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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 22, 2025 has been entered.
Response to Amendment
The amendment filed on September 22, 2025 has been entered. Upon further consideration, the Examiner is withdrawing the allowability of the subject matter indicated to be allowable in the previous office action in light of the rejections made in this office action.
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 21 and 22 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 21 and 22, the recitation “the shaft” renders the claims vague and indefinite because it lacks antecedent basis. It appears that Applicant intended to recite “the implant shaft.”
Appropriate correction is required.
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, 3-9 and 11-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Winslow et al. (US 7763050) in view of Steffee (US 5443514).
Regarding claims 1, 9, 21 and 22, Winslow et al. disclose a spinal facet implant system including: implant (600) configured for placement in a spinal facet joint space, the implant including: a leading distal portion and a trailing proximal portion (Fig. 8); and a facet screw 640 (col. 5, lines 26-67, cols. 6-7 and col. 8, lines 1-24).
Regarding claims 6 and 14, Winslow et al. disclose the implant to have a wedge shape (Fig. 4).
Regarding claims 7 and 15, Winslow et al. disclose the implant can be made of any suitable biocompatible material for e.g. metal or polymer (col. 5, lines 39-67, col. 6, lines 1-48).
Regarding claims 8 and 16, Winslow et al. disclose the implant can be inserted utilizing a posterior access approach (abstract).
Regarding claim 20, Winslow disclose the screw (240 or 640) to be inserted through the implant at an angle to engage an inferior vertebra (Figs. 4 and 9).
Winslow et al. disclose all elements of the claimed invention except for an inserter or driver assembly for implant placement including: a hollow implant shaft having a proximal end, a distal end, a lumen having an inner diameter, and an outer diameter configured to allow the implant shaft to extend through a lumen of a delivery device; and a rod longitudinally displaceable within the implant shaft to release the implant from the driver assembly, and a handle coupled with the proximal end of the implant shaft.
Steffee discloses an instrument with a hollow shaft 98 (Fig. 5); a rod 118 displaceable within the implant shaft 98 (Fig. 6); and a handle 84 (Fig. 6) coupled to the proximal end of the implant shaft 98 by means of rod 118 wherein the implant shaft has a distal end (Fig. 7) configured to clamp the implant by means of extensions 136 (Fig. 7) (col. 3, lines 24-68 and col. 4, lines 1-27).
Regarding claims 3 and 11, rod 118 is displaceable about a longitudinal axis of the rod to further assist in releasing the implant from the driver assembly.
It would have been obvious to one of ordinary skill in the art to have utilized the Steffee instrument to firmly grip the Winslow et al. implant to permit placement of the implant and rotation into position.
Response to Arguments
The Terminal Disclaimer filed on September 22, 2025 has been approved, overcoming the double-patenting rejections made in the previous office action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
October 17, 2025
/Anu Ramana/Primary Examiner, Art Unit 3775