DETAILED ACTION
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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.
Claim(s) 1,2,6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al WO 2013/133623.
Claims 1-2: Kim et al disclose a guided bone regeneration device that is intended for the reconstruction of a buccal bone defect and is composed of an optionally micro-perforated smooth wall which is made of titanium and has a shape that covers said buccal bone defect; wherein the titanium is pure, or is an alloy composed of titanium and at least one other chemical element. It is noted that a barrier membrane for guiding osseous tissue regeneration of alveolar bones, and more specifically, to a barrier membrane for guiding osseous tissue regeneration, wherein a barrier membrane used in alveolar bone regenerative surgery is formed by layering a non-resorbable membrane and a resorbable membrane, thereby allowing grafted alveolar bones to be well preserved without loss or infection even if severely lacking gingival connective cells and gingival epithelium, and blocking the infiltration of gingival epithelial cells into a regenerative site so as to exceedingly increase the success rate of alveolar bone regenerative surgery (see abstract, claims 2-3; The method according to claim 2 or 3,
The non-absorbent film is a bone membrane regeneration induced shielding membrane, characterized in that formed of titanium (Ti). of Kim).
Claim 6: Kim et al disclose wherein said device is alveolar or non-alveolar (see abstract)
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(s) 3-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al in view of Badaoui et al WO 2020/127291.
Claim 5: Kim et al disclose the invention substantially as claimed, but is silent regarding wherein it has a shape selected from a shell, a plate, and a mesh. However, Badaoui et al teach a device for guided bone regeneration, intended for the reconstruction of a buccal bone defect, composed of zirconium dioxide and having a shape which covers said buccal bone defect. The present invention also relates to a method for producing a device of the invention, comprising a step of constructing the device of the invention according to a three-dimensional representation obtained by means of a technique of maxillo-dental imaging of the bone (see abstract), Advantageously, whatever the form chosen, the device provides a hollow space, during its installation, between the wall thereof and the residual bone, so as to allow the introduction of a biomaterial inside the device of the invention. Any form allowing this objective to be achieved can be used by a person skilled in the art. It may for example be a shape chosen from a shell, a rigid plate, shell, and a net (also called mesh). As previously stated, the device of the invention is composed of zirconium dioxide (also called zyrcone or zyrconium oxide). The zirconium dioxide content of the device can for example be between 88% and 96%, for example 88%, or 89%, or 90% or 91% or 92% or 93% or 94% or 95% or 96%). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Kim with a shape selected from a shell, a plate, and a mesh as taught by Badaoui et al in order to allow it to cover all or part of the bone defect and to allow the reconstruction of all the bone volume lost.
Claims 3-4: Kim in view of Badaoui et al disclose the invention substantially as claimed but is silent regarding wherein said at least one other chemical element is selected from aluminum, vanadium, iron, hafnium, molybdenum, oxygen, palladium, tin, niobium, zirconium and tantalum. ], characterized in that wherein said alloy is selected from Ti-6AI-4V, Ti-6AI-7Nb, Ti-5AI-2,5Fe, Ti-13Ng- 13Zr, Ti-12Mo-6Zr-2Fe, Ti-15Mo-5Zr-3Al, Ti-15Mo-3Nb-3O, Ti-15Zr-4Nb-2Ta-0.2Pd, Ti- 15Sn-4Nb-2Ta-0.2Pd, Ti-35Nb-7Zr-5Ta, Ti-29Nb-13Ta-4.6Zr, Ti-35Nb-5Ta-7Zr-0.40 and Ti-Mo. It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the device with included at least one other chemical element is selected from aluminum, vanadium, iron, hafnium, molybdenum, oxygen, palladium, tin, niobium, zirconium and tantalum. ], characterized in that wherein said alloy is selected from Ti-6AI-4V, Ti-6AI-7Nb, Ti-5AI-2,5Fe, Ti-13Ng- 13Zr, Ti-12Mo-6Zr-2Fe, Ti-15Mo-5Zr-3Al, Ti-15Mo-3Nb-3O, Ti-15Zr-4Nb-2Ta-0.2Pd, Ti- 15Sn-4Nb-2Ta-0.2Pd, Ti-35Nb-7Zr-5Ta, Ti-29Nb-13Ta-4.6Zr, Ti-35Nb-5Ta-7Zr-0.40 and Ti-Mo, since it has been held to be within the general skill of a worker in the art to select a known material on the basic of its suitability for the intended use or as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 7-8: Badaoui et al teach at least one perforation for stabilizing said device, said perforation being designed to receive an osteosynthesis screw;wherein the microperforations are arranged on all or part of the wall.( the device of the invention may comprise at least one perforation for stabilizing the device, each perforation being intended to receive a osteosynthesis screw. As such, the perforation (s) is / are made (s) on the vestibular wall of the device. The number of perforations can be determined according to conventional criteria applied in this area, for example depending on the size of the bone defect. As such, it can be a number of perforations between 1 and 4, or even between 1 and 20, or even more, depending on the needs and the volume to be reconstructed. Advantageously, the device can also include microperforations on all or part of its wall. The microperforations can be distributed over said wall in a uniform manner, or in a manner irregular. The microperforations can have a diameter of between 1 μm and 1 mm, 1 mm being preferably excluded, for example between 2 μm and 800 μm, or between 5 μm and 500 μm, or between 10 μm and 300 μm. The density of the microperforations on the wall can be between 1 and 100 microperforations per square centimeter, for example between 20 and 90)
Claims 9-12: Badaoui et al teach comprising at least one window., wherein the window is attached to an opening in the wall; wherein the window has an opening and closing system. , wherein said at least one window has dimensions inscribed in a rectangle from 1 to 20 mm high and from 1 to 30 mm wide (Advantageously, the device of the invention can comprise at least one window arranged in its wall, in particular intended for the insertion of a biomaterial and its condensation. The biomaterial, once inserted between the bone and the wall of the device of the invention, that is to say in the space to be reconstructed, will allow osteoinduction and thus reconstruct the desired bone. Any type of biomaterial suitable for bone reconstruction can be used in this context, like any type of bone substitute chosen from allogeneic, xenogenic, autogenic and synthetic bone substitutes, this list not being exhaustive. The size, shape and number of windows can be chosen by a person skilled in the art depending in particular on the size of the device of the invention, as well as on the nature of the bone defects to be treated. For example, the window can be square, round, oval or rectangular. It can for example be written in a rectangle from 1 to 20 mm high and 1 to 30 mm wide or more. The window can be drawn using any suitable technique known to those skilled in the art, for example using a 3D planner. The number of windows can be between 1 and 5, and can be, for example, 1, 2, 3, 4 or 5. However, the number of windows can be adapted by a person skilled in the art according to his needs. The window or windows can be stabilized by a fixing device, such as an osteosynthesis screw, wires, gears or even sockets. Advantageously, the function of a window is to allow the filling of the room or the space created by the device with biomaterials, as well as the compaction of the latter during the supply and during the fixing of the window.
Claim 13: Badaoui et al teach wherein said at least one window has dimensions inscribed in a rectangle from 1 to 20 mm high and from 1 to 30 mm wide. , with a thickness of between 0.6 mm and 1.8 mm. (it is noted that The size, shape and number of windows can be chosen by a person skilled in the art depending in particular on the size of the device of the invention, as well as on the nature of the bone defects to be treated. For example, the window can be square, round, oval or rectangular. It can for example be written in a rectangle from 1 to 20 mm high and 1 to 30 mm wide or more. The window can be drawn using any suitable technique known to those skilled in the art, for example using a 3D planner. The number of windows can be between 1 and 5, and can be, for example, 1, 2, 3, 4 or 5. However, the number of windows can be adapted by a person skilled in the art according to his needs. The window or windows can be stabilized by a fixing device, such as an osteosynthesis screw, wires, gears or even sockets. Advantageously, the function of a window is to allow the filling of the room or the space created by the device with biomaterials, as well as the compaction of the latter during the supply and during the fixing of the window. The device may have a thickness adapted to its function, that is to say allow protection of the biomaterial for the time necessary for bone reconstruction. As such, the skilled person can easily determine the appropriate thickness depending on the case. For example, the thickness of the device of the invention can be between 0.1 mm and 2.5 mm, for example be around 0.1 mm, or 0.2 mm, or 0.3 mm, or 0, 4mm, or 0.5mm, or 0.6mm or 0.7mm or 0.8mm or 0.9mm or 1.0mm or 1.1mm or 1.2mm or 1.3mm or 1, 4 mm or 1.5 mm or 1.6 mm or 1.7 mm or 1.8 mm or 1.9 mm or 2.0 mm or 2.1 mm or 2.2 mm or 2, 3 mm, or 2.4 mm, or 2.5 mm.)
Claims 14-17: Badaoui et al teach a step of constructing said device as a function of a 3D representation obtained by a maxillary-dental imaging technique of the bone defect. , wherein said 3D representation of said bone defect is digitally diagrammed on software adapted to quantify the bone substance to be regenerated; further has an optional additional layer of 1 mm thickness is added( advantageously, the device of the invention can also optionally include perforations at the crestal level, to allow the insertion of dental implants during the surgical stage of guided bone regeneration; Another object of the invention relates to a method of manufacturing a device of the invention as defined above. The process used may include in particular a step of construction of said device based on a 3D representation of the bone defect obtained by a dento-maxillary imaging technique, for example by means of a conical beam volume tomography technique (Cone beam).
Advantageously, and as indicated above, the 3D representation of the bone defect can be shown diagrammatically numerically on software suitable for quantifying the bone substance to be regenerated.
Optionally, the digital schematization makes it possible to obtain a diagram, from which the device of the invention will be manufactured so as to cover the 3D representation of the bone defect.Optionally, it is possible to add a layer with an additional thickness of 1 mm, so as to increase the volume to be covered and obtain a higher reconstructed volume, and to compensate for the formation of a superficial epithelial layer.)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VI X NGUYEN whose telephone number is (571)272-4699. The examiner can normally be reached Monday-Friday (6:30-4:30).
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/VI X NGUYEN/Primary Examiner, Art Unit 3771
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