DETAILED ACTION
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 with traverse of Species A, FIGS. 2A-5B, in the reply filed on 05 May 2026, is acknowledged. The traversal is on the ground(s) that a serious burden has not been shown. This is not found persuasive because various reasons for serious burden were appropriately explained. Different field of search may require searching different classes or subclasses or employing different queries such as limiting by text search, as described in the restriction requirement. Examiner notes that just one of the relevant classifications, A61F 2/447, includes over six thousand U.S. references. It is clear that the field of art is crowded. Even if other classes are not searched, a different field of search may comprise employing different search queries to narrow down and tailor the results for best examination.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05 May 2026.
Priority
The priority date is 29 January 2024.
Claim Objections
Claims 1-6 and 9-11 are objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 1 / lines 4-5: “formed in each said side wall”
Claim 1 / lines 7-8: “said at least one blade constructed and arranged to pierce [[the]] cortices of adjoining vertebral bodies of the joint”
Claim 1 / line 9: “wherein said at least one blade”
Claim 1 / lines 10-11: “to lock said at least one blade to the adjoining vertebral bodies.”
Claim 4 / lines 3-4: “the at least one blade”
Claim 5 / line 2: “the at least one blade”
Claim 6 / line 2: “the at least one blade”
Claim 6 / line 2: “[[the]] a perimeter”
Claim 6 / line 3: “the at least one blade”
Claim 9 / line 2: “said at least one blade”
Claim 9 / line 2: “to lock [[the]] a sacrum and ilium”
Claim 10 / line 4: “beyond [[the]] upper and lower planes”
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 2, 4, and 10 are rejected under 35 U.S.C. 112(b) 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.
As to claim 2, in lines 2-3 and line 4; claim 4, line 2; and claim 10, lines 2 and 4, the limitations “said peripheral wall” render the claims indefinite because it is unclear if this refers to the peripheral wall member previously recited in claim 1, or to a different peripheral wall. For examination purposes, the limitations will be interpreted in the former instance, as said peripheral wall member.
Further as to claim 2, the limitation “an insertion configuration” renders the claim indefinite because it is unclear if this refers to the insertion configuration previously recited in claim 1, or to a different insertion configuration. For examination purposes, the limitation will be interpreted in the former instance, as the insertion configuration.
Further as to claim 2, the limitation “an expanded configuration” renders the claim indefinite because it is unclear if this refers to the expanded configuration previously recited in claim 1, or to a different expanded configuration. For examination purposes, the limitation will be interpreted in the former instance, as the expanded configuration.
Further as to claim 10, the limitation “opposing first and second side walls” renders the claim indefinite, because it is unclear if this refers to the adjoining side walls previously recited in claim 1, or to different first and second side walls. For examination purposes, the limitation will be interpreted in the former instance, as the peripheral wall member is in a form of a cage.
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.
Claims 1-3, 5, 6, 9, and 10 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 8,795,368 to Trieu et al. (hereinafter, “Trieu”).
As to claim 1, Trieu discloses an interbody spacer for transfixing a joint comprising: a peripheral wall member (20) having two end walls (40, 42) spaced apart by adjoining side walls (36, 38) (col. 6 / lines 24-30) defining an internal space (34) therebetween (col. 5 / line 63 – col. 6 / line 3); a centrally disposed aperture (44, 52) formed in said side walls (col. 6 / line 38 – col. 7 / line 4) for receipt of a shaft (middle extending portion of 22, including 64, 66, and central body connecting 64 and 66, col. 7 / lines 5-9) extending between and rotationally coupled to said apertures (interpreted as language of intended use without positive recitation of a shaft); and at least one blade (68 including 72; 70 including 74; interpreted as blades because they are fully capable of cutting due to the edges on 72 and 74 and the extending position of 68 and 70) coupled (integrally) to said shaft, FIG. 3, said blade constructed and arranged to pierce the cortices of adjoining vertebral bodies upon rotation of said shaft (interpreted as language of intended use; the blades are fully capable of piercing the cortices of adjoining vertebral bodies since they extend outward from the shaft and wall member, and have pointed edges at least at 72 and 74 which would each pierce the bone in one direction of rotation; their relative hardness based on the material construction make them fully capable of piercing bone), FIG. 11; wherein said blade is rotated from an insertion configuration, FIG. 7, to an expanded configuration, FIG. 8, to lock said blade to adjoining vertebral bodies (interpreted as language of intended use; fully capable of locking the blade to adjoining vertebral bodies since the relative hardness of the blades would allow the blades to cut into and lock to the vertebral bodies).
As to claim 2, Trieu discloses the interbody spacer according to claim 1 wherein said blade is positioned between upper and lower planes of said peripheral wall forming an insertion configuration (at least a majority of the blade is between the upper and lower planes of said peripheral wall), FIG. 7, said blade extends beyond the upper and lower planes of said peripheral wall in an expanded configuration, FIG. 8.
As to claim 3, Trieu discloses the interbody spacer according to claim 1 wherein each said aperture is a slot (col. 6 / line 38 – col. 7 / line 4), said shaft slidably coupled to each said slot (col. 8 / lines 31-33).
As to claim 5, Trieu discloses the interbody spacer according to claim 1 wherein each said blade is constructed and arranged to obtain a ninety degree (90°) interface with adjacent bone (since the blades are rotated ninety degrees from the insertion to the expanded configuration into interface with the bone).
As to claim 6, Trieu discloses the interbody spacer according to claim 1 wherein each said blade includes a cutting edge (72, 74; fully capable of being a cutting edge due to their pointed edges, and relative hardness based on the material construction make them fully capable of cutting) formed around the perimeter of the blade (around that portion of the perimeter of the blade) and a surface of each said blade is treated to promote boney growth (col. 10 / lines 47-53; bone growth promoting agent disposed on the surfaces).
As to claim 9, Trieu discloses the interbody spacer according to claim 1 wherein said blade is constructed and arranged to lock the sacrum and ilium for transfixing the joint (interpreted as language of intended use; fully capable of locking the sacrum and ilium if placed therebetween, and since the relative hardness of the blades would allow the blades to cut into and lock to the adjacent bones).
As to claim 10, Trieu discloses the interbody spacer according to claim 1 wherein said peripheral wall includes opposing first and second side walls (36, 38) to form a cage, FIG. 1, said cage having openings (30, 32) to allow said blade to extend beyond the upper and lower planes of said peripheral wall (col. 5 / line 65 – col. 6 / line 2), FIG. 1.
Claims 1, 2, 5, 9, and 10 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 9,421,112 to Bal et al. (hereinafter, “Bal”).
As to claim 1, Bal discloses an interbody spacer for transfixing a joint comprising: a peripheral wall member (2), FIGS. 1-2B, having two end walls (walls with teeth 2.4) spaced apart by adjoining side walls (wall of 2.6 and wall of 2.10) defining an internal space (2.5, 2.7) therebetween; a centrally disposed aperture (apertures in the walls for receiving ends 3.2 and 3.1 of the shaft, FIG. 5) formed in said side walls for receipt of a shaft (3) extending between and rotationally coupled to said apertures (col. 5 / lines 10-20), FIGS. 1 and 5; and at least one blade (5) coupled to said shaft, said blade constructed and arranged to pierce the cortices of adjoining vertebral bodies upon rotation of said shaft; wherein said blade is rotated from an insertion configuration to an expanded configuration to lock said blade to adjoining vertebral bodies (col. 6 / lines 31-46).
As to claim 2, Bal discloses the interbody spacer according to claim 1 wherein said blade is positioned between upper and lower planes of said peripheral wall forming an insertion configuration, said blade extends beyond the upper and lower planes of said peripheral wall in an expanded configuration.
As to claim 5, Bal discloses the interbody spacer according to claim 1 wherein each said blade is constructed and arranged to obtain a ninety degree (90°) interface with adjacent bone (since the blades are rotated ninety degrees from the insertion to the expanded configuration into interface with the bone).
As to claim 9, Bal discloses the interbody spacer according to claim 1 wherein said blade is constructed and arranged to lock the sacrum and ilium for transfixing the joint (interpreted as language of intended use; fully capable of locking the sacrum and ilium if placed therebetween).
As to claim 10, Bal discloses the interbody spacer according to claim 1 wherein said peripheral wall includes opposing first and second side walls to form a cage, said cage having openings to allow said blade to extend beyond the upper and lower planes of said peripheral wall, FIG. 1.
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Bal in view of U.S. Patent Application Publication No. US 2023/0301795 to MacMillan et al. (hereinafter, “MacMillan”).
As to claim 4, Bal is silent as to including a lattice formed within said internal space of said peripheral wall, said lattice including a relief space for receipt of each said blade in the insertion configuration.
As to claim 1, MacMillan teaches an interbody spacer for transfixing a joint comprising: a peripheral wall member having two end walls (12, 14) spaced apart by adjoining side walls (16, 18) defining an internal space (24) therebetween (par. [0036]), FIGS. 2A-2B.
As to claim 4, MacMillan teaches the interbody spacer according to claim 1 including a lattice (26) formed within said internal space of said peripheral wall (par. [0036]), said lattice including a relief space (interior opening through lattice), FIGS. 2A-2B, to provide a scaffold for bone ingrowth to promote bone growth of the vertebrae and enhance fusion of the spine (par. [0045]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to line the interior of the walls of Bal’s spacer with a lattice as taught by MacMillan, to provide a scaffold for bone ingrowth to promote bone growth of the vertebrae and enhance fusion of the spine. Since the lattice lines the interior of the walls, it is formed within the internal space of the peripheral wall which is defined by the walls. As required by Bal, the lattice would be formed with a thickness that includes a relief space (negative space of the shape of internal space 2.5 in Bal, but smaller) for receipt of each blade in the insertion configuration, so that the blade can nest within the relief space, surrounded by the lattice, without the lattice interfering with movement of the blade into the expanded configuration.
As to claim 11, Bal discloses a bone spacer for connecting a first bone portion to a second bone portion, the bone spacer comprising: a peripheral wall (2), FIGS. 1-2B, defining an internal space (2.5, 2.7); a rotatable fastener connected to the peripheral wall, the rotatable fastener including a shaft (3), a first blade (one blade on 5) and a second blade (other blade on 5) (col. 5 / lines 10-20), FIGS. 1 and 5, the rotatable fastener movable from an insertion configuration to an expanded configuration (col. 6 / lines 31-46), the first and second blades positioned between upper and lower planes defined by the peripheral wall in the insertion configuration and extending beyond the upper and lower planes in the expanded configuration to engage the first and second bone portions.
Bal is silent as to the internal space including a lattice with a channel therein.
As to claim 11, MacMillan teaches a bone spacer for connecting a first bone portion to a second bone portion, the bone spacer comprising a peripheral wall defining an internal space (24) (par. [0036]), FIGS. 2A-2B, the internal space including a lattice (26) with a channel (interior opening through lattice) therein, FIGS. 2A-2B.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to line the interior of the walls of Bal’s spacer with a lattice as taught by MacMillan, to provide a scaffold for bone ingrowth to promote bone growth of the vertebrae and enhance fusion of the spine. Since the lattice lines the interior of the walls, it is formed within the internal space of the peripheral wall which is defined by the walls. As required by Bal, the lattice would be formed with a thickness that includes a channel (negative space of the shape of internal space 2.5 in Bal, but smaller) for receipt of each blade in the insertion configuration, so that the blade can nest within the relief space, surrounded by the lattice, without the lattice interfering with movement of the blade into the expanded configuration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
Prosecution Insights