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 7 is objected to because of the following informalities: the limitation of “the intermediate layer(s)” in lines 4-5 should be replaced with “the intermediate layer”. Appropriate correction is required.
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.
Claim(s) 1-6 and 8-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frid (US 2007/0162104, hereinafter “Frid”) in view of Cattano et al. (US 2013/0218255, hereinafter “Cattano”).
Referring to claim 1, Frig discloses an implantable endoluminal prosthesis for use in the treatment of cerebral aneurysm involving branches the prosthesis having a multilayer configuration (Figs. 2-3, 5 and 11; paras. [0082]-[0083]. Fig. 2 is reproduced below) comprising:
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at least one self-expandable braided framework 6 (Fig. 2) extending along an axis configured to expand from a radially compressed state in a delivery configuration to a radially expanded state (Paragraph [0019] discloses “In the case of a metal framework, the wires are preferably chosen from among the following materials [Phynox.RTM., Elgiloy.RTM., titanium and its alloys, Nitinol]. After the braiding stage, the metal wires of the stent according to the invention undergo heat treatment to impart them a hardening and a possible phase transition.” Claim 13 discloses “submitting the framework after braiding to a thermical treatment triggering a memory phase transition.” Examiner contends that based on the disclosure above one of ordinary skill in the art will understand that the endoluminal prosthesis of Frig is made from shape memory material to allow the prosthesis to collapse into a compressed state for delivering to the treatment site then transformed into a radially expanded state after the deployment of the prothesis);
the self-expandable braided framework being formed by wires (Fig. 2) and devoid of any impermeable cover layer (abstract and claim 1);
wherein the self-expandable braided framework comprises a plurality of layers (Fig. 2 shows the framework has three layers 8, 10 and 12; para. [0033]) of wires made of biocompatible material and forms a wall of the endoluminal prosthesis, each of the layers of wires forming a mesh, the meshes forming a lattice with a plurality of the wires of the layers the meshes being interlocked, the wires being integrated in the mesh of at least one adjacent layer (para. [0033] discloses “The framework 6 of the invention is a multiple braid which comprises, in the example shown, three layers 8, 10, 12 whose plies are not distinct: at the time of braiding, a given number of wires 14 of the plies of the first layer 8 are interlaced with the plies of the second layer 10 and/or of the third layer 12, forming a complex lattice (this applies to the figure shown, but it goes without saying that the interlacing can continue to the N.sup.th layer if the number of layers is N).”);
wherein the self-expandable braided framework further comprises a lumen in a cylindrical form having a circular cross-section, an axis, and a constant diameter (Figs. 2-3 and 5).
Frid discloses the invention substantially as claimed except for disclosing wherein a number of wires crossing a line parallel to the lumen axis in a given layer is higher in an outermost layer than in an innermost layer. However, in the same field of endeavor, which is an endoluminal prosthesis, Cattano discloses the prosthesis includes an inner braid layer 15 and an outer braid layer 14 (FIG. 6b; para. [0108]). Cattano discloses that “In general, it has proven advantageous if one layer 14, has a finer mesh structure than the other layer 15, 14. In other words, one of the two layers 14, 15 can comprise more wires 112, 122 than another layer 14, 15.” (para. [0112]) and “It is particularly preferable if the fine-meshed layer is the outer layer 14 and the wide-meshed layer is the inner layer 15.” (para. [0113]).
In view of Cattano’s teaching, it would have been obvious to one of ordinary skill in the art before the effective filling date of the application, to have made the outermost layer of Frid device to have more wires than the innermost layer to deliverrately influencing the blood flow into aneurysm without promoting a degeneration of the muscle cells of the aneurysm wall as suggested by Cattano (para. [0131]).
Referring to claim 2, Frid/Cattano discloses the cerebral implantable endoluminal prosthesis according to claim 1 wherein a ratio of the number of wires in the outermost layer to the innermost layer is at least 1.5 (examiner notes that Frid as modified by Cattano will have the condition of the outermost layer has more wire than the innermost layer. In paragraph [0033] Frid discloses the diameter of the wires, the density of the braiding, the number of layers and the number of wires 14 can be adjusted. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have perform routing experimentation of the number of wires 14 of the outer layer and inner layer to derive a ratio of the number of wires in the outermost layer to the innermost layer is at least 1.5 since it has been held that the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233).).
Referring to claim 3, Frid/Cattano discloses the cerebral implantable endoluminal prosthesis according to claim 1, wherein the number of wires forming the endoluminal prosthesis is comprised between 50 and 120 (in paragraph [0045] Frid discloses “By adjusting the number of wires, the number of layers and the size of the gaps between the wires, it is possible to obtain the required porosity with the present stent, thus opening up a practical possibility of applying the technique described above.” Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have perform routing experimentation of the number of wires 14 of the outer layer and inner layer to derive the number of wires forming the endoluminal prosthesis is comprised between 50 and 120 since it has been held that the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233).).
Referring to claim 4, Frid/Cattano discloses the cerebral implantable endoluminal prosthesis according to claim 1, having a nominal diameter comprised between 3 and 5.5 mm (in paragraph [0034] Frid discloses the stent can be manufactured for small vessel. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have perform routing experimentation of the number of wires 14, diameter of wire 14 and pitch angle of the outer layer and inner layer to derive a prosthesis with a nominal diameter of between 3 and 5.5 mm since it has been held that the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233).).
Referring to claim 5, Frid/Cattano discloses the cerebral implantable endoluminal prosthesis according to claim 1, wherein the wires forming the endoluminal prosthesis have a diameter comprised between 10 and 70 µm. (in paragraph [0021] Frid discloses the wires forming the endoluminal prosthesis have a diameter comprised between 25 and 80 µm. It would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have perform routing experimentation of the diameter of wires 14 to derive a diameter of between 10 and 70 µm since it has been held that the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233).).
Referring to claim 6, Frid/Cattano discloses the cerebral implantable endoluminal prosthesis according to claim 1, wherein a ratio of a surface coverage ratio of the outer layer to a surface coverage ratio of the inner layer is at least 1.5 (examiner notes that Frid as modified by Cattano will have the condition of the outermost layer has more wire than the innermost layer. The number of wire of each layer also directly relate to surface coverage. In other words the outermost layer of Frid/Cattano have more surface coverage than the innermost layer. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have perform routing experimentation of the number of wires 14 of the outer layer and inner layer to derive a ratio of a surface coverage ratio of the outer layer to a surface coverage ratio of the inner layer is at least 1.5 since it has been held that the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233).).
Referring to claim 8, Frid/Cattano discloses the cerebral implantable endoluminal prosthesis according to claim 1, wherein the biocompatible material is a metallic substrate selected from the group consisting of titanium, a nickel-titanium alloy, a stainless steel, and a cobalt-chromium-nickel alloy (para. [0019]: “the wires are preferably chosen from among the following materials [Phynox.RTM., Elgiloy.RTM., titanium and its alloys, Nitinol].”).
Referring to claim 9, Frid/Cattano discloses the cerebral implantable endoluminal prosthesis according to claim 1 wherein a ratio of the number of wires in the outermost layer to the innermost layer is at least 2 (in paragraph [0033] Frid discloses the diameter of the wires, the density of the braiding, the number of layers and the number of wires 14 can be adjusted. Examiner notes that Frid as modified by Cattano will have the condition of the outermost layer has more wire than the innermost layer. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have perform routing experimentation of the number of wires 14 of the outer layer and inner layer to derive a ratio of the number of wires in the outermost layer to the innermost layer is at least 1.5 since it has been held that the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233).)
Referring to claim 10, Frid/Cattano discloses the cerebral implantable endoluminal prosthesis according to claim 1, wherein the number of wires forming the endoluminal prosthesis is comprised between 80 and 102. (in paragraph [0045] Frid discloses “By adjusting the number of wires, the number of layers and the size of the gaps between the wires, it is possible to obtain the required porosity with the present stent, thus opening up a practical possibility of applying the technique described above.” Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have perform routing experimentation of the number of wires 14 of the outer layer and inner layer to derive the number of wires forming the endoluminal prosthesis is comprised between 80 and 102 since it has been held that the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233).).
Referring to claim 11, Frid/Cattano discloses the cerebral implantable endoluminal prosthesis according to claim 1, wherein the number of wires forming the endoluminal prosthesis is less than 100. (in paragraph [0045] Frid discloses “By adjusting the number of wires, the number of layers and the size of the gaps between the wires, it is possible to obtain the required porosity with the present stent, thus opening up a practical possibility of applying the technique described above.” Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have perform routing experimentation of the number of wires 14 of the outer layer and inner layer to derive the number of wires forming the endoluminal prosthesis is less than 100 since it has been held that the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233).).
Referring to claim 12, Frid/Cattano discloses the cerebral implantable endoluminal prosthesis according to claim 1, wherein the wires forming the endoluminal prosthesis have a diameter comprised between 20 and 50 µm. (in paragraph [0021] Frid discloses the wires forming the endoluminal prosthesis have a diameter comprised between 25 and 80 µm. It would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have perform routing experimentation of the diameter of wires 14 to derive a diameter of between 20 and 50 µm since it has been held that the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine experimentation in the art. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). MPEP 2145.05 II(B). (In re Aller, 105 USPQ 233).).
Referring to claim 13, Frid/Cattano discloses the cerebral implantable endoluminal prosthesis according to claim 1, wherein the wires forming the endoluminal prosthesis have a diameter comprised between 30 and 40 µm. (in paragraph [0021] Frid discloses the wires forming the endoluminal prosthesis have a diameter comprised between 25 and 80 µm).
Allowable Subject Matter
Claim 7 is 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.
Conclusion
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771