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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 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.
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) 1-9 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2018/0116790 (Ratz et al.) in view of USPAP 2021/0275299 (Peterson et al.).
Ratz discloses an implant delivery system for delivering a replacement heart valve implant to a native valve annulus, comprising:
an elongate shaft assembly including an implant holding portion (see implant positioned over inner catheter 124 within the distal portion of the sheath 114; fig. 22) comprising a proximal sheath (114) and a distal sheath (219) and an inner catheter (124 or 122) extending through the implant holding portion (Fig. 2A and 22);
wherein the implant holding portion is configured to constrain a replacement heart valve implant in a radially collapsed configuration (see Fig. 2A and 22);
wherein the elongate shaft assembly includes a secondary visual indicator (annular recess 239 of stent holder 132; wherein Ratz discloses the entire nosecone assembly can be radiopaque and viewable under fluoroscopy [0067]).
The phrase “configured to be visible under fluoroscopy with the imaging device when the imaging device is aligned with a reference plane associated with the native valve annulus; wherein the secondary visual indicator is not visible under fluoroscopy with the imaging device when the imaging device is misaligned with the reference plane associated with the native valve annulus” is a functional recitation that is not given full patentable weight, in that the prior art is not required to explicitly disclose the function but merely have the capability of performing the recited function. In this case, Applicant has disclosed an annular recess is capable of performing the recited function. Therefore, the annular recess (239) on the stent holder of Ratz having all the structural requirements of a secondary visual indicator is considered to be capable of indicating alignment with a reference plane of a target valve.
The Examiner notes that the term “reference plane associated with the native valve annulus” is given its broadest reasonable interpretation to encompass any arbitrarily assigned plane, as the limitation does not specify a particular direction of the plane relative to any particular patient anatomy.
Further regarding claim 1: Although the shaft assembly comprises a visual indicator (radiopaque marker 117) on the outer sheath (114) [0123], Ratz fails to disclose that a primary visual indicator is located on an inner catheter (124 or 122) within the interior of the heart valve implant. Peterson discloses another vascular implant delivery device configured to provide visual alignment of the implant with patient anatomy [0074], such as within a native valve annulus [0077]. Peterson teaches that a primary visual indicator (108 and/or 110) may be located on an inner shaft (114) of the delivery system at a location within the interior of the implant (104) to aid in indicating the location of the prosthesis along the central axis (see Figure 1B; [0075]). Peterson further teaches it is obvious to configure radiopaque markers in any shape and size to facilitate installation of the implant [0078]. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide a primary visual indicator on the inner catheter of Ratz that is positioned within the implant, as taught by Peterson, since the modification merely obtains a predictable result of providing visual indicators that assist in determining alignment of a prosthesis with patient anatomy.
Regarding claim 2, the phrase “a desired insertion depth of the replacement heart valve implant relative to the reference plane associated with the native valve annulus is about 7 millimeters from the reference plane associated with the native valve annulus to an inflow end of the replacement heart valve implant” is directed towards an intended use of the device and not given patentable weight. The capability of the Ratz assembly to place the prosthetic heart valve such that it is 7 mm from a reference plane of the native annulus meets the claim requirement.
Regarding claim 3, the primary visual indicator (117) is capable of indicating to the operator the actual insertion depth of the replacement heart valve implant relative to the reference plane associated with the native valve annulus, since it indicates a position of the heart valve in the delivery configuration of Fig. 1.
Regarding claim 4, the phrase “wherein when the secondary visual indicator is visible under fluoroscopy and the primary visual indicator is aligned with the reference plane under fluoroscopy, the actual insertion depth is within 10% of the desired insertion depth” is a functional recitation that is not given full patentable weight, in that the prior art is not required to explicitly disclose the function but merely have the capability of performing the recited function. In this case, the assembly is capable of being placed relative to some existing heart valve such that the secondary indicator (annular recess 239) is visible and the primary marker (117) is aligned with a reference plane of the valve, such that the actual insertion depth is within 10% of the desired insertion depth. As known in the art, the particular size and shape of the native annulus varies widely dependent on patient age, height, health, race, gender, etc.
Regarding claim 5: similar to claim 4, the claim is not given full patentable weight. The Ratz device is capable of being positioned relative to some existing valve and some assigned “reference plane” such that the secondary visual indicator (annular recess 239) is not be visible under fluoroscopy and the primary visual indicator is aligned with the reference plane when an actual insertion depth deviates from desired insertion depth by at least 10%.
Regarding claim 6: the elongate shaft assembly includes a stent holder (132) configured to engage an expandable framework of the replacement heart valve implant (70) in the radially collapsed configuration (Fig. 21; [0130]).
Regarding claim 7, the secondary visual indicator comprises an annular recess (239) formed within the stent holder (132) [0131].
Regarding claim 8: the phrase “wherein when the imaging device is aligned with the reference plane associated with the native valve annulus and the primary visual indicator is aligned with the reference plane under fluoroscopy, the annular recess is visible to the imaging device as a void oriented generally parallel to the reference plane” is functional recitation that is not given full patentable weight, in that the prior art is not required to explicitly disclose the function but merely have the capability of performing the recited function. In this case, Applicant has disclosed an annular recess is capable of performing the recited function. Therefore, the annular recess (239) on the stent holder (132) of Ratz having all the structural requirements of a secondary visual indicator is considered to be capable of being visible as a void oriented generally parallel to some assigned reference plane of a valve when the marker (117) and an imaging device are aligned with the reference plane.
Regarding claim 9, similar to claim 8, the annular recess is capable of being at least partially obscured from viewing by the imaging device wherein when an imaging device is misaligned with the reference plane associated with the native valve annulus and the primary visual indicator is aligned with the reference plane under fluoroscopy.
Regarding claim 12, it would have been an obvious matter of design choice to arrange the primary visual indicator taught by Peterson to be axially spaced apart from the secondary visual indicator (239) of Ratz, to obtain predictable results of indicating alignment of the delivery system to an operator.
Regarding claim 13, Ratz discloses a replacement heart valve implant (70) comprising an expandable framework (71) and a plurality of valve leaflets (92) secured to the expandable framework [0048-0050], the expandable framework being configured to shift between a radially collapsed configuration (Figure 2A) and a radially expanded configuration (Fig. 10, 14). Ratz, as modified above in regard to claim 1, teaches all the features of the delivery system in claim 13.
The phrase “a secondary visual indicator configured to be visible under fluoroscopy with the imaging device when the imaging device is aligned with a reference plane associated with the native valve annulus; wherein the secondary visual indicator is not visible under fluoroscopy with the imaging device when the imaging device is misaligned with the reference plane associated with the native valve annulus” is a functional recitation that is not given full patentable weight, in that the prior art is not required to explicitly disclose the function but merely have the capability of performing the recited function. In this case, Applicant has disclosed an annular recess is capable of performing the recited function. Therefore, the annular recess (239) on the stent holder of Ratz having all the structural requirements of a secondary visual indicator is considered to be capable of indicating alignment with a reference plane of a target valve.
Regarding claim 14, the imaging device is not positively recited here and only recited as part of the intended use of the delivery system. Therefore, the prior art is not required to disclose an imaging system. Nonetheless, Ratz discloses the use of fluoroscopy during delivery [0067; 0088; 0092]).
Regarding claim 15, the phrase “configured to position the replacement heart valve implant within the native valve annulus at an actual insertion depth relative to a reference plane associated with the native valve annulus that is within 10% of a desired insertion depth” is a functional recitation that is not given full patentable weight, in that the prior art is not required to explicitly disclose the function but merely have the capability of performing the recited function. In this case, the assembly is capable of being placed relative to some existing heart valve such that the secondary indicator (annular recess 239) is visible and the primary marker (117) is aligned with a reference plane of the valve, such that the actual insertion depth is within 10% of the desired insertion depth. As known in the art, the particular size and shape of the native annulus varies widely dependent on patient age, height, health, race, gender, etc.
Regarding claim 16: similar to claim 15, the claim is not given full patentable weight. The Ratz device is capable of being positioned relative to some existing valve and some assigned “reference plane” such that the secondary visual indicator (annular recess 239) is not be visible under fluoroscopy and the primary visual indicator is aligned with the reference plane.
Regarding claim 17: Modified Ratz discloses all the claimed components of the delivery system. Ratz teaches the steps of advancing the delivery system to a position adjacent the native valve annulus (Figure 16A-F) while the replacement heart valve implant is constrained within an implant holding portion of the implant delivery system; using imaging to confirm alignment with the annulus (106) ([0093]; [0154]); visualizing the radiopaque nosecone under fluoroscopy [0067]; and using a radiopaque marker to align the delivery system with the native valve annulus [0123]. Peterson teaches that the primary markers (108 and 110) are used to determine alignment of the implant (102) along the central axis A [0075] while the implant is in the constrained configuration and positioned at a native valve annulus [0077]. Additionally Peterson teaches that when expanded, the markers (108 and 110) are used to align the implant (102) with and ensure it is properly engaged with native structures of the surrounding anatomy [0076].
Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to algin the primary visual indicator of the delivery system with a reference plane of a native valve annulus under fluoroscopy, visualizing the secondary visual indicator (the radiopaque nosecone of Ratz) when it is aligned with a reference plane of the native annulus, and determining that the imaging device is aligned with the reference plane based on visibility of the secondary visual indicator. The language “…determining, based on visibility of the secondary visual indicator, that the imaging device is aligned with the reference plane…” is given its broadest reasonable interpretation to encompass a wide variety of planes that may be arbitrarily drawn through a heart valve annulus. Since the nosecone is radiopaque and viewed under fluoroscopy ([0067] of Ratz), visibility of the secondary visual indicator may indicate to an operator that the imaging device is sufficiently aligned with at least some plane associated with the native annulus.
Regarding claim 18, both the primary and secondary visual indicators of modified Ratz are considered to be capable of being visible when aligned with at least some plane associated with a native heart valve. Further, the secondary visual indicator of modified Ratz (annular recess 239 on the stent holder) is considered to be capable of not being visible under fluoroscopy when the imaging device is misaligned with at least some reference plane associated with the native annulus, Applicant has disclosed an annular recess is capable of performing the recited function. Additionally or alternatively, various objects may obstruct the view of the radiopaque nosecone, such as another surgical instrument, patient anatomy.
Regarding claim 19, the term “when the primary visual is aligned…” and “when the imaging device is not oriented” is not a positive recitation of a method step. Rather, the capability of modified Ratz to be used in the recited manner meets the claim requirements. Since Ratz discloses the secondary visual indicator is a recess in a radiopaque nosecone, and Applicant has disclosed a recess is capable of being used in the claimed manner, the modified Ratz assembly is capable of being used such that the recess is not visible if the imaging device is not properly aligned with the valve annulus.
Regarding claim 20, Ratz discloses the secondary visual indicator is a recess (239) in a radiopaque stent holder (132) [0067], wherein the stent holder engages the expandable framework of the implant when it is constrained.
Claim(s) 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ratz in view of Peterson, as applied to claim 1 above, and further in view of USPAP 2014/0277340 (White et al.).
Although Ratz is silent with respect to the width of the recess (239), Ratz does disclose the recess is configured to receive struts of a stent frame. White discloses another implant delivery system with a stent retaining feature (8610; Fig. 86A) having grooves configured to receive stent struts (8620) in a delivery configuration (see Fig. 86E; [0245]). White teaches that the width of the struts is approximately 0.016 0.018 inch [0227], which converts to 0.4 – 0.46 mm, wherein it can be seen that the strut receiving recesses (between bosses 8612) approximate this width. Since White teaches that it is known for stent strut width to be on the order of 0.4 mm, it would have been obvious to one of ordinary skill in the art to configure the annular recess of the Ratz device to have a width of 0.3 – 0.4 mm, in order to closely approximate the width of stent struts for retention purposes.
In regard to claim 11, it would have been further obvious to configure the annular recess of Ratz to have a radial depth defining a “remaining radial material thickness” of 0.07 +/- 0.01 millimeters. Since the claims have not defined a removed or remaining material, the limitation “remaining radial material” is given its broadest reasonable interpretation to encompass at least some portion of the boss or material surrounding the recess having a thickness of at least 0.07 mm.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. USPAP 2020/0323634 (Von Oepen et al.) discloses a secondary visual indicator (205) having an annular shape (see groove 256 in rim 220 into which indicator is received in Fig. 2B; [0036]) capable of performing the function of being visible when the imaging device is aligned with a reference plane associated with the native valve annulus (see also Fig. 6A-B; [0047]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
