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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 6 is objected to because of the following informalities: the recited feature of “the anterior-posterior distance” is believed to be meant for the section “between the femoral dwell point and the anterior edge of the condyle surface” since the claim does recite the “total anterior-posterior dimension” in the claim. It is suggested to make this more clear. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “substantially” in claims 1, 3, 5, 8, 10 is a relative term which renders the claims indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not evident to what degree of closeness one can consider a radii of curvature for a bearing surface by the clause “substantially tangential radii of curvature” and whether these curved areas have to be adjacent one another or be in contact. Additionally the same can be said for the clause “substantially linearly” as it is not evident if a size increase has to go up or remains about the same size with some variation in dimensions according to the scope of the limitation. Dependent claims carry the same issue as the claim they depend from.
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.
Claim(s) 1-3,11-21 are rejected under 35 U.S.C. 103 as being unpatentable over Wyss et al. (EP 2726020) in view of Wentorf (2012/0022658). Wyss et al. disclose a posterior stabilized knee prosthesis system 10 comprising: a set of femoral components of different sizes (Fig. 15) configured for attachment to distal femurs of different sizes. Figs. 1-4 of Wyss show each femoral component 12 having a pair of spaced apart condyles 52,54 defining an intercondylar notch 56 therebetween. Figs. 2-7 show a posterior cam 80. Wyss also discloses (paragraph 32) the system has a posterior cam positioned in the intercondylar notch. Wyss also discloses ((Figs. 15,20) at least one of the condyles has a condyle surface curved in the sagittal plane with multiple at least substantially tangential radii of curvature. It is also noted Wyss et al. show a knee prosthesis system is to include a tibial component 14 with a bearing surface 42 curved in the sagittal plane with multiple at least substantially tangential radii of curvature, and having a post 60 extending upwardly from the bearing surface. However, Wyss et al. was silent as to including a set of tibial components of different sizes configured for attachment to proximal tibiae of different sizes, 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; the radii of curvature of the condyle surface each increasing monotonically across increasing size of the femoral components, and the radii of curvature of the bearing surface each increasing monotonically across increasing size of the tibial components. Wentorf teaches (paragraphs 99,100,122) to provide a kit with a plurality of different size tibial components. 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 as taught by Wentorf with the knee prosthetic system of Wyss et al. such that the surgeon has the ability to appropriately match the anatomy of the patient’s knee and assure proper rotation in use once the components are implanted, see Wentorf paragraph 48. Regarding claim 2, Wyss et al. disclose (paragraph 47) the increase of the radii of curvature of the condyle surface across increasing size of the femoral components is strictly monotonic, see Figs. 9-11. With respect to claim 3, Fig. 20 of Wyss shows the radii of curvature of the condyle surface each increase at least substantially linearly across increasing size of 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, Wyss shows (Fig. 15) 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 Wyss modified with Wentorf in order to provide the optimal flexing knee prosthesis for the patient. Regarding claim 13, Wyss shows (Fig. 15) 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 Wyss modified with Wentorf in order to provide the optimal flexing knee prosthesis for the patient. Regarding claim 14, Wyss discloses (Fig. 20) 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 15. However, Wyss does not show that a ratio 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 Wyss 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 shows (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 Wyss modified with Wentorf in order to provide the optimal flexing knee prosthesis for the patient. Regarding claim 16, Wyss discloses (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, Wyss shows (Fig. 15) the third 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 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 Wyss modified with Wentorf in order to provide the optimal flexing knee prosthesis for the patient. Regarding claim 18, Fig. 15 of Wyss shows 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, Wyss 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). Since the ratio is determined from a finite number of possibilities and Wyss 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 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, Wyss shows (Fig. 15) the 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 Wyss 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 Wyss modified with Wentorf 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 Wyss discloses 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 discloses (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 Wyss et al. (EP 2726020) in view of Wentorf (2012/0022658) as applied to claim 1 above, and further in view of Chavane Herve et al. (FR 3074033). Wyss et al. in view of Wentorf 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, 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 Wyss et al. as modified with Wentorf 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 Wyss et al. (EP 2726020) in view of Wentorf (2012/0022658) and Chavane Herve et al. (FR 3074033) as applied to claim 4 above, and further in view of Parisi et al. (WO 2012/173704). Wyss et al. as modified by Wentorf and Chavane Herve et al. is explained above. However, Wyss et al. in view of Wentorf and 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 Wyss et al. as modified by Wentorf and 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 Wyss et al. (EP 2726020) in view of Wentorf (2012/0022658) as applied to claim 1 above, and further in view of Drury et al. (2019/0328535). Wyss et al. in view of Wentorf is explained supra. It is noted that each of the tibial components in a set have a tibial dwell point. However, Wyss et al. as modified by Wentorf 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 Wyss as modified with Wentorf 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 “substantial 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 Wyss et al. as modified by Wentorf 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 at least substantially 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. Thus, Wyss et al. can be said to disclose in the sets of family of femoral components to have 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 R3-R5 in Fig. 15 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.
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