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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/1/26 has been entered.
Response to Amendment
This action is entered in response to Applicant's Amendment and Reply of 5/1/26. Claims 47-48, 50-55, 57-62, 70-72 are pending. Claims 47, 48, 50, 60, 61, 62, 70 have been amended. Claims 71 and 72 are new.
Response to Arguments
Applicant’s arguments, see filed 5/1/26, with respect to the rejections of claims 47, 48, 50-55, 57-62, 70 under 35 U.S.C. 103 as being unpatentable over Li (US2019/0008495) in view of Inouye (US2018/0310925) have been fully considered but they are not persuasive. Applicant argues, the amendment to claim 47 to recite “the plurality of tissue engaging elements collectively project in a shared rotational direction” overcomes the previous rejection. Examiner disagrees, where the claimed “shared rotational direction” is interpreted as a direction around the longitudinal axis. Where at least some part of the tissue engaging member of Li as modified by Inouye would project in this direction. Therefore, the rejection has been maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 47, 48, 50-55, 57-62, and 70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 47 recites “the plurality of tissue engaging elements collectively project in a shared rotational direction”. However, there is no support in the disclosure for the limitation. From the Fig. 9F, the elongate members are spaced apart but it is not clear that the tissue engaging elements project in a shared rotational direction. Furthermore, there is no description in the specification that describes the tissue engaging members project to share a rotational direction. Therefore, Applicant failed to have possession of the claimed invention at the time of filing.
Claims 48, 50-55, 57-62, and 70 are rejected by dependency from claim 47.
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, 70-72 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; and the plurality of tissue engaging elements collectively project in a shared rotational direction.
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. Where the arrangement of the struts around the longitudinal axis would define how the tissue engaging elements project to a shared rotational direction. Where the tissue engaging elements as modified would project tangential to the length of the strut and the struts are arranged around the longitudinal axis; therefore, the tissue engaging elements would project in a shared rotational direction.
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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 from each other 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, the modified invention further discloses teaches wherein the plurality of tissue engaging elements are orthogonal and offset from the longitudinal centerline axis (the anchors are orthogonal to the longitudinal axis by being tangent to the struts as shown in Fig. 4 of Inouye, where the anchors are interpreted as being offset from the longitudinal axis by the expanded form of the occluder of Liu having the struts offset from the longitudinal axis).
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 elements 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 collectively define a lateral width of the corresponding strut, the outer surface and the inner surface each span across the lateral width (flat wire with length and width dimension would have the features claimed, see Fig. 2, [0058] of Li), wherein each tissue engaging element extends 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).
Regarding claim 71, Li discloses a device for occluding a left atrial appendage ([0052]), the device comprising:
a shaft assembly (32, Fig. 2); and
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 a 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]);
the shaft assembly is rotationally secured to the contact member (shaft 32 is secured to the frame 33 and is interpreted as rotationally secured by being able to be rotated with the frame 33, [0051]) to thereby be configured to rotate the plurality of struts at least in a first direction from a first rotational position to a second rotational position to thereby twist at least a portion of a left atrial appendage (the shaft 32 is configured to rotate the struts in a first direction from a first rotational position to a second rotational position being connected to the frame 33, therefore when the shaft 32 is rotated so will the frame 33).
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.
Regarding claim 72, 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]);
the first edge and the second edge collectively define a lateral width of the corresponding strut (flat wire with length and width dimension would have the features claimed, see Fig. 2, [0058]); the outer surface and the inner surface each span across the lateral width (flat wire with length and width dimension would have the features claimed, see Fig. 2, [0058]).
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; each tissue engaging element extends laterally from the lateral width of the corresponding strut.
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.
Where the modified invention further discloses each tissue engaging element extends laterally from the lateral width of the corresponding strut as shown in annotated Fig. 4 from the rejection of claim 47 and described in paragraph [0054] of Inouye, where the modified strut would have the tissue engaging element extend laterally in the same manner as taught by Inouye.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached on (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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