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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/04/2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 8-9, filed 12/04/2025, with respect to the rejection(s) of claim(s) 1, 16, and 19 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection of claim 1 is made in view of Naimark/Sawada to teach the newly recited limitations.
Allowable Subject Matter
Claims 16-19 and 24-28 are allowed.
The following is an examiner’s statement of reasons for allowance: Regarding claims 16 and 19, the prior art of record fails to teach or render obvious a device of method of delivering a patch to a target tissue site wherein a handle is fixedly attached to an outer tube and a fluid lumen extends into the handle and is movable distally relative to the handle to apply fluid to the patch, in combination with the remaining limitations of the claims.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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.
Claim(s) 1, 3, 6, 13-15, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Naimark et al. (US 2003/0073979) in view of Sawada et al. (US 2019/0000434).
Regarding claim 1, Naimark et al. discloses a delivery system (Elements of FIG 4a-4b, [0038-0044]), comprising: an inner member (150, [0040, 0044]); an outer tube (160) surrounding the inner member (FIG 4a-4b) and movable axially relative to the inner member [[0044]), wherein a space is defined between an outer surface of the inner member and an inner surface of the outer tube (see radial space in FIGs 4a-4b); an expandable element (140) disposed in the space at a distal portion of the system (FIG 4a), wherein the expandable element is a self expanding scaffold ([0040, 0043-0044] disclose the self expansion. The scaffold is formed by wire elements 170), wherein the self expanding scaffold is in a collapsed configuration (FIG 4a) having a first portion of the self-expanding scaffold overlapping with a second portion of the self expanding scaffold (In the collapsed configuration of FIG 4a, one wire element 170 is interpreted as forming a first portion and another radially spaced apart wire element is interpreted as a second portion. These first and second portions are overlapping at their midpoints 172 where they are held together by tip 24 and also are shown to be overlapping along their lengths in FIG 4a. This arrangement is interpreted as overlapping in a direction taken perpendicular to the longitudinal direction of the device), and wherein a proximal end of the self-expanding scaffold is immovable relative to the inner member ([0040], the proximal end of the wire elements 170 of the scaffold is secured to the distal end 180 of the inner member 150); and a patch (20. FIG 4a-4b,[0044, 0047-0056]) disposed in the space at the distal portion of the system (FIG 4a shows the patch disposed in the radial space), wherein the patch is in a folded configuration (Configuration of FIG 4a) having a portion of the patch radially outward of the second portion of the self-expanding scaffold (Because FIG 4a shows the patch disposed along the exterior surface of the scaffold, it is positioned radially outward of the second portion of the scaffold). Naimark et al. further discloses that alternative shaped of the expanding scaffold are possible ([0042] “although a circular shape is shown, it will be appreciated that the wire elements may be arranged in a variety of curved, elliptical or other looped shapes, that may together define three-dimensional, basket-like expandable assembly. The wire elements are preferably spaced apart from one another to substantially isolate the wire elements from one another, and are preferably spaced apart evenly. Also, preferably the wire elements are of the same length”).
Naimark et al. is silent regarding the patch having a portion of the patch radially inward of the first portion of the self expanding scaffold.
However, Sawada et al. teaches a patch (12, [0042]) deliverable to a target treatment site (P) on an expandable scaffold (15, forming the expansion member, [0052]), the expandable scaffold attached to an inner member (11) slidably received within an outer member (S, FIG 9) wherein in the collapsed configuration of the scaffolding an the folded configuration of the patch (FIGs 8 and 9) ,one portion of the patch radially inward of a first portion of the self-expanding scaffold while another portion of the patch ins radially outward of a second portion of the self-expanding scaffold (FIGs 8-9, [0058-0059] disclose the folding of the patch around the scaffold such that some segments of the patch are radially inward and some segments are radially outward. This folding configuration aids in neatly tucking the patch material such that an organized and reduced profile delivery configuration can be achieved.
Therefore, it would have bene obvious to one of ordinary skill in the art at the time of filing to modify the patch of Naimark et al. from being completely disposed on a radially outer surface of the scaffold to instead have a folded configuration which includes pleating some portions of the patch material into a radially inward collapsed position while other portions remain radially outward of the scaffold, as taught by Sawada et al., for the purpose of achieving a more compact delivery profile having a predictable radial expansion and thereby utilizing an commonly known technique for achieving the predictable result of arranging the patch around the scaffold for delivery.
Regarding claim 3, Naimark et al./Sawada disclose the invention substantially as claimed, as set forth above for claim 1. Naimark et al. further discloses a proximal end of the expandable element is fixedly attached to the inner member ([0040]).
Regarding claim 6, Naimark et al./Sawada disclose the invention substantially as claimed, as set forth above for claim 1. Naimark et al. further discloses the patch includes an adhesive on a radially outermost surface of the patch ([0046], FIG 2a).
Regarding claim 13, Naimark et al./Sawada disclose the invention substantially as claimed, as set forth above for claim 1. Naimark et al. further discloses moving the outer tube proximally relative to the inner member exposes the patch and the self expanding scaffold (Relative translation of the outer tube proximally would release the constraint and deploy the patch and scaffold member, FIGs 4a-4b, [0044]), so that the self-expanding scaffold expands to unfurl the patch and apply a radial force to the patch ([0044], as shown in FIG 4b where the radially expanded state is achieved as the device unfurls).
Regarding claim 14, Naimark et al./Sawada disclose the invention substantially as claimed, as set forth above for claim 1. Naimark et al. further discloses at least a portion of the self expanding scaffold is uncoated (The exterior surface of expandable scaffold is not disclosed as having an additional coating apart from the covering material. Further, FIG 4a shows that a proximal section of the expandable scaffold is not covered by the patch, which could also be interpreted as “not coated”).
Regarding claim 15, Naimark et al./Sawada disclose the invention substantially as claimed, as set forth above for claim 1. Naimark et al. further discloses the self expanding scaffold is asymmetric for contacting less than a full circumference of a bodily lumen (FIG 4b shows the asymmetrical shape wherein a distal portion achieves a different shape than a proximal segment and therefore the circumference is not contacted by the scaffold at the proximal end).
Regarding claim 22, Naimark et al./Sawada disclose the invention substantially as claimed, as set forth above for claim 1. Naimark et al. further discloses the inner member does not extend through the self-expanding scaffold (FIGs 4a-4b)
Claim(s) 11, 12, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Naimark et al. (US 2003/0073979) in view of Sawada et al. (US 2019/0000434), further in view of Smith et al. (US 2020/0038005).
Regarding claims 11 and 12, Naimark et al./Sawada discloses the invention substantially as claimed, as set forth above for claim 1.
Naimark is silent regarding a fluid lumen having an opening at a proximal end of the system and in fluid communication with the space, wherein the fluid lumen extends into an opening at a proximal portion of a radially outer surface of a handle at a proximal end of the outer tube and a proximal end of the fluid lumen includes a port for connection to a fluid source.
However, Smith teaches a delivery system (FIGS 3A-3D) for delivering a patching (820) at the distal end of an inner member (352) to a treatment site (60) within a body lumen (70), and having a fluid lumen ([0049] discloses fluid can be delivered through lumen 320 or another fluid channel, wherein either channel is interpreted as the fluid lumen) having an opening at a proximal end of the system (FIG 1, [0040], 114 is the opening of the fluid lumen which runs through shaft 104, equivalent to shaft 304) and in fluid communication with the space (The fluid lumen in in communication with the space between the inner member 352 and the outer tube 304), wherein the fluid lumen extends into an opening at a proximal portion of a radially outer surface of a handle at a proximal end of the outer tube (FIG 1, wherein 102 is the handle) and a proximal end of the fluid lumen includes a port for connection to a fluid source (115 is the valve for connecting to a fluid source). Smith further teaches that incorporating the fluid lumen aids in moistening the patch during deployment and enhancing the patches’ ability to attach to the tissue wall ([0049]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Naimark to comprise a fluid lumen having an opening at a proximal end of the system and in fluid communication with the space, wherein the fluid lumen extends into an opening at a proximal portion of a radially outer surface of a handle at a proximal end of the outer tube and a proximal end of the fluid lumen includes a port for connection to a fluid source, as taught by Smith, for the purpose of configuring the device to deliver a fluid to the patch upon application at the treatment site to moisten the patch and therefore enhance its ability to preferentially attach to the tissue ([0049]).
Regarding claim 23, Naimark et al./Sawada/Smith discloses the invention substantially as claimed, as set forth above for claim 11. The device as modified further discloses the fluid lumen is movable relative to the handle (Because the lumen is disposed in the outer tube, and the outer tube can bend relative to the handle in order to navigate to the treatment site, the fluid lumen is therefore movable relative to the handle because it can bend and therefore change position relative to the handle).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Naimark et al. (US 2003/0073979) in view of Sawada et al. (US 2019/0000434), further in view of Palermo (US 2021/0275336).
Regarding claim 21, Naimark et al./Sawada discloses the invention substantially as claimed, as set forth above for claim 1.
Naimark et al. is silent regarding the outer tube being transparent.
However, Palermo teaches in the same field of endeavor of delivery devices for a self expandable stent (10, FIG 2) wherein an outer tube of the delivery system (26, FIG 2, [0041]) is transparent (0041]) such that the inner sheath and stent can be visualized within the outer tube prior to deployment).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the outer tube of Naimark to be transparent, as taught by Palermo, for the purpose of allowing the position of the inner member and the expandable element to be visualized by the clinician prior to deployment, to ensure proper positioning (Palermo [0042]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771