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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 3, 2026 has been entered.
Response to Amendment
The amendment filed June 2, 2026 has been entered. Claims 1, 24-26, 33, 42-45, and 75-86 are pending.
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 for claims 1, 24-26, 33, 42-45, 75-81, and 84-86. Claims 82 and 83 are objected to.
Allowable Subject Matter
Claims 82 and 83 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:
The new grounds of rejection utilizes the new reference of Greenhalgh. While Greenhalgh teaches that a lumen may be used to deliver a flow stopping balloon as a space-making element (Col. 29, lines 52-55: “In some variations the apparatus and methods for using them may include a flow stopping proximal balloon (e.g., to be positioned proximal to clot), that may reduce pressure on clot during the procedure), Greenhalgh is deficient in reciting limitations defining such an inflatable space-making element in claim 1, particularly:
“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.”
Claim Rejections - 35 USC § 102
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.
Claims 1, 42, 43, 75, 77, and 79-81 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Greenhalgh et al. (US 9463035 B1) (hereinafter – Greenhalgh).
Re. Claim 1: Greenhalgh teaches a delivery device configured to deliver a therapeutic device to a surgical site (Figs. 3A-3F: catheter 301 is used to deliver a guidewire 313 or tractor region 342 to location of a clot 355; see similar features in remaining figures),
the delivery device comprising:
a proximally disposed handle (Col. 12, lines 56-68: “Any of the apparatuses described herein may also include a handle adapted to draw the flexible tube proximally relative to the catheter. The handle may be attached or attachable to the catheter and/or the flexible tube and may include separate controls for actuating each independently or, more preferably, in a coordinated manner (or toggle between these two modes). For example, any of these apparatuses may include a drive handle coupled to a proximal end region of the catheter, wherein the drive handle comprises a control configured to coordinate advancing of the catheter distally while retracting the flexible tube proximally when actuated“);
an elongated shaft extending distally from the handle, the shaft comprising a generally longitudinal therapeutic device lumen configured to deliver a working end of a therapeutic device therethrough (Fig. 1G: catheter 101; see similar element in each other figure; additionally, see outer catheters in Figs. 6A, 6B, 7A-9C, 12A, 12B, 13B, 14, 16, 17, 24, 25E, 27A, 31-38B),
wherein a first portion of the shaft is steerable (Col. 23, lines 21-23: “The guidewire may be a wire, smaller catheter or combination of devices that may be positioned (e.g., steered) to and/or through the clot;” Fig. 3A: guidewire used to steer apparatus to location of clot, followed by delivery of tractor element; see similar process in remaining figures); 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. 1C-1H: flexible tractor 144; see deliverable elements in each other figure; Examiner notes that the flexible tractor element demarcates a space where other tools engage a clot, or visualization tools as described at Col. 26, lines 3-7: “Visualization may be indirect (e.g., using fluoroscopy or equivalent techniques) or direct, e.g., using one optical fibers for direct visualization down the apparatus (e.g., thought the lumen of the apparatus)”),
wherein at least a portion of the space-making element is reconfigurable between a retracted longitudinally open configuration and a longitudinally open expanded configuration, 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 (Fig. 3F: mesh 344 covers an interior surface of the catheter 301 and also an exterior thereof in this position; see also, Figs. 4C, 4D, 4F, 5D, 6A-B, 7A-C, 8, 9A-9C, 10A, 11B, 12A-12B, 13B, 14, 16, 17, 21D, 23A, 23D, 24, 25E, 27A, 31-36, 38A-38B),
and discontinues covering the interior surface when in the expanded configuration (Fig. 3D, 3E: mesh 344 does not cover an interior surface in this configuration; see also, 4E, 5C, 5E, 23B).
Re. Claim 42: Greenhalgh teaches the invention according to claim 1. Greenhalgh further teaches the invention wherein the shaft further comprises an outer jacket (see outer catheters in Figs. 6A, 6B, 7A-9C, 12A, 12B, 13B, 14, 16, 17, 24, 25E, 27A, 31-38B) and
a structural component disposed radially within the outer jacket (see inner catheters in structures above).
Re. Claim 43: Greenhalgh teaches the invention according to claim 42. Greenhalgh further teaches the invention wherein the structural component comprises a hypotube (see citation of rejection of claim 42 – an inner catheter may be considered a “hypotube,” i.e., a thin-walled, hollow, metallic tube commonly used in medical devices).
Re. Claim 75: Greenhalgh teaches the invention according to claim 1. Greenhalgh 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 (Col. 26, lines 3-7: “Visualization may be indirect (e.g., using fluoroscopy or equivalent techniques) or direct, e.g., using one optical fibers for direct visualization down the apparatus (e.g., thought the lumen of the apparatus);” Examiner notes that the central lumen of the device may be used to alternately deliver a visualization device, a guidewire, or an inner catheter in embodiments having outer catheters).
Re. Claim 77: Greenhalgh teaches the invention according to claim 1. Greenhalgh 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 (Col. 14, lines 28-36: “Any of the apparatuses described herein may also include a vacuum source. For example any of these apparatuses may include a guidewire vacuum pump coupled to a proximal end of the guidewire lumen and configured to apply vacuum therethrough. For example, any of these apparatuses may include an outer catheter vacuum pump coupled to a space between the catheter and the flexible tube and configured to apply a vacuum within a lumen of the catheter between an inner wall of the catheter and the flexible tube”).
Re. Claim 79: Greenhalgh teaches the invention according to claim 1. Greenhalgh further teaches the invention wherein, in the retracted configuration, the space-making element has a width approximating a width of the shaft (Fig. 3F: at least a portion of mesh 344 is disposed within the shaft, thus approximating a width of the shaft; see similar configurations for traction element/mesh in other figures); and
wherein, in the expanded configuration, the space-making element has a width greater than and no longer approximating the width of the shaft (Figs. 3D, 3E, 3F: at least a portion of mesh 344 is disposed exterior to the shaft having a width larger than the width of the shaft; see similar configurations for traction element/mesh in other figures).
Re. Claim 80: Greenhalgh teaches the invention according to claim 1. Greenhalgh 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 (Fig. 3F: a frontal view of the device would show two concentric rings – a first ring formed by the section of the mesh 344 wrapping around sleeve 110 and a second ring formed by the inverted section of the mesh; see similar configurations for traction element/mesh in other figures; see Fig. 21C).
Re. Claim 81: Greenhalgh teaches the invention according to claim 80. Greenhalgh 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
(see cited figures of claim 80: any part of the interior of the catheter can be considered an interior recess which holds at least a portion of mesh/traction element).
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 24-26, 44, 45, 76, and 78 are rejected under 35 U.S.C. 103 as being unpatentable over:
Greenhalgh et al. (US 9463035 B1) (hereinafter – Greenhalgh) in view of
Chin et al. (US 20090062872 A1) (hereinafter – Chin).
Re. Claim 24: Greenhalgh teaches the invention according to claim 1, including wherein the first portion of the shaft is steerable in a first plane (Col. 23, lines 21-23: “The guidewire may be a wire, smaller catheter or combination of devices that may be positioned (e.g., steered) to and/or through the clot”).
However, Greenhalgh does not explicitly disclose wherein the handle comprises a steering actuator configured to steer the first portion of the shaft in the first plane.
Chin teaches 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 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”).
It would have been obvious to one having skill in the art before the effective filing date to have modified the device of Greenhalgh to include the steering elements and other structural modifications required therefore as taught by Chin, the motivation being that doing so enables steering of the device to be formed into one integrated unit, i.e., via a steering mechanism as opposed to requiring the separate guidewire of Greenhalgh.
Re. Claim 25: Greenhalgh as modified by Chin teaches the invention according to claim 24. Chin, in teaching further detail regarding the modification, 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: Greenhalgh as modified by Chin teaches the invention according to claim 24. Chin, in teaching further detail regarding the modification, 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 44: Greenhalgh teaches the invention according to claim 43, but does not teach 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.
Chin 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).
It would have been obvious to one having skill in the art before the effective filing date to have modified Greenhalgh to incorporate the plurality of solid portions and gaps as taught by Chin, the motivation being that such structural elements enables flexion of steerable elements within a certain bending range and side/direction (Paragraph 0106), thus increasing how the steerable device may bend, and further reduces flexural stress, compression, and the risk of cracking of the steerable elements (Paragraph 0108).
Re. Claim 45: Greenhalgh as modified by Chin teaches the invention according to claim 44. Chin, in teaching further details of the modification 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”).
Re. Claim 76: Greenhalgh teaches the invention according to claim 75, including the use of a lumen configurable to deliver a therapeutic device or a visualization device; however, Greenhalgh does not teach 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.
Chin teaches a variety of ports suitable receiving a variety of devices. Particularly, 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”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Greenhalgh to incorporate a handle and system of ports and lumens as taught by Chin, the motivation being that doing so enables multiple devices to be used at a target location simultaneously without interference between deliverable devices.
Re. Claim 78: Greenhalgh teaches the invention according to claim 77, but does not teach 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.
Chin 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).
It would have been obvious to one having skill in the art before the effective filing date to have modified Greenhalgh to include the aspiration ports and lumens as taught by Chin, the motivation being that doing so allows for simultaneous aspiration or irrigation (Paragraph 0019), or selective aspiration at one location of an aspiration lumen (Paragraph 0019), or the capability to include alternate vacuum/suction sources.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over:
Greenhalgh et al. (US 9463035 B1) (hereinafter – Greenhalgh) in view of
Chin et al. (US 20090062872 A1) (hereinafter – Chin) in further view of
Lentz et al. (US 20050177132 A1) (hereinafter – Lentz).
Re. Claim 33: Greenhalgh as modified by Chin 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 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 Greenhalgh as modified by Chin 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).
Claims 84-86 are rejected under 35 U.S.C. 103 as being unpatentable over:
Greenhalgh et al. (US 9463035 B1) (hereinafter – Greenhalgh) in view of
Lentz et al. (US 20050177132 A1) (hereinafter – Lentz).
Re. Claim 84: Greenhalgh teaches the invention according to claim 1, including wherein a device is steerable; however, Greenhalgh is not explicit regarding particular planes in which the device is flexible. Thus, Greenhalgh does not teach the invention wherein:
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.
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 Greenhalgh to have a various portions 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 85: Greenhalgh as modified by Lentz teaches the invention according to claim 84. Lentz, in teaching further details regarding the modification, further teaches the invention 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 annotated Fig. 6 – 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).
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Re. Claim 86: Greenhalgh as modified by Lentz teaches the invention according to claim 84. Lentz, in teaching further detail regarding the modification, further teaches the invention 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 (this is the inverse of claim 85; the citations of claim 85 apply equally 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
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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