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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a tapered head and a retaining head, the retaining head disposed at distal ends of the second inner tube and the guidewire tube, the tapered head disposed at a distal end of the first inner tube” of claim 10 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2 and 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prabhu (US 20180133007 A1) (noted on IDS) in view of Okabe (WO 2021194899 A1) (noted on IDS).
Regarding claim 1, Prabhu discloses an implant delivery handle (Figure 15-16), comprising two transmission systems (1056, 1057) arranged along an axial direction of a first inner tube (1020) (Figure 15; Paragraph 0077), a distal one (1057) of the transmission systems coupled to a proximal end (1024) of the first inner tube (Figure 15; Paragraph 0077), and a proximal one (1056) of the transmission systems coupled to a proximal end (1014) of a second inner tube (1000) (Figure 15; Paragraph 0077).
Prabhu fails to explicitly disclose wherein each of the transmission systems comprises a lead screw, an inner tube coupling member, an outer gear and an inner gear, the outer gear rotatably engaging the inner gear and configured to drive the inner gear to rotate, the lead screw connected to the first inner tube or the second inner tube through the inner tube coupling member, the lead screw also engaging the inner gear and rotating with the inner gear, thereby driving the first inner tube or the second inner tube to axially move, wherein a transmission ratio of the outer gear to the inner gear is greater than 1.
Okabe teaches the transmission systems (206, 208) comprise a lead screw (2506), an inner tube coupling member (any of the axially translating components (e.g., shaft assemblies such as the outer sheath assembly 22, the mid shaft assembly 21, the inner assembly 18, and/or the nose cone assembly 31)) (Figure 25A-B; Paragraph 0267), the outer gear (2502) rotatably engaging the inner gear (2504) and configured to drive the inner gear to rotate (Figure 25A-B; Paragraph 0266), the lead screw connected to the first inner tube or the second inner tube through the inner tube coupling member (Figure 25A-B; Paragraph 0267), the lead screw also engaging the inner gear and rotating with the inner gear (Figure 25 A-B; Paragraph 0267), thereby driving the first inner tube or the second inner tube to axially move (Paragraph 0267), wherein a transmission ratio of the outer gear to the inner gear is greater than 1.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Prabhu to include wherein each of the transmission systems comprises a lead screw, an inner tube coupling member, an outer gear and an inner gear, the outer gear rotatably engaging the inner gear and configured to drive the inner gear to rotate, the lead screw connected to the first inner tube or the second inner tube through the inner tube coupling member, the lead screw also engaging the inner gear and rotating with the inner gear, thereby driving the first inner tube or the second inner tube to axially move, wherein a transmission ratio of the outer gear to the inner gear is greater than 1, as taught by Okabe, as both references and the claimed invention are directed to medical implant delivery systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Prabhu with the teachings of Okabe by incorporating wherein each of the transmission systems comprises a lead screw, an inner tube coupling member, an outer gear and an inner gear, the outer gear rotatably engaging the inner gear and configured to drive the inner gear to rotate, the lead screw connected to the first inner tube or the second inner tube through the inner tube coupling member, the lead screw also engaging the inner gear and rotating with the inner gear, thereby driving the first inner tube or the second inner tube to axially move, wherein a transmission ratio of the outer gear to the inner gear is greater than 1 in order to simplify the control system by being able to control the wire with one knob rather than the 2 in Prabhu.
Regarding claim 2, Okabe further teaches wherein the outer gear is disposed over the inner gear, and the outer gear meshes with the inner gear (Figure 25; Paragraph 0267).
Regarding claim 8, the combination of Prabhu and Okabe teaches the implant delivery handle of claim 1, and Okabe further teaches wherein: the lead screw is arranged coaxially with the inner gear (Figure 25; Paragraph 0267), the lead screw has an external thread, the inner tube coupling member has an internal thread (Figure 25; Paragraph 0267), the inner tube coupling member threadedly engages with the lead screw (Figure 25; Paragraph 0267), and as a result of threaded rotation of the lead screw, the inner tube coupling member would be fully capable of driving axial movement of the first inner tube or the second inner tube.
Regarding claim 9, Prabhu as modified by Okabe teaches an implant delivery system, comprising the implant delivery handle of claim 1 (see rejection of claim 1 above) and Prabhu further discloses a catheter assembly, the catheter assembly comprising the first inner tube (1020), the second inner tube (1000) and a guidewire tube (1030), which nest one within another from the outside inwards (Figure 15; Paragraph 0077), wherein the implant delivery handle drives axial movement of the first and second inner tubes (Paragraph 0077).
Regarding claim 10, Prabhu as modified by Okabe teaches an implant system, comprising the implant delivery handle of claim 1 (see rejection of claim 1 above), and Prabhu further teaches the first inner tube, the second inner tube, a guidewire tube (1030), and a retaining head (distal ends of 1000 and 1030), the retaining head disposed at distal ends of the second inner tube and the guidewire tube, wherein an implant (replacement valve) is crimped (Paragraph 0061), and wherein the implant delivery handle drives axial movement of the first and second inner tubes, thereby is fully capable of achieving loading, delivery and release of the implant (Paragraph 0077) but fails to disclose a tapered head, the tapered head disposed at a distal end of the first inner tube.
However, an alternative embodiment of Prabhu teaches the tapered head (964) disposed at a distal end of an inner tube (924) (Paragraph 0050). As a result of the combination, the implant would be crimped within a distal end portion of the first inner tube between the tapered head and the retaining head.
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Prabhu with the teachings of the alternative embodiment of Prabhu by incorporating the tapered head disposed at a distal end of the first inner tube in order to reduce material in the catheter and tune the flexibility (Prabhu Paragraph 0050).
Regarding claim 11, Prabhu as modified by Okabe teaches a method of use of the implant delivery system of claim 9, and Okabe further teaches the method comprising:
rotating the outer gear in a first direction, causing simultaneous rotation of the inner gear with the outer gear, and the lead screw rotating with the inner gear, the rotation of the lead screw causes the inner tube coupling member to drive axial advancement of the first inner tube or the second inner tube (Paragraph 0264; 0267); and
rotating the outer gear in a direction opposite to the first direction, causing synchronous rotation of the inner gear with the outer gear, and the lead screw rotating with the inner gear, the rotation of the lead screw causes the inner tube coupling member to drive axially retraction of the first inner tube or the second inner tube (Paragraph 0264; 0267).
Claim(s) 3-4 and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prabhu in view of Okabe as applied to claim 1 above, and further in view of Solar (US 6004328 A).
Regarding claim 3, Prabhu modified by Okabe teaches the implant delivery handle of claim 1, but fails to explicitly disclose wherein: the inner tube coupling member in the distal transmission system is connected to an outer wall surface of the proximal end of the first inner tube, disposed over the second inner tube and configured to proximally seal a gap between the first inner tube and the second inner tube, and the inner tube coupling member in the proximal transmission system is connected to an outer wall surface of the proximal end of the second inner tube, disposed over a guidewire tube in a catheter assembly and configured to proximally seal a gap between the second inner tube and the guidewire tube.
However, Solar teaches the inner tube coupling member (46) in a transmission system connected to an outer wall surface of the proximal end of the first inner tube (14), disposed over the second inner tube (24) and configured to proximally seal a gap between the first inner tube and the second inner tube (Figure 5; Col 7, line 22-27).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Prabhu as modified by Okabe such that the inner tube coupling member in the distal transmission system is connected to an outer wall surface of the proximal end of the first inner tube, disposed over the second inner tube and configured to proximally seal a gap between the first inner tube and the second inner tube, as taught by Solar, as both references and the claimed invention are directed to medical implant delivery systems. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Prabhu as modified by Okabe with the teachings of Solar by incorporating the inner tube coupling member in the distal transmission system is connected to an outer wall surface of the proximal end of the first inner tube, disposed over the second inner tube and configured to proximally seal a gap between the first inner tube and the second inner tube in order to securely connect the tubes and prevent any leakage.
Similarly, the configuration could be replicated in both the distal and proximal transmission systems such that to include the inner tube coupling member in the proximal transmission system is connected to an outer wall surface of the proximal end of the second inner tube, disposed over a guidewire tube in a catheter assembly and configured to proximally seal a gap between the second inner tube and the guidewire tube so there are no gaps between the tubes to ensure no fluid leakage during a procedure.
Regarding claim 4, Prabhu as modified by Okabe teaches the implant delivery handle of claim 1, but fails to explicitly disclose wherein: the inner tube coupling member in the distal transmission system comprises a first seal, a second seal and a third seal, which are disposed over a second inner tube, wherein the proximal end of the first inner tube is snugly secured in a distal end of the first seal, and the second seal is elastically switched between a proximal end of the first seal and a distal end of the third seal, when the second seal is compressed by both the first and third seals, the second seal fits against the outer wall surface of the second inner tube, thereby sealing the gap between the proximal end of the first inner tube and the second inner tube; and the inner tube coupling member in the proximal transmission system comprises a fourth seal, a fifth seal and a sixth seal, which are disposed over the guidewire tube in the catheter assembly, wherein the proximal end of the second inner tube is snugly secured in a distal end of the fourth seal, and the fifth seal is elastically switched between a proximal end of the fourth seal and a distal end of the sixth seal, when the fifth seal is compressed by both the fourth and sixth seals, the fifth seal fits against an outer wall surface of the guidewire tube, thereby sealing the gap between the proximal end of the second inner tube and the guidewire tube.
However, Solar teaches the inner tube coupling member in the transmission system comprises a first seal (48), a second seal (64) and a third seal (60) (Figure 5; Col 7 line 22-27, 45-48, 59-63), which are disposed over a second inner tube (24), wherein the proximal end (16) of the first inner tube (14) is snugly secured in a distal end of the first seal (Col 7, line 22-24), and the second seal is elastically switched between a proximal end of the first seal and a distal end of the third seal (Col 7 line 59- Col 8 line 4), when the second seal is compressed by both the first and third seals, the second seal fits against the outer wall surface of the second inner tube, thereby sealing the gap between the proximal end of the first inner tube and the second inner tube (Figure 5; Col 7 line 59- Col 8 line 4).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Prabhu as modified by Okabe with the teachings of Solar by incorporating the inner tube coupling member in the distal transmission system comprises a first seal, a second seal and a third seal, which are disposed over a second inner tube, wherein the proximal end of the first inner tube is snugly secured in a distal end of the first seal, and the second seal is elastically switched between a proximal end of the first seal and a distal end of the third seal, when the second seal is compressed by both the first and third seals, the second seal fits against the outer wall surface of the second inner tube, thereby sealing the gap between the proximal end of the first inner tube and the second inner tube in order to prevent the escape of any fluid (Solar Col 8, line 1).
Similarly, the configuration could be replicated in both the distal and proximal transmission systems such that to include the inner tube coupling member in the proximal transmission system comprises a fourth seal, a fifth seal and a sixth seal, which are disposed over the guidewire tube in the catheter assembly, wherein the proximal end of the second inner tube is snugly secured in a distal end of the fourth seal, and the fifth seal is elastically switched between a proximal end of the fourth seal and a distal end of the sixth seal, when the fifth seal is compressed by both the fourth and sixth seals, the fifth seal fits against an outer wall surface of the guidewire tube, thereby sealing the gap between the proximal end of the second inner tube and the guidewire tube to further prevent leakage of fluid between the second inner tube and the guidewire tube.
Regarding claim 6, the combination of Prabhu, Okabe, and Solar teaches (Original) The implant delivery handle of claim 4, and Solar further teaches wherein: the first, second and third seals are all tubular structures (Figure 5; Col 7 line 22-27, 45-48, 59-63), the second seal is disposed within the proximal end of the first seal (Figure 5), and the distal end of the third seal is disposed within the proximal end of the first seal and configured to act together with the first seal to compress the second seal so that the second seal experiences an inner diameter decrease and fits against the second inner tube, inner diameters of the first, second and third seals are all greater than or equal to an outer diameter of the second inner tube (Figure 5; Col 7 line 79- Col 8 line 4), an inner diameter of the proximal end of the first seal is greater than an inner diameter of the distal end of the first seal (Figure 5), an outer diameter of the second seal lies between the inner diameter of the distal end of the first seal and the inner diameter of the proximal end of the first seal (Figure 5), and an outer diameter of the distal end of the third seal lies between an inner diameter of a distal end of the second seal and the inner diameter of the proximal end of the first seal (Figure 5).
Regarding claim 7, the combination of Prabhu, Okabe and Solar teaches the implant delivery handle of claim 4, and Solar further teaches wherein: the fourth, fifth and sixth seals are all tubular structures, the fifth seal is disposed within the proximal end of the fourth seal (Figure 5; Col 7 line 22-27, 45-48, 59-63), and the distal end of the sixth seal is disposed within the proximal end of the fourth seal and configured to act together with the fourth seal to compress the fifth seal so that the fifth seal experiences an inner diameter decrease and fits against the guidewire tube (Figure 5; Col 7 line 59- Col 8 line 4), inner diameters of the fourth, fifth and sixth seals are all greater than or equal to an outer diameter of the guidewire tube (Figure 5), an inner diameter of the proximal end of the fourth seal is greater than an inner diameter of the distal end of the fourth seal, an outer diameter of the fifth seal lies between the inner diameter of the distal end of the fourth seal and the inner diameter of the proximal end of the fourth seal (Figure 5), and an outer diameter of the distal end of the sixth seal lies between an inner diameter of a distal end of the fifth seal and the inner diameter of the proximal end of the fourth seal (Figure 5).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Prabhu in view of Okabe and Solar as applied to claim 4 above, and further in view of Delap (US 20120041532 A1).
Regarding claim 5, Prabhu as modified by Okabe and Solar teaches the implant delivery handle of claim 4 but fails to explicitly disclose wherein the second and fifth seals are each made of a material comprising a polymeric material and the second and fifth seals each have a Shore A hardness of 35 HA to 55 HA.
However, Delap teaches seals (24) with a Shore A hardness of 40-50, which is included in the claimed range of 35-55 (Paragraph 0028).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to fashion the seals from silicone rubber with a Shore A hardness of 40-50, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/KATHERINE H MENDEZ/Primary Examiner, Art Unit 3771
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