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 .
Election/Restrictions
Claims 4-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/8/26.
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 2 and 18 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.
Claim 2 recites “a percentage of the anterior-posterior dimension in the range of 33% to 39%” however fails to describe what this relates to – two points being a percentage apart does not clarify the metes and bounds of the claim.
Claim 18 recites “a percentage of the anterior- posterior dimension in the range of about 60% to about 70%” however fails to describe what this relates to – two points being a percentage apart does not clarify the metes and bounds of the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 18 and 20 are rejected under 35 U.S.C. 102a1 as being anticipated by Hofmann USP 4963152.
Regarding claim 1, Hofmann teaches a tibial insert component, comprising:
a medial concave surface (34) shaped to engage a medial condyle of a femoral component, and
a lateral concave surface (38) shaped to engage a lateral condyle of the femoral component, wherein the lateral concave surface extends from an anterior edge to a posterior edge,
wherein medial and lateral concave surfaces are asymmetric relative (column 2 lines 25-52) to each other and wherein the lateral concave surface includes a distal- most section that defines a straight line when the tibial insert component is viewed in a first sagittal plane. A small section forms a straight line.
Regarding claim 2, Hofmann teaches a tibial insert component of claim 1, further comprising an anterior end (42a) and a posterior end (42b), wherein an anterior-posterior dimension of the tibial insert component is defined between the anterior end and the posterior end, and
wherein the medial concave surface includes a distal-most point that is positioned, relative to the posterior end, a percentage of the anterior- posterior dimension in the range of 33% to 39%. Based on the 112 rejection above, it is unclear what Applicant is claiming. There is a distance between the two parts of the tibial insert.
Regarding claim 3, Hofmann teaches a tibial insert component of claim 1, wherein the medial concave surface includes a distal-most point, and wherein
a first height is defined between an anterior edge of the medial concave surface and the distal-most point of the medial concave surface when the tibial insert component is viewed in a second sagittal plane (see figure 5) there is a height, and
a second height is defined between an anterior edge of the lateral concave surface and the distal-most section of the lateral concave surface when the tibial insert component is viewed in the first sagittal plane (see figure 5) there is a height.
Regarding claim 18, Hofmann teaches a tibial insert component of claim 1, further comprising an anterior end and a posterior end, wherein an anterior-posterior dimension of the tibial insert component is defined between the anterior end and the posterior end (see figure 5), and
wherein the medial concave surface includes a distal-most point that is positioned, relative to the anterior end, a percentage of the anterior- posterior dimension in the range of about 60% to about 70%. Based on the 112 rejection above, it is unclear what Applicant is claiming. There is a distance between the two parts of the tibial insert.
Regarding claim 20, Hofmann teaches a tibial insert component of claim 1, further comprising a posterior channel formed on a bottom surface of the tibial insert, opposite the medial concave surface and the lateral concave surface, and shaped to receive a posterior buttress of a tibial tray, and
an anterior channel formed on the bottom of the tibial insert configured to receive an anterior buttress of the tibial tray – see figure 7 for channels – figure 10 shows the tray with insert.
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 16 is rejected under 35 U.S.C. 103 as being unpatentable over Hofmann USP 4963152 as applied to claim 1 above, and further in view of Bojarski AU-2013243258-A1 (AKA WO 2013152341)
Regarding claim 16, Hofmann teaches a tibial insert component of claim 1, wherein the medial concave surface includes a distal-most point, and wherein an anterior height is defined between an anterior edge of the medial concave surface and the distal-most point of the medial concave surface when the tibial insert component is viewed in a second sagittal plane (see figure 5), however fails to explicitly teach the anterior height being in the range of about 10.6 millimeters to about 10.7 millimeters.
Hofmann teaches thicknesses ranging from 7mm to 16mm including the baseplate [000192].
Bojarski teaches a tibia insert and baseplate (tray) where in the tray is 2mm or 3mm for example.
It 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 to use a baseplate of 2mm-3mm as taught by Bojarski as these ranges are taught as known in the art. For a baseplate of 2mm-3mm, the insert of Hofmann would be 4mm to 14mm thus meeting the claimed 10.6mm to 10.7mm. It is noted in [0116] of Applicant, “In the illustrative embodiment, the anterior height 154 is in a range of 10.6 to 10.7 millimeters.” Thus this number is merely exemplary and not critical thus Applicant has no criticality for this range and as the art suggests, the ranges are based on the particular patient at hand.
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 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hofmann USP 4963152 as applied to claim 1 above,
Regarding claim 17, Hofmann teaches a tibial insert component of claim 1, further comprising an anterior end and a posterior end, and wherein the medial concave surface includes a distal-most point however fails to explicitly indicate that it is positioned, relative to the posterior end, a distance equal to about 17.6 millimeters. It is noted that Applicant merely states “In the illustrative embodiment, the anterior-posterior distance 152 is equal to about 17.6 millimeters” [0114] – thus Applicant has claimed no criticality to this dimension. Hofman also teaches a medial concave surface but fails to explicitly teach this distance, however, In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The device of Hofmann would not function differently using such a distance, especially considering ranges of sizes of tibial insert are used based on the patient.
Regarding claim 19, Hofmann teaches a tibial insert component of claim 1, wherein an anterior height is defined between an anterior edge of the lateral concave surface and the distal-most section of the lateral concave surface when the tibial insert component is viewed in a second sagittal plane, however fails to explicitly teach the anterior height being in the range of about 2.0 millimeters to about 2.2 millimeters. It is noted that Applicant merely states “In the illustrative embodiment, the anterior height 184 is in a range of 2.0 to 2.2 millimeters.” [0118] – thus Applicant has claimed no criticality to this dimension. Hofman also teaches a height but fails to explicitly teach this particular height, however, In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. The device of Hofmann would not function differently using such a height, especially considering ranges of sizes of tibial insert are used based on the patient.
Conclusion
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/AMY R WEISBERG/Supervisory Patent Examiner, Art Unit 3612
