Detailed Action
This is the first office action on the merits for US application number 19/252,910.
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 Objections
Claim(s) 1, 8, and 15 is/are objected to because of the following informalities:
Claim 1 line 1 should read “a soft tissue, the system comprising”.
Claim 1 line 20 should read “interlocking with [[of ]]a first bone block”.
Claim 8 line 1 should read “a soft tissue, the system comprising”.
Claim 15 line 1 should read “a soft tissue, the system comprising”.
Appropriate correction is required.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donnelly et al. (US 2005/02070905, hereinafter “Donnelly”) in view of Hyer et al. (US 2022/0152715, hereinafter “Hyer”).
The claimed phrases “formed” and “pre-formed” are being treated as product by process limitations; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claim 1-7, Donnelly discloses a system (5, 200, 50, 300, 310, Figs. 1A-10) capable of reconstructing a soft tissue (abstract), the system comprising: a first interference bone screw (femoral 5, Figs. 1A-1C, 6, and 10, ¶42) comprising: a first shaft (Figs. 1A-1C) comprising: a first proximal end (16); a first distal end (14); and a first longitudinal axis (horizontal as shown in Figs. 1A and 1C, Figs. 1A and 1C); and a first helical thread (thread shown in Figs. 1A-1C and described as “plurality of thread flights 30” in ¶39, Figs. 1A-1C, ¶39) disposed about the first shaft along the first longitudinal axis between a first location and a second location along the first shaft (Figs. 1A-1C); and a second interference bone screw (tibial 5, Figs. 1A-1C, 9, and 10, ¶42) comprising: a second shaft (Figs. 1A-1C) comprising: a second proximal end (16); a second distal end (14); and a second longitudinal axis (horizontal as shown in Figs. 1A and 1C, Figs. 1A and 1C); and a second helical thread (thread shown in Figs. 1A-1C and described as “plurality of thread flights 30” in ¶39, Figs. 1A-1C, ¶39) disposed about the second shaft along the second longitudinal axis between a third location and a fourth location along the second shaft (Figs. 1A-1C), wherein: the first helical thread of the first interference bone screw is capable of interlocking with a first bone block (femoral 220, Figs. 6 and 10, ¶42 discloses tapping the bone tunnel and bone block and then threading 5 in to secure the bone block in the bone tunnel), the first bone block with which the first interference bone screw is capable of interlocking placed intermediate the first interference bone screw and a first portion of a soft tissue implant (portion of 210 connected to the first bone block, Figs. 3 and 10) within a first bone tunnel formed in a first bone (Figs. 6 and 10, ¶42); and the second helical thread of the second interference bone screw is capable of interlocking with a second bone block (tibial 220, Figs. 9 and 10, ¶42 discloses tapping the bone tunnel and bone block and then threading 5 in to secure the bone block in the bone tunnel), the second bone block which the second interference bone screw is capable of interlocking placed intermediate the second interference bone screw and a second portion of the soft tissue implant portion of 210 connected to the first bone block, Figs. 3 and 10) capable of coupling the second portion of the soft tissue implant within a second bone tunnel formed in a second bone (Figs. 9 and 10, ¶42). As to claim 6, Donnelly discloses that at least one of: the first bone block comprises a first pre-formed thread (Figs. 4 and 5, ¶42 discloses tapping the bone block with 310 prior to insertion of the screw) capable of receiving the first helical thread therein (Figs. 6 and 10, ¶42); and the second bone block comprises a second pre-formed thread (Figs. 7 and 8, ¶42 discloses tapping the bone block with 310 prior to insertion of the screw) capable of receiving the second helical thread therein (Figs. 9 and 10, ¶42). As to claim 7, Donnelly discloses that at least one of: the first bone tunnel comprises a first bone tunnel pre-formed thread (Figs. 4 and 5, ¶42 discloses tapping the bone tunnel with 310 prior to insertion of the screw) capable of receiving the first helical thread therein (Figs. 6 and 10, ¶42); and the second bone tunnel comprises a second bone tunnel pre-formed thread (Figs. 7 and 8, ¶42 discloses tapping the bone block with 310 prior to insertion of the screw) capable of receiving the second helical thread therein (Figs. 9 and 10, ¶42).
Donnelly is silent to the first helical thread comprising a first concave undercut surface and the second helical thread comprising a second concave undercut surface. As to claim 2, Donnelly is silent to the first concave undercut surface of the first helical thread comprises a standard thread orientation; and the second concave undercut surface of the second helical thread comprises an inverted thread orientation. As to claim 3, Donnelly is silent to the first concave undercut surface of the first helical thread comprises an inverted thread orientation; and the second concave undercut surface of the second helical thread comprises a standard thread orientation. As to claim 4, Donnelly is silent to the first concave undercut surface of the first helical thread comprises a first standard thread orientation; and the second concave undercut surface of the second helical thread comprises a second standard thread orientation. As to claim 5, Donnelly is silent to the first concave undercut surface of the first helical thread comprises a first inverted thread orientation; and the second concave undercut surface of the second helical thread comprises a second inverted thread orientation.
Hyer teaches a similar bone screw (300, Figs. 3A-3D) comprising: a shaft (Figs. 3A-3D) comprising: a proximal end (301, i.e. upper end as shown in Figs. 3C and 3D, Figs. 3C and 3D); a distal end (302, i.e. lower end as shown in Figs. 3C and 3D, Figs. 3C and 3D); and a longitudinal axis (303, i.e. vertical as shown in Figs. 3C and 3D, Figs. 3C and 3D); and a helical thread (310, 320) disposed about the shaft along the longitudinal axis between a first location and a second location along the first shaft (Figs. 3A-3D), the helical thread comprising a concave undercut surface (upper facing surface of 310 as shown in Fig. 3D, Fig. 3D); wherein the helical thread of the bone screw is capable of interlocking with a bone block placed intermediate the bone screw and a soft tissue implant within a bone tunnel formed in a first bone (¶111 discloses fixation in bone) capable of coupling the soft tissue implant within the bone tunnel (¶111 discloses fixation in bone); wherein the helical thread comprises a standard helical thread (310, Fig. 3D) and an inverted helical thread (320, Fig. 3D). As to claim 2, Hyer teaches that the concave undercut surface of the helical thread comprises a standard thread orientation (as defined, Fig. 3D); and the concave undercut surface of the helical thread comprises an inverted thread orientation (as defined, Fig. 3D). As to claim 3, Hyer teaches that the concave undercut surface of the helical thread comprises an inverted thread orientation (as defined, Fig. 3D); and the concave undercut surface of the helical thread comprises a standard thread orientation (as defined, Fig. 3D). As to claim 4, Hyer teaches that the concave undercut surface of the helical thread comprises a standard thread orientation (as defined, Fig. 3D). As to claim 5, Hyer teaches that the concave undercut surface of the helical thread comprises an inverted thread orientation (as defined, Fig. 3D).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the thread on each of the first and second bone screws as disclosed by Donnelly to have a standard helical thread and an inverted helical thread with concave undercuts as taught by Hyer in order to achieve optimal fixation within a given bone/tissue (Hyer ¶111) to secure each respective bone block in the respective bone tunnel (Donnelly ¶42).
As a result, as to claim 2, the combination of Donnelly and Hyer discloses that the first concave undercut surface of the first helical thread comprises a standard thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D); and the second concave undercut surface of the second helical thread comprises an inverted thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D). As to claim 3, the combination of Donnelly and Hyer discloses that the first concave undercut surface of the first helical thread comprises an inverted thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D); and the second concave undercut surface of the second helical thread comprises a standard thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D). As to claim 4, the combination of Donnelly and Hyer discloses that the first concave undercut surface of the first helical thread comprises a first standard thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D); and the second concave undercut surface of the second helical thread comprises a second standard thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D). As to claim 5, the combination of Donnelly and Hyer discloses that the first concave undercut surface of the first helical thread comprises a first inverted thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D); and the second concave undercut surface of the second helical thread comprises a second inverted thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D).
As to claim 8-10, Donnelly discloses a system (5, 200, 50, 300, 310, Figs. 1A-10) capable of reconstructing a soft tissue (abstract), the system comprising: a first interference bone screw (femoral 5, Figs. 1A-1C, 6, and 10, ¶42) comprising: a first shaft (Figs. 1A-1C) comprising: a first proximal end (16); a first distal end (14); and a first longitudinal axis (horizontal as shown in Figs. 1A and 1C, Figs. 1A and 1C); and a first helical thread (thread shown in Figs. 1A-1C and described as “plurality of thread flights 30” in ¶39, Figs. 1A-1C, ¶39) disposed about the first shaft along the first longitudinal axis between a first location and a second location along the first shaft (Figs. 1A-1C); and a second interference bone screw (tibial 5, Figs. 1A-1C, 9, and 10, ¶42) comprising: a second shaft (Figs. 1A-1C) comprising: a second proximal end (16); a second distal end (14); and a second longitudinal axis (horizontal as shown in Figs. 1A and 1C, Figs. 1A and 1C); and a second helical thread (thread shown in Figs. 1A-1C and described as “plurality of thread flights 30” in ¶39, Figs. 1A-1C, ¶39) disposed about the second shaft along the second longitudinal axis between a third location and a fourth location along the second shaft (Figs. 1A-1C), wherein: the first interference bone screw is capable of interlocking with a bone block (femoral 220, Figs. 6 and 10, ¶42 discloses tapping the bone tunnel and bone block and then threading 5 in to secure the bone block in the bone tunnel) engaged with a first portion of a soft tissue implant (portion of 210 connected to the first bone block, Figs. 3 and 10) capable of coupling the first portion of the soft tissue implant within a first bone tunnel formed in a first bone (Figs. 6 and 10, ¶42); and the second interference bone screw is capable of interlocking with a second portion of the soft tissue implant (tibial 220, Figs. 9 and 10, ¶42 discloses tapping the bone tunnel and bone block and then threading 5 in to secure the bone block in the bone tunnel) capable of coupling the second portion of the soft tissue implant within a second bone tunnel formed in a second bone (Figs. 9 and 10, ¶42). As to claim 10, Donnelly discloses that the first interference bone screw comprises at least one first minor diameter (Figs 1A-1C and 10); and the second interference bone screw comprises at least one second minor diameter (Figs 1A-1C and 10). As to claim 12, Donnelly discloses that the at least one first minor diameter is capable of decreasing in size toward the first distal end of the first shaft (on the left third of the screw as shown in Fig. 1C, Figs. 1A and 1C); and the at least one second minor diameter is capable of decreasing in size toward the second distal end of the second shaft (on the left third of the screw as shown in Fig. 1C, Figs. 1A and 1C). As to claim 13, Donnelly discloses that the at least one first minor diameter is capable of continuously decreasing in size toward the first distal end of the first shaft (on the left third of the screw as shown in Fig. 1C, Figs. 1A and 1C); and the at least one second minor diameter is capable of continuously decreasing in size toward the second distal end of the second shaft (on the left third of the screw as shown in Fig. 1C, Figs. 1A and 1C). As to claim 14, Donnelly discloses that the at least one first minor diameter is capable of discretely decreasing in size toward the first distal end of the first shaft (on the left third of the screw as shown in Fig. 1C in small increments, Figs. 1A and 1C); and the at least one second minor diameter is capable of discretely decreasing in size toward the second distal end of the second shaft (on the left third of the screw as shown in Fig. 1C in small increments, Figs. 1A and 1C).
Donnelly is silent to the first helical thread comprising a first concave undercut surface and the second helical thread comprising a second concave undercut surface. As to claim 9, Donnelly is silent to the first concave undercut surface comprises at least one of: a first standard thread orientation; and a first inverted thread orientation; and the second concave undercut surface comprises at least one of: a second standard thread orientation; and a second inverted thread orientation.
Hyer teaches a similar bone screw (300, Figs. 3A-3D) comprising: a shaft (Figs. 3A-3D) comprising: a proximal end (301, i.e. upper end as shown in Figs. 3C and 3D, Figs. 3C and 3D); a distal end (302, i.e. lower end as shown in Figs. 3C and 3D, Figs. 3C and 3D); and a longitudinal axis (303, i.e. vertical as shown in Figs. 3C and 3D, Figs. 3C and 3D); and a helical thread (310, 320) disposed about the shaft along the longitudinal axis between a first location and a second location along the first shaft (Figs. 3A-3D), the helical thread comprising a concave undercut surface (upper facing surface of 310 as shown in Fig. 3D, Fig. 3D); wherein the bone screw is capable of interlocking with a bone block placed intermediate the bone screw and a soft tissue implant within a bone tunnel formed in a first bone (¶111 discloses fixation in bone) capable of coupling the soft tissue implant within the bone tunnel (¶111 discloses fixation in bone); wherein the helical thread comprises a standard helical thread (310, Fig. 3D) and an inverted helical thread (320, Fig. 3D). As to claim 9, Hyer teaches that the concave undercut surface comprises at least one of: a standard thread orientation (as defined, Fig. 3D); and an inverted thread orientation (as defined, Fig. 3D).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the thread on each of the first and second bone screws as disclosed by Donnelly to have a standard helical thread and an inverted helical thread with concave undercuts as taught by Hyer in order to achieve optimal fixation within a given bone/tissue (Hyer ¶111) to secure each respective bone block in the respective bone tunnel (Donnelly ¶42).
As a result, as to claim 9, the combination of Donnelly and Hyer discloses that the first concave undercut surface comprises at least one of: a first standard thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D); and a first inverted thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D); and the second concave undercut surface comprises at least one of: a second standard thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D); and a second inverted thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D).
As to claim 11, the combination of Donnelly and Hyer discloses the invention of claim 10 as well as appears to show that the at least one first minor diameter is constant along at least a portion of the first helical thread (on a central portion of the screw as shown in Fig. 1C, Figs. 1A and 1C); and the at least one second minor diameter is constant along at least a portion of the second helical thread (on a central portion of the screw as shown in Fig. 1C, Figs. 1A and 1C).
The combination of Donnelly and Hyer is silent to an explicit disclosure that the at least one first minor diameter is constant along at least a portion of the first helical thread; and the at least one second minor diameter is constant along at least a portion of the second helical thread.
It would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the apparently constant portions of the first and second minor diameters of the combination of Donnelly and Hyer to specifically be constant, since Applicant has not disclosed that such is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a minor diameter for engaging bone (Donnelly Figs. 1A, 1C, and 10).
As to claim 15-17, 19, and 20, Donnelly discloses a system (5, 200, 50, 300, 310, Figs. 1A-10) capable of reconstructing a soft tissue (abstract), the system comprising: a first interference bone screw (femoral 5, Figs. 1A-1C, 6, and 10, ¶42) comprising: a first shaft (Figs. 1A-1C) comprising: a first proximal end (16); a first distal end (14); and a first longitudinal axis (horizontal as shown in Figs. 1A and 1C, Figs. 1A and 1C); and a first helical thread (thread shown in Figs. 1A-1C and described as “plurality of thread flights 30” in ¶39, Figs. 1A-1C, ¶39) disposed about the first shaft along the first longitudinal axis between a first location and a second location along the first shaft (Figs. 1A-1C); and a second interference bone screw (tibial 5, Figs. 1A-1C, 9, and 10, ¶42) comprising: a second shaft (Figs. 1A-1C) comprising: a second proximal end (16); a second distal end (14); and a second longitudinal axis (horizontal as shown in Figs. 1A and 1C, Figs. 1A and 1C); and a second helical thread (thread shown in Figs. 1A-1C and described as “plurality of thread flights 30” in ¶39, Figs. 1A-1C, ¶39) disposed about the second shaft along the second longitudinal axis between a third location and a fourth location along the second shaft (Figs. 1A-1C), wherein: the first helical thread of the first interference bone screw is capable of interlocking with a first portion of a soft tissue implant (femoral 220, Figs. 6 and 10, ¶42 discloses tapping the bone tunnel and bone block and then threading 5 in to secure the bone block in the bone tunnel) engaged with a first portion of a soft tissue implant (portion of 210 connected to the first bone block, Figs. 3 and 10) capable of coupling the first portion of the soft tissue implant within a first bone tunnel formed in a first bone (Figs. 6 and 10, ¶42); and the second helical thread of the second interference bone screw is capable of interlocking with a second portion of the soft tissue implant (tibial 220, Figs. 9 and 10, ¶42 discloses tapping the bone tunnel and bone block and then threading 5 in to secure the bone block in the bone tunnel) capable of coupling the second portion of the soft tissue implant within a second bone tunnel formed in a second bone (Figs. 9 and 10, ¶42). As to claim 17, Donnelly discloses that the first interference bone screw comprises at least one first major diameter (Figs 1A-1C and 10); and the second interference bone screw comprises at least one second major diameter (Figs 1A-1C and 10). As to claim 19, Donnelly discloses that the at least one first major diameter is capable of continuously decreasing in size toward the first distal end of the first shaft (on the left third of the screw as shown in Fig. 1C, Figs. 1A and 1C); and the at least one second major diameter is capable of continuously decreasing in size toward the second distal end of the second shaft (on the left third of the screw as shown in Fig. 1C, Figs. 1A and 1C). As to claim 20, Donnelly discloses that the at least one first major diameter is capable of discretely decreasing in size toward the first distal end of the first shaft (on the left third of the screw as shown in Fig. 1C in small increments, Figs. 1A and 1C); and the at least one second major diameter is capable of discretely decreasing in size toward the second distal end of the second shaft (on the left third of the screw as shown in Fig. 1C in small increments, Figs. 1A and 1C).
Donnelly is silent to the first helical thread comprising a first concave undercut surface and the second helical thread comprising a second concave undercut surface. As to claim 16, Donnelly is silent to the first concave undercut surface comprises at least one of: a first standard thread orientation; and a first inverted thread orientation; and the second concave undercut surface comprises at least one of: a second standard thread orientation; and a second inverted thread orientation.
Hyer teaches a similar bone screw (300, Figs. 3A-3D) comprising: a shaft (Figs. 3A-3D) comprising: a proximal end (301, i.e. upper end as shown in Figs. 3C and 3D, Figs. 3C and 3D); a distal end (302, i.e. lower end as shown in Figs. 3C and 3D, Figs. 3C and 3D); and a longitudinal axis (303, i.e. vertical as shown in Figs. 3C and 3D, Figs. 3C and 3D); and a helical thread (310, 320) disposed about the shaft along the longitudinal axis between a first location and a second location along the first shaft (Figs. 3A-3D), the helical thread comprising a concave undercut surface (upper facing surface of 310 as shown in Fig. 3D, Fig. 3D); wherein the helical thread of the bone screw is capable of interlocking with a portion of a soft tissue implant (¶111 discloses fixation in bone) capable of coupling the first portion of the soft tissue implant within abone tunnel formed in a bone (¶111 discloses fixation in bone); wherein the helical thread comprises a standard helical thread (310, Fig. 3D) and an inverted helical thread (320, Fig. 3D). As to claim 16, Hyer teaches that the concave undercut surface comprises at least one of: a standard thread orientation (as defined, Fig. 3D); and an inverted thread orientation (as defined, Fig. 3D).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the thread on each of the first and second bone screws as disclosed by Donnelly to have a standard helical thread and an inverted helical thread with concave undercuts as taught by Hyer in order to achieve optimal fixation within a given bone/tissue (Hyer ¶111) to secure each respective bone block in the respective bone tunnel (Donnelly ¶42).
As a result, as to claim 16, the combination of Donnelly and Hyer discloses that the first concave undercut surface comprises at least one of: a first standard thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D); and a first inverted thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D); and the second concave undercut surface comprises at least one of: a second standard thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D); and a second inverted thread orientation (Donnelly Fig. 1C; Hyer Fig. 3D).
As to claim 18, the combination of Donnelly and Hyer discloses the invention of claim 17 as well as appears to show that the at least one first major diameter is constant along at least a portion of the first helical thread (on the right half of the screw as shown in Fig. 1C, Figs. 1A and 1C); and the at least one second major diameter is constant along at least a portion of the second helical thread (on the right half of the screw as shown in Fig. 1C, Figs. 1A and 1C).
The combination of Donnelly and Hyer is silent to an explicit disclosure that the at least one first major diameter is constant along at least a portion of the first helical thread; and the at least one second major diameter is constant along at least a portion of the second helical thread.
It would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the apparently constant portions of the first and second major diameters of the combination of Donnelly and Hyer to specifically be constant, since Applicant has not disclosed that such is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a major diameter for engaging bone (Donnelly Figs. 1A, 1C, and 10).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
