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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/10/2025 has been entered.
Priority
This application claims priority from provisional application 62/921,378 filed 06/12/2019.
Status of Claims
Claims 1-24 and 26-54 are pending.
Claims 5-8, 10-19, 30-31, 33, and 47-48 have been withdrawn from consideration. New claims 47-48 were withdrawn as being dependent upon withdrawn claims.
Claim 25 has been cancelled.
Election/Restrictions
Applicant elected Species 12 (Figures 29AB), Species E (Triangle Shaped Lumen), and Species A (Figures 8) without traverse on 07/05/2024.
Information Disclosure Statement
The Information Disclosure Statements filed on 08/22/2025 and 11/16/2025 has been considered by the examiner.
Specification
The previous objections to the disclosure have been withdrawn in view of the applicant’s amendments.
Claim Objection
Claim 28 is objected to for the following minor typo in line 3. The claim recites “a longitudinal axis the segment of the second medical device” but should recite “a longitudinal axis of the segment of the second medical device.”
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Claim Rejections - 35 USC § 112
The previous 112 rejections have been withdrawn in view of the applicant’s amendments.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 45 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 45 lacks antecedent basis for the recitation of “the orientation of the first treatment device” in line 1. The applicant is advised to amend this recitation to recite “an orientation of the first treatment device”.
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.
Claim(s) 1-3, 9, 20, 22-29, 32, 34-46, and 49-54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austin et al (Austin) US 2008/0015674 A1 in view of Savage et al (Savage) USPN 5,507,725 and Sung et al (Sung) US 20140031788 A1.
1. Austin discloses an intravascular system 100 for treating of a blood vessel, the intravascular system comprising:
a catheter 110 defining a longitudinal axis (along 215) and a first lumen terminating in a distal end hole (right side of figure 1), the first lumen having a first transverse cross-sectional configuration (Figure 3A);
a first delivery device 105 having an elongated member (shaft 105) configured for insertion into the first lumen of the catheter (Figure 1),
a first stent 135 supported by the first delivery device; and
the first elongated member (shaft 105) supporting the first stent such that the first elongated member and the first stent are movable through the first lumen of the catheter to facilitate delivery of the first stent to a target location within the blood vessel (Figures 1-2D), the first elongated member movable relative to the first delivery member and extendable therefrom into the catheter, the first elongate member having a second transverse cross-sectional configuration corresponding to the first transverse cross-sectional configuration (Figures 3A-C).
However, Austin does not disclose the pull wires or noncircular cross-sections that inhibit rotation of the first elongated member within the catheter and control orientation of the first stent relative to the catheter.
Savage teaches the use of a steerable catheter comprising pull wires (Savage discloses the use of 2 or more wires 24a, 24b-24n) extending in a non-parallel relation to the longitudinal axis (Figure 21 shows the wire access channel has a helical non-parallel relation to the central axis) wherein the at least one pull wire is configured to apply a torsional force to the catheter to vary a rotational position thereof (by pulling the wire along the helical shaped path it applies the force along the same curved path causing a torsional force additionally by applying varied forces on the different wires when there is more than 2 the operator can also ) in the same field of endeavor for the purpose of providing the ability to better navigate the catheter through the complex shapes of a patient’s vasculature.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the walls of the catheter Austin to have the helical shaped recesses and to include the pull wires and controls as taught by Savage in order to providing the surgeon with better control over the position of the catheter during navigation through the complex shapes of a patient’s vasculature.
Sung teaches the use of a medical delivery device comprising an outer catheter 10 and an inner delivery device 20 (Figures 3ab) comprising triangular cross-sections (Figure 4f) in the same field of endeavor for the purpose of reinforcing the delivery device while locking it into a specific orientation.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the catheter and delivery device of Austin to have triangular cross-sections as taught by Sung in order to prevent unwanted rotation and preserve the devices desired orientation.
2. Austin discloses the first delivery device including: a delivery member (107 and adjacent recessed bed) supporting the first treatment device (stent 135), wherein the delivery member and the first treatment device are insertable into the blood vessel through the catheter (Figures 2A/B), the first elongated member being defined by the delivery member (the first elongated member is part of the delivery member so it is inherently defined by it).
3. and 22. Austin discloses the first stent is configured for self-expansion such that the first stent automatically expands in the blood vessel upon exposure from the catheter [0026].
9. Austin as modified discloses the catheter includes at least one steerable segment (bend end shown in Figure 21 of Savage) to increase precision in placement of the catheter (Figure 21) and at least one steering wire (Savage discloses multiple 24a, 24b-24n) attached to an activating mechanism on a handle of the catheter (Bottom of Figure 1 of Savage), wherein a force is applied to the at least one steering wire by applying a force to the activating mechanism on the handle of the catheter (abstract).
20. The combination discloses a system for predictable rotational orientation (a person of ordinary skill in the art is fully capable of predicting the orientation of any catheter based on the implant site and the forces they apply to it) of a stent during delivery (100 Austin), the system comprising:
a first medical device 105 supporting the stent 135; and
a second medical device 110 defining a longitudinal axis (along 215) configured to receive the first medical device (Figure 1), wherein the first medical device and the second medical device include corresponding non-circular transverse cross-sectional configurations forming non-circular inner surface of the second medical device and forming a non-circular outer surface along a majority of an outer surface of the first medical device (see modification in view of Sung above) to inhibit rotation of the first medical device within the second medical device and thereby control orientation of the treatment device, wherein the second medical device includes at least one pull wire substantially within a wall of at least a segment of the second medical device, wherein the at least one pull wire extends in a helical pattern about the longitudinal axis and is configured to facilitate variation in a rotational position of the second medical device (see modification in view of Savage above).
In regards to claim 23, it would have been obvious to a Phosita to provide both the first and second medical devices with the same steerable segments and corresponding pull wires because they are separately movable and it would provide the operator with increased control over each device to optimize insertion and withdrawn of the catheter during implantation of the stent.
24. The combination discloses an intravascular system comprising:
a first medical device 105;
a second medical device 110 configured to receive the first medical device (Figure 1), wherein the first medical device and the second medical device include corresponding non-circular transverse cross-sectional configurations forming a non-circular inner surface of the second medical device along a majority of its length and a corresponding similar non-circular outer surface configuration of a delivery system of the first medical device along a majority of its length to inhibit rotation of the first medical device within the second medical device (see modification in view of Sung above); and
at least one pull wire connected to the second medical device to vary a rotational position of a segment of the second medical device via torsional force applied to second medical device via the at least one pull wire, the torsional force effecting rotation of the second medical device along all or a portion of a length of the second medical device (see modification in view of Savage above).
26. The combination discloses the at least one pull wire extends through at least one channel 24 formed in an outer wall of the second medical device (Figures 3 and 21 of Savage).
27. The combination discloses an activating mechanism connected to the at least one pull wire (bottom of Figure 1 of Savage) and configured to apply the torsional force to the segment of the second medical device (the torsional force is due to the helical nature of the channel 24 shown in Figure 21 and also controlled by applying different forces to 3 or more wires), wherein the activating mechanism is positioned on a handle at a proximal end (bottom of Figure 1 of Savage).
28. The combination discloses at least one pull wire includes a non-linear configuration wherein it is wound at least in part about a longitudinal axis the segment of the second medical device (Figure 21 of Savage).
29. 38. 52. The combination discloses the at least one pull wire includes a first pull wire connected to the second medical device to vary the rotational position of the second medical device in a first direction and a second pull wire connected to the second medical device to vary rotational position of the second medical device in a second opposite direction (Savage discloses the use of a plurality of wires 24a, 24b-24n capable moving the device in opposing directions 4:61-63)
32. Pryor discloses the activating mechanism on the handle of the catheter is a rotating wheel 830 Figure 8.
34. 35. Austin discloses the treatment device is a stent 135 Figure 1.
36. Austin discloses the treatment device is configured to be pre-loaded onto a delivery system (this is also considered to be intended use limitation, the stent of Austin is fully cable of being preloaded because it is compressed to be small enough to be inserted when preloaded onto the delivery system), wherein the delivery system has an outer surface that corresponds to the inner surface of the non-circular transverse cross sectional configuration of the second medical device along the majority of its length so as to inhibit rotation of the treatment device during delivery (see modification in view of Sung above).
37. The combination discloses that rotating a terminal segment of the second medical device alters an orientation of delivery of the first medical device therethrough (in view of their triangular cross-sections and tight tolerances they inherently rotate together, see modification in view of Sung above).
39. 41. 43. 53. The combination discloses the intravascular system is configured such that the first delivery device is insertable into the catheter before or following rotation of the catheter and/or with the first treatment device inside of the catheter (the device and catheter have the same cross-sections so they can be inserted at any time, additionally the claim broadly allows for 360 degree rotation which would inherently allow any catheter to read upon this recitation).
40. 42. 44. The combination discloses the catheter and the first delivery device are configured such that rotation of the catheter causes corresponding rotation of the first delivery device (in view of their triangular cross-sections and tight tolerances they inherently rotate together, see modification in view of Sung above)
45. 50. Austin discloses the orientation of the first treatment device is determined prior to delivery into the catheter (this is inherent of ever medical device, the surgeon sees the device in his hands and establishes the orientation prior to insertion of the device, any other action would be negligent).
46. Austin discloses the first delivery device includes: a body 112, wherein the delivery member is configured for movement through the body (Figures 2A-B).
49. The combination discloses the at least one steering wire is configured to cause deflection of the catheter to thereby bend the catheter in at least one direction (see modification in view of Savage and Figures 20-21 of Savage).
51. The combination discloses the at least one steerable segment is configured to bend in at least one direction (see modification in view of Savage and Figures 20-21 of Savage).
54. The combination discloses the intravascular system is configured such that the first medical device is positioned within the second medical device during rotation of the segment of the second medical device (once inserted there is no structural limitation preventing the two components from being rotated or moved in any manner together as a unit whether during surgery or prior to it).
Claim(s) 4 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Austin and Sung (Combination 1) as applied to claims 1-3, 20, and 22 above, and further in view of St Germain et al (St Germain) USPN 5,534,007.
Combination 1 discloses the invention substantially as claimed being a stent delivery device usable with a balloon expandable stent. However, Combination does not disclose the delivery device comprises a balloon for expanding the stent.
St Germain teaches the use of a delivery device comprising a balloon expandable stent positioned over an expansion balloon (5:28-33) in the same field of endeavor for the purpose of ensuring full expansion of the stent.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the balloon expansion instrumentation with the delivery device of combination 1 in order to ensure complete expansion of the implant site and the stent.
In regards to the outer and inner surfaces corresponding to each other of claim 21, see modification in view of Sung above.
Response to Arguments
Applicant's arguments filed 10/10/2025 have been fully considered but they are not persuasive.
The applicant argues that the prior art fails to disclose that the claimed pull wires with non-parallel relation to the longitudinal axis. This is not persuasive because the prior art combination has been modified to include the pull wire system of Savage. Savage discloses use of multiple pull wires within the walls of a catheter for manipulating the shape and delivery path of the catheter. Savage further discloses the use of wires along a helical path not parallel to the longitudinal axis. These wires achieve torsional forces through the helical path as well as by pulling with varied forces (for example using 3 wires with sequentially less pull force will achieve a torsional force).
The applicant is on notice that 5-8, 30-31, 33, and 47-48 appear to be ready for rejoinder upon indication of allowable subject matter, but that claims 10-19 are not commensurate with the scope of the other claims and would be rejectable with prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am-6 pm.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774