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 .
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.
Claim(s) 34-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanders (U.S. Pub. No. 2010/0312249 A1, hereinafter “Sanders”) in view of Weisel et al. (U.S. Pub. No. 2006/0069399 A1, hereinafter “Weisel”).
Sanders discloses, regarding claim 32, a method of retrieving a bone tie (48, see Fig. 1), the method comprising: forming a first lumen through a first bone portion and a second bone portion (see annotated Fig. 1 below); forming a second lumen in the second bone portion (see annotated Fig. 1 below); advancing a retriever portion of a shaft of a bone tie retriever into the second lumen (see annotated Fig. 1 below), the bone tie retriever comprising a depth stop (32) protruding laterally from the shaft of the bone tie retriever (see Fig. 1, see para. [0041]), a catcher mechanism (see annotated Fig. 1 below), wherein the depth stop limits the depth of penetration of the bone tie retriever relative to the second bone portion when the depth stop abuts the second bone portion (see Fig. 1, see para. [0041]); and removing the bone tie retriever (see para. [0048]).
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Regarding claim 34, wherein the first lumen and the second lumen intersect (see Fig. 1).
Regarding claim 35, wherein the depth stop positions the bone tie retriever relative to a bone tie advancer (see Fig. 1).
Regarding claim 36, wherein the depth stop facilitates alignment of a channel of the retriever portion with the first lumen (see Fig. 1).
Regarding claim 37, wherein a head (50, e.g. bead, see para. [0044]) of the bone tie is retained by the bone tie retriever (see paras. [0044]-[0045]).
Regarding claim 38, further comprising advancing the catcher mechanism to retain a head (50, e.g. bead, see para. [0044]) of the bone tie within the retriever portion (see paras. [0044]-[0045]).
Sanders fails to disclose, regarding claim 32, wherein the depth stop is proximal to one or more alignment features that facilitate sliding of the catcher mechanism.
Weisel discloses a method of using a surgical suturing device (10, see Figs. 1-3), to retrieve a bone tie (32) with a catch (28), and a depth stop (e.g. end of 14), the catch includes one or more alignment features (18) that facilitate sliding of the catcher mechanism (see Figs. 1-2), wherein the depth stop is proximal to one or more alignment features (see annotated Fig. 1 below) in order to prevent the catch from entering the shaft in the retracted position (see para. [0071]) and in order to enable the surgeon to retract and extend in a controlled manner with a thumb slide (see para. [0073]).
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the catch in Sanders to include one or more alignment features that facilitate sliding of the catcher mechanism, wherein the depth stop is proximal to one or more alignment features in view of Weisel in order to in order to prevent the catch from entering the shaft in the retracted position and in order to enable the surgeon to retract and extend in a controlled manner with a thumb slide.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sanders in view of Weisel, as applied to claim 32 above, and in further view of Alamin et al. (U.S. Pub. No. 2006/0004367 A1, hereinafter “Alamin”).
Sanders in view of Weisel discloses all of the features of the claimed invention, as previously set forth above. Sanders further discloses creating lumens in the bone of the patient which may be other locations, than shown (see para. [0016]), however fails to explicitly disclose, regarding claim 33, wherein the first lumen extends through the facet joint space.
Alamin discloses a method of creating opposing lumens through a facet joint (see Fig. 2, see para. [0045]) in order to enable the surgeon to apply compressive forces across the facet joints to promote fusion and / or stabilizing the joints (see para. [0045]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Sanders in view of Weisel to be used in the spine and to have the lumens extending through the facet joint space in further view of Alamin in order to enable the surgeon to use the bone tie, tools, and method in other locations such as enabling the surgeon to apply compressive force across the facet joints to promote fusion and/or stabilizing the joints.
Claim(s) 39-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fallin et al. (U.S. Pub. No. 2017/0112511 A1, hereinafter “Fallin”) and in view of Howlett et al. (U.S. Pub. No. 2011/0054483 A1, hereinafter “Howlett”).
Fallin discloses, regarding claim 39, a method of retrieving a bone tie (191, see Figs. 1, 5-8, see para. [0043]), the method comprising: advancing a retriever portion (see annotated Fig. 7 below) of a bone tie retriever (110) into a lumen of a bone portion (see annotated Fig. 5 below), wherein the bone tie retriever is advanced into the lumen a depth (150) relative to a surface of the bone portion (e.g. surface of 198), wherein the bone tie retriever extends into the bone portion a predetermined distance (see Fig. 5, see paras. [0039]-[0040]); and retrieving the bone tie with the bone tie retriever (see para. [0037] “passer 136 may then be used to pull a flexible element such as, for example, a passing suture or a repair suture through the tunnel members 110, 120 to pass the flexible element through, for example, a bone”).
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Regarding claim 40, further comprising aligning a channel (146) of the bone tie retriever with a curved lumen (166, see Fig. 7).
Regarding claim 41, wherein the lumen is straight (see Fig. 5, see para. [0039] “tunnel”, see also annotated Fig. 7 above).
Regarding claim 42, wherein the depth stop is positioned proximal (note that when 188 is positioned within 146 and 166, the depth stop is positioned proximal) to a catcher mechanism (188).
Regarding claim 43, further comprising retaining a head (e.g. end of 191 placed in loop 188) of the bone tie within the retriever portion (see para. [0043]).
Fallin discloses indicia (150) to indicated a depth of penetration into the bone (see para. [0039]); however, Fallin fails to explicitly disclose, regarding claim 39, the bone tie retriever comprising a depth stop larger than the lumen, wherein the bone tie retriever is advanced into the lumen until the depth stop abuts an outer surface of the bone portion, wherein the bone tie retriever extends into the bone portion a predetermined distance; and wherein the depth stop is fixed relative to the retriever portion of the bone tie retriever; and forming a lumen in a bone portion with a lumen-forming tool; removing the lumen-forming tool from the lumen.
Fallin discloses using a lumen-forming tool (204 and 206) to form a second lumen in the bone (see Fig. 20, see para. [0053] “second, or medial, tunnel”) and removing the lumen-forming tool from the second lumen (e.g. prior to insertion of 120, see Figs. 20-21 and paras. [0053]-[0054]) in order to create a small puncture to cause minimal trauma to the tissues and facilitate multiple targeting attempts if needed (see para. [0053]).
Howlett discloses a drill bit (102) for insertion into a bone (see Figs. 1-3, see para. [0009]) with an adjustable depth stop (106, see paras. [0009] and [0015]) that abuts the surface of the bone (see para. [0009]) and has a larger diameter / extends laterally from the drill bit (see Fig. 1) and wherein the depth stop is fixed relative to the retriever portion of the bone tie retriever (note that once the snap fit is engaged the depth stop is considered fixed relative to the sleeve / drill bit, see para. [0018] “snap-fit is sufficient to secure the stop 106 both rotationally and axially relative to the sleeve 104 and, in turn, drill bit 102”) in order to provide the surgeon with careful and precise control over the depth of the bore and provide the surgeon with added safety against drilling the bore too deep (see para. [0009]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Fallin to include using a lumen-forming tool to form a lumen in the bone and removing the lumen-forming tool from the lumen prior to advancing a retriever portion into the lumen in view of Fallin in order to create a small puncture to cause minimal trauma to the tissues and facilitate multiple targeting attempts if needed. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bone tie retriever in Fallin to comprise a depth stop having a larger diameter / laterally protruding than / from the retriever portion of the bone tie retriever, wherein the bone tie retriever is advanced into the second lumen until the depth stop abuts a surface of the bone, and adjusting the position of the depth stop in view of Howlett in order to provide the surgeon with careful and precise control over the depth of the insertion and provide the surgeon with added safety against too deep insertion.
Allowable Subject Matter
Claim(s) 24-31 is/are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof could be found which disclose, or suggest: a method of retrieving a bone tie, the method comprising: advancing a retriever portion of a bone tie retriever into the second lumen, the bone tie retriever comprising a depth stop, wherein the bone tie retriever is advanced into the second lumen until the depth stop abuts a surface of the second bone portion, wherein the depth stop positions the retriever portion relative to the first lumen; and as per claim 24, wherein a catch of a catcher mechanism is configured to slide only distal to the depth stop and proximal to a distal end of the retriever portion.
Response to Arguments
Applicant's arguments filed 6/17/2026, with respect to claim(s) 32-38, have been fully considered and with regard to the typographical error on page 6 of the office action mailed on 3/25/2026 addressing the claim limitation of claim 32 is persuasive. The Office action used Weisel to teach the inclusion of one or more alignment features (18) that facilitate sliding of the catcher mechanism (28). However incorrectly addressed the limitation of claim 32 as reciting “one or more alignment features (18) that facilitate sliding of the catcher mechanism (see Figs. 1-2) that are proximal to the depth stop (e.g. 14, see Fig. 1)” (emphasis added), instead of “wherein the depth stop is proximal to one or more alignment features that facilitate sliding of the catcher mechanism” (emphasis added), as required by claim 32. The rejection has been modified to correctly refer to this limitation, however the argument of Weisel not disclosing a depth stop that is proximal to the one or more alignment features is not considered persuasive. Since claim 32 does not set forth a reference direction for what is considered proximal and distal relative to the parts of the bone retriever, the Weisel rejection still applies, since the depth stop in Weisel can be considered to be proximal to the one or more alignment features (see annotated Fig. 1 above).
Applicant's arguments filed 6/17/2026 with respect to the amendments to claim(s) 39-43 have been fully considered but they are not persuasive. The Applicant asserts that Fallin in view of Howlett fails to disclose, regarding the amendment to claim 39, “forming a lumen in a bone portion with a lumen-forming tool; removing the lumen-forming tool from the lumen”. The Office respectfully disagrees. Fallin discloses using a lumen-forming tool (204 and 206) to form a second lumen in the bone (see Fig. 20, see para. [0053] “second, or medial, tunnel”) and removing the lumen-forming tool from the second lumen (e.g. prior to insertion of 120, see Figs. 20-21 and paras. [0053]-[0054]) in order to create a small puncture to cause minimal trauma to the tissues and facilitate multiple targeting attempts if needed (see para. [0053]). As set forth above, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method in Fallin to include using a lumen-forming tool to form a lumen in the bone and removing the lumen-forming tool from the lumen prior to advancing a retriever portion into the lumen in view of Fallin in order to create a small puncture to cause minimal trauma to the tissues and facilitate multiple targeting attempts if needed.
Conclusion
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/M.C.G/ Examiner, Art Unit 3773 /JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
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