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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/03/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/03/2025 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
2. Applicant’s arguments with respect to claim(s) 1 and 18 regarding the amended limitations of “wherein the core portion and the securement portions comprise different materials” 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, while Le provides a disclosure of wherein the anchor may be formed from a “combination” of the disclosed materials (see Col. 7, Lines 20-35 and Lines 50-55) none of either Le, Belson or Thompson are relied upon to provide an express teaching of “wherein the core portion and the securement portions comprise different materials.”
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) 1-6, 8 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Le (US 5545180 A) (previously of record), in view of Belson (US 2015/0073478 A1)(previously of record), further in view of Arai (US 2015/0282801 A1).
Regarding claim 1, Le discloses:
A bone anchor (see Fig. 3) comprising:
a core portion including a head (distal nose of 40, see Fig. 3) and a rod (shaft 20, see Fig. 3), wherein the rod includes a channel (socket 26, see Figs. 3 and 5); and
a securement portion (radially-protruding umbrella-shaped distal end, see Fig. 3) including a plurality of wings (wings 60, see Fig. 3), the securement portion positioned around at least a portion of the rod (see Fig. 3);
wherein the plurality of wings curve away from a central axis of the rod in a rest position and are configured to bend towards and away from the central axis of the rod (see Col. 5, Lines 14-21).
However, while Le discloses wherein the anchor member may be made from a combination of various materials (see Col. 7, Lines 20-35 and Lines 50-55) in addition to wherein the socket may comprise any cross-section (see Col. 6, Lines 4-6) while being silent as to any specific description pertaining to the depth the socket may extend, Le does not expressly disclose wherein the channel of the rod extends along an entire length of the rod; and wherein the core portion and the securement portions comprise different materials.
In the same field of endeavor, namely bone anchoring devices, Belson teaches wherein a surgical anchor (see Fig. 3A) comprises a channel (lumen 306, see Fig. 3A) extending entirely through the anchor device (see Fig. 3A, see also Para. [0020]) which is configured to removably receive a needle puncture needle therein, or other tissue penetrating tip, allowing a user to puncture and guide the anchor into and thorough tissue using the tip of the needle shaft (see Para. [0020]).
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 socket of Le to extend through the entirety of the device, as taught and suggested by Belson to, in this case, removably receive additional instruments therein to, for example, allow for the removable passage of a puncture tip to aid in guiding the anchor to a desired intended use site (see Belson Para. [0020]).
In the same field of endeavor, namely bone anchoring devices, Arai teaches wherein a surgical bone anchor (anchor 100, see Fig. 1B-1C) comprising a core portion (body 102 and tip 112, see Figs. 1B-1C) and a securement portion (radially-protruding umbrella-shaped distal end, see Fig. 1C) having a plurality of wings (wings 104, see Fig. 1C), wherein each portion of the anchor may be made from either the same material or different materials (see Para. [0010]).
Since Le expressly discloses wherein the anchor may be formed from either one of or “combinations” of the disclosed materials, 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 arrangement for another (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of forming the “core portion” and “securement portion” of the device of Le from different materials. Since both Le and Arai disclose wherein their respective anchor devices may be made from either a single material or a combination (i.e., one or more) materials, one of ordinary skill in the art would have expected the device of Le to function equally well with the core portion and securement portions formed from either the same material or different material, without impacting the overall functionality of the device.
Regarding claim 2, the combination of Le, Belson and Arai discloses the limitations of claim 1, Le further discloses wherein the securement portion includes four wings (see Fig. 1).
Regarding claim 3, the combination of Le, Belson and Arai discloses the invention of claim 1, Le further discloses wherein the securement portion is constructed of a shape memory material (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).
Regarding claim 4, the combination of Le, Belson and Arai discloses the invention of claim 3, Le further discloses wherein the shape memory material is nitinol (see Col. 7, Lines 50-55).
Regarding claim 5, the combination of Le, Belson and Arai discloses the invention of claim 1, Le 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 (wings 60 are configured to bend and are made from a memory-shape material (see Col. 7, Lines 50-55) and are seen to therefore be capable of bending towards the central axis such that the wings are substantially parallel thereto).
Regarding claim 6, the combination of Le, Belson and Arai discloses all of the limitations of the invention of claim 5.
However, while Le further discloses wherein the wings may comprise any number or shape (see Col. 4, Lines 45-50), Le does not expressly disclose 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 (interpreted to mean wherein the wings of the securement portion “envelop” the entire length of the rod in along an axis parallel to the longitudinal axis).
However, in the same field of endeavor, namely suture anchor devices, Belson teaches a suture anchor (see Fig. 2A) comprising a central rod defining a center axis (retaining peg 204, see Fig. 2A) and a plurality of wings (retention arms 202, see Fig. 2A) that extend longitudinally so as to surround the entire longitudinal length of the central rod (as shown in Fig. 2A).
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 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 wings of Le extend along a length such that the wings surround the entire longitudinal length of the shaft, because Belson discloses that such a configuration is known in the art to achieve the function of allowing the arms to flex out and dig into tissue when the anchor is tensioned proximally into tissue (see Para. [0019]). One of ordinary skill in the art would have had a reasonable expectation of success that the wings of Le would function properly with either the current, shortened configuration, or with an elongated configuration as disclosed by Belson, since both arrangements are understood to allow the wings to retain the function of digging into and anchoring the device into tissue or bone. Further, none of either Le, Belson, or the claimed invention provide any criticality to the length of the wings in regards to a specific function and therefore, one of ordinary skill in the art would have expected the wings of Le to operate normally with the new elongate configuration, as disclosed to be known in the art by Belson. Further, the examiner notes that suture anchors with wings that envelop the entirety of the longitudinal length of a central retention rod are known and common in the art, as noted by the reference provided below in the “Conclusion” portion of this office action.
Regarding claim 8, the combination of Le, Belson and Arai discloses the invention of claim 1, Le further discloses wherein the rod includes an opening with a central axis perpendicular to the central axis of the rod (hole 30, see Fig. 3).
Regarding claim 11, the combination of Le, Belson and Arai discloses the invention of claim 1, Le further discloses wherein the core portion and the securement portion are integrally formed as a single component (see Fig. 5 showing wherein the shaft 20 of the anchor is formed as an integral component with the radially-outwardly extending portion comprising wings 60).
Regarding claim 12, the combination of Le, Belson and Arai discloses the invention of claim 1, Le further discloses wherein the securement portion further includes a cylindrical base from which the plurality of wings extend (see Examiner’s Diagram of Fig. 5 below illustrating a “cylindrical base” of the securement portion from which the wings extend radially from; the base is cylindrical due to the circular cross-section as evident from Fig. 2), and wherein the base contacts the head (see Examiner’s Diagram of Fig. 5 below showing wherein the “cylindrical base” of the securement portion that is in contact with the distal nose 40), the cylindrical base comprising an unbroken cylindrical wall (see Examiner’s Diagram of Fig. 5 below showing the identified “cylindrical base” having a continuous peripheral surface).
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Examiner’s Diagram of Fig. 5
Regarding claim 13, the combination of Le, Belson and Arai discloses the invention of claim 12, Le further discloses wherein the base contacts the head on a first side of the base and the plurality of wings extend from a second side of the base, the first side being opposite the second side (see Examiner’s Diagram of Fig. 5 above illustrating wherein the “cylindrical base portion” contacts the nose 40 at a “first side” and the wings 60 extend from the base portion at a “second side” opposite to the first side).
Regarding claim 14, the combination of Le, Belson and Arai discloses the invention of claim 1, Le further discloses wherein each of the plurality of wings is equally dispersed around the central axis of the rod (see Fig. 1 showing where two wings are present on each radial side of the anchor).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Le (US 5545180 A) (previously of record) in view of Belson (US 2015/0073478 A1)(previously of record), further in view of Arai (US 2015/0282801 A1), further in view of Bourque (US 2007/0219557 A1) (previously of record).
Regarding claim 9, the combination of Le, Belson and Arai discloses all of the limitations of the invention of claim 1.
However, Le further does not expressly disclose wherein the core portion and the securement portion are separate components.
However, 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) 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, 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 Le being formed as separate components that are secured to one-another in a press-fit arrangement, as disclosed by Bourque, since Bourque discloses wherein it is known in the art to form suture anchors from the securement of more than one component to one-another. Therefore, one of ordinary skill in the art would have expected the anchor of Le to function properly having either a core and securement portion formed as a single, integral component, or where the core and securement portion are separate components that may be 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 10, the combination of Le, Belson, Arai and Bourque discloses the invention of claim 9, Le, as modified by Bourque, further discloses wherein the core portion and securement portion are press fit together (see Bourque Para. [0057], as incorporated into the device of Le).
Claim(s) 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Le (US 5545180 A) (previously of record), in view of 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 Arai (US 2015/0282801 A1).
Regarding claim 18, Le discloses:
A bone anchor insertion system (see Fig. 13) comprising:
an inserter (rod 100, see Fig. 1) having an insertion end (distal end of rod 100 that mates with square socket 26 as shown in Figs. 13-14, see also Col. 6, Lines 1-5);
suture material (suture 350, see Fig. 13); and
a bone anchor (bone anchor 10, see Fig. 13, references to the bone anchor in Fig. 13 will rely on a more detailed viewing shown in Figs. 1-5) including:
a core portion having a head (distal nose of 40, see Fig. 3) and a rod (shaft 20, see Fig. 3);
wherein the rod includes a channel (square notch 26, see Fig. 3);
a securement portion (radially-protruding umbrella-shaped distal end, see Fig. 3) including a plurality of wings (wings 60, see Fig. 3), the securement portion positioned around at least a portion of the rod (see Fig. 3);
wherein the plurality of wings curve away from a central axis of the in a rest position (see Fig. 3) and are configured to bend towards and away from the central axis of the rod (see Col. 5, Lines 14-21, see also Figs. 13-15 showing the wings 60 bending toward the shaft 20 when being inserted into a bone, before expanding when released to anchor in-place);
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 (shown in Figs. 13-14, see also Col. 6, Lines 1-5 and 6-15).
However, while Le discloses wherein the anchor member may be made from a combination of various materials (see Col. 7, Lines 20-35 and Lines 50-55), in addition to wherein in an alternative embodiment, a pair of integral recesses (211a and 211b, see Figs. 1-22) are configured to receive a suture therein to keep the suture out of the way during insertion and implantation of a suture anchor (see Col. 6, Lines 60-67), and wherein the socket may comprise any cross-section (see Col. 6, Lines 4-6) while being silent as to any specific description pertaining to the depth the socket may extend, Le does not expressly disclose wherein the channel of the rod extends along an entire length of the rod; in the embodiment shown in Fig. 13, wherein the inserter comprises a tapered groove that is configured to receive suture material therein; and wherein the core portion and the securement portions comprise different materials.
However, 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 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).
Therefore, 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 100 of Le to comprise a pair of longitudinally-extending slots configured to receive a suture thread therein, 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 anchoring devices, Belson teaches wherein a surgical anchor (see Fig. 3A) comprises a channel (lumen 306, see Fig. 3A) extending entirely through the anchor device (see Fig. 3A, see also Para. [0020]) which is configured to removably receive a needle puncture needle therein, or other tissue penetrating tip, allowing a user to puncture and guide the anchor into and thorough tissue using the tip of the needle shaft (see Para. [0020]).
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 socket of Le to extend through the entirety of the device, as taught and suggested by Belson to, in this case, removably receive additional instruments therein to, for example, allow for the removable passage of a puncture tip to aid in guiding the anchor to a desired intended use site (see Belson Para. [0020]).
In the same field of endeavor, namely bone anchoring devices, Arai teaches wherein a surgical bone anchor (anchor 100, see Fig. 1B-1C) comprising a core portion (body 102 and tip 112, see Figs. 1B-1C) and a securement portion (radially-protruding umbrella-shaped distal end, see Fig. 1C) having a plurality of wings (wings 104, see Fig. 1C), wherein each portion of the anchor may be made from either the same material or different materials (see Para. [0010]).
Since Le expressly discloses wherein the anchor may be formed from either one of or “combinations” of the disclosed materials, 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 arrangement for another (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of forming the “core portion” and “securement portion” of the device of Le from different materials. Since both Le and Arai disclose wherein their respective anchor devices may be made from either a single material or a combination (i.e., one or more) materials, one of ordinary skill in the art would have expected the device of Le to function equally well with the core portion and securement portions formed from either the same material or different material, without impacting the overall functionality of the device.
Regarding claim 20, the combination of Le, Belson, Arai and Thompson disclose the system of claim 18, Le, as modified by Belson, 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 (the hole 30 within the shaft 20 keeps the suture within the plurality of wings as the bone anchor is driven through a bone canal since the suture is attached thereto, in addition to keeping the suture within the channel of Le, as incorporated from the teachings of Belson, which now include the hole disposed therethrough).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Le (US 5545180 A) (previously of record), in view of 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 Arai (US 2015/0282801 A1), 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 Le, Belson, Arai and Thompson disclose all of the limitations of the system of claim 18.
However, none of either Le, Belson, Arai or Thompson expressly disclose wherein the head includes two separate components joined by a bar.
However, 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 suture anchor of Le 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 7572283 B1 to Meridew, US 10806444 B2 to Reeser, US 7976565 B1 to Mewidew and US 9050065 B2 to Whitman 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.
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