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 .
Allowable Subject Matter
Claims 111-123 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art Solem et al. U.S. Publication 2001/0018611 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 131-132 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maisano et al. U.S. Publication 2016/0367367 A1.
Regarding Claim 124, Maisano et al. discloses 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 with a proximal end and a distal end; 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, when implanted at an implant location, the first implant 60a/40a is configured to be proximal a heart tissue and the second implant 60b/40b is configured to be distal the heart tissue such that the heart tissue is positioned between the first implant and the second implant (as seen in Figure 5A); and wherein the tether lock 150 is configured to substantially prevent movement of the first implant along the tension member in a proximal direction when locked (paragraphs [0178], [0220], [0223]).
Regarding Claim 131, Maisano et al. discloses wherein the heart valve is a tricuspid valve (abstract and paragraphs [0010], [0024], [0044]).
Regarding Claim 132, Maisano et al. discloses wherein the tether lock 150 is configured to translate distally along the tension member when the tether lock is pushed in a distal direction (paragraph [0178], [0220], [0223]).
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, 128 and 133-135 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maisano et al. U.S. Publication 2016/0367367 A1.
Regarding Claims 125, 128, in the embodiment used in the rejection above, Figure 5A 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 and 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. In an alternative embodiment as seen in Figure 4C, Maisano et al. teaches an implant assembly comprising a first stent 60b arranged on a tension member 42 and a second stent 60a arranged on the tension member 42 and a tension lock 150 used to adjust the length of the tensioning member 42 (paragraph [0213]), wherein the first stent 60b and second stent 60a comprises nitinol wire frame (see Figure 4C and paragraphs [0158-0159] and [0179]) for the purpose of allowing the stent to crimp to a small diameter for delivery in a catheter and allowing deployment by self-expansion to a much larger diameter in order to anchor the stent to the wall of the heart by friction (paragraph [0179]). 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 Figure 5A of Maisano to further include a first and second implant that is in the form of a stent having a nitinol wire frame and configured to self-expand from a first size to a second size as taught in Figure 4C for the purpose of allowing the stent to crimp to a small diameter for delivery in a catheter and allowing deployment by self-expansion to a much larger diameter in order to anchor the stent to the wall of the heart by friction.
Regarding Claim 133, 134, Maisano et al. discloses a delivery catheter 142 configured to deliver the implant assembly of Claim 124 to the heart tissue (see Figure 5A and paragraphs [0218-0219]). However, in the embodiment used in the rejection above Figure 5A does not expressly disclose the delivery catheter comprising: an outer catheter carrying the implant assembly of Claim 124; wherein the first implant and the second implant are in a compressed configuration within the outer catheter; and a pushing catheter 144 configured to be advanced within the outer catheter and wherein the pushing catheter is configured to deploy the second implant from the outer catheter after the outer catheter is advanced through the heart tissue. In an alternative embodiment as seen in Figures 4C and 7A-7B, Maisano et al. teaches an implant assembly comprising a first stent 60b arranged on a tension member 42 and a second stent 60a arranged on the tension member 42 and a tension lock 150 used to adjust the length of the tensioning member 42 (paragraph [0213]) and delivering the stents includes having a delivery system 200 comprising an outer catheter 22 that compresses the stent and an inner pushing catheter 202 that houses a torque-delivering and anchor-pulling tube 208 that retracts the outer catheter proximally to deploy the second stent 60a first (paragraphs [0189-0192]). 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 Figure 5A of Maisano to further include a first and second implant in the form of a stent as taught in Figure 4C and having a delivery system in the form of an outer catheter and an inner pushing catheter as taught in Figures 7A-7B for the purpose of implanting the first implant and second implant in a compressed configuration within the outer catheter and having an inner pushing catheter that would be able to retract the outer catheter proximally to push the stent outwardly to deploy to the implantation site.
Regarding Claim 135, in the embodiment used in the rejection above, Figure 5A does not expressly disclose wherein after deploying the second implant, the pushing catheter is configured to deploy the first implant from the outer catheter when the outer catheter is at least partially withdrawn from the heart tissue. In an alternative embodiment as seen in Figures 4A-4C and 7A-7B, Maisano et al. teaches an implant assembly comprising a first stent 60b arranged on a tension member 42 and a second stent 60a arranged on the tension member 42 and a tension lock 150 used to adjust the length of the tensioning member 42 (paragraph [0213]) and delivering the stents includes having a delivery system 200 comprising an outer catheter 22 that compresses the stent and an inner pushing catheter 202 that houses a torque-delivering and anchor-pulling tube 208 that retracts the outer catheter proximally to deploy the second stent 60a first (paragraphs [0189-0192]) and after deploying said second stent 60a, the pushing catheter is used to further deploy the first stent 60b (see Figures 4A-4C). 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 Figure 5A of Maisano to further include a first and second implant in the form of a stent, having a second stent delivered first and then delivering a first stent as taught in Figure 4A-4C and having a delivery system in the form of an outer catheter and an inner pushing catheter as taught in Figures 7A-7B for the purpose of implanting the first implant and second implant in a compressed configuration within the outer catheter and having an inner pushing catheter that would be able to retract the outer catheter proximally to push the stent outwardly to deploy to the implantation site.
Claim(s) 126-127, 129-130 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maisano et al. U.S. Publication 2016/0367367 A1 in view of Hauser et al. WO2009/134701 A2.
Regarding Claims 126, 127, 129, 130, Maisano et al. discloses a first implant and a second implant in the form of a nitinol wire frame (see claim rejections to claims 125 and 128 above). However, Maisano et al. does not expressly disclose wherein the first implant comprises a covering surrounding the perimeter of the nitinol wire frame and wherein the covering comprises a biocompatible material configured to facilitate growth of tissue over the covering and wherein the second implant comprises a covering surrounding the perimeter of the nitinol wire frame, wherein the covering comprises a biocompatible material configured to facilitate growth of tissue over the covering. Hauser et al. teaches in Figure 5 an implant assembly 20 in the same field of endeavor comprising a tether member 80 and a first stent 10 comprising a nitinol frame (paragraph [0033]) and a covering to reduce the likelihood of thrombi formation and to encourage tissue ingrowth using coatings (paragraph [0067]). 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 Maisano’s first stent and second stent to further include a covering formed of a biocompatible material as taught by Hauser to reduce thrombi formation and encourage tissue ingrowth.
Conclusion
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEEMA MATHEW/
Primary Examiner, Art Unit 3774