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, see page 8 of response (pg 2 of remarks), filed 6/26/26, with respect to the rejection(s) of claim(s) 1-3, 11-21 under 35 U.S.C. 103 over Wyss in view Wentorf have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Wright et al. (2014/0142714). However, the examiner must also note that claim 1 is extremely broad in that it fails to define how many tangential radii are required or even where they begin and end, thus it can be said the prior art which inherently has radii of curvatures also include tangential radii of curvature and since the prior art teaches an increase in size of components, the same must be true for its radii.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3,11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Wright et al. (2014/0142714) in view of Wyss et al. (EP 2726020). Wright et al. disclose (Fig. 17) a posterior stabilized knee prosthesis system comprising: a set of femoral components 300 of different sizes (paragraph 104) configured for attachment to distal femurs of different sizes, each femoral component having a pair of spaced apart condyles defining an intercondylar notch therebetween (paragraph 113). Wright et al. disclose (paragraph 20) that at least one of the condyles has a condyle surface curved in the sagittal plane with multiple tangential radii of curvature. However, Wright et al. did not disclose having a posterior cam positioned in the intercondylar notch. Wyss et al. show (Figs. 2-7) a posterior cam 80. Wyss et al. also teach (paragraph 32) the system has a posterior cam positioned in the intercondylar notch. It would have been obvious to one of ordinary skill in the art to utilize a posterior cam as taught by Wyss et al. in the prosthesis system of Wright et al. to engage with the tibial bearing and assist in movement control. It is also noted Wright et al. show (Fig. 1) a knee prosthesis system is to include a tibial component 14 with a bearing surface 42 curved in the sagittal plane with multiple tangential radii of curvature, and having a surface extending upwardly from the bearing surface. However, the bearing did not have a post as the extending structure. Wyss et al. teach a tibial bearing can include a post extending upward from the bearing surface to engage the intercondylar notch. It would have been obvious to one of ordinary skill in the art to utilize a post on the bearing surface as taught by Wyss et al. with the prosthesis system of Wright et al. such that it has a guided connection with femoral and tibial components to keep the component engaged when in flexion and extension motions. Wright et al. also disclosed (paragraphs 135,136) to include a set of tibial components of different sizes configured for attachment to proximal tibiae of different sizes, each tibial component having a bearing surface curved in the sagittal plane with multiple tangential radii of curvature, and having a post extending upwardly from the bearing surface; each size of femoral component being engageable to at least one size of tibial component to articulate by contact between the condyle surface and the bearing surface and/or by contact between the cam and the post; all of the radii of curvature of the condyle surface each increasing monotonically across increasing size of the femoral components, and all of the radii of curvature of the bearing surface each increasing monotonically across increasing size of the tibial components. Thus, it would have been obvious to one of ordinary skill in the art to use a set of tibial components of different sizes configured for attachment to proximal tibiae of different sizes for a set of condyle components and tibial components of Wright knee prosthetic system as modified with Wyss et al. such that the surgeon has the ability to appropriately match the anatomy of the patient’s knee to assure proper rotation in use once the components are implanted, see Wright paragraph 136. Regarding claims 2,3 Wright could be said to disclose (paragraph 104) the increase of radii of curvature of the condyle surface across increasing size of the femoral components is strictly monotonic as Fig. 18 shows a radius all increase. Further it must be noted claim 1 recites arbitrary radii of curvature with no established boundaries of where these begin and end, thus, it clearly can be said with the increased sized components there are increases in radii for the increased size femoral components and also the table of Fig 18 show linear increases in size for the femoral components. Regarding claim 11, Wyss discloses (paragraphs 9-11,41,43) the condyle surface of each femoral component comprises: a first curved surface section with a first radius of curvature contacting the bearing surface during flexion between extension and a first degree of flexion; and a second curved surface section with a second radius of curvature contacting the bearing surface during flexion between the first degree of flexion and a larger second degree of flexion. With respect to claim 12, Wright shows (Figs. 22,23) increasing size of the femoral components. However, Wyss does not show that a ratio of the first radius of curvature to the second radius of curvature decreases monotonically across increasing size of the femoral components. Please note that "determining where in a disclosed set of percentage ranges the optimum combination of percentages lies is prima facie obvious." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003); see also In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1365 (Fed. Cir. 1997) ("It is not inventive to discover the optimum or workable ranges by routine experimentation." (quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995)). Thus, one of ordinary skill in the art is an obvious expedient to find the optimal values to provide a ratio of the first radius of curvature to the second radius of curvature decreases monotonically across increasing size of the femoral components in the set of Wright modified with Wyss in order to provide the optimal flexing knee prosthesis for the patient. Regarding claim 13, Wright shows (Fig. 22) the first radius of curvature increasing for increasing size components in a set or family of femoral components, in addition to the second radius of curvature increasing in radius for the increasing of size of femoral components with the second radii being less than the first. However, the table of Wyss did not provide values for a ratio of the first radius of curvature to the second radius of curvature that decreases in a range of 1.380 to 1.240. Again, as mentioned above ("It is not inventive to discover the optimum or workable ranges by routine experimentation." (quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995) SO one of ordinary skill in the art is highly skilled (orthopedic surgeon) and capable of finding the optimal values to provide a ratio of the first radius of curvature to the second radius of curvature that decreases in a range of 1.380 to 1.240 for femoral components in the set of Wright modified with Wyss in order to provide the optimal flexing knee prosthesis for the patient. Regarding claim 14, Wright discloses (Fig. 23) the condyle surface of each femoral component comprises a third curved surface section with a third radius of curvature contacting the bearing surface during flexion between the second degree of flexion and a larger third degree of flexion, see paragraph 136. It is noted in the tables of Wright ratios of the second radius of curvature to the third radius of curvature decreases monotonically across increasing size of the femoral components. Since the ratio is determined from a finite number of possibilities and Wright discloses values for the radii of curvatures that could result in decreases in the ratio it would have been obvious to one of ordinary skill in the art to optimize the radii of curvature for the second and third radii of curvatures to provide a ratio that decreases monotonically across increasing size of femoral components since it is a result expected variable and the surgeon desires to provide the optimal range of flexion with the contact between the curved surfaces engaging in the bearing region. Regarding claim 15, Wyss teaches (Fig. 20) the second radius of curvature has decreased relative to the first radius of curvature with increasing size of the femoral components. It is also noted that the third radius of curvature has decreased relative to the second radius of curvature and the calculated values for the ratio of the second radius of curvature to the third radius of curvature decreases, but did not explicitly have the range be between 1.031 to 1.019. Again as mentioned above ("It is not inventive to discover the optimum or workable ranges by routine experimentation." (quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995) so one of ordinary skill in the art is highly skilled (orthopedic surgeon) and capable of finding the optimal values to provide a ratio of the second radius of curvature to the third radius of curvature that decreases in a range of 1.031 to 1.019 for femoral components in the set of Wright modified with Wyss in order to provide the optimal flexing knee prosthesis for the patient. Regarding claim 16, Wyss also teaches (Fig. 15) the condyle surface of each femoral component comprises a fourth curved surface section with a fourth radius of curvature contacting the bearing surface during flexion between the third degree of flexion and a larger fourth degree of flexion, see paragraph 12. It is also noted that the calculated values for the third and fourth radii curvatures in comparative ratios decreases monotonically across increasing size of the femoral components. Regarding claim 17, Wright shows (Fig. 22) the radius of curvature has decreased with increasing size of the femoral components and thus it would be obvious that the third radius of curvature decreased relative to the first radius of curvature. It is also noted that the fourth radius of curvature has decreased relative to the third radius of curvature and the calculated values for the ratio of the third radius of curvature to the fourth radius of curvature decreases, but did not explicitly have the range be between 1.059 to 1.036. Again as mentioned above ("It is not inventive to discover the optimum or workable ranges by routine experimentation." (quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995) so one of ordinary skill in the art is highly skilled (orthopedic surgeon) and capable of finding the optimal values to provide a ratio of the third radius of curvature to the fourth radius of curvature that decreases in a range of 1.059 to 1.036 for femoral components in the set of Wright modified with Wyss in order to provide the optimal flexing knee prosthesis for the patient. Regarding claim 18, Fig. 15 of Wyss teaches the condyle surface of each femoral component comprises a fifth curved surface section with a fifth radius of curvature contacting the bearing surface during flexion between the fourth degree of flexion and a larger fifth degree of flexion, see paragraph 13. However, Wright did not explicitly disclose to provide a ratio of the fourth radius of curvature to the fifth radius of curvature decreases monotonically across increasing size of the femoral components. Again as mentioned above ("It is not inventive to discover the optimum or workable ranges by routine experimentation." (quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995). It is noted that the tables of Wright show ratios that decrease monotonically. Since the ratio is determined from a finite number of possibilities and Wright as modified with Wyss disclose values for the radii of curvatures that could result in decreases in the ratio it would have been obvious to one of ordinary skill in the art to optimize the radii of curvature for the fourth and fifth radii of curvatures to provide a ratio that decreases monotonically across increasing size of femoral components since it is a result expected variable and the surgeon desires to provide the optimal range of flexion with the contact between the curved surfaces engaging in the bearing region. Regarding claim 19, Wright shows (tables of Figs. 22,23) the ratio decrease between compared radius of curvature and thus there inherently is a fourth radius of curvature increasing for increasing size components in a set or family of femoral components, in addition to the fifth radius of curvature increasing in radius for the increasing of size of femoral components with the fifth radii being less than the fourth. However, the table of Wright did not provide values for a ratio of the fourth radius of curvature to the fifth radius of curvature that decreases in a range of 1.020 to 1.012. Thus, one of ordinary skill in the art is highly skilled (orthopedic surgeon) and capable of finding the optimal values to provide a ratio of the fourth radius of curvature to the fifth radius of curvature that decreases in a range of 1.020 to 1.012 for femoral components in the set of Wright modified with Wyss in order to provide the optimal flexing knee prosthesis for the patient. With respect to claim 20, it is also not explicitly disclosed, but the first and fifth radii of curvature have values in a finite number of possibilities and Wright in view of Wyss disclose values (see Fig. 15) to provide the radii to result in a ratio decreasing monotonically, but not in a range of 1.537 to 1.326. Thus it would have been obvious to one of ordinary skill in the art to optimize the radii of curvature for the first radius of curvature and the fifth radius of curvature to alter the radii and provide a ratio between the first and fifth radius of curvatures to decrease monotonically in a range of 1.537 to 1.326 to provide the optimal range of flexion for the patient's knee. Such a modification only involves routine skill in the art due to a finite number of options in varying these radii. Regarding claim 21, Wyss teaches (paragraph 51) that the cam initially engages the post at a degree of flexion between 35° and 60°.
Claim(s) 4,5 are rejected under 35 U.S.C. 103 as being unpatentable over Wright et al. (2014/0142714) in view of Wyss et al. (EP 2726020) as applied to claim 1 above, and further in view of Chavane Herve et al. (FR 3074033). Wright as modified with Wyss et al. is explained supra. It is noted that Wyss et al. disclose (Fig. 15) different sizes for a family or set of femoral components of which it is inherent each has a femoral dwell point or the lowest apex at the bottom surface of a condyle. However, Wright as modified with Wyss et al. did not explicitly state an anterior-posterior distance between the femoral dwell point and an anterior edge of the condyle surface increases monotonically across increasing size of the femoral components. Chavane Herve et al. teach (Fig. 1) an anterior edge of the condyle surface increases monotonically across increasing size of the femoral components (0-8). It would have been obvious to one of ordinary skill in the art to provide a set of femoral implants that increase monotonically between the anterior- posterior distance between the femoral dwell point and an anterior edge of the condyle surface for each of the increased size femoral components as taught by Chavane Herve et al. with the set of femoral components of Wright as modified with Wyss et al. in order to provide optimal femoro-patellar joint mobility, see Chavane-Herve pg. 10 trans. With respect to claim 5, it can be construed that per the teaching of Chavane-Herve et al. (Fig. 1) as shown the anterior-posterior distance between the femoral dwell point and the anterior edge of the condyle surface increases at least substantially linearly across increasing size of the femoral components.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wright et al. (2014/0142714) in view of Wyss et al. (EP 2726020) and Chavane Herve et al. (FR 3074033) as applied to claim 4 above, and further in view of Parisi et al. (WO 2012/173704). Wright et al. in view of Wyss et al. as modified by Chavane Herve et al. is explained above. However, Wright et al. as modified with Wyss et al. in view of Chavane Herve et al. did not disclose the anterior-posterior distance is between 55% and 65% of a total anterior- posterior dimension of the respective femoral component. Parisi et al. teach (paragraph 159) that in varying an anterior feature of different sizes one can vary one size to be within a range of 55% -65% of a main or average size. It would have been obvious to one of ordinary skill in the art to provide an anterior-posterior distance is between 55% and 65% of a total anterior-posterior dimension of the respective femoral component in altering sizes of femoral components per the teaching of Parisi et al. and use in the set of Wright in view of Wyss et al. as modified by Chavane Herve et al. such that one can provide the optimal flexion and minimize bone resection, see Parisi paragraph 77.
Claim(s) 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wright et al. (2014/0142714) in view of Wyss et al. (EP 2726020) as applied to claim 1 above, and further in view of Drury et al. (2019/0328535). Wright as modified with Wyss et al. is explained supra. It is noted that each of the tibial components in a set have a tibial dwell point. However, Wright in view of Wyss et al. did not disclose an anterior- posterior distance between the tibial dwell point and an anterior edge of the bearing surface increases monotonically across increasing size of the tibial components. Drury et al. teach (paragraph 7) that in providing a tibial component in a posterior stabilized prosthesis one considers for the tibial component to properly adjust an anterior- posterior distance between the tibial dwell point and an anterior edge of the bearing surface. It would have been obvious to one of ordinary skill in the art to increase monotonically the anterior-posterior distance between the tibial dwell point and an anterior edge of the bearing surface in each of the tibial components of the set of tibial components across increasing sizes with the prosthesis set of Wright as modified with Wyss such that one can provide a more stable condyle within the tibial bearing surface when in flexing, paragraph 82. Regarding claim 8, it can be construed that Drury et al. teach (Fig. 10) a linear increase in size of tibial components, thus it would be obvious that one can provide an anterior-posterior distance between the tibial dwell point and the anterior edge of the bearing surface increasing at least substantially linearly across increasing size of the tibial components with the prosthesis knee system set of Wright et al. per the teaching of Drury as such a modification only involves routine skill in the art. Regarding claim 9, Drury et al. teach (paragraphs 15,16) that an anterior-posterior distance is between 60% and 70% of a total anterior-posterior dimension of the respective tibial component. With respect to claim 10, please note claims are given their broadest reasonable interpretation and the recitation of "multiple tangential radii of curvature of the condyle surface of each femoral component decrease monotonically in posterior direction along the condyle surface" is broad and non-specific where specifically it is established or to what amount. Thus, Wright et al. can be said to disclose in the sets of family of femoral components to have multiple tangential radii of curvature of the condyle surface of each femoral component decrease monotonically in posterior direction along the condyle surface, see for example Fig. 22a all decrease monotonically with increasing size. It can also be seen in Fig. 20 multiple at least substantially tangential radii of curvature of the condyle surface of each femoral component decrease monotonically in posterior direction along the condyle surface, see for example R1-R3.
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 BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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