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 .
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 1-20 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.
Regarding claim 1, lines 15-16 recite “a prosthesis longitudinal direction” which is unclear because the claim refers to an “endoprosthesis” as well as various components, but never refers to a prosthesis. Claim 1 is further unclear because lines 18, and 31-32 also each refer to “a prosthesis longitudinal direction”. Are these prosthesis longitudinal directions the same as the prosthesis longitudinal direction first mentioned in lines 15-16? If so, they should refer back to the/said prosthesis longitudinal direction. For examination, a prosthesis longitudinal direction is interpreted as a longitudinal direction of the knee joint endoprosthesis in an extended position and each recitation of “a prosthesis longitudinal direction” is considered this same longitudinal direction.
Claim 3 recites “wherein the knee joint endoprosthesis set comprises only two meniscal components”. How can the knee joint endoprosthesis set of claim 1, which requires a tibial component and a femoral component, comprise only two meniscal components? It must also comprise at least the tibial component and femoral component. For examination this claim is interpreted to mean that the first and second meniscal components are the only meniscal components in the set.
Claim 11, lines 2-4 define “a meniscal component sliding face”, “a medial sliding face region”, and “a lateral sliding face region” but these appear to already be defined in claim 1 which is unclear. It seems “and a meniscal component sliding face cooperating with the femoral component with a medial sliding face region and a lateral sliding face region” could be deleted from claim 11 since these limitations are already defined in claim 1. Line 5 of claim 11 recites “the two sliding face regions” but there appear to actually be four since claim 1 recites “each of the first meniscal component and the second meniscal component comprises a meniscal component sliding face…with a medial sliding face region and a lateral sliding face region”. To clarify the issue, in claim 11, line 5 “the two sliding face regions” could instead recite --the medial sliding face region and lateral sliding face region of the first meniscal component--.
Regarding claim 13, lines 13-14 recite “a prosthesis longitudinal direction” which is unclear because the claim refers to an “endoprosthesis” as well as various components, but never refers to a prosthesis. Claim 13 is further unclear because lines 18, and 29-30 also each refer to “a prosthesis longitudinal direction”. Are these prosthesis longitudinal directions the same as the prosthesis longitudinal direction first mentioned in lines 13-14? If so, they should refer back to the/said prosthesis longitudinal direction. For examination, a prosthesis longitudinal direction is interpreted as a longitudinal direction of the knee joint endoprosthesis in an extended position and each recitation of “a prosthesis longitudinal direction” is considered this same longitudinal direction.
Claim 15, line 3 also recites “a prosthesis longitudinal direction” which has the same issues discussed above with respect to claims 1 and 13.
Claim 19 recites “a prosthesis longitudinal direction” multiple times which has the same issues discussed above with respect to claims 1 and 13.
Claim 20 recites “at least two knee joint endoprosthesis sets”, but it is unclear if this is referring back to one of the sets in a) or b) in claim 19. It is further unclear which femoral component, first meniscal component, and tibial component claim 20 is referring to since claim 19 recites two different sets comprising components by the same names.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 repeats a limitation from claim 1 (see claim 1, lines 28-29) and therefore doesn’t further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 and 3-20 are rejected under 35 U.S.C. 103 as being unpatentable over Blaha et al. US 5,964,808 (hereafter referred to as Blaha) in view of Wentorf et al. US 2014/0249641 (hereafter referred to as Wentorf).
Regarding claim 1, Blaha disclose a knee joint endoprosthesis set for replacing a knee joint of a patient, the knee joint endoprosthesis set comprising: a knee joint endoprosthesis (figs. 30-40) comprising: a femoral component 3.23, a tibial component 3.43, and a first meniscal component 3.45, a second meniscal component (col.4, lines 30-33 discloses a left knee prosthesis that is a mirror image of the right knee prosthesis shown in fig.30, therefore the left meniscal component is considered a second meniscal component), a coupling device for coupling the tibial component and at least the first meniscal component in a coupling position (col.13, lines 37-43 discloses attachment aids for securing the meniscal component to the tibial component), wherein the first meniscal component and the second meniscal component are configured differently (since they are a mirror image of each other they are configured differently), wherein for forming the knee joint endoprosthesis, one of the first meniscal component and the second meniscal component is arranged between the femoral component and the tibial component cooperating therewith (fig.30), wherein the first meniscal component and the second meniscal component are configured mirror symmetrically to one another relative to a first mirror plane extending in a prosthesis longitudinal direction (col.4, lines 30-33 discloses mirror symmetry of components which must be relative to a first mirror plane extending in a prosthesis longitudinal direction in order to be used in a left knee which is substantially symmetric with the right knee relative to a sagittal plane which extends in a prosthesis longitudinal direction/vertical direction when the knee is extended), wherein the femoral component comprises a condyle portion (the portion comprising the medial and lateral condyles) with a medial condyle 3.27 and a lateral condyle 3.29, wherein each of the first meniscal component and the second meniscal component comprises a meniscal component sliding face (top face) cooperating with the medial condyle and the lateral condyle with a medial sliding face region 3.79 and a lateral sliding face region 3.81, wherein the medial condyle 3.27 and the medial sliding face region 3.79 form a medial sliding pairing (figs. 35, 37, 39), wherein the lateral condyle 3.29 and the lateral sliding face region 3.81 form a lateral sliding pairing (figs. 36, 38, 40), wherein at least one of a shape and a size of the medial sliding face region and of the lateral sliding face region differ from one another (fig.31 shows different shapes and sizes for the medial and lateral sliding face regions), and wherein the condyle portion of the femoral component is of mirror symmetrical configuration relative to a femoral component mirror plane extending in the prosthesis longitudinal direction (col.13, lines 18-21 says 3.23 is the same as 23 and col.6, lines 28-35 discloses the condyle portions of the femoral component are identical or symmetric to one another such that their radii R1 and R2 match). Blaha discloses the invention substantially as claimed, but Blaha does not disclose that the coupling device is of mirror symmetrical configuration relative to a coupling device mirror plane extending in the prosthesis longitudinal direction, wherein the coupling device can couple both meniscal components to the tibial component.
Wentorf teaches a knee joint endoprosthesis, in the same field of endeavor, wherein the tibial tray has a raised rim 13 around the proximal surface 11 for the purpose of receiving, surrounding, and holding a tibial bearing component therein (par.37). Wentorf further teaches the tibial tray can have a symmetric outer periphery 222 for the purpose of allowing the same baseplate to be implanted onto either a patient’s right tibia or left tibia (par.59; figs. 1 and 5). Wentorf states that when the baseplate has a symmetric outer periphery the lateral and medial compartments 14 and 16 are the same shape and size (par.59; fig.1), therefore the coupling device/raised rim is of mirror symmetrical configuration relative to a coupling device mirror plane (a vertical central plane of the tibial component extending in the anterior-posterior direction).
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 tibial component and coupling device of Blaha to be symmetrical with respect to a vertical central plane of the tibial component extending in the anterior-posterior direction as taught by Wentorf in order to allow for the tibial component to be used in either a left or right knee. It would have been further obvious to modify a coupling portion of the first and second meniscal components that is received in the tibial component to also be symmetric with respect to a vertical central plane extending in the anterior-posterior direction in order to allow for the meniscal components to be received in the universal tibial component taught by Wentorf.
Regarding claim 3, Blaha discloses right and left meniscal components (col.4, lines 30-33). It would have been obvious to provide just the right and left meniscal components in order to allow for the surgeon to select the proper meniscal component when only one knee joint is being replaced, or in order to allow the surgeon to replace both the right and left knee joints. It would have been further obvious to only provide a single pair of right and left meniscal components in order to simplify the set and minimize costs.
Regarding claim 4, Blaha discloses an immovable meniscal component (col.13, lines 34-43) and Wentorf discloses the coupling device fixedly couples the meniscal component to the tibial component (par.37).
Regarding claims 5-7, for the meniscal and tibial components of Blaha as modified to include the coupling device taught by Wentorf as discussed above, the first coupling portions are considered the portions of the meniscal components of Blaha that are received in the tibial component and the second coupling portion is considered the raised rim of the tibial component taught by Wentorf. Wentorf teaches mechanical fastening or molding to fixedly couple the meniscal component to the tibial component (par.37). These are considered at least positive-locking engagement. Since the outer perimeter and the raised rim (which is the second coupling portion) of the tibial component of Blaha in view of Wentorf has mirror symmetry relative to a vertical central plane extending in the anterior-posterior direction, it would have been obvious to provide the first coupling portion of each meniscal component with mirror symmetry in order to allow for the meniscal components to fit within the symmetrical raised rim.
Regarding claim 8, the mirror planes are considered vertical central planes extending in the anterior-posterior direction of each of the femoral component and coupling device which are aligned when assembled.
Regarding claims 9 and 10, see Blaha figs. 31 and 33-40. The medial joint region has a higher congruency (figs. 31, 33, 35, 37, and 39) than the lateral joint region (figs. 31, 36, 38, and 40) and the medial joint region defines a ball-jointed region (fig.33).
Regarding claims 11 and 12, as discussed above regarding claims 5-7, since the outer perimeter and the raised rim (which is the second coupling portion) of the tibial component of Blaha in view of Wentorf has mirror symmetry, it would have been obvious to provide the first coupling portion of the first meniscal component with mirror symmetry in order to allow for the meniscal components to fit within the symmetrical raised rim. Fig.31 of Blaha discloses different shapes and sizes of the medial sliding face region and the lateral sliding face region, therefore the two sliding face regions are asymmetric relative to the coupling portion mirror plane which is a vertical central plane extending in the anterior-posterior direction of the tibial component.
Regarding claim 13, see the rejection of claim 1 above which addresses most of claim 13. Claim 13 additionally requires a second femoral component wherein one of the first and second femoral components is configured as a left femoral component and wherein the other of the first and second femoral components is configured in the form of a right femoral component. Blaha teaches fig.30 is a right knee prosthesis and the left knee prosthesis is a substantial mirror image thereof (col., lines 30-34). 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 a second femoral component, such that there are right and left femoral components in order to replace either or both of the left or right knee joints.
Regarding claim 14, the condylar portions of the femoral components are the same (Blaha col.6, lines 6-8 disclose that R1 and R2 are equal and Blaha col.6, lines 28-35 discloses that R1 and R2 are the same for the medial and lateral condyles therefore the mirrored left/right femoral components all have the same R1 and R2) and are therefore capable of being combinable with the first and second meniscal components as desired.
Regarding claims 15 and 16, Blaha discloses fig.30 is a right knee prosthesis and the left knee prosthesis is a substantial mirror image thereof (col., lines 30-34). The second mirror plane is considered a sagittal plane of which the right and left knee prostheses are symmetric with respect to. The first mirror plane is the sagittal plane of which the right and left meniscal components are symmetric with respect to. The first and second mirror planes can therefore be the same since they are both part of the sagittal plane that the left and right knee prostheses have mirror symmetry relative to.
Regarding claims 17 and 18, Wentorf teaches a universal tibial component that can be used in either the left knee or right knee as discussed above with respect to at least claim 1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide two identical tibial components in the set of Blaha in view of Wentorf in order to allow for replacement of both the left and right knees using universal tibial components.
Regarding claim 19, claim 19 recites that a knee joint endoprosthesis system comprises either “a)” or “b)”. a) is the same as claim 1 which is discussed above and b) is the same as claim 13 which is discussed above; see the rejections of claims 1 and 13 above.
Regarding claim 20, while the claim is unclear as discussed above under 35 U.S.C. 112(b), it appears the claim may be requiring additional components of various sizes. Providing a kit with various sizes of components is standard in the art of knee prostheses. Wentorf specifically teaches the tibial component 10 may be provided in a kit or set of different sizes (par.79). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide each of the femoral components, tibial components and meniscal components in different sizes in order to allow for the surgeon to select a size that best suits a particular patient’s anatomy.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Blaha in view of Wentorf as applied to claim 1 above, and further in view of Bhatnagar et al. US 2008/0195108 (hereafter referred to as Bhatnagar). Blaha in view of Wentorf discloses the knee joint endoprosthesis set according to claim 1 as discussed above. Blaha teaches a left knee prosthesis being a substantial mirror image of the right knee prosthesis shown in fig.30 (col.4, lines 30-33). Wentorf teaches a tibial component that is symmetrical in order to be able to be used in either the left or right knee. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to only provide a single tibial component since the tibial component as taught by Wentorf could be used in either the left or right knee. Providing a single tibial component would be cheaper than providing two tibial components if only one is required, for instance when only one knee joint is being replaced. While Blaha in view of Wentorf discloses the invention substantially as claimed, Blaha in view of Wentorf does not disclose that the femoral component consists of only one single femoral component.
Bhatnagar teaches a knee prosthesis, in the same field of endeavor, wherein a femoral component 310 (fig.7) is a universal femoral component for the purpose of being configured to approximately fit both a left femur and a right femur (par.83).
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 knee joint endoprosthesis of Blaha in view of Wentorf to include a universal femoral component as taught by Bhatnagar in order to allow for the femoral component to be used in either the left or right knee. It would have been further obvious to provide a single universal femoral component, as taught by Bhatnagar, a single universal tibial component, as taught by Wentorf, with both the left and right meniscal components as disclosed by Blaha wherein the left and right meniscal components are necessary for the mirrored kinematics of the right and left knees. Such a set would allow for less components and at the same time the ability to use the set in either the left or right knee.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hazebrouck et al. US 2013/0184830 discloses commonly sized and shaped mating features for coupling various meniscal components to a tibia component (fig.5). Sharkey et al. US 6,923,832 discloses a symmetric tibial component with a symmetric coupling portion, wherein the tibial component is symmetric so that it can be used in a left or right knee (fig.3). Lawes US 5,047,057 discloses a symmetric tibial component that can receive differently configured meniscal components (figs. 13-15). Lacey US 4,759,767 discloses a symmetric tibial component with a symmetric coupling portion.
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 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, 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.
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.
/MEGAN Y WOLF/Primary Examiner, Art Unit 3774