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 14 August 2026. As directed by the amendment: claims 1, 4, 6-8, and 11 have been amended, claims 2, 9, 12, and 16 are cancelled, and claims 17-23 have been newly added. Claims 1, 3-8, 10, 11, 13-15, and 17-23 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the previous claim objections, but further claim objections are presented below as necessitated by the current claim amendments.
The amendments to the claims are sufficient to overcome the previous rejections under 35 U.S.C. 112(a) and (b), which are correspondingly withdrawn. The cancellation of claim 16 has rendered moot its relevant rejection under 35 U.S.C. 112(b). Further rejections under 35 U.S.C. 112(a) and (b) are presented below as necessitated by the current claim amendments.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 have been considered but are moot because the new ground of rejection does not rely on any combination or interpretation of any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Of particular note as to Graser (US 2008/0208349), Applicant contends that the claimed “underside” is explicitly defined as being located on the outer peripheral surface and therefore using internal dimensions in Graser fail to define an “underside” step on the outer peripheral surface. Examiner respectfully submits that the claim does not recite that the underside is located on the outer peripheral surface. As interpreted in Graser, the diameters (internal and/or external) cooperate to define the underside, or under or lower side or portion that is under the upper side or portion, because the diameters define the boundaries of the anchor sleeve and thus the dimensions of its underside. The shock absorber in Graser in view of Kuster (US 10,729,480) contacts this underside because the shock absorber in view of Kuster is a coating on the outer surface of the entire device and thus contacts the underside portion of the device by being coated over it.
As to Kuster, Applicant contends that the surface coating is thin, superficial, and conformal and thus lacks structural volume, does not occupy the underside, and possesses no groove. Examiner respectfully submits that the surface coating, disclosed by Kuster as a thin membrane, does have structural volume because even though it is thin, it is not lacking in structure or nonexistent. As interpreted in the rejections below, the coating taught in Kuster contacts the underside and is fitted in the groove.
Applicant further contends that adding a coating layer onto Graser would add thickness, causing the coated section to extend outward, and therefore Graser in view of Lopez and Kuster cannot teach an outer peripheral surface of the shock absorber has the same diameter as the anchor sleeve. Examiner respectfully submits that in the expanded position in Graser, a distal area of the header has a larger diameter than a proximal area of the header. Therefore, an outer peripheral surface of the shock absorber at a particular longitudinal location when the header is enlarged, has the same diameter as an outer peripheral surface of the anchor sleeve at a location distal to where the diameter of the outer peripheral surface of the shock absorber is taken, due to the angle of the bodies of the enlarged header body and since the shock absorber is layered on the outer surface of the anchor sleeve/header.
As to Park (US 2008/0234682) in view of Lopez and Canham (US 6,322,895), Applicant contends that if Canham’s shock absorber were placed over Park’s actively expanding legs, outward radial expansion during pin insertion would deform or dislodge the shock absorber and prevent the shock absorber from maintaining a flush outer diameter. Wrapping a shock absorbing member around actively expanding prongs would impede their outward expansion, rendering Park inoperable for its intended purpose. Examiner respectfully submits that Canham teaches coating surfaces of surgical implants with a layer of polysilicon. Canham does not teach a membrane as in Kuster, but a layer applied to the surfaces of the implant. Since the layer is applied directly to the surfaces, it would not be affected by movement of the expanding bodies, and would not impede expansion of the expanding bodies in Park.
As to Chanduszko (US 8,257,389), Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Claim Objections
Claims 4, 5, and 19 are objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 4 / line 3: “a peripheral surface of the pin header,”
Claim 5 / lines 1-2: “
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19 and 20 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claim 19, the limitation that the slant angles are measured with respect to a longitudinal axis of the header body is not supported by the specification as originally filed, which recites that the slant angles are measured with respect to a vertical line (FIG. 6A).
As to claim 20, the limitation that the long hole is stadium-shaped with a pair of parallel straight sides connected by arcuate end portions is not supported by the specification as originally filed. FIG. 4B describes a long hole but does not describe “stadium-shaped” or “parallel straight sides” or “arcuate end portions.”
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, 3-8, 10, 11, 13-15, and 17-23 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 / lines 21-22, the limitation “wherein a shock absorber is fitted to a groove formed on the header contacting the underside of the anchor sleeve” renders the claims indefinite, because it is unclear as to what feature is contacting the underside: the shock absorber, the groove, or the header. Since neither the groove nor the header are disclosed as contacting the underside, the limitation will be interpreted as wherein a shock absorber is fitted to a groove formed on the header, the shock absorber contacting the underside of the anchor sleeve.
As to claim 17, the limitation “an outer peripheral surface of the header body” (lines 2-3) renders the claims indefinite, because it is unclear if this refers back to the previously recited outer peripheral surface of the header (claim 1), or to a different outer peripheral surface of the header body. For examination purposes, the limitation will be interpreted in the former instance, as the outer peripheral surface of the header.
As to claim 18, the limitation “an outer diameter of the shock absorber” renders the claims indefinite, because it is unclear if this refers back to the previously recited diameter of an outer peripheral surface of the shock absorber (claim 1), or to a different outer diameter. For examination purposes, the limitation will be interpreted in the former instance, as the diameter of the outer peripheral surface of the shock absorber.
As to claim 19, the limitation “the slant surface of the hollow portion” (line 1) renders the claim indefinite because it lacks proper antecedence in the claims. For examination purposes, the limitation will be interpreted as the slant surface of the anchor sleeve. Amendment as such requires corresponding amendment to the same limitation in claim 19 / line 4.
Further as to claim 19, the limitation “a lower end of the header body” (line 2) renders the claim indefinite because it is unclear if this refers back to the previously recited lower end of the header body (claim 1), or to a different lower end. For examination purposes, the limitation will be interpreted in the former instance, as the lower end of the header body.
Further as to claim 19, the limitation “an outer peripheral surface of the pin header” (line 3) renders the claim indefinite because it is unclear if this refers back to the previously recited peripheral surface (claim 4 / line 3) or to a different outer peripheral surface. For examination purposes, the limitation will be interpreted in the former instance, as the peripheral surface of the pin header.
As to claim 23, the limitation “an outer peripheral surface of the upper portion of the header body” renders the claim indefinite because it is unclear if this refers back to the previously recited outer peripheral surface of the header (claim 1), or to a different outer peripheral surface of the upper portion of the header body. For examination purposes, the limitation will be interpreted in the former instance, as the outer peripheral surface of the header at the upper portion of the header body.
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, 3, 7, 8, 13-15, 17, 18, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2008/0208349 to Graser in view of U.S. Patent Application Publication No. US 2009/0292361 to Lopez and U.S. Patent No. US 10,729,480 to Kuster et al. (hereinafter, “Kuster”).
As to claim 1, Graser discloses an anchor for cortical bone comprising: an anchor sleeve (10) having a header (distal portion, including 14 up to and including the line between 12 and 14) located on a lower end portion thereof, a diameter of the header (inner diameter at the distal end of 14, in the position of FIG. 2B) being smaller than a diameter of a rest of the anchor sleeve (outer diameter at 12, or any other diameter of 10, where the anchor sleeve includes all of 10 including the header), FIG. 2B, to define an underside of the anchor sleeve (the under or lower side or portion of 10, which is under the upper side or portion of 10 based on perspective, including at least all of the header; the inner diameter of the header at the distal end of 14 and the diameter of the rest of the anchor sleeve define the under or lower side or portion of 10 because the diameters define the boundaries of the anchor sleeve and thus the dimensions of its underside), the header configured to be inserted into the cortical bone, FIG. 1, enlarged by an external force (par. [0025]-[0027]), and fixed to the cortical bone; and an anchor pin (30) inserted into the anchor sleeve configured to transmit the external force for enlarging the header when the anchor pin is pushed (moved distally) (par. [0028]), FIG. 2B, wherein the header of the anchor sleeve has a header body (14) equally divided into a plurality of bodies (28) by a plurality of incised portions (26a-26c) configured to enlarge through the external force (par. [0027]), FIGS. 2B-2C, wherein the anchor sleeve has a hollow portion configured to receive the anchor pin and extending from a top end portion of the anchor sleeve to a lower end of the header body, FIG. 2B, the hollow portion at the lower end of the header body having a smaller diameter (in the position of FIG. 2B, the diameter of the narrow gap between 28s) than a pin header (tip of 30) of the anchor pin, FIG. 2B, wherein the header enlarges when the pin header of the anchor pin is pushed and inserted into the hollow portion in a direction from the top end portion toward the lower end portion of the anchor sleeve, wherein the anchor pin comprises a pin body (30) inserted into the anchor sleeve, a top end portion (18) of the pin body configured to protrude from the top end portion of the anchor sleeve (at least during assembly, before full seating of the pin body in the anchor sleeve, and/or if the pin body is backed out from the anchor sleeve), and the pin header located on a lower end of the pin body, FIG. 2B, the pin header having a larger area than the hollow portion at the lower end of the header body (the pin header has a larger area across it than the hollow portion at the narrow gap between 28s), FIG. 2B, a groove (at line between 12 and 14, which becomes a groove when the header is enlarged to pivot away from the proximal portion of the anchor sleeve at/forming the groove) formed on the header of the anchor sleeve, FIG. 1.
As to claim 3, Graser discloses the anchor according to claim 1, wherein each of the plurality of the incised portions has an enlarged range enlarging hole (24a-24c), FIG. 2B, defined on an end thereof in a longitudinal direction configured to enlarge an enlarged range of the header (par. [0027]).
As to claim 7, Graser discloses the anchor according to claim 1, further comprising a first fastener (22a-22b) located on the top end portion of the anchor sleeve configured to be fixed to a body of a dedicated applicator (interpreted as language of intended use without positive recitation of a dedicated applicator; fully capable of being fixed to a body of a dedicated applicator) (par. [0026]), FIG. 1; and a second fastener (threaded end of 30 including 20) located on the top end portion of the pin body configured to be coupled to a handle rotatably located inside the body of the dedicated applicator (interpreted as language of intended use without positive recitation of a handle and dedicated applicator; fully capable of being fixed to a handle) (par. [0026]), FIGS. 1 and 2B, wherein the anchor sleeve and the anchor pin are coupled with a plurality of screw threads (36a-36b) thereon (par. [0029]), and relatively movable through a rotation of the handle of the dedicated applicator when the body is fixed to the first fastener (interpreted as language of intended use).
As to claim 13, Graser discloses the anchor according to claim 3, wherein each of the enlarged range enlarging holes is a circular hole having a larger diameter than a dimension of a respective one of the plurality of the incised portions, FIG. 2B.
As to claim 14, Graser discloses the anchor according to claim 3, wherein each of the enlarged range enlarging holes is a long hole (because it is longer about a circumferential direction than a width of the incised portion) extending laterally from a respective one of the plurality of the incised portions, FIG. 2B.
As to claim 17, Graser discloses the anchor of claim 1, wherein the underside of the anchor sleeve includes: a first underside (distal facing side of 14) extending perpendicularly from an outer peripheral surface (e.g. outer surface of the header body) of the header body, and a second underside (sides of the header; the first and second undersides are sides of the underside because the underside comprises the under or lower side or portion of 10, which is under the upper side or portion of 10 based on perspective, including at least all of the header, as interpreted above) extending from an outer end of the first underside to an outer peripheral surface of the rest of the anchor sleeve (at a proximal portion of 12), wherein a diameter of the second underside decreases toward the first underside (the inner diameter of the second underside/sides of the header decreases toward the first underside along angled sides, FIG. 2B).
As to claim 23, Graser discloses the anchor of claim 1, wherein the header body includes: a lower portion (lower portion of the segmented portion of 14) divided into the plurality of bodies by the plurality of incised portions, FIG. 2B; and an upper portion (upper portion of the segmented portion of 14) disposed between the lower portion and the underside of the anchor sleeve (since the underside includes at least all of the header, the upper portion of the header body is between the lower portion of the header body and a rest of the header body, e.g. above the segmented portion).
Graser is silent as to wherein the header has a patterned friction protrusion on at least a portion of an outer peripheral surface thereof, the patterned friction protrusion having a dot pattern to increase fixing force with the cortical bone by generating shear force when the header is enlarged by the anchor pin.
Lopez teaches a bone anchor, FIG. 21, comprising a patterned friction protrusion on at least a portion of an outer peripheral surface thereof, the patterned friction protrusion having at least one dot pattern (199) (par. [0141]).
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 Graser’s anchor including the header with a patterned friction protrusion having and created by a dot pattern in the outer surface, to promote bone ingrowth and therefore result in strong anchoring of the anchor in the bone, as taught by Lopez. The dot pattern increases fixing force with the cortical bone because it promotes bone ingrowth, and generates shear force when the header is enlarged by the anchor pin since the dots project from the outer surface.
Graser is silent as to a shock absorber is fitted to a groove formed on the header contacting the underside of the anchor sleeve, wherein an outer peripheral surface of the shock absorber has the same diameter as the anchor sleeve to prevent damages to the cortical bone caused by friction with the underside of the anchor sleeve (claim 1); wherein the shock absorber is configured to be between the anchor sleeve and the cortical bone, and wherein the shock absorber is configured to absorb a shock transmitted from the anchor sleeve to the cortical bone (claim 8); wherein the shock absorber is made of rubber or silicone (claim 15); wherein an outer diameter of the shock absorber is equal to a diameter of the anchor sleeve at an intersection where the first underside meets the second underside (claim 18); wherein the shock absorber is seated on an outer peripheral surface of the upper portion of the header body (claim 23).
Kuster teaches coating an expanding orthopedic implant with a layer of silicone rubber to avoid ingrowth of bone into the expanded portion (col. 9 / lines 53-62), FIG. 7.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to coat an outer peripheral surface of the anchor sleeve including the header in Graser with a layer of silicone rubber, as taught by Kuster, to avoid ingrowth of bone into the enlarged header to prevent interference with the interaction of the anchor pin and the anchor sleeve, and to allow revision surgery if required. The layer of silicone rubber, being a coating on the outer surface of the anchor sleeve including the header, would thus be between the anchor sleeve and the cortical bone when the anchor is implanted into the bone, and is a shock absorber because it is fully capable of absorbing a shock transmitted from the anchor sleeve to the bone because of its location between the anchor sleeve and the bone. The thickness of the layer of silicone rubber would absorb or dampen a shock from the anchor sleeve since it is a piece of intervening material. As described above, Graser discloses a groove (at line between 12 and 14, which becomes a groove when the header is enlarged to pivot away from the anchor sleeve at/forming the groove) formed on the header of the anchor sleeve, so that the layer of silicone rubber which is a coating on the outer surface of the entire device would be fitted into the groove. The layer of silicone rubber also contacts the underside, which comprises at least all of the header, and thus the layer of silicone rubber which is a coating on the outer surface of the entire device would contact the underside portion of the device by being coated over it. The shock absorber is seated on an outer peripheral surface of the upper portion of the header body since the layer of silicone rubber is a coating on the outer surface of the entire device. When the header is enlarged, a distal area of the header (which is a distal area of the anchor sleeve since the anchor sleeve comprises the header) has a larger diameter than a proximal area of the header. Since the shock absorber is a layer on the outer surface of the anchor sleeve/header, it has a slightly greater diameter at its outer peripheral surface than the adjacent outer peripheral surface of the underlying anchor sleeve. Then, an outer peripheral surface of the shock absorber at a particular longitudinal location when the header is enlarged, has the same diameter as an outer peripheral surface of the anchor sleeve at a location distal to where the diameter of the outer peripheral surface of the shock absorber is taken, due to the angle of the bodies of the enlarged header body and since the shock absorber is layered on the outer surface of the anchor sleeve/header. Similarly, an outer diameter of the shock absorber at a particular proximal longitudinal location when the header is enlarged is equal to a diameter of the anchor sleeve (not including the shock absorber) at an intersection (distal outer edge of 10/14) where the first underside meets the second underside. The shock absorber is fully capable of preventing damages to the cortical bone caused by friction with the underside of the anchor sleeve since it is a coating on the anchor sleeve that would reduce friction with the bone (interpreted as language of intended use).
As to claims 21 and 22, Graser/Lopez/Kuster are silent as to wherein the number of the plurality of the incised portions is two, three, or four; wherein the number of the plurality of the incised portions is four, and the plurality of the incised portions are arranged at 90-degree intervals along a circumferential direction of the header body.
Graser contemplates different numbers of bodies and incised portions, including four (par. [0033]).
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 four incised portions and four respective bodies, since Graser contemplates providing different numbers of bodies and incised portions, including four, to achieve different goals such as more or less easy to expand, and more or less secure placement. Since Graser also discloses that the plurality of bodies are equally sized and radially arranged (par. [0032]), the four incised portions would be arranged at 90-degree intervals along a circumferential direction of the header body to provide four equally sized and radially arranged bodies.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Graser in view of Lopez and Kuster (hereinafter, “Graser/Lopez/Kuster”), as applied to claims 1, 3, 7, 8, 13-15, 17, 18, and 21-23 above, and further in view of U.S. Patent No. US 8,685,034 to Giersch et al. (hereinafter, “Giersch”).
Graser/Lopez/Kuster disclose further comprising a belt insertion groove along a circumferential surface of the anchor sleeve (a belt insertion groove comprising a root of the inner thread along an interior circumferential surface of the anchor sleeve) and the second fastener (the belt insertion groove comprising a root of the thread on the threaded end of the anchor pin); but are silent as to a fixing belt inserted into the belt insertion groove configured to allow the anchor sleeve and the second fastener to be connected to each other wherein the anchor sleeve and the second fastener are coupled with the fixing belt.
Giersch teaches that a fixing belt (O-ring) is inserted into a belt insertion groove (roots of complementary threads) to connect complementarily threaded components to each other without play (col. 3 / lines 36-43).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Graser/Lopez/Kuster a fixing belt (O-ring; in the shape of a belt, and provides fixing of two components to each other) inserted into the belt insertion groove (between the complementary threads/in the roots of the threads of the anchor sleeve and the second fastener) to allow the anchor sleeve and the second fastener to be connected to each other wherein the anchor sleeve and the second fastener are coupled with the fixing belt, since the fixing belt (O-ring) takes the play out of the threaded connection as taught by Giersch, therefore ensuring that the anchor sleeve and the anchor pin are correctly threaded into each other for accurate deploying of the bodies of the anchor sleeve, and to secure the anchor sleeve and the anchor pin relative to each other in the relatively deployed position.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Graser in view of Lopez and Kuster (hereinafter, “Graser/Lopez/Kuster”), as applied to claims 1, 3, 7, 8, 13-15, 17, 18, and 23 above, and further in view of U.S. Patent No. US 10,145,648 to Holder et al. (hereinafter, “Holder”).
Graser/Lopez/Kuster are silent as to wherein the long hole is stadium-shaped and defined by a pair of parallel straight sides extending laterally relative to a longitudinal direction of the respective one of the plurality of the incised portions and arcuate end portions connecting the pair of parallel straight sides.
Holder teaches an incised portion (58) having an enlarged range enlarging hole (62) defined on an end thereof (col. 3 / lines 52-53), FIG. 7; wherein the enlarged range enlarging hole is a long hole extending laterally from the incised portion (since the enlarged range enlarging hole is wider than and extends to the lateral sides of the incised portion); wherein the long hole is stadium-shaped, FIG. 7, and defined by a pair of parallel straight sides extending laterally relative to a longitudinal direction of the incised portion (the parallel straight sides extend laterally of and along the longitudinal direction of the incised portion) and arcuate end portions connecting the pair of parallel straight sides, FIG. 7.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the shape of the enlarged range enlarging holes in Graser/Lopez/Kuster a long hole that is stadium-shaped, as taught by Holder, since this would provide further stress relief in the area and allow for greater flexing of the plurality of bodies in Graser/Lopez/Kuster.
Claims 1, 4, 5, 11, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2008/0234682 to Park in view of Lopez and U.S. Patent No. US 6,322,895 to Canham.
As to claim 1, Park discloses an anchor, FIGS. 5C-5D, for cortical bone comprising: an anchor sleeve (46 and 73s) having a header (73s) located on a lower end portion thereof, a diameter of the header (outer diameter at distal end portions of 73s) being smaller than a diameter of a rest of the anchor sleeve (the diameter at the distal end portions of the header is smaller than any other outer diameter of a rest of the anchor sleeve, where the anchor sleeve includes the header) to define an underside of the anchor sleeve (downward facing surfaces of 73s in the position of FIG. 5C, where the anchor sleeve includes the header and thus the underside of the header is the underside of the anchor sleeve), the header configured to be inserted into the cortical bone (par. [0039]), enlarged by an external force, FIG. 5D, and fixed to the cortical bone (in the enlarged configuration, the anchor is fixed to the cortical bone because its backout is prevented); and an anchor pin (70 and 36) inserted into the anchor sleeve configured to transmit the external force for enlarging the header when the anchor pin is pushed, FIGS. 5C-5D, wherein the header of the anchor sleeve has a header body equally divided into a plurality of bodies (73s) by a plurality of incised portions (slits between 73s) configured to enlarge through the external force, FIGS. 5C-5D, wherein the anchor sleeve has a hollow portion configured to receive the anchor pin and extending from a top end portion of the anchor sleeve to a lower end of the header body, the hollow portion at the lower end of the header body having a smaller diameter (in the position of FIG. 5C, the diameter of the narrow gap between 73s) than a pin header (tapered tip) of the anchor pin, wherein the header enlarges when the pin header of the anchor pin is pushed and inserted into the hollow portion in a direction from the top end portion toward the lower end portion of the anchor sleeve, FIGS. 5C-5D, wherein the anchor pin comprises a pin body inserted into the anchor sleeve, a top end portion (36) of the pin body configured to protrude from the top end portion of the anchor sleeve (at least during assembly, before full seating of the pin body in the anchor sleeve, the top end portion of 70 also protrudes as in FIG. 5C, and/or if the pin body is backed out from the anchor sleeve), and the pin header located on a lower end of the pin body, the pin header having a larger area than the hollow portion at the lower end of the header body (the pin header has a larger area across it than the hollow portion at the narrow gap between 73s), FIG. 5C, a groove (groove formed proximal to ends 75) formed on the header of the anchor sleeve, FIG. 5C.
As to claim 4, Park discloses the anchor according to claim 1, wherein the hollow portion has a first inner diameter (in the position of FIG. 5C, the diameter of the wider gap between 73s where they connect to 46) greater than the diameter at the lower end of the header body (in the position of FIG. 5C, the diameter of the narrow gap between 73s), the pin header has a slant surface (slanted surface of the tapered tip) on a peripheral surface, wherein the slant surface is tapered in a longitudinal direction of the pin header and a slant angle (angle between a vertical axis along the outer edge of a proximal end of the anchor pin and the slant surface of the pin header) of the slant surface of the pin header is smaller than a slant angle (angle between the vertical axis and the slant surface of 73 against which the anchor pin pushes) of a slant surface of the anchor sleeve, and wherein the slant surface of the pin header is configured to move along the slant surface of the anchor sleeve to enlarge the header, FIGS. 5C-5D.
As to claim 5, Park discloses the anchor according to claim 4, wherein the slant angle of the slant surface of the anchor sleeve is different from the slant angle of the slant surface of the pin header (the pin header is more acutely angled), FIG. 5C, wherein a length of the anchor pin or the header is adjusted to control an enlarged range of the header (at least during manufacture, the lengths of the pin and header are adjusted to control the enlarged range/to obtain desired enlarging; in addition or alternatively, the inserted length of the anchor pin into the header is adjusted to gradually enlarge the header or to stop the enlargement when insertion is stopped).
As to claim 11, Park discloses wherein the anchor pin (where the anchor pin includes the attached driver 36, shown in another embodiment in FIGS. 3A-3B) has a length greater than a length of the anchor sleeve and the top end portion (handle end of 36) of the pin body opposite the pin header protrudes from the top end portion of the anchor sleeve opposite the lower end portion when the pin header is located at the lower end of the header body.
As to claim 19, Park discloses the anchor according to claim 4, wherein the slant surface of the hollow portion is defined on an inner peripheral surface at a lower end of the header body (the slant surface of the hollow portion is at least partially at a lower end of the header body, where the lower end of the header body includes a distal portion of the slant surface and below), the slant surface of the pin header is defined on an outer peripheral surface of the pin header, FIG. 5C, and the slant angle of the slant surface of the pin header and the slant angle of the slant surface of the hollow portion are measured with respect to a longitudinal axis of the header body (since a longitudinal axis of the header body, which can comprise various axes along a length of the header body, is parallel to or coincident with the vertical axis, measuring the slant angles with respect to the vertical axis or a longitudinal axis of the header body would result in the same angles).
Park is silent as to wherein the header has a patterned friction protrusion on at least a portion of an outer peripheral surface thereof, the patterned friction protrusion having a dot pattern to increase fixing force with the cortical bone by generating shear force when the header is enlarged by the anchor pin.
Lopez teaches a bone anchor, FIG. 21, comprising a patterned friction protrusion on at least a portion of an outer peripheral surface thereof, the patterned friction protrusion having at least one dot pattern (199) (par. [0141]).
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 Graser’s header with a patterned friction protrusion having and created by a dot pattern in the outer surface, as taught by Lopez, to increase friction between the header and adjacent tissue and/or bone to reduce the possibility of backout of the anchor. The dot pattern is fully capable of increasing fixing force with the cortical bone (interpreted as language of intended use) because it would promote bone ingrowth when adjacent to bone, and generates shear force when the header is enlarged by the anchor pin since the dots project from the outer surface.
Park is silent as to a shock absorber is fitted to a groove formed on the header contacting the underside of the anchor sleeve, wherein an outer peripheral surface of the shock absorber has the same diameter as the anchor sleeve to prevent damages to the cortical bone caused by friction with the underside of the anchor sleeve.
Canham teaches coating surgical implants with a layer of polysilicon to improve adhesion with bone (col. 14 / lines 8-15).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to coat an outer peripheral surface of the anchor sleeve including the header in Park with a layer of polysilicon to improve adhesion with bone, as taught by Canham, to promote stability of the implanted device. The layer of polysilicon, being a coating on the outer surface of the anchor sleeve including the header, would thus be fitted to the groove formed on the header in Park which is located on the lower end portion of the anchor sleeve, and is a shock absorber because it is fully capable of absorbing a shock transmitted from the anchor to the bone because of its location between the anchor and the bone. The thickness of the layer of polysilicon would absorb or dampen a shock from the anchor since it is a piece of intervening material. The layer of polysilicon also contacts the underside of the anchor sleeve, which includes downward facing surfaces of the header, and thus the layer of polysilicon which is a coating on the outer surface of the entire device would contact the underside portion of the device by being coated over it. In the position of FIG. 5C, the header (where the anchor sleeve comprises the header) has angled distally tapering sides. Since the shock absorber is a layer on the outer surface of the anchor sleeve/header, it has a slightly greater diameter at its outer peripheral surface than the adjacent outer peripheral surface of the underlying anchor sleeve. Then, an outer peripheral surface of the shock absorber at a particular longitudinal location in FIG. 5C, has the same diameter as an outer peripheral surface of the anchor sleeve at a location proximal to where the diameter of the outer peripheral surface of the shock absorber is taken, due to the angle of the outer peripheral surface of the bodies of the header body which distally taper and since the shock absorber is layered on the outer surface of the anchor sleeve/header. The shock absorber is fully capable of preventing damages to the cortical bone caused by friction with the underside of the anchor sleeve since it is a coating on the anchor sleeve that would reduce friction with the bone (interpreted as language of intended use).
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 8,257,389 to Chanduszko et al. (hereinafter, “Chanduszko”), in view of Lopez.
As to claim 1, Chanduszko discloses an anchor for cortical bone (interpreted as language of intended use; fully capable of insertion into any tissue including bone), FIGS. 6a-6b, comprising: an anchor sleeve (proximal expanding arms) having a header (108, 110, and distal expanding arms) located on a lower end portion thereof, a diameter of the header (at 108) being smaller than a diameter of a rest (proximal expanding arms, in the position of FIG. 6a) of the anchor sleeve to define an underside of the anchor sleeve (distal facing surfaces of the proximal expanding arms, in the position of FIG. 6a), the header configured to be inserted into the cortical bone, enlarged by an external force (col. 5 / lines 45-62), and fixed to the cortical bone (interpreted as language of intended use); and an anchor pin (124) inserted into the anchor sleeve configured to transmit the external force for enlarging the header when the anchor pin is pushed, FIGS. 6a-6b, wherein the header of the anchor sleeve has a header body equally divided into a plurality of bodies (expanding arms) by a plurality of incised portions (spaces between the arms) configured to enlarge (radially) through the external force, FIG. 6b, wherein the anchor sleeve has a hollow portion configured to receive the anchor pin and extending from a top end portion of the anchor sleeve to a lower end of the header body, FIG. 6a, the hollow portion at the lower end of the header body having a smaller diameter (diameter taken across the hollow portion between crests of internal threads in 110) than a pin header (diameter taken at crests of external thread on 124) of the anchor pin, wherein the header enlarges (radially at expanding arms) when the pin header of the anchor pin is pushed and inserted into the hollow portion in a direction from the top end portion toward the lower end portion of the anchor sleeve, FIG. 6b, wherein the anchor pin comprises a pin body inserted into the anchor sleeve, a top end portion of the pin body configured to protrude from the top end portion of the anchor sleeve, FIG. 6b, and the pin header located on a lower end of the pin body, the pin header having a larger area (taken across the end of 124 at the crests of external thread on 124) than the hollow portion (area between crests of internal threads of 110) at the lower end of the header body, wherein a shock absorber (coating, col. 17 / lines 15-18; fully capable of acting as a shock absorber since it is located between the anchor sleeve and any adjacent tissue) is fitted to a groove (around 108, which is a groove relative to the expanding arms; the shock absorber/coating is fitted to the groove because it coats the entire device including the recess/groove at 108 between the proximal and distal expanding arms) formed on the header contacting the underside of the anchor sleeve (the shock absorber contacts the underside of the anchor sleeve at the distal facing surfaces of the proximal expanding arms because it coats the entire device), wherein an outer peripheral surface of the shock absorber has the same diameter as the anchor sleeve (because the shock absorber is a coating on top of the anchor sleeve which includes the header, and because the expanding arms are angled, the diameter of the outer peripheral surface of the shock absorber is the same as the diameter of the outer peripheral surface of the anchor sleeve at a different longitudinal location) to prevent damages to the cortical bone caused by friction with the underside of the anchor sleeve (interpreted as language of intended use; fully capable of preventing damage to any adjacent tissue including bone since the shock absorber is a coating between the anchor sleeve including the underside, and the tissue).
As to claim 6, Chanduszko discloses the anchor according to claim 1, wherein the header is detachably attached to the rest of the anchor sleeve by a screw thread coupling (threads on 124 and 110; the screw thread coupling detachably attaches the header at 110 and the anchor sleeve at the proximal expanding arms in a compressed position of FIG. 6b) and configured to be replaced (interpreted as language of intended use; the whole device is fully capable of being replaced).
Chanduszko is silent as to wherein the header has a patterned friction protrusion on at least a portion of an outer peripheral surface thereof, the patterned friction protrusion having a dot pattern to increase fixing force with the cortical bone by generating shear force when the header is enlarged by the anchor pin.
Lopez teaches a bone anchor, FIG. 21, comprising a patterned friction protrusion on at least a portion of an outer peripheral surface thereof, the patterned friction protrusion having at least one dot pattern (199) (par. [0141]).
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 Chanduszko’s expanding arms of the header with a patterned friction protrusion having and created by a dot pattern in the outer surface, as taught by Lopez, to increase catching power of the expanding arms. The dot pattern increases fixing force with any tissue to which it is adjacent (interpreted as language of intended use) by generating shear force when the header is enlarged by the anchor pin since the dots project from the outer surface.
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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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
