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, claims 1-6, 10, and 11 in the reply filed on 10 November 2025 is acknowledged. The traversal is on the ground(s) that there must be serious burden on the Examiner if restriction is not required. Applicant contends that the species do not require a different field of search, but are in a field of art that is clearly defined and narrow. This is not found persuasive because the structural differences between the species could lead to different searches, such as clamps versus tulip heads, as well as different out of art searches for various structural elements. These considerations add to the serious burden.
Applicant contends that the species are not likely to raise different non-prior art issues under 35 USC 101 because they are devices. Examiner respectfully submits that, in general, a 101 rejection could arise in an apparatus claim by the improper claiming of the human body. Similarly, issues under 35 USC 112 could arise based on the claim language. These considerations add to the serious burden.
Applicant contends that the particular reasons relied upon by the Examiner should be concisely stated and not a mere statement of conclusion. Examiner respectfully submits that the reasons are as listed; presenting a full search strategy is outside the scope of a Restriction Requirement and unreasonable in the given timeframe. The reasons are listed as likely, because the given timeframe does not allow a full fleshing out of these potential issues, but the potential of these issues arising between the species is enough to constitute a serious burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species B, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10 November 2025.
Priority
The priority date is 16 June 2023.
Claim Objections
Claims 1-6, 10, and 11 are objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 1 / line 22: “to be configured to penetrate [[the]] a vertebra S1 of [[the]] a sacrum”
Claim 1 / line 27: “so as to be configured to penetrate at least into [[the]] a vertebra S2”
Claim 1 / line 30: “an inner face [[of]] which”
Claim 2 / line 3: “is dimensioned and configured, in the assembled configuration, to pass”
Claim 2 / line 4: “[[the]] an iliac bone”
Claim 3 / line 3: “the threaded extension”
Claim 3 / line 6: “each of the proximal and distal dome caps”
Claim 3 / line 7: “the threaded extension”
Claim 3 / line 12: “each of the proximal and distal dome caps”
Claim 3 / line 18: “the threaded extension”
Claim 3 / line 20: “the threaded extension”
Claim 6 / line 1: “the threaded extension”
Claim 6 / line 1: “making the threaded extension breakable”
Claim 6 / line 3: “the threaded extension”
Claim 10 / lines 2-3: “is dimensioned and configured, in the assembled configuration, to pass”
Claim 10 / line 3: “[[the]] an iliac bone”
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 1-6, 10, and 11 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 1, the limitation “the threaded surface” (lines 13-14) renders the claims indefinite, because it lacks proper antecedent basis in the claims. It is unclear if this refers back to the previously recited tapped surface, or to a different threaded surface. For examination purposes, the limitation will be interpreted in the former instance, as the tapped surface.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “between 70 degrees and 110 degrees,” and the claim also recites “preferably comprised between 85 and 95 degrees” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
As to claim 3, the limitation “the spinal rod” (line 14) renders the claims indefinite, because it lacks proper antecedent basis in the claims. It is unclear if this refers back to the previously recited vertebral rod (claim 1 / line 37), or to a different spinal rod. For examination purposes, the limitation will be interpreted in the former instance, as the vertebral rod.
Further as to claim 3, the limitation “the ports” (line 18) renders the claims indefinite, because it lacks proper antecedent basis in the claims. It is unclear if this refers back to the previously recited orifices (claim 3 / line 7), or to different ports. For examination purposes, the limitation will be interpreted in the former instance, as the orifices.
As to claim 4, the limitation “the lower and upper dome caps” (lines 2-3) renders the claim indefinite, because it lacks proper antecedent basis in the claims. It is unclear if this refers back to the previously recited proximal and distal dome caps, or to different lower and upper dome caps. For examination purposes, the limitation will be interpreted in the former instance, as the proximal and distal dome caps.
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 1, 2, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 7,189,236 to Taylor et al. (hereinafter, “Taylor”), in view of U.S. Patent No. US 6,595,993 to Donno et al. (hereinafter, “Donno”).
As to claim 1, Taylor discloses a sacral fixation system, comprising:
a plate (30), FIGS. 2-3, comprising:
a proximal face and a distal face opposite the proximal face, a plate plane
extending between the distal and proximal faces,
a first housing (35) (col. 4 / lines 63-67) extending along a first axis by connecting the distal and proximal faces to each other, FIG. 2, the first housing including both a first hole, FIG. 2, which opens onto the distal face, and a first bottom (distal interior rim), FIG. 2, wherein the first hole is drilled (The claimed phrase is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference), and which connects the first hole and the proximal face,
a second housing (36) (col. 4 / line 63 – col. 5 / line 4) extending along a second axis by connecting the distal and proximal faces to each other, FIG. 2, the second housing including both a second hole, which opens onto the distal face, a surface (proximal interior surface of 36), which opens onto the proximal face, and a second bottom (distal interior surface of 36), which has a concave shape (since it is the curved concave interior surface), wherein the second hole is drilled (The claimed phrase is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference), and which connects the second hole and the surface, and
a plate axis (along a length of the plate) belonging to the plate plane and intersecting with the first and second axes, FIG. 2, the second axis forming, in projection onto a plane perpendicular to the plate axis, a first angle (approximately 60 degrees) comprised between 30 and 60 degrees with the plate plane (col. 5 / lines 1-4), and the second axis and the plate axis forming a second angle comprised between 45 degrees and 110 degrees (the second angle is about 90 degrees if, when viewed from above the plate, the second axis extends out to the left of the plate, based on the angled shape of 36 and the 60 degree first angle, such that, from above, the second axis and the plate axis are orthogonal);
- a first screw (not shown; received in 35), which, when the system is in an assembled configuration, is received in the first housing, extending into the first hole and emerging from the distal face so as to penetrate the vertebra S1 of the sacrum of a patient (interpreted as language of intended use; fully capable of penetrating the S1 vertebra if the plate and first housing 35 are positioned thereabove);
- a second screw (not shown; received in 36) which comprises a threaded rod and a head, the second screw being, when the system is in the assembled configuration, received in the second housing and the rod extends into the second hole and emerges from the distal face so as to be able to penetrate at least into the vertebra S2 of the sacrum of the patient (interpreted as language of intended use; fully capable of penetrating the S2 vertebra if the plate and second housing 36 are positioned thereabove); and
- a connecting device (39 and 38) which, when the system is in the assembled configuration, is arranged on the proximal face between the first and second housings and connects the plate to a vertebral rod (col. 5 / lines 18-31).
As to claim 2, Taylor discloses the system according to claim 1, wherein the second angle is comprised between 70 degrees and 110 degrees (the second angle is about 90 degrees, as above), preferably comprised between 85 and 95 degrees, and the second screw is dimensioned, in the assembled configuration, to pass through the vertebra S2 and reach the iliac bone of the patient (interpreted as language of intended use; the second screw is fully capable of passing through the vertebra S2 and reaching the iliac bone if the plate and second housing 36 are positioned thereabove).
As to claim 10, Taylor discloses the system according to claim 1, wherein the second angle is comprised between 85 and 95 degrees (the second angle is about 90 degrees, as above), and the second screw is dimensioned, in the assembled configuration, to pass through the vertebra S2 and reach the iliac bone of the patient (interpreted as language of intended use; the second screw is fully capable of passing through the vertebra S2 and reaching the iliac bone if the plate and second housing 36 are positioned thereabove).
Taylor is silent as to the second housing including a tapped surface, the second bottom connects the second hole and the threaded surface; the second screw head being substantially spherical matching the second bottom, the second screw being, when the system is in the assembled configuration, received in the second housing such that the head bears against the second bottom; a locking cap which comprises a skirt having an outer face threaded to match the tapped surface and an inner face of which matches the head of the second screw, and which, when the system is in the assembled configuration, is received in the second housing by interposing the skirt radially between the head of the second screw and the tapped surface, so that the head of the second screw is received in the skirt and is pressed against the inner face.
As to claim 1, Donno teaches a sacral fixation system, comprising:
a plate (7) comprising:
a proximal face and a distal face opposite the proximal face, a plate plane
extending between the distal and proximal faces,
a first housing (plate hole on the right in FIG. 4) extending along a first axis by connecting the distal and proximal faces to each other, the first housing including both a first hole (17), which opens onto the distal face, and a first bottom (spherical bottom of the first housing), wherein the first hole is drilled, and which connects the first hole and the proximal face,
a second housing (plate hole on the left in FIG. 4) extending along a second axis by connecting the distal and proximal faces to each other, the second housing including both a second hole (17), which opens onto the distal face, a tapped surface (proximal internally threaded surface), which opens onto the proximal face, FIG. 4, and a second bottom (spherical bottom of the second housing), which has a concave shape, wherein the second hole is drilled, and which connects the second hole and the threaded surface, FIG. 4, and
a plate axis belonging to the plate plane and intersecting with the first and second axes, the second axis forming, in projection onto a plane perpendicular to the plate axis, a first angle comprised between 30 and 60 degrees with the plate plane, and the second axis and the plate axis forming a second angle comprised between 45 degrees and 110 degrees;
- a first screw (12), which, when the system is in an assembled configuration, is received in the first housing, extending into the first hole and emerging from the distal face;
- a second screw (12) which comprises a threaded rod and a head (13), the head being substantially spherical matching the second bottom (col. 2 / line 65 – col. 3 / line 2), the second screw being, when the system is in the assembled configuration, received in the second housing such that the head bears against the second bottom, FIG. 4, and the rod extends into the second hole and emerges from the distal face, FIG. 4;
- a locking cap (15) which comprises a skirt (radially outward portion) having an outer face threaded to match the tapped surface, FIG. 4, and an inner face (external face of 26; inwardly positioned relative to the skirt) of which matches the head of the second screw (col. 3 / lines 14-16), FIG. 4, and which, when the system is in the assembled configuration, is received in the second housing by interposing the skirt radially between the head of the second screw and the tapped surface, so that the head of the second screw is received in the skirt and is pressed against the inner face (col. 2 / lines 52-55).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Taylor’s system to include a locking cap as taught by Donno, and to modify the second screw as taught by Donno so that the interaction of the second screw, the second housing, and the locking cap allows for angulation of the second screw into a desired position relative to the plate, to accommodate fixation into a stronger part of the bone or in a position that prevents backout. Taylor contemplates that the second housing may be at an angle; the potential of angulation of the second screw would additionally allow for a variety of positions of the second screw to best accommodate the patient bone morphology and ensure strong fixation. To accommodate this modification and the inclusion of the locking cap, the second housing would have a tapped surface to receive the threaded skirt of the locking cap, and a concave second bottom that is substantially spherical to receive the second screw head. The second screw would be of the form as taught by Donno (Taylor contemplates screws but does not show them or describe their shape), comprising a substantially spherical head matching the second bottom so that the head bears against the second bottom. The locking cap skirt would be threaded to match the tapped surface, and the inner face would match the head of the second screw, so that the skirt is radially interposed between the second screw head and the tapped surface, so that the head of the second screw is received in the skirt and is pressed against the inner face, and the locking cap can be threadedly tightened into the second housing to secure the second screw in position.
Claims 3, 4, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor in view of Donno (hereinafter, “Taylor/Donno”), as applied to claims 1, 2, and 10 above, and further in view of U.S. Patent Application Publication No. US 2008/0306551 to Sanders et al. (hereinafter, “Sanders”).
As to claim 3, Taylor/Donno disclose the system according to claim 1, wherein the plate further comprises a recess (Taylor, 44), FIG. 3, and the connecting device comprises:
- a threaded extension (38) fixedly connected to the recess of the plate (col. 5 / lines 12-13), the extension extending along an extension axis;
- a connector (39), comprising a proximal cap (upper half of 39, including proximal 49) and a distal cap (lower half of 39, including distal 49), the distal cap matching the recess (the distal cap matches or is suitably associated with the recess since they have matching openings), each cap comprising:
an orifice (50) with a diameter greater than a diameter of the extension (col. 5 / lines 18-21), FIGS. 2-3, the orifices of the proximal and distal caps being coaxial and centered on a connector axis, FIG. 3,
a bearing surface (facing surfaces of 49s), the bearing surfaces facing each other along the connector axis, FIG. 3;
each cap being movable along the connector axis in order to bring the bearing surfaces into contact with each other along the connector axis (fully capable of being brought into contact with each other with sufficient force) and to tighten the connector around the spinal rod (col. 5 / lines 24-25),
- a nut (40), FIGS. 2-3, including a tightening portion (threaded body of the nut), the tightening portion comprising a distal surface matching the proximal cap (matching or suitably associated with the orifice in the proximal cap), FIG. 3,
and wherein, when the system is in the assembled configuration:
- the connector is fitted onto the extension through the ports of the distal and proximal caps (col. 5 / lines 18-21), FIGS. 2-3; and
- the nut is screwed onto the extension, the distal surface bears against the proximal cap, the nut holds the distal cap against the recess (against the opening of the recess) and holds the bearing surfaces in contact along the connector axis; and
- the connector is tightened around the vertebral rod.
As to claim 6, Taylor/Donno disclose the system according to claim 3, wherein the extension includes a line of least resistance (47) making same breakable when a bending or torsional torque equal to a bending or torsional breaking torque is applied to the extension (fully capable of being breakable under torque) (col. 5 / lines 16-17).
Taylor/Donno are silent as to the proximal and distal caps being domes (claim 3); wherein the proximal and distal dome caps are hemispherical and when the system is in the assembled configuration, the lower and upper dome caps are co-radial (claim 4).
Sanders teaches a connecting device comprising
- a connector (par. [0051]-[0052]), FIG. 6A, comprising a proximal dome cap (162) and a distal dome cap (164), each dome cap comprising:
an orifice with a diameter, the orifices of the proximal and distal dome caps being coaxial and centered on a connector axis,
a bearing surface, the bearing surfaces facing each other along the connector axis;
each dome cap being movable along the connector axis in order to bring the bearing surfaces into contact with each other along the connector axis and to tighten the connector around the spinal rod, FIG. 6B,
- a nut (148, 172), including a tightening portion, the tightening portion comprising a distal surface matching the proximal dome cap (par. [0052]),
and wherein, when the system is in the assembled configuration:
- the nut is screwed on, the distal surface bears against the proximal dome cap, the nut holds the distal dome cap and holds the bearing surfaces in contact along the connector axis; and
- the connector is tightened around the vertebral rod.
Sanders teaches wherein the proximal and distal dome caps are hemispherical (par. [0051]) and when the system is in the assembled configuration, the lower and upper dome caps are co-radial (share at least one radial direction), FIG. 6A.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector in Taylor/Donno so that the proximal and distal caps are domes as taught by Sanders, wherein the proximal and distal dome caps are hemispherical and when the system is in the assembled configuration, the lower and upper dome caps are co-radial, in order to provide a ball and socket type universal joint allowing the connector, and thus the rod, to assume any desired orientation relative to the plate, so that fixating the plate does not pull on the rod in undesirable ways. Taylor contemplates that the orientation of the threaded extension be movable relative to the plate and the distal cap receives a hemispherical dome on the plate for movement thereabout; modifying the connector such that the distal cap is a hemispherical dome, that fits into a complementary recess in the plate, would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention because a mere reversal of the essential working parts of a device involves only routine skill in the art (the male/female portions are reversed on the plate and the distal cap). Similarly modifying the proximal cap to be a hemispherical dome, with the nut complementary shaped (hemispherical recess) for secure tightening of the connector about the rod and the distal dome cap against the recess, would allow for orientational adjustment of the connector and thus the rod relative to the plate.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor/Donno in view of Sanders (hereinafter, “Taylor/Donno/Sanders”), as applied to claims 3, 4, and 6 above, and further in view of U.S. Patent No. US 6,554,831 to Rivard et al. (hereinafter, “Rivard”).
As to claim 5, Taylor/Donno/Sanders are silent as to wherein the nut further comprises a screwing portion supported by the tightening portion, configured to detach from the tightening portion when a torque equal to a maximum screwing torque is applied to the screwing portion.
Rivard teaches a threaded extension (30), FIG. 2, a connector (22), and a nut (40), including a tightening portion (distal portion), wherein the nut further comprises a screwing portion (proximal portion) supported by the tightening portion, configured to detach (at 42) from the tightening portion when a torque equal to a maximum screwing torque is applied to the screwing portion (col. 3 / line 60 – col. 4 / line 6).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the nut with a screwing portion connected to the tightening portion by an annular weak region, so that there is extra gripping area for torqueing the nut down, but the screwing portion will break off at the weak region upon a maximum torque being applied, to prevent overtorqueing and overtightening. The threaded extension also breaks off at the line of least resistance as disclosed by Taylor, so that any extra length of the threaded extension and the nut are broken off upon tightening of the nut, so that the system is minimally invasive upon implantation.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor/Donno, as applied to claims 1, 2, and 10 above, and further in view of U.S. Patent No. US 11,317,952 to Heavener et al. (hereinafter, “Heavener”).
As to claim 11, Taylor/Donno are silent as to a drill guide comprising:
- a distal surface morpho-adapted to a posterior region of the patient's sacrum;
- a first guide hole centered along a first guide axis, and
- a second guide hole centered along a second guide axis, the first guide hole and the second guide hole being oriented identically to the first and the second screws when the system is in the assembled configuration.
Heavener teaches a plate, FIG. 33(e), comprising a first housing (one screw hole on the left) for receiving a first screw; a second housing (angled screw hole on the right) for receiving a second screw; a drill guide, FIG. 33(b), comprising:
- a distal surface morpho-adapted to the bone;
- a first guide hole centered along a first guide axis, and
- a second guide hole centered along a second guide axis, the first guide hole and the second guide hole being oriented identically to the first and the second screws when the system is in the assembled configuration, so as to predrill bone holes for the screws and to guide the plate to the accurate location on the bone.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the system of Taylor/Donno as part of an assembly comprising a drill guide that has guide holes oriented identically to the first and the second screws to allow predrilling of the bone holes for the screws and to guide the plate to the accurate location on the bone. It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the drill guide with a distal surface morpho-adapted to a posterior region of the patient's sacrum, to allow proper placement of the drill guide on the relevant bone of the particular patient, as taught by Heavener.
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