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 action is entered in response to Applicant's Amendment and Reply of 10/28/25. Claims 47, 51, and 70 has been amended. Claims 47-48, 50-55, 57-62, 70 are pending.
Response to Arguments
Applicant’s arguments, see filed 10/28/25, with respect to the rejections of claims 47, 48, 50, 51, 53-55, 57, 58, 60-62, 70 under 35 U.S.C. 102(a)(1) as being anticipated by Inouye (US2018/0310925) have been fully considered and the amendment overcomes the previous rejection. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Li (US2019/0008495) in view of Inouye (US2018/0310925).
Claim Rejections - 35 USC § 103
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.
Claims 47, 48, 50-55, 57-62, 70 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US2019/0008495) in view of Inouye (US2018/0310925).
Regarding claim 47, Li discloses a device for occluding a left atrial appendage ([0052]), the device comprising:
a contact member (33, see Fig. 2) comprising:
a plurality of struts (wires 331), wherein each strut of the plurality of struts includes:
a first edge extending along a length of the strut (the wire 331 can be flat wire with a length and width dimension and therefore would have a first edge along the wire, the first edge interpreted as an edge of the wire facing outward to the walls of the LAA, [0058]), the first edge including terminal ends (where the wires of the frame are welded to 333 and 334, [0058]), the first edge bowing radially outward from each of the terminal ends (see Fig. 2), a second edge extending along the length of the strut (the second edge interpreted as the other edge of the wire, opposite to the first edge and still facing outward to the walls of the LAA, [0058]), an outer surface extending between the first edge and the second edge (the outer surface between the first and second edge would define one dimension of the flat wire, [0058]), and
an inner surface extending between the first edge and the second edge, opposite to the outer surface (inner surface is the surface opposite the outer surface of the flat wire, facing inward toward the longitudinal axis of the device, [0058]); and
a plurality of tissue engaging elements (332, [0055], see Fig. 2) coupled with each of the plurality of struts (see Fig. 2);
wherein: at least a middle portion of each of the plurality of struts is configured to move in a radial outward direction as the contact member expands from a first state to a second state (first state is interpreted as the delivery state, and second state is interpreted as the expanded state, [0089]).
Li does not explicitly disclose each tissue engaging element being positioned along and extending from, the first edge of a corresponding strut of the plurality of struts, each of the plurality of tissue engaging elements includes a first engaging edge and a second engaging edge extending from a respective strut of the plurality of struts to thereby form a tip, wherein the first engaging edge faces a proximal direction and the second engaging edge faces a distal direction to thereby intersect to form the tip. Inouye teaches a device for occluding a left atrial appendage ([0050]). The device having a plurality of tissue engaging elements (146) coupled with each of the plurality of struts, each tissue engaging element being positioned along, and extending from, the first edge of a corresponding strut of the plurality of struts (see annotated Fig. 4). Inouye further teaches each of the plurality of tissue engaging elements includes a first engaging edge (see annotated Fig. 4) and a second engaging edge (see annotated Fig. 4) extending from a respective strut of the plurality of struts to thereby form a tip (154), wherein the first engaging edge faces a proximal direction (the direction is out of the LAA, see Fig. 3) and the second engaging edge faces a distal direction (the direction is into the LAA, see Fig. 3) to thereby intersect to form the tip.
It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have substituted the tissue engaging elements of Inouye for the tissue engaging elements of Li, since the substitution would have yielded the same predictable result of engaging an exterior element for holding the element.
Where one having ordinary skill in the art would have known to provide the proper number of struts (where the struts of Li are spaced substantially as shown in Fig. 2 and are only 6 in number, [0054]) or the proper dimension of the tissue engaging elements so that the tissue engaging elements would not interfere with the movement of the struts.
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Regarding claim 48, Li/Inouye makes obvious the device of Claim 47, Li further discloses wherein the plurality of struts are equidistantly spaced about a longitudinal centerline axis of the contact member (see configuration in Fig. 4 of struts 331 being equidistant).
Regarding claim 50, Li/Inouye makes obvious the device of Claim 47, Inouye further teaches wherein the plurality of tissue engaging elements are configured to penetrate or engage a tissue of the left atrial appendage at an orthogonal angle relative to a surface of the tissue of the left atrial appendage (the anchors are proximally facing and therefore are capable of penetrating or engaging tissue at the orthogonal angle relative to the surface of the tissue, especially by being arranged tangential to the strut as shown in Fig. 4).
Regarding claim 51, Li/Inouye makes obvious the device of Claim 47, Inouye further teaches wherein the tip of each of the plurality of tissue engaging elements includes a pointed distal tip (154, see Fig. 4).
Regarding claim 52, Li/Inouye makes obvious the device of Claim 47; yet, does not explicitly disclose wherein each strut comprises at least five tissue engaging elements. However, the modified invention discloses the framework may include a plurality of tissue engaging elements ([0020], [0024], [0054] of Inouye). Therefore, the modified invention sets forth that the number of tissue engaging elements is a result effective variable dependent on how much tissue is to be engaged or avoided ([0058] of Inouye). Further, Applicant hasn’t established a criticality to the claimed limitation of each strut comprising at least five tissue engaging elements, therefore there is no allegation of criticality or any evidence demonstrating any difference across the range. Id. at 1345, 101 USPQ2d at 1777. Applicant merely states each strut has five tissue anchors in paragraph [0275] of the specification. It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Li/Inouye to have at least five tissue engaging elements, as it involves only adjusting the amount of engagement of the contact member with tissue for holding the implant in place. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have each strut comprise at least five anchors, since it would only involve routine skill in the art in order to have each strut comprise five anchors as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.”
Regarding claim 53, Li/Inouye makes obvious the device of Claim 47, Li further discloses wherein each of the plurality of struts has a proximal portion, a distal portion, and a middle portion (see Figs. 2, 4, [0051]), and wherein the proximal portion and the distal portion of each of the plurality of struts is restrained in at least a radial direction (where examiner interprets these proximal and distal ends as being restrained in a radial direction, by remaining closer to the longitudinal axis of the device and not radially expanded outward, see Fig. 2).
Regarding claim 54, Li/Inouye makes obvious the device of Claim 53, the modified invention discloses the proximal portion and the distal portion of each of the plurality of struts (331) does not have any tissue engagement elements thereon (see Figs. 2, 4 of Li; where the substituted tissue engagement elements of Inouye would be at the same location as the tissue engaging elements 332 of Li).
Regarding claim 55, Li/Inouye makes obvious the device of Claim 47, yet, does not explicitly disclose the plurality of tissue engaging elements are integrally formed with each of the plurality of the struts. Inouye further teaches wherein the plurality of tissue engaging elements are integrally formed with each of the plurality of struts ([0063], Fig. 3). It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to have modified the tissue engaging elements to be integrally formed as taught by Inouye since it is known to manufacture the framework of an LAA occluder in this manner to cut a tube with features from a tubular structure ([0063] of Inouye).
Regarding claim 57, Li/Inouye makes obvious the device of Claim 47, Inouye further discloses wherein the plurality of tissue engaging elements (146) have a triangular shape (see Fig. 4).
Regarding claim 58, Li/Inouye makes obvious the device of Claim 47, the modified invention discloses wherein the plurality of struts (331) are configured to be rotatable at least in a first direction from a first rotational position to a second rotational position that is at least 90 degrees from the first state to, when the contact member is in the second state, twist at least a portion of a left atrial appendage. The device is capable of being rotated in this manner in order to twist the LAA. The prior art is not required to disclose the implant twisting the tissue but merely have the capability of being manipulated in the recited manner. Therefore, the operator is capable of rotating the implant and twisting the LAA, since the claims do not actually require the LAA to be twisted.
The phrase “configured to be rotatable” is functional language that is not given full patentable weight, in that the prior art is not required to disclose the recited function. The mere capability of the prior art to be manipulated in the recited manner in order to achieve the recited function meets the claim requirements. In this case the elongate shaft can rotate the implant and therefore meets the claimed requirements.
Regarding claim 59, Li/Inouye makes obvious the device of Claim 58, Li further discloses further comprising a securing element (31, [0063]) configured to engage a tissue of the left atrium and/or the left atrial appendage to prevent the left atrial appendage that has been twisted from untwisting (would be capable of preventing the LAA from untwisting when sealed to the ostium of the LAA).
Regarding claim 60, Li/Inouye makes obvious the device of Claim 47, the modified invention further discloses wherein the contact member is configured such that, when the contact member is in the second state and is rotated in a first direction, one or more of the plurality of struts and one or more of the plurality of tissue engaging features engage the tissue of the left atrial appendage (the device is capable of being rotated in this manner and the struts and tissue engaging features engage tissue of the LAA. The prior art is not required to disclose the implant rotating and engaging tissue but merely have the capability of being manipulated in the recited manner).
Regarding claim 61, Li/Inouye makes obvious the device of Claim 47, the modified invention further disclose wherein the contact member is configured such that, when the contact member is in the second state and is rotated in a first direction, one or more of the plurality of struts and one or more of the plurality of tissue engaging features engage the tissue of the left atrial appendage and cause the left atrial appendage to twist or rotate in the first direction. The device is capable of being rotated in this manner in order to twist the LAA. The prior art is not required to disclose the implant twisting the tissue but merely have the capability of being manipulated in the recited manner. Therefore, the operator is capable of rotating the implant and twisting the LAA, since the claims do not actually require the LAA to be twisted.
Regarding claim 62, Li/Inouye makes obvious the device of Claim 47, the modified invention discloses wherein the contact member is configured such that, when the contact member is in the second state and is rotated in a first direction, one or more of the plurality of struts and one or more of the plurality of tissue engaging features engage the tissue of the left atrial appendage and cause the left atrial appendage to twist or rotate in the first direction thereby inwardly constricting the opening of the left atrial appendage toward the implant (the device is capable of being rotated in this manner in order to twist the LAA, the prior art is not required to disclose the implant twisting the tissue but merely have the capability of being manipulated in the recited manner, therefore the operator is capable of rotating the implant and twisting the LAA, since the claims do not actually require the LAA to be twisted).
Regarding claim 70, Li/Inouye makes obvious the device of Claim 47, the modified invention discloses wherein the first edge and the second defining a lateral width of the corresponding strut, the outer surface and the inner surface each spanning across the lateral width (flat wire with length and width dimension would have the features claimed, see Fig. 2, [0058] of Li), each tissue engaging element extending laterally from the lateral width of the corresponding strut (see annotated Fig. 4, [0054] of Inouye, where the modified strut would have the tissue engaging element extend laterally in the same manner as taught by Inouye)
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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799