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 § 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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buck (EP0622052) herein after Buck in view of Udduttula et al (Bioinert Ceramics for Biomedical Applications) herein after Udduttula.
Regarding claim 1, Buck teaches a customized device (11) for installation between soft tissue and an initial bone structure (Figure 5, device 11 is situated between soft tissue 2 and bone 1) to contribute to enhanced bone formation, reshaping of bone, or healing of bone (col. 1, lines 1-3), and having an inner surface (as shown in Figure 5 below, inner surface of 11 facing towards bone 1) arranged to be directed towards the initial bone structure (1) when the device has been installed, the inner surface being shaped to define an outer shape of new bone (Figure 5 shows the current bone 1 and the device 11, whereas the Figure 6 shows the new bone 1 is in the shape of the device 11 after bone regeneration), and an outer surface arranged to be directed towards the soft tissue when the device has been installed (outer surface of 11, towards the soft tissue 2).
However, does not teach the material used to make the device is an inert inorganic material without osseoconductive properties.
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Udduttula teaches that materials that can be used to make such devices are inert inorganic materials (Page 3, Figure 1, Page 2, lines 3-5) which corresponding to the limitation ‘inert inorganic material without osseoconductive properties’.
Therefore, it would have been obvious to one in the ordinary skill in the art before the filing date of the application to use biocompatible inert materials (Page 3, Figure 1) as taught by Udduttula, in the device (11) of Buck, in order to prevent bone apposition or osseointegration in the space maintained by the device.
Regarding claim 2, Buck teaches the device according to claim 1 wherein the inner surface is raised in a region to accommodate an upper part of a dental implant to be installed together with the device (Figure 5, the inner surface of the device 11 is raised to cover/accommodate the implant 13).
Regarding claim 3, Buck teaches the device according to claim 1, comprising a hole (Figure 5, 12 screws attached through screw holes) through the device at an intended location of a dental implant.
Regarding claim 4, Buck teaches the device according to claim 1, wherein an edge connects the inner and outer surfaces (the lining/perimeter of device 11 is an edge that connects the inner and outer surfaces of the device, Figure 5), which edge forms a boundary where the soft tissue is separated from the bone tissue when the device has been installed (edge or the boundary of the device 11, separates the soft tissue 2 and the bone 1).
Regarding claim 5, Buck teaches the device according to claim 1, However, does not teach that the device is made of inorganic materials.
Udduttula teaches wherein such devices can be composed of an inorganic material (page 2, lines 3-5, and Page 3, Figure 1) such as silicon nitride, alumina, titania, zirconia, aluminates or composites based on these materials (page 3, Figure 1).
Therefore, it would have been obvious to one in the ordinary skill in the art before the filing date of the application to use biocompatible inorganic materials (Page 3, Figure 1) as taught by Udduttula, in the device (11) of Buck, in order to prevent bone apposition or osseointegration in the space maintained by the device.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buck (EP0622052) herein after Buck in view of Udduttula et al (Bioinert Ceramics for Biomedical Applications) herein after Udduttula as in claim 1, and in further view of Liacouras et al (US 11,540,900) herein after Liacouras.
Regarding claim 6, Buck teaches the device according to claim 1, and inner surface defines a shape to install the dental implant (Figure 6, the shape around the implant 13 inside the bone 1), however, does not teach using a drill guide for the installation of the implant.
Liacouras teaches using of a drill guide for installation of dental implants to be placed on the new bone structure (Col. 2, lines 19-24).
Therefore, it would have been obvious to one in the ordinary skill in the art before the filing date of the application to modify the installing of the dental implant (13) of Buck to incorporate the use of a drill guide when installing the dental implant as taught by Liacouras, in order to improve the device placement accuracy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA N. SAMARASEKARA whose telephone number is (571)272-9653. The examiner can normally be reached Monday-Friday 8:00 am - 4:00 pm.
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/SARA N SAMARASEKARA/Examiner, Art Unit 3772
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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