BDETAILED 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 .
Response to Amendment
The amendment filed January 30, 2026 has been entered. Claims 1, 24-26, 33, 42-45, and 75-86 are pending.
Applicant’s amendments obviate previous rejections of claims under 35 U.S.C. 112(b).
Applicant’s amendments overcome the prior arts of reference previously applied in the Non-Final Rejection dated September 30, 2025; however, a new grounds of rejection is presented under 35 U.S.C. 103.
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.
Claims 1, 24-26, 75-83 are rejected under 35 U.S.C. 103 as being unpatentable over:
Chin et al. (US 20090062872 A1) (hereinafter – Chin) in view of
Chin et al. (US 20140066961 A1) (hereinafter – Chin ‘961).
Re. Claim 1: Chin teaches a delivery device configured to deliver a therapeutic device to a surgical site (Paragraphs 0008, 0018, 0019, 0088, 0100: discussion of introducing therapeutic devices or agents),
the delivery device comprising:
a proximally disposed handle (Fig. 1; Paragraph 0062: particularly, “An optional housing 118 or a handle structure may also be provided at the proximal end 104 of the shaft 102”);
an elongated shaft extending distally from the handle (Fig. 1: shaft 102),
the shaft comprising a generally longitudinal therapeutic device lumen configured to deliver a working end of a therapeutic device therethrough (Paragraph 0008: particularly, “…the other lumen being suitable for allowing passage of therapeutic instruments or injection of medications;” similarly recited in Paragraphs 0018, 0019; Paragraph 0071: discussion of trocar delivery; Paragraph 0083: “Thereafter, the atraumatic balloon 116 may be deployed or otherwise used to deform surrounding tissue and/or to make space available for the balloon cannula device 100 or other therapy or treatment device provided by working channel 126 (e.g., FIG. 3);” Paragraph 0098: “The channels and/or ports of the balloon cannula device 100 may be configured to accept wide variety of therapy devices suited to the type of therapy being performed;” Paragraphs 0099, 0100, 0101, 0122, 0124),
wherein a first portion of the shaft is steerable (Fig. 15A-15C: steering mechanism; Paragraphs 0062, 0071, 0072, 0083, 0100, 0103, 0104, 0110, 0112, 0113: discussion of steering mechanism 120 or steering assembly); and
a space-making element disposed proximate a distal end portion of the shaft and configured to separate biological tissues to demarcate a working space (Figs. 3-7: balloon 116; Figs. 11A-11B: balloon 202; Figs. 12A-12B: balloon 220),
wherein at least a portion of the space-making element is reconfigurable between a retracted configuration and an expanded configuration (Figs. 4, 11A, 12A: non-expanded, i.e., retracted configuration).
Chin does not teach the invention wherein at least a portion of the space-making element wraps over a distal end of the shaft to cover an exterior surface and an interior surface of the shaft when in the retracted configuration, and discontinues covering the interior surface when in the expanded configuration.
Chin ‘961 teaches the invention wherein at least a portion of the space-making element wraps over a distal end of the shaft to cover an exterior surface and an interior surface of the shaft when in the retracted configuration, and discontinues covering the interior surface when in the expanded configuration (Fig. 7B, described as “once balloon 120 is everted from sleeve 110” at Paragraph 0068; Figs. 9A-9C; Figs. 10A-10C).
It would have been obvious to one having skill in the art before the effective filing date to have modified Chin to provide a lumen having the balloon and associated everting/expansion elements of Chin ‘961, the motivation being that doing so provides a balloon which is significantly larger than the exterior-mounted balloon of Chin, since a large portion of the balloon may be stored within the shaft, and further provides a balloon whose eversion allows for a distal portion thereof to extend across a site of an obstruction to deliver surgical tools (Paragraph 0007).
Re. Claim 24: Chin as modified by Chin ‘961 teaches the invention according to claim 1. Chin further teaches the invention wherein the first portion of the shaft is steerable in a first plane (Paragraph 0021: “In certain steerable embodiments, the tubular body further comprises at least one deflection wire and a flexion plane. The first lumen of the tubular body comprises a first central axis, the second lumen of the tubular body may comprise a second central axis, and the first central axis and the second central axis are located generally along a plane perpendicular to the flexion plane of the tubular body;” Paragraph 0103: “The steering mechanism 120 may be configured to provide any of a variety of steering features, including various bending planes, various bending ranges, extension and retraction ranges, and rotations ranges, for example;” Paragraph 0113: describing bending plane 332 relative to control by steering mechanism); and
wherein the handle comprises a steering actuator configured to steer the first portion of the shaft in the first plane (Paragraph 0062: “An optional housing 118 or a handle structure may also be provided at the proximal end 104 of the shaft 102. The housing 118 may facilitate manipulation of the balloon cannula device by the user, in addition to optionally supporting the ports 108, 110, 112, and 114 and an optional steering mechanism 120 or steering assembly. The steering mechanism 120 may be manipulated using one or more actuators located on the housing 118. In the particular embodiment depicted in FIG. 1, the actuator comprises a lever 122 projecting from the housing 120, but in other embodiments, any of a variety of actuators may be provided. These and other components of the balloon cannula device 100 are described in greater detail below”).
Re. Claim 25: Chin as modified by Chin ‘961 teaches the invention according to claim 24. Chin further teaches the invention wherein the first portion of the shaft is steerable uni-directionally in the first plane (Fig. 20: shaft is capable of steering uni-directionally; Examiner notes that a shaft which is capable of being steered in two directions is also capable of being steered in one direction).
Re. Claim 26: Chin as modified by Chin ‘961teaches the invention according to claim 24. Chin further teaches the invention wherein the first portion of the shaft is steerable bi-directionally in the first plane (Fig. 20: shaft is capable of steering bi-directionally).
Re. Claim 75: Chin as modified by Chin ‘961 teaches the invention according to claim 1. Chin further teaches the invention wherein the shaft further comprises a generally longitudinal visualization device lumen configured to deliver a working end of a visualization device therethrough (Paragraph 0008: “…one of said lumens being suitable for allowing the passage of an endoscope;” similarly recited in Paragraphs 0018, 0019; Paragraph 0020: “visualization channel;” Figs. 3-5, 7, 8: visualization channel 128; Paragraph 0093: “visualization channel 240;” Paragraph 0113: “visualization channel 324;” Paragraph 0116: “visualization channel (not shown)”).
Re. Claim 76: Chin as modified by Chin ‘961 teaches the invention according to claim 75. Chin further teaches the invention wherein the handle comprises a proximal port operatively connected to the therapeutic device lumen and the visualization device lumen; and
wherein the proximal port is configured to receive the therapeutic device and the visualization device therethrough
(Fig. 3; Paragraph 0062: “Ports 108, 110, 112, and 114 may be configured for any of a variety of usages, including but not limited to infusion/drainage/suction of fluids or materials, insertion/removal or supporting an endoscope or fiber-optic device, inflation/deflation of the inflatable balloon 116, and for insertion/removal or support of other instruments or tools; An optional housing 118 or a handle structure may also be provided at the proximal end 104 of the shaft 102. The housing 118 may facilitate manipulation of the balloon cannula device by the user, in addition to optionally supporting the ports 108, 110, 112, and 114 and an optional steering mechanism 120 or steering assembly;” Paragraph 0064: “Proximally, one or more of the lumens or channels 126, 128, 130 and 132 of the tubular shaft 102 may be in communication with one or more ports 108, 110, 112 and 114;” Paragraph 0098: “The channels and/or ports of the balloon cannula device 100 may be configured to accept wide variety of therapy devices suited to the type of therapy being performed;” Paragraph 0099: “It is contemplated that functions of various lumens in a cannula device may be suitably interchanged”).
Re. Claim 77: Chin as modified by Chin ‘961 teaches the invention according to claim 1. Chin further teaches the invention wherein the shaft further comprises a first generally longitudinal suction lumen configured to facilitate application of suction proximate the distal end portion of the shaft (Paragraph 0064: “…another channel 130 is in communication with an irrigation/aspiration port 108; Paragraph 0099: “As shown in FIG. 8, the balloon cannula device 100 may comprise a shaft 102 with a non-circular visualization or irrigation channel 128, a non-circular working channel 126 which may be used to provide therapy device or as aspiration port, a balloon inflation lumen 132, and additional port 130 for irrigation or aspiration”).
Re. Claim 78: Chin as modified by Chin ‘961 teaches the invention according to claim 77. Chin further teaches the invention wherein the shaft further comprises a second generally longitudinal suction lumen configured to facilitate application of suction proximate the distal end portion of the shaft (Fig. 8 as described in Paragraph 0099: elements 126 and 130 may be used as aspiration ports).
Re. Claim 79: Chin teaches the invention according to claim 1. Chin ‘961 further teaches the invention wherein,
in the retracted configuration, the space-making element has a width approximating a width of the shaft (Figs. 9A, 10A); and
wherein, in the expanded configuration, the space-making element has a width greater than and no longer approximating the width of the shaft (Fig. 9B, 9C; Figs. 10B, 10C).
Re. Claim 80: Chin as modified by Chin ‘961 teaches the invention according to claim 1. Chin ‘961 further teaches the invention wherein, in the retracted configuration, at least a portion of the space-making element forms at least two concentric rings proximate the distal end portion of the shaft (Figs. 4A, 4BFigs. 9A, 10A: a frontal view of the device would show two concentric rings – a first ring formed by the section of the balloon wrapping around sleeve 110 and a second ring formed by the inverted section of the balloon, both of which are “proximate” a distal end of the shaft).
Re. Claim 81: Chin as modified by Chin ‘961 teaches the invention according to claim 80. Chin ‘961 further teaches the invention wherein the distal end portion of the shaft comprises a interior recess configured to receive at least a portion of the space-making element in the retracted configuration (Figs. 9A, 10A: any part of the interior of the tube 110 can be considered an interior recess which holds at least a portion of balloon 120).
Re. Claim 82: Chin teaches the invention according to claim 1. Chin further teaches the invention wherein the space-making element comprises an inflatable space-making element (Paragraph 0006: “…the balloon may be inflated…;” Figs. 4, 5, 11A, 11B, 12A, 12B: inflation and deflation of balloon element; additionally, see incorporated balloon of Chin ‘961).
Re. Claim 83: Chin teaches the invention according to claim 82. Chin further teaches the invention wherein the shaft comprises a first generally longitudinal inflation lumen operatively coupled to supply inflation fluid to the inflatable space- making element (Paragraph 0020: “inflation channel;” Paragraph 0063: “inflation/deflation channel 132”).
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.
Claims 42-45 are rejected under 35 U.S.C. 103 as being unpatentable over:
Chin et al. (US 20090062872 A1) (hereinafter – Chin) in view of
Chin et al. (US 20140066961 A1) (hereinafter – Chin ‘961) in further view of
Seto et al. (US 20140163321 A1) (hereinafter – Seto).
Re. Claim 42: Chin as modified by Chin ‘961 teaches the invention according to claim 1. Chin teaches a structural component (see prior citations of steerable sections in the independent claim). Chin as modified by Chin ‘961 does not teach a shaft comprising an outer jacket.
Seto teaches analogous art in the technology of bending tubes for insertion of a medical instrument (Title; Abstract; Paragraph 0003). Seto further teaches an outer jacket over a structural component (Fig. 10: bending tube 20) disposed radially within the outer jacket (Abstract: “…the wire guides covered by the outer coat member…;” Paragraphs 0090, 0101; Fig. 10: outer coat 18) which is considered analogous to the steerable section of Chin.
It would have been obvious to one having skill in the art before the effective filing date to have modified Chin as modified by Chin ‘961 to include an outer jacket over a structural component as taught by Seto, the motivation being that such an outer jacket provides a protective layer over the bending components.
Re. Claim 43: Chin as modified by Chin ‘961 and Seto teaches the invention according to claim 42. Chin further teaches the structural component (covered by a coat member as modified by Seto) which can be considered a hypotube (Figs. 16-18; Paragraph 0109: “In some embodiments, the outer diameter of the flex region may be about 0.05 inches to about 0.3 inches, sometimes about 0.08 inches to about 0.15 inches, and other times about 0.1 inches to about 0.12 inches”).
Re. Claim 44: Chin as modified by Chin ‘961 and Seto teaches the invention according to claim 42. Chin further teaches the invention wherein the hypotube comprises a plurality of solid portions and a plurality of gaps configured to facilitate desired flexibility characteristics of the shaft (Figs. 16-20).
Re. Claim 45: Chin as modified by Chin ‘961 and Seto teaches the invention according to claim 44. Chin further teaches the invention
wherein the hypotube comprises a first arrangement of the solid portions and the gaps in the first portion of the shaft (Figs. 16-20) and
a second arrangement of the solid portions and the gaps in a second portion of the shaft so that the first portion of the shaft and the second portion of the shaft have different flexibility characteristics (Paragraph 0107: particularly, “The slots 272 may be equally or unequally spaced along the longitudinal length of the shaft 270. In one example, the slots that are located about the ends of the flex region may be spaced farther apart than the slots located about the middle of the flex region”).
Claims 33 and 84-86 are rejected under 35 U.S.C. 103 as being unpatentable over:
Chin et al. (US 20090062872 A1) (hereinafter – Chin) in view of
Chin et al. (US 20140066961 A1) (hereinafter – Chin ‘961) in further view of
Lentz et al. (US 20050177132 A1) (hereinafter – Lentz).
Re. Claim 33: Chin as modified by Chin ‘961 teaches the invention according to claim 24, but does not teach the invention wherein a second portion of the shaft is flexible in a second plane generally perpendicular to the first plane.
Lentz teaches analogous art in the technology of articulated medical instruments (Abstract). Lentz further teaches the invention wherein a second portion of the shaft is flexible in a second plane generally perpendicular to the first plane (Abstract; Paragraph 0012: “…a first section having slits arranged as described above for bending in a first plane, a second section having slits arranged as described above for bending in a second plane (e.g. normal to the first plane)…”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Chin as modified by Chin ‘961 to have a second portion of the shaft being flexible in a second plane normal to the first plane as taught by Lentz, the motivation being that doing so improves the catheter’s capability to navigate through a patient’s anatomy by increasing degrees of freedom by which the catheter may bend (Paragraphs 0004-0006).
Re. Claim 84: Chin as modified by Chin ‘916 teaches the invention according to claim 1. Chin teaches a device which is capable of bending in at least one plane (Figs. 16-20).
Lentz teaches a device having a section which bends in a direction normal to that of another section (Abstract; Paragraph 0012: “…a first section having slits arranged as described above for bending in a first plane, a second section having slits arranged as described above for bending in a second plane (e.g. normal to the first plane)…”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Chin as modified by Chin ‘916 to have a second portion of the shaft being flexible in a second plane normal to the first plane as taught by Lentz, the motivation being that doing so improves the catheter’s capability to navigate through a patient’s anatomy by increasing degrees of freedom by which the catheter may bend (Paragraphs 0004-0006).
When viewing the combination of Chin as modified by Chin ‘916 in view of Lentz, a second portion as described in claim 84 can be identified by appropriately delineating portions of a device having sections bending in different planes as shown in Fig. 6 of Lentz:
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As evidenced above, when modifying Chin to include a section which bends in a plane normal to that of another section, at least a portion of the combined bending section reads upon the claim limitations of:
“a second portion of the shaft is flexible in a first plane; and
the second portion of the shaft is flexible in a second plane, the
second plane generally perpendicular to the first plane.”
Re. Claim 85: Chin as modified by Chin ‘916 and Lentz teaches the invention according to claim 84. Lentz, in teaching further detail regarding the modification, teaches wherein a flexibility of the second portion of the shaft in the first plane is greater than a flexibility of the second portion of the shaft in the second plane (see rejection of claim 84 – a portion of the second portion identified in the annotated figure of Lentz shows an area wherein a flexibility of the second portion of the shaft in the first plane is greater than a flexibility of the second portion of the shaft in the second plane).
Re. Claim 86: Chin as modified by Chin ‘916 and Lentz teaches the invention according to claim 84. Lentz, in teaching further detail regarding the modification, teaches wherein a stiffness of the second portion of the shaft in the first plane is greater than a stiffness of the second portion of the shaft in the second plane (these limitations represent the inverse of claim 85; the citations of claim 85 apply analogously to claim 86).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791