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 Amendment
Claims 1-8, 14-25 are pending in the application. Claims 1-8 and 17-20 are withdrawn. Claims 10-13 are cancelled. Claims 14, 21, and 22 have been amended. Claims 14-16 and 21-25 are rejected.
Claim Rejections - 35 USC § 103
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.
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) claims 14-16 and 21-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited Thornton (US PG Pub 2010/0298929) in view of LaDuca et al (US PG Pub 2006/0155366).
Regarding claim 14, Thornton teaches a system for anchoring an atrioventricular spacer (blocker) within an atrioventricular valve between an atrium and a ventricle (See Fig. 15F), the valve having leaflets extending inward from a tissue annulus, comprising:
a compressible and expandable spacer (blocker 4501) (See paragraphs [0008], [0118], [0144], [0146], and [0147]) having a proximal end and a distal end (See Figs. 15E and 15F) and being sized to fit within the leaflets of the atrioventricular valve (See Fig. 15F) and configured to coapt against the leaflets to reduce regurgitation therebetween (See paragraph [0148]), the spacer having a long dimension with a length such that the proximal end resides within the atrium and the distal end resides within the ventricle (See Fig. 15F), the spacer having a compressed delivery configuration and a radially expanded implant configuration (See paragraphs [0144]-[0149]);
a plurality of tethers (4510) connected to and extending in an outward array from the spacer generally perpendicular to the long dimension (See Figs. 15E-15G);
a tissue anchor (4515) on a free end of each of the tethers (See Figs. 15E-15G; paragraph [0145]-[0146]), each tissue anchor being configured to be secured to the tissue annulus (See Figs. 15F and paragraph [0146]) so that the array of the tethers around the spacer holds the spacer centrally within the valve leaflets (See Fig. 15G).
Thornton does not explicitly teach in the embodiment of Figs. 15A-15I that each tether has a variable length to enable the plurality of tethers to be adjusted to be taut between the tissue annulus and the spacer.
Thornton teaches in other embodiments (Figs. 17 ad 19) the tethers (4615 and 4820) have variable lengths to enable the plurality of tethers to be adjusted taut (See paragraphs [0154] and [1060]) between the tissue annulus and the spacer to hold the spacer (blocker) centrally (See Fig. 19C and paragraph [0160]). Thornton also repeatedly states the various blockers and anchors may all be used interchangeably (See paragraphs [0122], [0123], [0143], [0149]) and expressly contemplates that the anchoring mechanisms can be adjusted after deployment (See paragraph [0130]).
It would have been obvious to one of ordinary skill in the art at the time of filing to have each of the plurality of tethers have a variable length so as to enable the plurality of tethers to be adjusted to be taut between the tissue annulus and the spacer so that the array of the tethers around the spacer holds the spacer centrally within the valve leaflets since Thornton expressly contemplates having the anchoring devices be adjustable with varying lengths. Furthermore, it is widely known in the art to have adjustable tethers attached to anchors so as to allow a customized proper positioning within the patient based on their particular anatomy and condition thus making the device more effective.
Thornton teaches a generic extracorporeal handle (1126) which permits independent control of the various components of the device (See paragraph [0220]). Thornton does not explicitly teach the handle comprises a Y-junction comprising a plurality of branches wherein a tether of the plurality of tethers is routed through a branch of the plurality of branches such that the variable length of the tether is separate adjustable from the variable length of the remaining plurality of tethers.
LaDuca teaches an analogous implantable medical device with a delivery component comprising an extracorporeal handle (34) comprising a Y-junction comprising a plurality of branches (74, 76, 78) wherein a tether of the plurality of tethers is routed through a branch of the plurality of branches such that the variable length of the tether is separate adjustable from the variable length of the remaining plurality of tethers. (See Fig. 2A; paragraphs [0051]-[0058]). LaDuca teaches separate tethers (strings) are associated with each control hub to allow for independent tensioning of the tethers (See paragraphs [0053]- [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the teachings of LaDuca into the device of modified Thornton, since Thornton teaches a generic handle for control of the various components while LaDuca teaches a specific branched handle that allows for independent control of tension on multiple separate tethers allowing for precise control of delivering the medical device. As stated in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B). Additionally, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183)
Regarding claim 15, modified Thornton teaches the system as set forth in claim 14 above and further teaches each tether connects to the proximal end of the spacer at a central axis thereof (See Figs. 15E and 15F note tethers at proximal end which engage the valve annulus).
Regarding claim 16, modified Thornton teaches the system as set forth in claim 15 above and further teaches a plurality of ventricular tethers (4315) connected to and extending from the distal end of the spacer at a central axis thereof (See Fig. 15C), and a ventricular anchor (4305) on a free end of each of the ventricular tethers (See Fig. 15C), each ventricular anchor being configured to be secured to tissue within the ventricle (See paragraphs [0144]-[0145]) so that the array of the ventricle tethers around the spacer holds the spacer within the valve leaflets. (See Figs. 15C and 15F; paragraphs [0143]-[0149]).
Modified Thornton does not explicitly teach in the embodiment as shown in Figs. 15A-15I that each ventricular tether has a variable length to enable the plurality of ventricular tethers to be adjusted to be taut between the ventricle and the spacer. Thornton teaches in other embodiments (Figs. 17 ad 19) the tethers (4615 and 4820) have variable lengths to enable the plurality of tethers to be adjusted taut (See paragraphs [0154] and [1060]) between the tissue annulus and the spacer to hold the spacer (blocker) centrally (See Fig. 19C and paragraph [0160]). Thornton also repeatedly states the various blockers and anchors may all be used interchangeably (See paragraphs [0122], [0123], [0143], [0149]) and expressly contemplates that the anchoring mechanisms can be adjusted after deployment (See paragraph [0130]).
It would have been obvious to one of ordinary skill in the art at the time of filing to have each of the plurality of ventricular tethers also have a variable length so as to enable the plurality of ventricular tethers to be adjusted to be taut between the ventricle and the spacer so that the array of the ventricular tethers around the spacer holds the spacer within the valve leaflets since Thornton expressly contemplates having the anchoring devices be adjustable with varying lengths. Furthermore, it is widely known in the art to have adjustable tethers attached to anchors so as to allow a customized proper positioning within the patient based on their particular anatomy and condition thus making the device more effective.
Regarding claim 21, Thornton teaches a system for anchoring a spacer (blocker) within an atrioventricular valve (See Fig. 15F), the valve having leaflets, the system, comprising:
a spacer (blocker 4501) (blocker 4501) (See paragraphs [0008], [0118], [0144], [0146], and [0147]) having a proximal end and a distal end (See Figs. 15E and 15F) configured to be disposed between the valve leaflets such that the leaflets coapt against the spacer (See paragraph [0148]), the spacer having a compressed delivery configuration and a radially expanded implant configuration (See paragraphs [0144]-[0149]);
a plurality of tethers (4510) connected to and extending in an outward array from the spacer (See Figs. 15E-15), and a tissue anchor (4515) coupled to a free end of each tether (See Figs. 15E-15G; paragraph [0145]-[0146]), each tissue anchor being configured to be secured to tissue adjacent an annulus of the valve (See Figs. 15F and 15G and paragraph [0146]),
Thornton does not explicitly teach in the embodiment of Figs. 15A-15I that each tether has a variable length wherein the variable length of the plurality of tethers enables adjustment of a distance between the spacer and the tissue.
Thornton teaches in other embodiments (Figs. 17 and 19) the tethers (4615 and 4820) where the tethers have variable lengths and the variable length of the tether enables adjustment of a distance between the spacer and tissue. (See paragraphs [0154] and [0160] and Fig. 19C) Thornton also repeatedly states the various blockers and anchors may all be used interchangeably (See paragraphs [0122], [0123], [0143], [0149]) and expressly contemplates that the anchoring mechanisms can be adjusted after deployment (See paragraph [0130]).
It would have been obvious to one of ordinary skill in the art at the time of filing to have each tether have a variable length to allow for adjustment of a distance between the spacer and the tissue since Thornton expressly contemplates having the anchoring devices be adjustable with varying lengths. Furthermore, it is widely known in the art to have adjustable tethers attached to anchors so as to allow a customized proper positioning within the patient based on their particular anatomy and condition thus making the device more effective.
Thornton teaches a generic extracorporeal handle (1126) which permits independent control of the various components of the device (See paragraph [0220]) Thornton does not explicitly teach the handle comprises a Y-junction comprising a plurality of branches wherein a tether of the plurality of tethers is routed through a branch of the plurality of branches such that the variable length of the tether is separate adjustable from the variable length of the remaining plurality of tethers.
LaDuca teaches an analogous implantable medical device with a delivery component comprising an extracorporeal handle (34) comprising a Y-junction comprising a plurality of branches (74, 76, 78) wherein a tether of the plurality of tethers is routed through a branch of the plurality of branches such that the variable length of the tether is separate adjustable from the variable length of the remaining plurality of tethers. (See Fig. 2A; paragraphs [0051]-[0058]). LaDuca teaches separate tethers (strings) are associated with each control hub to allow for independent tensioning of the tethers (See paragraphs [0053]- [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the teachings of LaDuca into the device of modified Thornton since Thornton teaches a generic handle for control of the various components while LaDuca teaches a specific branched handle that allows for independent control of tension on multiple separate tethers allowing for precise control of delivering the medical device. As stated in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B). Additionally, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183)
Regarding claim 22, modified Thornton teaches the system as set forth in claim 21 above and further teaches the variable length of the plurality of tethers enables adjustment of a distance between the spacer and the tissue anchors. (It is noted that the tethers as modified to have variable length above would be capable of adjusting between the spacer (blocker) and the anchor).
Regarding claim 23, modified Thornton teaches the system as set forth in claim 22 above and further teaches each tether (4510) connects to the proximal end of the spacer proximate a central axis thereof. (See Fig. 15F)
Regarding claim 24, modified Thornton teaches the system as set forth in claim 23 above and further teaches one or more of the plurality of tethers extend from a distal end of the spacer. (See Fig. 15F, note there is at least one tether on the distal end which anchors in the ventricle).
Regarding claim 25, modified Thornton teaches the system as set forth in claim 24 above and further teaches one or more of the tissue anchors is configured to be secured to tissue on a ventricular side of the valve. (See Fig. 15F, note there is at least one tether on the distal end which anchors in the ventricle).
Response to Arguments
Applicant’s amendments have overcome the 35 U.S.C. 112 rejections set forth in the Non-Final Rejection dated June 30, 2025.
Applicant's arguments filed September 30, 2025 have been fully considered but they are not persuasive. Applicant’s arguments are entirely directed to Thornton failing to teach a Y-junction handle with the features newly added to the amended claims. LaDuca has been added to address these new limitations. See rejection above.
The remainder of applicant’s arguments amount to an allegation of patentability based on the alleged deficiencies of the primary reference. For the reasons set forth above, this is unpersuasive.
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 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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/R.S.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774