Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 1, 7, and 13 are objected to because of the following informalities: in claim 1 (line 2), claim 7 (line 3), and claim 13 (line 6), “comprising a plurality struts each strut having” should read “comprising a plurality struts, each strut having” (comma added). Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-2, 4-7, 9-13, and 15-18 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Callaghan et al. (US 2006/0122647). Regarding claim 1, discloses a device comprising: a frame (e.g., 30; fig. 10) comprising a plurality of struts (32), each strut having a proximal end and a distal end; a proximal collar (22) attached to the proximal ends of the plurality of struts; a distal collar (52/186/322; fig. 8, 11, 20) attached to the distal ends of the plurality of struts; a cover (242; fig. 9) disposed over the frame and the proximal collar, the cover comprising a proximal portion and a distal portion; and wherein a lateral size of the frame is increased by movement of the proximal collar inside the cover away from the proximal portion of the cover (e.g., consider movement of proximal collar in distal direction from fig. 9 to fig. 10, noting struts 32 may be shape memory and thus frame 30 will radially expand on its own when exposed from cover 242; [0078]). The language “for reducing regurgitation in a native valve” is drawn to the intended use of the device and thus the prior art must only be capable of carrying out the function to meet this limitation. The device of Callaghan can be placed between the edges of native valve leaflets such that opposing leaflets together are held between 30 and 40 of the device, similar to how tissue is secured between 30 and 40 in fig. 4D of Callaghan, to secure the leaflets together to reduce regurgitation in a native valve.
Regarding claim 2, the device of Callaghan further comprising an anchor (e.g., catch element 188; fig. 13, which holds frame in the radially expanded configuration) configured to secure a position of the frame relative to the native valve (noting device is capable of being deployed between leaflets instead of within a septal defect).
Regarding claim 7, Callaghan discloses a device comprising: a coaptation member comprising; a frame (30) comprising a plurality of struts (32) each strut having a proximal end and a distal end; a proximal collar (22) attached to the proximal ends of the plurality of struts; a distal collar (39/52/186/322; fig. 2E, 8, 11, 20) attached to the distal ends of the plurality of struts; a cover (242) disposed over the frame and the proximal collar (see fig. 9), the cover comprising a proximal portion and a distal portion; wherein a lateral size of the frame is increased by movement of the proximal collar inside the cover away from the proximal portion of the cover (from fig. 9 to fig. 10, noting frame is shape memory; [0078]) and an anchor (e.g., 188) connected to the coaptation member, wherein the anchor is configured to secure a position of the coaptation member relative to the native valve (i.e., by locking 30 and 40 in the radially expanded configuration). The device of Callaghan is capable of being placed between the edges of native valve leaflets such that opposing leaflets are held together between 30 and 40 of the device, similar to how tissue is secured between 30 and 40 in fig. 4D, to secure the leaflets together to reduce regurgitation in a native valve.
Regarding claim 13, Callaghan discloses a system comprising: an outer catheter (350; fig. 21); a first shaft (348; fig. 21,22) that extends through the outer catheter; a second shaft (380) that extends through the outer catheter; a coaptation member comprising: a frame (30) comprising a plurality of struts (32) each strut having a proximal end and a distal end; a proximal collar (22; fig. 20) attached to the proximal ends of the plurality of struts, the proximal collar further attached to the first shaft (at 346, via 314 and 40; see fig. 20, 22); a distal collar (39/322; fig. 20,22) attached to the distal ends of the plurality of struts, the distal collar further attached to the second shaft (via 324; fig. 22); a cover (356; fig. 21, 22) having a proximal portion and a distal portion, the cover disposed over the frame and the proximal collar (see fig. 22); wherein a lateral size of the frame is increased by movement of the proximal collar, with a portion of the first shaft inside the cover, away from the proximal portion of the cover (movement from fig. 22 to position similar to fig. 35, noting frame is shape memory as per [0078]); and an anchor (e.g., 326) connected to the coaptation member, wherein the anchor is configured to secure a position of the coaptation member relative to the native valve (i.e., by securing the coaptation member in the radially expanded configuration). The system of Callaghan is capable of reducing regurgitation in a native valve. In particular, the coaptation member can be placed between the edges of native valve leaflets such that opposing leaflets are held between 30 and 40 of the device, similar to how tissue is secured between 30 and 40 in fig. 4D, to secure the leaflets together to reduce regurgitation in a native valve.
Regarding claim 4, 9, and 15, the distal collar (39/52/186/322) is disposed inside the cover (242) (see configurations in fig. 9 and fig. 22).
Regarding claim 5, 6, 10, 11, and 16, moving the proximal collar inside the cover away from the proximal portion of the cover moves the proximal ends and the distal ends of the plurality of struts closer together to cause the struts to bend outward, thus increasing the lateral size of the frame (movement from fig. 9 to fig. 10, or fig. 22 to position similar to fig. 35, noting struts are shape memory). The frame of Callaghan is configured to both laterally increase in size and laterally decrease in size (noting device could be retracted back into the cover prior to being locked in the expanded configuration).
Regarding claims 12 and 17, the anchor can be considered portion 40 instead of the catch element (188 or 326), which comprises a pair of anchor members (consider two of the struts 42 of anchor 40) configured to be secured directly to the native valve members. Portion 40 anchors frame 30 to the tissue once portion 40 has expanded, noting that the tissue is held between expanded 40 and expanded 30.
Regarding claim 18, the first shaft (348) and the second shaft (380) are concentrically disposed for sliding movement within the outer catheter (see figs. 21, 22, 28 and 29).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3, 8, and 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Callaghan in view of Kapadia et al. (US 2007/0185571). Callaghan discloses the invention substantially as stated above including a cover comprising one or more panels of flexible material (i.e., tube 242/356 is considered a panel of material that has been curved into tubular shape; tube is able to follow vasculature to get to heart as understood in view of fig. 3A, and is thus considered flexible), but fails to expressly disclose that the panel comprises bioprosthetic tissue or a flexible polymer.
Kapadia discloses another device for reducing regurgitation in a native valve that includes a cover in the form of a flexible sheath (catheter 88; figs. 11-16). Kapadia discloses that the flexible sheath may comprise a flexible, resiliently yieldable polymer such as silicone, PTFE or ePTFE ([0063]). It would have been obvious to one of ordinary kill in the art to have modified the prior art of Callaghan to construct the cover (sheath 242) of a flexible polymer since Kapadia teaches that such a material is known as suitable for the construction of a flexible catheter used to house and advance an expandable device delivered to the heart and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
Conclusion
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KSH 10/14/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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