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 .
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.
Response to Amendment
The amendment filed 05/19/2025 has been entered. Claims 1, 2, 5, 6, 8-13, 15-17, and 19-24 remain pending in the application. Claim 25 is withdrawn. Claims 3, 4, 7, 14, 18, and 26-30 are cancelled.
Response to Arguments
Applicant's arguments filed 05/19/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that Picha is used for hard tissue and not for tendons/ligaments, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since Picha does not explicitly disclose that is cannot be used for tendons/ligaments and Coughlin as modified by Picha to fine tune the size is structurally the same as the implant as claimed, this would still read on the claimed language.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 5, 6, 8, 10-13, 15-17, 19, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over US 20070123988 A1 (hereafter --Coughlin--) in view of US 20130110255 A1 (hereafter --Picha--).
Regarding Claim 1, Coughlin discloses an implant (see implant 10 in Figure 1 below) for attaching a tendon or a ligament to a hard tissue (see Abstract) comprising:
(a) a head (see annotated head 12 in Figure 1 below) having an upper surface (see annotated upper surface in Figure 1 below), and a lower surface (see annotated lower surface in Figure 1 below), and an aperture between the upper surface and the lower surface (see annotated aperture 18 in Figure 1 below);
(b) a first prong extending from the lower surface of the head (lower surface is the on the right of the aperture and inside of the curve), and having a first prong outer surface, a first prong inner surface, and a first prong tip (see annotated first prong 14A, first prong inner and outer surfaces, and tip in Figure 1 below);
(c) a second prong extending from the lower surface of the head (lower surface is the on the right of the aperture and inside of the curve), and having a second prong outer surface, a second prong inner surface, and second prong tip (see annotated second prong 14B, second prong inner and outer surfaces, and tip in Figure 1 below);
(f) second pillars for contacting a tendon or a ligament (see paragraph [0042]), the second pillars being distributed on the first prong inner surface and the second prong inner surface (see annotated second pillars 16 in Figure 1 below), and extending distally therefrom, and each second pillar being integral to the first prong or the second prong (see annotated second pillars 16 in Figure 1 below), having a distal end (see annotated distal ends of second pillars 16 in Figure 1 below), and
(g) second slots to be occupied by the tendon or the ligament, the second slots being defined by the second pillars (see annotated second slots in Figure 1 below).
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Coughlin fails to disclose first pillars for contacting a hard tissue, the first pillars being distributed on the first prong outer surface and the second prong outer surface, as well as the claimed dimensions of the second pillars, Young modulus of elasticity threshold, and slot to pillar ratios.
Picha discloses an implant (110) with pillars (140) for contacting hard tissue.
Picha teaches an implant comprising of: pillars for contacting a hard tissue that are perpendicular to the surfaces they are on (see paragraph [0042]), the pillars being distributed across an area of at least 20 mm^2 on each and extending distally therefrom (see paragraph [0040] of Picha), and each first pillar being integral to the first prong or the second prong (see paragraph [0009] of Picha), having a distal end, having a transverse area of (100 x 100) to (2,000 x 2,000) um^2 (see paragraph [0028] of Picha), and having a height of 100 to 2,000 um (see paragraph [0028] of Picha); slots (slot = spaces between pillars) to be occupied by the hard tissue (see paragraph [0009] of Picha), the slots being defined by the pillars and each slot having a width of 100 to 2,000 um as measured along the shortest distance between adjacent pillars (see paragraph [0009] of Picha); the pillars also having an option for a transverse area range of (200 x 200) to (4,000 x 4,000) um^2, and having an option to have a height of 100 to 5,000 um (see paragraph [0028] of Picha); and each slot having an option to have a width range of 400 to 4,000 um as measured along the shortest distance between adjacent second pillars (see paragraph [0029] of Picha); wherein: the implant has a Young’s modulus of elasticity of at least 3 GPa (see paragraph [0034]), an option for the ratio of (i) the sum of the volumes of the slots to (ii) the sum of the volumes of the pillars and the volumes of the slots (“first surface ratio”) of 0.40:1 to 0.90:1 (see paragraph [0049] of Picha), and an option for the ratio of (i) the sum of the volumes of the slots to (ii) the sum of the volumes of the pillars and the volumes of the second slots (“second surface ratio”) of 0.60:1 to 0.98:1 (see paragraph [0049] of Picha); and the second surface ratio is greater than the first surface ratio. Both Picha and Coughlin are implants for implantation into hard tissue, such as bone. Coughlin however lacks pillars on the outside surfaces of the implant, in which Picha has on the outer surface of the implant. These pillars upon implantation are pressed deeply into hard tissue, allowing enhanced load transfer, potentially eliminating micro-motion and migration of the implant over time, accommodating torque, and/or eliminating the need for adhesives such as cement or grout to hold the implant in place (see paragraph [0026] of Picha). The addition of these pillars and other mechanical properties such as the elasticity and dimensions of the slots to Coughlin would not only make the implant longer lasting and more resilient to load, but would also promote rich vascularization of the hard tissue of the interface, enhancing wound healing, providing nutritional support, accelerating healing, remodeling, and integration of the hard tissue, and limiting the potential for infection of the hard tissue (see paragraph [0026] of Picha).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add distally extending integral pillars that are perpendicular (and thereby slots) for contacting hard tissue as disclosed by Picha to the outer surfaces of the prongs of the implant of Coughlin to form the claimed “first pillars” and “first slots” as these pillars, upon implantation, provide immediate load transfer and prevent stress shielding (as taught by Picha in paragraph [0010]) as well as prevent detrimental cellular reactions at the interface, such as formation of fibrous tissue, seroma, or thrombosis (as taught by Picha in paragraph [0026]).
Regarding the size of the first pillars, it would further have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention for the added “first” pillars and slots to have the following size limitations: being distributed across an area of at least 20 mm^2 on each prong, having a transverse area of (100 x 100) to (2,000 x 2,000) um^2, having a height of 100 to 2,000 um, the slots being defined by the pillars and each slot having a width of 100 to 2,000 um as measured along the shortest distance between adjacent pillars as these ranges are all within the ranges taught by Picha for the pillars, and can be altered in order to tailor the device for a particular application, as the implant can be designed according to the type of hard tissue (see paragraph [0039] for the different applications of the implant and paragraph [0062] for an example), as well as the patient’s needs (see paragraph [0074]).
Furthermore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the “second pillars” and “second slots” of Coughlin to have the following size limitations: being distributed across an area of at least 20 mm^2 on each prong inner surface, the second pillars having a transverse area of (200 x 200) to (4,000 x 4,000) um^2, and having a height of 100 to 5,000 um, and each second slot having a width of 400 to 4,000 um as measured along the shortest distance between adjacent second pillars in order to tailor the device for a particular application as the implant can be designed according to the type of hard tissue (see paragraph [0039] for the different applications of the implant and paragraph [0062] for an example), as well as the patient’s needs (see paragraph [0074]). As taught by paragraph [0074] of Picha, the size, area of implant the pillars are distributed on, different amounts, and directions of extension could all be designed accordingly to the patient and application.
Additionally, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the implant of Coughlin have a ratio of (i) the sum of the volumes of the first slots to (ii) the sum of the volumes of the first pillars and the volumes of the first slots (“first surface ratio”) of 0.40:1 to 0.90:1 (see paragraph [0049] of Picha denoting an option for the ratio to be 0.40:1 to 0.90:1), and (3) a ratio of (i) the sum of the volumes of the second slots to (ii) the sum of the volumes of the second pillars and the volumes of the second slots (“second surface ratio”) of 0.60:1 to 0.98:1 (see paragraph [0049] to see options 0.51:1 to 0.90:1 or paragraph [0055] showing the range of 0.92:1 to 1.4:1) since Picha teaches that the ranges provide a high resilience to load to prevent implant migration (see paragraph [0051]). It would have also been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the implant of Coughlin have a Young’s modulus of elasticity of at least 3 GPa, as an elasticity of over 10 GPa as taught by Picha (see paragraph [0011]) exhibits mechanical properties that result in long lasting implants and load resilience (see paragraph [0026] of Picha).
Furthermore, it would have been obvious to someone of ordinary skill of the art before the effective filing date of the claimed invention to have the second surface ratio greater than the first surface ratio, as Picha teaches an option for a ratio to start with 0.40:1 or 0.51:1, anticipating the claimed requirement for the first pillars to have a smaller surface ratio than the second pillars. Additionally, it would have been an obvious matter of design choice to have the first pillars surface ratio be smaller than the ratio of the second pillars in order to tailor the device for a particular application as the implant can be designed according to the type of hard tissue (see paragraph [0039] for the different applications of the implant and paragraph [0062] for an example), as well as the patient’s needs (see paragraph [0074]).
Regarding Claim 2, Coughlin discloses the implant of claim 1.
However, Coughlin fails to disclose wherein the implant is made of one or more materials selected from implantable-grade polyaryletherketone that is essentially unfilled, implantable- grade polyetheretherketone, implantable-grade polyetherketoneketone, titanium, stainless steel, cobalt-chromium alloy, titanium alloy, Ti-6A1-4V titanium alloy, Ti-6A1-7Nb titanium alloy, ceramic material, silicon nitride (Si3N4), implantable-grade composite material, implantable- grade polyaryletherketone with filler, implantable-grade polyetheretherketone with filler, implantable-grade polyetheretherketone with carbon fiber, or implantable-grade polyetheretherketone with hydroxyapatite.
Picha teaches that it is known in the art to form hard tissue implants from implantable- grade polyetheretherketone, titanium, stainless steel, cobalt-chromium alloy, or titanium alloy (see paragraph [0036]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the implant of Coughlin as modified to be comprised of any of the materials since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding Claim 5, Coughlin as modified discloses the implant of claim 1, wherein the first prong and the second prong extend perpendicularly from the lower surface of the head (see lower surface and prongs in Figure 1 above).
Regarding Claim 6, Coughlin as modified discloses the implant of claim 1, wherein the first prong is tapered toward the first prong tip, and the second prong is tapered toward the second prong tip (see Figure 1 above, see also claims 7 and 20).
Regarding Claim 8, Coughlin as modified teaches implant of claim 1, wherein the first pillars are perpendicular to the first prong outer surface and the second prong outer surface (see paragraph [0042], see explanation of the claim 1 rejection above).
Regarding Claim 10, Coughlin as modified discloses the implant of claim 1, wherein the second pillars extend in a uniform direction (see Figure 1 above).
Regarding Claim 11, Coughlin as modified discloses the implant according to claim 1.
Coughlin as modified fails to disclose wherein the second pillars on the first prong inner surface are angled toward the first prong tip and the second pillars on the second prong inner surface are angled toward the second prong tip.
Picha teaches pillars that are oriented forward at an acute angle relative to the direction of the pressing of the implant into the body (see paragraph [0081]).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the second pillars of Coughlin on the inner surfaces of the first and second prongs to be angled towards the first and second prong tips as angling the pillars towards the direction of insertion or “pressing” provides immediate load transfer between the implant and hard tissue and prevents stress shielding of the hard tissue as taught by Picha (see paragraph [0081]). The prong tips are in the direction of pressing as denoted by a tool-engaging portion being located on the head to press, drive, or insert the implant into a hard tissue (see paragraph [00104] of the Instant Application).
Regarding Claim 12, Coughlin as modified discloses the implant of claim 1, wherein the transverse area of each first pillar is (200 x 200) um2 to (1,000 x 1,000) um2 (see paragraph [0028] of Picha, see also claim 1 rejection explanation above).
Regarding Claim 13, Coughlin as modified discloses the implant of claim 1, wherein the height of each first pillar is 200 to 900 um (see paragraph [0029] of Picha, see also claim 1 rejection explanation above).
Regarding Claim 15, Coughlin as modified discloses the implant of claim 1, wherein the width of each first slot is 200 to 900 um (see paragraph [0009] of Picha, see also claim 1 rejection explanation above).
Regarding Claim 16, Coughlin as modified discloses the implant of claim 1, wherein the transverse area of each second pillar is (400 x 400) um2 to (2,000 x 2,000) um2. (see paragraph [0028]) of Picha, see also claim 1 rejection explanation above).
Regarding Claim 17, Coughlin as modified discloses the implant of claim 1, wherein the height of each second pillar is 200 to 4,000 um (see paragraph [0028] of Picha, see also claim 1 rejection explanation above).
Regarding Claim 19, Coughlin as modified discloses the implant of claim 1, wherein the width of each second slot is 500 to 3,000 um (see paragraph [0029] of Picha, see also claim 1 rejection explanation above).
Regarding claims 23 and 24: Coughlin is silent as to whether one or more of the head, the first prong, the first pillars, the second prong, or the second pillars are non-porous or porous. Picha teaches that one or more of the head, the first prong, the first pillars, the second prong, or the second pillars are non-porous or porous, and a combination of these types of materials is known in the art (see paragraphs [0037] and [0043]). Picha teaches that porous surfaces allow for migration and proliferation of osteoblasts and mesenchymal cells [0030].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have one or more components of the implant can be made of porous or nonporous material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over US 20070123988 A1 (hereafter --Coughlin--) in view of US 20130110255 A1 (hereafter --Picha--), and in further view of WO 2009018565 A1 (hereafter --Rohlinger--).
Regarding Claim 9, Coughlin as modified discloses the implant of claim 1 (see explanation of the claim 1 rejection above).
However, Coughlin as modified fails to disclose wherein the first pillars are angled towards the head.
Nevertheless, Rohlinger discloses and implant with a head and a first prong (114) and a second prong (106) with first pillars (134) on the outside surfaces of the prongs made of titanium and its alloys, stainless steels, porous materials, or polyetheretherketone (see paragraph [0040]). Rohlinger teaches wherein the first pillars are angled towards the head (see Figure 4 below).
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Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have the first pillars of Coughlin as modified be angled towards the head as by doing so would provide a secure connection between the implant and the bone as taught by Rohlinger (see paragraph [0037]).
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over US 20070123988 A1 (hereafter --Coughlin--) in view of US 20130110255 A1 (hereafter --Picha--), and in further view of CA 2063159 C (hereafter --Sanders--).
Regarding Claim 20, Coughlin as modified discloses the implant of claim 1, wherein the implant has first prong length from the head to the first prong tip, the implant has a second prong length from the head to the second prong tip.
However, Coughlin as modified fails to disclose wherein the head has a head diameter at a widest portion of the head, the implant has a second prong length from the head to the second prong tip, the implant has a ratio of the first prong length to the head diameter of 2.0 to 10, and the implant has a ratio of the second prong length to the head diameter of 2.0 to 10, as Coughlin as modified is silent as to the dimensions of the implant.
Nevertheless, Sanders discloses an implant with a head, a first prong, a second prong, a first prong tip, and a second prong tip (see Figure below). Sanders teaches wherein the head has a head diameter at a widest portion of the head ranging from 7.4 – 7.7 mm, and the first prong has a first prong length from the head to the first prong tip ranging from 11.2 mm – 11.7 mm, and the second prong has a second prong length from the head to the first prong tip ranging from 11.2 mm – 11.7 mm (see page 10, lines 4-15). Sanders therefore teaches the implant having a ratio of the first prong length to the head diameter of 1.5, and the implant has a ratio of the second prong length to the head diameter of 1.5.
Sanders sets forth that the ratio of the head diameter to the prong length is a result effective variable, wherein having a head diameter at the widest portion of the head facilitates insertion instrument connection to drive the implant into the tissue and bone (see page 5, lines 12-14), and having a prong length between 11.2 and 11.7 mm and a head diameter ranging from 7.4 – 7.7 mm are possible dimensions of an implant to utilize for securing tissue to bone (see page 9, lines 24-26). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a ratio of the first and second prong lengths to the head of the implant to range from 2.0 to 10, for the purpose of sufficiently sizing the implant to the patient’s bone, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
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Regarding Claim 21, Coughlin as modified discloses the implant according to claim 1, wherein the head has a head diameter of 4 to 20 mm at a widest portion of the head (see page 10, lines 4-15 and the Figure above, see also above explanation of the claim 20 rejection).
Regarding Claim 22, Coughlin as modified discloses the implant according to claim 1, wherein the implant has a first prong length of 8 to 40 mm from the head to the first prong tip, and the implant has a second prong length of 8 to 40 mm from the head to the second prong tip (see page 10, lines 4-15 and the Figure above, see also above explanation of the claim 20 rejection).
Conclusion
THIS ACTION IS MADE FINAL. 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 PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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