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 . Claims 1-7, & 11-28 are pending and examined below.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive. Applicant argues that the amendments to the independent claim overcome the rejections of record (pages 9-18) and that the dependent claims rise and fall with the same arguments (pages 9-18).
Regarding applicants argument in reference to the foot 450 of prior art, Sinnott, not being capable of clamping a leaflet, the examiner respectfully disagree. The surfaces of the suture passer can be capable to clamp a leaflet against its surface, by pressing against the backside of the leaflet, or using the needle to press it against the surface of leaflet. Where it is being pressed against or clamped to one surface would mean the leaflet would be between the two surfaces, and Sinnott’s device would be capable of clamping a leaflet.
Although the applicant argues that the jaw is moveable to hold the leaflet (pgs. 11-12), this is not what claim 1 recites. Claim 1 recites “the leaflet grabbing structure is capable of clamping a leaflet “ and in this case, the Sinnott’s device discloses the claimed structural features of the leaflet grabbing structure, and is considered to be capable of performing the function of clamping a leaflet. The limitations are interpreted in light of the specification but not read into the claims. Therefore, the applicant’s argument is not sufficient to overcome the rejection of record and the claims remains rejected.
In regards to the 112b rejections, claims 5-6, 13-16, and parts of claim 27 have overcome the rejection of record. Claim 27 still recites the limitation “the implant that has a proximal implant part” in line 2. Claim 27 does not overcome the 112b rejection of record. This must be corrected prior to issue of allowance. Please see the rejection below.
Claim Rejections - 35 USC § 112
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 27 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 27 recites the limitation “the implant that has a proximal implant part,” is unclear whether this is the same or different proximal implant part from Claim 1. For the purpose of examination, they are regarded as the same implant.
Claim Objections
Claim 4 objected to because of the following informalities:
Claim 4 recites the limitation “at least a part of an implant” in line 4. It is unclear whether this is the same or different implant from claim 1. For the purpose of examination, they are regarded as the same.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-7, 11-20, & 22-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinnott et al. (US 20170202550 A1) hereinafter, Sinnott, in view of Lam et al. (US 20060271073 A1) hereinafter, Lam, and further in view of Caffes et al. (US 20190290260 A1) hereinafter, Caffes.
Regarding claim 1, Sinnott teaches an instrument (100, Fig. 1), the instrument comprising (100, Fig. 1):
a tubular arrangement defining an axis (456, Fig. 10A) and an axial direction (100 is tubular shaped, Fig. 1);
a leaflet grabbing structure (450, Fig. 2), the leaflet grabbing structure comprising a main body (left portion of 450, Fig. 9) and a jaw (468, Fig. 9); wherein the jaw comprises a first proximally facing abutment surface (474, Fig. 10A) and the main body comprises a second, distally facing abutment surface (492, Fig. 10A);
the instrument further comprising a needle (350, Fig. 2), and wherein the needle is movable relative to the main body in axial directions (Figs. 2 & 24), the needle being configured to accommodate an implant (500, Fig. 26) that has a proximal implant part (504, Fig. 30), a distal implant part (502, Fig. Fig. 30), and a chord (suture 500 between 502 & 504, Fig. 30) connecting the distal implant part and the proximal implant part to each other (Fig. 30); whereby
the leaflet grabbing structure (450, Fig. 2) is capable of clamping a leaflet (510, Fig. 28) of the heart valve between the first and second abutment surfaces (474 & 492 respectively, Fig 10A, ¶0065); and wherein
the main body (left portion of 450, Fig. 9) has a main body channel (454, Fig. 9) with a main body channel distal portion open to a lateral side (454 opens up to opening area between 464 & 474, Figs. 9 & 10A) and extending to a distal end of the main body (Fig. 9), and
the jaw (468, Fig. 9) has a jaw channel (472 with 484, Fig. 9) open to the lateral side (Fig. 9) and extending through the jaw from the proximally facing abutment surface (474, Fig. 10A) of the jaw to a distal side (476, Fig. 10A) of the jaw, wherein,
the main body channel (454, Fig. 9) and the jaw channel (472 with 484, Fig. 9) are aligned axially to form a common channel (common channel formed with axis 456, Fig. 9), wherein
the needle is movable through the main body channel and the jaw channel (Fig. 24) so as to project from the jaw channel at the distal side of the while the leaflet is clamped between the first and second abutment surfaces (Fig. 29), wherein
the jaw channel (472 with 484, Fig. 9) is open to the lateral side along a full axial length of the jaw channel (Fig. 9), so that after implantation of the distal implant part distally of the clamped leaflet and after retraction of the needle, the proximal implant part, while the chord is attached to both the proximal implant part and to the implanted distal implant part, is capable of escaping from the main body channel to the lateral side (¶0065).
Sinnott teaches a needle but does not disclose the needle to be cannulated. However, Lam teaches methods and apparatus for securing and deploying tissue anchors (abstract, Lam) wherein
wherein the needle (needle deployment assembly 60', Figs. 15A-15C, Lam), is cannulated (needle lumen or opening 74, Fig. 13, Lam) and forms an inner tube (needle lumen or opening 74, Fig. 13, Lam).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott with the above teachings of Lam in order to allow one or more tissue anchors to be deployed for securing the tissue (¶0050, Lam).
Sinnott in view of Lam teaches an instrument to pass a suture but does not disclose it for repairing an atrioventricular heart valve in a minimally invasive manner. However, Caffes teaches a suture attachment catheter configured to repair a heart valve (abstract, Caffes)
for repairing an atrioventricular heart valve in a minimally invasive manner (¶0007, Caffes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott and Lam with the above teachings of Caffes in order to provide minimally invasive systems and methods for intravascularly accessing the heart and performing a transcatheter repair of a heart valve (¶0007, Caffes).
Regarding claim 2, Sinnott teaches
wherein the common channel (common channel formed with axis 456, Fig. 9, Sinnott) has a position that is not central with respect to the tube axis (Fig. 9, Sinnott).
Regarding claim 3, Sinnott and Lam does not teach the jaw is moveable. However, Caffes teaches
wherein the jaw is movable relative to the main body in the axial direction (proximal jaw 108 is selectively slideable along rail 110, Fig. 1A, ¶0034, Caffes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott and Lam with the above teachings of Caffes in order to effectively increase the distance between the proximal jaw and the distal jaw (¶0034, Caffes).
Regarding claim 4, Sinnott does not disclose an anchor carrier. However, Lam teaches
wherein the instrument further comprises an anchor carrier (76, Fig. 15D, Lam) being arranged within the inner tube (needle lumen or opening 74, Fig. 14, Lam) and being axially movable relative to it (Figs. 15D-15F, Lam), the anchor carrier being configured to carry at least a part of an implant (84, Fig. 15D, Lam) that is secured or capable of being secured to an artificial chord (132’, Fig. 15C, Lam).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott with the above teachings of Lam in order to allow one or more tissue anchors to be deployed for securing the tissue (¶0050, Lam).
Regarding claim 5, Sinnott does not disclose an anchor carrier. However, Lam teaches
being configured for a distal implant part (82, Fig. 15C, Lam) and a proximal implant part (84, Fig. 15C, Lam) being arranged beside one another (Fig. 15A, Lam), with the proximal implant part (84, Fig. 15C, Lam) arranged proximally of the distal implant part (82, Fig. 15C, Lam), wherein the anchor carrier (76, Fig. 15D, Lam) forms an anchor seat (distal part of 76, Fig. 15C, Lam) that is configured to carry the proximal implant part (84, Fig. 15C, Lam) of the implant.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott with the above teachings of Lam in order to allow one or more tissue anchors to be deployed for securing the tissue (¶0050, Lam).
Regarding claim 6, Sinnott does not disclose the proximal implant part from escaping from the anchor carrier. However, Lam teaches
wherein the inner tube (needle lumen or opening 74, Fig. 13, Lam) or a sleeve element inside the inner tube prevents the proximal implant part (84, Fig. 15C, Lam) from escaping from the anchor carrier (76, Fig. 15D, Lam) as long as the proximal implant part (84, Fig. 15C, Lam) is received in the anchor seat and is within the inner tube (needle lumen or opening 74, Fig. 14, Lam) or sleeve element.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott with the above teachings of Lam in order to eject distal anchor 82 on the distal side of the approximate tissue while proximal anchor 84 remains in the needle deployment assembly and can be disposed on the proximal side of the approximated tissue (Fig. 15C, ¶0081, Lam).
Regarding claim 7, Sinnott in view of Lam does not teach a marker for determining a position by echography and/or radiography. However, Caffes teaches
wherein the anchor carrier comprises a marker for determining a position by echography and/or radiography (echocardiography, ¶0005, Caffes), and wherein the main body and/or the jaw comprises a marker for determining a position by echography and/or radiography, for determination of relative positions of the anchor carrier and of the main body and/or jaw (fiber optic cables 359, Fig. 7, Caffes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott and Lam with the above teachings of Caffes in order to aid in verifying proper leaflet capture (¶0048, Caffes).
Regarding claim 11, the combination of Sinnott, Lam, and Caffes teaches
wherein the common channel (common channel formed with axis 456, Fig. 9, Sinnott) is open to the lateral side by the main body (left portion of 450, Fig. 9, Sinnott) and the jaw (468, Fig. 9, Sinnott) having a recess (484, Fig. 9, Sinnott) that has a distal recess portion (distal tip of 484, Fig. 9, Sinnott) and proximally thereof, an implant release portion (portion between 492 and 474, Fig. 10A, Sinnott), wherein the implant release portion of the recess runs in the main body (Fig. 9, Sinnott), and wherein the implant release portion of the recess is wider than the distal recess portion (Fig. 9, Sinnott).
Regarding claim 12, the combination of Sinnott, Lam, and Caffes teaches
wherein the distal recess portion has a first sub-portion running in the jaw and a second sub-portion running in the main body, distally of the implant release portion (Fig. 9, Sinnott).
Regarding claim 13, the combination of Sinnott, Lam, and Caffes teaches
wherein an opening angle α of the recess by which the main body channel is open to the lateral side is at least 45o (angle 470 preferably 35 to 45 degrees, ¶0058, Sinnott).
Regarding claim 14, Sinnott does not teach a tube encompassing the cannulated needle. However, Lam teaches
further comprising a needle guide (64, Fig. 5A, Lam) being a tube encompassing the cannulated needle and being accommodated inside the main body channel (Fig. 5A, ¶0054, Lam).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott with the above teachings of Lam in order maintaining communication between the lumen of sheath 64 and needle opening 74 (¶0054, Lam).
Regarding claim 15, the combination of Sinnott, Lam, and Caffes teaches
wherein the jaw channel is open to a single lateral side (Fig. 9, Sinnott).
Regarding claim 16, the combination of Sinnott, Lam, and Caffes teaches
wherein the first and second abutment surfaces (474 & 492 respectively, Fig. 10A, ¶0065, Sinnott) at a position around a mouth of the jaw channel in the first abutment surface and a mouth of the main body channel in the second abutment surface, define at least one plane being at an angle different from 90o to the tube axis (Figs. 9-10A, Sinnott).
Regarding claim 17, the combination of Sinnott, Lam, and Caffes teaches
wherein a distal end of the needle (364, Fig. 11, Sinnott) defines a distal needle end plane (382, Fig. 11, Sinnott) that is at an angle different from 90o to the axis (456, Fig. 24, Sinnott), and wherein the distal needle end plane and the plane defined by the first and second abutment surfaces (474 & 492 respectively, Fig. 10A, ¶0065, Sinnott) are inclined in different directions (Figs. 9 & 24, Sinnott).
Regarding claim 18, Sinnott and Lam does not teach axial movement of the jaw. However, Caffes teaches
further comprising an operating mechanism suitable to operate the axial movement of the jaw relative to the main body and to adjust the distance between the main body and the jaw, wherein the operating mechanism comprises a push-pull rod or a threaded rod (proximal jaw 108 can selectively slide along rail 110 between a first, proximal position in Figs. 1A & 1B and second, distal position in Fig. 1C where sliding is equivalent to a push pull rod, ¶0034, Caffes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott and Lam with the above teachings of Caffes in order to effectively increase the distance between the proximal jaw and the distal jaw (¶0034, Caffes).
Regarding claim 19, the combination of Sinnott, Lam, and Caffes teaches
further comprising at least one guiding rod (462, Fig. 10A, Sinnott) configured to prevent non-axial movements of the jaw (468, Fig. 9, Sinnott) relative to the main body.
Regarding claim 20, Sinnott does not teach a guidewire. However, Lam teaches
wherein the main body and the jaw further comprise a guide wire channel (12, Fig. 11A, Lam) suitable to incorporate a guide wire (152, Fig. 11A, Lam).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott with the above teachings of Lam in order to articulate the launch tube configuration as well as jaw member articulation (¶0077, Lam).
Regarding claim 22, the combination of Sinnott, Lam, and Caffes teaches
wherein the tubular arrangement (100 is tubular shaped, Fig. 1, Sinnott) comprises a first tube (300, Fig. 2, Sinnott), wherein the leaflet grabbing structure (450, Fig. 2, Sinnott) is arranged at a distal part of the first tube (300, Fig. 1, Sinnott) and is contiguous to the first tube, and wherein the needle (350, Fig. 2, Sinnott) is releasable from the first tube and movable relative to the main body (left portion of 450, Fig. 9, Sinnott) in axial directions (Figs. 22 & 24, Sinnott).
Regarding claim 23, Sinnott teaches
wherein the tubular arrangement comprises an outer catheter (400, Fig. 1, Sinnott) being configured as a guide catheter. Sinnott does not teach the outer catheter being dimensioned to accommodate the leaflet grabbing structure. However, Lam teaches
the outer catheter (92, Fig. 8D, Lam) being dimensioned to accommodate the leaflet grabbing structure (20 & 22, Fig. 8D, Lam) within an interior of the outer catheter (92, Fig. 8D, Lam).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott with the above teachings of Lam in order to maintain its configuration within the patient body (¶0066, Lam).
Regarding claim 24, Sinnott and Lam does not teach determining the relative positions of the jaw and the main body by echography and/or radiography. However, Caffes teaches
wherein the jaw (proximal jaw 308, Fig. 7, Caffes) and the main body (body near proximal jaw 308, Fig. 7, Caffes) each comprise a marker (fiber optic cables 359, Fig. 7, Caffes) for determining the relative positions of the jaw and the main body by echography and/or radiography (echocardiography, ¶0005, Caffes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott and Lam with the above teachings of Caffes in order to aid in verifying proper leaflet capture (¶0048, Caffes).
Regarding claim 25, Sinnott and Lam does not teach a fold-out structure. However, Caffes teaches
further comprising a fold-out structure (1114, Figs. 10A-10C, Caffes) equipped to fold out and to protrude, when folded out, radially-outward out of the cylindrical volume defined by the outer surface of the main body and jaw (stabilizing loops 1114 protrude and fold out of leaflet capture catheter 1102, Figs. 10A-10C, Caffes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott and Lam with the above teachings of Caffes in order to provide additional area for leaflet contact in order to increase the time and efficiency of leaflet capture (¶0053, Caffes).
Regarding claim 26, Sinnott and Lam does not teach a fold-out structure. However, Caffes teaches
wherein the fold-out structure (1114, Figs. 10A-10C, Caffes) is a fold-out support extending an area of at least one of the abutment surface (1108, Fig. 10C, Caffes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott and Lam with the above teachings of Caffes in order to provide additional area for leaflet contact in order to increase the time and efficiency of leaflet capture (¶0053, Caffes).
Regarding claim 27, Sinnott teaches
an assembly, comprising the instrument according to claim 1, and further comprising the implant (500, Fig. 26, Sinnott) that has a proximal implant part (504, Fig. 30, Sinnott), the distal implant part (502, Fig. Fig. 30, Sinnott), and the chord (suture 500 between 502 & 504, Fig. 30, Sinnott) connecting the proximal implant part and the distal implant part. Sinnott does not teach the implant being accommodated within the needle. However, Lam teaches
the implant (82 & 84, Figs. 15A-C, Lam) being accommodated within the needle with the distal implant part (82, Fig. 15C, Lam) being arranged distally of the proximal implant part (84, Fig. 15C, Lam).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott with the above teachings of Lam in order to allow one or more tissue anchors to be deployed for securing the tissue (¶0050, Lam).
Regarding claim 28, the combination of Sinnott, Lam, and Caffes teaches
a method of replacing or supplementing damaged natural chordae tendineae of a human or animal heart of a patient in need thereof, the method comprising using the instrument according to claim 1 for implanting an implant that has a chord (suture 500 between 502 & 504, Fig. 30, Sinnott) replacing or supplementing the damaged natural chordae tendinae.
Sinnott in view of Lam teaches the method comprising using the instrument according to claim 1 for implanting the implant that has the chord but does not specify the method of replacing or supplementing damaged natural chordae tendineae of a human or animal heart of a patient in need thereof. However, Caffes teaches
a method of replacing or supplementing damaged natural chordae tendineae of a human or animal heart of a patient in need thereof, replacing or supplementing the damaged natural chordae tendinae (method of inserting a suture in a beating heart of a patient to function as an artificial chordae, Figs. 17A-17G, ¶0027, Caffes).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sinnott and Lam with the above teachings of Caffes in order to provide a minimally invasive systems and methods for intravascularly accessing the heart and performing a transcatheter repair of a heart valve by inserting a suture as an artificial chordae into a heart valve leaflet (¶0007, Caffes).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinnott in view of Lam, Caffes, and further in view of Medema et al. (US 20160220372 A1) hereinafter, Medema.
Regarding claim 21, the combination of Sinnott, Lam, and Caffes teaches
wherein the needle has a sharpened distal end (384, Fig. 12, Sinnott).
Sinnott in view of Lam and Caffes does not disclose the needle from a laser cut section. However, Medema teaches replacement of diseased mitral valve chordae with expanded polytetrafluoroethylene sutures (abstract, Medema) wherein
the needle (needle 202, Fig. 2B, Medema) has a sharpened distal end and proximally therefrom a laser cut section (laser, ¶0052, Medema).
It would have been obvious to one of ordinary skill in the pertinent art before the effective filing date of the claimed invention to modify the teachings of Sinnott, Lam, and Caffes with the above teachings of Medema as it is a known technique in the art to use heat/laser to cut.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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