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 .
Response to Amendment
The amendments filed on 07/08/2026 have been entered. Claims 1-7, 9-14, and 17 remain pending in the application. The amendments overcome the rejection of claim 1 under 35 USC 112(b) set forth in the previous office action dated 04/08/2026.
Response to Arguments
Applicant’s arguments, see pages 7-9, filed 07/08/2026, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Beerens (US 2017/0209274) to teach the limitations regarding the different suture inlet holes and common suture outlet hole through which the first and second suture ends pass.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-7, 9-14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ferree (US 2007/0276494) in view of Ryan et al. (US 2019/0343644), further in view of Khowaylo et al. (US 2020/0000574), further in view of Beerens (US 2017/0209274).
Regarding claim 1, Ferree discloses a minimally invasive spinal annulus fibrosus repairing device (FIGs 8A-8G, [0099-0105]), comprising: at least one bone anchor (103a-d, FIGs 8E-8F; same as anchors 103 shown in FIGs 3A-3B, [0078, 0086]), configured to be vertically disposed on a posterior surface of a vertebral bone adjacent to an intervertebral disc (FIGs 8E and 8F show insertion on a posterior surface for a vertebral bone 124, 122 adjacent to disk 120, [0104]. FIG 5B best shows in insertion is vertical), wherein the at least one bone anchor includes a body with a needle tip (Pointed tip shown in FIG 3A-3B) and a suture fixing portion (Eyelet 104) away from the needle tip (FIG 3B), the suture fixing portion forms a perforation that penetrates the body radially (Allowing for passage of sutures 101, [0078 and 0101]), and the body is made of a porous structure ([0078] discloses anchor 103 can be bioresorbable, which is understood to be a porous structure); at least one annulus fibrosus anchor (110 and 115, FIG 8A), configured to be vertically disposed inside the annulus fibrosus of the intervertebral disc (the device is shaped, sized, and formed of a material such that it is at least configured for a portion to be disposed inside of the annulus fibrosus), wherein the at least one annulus fibrosus anchor has a first surface and a second surface spaced apart from the first surface (Top and bottom surfaces such as those visible in FIG 8A and the opposing back surfaces), at least two suture inlet holes are formed on the first surface (Each of 110 or 115 comprise two through holes which pass from the first surface to the second surface through which the suture passes, FIG 8A), at least one suture outlet hole is formed on the second surface (Each of 110 or 115 comprise two through holes which pass from the first surface to the second surface through which the suture passes, FIG 8A), and a suture penetrating tunnel is defined between the at least two suture inlet holes and the at least one suture outlet hole (The passage through the material from the inlet to outlet hole forms the tunnel); and at least one suture (117 and 101a-d, 105a-d), having a first end and a second end located at an opposite end of the first end (Such as the free ends of 117 shown in FIG 117 or the free ends 105a-d), wherein the first end and the second end are threaded in through corresponding suture inlet holes respectively, pass through the suture penetrating tunnel, and exit from the at least one suture outlet hole (In order to pass as shown in FIG 8A), and the first end and the second end of the at least one suture are configred to be fixed to the suture fixing portion of the at least one bone anchor (In the full device of FIGs 8B-8G each of the elements are fixed to one another and the suture free ends can be pulled to tensions the device such that one element is brought closer to another); and wherein the suture penetrating tunnel includes a first tunnel portion and a second tunnel portion opposite to the first tunnel portion (As shown in FIG 8A-8B, there are two lengths of suture 117 which pass through both 115 and 110, therefore there exists a first and second tunnel portion).
Ferree is silent regarding the body of the at least one bone anchor further including a solid frame, and the porous structure is concentrated inside the solid frame and presented in a center of the solid frame.
However, Ryan et al. discloses a bone anchor (10, FIGS 1-7) for implant in a vertebra ([0088]) having a solid frame (30, [0088-0089], FIGS 5-7) and a porous structure (50, [0087-0092], FIGs 1-4) concentrated inside the solid frame and presented in a center of the solid frame (FIG 2, [0087-0088]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the body of the at least one bone anchor such that it comprises a solid frame and a porous structure concentrated inside of and presented in a center of the solid frame, as taught by Ryan et al., for the purpose of providing the bone anchor with adequate construction strength while maximizing the potential for bony in-growth and allowing for clear radiographic imaging ([0092]).
The device as modified is further silent regarding the at least one bone anchor having a shape of an unthreaded quadrangular prismatic anchor.
However, Khowaylo et al. discloses a bioabsorbable anchor (2500, FIG 25-31, abstract) for use anchoring sutures attached to tendons or ligaments to bone ([0069]) wherein the shape of the bone anchor is an unthreaded quadrangular prism ([0085]). Khowaylo further discloses that a quadrangular prismatic anchor shape is interchangeable with a number of different shapes commonly known in the art such as cylindrical, conical, a triangular prism, a pentagonal prism, and a hexagonal prism ([0085]) and can comprise protrusions (2614, [0083-0084]) to assist in anchoring without the use of threads.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the shape of the anchor to be an unthreaded quadrangular prismatic anchor, as taught by Khowaylo, for the purpose of substituting a commonly known bone anchor shape for achieving the predictable result of securely anchoring into a bone tissue of attachment of sutures for a desired treatment using a shape which is known to have the desired structural properties for anchoring.
Ferree is further silent regarding the first and second tunnel portions are formed from different suture inlet holes while sharing a common suture outlet hole of the at least one suture outlet hole and an included angle of 30- 90 degrees being formed between an extension line of a length direction of the first tunnel portion and an extension line of a length direction of the second tunnel portion, and wherein both the first end and the second end of the at least one suture exit from the common suture outlet hole on a side of the annulus fibrosus anchor configured to be positioned adjacent to an inner surface of the annulus fibrosus.
However, Beerens teaches a fixation member (100, FIG 4A-4C) for anchoring a suture ([0049-0050]) to a tissue, the fixation member having a first tunnel portion (see annotated FIG 4B below) and a second tunnel portion (ee annotated FIG 4B below) opposite to the first tunnel portion wherein the first and second tunnel portions are formed from different suture inlet holes (top surface openings of 25 and 27) while sharing a common suture outlet hole (Bottom opening of 23) and an included angle of 30- 90 degrees being formed between an extension line (See dashed line of first tunnel) of a length direction of the first tunnel portion and an extension line (See dashed line of second tunnel) of a length direction of the second tunnel portion (FIG 4B shows the angle between the two tunnel portions being less than 90 degrees and greater than 30 degrees). Beerens further teaches that sutures can be passed through the implant “from inside to outside and the other way around” [0050], meaning form the top openings down through the bottom opening.
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the first and second tunnel portions of Ferree to comprise two separate suture inlet holes on the first surface which converge at a shared common outlet hole on the second surface, and form an angle of 30- 90 degrees between the axes of the first and second tunnel, as taught by Beerens, for the purpose of allowing the force of the sutures to be distributed more evenly over a greater surface area while still being pulled form a single point, thus minimizing trauma to the surrounding tissue. [0050] of Beerens teaches “the shape of provided by the shown hole geometry allows suturing after placing the implant, instead of having to arrange sutures in and/or through the implant before placement. The risk of damaging the underlying tissue by accident is reduced. Furthermore, these holes can prevent pressure build-up underneath the implant. The holes described here allow for a wide variety of needle sizes. Also, the needle can be used to suture from outside to outside (through the channel) but also from inside to outside and the other way around”. In the device as modified, both the first end and the second end of the at least one suture exit from the common suture outlet hole on a side of the annulus fibrosus anchor configured to be positioned adjacent to an inner surface of the annulus fibrosus, due to the particular orientation of the device.
Regarding claim 2, Ferree/Ryan et al./Khowaylo/Beerens disclose the invention substantially as claimed, as set forth above for claim 1. Ferree further discloses when an amount of the bone anchor is one, an amount of the annulus fibrosus anchor is at least two (The device of FIG 8E shows at least one bone anchors 103 and at least two annulus fibrosus anchors 110/115. Examiner notes that the use of “when” makes this limitation a conditional statement that does not necessarily need to be present), when the amount of the annulus fibrosus anchor is one, the amount of the bone anchor is at least two (The device of FIG 8E shows at least one annulus fibrosus anchors 110 and at least two bone anchors 103. Examiner notes that the use of “when” makes this limitation a conditional statement that does not necessarily need to be present), the at least one bone anchor and the at least one annulus fibrosus anchor define a repairing region (Regions covered by the full length and width of the assemble device of FIGs 8D-8G), and the repairing region has an area larger than that of a tear of the annulus fibrosus of the intervertebral disc (This region is larger than the disk and therefore is also larger than a tear in the tissue of the disk).
Regarding claim 3, Ferree/Ryan et al./Khowaylo/Beerens disclose the invention substantially as claimed, as set forth above for claim 2. Ferree further discloses the amount of the at least one bone anchor is two (Anchors 103a-d are at least two), and the amount of the at least one annulus fibrosus anchor is two (110 and 115).
Regarding claim 4, Ferree/Ryan et al./Khowaylo/Beerens disclose the invention substantially as claimed, as set forth above for claim 1. Ferree further discloses the at least one suture forms a pulling direction after exiting from the at least one suture outlet hole, and an included angle of 90 degrees is formed between the pulling direction and an extension direction that is perpendicular to a tear of the annulus fibrosus of the intervertebral disc (After exiting the suture outlet hole, the suture can form a pulling direction in may direction i.e. straight outward along the direction of its length or to and side angle after exiting the outlet hole. Further, a tear of the annulus fibrosus can occur in any direction and the device can be positioned relative to said tear such that an extension direction is formed as a 90 degree angle relative to the tear and relative to the pulling direction of the suture. Therefore, the limitation is met because the claimed condition are capable of being achieved by the device of Ferree depending on the particular positioning of the device and the direction which a user pulls the suture).
Regarding claim 5, Ferree/Ryan et al./Khowaylo/Beerens disclose the invention substantially as claimed, as set forth above for claim 1. Ferree further discloses the at least one bone anchor has a length of 10-20 mm (0078]) and a width of 3-5 mm ([0078]).
Regarding claim 6, Ferree/Ryan et al./Khowaylo/Beerens the invention substantially as claimed, as set forth above for claim 1. Ferree further discloses the at least one annulus fibrosus anchor has a length of 3-6 mm and a width of 1-3 mm ([0079] discloses a length of 5mm and a thickness/width of 1mm).
Regarding claim 7, Ferree/Ryan et al./Khowaylo/Beerens disclose the invention substantially as claimed, as set forth above for claim 1. Ferree further discloses an amount of the suture inlet holes is two (FIG 8A shows two suture inlet holes in both 110 and 115).
Regarding claim 9, Ferree/Ryan et al./Khowaylo/Beerens disclose the invention substantially as claimed, as set forth above for claim 1. Ferree further discloses the at least one annulus fibrosus anchor has a columnar structure ([0083] discloses 115 can be a circle or planar disk. Since the anchor can be a circular shape and has a depth of at least some dimension, the anchor is interpreted as being a columnar structure).
Regarding claim 10, Ferree/Ryan et al./Khowaylo/Beerens disclose the invention substantially as claimed, as set forth above for claim 9. Ferree further discloses the at least one annulus fibrosus anchor has a cylindrical structure ([0083] discloses 115 can be a circle or planar disk. Since the anchor can be a circular shape and has a depth of at least some dimension, the anchor is interpreted as being a cylindrical structure).
Regarding claim 11, Ferree/Ryan et al./Khowaylo/Beerens disclose the invention substantially as claimed, as set forth above for claim 1. Ferree further discloses the at least one annulus fibrosus anchor has a material made of artificial fiber, heterogeneous fiber, titanium alloy, cobalt-based alloy, ceramic, stainless steel, polyetheretherketone (PEEK) resin, or artificial bone ([0078] discloses 110 can be made of a polyester, which is an artificial fiber).
Regarding claim 12, Ferree/Ryan et al./Khowaylo/Beerens disclose the invention substantially as claimed, as set forth above for claim 1. Ferree further discloses the first end and the second end of the at least one suture pass through the suture penetrating tunnel and exit from the at least one suture outlet hole (FIG 8A), and the first end and the second end of the at least one suture fixed on the suture fixing portion of the at least one bone anchor are drawn to form a bundle shape in order to seal a tear of the fibrous annulus of the intervertebral disc (Tightening the two ends of the suture and creating a knot is interpreted as ‘forming a bundle shape’, which seals the tear by fixing the device in place and therefore performing the intended treatment).
Regarding claim 13, Ferree/Ryan et al./Khowaylo/Beerens disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified further discloses the body of the at least one bone anchor has a cross-sectional shape of polygon or sheet (The shape as modified to be a quadrangular prism has a polygon cross section).
Regarding claim 14, Ferree/Ryan et al./Khowaylo/Beerens disclose the invention substantially as claimed, as set forth above for claim 1. Ferree further discloses the suture fixing portion of the body of the at least one bone anchor is a loop (The material surrounding suture opening 104 is interpreted as forming a loop because it encircles and produces a curve that bends around and connects with itself).
Regarding claim 17, Ferree/Ryan et al./Khowaylo/Beerens discloses a method of using the minimally invasive spinal annulus fibrosus repairing device according to claim 1 (see rejection above), comprising the following steps: fixing the at least one bone anchor on the vertebral bone of the annulus fibrous adjacent to the intervertebral disc, wherein the needle tip is embedded in the vertebral bone (As shown in FIG 5B), and the suture fixing portion is exposed out of the vertebral bone (FIG 8E-8F show a portion of 103 exposed outside of the bone and suture 101 passing therethrough, which is understood to be exposed out of the vertebral bone); threading the first end and the second end of the at least one suture through the at least two suture inlet holes of the at least one annulus fibrosus anchor, and passing through the suture penetrating tunnel to exit from the at least one suture outlet hole (Thus creating the structure shown in FIG 8A, [0099]); implanting the at least one annulus fibrosus anchor with the at least one suture into the annulus fibrosus of the intervertebral disc ([0100-0105]), and pulling the first end and the second end of the at least one suture out of the annulus fibrosus of the intervertebral disc [0083, 0101]); and spanning the at least one suture that is pulled out of the annulus fibrosus of the intervertebral disc over a tear of the annulus fibrosus of the intervertebral disc (FIGs 8B-8F shows the span of the suture over disk 120 which comprises the tear), wherein the first end and the second end of the at least one suture are fixed to the suture fixing portion of the at least one bone anchor (In the completely installed device such as described in [0103-0104], all sutures are properly tensions and secured into place, thereby forming an integral structure. Therefore, the first end and the second end of the at least one suture are fixed to the suture fixing portion of the at least one bone anchor).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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