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 amendment filed on 1/13/2026. As directed by the amendment, the status of the claim(s) are:
Claim(s) 16-20 is/are new;
Claim(s) 1-20 is/are presently pending;
Claim(s) 1-8 are withdrawn;
Claim(s) 9-20 are presently examined on the merits.
Response to Arguments
Applicant argues on p. 5-6 of remarks that primary reference Suresh does not teach the claimed limitation of Nitinol attachment barbs extending from multiple elongate fabric elements because the embodiments described in Suresh are of either a single material or have anchors pass through a sheet which is not “attachment barbs extending from” as integral components of a fabric framework as in the claimed invention.
After review this is not persuasive for the following reasons. Suresh teaches (emphasis added):
[0019] In some embodiments, a reinforcing element may be made from a bio-prosthetic like a porcine or bovine pericardium, or a prosthetic material like polyester or PTFE. Such a product may be fabricated by weaving or knitting or by using one or more continuous sheets. Optionally, the reinforcing element could have radiopaque markings. Furthermore, the reinforcing element could be made of ion exchange material, which can act as an artificial muscle.
[0149] In some embodiments, reinforcing element 908 may include a "mesh basket" as depicted in FIG. 13. Reinforcing element 908 may be formed at least in part by a plurality of conduits 910. Conduits 910 may be formed at least partially of shape memory metals, properties of which are described herein. A specific example of a shape memory metal from which conduits may be formed includes, but is not limited to, nitinol. In some embodiments, a reinforcing element may be formed from any biocompatible material (or any material which may be adapted to be biocompatible) that may offer increased structural strength and/or integrity to a portion of the heart to which the reinforcing element is attached.
[0154] In some embodiments, a coupling mechanism may include a plurality of elongated members 912, as depicted in FIG. 14. FIG. 14 does not depict a plurality of conduits 910 for purposes of clarity. Elongated members 912 may be at least in part formed from shape memory metals (e.g., nitinol). In some embodiments, elongated members 912 may include pointed, sharp, and/or needle tipped distal ends 914. Elongated members 912 may be positioned in conduits 910 (depicted in FIG. 13). One or more elongated members may be positioned in the conduits. In certain embodiments, only one elongated member may be positioned in each conduit. When in a retracted or inactivated state, at least distal ends 914 may be positioned substantially in conduits 910. When in an extended or activated state, at least distal ends 914 may be extended substantially beyond the distal end of each respective conduit 910. Distal ends 914 of elongated members 912 may be predisposed (e.g., preshaped in the case of shape memory metal based elongated members) to exist in a substantially inwardly curled state as depicted in FIG. 14. FIG. 15 depicts reinforcing element 908 with distal ends 914 of the elongated members activated and extended from conduits 910.
[0158] In some embodiments, coupling portions may be formed from shape memory metals. Shape memory alloys have a unique property of shape retention at different states. The material exists at two forms i.e. Austenite and Martensite. For example a wireform may be formed into a particular shape in an Austenite state and deformed i.e. stretched to make it straight, this deformation process will convert the wireform into its Martensite state. However, when the wire is heated above a transformation temperature it goes back to its Austenite state, and recovers its original shape. A reversible solid-state phase transformation from austenite to martensite occurs, for example, on cooling (or by deformation) and the reverse transformation from martensite to austenite occurs, for example, on heating (or upon release of deformation). The transformation temperature is dependent on the material composition. Materials can be engineered to have transformation temperatures just a few degrees above body temperature (e.g., 45.degree. C.). There are many companies, which specialize in nitinol fabrication like Memry Corporation (www.memry.com), Nitinol Devices and Components (www.Nitinol.com).
[0171] In some embodiments, a reinforcing element may include at least one suture, wire, rod, bar, band, sheet, ribbon, combination or other suitable structural device. Structural devices may be formed from shape memory or superelastic material (e.g., Nitinol), polymer, metal, metal alloy, or combination of the above materials, and/or any suitable material.
[0184] In certain embodiments, reinforcing element 908 may include a plurality of engagement mechanisms 920. Engagement mechanisms 920 may be formed as part of and/or coupled to the outer perimeter of portions of reinforcing element 908. In some embodiments, reinforcing element 908 may include at least two engagement mechanisms 920. The engagement mechanisms may be positioned substantially equidistant around the outer perimeter of the reinforcing element. The engagement mechanisms may be positioned substantially within plane 922 oriented substantially perpendicular to central axis 924 (as depicted in FIG. 29) of the deployed reinforcing element.
[0200] In some embodiments, securing mechanisms may be employed to secure a reinforcing element to a surface of a heart. Securing mechanisms or anchors may inhibit movement and/or dislodgement upon being deployed into tissue. Securing mechanisms may include anchoring features. Anchoring features may include barbed anchor features. Anchoring features may include coiled anchor features. Anchoring features may assist securing mechanisms to inhibit movement of a reinforcement element after deployment. Securing mechanisms may be self-expanding. Securing mechanisms may be formed from shape memory or superelastic materials (e.g., polymer, metal, or metal alloys). Securing mechanisms may be formed from swellable materials. Securing mechanisms may be formed from any combination of discussed or other suitable materials.
[0204] In some embodiments, a reinforcing element may be formed from woven or knitted Dacron polyester. In some embodiments, a reinforcing element may be formed from woven or knitted biocompatible fabric. In some embodiments, a reinforcing element may be formed from polymer, metal, metal alloy, or a combination or other suitable material. Reinforcing elements may be formed from autogenous/autologous, and/or synthetic biocompatible materials. Synthetic biocompatible materials may include silicone, rubber, polyurethane, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyester, Dacron.TM., Mylar.TM., polyethylene, PET (Polyethylene terephthalate), polyamide, polyamide, PVC, Kevlar.TM. (polyaramid), polyetheretherketone (PEEK), polypropylene, polyisoprene, polyolefin, or a composite of these or other suitable materials.
From the above, it is clear that the “reinforcing element” can be made of fabric and the Nitinol can be used to as an anchor in a “coupling mechanism”, “engagement mechanism”, and/or “securing mechanism” with the “reinforcing element”; see especially [0171] in which a combination of materials for the device is described. As for the “Nitinol attachment barbs extending from the multiple elongate fabric elements”; the instant figures as cited, especially Fig. 14-15 and Fig. 27-27 depict this in light of the above teaching in which different combinations of material, fabric for the “reinforcing element” and Nitinol for the anchor are used. Even as argued by Applicant that the anchors are within “conduits”; best seen in Fig. 17, [0149], [0154], this would read on the limitation because as extended, the anchors coming out of the conduits would be “extending from the multiple elongate fabric elements” because the conduits are part of the “reinforcing element” which can be made of fabric.
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) 9-16, 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Suresh (US 20060025800 A1; 2/2/2006; cited in IDS; cited in previous office action).
Regarding claim 9, Suresh teaches an intraventricular implantable device configured to augment cardiac function (Abstract; Fig. 12; [0018]; [0020]), the device comprising a framework comprising:
multiple elongate fabric elements arranged in a conical shape that defines a central longitudinal axis, the multiple elongate fabric elements including multiple longitudinally-extending fabric elements extending toward an apex of the conical shape (Fig. 3a; Fig. 4; Fig. 7; Fig. 15; Fig. 27-28; [0019] “polyester or PTFE”; [0149]; [0204]) and
multiple Nitinol attachment barbs extending from the multiple elongate fabric elements, wherein the framework is sized to reside against an inner wall of a ventricle of a human heart (Fig. 14-15; Fig. 17-23; Fig. 27-28; [0018]; [0020]; [0149]; [0154]; [0158]; [0171]; [0184]; [0200]).
Regarding claim 10, Suresh teaches wherein the framework comprises multiple rectangular cells defined by the multiple elongate fabric elements (Fig. 7; Fig. 27-28; [0019]; [0172]).
Regarding claim 11, Suresh teaches wherein the framework comprises at least one U-shaped cell with an open side (interpreted in light of instant Fig. 17, 514; instant specification p. 15 lines 19-25; Suresh Fig. 12, top has U-shaped cells; [0172]).
Regarding claim 12, Suresh teaches wherein the framework defines a circular opening at each end of the intraventricular implantable device (Fig. 12-15; [0166] “ring…opening”).
Regarding claim 13, Suresh teaches a method of treating heart failure of a patient ([0015]-[0016]), the method comprising:
implanting the device of any one of the preceding claims in a ventricle of the patient (Fig. 12; [0017]-[0018]; [0020]).
Regarding claim 14, Suresh teaches wherein the ventricle is a right ventricle ([0018] “right ventricle”; [0020]; [0027]).
Regarding claim 15, Suresh teaches wherein the ventricle is a left ventricle (Fig. 5-6; [0018] “left…ventricle”; [0020]; [0027]).
Regarding claim 16, Suresh teaches wherein the multiple elongate fabric elements comprise a network of thin strips of fabric created from a single fabric sheet (this limitation is interpreted as product by process claim; see MPEP 2113; Fig. 3a; Fig. 4; Fig. 7; Fig. 15; Fig. 27-28; [0019] “polyester or PTFE”; [0149]; [0204]).
Regarding claim 19, Suresh teaches wherein the multiple Nitinol attachment barbs are oriented to point either upward, downward, or a combination of both upward and downward relative to the central longitudinal axis (Fig. 14-15; Fig. 27-28; the anchors have a downward hook that begin by extending up from the reinforcing elements of the device).
Regarding claim 20, Suresh teaches wherein the framework comprises an open U-shaped cell having a single open U-shaped cell providing clearance space for papillary muscles or chordae tendineae (interpreted in light of instant Fig. 17, 514; instant specification p. 15 lines 19-25; Suresh Fig. 12, top has U-shaped cells; [0172]; note that this is an open ended claim “comprises…having”; MPEP 2111.03 and so is not limited to a device/structure that only has a “single” U-shaped cell and excludes devices/structures that possess more than one U-shaped cell; also note that “providing clearance space for papillary muscles or chordae tendineae” is intended use; For the purposes of examination, Applicant is reminded that this is a product claim. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.).
Allowable Subject Matter
Claims 17-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of claim 17 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the multiple Nitinol attachment barbs extend through openings at strip-to-strip intersections of the multiple elongate fabric elements.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of claim 18 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the multiple Nitinol attachment barbs are joined to the framework with a polymeric adhesive coating.
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 Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792