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 .
Claims 1-22 are examined in this office action.
Claim Rejections - 35 USC § 102
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 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, 4-7, 11, 14, 15, 17, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Govari et al. (EP 3797720 A1).
Regarding claim 1, Govari discloses a catheter shaft (catheter 40, Fig. 1) comprising:
a single piece strut (inner portion 64, Fig. 2) having a central portion (member 37, Fig. 3) defining a central lumen (lumen 60-1, Fig. 2) extending therethrough and a pair of opposing arms extending radially away from the central portion (See annotated Fig. 2), each of the pair of opposing arms defining a respective biased lumen (lumen 60-2 and lumen 60-6, Fig. 2) extending therethrough; and
a first tubular layer (inner portion 64, Fig. 2) surrounding the strut (inner portion 64, Fig. 2) and defining two opposing side lumens (lumen 60-4 and lumen 60-8, Fig. 2) extending through the catheter shaft between the first tubular layer and the strut.
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Regarding claim 2, Govari discloses the catheter shaft (catheter 40, Fig. 1) as recited above, wherein
the first tubular layer (inner portion 64, Fig. 2) is integrally formed with the strut (inner portion 64, Fig. 2) from a single polymeric material ("… the inner portion 64 may be formed from any suitable biocompatible material, for example, a flexible biocompatible plastic or the like." - Para [0055]).
Regarding claim 4, Govari discloses the catheter shaft (catheter 40, Fig. 1) as recited above, further comprising
a second tubular layer (outer portion 62, Fig. 2) surrounding the first tubular layer (inner portion 64, Fig. 2).
Regarding claim 6, Govari discloses the catheter shaft (catheter 40, Fig. 1) as recited above, further comprising
a reinforcing layer (braiding layer 66, Fig. 2) disposed between the first tubular layer (inner portion 64, Fig. 2) and the second tubular layer (outer portion 62, Fig. 2) ("… an outer portion 62 and an inner portion 64 separated by a braiding layer 66." - Para [0054]).
Regarding claim 7, Govari discloses the catheter shaft (catheter 40, Fig. 1) as recited above, wherein
the reinforcing layer (braiding layer 66, Fig. 2) comprises a braided metallic mesh ("the braiding layer 66 may be any suitable wire for example, but not limited to, a flat wire braid." - Para [0055]).
Regarding claim 11, Govari discloses the catheter shaft (catheter 40, Fig. 1) as recited above, wherein
the strut (inner portion 64, Fig. 2) further comprises a pair of walls extending radially away from the central portion to the first tubular layer and dividing each of the two opposing side lumens into a respective pair of sub-lumens (See annotated Fig. 2).
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Regarding claim 14, Govari discloses a method of manufacturing (“… the methods described herein …’ – Para [0052]) a catheter shaft (catheter 40, Fig. 1), comprising:
forming a single-piece strut (inner portion 64, Fig. 2) having a central portion (member 37, Fig. 3) defining a central lumen (lumen 60-1, Fig. 2) extending therethrough and a pair of opposing arms extending radially away from the central portion (See annotated Fig. 2), each of the pair of opposing arms defining a respective biased lumen (lumen 60-2 and lumen 60-6, Fig. 2) extending therethrough; and
forming a first tubular layer (inner portion 64, Fig. 2) around the strut to define two opposing side lumens extending through the catheter shaft between the first tubular layer and the strut (lumen 60-4 and lumen 60-8, Fig. 2).
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Regarding claim 15, Govari discloses the method (“… the methods described herein …’ – Para [0052]) as recited above, wherein
forming the single-piece strut (inner portion 64, Fig. 2) and forming the first tubular layer (inner portion 64, Fig. 2) around the strut comprise integrally forming the single-piece strut and the first tubular layer from a single polymeric material ("… the inner portion 64 may be formed from any suitable biocompatible material, for example, a flexible biocompatible plastic or the like." - Para [0055]) .
Regarding claim 17, Govari discloses the method (“… the methods described herein …’ – Para [0052]) as recited above, further comprising
forming a second tubular layer (outer portion 62, Fig. 2) around the first tubular layer (inner portion 64, Fig. 2).
Regarding claim 19, Govari discloses the method (“… the methods described herein …’ – Para [0052]) as recited above, further comprising
forming a reinforcing layer (braiding layer 66, Fig. 2) between the first tubular layer (inner portion 64, Fig. 2) and the second tubular layer (outer portion 62, Fig. 2) ("… an outer portion 62 and an inner portion 64 separated by a braiding layer 66." - Para [0054]).
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) 3 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (EP 3797720 A1) in view of McDaniel (EP 2301617).
Regarding claim 3, Govari in view of McDaniel discloses the catheter shaft (Govari, catheter 40, Fig. 1) as recited above, wherein
Govari does not expressly disclose that the strut comprises a first polymeric material, the first tubular layer comprises a second polymeric material different from the first polymeric material, and the strut is bonded to the first tubular layer.
McDaniel teaches that the strut (inner layer 50, Fig. 3B) comprises a first polymeric material ("… the inner layer 50 includes a melt extrudable polymeric material, e.g., nylon or polyimide …" - Para [0031]), the first tubular layer (outer wall 56, Fig. 3B) comprises a second polymeric material different from the first polymeric material ("… the outer wall 56 includes a melt extrudable polymeric material, e.g., nylon, polyurethane or PEBAX." - Para [0031]), and the strut is bonded to the first tubular layer ("… the material extruded to form the outer wall 56 melts and flows into the gaps or interstitial spaces of the braided mesh 52 and the bias members 54 which integrally forms them to the inner layer 50 for a layered but integrated construction." - Para [0035]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the catheter shaft of Govari to include that the strut comprises a first polymeric material, the first tubular layer comprises a second polymeric material different from the first polymeric material, and the strut is bonded to the first tubular layer as taught by McDaniel to provide improved flexural and torsional stability (McDaniel, Para [0035]).
Regarding claim 16, Govari in view of McDaniel discloses the method (“… the methods described herein …’ – Para [0052]), as recited above, wherein
Govari does not expressly disclose forming the single-piece strut comprises forming the single piece strut from a first polymeric material; forming the first tubular layer comprises forming the first tubular layer from a second polymeric material different from the first polymeric material; and wherein the method further comprises bonding the first tubular layer to the single-piece strut.
McDaniel teaches forming the single-piece strut (inner layer 50, Fig. 3B) comprises forming the single piece strut from a first polymeric material ("… the inner layer 50 includes a melt extrudable polymeric material, e.g., nylon or polyimide …" - Para [0031]); forming the first tubular layer (outer wall 56, Fig. 3B) comprises forming the first tubular layer from a second polymeric material different from the first polymeric material ("… the outer wall 56 includes a melt extrudable polymeric material, e.g., nylon, polyurethane or PEBAX." - Para [0031]); and wherein the method further comprises bonding the first tubular layer to the single-piece strut ("… the material extruded to form the outer wall 56 melts and flows into the gaps or interstitial spaces of the braided mesh 52 and the bias members 54 which integrally forms them to the inner layer 50 for a layered but integrated construction." - Para [0035]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Govari to include forming the single-piece strut comprises forming the single piece strut from a first polymeric material; forming the first tubular layer comprises forming the first tubular layer from a second polymeric material different from the first polymeric material; and wherein the method further comprises bonding the first tubular layer to the single-piece strut as taught by McDaniel to provide improved flexural and torsional stability (McDaniel, Para [0035]).
Claim(s) 5 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (EP 3797720 A1) in view of Laduca et al. (US Pub No,. 20180344981 A1).
Regarding claim 5, Govari in view of Laduca discloses the catheter shaft (Govari, catheter 40, Fig. 1) as recited above, wherein
Govari does not expressly disclose that a material of which the second tubular layer is formed has a lower critical solid-state thermal transition temperature than a material of which the strut is formed.
Laduca teaches that a material of which the second tubular layer (lumen 40, Fig. 5) is formed has a lower critical solid-state thermal transition temperature ("One or more of the lumens 40 can be lined with PTFE or other materials that have a higher melting point than the encapsulating material …” – Para [0070]) than a material of which the strut (shaft 12, Fig. 1) is formed.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the catheter shaft of Govari to include that a material of which the second tubular layer is formed has a lower critical solid-state thermal transition temperature than a material of which the strut is formed as taught by Laduca to navigate torturous vessels (Laduca, Para [0003]).
Regarding claim 18, Govari in view of Laduca discloses the method (“… the methods described herein …’ – Para [0052]) as recited above, wherein
Govari does not expressly disclose a material of which the second tubular layer is formed has a lower critical solid-state thermal transition temperature than a material of which the first tubular layer is formed.
Laduca teaches a material of which the second tubular layer (lumen 40, Fig. 5) is formed has a lower critical solid-state thermal transition temperature ("One or more of the lumens 40 can be lined with PTFE or other materials that have a higher melting point than the encapsulating material …" - Para [0070]) than a material of which the first tubular layer is formed (shaft 12, Fig. 1).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Govari to include a material of which the second tubular layer is formed has a lower critical solid-state thermal transition temperature than a material of which the first tubular layer is formed as taught by Laduca to navigate torturous vessels (Laduca, Para [0003]).
Claim(s) 8 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (EP 3797720 A1) in view of Aeby et al. (US 20090177095 A1).
Regarding claim 8, Govari in view of Aeby discloses the catheter shaft (Govari, catheter 40, Fig. 1) as recited above, wherein
a line extending through the biased lumens and the central lumen defines a deflection axis (Govari, See annotated Fig. 2), a line extending through a center of the central lumen and perpendicular to the deflection axis defines a neutral axis (Govari, See annotated Fig. 2).
Govari does not expressly disclose that an area moment of inertia of the strut about the neutral axis is less than or equal to an area moment of inertia of the strut about the deflection axis.
Aeby teaches that an area moment of inertia of the strut about the neutral axis ("… axis x-x identifies the axis about which the area moment of inertia is minimum." - Para [0058]) is less than or equal to an area moment of inertia of the strut about the deflection axis ("The area moment of inertia about the inertial axis y-y is about twenty times greater than the area moment of inertia about eh inertial axis x-x." - Para [0058]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the catheter shaft of Govari to include that an area moment of inertia of the strut about the neutral axis is less than or equal to an area moment of inertia of the strut about the deflection axis as taught by Aeby to cause deflection (Aeby, Para [0058]).
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Regarding claim 20, Govari in view of Aeby discloses the method (“… the methods described herein …’ – Para [0052]) as recited above, wherein
the single-piece strut defines a deflection axis (Govari, See annotated Fig. 2 above) extending through the biased lumens and the central lumen and a neutral axis (Govari, See annotated Fig. 2 above) perpendicular to the deflection axis.
Govari does not expressly disclose an area moment of inertia of the strut about the neutral axis is less than or equal to an area moment of inertia of the strut about the deflection axis.
Aeby teaches an area moment of inertia of the strut about the neutral axis ("… axis x-x identifies the axis about which the area moment of inertia is minimum." - Para [0058]) is less than or equal to an area moment of inertia of the strut about the deflection axis ("The area moment of inertia about the inertial axis y-y is about twenty times greater than the area moment of inertia about eh inertial axis x-x." - Para [0058]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Govari to include an area moment of inertia of the strut about the neutral axis is less than or equal to an area moment of inertia of the strut about the deflection axis as taught by Aeby to cause deflection (Aeby, Para [0058]).
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (EP 3797720 A1) in view of Aeby et al. (US 20090177095 A1) and in further view of McDaniel (EP 2301617).
Regarding claim 9, Govari in view of Aeby and McDaniel discloses the catheter shaft (Govari, catheter 40, Fig. 1) as recited above, further comprising
Govari in view of Aeby does not expressly disclose a pair of biasing ribbons positioned along the neutral axis equidistant from the deflection axis.
McDaniel teaches a pair of biasing ribbons (elongated bias members 54, Fig. 3A) positioned along the neutral axis (See annotated Fig. 4) equidistant from the deflection axis (See annotated Fig. 4).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the catheter shaft of Govari in view of Aeby to include a pair of biasing ribbons positioned along the neutral axis equidistant from the deflection axis as taught by McDaniel to resist flexure (McDaniel, Abstract).
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Regarding claim 10, Govari in view of Aeby and McDaniel discloses the catheter shaft (Govari, catheter 40, Fig. 1) as recited above, wherein
Govari in view of Aeby does not expressly disclose that the pair of biasing ribbons comprises a pair of metallic ribbons
McDaniel teaches that the pair of biasing ribbons comprises a pair of metallic ribbons ("… the bias members 54 can be wires made of stainless steel …" - Para [0034]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the catheter shaft of Govari in view of Aeby to include that the pair of biasing ribbons comprises a pair of metallic ribbons as taught by McDaniel to resist flexure (McDaniel, Abstract).
Claim(s) 12, 13, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (EP 3797720 A1) in view of Kanner et al (US Pub No. 20020151921 A1).
Regarding claim 12, Govari in view of Kanner discloses the catheter shaft (Govari, catheter 40, Fig. 1) as recited above, further comprising:
a first pull wire (Govari, elongated member 72, Fig. 3) extending through a first biased lumen (Govari, lumen 60-2, Fig. 3);
a second pull wire (Govari, elongated member 72, Fig. 3) extending through a second biased lumen (Govari, lumen 60-6, Fig. 3); and
an elongated member (Govari, elongated member 37, Fig. 3) extending through the central lumen (Govari, lumen 60-1, Fig. 30).
Govari does not expressly disclose a loop-activating wire extending through the central lumen.
Kanner teaches a loop-activating wire (loop activation wire 654, Fig. 29) extending through the central lumen.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the catheter shaft of Govari to include a loop-activating wire extending through the central lumen as taught by Kanner to add stiffness to the area (Kanner, Para [0060]).
Regarding claim 13, Govari in view of Kanner discloses the catheter shaft (Govari, catheter 40, Fig. 1) as recited above, further comprising:
a plurality of electrical conductors (Govari, elongated members 70, Fig. 3) (Govari, "… each elongated member 70 may be a tube, rod or wire comprised of any suitable material …" - Para [0060]) extending through at least one of the two opposing side lumens (Govari, lumen 60-4 and lumen 60-8, Fig. 3).
Regarding claim 21, Govari in view of Kanner discloses a catheter shaft (Govari, catheter 40, Fig. 1) formed according to a process (Govari, “… the methods described herein …’ – Para [0052]) comprising:
forming a single-piece strut (Govari, inner portion 64, Fig. 2) having a central portion (Govari, member 37, Fig. 3) defining a central lumen (Govari, lumen 60-1, Fig. 2) extending therethrough and a pair of opposing arms extending radially away from the central portion (Govari, See annotated Fig. 2 above), each of the pair of opposing arms defining a respective biased lumen extending therethrough (Govari, lumen 60-2 and lumen 60-6, Fig. 2);
forming a first tubular layer around the strut (Govari, inner portion 64, Fig. 2) to define two opposing side lumens (Govari, lumen 60-4 and lumen 60-8, Fig. 2) extending through the catheter shaft between the first tubular layer (Govari, inner portion 64, Fig. 2) and the strut;
disposing a first pull wire (Govari, elongated member 72, Fig. 3) in a first biased lumen (Govari, lumen 60-2, Fig. 3);
disposing a second pull wire (Govari, elongated member 72, Fig. 3) in a second biased lumen (Govari, lumen 60-6, Fig. 3); and
disposing an elongated member (Govari, elongated member 37, Fig. 3) in the central lumen (lumen 60-1, Fig. 30).
Govari does not expressly disclose a loop-activating wire extending through the central lumen.
Kanner teaches a loop-activating wire (loop activation wire 654, Fig. 29) extending through the central lumen.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the process of Govari to include a loop-activating wire extending through the central lumen as taught by Kanner to add stiffness to the area (Kanner, Para [0060]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (EP 3797720 A1) in view of Kanner et al (US Pub No. 20020151921 A1) and in further view of Aeby et al. (US 20090177095 A1).
Regarding claim 22, Govari in view of Kanner and Aeby disclose the method (Govari, “… the methods described herein …’ – Para [0052]) as recited above, wherein
the single-piece strut defines a deflection axis (Govari, See annotated Fig. 2 above) extending through the biased lumens and the central lumen and a neutral axis (Govari, See annotated Fig. 2 above) perpendicular to the deflection axis.
Govari in view of Kanner does not expressly disclose an area moment of inertia of the strut about the neutral axis is less than or equal to an area moment of inertia of the strut about the deflection axis.
Aeby teaches an area moment of inertia of the strut about the neutral axis ("… axis x-x identifies the axis about which the area moment of inertia is minimum." - Para [0058]) is less than or equal to an area moment of inertia of the strut about the deflection axis ("The area moment of inertia about the inertial axis y-y is about twenty times greater than the area moment of inertia about eh inertial axis x-x." - Para [0058]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Govari in view of Kanner to include an area moment of inertia of the strut about the neutral axis is less than or equal to an area moment of inertia of the strut about the deflection axis as taught by Aeby to cause deflection (Aeby, Para [0058]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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/ESHA PRAKASH KASHYAP/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
