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 .
Allowable Subject Matter
Claims 12, 13, and 19 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.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art fails to teach or disclose the limitations including but not limited to wherein the step of cutting away the portion of the bone includes removal of a region of bone located under an intended post-operative location of a concave portion of a completed implant provided by the implant components in combination and the step of fitting multiple implant components to the bone includes locking at least one earlier fitted implant component into position on the bone by placing at least one later fitted implant component at an intended post-operative location of the at least one later fitted implant component relative to the bone.
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 4 and 5 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 4 recites “disposing an implant component between the two bone portions.” In lines 5-6. It is unclear whether this implant component is one of the implant components of claim 1. Claim 5 then recites “inserting a second implant component” in lines 1-2. It is unclear how this implant component could be a second implant component, as at least two implant components are already recited in claims 1 and 4. Appropriate clarification and correction are required.
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, 7, 11, 14, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Pub. No. 2009/0312798 to Varela.
As to Claim 1, Varela discloses a method for treating bone [0006]. The method comprises cutting away a portion of a bone to form a plurality of pathways for implant insertion (implant disposed through bore drilled through bony structure, [0017]), and inserting a plurality of implant components (12, 14) into the bone to replace the cut away portion of the bone [0017, 0018], including the step of passing at least one protrusion of each of the implant (including distal end 16 and sleeve 20, [0018], Fig. 1) components into a respective one of the pathways [0017], at least one of the implant components (12) being applied to the bone along a first direction and at least one of the implant components (14) being applied to the bone along a second direction transverse to the first direction (orientation seen in Fig. 1) so that the implant components engage to secure each other within their respective pathways (engagement between 16 and 20, Fig. 1, [0018]).
As to Claim 3, Varela discloses a method for treating bone wherein one of the implant components (14) includes a channel (20. [0018]) extending along a surface thereof (Fig. 1) configured to engage with the bone such that the channel aligns with one of the pathways [0018], and wherein another of the implant components (12) is configured to simultaneously engage both the channel and the one of the pathways [0018].
As to Claim 7, Varela discloses a method for treating bone wherein the implant components (12, 14) are configured to interlock by engaging corresponding protrusions (16) and recesses (within 20), thereby preventing relative movement of the components once fitted into the bone [0018].
As to Claim 11, Varela discloses a method for treating bone [0006]. The method comprises cutting away a portion of a bone creating multiple pathways for implant insertion in the remaining bone (implant disposed through bore drilled through bony structure, [0017]), and fitting multiple implant components (12, 14) into the bone to replace the cut away portion of the bone [0017, 0018], including the step of passing at least one protrusion of each of the implant (including distal end 16 and sleeve 20, [0018], Fig. 1) components into a respective one of the pathways [0017], at least one of the implant components (12) being applied to the bone along a first direction and at least one of the implant components (14) being applied to the bone along a second direction transverse to the first direction (orientation seen in Fig. 1).
As to Claim 14, Varela discloses a method for treating bone wherein each of the implant components (12, 14) is fitted to the bone along a different direction than any other of the implant components (orientation seen in Fig. 1).
As to Claim 18, Varela discloses a method for treating bone wherein the implant components (12, 14) include interlocking features (16, 20) that engage corresponding features on adjacent implant components [0018].
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.
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.
Claims 2, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2009/0312798 to Varela in view of U.S. Patent No. 11,160,589 to Lee et al.
As to Claim 10, Varela discloses a method for treating bone wherein the pathways are formed as negative non-planar features, and the protrusions of the implant components are complementary positive non-planar features that engage the pathways (implant disposed through bore drilled through bony structure, [0017]).
As to Claims 2, 9 and 10, Varela discloses the claimed invention except for wherein at least one of the pathways is curved, wherein the implant components include flexible tabs configured to deform during insertion to secured within the pathways.
Lee discloses a method of treating bone (Col. 5, Lines 15-19) wherein at least one of the pathways (216a, 216b) is curved (Col. 5, Lines 30-61). The implant components include flexible tabs configured to deform during insertion to secured within the pathways (e.g. deformation described in Col. 8, Lines 35-52) in order to allow for the implant components to be inserted using a smooth non-torsional force (Col. 5, Lines 56-61).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of treating bone of Varela with the curved pathway modification of Lee in order to allow for the implant components to be inserted using a smooth non-torsional force.
Claims 4, 5, 8, 16, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2009/0312798 to Varela in view of U.S. Patent Pub. No. 2020/0046412 to Nachtrab et al.
As to Claim 5, Varela discloses a method for treating bone further including a step of inserting a second implant (12) component through an aperture (within 20) of the implant component to engage both remaining bone portions and lock the implant component in place [0018].
As to Claims 4, 5, 8, 16, 17, and 20, Varela discloses the claimed invention except for wherein the step of cutting away a portion of the bone includes removing the cut away portion of the bone and separating the remaining bone into two remaining bone portions, and comprising the further steps of distracting the two remaining bone portions, and while the two remaining bone portions are distracted, disposing an implant component between the two bone portions, wherein the implant components are based on patient specific data, wherein the method comprises, before cutting the bone, using patient specific data to identify the portion of the bone to be removed, including locating an injured region of the bone and planning placement of slots to stably retain a prosthesis for functionally replacing the portion of bone to be removed, and comprising designing the implant components such that the implant components can functionally replace the portion of the bone to be removed when fitted to the bone.
Nachtrab discloses a method of treating bone [0011, 0061]. The step of cutting away a portion of the bone includes removing the cut away portion of the bone and separating the remaining bone into two remaining bone portions [0108], and comprising the further steps of distracting the two remaining bone portions (distraction described in [0087]), and while the two remaining bone portions are distracted, disposing an implant component between the two bone portions (400a, [0074-0076, 0108]). The implant components are based on patient specific data [0011, 0061-0062]. The method comprises, before cutting the bone, using patient specific data to identify the portion of the bone to be removed, including locating an injured region of the bone and planning placement of slots to stably retain a prosthesis for functionally replacing the portion of bone to be removed [0011, 0061-0062]. The method includes comprising designing the implant components such that the implant components can functionally replace the portion of the bone to be removed when fitted to the bone [0064] in order to allow for the target bones to be placed in a pre-operatively planned corrected position prior to placing the implant components [0108].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of treating bone of Varela with the bone distraction modification of Nachtrab in order to allow for the target bones to be placed in a pre-operatively planned corrected position prior to placing the implant components.
Claims 6 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2009/0312798 to Varela in view of U.S. Patent Pub. No. 2003/0135216 to Sevrain.
As to Claims 6 and 15, Varela discloses the claimed invention except for including securing a selected one of the implant components to the bone by disposing a pair of pins through the selected one of the implant components and into the bone such that the pair of pins engage one other within the bone, wherein four implant components are fitted to the bone.
Sevrain discloses a method for treating bone [0002, 0010]. The method securing the implant component (P) to a first one (V1) of the remaining bone portions by disposing a pair of pins (10, 20) through the implant component and into the first one of the remaining bone portions (Figs. 1 and 2) such that the pair of pins engages one another within the first one of the remaining bone portions (at 12, [0026, 0027]). The pair of pins (10, 12) is a first pair of pins and further comprising securing the implant component (P) to a second one (V2) of the remaining bone portions by disposing a second pair of pins (second pair 10, 20, Fig. 2) through the implant component and into the second one of the remaining bone portions (V2) such that the second pair of pins engages one another within the second one of the remaining bone portions (Figs. 1, 2, [0026-0027]). Four implant components (10, 20, 10, 20, are fitted to the bone (seen in Fig. 2) in order to provide a means for securing fixation of the implant to the bone portions [0027].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method for treating bone of Varela with the securing pin modification of Sevrain in order to provide a means for securing fixation of the implant to the bone portions.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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