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 Objections
Claim 1 is objected to because of the following informalities:
The claim recites “the surface is configured to substantially evenly engage with the anatomical surface of the specific patient the implantable medical device implanted in the patient” in lines 6-8. It appears that the claim should read “the surface is configured to substantially evenly engage with the anatomical surface of the specific patient when the implantable medical device implanted in the patient.” Appropriate clarification and correction is required.
Claim 13 is objected to because of the following informalities:
The claim recites “The method of claim 12, wherein further comprising fastening…”
It appears that the claim should read “The method of claim 12, wherein the method further comprises fastening…” Appropriate clarification and 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 13 is 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 13 recites the limitation "the component" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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 1-5 and 7-17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2007/0276501 to Betz et al. in view of U.S. Patent Pub. No. 2016/0270931 to Trieu.
As to Claim 1, Betz discloses an implantable medical device (75, Fig. 10, [0078]). The device comprises a component (72, 73) having a body with a surface that has a contour that is substantially complementary to an anatomical surface of a specific patient [0134]. The device includes a component-engaging part integrally formed with the body (interior of body 75 interface with superior and inferior endplate surfaces 72, 73, Fig. 10, [0134]). The surface is configured to substantially evenly engage with the anatomical surface of the specific patient when the implantable medical device implanted in the patient [0019-0020, 0078].
As to Claim 2, Betz discloses an implantable medical device wherein the anatomical surface is a specific anatomical surface unique to the specific patient such that the one or more surfaces have been explicitly designed for the specific patient [0078].
As to Claim 3, Betz discloses an implantable medical device wherein the one or more surfaces (of 72, 73) are for the specific patient such that at least part of the one or more surfaces will not evenly engage a separate patient (patient-specific described in [0078]).
As to Claim 4, Betz discloses an implantable medical device wherein the anatomical surface is taken in-situ within a human or animal patient (image data 21, [0073]).
As to Claim 5, Betz discloses an implantable medical device wherein the one or more surfaces are custom manufactured to be complementary to the anatomical surface of the specific patient based on a scan of the anatomical surface of the specific patient [0073, 0078].
As to Claim 7, Betz discloses an implantable medical device wherein the body has a set of teeth (69, Fig. 10, [0135]) to further securely engage with the anatomical surface by being able to puncture therethrough [0135].
As to Claim 9, Betz discloses an implantable medical device wherein the body is contoured such that the body is convex in some regions and concave in other regions and the body is configured to engage complimentary concave and convex portions, respectively, of the anatomical surface of the specific patient (concave and convex contour seen in Figs. 5A-5C, [0112, 0075, 0134])
As to Claim 10, Betz discloses an implantable medical device wherein the anatomical surface is a unique anatomical surface of the specific patient, and the contour is unique such that the one or more surfaces uniquely correspond to the unique anatomical surface [0075, 0078, 0134].
As to Claim 11, Betz discloses an implantable medical device wherein the body is a first body (72) with a first surface having a first contour [0134], the implantable medical device further comprising a second body (73) with a second surface having a second contour that is substantially complementary to a separate anatomical surface of the specific patient [0134], the second body integrally formed with the component-engaging part (interior of body 75, Fig. 10, [0134].)
As to Claim 12, Betz discloses a method for manufacturing a medical device [0024-0025, 0078, 0081]. The method comprises designing a body (of 75) with a surface (72) that has a contour substantially complementary to an anatomical surface of a specific patient [0075, 0078, 0134], adjusting a height of a component-engaging part that is integrally formed with the body to form at least part of a medical device (height discussed in [0075]), such that when the medical device is implanted into the specific patient the surface substantially engages with the anatomical surface of the specific patient [0075, 0134]).
As to Claim 13, Betz discloses a method wherein the method further comprises fastening the component to the component-engaging part [0134].
As to Claim 14, Betz discloses a method further comprising adjusting at least a portion of the component-engaging part relative to another portion of the component-engaging part (based on wedge angle, concavity, convexity, [0075]).
As to Claim 15, Betz discloses implantable medical device (75, Fig. 10, [0078]). The device comprises a body (including 72, 73, 75) having a surface that has a contour that is substantially complementary to an anatomical surface of a specific patient (of 72, 73, [0134]), and a spacer (interior of 75) integrally formed with the body (Fig. 10), wherein the surface is configured to substantially evenly engage with the anatomical surface of the specific patient [0019-0020, 0078].
As to Claim 16, Betz discloses implantable medical device wherein the spacer (of 75) has an adjustable height (variable height discussed in [0075]).
As to Claim 17, Betz discloses a method for manufacturing a medical device [0024-0025, 0078, 0081]. The method comprises designing a body (of 75) with a surface (72) that has a contour substantially complementary to an anatomical surface of a specific patient [0075, 0078, 0134], adjusting a height of spacer (of 75) that is integrally formed with the body to form at least part of a medical device (height discussed in [0075]), such that when the medical device is implanted into the specific patient the surface substantially engages with the anatomical surface of the specific patient [0075, 0134]).
As to Claims 1-5 and 7-17, Betz discloses the claimed invention except for wherein the body, component-engaging part, and spacer are at least in part manufactured by additive manufacturing, wherein the additive manufacturing is in the form of 3D printing,
Trieu discloses an implantable medical device (10, Fig. 1, [0022]) including a body (including 14 and 16), component-engaging part (20, 50), and spacer (18) formed to be substantially complementary to an anatomical surface of a specific patient [0025, 0081, 0085, 0105]. The body and a component engaging part (of 20, 50) are at least in part manufactured by additive manufacturing [0028-0030]. The additive manufacturing is in the form of 3D printing [0028-0030] in order to provide a convenient, localized method of manufacture for the implant components, and suitable fit for multiple endplate surfaces [0028-0030, 0047].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the implantable medical device of Betz with the additive manufacturing and second custom surface modification of Trieu in order to provide a convenient, localized method of manufacture for the implant components, and suitable fit for multiple endplate surfaces.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2007/0276501 to Betz et al. U.S. Patent Pub. No. 2016/0270931 to Trieu in view of U.S. Patent Pub. No. 2010/0240012 to Lange et al.
As to Claim 6, Betz and Trieu discloses the claimed invention except for wherein a triangulated point surface definition is used to assist in defining the surface.
Lange discloses a method for producing an implant [0008] wherein a triangulated point surface definition is used to assist in defining the surface [0009] in order to provide accurate date of the desired surface contour [0009].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the implant of Betz and Trieu with the triangulated point modification of Lange in order to provide accurate date of the desired surface contour.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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