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.
Claim(s) 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Martin (Pub. No.: US 2020/0391009) in view of Krolik et al (Pub. No.: US 2018/0015257).
Regarding claims 1-2, 5, Martin discloses a catheter tubing comprising:
a tubular structure extending along an axial length and having a passageway (lumen) [see 0016-0018, 0102-0103];
a tubular layer forming at least a portion of a wall of the tubular structure and comprising a plurality of material sections extending spirally along at least a portion of the axial length, where each material section is joined to an adjacent material section [see 0013-0025, 0041, 0084, 0102];
wherein the plurality of material sections include at least a first material section and a
second material section, the first material section comprises a first structural property and the
second material section comprises a second structural property, where the first structural
property differs from the second structural property [see 0013-0025, 0083];
at least one lumen extending within at least one of the plurality of material sections [see 0017-0018, 0026].
Martin doesn’t disclose where the at least one lumen permits fluid flow therethrough.
Nonetheless, Krolik et al disclose at least one lumen permits fluid flow therethrough and at least one opening in the tubular layer, where the at least one opening is fluidly coupled to the at least one lumen [see 0058, 0061, 0065]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Martin and Krolik et al by using at least one lumen permits fluid flow therethrough and at least one opening in the tubular layer, where the at least one opening is fluidly coupled to the at least one lumen; to allow fluid to pass from the lumen within the tubular member 150, for example fluid from the inflation port 106, to a cavity or recess or balloon outside the tubular member 150 [see 0065].
Regarding claim 3, Martin doesn’t disclose a balloon having a balloon material over the at least one opening,
where the balloon material is affixed to the tubular layer such that pressurization of the at least one lumen causes expansion of the balloon.
Nonetheless, Krolik et al disclose a balloon (200, see 0071) having a balloon material over the at least one opening [see 0070-0074, figs 5-9]
where the balloon material is affixed to the tubular layer such that pressurization of the at least one lumen causes expansion of the balloon [see 0070-0074, figs 5-9]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Martin and Krolik et al by using a balloon having a balloon material over the at least one opening, where the balloon material is affixed to the tubular layer such that pressurization of the at least one lumen causes expansion of the balloon; to expand or stretch to a selected or preferred diameter and maintain that diameter even with possible expected higher pressures [see 0071].
Regarding claim 4, Martin doesn’t disclose a balloon material extending along the tubular layer having an interior surface at least partially joined to an exterior of the tubular layer
wherein such that when pressurized by the at least one opening in the tubular layer, the balloon material expands away from the exterior of the tubular layer to assume a balloon shape on the tubular structure
Nonetheless, Krolik et al disclose a balloon material extending along the tubular layer having an interior surface at least partially joined to an exterior of the tubular layer [see 0070-0074, figs 5-9]
wherein such that when pressurized by the at least one opening in the tubular layer, the balloon material expands away from the exterior of the tubular layer to assume a balloon shape on the tubular structure [see 0070-0074, figs 5-9]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Martin and Krolik et al by using a balloon material extending along the tubular layer having an interior surface at least partially joined to an exterior of the tubular layer
wherein such that when pressurized by the at least one opening in the tubular layer, the balloon material expands away from the exterior of the tubular layer to assume a balloon shape on the tubular structure; to expand or stretch to a selected or preferred diameter and maintain that diameter even with possible expected higher pressures [see 0071].
Regarding claim 6, Martin discloses wherein at least one of the plurality of tubular extensions includes a reinforcement structure (support structure) [see 0079, 0096].
Regarding claim 7, Martin doesn’t disclose wherein the plurality of material sections
comprises a first material section comprising an expandable material and where the at least
one lumen comprises a first lumen within the first material section,
wherein pressurization of the first lumen causes the first material section to expand radially outward from the tubular layer to forms a spiral structure extending along at least a portion of the axial length of the tubular layer.
Nonetheless, Krolik et al disclose wherein the plurality of material sections comprises a first material section comprising an expandable material and where the at least one lumen comprises a first lumen within the first material section [see 0070-0074, figs 5-9];
wherein pressurization of the first lumen causes the first material section to expand radially outward from the tubular layer to forms a spiral structure extending along at least a portion of the axial length of the tubular layer [see 0070-0074, figs 5-9].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Martin and Krolik et al by an expandable material and where the at least one lumen comprises a first lumen within the first material section,
wherein pressurization of the first lumen causes the first material section to expand radially outward from the tubular layer to forms a spiral structure extending along at least a portion of the axial length of the tubular layer; to expand or stretch to a selected or preferred diameter and maintain that diameter even with possible expected higher pressures [see 0071].
Regarding claim 8, Martin discloses a support structure within or exterior a passageway [see 0096, figs 5-9. 21-24]
Regarding claim 9, Martin discloses a liner interior to or embedded with the support structure [figs 5-9. 21-24]
Regarding claim 10, Martin discloses medical tubing comprising:
an elongate body extending along an axial length [see 0013-0025];
a plurality of material sections extending spirally along at least a first portion of the
axial length to form at least a portion of a wall of the elongate body, the plurality of material
sections including a first material section [see 0013-0025];
Martin doesn’t disclose the first material section includes a first functional lumen extending therein, such that pressurization of the first functional lumen causes the first material section to
expand radially outward from the plurality of material sections to form an expanded spiral
shape on the elongate body.
Nonetheless, Krolik et al disclose the first material section includes a first functional lumen extending therein, such that pressurization of the first functional lumen causes the first material section to expand radially outward from the plurality of material sections to form an expanded spiral shape on the elongate body [see 0070-0074, figs 5-9].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Martin and Krolik et al by having the first material section includes a first functional lumen extending therein, such that pressurization of the first functional lumen causes the first material section to expand radially outward from the plurality of material sections to form an expanded spiral shape on the elongate body; to expand or stretch to a selected or preferred diameter and maintain that diameter even with possible expected higher pressures [see 0071].
Regarding claim 11, Martin discloses wherein the plurality of material sections
comprises at least a second material section extending spirally over at least a second portion
of the axial length [see 0015-0025].
Regarding claims 12-16, Martin doesn’t disclose where the second material section includes a
second functional lumen in fluid communication with at least one opening in a surface of the
elongate body;
a balloon material covering the at least one opening.
wherein the expanded spiral shape comprises a plurality of turns having a spacing.
wherein the spacing of the plurality of turns prevents fluid flow between the plurality of turns, such that the expanded spiral shape comprises an occlusion region when expanded.
wherein the spacing of the plurality of turns permits permit fluid flow between the plurality of turns.
Nonetheless, Krolik et al disclose where the second material section includes a
second functional lumen in fluid communication with at least one opening in a surface of the
elongate body;
a balloon material covering the at least one opening.
wherein the expanded spiral shape comprises a plurality of turns having a spacing.
wherein the spacing of the plurality of turns prevents fluid flow between the plurality of turns, such that the expanded spiral shape comprises an occlusion region when expanded.
wherein the spacing of the plurality of turns permits permit fluid flow between the plurality of turns [see claim 79, 0070-0074, figs 5-9, 22-24].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Martin and Krolik et al by using a
second functional lumen in fluid communication with at least one opening in a surface of the
elongate body;
a balloon material covering the at least one opening.
wherein the expanded spiral shape comprises a plurality of turns having a spacing.
wherein the spacing of the plurality of turns prevents fluid flow between the plurality of turns, such that the expanded spiral shape comprises an occlusion region when expanded.
wherein the spacing of the plurality of turns permits permit fluid flow between the plurality of turns; to expand or stretch to a selected or preferred diameter and maintain that diameter even with possible expected higher pressures [see 0071].
Regarding claim 17, Martin discloses where the plurality of material sections comprises a tubular member having a spiral region removed to accommodate the first material section [see 0015-0025].
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) 18-22, 25-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martin (Pub. No.: US 2020/0391009)
Regarding claim 18, Martin discloses catheter tubing comprising:
a tubular structure extending along an axial length and having a passageway [see 0015-0025];
a composite layer forming at least a portion of a wall of the tubular structure and comprising a plurality of tubing extensions extending spirally along at least a portion of the axial length [see 0015-0025].,
where at least one of the plurality of tubing extensions includes a lumen extending therein [see 0017-0018, 0026].
Regarding claim 19, Martin discloses wherein at least a first tubing extension from the plurality of tubing extensions changes structural properties over a length of the first tubing extension [see 0015-0025].
Regarding claim 20, Martin discloses wherein a structural property of at least two of the plurality of tubing extensions is different [see 0015-0025].
Regarding claim 21, Martin discloses wherein the plurality of tubing extensions includes a solid tubular extension [see 0092].
Regarding claim 22, Martin discloses wherein the plurality of tubing extensions includes a tubing extension having one or more openings in an exterior surface of the composite layer [see figs 22-24].
Regarding claim 25, Martin discloses a support structure interior to or embedded within the plurality of tubing extensions [see 0096, figs 5-9. 21-24]
Regarding claim 26, Martin discloses a liner interior to or embedded with the support structure [figs 5-9. 21-24]
Claim(s) 23-24, 27-33 are rejected under 35 U.S.C. 103 as being unpatentable over Martin (Pub. No.: US 2020/0391009) in view of Krolik et al (Pub. No.: US 2018/0015257).
Regarding claims 23-24, Martin doesn’t disclose a balloon material exterior to the one or more openings, such that pressurization through the one or more openings causes the balloon material to expand radially outward from the tubular structure.
wherein the plurality of tubing extensions includes an expandable tubing extension with a functional lumen such that pressurization of the functional lumen causes the expandable tubing extension to expand radially away from the composite layer to form an expanded spiral shape about an exterior of the tubular structure.
Nonetheless, Krolik et al disclose a balloon material exterior to the one or more openings, such that pressurization through the one or more openings causes the balloon material to expand radially outward from the tubular structure.
wherein the plurality of tubing extensions includes an expandable tubing extension with a functional lumen such that pressurization of the functional lumen causes the expandable tubing extension to expand radially away from the composite layer to form an expanded spiral shape about an exterior of the tubular structure [see 0070-0074, figs 5-9]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Martin and Krolik et al by using a balloon material exterior to the one or more openings, such that pressurization through the one or more openings causes the balloon material to expand radially outward from the tubular structure.
wherein the plurality of tubing extensions includes an expandable tubing extension with a functional lumen such that pressurization of the functional lumen causes the expandable tubing extension to expand radially away from the composite layer to form an expanded spiral shape about an exterior of the tubular structure; to expand or stretch to a selected or preferred diameter and maintain that diameter even with possible expected higher pressures [see 0071].
Regarding claim 27, Martin discloses a catheter tubing comprising:
a tubular structure having a wall and a passageway extending in the tubular structure [see 0015-0025];
a material section extending spirally in a portion of the wall over a first axial length,
where the material section comprises a functional lumen extending therein along the first
axial length [see 0017-0026].
Martin doesn’t disclose where the functional lumen is fluidly isolated from the passageway such that the functional lumen can be pressurized independently from the passageway.
Nonetheless, Krolik et al disclose the functional lumen is fluidly isolated from the passageway such that the functional lumen can be pressurized independently from the passageway [see 0071-0074, 0086]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Martin and Krolik et al by functional lumen is fluidly isolated from the passageway such that the functional lumen can be pressurized independently from the passageway; to expand or stretch to a selected or preferred diameter and maintain that diameter even with possible expected higher pressures [see 0071].
Regarding claim 28, Martin discloses wherein the material section comprises a first structural characteristic that is different from an axially adjacent material in the portion of the wall [see 0015-0025].
Regarding claim 29, Martin discloses where the functional lumen terminates in at least one opening at a surface of the tubular structure [see 0026].
Regarding claims 30-31, Martin doesn’t disclose an expandable material at an exterior of the tubular structure and fluidly coupled to the at least one opening, such that pressurization of the functional lumen causes the expandable material to radially expand away from a surface of the tubular structure.
wherein the material section is configured to expand outwardly from the tubular structure upon pressurization of the functional lumen such that the material section forms an expanded spiral shape over an exterior of the tubular structure.
Nonetheless, Krolik et al disclose an expandable material at an exterior of the tubular structure and fluidly coupled to the at least one opening, such that pressurization of the functional lumen causes the expandable material to radially expand away from a surface of the tubular structure.
wherein the material section is configured to expand outwardly from the tubular structure upon pressurization of the functional lumen such that the material section forms an expanded spiral shape over an exterior of the tubular structure [see 0070-0074]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Martin and Krolik et al byan expandable material at an exterior of the tubular structure and fluidly coupled to the at least one opening, such that pressurization of the functional lumen causes the expandable material to radially expand away from a surface of the tubular structure.
wherein the material section is configured to expand outwardly from the tubular structure upon pressurization of the functional lumen such that the material section forms an expanded spiral shape over an exterior of the tubular structure; to expand or stretch to a selected or preferred diameter and maintain that diameter even with possible expected higher pressures [see 0071].
Regarding claim 32, Martin discloses wherein a material property of the material section changes over a portion of the first axial length [see 0015-0025]
Regarding claim 33, Martin discloses wherein the wall of the tubular structure further includes a plurality of additional material sections extending spirally in the portion of
the wall [see 0015-0025].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/Primary Examiner, Art Unit 3797
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