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 23 February 2026 have been entered. Claim 22 is new. Claims 1-22 are pending.
Response to Arguments
Applicant’s arguments with respect to claims 1, 20, and 21 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 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 1-2, 4-8, 10-14, 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Mansmann (US 2018/0289493 A1), “Mansmann” in view of Albertorio (US 2011/0153028 A1), “Albertorio”.
Regarding claim 1, Mansmann teaches a device configured for use as a medical implant, the device comprising the inner surface of the perimeter wall (Fig. 15A, sidewall 515) comprising a barrier layer (Fig. 15B, barrier layer 538A), but fails to teach an anchor body and ring shape.
Mansmann teaches a second embodiment comprising a ring comprising a lattice surrounding a portion of the cavity and positioned between the rim and a bottom surface of the anchor body (Fig. 6A, flexible material attachment portion 40 formed as a lattice structure is cylindrical in shape and positioned within cavity 222 and between upper edge 228 and bottom wall 220 [0117]), and arranged along only a portion of the inner surface of the perimeter wall adjacent to the rim and extending into the cavity (Fig. 6B, flexible material attachment portion 40 formed as a lattice structure is positioned within cavity 222 and only sections of the lattice cross-struts engage with the sidewall 218 [0117]), leaving an open area contiguous with the cavity in a central part of the ring (Fig. 6A, flexible material attachment portion 40 extends across inner surface 233 of bottom wall 220 of cavity 222 (i.e., leaves center of cavity open within) [0117]); a non-lattice region arranged along a portion of the inner surface of the perimeter wall between the ring and the bottom surface of the anchor body (Fig. 6A, bottom wall 220 of implant 210 is not a lattice and extends down to its lower-most underside forming aperture 224 (i.e., extending perimeter wall downwards) [0116]), wherein the ring is separate from the non-lattice region (Fig. 6A, bottom wall 220 is separate from flexible material attachment portion 40). Mansmann discloses that the cross-strut configuration adds additional surface area, support, and increased retaining surfaces to the implant [0117]. 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 perimeter wall and barrier layer taught by the first embodiment of Mansmann with the ring and non-lattice region taught by the second embodiment of Mansmann in order to increase the retention abilities of the implant. However, Mansmann fails to teach a portion of the outer surface of the perimeter wall comprising a porous layer configured to promote bone ingrowth.
Albertorio teaches an osteochondral implant wherein a portion of an outer surface of the perimeter wall comprising a porous layer configured to promote bone ingrowth (Fig. 2, base 210 comprises a porous coating 215 to facilitate bone ongrowth and/or ingrowth [0024]). Albertorio discloses that the porous substrate for bony ingrowth comprises a pattern porosity similar to the porosity of cancellous bone [0017]. 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 layer taught by Albertorio with the perimeter wall taught by Mansmann in order to better integrate the implant into a patient’s bone.
Regarding claim 2, Mansmann teaches a second embodiment wherein the lattice comprises a plurality of struts and a plurality of cross-struts (Fig. 6A, attachment portion 40 formed as a lattice is formed of struts and cross-struts [0117]). Mansmann discloses that the cross-strut configuration adds additional surface area, support, and increased retaining surfaces to the implant [0117]. 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 struts taught by the first embodiment of Mansmann with the cross-struts taught by the second embodiment of Mansmann in order to increase the retention abilities of the implant.
Regarding claim 4, Mansmann teaches a first embodiment including the perimeter wall (Fig. 15A, sidewall 515) defines the lattice (Fig. 15A, attachment layer 540a), the non-lattice region (Fig. 15C, sidewall portion 532a), and the cavity (Fig. 14A, flexible material 514), but fails to teach a first diameter of the cavity, and a second diameter of the cavity, the first diameter being greater than the second diameter, and wherein the lattice is arranged in part along the first diameter, and the non-lattice region is arranged along the second diameter.
Mansmann teaches a third embodiment having a first region (Fig. 10C, sidewall 18 creates cylindrical region) defines a first diameter (Fig. 10C, sidewall 18 defines a diameter of anchor 12), and a second region (Fig. 10C, top opening 26 creates circular region) defining a second diameter (Fig. 10C, top opening 26 defines a diameter of anchor 12), the first diameter being greater than the second diameter (Fig. 10C, top opening 26 is angled inwardly on anchor 12 and therefore creates a smaller diameter), and wherein the lattice (Fig. 10C, bone attachment layer 36) is arranged in part along the first diameter (Fig. 10C, bone attachment layer is attached on sidewall 18), and the non-lattice region (Fig. 10C, upper edge 28) is arranged along the second diameter (Fig. 10C, upper edge 28 creates top opening 26). Mansmann discloses that this anchor embodiment is produced through 3D printing [0128]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the lattice region and positioning of the non-lattice region to reflect the 3D printed embodiment in order to produce the anchor with more efficiency and at a lower cost.
Regarding claim 5, the first and second embodiments of Mansmann does not include a curved profile, however Mansmann further discloses that the third embodiment includes the perimeter wall (Fig. 10C, sidewall 18) comprises a curved profile (Fig. 10C, sidewall 18 creates cylindrical region) adjacent the first diameter (Fig. 10C, sidewall 18 defines a diameter of anchor 12). Mansmann discloses that this anchor embodiment is produced through 3D printing [0128]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the lattice region and positioning of the non-lattice region to reflect the 3D printed embodiment in order to produce the anchor with more efficiency and at a lower cost.
Regarding claim 6, Mansmann teaches a second embodiment wherein the non-lattice region comprises a smooth surface (Fig. 6A, bottom wall 220 of implant 210 is not a lattice (i.e., smooth)).
Regarding claim 7, Mansmann teaches a first embodiment wherein the non-lattice region (Fig. 15C, sidewall portion 532a) extends along the inner surface of the perimeter wall for a greater distance than the lattice (Fig. 15A, sidewall portion 532a (and sidewall 515 in general) extend higher than attachment layer 540a).
Regarding claim 8, Mansmann teaches a first embodiment wherein a portion of each strut of the plurality of struts is arranged adjacent a curved portion of the inner surface of the perimeter wall (Fig. 15A, attachment layer 540a comprising struts extends along entire sidewall 515).
Regarding claim 10, Mansmann teaches a first embodiment wherein the plurality of cross-struts (Fig. 15A, attachment layer 540a comprises struts [0050]) defines a curved upper surface adjacent the rim (Fig. 15A, sidewall 515 forms lip (i.e., rim) that is curved and comprises sidewall portion 532a).
Regarding claim 11, Mansmann teaches a first embodiment wherein the elastic articulating component (Fig. 14A, flexible material 514) is molded within the anchor body (Fig. 14A, flexible material 514 is fitted to anchor 512), and the elastic articulating component (Fig. 14A, flexible material 514) surrounds portions of the lattice (Fig. 14B, flexible material 514 is layered with attachment layer 540a).
Regarding claim 12, Mansmann teaches a first embodiment wherein an outer porous layer (Fig, 14A, bone attachment layer 536a) is arranged on an outer surface of the perimeter wall (Fig. 14B, bone attachment layer 536a is on top of sidewall 515).
Regarding claim 13, Mansmann teaches a first embodiment wherein a first thickness of the outer porous layer (Fig, 14A, bone attachment layer 536a) is at least three times larger than a second thickness of the perimeter wall (Fig. 14A, sidewall 515) in a region of the outer porous layer (Fig. 14A, bottom- most portion of bone attachment layer 536a is at least 0.5mm thick [0150])
Regarding claim 14, Mansmann teaches a first embodiment wherein the rim (Fig. 15A, sidewall 515 forms lip (i.e., rim)) has a second thickness (Fig. 14B, inner surface 532) which is greater than the second thickness of the perimeter wall (Fig. 14B, bottom wall 516) in the region of the outer porous layer (Fig, 14A, bone attachment layer 536a) the second thickness is less than the first thickness of the outer porous layer (Fig. 14A-B, inner surface 532 is thinner than bottom-most portion of bone attachment layer 536a).
Regarding claim 16, Mansmann teaches a first embodiment wherein the elastic articulating component (Fig. 14A, flexible material 514) is formed from hydrogel (Fig. 14A, flexible material 514 is made from hydrogel [0035])
Regarding claim 19, Mansmann teaches a first embodiment wherein a space (Fig. 15B, spaces between struts of attachment layer 540 (at edges as well)) is provided between portions of the lattice (Fig. 15A, attachment layer 540a) and the inner surface of the perimeter wall (Fig. 15A, sidewall 515).
Claims 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Mansmann (US 2018/0289493 A1), “Mansmann” in view of Albertorio (US 2011/0153028 A1), “Albertorio” and further in view of Mansmann (US 2005/0287187 A1), “Mansmann 187”.
Regarding claim 3, Mansmann teaches a second embodiment comprising the plurality of struts (Fig. 6A, flexible material attachment portion 40 comprises struts and cross-struts) but fails to teach a vertical bearing surface and the plurality of cross-struts defines a curved top surface.
Mansmann 187 teaches a meniscal implant wherein a plurality of struts defines a vertical bearing surface (Fig. 5, penetrating mesh strands 44 pass through hydrogel polymer 20 in the opposite direction of peripheral strands 42 [0130]) and the plurality of cross-struts defines a curved top surface (Fig. 5, peripheral strands 42 extend out of implant 10 around rim surface 24 to form arc-like shape [0130]). Mansmann 187 discloses that this wedge-shaped meniscal implant is shaped specially to be anchored to soft tissue and to limited areas of bone [0128]. 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 implant taught by Mansmann with the orientation of struts and cross-struts taught by Mansmann 187 in order to provide an implant specifically suited to a cartilaginous region to best fit the patient needs.
Regarding claim 9, Mansmann fails to teach the limitations of claim 9. However, Mansmann 187 teaches wherein each cross-strut of the plurality of cross-struts has a portion extending outwardly from the inner surface of the perimeter wall (Fig. 5, peripheral strands 42 extend out of implant 10 around rim surface 24 [0130]) and wherein each strut of the plurality of struts has a portion extending toward the bottom surface of the anchor body (Fig. 5, penetrating mesh strands 44 pass through hydrogel polymer 20 of implant 10 near end comprising treated surface 26 (i.e., bottom) [0130]). Mansmann 187 discloses that this wedge-shaped meniscal implant is shaped specially to be anchored to soft tissue and to limited areas of bone [0128]. 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 implant taught by Mansmann with the orientation of struts and cross-struts taught by Mansmann 187 in order to provide an implant specifically suited to a cartilaginous region to best fit the patient needs.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mansmann (US 2018/0289493 A1), “Mansmann” in view of an embodiment.
Regarding claim 15, the first embodiment of Mansmann fails to teach the limitations of claim 15. However, Mansmann teaches a fourth embodiment that includes portions of the plurality of struts extend away from the inner surface of the perimeter wall (Fig. 20D, attachment layer 640 comprises struts angled outward from barrier layer 638), and portions of the plurality of struts extend toward the bottom surface of the anchor body (Fig. 20D, attachment layer 640 comprises struts angled toward barrier layer 638), and wherein the plurality of struts form gaps between each strut of the plurality of struts and the inner surface of the perimeter wall (Fig. 20D, attachment layer 640 comprises angled struts that form gaps between attachment layer 640 and barrier layer 638).
Mansmann discloses that this fourth embodiment comprises apertures which form cannulae to better hold the bone attachment layer [0157]. 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 lattice region taught by the first embodiment of Mansmann with the strut design taught by the fourth embodiment of Mansmann in order to avoid detachment of the bone attachment layer to the anchor during use of the device.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Mansmann (US 2018/0289493 A1), “Mansmann” in view of an embodiment.
Regarding claim 17, Mansmann further discloses that the first embodiment includes the lattice region (Fig. 15A, attachment layer 540a), but the first embodiment does not have the lattice region defined along a circumferential area of the inner surface of the perimeter wall.
However, a fifth embodiment of Mansmann describes the lattice region (Fig. 11B, flexible material 40) that is defined along an uninterrupted circumferential area of the inner surface of the perimeter wall (). Mansmann discloses that this fifth embodiment is produced through 3D printing [0131]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first embodiment of Mansmann according to the teaching of the fifth embodiment of Mansmann in order to in order to produce the anchor with more efficiency and at a lower cost.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Mansmann (US 2018/0289493 A1), “Mansmann” in view of Patrick et al. (US 2016/0287392 A1) “Patrick”.
Regarding claim 18, Mansmann teaches a first embodiment including the ring (), but the first embodiment does not have at least one lattice region only defined in a region directly adjacent to the rim.
However, Patrick teaches the ring that is only defined in a region directly adjacent to the rim (Fig. 12B, region of hydrogel 1212 adjacent to porous material 1214). Patrick discloses that the interaction between the porous material and the annular region (detent 1216) provide sufficient hold so that the porous material can be non-porous material [0148]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide any necessary amount of lattice region at any necessary location, through routine experimentation, so as to provide a suitable bond between the hydrogel and porous/non-porous material that has the least manufacturing cost and most implantation success rate.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0289493 A1, “Mansmann” in view of Ryan et al. (US 2019/0343644 A1), “Ryan” and further in view of Lynn et al. (GB 2454325 A) “Lynn”.
Regarding claim 20, Mansmann teaches a first embodiment including a medical implant, wherein the medical implant (Fig. 13A, implant system 500) includes an elastic articulating component (Fig. 14A, flexible material 514) molded with an anchor body (Fig. 15A, anchor 512) comprising a perimeter wall (Fig. 15A, sidewall 515) defining a cavity (Fig. 15A, cavity 517) and having an inner surface comprising a barrier layer (Fig. 15B, barrier layer 538A) and including a portion of an outer surface of the perimeter wall comprising a porous layer configured to promote bone ingrowth and including a ring comprising a lattice (Fig. 15A, attachment layer 540a) surrounding a portion of cavity and formed around only a portion of the inner surface of the perimeter wall and extending between the upper rim and a bottom surface of the anchor body and extending into a portion of the cavity, adjacent an upper rim of the perimeter wall (Fig. 15A, attachment layer 540a is placed within lip of sidewall 515) and a non-lattice region (Fig. 15C, sidewall portion 532a) arranged along a portion of the inner surface of the perimeter wall (Fig. 10C, sidewall 18) between the ring (Fig. 10A, bone attachment layer 36) and the bottom surface (Fig. 10C, bottom wall 20) of the anchor body (Fig. 10C, anchor body 16), wherein the ring (Fig. 15A, attachment layer 540a) is separate from the non-lattice region (Fig. 15C, sidewall portion 532a), but the second embodiment does not include a lattice portion formed as a ring, and a medical implant tool comprising: an outer sleeve; and a plunger arranged inside of the outer sleeve such that the plunger is axially moveable relative to the outer sleeve, the plunger defining a collar dimensioned to receive a portion of a medical implant, and the collar is dimensioned to receive a portion of the articulating component, and the collar is configured to engage against a rim defined by the anchor body.
Mansmann teaches a second embodiment wherein the lattice region is arranged as a ring (Fig. 10A, bone attachment layer 36 is a cylindrical shape). Mansmann discloses that this second embodiment is produced through 3D printing [0128]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the lattice region and positioning of the non-lattice region to reflect the 3D printed embodiment in order to produce the anchor with more efficiency and at a lower cost. However, the embodiments of Mansmann fail to teach a lattice region arranged along only a portion of the inner surface of the perimeter wall and a medical implant tool.
Ryan teaches a transforaminal lumbar interbody fusion implant comprising a lattice region (Fig. 40, integral porous structure 250) arranged along only a portion of the inner surface of the perimeter wall (Fig. 40, integral porous structure 250 is placed within portions of the inner perimeter IP of the body 211 [0116-0119]). Ryan discloses that the configuration of the porous structure provides the implant with sufficient structural integrity and mechanical stability [0087]. 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 device taught by the first embodiment of Mansmann with the shape of the lattice structure taught by the second embodiment of Mansmann and the configuration of the lattice regions as taught by Ryan in order to better incorporate the implant with the surrounding bone. However, Mansmann in view of Ryan still fails to teach a medical implant tool.
Mansmann fails to teach a medical implant tool including an outer sleeve and a plunger arranged inside of the outer sleeve such that the plunger is axially moveable relative to the outer sleeve, the plunger defining a collar dimensioned to receive a portion of the medical implant; inserting the medical implant inside an opening in the patient's bone; engaging the medical implant with the medical implant tool to secure the medical implant within the patient's bone, such that the collar surrounds and receives a portion of the elastic articulating component and the collar engages the rim of the anchor body; and activating the plunger to engage the rim to press the medical implant within the opening in the patient's bone.
Lynn teaches a medical implant tool (Fig. 1, implant delivery device 10) comprising: an outer sleeve (Fig. 1, sleeve 130); and a plunger (Fig. 1, plunger 30) arranged inside of the outer sleeve such that the plunger is axially moveable relative to the outer sleeve (Fig. 1, plunger 30 is positioned within sleeve 130 and moves individually), the plunger defining a collar (Fig. 1, distal end of plunger 30 forms a collar) dimensioned to receive a portion of a medical implant (Fig. 1, implant 100), the collar is dimensioned to receive a portion of the articulating component (Fig. 1, implant 100 engages with distal end of plunger 30), and the collar is configured to engage against a rim (Fig. 1, proximal end of implant 100) defined by the anchor body.
Lynn discloses that the plunger is for improved handling, positioning and discharge of an implant into a desired implantation site without damage or unwanted compression forces upon the implant (pg. 1, lines 37-39). Lynn discloses that the delivery tool is for delivering implants that are soft or spongy (pg. 9, lines 1-3), similar to the implant described by Mansmann, so that they are not damaged during the delivery process. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to couple the medical implant of Mansmann with the medical implant tool of Lynn in order to best place the implant within the cavity of the knee where the cartilage is damaged and to avoid unnecessary damage to the implant itself.
Regarding claim 21, Mansmann teaches a method of inserting a medical implant (flexible implant can be rolled-up for insertion during surgery [0016]), the method comprising: providing the medical implant (Fig. 13A, implant system 500), a first embodiment of the medical implant including an elastic articulating component (Fig. 14A, flexible material 514) molded with and held within an anchor body (Fig. 15A, anchor 512) comprising a perimeter wall (Fig. 15A, sidewall 515) defining a cavity (Fig. 15A, cavity 517) and having an inner surface comprising a barrier layer and including a portion of an outer surface of the perimeter wall comprising a porous layer configured to promote bone ingrowth, and including a ring comprising a lattice (Fig. 15A, attachment layer 540a) surrounding a portion of the cavity and formed around only a portion of the inner surface of the perimeter wall adjacent an upper rim of the perimeter wall (Fig. 15A, attachment layer 540a is placed within lip of sidewall 515) and extending between the rim and a bottom surface of the anchor body and extending into a portion of the cavity while leaving a central open area contiguous with the cavity, and a non-lattice region (Fig. 15C, sidewall portion 532a) comprising a barrier layer (Fig. 15B, barrier layer 538A) arranged along a portion of the inner surface of the perimeter wall between the ring and the bottom surface of the anchor body (Fig. 15A, attachment layer 540a is placed within lip of sidewall 515 and positioned in cavity 517 [0142]), wherein the ring (Fig. 15A, attachment layer 540a) is separate from the non-lattice region (Fig. 15C, sidewall portion 532a), the elastic articulating component (Fig. 14A, flexible material 514) formed from hydrogel (Fig. 14A, flexible material 514 is made from hydrogel [0035]). The first embodiment of the medical implant does not include a lattice portion formed as a ring, and a medical implant tool wherein the medical implant tool including an outer sleeve and a plunger arranged inside of the outer sleeve such that the plunger is axially moveable relative to the outer sleeve, the plunger defining a collar dimensioned to receive a portion of the medical implant; inserting the medical implant inside an opening in the patient's bone; engaging the medical implant with the medical implant tool to secure the medical implant within the patient's bone, such that the collar surrounds and receives a portion of the elastic articulating component and the collar engages the rim of the anchor body; and activating the plunger to engage the rim to press the medical implant within the opening in the patient's bone.
Mansmann teaches a second embodiment of the medical implant wherein the lattice region is arranged as a ring (Fig. 10A, bone attachment layer 36 is a cylindrical shape). Mansmann discloses that this second embodiment is produced through 3D printing [0128]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the lattice region and positioning of the non-lattice region to reflect the 3D printed embodiment in order to produce the anchor with more efficiency and at a lower cost. However, the embodiments of Mansmann fail to teach a lattice region arranged along only a portion of the inner surface of the perimeter wall and a medical implant tool.
Ryan teaches a transforaminal lumbar interbody fusion implant comprising a lattice region (Fig. 40, integral porous structure 250) arranged along only a portion of the inner surface of the perimeter wall (Fig. 40, integral porous structure 250 is placed within portions of the inner perimeter IP of the body 211 [0116-0119]). Ryan discloses that the configuration of the porous structure provides the implant with sufficient structural integrity and mechanical stability [0087]. 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 device taught by the first embodiment of Mansmann with the shape of the lattice structure taught by the second embodiment of Mansmann and the configuration of the lattice regions as taught by Ryan in order to better incorporate the implant with the surrounding bone. However, Mansmann in view of Ryan still fails to teach a medical implant tool.
Lynn teaches a medical implant tool (Fig. 1, implant delivery device 10) wherein the medical implant tool includes an outer sleeve (Fig. 1, sleeve 130) and a plunger (Fig. 1, plunger 30) arranged inside of the outer sleeve such that the plunger is axially moveable relative to the outer sleeve (Fig. 1, plunger 30 is positioned within sleeve 130 and moves individually), the plunger defining a collar (Fig. 1, distal end of plunger 30 forms a collar) dimensioned to receive a portion of the medical implant (Fig. 1, implant 100), inserting the medical implant inside an opening in the patient's bone (the cavity where the implant is to be delivered is within bone and cartilage (pg. 4, lines 18-20)); engaging the medical implant with the medical implant tool to secure the medical implant within the patient's bone, such that the collar surrounds and receives a portion of the elastic articulating component (Fig. 1, implant 100 engages with distal end of plunger 30) and the collar engages the rim of the anchor body (Fig. 1, proximal end of implant 100), and activating the plunger to engage the rim to press the medical implant within the opening in the patient's bone (Figs. 2a-c, implant delivery device 10 actuates (i.e., presses) the implant 100 into delivery site (i.e., opening in patient’s bone)).
Lynn discloses that their described plunger is for improved handling, positioning and discharge of an implant into a desired implantation site without damage or unwanted compression forces upon the implant (pg. 1, lines 37-39). Lynn further discloses that the delivery tool is for delivering implants that are soft or spongy (pg. 9, lines 1-3), similar to the implant described by Mansmann, so that they are not damaged during the delivery process. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to couple the medical implant of Mansmann with the medical implant tool of Lynn in order to most accurately and seamlessly place the implant within the cavity of the bone and to avoid unnecessary damage to the implant itself.
Regarding claim 22, Mansmann teaches a method of making a medical implant, the method comprising: forming an anchor body as a container (Fig. 6A, anchor 212 formed comprising cavity 222), the anchor body formed comprising: a perimeter wall (Fig. 6A, sidewall 218) including an upper rim and having an inner surface defining a cavity dimensioned to receive an elastic articulating component (Fig. 6A, sidewall 218 comprises upper edge 228 which forms cavity 222 which holds flexible material 214), the inner surface of the perimeter wall comprising a barrier layer (Fig. 6A, barrier layer 38); a ring comprising a lattice surrounding a portion of the cavity and positioned between the rim and a bottom surface of the anchor body (Fig. 6A, flexible material attachment portion 40 formed as a lattice structure is cylindrical in shape and positioned within cavity 222 and between upper edge 228 and bottom wall 220 [0117]), and arranged along only a portion of the inner surface of the perimeter wall adjacent to the rim and extending into the cavity (Fig. 6B, flexible material attachment portion 40 formed as a lattice structure is positioned within cavity 222 and only sections of the lattice cross-struts engage with the sidewall 218 [0117]), leaving an open area contiguous with the cavity in a central part of the ring (Fig. 6A, flexible material attachment portion 40 extends across inner surface 233 of bottom wall 220 of cavity 222 (i.e., leaves center of cavity open within) [0117]); and a non-lattice region arranged along a portion of the inner surface of the perimeter wall between the ring and the bottom surface of the anchor body (Fig. 6A, bottom wall 220 of implant 210 is not a lattice and extends down to its lower-most underside forming aperture 224 (i.e., extending perimeter wall downwards) [0116]), wherein the ring is separate from the non-lattice region (Fig. 6A, bottom wall 220 is separate from flexible material attachment portion 40); and positioning an elastic articulating component within the cavity and attached to the lattice (Fig. 6A, flexible material 214 is positioned throughout the cavity 222 [0117]), but fails to teach a portion of an outer surface of the perimeter wall comprising a porous layer configured to promote bone ingrowth.
Albertorio teaches an osteochondral implant wherein a portion of an outer surface of the perimeter wall comprising a porous layer configured to promote bone ingrowth (Fig. 2, base 210 comprises a porous coating 215 to facilitate bone ongrowth and/or ingrowth [0024]). Albertorio discloses that the porous substrate for bony ingrowth comprises a pattern porosity similar to the porosity of cancellous bone [0017]. 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 layer taught by Albertorio with the perimeter wall taught by Mansmann in order to better integrate the implant into a patient’s 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
Prosecution Insights