lack of motion between the implant engagement portions 21.
New grounds of rejection have been made in this office action.
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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May 30, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
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