DETAILED ACTION
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.
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 1-2, 7-9, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer (US 20120277729 A1) in view of Stefanchik et al. (US 20090149710 A1).
Regarding claim 1, Melsheimer discloses a rigidizing device (100) comprising:
an elongate flexible tube (102);
a region arranged along a length of the elongate flexible tube configured to be rigidized when a pressure is applied within the region (Figs. 2A-2B, Paragraph [0017]),
wherein the region comprises a pressure chamber (108) including a variable stiffness layer (110) within a space in a wall of the elongate flexible tube (Figs. 1-2B),
wherein the region is configured to convert between a flexible configuration, in which the variable stiffness layer is movable within the space, and a rigid configuration, in which the application of pressure constricts the space and limits movement of the variable stiffness layer (Figs. 2A-2B, Paragraphs [0016]-[0017]).
Melsheimer is silent regarding
a plurality of regions arranged along a length of the elongate flexible tube configured to be separately rigidized when a pressure is applied within each of the plurality of regions,
wherein each region comprises a pressure chamber including a variable stiffness layer within a space in a wall of the elongate flexible tube,
wherein each region is separately configured to convert between a flexible configuration, in which the variable stiffness layer is movable within the space, and a rigid configuration, in which the application of pressure constricts the space and limits movement of the variable stiffness layer.
In analogous art, Stefanchik teaches
a plurality of regions configured to be separately rigidized when a pressure is applied within each of the plurality of regions (Paragraph [0037]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the region of Melsheimer to incorporate the teachings of Stefanchik to incorporate a plurality of regions configured to be separately rigidized when a pressure is applied within each of the plurality of regions in order to provide selective, localized stiffening at various desired locations (Paragraph [0037]). The modification of Melsheimer in view of Stefanchik would teach wherein each region comprises a pressure chamber including a variable stiffness layer within a space in a wall of the elongate flexible tube and wherein each region is separately configured to convert between a flexible configuration, in which the variable stiffness layer is movable within the space, and a rigid configuration, in which the application of pressure constricts the space and limits movement of the variable stiffness layer because Melsheimer was modified by Stefanchik to teach a plurality of regions, therefore each region of Melsheimer would teach the above limitations.
Regarding claim 2, Melsheimer in view of Stefanchik disclose the device of claim 1, but Melsheimer is silent regarding further comprising a plurality of pressure lines, wherein each region of the plurality of regions connects to one of the pressure lines of the plurality of pressure lines.
Stefanchik teaches a plurality of pressure lines, wherein each region of the plurality of regions connects to one of the pressure lines of the plurality of pressure lines (Paragraph [0037]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Melsheimer in view of Stefanchik to incorporate the teachings of Stefanchik to incorporate a plurality of pressure lines, wherein each region of the plurality of regions connects to one of the pressure lines of the plurality of pressure lines in order to in order to provide selective, localized stiffening at various desired locations (Paragraph [0037]).
Regarding claim 7, Melsheimer in view of Stefanchik disclose the device of claim 1, wherein the variable stiffness layer in each region of the plurality of regions comprises a plurality of strand lengths that are configured to move relative to each other in the flexible configuration and are limited from moving relative to each other in the rigid configuration (Paragraphs [0016]-[0017], Figs. 2A-2B, Melsheimer).
Regarding claim 8, Melsheimer in view of Stefanchik disclose the device of claim 7, wherein the variable stiffness layer in each region of the plurality of regions comprises a braid layer (110, Melsheimer).
Regarding claim 9, Melsheimer in view of Stefanchik disclose the device of claim 7, wherein the variable stiffness layer in each region of the plurality of regions comprises a woven layer (110, Melsheimer).
Regarding claim 14, Melsheimer in view of Stefanchik disclose the device of claim 1, wherein the plurality of regions are configured to be separately rigidized when a negative pressure is applied within each of the plurality of regions (Paragraph [0017], Melsheimer).
Regarding claim 15, Melsheimer in view of Stefanchik disclose the device of claim 1, wherein the plurality of regions arranged along a length of the elongate flexible tube are each cylindrical regions (One of ordinary skill in the art would recognize that the region of Melsheimer is cylindrical, therefore the modification of the cylindrical region Melsheimer to incorporate a plurality of regions would result in a plurality of cylindrical regions).
Regarding claim 16, Melsheimer discloses a rigidizing device (100) comprising:
an elongate flexible tube (102);
a cylindrical region arranged along a length of the elongate flexible tube configured to be rigidized when a pressure is applied within the cylindrical region (Figs. 2A-2B, Paragraph [0017]),
wherein the region comprises a pressure chamber (108) including a variable stiffness layer (110) within a space in a wall of the elongate flexible tube (Figs. 1-2B),
wherein the region is configured to convert between a flexible configuration, in which the variable stiffness layer is movable within the space, and a rigid configuration in which the application of pressure constricts the space and limits movement of the variable stiffness layer (Figs. 2A-2B, Paragraphs [0016]-[0017]).
Melsheimer is silent regarding
a plurality of cylindrical regions arranged along a length of the elongate flexible tube configured to be separately rigidized when a pressure is applied within each of the plurality of cylindrical regions,
wherein each region comprises a pressure chamber including a variable stiffness layer within a space in a wall of the elongate flexible tube,
wherein each region is configured to separately convert between a flexible configuration, in which the variable stiffness layer is movable within the space, and a rigid configuration in which the application of pressure constricts the space and limits movement of the variable stiffness layer; and
a plurality of pressure lines, wherein each region of the plurality of cylindrical regions connects to one of the pressure lines of the plurality of pressure lines.
In analogous art, Stefanchik teaches
a plurality of regions configured to be separately rigidized when a pressure is applied within each of the plurality of regions (Paragraph [0037]); and
a plurality of pressure lines, wherein each region of the plurality of cylindrical regions connects to one of the pressure lines of the plurality of pressure lines (Paragraph [0037]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the region of Melsheimer to incorporate the teachings of Stefanchik to incorporate a plurality of regions configured to be separately rigidized when a pressure is applied within each of the plurality of regions in order to provide selective, localized stiffening at various desired locations (Paragraph [0037]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Melsheimer in view of Stefanchik to incorporate the teachings of Stefanchik to incorporate a plurality of pressure lines, wherein each region of the plurality of regions connects to one of the pressure lines of the plurality of pressure lines in order to in order to provide selective, localized stiffening at various desired locations (Paragraph [0037]). The modification of Melsheimer in view of Stefanchik would teach wherein wherein each region comprises a pressure chamber including a variable stiffness layer within a space in a wall of the elongate flexible tube and wherein each region is configured to separately convert between a flexible configuration, in which the variable stiffness layer is movable within the space, and a rigid configuration in which the application of pressure constricts the space and limits movement of the variable stiffness layer because Melsheimer was modified by Stefanchik to teach a plurality of regions, therefore each region of Melsheimer would teach the above limitations.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer (US 20120277729 A1) in view of Stefanchik et al. (US 20090149710 A1) further in view of Vargas (US 20040054322 A1).
Regarding claim 5, Melsheimer in view of Stefanchik disclose the device of claim 1, but are silent regarding further comprising a steerable distal section.
In analogous art, Vargas teaches a steerable distal section (3).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Melsheimer in view of Stefanchik to incorporate the teachings of Vargas to incorporate a steerable distal section in order to steer the device in the desired direction of insertion and advance it through the body (Paragraph [0041]) and provide directional control (Paragraph [0042]).
Regarding claim 6, Melsheimer in view of Stefanchik further in view of Vargas disclose the device of claim 5, but Melsheimer in view of Stefanchik are silent regard further comprising a plurality of cables to control the steerable distal section.
Vargas teaches a plurality of cables to control the steerable distal section (Paragraph [0038]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the device of Melsheimer in view of Stefanchik further in view of Vargas to incorporate the teachings of Vargas to incorporate a plurality of cables to control the steerable distal section in order to actuate the steerable tip (Paragraph [0038]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer (US 20120277729 A1) in view of Stefanchik et al. (US 20090149710 A1) further in view of Schaefer et al. (US 6709429 B1).
Regarding claim 10, Melsheimer in view of Stefanchik disclose the device of claim 7, but are silent regarding wherein the variable stiffness layer in each region of the plurality of regions comprises longitudinal strands extending along a long axis of the elongate flexible tube.
In analogous art, Schaefer teaches longitudinal strands (34) extending along a long axis of the elongate flexible tube (Fig. 2).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the wherein the variable stiffness layer in each region of the plurality of regions of Melsheimer in view of Stefanchik to incorporate the teachings of Schaefer to incorporate longitudinal strands extending along a long axis of the elongate flexible tube in order to limit elongation of the catheter and maintain precise control of the catheter (Col 6, lines 59-60).
Claims 11, 17, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer (US 20120277729 A1) in view of Stefanchik et al. (US 20090149710 A1) further in view of Horzewski et al (US 5470322 A).
Regarding claim 11, Melsheimer in view of Stefanchik disclose the device of claim 1, but are silent regarding wherein at least some of the plurality of regions have rigid configurations of different stiffnesses.
In analogous art, Horzewski teaches wherein at least some regions of the plurality of regions (32/33) have different stiffnesses (Col 3, lines 24-35).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the elongate flexible tube of Melsheimer in view of Stefanchik to incorporate the teachings of Horzewski to incorporate at least some regions of the plurality of regions having different stiffnesses in order to provide both pushability and steerability (Col 1, lines 40-43). The modification of Melsheimer in view of Stefanchik further in view of Horzewski would teach wherein at least some of the plurality of regions have rigid configurations of different stiffnesses because the elongate flexible tube of Melsheimer in view of Stefanchik was modified to have a stiffness that varies along the length of it, which would result in at least some regions of the plurality of regions to have rigid configurations of different stiffnesses.
Regarding claim 17, Melsheimer discloses a rigidizing device (100) comprising:
an elongate flexible tube (102);
a region arranged along a length of the elongate flexible tube configured to be converted from a flexible configuration to a more rigid configuration when a pressure is applied within a wall of the elongate flexible tube (Figs. 2A-2B, Paragraph [0017]); and
a variable stiffness layer (110) within the region within a space in the wall of the elongate flexible tube (Figs. 1-2B), wherein the variable stiffness layer is movable within the space in the flexible configuration and wherein the application of pressure constricts the space and limits movement of the variable stiffness layer (Figs. 2A-2B, Paragraphs [0016]-[0017]).
Melsheimer is silent regarding
a plurality of regions arranged along a length of the elongate flexible tube configured to be converted from a flexible configuration to a more rigid configuration corresponding to each region of the plurality of regions when a pressure is applied within a wall of the elongate flexible tube, wherein at least some regions of the plurality of regions have different stiffnesses in the more rigid configuration then other regions of the plurality of regions when the pressure is applied; and
a variable stiffness layer within each region of the plurality of regions within a space in the wall of the elongate flexible tube.
In analogous art, Stefanchik teaches
a plurality of regions configured to be converted from a flexible configuration to a more rigid configuration (Paragraph [0037]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the region of Melsheimer to incorporate the teachings of Stefanchik to incorporate a plurality of regions configured to be converted from a flexible configuration to a more rigid configuration in order to provide selective, localized stiffening at various desired locations (Paragraph [0037]). The modification of Melsheimer in view of Stefanchik would teach wherein a plurality of regions arranged along a length of the elongate flexible tube configured to be converted from a flexible configuration to a more rigid configuration corresponding to each region of the plurality of regions when a pressure is applied within a wall of the elongate flexible tube and a variable stiffness layer within each region of the plurality of regions within a space in the wall of the elongate flexible tube because Melsheimer was modified by Stefanchik to teach a plurality of regions, therefore each region of Melsheimer would teach the above limitations.
In analogous art, Horzewski teaches wherein at least some regions of the plurality of regions (32) have different stiffnesses then other regions of the plurality of regions (33, Col 3, lines 24-35).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the elongate flexible tube of Melsheimer in view of Stefanchik to incorporate the teachings of Horzewski to incorporate at least some regions of the plurality of regions having different stiffnesses then other regions of the plurality of regions in order to provide both pushability and steerability (Col 1, lines 40-43). The modification of Melsheimer in view of Stefanchik further in view of Horzewski would teach wherein at least some regions of the plurality of regions have different stiffnesses in the more rigid configuration then other regions of the plurality of regions when the pressure is applied because the elongate flexible tube of Melsheimer in view of Stefanchik was modified to have a stiffness that varies along the length of it, which would result in at least some regions of the plurality of regions to have different stiffnesses in the more rigid configuration then other regions of the plurality of regions when the pressure is applied.
Regarding claim 20, Melsheimer in view of Stefanchik further in view of Horzewski disclose the device of claim 17, wherein the plurality of regions arranged along the length of the elongate flexible tube are configured to be converted from the flexible configuration to the more rigid configurations when a negative pressure is applied (Paragraph [0017, Melsheimer).
Regarding claim 21, Melsheimer in view of Stefanchik further in view of Horzewski disclose the device of claim 16, further comprising a lumen (116, Melsheimer) extending through the elongate flexible tube (Fig. 1, Melsheimer).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer (US 20120277729 A1) in view of Stefanchik et al. (US 20090149710 A1) further in view of Soltesz (US 5254107 A).
Regarding claim 12, Melsheimer in view of Stefanchik disclose the device of claim 11, wherein the variable stiffness layer of the plurality of regions each comprises a braid layer (110, Melsheimer), but are silent regarding further wherein the at least some of the plurality of regions have different braid angles of their braid layers.
In analogous art, Soltesz teaches variable pitch braid (Col 5, lines 18-20).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified at least some of the plurality of regions of Melsheimer in view of Stefanchik to incorporate the teachings of Soltesz to incorporate having different braid angles in order to vary the physical characteristics of the catheter along its length (Col 5, lines 18-20).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer (US 20120277729 A1) in view of Stefanchik et al. (US 20090149710 A1) further in view of Vargas (US 20040054322 A1).
Regarding claim 13, Melsheimer in view of Stefanchik disclose the device of claim 1, wherein the plurality of regions are configured to be separately rigidized when a negative pressure is applied within each of the plurality of regions (Paragraph [0017, Melsheimer), but are silent regarding wherein the plurality of regions are configured to be separately rigidized when a positive pressure is applied within each of the plurality of regions.
In analogous art, Vargas teaches that a device may be rigidized via pressure which can be either positive pressure or relative vacuum (Paragraph [0076]).
The substitution of one known material (positive pressure as taught in Vargas) for another (negative pressure taught in Melsheimer) would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention since Vargas teaches that positive or negative pressure can be applied for rigidizing and the substitution of the positive pressure as taught Vargas would have yielded predictable results, namely, a device of Melsheimer that would rigidizing upon application of a pressure. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer (US 20120277729 A1) in view of Stefanchik et al. (US 20090149710 A1) further in view of Horzewski et al (US 5470322 A) further in view of Soltesz (US 5254107 A).
Regarding claim 18, Melsheimer in view of Stefanchik further in view of Horzewski disclose the device of claim 17, wherein the variable stiffness layer comprises a braid layer (110, Melsheimer), but are silent regarding further wherein the variable stiffness layer at some regions of the plurality of regions have different braid angles.
In analogous art, Soltesz teaches variable pitch braid (Col 5, lines 18-20).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified at least some of the plurality of regions of Melsheimer in view of Stefanchik further in view of Horzewski to incorporate the teachings of Soltesz to incorporate having different braid angles in order to vary the physical characteristics of the catheter along its length (Col 5, lines 18-20).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Melsheimer (US 20120277729 A1) in view of Stefanchik et al. (US 20090149710 A1) further in view of Horzewski et al (US 5470322 A) further in view of Vargas (US 20040054322 A1).
Regarding claim 19, Melsheimer in view of Stefanchik further in view of Horzewski disclose the device of claim 17, wherein the plurality of regions arranged along the length of the elongate flexible tube are configured to be converted from the flexible configuration to the more rigid configurations when a negative pressure is applied (Paragraph [0017, Melsheimer), but are silent regarding wherein the plurality of regions arranged along the length of the elongate flexible tube are configured to be converted from the flexible configuration to the more rigid configurations when a positive pressure is applied.
In analogous art, Vargas teaches that a device may be rigidized via pressure which can be either positive pressure or relative vacuum (Paragraph [0076]).
The substitution of one known material (positive pressure as taught in Vargas) for another (negative pressure taught in Melsheimer) would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention since Vargas teaches that positive or negative pressure can be applied for rigidizing and the substitution of the positive pressure as taught Vargas would have yielded predictable results, namely, a device of Melsheimer that would rigidizing upon application of a pressure. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Allowable Subject Matter
Claims 3-4 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:
As to claim 3, although Melsheimer in view of Stefanchik teach the limitations of claim 1 as described above, Melsheimer in view of Stefanchik are silent to wherein each region of the plurality of regions comprises a bladder layer configured to push against the variable stiffness layer to constrict the space when pressure is applied in combination with the limitations of claim 1. Because claim 3 contains allowable subject matter, dependent claim 4 also contains allowable subject matter for the same reasons above.
Conclusion
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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