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 .
Claim Objections
Claims 12 and 19 are objected to because of the following informalities: Claim 12 recites “an adjacent locking mechanism of the plurality of actuation members”, in line 12, which appears to include a typographical error in which the limitation “plurality of actuation members” should be replaced with – plurality of locking mechanisms –. Claim 19 recites “inserting a prosthetic heart valve”, which appears to include a typographical error in which the term “a” should be replaced with the term – the – since the prosthetic heart valve is previous recited in the claim. Appropriate correction is required.
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) 1-12, 16, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2018/0153689 A1 to Maimon et al. (Maimon).
Regarding claim 1
Maimon teaches a mechanically expanding heart valve and delivery apparatus therefore (title).
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Maimon meets the limitations of a prosthetic heart valve comprising: a frame (22) comprising a plurality of struts (32, 42; fig. 2), an actuation member (86), a locking mechanism (94), a first end portion, and a second end portion (see annotated fig. 8 above), wherein the frame is movable from a radially-compressed configuration (paragraph 0119 discloses that the frame can be manipulated into a radially compressed or contracted configuration; figs. 6 and 7) to a plurality of radially-expanded configurations (paragraph 0141 discloses applying a distally directed pushing force to effect radial expansion of the frame; paragraph 0145 for example discloses that the frame and thus the valve 14 can be manipulated between a fully expanded state and a fully compressed state, including states in between fully compressed and fully expanded), wherein the plurality of struts and the locking mechanism are integrally formed as a unitary component (fig. 8 shows that the struts and locking mechanism are integrally formed as a unitary component), wherein the actuation member extends from the first end portion of the frame toward the second end portion of the frame (fig. 8 shows the actuation member 86 extends from the first end portion toward the second end portion), wherein the locking mechanism (94) is disposed at the second end portion of the frame (see annotated fig. 8 above) and is configured to receive the actuation member (fig. 8 shows that the locking mechanism receives the actuation member), and wherein the locking mechanism is configured to selectively engage the actuation member such that the actuation member is movable in a first direction relative to the frame when the frame is in a first radially-expanded configuration (paragraphs 0167-0168 disclose that the distal end of the actuation members can have locking features to promote locking engagement of jaws 102 of the clamping mechanism 98 with the actuation members 86 such that the actuation member can function as a ratchet that allows the actuation member to be pulled through the clamp in a first direction to expand the frame; figs. 12A – any expansion state between fully compressed state and fully expanded state is construed to be a first radially-expanded configuration as disclosed in paragraph 0145), thereby allowing further radial expansion of the frame from the first radially-expanded configuration to a second radially-expanded configuration (fully expanded state that is reached when the actuation member is pulled farther in the first direction than when it is in the expanded state between fully compressed and fully expanded) (paragraph 0189 discloses that the frame can be fully expanded or expanded to a desired size less than the fully expanded state for the purpose of allowing implantation in various size annuluses because of optimal sizing being achieved), and such that the actuation member is prevented from moving in a second direction relative to the frame when the frame is in the first radially-expanded configuration, thereby preventing the frame from moving from the first radially-expanded configuration to the radially-compressed configuration (paragraph 0167 discloses that the ratchet function of the actuation member and the clamp allows actuation in a first expansion direction, but the engagement of jaws 102 in slots 314 resist movement in a second, opposite direction – therefore, in the first radially expanded configuration that is an expansion state between fully compressed and fully expanded the frame is prevented from movement back toward the fully compressed state and only allowed movement toward further expansion).
Regarding claim 2
Maimon teaches the prosthetic heart valve of claim 1, further comprising a valve structure (14) coupled to the frame (22) (fig. 1), wherein the valve structure comprises a plurality of leaflets (48; paragraph 0125) configured for allowing blood to flow in an antegrade direction and to restrict blood from flowing in a retrograde direction (paragraph 0018 discloses regulating the flow of blood through the valve structure with leaflets mounted to the frame – the leaflets of Maimon are construed to be fully capable of allowing blood to flow in an antegrade direction and restrict flow in a retrograde direction in the same way as applicant’s).
Regarding claim 3
Maimon teaches the prosthetic heart valve of claim 1, wherein the actuation member (86) of the frame (22) comprises a first threaded portion configured for threadably coupling the actuation member to a second threaded portion of a delivery apparatus (paragraphs 0159-0160 discloses the actuation members being secured to the handle of the delivery apparatus via a retaining member that comprises a screw member/first threaded portion 186 that extends through a captured nut/second threaded portion 194 such that rotation of a knob 188 causes a plug member 184 to move toward or away from the surface 192 of bore 190, thereby clamping the actuation member against movement when the knob is fully tightened and allowing actuation members to move when the plug member moves away from surface 192; fig. 13).
Regarding claim 4
Maimon teaches the prosthetic heart valve of claim 1, wherein the frame comprises a lumen configured for receiving a plurality of shafts (positioning members; 76 are shown to be received in lumen of frame 22; fig. 8) of a delivery apparatus (18) configured for releasably coupling the prosthetic heart valve (14) to the delivery apparatus via a non-threaded connection (paragraphs 0137-0138 disclose non-threaded connection between the valve and the delivery apparatus).
Regarding claim 5
Maimon teaches the prosthetic heart valve of claim 1, wherein the actuation member (86), the plurality of struts (32), and the locking mechanism (94) are integrally formed as a unitary component (fig. 8 shows these components being integrally formed as a unitary component).
Regarding claim 6
Maimon teaches the prosthetic heart valve of claim 1, wherein the plurality of struts of the frame comprises a plurality of pivoting struts (32) and a plurality of non-pivoting struts (42) (paragraph 0119 discloses pivoting struts and paragraph 0122 discloses non-pivoting struts; fig. 2), wherein the pivoting struts are integrally formed with or fixedly coupled to the non-pivoting struts, and wherein the pivoting struts pivot relative to the non-pivoting struts as the frame moves from the radially-compressed configuration to the first radially-expanded configuration (paragraph 0123 discloses pivoting struts pivoting relative to non-pivoting struts as the frame moves).
Regarding claim 7
Maimon teaches the prosthetic heart valve of claim 6, wherein the actuation member (86) is coupled to a first non-pivoting strut of the plurality of non-pivoting struts (paragraph 0122 discloses non-pivoting struts 42 may be included on the frame as shown in fig. 2; the actuation member 86 would be coupled to at least one non-pivoting strut when included on the frame, particularly since each element of the frame is construed to be coupled, at least indirectly, to each of the other elements of the fame), which is disposed at the first end portion of the frame (the actuation member is connected to an apex at the first end portion of the frame; see annotated fig. 8 above), and wherein the locking mechanism (94) is formed in a second non-pivoting strut of the plurality of non-pivoting struts (paragraph 0122 discloses non-pivoting struts 42 may be included on the frame as shown in fig. 2; the locking mechanism 94 would be coupled to at least one non-pivoting strut when included on the frame, particularly since each element of the frame is construed to be coupled, at least indirectly, to each of the other elements of the fame), which is disposed at the second end portion of the frame (the locking mechanism is connected to the second end portion of the frame; see annotated fig. 8 above).
Regarding claim 8
Maimon teaches the prosthetic heart valve of claim 1, wherein the actuation member (86) comprises an elongate shaft (76) (fig. 9).
Regarding claim 9
Maimon teaches the prosthetic heart valve of claim 1, wherein the actuation member (86) comprises an elongate rod (72) (fig. 1).
Regarding claim 10
Maimon teaches the prosthetic heart valve of claim 1, wherein the actuation member comprises a circular cross-sectional profile taken in a plane perpendicular to a longitudinal axis of the actuation member (paragraph 0141 discloses that the actuation members can comprise wires, sutures, strings, or similar materials, at least some of which comprise a circular cross-sectional profile as claimed).
Regarding claim 11
Maimon teaches the prosthetic heart valve of claim 1, wherein the actuation member comprises a non-circular cross-sectional profile taken in a plane perpendicular to a longitudinal axis of the actuation member (paragraphs 0159-0160 discloses the actuation members being secured to the handle of the delivery apparatus via a retaining member that comprises a screw member/first threaded portion 186 that extends through a captured nut/second threaded portion 194 such that rotation of a knob 188 causes a plug member 184 to move toward or away from the surface 192 of bore 190, thereby clamping the actuation member against movement when the knob is fully tightened and allowing actuation members to move when the plug member moves away from surface 192; fig. 13 – therefore, the actuation members are construed to comprise the captured nut 194 which has a non-circular cross-sectional profile as claimed).
Regarding claim 12
Maimon meets the limitations of prosthetic heart valve comprising: a frame (22) comprising a plurality of struts (32, 42), a plurality of actuation members (86; fig. 8), a plurality of locking mechanisms (94; fig. 8), a first end portion and a second end portion (see annotated fig. 8 above), wherein the frame is movable from a radially-compressed configuration (paragraph 0119 discloses that the frame can be manipulated into a radially compressed or contracted configuration; figs. 6 and 7) to a plurality of radially-expanded configurations (paragraph 0141 discloses applying a distally directed pushing force to effect radial expansion of the frame; paragraph 0145 for example discloses that the frame and thus the valve 14 can be manipulated between a fully expanded state and a fully compressed state, including states in between fully compressed and fully expanded), wherein the plurality of struts and the plurality of locking mechanisms are integrally formed as a unitary component (fig. 8 shows that the struts and locking mechanisms are integrally formed as a unitary component), wherein the plurality of actuation members extends from the first end portion of the frame toward the second end portion of the frame (fig. 8 shows the actuation member 86 extends from the first end portion toward the second end portion), wherein the plurality of locking mechanisms (94) is disposed at the second end portion of the frame (see annotated fig. 8 above), each locking mechanism of the plurality of locking mechanisms being spaced circumferentially relative to an adjacent locking mechanism of the plurality of actuation members and configured to receive a respective actuation member of the plurality of actuation members (fig. 8 shows that each locking mechanism receives a respective actuation member) and to selectively engage the respective actuation member such that the respective actuation member is movable in a first direction relative to the frame when the frame is in a first radially-expanded configuration (paragraphs 0167-0168 disclose that the distal end of the actuation members can have locking features to promote locking engagement of jaws 102 of the clamping mechanism 98 with the actuation members 86 such that the actuation member can function as a ratchet that allows the actuation member to be pulled through the clamp in a first direction to expand the frame; figs. 12A – any expansion state between fully compressed state and fully expanded state is construed to be a first radially-expanded configuration as disclosed in paragraph 0145), thereby allowing the frame to radially expand from the first radially-expanded configuration to a second radially-expanded configuration (fully expanded state that is reached when the actuation member is pulled farther in the first direction than when it is in the expanded state between fully compressed and fully expanded) (paragraph 0189 discloses that the frame can be fully expanded or expanded to a desired size less than the fully expanded state for the purpose of allowing implantation in various size annuluses because of optimal sizing being achieved), and such that the respective actuation member is prevented from moving in a second direction relative to the frame when the frame is in the first radially-expanded configuration, thereby preventing the frame from moving from the first radially-expanded configuration to the radially-compressed configuration (paragraph 0167 discloses that the ratchet function of the actuation member and the clamp allows actuation in a first expansion direction, but the engagement of jaws 102 in slots 314 resist movement in a second, opposite direction – therefore, in the first radially expanded configuration that is an expansion state between fully compressed and fully expanded the frame is prevented from movement back toward the fully compressed state and only allowed movement toward further expansion).
Regarding claim 16
Maimon teaches the prosthetic heart valve of claim 12, wherein the plurality of actuation members comprises exactly three actuation members, and wherein the plurality of locking mechanisms comprises exactly three locking mechanisms (fig. 8 shows exactly three actuation members 86 and exactly three locking mechanisms 94).
Regarding claim 19
Maimon meets the limitations of a method of implanting a prosthetic heart valve (paragraph 0002 discloses methods and delivery assemblies for and including mechanically expandable prosthetic heart valves), comprising: inserting a prosthetic heart valve into a patient’s vasculature (paragraph 0049 discloses implanting a prosthetic heart valve 14 by inserting into a patient’s vasculature), the prosthetic heart valve releasably coupled to a distal end portion of a delivery apparatus (paragraph 0005 discloses that the prosthetic valve is releasably coupled to a delivery assembly) and in a radially-compressed configuration (paragraph 0119 discloses a radially compressed or contracted configuration for insertion/delivery); advancing the prosthetic heart valve through the patient’s vasculature to an implantation location (paragraph 0119 discloses inserting the prosthetic valve into a patient for implantation); expanding the prosthetic heart valve to a radially-expanded configuration (paragraph 0119 discloses manipulation into an expanded state and release from the delivery apparatus) by applying an axially-compressive force on the prosthetic heart valve with the delivery apparatus (paragraph 0138 discloses that the delivery device applies an axially-compressive force on the prosthetic valve to contain the prosthetic valve in a radially compressed state for delivery); and locking the prosthetic heart valve in the radially-expanded configuration by engaging an actuation member (76 and 86) and a locking mechanism (94) of the prosthetic heart valve such that the prosthetic heart valve is prevented from moving from the radially-expanded configuration to the radially-compressed configuration (paragraph 0167 discloses that the ratchet function of the actuation member and the clamp allows actuation in a first expansion direction, but the engagement of jaws 102 in slots 314 resist movement in a second, opposite direction – therefore, in the first radially expanded configuration that is an expansion state between fully compressed and fully expanded the frame is prevented from movement back toward the fully compressed state and only allowed movement toward further expansion), wherein the locking mechanism is integrally formed with a frame of the prosthetic heart valve (fig. 9 shows that the locking mechanism 94 is integrally formed with a frame 22 of the prosthetic heart valve 14 as claimed).
Regarding claim 20
Maimon teaches the method of claim 19, wherein the actuation member is integrally formed with the frame and the locking mechanism (fig. 8 shows the actuation member 76 and 86 integrally formed with the frame 22 and locking mechanism 94 as claimed).
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) 13-15 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maimon.
Regarding claim 13
Maimon teaches the prosthetic heart valve of claim 12, wherein the plurality of actuation members comprises 3 actuation members, and wherein the plurality of locking mechanisms comprises 3 locking mechanisms (fig. 8). However, Maimon does not explicitly disclose 2-15 actuation members or 2-15 locking mechanisms.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of actuation members and locking mechanisms of Maimon from 3 to between 2-15 as applicant appears to have placed no criticality on the claimed range (see pp. [0182] indicating the amount “can” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 14
Maimon teaches the prosthetic heart valve of claim 12, wherein the plurality of actuation members comprises 3 actuation members, and wherein the plurality of locking mechanisms comprises 3 locking mechanisms (fig. 8). However, Maimon does not explicitly disclose 3-12 actuation members or 3-12 locking mechanisms.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of actuation members and locking mechanisms of Maimon from 3 to between 3-12 as applicant appears to have placed no criticality on the claimed range (see pp. [0182] indicating the amount “can” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 15
Maimon teaches the prosthetic heart valve of claim 12, wherein the plurality of actuation members comprises 3 actuation members, and wherein the plurality of locking mechanisms comprises 3 locking mechanisms (fig. 8). However, Maimon does not explicitly disclose 6-9 actuation members or 6-9 locking mechanisms.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of actuation members and locking mechanisms of Maimon from 3 to between 6-9 as applicant appears to have placed no criticality on the claimed range (see pp. [0182] indicating the amount “can” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 17
Maimon teaches the prosthetic heart valve of claim 12, wherein the plurality of actuation members comprises 3 actuation members, and wherein the plurality of locking mechanisms comprises 3 locking mechanisms (fig. 8). However, Maimon does not explicitly disclose exactly six actuation members or exactly six locking mechanisms.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of actuation members and locking mechanisms of Maimon from 3 to exactly six as applicant appears to have placed no criticality on the claimed range (see pp. [0333] indicating an “example” amount within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 18
Maimon teaches the prosthetic heart valve of claim 12, wherein the plurality of actuation members comprises 3 actuation members, and wherein the plurality of locking mechanisms comprises 3 locking mechanisms (fig. 8). However, Maimon does not explicitly disclose exactly nine actuation members or exactly nine locking mechanisms.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the amount of actuation members and locking mechanisms of Maimon from 3 to exactly nine as applicant appears to have placed no criticality on the claimed range (see pp. [0334] indicating an “example” amount within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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