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 12/22/2025 have been fully considered. Arguments regarding the claim objections, 101 rejections, and 102 rejections are persuasive in light of the amendments. Claims 1 and 18 were amended to include features addressed in rejections under 35 U.S.C. 103. Arguments regarding the rejection of claims under 35 U.S.C. 103 as being unpatentable over Tornier in view of Rydell are not persuasive. Applicant argues Rydell does not cure the deficiencies of Tornier because Rydell teaches fixation pegs with continuous circumferential grooves that extend around the entire peg for cement retention and does not teach or suggest discrete raised projections that are circumferentially spaced from one another with recessed regions between them. This is not persuasive because applicant does not point out what circumferential grooves extend continuously around the entire peg. Rydell clearly shows discrete raised features that are circumferentially spaced from one another with recessed groove regions between adjacent projections in 3A-3B and 4A-4B. See the annotated figures from Rydell below.
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Applicant’s arguments regarding the rejection of claims under 35 U.S.C. 103 as being unpatentable over Tornier in view of Schumacher have been fully considered but they are not persuasive. Applicant argues Schumacher is directed to deployable bone anchors for soft tissue attachment like ligament or tendons not patellar prostheses for total knee arthroplasty. The examiner is unsure if applicant is looking at the correct reference because Schumacher does not disclose deployable bone anchors for soft tissue attachment. Applicant also quotes par.68 of Schumacher as saying “expand radially outward upon application of load”. But par.68 of Schumacher states “FIG. 46 is a perspective view of the drill of FIG. 37;”. The examiner was unable to find the terms “expand” “radially” or “load” in a text search of Schumacher so the examiner is unclear what the argument is based on. The embodiment of Schumacher relied upon in the rejection includes pins on a knee prosthesis for anchoring in bone which is the same as the pins of the instant application. Applicant argues Schumacher teaches cement-free fixation for soft tissue anchoring. Applicant does not point out support for this argument and the examiner fails to find any discussion of cement-free fixation for soft tissue anchoring in Schumacher. In fact, Schumacher states in par.356 that the tibial tray is fit onto the prepared tibia and may be implanted with or without cement. Therefore, it is clear that Schumacher is not directed to cement-free fixation for soft tissue anchoring and instead can be used in cement fixation of a prosthesis to bone. Applicant further argues that the Office Action has not articulated why one of ordinary skill in the art would combine a cement-based fixation system in Tornier with cement-free deployable anchor mechanism in Schumacher. As discussed above, Schumacher does not discuss a cement-free deployable anchor mechanism. The embodiment relied upon in Schumacher discloses pins for anchoring in bone, therefore a person of ordinary skill in the art would have found it obvious to combine the features of the pins of Schumacher with the pins of Tornier in order to better secure the prosthesis to bone.
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 1-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tornier US 2003/0083751 (hereafter referred to as Tornier) and further in view of Rydell et al. US 2006/0247787 (hereafter referred to as Rydell).
Regarding claim 1, Tornier discloses a patellar prosthesis 3, comprising an anterior surface (bone contacting surface shown in fig.7) adapted to mate with a corresponding prepared surface of a natural patella R (fig.2); the anterior surface having a plurality of pins 35 extending from the anterior surface, wherein at least one of the plurality of pins is formed from a plastic material (par.15 discloses one-piece plastic patellar component), and, wherein each of the plurality of pins has an outer surface between an end and the anterior surface (figs. 2, 4, 5, and 7 shown each pin has an outer surface between an end and the anterior surface); one or more projections (the lower wider portion extending outwardly from the outer surface of the pin as shown in figs. 2, 4, 5, and 7) on the at least one plastic pin extending outwardly from the outer surface of the at least one plastic pin; and wherein the one or more projections on the at least one plastic pin is capable of contacting a surface of a hole formed in the prepared surface of the patella into which the pin is intended to be inserted and thereby can mechanically restrains the patellar prothesis from moving relative to the natural patella while bone cement cures between the anterior surface and the prepared surface of the natural patella (fig.2 shows the pegs in the patellar bone). Note that lines 13-17 are directed to an intended use of the patellar prosthesis and the patellar prosthesis of Tornier is capable of being inserted into a hole in the natural patella as claimed. While no cement is positively claimed, Tornier does disclose using cement (par.43). The term “mechanically restrains” is dependent on not only the pegs but also on the size of the hole formed in the patella which cannot be positively claimed in a device claim. Therefore, at least when a hole is formed to be the same size or smaller than the pegs, a mechanical interference fit between the patellar prosthesis of Tornier and the bone can be formed. Tornier discloses the invention substantially as claimed but does not disclose that the projections comprise discrete raised features that are circumferentially spaced from one another with recessed groove regions between adjacent projections.
Rydell teaches a prosthesis 232, 332 with a bone anchoring pin 236, 336 (figs. 3A-4B), in the same field of endeavor, wherein the pin comprises projections 236, 348, the projections comprising discrete raised features 236, 348 that are circumferentially spaced apart from one another with recessed groove regions (considered grooves 242 in figs. 3A-3B or considered the recesses between the barbs 338 in figs. 4A-4B) between adjacent projections (figs. 3A-4B) for the purpose of reducing the likelihood that the prosthesis will migrate out of position (par.26) and reducing the likelihood the prosthesis will rotate in situ (par.28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify each of the pins of Tornier to include the projections comprising discrete raised features that are circumferentially spaced from one another with recessed groove regions between adjacent projections as taught by Rydell in order to better prevent the patellar prosthesis from migrating out of position and rotating in situ.
Regarding claim 2, see par.15 of Tornier for plastic. No specific polymer is claimed and because the plastic patellar prosthesis of Tornier is for use in the human body, the plastic is inherently medically safe.
Regarding claims 3 and 4, see “one-piece” in par.15 of Tornier as well as figs. 2, 4, 5, and 7 of Tornier and figs. 3A-4B of Rydell for the pins and projections being integral with the prostheses.
Regarding claims 5 and 6, the projections taught by Rydell extend along a length of the pin. Claim 6 does not require the projections extend along the entire length of the pins.
Regarding claim 7, see Tornier figs. 4, 5, and 7 for three pins.
Regarding claims 8 and 9, see Rydell figs. 4A-4B for at least three projections 348 which are equally spaced and extend axially along a length of the pin. Note that the claims do not limit the equally spaced projections to only three, therefore the four longitudinal projections taught by Rydell which are equally spaced to an adjacent projection meet the claim since four includes three. Even if the claims were amended to limit the projections to consist of three projections, such a modification would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention since it has been held that it is not inventive to discover the optimum or workable ranges by routine experimentation and would be an obvious extension of prior art teachings (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Regarding claims 10 and 11, see Tornier figs. 2 and 7 for the anterior surface further comprising a planar surface and at least one recess 36 in the planar surface, wherein the three pins emanate from the planar surface (figs.2 and 7).
Regarding claim 12, see Rydell figs. 3A-3B for the outer surface of the pin comprising one or more recesses 242.
Regarding claim 13, see Tornier figs. 2 and 7 for the anterior surface further comprising a planar surface and at least one recess 36 in the planar surface, wherein the three pins emanate from the planar surface (figs.2 and 7) and see Rydell figs. 3A-3B for the outer surface of the pin comprising one or more recesses 242.
Regarding claims 15 and 16, see Rydell figs. 3A-3B for the projections 236 being oriented circumferentially and at an angle of 90 degrees relative to a longitudinal axis of the pins.
Regarding claim 17, see Rydell figs. 4A-4B for circumferential 336 and longitudinal 348 projections.
Regarding claim 18, see the rejection of claim 1 above. Tornier further discloses a femoral component 2 and tibial component 1, wherein the patellar component 3 comprises a posterior surface 31-33 for engaging the femoral component (fig.1; par.32). Tornier as modified by Rydell comprises pins having projections that have a greater diameter than a pin diameter. The total knee prosthesis of Tornier in view of Rydell is capable of being used as claimed such that the projection diameters are equal to or greater than a diameter of a hole formed in the natural patella when the pin is pressed therein. As discussed above with respect to claim 1, the hole formed in the natural patella cannot be positively claimed and is directed to an intended use of the prosthesis.
Regarding claim 19, Tornier discloses three pins (fig.7) and Rydell teaches at least three equally spaced projections (figs. 4A-4B). Note that the claims do not limit the equally spaced projections to only three, therefore the four longitudinal projections taught by Rydell which are equally spaced to an adjacent projection meet the claim since four includes three. Even if the claims were amended to limit the projections to consist of three projections, such a modification would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention since it has been held that it is not inventive to discover the optimum or workable ranges by routine experimentation and would be an obvious extension of prior art teachings (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Regarding claim 20, the maximum diameter of each pin of the prosthesis of Tornier in view of Rydell can be greater than a diameter of a hole in the natural patella into which each pin is inserted. This claim is directed to the intended use of the prosthesis. A person could form a hole that is smaller than the maximum diameter of each pin in which case the maximum diameter of each pin is greater than the diameter of the hole in the natural patella.
Claims 1-14 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tornier in view of Schumacher et al. US 2021/0000613 (hereafter referred to as Schumacher).
Regarding claim 1, Tornier discloses a patellar prosthesis 3, comprising an anterior surface (bone contacting surface shown in fig.7) adapted to mate with a corresponding prepared surface of a natural patella R (fig.2); the anterior surface having a plurality of pins 35 extending from the anterior surface, wherein at least one of the plurality of pins is formed from a plastic material (par.15 discloses one-piece plastic patellar component), and, wherein each of the plurality of pins has an outer surface between an end and the anterior surface (figs. 2, 4, 5, and 7 shown each pin has an outer surface between an end and the anterior surface); one or more projections (the lower wider portion extending outwardly from the outer surface of the pin as shown in figs. 2, 4, 5, and 7) on the at least one plastic pin extending outwardly from the outer surface of the at least one plastic pin; and wherein the one or more projections on the at least one plastic pin is capable of contacting a surface of a hole formed in the prepared surface of the patella into which the pin is intended to be inserted and thereby can mechanically restrains the patellar prothesis from moving relative to the natural patella while bone cement cures between the anterior surface and the prepared surface of the natural patella (fig.2 shows the pegs in the patellar bone). Note that lines 13-17 are directed to an intended use of the patellar prosthesis and the patellar prosthesis of Tornier is capable of being inserted into a hole in the natural patella as claimed. While no cement is positively claimed, Tornier does disclose using cement (par.43). The term “mechanically restrains” is dependent on not only the pegs but also on the size of the hole formed in the patella which cannot be positively claimed in a device claim (see the rejection under 101 above). Therefore, at least when a hole is formed to be the same size or smaller than the pegs, a mechanical interference fit between the patellar prosthesis of Tornier and the bone can be formed. Tornier discloses the invention substantially as claimed but does not disclose that the projections comprise discrete raised features that are circumferentially spaced from one another with recessed groove regions between adjacent projections.
Schumacher teaches a knee prosthesis with bone anchoring pins 368, 370, 396, and 398 (figs. 54-56 and 61-64), in the same field of endeavor, wherein each pin has projections 376, 402 that comprise discrete raised features 376, 402 that are circumferentially spaced from one another with recessed groove regions 374, 400 (figs. 54-56 and 61-64; pars. 363 and 365) between adjacent projections (figs. 54-56 and 61-64) for the purpose of providing further fixation in the bone (par.348).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify each of the pins of Tornier to include the projections comprising discrete raised features that are circumferentially spaced from one another with recessed groove regions between adjacent projections as taught by Schumacher in order to better fixate the patellar prosthesis in bone.
Regarding claim 2, see Tornier par.15 for plastic. No specific polymer is claimed and because the plastic patellar prosthesis of Tornier is for use in the human body, the plastic is inherently medically safe.
Regarding claims 3 and 4, see “one-piece” in par.15 of Tornier as well as figs. 2, 4, 5, and 7 of Tornier and figs. 54-56 and 61-64 of Schumacher for the pins and projections being integral with the patellar prosthesis.
Regarding claims 5 and 6, the projections taught by Schumacher extend along the length of the pin. Claim 6 does not require the projections extend along the entire length of the pins.
Regarding claim 7, see Tornier figs. 4, 5, and 7 for three pins.
Regarding claims 8 and 9, see Schumacher figs. 54-56 and 61-64 for at least three projections 376, 402 which are equally spaced and extend axially along a length of the pin. Note that the claims do not limit the equally spaced projections to only three, therefore the four longitudinal projections taught by Schumacher which are equally spaced to an adjacent projection meet the claim since four includes three. Even if the claims were amended to limit the projections to consist of three projections, such a modification would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention since it has been held that it is not inventive to discover the optimum or workable ranges by routine experimentation and would be an obvious extension of prior art teachings (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Regarding claims 10 and 11, see Tornier figs. 2 and 7 for the anterior surface further comprising a planar surface and at least one recess 36 in the planar surface, wherein the three pins emanate from the planar surface (figs.2 and 7).
Regarding claim 12, see Schumacher for the outer surface of the pin comprising one or more recesses 374, 400 (figs. 54-56 and 61-64; pars. 363 and 365).
Regarding claim 13, see Tornier figs. 2 and 7 for the anterior surface further comprising a planar surface and at least one recess 36 in the planar surface, wherein the three pins emanate from the planar surface (figs.2 and 7) and see Schumacher for the outer surface of the pin comprising one or more recesses 374, 400 (figs. 54-56 and 61-64; pars. 363 and 365).
Regarding claim 14, Schumacher further teaches the projections have a serrated edge (pars. 363 and 365; figs. 54-56 and 61-64).
Regarding claim 18, see the rejection of claim 1 above. Tornier further discloses a femoral component 2 and tibial component 1, wherein the patellar component 3 comprises a posterior surface 31-33 for engaging the femoral component (fig.1; par.32). Tornier as modified by Schumacher comprises pins having projections that have a greater diameter than a pin diameter. The total knee prosthesis of Tornier in view of Schumacher is capable of being used as claimed such that the projection diameters are equal to or greater than a diameter of a hole formed in the natural patella when the pin is pressed therein. As discussed above with respect to claim 1, the hole formed in the natural patella cannot be positively claimed and is directed to an intended use of the prosthesis.
Regarding claim 19, Tornier discloses three pins (fig.7) and Schumacher teaches at least three equally spaced projections (figs. 54-56 and 61-64). Note that the claims do not limit the equally spaced projections to only three, therefore the four longitudinal projections taught by Schumacher which are equally spaced to an adjacent projection meet the claim since four includes three. Even if the claims were amended to limit the projections to consist of three projections, such a modification would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention since it has been held that it is not inventive to discover the optimum or workable ranges by routine experimentation and would be an obvious extension of prior art teachings (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Regarding claim 20, the maximum diameter of each pin of the prosthesis of Tornier in view of Schumacher can be greater than a diameter of a hole in the natural patella into which each pin is inserted. This claim is directed to the intended use of the prosthesis. A person could form a hole that is smaller than the maximum diameter of each pin in which case the maximum diameter of each pin is greater than the diameter of the hole in the natural patella.
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