DETAILED ACTION
Claim Objections
Claim(s) 16, 21 is/are objected to because of the following informalities:
Within claim 16, line 13 (and claim 21, line 2): “the valve” should be changed to –the prosthetic heart valve-- to maintain consistent claim terminology.
Appropriate correction is required.
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 .
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 2-6, 8-9, 19, 22-25 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Within claim 2, lines 1-3: Applicant claims, “wherein the prosthetic heart valve is fully self-expanding and is configured to radially self-expand to the radially expanded state when released from a restraining mechanism”; it is unclear, and therefore indefinite, how the prosthetic heart valve can be BOTH fully self-expanding (as required by the aforementioned claim requirement) AND the actuator member being configured to apply a proximally directed force to the frame to radially expand and/or lock the prosthetic heart valve (as required by claim 1, lines 6-8). If the prosthetic heart valve is fully expandable then the actuator member would never apply a proximal force to the frame to either radially expand it (as it’s self-expanding) nor to lock it (instead, in locking it the actuator member would merely prevent the sliding in an opposite distal direction past the lock ALONE without applying a proximally directed force). Claim(s) 4, which depend from claim 2, inherit all the problems associated with claim 2.
Within claim 3, lines 2-3: Applicant claims, “a partially radially expanded state”; it is unclear, and therefore indefinite, if this is the same as OR different from the “partially radially expanded state” within claim 1, line 5. Claim(s) 5, which depend from claim 3, inherit all the problems associated with claim 3.
Within claim 6, lines 1-2: Applicant claims, “the locking element is integrally formed in the frame”; it is unclear, and therefore indefinite, if the locking element is part of (as in integrally formed IN the frame), as required by the aforementioned claim requirement OR a separate structure from the frame (as required by claim 1, lines 2-9).
Within claim 8, line 2: Applicant claims, “the openings”; it is unclear, and therefore indefinite, how many opening(s) are required by the claim – at least two (as openings is plural), as required by the aforementioned claim requirement OR at least one (as required by claim 7, line 3).
Within claim 9, line 2: Applicant claims, “the openings”; it is unclear, and therefore indefinite, how many opening(s) are required by the claim – at least two (as openings is plural), as required by the aforementioned claim requirement OR at least one (as required by claim 7, line 3).
Within claim 19, line 2: Applicant claims, “a partially radially expanded state”; it is unclear, and therefore indefinite, if this is the same as OR different from the “partially radially expanded state” within claim 16, lines 4-5.
Within claim 19, lines 2-4: Applicant claims, “wherein the actuator member is configured to be pulled in the proximal direction to further radially self-expand the frame to the radially expanded state”; it is unclear, and therefore indefinite, how the actuator being pulled results in SELF-expansion – Examiner is curious if the aforementioned claim requirement should instead read --wherein the actuator member is configured to be pulled in the proximal direction to further radially expand the frame to the radially expanded state--.
Within claim 20, lines 1-3: Applicant claims, “wherein the frame is configured to radially self-expand to the radially expanded state”; it is unclear, and therefore indefinite, how the frame can be BOTH fully self-expanding (as required by the aforementioned claim requirement) AND the actuator member being configured to apply a proximally directed force to the frame to radially expand and/or lock the prosthetic heart valve (as required by claim 16, lines 9-11). If the frame is fully expandable then the actuator member would never apply a proximal force to the frame to either radially expand it (as it’s self-expanding) nor to lock it (instead, in locking it the actuator member would merely prevent the sliding in an opposite distal direction past the lock ALONE without applying a proximally directed force).
Within claim 22, line 11: Applicant claims, “the locking element engages the tension member”; it is unclear, and therefore indefinite, if the locking element engages (as required by the aforementioned claim requirement) OR is configured to engage (as required by claim 22, line 8). Claim(s) 23-25, which depend from claim 22, inherit all the problems associated with claim 22.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5-6, 12-15, 22-25 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Salahieh et al. (US 2005/0137686 A1).
With respect to claim 1:
Salahieh et al. discloses a prosthetic valve (apparatus 10), as can be seen in figs. 1-4 (paragraph [0075]), comprising:
An annular frame (subsection of anchor 30) comprising an inflow end (closer to the bottom of the page in fig. 1A) and an outflow end (closer to the top of the page in fig. 1A), wherein the frame (subsection of anchor 30) is radially compressible and expandable between a radially compressed state (collapsed delivery configuration), as can be seen in fig. 3A, and a radially expanded state (fully deployed), as can be seen in figs. 4F (paragraphs [0085, 0088, 0090]), and wherein the frame (subsection of anchor 30) is configured to radially self-expand from the radially compressed state (collapsed delivery configuration) to at least a partially radially expanded state (partially deployed configuration) (paragraph [0088]);
An actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) coupled to the frame (subsection of anchor 30) at first and second axially spaced locations (at eyelets 45 and at end of anchor 30), as can be seen in figs. 3A-3B (paragraphs [0079, 0085-0086]), wherein the actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) is configured to apply a proximally directed force (toward the downstream end) to the frame (subsection of anchor 30) to radially expand and/ or lock the prosthetic heart valve (apparatus 10) (paragraphs [0086, 0089-0090]); and
A locking element (female interlocking element 42) coupled to the frame (subsection of anchor 30) at the second location, as can be seen in figs. 3A-3B, wherein the locking element (female interlocking element 42) is configured to allow the actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) to slide in only a proximal direction (toward the downstream end) relative to the frame (subsection of anchor 30) and to continuously engage the actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) to prevent to actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) from sliding in an opposite distal direction past the locking element (female interlocking element 42) (as can be seen in the figs. - the locking element (female interlocking element 42) only allows one way slidable movement with a portion of the actuator member (posts 38A-C); and the plurality of arrowheads 46, as can be seen in figs. 11B-11D, will create continuous (due to the multiple arrowheads 46) engagement between the locking element (female interlocking element 42) and a portion of the actuator member (posts 38A-C)).
With respect to claim 3:
Wherein the prosthetic heart valve (apparatus 10) is partially self-expanding and is configured to radially self-expand to the partially radially expanded state (partially deployed configuration) when released from a restraining mechanism (sheath 110) (paragraphs [0085, 0088]), wherein the partially radially expanded state (partially deployed configuration) is a state between the radially compressed state (collapsed delivery configuration) and the radially expanded state (fully deployed) (paragraphs [0088-0090]).
With respect to claim 5:
Wherein the actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) is configured to radially expand the valve from the partially radially expanded state (partially deployed configuration) to the radially expanded state (fully deployed) (paragraphs [0089-0090]).
With respect to claim 6:
Wherein the locking element (female interlocking element 42) is integrally formed in the frame (subsection of anchor 30) (the locking element (female interlocking element 42) are part of the laser cut frame (anchor 30)) (paragraphs [0077, 0079]).
With respect to claim 12:
Wherein the actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) comprises one or more of a suture, string, wire (wires 50, wires 62), cord, and/or cable (paragraph [0079]).
With respect to claim 13:
Wherein the actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) is configured to be pulled to radially expand and/or lock the prosthetic heart valve (apparatus 10) (paragraphs [0086, 0088-0090]).
With respect to claim 14:
Wherein the locking element (an alternative to the female interlocking element 42, as seen in figs. 17-18, specifically the female interlocking element 308) comprises a spring tooth (tab 310) that is naturally biased to provide a compressive force to the portion of interlocking element 302 between eyelet 304 and openings) to the actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) to prevent movement of the actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) relative to the locking element (an alternative to the female interlocking element 42 as seen in figs. 17-18, specifically the female interlocking element 308) in the distal direction (paragraph [0116]).
With respect to claim 15:
Wherein the locking element (an alternative to the female interlocking element 42, as seen in figs. 17-18, specifically the female interlocking element 308)/ spring tooth (tab 310) is formed in an axially extending opening in a strut (structure defining the female interlocking element 308) of the frame (subsection of anchor 30).
With respect to claim 22:
Salahieh et al. discloses a prosthetic valve (apparatus 10), as can be seen in figs. 1-4 (paragraph [0075]), comprising:
An annular frame (subsection of anchor 30) comprising an inflow end (closer to the bottom of the page in fig. 1A) and an outflow end (closer to the top of the page in fig. 1A), wherein the frame (subsection of anchor 30) is radially compressible and expandable between a radially compressed state (collapsed delivery configuration), as can be seen in fig. 3A, and a radially expanded state (fully deployed), as can be seen in figs. 4F (paragraphs [0085, 0088, 0090]), and wherein the frame (subsection of anchor 30) is configured to self-expand from the radially compressed state (collapsed delivery configuration) to at least a partially expanded state (partially deployed configuration) (paragraph [0088]);
A tension member (in combination wires 50, and posts 38A-C) coupled to the frame (subsection of anchor 30) at first and second axially spaced locations (at eyelets 45 and at end of anchor 30), as can be seen in figs. 3A-3B, along the frame (subsection of anchor 30) (paragraphs [0079, 0085-0086]); and
A locking element (female interlocking element 42) configured to engage the tension member (in combination wires 50, and posts 38A-C) at the second location (at end of anchor 30) and configured to allow the tension member (in combination wires 50, and posts 38A-C) to be pulled proximally (toward the downstream end) relative to the locking element (female interlocking element 42) and resist distal movement (toward the upstream end) of the tension member (in combination wires 50, and posts 38A-C) relative to the locking element (female interlocking element 42), wherein the locking element (female interlocking element 42) is configured to engage the tension member (in combination wires 50, and posts 38A-C) such that slack is present (prior to wires 50 being retracted) in the tension member (in combination wires 50, and posts 38A-C) when the frame (subsection of anchor 30) self-expand to at least the partially expanded state (partially deployed configuration) and application of pulling forces to the tension member (in combination wires 50, and posts 38A-C) is effective to remove the slack (after wires 50 are retracted) from the tension member (in combination wires 50, and posts 38A-C) to retain the frame (subsection of anchor 30) in the at least partially expanded state (fully deployed) (paragraphs [0085, 0088-0090]).
With respect to claim 23:
Wherein the locking element (an alternative to the female interlocking element 42 as seen in figs. 17-18, specifically the female interlocking element 308) comprises a spring tooth (tab 310) (paragraph [0116]).
With respect to claim 24:
Wherein the tension member (in combination wires 50, and posts 38A-C) comprises one or more of a suture, string, wire (wires 50), cord, and/or cable (paragraph [0079]).
With respect to claim 25:
Wherein, when slack is present in the tension member (in combination wires 50, and posts 38A-C), the frame (subsection of anchor 30) is configured to be radially compressed (retrieved and repositioned) without disengaging (prior to engaging) the locking member (female interlocking element 42) (paragraph [0078]).
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.
Claim(s) 16-19, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. (US 2005/0137686 A1) in view of Griffin et al. (US 2019/0060063 A1).
With respect to claim 16:
Salahieh et al. discloses the invention substantially as claimed. Specifically, Salahieh et al. discloses a prosthetic valve (apparatus 10), as can be seen in figs. 1-4 (paragraph [0075]), comprising:
An annular frame (subsection of anchor 30) comprising an inflow end (closer to the bottom of the page in fig. 1A) and an outflow end (closer to the top of the page in fig. 1A), wherein the frame (subsection of anchor 30) is radially compressible and expandable between a radially compressed state (collapsed delivery configuration), as can be seen in fig. 3A, and a radially expanded state (fully deployed), as can be seen in figs. 4F (paragraphs [0085, 0088, 0090]), and wherein the frame (subsection of anchor 30) is configured to radially self-expand from the radially compressed state (collapsed delivery configuration) to at least a partially radially expanded state (partially deployed configuration) (paragraph [0088]) when a restraining mechanism (such as a constraining wire) configured to hold the frame (subsection of anchor 30) in the radially compressed state is loosened (NOTE: Applicant has not positively recited the restraining mechanism, merely that the frame is configured to (i.e. is capable) of being used with a restrainment mechanism which can be loosened; as such, the annular frame (subsection of anchor 30) is considered by Examiner to be capable of use with a constraining wire);
An actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) coupled to the frame (subsection of anchor 30) at first and second axially spaced locations (at eyelets 45 and at end of anchor 30), as can be seen in figs. 3A-3B (paragraphs [0079, 0085-0086]), wherein the actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) is configured to apply a proximally directed force (toward the downstream end) to the frame (subsection of anchor 30) to radially expand and/ or lock the prosthetic heart valve (apparatus 10) (paragraphs [0086, 0089-0090]); and
A locking element (female interlocking element 42) coupled to the frame (subsection of anchor 30) at the second location, as can be seen in figs. 3A-3B, wherein the locking element (female interlocking element 42) is configured to prevent radial compression of the prosthetic heart valve (apparatus 10) when the actuator is in a taut state by allowing the actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) to slide in only a proximal direction (toward the downstream end) relative to the frame (subsection of anchor 30) and to continuously lock the actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) to prevent to actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) from sliding in an opposite distal direction past the locking element (female interlocking element 42) (as can be seen in the figs. - the locking element (female interlocking element 42) only allows one way slidable movement with a portion of the actuator member (posts 38A-C); and the plurality of arrowheads 46, as can be seen in figs. 11B-11D, will create continuous (due to the multiple arrowheads 46) engagement between the locking element (female interlocking element 42) and a portion of the actuator member (posts 38A-C)).
However, Salahieh et al. does not disclose the prosthetic heart valve to comprises a skirt assembly that extends circumferentially around the frame (subsection of anchor 30) and comprises a sleeve that is configured to receive a restraining mechanism which is configured of being loosened.
Griffin et al. teaches a prosthetic heart valve (prosthesis 100) (paragraph [0041]), as can be seen in figs. 1-2 comprising:
An annular frame (frame 102) comprising an inflow end and an outflow end, wherein the frame (frame 102) is radially compressible and expandable between a radially compressed state (radially compressed configuration) and a radially expanded state (radially expanded state) (paragraph [0040]), and wherein the frame (frame 102) is configured to radially self-expand from the radially compressed state (radially compressed configuration) to at least a partially radially expanded state (radially expanded state) when a restraining mechanism (elongate member 108) configured to hold the frame (frame 102) in the radially compressed state (radially compressed configuration) is loosened (paragraphs [0043, 0045]);
A skirt assembly (outer layer 105) that extends circumferentially around the frame (frame 102), wherein the skirt assembly (outer layer 105) comprises a sleeve (folded fixation member 106) that is configured to restrain the restraining mechanism (elongate member 108) (paragraph [0040, 0045]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the restrainment mechanism (delivery sheath 110), as disclosed by Salahieh et al., with BOTH the restraining mechanism (elongate member 108) and skirt assembly (outer layer 105) with the sleeve (folded fixation member 106), as taught by Griffin et al., both sets of structures are used for the same purpose (to restrain a self expanding prosthesis during delivery) and are therefore considered obvious substitutes for each other. Additionally, the skirt assembly (outer layer 105), as taught by Griffin et al., imparts an additional advantage of creating a seal with the native anatomy (Griffin et al. paragraphs [0040, 0044]).
With respect to claim 17:
Wherein the locking element (female interlocking element 42), as disclosed by Salahieh et al., is coupled to an outflow apex of the frame (subsection of anchor 30) (when the apparatus 10 is fully deployed, as can be seen in Salahieh et al. fig. 1B).
With respect to claim 18:
Wherein the actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C), as disclosed by Salahieh et al., comprises one or more of a suture, string, wire (wires 50, wires 62), cord, and/or cable (Salahieh et al. paragraph [0079]).
With respect to claim 19:
Wherein the prosthetic heart valve (apparatus 10), as disclosed by Salahieh et al. and modified by Griffin et al. (as discussed above), is configured to radially self-expand to a partially radially expanded state (partially deployed configuration) (Salahieh et al. paragraphs [0085, 0088]), and wherein the actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C) is configured to be pulled in the proximal direction to further expand the frame (subsection of anchor 30) to the radially expanded state (fully deployed) (Salahieh et al. paragraphs [0088-0090]).
With respect to claim 21:
Wherein the actuator member (in combination tubes 60, wires 50, wires 62, posts 38A-C), as disclosed by Salahieh et al., is configured to be pulled in the proximal direction to lock the valve (apparatus 10) in the radially expanded state (fully deployed) (Salahieh et al. paragraphs [0088-0090]).
Allowable Subject Matter
Claim(s) 7, 10-11 is/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.
Claim(s) 8-9 is/are would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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: Examiner can find no references alone nor in combination which would render obvious:
With respect to claim 7:
A prosthetic heart valve (as required by claim 1) AND wherein the frame comprises vertical struts at both the first and second locations of the frame, and wherein the actuator member extends through the one or more opening in one or more of the vertical struts (the frame, as disclosed by Salahieh et al. (discussed above) neither discloses vertical struts (with one or more openings) at both the first and second locations of the frame nor the actuator member extending through the aforementioned openings).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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/REBECCA S PRESTON/Examiner, Art Unit 3774