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
This Office Action is responsive to the amendment filed on 04 December 2025. As directed by the amendment: Claims 1, 2, 4, 6, 9, and 10 have been amended, and claims 11-20 stand withdrawn. Claims 1-20 currently stand pending in the application.
The amendments to claim 9 have resolved the drawing objection listed in the previous action, which is accordingly withdrawn.
The amendments to the claims are not sufficient to resolve the claim objections listed in the previous action, which are repeated in relevant part below, in addition to further claim objections necessitated by the current claim amendments.
The amendments to the claims have resolved the rejection under 35 U.S.C. 112(b) listed in the previous action, which is correspondingly withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The rejection in view of Zappacosta et al. (US 2022/0061999) was not specifically challenged in the argument.
Claim Objections
Claims 1-10 are objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 1 / lines 6-7: “wherein each of the one or more pegs of the femoral implant has a bullet shape”
Claim 1 / lines 10-11: “wherein each of the one or more pegs of the tibial tray implant has a bullet shape”
Claim 4 / line 3: “the resected femur and the resected tibia.”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 fails to further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 11,406,502 to Nguyen et al. (hereinafter, “Nguyen”), in view of U.S. Patent No. US 9,155,819 to Fonte et al. (hereinafter, “Fonte”) and U.S. Patent Application Publication No. US 2022/0061999 to Zappacosta et al. (hereinafter, “Zappacosta”).
As to claim 1, Nguyen discloses a knee arthroplasty implant system comprising: a femoral implant (102) having an anterior flange (300), a pair of posterior condylar flanges (302), and a distal portion (304) therebetween (col. 6 / line 57 – col. 7 / line 3), FIGS. 1 and 3, the femoral implant has an outer articulating surface (140, 142) with a smooth rounded shape that is configured to approximate an exterior distal femur surface of a natural human knee (col. 5 / lines 10-14), FIG. 1, and an inner surface (126) shaped to match a resected femur with five resection cuts, FIG. 3, and one or more pegs (150) extending from the inner surface (col. 5 / lines 21-23), FIG. 3, wherein each of the one or more pegs has a bullet shape comprising fins radiating outwards, FIG. 1; and a tibial tray implant (116) having a plate with a perimeter wall (610) defining an insert receiving space (612) (col. 10 / lines 24-35), FIG. 6, a distal surface (136) configured to contact a resected tibia, FIG. 7, a keel (192-196) extending from the distal surface, FIG. 7, and one or more pegs (190) extending from the distal surface (col. 10 / line 63 – col. 11 / line 7), wherein each of the one or more pegs has a bullet shape comprising fins radiating outwards, FIG. 7, wherein the inner surface of the femoral implant and the distal surface of the tibial tray implant each define a trabecular structure (where the term trabecular is commonly understood to mean formed by a network of interconnected beams, and a porous structure would have interconnected beams forming the pores; col. 6 / lines 46-56, col. 10 / lines 11-18), which is configured to provide a scaffold for bone healing and interdigitation (interpreted as language of intended use; fully capable of providing a scaffold for bone healing and interdigitation since the porosity promotes bone in-growth).
As to claim 5, Nguyen discloses the system of claim 1, wherein the trabecular structure is created by three-dimensional printing (col. 6 / lines 38-42, col. 10 / lines 3-5).
As to claim 6, Nguyen discloses the system of claim 1, wherein the pegs (150, 190) of the femoral implant and the tibial tray implant each have a bullet shaped profile with fins radiating outward from the respective peg, FIGS. 1 and 7.
As to claim 7, Nguyen discloses the system of claim 1, wherein the inner surface of the femoral implant includes an anterior femur cut surface (300), a posterior femur cut surface (302), a distal femur cut surface (310), an anterior chamfer cut surface (306), and a posterior chamfer cut surface (308) (col. 6 / line 60 – col. 7 / line 3), FIG. 3.
As to claim 8, Nguyen discloses the system of claim 7, wherein the trabecular structure extends along the anterior femur cut surface, the posterior femur cut surface, the distal femur cut surface, the anterior chamfer cut surface, and the posterior chamfer cut surface (since the porous structure is along all of the inner surface 126).
As to claim 9, Nguyen discloses the system of claim 1, wherein the trabecular structure of the inner surface of the femoral implant is surrounded by a solid wall (320), FIG. 3.
As to claim 10, Nguyen discloses the system of claim 1, wherein the femoral implant and the tibial tray implant are cementless and are securable to bone without cement (interpreted as language of intended use; the implants are fully capable of being secured to bone without cement).
Assuming arguendo, Nguyen discloses a porous structure but is silent as to a trabecular structure.
Fonte teaches a 3D porous coating for orthopedic implants that more accurately resembles trabecular bone to promote bone ingrowth deeper into the porous coating and provide better long-term implant fixation (col. 3 / lines 6-9, col. 13 / lines 58-67, col. 23 / line 66 – col. 24 / line 17).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the porous structure required by Nguyen as a 3D porous coating that resembles trabecular bone (i.e. a trabecular structure), as taught by Fonte, to promote bone ingrowth deeper into the porous coating and provide better long-term implant fixation. Nguyen discloses a porous structure but does not specifically describe the structure, and Fonte’s teaching of a trabecular structure would provide the porosity required by Nguyen. As required by Nguyen, the trabecular structure would be on the inner surface of the femoral implant and the distal surface of the tibial tray implant, where the implants contact the respective bone to allow bone in-growth.
Nguyen is silent as to each of the pegs comprising six fins.
Zappacosta teaches that pegs (34) of a knee implant each have a bullet shape comprising six fins (38) radiating outward from the peg (par. [0074]), FIGS. 1-3.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide each peg of the femoral implant and the tibial tray implant in Nguyen with six fins, since Zappacosta teaches that bullet shaped pegs with six fins are effective in fixating a knee implant into the respective bone, and since the mere duplication of the essential working parts of a device (the number of fins on each peg) involves only routine skill in the art.
As to claims 2-4, Nguyen is silent as to wherein the trabecular structure has a grid, lattice, or honeycomb pattern configured to promote bony in-growth (claim 2); wherein the trabecular structure has a porosity in the range of 50-80% (claim 3); wherein a thickness of the trabecular structure is oversized for an increased press fit in an area of the trabecular structure to ensure contact with the resected femur and tibia (claim 4).
Fonte teaches a 3D porous coating for orthopedic implants comprises a trabecular structure that has a honeycomb pattern, or a repeating grid/lattice pattern, that facilitates bone in-growth into the coating (col. 22 / lines 11-17), and is made from shape memory material to match the stiffness of bone and to customize the porosity (col. 13 / line 58 – col. 14 / line 31, col. 18 / lines 42-59, col. 23 / line 28 – col. 24 / line 17). When the shape memory material expands once the implant onto which it is coated contacts the bone, the trabecular structure fills gaps between the porous coating and adjacent bone to create an interference fit between the implant and bone tissue, thereby enhancing osseointegration and facilitating immediate and long term fixation (col. 4 / lines 21-34, col. 9 / lines 11-17, col. 23 / line 66 – col. 24 / line 17). Fonte teaches the porosity can be between 65% and 90% (col. 23 / lines 18-19).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the trabecular structure with a honeycomb pattern configured to promote bony in-growth into the pores or apertures of the coating, as taught by Fonte, and to comprise the coating of a shape memory material to match the stiffness of bone and to customize the porosity, so that when the shape memory material expands once the implant onto which it is coated contacts the bone, the trabecular structure fills gaps between the porous coating and adjacent bone to create an interference fit between the implant and bone tissue, thereby enhancing osseointegration and facilitating immediate and long term fixation. Upon shape recovery and expansion of the shape memory material once implanted, the thickness of the trabecular structure is relatively oversized (at least compared to its previous size) for an increased press fit between the implant and respective bone in areas where the trabecular structure contacts the bone to ensure contact with the respective bone (femur or tibia) and to enhance osseointegration due to the strain on the bone from the expanding implant coating.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the porosity of the trabecular structure in the range of 50-80%, since Fonte teaches a range of 65-90%, and taking the bottom goalpost of Fonte’s range (65%) would be in the claimed range, and 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. The low end of the range would accommodate a certain level of osseointegration with a bone having particular bone quality and other characteristics for which the lower value of porosity would be compatible, while also ensuring structural quality and strength of the trabecular structure.
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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775