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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 16 April 2026. As directed by the amendment: claims 1-6, 10, and 11 have been amended and claims 7-9 are withdrawn. Claims 1-11 currently stand pending in the application.
The amendments to the claims are not sufficient to overcome the previous claim objections, which are repeated below in relevant part.
The amendments to the claims are sufficient to overcome the previous rejections under 35 U.S.C. 112(b), which are correspondingly withdrawn.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As to Taylor et al. (US 7,189,236), Applicant contends that Taylor does not disclose a second housing including a threaded surface; nor a second screw including a threaded rod and a head that is substantially spherical. Examiner respectfully submits that Taylor is modified in view of Donno et al. (US 6,595,993) to meet these limitations. Examiner notes that Taylor discloses screws, where a screw is defined as having a threaded rod.
Applicant contends that Taylor describes the angle between the axis of hole 36 and the distal face of the plate as approximately 60 degrees, but that this angle can be in any generatrix. Examiner respectfully submits that Taylor shows in FIG. 2 that hole 36 is angled so that a screw inserted therethrough would project out toward the left, due to the raised portion of the hole on only the left side. Coupled with Taylor’s disclosure that the hole 36 has an axis at an angle of approximately 60 degrees relative to the distal face of the plate, this meets the limitations of 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), 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). Examiner also notes that a plurality of second axes, at different angles/any angle, can pass through the second housing; the second housing would extend along/next to each of these second axes even if the axis is not exactly in the center of the second housing. Then, at least one or plural ones of the plurality of second axes would form the first and second angles. In other words, even if the second housing itself is not angled, the second axis can be angled as described and interpreted above.
Applicant contends that Taylor does not disclose a first screw emerging from the distal face and configured to penetrate a vertebra S1 of a sacrum of a patient and a second screw received in the second housing and the threaded rod extends into the second hole and emerges from the distal face to be configured to penetrate at least into a vertebra S2 of the sacrum of the patient. Examiner respectfully submits that this is interpreted as language of intended use; Taylor’s first and second screws are fully capable of penetrating the vertebrae S1 and S2 at the same time since the housings/screws are spaced apart along the length of the plate. The plate would be fully capable of directing the screws into these vertebrae of a patient of the age and size that are compatible to the plate size and housing spacing.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As to Donno, Applicant contends that Donno does not disclose the limitations regarding a plate axis, a first angle, and a second angle. Examiner respectfully submits that Donno is relied upon simply as a teaching of a locking cap, and that the limitations regarding a plate axis, a first angle, and a second angle are disclosed by Taylor. Examiner notes that the same interpretation of a plurality of axes extending through the second housing (see above with respect to Taylor) could be applied to Donno.
Applicant contends that Donno does not disclose a first screw emerging from the distal face and configured to penetrate a vertebra S1 of a sacrum of a patient and a second screw received in the second housing and the threaded rod extends into the second hole and emerges from the distal face to be configured to penetrate at least into a vertebra S2 of the sacrum of the patient. Again, the rejections are based on combinations of references, and Examiner respectfully submits that Taylor is relied upon to disclose these capabilities of intended use. Donno is relied upon simply as a teaching of a locking cap, which is provided onto Taylor’s system. Even if Donno were to be applied to the S1 and S2 vertebrae, it would be capable of this with the appropriately sized patient.
Claim Objections
Claims 3-6 and 10 are objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 3 / lines 28-29: “the threaded extension”
Claim 3 / 31: “the threaded extension”
Claim 10 / line 6: “[[the]] an iliac bone”
Claim Rejections - 35 USC § 112
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, and 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 a first hole, FIG. 2, that opens onto the distal face, and a first bottom (distal interior rim), FIG. 2, at which 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 that 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 a second hole that opens onto the distal face, a surface (proximal interior surface of 36) that opens onto the proximal face, and a second bottom (distal interior surface of 36) that has a concave shape (since it is the curved concave interior surface) at which 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 that 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), 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 and configured to penetrate a vertebra S1 of a 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) comprising 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 threaded rod extends into the second hole and emerges from the distal face to be configured to penetrate at least into a 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 disposed 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), and the second screw is dimensioned and configured, in the assembled configuration, to pass through the vertebra S2 and reach an 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 and configured, 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 threaded surface, the second bottom connects the second hole and the threaded surface; the second screw head that is 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 comprising a skirt having an outer face threaded to match the threaded surface and an inner face that 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 threaded 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, and 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 a first hole (17) that opens onto the distal face, and a first bottom (spherical bottom of the first housing) at which the first hole is drilled and that 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 a second hole (17) that opens onto the distal face, a threaded surface (proximal internally threaded surface) that opens onto the proximal face, FIG. 4, and a second bottom (spherical bottom of the second housing) that has a concave shape at which the second hole is drilled and that 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, 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) comprising a threaded rod and a head (13) that is 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 threaded rod extends into the second hole and emerges from the distal face, FIG. 4;
a locking cap (15) comprising a skirt (radially outward portion) having an outer face threaded to match the threaded surface, FIG. 4, and an inner face (external face of 26; inwardly positioned relative to the skirt) that 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 threaded 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 threaded 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 threaded 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 threaded 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 threaded 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 of the proximal and distal caps comprising:
an orifice (50) with a diameter greater than a diameter of the threaded 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, and
a bearing surface (facing surfaces of 49s), the bearing surfaces facing each other along the connector axis, FIG. 3,
each of the proximal and distal caps 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 vertebral rod (col. 5 / lines 24-25), and
a nut (40), FIGS. 2-3, including a tightening portion (threaded body of the nut) 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 orifices 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 threaded extension includes a line of least resistance (47) making the threaded extension breakable when a bending or torsional torque equal to a bending or torsional breaking torque is applied to the threaded 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 proximal and distal 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 of the proximal and distal dome caps 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 of the proximal and distal dome caps 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 vertebral rod, FIG. 6B,
a nut (148, 172) including a 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 proximal and distal 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 proximal and distal 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, the screwing portion being 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, the screwing portion being 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 sacrum of the patient;
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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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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.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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