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 Arguments
Applicant's arguments filed 3/20/2026 have been fully considered. Arguments regarding the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Jurgutis are persuasive in light of the amendments. However, new grounds of rejection for claim 1 and its dependents are made in light of the amendments.
Regarding the rejection of claims 5 and 21 under 35 U.S.C. 103 as being unpatentable over Frey in view of Noiles, applicant argues the combination of Frey and Noiles does not render these claims obvious. Applicant argues Frey does not disclose a layered structure combining a solid wall with porous material. It is true that Frey does not disclose a layered structure, but Frey does disclose a solid wall made of metal and Noiles is relied upon to teach a porous coating, which is well-known and commonplace in the art. Applicant argues Noiles teaches porous coating of the sleeves can be performed using standard techniques such as by heating the coated sleeve to fuse the balls and sleeve together and this coating process results in a surface treatment on the exterior of the sleeve not a layered structure formed with the porous material as recited in claims 5 and 21. The argument that the coating process of Noiles results in a surface treatment on the exterior of the sleeve and this is not a layered structure formed with the porous material is unpersuasive because applicant explains that the porous coating is on the exterior of the sleeve and this is clearly a layered structure. The surface treatment of Noiles is a porous coating on the exterior of the sleeve. The claims require a layered structure formed by a solid wall and a porous material. This is the exact structure taught by Noiles (see fig.2). Frey as modified by Noiles to include a porous coating results in a wall forming a layered structure with the porous material since the solid wall of Frey can be considered one layer and the porous coating another layer. Applicant argues adding Noiles’ porous coating to Frey’s sleeve would merely apply a surface layer of metal balls to the exterior of Frey’s existing wall structure and this would not create a wall that forms a layered structure with the porous material. Applicant argues the porous coating of Noiles is a surface treatment that sits on top of the underlying sleeve structure not an integrated layer construction where the solid wall and porous material are arranged as layers of the wall itself. This is not persuasive because “sits on top of the underlying sleeve structure” plainly describes layers. The porous coating of Noiles must be “an integrated layer” with the solid wall otherwise the porous layer would not stay on the solid wall. The examiner fails to see how a porous layer on a solid wall does not define a layered structure and maintains that the solid wall of Frey comprising a porous coating as taught by Noiles defines a layered structure formed by the solid wall layer and the porous coating layer.
Terminal Disclaimer
The terminal disclaimer filed on 3/20/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Pat. No. 12,263,087 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
Claim 3 is 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.
Claim 3 recites the limitation "the wall" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1-3, 6, 10-12, 15, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Siguier FR 2896985 A1 (hereafter referred to as Siguier) in view of Noiles US 4,790,852 (hereafter referred to as Noiles).
Regarding claim 1, Siguier discloses an augment device for a joint endoprosthesis (fig.1), the augment device comprising a stem 1 of the joint endoprosthesis, a unitary sleeve 4 having a top and a bottom, a distance between said top and said bottom defining an entire height of said sleeve (fig.1), wherein the sleeve surrounds a channel extending through the sleeve from the top to the bottom of the sleeve wherein the channel is configured to receive the stem of the joint endoprosthesis (fig.2), wherein the channel is configured so the stem extends past both the top of the sleeve and the bottom of the sleeve (fig.1), the sleeve comprising an inner face and an outer face, the inner face defining the channel (figs. 2 and 3 show inner and outer faces), and a distance between the inner face and the outer face defining a thickness (figs. 2-3), the sleeve further comprising a material configured for ingrowth of bony material, wherein the material is on the outer face of the sleeve (see the translation on pg.5 under “[0013]” which discloses the sleeve can be covered with hydroxyapatite allowing for bone regrowth and osteoinduction), a void 5, 10 (figs. 2 and 3 respectively) configured for compression of the channel, wherein the sleeve is compressible in at least one of a media-lateral direction and an anterior/posterior direction (figs.2 and 3 show the channel can be expanded therefore the channel can be compressed; also see the translation on pg. 4 in the paragraph under “[0010]” which discloses the compressibility/expandability of the sleeve). While hydroxyapatite is usually porous when used to promote bone growth, Siguier does not specifically say that the coating is a porous coating.
Noiles teaches a sleeve, in the same field of endeavor, wherein the outside surface of the sleeve comprises a porous coating for the purpose of further enhancing bone ingrowth (fig. 2; col.3, lines 20-23).
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 coating of the sleeve of Siguier, if necessary, to be porous as taught by Noiles in order to further enhance bone ingrowth which stabilizes the position of the device in the bone.
Regarding claim 2, see Siguier figs. 2 and 3 which show the sleeve can be expanded in both the medial-lateral direction and the anterior/posterior direction which means the sleeve is likewise capable of being compressed in both directions at least by nature of the slots 5 and 10 as well as the indent 11 in fig.3.
Regarding claim 3, Siguier fig.2 shows a solid wall forming the inner face and the translation on pg.5 under paragraph “[0013]” discloses the sleeve can be metal such as stainless steel or titanium. Therefore, the wall is capable of forming a bulkhead over the entire sleeve to block cement. This feature also depends on the properties of the unclaimed cement.
Regarding claim 6, see fig.1 of Siguier which shows the sleeve is generally conical and wider at its top and has a cone angle between 10 and 45 degrees.
Regarding claim 10, see figs. 2 and 3 of Siguier which shows a solid top surface considered a top cover that leaves the channel open.
Regarding claims 11 and 12, Siguier in view of Noiles discloses the augment device of claim 10 as discussed above, but Siguier does not disclose that the sleeve comprises at least one recess and the top cover further comprises at least one extension cover which is configured to cover side faces or a bottom face of the recess, wherein the top cover and the at least one extension cover are connected such as to provide a continuous top bulkhead.
Noiles teaches an augment device comprising a sleeve 13, in the same field of endeavor, wherein the sleeve comprises recesses 26 and a top cover comprises at least one extension cover which is configured to cover side faces or a bottom face of the recess 26, wherein the top cover and the at least one extension cover are connected such as to provide a continuous top bulkhead (fig.3) for the purpose of mating with pins on the stem to prevent the stem from rotating within the sleeve (col.4, lines 21-26).
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 sleeve and stem of Siguier to include the recesses and pins, respectively, taught by Noiles in order to prevent the stem from rotating within the sleeve.
Regarding claim 15, see the rejection of claims 11-12 above. The recesses taught by Noiles, in combination with the channel, may also be considered a passageway that extends through the entire sleeve across the channel (see Noiles fig.3).
Regarding claim 22, see Siguier fig.2 for a solid inner wall forming a layered structure with the porous material.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Siguier in view of Noiles as applied to claim 1 above, and further in view of German et al. US 2004/0049286 (hereafter referred to as German). Siguier in view of Noiles discloses the device of claim 1 as discussed above, but the stem and sleeve of Siguier in view of Noiles are for a hip joint endoprosthesis and Siguier and Noiles do not disclose that the augment device is a tibial augment for a knee joint endoprosthesis.
German teaches an augment device, in the same field of endeavor, wherein an augment device 104 is a tibial augment for a knee joint endoprosthesis (fig.17), for the purpose of stabilizing a keeled tibial implant in case of bone loss (pars.40 and 42).
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 hip augment of Siguier in view of Noiles to be shaped like the tibial augment taught by German in order to augment a keeled tibial implant to improve its anchoring in a tibia.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Siguier in view of Noiles as applied to claim 1 above, and further in view of Despres, III et al. US 2002/0016635 (hereafter referred to as Despres). Siguier in view of Noiles discloses the device of claim 1 as discussed above, but does not specifically disclose that the porous material comprises interconnected pores.
Despres teaches a joint endoprosthesis, in the same field of endeavor, wherein a porous material comprises interconnected pores for the purpose of allowing for tissue in-growth and/or on-growth (par.32).
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 porous material of Siguier in view of Noiles, if necessary, to include interconnected pores as taught by Despres in order to improve bone ingrowth/ongrowth to the material.
Claims 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Siguier in view of Noiles as applied to claims 1, 11, and 22 above, and further in view of Frey et al. US 4,961,748 (hereafter referred to as Frey). Claims 21 and 24 have been substantially addressed above since claims 21 and 24 are substantially the same as the combination of claims 1, 11, and 22. While Siguier discloses the sleeve is compressible and expandable as discussed above, Siguier in view of Noiles does not specifically disclose that the sleeve is configured to provide elasticity in the medial-lateral direction.
Frey teaches an augment device comprising a sleeve 1, in the same field of endeavor, wherein the metal sleeve retains resiliency for the purpose of allowing the sleeve to receive inserts in a subsequent re-operation (col.3, lines 33-40).
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 sleeve of Siguier in view of Noiles, if necessary, such that the sleeve retains resiliency and is therefore elastic as taught by Frey in order to allow for the sleeve to be used in a subsequent revision operation if needed.
Claims 5 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Frey in view of Noiles.
Regarding claim 5, Frey discloses an augment device for a joint endoprosthesis (the augment device is a sleeve at least for a hip joint endoprosthesis, specifically the acetabular component), the augment device comprising: a sleeve 1 having a top and a bottom, a distance between said top and said bottom defining an entire height of said sleeve, wherein the sleeve surrounds a channel extending through the sleeve from the top to the bottom of the sleeve wherein the channel is configured to receive a stem of the joint endoprosthesis (figs. 1 and 2 show a through channel which is capable of receiving a stem of a joint endoprosthesis which is not positively recited), and wherein the channel is open from the top of the sleeve to the bottom of the sleeve (fig.1), the sleeve comprising an inner face and an outer face, the inner face defining the channel, and a distance between the inner face and the outer face defining a thickness (fig.1 shows inner face, outer face, and thickness), the sleeve further comprising a wall that surrounds the channel and extends along the entire height of the sleeve, the wall being made of solid material (the material of the sleeve is solid metal and the sleeve/wall surrounds the channel and extends along the entire height of the sleeve; in other words the wall extends for the entire height of the sleeve because the wall forms the sleeve), a top cover, wherein the top cover covers a top surface of the top of the sleeve, wherein the sleeve comprises at least one recess on the top of the sleeve, wherein the top cover and the recess are connected such as to provide a continuous top bulkhead (the top surface is continuous from end to end; see the annotated fig.2 below), and wherein the at least one recess is configured to contact a portion of the joint endoprosthesis (the joint endoprosthesis is not required by the claim and the recesses of Frey are capable of contacting an arbitrary portion of an arbitrary joint endoprosthesis), and a void 2 configured for compression of the channel (see the slot 2 in fig.1 capable of allowing compression of the channel), wherein the sleeve is compressible in at least one of a media-lateral direction and an anterior/posterior direction (the slot and thinner regions allow for the sleeve to be compressed; col.3, lines 33-39 disclose the sleeve maintains resiliency therefore it is compressible), and wherein the bottom is stepped, and wherein a first portion of the bottom comprises a reduced height as compared to a second portion of the bottom and a transition surface connects the first portion to the second portion (see the annotated fig.2 below). Frey discloses the invention substantially as claimed and further discloses the outer face of the sleeve has a surface structure intended to promote the invasion and ingrowth of tissue (col.3, lines 9-14), however, Frey does not disclose that the sleeve further comprises a porous material configured for ingrowth of bony material, wherein the porous material is on the outer face of the sleeve, and wherein the wall forms a layered structure with the porous material.
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Noiles teaches a sleeve, in the same field of endeavor, wherein the sleeve comprises a porous material 114 configured for ingrowth of bony material, wherein the porous material is on the outer face of a wall of the sleeve and the wall is made of solid material and forms a layered structure with the porous material (fig.2) for the purpose of further enhancing bone ingrowth (col.7, lines 33-43).
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 sleeve of Frey to include a porous outer coating as taught by Noiles in order to further enhance bone ingrowth which stabilizes the position of the device in the bone. The sleeve of Frey, which comprises a solid wall, as modified to include a porous coating as taught by Noiles results in a wall forming a layered structure with the porous material since the wall can be considered one layer and the porous coating another layer.
Regarding claim 21, see the rejection of claim 5 above. Further, the sleeve of Frey in view of Noiles provides elasticity in the media-lateral direction since Frey discloses the metal sleeve maintains resiliency (col.3, lines 33-39).
Allowable Subject Matter
Claims 16-20 and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/
Primary Examiner, Art Unit 3774