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 .
Status of Claims
Claims 1-9 and 11-15 are pending and examined below.
Response to Arguments
The remarks of 08/27/2025 have been fully considered but they are not persuasive.
Applicant argues that the prior art of record doesn’t explicitly teach or disclose all the elements of claims 1,11, and 12. Applicant’s arguments are drawn to the following claim language:
“a mechanism disposed on one or more of a distal end of the rigid proximal portion or a proximal end of the flexible distal portion, the mechanism configured to releasably attached to attach the rigid proximal portion to the flexible distal portion”; and
“wherein said sheath is attached to the core element at one or more locations along an axial length of the core element”
These arguments are moot in light of the new 103 rejection below.
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0216078 (Starksen) in view of US 2004/0054301 (Cassell) in view of US 6,039,700 (Sauter)
Regarding claim 1: Starksen discloses a tether-anchor assembly (Fig. 5) comprising:
a tether (Fig. 9B, 534) comprising a proximal portion (see Fig. 9B, wherein 534 comprises a proximal portion) and a distal portion (portion (see Fig. 9B, wherein 534 comprises a distal portion) releasably attached to the proximal portion (¶0085, wherein the distal portion of the tether being cut from the proximal portion corresponds to a releasable attachment); and
a tissue-piercing anchor (Fig. 9B, 526) comprising an eyelet (¶0076, “eyelet”) wherein the distal portion of the tether is coupled to the eyelet (See Fig. 9B, wherein distal portion of tether 534 is coupled to 526 via eyelets).
Starksen doesn’t explicitly teach or disclose a rigid proximal portion and a flexible distal portion.
Cassell discloses a rigid proximal portion (¶0026, a relatively rigid polymer proximate proximal end 14) and a flexible distal portion (¶0026, relatively flexible polymer near distal end 16).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tether of Starksen with a rigid proximal portion and a flexible distal portion, as taught by Cassell, in order to maintain the desired level of stiffness near the proximal end for implantation of a device (¶0032).
Starksen doesn't explicitly teach or discloses a mechanism disposed on one or more of a distal end of the rigid proximal portion or a proximal end of the flexible distal portion, the mechanism configured to releasably attached to attach the rigid proximal portion to the flexible distal portion. Cassell discloses a rigid proximal portion and a flexible distal portion but doesn't explicitly teach or disclose a mechanism configured to releasably attach the two portions.
Sauter discloses a mechanism configured to releasably attached two portions of a guidewire (Fig. 3, wherein connection 7/8 releasably attaches two portions)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the rigid proximal portion and a flexible distal portion with a releasable attachment, as taught by Sauter, in order to release the flexible distal portion after implantation.
Regarding claim 2: Starksen discloses wherein the tissue-piercing anchor (Fig. 9B, 526) is fixedly coupled to said tether (Fig. 9B, 534) via a knot assembly (¶0080, “knot”)
Starksen doesn’t explicitly teach or disclose a flexible distal portion.
Cassel discloses a flexible distal portion (¶0026, relatively flexible polymer near distal end 16).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify tether of Starken with a flexible distal portion, as taught by Cassel, in order to maintain the desired level of stiffness near the proximal end for implantation of a device (¶0032).
Regarding claim 3: Starksen discloses a tether (see rejection of claim 1) but doesn’t explicitly teach or disclose a flexible distal portion with a first torsional stiffness and a rigid proximal portion with a second torsional stiffness.
Cassel discloses wherein the flexible distal portion (¶0026, relatively flexible polymer near distal end 16) has a first torsional stiffness and the rigid proximal portion (¶0026, relatively flexible polymer near distal end 16) has a second torsional stiffness that is higher than the first torsional stiffness (¶0023, wherein using filler can increase torsional stiffness)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tether of Starksen with a first torsional stiffness and a second torsional stiffness, as taught by Cassel, in order to produce strength where needed while allowing for fine movement in other areas of the tether.
Claim(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0216078 (Starksen) in view of US 2004/0054301 (Cassell) in view of US 6,039,700 (Sauter), as applied to claims above, and further in view of US 5,538,513 (Okajima)
Regarding claim 4, Starken doesn’t explicitly teach or disclose material properties related to a compression test. Cassell doesn’t explicitly teach or disclose material properties related to a compression test. Sauter doesn't explicitly teach or disclose material properties related to a compression test.
Okajima discloses wherein the force required to cause the rigid proximal portion (22) to yield in a compression test is greater than the force required to cause the flexible distal portion (23) to yield in a compression test (column 2, lines 37-44; Table 1).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tether of Starksen in view of Cassell in view of Sauter with a rigid portion with greater compressive strength, as taught by Okajima, in order to provide several variations on the rigidity facilitating excellent kink-resistant, pushing, and torque transmission characteristics as well as higher safety (Okajima, column 3, lines 18-31).
Regarding claim 5, Starksen discloses a tether (Fig. 9B, 534) with a proximal portion (Fig. 9B, wherein the portion proximal to the most proximal anchor corresponds to the proximal portion) but doesn’t explicitly further separate the proximal portion into a first and second portion. Cassell doesn’t explicitly separate the proximal portion into a first and second portion. Sauter doesn't explicitly teach or disclose doesn’t explicitly separate the proximal portion into a first and second portion
Okajima discloses wherein the rigid proximal portion (22) comprises a first portion (222) and a second portion (221), wherein the first portion (222) is more rigid than the second portion (221; column 6, lines 39-53).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the proximal portion of the tether of Starksen in view of Cassell in view of Sauter with a first portion that is more rigid than the second portion, as taught by Okajima, because doing so would provide several variations on the rigidity facilitating excellent kink-resistant, pushing, and torque transmission characteristics as well as higher safety (Okajima, column 3, lines 18-31).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0107812 (Fabro) in view of US 2010/0121319 (Chu) in view of US 2013/0253474 (Farhangnia)
Regarding claim 6, Fabro discloses a tether (Fig. 9B, 520), comprising:
a core element (Fig. 9B, 534) having a distal portion and a proximal portion (See Fig. 9B, wherein 534 has a distal and proximal portion);
wherein said proximal portion is located in a tubular sheath (¶0090, termination device, see also ¶0025 wherein termination device can be a sheath); and
wherein said distal portion is configured to be used as a tensioning element (¶0085, wherein tether 534 is configured for this intended use because it can be cinched) and detachable from said proximal portion of said core element (¶0085, wherein 534 is detachable because it can be cut by the termination device).
Fabro doesn’t explicitly teach or disclose said sheath having a higher torsional stiffness than said core element
Chu discloses wherein the sheath has a higher torsional stiffness than the tether (¶0088, wherein sheath 138 comprises stiffening elements to increase torqueability, and therefore has a higher torsional stiffness than the tether)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the sheath of Fabro to have a greater torsional stiffness than the tether, as taught by Chu, in order to prevent issues such as kinking while the device is being advanced through the body.
Fabro discloses a core (Fig. 9B, 534) and a sheath (¶0090, termination device, see also ¶0025 wherein termination device can be a sheath) but doesn't explicitly teach or disclose wherein said sheath is attached to the core element at one or more locations along an axial length of the core element. Chu doesn't explicitly teach or disclose wherein said sheath is attached to the core element at one or more locations along an axial length of the core element
Farhangnia discloses wherein said sheath (Fig. 1J, 68) is attached (Fig. 1J, 60) to the core element (Fig. 1J, 60) at one or more locations along an axial length of the core element (Fig. 1J, see also ¶0077, “the sheath 68 may be attached 60 to solid core guidewire and or flexible device 67”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the sheath and core of Fabro in view of Chu to be connected at one or more locations along an axial length of the core element, as taught by Farhangnia, in order to reduce friction while navigating the guidewire.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0107812 (Fabro) in view of US 2010/0121319 (Chu) in view of US 2013/0253474 (Farhangnia), as applied above, and further in view of US 2005/0192581 (Molz)
Regarding claim 7, Fabro discloses a sheath (see rejection of claim 6) but doesn’t explicitly teach or disclose a biodegradable sheath. Chu doesn’t explicitly teach or disclose a biodegradable sheath. Farhangnia doesn’t explicitly teach or disclose a biodegradable sheath
Molz discloses a tether (Fig. 1, 12, ¶0020) with a sheath (Fig. 1, 18, ¶0020) made from biodegradable material (claim 27, wherein sheath is composed of biodegradable material)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the sheath of Fabro in view of Chu in view of Farhangnia with biodegradable material, as taught by Molz, in order to remove the sheath after implantation without the need for an additional procedure.
Regarding claim 8, Fabro discloses a sheath (see rejection of claim 6) but doesn’t explicitly teach or disclose that it is made from a non-biodegradable material. Chu doesn’t explicitly teach or disclose a non-biodegradable material. Farhangnia doesn’t explicitly teach or disclose a doesn’t explicitly teach or disclose a non-biodegradable material.
Molz discloses a tether (Fig. 1, 12, ¶0020) with a sheath (Fig. 1, 18, ¶0020) made from non-biodegradable material (claim 28, wherein sheath is composed of a non-biodegradable material)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the sheath of Fabro in view of Chu in view of Farhangnia with a non-biodegradable material, as taught by Molz, in order to retain the sheath after implantation.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0107812 (Fabro) in view of US 2010/0121319 (Chu) in view of US 2013/0253474 (Farhangnia), as applied to claims above, and further in view of US 2010/0198208 (Napp)
Regarding claim 9, Fabro discloses a sheath with a distal portion (see rejection of claim 6) but doesn’t explicitly teach or disclose that the distal portion is in the range from about 5cm to about 30cm in length. Chu doesn’t explicitly teach or disclose that the distal portion is in the range from about 5cm to about 30cm in length. Farhangnia doesn’t explicitly teach or disclose that the distal portion is in the range from about 5cm to about 30cm in length
Napp discloses wherein said distal portion is in the range of from about 5 cm to about 30cm in length (¶0435, “5cm to about 10cm”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the distal portion of the core element of Fabro in view of Chu in view of Farhangnia to be between 5cm to 30cm in length, as taught by Napp, in order to easily navigate the aorta and the valves within the heart during implantation.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0107812 (Fabro) in view of US 2010/0121319 (Chu) in view of US 6,039,700 (Sauter)
Regarding claim 11, Fabro discloses a tether (Fig. 9B, 520), comprising:
a core element (Fig. 9B, 534) having a distal portion and a proximal portion (See Fig. 9B, wherein 534 has a distal and proximal portion); and
wherein said distal portion is configured to be used as a tensioning element (¶0085, wherein tether 534 is configured for this intended use because it can be cinched at the distal portion) and detachable from said proximal portion of said core element (¶0085, wherein the distal portion of 534 is detachable because it can be cut by the termination device).
Fabro doesn’t explicitly teach or disclose a coating to increase torsional stiffness.
Chu discloses a coating (¶0088, coating) to increase torsional stiffness (¶0088, wherein increased torqueability corresponds to increased torsional stiffness)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the proximal portion of the core element of Fabro with a coating to increase torsional stiffness, as taught by Chu, in order to make the device more resilient.
Fabro doesn't explicitly teach or disclose a mechanism disposed on one or more of a distal end of the proximal portion or a proximal end of the distal portion, the mechanism configured to detach the distal portion from said proximal portion. Chu doesn't explicitly teach or disclose a mechanism disposed on one or more of a distal end of the proximal portion or a proximal end of the distal portion, the mechanism configured to detach the distal portion from said proximal portion
Sauter discloses a mechanism configured to releasably attach two portions of a guidewire (Fig. 3, wherein connection 7/8 releasably attaches two portions)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the rigid proximal portion and the flexible distal portion of Fabro in view of Chu with a releasable attachment, as taught by Sauter, in order to release the flexible distal portion after implantation.
Claim(s) 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0216078 (Starksen) in view of US 2004/0054301 (Cassell) in view of US 2007/0055206 (To et al.) in view of US 6,039,700 (Sauter)
Regarding claim 12, Starksen discloses a method of using a tether (Fig. 10B, tether 534), comprising:
advancing a tether (¶0083, wherein 520 is advanced and includes tether 534) to a predetermined location (¶0083, wherein the mitral valve corresponds to a predetermined location);
advancing a surgical device (¶0086, wherein the termination device corresponds to a surgical device) over said tether (Fig. 10D, 534);
detaching said flexible distal portion from said proximal portion (¶0096, wherein cutting tether 534 corresponds to detaching);
Starksen discloses a tether (Fig. 10B, 534) but doesn’t explicitly teach or disclose a rigid proximal portion and a flexible distal portion.
Cassell discloses a tether (Fig. 1, guidewire shaft 10) comprising a rigid proximal portion (¶0026, a relatively rigid polymer proximate proximal end 14) and a flexible distal portion (¶0026, relatively flexible polymer near distal end 16).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the tether of Starksen with a rigid proximal portion and a flexible distal portion, as taught by Cassell, in order to maintain the desired level of stiffness near the proximal end for implantation of a device (¶0032).
Starksen doesn’t explicitly teach or disclose proximally withdrawing the proximal portion of the tether. Cassell doesn’t explicitly teach or disclose proximally withdrawing the proximal portion of the tether.
To et. al discloses proximally withdrawing (¶0053, “withdrawn”) said proximal portion (¶0053, wherein the device includes proximally end of tether 708).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of Starksen in view of Cassell with a step to withdraw the tether, as taught by To et. al , in order to remove the device form the body after the procedure is complete.
Starksen doesn't explicitly teach or discloses a mechanism disposed on one or more of a distal end of the rigid proximal portion or a proximal end of the flexible distal portion, the mechanism configured to releasably attached to attach the rigid proximal portion to the flexible distal portion. Cassell discloses a rigid proximal portion (¶0026, a relatively rigid polymer proximate proximal end 14) and a flexible distal portion (¶0026, relatively flexible polymer near distal end 16) but doesn't explicitly teach or disclose a mechanism configured to releasably attach the two portions. To et al. doesn't explicitly teach or disclose doesn't explicitly teach or disclose a mechanism configured to releasably attach the two portions.
Sauter discloses a mechanism configured to releasably attached to attach the rigid proximal portion to the flexible distal portion (Fig. 3, wherein connection 7/8 releasably attaches two portions)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the rigid proximal portion and the flexible distal portion of Starken in view of Cassell in view of To et. al with a releasable attachment, as taught by Sauter, in order to release the flexible distal portion after implantation.
Regarding claim 13, Starksen discloses advancing a cutting device (¶0086, wherein termination device corresponds to a cutting device) over said tether (¶0086, 534) and cutting said flexible distal portion from said rigid proximal portion (¶0086, wherein cutting tether just proximal to most-proximal anchor corresponds to cutting said).
Regarding claim 14, Starksen discloses positioning a plurality of anchors (Fig. 9B, wherein anchors 526 corresponds to a plurality of anchors) along said flexible distal portion (Fig. 9B, wherein the distal portion corresponds to the part of the tether 532 with anchors 534)
Regarding claim 15, Starksen discloses attaching the plurality of anchors (Fig. 10B, 526) to cardiac tissue (See Fig. 10B, see also ¶0084, wherein the tissue of valve annulus VA corresponds to cardiac tissue).
Conclusion
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 extension fee 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 date of this final action.
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774