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 . Claims 1-9, 12, 14-19, 21-22, 24- 25, 30-33, 36, 39-40, 47, 49-53, 60-61, and 63-73 are pending and examined below.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/18/2025 has been entered.
Response to Arguments
Applicant's arguments filed 06/18/2025 have been fully considered but they are not persuasive.
Applicant argues on pages 1-3 that the tubular frame of the claimed invention has a “porous outer surface that creates an area of cross flow for blood flow through the tubular frame” whereas the prior art does not disclose a specific structural configuration that creates an area of cross flow through a porous tubular frame. The examiner respectfully disagrees. It appears the “porous outer surface” of the tubular frame is the space 116 between the struts 114 as discussed in [0114]. The prior art, McLean, shows in Figs. 10A-11E and 20A-20E, a tubular structure with struts and space in between, therefore, it will be fully capable of performing the intended use of “creates an area of cross flow for blood through the tubular frame” once it expands to exert a radial force against the leaflets. The radial stiffness of the tubular frame against the valve leaflets would exert a force pressing the leaflets outwards and against the vessel wall (Fig. 10B, McLean) which is how the applicant’s disclosure describes how the “cross flow 36” is created (pushing of the native leaflets 12 can create the area of cross flow 36, [0137]).
In regards to the cylindrical wire argument on pages 3-4, McLean discloses the claimed invention except for the cylindrical wire. It would have been an obvious matter of design choice to change the shape of the arm as McLean discloses it can be a variety of shape, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art
Applicant's argument has been considered but is not persuasive. Please see the rejection below.
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.
Claims 9 & 33 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.
In regards to claims 9 and 33 in reference to the claim limitation “maintaining mechanical isolation between the expanding member and the tubular frame,” the disclosure does not disclose any relationship between the expanding member and the tubular frame maintaining any force so it is unclear of what the applicant means by “mechanical isolation between the expanding member and the tubular frame.”
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.
Claims 1-9, 12, 14-19, 21-22, 24-25, 30-33, 36, 39-40, 47, 49-53, 60-61, & 63-73 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.
Claim 1 recites the limitation “a porous outer surface” in line 11. It is unclear if this is the same or different from “a porous outer surface” from line 2. For the purpose of examination, they are regarded as the same.
Claim 2 recites the limitation “an outer surface” in line 2. It is unclear if this is the same or different from “a porous outer surface” of claim 1. For the purpose of examination, they are regarded as the same.
Claim 4 recites the limitation “an outer surface” in lines 1-2. It is unclear if this is the same or different from “a porous outer surface” of claim 1. For the purpose of examination, they are regarded as the same.
Claim 5 recites the limitation “a porous outer surface” in line 16. It is unclear if this is the same or different from “a porous outer surface” from line 2.
Claim 6 recites the limitation “the outer surface” in lines 6-7. It is unclear if this is the same or different from “a porous outer surface” from line 2.
Claim 6 recites the limitation “a porous outer surface” in line 18. It is unclear if this is the same or different from “a porous outer surface” from line 2.
Claim 9 recites the limitation “the outer surface” in line 2. It is unclear if this is the same or different from “a porous outer surface” from claim 6.
Claim 18 recites the limitation “a porous outer surface” in line 18. It is unclear if this is the same or different from “a porous outer surface” from line 2.
Claim 33 recites the limitation “a lattice network” in line 26. It is unclear if this is the same or different from “a lattice network” from line 8.
All dependent claims are likewise rejected.
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) 1-9, 12, 14-15, 17-19, 21-22, 24-25, 31-33, 36, 39-40, 49-50, 60-61, 63-66, and 68-73 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McLean et al. (US 20150328001 A1) hereinafter, McLean.
Regarding claim 1, McLean teaches a valve (100, Figs. 10A-F) comprising:
a tubular frame (120, Fig. 11D) having a porous outer surface (Figs. 11A-E) and length extending from a first end (121, Fig. 11D) to a second end (123, Fig. 11D) of the tubular frame (120, Fig. 11D);
valve leaflets (132, Fig. 11D) disposed within the tubular frame (120, Fig. 11D); and
an expanding member (110, Figs. 80A & 84A) extending radially outward from the tubular frame (120, Fig. 80A & 84A) at a position along a longitudinal axis of the tubular frame (120, Fig. 80A & 84A); wherein:
the expanding member (110, Figs. 80A & 84A) is configured to exert a pushing force on one or more native valve leaflets in a direction away from the tubular frame when the valve is deployed (outward radial force, ¶0350); and
the tubular frame (120, Figs. 11A-E) having a porous outer surface (Figs. 11A-E) creates an area of cross flow for blood through the tubular frame (in this case, the struts of 120 device discloses all the claimed structural features and is considered to be capable of creating an area of cross flow for blood through the tubular frame, Figs. 10A-F & 11A-E).
Regarding claim 2, McLean teaches the valve (100, Fig. 10C) of claim 1, wherein
the tubular frame (120, Fig. 11B) comprises an outer surface (127, Fig. 11B) and defines an inner lumen (126, Fig. 11B); wherein
the tubular frame (120, Fig. 11B) length is along a longitudinal axis (101, Fig. 11B) of the tubular frame (120, Fig. 11B); wherein
the valve leaflets (132, Fig. 11B) are disposed within the inner lumen (126, Fig. 11B); wherein
the valve leaflets (132, Fig. 11B) have a first end (area towards the top of Fig. 80A) proximate the first end (121, Fig. 11D) of the tubular frame (120, Fig. 11D); wherein
the valve leaflets (132, Fig. 11B) have a second end (area towards the bottom of Fig. 80A) that extends partially between the first end (121, Fig. 11D) and the second end (123, Fig. 11D) of the tubular frame (120, Fig. 11D); wherein
the expanding member exerts a fixation-free pushing force (outward radial force, Figs. 84A-84C, ¶0350), the expanding member being fixation-free of one or more of the native valve leaflets (anchoring member 110 will be equipped with atraumatic tissue engagement elements 170 which do not penetrate tissue or inhibit device relocation once the anchoring member 110 has been deployed, ¶0270); and wherein
the expanding member (110, Figs. 80A & 84A) extends from the tubular frame (120, Fig. 80A) at a position proximate the second end of the valve leaflets (area towards the bottom of Fig. 80A).
Regarding claim 3, McLean teaches
wherein the expanding member (110, Fig. 80A) is further configured to transition between a collapsed configuration (Fig. 46B) and an expanded configuration (Fig. 52B) where the expanding member curves toward (Fig. 80C) the second end (123, Fig. 80C) of the tubular frame (120, Fig. 80C).
Regarding claim 4, McLean teaches
wherein the tubular frame (120, Fig. 11C) comprises an outer surface defined by a lattice network (expandable geometries of closed cells, Fig. 11C, ¶0199).
Regarding claim 5, McLean teaches a valve (100, Fig. 10C) comprising:
a tubular frame (120, Fig. 11D) comprising a porous outer surface (127, Fig. 11B) and defining an inner lumen (126, Fig. 11B),
the tubular frame (120, Fig. 11B) having a length along a longitudinal axis (101, Fig. 11B) of the tubular frame, the length extending from a first end (121, Fig. 11D) to a second end (123, Fig. 11D) of the tubular frame (120, Fig. 11D);
valve leaflets (132, Fig. 11B) disposed within the inner lumen (126, Fig. 11B); and
an expanding member (110, Fig. 80A) having a collapsed configuration (Fig. 46B) and an expanded configuration (Fig. 52B), wherein,
in the collapsed configuration (Fig. 46B), the expanding member is folded towards the second end (123, Fig. 80C) of the tubular frame (120, Fig. 80C), and wherein,
in the expanded configuration, the expanding member extends radially outward (110 pushes radially outward, Figs. 14C & 15, ¶0221) from 5 mm to 15 mm from the outer surface of the tubular frame (120 may have a diameter in the range of about 25 mm to about 32 mm, therefore, the expanding member must extend less than those ranges to stay within that range, ¶0217); wherein:
the expanding member (110, Fig. 84A) is configured to:
extend from the tubular frame (120, Fig. 84A) at a position proximate the second end (area towards the bottom of Fig. 84A) of the valve leaflets; and
exert a pushing force away from the valve and on an entire length of an outer surface of a native valve leaflet when the valve is deployed (outward radial force, Figs. 84A-84C, ¶0350); and
the tubular frame having a porous outer surface creates an area of cross flow for blood through the tubular frame (in this case, the 120 device discloses all the claimed structural features and is considered to be capable of creating an area of cross flow for blood through the tubular frame, Figs. 10A-F & 11A-E).
Regarding claim 6, McLean teaches a valve (100, Fig. 10C) comprising:
a tubular frame (120, Fig. 11D) comprising a porous outer surface (127, Fig. 11B) and defining an inner lumen (126, Fig. 11B),
the tubular frame (120, Fig. 11B) having a length extending from a first end (121, Fig. 11D) to a second end (123, Fig. 11D) along a longitudinal axis (, Fig. 11B) of the tubular frame (120, Fig. 11D);
valve leaflets (132, Fig. 11B) disposed within the inner lumen (126, Fig. 11B); and
an expanding member (110, Fig. 80A) extending radially outward (110 pushes radially outward, Figs. 14C & 15, 0221) from 5 mm to 15 mm (120 may have a diameter in the range of about 25 mm to about 32 mm, therefore, the expanding member must extend less than those ranges to stay within that range, ¶0217) from the outer surface of the tubular frame (120, Fig. 11B) at a position along the longitudinal axis (101, Fig. 11B) of the tubular frame; wherein
the valve leaflets (132, Fig. 11B) have a first end (area towards the top of Fig. 80A) proximate the first end (121, Fig. 11D) of the tubular frame (120, Fig. 11D) and
a second end (area towards the bottom of Fig. 80A) that extends partially between the first end (121, Fig. 11D) and the second end (123, Fig. 11D) of the tubular frame (120, Fig. 11D); and wherein
the expanding member (110, Fig. 80A):
extends from the tubular frame (120, Fig. 80A) at a position proximate the second end of the valve leaflets (area towards the bottom of Fig. 80A);
conforms to a shape of a vessel wall (110 to conform to the native anatomy, ¶0215); and
is configured to exert a force on a native valve leaflet when the valve is deployed (170 on anchoring member 110 exerts frictional forces on cardiac tissue, Fig. 80A, 0273), pushing the native valve leaflet against the vessel wall (the leaflets LF can lie in apposition against the outer wall 142, Fig. 10B, ¶0194) ; and
the tubular frame having a porous outer surface creates an area of cross flow for blood through the tubular frame (in this case, the 120 device discloses all the claimed structural features and is considered to be capable of creating an area of cross flow for blood through the tubular frame, Figs. 10A-F & 11A-E).
Regarding claim 7, McLean teaches
wherein the expanding member (110, Fig. 28) comprises a plurality of arms (114, Fig. 10C) sufficiently spaced around the tubular frame so that coronary arteries are avoided when implanted in an aorta (¶0194 & ¶0212); and wherein
each arm of the plurality of arms one or more:
has a width less than or equal to 3.0 mm; has a width less than or equal to 1.0 mm; has a diameter of less than or equal to 3.0 mm; has a diameter of less than or equal to 1.0 mm (various lengths and accordingly having variable heights; may be greater than the overall height of the anchoring member 110, be intermediate between the respective heights of the anchoring member 110 and the valve support 120, or be less than the overall height of both the anchoring member 110, height of valve support 120 is approximately 14-17 mm, ¶0199 & 0260); and
is a cylindrical wire (variety of shapes, ¶0212). McLean discloses the claimed invention except for the cylindrical wire. It would have been an obvious matter of design choice to change the shape of the arm as McLean discloses it can be a variety of shape, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 8, McLean teaches
wherein the expanding member (110, Fig. 28) is a continuous flange (Figs. 10A & 80A).
Regarding claim 9, McLean teaches
wherein the extension of the expanding member from 5 mm to 15 mm from the outer surface of the tubular frame (valve support 120 may have a diameter in the range of about 25 mm to about 32 mm, therefore, the expanding member must extend less than those ranges to stay within that range, ¶0217) provides sufficient radial force to push the native valve leaflet against the vessel wall while maintaining mechanical isolation between the expanding member and the tubular frame (there is space between the 110 and 120, therefore when 110 is pushing the leaflet against the vessel wall, it maintains a mechanical isolation between 110 and 120 (Fig. 10B, ¶0194 & ¶0220).
Regarding claim 12, McLean teaches
wherein the second end of the valve leaflets (132 of valve 130, Figs. 11B & 80AC) is positioned approximately halfway between the first end (121, Fig. 80C) and the second end (123, Fig. 80C) of the tubular frame (120, Fig. 80C).
Regarding claim 14, McLean teaches
wherein the expanding member (110, Fig. 80A) is further configured to transition between a collapsed configuration (Fig. 46B) and an expanded configuration (Fig. 52B).
Regarding claim 15, McLean teaches
wherein the expanding member (110, Fig. 80A) is in the expanded configuration (Fig. 52B), the expanding member curves toward (Fig. 80C) the second end (123, Fig. 80C) of the tubular frame (120, Fig. 80C).
Regarding claim 17, McLean teaches wherein
the outer surface of the tubular frame (120, Fig. 11C) is defined by a lattice network (expandable geometries of closed cells, Fig. 11C, ¶0199).
Regarding claim 18, McLean teaches a sleeve for a valve (100, Fig. 10C) comprising:
a tubular frame (120, Fig. 11D) comprising a porous outer surface (127, Fig. 11B) and defines an inner surface (126, Fig. 11B)
the tubular frame (120, Fig. 11D) having a length along a longitudinal axis (101, Fig. 11B) of the tubular frame (120, Fig. 11B),
the length extending from an upstream first end (121, Fig. 11D) to a downstream second end (123, Fig. 11D) of the tubular frame (120, Fig. 11D); and
an expanding member (110, Fig. 80A) extending radially outward from 5 mm to 15 mm (valve support 120 may have a diameter in the range of about 25 mm to about 32 mm, therefore, the expanding member must extend less than those ranges to stay within that range, ¶0217) from the outer surface of the tubular frame (120, Fig. 80A) at a position (Figs. 80A-80F) along the longitudinal axis (longitudinal dimension L-L, Fig. 80A) of the tubular frame (120, Fig. 80A) between the upstream first end and the downstream second end of the tubular frame; wherein
the expanding member (110, Fig. 80A) is configured to:
exert a pushing force in a direction away (outward radial force, ¶0350) from the tubular frame on a native defective valve leaflet when the sleeve is deployed (engaging elements 170 on anchoring member 110 exerts frictional forces on cardiac tissue, Fig. 80A, ¶0273), so that the defective valve leaflet does not contact the outer surface of the tubular frame (valve support 120, Fig. 66D); and
transition between a collapsed configuration (Fig. 46B) and an expanded configuration (Fig. 52B); wherein
the tubular frame having a porous outer surface creates an area of cross flow for blood through the tubular frame (in this case, the 120 device discloses all the claimed structural features and is considered to be capable of creating an area of cross flow for blood through the tubular frame, Figs. 10A-F & 11A-E); wherein,
in the collapsed configuration, the expanding member (110, Fig. 80C) is folded towards the downstream second end of the tubular frame (123, Fig. 80C); wherein,
in the expanded configuration, the expanding member (110, Fig. 80C) curves toward the downstream second end of the tubular frame (123, Fig. 80C); and wherein
the inner surface (126, Fig. 11B) is configured to contact an exterior surface (127, Fig. 11B) of the valve (100, Fig. 10C) when the sleeve is deployed.
Regarding claim 19, McLean teaches
wherein the expanding member (110, Fig. 28) comprises a plurality of arms (114, Fig. 10C) sufficiently spaced around the tubular frame so that coronary arteries are avoided when implanted in an aorta (¶0194 & ¶0212).
Regarding claim 21, McLean teaches
wherein a width of each arm of the plurality of arms (114, Fig. 10C) is less than or equal to 3.0 mm (various lengths and accordingly having variable heights; may be greater than the overall height of the anchoring member 110, be intermediate between the respective heights of the anchoring member 110 and the valve support 120, or be less than the overall height of both the anchoring member 110, height of valve support 120 is approximately 14-17 mm, ¶0199 & ¶0260).
Regarding claim 22, McLean teaches
wherein each arm of the plurality of arms (114, Fig. 10C) are cylindrical wires (variety of shapes, ¶0212). McLean discloses the claimed invention except for the cylindrical wire. It would have been an obvious matter of design choice to change the shape of the arm as McLean discloses it can be a variety of shape, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Regarding claim 24, McLean teaches
wherein each arm of the plurality of arms (114, Fig. 10C) has a diameter of less than or equal to 3.0 mm (various lengths and accordingly having variable heights; may be greater than the overall height of the anchoring member 110, be intermediate between the respective heights of the anchoring member 110 and the valve support 120, or be less than the overall height of both the anchoring member 110, height of valve support 120 is approximately 14-17 mm, ¶0199 & 0260).
Regarding claim 25, McLean teaches
wherein the expanding member (110, Fig. 28) is a continuous flange (Figs. 10A & 80A).
Regarding claim 31, McLean teaches
wherein the outer surface of the tubular frame (120, Fig. 11C) is defined by a lattice network (expandable geometries of closed cells, Fig. 11C, ¶0199).
Regarding claim 32, McLean teaches
wherein the inner surface (126, Fig. 11B) of the tubular frame (120, Fig. 11B) comprises an interior attachment (310, Fig. 22A) configured to contact the exterior surface (127, Fig. 11B) of the valve (100, Fig. 10C) and prevent the tubular frame (120, Fig. 22A) from moving with respect to the valve (100, Fig. 10C).
Regarding claim 33, McLean teaches a valve (100, Fig. 10C) system comprising:
a stent (120, Fig, 11B, 0361) comprising:
a stent frame (120, Fig. 11D) comprising an outer surface (127, Fig. 11B) and defining an inner lumen (126, Fig. 11B),
the stent frame (120, Fig. 11D) having a length along a longitudinal axis (longitudinal dimension L-L, Fig. 80A) of the stent frame (120, Fig. 80A),
the length extending from an upstream a first end (121, Fig. 11D) to a downstream second end (123, Fig. 11D) of the stent frame (120, Fig. 11D); and
a plurality of valve leaflets (132, Fig. 11B) disposed within the inner lumen (126, Fig. 11B); and
a tubular frame (120, Fig. 11D) defined by a lattice network having pores (expandable geometries of closed cells, Fig. 11C, ¶0199) and configured to contact the outer surface (127, Fig. 11B) of the stent frame (120, Fig. 11D),
the tubular frame (120, Fig. 11D) comprising an expanding member (110, Fig. 80A) extending radially outward (110 pushes radially outward, Figs. 14C & 15, 0221) from 5 mm to 15 mm (120 may have a diameter in the range of about 25 mm to about 32 mm, therefore, the expanding member must extend less than those ranges to stay within that range, ¶0217) from the outer surface of the tubular frame (120, Fig. 11B); wherein
the expanding member comprises a plurality of cylindrical wires (variety of shapes, ¶0212, McLean discloses the claimed invention except for the cylindrical wire. It would have been an obvious matter of design choice to change the shape of the arm as McLean discloses it can be a variety of shape, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.),
that are circumferentially spaced apart at intervals sufficient to avoid obstruction of coronary arteries when the valve is implanted in an aortic position (¶0194 & ¶0212); wherein
the expanding member (110, Fig. 80A) is configured to:
conform to a shape of a respective vessel wall (110 to conform to the native anatomy, ¶0215); and
exert a pushing force in a direction away (outward radial force, ¶0350) from the tubular frame on an entire length of one or more native defective valve leaflets when the valve system is implanted (engaging elements 170 on anchoring member 110 exerts frictional forces on cardiac tissue, Fig. 80A, ¶0273), both:
pushing the one or more native defective valve leaflets against the respective vessel wall (the leaflets LF can lie in apposition against the outer wall 142, Fig. 10B, ¶0194); and avoiding contact of the one or more native defective valve leaflets (LF, Fig. 66D) from the outer surface of the tubular frame (120, Fig. 66D); wherein
the expanding member exerts a fixation-free pushing force (Figs. 84A-84C), the expanding member being fixation-free of the one or more defective native valve leaflets, such that the expanding member does not penetrate, pinch, grasp or clamp to the one or more defective native valve leaflets (110 will be equipped with atraumatic tissue engagement elements 170 which do not penetrate tissue or inhibit device relocation once the anchoring member 110 has been deployed, ¶0270); wherein
the tubular frame (120, Fig. 11B) defined by a lattice network (expandable geometries of closed cells, Fig. 11C, ¶0199) creates an area of cross flow for blood to flow from the inner lumen of the stent frame to a position outside of the tubular frame (in this case, the 120 device discloses all the claimed structural features and is considered to be capable of creating an area of cross flow for blood through the tubular frame, Figs. 10A-F & 11A-E); wherein
the extension of the expanding member from 5 mm to 15 mm from the outer surface of the tubular frame (120 may have a diameter in the range of about 25 mm to about 32 mm, therefore, the expanding member must extend less than those ranges to stay within that range, ¶0217) provides sufficient radial force (outward radial force, ¶0350) to push the native valve leaflet against the vessel wall while maintaining mechanical isolation between the expanding member and the tubular frame (there is space between the 110 and 120, therefore when 110 is pushing the leaflet against the vessel wall, it maintains a mechanical isolation between 110 and 120 (Fig. 10B, ¶0194 & ¶0220); and wherein one or more of:
the tubular frame (120, Fig. 11D) is positioned on the outer surface (127, Fig. 11B) of the stent frame at a position such that the expanding member (110, Fig. 80A) extends from the tubular frame (120, Fig. 11D) proximate the downstream second end (area towards the bottom of Fig. 80A) of the plurality of valve leaflets; or
the expanding member (110, Fig. 80A) is further configured to transition between a collapsed configuration (Fig. 46B) and an expanded configuration (Fig. 52B), wherein,
when the expanding member (110, Fig. 80A) is in the expanded configuration (Fig. 52B) and the tubular frame (120, Fig. 11D)
is in contact with the outer surface (127, Fig. 11B) of the stent frame (120, Fig. 11D),
the expanding member curves toward (Fig. 80C) the downstream second end (123, Fig. 80C) of the stent frame.
Regarding claim 36, McLean teaches
wherein a width of each cylindrical wire (114, Fig. 10C) is less than or equal to 3.0 mm (various lengths and accordingly having variable heights; may be greater than the overall height of the anchoring member 110, be intermediate between the respective heights of the anchoring member 110 and the valve support 120, or be less than the overall height of both the anchoring member 110, height of valve support 120 is approximately 14-17 mm, ¶0199 & ¶0260).
Regarding claim 39, McLean teaches
wherein each cylindrical wire (114, Fig. 10C) has a diameter of less than or equal to 3.0 mm (various lengths and accordingly having variable heights; may be greater than the overall height of the anchoring member 110, be intermediate between the respective heights of the anchoring member 110 and the valve support 120, or be less than the overall height of both the anchoring member 110, height of valve support 120 is approximately 14-17 mm, ¶0199 & ¶0260).
Regarding claim 40, McLean teaches
wherein the expanding member (110, Fig. 28) is a continuous flange (Figs. 10A & 80A).
Regarding claim 49, McLean teaches
wherein an inner surface (126, Fig. 11B) of the tubular frame (120, Fig. 11B) comprises an interior attachment (310, Fig. 22A) configured to contact the outer surface (127, Fig. 11B) of the stent frame (120, Fig. 22A) and prevent the tubular frame (120, Fig. 22A) from moving with respect to the stent frame.
Regarding claim 50, McLean teaches a method for replacing a native defective valve (Figs. 79A & 79B), comprising:
delivering the valve (1700, Fig. 79A) of claim 6 proximate to the native defective valve (Fig. 79A) such that the second end (123, Fig. 11D) of the tubular frame (120, Fig. 11D) is proximate the native defective valve (Fig. 79A);
expanding the expanding member (110, Fig. 80A) from the collapsed configuration (Fig. 46B) to the expanded configuration (Fig. 52B);
advancing the second end of the tubular frame between defective leaflets of the native defective valve (Fig. 79A), wherein
the expanding member (110, Fig. 79D) contacts the defective leaflets as the tubular frame is advanced between the defective leaflets (anterior leaflet (AL) and posterior leaflet (PL), Fig. 79D); and
pushing the defective leaflets against the vessel wall via the expanding member (the leaflets LF can lie in apposition against the outer wall 142, Fig. 10B, ¶0194).
Regarding claim 60, McLean teaches
wherein the expanding member (110, Fig. 28) is a continuous flange (Figs. 10A & 80A).
Regarding claim 61, McLean teaches
wherein the expanding member extends from 5 mm to 15 mm from the outer surface of the tubular frame (120 may have a diameter in the range of about 25 mm to about 32 mm, therefore, the expanding member must extend less than those ranges to stay within that range, ¶0217).
Regarding claim 63, McLean teaches
wherein the valve leaflets (132, Fig. 11B) have a first end (area towards the top of Fig. 80A) and a second end (area towards the bottom of Fig. 80A),
wherein the first end (area towards the top of Fig. 80A) of the valve leaflets is proximate the first end (121, Fig. 11D) of the tubular frame (120, Fig. 11D), and wherein
the second end (area towards the bottom of Fig. 80A) of the of valve leaflets extends partially between the first (121, Fig. 11D) and second end (123, Fig. 11D) of the tubular frame (120, Fig. 11D).
Regarding claim 64, McLean teaches
wherein the second end of the valve leaflets (132, Figs. 11B & 80AC) is positioned approximately halfway between the first end (121, Fig. 80C) and the second end (123, Fig. 80C) of the tubular frame (120, Fig. 80C).
Regarding claim 65, McLean teaches
wherein the expanding member (110, Fig. 80A) extends from the tubular frame (120, Fig. 11D) at a position proximate the second end (area towards the bottom of Fig. 80A) of the valve leaflets.
Regarding claim 66, McLean teaches
wherein, when the expanding member (110, Fig. 80A) is in the expanded configuration (Fig. 52B), the expanding member curves toward (Fig. 80C) the second end (123, Fig. 80C) of the tubular frame (120, Fig. 80C).
Regarding claim 68, McLean teaches
wherein the outer surface of the tubular frame (120, Fig. 11C) is defined by a lattice network (expandable geometries of closed cells, Fig. 11C, ¶0199).
Regarding claim 69, McLean teaches
further comprising partially unsheathing the valve such that the expanding member is unsheathed, thereby allowing the expanding member to expand into its expanded configuration (unsheathed and expanded, ¶0254).
Regarding claim 70, McLean teaches
the tubular frame (120, Fig. 11C) is configured to transition between a collapsed configuration (Fig. 46B) and an expanded configuration (Fig. 52B);
in the expanded configuration (Fig. 52B), the outer surface of the tubular frame (120, Fig. 52B) expands to contact the vessel wall (Fig. 52B); and
the method further comprises fully unsheathing the valve to allow the tubular frame to expand and contact the vessel wall (unsheathed and expanded, ¶0254).
Regarding claim 71, McLean teaches
the valve (100, Fig. 10C) comprises an expandable balloon (300, Fig. 51A) disposed between the valve leaflets (location at or near a native mitral valve, ¶0293);
the tubular frame (120, Fig. 11C) is configured to transition between a collapsed configuration (Fig. 46B) and an expanded configuration (Fig. 52B);
in the expanded configuration (Fig. 52B), the outer surface of the tubular frame (120, Fig. 52B) expands to contact the vessel wall (Fig. 52B); and
the method further comprises:
unsheathing the valve (100, Fig. 10C), thereby allowing the expanding member (110, Fig. 80A) to expand into its expanded configuration (unsheathed and expanded, ¶0254);
expanding the expandable balloon (300, Fig. 51A) such that the valve expands and contacts the vessel wall (unsheathed and expanded, ¶0254); and removing the expandable balloon from the valve (¶0293).
Regarding claim 72, McLean teaches
further comprising reducing a risk of thrombosis between the valve leaflets and the tubular frame (reduce thrombus deposition, ¶0361).
Regarding claim 73, McLean teaches
further comprising increasing a flow of blood to a coronary artery (to provide better flow dynamics, ¶0361).
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) 16, 30, 47, 51-53, and 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLean in view of Wilson et al. (US 8163008 B2), hereinafter, Wilson.
Regarding claims 16, 30, 47, and 67 McLean teaches an expanding member (anchoring member 110, Fig. 80A, McLean) but does not teach it comprising radiopaque markers. However, Wilson discloses a device and method for improving flow through a native blood vessel valve (abstract, Wilson)
wherein the expanding member comprises one or more radiopaque markers (radiopaque material, col. 15 line 4, Wilson).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of McLean with the above teachings of Wilson in order to monitor (the device) using X-ray equipment (col. 15 line 5, Wilson).
Regarding claim 51, McLean teaches
advancing the valve between the defective leaflets until the expanding member (610, Fig. 57E, McLean) is approximately perpendicular to the tubular frame (120, Fig. 57E, McLean). McLean does not teach taking a fluorographic image. However, Wilson discloses
taking a fluorographic image of the valve to confirm the expanding member is approximately perpendicular to the tubular frame (radiopaque material, col. 15 line 4, Wilson).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of McLean with the above teachings of Wilson in order to monitor (the device) using X-ray equipment (col. 15 line 5, Wilson).
Regarding claim 52, McLean does not teach taking a fluorographic image. However, Wilson discloses
further comprising taking a fluorographic image of the valve to confirm the expanding member is approximately parallel to an annular plane (radiopaque material, col. 15 line 4, Wilson).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of McLean with the above teachings of Wilson in order to monitor (the device) using X-ray equipment (col. 15 line 5, Wilson).
Regarding claim 53, McLean teaches
further comprising repositioning the valve when the expanding member is not approximately parallel to the annular plane (device 100 may be repositionable, ¶0270, McLean).
Conclusion
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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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