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
This office action is responsive to the arguments presented on 04/27/2026. As directed by the response: claims 124, 132 has been amended and claims 1-110 has been canceled. Thus, claims 111-135 are presently pending in the application.
Response to Arguments
In light of the amendment to claim 124 to include “a distal portion of the first implant is configured to be proximal a heart tissue and a proximal portion of the second implant is configured to be distal the heart tissue such that the heart tissue is positioned between the distal portion of the first implant and the proximal portion of the second implant” has overcome the previous rejection over Maisano et al. U.S. Publication 2016/0367367 A1. However, upon further consideration, a new ground(s) of rejection is made in view of Call et al. U.S. Publication 2016/0338829 A1.
Allowable Subject Matter
Claims 111-123 are allowed. The closest prior art Call et al. U.S. Publication 2016/0338829 A1 fails to teach nor render obvious wherein a distal end of the tension member passes through the first implant at a first point, encircles at least a portion of the second implant before passing through the first implant at a second point, and rejoins the tension member at a slidable connection point; wherein when tension is applied to the tension member in a proximal direction, the first implant is drawn towards the second implant in a distal direction.
Claim Rejections - 35 USC § 102
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 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) 124 and 132-135 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Call et al. U.S. Publication 2016/0338829 A1.
Regarding Claim 124, Call et al. discloses an implant assembly for repair of a heart valve, the implant assembly comprising: a tension member 162 with a proximal end and a distal end; a first implant 156 arranged on the tension member 162; a second implant 166 arranged at the distal end of the tension member 162; and a grommet lock 174 arranged on the tension member proximal the first implant 156; wherein, when implanted at an implant location, a distal portion of the first implant is configured to be proximal a heart tissue and a proximal portion of the second implant is configured to be distal the heart tissue such that the heart tissue is positioned between the distal portion of the first implant and the proximal portion of the second implant (as seen in the annotated Figure 16 above); and wherein the grommet lock 174 is configured to substantially prevent movement of the first implant along the tension member in a proximal direction when locked (paragraph [0050]).
Regarding Claim 132, Call et al. discloses wherein the grommet lock 174 is configured to translate distally along the tension member 162 when the grommet lock is pushed in a distal direction (as seen in Figure 15 and paragraph [0050]).
Regarding Claim 133, Call et al. discloses a delivery catheter configured to deliver the implant assembly of Claim 124 to the heart tissue (as seen in Figures 13-16), the delivery catheter comprising: an outer catheter 126 carrying the implant assembly of Claim 124; wherein the first implant 156 and the second implant 166 are in a compressed configuration (held within the delivery catheter until deployed) within the outer catheter 126; and a pushing catheter 158 configured to be advanced within the outer catheter 126 (as seen in Figures 13-16).
Regarding Claim 134, Call et al. discloses wherein the pushing catheter 158 is configured to deploy the second implant 166 from the outer catheter 126 after the outer catheter is advanced through the heart tissue (as seen in Figure 13-14 and paragraphs [0048-0049]).
Regarding Claim 135, Call et al. discloses wherein after deploying the second implant 166, the pushing catheter 158 is configured to deploy the first implant 156 from the outer catheter 126 when the outer catheter 126 is at least partially withdrawn from the heart tissue (as seen in Figure 13-14 and paragraphs [0048-0049]).
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.
Claim(s) 125-126, 128-129 is/are rejected under 35 U.S.C. 103 as being unpatentable over Call et al. U.S. Publication 2016/0338829 A1 in view of Ziotnick et al. U.S. Publication 2011/0029071 A1.
Regarding Claim 125, Call et al. does not expressly disclose wherein the first implant comprises a perimeter defined by a nitinol wire frame; and the first implant is configured to expand during implanting from a first size to a second size on exposure to body temperature during implantation. Zlotnick et al. teaches an implant assembly in the same field of endeavor comprising a first implant 54 arranged on a tension member 58 (paragraph [0111] and as seen in Figures 4C), the first implant 54 is defined by a nitinol wire frame (meshed frame, see Figures 4B and 7B and paragraphs [0264] and [0361]) for the purpose of having an anchor that configured to self-expand when released and resume a desired shape for exerting cardiac remodeling forces (paragraph [0462] also see Figures 7A-7B showing the compressed and expanded states). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Call’s first implant to define a nitinol wire frame as taught by Zlotnick et al. for the purpose of having an anchor that configured to self-expand when released and resume a desired shape for exerting cardiac remodeling forces.
Regarding Claim 126, Call et al. does not expressly disclose wherein the first implant comprises a covering surrounding the perimeter of the nitinol wire frame. Zlotnick et al. teaches an implant assembly in the same field of endeavor comprising a first implant 54 arranged on a tension member 58 (paragraph [0111] and as seen in Figures 4C), the first implant 54 is defined by a nitinol wire frame 60 (meshed frame, see Figures 4B and 7B and paragraphs [0264] and [0361]) and a covering 64 surrounding the frame 60 (paragraphs [0269], [0313]) for the purpose of having an anchor that configured to self-expand when released and resume a desired shape for exerting cardiac remodeling forces (paragraph [0462] also see Figures 7A-7B) and having a covering surrounding the frame to reduce pressure trauma on the surface of the heart and more evenly distribute the pressure over the surface of the heart (paragraph [0269] and as seen in Figure 4B). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Call’s first implant to define a nitinol wire frame and a covering surround the frame as taught by Zlotnick et al. for the purpose of having an anchor that configured to self-expand when released and resume a desired shape for exerting cardiac remodeling forces and having a covering surrounding the frame to reduce pressure trauma on the surface of the heart and more evenly distribute the pressure over the surface of the heart.
Regarding Claim 128, Call et al. does not expressly disclose wherein: the second implant comprises a perimeter defined by a nitinol wire frame; and the second implant is configured to expand during implanting from a first size to a second size on exposure to body temperature during implantation. Zlotnick et al. teaches an implant assembly in the same field of endeavor comprising a first implant 54 arranged on a tension member 58 (paragraph [0111] and as seen in Figures 4C), the implant 54 is defined by a nitinol wire frame (meshed frame, see Figures 4B and 7B and paragraphs [0264] and [0361]) for the purpose of having an anchor that configured to self-expand when released and resume a desired shape for exerting cardiac remodeling forces (paragraph [0462] also see Figures 7A-7B showing the compressed and expanded states). The teaching of creating an anchor/implant defined by a nitinol wire frame can be used to apply to the first and/or second implant to create a self-expanding anchor that exerts cardiac remodeling forces on the cardiac tissue. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Call’s second implant to define a nitinol wire frame as taught by Zlotnick et al. for the purpose of having an anchor that configured to self-expand when released and resume a desired shape for exerting cardiac remodeling forces.
Regarding Claim 129, Call et al. does not expressly disclose wherein the second implant comprises a covering surrounding the perimeter of the nitinol wire frame. Zlotnick et al. teaches an implant assembly in the same field of endeavor comprising an implant 54 arranged on a tension member 58 (paragraph [0111] and as seen in Figures 4C), the implant 54 is defined by a nitinol wire frame 60 (meshed frame, see Figures 4B and 7B and paragraphs [0264] and [0361]) and a covering 64 surrounding the frame 60 (paragraphs [0269], [0313]) for the purpose of having an anchor that configured to self-expand when released and resume a desired shape for exerting cardiac remodeling forces (paragraph [0462] also see Figures 7A-7B) and having a covering surrounding the frame to reduce pressure trauma on the surface of the heart and more evenly distribute the pressure over the surface of the heart (paragraph [0269] and as seen in Figure 4B). The teaching of a covering surrounding a self-expanding mesh frame on the anchor can be applied to the first or second implant to create a self-expanding anchor that exerts cardiac remodeling forces on the cardiac tissue and a covering that can reduce trauma exerted by the anchor on the heart tissue. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Call’s second implant to define a nitinol wire frame and a covering surround the frame as taught by Zlotnick et al. for the purpose of having an anchor that configured to self-expand when released and resume a desired shape for exerting cardiac remodeling forces and having a covering surrounding the frame to reduce pressure trauma on the surface of the heart and more evenly distribute the pressure over the surface of the heart.
Claim(s) 127 and 130 is/are rejected under 35 U.S.C. 103 as being unpatentable over Call et al. U.S. Publication 2016/0338829 A1 in view of Ziotnick et al. U.S. Publication 2011/0029071 A1 and further in view of Rowe et al. U.S. Publication 2013/0030522 A1.
Regarding Claim 127, Call et al. does not expressly disclose wherein the covering comprises a biocompatible material configured to facilitate growth of tissue over the covering. Rowe et al. teaches an implant assembly in the same field of endeavor comprising a first implant 900 arranged on a tension member 912 (paragraph [0111] and as seen in Figures 9A-9B), the first implant 900 is defined by a self-expanding frame (paragraph [0111]) and a covering 910 comprises a biocompatible material that facilitates ingrowth of the heart wall tissue to secure the implant to the heart tissue (paragraph [0113]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Call’s first implant to include a covering formed from a biocompatible material that facilitates ingrowth as taught by Rowe et al. for the purpose of securing the implant to the heart tissue.
Regarding Claim 130. Call et al. discloses a first and second implant (see rejection above). However, Call et al. does not expressly disclose wherein the covering of the second implant comprises a biocompatible material configured to facilitate growth of tissue over the covering. Rowe et al. teaches an implant assembly in the same field of endeavor comprising an implant 900 arranged on a tension member 912 (paragraph [0111] and as seen in Figures 9A-9B), the implant 900 is defined by a self-expanding frame (paragraph [0111]) and a covering 910 comprises a biocompatible material that facilitates ingrowth of the heart wall tissue to secure the implant to the heart tissue (paragraph [0113]). The teaching to add a covering that is formed of a biocompatible material to a self-expanding frame can be applied to the first implant and the second implant. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Call’s second implant to include a covering formed from a biocompatible material that facilitates ingrowth as taught by Rowe et al. for the purpose of securing the implant to the heart tissue.
Claim(s) 131 is/are rejected under 35 U.S.C. 103 as being unpatentable over Call et al. U.S. Publication 2016/0338829 A1 in view of Maisano et al. U.S. Publication 2016/0367367 A1.
Regarding Claim 131, Call et al. does not expressly disclose wherein the heart valve is a tricuspid valve. Maisano et al. teaches an implant assembly as seen in Figure 5A for repair of a heart valve (abstract and paragraphs [0148], [0178]), the implant assembly comprising: a tension member 42; a first implant 60a/40a arranged on the tension member 42; a second implant 60b/40b arranged at the distal end of the tension member 42; and a tether lock 150 arranged on the tension member 42 proximal the first implant 40a, wherein the implant is utilized to treat a patient’s heart, including a tricuspid valve (abstract and paragraphs [0024], [0044-0046]) for the purpose of reducing regurgitation of a tricuspid valve and enhance coaptation of the valve (paragraph [0005], [0160], [0190], [0231]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Call’s implant assembly to be used in treating a tricuspid valve as taught by Maisano et al. for the purpose of reducing regurgitation of a tricuspid valve and enhance coaptation of the valve.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson 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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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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