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 .
Drawings
Color photographs and color drawings (including photocopies of color drawings) are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claims 1,4,6, and 7 objected to because of the following informalities: In 1, 4, 6, and 7, “comprises” appears to be a typographical error and should be corrected to “comprise”.
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.
Claim 5-15 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 5, which recites, “grooves formed in a structure that is continuous with each other along,” however it is unclear what is meant by “each other” since the thing that is continuous is a singular “structure.”
Further regarding claim 5, the final limitation, recites, “wherein a straight line distance (dl) between an outermost surface of one of the two protrusions in a first direction and an outermost surface of the remaining protrusion in the first direction,” however the claim previously recites only two protrusions, so it is unclear what would be the remaining protrusion.
Further regarding claim 5, which recites that distance dl “is equal to a length (11) of a remaining groove except for a first groove opened toward a front of the bearing component among the grooves in the first direction or greater than the length (11) in the first direction,” it is unclear which of the previously recited “grooves” would be considered the “remaining groove” vs the “first groove.” As best understood, the limitation is considered to be describing the accommodation portion as being able to accommodate the protrusion portion with grooves that are a part of the accommodation portion.
Claims 6-15 are rejected based on their dependency on claim 5.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding Claim 1, the limitation reads “a tibial component directly fixed to a bone resection surface of tibia,” positively claiming the tibia, also referred as the shin bone in the disclosure. While inventions can be configured to be implanted into human organisms the disclosure cannot be dependent on and positively claim the human body. This rejection can be overcome by adding the language “configured to” where appropriate.
Regarding Claim 4, the limitation reads “a femoral component directly fixed to a bone resection surface of femur,” positively claiming the femur, also referred as the thigh bone in the disclosure. While inventions can be configured to be implanted into human organisms the disclosure cannot be dependent on and positively claim the human body. This rejection can be overcome by adding the language “configured to” where appropriate.
Regarding Claim 5, the limitation reads “a tibial component directly fixed to a bone resection surface of tibia,” positively claiming the tibia, also referred as the shin bone in the disclosure. Claim 5 also includes a limitation that reads “a femoral component directly fixed to a bone resection surface of femur,” positively claiming the femur, also referred as the thigh bone in the disclosure. While inventions can be configured to be implanted into human organisms the disclosure cannot be dependent on and positively claim the human body. This rejection can be overcome by adding the language “configured to” where appropriate.
Claims 2-3 and 6-15 are rejected based on their dependency on claims 1 and 5, respectively.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1 and 4-7 and 10-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 8137407 B2 (“Todd”).
Regarding Claim 1, Todd discloses an artificial knee joint replacement (See [9] for knee joint replacement), comprising:
a tibial component directly fixed to a bone resection surface of tibia (See Fig. 1 exemplary tibial implant 300) and configured to have a protrusion portion protruding from an upper fastening surface thereof (See Fig. 1, protrusion disclosed as protuberance 420, 380),
wherein the protrusion portion consists of two protrusions spaced apart from each other along a first direction reference line of the tibial component (See Fig. 1 protuberance 420, 380, see Fig. 2 for axis 490 for reference line),
wherein the two protrusions (See Fig. 1 protuberance 420, 380) comprise:
a first protrusion (See Fig. 1 protuberance 380) configured to protrude from the upper fastening surface spaced a first distance from a rear indentation portion of the tibial component (See Figs. 1-5, See [28] for protuberance 380), and have a dovetail-shaped cross-sectional structure in which a width or cross-sectional area gradually decreases as going downward (See Figs. 1-5, See [28] for protuberance 380, medial-lateral span 740 for width of protuberance); and
a second protrusion (See Fig. 1 protuberance 420) configured to protrude from the upper fastening surface spaced a second distance from an anterior curvature point of the tibial component (See Figs. 1-5, See [27] protuberance 420), and whose surface facing the first protrusion is inclined downward in a direction of the first protrusion (See Fig. 1 for 420’s incline downward facing 380).
Regarding Claim 4, Todd further discloses an artificial knee joint replacement (See [9] for knee joint replacement), comprising:
a bearing component (See Fig 1 insert 120 relates to bearing component) interposed between a femoral component directly fixed to a bone resection surface of femur and the tibial component described in claim 1 (See Fig. 1 exemplary tibial implant 300), and configured to have an accommodation portion (See Fig 1. for slot 220 relates to accommodation portion) formed on a lower fastening surface thereof to correspond to the protrusion portion of the tibial component (See Fig. 1 protuberance 420, 380),
wherein the accommodation portion (See Fig 1. for slot 220 relates to accommodation portion) consists of grooves (Fig 9 for grooves and rails relate to neck portion 1420) formed in a structure that is continuous with each other along a first direction reference line (Reference lines relate to axes 1220, 1260, and 1040) of the bearing component (See Fig 8 for underside of insert 120),
wherein the grooves (Fig 9 for grooves and rails relate to neck portion 1420) comprise:
a first groove configured to open toward a front of the bearing component (See Figs. 9 and 10 for 1400 tapered portion of slot relates to first groove); and
a second groove (See Figs. 9 and 10 for 1440 head portion of slot relates second groove) formed in succession behind the first groove deeper than the first groove (See Figs. 9 and 10 for 1440 deeper than 1400),
wherein the second groove (See Figs. 9 and 10 for 1440 head portion of slot relates second groove) is subdivided into:
a binding area (See Fig 10 for 1440 head portion of slot with extra area for binding) provided with a binding rail (See Fig 9 for 1420 neck portion that relates to rail); and a binding guide area configured to guide a protrusion formed on the tibial component to slide toward the binding area to be bound (See Fig 8 for bottom view of slot and arrows to show insertion).
Regarding Claim 5, An artificial knee joint replacement (See [9] for knee joint replacement), comprising:
a tibial component directly fixed to a bone resection surface of tibia (See Fig. 1 exemplary tibial implant 300) and configured to have a protrusion portion protruding from an upper fastening surface thereof (See Fig. 1, protrusion disclosed as protuberance 420, 380); and
a bearing component (See Fig 1 insert 120 relates to bearing component) interposed between a femoral component directly fixed to a bone resection surface of femur and the tibial component tibia (See Fig. 1 exemplary tibial implant 300), and configured to have an accommodation portion (See Fig 1. for slot 220 relates to accommodation portion) formed on a lower fastening surface thereof to correspond to the protrusion portion component (See Fig. 1 protuberance 420, 380),
wherein the protrusion portion consists of two protrusions component (See Fig. 1 protuberance 420, 380) spaced apart from each other along a first direction reference line of the tibial component (See Fig. 1 exemplary tibial implant 300), and
wherein the accommodation portion (See Fig 1. for slot 220 relates to accommodation portion) consists of grooves (Fig 9 for grooves and rails relate to neck portion 1420) formed in a structure that is continuous with each other along a first direction reference line (Reference lines relate to axes 1220, 1260, and 1040) of the bearing component (See Fig 8 for underside of insert 120),
wherein a straight-line distance (d1) between an outermost surface of one of the two protrusions component (See Fig. 1 protuberance 420, 380) in a first direction (See Fig. 2 for axis 490) and an outermost surface of the remaining protrusion in the first direction is equal to a length (l1) of a remaining groove (See Figs. 9 and 10 for 1440 head portion of slot relates second groove) except for a first groove opened toward a front of the bearing component among the grooves in the first direction or greater than the length (l1) in the first direction (See Figs. 9 and 10 for portion 1440 in relation to portion 1400).
As previously stated in 112(b) rejection, the final limitation of claim 5 creates ambiguity and has unclear wording. In terms of examination, the limitation is considered to be describing the accommodation portion (See Fig 1. for slot 220 relates to accommodation portion) as being able to accommodate the protrusions portion (See Fig. 1 protuberance 420, 380) with grooves (See Figs. 9 and 10 for portion 1440 in relation to portion 1400) that are a part of the accommodation portion.
Regarding Claim 6, The artificial knee joint replacement (See [9] for knee joint replacement) of claim 5, wherein the two protrusions comprise:
a first protrusion (See Fig. 1 protuberance 380) configured to protrude from the upper fastening surface spaced a first distance from a rear indentation portion of the tibial component (See Figs. 1-5, See [28] for protuberance 380), and have a dovetail-shaped cross-sectional structure in which a width or cross-sectional area gradually decreases as going downward (See Figs. 1-5, See [28] for protuberance 380, medial-lateral span 740 for width of protuberance); and
a second protrusion (See Fig. 1 protuberance 420) configured to protrude from the upper fastening surface spaced a second distance from an anterior curvature point of the tibial component (See Figs. 1-5, See [27] protuberance 420), and whose surface facing the first protrusion is inclined downward in a direction of the first protrusion (See Fig. 1 for 420’s incline downward facing 380).
Regarding Claim 7, The artificial knee joint replacement (See [9] for knee joint replacement) of claim 6, wherein the grooves (Fig 9 for grooves and rails relate to neck portion 1420) comprise:
the first groove formed to a depth lesser than a height of the second protrusion component (See Figs. 9 and 10 for 1400 tapered portion of slot relates to first groove); and
a second groove formed in succession behind the first groove deeper than the first groove (See Figs. 9 and 10 for 1440 head portion of slot relates second groove),
wherein the second groove is subdivided into:
a binding area provided with a binding rail (See Fig 9 for 1420 neck portion that relates to rail) in which a part of an outer surface of the first protrusion having the dovetail-shaped cross- sectional structure is engaged and fixed (See Fig 10 for 1440 head portion of slot with extra area for binding);
and a binding guide area configured to guide the first protrusion to slide toward the binding area to be bound (See Fig 8 for bottom view of slot and arrows to show insertion).
Regarding Claim 10, The artificial knee joint replacement (See [9] for knee joint replacement) of claim 7, wherein a moment the first protrusion moved along the binding guide area reaches a predetermined binding position in the binding area (See Figs. 9 and 10 for 1440 head portion of slot relates second groove; See Fig 10 for 1440 head portion of slot with extra area for binding),the second protrusion is caught on a step formed at a boundary between the first groove and the second groove (See Figs. 8 and 10 for recess 1300 which has 1320 smooth ceiling at same level as 1420 neck portion as seen in fig 10 to create catch of second protrusion).
Regarding Claim 11, The artificial knee joint replacement (See [9] for knee joint replacement) of claim 5, wherein the bearing component is a composite of one selected from ultra-high molecular weight polyethylene (UHMWPE), polyether ether ketone (PEEK), carbon fiber reinforced polymer, and glass fiber reinforced polymer, or a combination of two or more (See [2] for use of UHMWPE for knee joint replacement).
Regarding Claim 12, The artificial knee joint replacement (See [9] for knee joint replacement) of claim 11, wherein as the UHMWPE, conventional PE (CPE) or highly crosslinked PE (HXLPE) is used (See [2] for use of UHMWPE for knee joint replacement).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2, 8, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 8137407 B2 (“Todd”).
Regarding Claim 2, Todd discloses the artificial knee joint replacement (See [9] for knee joint replacement) of claim 1, wherein the first protrusion (See Fig. 1 protuberance 380) has a planar uppermost surface with a largest area and is a protrusion having a dovetail-shaped cross-sectional structure in which a cross-sectional area gradually decreases downward.
However, Todd does not explicitly disclose “the shape is a rectangle or square.” Yet, Todd discloses a rounded rectangular shape (Fig 1, protuberance 380) which is performing the same function as the protrusion of the application’s disclosure and which is an implicit disclosure suggesting a rectangle. Courts have found that simple substitutions of known elements for another (i.e. simple rectangular shapes) to obtain predictable results is obvious (MPEP 2143). Therefore, it would have been obvious before the effective filling date of the claimed invention for one of ordinary skill in the art to change the shape of the protrusion taught by Todd to have any known rectangular shape.
Regarding Claim 8, Todd discloses the artificial knee joint replacement (See [9] for knee joint replacement) of claim 6, wherein the first protrusion (See Fig. 1 protuberance 380) has a planar uppermost surface with a largest area and is a protrusion having a dovetail-shaped cross-sectional structure in which a cross-sectional area gradually decreases downward.
However, Todd does not explicitly disclose “the shape is a rectangle or square.” Yet, Todd discloses a rounded rectangular shape (Fig 1, protuberance 380) which is performing the same function as the protrusion of the application’s disclosure and which is an implicit disclosure suggesting a rectangle. Courts have found that simple substitutions of known elements for another (i.e. simple rectangular shapes) to obtain predictable results is obvious (MPEP 2143). Therefore, it would have been obvious before the effective filling date of the claimed invention for one of ordinary skill in the art to change the shape of the protrusion taught by Todd to have any known rectangular shape.
Regarding Claim 14, Todd discloses the artificial knee joint replacement (See [9] for knee joint replacement) of claim 7, wherein the first protrusion (See Fig. 1 protuberance 380) has a planar uppermost surface with a largest area and is a protrusion having a dovetail-shaped cross-sectional structure in which a cross-sectional area gradually decreases downward.
However, Todd does not explicitly disclose “the shape is a rectangle or square.” Yet, Todd discloses a rounded rectangular shape (Fig 1, protuberance 380) which is performing the same function as the protrusion of the application’s disclosure and which is an implicit disclosure suggesting a rectangle. Courts have found that simple substitutions of known elements for another (i.e. simple rectangular shapes) to obtain predictable results is obvious (MPEP 2143). Therefore, it would have been obvious before the effective filling date of the claimed invention for one of ordinary skill in the art to change the shape of the protrusion taught by Todd to have any known rectangular shape.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 8137407 B2 (“Todd”) in view of “Ultra-high molecular weight polyethylene (UHMWPE) for hip and knee arthroplasty: The present and the future” (“Bistolfi”).
Regarding Claim 13, Todd discloses the artificial knee joint replacement in the UHMWPE (See [2] for use of UHMWPE for knee joint replacement).
Todd does not detail the use of Vitamin E in the UHMWPE, however “Ultra-high molecular weight polyethylene (UHMWPE) for hip and knee arthroplasty: The present and the future” (“Bistolfi”) which teaches of research surrounding joint replacements, discloses the use of vitamin E for joints (Page 5 Section 5. Effectiveness of Vitamin E and other new antioxidants on the polyethylene).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to crosslink the UHMWPE joint of Todd with vitamin E as Bistolfi teaches that crosslinking with vitamin E can lead to less bacteria build up and slower degradation of the joint.
Allowable Subject Matter
Claim 3, 9, and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding Claims 3, 9, and 15, the closest prior art US 8137407 B2 (“Todd”) discloses a protrusion that is inclined downward yet does not disclose the specifics of the recited features of claims 3, 9, and 15. Claims 3, 9, and 15 describe the protrusion that is shaped like a right triangle with a width smaller than that of the other protrusion which is not suggested or disclosed by the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lukas M Lehman whose telephone number is (571)272-5040. The examiner can normally be reached M-F 7:30-5.
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/L.M.L./Patent Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774