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 .
Drawings
Replacement drawings received on 12/29/2025 are accepted.
Response to Arguments
Applicant’s arguments with respect to claims 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.
Claim Objections
Claims 32 and 42 are objected to because of the following informalities: it is unclear what is meant by the limitation “loading.” The disclosure does not further define the term. It appears one instance of “loading” was deleted in both claims, but missed a second instance of “loading”.
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.
Claims 1-4, 7, 10, 14-15, 21-22, 29-32, 35, 40, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Morriss (US 20030074021) in view of Champagne (US 20130274879 A1) and Van Der Burg (US 20090171400 A1).
Regarding claim 1, Morriss teaches a device ([0003]), for joining a first tissue to a second tissue ([0003]) comprising a base comprising opposed first and second surfaces (see elements 305 and 307 in figure 3E), and a plurality of recurved tines (see tine element 300 in figure 3A, see a plurality of tine elements in figure 1C) oriented to a tine axis (see orientation of tines in figure 12B) and extending from the first surface of the base (see tine element 300 in figure 3A), the plurality of recurved tines providing unidirectional traction of the first tissue along the tine axis toward the first surface (see “fixation” or “stabilization” in [0002]) , and wherein each recurved tine of the plurality of recurved tines comprise a pointed tip (for example see tines in figures 3a-3d, the tines have pointed tips), a tine base having a first rear-most position (for example see tine element 300 in fig 3a, the left side of the base is the first rear most position), and a cross sectional profile comprising a max tine diameter at the tine base (see figure 3e) of the tine tapering to the pointed tip (see fig 3e) and wherein the first surface of the device configured to secure a first at the plurality of recurved tines and the second surface configured to secure the second tissue to the device to join the first tissue to the second tissue ([0125]).
Morriss is silent to the dimensions of the maximum tine base diameter ranging from about 1.25 mm to about 1.5 mm. Champagne teaches a device for tissue stabilization and tendon repair (abstract) wherein the maximum tine diameter ranges ([0036], stiplet base diameter) from about 1.25 mm to about 1.5 mm ([0036], the range 0.5 mm and 4 mm encompasses 1.25mm-1.5mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings the tine diameter of Champagne with the device of Morriss. In order to, optimize friction of the tissue and the device ([0036]).
Morriss is silent to the tine separation distance each row. Champagne teaches a device for tissue stabilization and tendon repair (abstract) wherein the plurality of recurved tines (see stiplets 18 orientation in fig 3a) is separated by a tine separation distance s, wherein s ranges from about 0.5r to about 5r ([0036], this range would equal .25 mm-20 mm) and r is a cross-sectional diameter of each tine ([0037], .5-5mm is included in .25 mm-20 mm, therefore the separation distance can be optimized to be about 0.5r to about 5r).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings the tine spacing of Champagne with the device of Morriss. In order to choose a spacing that optimizes friction of the specific tissue and the device ([0036]).
Morriss in view of Champagne is silent second rear-most position. Van Der Burg teaches an apparatus for tissue anchoring (abstract) wherein the cross-sectional profile has a second rear-most position between the tine base and the pointed tip, the second rear-most position being rearward of the first rear-most position (see annotated fig 1H below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of a second rearmost position, taught by Van Der Burg, to the tine shape taught by Morris, in order to complete a simple substitution of one known tine rear-shape for another to obtain predictable results of grasping tissue anatomy as desired (MPEP 2143), further note Morris teaches that the tine shapes can vary depending on anatomy and tissue type ([0123]).
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Annotated Figure 1H
Regarding claim 2, Morriss further teaches wherein the second surface is configured to secure the second tissue to the device using at least one fastener selected from a suture, a screw, a staple, an anchor, a nail, and any combination thereof ([0137], see element 1212 in figure 12a).
Regarding claim 3, Morriss further teaches wherein the base defines at least one fastener fitting extending through the first and second surfaces of the base, the at least one fastener fitting configured to receive at least a portion of the at least one fastener to secure the device to the second tissue ([0137], see element 1218 in figure 12B).
Regarding claim 4, Morriss further teaches wherein the first tissue and second tissue are selected independently from a hard tissue comprising a bone tissue and a soft tissue selected from a ligament, a tendon, a muscle, a cartilage tissue, an adipose tissue, and any combination thereof ([0132]).
Regarding Claim 7 , Morriss further teaches wherein the device further comprising a second plurality of recurved tines oriented to a second tine axis and extending from the second surface of the base ([0125], see elements 308 and 307 in figure 3E), the second plurality of recurved tines providing unidirectional traction of the second tissue along the second tine axis toward the first surface (see “fix the device in place” in [125]), wherein the second tine axis is oriented in a direction opposite to the first tine axis and the second tissue is further joined to the device at the second plurality of recurved tines (see “not limited to the combinations” in [0125]).
Regarding claim 10, Morriss further teaches wherein the base further defines a plurality of pores ([0120]), each pore of the plurality of pores extending at least partly from the first surface to the second surface (see orientation of element 100 in 1A, for element 100 to be porous the pores would have to be at least partially extending from the front surface to the back surface), wherein at least a portion of the plurality of pores are arranged in a pattern over at least a portion of the tine base ([0120], see row and column lattice in figure 1A).
Regarding claim 14, Morriss further teaches wherein at least one of the first surface and the second surface are contoured ([0024], [0120]), the first surface contoured to conform with a surface of the first tissue of an individual patient and the second surface contoured to conform with a surface of the second tissue of the individual patient ([0191], surfaces are connected so both are contoured).
Regarding Claim 15, Morriss further teaches wherein each recurved tine of the second plurality of tines comprises a cross-sectional profile comprising a maximum tine diameter at a base of the tine tapering to a pointed tip (see design of element 304 in figure 3D). Morris teaches a device wherein the recurved tine of the first and second plurality of tines further comprises a curvature defined by a ratio w'/w (see curvature defined by “optimal angle” in [0128], which corresponds to applicants’ definition of w’/w=2.5, which is defined as ideal curvature in paragraph [0129] of the instant application), w comprising a distance between a rear-most position and a forwardmost position of the tine at the base of the tine, w' comprising a distance between the rear-most position and a tip position of the tine (see curvature defined by “optimal angle” in [0128], which corresponds to applicants’ definition of w and w’, which is defined in the instant application).
Morriss is silent to the dimensions of the maximum tine diameter ranging from about 1.25 mm to about 1.5 mm. Champagne teaches a device for tissue stabilization and tendon repair (abstract) wherein the maximum tine diameter ranges ([0036], stiplet base diameter) from about 1.25 mm to about 1.5 mm ([0036], the range 0.5 mm and 4 mm encompasses 1.25mm-1.5mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings the tine diameter of Champagne with the device of Morriss. In order to, optimize friction of the tissue and the device ([0036]).
Regarding claim 21, Morriss further teaches wherein at least one of the first and second plurality of tines is arranged in an array comprising at least one row (See figures 1A-D).
Regarding claim 22, Morris further discloses that at least one of the first and second plurality of tines is arranged in an array comprising at least two rows of tines and at least one column of tines (see figures 1A-D), wherein each column of tines comprises one tine from each row of the at least two rows of tines (See figures 1A-D) and wherein each tine in each row is offset from each tine in each adjacent row (tines are offset, see orientation in figures 5).
Morriss is silent to the tine separation distance each row. Champagne teaches a device for tissue stabilization and tendon repair (abstract) wherein each adjacent pair of tines (see stiplets 18 orientation in fig 3a) is separated by a tine separation distance s, wherein s ranges from about 0.5r to about 5r ([0036], this range would equal .25 mm-20 mm) and r is a cross-sectional diameter of each tine ([0037], .5-5mm is included in .25 mm-20 mm, therefore the separation distance can be optimized to be about 0.5r to about 5r).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings the tine spacing of Champagne with the device of Morriss. In order to choose a spacing that optimizes friction of the specific tissue and the device ([0036]).
Regarding claim 29, Morriss further teaches wherein the device comprising a biocompatible material ([0121]).
Regarding claim 30, Morriss further teaches wherein the biocompatible material is selected from a polymer, a collagen, a mineralized collagen, a metal, a minerally coated metal, a ceramic coated metal, and any combination thereof ([0121]).
Regarding claim 31, Morriss further teaches wherein at least a portion of the device comprises a biodegradable material ([0121]).
Regarding claim 32, Morriss further teaches, wherein the device further comprising an orthobiologic coating or loading, the orthobiologic coating comprising a tissue growth factor, biologic drugs, platelet-rich plasmas (PRP), mesenchymal stem cells (MSCs), and any combination thereof ([0190]).
Regarding claim 35, Morriss teaches a device ([0003]) for joining a soft tissue to a hard tissue comprising: a base comprising opposed first and second surfaces (see elements 305 and 307 in figure 3E), a plurality of recurved tines (see tine element 300 in figure 3A, see a plurality of tine element in figure 1C) oriented to a tine axis (see orientation of tines in figure 12B) and extending from the first surface of the base (see tine element 300 in figure 3A), wherein each tine comprises a pointed tip (for example see tines in figures 3a-3d, the tines have pointed tips), a tine base having a first rear-most position (for example see tine element 300 in fig 3a, the left side of the base is the first rear most position), a cross-sectional profile comprising a maximum tine diameter at a base of the tine tapering to a pointed tip (see design of element 304 in figure 3D), and a curvature defined by a ratio w'/w, w comprising a distance between a rear-most position and a forwardmost position of the tine at the base of the tine, and w’ comprising a distance between the rear-most position and a tip position of the tine (see curvature defined by “optimal angle” in [0128], see w’/w is defined as optimal curvature in pending application 17/766,503, it would be obvious to try curving the tines to the optimal range).
Morriss is silent to the dimensions of the maximum tine diameter ranging from about 1.25 mm to about 1.5 mm and the tine spacing. Champagne teaches a device for tissue stabilization and tendon repair (abstract) wherein the maximum tine diameter ranges ([0036], stiplet base diameter) from about 1.25 mm to about 1.5 mm ([0036], the range 0.5 mm and 4 mm encompasses 1.25mm-1.5mm) and a tine array comprising at least one row of tines (fig 3a), wherein each adjacent pair of tines within each row of tines is separated by a tine separation distance s comprising about 3r ([0036], 3r=1.5 mm-12mm) wherein r is the radius of each tine ([0037], .5-5 mm overlaps 1.5 mm-12 mm, therefore the separation distance can be optimized to be about 3r).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings the tine diameter and spacing of Champagne with the device of Morriss. In order to, choose a diameter and spacing that optimizes friction of the specific tissue and the device ([0036]).
Morriss in view of Champagne is silent second rear-most position. Van Der Burg teaches an apparatus for tissue anchoring (abstract) wherein the cross-sectional profile has a second rear-most position between the tine base and the pointed tip, the second rear-most position being rearward of the first rear-most position (see annotated fig 1H)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of a second rearmost position, taught by Van Der Burg, to the tine shape taught by Morris, in order to complete a simple substitution of one known tine rear-shape for another to obtain predictable results of grasping tissue anatomy as desired (MPEP 2143), further note Morris teaches that the tine shapes can vary depending on anatomy and tissue type ([0123]).
Regarding claim 40, Morriss further teaches that the base further defines a plurality of pores ([0120]), each pore of the plurality of pores extending at least partly from the first surface to the second surface (see orientation of element 100 in 1A, for element 100 to be porous the pores would have to be at least partially extending from the front surface to the back surface), wherein at least a portion of the plurality of pores are arranged in a lattice pattern over at least a portion of the base, ([0120], see row and column lattice in figure 1A).
Regarding claim 42, Morriss further teaches that the device further comprising an orthobiologic coating or loading, the orthobiologic coating comprising a tissue growth factor, biologic drugs, platelet-rich plasma (PRP), mesenchymal stem cells (MSCs), and any combination thereof ([0190]).
Claims 33 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Morriss (US 20030074021) in view of Champagne (US 20130274879 A1) and Van Der Burg (US 20090171400 A1) and in further view of Halbrecht (US 20100131069 A1).
Regarding claims 33 and 43, Morriss in view of Champagne and Van der Burg does not exactly teach wherein the devices further comprise an adhesive coating. Halbrecht teaches a system for tendon realignment (abstract) wherein the device further comprising an adhesive coating ([0028]).
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 device of Morriss in view of Champagne to incorporate an adhesive coating as taught by Halbrecht in order to predictably allow the “implant to adapt to the differential forces facing these surfaces” ([0028]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/H.L.P./Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774