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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 January 2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 20 January 2026. As directed by the amendment: claims 1, 6, 11, 12, 15, 16, and 19 have been amended, claims 2, 13, 17, and 18 are cancelled, and claims 20-26 are newly added. Claims 1, 3-12, 14-16, and 19-26 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the claim objections presented in the previous Office Action, which are correspondingly withdrawn. Further claim objections as necessitated by the claim amendments are presented below.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(b) and 112(d) listed in the previous action, which are correspondingly withdrawn. Further rejections under 35 U.S.C. 112(b) as necessitated by the claim amendments are presented below.
Response to Arguments
Applicant’s arguments, see pages 9-10 of the arguments, filed 20 January 2026, with respect to the drawing objections, have been fully considered and are persuasive. The drawing objections have been withdrawn.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(1)/(2) and 103 have been considered but are moot because the new ground of rejection does not rely on any interpretation of the references or combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Of particular note as to Kirschman et al. (US 8,945,193), Applicant contends that Kirschman does not teach any fenestrations that have a circumferential width smaller than the axial length nor fenestrations having a circumferential width decreasing continuously in a proximal direction. Examiner respectfully submits that in FIG. 20B of Kirschman, the triangle shaped fenestrations have a circumferential width, taken at a proximal tip of the triangle, that is smaller than the axial length. The triangle shaped fenestrations have a circumferential width that decreases continuously in a proximal direction from a maximum width at the bottom of the triangle to a minimum width at the proximal tip of the triangle.
Applicant contends that Kirschman does not teach a plurality of such fenestrations having a circumferential width decreasing continuously in a proximal direction arranged at a same first distance from the proximal end of the shaft. 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). Aeschlimann et al. (US 9,724,206) discloses the plurality of lateral channels being arranged at a same first distance from the proximal end of the shaft. Kirschman is relied upon to modify the shape of the lateral channels, not their positioning.
Applicant contends that Kirschman does not contain any teaching that the shape would be beneficial. Examiner respectfully submits that Kirschman teaches lateral channels for allowing material extrusion therethrough can be any desired shape such as a triangle. A triangle shape is one of many possible shapes that one would look to for creating channels through a bone anchor for allowing material extrusion therethrough, as also required by Aeschlimann. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant’s arguments with respect to Shevgoor et al. (US 9,399,112) have been considered but are moot because the new ground of rejection does not rely Shevgoor for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 11, 12, and 20-26 are objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 20 / lines 7-8: “extending in [[the]] a direction of the axis”
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.
Claim 15 is 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 15, the limitations that the at least one locking element protrudes from a general level of a surface portion of the at least one through opening (of the implant), and the at least one locking element being an integral part of the bone anchor and constituting a part of a bulk of the bone anchor, are not supported by the specification as originally filed. Although the specification recites that the locking element may protrude from a surface portion of the bone anchor or the through opening, these are listed as alternatives. If the locking element protrudes from a surface portion of the through opening, it is not integral to the bone anchor or constituting part of the bulk of the bone anchor.
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 11, 12, 15, and 19-26 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 15, the limitations “said surface portion” (lines 7-8 and 8-9) render the claim indefinite, because it is unclear if this refers to the previously recited surface portion of the bone anchor or surface portion of the at least one through opening. For examination purposes, the limitations will be interpreted as said surface portion of the bone anchor. Examiner notes that amendment to overcome the above rejection under 35 U.S.C. 112(a), e.g. deletion of the phrase “or from a general level of a surface portion of the at least one through opening”, may render moot this rejection under 35 U.S.C. 112(b).
As to claim 19, the limitation “the distal direction” renders the claim indefinite because it lacks proper antecedent basis in the claims. For examination purposes, the limitation will be interpreted as a distal direction.
As to claim 20, the limitation “the plurality of lateral channels” (line 12) renders the claims indefinite because it lacks proper antecedent basis in the claims. Amendment is suggested to “the at least one lateral channel”. Corresponding amendments would be required on claim 20 / line 14, claim 11 / line 2, claim 12 / lines 2-3, claim 21 / line 4, claim 22 / line 2, claim 23 / line 1, claim 24 / lines 1-2, claim 25 / line 2, claim 26 / line 2.
Further as to claim 20, it is unclear how at least one lateral channel (see above rejection of claim 20 under 35 U.S.C. 112(b)) can be arranged at a same first distance from the proximal end of the shaft (lines 12-13), since at least one lateral channel allows for the possibility of one lateral channel, making it unclear what the one lateral channel can be arranged at a same first distance as.
Further as to claim 20, the following limitations render the claims indefinite because they lack clarity and their meaning is indecipherable: “wherein the circumferential width at axial positions that correspond to axial positions of a middle region of the lateral channel, the circumferential width decreases continuously in a proximal direction and decreases along at least or of the axial length of the lateral channel” (lines 15-18). The first phrase “wherein the circumferential width at axial positions that correspond to axial positions of a middle region of the lateral channel” appears incomplete. The last phrase “decreases along at least or of the axial length of the lateral channel” is indefinite because it is unclear how the width can decrease along at least the axial length which implies that it could decrease more than the axial length, but the width is only measured along the axial length. It is unclear how the width can decrease “of the axial length”. Examiner notes that the width does not decrease continuously in a proximal direction along the entire axial length of the lateral channel, since there is a distal portion in which the width increases in a proximal direction to the maximum width.
As to claim 21, the limitation “the material” (lines 3-4) renders the claim indefinite because it lacks proper antecedent basis in the claims. For examination purposes, the limitation will be interpreted as “the liquefied thermoplastic element”.
Further as to claim 21, the limitation “to direct different portions of the material to the different ones of the lateral channels” is indefinite because, in view of the above recommended amendment to “the at least one lateral channel”, it is unclear how different portions of the liquefied thermoplastic element can be directed to different ones of the at least one lateral channel, when at least one lateral channel may include one lateral channel so that different portions cannot be directed to different ones of one channel. The phrase “the different ones” also lacks proper antecedent basis in the claims. For examination purposes, the limitation will be interpreted as the at least one lateral channel comprises a plurality of lateral channels, and wherein the cavity distal end is angularly structured so as to direct different portions of the liquefied thermoplastic element to different ones of the plurality of lateral channels.
As to claim 24, the limitation “the distal direction” renders the claim indefinite because it lacks proper antecedent basis in the claims. For examination purposes, the limitation will be interpreted as a distal direction.
As to claim 25, in view of the above recommended amendment to “the at least one lateral channel”, which allows for one lateral channel, it is unclear how one lateral channel can be arranged regularly spaced from each other. For examination purposes, the limitation will be interpreted as the at least one lateral channel comprises a plurality of lateral channels, and all lateral channels of the plurality of lateral channels are arranged regularly spaced from each other around the circumferential surface.
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, and 6-10 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by, or in the alternative, under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 8,974,506 to Wenger et al. (hereinafter, “Wenger”).
As to claim 1, Wenger discloses a kit of parts of a fenestrated bone anchor (11 and 18), FIGS. 6-7, together with a thermoplastic element (21) (not shown in FIGS. 6-7 but shown for exemplary purposes in FIGS. 1a and 2) (col. 9 / lines 36-50), the bone anchor being configured for being anchored in live bone tissue of a human or animal patient, wherein the bone anchor comprises a shaft with a proximal end, a distal end, a longitudinal axis and a circumferential surface extending from the proximal end to the distal end, FIG. 6, wherein the shaft further comprises a longitudinal cavity (13 proximal to 18) extending in a direction of the longitudinal axis from the proximal end towards the distal end and a plurality of lateral channels (14) extending through a wall of the shaft from the longitudinal cavity to the circumferential surface (col. 9 / lines 27-30), the wall having a wall thickness, FIG. 6, the plurality of lateral channels being arranged at a same first distance from the proximal end of the shaft, FIG. 6, the plurality of lateral channels having a cross section with an axial length and a width smaller than the axial length, shown for exemplary purposes in FIG. 3, wherein said wall thickness increases gradually in a circumferential direction towards the plurality of lateral channels (the wall thickness includes the thickness/height of the thread that extends around the bone anchor at the location where the wall thickness is measured; the wall thickness increases gradually in a circumferential direction towards each of the channels, since thickness measured in a circumferential direction at a longitudinal location of the lateral channels would increase from a lesser thickness at a point about a circumference at the root of the thread, and a greater thickness at the crest of the thread, with the crest seen in FIG. 6 at/adjacent the lateral channel), and wherein the thermoplastic element has a shape adapted to be inserted into the longitudinal cavity from the proximal end (col. 9 / lines 36-39), the thermoplastic element being capable of being liquefied by being pressed against a distal end (at 18) of the longitudinal cavity while energy is coupled into the thermoplastic element (col. 9 / lines 40-46, col. 12 / lines 6-10).
As to claim 3, Wenger discloses the kit of parts according to claim 1, wherein all of the plurality of lateral channels are regularly spaced from each other around the circumferential surface (col. 9 / lines 28-30).
As to claim 6, Wenger discloses the kit of parts according to claim 1, wherein a cross section of the bone anchor or of the longitudinal cavity taken through at least one of the plurality of lateral channels has a lobed form (a cross section of the longitudinal cavity has a lobed form internally due to separation into lobes by 15s).
As to claim 7, Wenger discloses the kit of parts according to claim 6, wherein in a proximal direction away from the plurality of lateral channels the lobed form of the cross section of the bone anchor gradually transitions to a circular form (as the 15s taper off proximally to leave only the circular form of the longitudinal cavity).
As to claim 8, Wenger discloses the kit of parts according to claim 1, said bone anchor further comprising a head (11.3), shown for exemplary purposes in FIG. 3, and being configured to fixate a bone plate relative to bone tissue (interpreted as language of intended use; the bone anchor with head is fully capable of fixating a bone plate if inserted through a through opening of the bone plate), wherein the bone plate comprises a through opening adapted to the bone anchor (interpreted as language of intended use).
As to claim 9, Wenger discloses the kit of parts according to claim 1, said bone anchor further comprising retention structures (11.4) arranged on the circumferential surface of the shaft (col. 12 / lines 1-2), FIG. 6.
As to claim 10, Wenger discloses the kit of parts according to claim 9, wherein the retention structures comprise at least one of a thread (11.4) (col. 12 / lines 1-2), FIG. 6, circumferential ribs, sharp edges, teeth, surface roughness, undercut surface structures and an osseointegration enhancing surface coating.
Assuming arguendo, Wenger is silent as to the plurality of lateral channels having a cross section with an axial length and a width smaller than the axial length.
In FIG. 3, Wenger shows a plurality of lateral channels (14) having a cross section with an axial length and a width smaller than the axial length.
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 lateral channels in the shape as shown in FIG. 3 of Wenger, since Wenger discloses that this is an appropriate shape for the channels to allow liquefied material to be pressed out.
Claims 1, 3-5, 8, 11, 12, 20-23, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 9,724,206 to Aeschlimann et al. (hereinafter, “Aeschlimann”) in view of U.S. Patent No. US 8,945,193 to Kirschman et al. (hereinafter, “Kirschman”).
As to claim 1, Aeschlimann discloses a kit of parts of a fenestrated bone anchor (1.1) together with a thermoplastic element (1.2) (col. 2 / lines 11-14, col. 12 / lines 56-66), FIG. 11, the bone anchor being configured for being anchored in live bone tissue of a human or animal patient, wherein the bone anchor comprises a shaft with a proximal end, a distal end, a longitudinal axis and a circumferential surface extending from the proximal end to the distal end, FIG. 11, wherein the shaft further comprises a longitudinal cavity extending in a direction of the longitudinal axis from the proximal end towards the distal end, FIG. 11, and a plurality of lateral channels (proximal-most set of channels) extending through a wall of the shaft from the longitudinal cavity to the circumferential surface, FIG. 11, the wall having a wall thickness, the plurality of lateral channels being arranged at a same first distance from the proximal end of the shaft (the first distance is between the proximal-most set of channels and the proximal end of the shaft), and wherein the thermoplastic element has a shape adapted to be inserted into the longitudinal cavity from the proximal end, FIG. 11, the thermoplastic element being capable of being liquefied by being pressed against a distal end of the longitudinal cavity while energy is coupled into the thermoplastic element (col. 12 / lines 56-66).
As to claim 3, Aeschlimann discloses the kit of parts according to claim 1, wherein all of the plurality of lateral channels are regularly spaced from each other around the circumferential surface, FIG. 11.
As to claim 4, Aeschlimann discloses the kit of parts according to claim 1, wherein the first distance is smaller than a second distance between all of the plurality of lateral channels and the distal end of the shaft (the second distance is between the proximal-most set of channels and the distal end of the shaft), FIG. 11.
As to claim 5, Aeschlimann discloses the kit of parts according to claim 1, wherein the first distance is smaller than about one half of a total axial length of the shaft, FIG. 11.
As to claim 8, Aeschlimann discloses the kit of parts according to claim 1, said bone anchor further comprising a head (2) and being configured to fixate a bone plate relative to bone tissue (interpreted as language of intended use; the bone anchor is fully capable of fixating a bone plate if the head is inserted through a through opening of the bone plate), wherein the bone plate comprises a through opening adapted to the bone anchor.
Aeschlimann is silent as to the plurality of lateral channels having a cross section with an axial length and a width smaller than the axial length (claim 1).
Kirschman teaches a fenestrated bone anchor comprises a shaft comprising a longitudinal cavity and a plurality of lateral channels (154) extending through a wall of the shaft from the longitudinal cavity to a circumferential surface of the shaft, where the lateral channels can be any desired shape such as a triangle as shown in FIG. 20B (col. 12 / lines 1-4). Such a triangle shape has a cross section with an axial length and a width (taken at a proximal tip of the triangle) smaller than the axial length, and wherein said width increases in a distal direction, FIG. 20B.
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 Aeschlimann’s lateral channels with a triangle shape, since Kirschman teaches that lateral channels for allowing material to flow from inside the longitudinal cavity of the shaft out to the surrounding bone can take any of a variety of shapes such as a triangle. Aeschlimann’s shaft would then have a plurality of triangular lateral channels, in the positions along the shaft as disclosed by Aeschlimann.
Aeschlimann is silent as to wherein said wall thickness increases gradually in a circumferential direction towards the plurality of lateral channels (claim 1).
Aeschlimann contemplates providing a thread to fix the bone anchor into bone tissue (col. 11 / lines 56-58).
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 bone anchor in Aeschlimann FIG. 11 with an external thread to anchor into bone tissue for secure fixation therein. Then, the wall thickness increases gradually in a circumferential direction towards the plurality of lateral channels because the wall thickness includes the thickness/height of the thread that extends around the bone anchor at the location where the wall thickness is measured; the wall thickness increases gradually in a circumferential direction towards each of the channels, since thickness measured in a circumferential direction at a longitudinal location of the lateral channels would increase from a lesser thickness at a point about a circumference at the root of the thread, and a greater thickness at the crest of the thread.
As to claim 20, Aeschlimann discloses a kit of parts of a fenestrated bone anchor (1.1) together with a thermoplastic element (1.2) (col. 2 / lines 11-14, col. 12 / lines 56-66), FIG. 11, the bone anchor being configured for being anchored in live bone tissue of a human or animal patient, wherein the bone anchor comprises a shaft with a proximal end, a distal end, a longitudinal axis and a circumferential surface extending from the proximal end to the distal end, FIG. 11, wherein the shaft further comprises a longitudinal cavity extending in the direction of the axis from the proximal end towards the distal end and ending in a cavity distal end, FIG. 11, and, proximally of the cavity distal end, at least one lateral channel (proximal-most set of channels) extending through a wall of the shaft from the longitudinal cavity to the circumferential surface, FIG. 11, the plurality of lateral channels being arranged at a same first distance from the proximal end of the shaft (the first distance is between the proximal-most set of channels and the proximal end of the shaft), and wherein the thermoplastic element has a shape adapted to be inserted into the longitudinal cavity from the proximal end, FIG. 11, the thermoplastic element being capable of being liquefied by being pressed against the cavity distal end while energy is coupled into the thermoplastic element (col. 12 / lines 56-66).
As to claim 11, Aeschlimann discloses the kit of parts according to claim 20, wherein at axial positions of the plurality of lateral channels, a stiffness of the anchor against bending increases gradually towards proximally (the stiffness increases gradually in a proximal direction from the lateral channel as the wall becomes more solid).
As to claim 21, Aeschlimann discloses the kit of parts according to claim 20, wherein the cavity distal end has a shape different from circularly symmetrical about the axis (at least as much as the claimed invention; e.g. if the axis is off center, the cavity distal end is not symmetrical about the axis), and wherein the cavity distal end is angularly structured so as to direct different portions of the material to the different ones of the lateral channels, FIG. 11.
As to claim 23, Aeschlimann discloses the kit of parts according to claim 20, wherein the lateral channels (proximal-most set of channels) are situated in a proximal half of the shaft, FIG. 11.
As to claim 25, Aeschlimann discloses the kit of parts according to claim 20, wherein all lateral channels of the plurality of the lateral channels are arranged regularly spaced from each other around the circumferential surface, FIG. 11.
As to claim 26, Aeschlimann discloses the kit of parts according to claim 23, wherein the first distance is smaller than a second distance between all the lateral channels (proximal-most set of channels) and the distal end of the shaft, FIG. 11.
Aeschlimann is silent as to the plurality of lateral channels having a cross section with an axial length and a circumferential width smaller than the axial length and wherein the circumferential width at axial positions that correspond to axial positions of a middle region of the lateral channel, the circumferential width decreases continuously in a proximal direction and decreases along at least or of the axial length of the lateral channel, whereby an average circumferential width of a proximal half of the lateral channel is substantially smaller than an average circumferential width of a distal half of the lateral channel (claim 20); wherein across a substantial portion of an axial extension of the plurality of lateral channels, a polar second moment of area of the bone anchor gradually increases towards proximally (claim 12).
Kirschman teaches a fenestrated bone anchor comprises a shaft comprising a longitudinal cavity and a plurality of lateral channels (154) extending through a wall of the shaft from the longitudinal cavity to a circumferential surface of the shaft, where the lateral channels can be any desired shape such as a triangle as shown in FIG. 20B (col. 12 / lines 1-4). Such a triangle shape has a cross section with an axial length and a width (taken at a proximal tip of the triangle) smaller than the axial length, and wherein said width increases in a distal direction, FIG. 20B. As best understood, Kirschman thus teaches wherein the circumferential width at axial positions that correspond to axial positions of a middle region of the lateral channel, the circumferential width decreases continuously in a proximal direction and decreases along at least or of the axial length of the lateral channel, whereby an average circumferential width of a proximal half of the lateral channel is substantially smaller than an average circumferential width of a distal half of the lateral channel, all due to the triangle shape. At axial positions of the plurality of lateral channels, a stiffness of the anchor against bending increases gradually towards proximally, because the stiffness increases gradually in a proximal direction from the lateral channel as the proximal end of the triangle shape lateral channel decreases in width and thus the wall becomes more solid and thus stiffer than the shaft wall perforated by the lateral channel. Across a substantial portion of an axial extension of the plurality of lateral channels, a polar second moment of area of the bone anchor gradually increases towards proximally, since the area of the lateral channel decreases in the proximal direction.
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 Aeschlimann’s lateral channels with a triangle shape, since Kirschman teaches that lateral channels for allowing material to flow from inside the longitudinal cavity of the shaft out to the surrounding bone can take any of a variety of shapes such as a triangle. Aeschlimann’s shaft would then have a plurality of triangular lateral channels, in the positions along the shaft as disclosed by Aeschlimann.
As to claim 22, Aeschlimann discloses the kit of parts according to claim 20, wherein the bone anchor has a distal part distally of the lateral channels (proximal-most set of channels) and of the cavity distal end.
Aeschlimann is silent as to the distal part having circumferential retention structures for retaining the bone anchor in bone tissue (claim 22).
Aeschlimann contemplates providing a thread to fix the bone anchor into bone tissue (col. 11 / lines 56-58).
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 bone anchor in Aeschlimann FIG. 11 with an external thread (circumferential retention structures) for retaining the bone anchor in bone tissue for secure fixation therein. At least part of the thread would be on the distal part distally of the lateral channels (proximal-most set of channels) and of the cavity distal end, since there is a portion of the circumferential surface distal to those features and on which the thread would be provided for fixation into the bone.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Aeschlimann in view of Kirschman, hereinafter, “Aeschlimann/Kirschman”), as applied to claims 1, 3-5, 8, 11, 12, 20-23, 25, and 26 above, and further in view of U.S. Patent Application Publication No. US 2009/0248163 to King et al. (hereinafter, “King”).
Aeschlimann/Kirschman are silent as to wherein at least one of the plurality of lateral channels is pear-shaped with the width increasing in the distal direction.
King teaches that a channel in a device for allowing flow of material therethrough may comprise a pear-shape (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 modify at least one of the lateral channels to be pear-shaped, since King teaches that this is an appropriate shape for allowing flow of material therethrough. As applied to Aeschlimann/Kirschman, which disclose a triangle shape lateral channel that widens distally, the pear-shape lateral channel taught by King would also have a width increasing in the distal direction. The triangle shape would have rounded corners and sides to achieve the pear shape, which increases ease of manufacture and reduces stress points in the channels, and also allows smooth flow of the liquefied material therethrough.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Aeschlimann in view of Kirschman, hereinafter, “Aeschlimann/Kirschman”), as applied to claims 1, 3-5, 8, 11, 12, 20-23, 25, and 26 above, and further in view of U.S. Patent Application Publication No. US 2009/0248163 to King et al. (hereinafter, “King”).
Aeschlimann/Kirschman disclose at least one of the plurality of lateral channels has the width increasing in the distal direction (modification in view of Kirschman above), but are silent as to the at least one of the plurality of lateral channels is pear-shaped with the width increasing in the distal direction.
King teaches that a channel in a device for allowing flow of material therethrough may comprise a pear-shape (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 modify at least one of the lateral channels to be pear-shaped, since King teaches that this is an appropriate shape for allowing flow of material therethrough. As applied to Aeschlimann/Kirschman, which disclose a triangle shape lateral channel that widens distally, the pear-shape lateral channel taught by King would also have a width increasing in the distal direction. The triangle shape would have rounded corners and sides to achieve the pear shape, which increases ease of manufacture and reduces stress points in the channels, and also allows smooth flow of the liquefied material therethrough.
Claims 1, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 10,206,720 to Laubert et al. (hereinafter, “Laubert”), in view of Wenger.
As to claim 1, Laubert discloses a bone anchor (30) for being anchored in live bone tissue of a human or animal patient (col. 10 / lines 7-24), wherein the bone anchor comprises a shaft with a proximal end, a distal end, a longitudinal axis and a circumferential surface extending from the proximal end to the distal end.
As to claim 14, Laubert discloses a surgical system, FIGS. 12-16, comprising an implant (10a) with at least one through opening (11a-c) defining an opening axis and at least one bone anchor according to claim 1 and being configured to fixate the implant relative to bone tissue of a human or animal patient (col. 10 / lines 7-24), the bone anchor comprising a head and the shaft, the at least one through opening and the bone anchor being adapted to each other for the shaft to be able to pass through the at least one through opening and the head to be retained by a proximal surface of the implant or within the through opening in a final position (col. 11 / lines 19-53), FIGS. 15-16.
As to claim 15, Laubert discloses the system according to claim 14 wherein, for locking the bone anchor in said final position, the system further comprises at least one locking element (48) being moveable between a relaxed position in which it protrudes from a general level of a surface portion of the bone anchor (the locking elements protrude outwardly from a general level of an exterior surface of the anchor at the shaft) or from a general level of a surface portion of the at least one through opening and a resiliently tensioned position in which it protrudes less or not at all from said level (the locking elements are tensioned inwardly) (col. 12 / lines 8-20), wherein the at least one locking element is an integral part of the bone anchor, FIGS. 1-2, constituting a part of said surface portion (exterior surface) and of a bulk of the bone anchor (comprising the thickness of the locking element) situated underneath said surface portion, wherein a void in the surface portion delimits the at least one locking element and further extends underneath the at least one locking element or through said bulk, FIGS. 1-2.
Laubert is silent as to a kit of parts of a fenestrated bone anchor together with a thermoplastic element, wherein the shaft further comprises a longitudinal cavity extending in a direction of the longitudinal axis from the proximal end towards the distal end and a plurality of lateral channels extending through a wall of the shaft from the longitudinal cavity to the circumferential surface, the wall having a wall thickness, the plurality of lateral channels being arranged at a same first distance from the proximal end of the shaft, the plurality of lateral channels having a cross section with an axial length and a width smaller than the axial length, wherein said wall thickness increases gradually in a circumferential direction towards the plurality of lateral channels, and wherein the thermoplastic element has a shape adapted to be inserted into the longitudinal cavity from the proximal end, the thermoplastic element being capable of being liquefied by being pressed against a distal end of the longitudinal cavity while energy is coupled into the thermoplastic element.
Wenger teaches a kit of parts of a fenestrated bone anchor (11 and 18), FIGS. 6-7, together with a thermoplastic element (21) (not shown in FIGS. 6-7 but shown for exemplary purposes in FIGS. 1a and 2) (col. 9 / lines 36-50), the bone anchor being configured for being anchored in live bone tissue of a human or animal patient, wherein the bone anchor comprises a shaft with a proximal end, a distal end, a longitudinal axis and a circumferential surface extending from the proximal end to the distal end, FIG. 6, wherein the shaft further comprises a longitudinal cavity (13 proximal to 18) extending in a direction of the longitudinal axis from the proximal end towards the distal end and a plurality of lateral channels (14) extending through a wall of the shaft from the longitudinal cavity to the circumferential surface (col. 9 / lines 27-30), the wall having a wall thickness, FIG. 6, the plurality of lateral channels being arranged at a same first distance from the proximal end of the shaft, FIG. 6, the plurality of lateral channels having a cross section with an axial length and a width smaller than the axial length, shown for exemplary purposes in FIG. 3, wherein said wall thickness increases gradually in a circumferential direction towards the plurality of lateral channels (the wall thickness includes the thickness/height of the thread that extends around the bone anchor at the location where the wall thickness is measured; the wall thickness increases gradually in a circumferential direction towards each of the channels, since thickness measured in a circumferential direction at a longitudinal location of the lateral channels would increase from a lesser thickness at a point about a circumference at the root of the thread, and a greater thickness at the crest of the thread, with the crest seen in FIG. 6 at/adjacent the lateral channel), and wherein the thermoplastic element has a shape adapted to be inserted into the longitudinal cavity from the proximal end (col. 9 / lines 36-39), the thermoplastic element being capable of being liquefied by being pressed against a distal end (at 18) of the longitudinal cavity while energy is coupled into the thermoplastic element (col. 9 / lines 40-46, col. 12 / lines 6-10).
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 Laubert’s bone anchor to have a longitudinal cavity that opens to lateral channels extending through the wall of the shaft and a thermoplastic element inserted in the longitudinal cavity that is liquefied to pass out of the lateral channels, as taught by Wenger, to allow the flow of the liquefied material into the surrounding bone to provide solid anchoring after re-solidifying.
Assuming arguendo, Wenger is silent as to the plurality of lateral channels having a cross section with an axial length and a width smaller than the axial length.
In FIG. 3, Wenger shows a plurality of lateral channels (14) having a cross section with an axial length and a width smaller than the axial length.
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 lateral channels in the shape as shown in FIG. 3 of Wenger, since Wenger discloses that this is an appropriate shape for the channels to allow liquefied material to be pressed out.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Laubert in view of Wenger (hereinafter, “Laubert/Wenger”), as applied to claims 1, 14, and 15 above, and further in view of U.S. Patent Application Publication No. US 2017/0354504 to Welch et al. (hereinafter, “Welch”).
As to claim 16, Laubert/Wenger disclose the system according to claim 14, wherein the implant (Laubert, 10a) is a load bearing bone implant configured to be implanted in the human or animal patient between surfaces of live bones or bone fragments (as an intervertebral implant), configured to transmit forces acting between the bones or bone fragments (due to its solid structure; interpreted as language of intended use), and configured to be integrated between the bones or bone fragments by bone growth after surgery (interpreted as language of intended use; fully capable of being integrated by bone growth around and through).
Laubert/Wenger are silent as to the implant comprising a porous implant body and a support frame, wherein the porous implant body comprises: opposite ingrowth surfaces configured to be positioned against surfaces of the bones or bone fragments, an open porosity constituting throughout the porous implant body a three-dimensional network of porosity channels of dimensions for bone ingrowth, and a plurality of supply channels, wherein each one of the plurality of supply channels has a mouth in at least one of the ingrowth surfaces and extends into or through the porous implant body substantially parallel to said forces, and wherein the plurality of supply channels have cross sections larger than cross sections of the porosity channels and small enough for being bridgeable by spontaneous bone growth without additional bone growth enhancing material.
Welch teaches a load bearing bone implant configured to be implanted in a human or animal patient between surfaces of live bones or bone fragments, FIG. 5, configured to transmit forces acting between the bones or bone fragments (due to its solid structure; interpreted as language of intended use), and configured to be integrated between the bones or bone fragments by bone growth after surgery (interpreted as language of intended use; fully capable of being integrated by bone growth around and through), the implant comprising a porous implant body (porous matrix) and a support frame (perimeter frame shown in FIG. 5 and/or ceramic granules which support the BMP), FIG. 5, wherein the porous implant body comprises: opposite ingrowth surfaces (superior and inferior surfaces) configured to be positioned against surfaces of the bones or bone fragments, an open porosity (microporous matrix) constituting throughout the porous implant body a three-dimensional network of porosity channels of dimensions for bone ingrowth (par. [0016], [0018]), and a plurality of supply channels (1-2 mm openings) (par. [0018]), FIG. 5, wherein each one of the plurality of supply channels has a mouth in at least one of the ingrowth surfaces, FIG. 5, and extends into or through the porous implant body substantially parallel to said forces, FIG. 5, and wherein the plurality of supply channels have cross sections larger than cross sections of the porosity channels (par. [0018]) and small enough for being bridgeable by spontaneous bone growth without additional bone growth enhancing material (interpreted as language of intended use; fully capable of being bridged by spontaneous bone growth when implanted).
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 implant of Laubert/Wenger to have a porous implant body comprising a network of microporous porosity channels and supply channels, as taught by Welch, to serve as a scaffold for new bone growth as ingrowth and on-growth to promote bone fusion and spinal stability.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRACY L KAMIKAWA/Examiner, Art Unit 3775
Prosecution Insights