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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/17/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/17/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, applicant contends that none of either Arai (US 2015/0142024 A1) (previously of record), Belson (US 2015/0073478 A1) (previously of record) or Thompson (US 5662654 A) (previously of record) expressly disclose or adequately suggest the amended limitations of “the unbroken hollow cylindrical wall extending between a first end and a second side opposite the first end along a length of the cylindrical base;…wherein all the wings of the securement portion extend from the second end of the cylindrical base and are circumferentially arranged about the second end,…and wherein, when the core portion and securement portion are assembled,…the first end of the cylindrical base contacts the first surface of the head”. This is on the grounds that the wings 140 extend along the length of the sleeve 135 of Arai and thus do not extend from the second end (i.e., the proximal end) of the cylindrical base, as required by the amended limitations. Applicant’s arguments pertaining to this amended limitation are moot as none of the above-cited references are relied upon to disclose this amended limitation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-2, 5-6, 9 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arai (US 2015/0142024 A1) (previously of record) in view of Belson (US 2015/0073478 A1) (previously of record), further in view of Diaz (US 2023/0042559 A1) (previously of record).
Regarding claim 1, Arai discloses:
A bone anchor (see Fig. 1) comprising:
a core portion (see Fig. 3) including:
a head (core body 105 and tip 102 defining a distal head element; see Fig. 1) having a first surface (proximal surface of core body 105 extending radially outward from elongated member 125; see Examiner’s Diagram of Fig. 3 below); and
a rod (elongated member 125; see Figs. 1 and 3) extending from the first surface along a central axis of the rod (see Fig. 3);
wherein the rod comprising a channel (see Fig. 3 showing a channel opening at the distal end of the elongated member 125); and
a single securement portion (wing assembly 110; see Fig. 4) including:
a cylindrical base (sleeve body 135; see Fig. 4; see also Para. [0026] and [0037] mentioning wherein the cross-section of the elongated member 125 and sleeve body 135 may alternatively be circular, resulting in a cylindrical-shaped sleeve body 135 that accommodates the alternative circular cross-section of the elongated member 125), wherein the cylindrical base comprises an unbroken hollow cylindrical wall forming an exterior circumferential surface of the securement portion (see Fig. 4 showing a monolithically-formed sleeve body 135 without any breaks/openings), the unbroken hollow cylindrical wall extending between a first end (distal-most portion of sleeve body 135; see Fig. 4) and a second end opposite the first and along a length of the cylindrical base (proximal portion of sleeve body 135; see Fig. 4);
a plurality of wings (wings 140; see Fig. 4) integrally coupled to the cylindrical base (see Fig. 4), wherein all the wings of the securement portion are circumferentially arranged about the cylindrical base (see Fig. 4; see also Para. [0034]; wings 140 may include four rows that extend around the circumference of the sleeve body 135);
wherein the plurality of wings curve away from the central axis of the rod in a rest position (see Fig. 1) and are configured to bend towards and away from the central axis of the rod (see Para. [0015] and [0021] mentioning wherein the wings are flexible such that they fold inwardly during insertion into bone and fold outwardly once inserted to prevent the anchor from being dislodged); and
wherein the core portion and the securement portion comprise different materials (see Para. [0026]); and
wherein when the core portion and the securement portion are assembled, the securement portion is positioned around at least a portion of the rod (see Para. [0025]-[0026] and [0037]; wing assembly 110 is secured around elongated member 125) and the first end of the cylindrical base contacts first surface of the head (see Fig. 1 showing abutting contact between the distal-most portion of the sleeve body 135 and the “first surface” of the core body 105).
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Examiner’s Diagram of Fig. 3
However, while Arai discloses wherein the elongated member is configured to connect to an insertion tool (see Para. [0015], [0024]-[0028] and [0042]), Arai does not provide substantial detail discussion the connection between these two components and thus does not expressly disclose:
wherein the channel of the rod extends through the rod along an entire length of the rod; and
wherein all the wings of the securement portion extend from the second end of the cylindrical base.
In the same field of endeavor, namely tissue/bone anchoring devices, Belson teaches a surgical anchor (see Fig. 3A) comprising a core body including a rod (body 302; see Figs. 3A-3B) having a channel (lumen 306; see Fig. 3A) extending through the rod along an entire length of the rod (see Fig. 3A; see also Para. [0020]) which is configured to removably receive a guide shaft therein (shaft 320; see Figs. 3A-3B), allowing a user to removably couple a guide shaft to the surgical anchor for navigation to an intended site (see Para. [0020]).
Since Arai discloses use of an insertion device to guide the anchor to a target site (see Para. [0015], [0024]-[0028] and [0042]) but does not provide substantial detail pertaining to the structure thereof or connection to the anchor device, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to the prior art for similar insertion/guide shaft devices configured to be removably coupled to a surgical anchor device and to have modified the elongated member 125 of Arai to comprise a longitudinal channel extending along an entire length thereof as taught and suggested by Belson to, in this case, provide a channel within the surgical anchor configured to removably receive a guide shaft therein to guide the anchor device to an intended target site (see Belson Para. [0020]).
Additionally, in the same field of endeavor, namely bone anchors, Diaz teaches a bone anchor (bone anchor 900; see Fig. 9A) comprising a securement portion including a cylindrical base (anchor body 902; see Fig. 9A); wherein the cylindrical base comprises an unbroken hollow cylindrical wall forming an exterior circumferential surface of the securement portion (see Figs. 9A-9C); the unbroken hollow cylindrical wall extending between a first end (distal-most portion of anchor body 902; see Fig. 9A) and a second end opposite the first and along a length of the cylindrical base (proximal-most portion of anchor body 902; see Fig. 9A); and a plurality of wings (wings 956; see Fig. 9A) integrally coupled to the cylindrical base (see Fig. 9A; see also Para. [0052]); wherein the plurality of wings are circumferentially arranged about the second end of the cylindrical base (see Figs. 9A-9D) to assist engagement with a body socket (see Para. [0052]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known bone anchor wing arrangement for another (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of modifying the wings along the sleeve body of Arai to extend from the proximal, “second end” thereof as disclosed by Diaz as a known alternative bone anchor wing arrangement. While Arai shows an exemplary wing arrangement in Fig. 4, Arai does not disclose any express criticality to the configuration shown, indicating merely that the bone anchor requires a plurality of flexible (i.e., expandable and contractable) wings extending proximally along the length of the sleeve body 135 that are formed as pairs on opposing sides of the sleeve body (see Para. [0003]-[0006], [0020]-[0021] and [0034]). The wings of Diaz are also disclosed to be flexible and extend proximally along a length of the respective sleeve body (i.e., anchor body 902) and are configured to assist engagement of the surgical anchor with a bone socket (see Diaz Para. [0052]). As the two known alternative bone anchor wing assemblies are configured to perform the same core function of securing an anchor within a bone socket, one of ordinary skill in the art would have expected the device of Arai to function equally well with either a wing configuration having a plurality of wings extending along the length of the sleeve body or, alternatively, a wing configuration having wings extending from the proximal, “second end” of the sleeve body without hindering the operational functionality of the device.
Regarding claim 2, the combination of Arai, Belson and Diaz disclose the invention of claim 1, Arai, as modified by Diaz, further discloses wherein the securement portion includes four wings (see Arai Figs. 1 and 4 showing four wings located on the sleeve body; see also Diaz Figs. 9A-9D showing the alternative bone anchor wing arrangement, incorporated into the device of Arai, comprising four wings).
Regarding claim 5, the combination of Arai, Belson and Diaz disclose the invention of claim 1, Arai further discloses wherein the plurality of wings are configured to bend towards the central axis of the rod such that the plurality of wings are substantially parallel to the central axis of the rod (see Para. [0015] and [0021] mentioning wherein the wings are flexible such that they fold inwardly during insertion into bone; see also Figs. 2A-2C showing wherein the wings bend toward the sleeve body to become substantially parallel therewith; due to the flexibility of the wings, should enough force be applied, the wings are understood to be reasonably capable of becoming substantially parallel with the elongated member and sleeve body).
Regarding claim 6, the combination of Arai, Belson and Diaz disclose the invention of claim 5, Arai, as modified by Diaz, further discloses wherein when the plurality of wings are substantially parallel to the central axis of the rod, the securement portion surrounds the entire length of the rod (see Arai Figs. 1-2C showing wherein sleeve body 135 is positioned such that is surrounds the entire length of the elongated body 125; see also Diaz Figs. 9A-9B showing wherein the wings of the alternative wing arrangement, as incorporated into the device of Arai, extend substantially parallel to the central axis).
Regarding claim 9, the combination of Arai, Belson and Diaz disclose the invention of claim 1, Arai further discloses wherein the core portion and the securement portion are separate components (see Figs. 3-4 showing the core portion (i.e., core body 105 and tip 102) and securement portion (i.e., wing assembly 110) as separate components).
Regarding claim 14, the combination of Arai, Belson and Diaz disclose the invention of claim 1, Arai, as modified by Diaz, further discloses wherein each of the plurality of wings is equally dispersed around the central axis of the rod (see Diaz Figs. 9A-9C; see also Diaz Para. [0052] mentioning wherein four wings may be included; see also Arai Para. [0034] mentioning wherein wings are included as pairs positioned on opposing sides of the sleeve body 135).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arai (US 2015/0142024 A1) (previously of record) in view of Belson (US 2015/0073478 A1) (previously of record), further in view of Diaz (US 2023/0042559 A1) (previously of record), as applied to claim 1, further in view of Le (US 5545180 A) (previously of record).
Regarding claim 3, the combination of Arai, Belson and Diaz disclose all of the limitations of the invention of claim 1.
However, while Arai discloses wherein the wing assembly may be made from a flexible material (see Para. [0021]), Arai does not expressly disclose wherein the securement portion is constructed of a shape memory material.
In the same field of endeavor, namely bone anchor devices, Le teaches a bone anchor device (see Fig. 3) comprising a core portion (distal nose of 40 and shaft 20; see Fig. 3) and a securement portion (radially-protruding umbrella-shaped distal end; see Fig. 3) having a plurality of wings extending therefrom (wings 60; see Fig. 3); wherein the securement portion is made from a shape memory material, namely, nitinol (see Col. 7, Lines 50-55 mentioning wherein the anchor may be made from nitinol as an exemplary material, which is a shape-memory material).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the wing assembly of Arai, as modified by Diaz, to be formed from nitinol as disclosed by Le since it has been held that the selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Regarding claim 4, the combination of Arai, Belson, Diaz and Le disclose the invention of claim 3, Arai, as modified by Le, further discloses wherein the shape memory material is nitinol (see Le Col. 7, Lines 50-55 mentioning wherein nitinol has been used to form the wing assembly of Arai as a known alternative material used to form bone anchor devices).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arai (US 2015/0142024 A1) (previously of record) in view of Belson (US 2015/0073478 A1) (previously of record), further in view of Diaz (US 2023/0042559 A1) (previously of record), as applied to claim 1, further in view of Housman (US 2017/0311943 A1) (previously of record).
Regarding claim 8, the combination of Arai, Belson and Diaz disclose all of the limitations of the invention of claim 1.
However, Arai does not expressly disclose wherein the rod includes an opening with a central axis perpendicular to the central axis of the rod.
In the same field of endeavor, namely bone anchors, Housman teaches a surgical anchor device (see Fig. 4) comprising a core portion including a head (tapered portion 406; see Fig. 4) and a rod (body 402; see Fig. 4); wherein the rod includes an opening with a central axis perpendicular to the central axis of the rod (suture eyelet 414; see Fig. 4) dimensioned to receive a suture therein (see Para. [0044]).
While Arai discloses wherein a suture eyelet aperture may be included along the core body 105 (see Fig. 3; see also Para. [0032]), this is disclosed to be an optional configuration and exemplary location. It would have thus been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the elongated member 125 of Arai to include a suture eyelet therein having a central axis perpendicular to the central axis of said elongated member 125 as disclosed by Housman to, in this case, provide an alternative known location for a suture eyelet within bone anchoring devices (see Housman Para. [0044]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arai (US 2015/0142024 A1) (previously of record) in view of Belson (US 2015/0073478 A1) (previously of record), further in view of Diaz (US 2023/0042559 A1) (previously of record), as applied to claim 9, further in view of Bourque (US 2007/0219557 A1) (previously of record).
Regarding claim 10, the combination of Arai, Belson and Diaz discloses all of the limitations of the invention of claim 9.
However, Arai does not expressly disclose wherein the core portion and securement portion are press fit together.
In the same field of endeavor, namely bone anchoring devices comprising a central shaft and securement portion, Bourque teaches wherein a bone anchor (see Fig. 4; see also Para. [0054]-[0056]) comprising a central shaft (anchoring portion 108; see Fig. 4) and a securement portion (plug 106; see Fig. 4) which may be formed as two separate pieces that are “press-fit” into securement with one-another prior to use (see Para. [0057]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the anchor of Arai to have the sleeve body of the wing assembly be secured to the elongated body of the core portion of the anchor device by a press-fit engagement as disclosed by Bourque as a matter of utilizing a known alternative connection technique disclosed by analogous prior art. One of ordinary skill in the art would have expected the anchor of Arai to function properly should the sleeve body of the wing assembly be secured to the elongated body by an interference fit or press-fit engagement as the resulting connecting would yield a single unit to be secured within a target bone. Further, applicant places no criticality on the claimed arrangement, indicating that the core portion and securement portion may be either press-fit as separate components, or formed as an integral single component (see Specification Para. [0017]-[0018] and [0052]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arai (US 2015/0142024 A1) (previously of record) in view of Belson (US 2015/0073478 A1) (previously of record), further in view of Diaz (US 2023/0042559 A1) (previously of record), as applied to claim 1, further in view of Housman (US 2017/0311943 A1) (previously of record).
Regarding claim 11, the combination of Arai, Belson and Diaz disclose all of the limitations of the invention of claim 1.
However, none of either Arai, Belson or Diaz expressly disclose wherein the core portion and the securement portion are integrally formed as a single component.
In the same field of endeavor, namely surgical anchor devices, Housman teaches a surgical anchor device (see Fig. 4) comprising a core rod portion (body 402; see Fig. 4) and a wing portion (wings 412; see Fig. 4); wherein the wing portion may be either formed integrally with the core rod portion or, alternatively, may be formed as a separate component that is later connected to the core rod portion (see Para. [0045]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element/arrangement for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)), to have obtained the predictable result of having the core portion and securement portion of Arai being formed as a single integral component, as disclosed by Housman, since Housman discloses wherein it is known in the art to form suture anchors as either a single, monolithic component or as separate components later connected together without impacting the functionality of the device. Therefore, one of ordinary skill in the art would have expected the anchor of Arai to function properly having either a core and securement portion formed as a single, integral component, or as separate components later secured together, since both alternative arrangements arrive at the same single bone anchor result, which are each disclosed to function properly as a single unit to be secured within a bone. Further, applicant places no criticality on the claimed arrangement, indicating that the core portion and securement portion may be either press-fit as separate components, or formed as an integral single component (see Specification Para. [0017]-[0018] and [0052]).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arai (US 2015/0142024 A1) (previously of record) in view of Belson (US 2015/0073478 A1) (previously of record), further in view of Thompson (US 5662654 A) (previously of record), further in view of Diaz (US 2023/0042559 A1) (previously of record).
Regarding claim 18, Arai discloses:
A bone anchor insertion system comprising:
suture material (see Para. [0032]-[0033] mentioning use of a suture); and
a bone anchor (see Fig. 1) comprising:
a core portion (see Fig. 3) including:
a head (core body 105 and tip 102 defining a distal head element; see Fig. 1) having a first surface (proximal surface of core body 105 extending radially outward from elongated member 125; see Examiner’s Diagram of Fig. 3 below); and
a rod (elongated member 125; see Figs. 1 and 3) extending from the first surface along a central axis of the rod (see Fig. 3);
wherein the rod comprising a channel (see Fig. 3 showing a channel opening at the distal end of the elongated member 125); and
a single securement portion (wing assembly 110; see Fig. 4) including:
a cylindrical base (sleeve body 135; see Fig. 4; see also Para. [0026] and [0037] mentioning wherein the cross-section of the elongated member 125 and sleeve body 135 may alternatively be circular, resulting in a cylindrical-shaped sleeve body 135 that accommodates the alternative circular cross-section of the elongated member 125), wherein the cylindrical base comprises an unbroken hollow cylindrical wall forming an exterior circumferential surface of the securement portion (see Fig. 4 showing a monolithically-formed sleeve body 135 without any breaks/openings), the unbroken hollow cylindrical wall extending between a first end (distal-most portion of sleeve body 135; see Fig. 4) and a second end opposite the first end along a length of the cylindrical base (proximal portion of sleeve body 135; see Fig. 4); and
a plurality of wings (wings 140; see Fig. 4) integrally coupled to the cylindrical base (see Fig. 4), wherein all the wings of the securement portion are circumferentially arranged about the cylindrical base (see Fig. 4; see also Para. [0034]; wings 140 may include four rows that extend around the circumference of the sleeve body 135);
wherein when the core portion and the securement portion are assembled, the securement portion is positioned around at least a portion of the rod (see Para. [0025]-[0026] and [0037]; wing assembly 110 is secured around elongated member 125) and the first end of the cylindrical base contacts the first surface of the head (see Fig. 1 showing abutting contact between the distal-most portion of the sleeve body 135 and the “first surface” of the core body 105);
wherein the plurality of wings curve away from the central axis of the rod in a rest position (see Fig. 1) and are configured to bend towards and away from the central axis of the rod (see Para. [0015] and [0021] mentioning wherein the wings are flexible such that they fold inwardly during insertion into bone and fold outwardly once inserted to prevent the anchor from being dislodged);
wherein the core portion and the securement portion comprise different materials (see Para. [0026]).
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Examiner’s Diagram of Fig. 3
However, while Arai discloses wherein the elongated member is configured to connect to an insertion tool (see Para. [0015], [0024]-[0028] and [0042]), Arai does not provide substantial detail discussion the connection between these two components and thus does not expressly disclose:
wherein the channel of the rod extends through the rod along an entire length of the rod;
an inserter having an insertion end with a tapered groove;
wherein the inserter's insertion end is configured to be positioned within the channel of the rod so that the bone anchor is driven through a bone canal via the inserter; and
wherein the suture material is positioned through the rod and within the tapered groove; and additionally,
wherein all the wings of the securement portion extend from the second end of the cylindrical base.
In the same field of endeavor, namely bone anchoring devices, Belson teaches a surgical anchor (see Fig. 3A) comprising a rod body (body 302; see Figs. 3A-3B) having a channel (lumen 306; see Fig. 3A) extending entirely through the rod body of the anchor device (see Fig. 3A; see also Para. [0020]) which is configured to removably receive a guide shaft therein (shaft 320; see Figs. 3A-3B), allowing a user to removably couple a guide shaft to the anchor device for navigation to an intended site (see Para. [0020]).
Since Arai discloses use of an insertion device to guide the anchor to a target site (see Para. [0015], [0024]-[0028] and [0042]) but does not provide substantial detail pertaining to the structure thereof or connection to the anchor device, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have looked to the prior art for similar insertion/guide shaft devices configured to be removably coupled to an anchoring device and to have modified the elongated member 125 of Arai to comprise a longitudinal channel extending through the entire length thereof as taught and suggested by Belson to, in this case, provide a channel within the surgical anchor configured to removably receive a guide shaft therein to guide the anchor device to an intended target site (see Belson Para. [0020]).
Additionally, in the same field of endeavor, namely suture anchors, Thompson teaches wherein a suture anchor inserter (see Fig. 8) is configured to comprise a pair of longitudinally-extending grooves (grooves 55; see Fig. 8) which are configured to receive a suture therein (see Col. 13, Lines 51-65) to ensure that the suture is not abraded by the surrounding bone during the insertion process, thereby retaining the strength of the suture (see Col. 13, Lines 51-65).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the elongated member 125 of Arai, as modified by Belson, to comprise a pair of longitudinally-extending slots configured to receive the inserter and accompanying suture thread therein (as a suture is also disclosed to be used in the device of Arai, see Para. [0032]-[0033]), as taught and suggested by Thompson to, in this case, ensure that the suture is not abraded by the surrounding bone during the insertion process, thereby retaining the strength of the suture (see Thompson Col. 13, Lines 51-65).
Additionally, in the same field of endeavor, namely bone anchors, Diaz teaches a bone anchor (bone anchor 900; see Fig. 9A) comprising a securement portion including a cylindrical base (anchor body 902; see Fig. 9A); wherein the cylindrical base comprises an unbroken hollow cylindrical wall forming an exterior circumferential surface of the securement portion (see Figs. 9A-9C); the unbroken hollow cylindrical wall extending between a first end (distal-most portion of anchor body 902; see Fig. 9A) and a second end opposite the first and along a length of the cylindrical base (proximal-most portion of anchor body 902; see Fig. 9A); and a plurality of wings (wings 956; see Fig. 9A) integrally coupled to the cylindrical base (see Fig. 9A; see also Para. [0052]); wherein the plurality of wings are circumferentially arranged about the second end of the cylindrical base (see Figs. 9A-9D) to assist engagement with a body socket (see Para. [0052]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known bone anchor wing arrangement for another (KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of modifying the wings along the sleeve body of Arai to extend from the proximal, “second end” thereof as disclosed by Diaz as a known alternative bone anchor wing arrangement. While Arai shows an exemplary wing arrangement in Fig. 4, Arai does not disclose any express criticality to the configuration shown, indicating merely that the bone anchor requires a plurality of flexible (i.e., expandable and contractable) wings extending proximally along the length of the sleeve body 135 that are formed as pairs on opposing sides of the sleeve body (see Para. [0003]-[0006], [0020]-[0021] and [0034]). The wings of Diaz are also disclosed to be flexible and extend proximally along a length of the respective sleeve body (i.e., anchor body 902) and are configured to assist engagement of the surgical anchor with a bone socket (see Diaz Para. [0052]). As the two known alternative bone anchor wing assemblies are configured to perform the same core function of securing an anchor within a bone socket, one of ordinary skill in the art would have expected the device of Arai to function equally well with either a wing configuration having a plurality of wings extending along the length of the sleeve body or, alternatively, a wing configuration having wings extending from the proximal, “second end” of the sleeve body without hindering the operational functionality of the device.
Regarding claim 19, the combination of Arai, Belson, Thompson and Diaz disclose all of the limitations of the invention of claim 18.
However, none of the combination, as currently presented, expressly discloses wherein the head includes two separate components joined by a bar.
Diaz further teaches where a bone anchor (bone anchor 500; see Figs. 5A-5B) comprising a head (distal portion of the bone anchor 500; see Fig. 5A-5B) having a pair of through-holes (through holes 528 and 538; see Figs. 5A-5B) that are separated by a post (post 540; see Fig. 5A-5B), configured to receive a suture through one of the through-holes, before being wrapped around the post and inserted back into the second through hole to allow a suture to be secured thereto (see Para. [0041]) to be used in a final or supplementary suturing procedure once the bone anchor is in place (see Para. [0048]). The examiner notes that the function of all of the different embodiments of the through-holes are consistent with one-another unless otherwise stated and serve to perform the function of securing a suture therethrough for further suturing procedures once the anchor is in-place as mentioned Para. [0048].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the head portion of the anchor of Arai to include two through-holes that are joined by a post, as taught and suggested by Diaz to, in this case, allow the suture to be passed through each through-hole and around the post to be used in a final or supplementary suturing procedure once the bone anchor is in place (see Diaz Para. [0048]).
Regarding claim 20, the combination of Arai, Belson, Thompson and Diaz disclose the invention of claim 18, Arai, as modified by Belson and Thompson, further discloses wherein the rod is configured to maintain the suture material within the channel and within the plurality of wings as the bone anchor is driven through the bone canal via the inserter (as the inserter device of Arai has been modified to pass through the channel within the elongate body 125 of the anchor device, the elongate body 125 contains and maintains the suture within the channel as the anchor is navigated to a target site by the inserter to protect the suture from the external environment during navigation per Thompson Col. 13, Lines 51-65).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2019/0175345 A1 to Schaffner, US 2022/0133466 A1 to Wedam and US 5662654 A to Thompson all disclose bone anchor devices comprising a plurality of wings extending from the proximal end thereof.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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, Darwin Erezo can be reached on 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
