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 04 November 2025. As directed by the amendment: claims 1, 3-8, and 10 have been amended, claims 2 and 9 are cancelled, and claims 11-15 have been newly added. Claims 1, 3-8, and 10-15 currently stand pending in the application.
The amendments to the abstract are sufficient to overcome the previous specification objection, which is accordingly withdrawn.
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 not sufficient to overcome the previous rejections under 35 U.S.C. 112(b), which are repeated below in relevant part.
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.
Claim Objections
Claims 3, 7, 8, 10, and 13-15 are objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 3 / lines 1-2: “each of the plurality of the incised portions has”
Claim 7 / lines 1-2: “a first
Claim 7 / line 4: “a second
Claim 7 / line 8: “the first
Claim 8 / line 2: “[[an]] the outer peripheral surface”
Claim 10 / lines 2-3: “the second
Claim 10 / line 5: “the second
Claim 10 / line 6: “the second
Claim 13 / lines 1-2: “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.”
Claim 14 / lines 1-2: “wherein each of the enlarged range enlarging holes is a long hole extending laterally from a respective one of the plurality of the incised portions.”
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 12 and 15 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 12, the limitation that the header has a friction improving screw thread is not supported by the specification as originally filed, because the specification does not recite that the header can have both a friction improving screw thread as recited in claim 12, and a patterned friction protrusion having at least one pattern of a vertical line and horizontal line lattice pattern, a diagonal line lattice pattern, a dot pattern, and a wavy line and straight-line mixing pattern as recited in claim 1.
As to claim 15, the limitation that the shock absorber is made of at least one material selected from rubber or silicon is not supported by the specification as originally filed. Firstly, the specification recites “silicone” and not “silicon.” Further, the specification does not recite that the shock absorber is made of at least one material selected from rubber or silicon, but rather recites that the shock absorber is made of rubber or silicone (not at least one of them, which allows for the possibility of both).
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 4 and 5 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 4, the limitation “the slant surface of the anchor sleeve” (lines 7-8) renders the claims indefinite because it lacks proper antecedent support in the claims. For examination purposes, the limitation will be interpreted as, and amendment is suggested to, “a slant surface of the anchor sleeve”.
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, 13, and 14 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 No. 2,857,670 to Kiernan, Jr. (hereinafter, “Kiernan”).
As to claim 1, Graser discloses an anchor for cortical bone comprising: an anchor sleeve (12) having a header (14) located on a proximal end portion 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 toward the cortical bone (par. [0028]), FIG. 2B, wherein the header of the anchor sleeve has a header body (14) proportionally divided into a plurality of bodies (28) with 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, the hollow portion at a proximal end of the header having a smaller diameter (in the position of FIG. 2B, the diameter of the narrow gap between 28s) than the anchor pin wherein the header enlarges when a pin header (tapered tip of 30) of the anchor pin is inserted into the hollow portion at the proximal end of the header.
As to claim 3, Graser discloses the anchor according to claim 1, wherein each of the plurality of the incised portions have 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 mechanism fastener (22a-22b) located on top 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) (par. [0026]), FIG. 1; and a second mechanism fastener (threaded end of 30 including 20) located on top of the anchor pin 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) (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 mechanism fastener (interpreted as language of intended use).
As to claim 13, Graser discloses the anchor according to claim 3, wherein the enlarged range enlarging hole is a circular hole having a larger diameter than the incised portion, FIG. 2B.
As to claim 14, Graser discloses the anchor according to claim 3, wherein the enlarged range enlarging hole is a long hole (because it is longer about a circumferential direction than a width of the incised portion) extending laterally from the incised portion, FIG. 2B.
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 at least one pattern of a vertical line and horizontal line lattice pattern, a diagonal line lattice pattern, a dot pattern, and a wavy line and straight-line mixing pattern.
Kiernan teaches an anchor for cortical bone comprising: an anchor sleeve (44) having a header (14 and 36s) located on a proximal end portion configured to be inserted into the cortical bone, enlarged by an external force (at 36s), and fixed to the cortical bone (col. 2 / lines 54-64); and an anchor pin (20) inserted into the anchor sleeve, FIGS. 7 and 10, configured to transmit the external force for enlarging the header when the anchor pin is pushed toward the cortical bone, wherein the header (at 14) has a patterned friction protrusion (protrusions between and created by grooves 30 and 32) on at least a portion of an outer peripheral surface thereof, FIG. 10, the patterned friction protrusion having at least one pattern of a vertical line and horizontal line lattice pattern (col. 2 / lines 35-38; the patterned friction protrusion has vertical and horizontal line lattice pattern within it), FIG. 10, a diagonal line lattice pattern, a dot pattern, and a wavy line and straight-line mixing pattern.
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 vertical and horizontal line lattice pattern in the outer surface of the header, to promote bone ingrowth and therefore result in strong anchoring of the anchor in the bone, as taught by Kiernan.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Graser in view of Kiernan (hereinafter, “Graser/Kiernan”), as applied to claims 1, 3, 7, 13, and 14 above, and further in view of U.S. Patent No. US 8,685,034 to Giersch et al. (hereinafter, “Giersch”).
Graser/Kiernan 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 mechanism 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 mechanism fastener to be connected to each other wherein the anchor sleeve and the second mechanism 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/Kiernan 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 mechanism fastener) to allow the anchor sleeve and the second mechanism fastener to be connected to each other wherein the anchor sleeve and the second mechanism 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.
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Graser in view of Kiernan (hereinafter, “Graser/Kiernan”), as applied to claims 1, 3, 7, 13, and 14 above, and further in view of U.S. Patent No. US 6,322,895 to Canham.
Graser/Kiernan are silent as to further comprising a shock absorber located on an outer peripheral surface of the header configured to be between the anchor sleeve and the cortical bone, 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 at least one material selected from rubber or silicon (claim 15).
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 and header in Graser/Kiernan 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 and 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 polysilicon would absorb or dampen a shock from the anchor sleeve since it is a piece of intervening material. The shock absorber would thus be made of silicon (polysilicon is a polycrystalline, highly purified form of silicon).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Graser/Kiernan, as applied to claims 1, 3, 7, 13, and 14 above, and further in view of U.S. Patent No. US 9,463,012 to Bonutti et al. (hereinafter, “Bonutti”).
Graser/Kiernan are silent as to wherein the header has a friction improving screw thread defined on at least a portion of the outer peripheral surface thereof, the friction improving screw thread comprising a helical thread.
Bonutti teaches that friction means on an outer surface of a tubular member may include friction improving screw thread (col. 24 / lines 3-6), where a thread around a tubular member is a helical thread.
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/Kiernan a friction improving helical screw thread, since as taught by Bonutti, an outer peripheral surface of a tubular member such as the header in Graser may include friction improving screw thread comprising a helical thread, to promote bone ingrowth and therefore result in strong anchoring of the anchor in the bone, avoiding undesirable backout.
Claims 1, 4-6, and 11 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 Kiernan.
As to claim 1, Park discloses an anchor, FIGS. 5C-5D, for cortical bone comprising: an anchor sleeve (46) having a header (73s) located on a proximal end portion 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 toward the cortical bone, FIGS. 5C-5D, wherein the header of the anchor sleeve has a header body proportionally divided into a plurality of bodies (73s) with 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, the hollow portion at a proximal end of the header having a smaller diameter (in the position of FIG. 5C, the diameter of the narrow gap between 73s) than the anchor pin wherein the header enlarges when a pin header (tapered tip) of the anchor pin is inserted into the hollow portion at the proximal end of the header.
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 proximal end of the header (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 the 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 6, Park discloses the anchor according to claim 1, wherein the header is detachably attached to the anchor sleeve (using sutures 60 through a tab-and-notch arrangement, FIGS. 4A-4B, par. [0039]) and configured to be replaced (interpreted as language of intended use; any apparatus or portion of the apparatus is capable of being replaced).
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 an end portion (handle end of 36) of the anchor pin opposite the pin header protrudes from an end of the anchor sleeve opposite the proximal end portion when the pin header is located at the proximal end of the header
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 at least one pattern of a vertical line and horizontal line lattice pattern, a diagonal line lattice pattern, a dot pattern, and a wavy line and straight-line mixing pattern.
Kiernan teaches an anchor for cortical bone comprising: an anchor sleeve (44) having a header (14 and 36s) located on a proximal end portion configured to be inserted into the cortical bone, enlarged by an external force (at 36s), and fixed to the cortical bone (col. 2 / lines 54-64); and an anchor pin (20) inserted into the anchor sleeve, FIGS. 7 and 10, configured to transmit the external force for enlarging the header when the anchor pin is pushed toward the cortical bone, wherein the header (at 14) has a patterned friction protrusion (protrusions between and created by grooves 30 and 32) on at least a portion of an outer peripheral surface thereof, FIG. 10, the patterned friction protrusion having at least one pattern of a vertical line and horizontal line lattice pattern (col. 2 / lines 35-38; the patterned friction protrusion has vertical and horizontal line lattice pattern within it), FIG. 10, a diagonal line lattice pattern, a dot pattern, and a wavy line and straight-line mixing pattern.
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 Park’s header with a patterned friction protrusion having and created by a vertical and horizontal line lattice pattern in the outer surface of the header, to promote bone ingrowth and therefore result in strong anchoring of the anchor in the bone, as taught by Kiernan and as required by Park.
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