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 with respect to the 35 U.S.C. § 102 and 103 rejections of claim(s) 1-6, 8-18 have been considered but are moot in view of the new grounds for rejection.
Applicant has amended claims 1 and 9 to remove the words “at least” with respect to the degree of attachment of the attachment cuff. In response to Applicant’s amendment Examiner has added reference Gabbay (US Pub No.: 2005/0075727).
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.
Claims 1, 3, 8-9, and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Woo (US7575592B2, figure citations are from PCT equivalent WO2008042092A2) in view of Henderson (US20040122507A1) and Gabbay (US Pub No.: 2005/0075727).
Regarding Claim 1, Woo discloses a synthetic blood vessel graft (Abstract) and teaches a valve prosthesis assembly (Fig. 4, composite device formed by valve 10 and graft 100; see Col. 3, Lines 24-25) comprising:
a replacement valve (Figs. 1 and 2, artificial heart valve 10)
including an attachment cuff (Figs. 1 and 2, sewing cuff 20 is included in artificial heart valve 10),
wherein the replacement valve includes a first side and a second side opposite the first side (Modified Figs. 1 and 2, valve 10 has a first side and a second side opposite to the first);
wherein the attachment cuff provides an outer perimeter (cuff 20 would have an outer perimeter shown in figures 2 and 4)
wherein the outer perimeter includes an outer circumference of the replacement valve (Cuff part 20 has an outer circumference as the Cuff is a circular sewing cuff depicted in figure 4)
and an outer layer graft (Fig. 4, Graft tube 110) coupled together to the replacement valve at the attachment cuff (Fig. 4, Tube 110 as a part of Graft 100 is attached to valve 10 at cuff 20, also see Col. 3, lines 7-13)
Woo further teaches that the outer layer graft is adjacent to the first side of the replacement valve (Modified Fig. 4, Tube 110 as a part of Graft 100 is on the first side of valve 10; also see Col. 3, Lines 7-10).
Woo does not teach multiple graft layers, however, Henderson, discloses an implantable graft (Abstract) that can be used to replace blood vessels (see [0038]) and further teaches
an inner layer graft (Fig. 2, primary tubular body 4),
an inner layer graft and an outer layer graft coupled together (in figure 2 via adhesive 46) to the replacement valve at the attachment cuff (it is argued that the graft of Henderson can be coupled to the valve of Woo at the attachment cuff 20)
wherein the inner graft layer and the outer layer graft that define a chamber therebetween (Fig. 2, secondary lumen 22 is defined between tubular bodies 4 and 16),
wherein the inner layer graft and the outer layer graft coupled together (in figure 2 via adhesive part 46) at the replacement valve extends along a portion of the outer perimeter of the attachment cuff of the replacement valve (it is argued that the layered graft of Henderson could be incorporated into the device of Woo in place of the graft of Woo such that the graft would be coupled to the attachment cuff 20 of Woo like the graft 100 with tubular part 110 is attached to the valve in figure 4 of Woo), wherein the portion is less than the entirety of the outer circumference of the attachment cuff (the graft of Woo has a smaller perimeter than the outer circumference of part 20 in figure 4. As such, it is argued that the perimeter of Henderson would need to be less than the perimeter of part 20 of Woo for the attachment to function)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to define a chamber in the form of a secondary lumen between the inner graft layer as taught by Henderson and the outer graft layer as taught by Woo in order to contain additional materials for future use (see [0035]).
However, Woo in view of Henderson does not teach wherein the portion is 120 degrees of the outer circumference of the cuff.
Instead, Gabbay (US Patent No.: 6,419,695) teaches wherein the portion is 120 degrees of the outer circumference of the cuff (in figures 1-2 with the portion being part 20 that is wrapped about cuff part 12 in column 3 lines 27-36).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Gabbay into the device of Woo since these are result effective variables that contribute to the overall functionality of the device of Woo, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering an optimum value of a result effective variable involves only routine skill in the art and the modification as suggested would allow for a buttress that provides a surface “with which a leaflet of the heart valve may move into and out of engagement for helping control blood flow relative to the apparatus and heart valve” as per the abstract of Gabbay, where the arrangement of the buttress is designed to interface with a leaflet as per column 5 lines 13-33. MPEP 2144.05.
Examiner also notes that, as a tricuspid valve is disclosed in column 9 lines 14-21, it stands to reason that each leaflet occupies 1/3 or 120 degrees of the valve device. With the buttresses matching up to the leaflet in column 5 lines 13-33, it stands to reason that part 20 can be configured to extend to 120 degrees in a tricuspid valve.
Regarding Claim 3, Woo in view of Henderson and Gabbay teaches a valve prosthesis assembly,
Wherein Woo teaches the outer layer graft is on the first side of the replacement valve (Modified Fig. 4, Tube 110 as a part of Graft 100 is on the first side valve 10; also see Col. 3, Lines 7-10)
Woo does not teach multiple graft layers, however, Henderson further teaches a graft,
wherein distal ends of the inner layer graft and the outer layer graft are spaced apart (Fig. 2, secondary lumen 22 spaces the tubular bodies 4 and 16 apart).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a secondary lumen as taught by Henderson as a chamber that spaces apart the graft layers as taught by Woo in view of Spindler in order to contain additional materials for future use (see [0035]).
Regarding Claim 8, Woo in view of Gabbay does not teach multiple graft layers, however, Henderson further teaches a graft,
wherein the chamber defined by the inner layer graft and the outer layer graft is configured to receive a second replacement valve therein (Fig. 2, secondary lumen 22 is defined between tubular bodies 4 and 16, a secondary lumen is a capable of receiving a second replacement valve).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to define a chamber between an inner layer graft, as taught by Henderson, and an outer layer graft, as taught by Woo, in order to contain additional materials for future use (see [0035]).
Regarding Claim 9, Woo teaches a valve prosthesis assembly (Fig. 4, composite device formed by valve 10 and graft 100; see Col. 3, Lines 24-25) comprising:
a replacement valve (Figs. 1 and 2, artificial heart valve 10) comprising an attachment cuff (Figs. 1 and 2, sewing cuff 20 is included in artificial heart valve 10);
wherein the attachment cuff comprises an outer perimeter (part 20 would have an outer perimeter shown in figures 2 and 4);
wherein the outer perimeter includes an outer circumference of the replacement valve (Cuff part 20 has an outer circumference as the Cuff is a circular sewing cuff depicted in figure 4)
and a graft coupled to the attachment cuff of the replacement valve (Fig. 4, Graft 100 is attached cuff 20 of valve 10 at, also see Col. 3, lines 7-13),
wherein the graft comprises:
a graft layer (Fig. 4, Graft tube 110, where this layer corresponds to the recited second graft layer), and
wherein the graft extends around a portion of the outer perimeter of the attachment cuff of the replacement valve (graft sutures extend through parts 20 and 120 in column 3 lines 24-42, wherein the sutures are part of the graft in column 3 lines 24-42), wherein the portion is less than an entirety of the outer circumference of the attachment cuff (as only a suture attachment is present in column 3 lines 24-42, an attachment less than a full perimeter of the attachment cuff 20 is present. Additionally, Col. 2, Lines 61-62, mounting cuff 120 is part of Graft 100; Fig. 4, mounting cuff 120 extends around sewing cuff 20; also see Col. 3, lines 13-23. The graft of Woo has a smaller perimeter than the outer circumference of part 20 in figure 4. As such, it is argued that the perimeter of Henderson would need to be less than the perimeter of part 20 of Woo for the attachment to function).
Woo does not teach multiple graft layers, however, Henderson further teaches a graft that comprises
a first graft layer (Fig. 2, primary tubular body 4);
and a second graft layer coupled to the first graft layer (Fig. 2, secondary tubular body 16 is coupled to primary tubular body 4 by adhesive 46, see [0039]).
wherein a chamber is defined between a first graft layer and a second graft layer (Fig. 2, secondary lumen 22 is defined between tubular bodies 4 and 16) and wherein the portion is at least 120 degrees of the outer circumference of the cuff (as the inner graft layer of Henderson and the outer graft layer of Woo are both depicted as being annular, an attachment about 360 degrees of the circumference is present, wherein 360 degrees satisfies the limitation of at least 120 degrees).
.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to define a chamber between a first graft layer as taught by Henderson and a graft as taught by Woo in order to contain additional materials for future use (see [0035]).
However, Woo in view of Henderson does not teach wherein the portion is 120 degrees of the outer circumference of the cuff.
Instead, Gabbay (US Patent No.: 6,419,695) teaches wherein the portion is 120 degrees of the outer circumference of the cuff (in figures 1-2 with the portion being part 20 that is wrapped about cuff part 12 in column 3 lines 27-36).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Gabbay into the device of Woo since these are result effective variables that contribute to the overall functionality of the device of Woo, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering an optimum value of a result effective variable involves only routine skill in the art and the modification as suggested would allow for a buttress that provides a surface “with which a leaflet of the heart valve may move into and out of engagement for helping control blood flow relative to the apparatus and heart valve” as per the abstract of Gabbay, where the arrangement of the buttress is designed to interface with a leaflet as per column 5 lines 13-33. MPEP 2144.05.
Examiner also notes that, as a tricuspid valve is disclosed in column 9 lines 14-21, it stands to reason that each leaflet occupies 1/3 or 120 degrees of the valve device. With the buttresses matching up to the leaflet in column 5 lines 13-33, it stands to reason that part 20 can be configured to extend to 120 degrees in a tricuspid valve.
Regarding Claim 13, Woo in view of Gabbay does not teach multiple layers, however, Henderson further teaches a graft,
wherein the chamber defined between the first graft layer and the second graft layer is configured to receive a second replacement valve therein (Fig. 2, secondary lumen 22 is defined between tubular bodies 4 and 16, a secondary lumen is a capable of receiving a second replacement valve).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to define a chamber between a first graft layer as taught by Henderson and a graft as taught by Woo in order to contain additional materials for future use (see [0035]).
Regarding Claim 14, Woo in view of Henderson and Gabbay teaches a valve prosthesis assembly,
wherein Woo teaches the replacement valve comprises an aortic replacement valve (see Col. 1, Lines 33-34 and 59-60, for use with valve to perform Bentall procedure, so valve 10 can be an aortic valve).
Regarding claim 15, Woo in view of Henderson and Gabbay teaches the valve prosthesis assembly of Claim 1,
wherein Henderson teaches that the inner layer graft comprises an inner surface, an outer surface, a first side edge and a second side edge (figure 2, paragraph [0039], inner surface part 6 and outer surface part 8 are defined where edges are assumed to be present at the end of the graft, one such end shown in figure 2),
wherein the outer layer graft comprises an inner surface, an outer surface, a first side edge and a second side edge (shown in figure 2, and [0039], inner wall 18, outer wall 20 at part 16, where edges are assumed to be present at the end of the graft, one such end shown in figure 2) ,
wherein the first side edge of the inner layer graft and first side edge of the outer layer graft are coupled (coupling about a first end shown in figure 2 with adhesive 46, adhesive defined in [0039]), and wherein the second side edge of the inner layer graft and second side edge of the outer layer graft are coupled (it is argued that the adhesive 46 would attach the inner and outer layers together as per [0039] as [0039] discloses that portions of the walls that are in contact would have an adhesive).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to define a chamber in the form of a secondary lumen between the inner graft layer as taught by Henderson and the outer graft layer as taught by Woo in order to contain additional materials for future use (see [0035]).
Regarding claim 16, Woo in in view of Henderson and Gabbay teach the valve prosthesis assembly of Claim 15, wherein Henderson teaches that the upper edges of the inner layer graft outer surface and the outer layer graft inner surface are not coupled together (shown in figure 2, where the adhesive 46 is only on one side of the inner and outer layer. The upper edge of the layers of the graft does not have adhesive part 46 in figure 2, where part 46 is on the bottom end of the layers).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to define a chamber in the form of a secondary lumen between the inner graft layer as taught by Henderson and the outer graft layer as taught by Woo in order to contain additional materials for future use (see [0035]).
Regarding claim 17, Woo in in view of Henderson and Gabbay teach the valve prosthesis assembly of Claim 9, wherein Henderson teaches that the first graft layer comprises an inner surface, an outer surface, a first side edge and a second side edge (figure 2, paragraph [0039], inner surface part 6 and outer surface part 8 are defined where edges are assumed to be present at the end of the graft, one such end shown in figure 2),
wherein the second graft layer comprises an inner surface, an outer surface, a first side edge, and a second side edge (shown in figure 2, and [0039], inner wall 18, outer wall 20 at part 16, where edges are assumed to be present at the end of the graft, one such end shown in figure 2),
and wherein the first side edge of the first graft layer and the first side edge of the second graft layer are coupled (coupling about a first end shown in figure 2 with adhesive 46, adhesive defined in [0039]), and wherein the second side edge of the first graft layer and the second side edge of the second graft layer are coupled (it is argued that the adhesive 46 would attach the inner and outer layers together as per [0039] as [0039] discloses that portions of the walls that are in contact would have an adhesive).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to define a chamber in the form of a secondary lumen between the inner graft layer as taught by Henderson and the outer graft layer as taught by Woo in order to contain additional materials for future use (see [0035]).
Regarding claim 18, Woo in in view of Henderson and Gabbay teach the valve prosthesis assembly of Claim 17, wherein Henderson teaches upper edges of the first graft layer outer surface and the second graft layer inner surface are not coupled together (shown in figure 2, where the adhesive 46 is only on one side of the inner and outer layer. The upper edge of the layers of the graft does not have adhesive part 46 in figure 2, where part 46 is on the bottom end of the layers).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to define a chamber in the form of a secondary lumen between the inner graft layer as taught by Henderson and the outer graft layer as taught by Woo in order to contain additional materials for future use (see [0035]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Woo (US7575592B2, figure citations are from PCT equivalent WO2008042092A2) in view of Henderson (US20040122507A1) and Gabbay (US Patent No.: 6,419,695) as applied to claim 1 above, and further in view of Spindler (US 20200054435 A1).
Regarding Claim 2, Woo in view of Henderson and Gabbay a valve prosthesis assembly,
wherein Woo discloses the outer layer graft is on the first side of the replacement valve (Modified Fig. 4, Tube 110 as a part of Graft 100 is on the first side valve 10; also see Col. 3, Lines 7-10).
Woo does not teach multiple graft layers, however, Henderson further teaches a graft,
with an inner layer graft (Fig. 2, primary tubular body 4).
Woo in view of Henderson does not teach graft layers that are sewn together, However Spindler discloses a layered graft material,
wherein opposing side edges of the inner layer graft and the outer layer graft are sewn together (see [0024], layers can be attached to each other on any region aside from imbricated region, this would include opposing side edges of the layers; also see [0025], layers can be sewn together by sutures).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use sewing as an attachment mechanism as taught by Spindler between the inner and outer layers grafts as taught by Woo in view of Henderson in order to allow the regions that are not attached to have more movement or stretch (see [0024]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Woo (US7575592B2, figure citations are from PCT equivalent WO2008042092A2) in view of Henderson (US20040122507A1) and Gabbay (US Patent No.: 6,419,695) as applied to claim 1 above, and further in view of Campbell (US9301835B2).
Regarding Claim 4, in view of Henderson and Gabbay teaches a valve prosthesis assembly wherein Woo teaches that has an outer graft layer adjacent to the replacement valve (Modified Fig. 4, Tube 110 as a part of Graft 100 is on the first side valve 10; also see Col. 3, Lines 7-10).
Woo in view Henderson does not teach that the outer layer graft has a portion adjacent the second side of the replacement valve.
However, Campbell discloses a valved conduit including a bioprosthetic valve (Abstract) and further teaches a graft,
wherein the outer layer graft (Modified Figs. 2A and 2B, conduit 50) includes a portion (Modified Figs. 2A and 2B, conduit 50 has conduit segment 54, a segment is a portion) below the attachment cuff adjacent to the second side of the replacement valve (Modified Figs. 2A and 2B, conduit segment 54 is coupled to the bottom surface of valve 52, the bottom surface would correspond to the recited second side of the replacement valve; see Col. 8, Lines 39-41).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a portion of the outer layer graft that is adjacent to the second side of the replacement valve as taught by Campbell to the outer graft layer as taught by Woo in order to be able to trim either side of the graft for use in different parts of the body (see Col 8, Lines 43-49 and 60-61).
Claims 5-6 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Woo (US7575592B2, figure citations are from PCT equivalent WO2008042092A2) in view of Henderson (US20040122507A1) and Gabbay (US Patent No.: 6,419,695) as applied to claims 1 and 9 above, and further in view of Kassab (US20180235634A1).
Regarding Claim 5, Woo in view of Gabbay does not teach an inner layer graft, however, Henderson further teaches
an inner graft layer (Fig. 2, primary tubular body 4).
Woo in view of Henderson does not teach an inner layer graft that is imbricated, However, Kassab discloses a luminal graft (Abstract) for replacing damaged or compromised blood vessels (see [0067]) and further teaches a graft,
wherein the inner layer graft is imbricated (Modified Fig. 7, Graft 10 has a first edge 16 that overlaps with a second edge 18; see [0086] and [0098]), to imbricate is defined as “to overlap or to cause overlap” ).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to imbricate, as taught by Kassab, the inner layer graft as taught by Woo in view of Henderson in order to secure portions together with a closure mechanism that is flexible enough to allow curvature (see [0073] and [0086]-[0087]).
Regarding Claim 6, Woo in view of Henderson and Gabbay does not teach an inner graft layer with portions, however, Kassab discloses a luminal graft (Abstract) for replacing damaged or compromised blood vessels (see [0067]) and further teaches a graft,
wherein the inner layer graft comprises a first portion and a second portion (Modified Figs. 1 and 7, Graft 10 comprises a 1st portion and 2nd portion, a portion is defined as “a part of a whole”),
and wherein the first portion and the second portion overlap (Modified Fig. 7, Graft 10 has a first edge 16 of the 1st portion that overlaps with the second edge 18 of the second portion; see [0086] and [0098])
and are sewn together (Modified Fig. 7, 1st and 2nd portion are sewn together with a closure mechanism 22 comprising sutures; see [0098]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include portions that overlap and are sewn together as taught by Kassab to the inner layer graft as taught by Woo in view of Henderson in order to make the graft flexible enough to have curvature (see [0096] and[0098]).
Regarding Claim 10, Woo in view of Henderson and Gabbay does not teach a first graft layer with portions, however, Kassab further teaches a graft,
wherein the first graft layer comprises a first portion and a second portion (Modified Figs. 1 and 7, graft 10 comprises a 1st portion and 2nd portion, a portion is defined as “a part of a whole”),
and wherein the first portion and the second portion overlap (Modified Fig. 7, Graft 10 has a first edge 16 of the 1st portion that overlaps with the second edge 18 of the second portion; see [0086] and [0098]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include portions that overlap as taught by Kassab in the first graft layer as taught by Woo in view of Henderson in order to secure the portions together with a closure mechanism that is flexible enough to allow curvature (see [0073] and [0086]-[0087]).
Regarding Claim 11, Woo in view of Henderson and Gabbay does not teach a first graft layer with portions, however, Kassab further teaches a graft,
wherein the first portion of material is coupled to the second portion of material ( Modified Fig. 7, 1st and 2nd portion are sewn together with a closure mechanism 22 comprising sutures).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to couple the first portion of material to the second portion of material as taught by Kassab in the first graft layer as taught by Woo in view of Henderson in order to make the graft flexible enough to have curvature (see [0096] and [0098]).
Regarding Claim 12, Woo in view of Gabbay does not teach multiple graft layers.
However, Henderson further teaches a graft,
wherein the chamber defined between the first graft layer and the second graft layer is configured to receive a second replacement valve therein (Fig. 2, secondary lumen 22 is defined between tubular bodies 4 and 16, a secondary lumen is a capable of receiving a second replacement valve).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to define a chamber between a first graft layer as taught by Henderson and a graft as taught by Woo in order to contain additional materials for future use (see [0035]).
Woo in view of Henderson does not teach a first graft layer with portions, however, Kassab teaches a graft,
wherein the first portion of material (Modified Fig. 7, 1st portion of graft 10, a portion is defined as “a part of a whole”) is configured to be no longer coupled to the second portion of material when the second replacement valve is inserted into the chamber defined between the first graft layer and the second graft layer (Modified Fig. 7, 1st and 2nd portions are sewn together with a closure mechanism 22 comprising sutures; Sutures are capable of being separated).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to couple the first portion of material to the second portion of material as taught by Kassab in the first graft layer as taught by Woo in view of Henderson in order to make the graft flexible enough to have curvature (see [0096] and [0098]).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schraut (US Pub No.: 2014/0277417) discloses a cuff in [0057]-[0058], with attachment of a cuff to a stent in [0020]. Gabbay (US Pub No.: 2014/0214159) discloses a cuff attached to a valve in [0154] and a stent attachment in [0498].
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774