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 Arguments
Applicant's arguments filed 12/31/2025 have been fully considered but they are not persuasive. In response to applicant's argument that the references fail to show amended features of the invention (i.e., foldable protrusions), the examiner disagrees. See Manash (US 20200000579 A1) figures 47a, 47b and 47c, or further see new rejection for claim 1 below. The claim does not set forth a particular use of the folding protrusions which signifies broad requirements. Foldable is given its broadest reasonable interpretation. The shifting between the outward L-shaped bending in fig 47c and the flat configuration in fig 47a is considered folding, the strut is being bent or rearranged into different shapes.
Claim Objections
Claim 12 objected to because of the following informalities:
Claim 12 recites “the radially outwardly extending position” the claim should recite “a radially outward extending position.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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) 1-5 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manash (US 20200000579 A1).
Regarding claim 1, Manash teaches an implantable heart valve configured for implantation ([0002]) within an existing prosthetic heart valve, comprising ([0193])
a frame (see annotated figure 32/33) comprising a plurality of frame struts defining a lattice region (see annotated figure 32/33) at an inflow end (see annotated figure 32/33) and a plurality of arches (see annotated figure 32/33) at an outflow end (see annotated figure 32/33), and a central lumen extending therebetween (see annotated figure 32/33), the plurality of frame struts in the lattice region defining a plurality of intersections (see annotated figure 32/33) and a plurality of open spaces (see annotated figure 32/33);
a plurality of foldable (see figures 47a, 47b, and 47c, see [0152] describing straightening and lengthening to fold flat against the frame and see fig 47c is bent and folded outward and fig 47a shows protrusions folded flat, further note embodiments can be combined [0194]) protrusions extending radially outward from the plurality of frame struts (see annotated figure 32/33);
each of the foldable protrusions movable between a biased configuration (fig 47c), an intermediate folding configuration (fig 47b), and a folded configuration (fig 47a); and a valve coupled to the frame (see annotated figure 32/33), the valve positioned within the central lumen (see annotated figure 32/33). (see description of self-expanding properties providing biased configuration [0120; 0132]).
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Annotated figure 32/33
Regarding claim 2, Manash further teaches wherein the plurality of folding protrusions are disposed only on the lattice region of the frame (see annotated figure 32/33).
Regarding claim 3, Manash further teaches wherein the lattice region is devoid of outwardly extending projections other than the plurality of folding protrusions (see annotated figure 32/33).
Regarding claim 4, Manash further teaches wherein the valve includes a plurality of valve leaflets (see annotated figure 32/33), wherein the plurality of valve leaflets are positioned between the lattice region and the plurality of arches (see annotated figure 32/33, spreads between both regions).
Regarding claim 5, Manash further teaches wherein the plurality of frame struts in a region of the plurality of valve leaflets are devoid of the plurality of folding protrusions (see annotated figure 32/33, a region of the leaflets doesn’t have the protrusions).
Regarding claim 13, Manash further teaches wherein the plurality of foldable protrusions extend from at least some of the plurality of intersections (see annotated figure 32/33, protrusions are attached at intersection points).
Regarding claim 14, Manash further teaches wherein the plurality of open spaces in the lattice region are smaller than open spaces defined by the plurality of arches (see annotated figure 32/33, arch cells are much bigger).
Claim(s) 6-7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Manash (US 20200000579 A1) in view of Hacohen (US 9763657 B2).
Regarding claim 6, Manash is silent to the dimensions of the folding protrusions. Hacohen teaches a prosthetic valve (abstract) wherein each of the plurality of protrusions each have a length of between 1.5 mm and 5 mm (col 3, lines 56-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of protrusion length, as taught by Hacohen, to the device, as taught by Manash, since it has been held that where the general conditions of a claim are disclosed in the prior art, protrusion structure/shape/function, discovering the optimum range of a protrusion length that suits a patients anatomy involves only routine skill in the art (MPEP 2144.05 (II)).
Regarding claim 7, Manash is silent to the dimensions of the folding protrusions. Hacohen teaches a prosthetic valve (abstract) wherein the length of each of the plurality of protrusions is between 2 mm and 3 mm (col 3, lines 56-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of protrusion length, as taught by Hacohen, to the device, as taught by Manash, since it has been held that where the general conditions of a claim are disclosed in the prior art, protrusion structure/shape/function, discovering the optimum range of a protrusion length that suits a patients anatomy involves only routine skill in the art (MPEP 2144.05 (II)).
Regarding claim 9, Manash is silent to the dimensions of the folding protrusions. Hacohen teaches a prosthetic valve (abstract) wherein at least some of the plurality of protrusions extend upward or downward at an angle of 35-55 degrees relative to a longitudinal axis of the frame (col 3, lines 52-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of protrusion angle, as taught by Hacohen, to the device, as taught by Manash, since it has been held that where the general conditions of a claim are disclosed in the prior art, protrusion structure/shape/function, discovering the optimum range of a protrusion angle that suits a patients anatomy involves only routine skill in the art (MPEP 2144.05 (II)).
Regarding claim 10, Manash is silent to the dimensions of the folding protrusions. Hacohen teaches a prosthetic valve (abstract) wherein at least some of the plurality of protrusions extend upward or downward at an angle of 45 degrees relative to the longitudinal axis (col 3, lines 52-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of protrusion angle, as taught by Hacohen, to the device, as taught by Manash, since it has been held that where the general conditions of a claim are disclosed in the prior art, protrusion structure/shape/function, discovering the optimum range of a protrusion angle that suits a patients anatomy involves only routine skill in the art (MPEP 2144.05 (II)).
Claim(s) 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Manash (US 20200000579 A1) in view of Liu (CN 109567985 A).
Regarding claim 8, Manash is fails to teach perpendicular protrusions. Liu teaches a prosthetic valve (abstract) wherein at least some of the plurality of protrusions extend substantially perpendicular to a longitudinal axis of the frame (pg. 6, 1st paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of perpendicular protrusion, as taught by Liu, to some of the the existing protrusions, as taught by Manash, in order to best suit individual patients’ anatomical needs and secure the valve to the native structure of the patient’s heart (pg. 6, 1st paragraph).
Regarding claim 11, Manash further teaches a device with upwardly angled and downwardly angled protrusions (see annotated figure 35 a/b). Manash fails to teach perpendicular protrusions. Liu teaches a prosthetic valve (abstract) wherein at least some of the plurality of protrusions extend substantially perpendicular to a longitudinal axis of the frame (pg. 6, 1st paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of perpendicular protrusion, as taught by Liu, to some of the existing protrusions, as taught by Manash, in order to best suit individual patients’ anatomical needs and secure the valve to the native structure of the patient’s heart (pg. 6, 1st paragraph).
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Annotated figure 35 a/b
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Manash (US 20200000579 A1) in view of Braido (US 20160045165 A1).
Regarding claim 12, Manash further teaches a device wherein the plurality of folding protrusions are aligned with an outer surface of the plurality of frame struts during delivery, and move to the radially outwardly extending position when deployed in a patient's body ([0130]). Manash is silent regarding the shape memory material. Braido teaches a prosthetic valve (abstract) wherein the plurality of protrusions are formed of a shape memory material ([0151]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of protrusion material, as taught by Braido, to the existing protrusions, as taught by Manash, because it would be obvious to try choosing from a finite number of identified materials used in the art with an expectation of successful biocompatibility and safe implantation (MPEP 2144.05)
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Essinger (US 10376359 B2) in view of Manash (US 20200000579 A1).
Regarding claim 20, Essinger teaches an implantable heart valve assembly comprising a first implantable heart valve (see annotated fig 1) including a first frame (see annotated fig 1) comprising a first plurality of frame struts (see annotated fig 1) defining a first lattice region (see annotated fig 1) at a first inflow end of the first frame (see annotated fig 1) and a plurality of arches (see annotated fig 1) at an first outflow end of the frame (see annotated fig 1), and a first central lumen extending therebetween (see annotated fig 1), the lattice region having a first end defining the first inflow end of the frame (see annotated fig 1) and a second end adjacent the first plurality of arches (see annotated fig 1), wherein at least some of the first plurality of frame struts at the second end define a first outwardly extending stent regions (see annotated fig 1), and a first valve coupled to the frame (see annotated fig 1), the valve positioned within the first central lumen (see annotated fig 1).
Essinger fails to teach the details of a second valve. Manash teaches a second implantable heart valve [0193, including a second frame (see annotated figure 32/33) comprising a second plurality of frame struts (see annotated figure 32/33) defining a lattice region(see annotated figure 32/33) at a second inflow end (see annotated figure 32/33) and a plurality of arches (see annotated figure 32/33) at a second outflow end (see annotated figure 32/33), and a second central lumen extending therebetween (see annotated figure 32/33), the second plurality of frame struts in the second lattice region defining a plurality of intersections (see annotated figure 32/33) and a plurality of open spaces (see annotated figure 32/33), the second implantable heart valve including a plurality of foldable (see figures 47a, 47b, and 47c, further note embodiments can be combined [0194]) protrusions extending radially outward from the second plurality of frame struts (see annotated figure 32/33), and a second valve coupled to the second frame (see annotated figure 32/33), the second valve positioned within the second central lumen (see annotated figure 32/33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the second valve taught by Manesh with the first valve taught by Essinger, in order to combine known prior art elements according to known methods to yield predictable results. Manash teaches use of its valve with existing valves in the art ([0193]), valve-in-valve procedures are known are needed to suit various patient needs (MPEP 2143). Further, the claim does not set forth a relative position or combined placement of the two valves together within the patient’s body. Merely providing the two implants to an operator as separate components meets the significantly broad requirements.
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Annotated figure 1
Conclusion
THIS ACTION IS MADE FINAL. 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 HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 8:30PM-4:30PM EST M-F (occasionally off Fridays).
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/H.L.P./Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774