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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-6, 8, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shima (JP2009207611A).
With regards to claim 1, Shima discloses a system for insertion within a portion of a patient’s body (FIG 1), the system comprising: a sheath (11) having a proximal portion (to the right in FIG 1), a distal portion (to the left in FIG 1), and an inner lumen for passing a catheter or an implant through the inner lumen (sheath introducer 10 is inserted into lumen of sheath tube 11); an outer housing (12) positioned at the proximal portion of the sheath (FIG 2) and having an inner surface defining a cavity (23), the outer housing having a first portion (23a) and a second portion positioned proximal of the first portion (to the right of 23a in FIG 2), the inner surface at the first portion being tapered radially outward (23a, FIG 2) and the inner surface at the second portion having a cylindrical shape (to the right of 23a in FIG 2); and an inner housing (40) positioned within the cavity of the outer housing (FIG 3) and having an outer surface (outer part of FIG 5) and an inner surface (inner part of FIG 5), with the proximal portion of the sheath (FIG 2) sandwiched between the outer surface of the inner housing (outer part of FIG 5) and the inner surface of the second portion of the outer housing having the cylindrical shape (to the right of 23a in FIG 2) (FIG 3e, sheath 11 is between the outer surface of 40 and inner surface of housing 12), and the inner surface of the inner housing (inner part of FIG 5) defining a lumen for passing the catheter or the implant through to the inner lumen of the sheath (sheath introducer 10 is inserted into lumen of sheath tube 11).
With regards to claim 2, Shima discloses the system of claim 1, wherein the outer surface of the inner housing (FIG 3) includes a recess for receiving the proximal portion of the sheath (23a).
With regards to claim 3, Shima discloses the system of claim 1, wherein the proximal portion of the sheath has a first portion with a cylindrical shape (11) and a second portion positioned proximal of the first portion and flaring radially outward from the first portion (11a, FIG 3), the second portion of the sheath extending along the inner surface at the second portion of the outer housing (FIG 3).
With regards to claim 4, Shima discloses the system of claim 3, wherein the inner lumen of the sheath at the first portion of the sheath (11) has a diameter that is the same or greater than a diameter of the lumen of the inner housing (40) (FIG 3d shows inner housing 40 fit inside sheath 11, so the diameter of sheath 11 must be greater than that of inner housing 40).
With regards to claim 5, Shima discloses the system of claim 1, wherein the lumen of the inner housing has a cylindrical shape (41, FIG 5).
With regards to claim 6, Shima discloses the system of claim 1, wherein the inner housing (40) overlaps a proximal edge of the sheath (11) (FIG 5d).
With regards to claim 8, Shima discloses the system of claim 1, wherein the outer housing (12) includes a sleeve extending over the sheath distally from the inner housing (13, FIG 1).
With regards to claim 19, Shima discloses the system of claim 1, wherein the distal portion of the sheath (20) is configured to pass through an interatrial septum of the patient’s heart (the sheath is capable of passing through an interatrial septum).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shima (JP2009207611A) as applied to claim 1 above, and further in view of Graffam (8801696).
With regards to claim 7, Shima discloses the system of claim 1, but fails to disclose wherein the inner housing includes an alignment structure for rotationally aligning the inner housing with the cavity of the outer housing.
Graffam discloses a system for insertion within a portion of a patient’s body (10) with inner housing (300) and outer housing (200). Graffam teaches an alignment structure (275, 376 (FIG 3) for rotationally aligning the inner housing with the cavity of the outer housing (col 4, line 39). Therefore, 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 Shima’s system for insertion to include an alignment structure for rotationally aligning the inner housing with the cavity of the outer housing, as taught by Graffam, in order to properly align the two pieces (col 4, line 29).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shima (JP2009207611A) in view of Rafiee (20220117735).
With regards to claim 9, Shima discloses the system of claim 8, but fails to disclose that it is further comprising a handle housing positioned at the proximal portion of the sheath and extending over the sleeve.
Rafiee discloses a system for insertion within a portion of a patient’s body (Fig. 15A) with a catheter (1500) and sheath (1510). Rafiee teaches a handle housing (1502) positioned at the proximal portion of the sheath (1500) (FIG 15A). Therefore, 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 Shima’s system for insertion to include a handle housing positioned at the proximal portion of the sheath and extending over the sleeve, as taught by Rafiee, to aid in tensioning tether control ([0154]).
Claim(s) 10-18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shima (JP2009207611A) as applied to claim 1 above, and further in view of Patel (WO2018112429A1).
With regards to claim 10, Shima discloses the system of claim 1, but fails to disclose a pull tether extending along the sheath, the pull tether configured to be tensioned to deflect the distal portion of the sheath.
Patel discloses a system for insertion within a portion of a patient’s body (2), where the system has a sheath (20) an inner lumen (a guide wire can be introduced through the sheath [0088]), and a catheter (24, 64, 114). Patel teaches a pull tether (135, 136) extending along the sheath (20), the pull tether configured to be tensioned to deflect the distal portion of the sheath ([00147], where the tether is “controlling the bending”). Therefore, 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 Shima’s system for insertion to include a pull tether extending along the sheath, the pull tether configured to be tensioned to deflect the distal portion of the sheath, as taught by Patel, in order to control bending of the system ([00147]).
With regards to claim 11, Shima discloses the system of claim 1, but fails to disclose that it is further comprising a first delivery catheter configured to deploy a docking coil to a portion of the patient’s body, and wherein the inner lumen of the sheath and the lumen of the inner housing are configured for passing the first delivery catheter therethrough.
Patel discloses a system for insertion within a portion of a patient’s body (2), where the system has a sheath (20) an inner lumen (a guide wire can be introduced through the sheath [0088]), and a catheter (24, 64, 114). Patel teaches a first delivery catheter (24, 64) configured to deploy a docking coil (1, 12) to a portion of the patient’s body (FIG 9K), and wherein the inner lumen of the sheath and the lumen of the inner housing are configured for passing the first delivery catheter therethrough (114, [00142]). Therefore, 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 Shima’s system for insertion to include a first delivery catheter configured to deploy a docking coil to a portion of the patient’s body, and wherein the inner lumen of the sheath and the lumen of the inner housing are configured for passing the first delivery catheter therethrough, as taught by Patel, in order to allow for delivery of a docking coil, and to better secure a prosthesis to the heart (abstract).
With regards to claim 12, Shima as modified by Patel discloses the system of claim 11, further comprising the docking coil (Patel 1, 12).
With regards to claim 13, Shima as modified by Patel discloses the system of claim 12, wherein the docking coil (Patel 1, 12) is configured to form a coil extending around leaflets of a native heart valve (Patel FIG 9K, [00115]).
With regards to claim 14, Shima as modified by Patel discloses the system of claim 13, wherein at least a portion of the docking coil (Patel 1, 12) is configured to be positioned on an atrial side of the native heart valve (Patel [0082]) and at least a portion of the docking coil is configured to be positioned on a ventricular side of the native heart valve (Patel [0082]).
With regards to claim 15, Shima as modified by Patel discloses the system of claim 11, further comprising a second delivery catheter configured to deploy a prosthetic heart valve to the docking coil (Patel [0088], “With the delivery catheter 24 removed, a prosthetic valve, for example, a prosthetic transcatheter heart valve (THV) 60 can then be passed, for example, through the sheath 20 and secured within the anchoring device 1, as shown for example in FIG. 2C."), and wherein the inner lumen of the sheath and the lumen of the inner housing are configured for passing the second delivery catheter therethrough (Patel [0088]).
With regards to claim 16, Shima as modified by Patel discloses the system of claim 15, further comprising the prosthetic heart valve (Patel 60).
With regards to claim 17, Shima as modified by Patel discloses the system of claim 16, wherein the prosthetic heart valve (Patel 60) is configured to be positioned interior of leaflets of a native heart valve and configured to dock with the docking coil (Patel [0088]).
With regards to claim 18, Shima as modified by Patel discloses the system of claim 16, wherein the prosthetic heart valve (Patel 60) is configured to be deployed to a mitral valve or a tricuspid valve (Patel FIG 9O, [00119]).
With regards to claim 20, Shima discloses the system of claim 1, but fails to disclose that it is further comprising a deflection mechanism for deflecting the sheath.
Patel discloses a system for insertion within a portion of a patient’s body (2), where the system has a sheath (20) an inner lumen (a guide wire can be introduced through the sheath [0088]), and a catheter (24, 64, 114). Patel teaches a deflection mechanism (135, 136) for deflecting the sheath (20). Therefore, 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 Shima’s system for insertion to include a deflection mechanism for deflecting the sheath, as taught by Patel, in order to control bending of the system ([00147]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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