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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/24/26 has been entered.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 6/24/26. The claims 1-18, and 20 are pending. The claims 1, 3, and 10 has been amended.
Response to Arguments
Applicant’s arguments, filed 6/24/26 with respect to the rejections of claims 1, 7-11 under 35 U.S.C. 103 as being unpatentable over Von Oepen (US2018/0055637) in view of Vaturi (US11045311) and DeGraaf (US2018/0161557) have been fully considered and are found persuasive. Therefore, the rejection has been withdrawn. However, a new grounds of rejection has been made in view of Von Oepen (US2018/0055637) in view of Vaturi (US11045311) and Von Oepen (US2018/0028305) (Von Oepen-2).
Applicant’s arguments, filed 6/24/26 with respect to the rejections of claims 1, 4-6, and 9-11 under 35 U.S.C. 103 as being unpatentable over Von Oepen (US2018/0055637) in view of Jacobsen (US2003/0069522) and DeGraaf (US2018/0161557) have been fully considered and are found persuasive. Therefore, the rejection has been withdrawn. However, a new grounds of rejection has been made in view of Von Oepen (US2018/0055637) (“Oepen”) in view of Jacobsen (US2003/0069522) and Von Oepen (US2018/0028305) (Oepen-2).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “the distal end of the elongate catheter including a rigid distal valve cover”. However, there is no support in the disclosure for the limitation. From the specification paragraph [0087], it appears the valve cover is intended to bend. Furthermore, there is no description in the specification that describes the valve cover as rigid. Therefore, Applicant failed to have possession of the claimed invention at the time of filing.
Claims 2-11 are rejected under 35 U.S.C. 112(a) by dependency.
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 of this title, 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, 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Von Oepen (US2018/0055637) (“Oepen”) in view of Vaturi (US11045311) and Von Oepen (US2018/0028305) (Oepen-2).
Regarding claim 1, Oepen discloses a delivery system for delivering an IV device to a targeted anatomical site (see Abstract), the delivery system comprising:
an elongated catheter (112) having a proximal end and a distal end (see Fig. 1), the distal end of the elongate catheter including a rigid a distal valve cover (distal end of outer sheath 112, where the device 126 expands by proximal movement of the sheath 112 and the sheath 112 holds the device 126 in the collapsed state and would have some degree of rigidity, [0052], [0055]) configured for housing the IV device (houses replacement device 126, [0041]), a distal portion of the elongate catheter spaced apart from the distal end of the elongate catheter and proximally of the distal valve cover having a bending region capable of deflecting into a series of compound bends (catheter 112 is capable of being bent into a series of compound bends as the elongate member experiences a series of bends, a distal portion is interpreted as portion spaced apart from the distal end of the catheter 112 and proximal of the distal valve cover, [0080]),
a suture catheter (120) positioned slidably moveable within the elongate catheter and configured to maintain a connection with the IV device until deployment of the IV device ([0059]);
a guidewire tube (guidewire tubular member of guidewire lumen 122, [0134]) positioned within the suture catheter (see Fig. 2);
Oepen is silent regarding an atraumatic distal tip coupled to a distal end of the guidewire tube.
Vaturi in the same field of endeavor of a delivery device for an implant, specifically a prosthetic heart valve, teaches delivery using a guidewire inserted through a guide wire tube. The guidewire tube is threaded through the knurl (distal tip) and locks the knurl and the tube together (C10:L9-17). The knurl is atraumatic (knurl is blunted, C10:L13) and may be a delivery tip (C10:L1; C10:L66-67). It would have been obvious to one having ordinary skill in the art at the effective filing date of the application to have modified the distal tip of Oepen, as taught by Vaturi, to be atraumatic in order to prevent damage to tissues when the guidewire with guidewire tube is inserted through the vasculature (C10:L14).
Oepen is silent regarding a flexible screw mechanism disposed within the bending region, the screw mechanism being capable of deflection into the series of compound bends and configured to translate forces in a controlled motion when the elongate catheter is deflected into the series of compound bends so that the elongate catheter supports compression forces, tensile forces and torsional forces during loading of the IV device into the delivery system and unloading of the IV device from the delivery system.
Oepen discloses a hybrid delivery sheath with an inner layer having a coil 436 (inner tube) and a braided sleeve 438 (outer tube) that are compressed relative to each other (Paragraph [0105]); where the structures are mostly flexible ([0042]). Oepen-2 teaches a threaded coil 122 to elastically deform during passage through the patients vasculature and functions as a screw gear (screw mechanism) ([0048]). The threaded coil 122 engages complimentary threads on the delivery catheter 114 ([0052]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer sheath of Oepen to include an inner tube and an outer tube that are movable relative to each other by threaded engagement, as taught by Oepen-2, in order to move components in a more fine-tuned manner when releasing the IV device ([0052] of Oepen-2). Furthermore, the modification of the flexible screw mechanism would occur at a distal end near the IV and is capable of being bent in a series of bends, and is further capable of supporting compression forces, tensile forces and torsional forces during loading of the IV device into the delivery system and unloading of the IV device from the delivery system.
Regarding claim 7, Oepen/Vaturi/Oepen-2 makes obvious the delivery system of claim 1, Vaturi further teaches wherein the atraumatic distal tip comprises an elongate member (tube of knurl 1382, C19:L6-7) and a nosecone body (body of knurl 1382, see Fig. 16).
Regarding claim 8, Oepen/Vaturi/Oepen-2 makes obvious the delivery system of claim 7, Vaturi further teaches wherein the elongate member comprises an attachment element (locking feature of tube of knurl, C10:L16-17) configured to receive a complementary attachment element (where guide wire tube interfaces with locking feature of knurl, C10:L16-17) of the guidewire tube.
Regarding claim 9, Oepen/Vaturi/Oepen-2 makes obvious the delivery system of claim 1, Oepen further discloses wherein the suture catheter is coaxial with and received within a delivery catheter configured to receive a proximal end of the IV device (120 is within 116, and capable of receiving some portion of the IV device, see Fig. 2, [0051]).
Regarding claim 10, Oepen/Vaturi/Oepen-2 makes obvious the delivery system of claim 9, Oepen further discloses wherein the delivery catheter comprises an elongate tube with a free flowing tube disposed towards a distal end of the delivery catheter (112 is interpreted as a “free flowing tube” by being manipulated relative to other components, [0053] and comprises an elongate tube by extending from a proximal to distal end, see Fig. 1).
Regarding claim 11, Oepen/Vaturi/Oepen-2 makes obvious the delivery system of claim 1, Oepen further discloses comprising a control fixture (see Paragraphs [0009], [0065], [0070]) operatively coupled to the proximal ends of the elongate catheter and the suture catheter and configured to control the relative movement of the suture catheter and the guidewire tube.
Claims 1, 4-6, 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Von Oepen (US2018/0055637) (“Oepen”) in view of Jacobsen (US2003/0069522) and Von Oepen (US2018/0028305) (Oepen-2).
Regarding claim 1, Oepen discloses a delivery system for delivering an IV device to a targeted
anatomical site (see Abstract), the delivery system comprising: an elongate catheter (112) having a proximal end and a distal end (see Fig. 1), the distal end of the elongate catheter including a rigid a distal valve cover (distal end of outer sheath 112, where the device 126 expands by proximal movement of the sheath 112 and the sheath 112 holds the device 126 in the collapsed state and would have some degree of rigidity, [0052], [0055]) configured for housing the IV device (houses replacement device 126, [0041]), a distal portion of the elongate catheter spaced apart from the distal end of the elongate catheter and proximally of the distal valve cover having a bending region capable of deflecting into a series of compound bends (catheter 112 is capable of being bent into a series of compound bends as the elongate member experiences a series of bends, a distal portion is interpreted as portion spaced apart from the distal end of the catheter 112 and proximal of the distal valve cover, [0080]), a suture catheter (120) slidably moveable within the elongate catheter and configured to maintain a connection with the IV device until deployment of the IV device ([0059]);
a guidewire tube (guidewire tubular member of guidewire lumen 122, [0134]) positioned within the suture catheter (see Fig. 2);
Oepen is silent regarding an atraumatic distal tip coupled to a distal end of the guidewire tube. Jacobsen in the same field of endeavor of a delivery device for an IV device, teaches delivery using a guidewire (guide wire can be a tube [0087]) inserted through a catheter ([0003]). The guidewire tube is attached to an atraumatic distal tip ([0087]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the application to have modified the distal tip of Oepen, as taught by Jacobsen, to be atraumatic in order to prevent damage to tissues when the guidewire with guidewire tube is inserted through the vasculature ([0087] of Jacobsen).
Oepen is silent regarding a flexible screw mechanism disposed within the bending region, the screw mechanism being capable of deflection into the series of compound bends and configured to translate forces in a controlled motion when the elongate catheter is deflected into the series of compound bends so that the elongate catheter supports compression forces, tensile forces and torsional forces during loading of the IV device into the delivery system and unloading of the IV device from the delivery system.
Oepen discloses a hybrid delivery sheath with an inner layer having a coil 436 (inner tube) and a braided sleeve 438 (outer tube) that are compressed relative to each other (Paragraph [0105]); where the structures are mostly flexible ([0042]). Oepen-2 teaches a threaded coil 122 to elastically deform during passage through the patients vasculature and functions as a screw gear (screw mechanism) ([0048]). The threaded coil 122 engages complimentary threads on the delivery catheter 114 ([0052]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer sheath of Oepen to include an inner tube and an outer tube that are movable relative to each other by threaded engagement, as taught by Oepen-2, in order to move components in a more fine-tuned manner when releasing the IV device ([0052] of Oepen-2). Furthermore, the modification of the flexible screw mechanism would occur at a distal end near the IV and is capable of being bent in a series of bends, and is further capable of supporting compression forces, tensile forces and torsional forces during loading of the IV device into the delivery system and unloading of the IV device from the delivery system.
Regarding claims 4-6, Oepen/Jacobsen/Oepen-2 makes obvious the delivery system of claim 1; yet, the modified invention does not explicitly disclose wherein the atraumatic distal tip includes a radiographic or echogenic marker embedded therein, wherein the atraumatic distal tip comprises a rim member with a groove that receives the radiographic or echogenic marker having an annular form, wherein the atraumatic distal tip comprises the rim member with the groove that receives the radiographic or echogenic marker formed with a plurality of segments and a plurality of air pockets. Jacobsen further teaches where the guidewire 244 (distal end with channel is interpreted as the rim member, see Fig. 3) has a channel 248 (groove of claimed rim member) that seats a radiopaque coil (radiographic marker) wound in the channel (the coil has an annular form by being wound in the channel, [0065]). Where the coil can be welded (therefore embedded) within the channel ([0065]). Wherein the channel 248 (groove of claimed rim member) that seats a radiopaque coil (radiographic marker) is formed with a plurality of segments (segments of the coil, see Fig. 3) and a plurality of air pockets (spacing between the coils, see Fig. 3). It would have been obvious to one having ordinary skill in the art at the effective filing date to have the atraumatic distal tip of Oepen/Jacobsen/Oepen-2 include a radiographic marker embedded within a channel at the distal tip therein in order to provide a fluoroscopic visibility ([0091] of Jacobsen).
Regarding claim 9, Oepen/Jacobsen/Oepen-2 makes obvious the delivery system of claim 1,
Oepen further discloses wherein the suture catheter is coaxial with and received within a delivery catheter configured to receive a proximal end of the IV device (120 is within 116, and capable of receiving some portion of the IV device, see Fig. 2, [0051]).
Regarding claim 10, Oepen/Jacobsen/Oepen-2 makes obvious the delivery system of claim 9, Oepen further discloses wherein the delivery catheter comprises an elongate tube with a free flowing tube disposed towards a distal end of the delivery catheter (112 is interpreted as a “free flowing tube” by being manipulated relative to other components, [0053] and comprises an elongate tube by extending from a proximal to distal end, see Fig. 1).
Regarding claim 11, Oepen/Jacobsen/Oepen-2 makes obvious the delivery system of claim 1,
Oepen further discloses comprising a control fixture (see Paragraphs [0009], [0065], [0070]) operatively coupled to the proximal ends of the elongate catheter and the suture catheter and configured to control the relative movement of the suture catheter and the guidewire tube.
Claim 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Von Oepen (US2018/0055637) (“Oepen”) in view of Jacobsen (US2003/0069522) and Von Oepen (US2018/0028305) (Oepen-2), as applied to claim 1 above, and further in view of Inouye (US2020/0060849).
Regarding claim 2, Oepen/Jacobsen/Oepen-2 makes obvious the delivery system of claim 1; yet, does not explicitly disclose wherein the valve cover includes a radiopaque or echogenic marker. Inouye teaches in the same field of endeavor a medical system 10 for delivery of a medical implant 100 including a catheter 40. Where portions or all of the catheter 40 (distal end of the catheter is interpreted as the valve cover) may include radiopaque material (Paragraph [0131]). Additionally, radiopaque marker bands may be incorporated into the design (Paragraph [0131]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to have the valve cover include radiopaque markers as taught by Inouye in order to produce a bright image on a fluoroscopy screen from visualization of the delivery of the implant during the procedure (Paragraph [0131]).
Regarding claim 3, Oepen/Jacobsen/Oepen-2 makes obvious the delivery system of claim 1; yet, does not explicitly disclose wherein the catheter includes a radiographic or echogenic marker at or near a distal end thereof. Inouye teaches in the same field of endeavor a medical system 10 for delivery of a medical implant 100 including a catheter 40. Where portions or all of the catheter 40 (distal end of the catheter is interpreted as the valve cover) may include radiopaque material (Paragraph [0131]). Additionally, radiopaque marker bands may be incorporated into the design (Paragraph [0131]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to have the valve cover include radiopaque markers as taught by Inouye in order to produce a bright image on a fluoroscopy screen from visualization of the delivery of the implant during the procedure (Paragraph [0131]).
Allowable Subject Matter
Claims 12-18 and 20 are allowed.
The following is an examiner’s statement of reasons for allowance:
No prior art of record teaches or discloses “a connector including a disk and a stem formed separately from the disk and attached to the disk, the disk having a plurality of through-holes configured to receive tethers extending from the connector to the IV device” in combination with the other limitations recited in claim 12.
The closest prior art references of record, Von Oepen (US2018/0055637) (“Oepen”), Vaturi (US11045311), and on Oepen (US2018/0028305) (Oepen-2) fail to meet all the claimed limitations.
With regard to claim 12, Oepen discloses a delivery system for delivering an IV device to a targeted anatomical site (see Abstract), the delivery system comprising:
an elongate catheter (112) having a proximal end and a distal valve cover (distal end of outer sheath 112, where the device 126 expands by proximal movement of the sheath 112, [0052], [0055]) configured for housing the IV device (houses replacement valve 126, [0041]);
a suture catheter (120) slidably moveable within the elongate catheter and configured to maintain a connection with the IV device until deployment of the IV device ([0059]), the suture catheter being coaxial with and received within a delivery catheter configured to receive a proximal end of the IV device (120 is within 116, and capable of receiving some portion of the IV device, see Fig. 2, [0051]), the suture catheter (120) comprising a connecting including a disk (delivery disk 132, [0061]) and a stem (128) formed separately from the disk and attached to the disk ([0058]);
a guidewire tube (guidewire tubular member of guidewire lumen 122, [0134]) positioned within the suture catheter (see Fig. 2);
a control fixture (see Paragraphs [0009], [0065], [0070]) operatively coupled to the proximal ends of the elongate catheter and the suture catheter and configured to control the relative movement of the suture catheter and the guidewire tube.
Oepen is silent regarding an atraumatic distal tip coupled to a distal end of the guidewire tube.
Vaturi in the same field of endeavor of a delivery device for an implant, specifically a prosthetic heart valve, teaches delivery using a guidewire inserted through a guide wire tube. The guidewire tube is threaded through the knurl (distal tip) and locks the knurl and the tube together (C10:L9-17). The knurl is atraumatic (knurl is blunted, C10:L13) and may be a delivery tip (C10:L1; C10:L66-67). It would have been obvious to one having ordinary skill in the art at the effective filing date of the application to have modified the distal tip of Oepen, as taught by Vaturi, to be atraumatic in order to prevent damage to tissues when the guidewire with guidewire tube is inserted through the vasculature (C10:L14).
Oepen is silent regarding a screw mechanism disposed within the elongate catheter and configured to translate forces in a controlled motion so that the elongate catheter supports compression forces, tensile forces and torsional forces during loading and unloading of the IV device.
Oepen discloses a hybrid delivery sheath with an inner layer having a coil 436 (inner tube) and a braided sleeve 438 (outer tube) that are compressed relative to each other (Paragraph [0105]); where the structures are mostly flexible ([0042]). Oepen-2 teaches a threaded coil 122 to elastically deform during passage through the patients vasculature and functions as a screw gear (screw mechanism) ([0048]). The threaded coil 122 engages complimentary threads on the delivery catheter 114 ([0052]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer sheath of Oepen to include an inner tube and an outer tube that are movable relative to each other by threaded engagement, as taught by Oepen-2, in order to move components in a more fine-tuned manner when releasing the IV device ([0052] of Oepen-2). Furthermore, the modification of the flexible screw mechanism would occur at a distal end near the IV and is capable of being bent in a series of bends, and is further capable of supporting compression forces, tensile forces and torsional forces during loading of the IV device into the delivery system and unloading of the IV device from the delivery system.
However, the combination of references does not disclose or make obvious “the disk having a plurality of through-holes configured to receive tethers extending from the connector to the IV device”
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
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