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 .
Claim Status
Applicant’s Remarks and Amendments filed 2 February 2026 have been entered. Claims 19-20 are new. Claims 1 and 7-20 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 7-18 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.
Claim Objections
Claim 20 is objected to because of the following informalities: Claim 20 states “spaced apart from plurality of porous pre-formed surfaces” rather than “spaced apart from the plurality of porous pre-formed surfaces”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 7-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 17 recite the limitation "the length thereof" in lines 34 and 2, respectively. There is insufficient antecedent basis for this limitation in the claim. Further it is unclear whether “the length thereof” refers to the length of the femoral implant as a whole or a portion of it such as the length of the porous region. Claims 7-16 and 18-20 are rejected by dependency.
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.
Claims 1, 7-11, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fridshtand et al. (US 2006/0190092 A1), “Fridshtand” in view of Khandkar et al (US 2005/0177238 A1), “Khandkar” and further in view of Bergin et al. (US 2011/0144762 A1), “Bergin”.
Regarding claim 1, Fridshtand teaches a femoral implant (Fig. 1, hip stem 10) comprising: a body part (Fig. 2, proximal locking portion 40 and transition portion 80) having a longitudinal axis (Fig. 1, longitudinal axis 16) extending between a proximal end (Fig. 1, proximal end 12) and an opposing distal end (Fig. 1, distal end 14) and the body part (Fig. 2, proximal locking portion 40 and transition portion 80) comprising a bone growth part (Fig. 1, porous surface 60) configured to promote bone growth (Fig. 1, porous surface 60 promotes bony ingrowth [0027]) and a stem part (Fig. 1, distal shank 100) projecting from the bone growth part (Fig. 1, distal shank 100 extends from transition portion 80 comprising porous surface 60) at the distal end (Fig. 1, distal end 14) of the body part (Fig. 2, proximal locking portion 40 and transition portion 80) and configured to facilitate insertion into the femur (Fig. 1, distal shank 100 engages with intramedullary canal [0031]); a coupling part (Fig. 1, free end 21) to which an artificial femoral head is coupled (Fig. 1, stem 10 supports a femoral head component (not shown) [0024]); and a neck part (Fig. 1, neck 17) connecting the proximal end of the body part to the coupling part (Fig. 1, neck 17 links proximal end 12 and free end 21), wherein the bone growth part (Fig. 1, porous surface 60) comprises: a plurality of porous pore-formed surfaces that are radially spaced apart around the longitudinal axis of the body part (Fig. 2, porous surface geometry is a continuous layer around entire longitudinal axis 16 and has a structure similar to natural trabecular bone [0027]), but fails to teach the implant is configured to be inserted into an animal, or the frame part having upper and lower rails and upper and lower steps.
Khandkar teaches a bone graft comprising a frame part forming a solid surface that is less porous than the plurality of porous pore-formed surfaces (Fig. 15, bio-mimetic load bearing superstructure [0053] (black frame) of bone graft 710), the frame part (Fig. 15, bio-mimetic load bearing superstructure [0053]) comprising: a proximal rail (Modified Fig. 15, proximal rail of bio-mimetic load bearing superstructure [0053]) having the configuration of a continuous loop that encircles the longitudinal axis of the body part at a proximal end of the bone growth part (Modified Fig. 15, proximal rail encircles bone graft 710); a distal rail (Modified Fig. 15, distal rail of bio-mimetic load bearing superstructure [0053]) having the configuration of a continuous loop that encircles the longitudinal axis of the body part at a distal end of the bone growth part (Modified Fig. 15, distal rail encircles bone graft 710), each of the plurality of porous pore-formed surfaces being disposed between the proximal rail and the distal rail (Modified Fig. 15, porous osteoconductive scaffold [0052] is positioned between proximal and distal rails); a plurality of longitudinal rails that are spaced apart (Modified Fig. 15, longitudinal rails of bio-mimetic load bearing superstructure [0053]) and that each longitudinally extend from the proximal rail to the distal rail (Modified Fig. 15, longitudinal rails extend from proximal rail to distal rail), each of the plurality of longitudinal rails being disposed between a corresponding two of the plurality of porous pore-formed surfaces that are adjacently disposed (Modified Fig. 15, longitudinal rail pictured separates porous osteoconductive scaffold [0052]); an upper step encircling and radially outwardly projecting from the neck part to the proximal rail (Modified Fig. 15, proximal rail of bio-mimetic load bearing superstructure [0053] is disposed around the bone (i.e., radially outwardly projecting) and therefore creates a step between the bone and the proximal rail); and a lower step continuously encircling and radially outwardly projecting from the stem part (Modified Fig. 15, distal rail of bio-mimetic load bearing superstructure [0053] is disposed around the bone (i.e., radially outwardly projecting) and therefore creates a step between the bone and the distal rail), the lower step outwardly flaring from the stem part to the distal rail (Modified Fig. 15, distal rail is disposed around the bone and therefore creates an angled step (i.e., flared)), the lower step having an outer circumferential surface disposed entirely radially outward of an outer circumferential surface of the stem part (Modified Fig. 15, circumference of distal rail is radially displaced from the circumference of the bone (i.e., bone graft 710 is entirely externally placed surrounding the bone)), wherein the distal rail has a width extending along the length thereof that is disposed at a same level as an adjacent portion of the bone growth part (Modified Fig. 15, distal rail and porous osteoconductive scaffold [0052] are level with each other), the distal rail being disposed between the lower step and the plurality of porous pore-formed surfaces (Modified Fig. 15, distal rail is between the angled step and the porous osteoconductive scaffold [0052]), and wherein each of the proximal rail, distal rail, and the plurality of longitudinal rails form a solid surface that is less porous than the plurality of porous pore-formed surfaces (Fig. 15, bone graft 710 comprises a substrate block [0012] wherein the outer surfaces of the substrate block comprise low porosity for improved load bearing capacity compared to the high porosity mimicking cancellous bone for bone ingrowth [0038). Khandkar discloses that the bone graft enhances bone growth and fusion while also providing structural support [0049-0050]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the femoral implant taught by Fridshtand with the frame part, rails, and steps, taught by Khandkar in order to increase structural stability of the implant while promoting its integration. However, Fridshtand in view of Khandkar fails to teach the implant is configured to be inserted into an animal.
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Modified Figure 15
Bergin teaches an implant (Fig. 1, implant 10) that is inserted into an animal [0091]. Bergin discloses that the implant comprises bioabsorbable materials that allow for bone ingrowth and can be implanted into a human or an animal. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adapted Fridshtand in view of Khandkar’s femoral implant for animal implantation because of the implant’s bone ingrowth benefits that would promote quick healing and implant integration.
Regarding claim 7, Fridshtand teaches the porous formed surfaces (Fig. 1, porous surface 60), but Fridshtand fails to teach the frame part, and that both are manufactured by 3D printing.
Khandkar teaches a bone graft comprising a frame part (Fig. 15, bio-mimetic load bearing superstructure [0053] (black frame) of bone graft 710). Khandkar discloses that the bone graft enhances bone growth and fusion while also providing structural support [0049-0050]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the porous surfaces taught by Fridshtand with the frame part taught by Khandkar in order to increase structural stability of the implant while promoting its integration.
Fridshtand in view of Khandkar fails to teach that both are manufactured by 3D printing. However, “manufactured by 3D printing” is a product by process limitation that is not given patentable weight, as the process by which a product is made is not germane to the issue of patentability of the device itself.
Regarding claim 8, Fridshtand teaches the porous formed surfaces (Fig. 1, porous surface 60), but fails to teach they are disposed directly against the plurality of longitudinal rails, the proximal rail, and the distal rail and each extend radially outward to a common outer diameter.
Khandkar teaches a bone graft comprising porous formed surfaces that are disposed directly against the plurality of longitudinal rails, the proximal rail, and the distal rail and each extend radially outward to a common outer diameter (Modified Fig. 15, longitudinal rails separate porous osteoconductive scaffold [0052] and the rails and porous osteoconductive scaffold [0052] are level with each other). Khandkar discloses that the bone graft enhances bone growth and fusion while also providing structural support [0049-0050]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the porous formed surfaces taught by Fridshtand with the rails, taught by Khandkar in order to increase structural stability of the implant while promoting its integration.
Regarding claim 9, Fridshtand teaches wherein the stem part (Fig. 1, distal shank 100) extends distally from the bone growth part (Fig. 1, distal shank 100 extends from porous surface 60) while being reduced from the distal end of the bone growth part (Fig. 1, distal shank 100 tapers as it extends), but Fridshtand fails to teach the lower step.
Khandkar teaches a bone graft comprising a lower step (Modified Fig. 15, distal rail is disposed around the bone and therefore creates an angled step (i.e., flared)). Khandkar discloses that the bone graft enhances bone growth and fusion while also providing structural support [0049-0050]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the femoral implant taught by Fridshtand with the lower step, taught by Khandkar in order to increase structural stability of the implant while promoting its integration.
Regarding claim 10, Fridshtand teaches a neck part (Fig. 1, neck 17), but Fridshtand in view of Khandkar fails to teach wherein a size of the neck part varies depending on a size of the coupling part. Bergin teaches a hip prosthesis for a modular stem wherein a size of the neck part varies depending on a size of the coupling part (each part of the implant comes in various sizes [0006]). Bergin discloses that various sizes of parts of the implant are offered in order to accommodate various body sizes and types [0006]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the femoral implant taught by Fridshtand with the variously sized parts taught by Bergin in order to make the device more customizable to better fit a patient.
Regarding claim 11, Fridshtand teaches a coupling part (Fig. 1, free end 21) and a neck part (Fig. 1, neck 17), but Fridshtand in view of Khandkar fails to teach wherein as the size of the coupling part increases, the size of the neck part increases, and wherein as the size of the coupling part decreases, the size of the neck part decreases.
Bergin teaches a hip prosthesis for a modular stem wherein as the size of the coupling part increases, the size of the neck part increases, and wherein as the size of the coupling part decreases, the size of the neck part decreases (each part of the implant comes in various sizes [0006]). Bergin discloses that various sizes are offered in order to accommodate various body sizes and types. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the femoral implant taught by Fridshtand with a neck part and a coupling part taught by Bergin that increase or decrease in size concurrently in order to make the device customizable, and the head and neck portion of the implant more stable, to better fit a patient’s femur.
Regarding claim 16, Fridshtand teaches wherein bone growth part (Fig. 1, porous surface 60) has a plurality of corners (Fig. 2, porous surface 60 comprises edges and corners), but fails to teach each of the plurality of rails extending along a corresponding one of the plurality of corners.
Khandkar teaches a bone graft comprising each of the plurality of rails extending along a corresponding one of the plurality of corners (Modified Fig. 15, proximal, distal, and longitudinal rails extend along edges of porous osteoconductive scaffold [0052]). Khandkar discloses that the bone graft enhances bone growth and fusion while also providing structural support [0049-0050]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the bone growth part taught by Fridshtand with the rails taught by Khandkar in order to increase structural stability of the implant while promoting its integration.
Regarding claim 17, Fridshtand teaches wherein the stem part (Fig. 1, distal shank 100) has a solid exterior surface extending along the length thereof that is less porous than the plurality of porous pore-formed surfaces (Fig. 1, distal shank 100 is not formed of porous surface 60 material and is inserted into bone [0031].
Regarding claim 18, Fridshtand teaches wherein the body part (Fig. 2, proximal locking portion 40 and transition portion 80), the coupling part (Fig. 1, free end 21), and the neck part (Fig. 1, neck 17) are integrally formed as a single, unitary structure (Fig. 1, all aforementioned components are comprised in one solitary hip stem 10).
Regarding claim 19, Fridshtand teaches the plurality of porous pore-formed surfaces comprising four surfaces respectively disposed on four faces of the body part (Figs. 1-2, porous surface 60 extends around all sides of hip stem 10 [0027]), but fails to teach wherein the plurality of longitudinal rails are disposed on corners where adjacent surfaces meet, and the porous pore-formed surfaces and the frame part form a flat surface without protrusion relative to each other to allow the porous pore-formed surfaces to make close contact with an inner wall of the femur when inserted.
Khandkar teaches a bone graft wherein the plurality of longitudinal rails are disposed on corners where adjacent surfaces meet (Modified Fig. 15, longitudinal rails extend along edges of porous osteoconductive scaffold [0052]), and the porous pore-formed surfaces and the frame part form a flat surface without protrusion relative to each other to allow the porous pore-formed surfaces to make close contact with an inner wall of the femur when inserted (Modified Fig. 15, proximal, distal, and longitudinal rails and porous osteoconductive scaffold [0052] are level with each other). Khandkar discloses that the bone graft enhances bone growth and fusion while also providing structural support [0049-0050]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the porous pre-formed surfaces disposed on four surfaces of the body part taught by Fridshtand with the rails taught by Khandkar in order to increase structural stability of the implant while promoting its integration.
Regarding claim 20, Fridshtand fails to teach the limitations of claim 20. Khandkar teaches a bone graft wherein lower step (Modified Fig. 15, distal rail of bio-mimetic load bearing superstructure [0053] is disposed around the bone (i.e., radially outwardly projecting) and therefore creates a step between the bone and the distal rail) and the distal rail (Modified Fig. 15, distal rail of bio-mimetic load bearing superstructure [0053]) merge together at an outside corner that is spaced apart from plurality of porous pore-formed surfaces (Modified Fig. 15, angled step formed along underside of distal rail leads to distal rail itself which further separates from porous osteoconductive scaffold [0052]). Khandkar discloses that the bone graft enhances bone growth and fusion while also providing structural support [0049-0050]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the femoral implant taught by Fridshtand with the rails and lower step taught by Khandkar in order to increase structural stability of the implant while promoting its integration.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Fridshtand et al. (US 2006/0190092 A1), “Fridshtand” in view of Khandkar et al (US 2005/0177238 A1), “Khandkar” and Bergin et al. (US 2011/0144762 A1), “Bergin”, and further in view of Brown et al. (US 2006/0241776 A1), “Brown”.
Regarding claim 12, Fridshtand teaches the bone growth part (Fig. 1, porous surface 60), but Fridshtand in view of Kahndkar and Bergin fails to teach a locking hole into which a locking bolt is inserted to prevent sinking.
Brown teaches a porous implant having a locking hole (Fig. 16, hole for fastener 448) into which a locking bolt is inserted to prevent sinking (Fig. 16, fastener 448). Brown discloses that the fastener can be a screw and is used to secure the bone growth insert to the femoral implant stem [0073]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the femoral implant taught by Fridshtand with the locking features taught by Brown in order to prevent implant failure during placement and use post-operatively.
Regarding claim 13, Fridshtand in view of Khandkar and Bergin fails to teach the limitations in claim 13. Brown teaches a porous implant wherein the locking hole (Fig. 16, hole for fastener 448) is formed on an outer surface of the bone growth part (Fig. 16, hole is on the outside of insert 10). Brown discloses that the fastener can be a screw and is used to secure the bone growth insert to the femoral implant stem [0073]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the femoral implant taught by Fridshtand with the locking features taught by Brown in order to prevent implant failure during placement and use post-operatively.
Regarding claim 14, Fridshtand in view of Khandkar and Bergin fails to teach the limitations of claim 14. Brown teaches wherein a hole central axis (Fig. 16, line extending toward insert 10) of the locking hole (Fig. 16, hole for fastener 448) is perpendicular to an axis of the stem part (Fig. 16, line extending toward insert 10 is a perpendicular to stem portion 432). Brown discloses that the fastener can be a screw and is used to secure the bone growth insert to the femoral implant stem [0073]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the femoral implant taught by Fridshtand with the locking features taught by Brown in order to prevent implant failure during placement and use post-operatively.
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Fridshtand et al. (US 2006/0190092 A1), “Fridshtand” in view of Khandkar et al (US 2005/0177238 A1), “Khandkar” and Bergin et al. (US 2011/0144762 A1), “Bergin” and Brown et al. (US 2006/0241776 A1), “Brown”, and further in view of Miki et al. (US 2018/0153699 A1), “Miki”.
Regarding claim 15, Fridshtand teaches an axis of the stem part (Fig. 1, distal shank 100), but Fridshtand in view of Khandkar, Bergin, and Brown fails to teach wherein a hole central axis of the locking hole is not perpendicular to an axis of the stem part. Miki teaches a prosthetic hip system wherein a hole central axis (Fig. 24, axis through the center of hole 126) of the locking hole (Fig. 24, hole 126) is not perpendicular (Fig. 24, axis through the center of hole 126 is not perpendicular to the femur 128 central axis) to an axis of the stem part (Fig. 24, central axis of femur 128).
Miki discloses tools of an implant system that are operated along an axis extending through the neck and head of the femur and that the acetabular or femoral components can be used independently of each other [0074]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the femoral implant taught by Fridshtand with the non-perpendicular central hole axis of the locking hole to the stem axis in order to follow the shape of the femur, and therefore create a more synonymous implant that assimilates easily with the bone.
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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/G.G.R./ Examiner, Art Unit 3774
/SARAH W ALEMAN/ Primary Examiner, Art Unit 3774