Detailed Action
This is the first office action on the merits for US application number 18/974,972.
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 of Invention II of claims 8-16 and species a) of Figs. 1-8 in the reply filed on May 11, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Accordingly, claims 1-7, 17, and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the first and second bores each include threads” of claim 9 lines 1-2, the “linear fastening element” of claim 11 line 6, the “the linear fastening element is a screw configured to be rotatably inserted into a vertebral body” of claim 14 lines 1-2, the “the linear fastening element and curvilinear fastening element are inserted into the same one of the adjacent vertebral bodies” of claim 15 lines 1-2, and “the adjacent vertebral body that the linear fastening element is inserted into is different from the adjacent vertebral body that the curvilinear fastening element is inserted into” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 8, 11, and 15 is/are objected to because of the following informalities:
Claim 8 line 1 should read “An intervertebral spacer[[,]] comprising:”.
Claim 11 line 1 should read “An intervertebral spacer[[,]] comprising:”.
Claim 15 line 2 should read “the linear fastening element and curvilinear fastening element are inserted into [[the]]a same one of the adjacent vertebral bodies”.
Appropriate correction is required.
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.
Claim(s) 10 and 13-16 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 10 recites/recite the limitation "the rotation of the curvilinear fastening element" in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “prevent [[the]] rotation of the curvilinear fastening element”.
Claim(s) 13-16 is/are unclear with regards to the recitations of “the linear fastening element” and “the curvilinear fastening element” and if these are intended to refer to the functionally recited ‘elements’ of claim 11 lines 4-5 or the positively recited ‘members’ of lines 6 and 9 as well as antecedent basis support for the ‘elements’ of claims 13-16 as claim 11 lines 4-5 provides either “a linear fastening element” or “a curvilinear fastening element” and thus does not provide antecedent support for both “the linear fastening element” and “the curvilinear fastening element”. Examiner is interpreting this broadly and suggests amending to clarify to clearly and consistently provide antecedent basis for the claim terms.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 8, 10-14, and 16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mozeleski et al. (US 2016/0151171, hereinafter “Mozeleski”).
As to claim 8, Mozeleski discloses an intervertebral spacer (100, 200) comprising: a superior surface (upper surface as shown in Fig. 1, Fig. 1) and an inferior surface (lower surface as shown in Fig. 1, Fig. 1); a first bore (230, 330, Figs. 2 and 3) extending toward the superior surface (Figs. 1- 3); and a second bore (240, 340, Figs. 2 and 3) extending toward the inferior surface (Figs. 1-3), wherein each of the first and second bores are capable of receiving a linear fastening element (420, Figs. 1, 6A, and 6B, ¶74) or a curvilinear fastening element (410, Figs. 1, 6A, and 6B, ¶74).
As to claim 10, Mozeleski discloses that the first and second bores are each defined by a circumferential wall (Figs. 2, 3, 4, 8, 9, 14,15, and 17), wherein the circumferential wall of each of the first and second bores further includes a recess (336, Figs. 3 and 8, ¶76) capable of receiving a protrusion of the curvilinear fastening element (416, Fig. 7A, ¶76) capable of preventing rotation of the curvilinear fastening element (Figs. 3, 7A, and 8, ¶s 75 and 76).
As to claim 11, Mozeleski discloses an intervertebral spacer system (100) comprising: an intervertebral spacer (100, 200) capable of being positioned within an intervertebral space defined by adjacent vertebral bodies (Fig. 13, ¶s 24 and 74), wherein the intervertebral spacer includes a plurality of bores (230, 330, 240, 340, 350/360/“central bore” of ¶77, Figs. 2, 3, 8, and 9), each of the plurality of bores being capable of receiving either a linear fastening element (420, Figs. 1, 6A, and 6B, ¶74) or a curvilinear fastening element (410, Figs. 1, 6A, and 6B, ¶74); a linear fastening member (420, Figs. 1, 6A, and 6B, ¶74) capable of being inserted into one bore of the plurality of bores (240, 340, Figs. 1-3, 6A and, 6B) such that linear fastening element is inserted into one of the adjacent vertebral bodies (Figs. 1-3, 6A and, 6B, ¶74) capable of securing the intervertebral spacer within the intervertebral space (¶74); and a curvilinear fastening member (410, Figs. 1, 6A, and 6B, ¶74) capable of being inserted into a second bore of the plurality of bores (230, 330, Figs. 1-3, 6A and, 6B) such that the curvilinear fastening element is inserted into one of the adjacent vertebral bodies (Figs. 1-3, 6A and, 6B, ¶74) capable of securing the intervertebral spacer within the intervertebral space (¶74).
As to claim 12, Mozeleski discloses a linear fastening element (500, Figs. 9-10D, ¶77) is inserted into a third bore of the plurality of bores (350/360/“central bore” of ¶77, Figs. 3, 8, and 9, ¶s 77 and 79).
As to claim 13, Mozeleski discloses that the curvilinear fastening element includes a vertebral anchor (Figs. 6A-7B, ¶74) capable of being hammered into a vertebral body (due to the structure shown in Figs. 7A and 7B, Figs. 7A-9, ¶s 74 and 75).
As to claim 14, Mozeleski discloses that the linear fastening element is a screw (Figs. 1 and 6A-6B, ¶74) capable of being rotatably inserted into a vertebral body (due to the structure shown in Figs. 1, 6A, and 6B, Figs. 1, 6A, and 6B, ¶ 74).
As to claim 16, Mozeleski discloses that the adjacent vertebral body that the linear fastening element is inserted into is different from the adjacent vertebral body that the curvilinear fastening element is inserted into (Figs. 1, 6A, and 6B).
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Byrd et al. (US 2003/0153975, hereinafter “Byrd”).
As to claim 8, Byrd discloses an intervertebral spacer (10) comprising: a superior surface (upper surface as shown in Fig. 3, Fig. 3) and an inferior surface (lower surface as shown in Fig. 3, Fig. 3); a first bore (30/34/central bore as shown in Figs. 1 and 3, Figs. 1 and 3, ¶37) extending toward the superior surface (Figs. 1 and 3); and a second bore (30/32s/left and right bores as shown in Figs. 1 and 3, Figs. 1 and 3, ¶37) extending toward the inferior surface (Figs. 1 and 3), wherein each of the first and second bores are capable of receiving a linear fastening element (60/80, Figs. 1, 4, 5, 6, 8, and 10, ¶s 37 and 39).
As to claim 9, Byrd discloses the first and second bores each include threads (34/internal threads of ¶39, Figs. 3 and 6, ¶39) capable of mating with complimentary threads of the linear fastening element (83, Fig. 10, ¶39).
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 of this title, 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.
Claim(s) 11 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Byrd in view of Mozeleski.
As to claim 15, Byrd discloses an intervertebral spacer system (10, 80s, Figs. 1-15) comprising: an intervertebral spacer (10) capable of being positioned within an intervertebral space defined by adjacent vertebral bodies (abstract, ¶s 36 and 37), wherein the intervertebral spacer includes a plurality of bores (30/32s/left and right bores as shown in Figs. 1 and 3, 30/32s/left and right bores as shown in Figs. 1 and 3, 36s, Figs. 1 and 3, ¶37), each of the plurality of bores being capable of receiving a linear fastening element (60/80, Figs. 1, 4, 5, 6, 8, and 10, ¶s 37 and 39); and a linear fastening member (60/80, Figs. 1, 4, 5, 6, 8, and 10, ¶s 37 and 39) capable of being inserted into one bore of the plurality of bores (¶s 37 and 41) such that linear fastening element is inserted into one of the adjacent vertebral bodies (¶s 37 and 41) capable of securing the intervertebral spacer within the intervertebral space (¶s 36, 37, and 41).
Byrd is silent to each of the plurality of bores being configured to receive a curvilinear fastening element; and a curvilinear fastening member configured to be inserted into a second bore of the plurality of bores such that the curvilinear fastening element is inserted into one of the adjacent vertebral bodies to secure the intervertebral spacer within the intervertebral space. As to claim 15, Byrd is silent to the linear fastening element and curvilinear fastening element are inserted into the same one of the adjacent vertebral bodies.
Mozeleski teaches an intervertebral spacer system (100) comprising: an intervertebral spacer (100, 200) capable of being positioned within an intervertebral space defined by adjacent vertebral bodies (Fig. 13, ¶s 24 and 74), wherein the intervertebral spacer includes a plurality of bores (230, 330, 240, 340, 350/360/“central bore” of ¶77, Figs. 2, 3, 8, and 9), each of the plurality of bores being capable of receiving either a linear fastening element (420, Figs. 1, 6A, and 6B, ¶74) or a curvilinear fastening element (410, Figs. 1, 6A, and 6B, ¶74); a linear fastening member (420, Figs. 1, 6A, and 6B, ¶74) capable of being inserted into one bore of the plurality of bores (240, 340, Figs. 1-3, 6A and, 6B) such that linear fastening element is inserted into one of the adjacent vertebral bodies (Figs. 1-3, 6A and, 6B, ¶74) capable of securing the intervertebral spacer within the intervertebral space (¶74); and a curvilinear fastening member (410, Figs. 1, 6A, and 6B, ¶74) capable of being inserted into a second bore of the plurality of bores (230, 330, Figs. 1-3, 6A and, 6B) such that the curvilinear fastening element is inserted into one of the adjacent vertebral bodies (Figs. 1-3, 6A and, 6B, ¶74) capable of securing the intervertebral spacer within the intervertebral space (¶74); wherein the plurality of bores can receive a plurality of linear fastening elements, a plurality of curvilinear fastening members or a combination of linear fastening elements and curvilinear fastening members (¶74); wherein the plurality of bores are each configured to optionally receive either a linear fastening element or a curvilinear fastening member (¶74).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify system and the plurality of bores as disclosed by Byrd to include at least one curvilinear fastening member and modify the bores to be configured to receive either a linear fastening element or a curvilinear fastening member as taught by Mozeleski in order to provide options during spinal surgery to utilize the optimal bone fixation member for the patient's anatomy while utilizing the same modular cage system (¶74) as the anatomy of some patients' spines is prohibitive to utilizing existing intervertebral spacer designs and fixation means (Mozeleski ¶74). In forming the combination, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to specify that the linear fastening element and curvilinear fastening element of the combination of Byrd and Mozeleski are inserted into a same one of the adjacent vertebral bodies, since Applicant has not disclosed that such solve is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of accommodating the anatomy of some patients' spines with existing intervertebral spacer designs and fixation means (Mozeleski ¶74). That is, one of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to select either of the left or right bore 32 of the plurality of bores shown in Fig. 3 as disclosed by Byrd to include the curvilinear fastener and be configure to receive the curvilinear fastener as taught by Mozeleski in order to select from a finite number of solutions to accommodate the anatomy of some patients' spines with existing intervertebral spacer designs and fixation means (Mozeleski ¶74).
As a result, as to claim 15, the combination of Byrd and Mozeleski discloses that the linear fastening element and curvilinear fastening element are inserted into a same one of the adjacent vertebral bodies (Byrd left and right 32 as shown in Fig. 3; Mozeleski Figs. 6A and 6B, ¶74).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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 or telephone the Examiner.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMY R SIPP/Primary Examiner, Art Unit 3775
Prosecution Insights