Detailed Action
This is the first office action on the merits for US application number 19/287,311.
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 .
Priority
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/483,261, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 63/483,261 fails to provide adequate support for the “the proximal head portion comprises at least one bone engaging projection extending about outer sides thereof” of claim 4, the “a portion of the tether extends along the main body over the bone engagement projections” of claim 12, and the “the at least one secondary static bone anchor comprises an open cavity with at least one tether retention cross-member within the open cavity” of claim 18.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claim 4, the specification appears to lack proper antecedent basis for “the proximal head portion comprises at least one bone engaging projection extending about outer sides thereof”. That is, the specification is silent to such a disclosure and instead defines 111 as the head portion in ¶66 as shown in Fig. 10, which head 111 as having a generally conical shape with no structure that appears to be reasonably considered to be a one bone engaging projection extending about outer sides. Thus, the specification fails to provide proper antecedent basis for “the proximal head portion comprises at least one bone engaging projection extending about outer sides thereof”.
As to claim 12, the specification appears to lack proper antecedent basis for “a portion of the tether extends along the main body over the bone engagement projections”. That is, the specification is silent to such a disclosure and instead that the tether extends through groove 108 in ¶64. Thus, the specification fails to provide proper antecedent basis for “a portion of the tether extends along the main body over the bone engagement projections”.
As to claim 18, the specification appears to lack proper antecedent basis for “the at least one secondary static bone anchor comprises an open cavity with at least one tether retention cross-member within the open cavity”. That is, the specification is silent to such a disclosure and instead discloses that the static bone-engagement anchor 400 of Fig. 20 is configured to couple directly within a bone, and not with a bone plate or other bone-intermediary construct (¶87) with a similar disclosure for anchor 500 of Fig. 21 in ¶89. However, such is silent to the disclosure of the claimed cross-member. Thus, the specification fails to provide proper antecedent basis for “the at least one secondary static bone anchor comprises an open cavity with at least one tether retention cross-member within the open cavity”.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the ”the proximal head portion comprises at least one bone engaging projection extending about outer sides thereof” of claim 4, “a portion of the tether extends along the main body over the bone engagement projections” of claim 12, and “discloses that the tether comprises a plurality of tethers (Fig. 4), “wherein the at least one secondary static bone anchor comprises an open cavity with at least one tether retention cross-member within the open cavity” of claim 18, and wherein at least one the plurality of tethers is capable of use a tether passer comprising at least one loop or through hole (if one so chooses to use one as such)” of claim 20 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1, 8, 10/10a, 10/10b, 22, and 25 is/are objected to because of the following informalities:
Claim 1 line 1 should read “An implant system for dynamic stabilization of bones and/or tissue, the implant system comprising:”.
Claim 8 should read “wherein the distal portion of the piston member extends into a cannulation of the bumper”.
Claim 10/10a should read “the resilient bumper is positioned within the cannulation of the body portion”.
Claim 10/10b should read “the cannulation of the main body extends to a top side of the head portion”.
Claim 22 should read “the tether is coupled to a tensioning handle of the instrument that is removably and rotatably coupled to a housing body, and wherein the instrument is configured such that rotation of the tensioning handle wraps the tether about a portion of the tensioning handle and[[,]] facilitates tensioning the tether.”
Claim 25 should read “a method of dynamically stabilizing a distal tibiofibular syndesmosis joint, the method comprising:”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C.112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “retaining feature” in claim 1 line 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-25 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim(s) 1 is/are unclear with regards to at least one secondary tether anchor in line 4 being listed under the at least one tether section. Examiner is interpreting this as referring to, and suggests amending as, the implant system “comprising:
a dynamic bone anchor; [[and]]
at least one tether extending through and between the dynamic bone anchor; and
at least one secondary tether anchor,
wherein the dynamic bone anchor comprises:”.
Claim(s) 1 is/are unclear with regards to “a piston member positioned within the cannulation of the main body; and a resilient bumper positioned within cannulation of the body portion between at least a portion of the bumper and a retaining feature within the cannulation of the body portion” in lines 9-12 being indented under as part of the cannulated main body. Examiner is interpreting the piston member and the resilient bumper as referring to part of the dynamic bone anchor and not part of the cannulated main body while the retaining member is the wall of the main body an equivalents thereof as detailed in paragraphs 15 and 66 and suggests amending accordingly, e.g. adjusting the indenting and moving the retaining feature limitation.
Claim(s) 1 recites/recite the limitation “the cannulation of the main body” in line 9. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “[[the]]a cannulation of the main body”.
Claim(s) 1 is/are unclear with regards to “a resilient bumper positioned within cannulation of the body portion between at least a portion of the bumper” in lines 10-11 and how one is to reasonably interpreted the bumper positioned between a portion of itself. Further, there is insufficient antecedent basis for “cannulation of the body portion” in the claim. Examiner is interpreting this as referring to, and suggests amending as, “a resilient bumper positioned within a cannulation of the body portion
Claim(s) 1 is/are unclear with regards to “a retaining feature within the cannulation of the body portion” in lines 11-12 and how the retaining feature and equivalents thereof can be reasonably interpreted as being “within the cannulation of the body portion” when the retaining feature is defined as an interior wall of the body portion (¶s 15 and 66). That is, it is unclear how an interior wall can both define the cannulation and be within the cannulation for the inner walls shown in Fig. 10. Examiner is interpreting this as referring to, and suggests amending as, “a retaining feature
Claim(s) 10 and 10 is/are unclear with regards to there being 2 claims numbered as 10. Examiner is interpreting this as claim 10a and 10b throughout and suggests amending to appropriately number the claims, e.g. to cancel one of the claim 10s and provide such scope as may be desired in a new claim 24.
Claim(s) 11 is/are unclear with regards to its dependency from claim 10 and which of the claim 10s such is intended to depend from. Examiner is interpreting this as referring to 10/10b and suggests amending to correct for the duplicate claim numbering as indicated above.
Claim(s) 16-18 is/are unclear with regards to the dependency on claims 15 and 16 and where the secondary anchor is originally shown and described to comprise a soft anchor able to deform and a bone plate and a cap and a static anchor, i.e. there appears to be no such support for these used as one anchor. Instead, Examiner is interpreting this as referring to the system comprising each of these structures and suggests amending to clarify.
Claim(s) 23 recites/recite the limitation "the cannulation of the head portion". There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “[[the]]a cannulation of the head portion”. However, this is further unclear as there are a total of three cannulations recited, i.e. that of the main body in claim 1 line 9, that of the body portion in claim 1 line 10, and that of the head portion of claim 23. Thus, it is unclear to what cannulation is being recited in claim 23 that is in addition to the previously recited cannulations. Examiner is interpreting these cannulations as referring to portions of a cannulation and suggests amending to clarify.
Claim(s) 24 recites/recite the limitation " the length of the portion of the tether ". There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “[[the]]a length of [[the]]a portion of the tether”.
Claim(s) 25 recites/recite the limitation "at least one of a fibula or a tibia of the joint". There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, at least one of a fibula or a tibia of [[the]]a joint”.
Claim(s) 2-9, 12-15, and 19-22 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
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 of this title, 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) 1-7, 9-14, 20, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderhub et al. (US 2009/0326579, hereinafter “Anderhub”) in view of Nguyen et al. (US 2011/0112576, hereinafter “Nguyen”).
As to claims 1-7, 9-12, 20, and 21, Anderhub discloses an implant system (abstract) capable of use for dynamic stabilization of bones and/or tissue (¶s 31 and 37), comprising: a dynamic bone anchor (100); at least one tether (156, 157, Fig. 4) extending through and between the dynamic bone anchor (Fig. 4, ¶41); and at least one secondary tether anchor (¶43 discloses the suture strands being attached to bone, ¶49 discloses the suture strands being attached to living tissue as a ligament or tendon, i.e. by an anchor), wherein the dynamic bone anchor comprises: a cannulated main body (102) comprising: a proximal head portion (see illustration of Fig. 1, Fig. 1), a distal end portion (see illustration of Fig. 1, Fig. 1) and a body portion (see illustration of Fig. 1, Fig. 1) extending between the proximal head portion and the distal end portion (as defined, Fig. 1); a piston member (104) positioned within a cannulation of the main body (112, Fig. 3); and a resilient bumper (138, Fig. 3, ¶37) positioned within a cannulation of the body portion (Fig. 3, ¶37) and a retaining feature (140, Fig. 3, ¶37), wherein the body portion comprises bone engagement projections (108) extending about outer sides thereof (Fig. 1, ¶31), wherein the body portion comprises an outer opening (130 above 132 as shown in Figs. 1 and 2, Figs. 1 and 2, ¶33) extending through the bone engagement projections (Figs. 1 and 2), wherein the piston member comprises a first lateral through hole (portion of 126 that defines 132 as shown in Figs. 1 and 2, Figs. 1 and 2, ¶33), and the distal end portion comprises a second lateral through hole (portion of 130 that defines 132 as shown in Figs. 1 and 2, Figs. 1 and 2, ¶33) that is in communication with the first lateral through hole (Figs. 1 and 2, ¶33), and wherein the body portion comprises a lateral aperture (opening of the portion of 130 that defines 132 on the front side as shown in Figs. 1 and 2, Figs. 1 and 2, ¶33) that is in communication with the cannulation thereof (Figs. 1 and 2, ¶33) and is substantially aligned with the outer groove (Figs. 1 and 2, ¶33). As to claim 2, Anderhub discloses that the lateral aperture is positioned within the outer opening (Figs. 1 and 2, ¶33). As to claim 3, Anderhub discloses that the first lateral through hole is substantially aligned with the outer opening (Figs. 1 and 2, ¶33). As to claim 4, Anderhub discloses that the proximal head portion comprises at least one bone engaging projection extending about outer sides thereof (in as much as Applicant’s, Fig 1). As to claim 5, Anderhub discloses that the distal end portion is void of a bone engaging projection (at the lower most portion as shown in Fig. 3, Fig. 3). As to claim 6, Anderhub discloses that the piston member is capable of moving retained within the cannulation of the main body (along 136/134, Figs. 1 and 3, ¶35). As to claim 7, Anderhub discloses that a distal portion of the piston member comprises an elongated slot (126 above 132 as shown in Figs. 1-3, Figs. 1-3), and wherein a pin member (116) extends from a wall portion of the main body (Fig. 3) into the elongated slot (Fig. 3) capable of limiting the travel of the piston member through the cannulation (via 136, Fig. 3, ¶35). As to claim 9, Anderhub discloses that the retaining feature comprises an interior wall of the body portion (as defined, Fig. 3, ¶37). As to claim 10/10a, Anderhub discloses that the resilient bumper is positioned within the cannulation of the body portion between a distal portion of the bumper and the interior wall (Fig. 3, ¶37). As to claim 10/10b, Anderhub discloses that the cannulation of the main body extends to a top side of the head portion such that the cannulation forms a top side opening at the top side of the head portion that is in communication with the cannulation and the lateral aperture (Figs. 1-3). As to claim 11, Anderhub discloses that a portion of the tether extends through the top side opening, through the cannulation of the main body to the lateral aperture, through the lateral aperture, and along the outer opening to the second lateral through hole (Figs. 3 and 4). As to claim 12, Anderhub discloses that a portion of the tether extends along the main body over the bone engagement projections (, laterally through a first side of the second lateral throughhole, laterally through the first lateral throughhole, and laterally through a second side of the second lateral through hole in as much as Applicants, Figs. 1-4). As to claim 20, Anderhub discloses that the tether comprises a plurality of tethers (Fig. 4), and wherein at least one the plurality of tethers is capable of use a tether passer comprising at least one loop or through hole (if one so chooses to use one as such). As to claim 21, Anderhub discloses an instrument (Figs. 8-13) coupled with a dynamic bone anchor of the at least one dynamic bone anchor (Figs. 8-13) capable of inserting the dynamic bone anchor into a bone (502, Fig. 8, ¶49).
Anderhub is silent to the outer opening being an outer groove.
Nguyen teaches a similar implant system (Figs. 1-7) capable of use for dynamic stabilization of bones and/or tissue (¶3), the implant system comprising: a bone anchor (10) and at least one tether (44, Fig. 4) extending through the bone anchor (Fig. 4, ¶73), wherein the bone anchor comprises: a cannulated main body (20, Figs. 1-2B) comprising: a proximal head portion (see illustration of Fig. 1, Fig. 1), a distal end portion (see illustration of Fig. 1, Fig. 1) and a body portion (see illustration of Fig. 1, Fig. 1) extending between the proximal head portion and the distal end portion (as defined, Fig. 1); a piston member (30, Figs. 1 and 3) positioned within a cannulation of the main body (23, Figs. 1-2B); and wherein the body portion comprises bone engagement projections (28) extending about outer sides thereof (Figs. 1-2B), wherein the body portion comprises an outer groove (29) extending through the bone engagement projections (Figs. 1-2B), wherein the distal end portion comprises a lateral through hole (25, Figs. 1-2B), and wherein the body portion comprises a lateral aperture (25a, Figs. 1-2B, ¶70) that is in communication with the cannulation thereof (Figs. 1-2B, ¶70) and is substantially aligned with the outer groove (Figs. 1-2B). As to claim 2, Nguyen teaches that the lateral aperture is positioned within the outer groove (Figs. 1-2B, ¶70). As to claim 3, Nguyen teaches that the first lateral through hole is substantially aligned with the outer groove (Figs. 1-2B, ¶70).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the outer opening as disclosed by Anderhub to be an outer groove as taught by Nguyen in order to provide a housing for the suture/tether after positioning in bone (Nguyen ¶70).
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As to claim 13, the combination of Anderhub and Nguyen discloses the invention of claim 1 as well as use to attach soft tissue, such as a tendon or a ligament, to a bone (¶5).
The combination of Anderhub and Nguyen is silent to the system comprises a plurality of the dynamic bone anchors.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to construct the system of the combination of Anderhub and Nguyen having a plurality of the dynamic bone anchors, since mere duplication of the essential working parts of a device involves only routine skill in the art and one would be motivated to do so in order to provide attach soft tissue, such as a tendon or a ligament, to a bone (Anderhub ¶5) with improved additional stability and securement of the connection with improved durability of the connection.
Claim(s) 8 is/are rejected under 35 U.S.C.103 as being unpatentable over Anderhub and Nguyen in view of Eggli et al. (US 2012/0130492, hereinafter “Eggli”).
As to claim 8, the combination of Anderhub and Nguyen discloses the invention of claim 7 as well as the distal portion of the piston member extends to a cannulation of the bumper (Fig. 3).
The combination of Anderhub and Nguyen is silent to the distal portion of the piston member extends into the cannulation of the bumper.
Eggli teaches a similar system (10, 20, 30, Figs. 1 and 2) capable of use for dynamic stabilization of bones (Figs. 1 and 2), the system comprising: a dynamic bone anchor (10, Fig. 2); at least one tether (20) extending through the dynamic bone anchor (Figs. 1 and 2); and at least one secondary tether anchor (30), wherein the dynamic bone anchor comprises: a cannulated main body (3, Fig. 2, ¶40) comprising: a proximal head portion (4), a distal end portion (5) and a body portion (portion between 4 and 5 as shown in Fig. 2, Fig. 2) extending between the proximal head portion and the distal end portion (as defined, Fig. 2); a piston member (14) positioned within a cannulation of the main body (6, Fig. 2); and a resilient bumper (13) positioned within a cannulation of the body portion (Fig. 2) and a retaining feature (surface of 5 as shown in Fig. 2, Fig. 2), wherein the body portion comprises bone engagement projections (revolutions of 2, Fig. 2, ¶40) extending about outer sides thereof (Fig. 2), wherein the distal portion of the piston member comprises a protruding portion (16) that extends into a cannulation of the bumper (Fig. 2).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the distal portion of the piston member as disclosed by the combination of Anderhub and Nguyen by adding the protruding portion as taught by Eggli in order to surround the piston member with the resilient bumper (Eggli ¶41) in a known engagement between a piston member and resilient bumper (Eggli Fig. 2).
Claim(s) 15 is/are rejected under 35 U.S.C.103 as being unpatentable over Anderhub and Nguyen in view of Denham (US 2017/0172561).
As to claim 15, the combination of Anderhub and Nguyen discloses the invention of claim 14 as well as use to attach soft tissue, such as a tendon or a ligament, to a bone (¶5).
The combination of Anderhub and Nguyen is silent to the at least one secondary tether anchor comprises at least one soft bone anchor that is configured to deform into an enlarged shape upon tensioning of the tether extending thereto.
Denham teaches a similar system (20, Figs. 1-6) comprising: a tether (26) and at least one secondary tether anchor (22, 24, Fig. 1); wherein the at least one secondary tether anchor comprises at least one soft bone anchor (22) that is capable of deforming into an enlarged shape (Fig. 2) upon tensioning of the tether extending thereto (Figs. 1-6).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify that the at least one secondary tether anchor as disclosed by the combination of Anderhub and Nguyen includes a secondary tether anchor as taught by Denham in order to provide a known secondary tether anchor to attach soft tissue, such as a tendon or a ligament, to a bone (Anderhub ¶5; Denham Fig. 2).
Claim(s) 16-18 is/are rejected under 35 U.S.C.103 as being unpatentable over Anderhub, Nguyen, and Denham in view of Lyon (US 2013/0123841).
As to claims 16-18, the combination of Anderhub, Nguyen, and Denham discloses the invention of claim 15 as well as use to attach soft tissue, such as a tendon or a ligament, to a bone (¶5).
The combination of Anderhub, Nguyen, and Denham is silent to the at least one secondary tether anchor comprises at least one bone plate. As to claim 17, the combination of Anderhub, Nguyen, and Denham is silent to the at least one secondary tether anchor further comprises at least one anchor cap configured to couple with an aperture of the at least one bone plate, the at least one anchor cap comprising an open cavity with at least one tether retention cross-member within the open cavity. As to claim 18, the combination of Anderhub, Nguyen, and Denham is silent to the at least one secondary tether anchor comprises at least one static bone anchor configured to couple with an aperture of the at least one bone plate, the at least one static bone anchor comprising an open cavity with at least one tether retention cross-member within the open cavity.
Lyon teaches a similar system (Figs. 1-5 and 9-17) comprising: a tether (18) and at least one secondary tether anchor (12, 14, 16, Fig. 1); wherein the at least one secondary tether anchor comprises at least one bone plate (14, Fig. 1, 2, 4, 13, and 14). As to claim 17, Lyon teaches that the at least one secondary tether anchor further comprises at least one anchor cap (12, Fig. 1) capable of coupling with an aperture (50) of the at least one bone plate (Figs. 1-5 and 9-17), the at least one anchor cap comprising an open cavity (22) with at least one tether retention cross-member (30) within the open cavity (Fig. 1). As to claim 18, Lyon teaches that the at least one secondary tether anchor comprises at least one static bone anchor (12) capable of coupling with an aperture (50) of the at least one bone plate (Figs. 1-5 and 9-17), the at least one static bone anchor comprising an open cavity (22) with at least one tether retention cross-member (30) within the open cavity (Fig. 2).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify that the at least one secondary tether anchor as disclosed by the combination of Anderhub, Nguyen, and Denham includes a secondary tether anchor as taught by Lyon in order to provide a known secondary tether anchor to attach to a bone (Anderhub ¶5; Denham Fig. 2) to stabilize and fixate bone fractures (Lyon Figs. 13 and 14, ¶s 2 and 11).
Claim(s) 19 is/are rejected under 35 U.S.C.103 as being unpatentable over Anderhub and Nguyen in view of Singhatat et al. (US 2007/0142837, hereinafter “Singhatat”).
As to claim 19, the combination of Anderhub and Nguyen discloses the invention of claim 1 as well as use to attach soft tissue, such as a tendon or a ligament, to a bone (¶5).
The combination of Anderhub and Nguyen is silent to the at least one secondary tether anchor comprises at least one secondary static bone anchor configured to couple directly within a bone and not with a bone plate, wherein the at least one secondary static bone anchor comprises an open cavity with at least one tether retention cross-member within the open cavity.
Singhatat teaches a similar system (Figs. 4-14) comprising: a tether (30, Figs. 10-14) and at least one secondary tether anchor (200, Figs. 4-14); wherein the at least one secondary tether anchor comprises at least one secondary static bone anchor (4-14) capable of coupling directly within a bone and not with a bone plate (Figs. 4-14, ¶s 72, 73, 77, and 78), wherein the at least one secondary static bone anchor comprises an open cavity (225, Figs. 4-6) with at least one tether retention cross-member (230, Fig. 6) within the open cavity (Figs. 4-14).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify that the at least one secondary tether anchor as disclosed by the combination of Anderhub and Nguyen includes a secondary tether anchor as taught by Singhatat in order to provide a known secondary tether anchor to attach soft tissue, such as a tendon or a ligament, to a bone (Anderhub ¶5) to attach the suture/tether to bone (Singhatat ¶76).
Claim(s) 22 is/are rejected under 35 U.S.C.103 as being unpatentable over Anderhub and Nguyen in view of Rogers et al. (US 2022/0079576, hereinafter “Bojarski”).
As to claim 22, the combination of Anderhub and Nguyen discloses the invention of claim 21 as well as use to attach soft tissue, such as a tendon or a ligament, to a bone (¶5) and tensioning the tether (¶43) and providing a tension indicator (508, Fig. 8, ¶57).
The combination of Anderhub and Nguyen is silent to the tether is coupled to a tensioning handle of the instrument that is removably and rotatably coupled to a housing body, and wherein the instrument is configured such that rotation of the tensioning handle wraps the tether about a portion of the tensioning handle and, facilitates tensioning the tether, how the instrument is used to tension the tether as well as what structures are used to provide the tension.
Rogers teaches a similar system (10a, 10b, 20, 200, 300/500, Figs. 1A, 2A, 3A-6B) comprising: at least one bone anchor (200, 10a), a tether (20), a secondary tether anchor (10b), and an instrument (300/500) coupled with a bone anchor of the at least one bone anchor (Figs. 3A-4C) capable of inserting the bone anchor into a bone (Fig. 4A, ¶45), wherein the tether is coupled to a tensioning handle of the instrument (315, 310, 312) that is removably and rotatably coupled to a housing body (303, Figs. 3A, 4A, 4B, and 5B, ¶s 46 and 47), and wherein the instrument is configured such that rotation of the tensioning handle wraps the tether about a portion of the tensioning handle and facilitates tensioning the tether (Fig. 4C, ¶47).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify that the instrument and tensioning the tether as disclosed by the combination of Anderhub and Nguyen have a tensioning handle of removably and rotatably coupled to a housing body such that rotation of the tensioning handle wraps the tether about a portion of the tensioning handle and facilitates tensioning the tether as taught by Rogers in order to provide a known tensioning structure and process of tensioning a tether (Rogers Fig. 4C, ¶47) to achieve a target tension on the tether based on the mechanical properties of the and the desired laxity of the patient's joint or connection to avoid potentially inhibiting healing and integration of the primary tissue repair construct as well as potentially over-stressing or straining and potential failure of the primary repair construct (Rogers ¶48).
Claim(s) 23 and 24 is/are rejected under 35 U.S.C.103 as being unpatentable over Anderhub and Nguyen in view of Curtis et al. (US 2024/0225631, hereinafter “Curtis”).
As to claims 23 and 24, the combination of Anderhub and Nguyen discloses the invention of claim 21 as well as use to attach soft tissue, such as a tendon or a ligament, to a bone (¶5) and the tether extends through the first and lateral through holes (Fig. 2, ¶33), and wherein the tether extends from a cannulation of the head portion (via the through holes, Figs. 2 and 4).
The combination of Anderhub and Nguyen is silent to the tether extends from between the dynamic bone anchor and an insertion portion of the instrument that houses the dynamic bone anchor and out a distal end of the insertion portion. As to claim 24, the combination of Anderhub and Nguyen is silent to a length of a portion of the tether that extends between the dynamic bone anchor and the insertion portion to the distal end of the insertion portion substantially equals a longitudinal length of a portion of the dynamic bone anchor that is housed in the insertion portion from the distal end of the insertion portion.
Curtis teaches a similar system (102, 140, 150, 130, Figs. 1A-14) comprising: at least one bone anchor (102), a tether (140), and an instrument (150, 130) coupled with a bone anchor of the at least one bone anchor (Fig. 10-12B) capable of inserting the bone anchor into a bone (Figs. 12A and 12B, ¶89), wherein the tether extends from between the bone anchor and an insertion portion of the instrument that houses the bone anchor and out a distal end of the insertion portion (Figs. 10-12A). As to claim 24, Curtis teaches that a length of a portion of the tether that extends between the bone anchor and the insertion portion to the distal end of the insertion portion substantially equals a longitudinal length of a portion of the bone anchor that is housed in the insertion portion from the distal end of the insertion portion (Fig. 11).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify that the instrument as disclosed by the combination of Anderhub and Nguyen comprises an insertion end that houses the bone anchor as taught by Curtis in order to provide the system preloaded with the suture through the throughholes in the anchor to be passed through tissue to the bone (Curtis ¶86) to aid in attaching to a bone (Anderhub ¶5).
Claim(s) 25 is/are rejected under 35 U.S.C.103 as being unpatentable over Anderhub and Nguyen in view of Lyon (US 2013/0123841).
As to claim 25, the combination of Anderhub and Nguyen discloses the invention of claim 1 as well as use to attach soft tissue, such as a tendon or a ligament, to a bone (¶5) in a method of dynamically stabilizing (¶5), the method comprising: obtaining the implant system of claim 1 (see above).
The combination of Anderhub and Nguyen is silent to the method stabilizing a distal tibiofibular syndesmosis joint and implanting the dynamic bone anchor into at least one of a fibula or a tibia of a joint; and implanting the at least one secondary tether anchor into the other of the fibula or the tibia, wherein implanting the dynamic bone anchor comprises tensioning the tether between the dynamic bone anchor and the at least one secondary tether anchor to dynamically stabilize the joint.
Lyon teaches a similar system (Figs. 1-5 and 9-17) used in a method of stabilizing a distal tibiofibular syndesmosis joint (Figs. 13 and 14), the method comprising: obtaining the implant system (Figs. 1-5 and 9-17) comprising: a bone anchor (12), a tether (18), and at least one secondary tether anchor (14, 16, Fig. 1); implanting the bone anchor into at least one of a fibula or a tibia of a joint (Figs. 13 and 14); and implanting the at least one secondary tether anchor into the other of the fibula or the tibia (Figs. 13 and 14), wherein implanting the dynamic bone anchor comprises tensioning the tether between the dynamic bone anchor and the at least one secondary tether anchor to stabilize the joint (Figs. 13-15 and 17).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify that the method of dynamically stabilizing as disclosed by the combination of Anderhub and Nguyen to be used to stabilize a distal tibiofibular syndesmosis joint as taught by Lyon in order to provide a known secondary tether anchor to attach to a bone (Anderhub ¶5) to stabilize and fixate bone fractures (Lyon Figs. 13 and 14, ¶s 2 and 11).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see the attached PTO-892, Notice of References Cited.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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