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 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, Le (US 5545180 A) is no longer relied upon to disclose the amended limitations of “wherein the securement portion further comprises a cylindrical base from which the plurality of wings extend, the cylindrical base comprising an unbroken cylindrical wall forming an exterior circumferential surface of the securement portion, and wherein the cylindrical base contacts the head”
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, 8-9 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arai (US 2015/0142024 A1) in view of Belson (US 2015/0073478 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 (tip 102, see Fig. 1) and a rod (core body 105 and elongated member 125, see Figs. 1 and 3);
wherein the rod includes a channel (see Fig. 3 showing a channel opening at the distal end of the elongated member); and
a securement portion (wing assembly 110, see Fig. 4) including a plurality of wings (wings 140, see Fig. 4), the securement portion positioned around at least a portion of the rod (see Fig. 1);
wherein the plurality of wings curve away from a 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 portions comprise different materials (see Para. [0026]); and
wherein the securement portion further comprises a cylindrical base (sleeve body 135, see Fig. 4; see also Para. [0026] and [0037] mentioning wherein the cross-section of the elongated member and sleeve may alternatively be circular, resulting in a cylindrical-shaped sleeve body) from which the plurality of wings extend (see Fig. 4), the cylindrical base comprising an unbroken cylindrical wall forming an exterior circumferential surface of the securement portion (see Fig. 4 showing a monolithically-formed sleeve body without any breaks), and wherein the cylindrical base contacts the head (see Fig. 1 showing abutting contact between the distal portion of the sleeve body and the proximal portion of the core body).
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 along an entire length of the rod.
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 at least the core body 105 and elongated member 125 (i.e., the elongate body portion(s) of the anchor) of Arai to comprise a longitudinal channel extending through the length(s) thereof as taught and suggested by Belson to, in this case, provide a channel within the anchor body configured to removably receive a guide shaft therein to guide the anchor device to an intended target site (see Belson Para. [0020]).
Regarding claim 2, the combination of Arai and Belson disclose the invention of claim 1, Arai further discloses wherein the securement portion includes four wings (see Figs. 1 and 4 showing four wings located on the sleeve body).
Regarding claim 5, the combination of Arai and Belson 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 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 and Belson disclose the invention of claim 5, Arai 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 Figs. 1-2C showing wherein sleeve body 135 is positioned such that is surrounds the entire length of the elongated body 125).
Regarding claim 8, the combination of Arai and Belson disclose the invention of claim 1, Arai further discloses wherein the rod includes an opening with a central axis perpendicular to the central axis of the rod (aperture 130, see Figs. 1 and 3).
Regarding claim 9, the combination of Arai and Belson 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 and securement portion as separate components).
Regarding claim 14, the combination of Arai and Belson disclose the invention of claim 1, Arai further discloses wherein each of the plurality of wings is equally dispersed around the central axis of the rod (see Figs. 1 and 4 showing an equal number of wings disposed of diametrically-opposed sides of the sleeve body; see also Para. [0034]).
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 Le (US 5545180 A) (previously of record).
Regarding claim 3, the combination of Arai and Belson 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 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 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) 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 Bourque (US 2007/0219557 A1) (previously of record).
Regarding claim 10, the combination of Arai and Belson discloses all of the limitations of the invention of claim 9.
However, Arai does not expressly disclose a manner in which the sleeve body is joined to the elongated body and thus does not expressly disclose wherein the core portion and the securement portion are separate components.
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]).
Since Arai shows the sleeve body and elongated body as separated components but does not expressly disclose how the two components are joined together, 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 known methods of joining components of an anchor device. Thus, it would have been obvious to one of ordinary skill in the art to have modified the anchor of Arai to have the sleeve body of the wing assembly be secured to the elongated body of the anchor device by a press-fit engagement as disclosed by Bourque as a matter of utilizing a known 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 a 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 and 13 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 Housman (US 2017/0311943 A1).
Regarding claim 11, the combination of Arai and Belson disclose all of the limitations of the invention of claim 1.
However, none of either Arai or Belson 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]).
Regarding claim 13, the combination of Arai and Belson discloses all of the limitations of the invention of claim 1, Arai further discloses wherein the base contacts the head on a first side of the base (see Fig. 1).
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 Examiner’s Diagram of Housman Fig. 4 below) and a wing assembly portion (see Examiner’s Diagram of Housman Fig. 4 below illustrating a “wing assembly portion” of the anchor of Housman); wherein the wing assembly portion contacts the core rod portion at a first end thereof; and wherein the plurality of wings of the wing assembly extend from a second side of the wing assembly portion, the second side being opposite the first side (see Examiner’s Diagram of Housman Fig. 4 below).
While Arai shows a total of eight wings (i.e., two sets of four wings on opposite sides of the sleeve body as shown in Figs. 1 and 4), Arai does not provide any written disclosure pertaining to the number of wings or location in which the wings are disposed along the sleeve body, indicating the number and placement of the wings along the sleeve body is not a critical aspect of the disclosed device so long as at least one pair of wings is present along the length of the sleeve body. It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the sleeve body of Arai to comprise a plurality of wings disposed along a length thereof at a location spaced apart from the connection between the sleeve body and core body as disclosed as an alternative wing location arrangement by Housman. As Arai does not provide any disclosure regarding the amount of wings or locations thereof along the sleeve body, one of ordinary skill in the art would have expected the device of Arai to function equally well should the wings of Arai be disposed at a location spaced away from the contact point between the sleeve body and core body since the location does not appear to serve any functional purpose. Should at least one pair of wings remain present along the sleeve body, the device of Arai is understood to remain functional.
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Examiner’s Diagram of Housman Fig. 4
Claim(s) 18 and 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).
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) including:
a core portion (see Fig. 3) including a head (tip 102 and core body 105, see Fig. 1) and a rod (elongated member 125, see Figs. 1 and 3), (see Fig. 3 showing a channel opening at the distal end of the elongated member);
a securement portion (wing assembly 110, see Fig. 4) including a plurality of wings (wings 140, see Fig. 4), the securement portion positioned around at least a portion of the rod (see Fig. 1), the securement portion comprising a cylindrical base (sleeve body 135, see Fig. 4; see also Para. [0026] and [0037] mentioning wherein the cross-section of the elongated member and sleeve may alternatively be circular, resulting in a cylindrical-shaped sleeve body) from which the plurality of wines extend (see Fig. 4), the cylindrical base comprising an unbroken cylindrical wall forming an exterior circumferential surface of the securement portion (see Fig. 4 showing a monolithically-formed sleeve body without any breaks), wherein the cylindrical base contacts the head (see Fig. 1);
wherein the plurality of wings curve away from a 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 portions comprise different materials (see Para. [0026]).
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:
an inserter having an insertion end with a tapered groove;
wherein the channel of the rod extends along an entire length of the rod;
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.
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 at least the core body 105 and elongated member 125 (i.e., the elongate body portion(s) of the anchor) of Arai to comprise a longitudinal channel extending through the length(s) thereof as taught and suggested by Belson to, in this case, provide a channel within the anchor body 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 (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 insertion rod of Arai, as modified by Belson, to comprise a pair of longitudinally-extending slots configured to receive a 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).
Regarding claim 20, the combination of Arai, Belson and Thompson 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 of the anchor device, the elongate body contains 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).
Claim(s) 19 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), considered prior are because of a provisional patent application filed 1/17/2020.
Regarding claim 19, the combination of Arai, Belson and Thompson disclose all of the limitations of the invention of claim 18.
However, none of the combination expressly discloses wherein the head includes two separate components joined by a bar.
In the same field of endeavor, namely bone anchors including sutures, Diaz teaches where a 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 (528 and 538, see Figs. 5A-5B) that are separated by a 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]).
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 10383624 B2 to Gittings, US 2013/0267998 A1 to Vijay and US 2007/0167950 A1 to Tauro all disclose bone anchor devices comprising a mating socket disposed therein that either extends along the entire length of the bone anchor, or a description of wherein the depth of the socket is not a critical feature to the function of the device.
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 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
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