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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12 December 2025 has been entered.
Claim Status
Applicant’s Remarks and Amendments filed 16 October 2025 have been entered. Claims 1-20 are pending.
Response to Arguments
Applicant's arguments filed 16 October 2025 have been fully considered but they are not persuasive. Applicant’s arguments that the prior art does not teach “wherein the second portion of the expandable structure is configured to expand into apposition with tissue at or near the annulus when heated to a second temperature greater than body temperature” because the ligament taught by White “does not expand when heated to a second temperature greater than body temperature” (pg. 8 of remarks), and further that “the martensite/austenite transition temperature of the ligament 28 of White is ‘substantially higher than body temperature’ and ‘any attempt to heat the material above the phase transition temperature would have undesirable detrimental effects on surrounding tissue’”. Examiner respectfully disagrees. White discloses the ligament 28 may be in the form of a wire, tube, solid rod, or band having different cross-sectional shapes and sizes and comprises material that is inelastic at body temperature but allows for some constrained motion while resisting bodily shear forces [0047]. This material is preferably an implantable shape memory alloy (similar to Applicant’s invention), more preferably a nickel titanium alloy [0047]. The ligament, therefore, has a martensite/austenite transition temperature substantially greater than body temperature [0047]. Further, White discloses that the shape memory alloy which the ligament is formed from comprises a transition temperature selected to be higher than body temperature, preferably substantially higher in order to exhibit acceptable fatigue resistance [0054]. It is taught that the higher the transition temperature of the material the higher the fatigue resistance [0056]. The nickel titanium alloy that forms the ligament of White’s invention is formed with the intent of comprising a transition temperature substantially higher than body temperature. Applicant’s argument that White’s statement “any attempt to heat the material above the phase transition temperature would have undesirable detrimental effects on surrounding tissue” is moot because the transition temperature is already above body temperature to begin with in order to increase the ligament’s fatigue resistance. Further, as this device, and Applicant’s device, are both bodily inserted, there is no reason to believe that White would want the ligament to be heated to a temperature that would damage surrounding tissue of the patient. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the ligament material and it’s properties as taught by White with the anchor member taught by Ruiz and the self-expanding properties taught by Vad in order to provide a material that has increased fatigue resistance in order to prolong the life of the implant.
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 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz (US Pat. No. 6120534), “Ruiz” in view Vad (US 2013/0166010 A1), “Vad” and further in view of White (US 2009/0131981 A1), “White”.
Regarding claim 1, Ruiz teaches an anchor member (Fig. 5C, stent 50) configured to be positioned at a treatment site proximate a native valve annulus of a human patient (stent may be delivered into pulmonary valve (col. 2, lines 30-32)), the anchor member comprising: an expandable structure (Fig. 5C, stent 50 comprises mesh 51 that expands) comprising a first portion (Fig. 5C, conical portion 53) and a second portion (Fig. 5C, constricted region 54), each having a low-profile state and an expanded state (Fig. Figs. 7A-C, conical portion 53 and constricted region 54 are expandable to reflect various diameters), wherein, when the expandable structure (Fig. 5C, stent 50 comprising expandable mesh 51) is at body temperature and positioned at the treatment site (Fig. 7B, stent 50 is deployed to the pulmonary artery (col. 6, lines 35-40)) and released from a catheter (Fig. 6, delivery device 60): the second portion (Fig. 5C, constricted region 54) remains in its low-profile state (Fig. 7B, constricted region 54 remains low-profile when stent 50 is deployed), wherein the second portion of the expandable structure is configured to expand into apposition with tissue at or near the annulus (constricted region is heated to austenite phase and is enabled to be repeatedly constricted an enlarged to optimize the size of the constriction (col. 2, lines 46-54) (i.e., constricted region 54 may be heated to expand into contact with annulus wall)), but fails to teach the expandable structure is at body temperature and positioned at the treatment site, and wherein the first portion self-expands toward its expanded state and into apposition with tissue at or near the annulus to secure the anchor member at the treatment site, heating the second portion of the expandable structure to a second temperature greater than body temperature, and a shape memory alloy (“SMA”) having a martensite start temperature Ms greater than or equal to body temperature.
Vad teaches a self-expanding prosthesis wherein the first portion (Fig. 1A, self-expanding portion 110a) self-expands toward its expanded state and into apposition with tissue at or near the annulus to secure the anchor member at the treatment site (Fig. 2, self-expanding portion 110a expands to secure to lumen wall). Vad discloses that the self-expanding portion of the stent is designed to be flexible and kink resistant [0032]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first portion of the stent taught by Ruiz with the self-expandable design taught by Vad in order to avoid tangling of the stent during deployment. However, Ruiz in view of Vad fails to teach wherein the expandable structure positioned at the treatment site at body temperature, and heating the second portion of the expandable structure to a second temperature greater than body temperature, and a shape memory alloy (“SMA”) having a martensite start temperature Ms greater than or equal to body temperature.
White teaches an orthopedic device comprising a ligament at body temperature and positioned at the treatment site (nickel titanium alloy of ligament 28 remains in the martensite state at all times during use (i.e., body temperature); loading of the rod or ligament cannot induce a phase change from austenite to martensite (i.e., alloy is at body temperature when implanted) [0060]), and heating to a second temperature greater than body temperature (Fig. 1, ligament 28 comprises a nickel titanium alloy having an austenite transition temperature higher than body temperature [0047]), and a shape memory alloy (“SMA”) having a martensite start temperature Ms greater than or equal to body temperature (Fig. 1, ligament 28 comprises a nickel titanium alloy having a martensite transition temperature higher than body temperature [0047]). White discloses that shape memory alloys having a martensite/austenite transition temperature above body temperature exhibit higher fatigue resistance [0054, 0056]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the ligament material and it’s properties as taught by White with the anchor member taught by Ruiz and the self-expanding properties taught by Vad in order to provide a material that has increased fatigue resistance in order to prolong the life of the implant.
Regarding claim 9, Ruiz teaches the SMA (constricted region is formed of an alloy having a shape-memory property (col. 2, lines 44-46)), but fails to teach an austenite finish temperature Af less than 37°C.
Vad teaches a self-expanding prosthesis having an austenite finish temperature Af less than 37°C (Fig. 1A, self-expanding portion 110a comprising shape memory alloy comprises an Af of less than 37°C [0031]). Vad discloses that the self-expanding portion of the stent is designed to be flexible and kink resistant [0032]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first portion of the stent taught by Ruiz with the self-expandable design taught by Vad in order to avoid tangling of the stent during deployment.
Regarding claim 10, Ruiz teaches wherein the expandable structure (Fig. 5C, stent 50 comprising expandable mesh 51) is configured such that, when implanted at the native valve annulus (stent may be delivered into pulmonary valve (col. 2, lines 30-32)), the second portion is upstream of the first portion (Fig. 7B, when implanted constricted region 54 is upstream conical portion 53).
Claims 2-9 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz (US Pat. No. 6120534), “Ruiz” in view Vad (US 2013/0166010 A1), “Vad” and White (US 2009/0131981 A1), “White”, and further in view of Flomenblit et al. (US Pat. No. 5876434), “Flomenblit”.
Regarding claim 2, Ruiz teaches the SMA (constricted region is formed of an alloy having a shape-memory property (col. 2, lines 44-46)), but Ruiz in view of Vad and White fails to teach an austenite finish temperature Af that is: (a) greater than or equal to the second temperature, and (b) greater than body temperature.
Flomenblit teaches a spiral ribbon stent comprising an austenite finish temperature Af that is: (a) greater than or equal to the second temperature, and (b) greater than body temperature (Example 2 Table, Af ranges from 33-44.5°C (i.e., greater than body temperature of 37°C)). Flomenblit discloses that the stent could be delivered into the body without a covering sheath when deformed to a diameter of 2 mm or less because the As temperature is greater than body temperature and therefore wouldn’t cause deformation of the stent (col. 6, par. 5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the anchor member taught by Ruiz with the self-expanding features taught by Vad, the martensitic/austenite transition temperature features of the SMA ligament taught by White, and the austenite characteristics taught by Flomenblit in order to simplify the insertion of the stent.
Regarding claim 3, Ruiz in view of Vad and White fails to teach limitations of claim 3. Flomenblit teaches a spiral ribbon stent wherein the second temperature is no less than 40°C (Example 2 Table, Af ranges from 33-44.5°C). Flomenblit discloses that the stent could be delivered into the body without a covering sheath when deformed to a diameter of 2 mm or less because the As temperature is greater than body temperature and therefore wouldn’t cause deformation of the stent (col. 6, par. 5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Ruiz with the self-expanding features taught by Vad, the martensitic/austenite transition temperature features of the SMA ligament taught by White, and the austenite characteristics taught by Flomenblit in order to simplify the insertion of the stent.
Regarding claim 4, Ruiz in view of Vad and White fails to teach the limitations with claim 4. Flomenblit teaches a spiral ribbon stent wherein the second temperature is from about 37°C to about 40°C (Example 2 Table, Af ranges from 33-44.5°C). Flomenblit discloses that the stent could be delivered into the body without a covering sheath when deformed to a diameter of 2 mm or less because the As temperature is greater than body temperature and therefore wouldn’t cause deformation of the stent (col. 6, par. 5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Ruiz with the self-expanding features taught by Vad, the martensitic/austenite transition temperature features of the SMA ligament taught by White, and the austenite characteristics taught by Flomenblit in order to simplify the insertion of the stent.
Regarding claim 5, Ruiz teaches the SMA (constricted region is formed of an alloy having a shape-memory property (col. 2, lines 44-46)), but Ruiz in view of Vad fails to teach a martensite finish temperature Mf greater than or equal body temperature and an austenite finish temperature Af less than or equal to the second temperature.
White teaches an orthopedic device comprising a ligament having a martensite finish temperature Mf greater than or equal body temperature (Fig. 1, ligament 28 comprises a nickel titanium alloy having an martensite/austenite transition temperature higher than body temperature [0047]). White discloses that shape memory alloys having a martensite/austenite transition temperature above body temperature exhibit higher fatigue resistance [0054, 0056]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the ligament material and it’s properties as taught by White with the anchor member taught by Ruiz and the self-expanding properties taught by Vad in order to provide a material that has increased fatigue resistance in order to prolong the life of the implant. However, Ruiz in view of Vad and White fails to teach an austenite finish temperature Af less than or equal to the second temperature.
Flomenblit teaches a spiral ribbon stent comprising an austenite finish temperature Af less than or equal to the second temperature (Example 2 Table, Af ranges from 33-44.5°C). Flomenblit discloses that the stent could be delivered into the body without a covering sheath when deformed to a diameter of 2 mm or less because the As temperature is greater than body temperature and therefore wouldn’t cause deformation of the stent (col. 6, par. 5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Ruiz with the self-expanding features taught by Vad, and the martensitic/austenite transition temperature features of the SMA ligament taught by White, and the austenite characteristics taught by Flomenblit in order to simplify the insertion of the stent.
Regarding claim 6, Ruiz teaches the SMA (constricted region is formed of an alloy having a shape-memory property (col. 2, lines 44-46)), but Ruiz in view of Vad and White fails to teach an austenite finish temperature Af less than or equal to the second temperature.
Flomenblit teaches a spiral ribbon stent comprising an austenite finish temperature Af less than or equal to the second temperature (Example 2 Table, Af ranges from 33-44.5°C). Flomenblit discloses that the stent could be delivered into the body without a covering sheath when deformed to a diameter of 2 mm or less because the As temperature is greater than body temperature and therefore wouldn’t cause deformation of the stent (col. 6, par. 5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Ruiz with the self-expanding features taught by Vad, and the martensitic/austenite transition temperature features of the SMA ligament taught by White, and the austenite characteristics taught by Flomenblit in order to simplify the insertion of the stent.
Regarding claim 7, Ruiz teaches the SMA (constricted region is formed of an alloy having a shape-memory property (col. 2, lines 44-46)), but Ruiz in view of Vad fails to teach a martensite finish temperature Mf greater than or equal to body temperature, and an austenite finish temperature Af less than or equal to the second temperature.
White teaches an orthopedic device comprising teach a martensite finish temperature Mf greater than or equal to body temperature (Fig. 1, ligament 28 comprises a nickel titanium alloy having an martensite/austenite transition temperature higher than body temperature [0047]). White discloses that shape memory alloys having a martensite/austenite transition temperature above body temperature exhibit higher fatigue resistance [0054, 0056]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the ligament material and it’s properties as taught by White with the anchor member taught by Ruiz and the self-expanding properties taught by Vad in order to provide a material that has increased fatigue resistance in order to prolong the life of the implant. However, Ruiz in view of Vad and White fails to teach an austenite finish temperature Af less than or equal to the second temperature.
Flomenblit teaches a spiral ribbon stent comprising an austenite finish temperature Af less than or equal to the second temperature (Example 2 Table, Af ranges from 33-44.5°C). Flomenblit discloses that the stent could be delivered into the body without a covering sheath when deformed to a diameter of 2 mm or less because the As temperature is greater than body temperature and therefore wouldn’t cause deformation of the stent (col. 6, par. 5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Ruiz with the self-expanding features taught by Vad, and the martensitic/austenite transition temperature features of the SMA ligament taught by White, and the austenite characteristics taught by Flomenblit in order to simplify the insertion of the stent.
Regarding claim 8, Ruiz teaches the SMA (constricted region is formed of an alloy having a shape-memory property (col. 2, lines 44-46)) but Ruiz in view of Vad and White fails to teach a martensite finish temperature Mf less than body temperature, and an austenite finish temperature Af less than or equal to the second temperature.
Flomenblit teaches a martensite finish temperature Mf less than the first temperature (Example 2 Table, As ranges from 28-44°C), a martensite start temperature Ms greater than or equal to the first temperature (Example 2 Table, As ranges from 28-44°C), and an austenite finish temperature Af less than or equal to the second temperature (Example 2 Table, Af ranges from 33-44.5°C). Flomenblit discloses that the stent could be delivered into the body without a covering sheath when deformed to a diameter of 2 mm or less because the As temperature is greater than body temperature and therefore wouldn’t cause deformation of the stent (col. 6, par. 5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Ruiz with the self-expanding features taught by Vad, and the martensitic/austenite transition temperature features of the SMA ligament taught by White, and the austenite characteristics taught by Flomenblit in order to simplify the insertion of the stent.
Regarding claim 16, Ruiz teaches the second portion (Fig. 5C, constricted region 54), but fails to teach that it does not self-expand at or below the second temperature.
Vad teaches a self-expanding prosthesis (Fig. 2, self-expanding portion 110a) wherein the portion does not self-expand at or below the second temperature (Fig. 2, self-expanding portion 110a includes an Af of less than 37°C [0038]). Vad discloses that the self-expanding portion of the stent is designed to be flexible and kink resistant [0032]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first portion of the stent taught by Ruiz with the self-expandable design taught by Vad in order to avoid tangling of the stent during deployment. However, Ruiz in view of Vad and White fails to teach and a prosthetic valve configured to be carried by, mounted within, or coupled to the anchoring member.
Flomenblit teaches a spiral ribbon stent comprising a second temperature (Example 2 Table, Af ranges from 33-44.5°C). Flomenblit discloses that the stent could be delivered into the body without a covering sheath when deformed to a diameter of 2 mm or less because the As temperature is greater than body temperature and therefore wouldn’t cause deformation of the stent (col. 6, par. 5). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the stent taught by Ruiz with the austenite characteristics taught by Flomenblit in order to simplify the insertion of the stent. However, Ruiz in view of Flomenblit fails to teach a self-expanding prosthesis wherein the portion does not self-expand at or below the second temperature.
Claims 11-15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz (US Pat. No. 6120534), “Ruiz” in view of Vad (US 2013/0166010 A1), “Vad”, and White (US 2009/0131981 A1), “White”, and further in view of Dolan (US 2010/0234940 A1), “Dolan”.
Regarding claim 11, Ruiz teaches the expandable structure (Fig. 5C, stent 50 comprising expandable mesh 51), a first portion (Fig. 5C, conical portion 53) and a second portion (Fig. 5C, constricted region 54), but Ruiz in view of Vad and White fails to teach wherein the expandable structure is configured such that, when implanted at or near a native aortic valve annulus, the first portion is positioned within the aorta and at least a portion of the second portion is positioned within the left ventricle.
Dolan teaches a balloon-expandable stent wherein the expandable structure is configured such that, when implanted at or near a native aortic valve annulus (Fig. 9, stent portion 236 contacts native aortic valve), the first portion is positioned within the aorta (Fig. 9, stent portion 236 contacts native aortic valve) and at least a portion of the second portion is positioned within the left ventricle (Fig. 9, lower portion of balloon-expandable stent is within left ventricle). Dolan discloses that this stent and method of its delivery support a heart valve replacement procedure that involves minimal blood flow stoppage or interruption [0038]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the expandable structure taught by Ruiz with the placement taught by Dorn in order to minimize the stoppage of blood flow during the procedure.
Regarding claim 12, Ruiz teaches the expandable structure (Fig. 5C, stent 50 comprising expandable mesh 51), but Ruiz in view of Vad and White fails to teach wherein the expandable structure is configured such that, when implanted at or near a native aortic valve annulus, no portion of the first portion is pressing outwardly against the left ventricle.
Dolan teaches a balloon-expandable stent wherein the expandable structure is configured such that, when implanted at or near a native aortic valve annulus (Fig. 9, stent portion 236 is implanted at native aortic valve), no portion of the first portion is pressing outwardly against the left ventricle (Fig. 9, stent portion 236 is in contact with native aortic valve, not left ventricle). Dolan discloses that this stent and method of its delivery support a heart valve replacement procedure that involves minimal blood flow stoppage or interruption [0038]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the expandable structure taught by Ruiz with the placement taught by Dorn in order to minimize the stoppage of blood flow during the procedure.
Regarding claim 13, Ruiz teaches the expandable structure (Fig. 5C, stent 50 comprising expandable mesh 51), but Ruiz in view of Vad and White fails to teach that the expandable structure is configured such that, when implanted at or near an annulus of an aortic valve of the patient, no portion of the first portion is distal of the annulus.
Dolan teaches a balloon-expandable stent having an expandable structure that is configured such that, when implanted at or near an annulus of an aortic valve of the patient (Fig. 9, stent portion 236 is implanted at native aortic valve), no portion of the first portion is distal of the annulus (Fig. 9, stent portion 236 is not distal of the aortic valve annulus, lower portion of the stent near label 108 is distal to the annulus). Dolan discloses that this stent and method of its delivery support a heart valve replacement procedure that involves minimal blood flow stoppage or interruption [0038]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the expandable structure taught by Ruiz with the placement taught by Dorn in order to minimize the stoppage of blood flow during the procedure.
Regarding claim 14, Ruiz teaches wherein, when the expandable structure (Fig. 5C, stent 50 comprising expandable mesh 51) is implanted such that both the first (Fig. 5C, conical portion 53) and second portions (Fig. 5C, constricted region 54) are expanded and in contact with adjacent tissue (stent 50 may be heated to expand into contact with adjacent tissue walls (col. 2, lines 46-54)), the first portion presses outwardly against adjacent tissue with greater force than the second portion presses outwardly against adjacent tissue (Fig. 5C, conical portion 53 presses out with more force than constricted region 54 since the constricted region has a smaller diameter), but Ruiz in view of Vad and White fails to teach wherein the expandable structure is implanted at or near a native aortic valve annulus.
Dolan teaches a balloon-expandable stent wherein the expandable structure is implanted at or near a native aortic valve annulus (Fig. 9, stent portion 236 is implanted at native aortic valve). Dolan discloses that this stent and method of its delivery support a heart valve replacement procedure that involves minimal blood flow stoppage or interruption [0038]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the expandable structure taught by Ruiz with the placement taught by Dorn in order to minimize the stoppage of blood flow during the procedure.
Regarding claim 15, Ruiz teaches wherein the second portion (Fig. 5C, constricted region 54) is heat-expandable (constricted region is heated to austenite phase and is enabled to be repeatedly constricted an enlarged to optimize the size of the constriction (col. 2, lines 46-54)).
Regarding claim 17, Ruiz teaches an expandable device (Fig. 5C, stent 50 comprising expandable mesh 51) configured to be positioned at an implantation site proximate a native valve annulus (stent may be delivered into pulmonary valve (col. 2, lines 30-32)), the expandable device comprising: an anchoring member (Fig. 5C, stent 50) comprising: an expandable structure (Fig. 5C, mesh 51) comprising a first portion (Fig. 5C, conical portion 53) and a second portion (Fig. 5C, constricted region 54), wherein, when the first portion (Fig. 5C, conical portion 53) is released from a constrained delivery state (Fig. 6, stent 50 is constrained within delivery device 60), wherein the second portion (Fig. 5C, constricted region 54) remains in a low-profile state at body temperature (Fig. 7B, constricted region 54 remains low-profile when stent 50 is deployed), and secure the anchor member at the implantation site (Fig. 7B, stent 50 is radially expanded into intimate contact with the wall of the pulmonary artery (i.e., secured) [col. 6, lines 35-40)), but fails to teach the first portion is at body temperature and positioned at the treatment site, and self-expanding into apposition with tissue at or near the annulus to secure the anchor member at the implantation site, remaining in a low-profile state at body temperature, and expanding into apposition with tissue at or near the annulus when heated to a second temperature greater than body temperature secure the anchor member at the implantation site, and wherein the second portion is formed of a shape memory alloy ("SMA") having a martensite start temperature Ms greater than or equal to body temperature; and a prosthetic valve configured to be carried by, mounted within, or coupled to the anchoring member.
Vad teaches a self-expanding prosthesis wherein the first portion (Fig. 1A, self-expanding portion 110a) self-expands into apposition with tissue at or near the annulus to secure the anchor member at the implantation site (Fig. 2, self-expanding portion 110a expands to secure to lumen wall). Vad discloses that the self-expanding portion of the stent is designed to be flexible and kink resistant [0032]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first portion of the stent taught by Ruiz with the self-expandable design taught by Vad in order to avoid tangling of the stent during deployment. However, Ruiz in view of Vad fails to teach expanding into apposition with tissue at or near the annulus when heated to a second temperature greater than body temperature, and wherein the second portion is formed of a shape memory alloy ("SMA") having a martensite start temperature Ms greater than or equal to body temperature; and a prosthetic valve configured to be carried by, mounted within, or coupled to the anchoring member.
White teaches an orthopedic device capable of heating to a second temperature greater than body temperature (Fig. 1, ligament 28 comprises a nickel titanium alloy having an austenite transition temperature higher than body temperature [0047]), and a shape memory alloy ("SMA") having a martensite start temperature Ms greater than or equal to body temperature (Fig. 1, ligament 28 comprises a nickel titanium alloy having a martensite transition temperature higher than body temperature [0047]). White discloses that shape memory alloys having a martensite/austenite transition temperature above body temperature exhibit higher fatigue resistance [0054, 0056]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the ligament material and it’s properties as taught by White with the anchor member taught by Ruiz and the self-expanding properties taught by Vad in order to provide a material that has increased fatigue resistance in order to prolong the life of the implant. However, Ruiz in view of Vad and White fails to teach a prosthetic valve configured to be carried by, mounted within, or coupled to the anchoring member.
Dolan teaches a balloon-expandable stent comprising a prosthetic valve configured to be carried by, mounted within, or coupled to the anchoring member (Fig. 9, prosthetic valve 108 is deployed in tandem with stent portion 236). Dolan discloses that this stent and method of its delivery support a heart valve replacement procedure that involves minimal blood flow stoppage or interruption [0038]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the expandable structure taught by Ruiz with the self-expanding features taught by Vad, and the martensitic/austenite transition temperature features of the SMA ligament taught by White, with the placement taught by Dolan in order to minimize the stoppage of blood flow during the procedure.
Regarding claim 18, Ruiz teaches a system for treating a native cardiac valve of a human patient, the system comprising: a sheath (Fig. 6, catheter 61); an anchoring member (Fig. 5C, stent 50) configured to be delivered through the sheath to a treatment site proximate a native valve annulus (Fig. 6, stent may be delivered into pulmonary valve (col. 2, lines 30-32) by catheter 61), the anchoring member comprising: an expandable structure (Fig. 5C, stent 50 comprises mesh 51) comprising a first portion (Fig. 5C, conical portion 53) and a second portion (Fig. 5C, constricted region 54), wherein, when the first portion (Fig. 5C, conical portion 53) is at body temperature and positioned at the treatment site () and released from a constrained delivery state (Fig. 6, stent 50 is constrained within delivery device 60), wherein the second portion remains in a low-profile state at body temperature (Fig. 7B, constricted region 54 remains low-profile when stent 50 is deployed); and a heating element (Fig. 8B, heated fluid 81) carried by the distal end portion of the elongated member (Fig. 8B, catheter 80), wherein the heating element is configured to facilitate heating of the second portion to the second temperature (Fig. 8B, catheter 80 injects a stream of heated fluid 81 into the stent to raise the temperature of constricted region 73 (col. 7, lines 44-48)), but fails to teach wherein the first portion self-expands toward its expanded state and into apposition with tissue at or near the annulus to secure the anchor member at the treatment site, heating to a second temperature greater than body temperature, and wherein the second portion is formed of a shape memory alloy ("SMA") having a martensite start temperature Ms greater than or equal to body temperature; a prosthetic valve configured to be carried by, mounted within, or coupled to the anchoring member; an elongated member having a proximal end portion configured to be positioned at an extracorporeal location during implantation of the expandable structure and a distal end portion configured to be delivered through the sheath to the treatment site.
Vad teaches a self-expanding prosthesis wherein the first portion (Fig. 1A, self-expanding portion 110a) self-expands toward its expanded state and into apposition with tissue at or near the annulus to secure the anchor member at the treatment site (Fig. 2, self-expanding portion 110a expands to secure to lumen wall). Vad discloses that the self-expanding portion of the stent is designed to be flexible and kink resistant [0032]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the first portion of the stent taught by Ruiz with the self-expandable design taught by Vad in order to avoid tangling of the stent during deployment. However, Ruiz in view of Vad fails to teach heating to a second temperature greater than body temperature, and wherein the second portion is formed of a shape memory alloy ("SMA") having a martensite start temperature Ms greater than or equal to body temperature; a prosthetic valve configured to be carried by, mounted within, or coupled to the anchoring member; an elongated member having a proximal end portion configured to be positioned at an extracorporeal location during implantation of the expandable structure and a distal end portion configured to be delivered through the sheath to the treatment site.
White teaches an orthopedic device heated to a second temperature greater than body temperature (Fig. 1, ligament 28 comprises a nickel titanium alloy having an austenite transition temperature higher than body temperature [0047]) and a shape memory alloy ("SMA") having a martensite start temperature Ms greater than or equal to body temperature (Fig. 1, ligament 28 comprises a nickel titanium alloy having a martensite transition temperature higher than body temperature [0047]). White discloses that shape memory alloys having a martensite/austenite transition temperature above body temperature exhibit higher fatigue resistance [0054, 0056]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the ligament material and it’s properties as taught by White with the anchor member taught by Ruiz and the self-expanding properties taught by Vad in order to provide a material that has increased fatigue resistance in order to prolong the life of the implant. However, Ruiz in view of Vad and White fails to teach a prosthetic valve configured to be carried by, mounted within, or coupled to the anchoring member; an elongated member having a proximal end portion configured to be positioned at an extracorporeal location during implantation of the expandable structure and a distal end portion configured to be delivered through the sheath to the treatment site.
Dolan teaches a balloon-expandable stent comprising a prosthetic valve configured to be carried by, mounted within, or coupled to the anchoring member (Fig. 9, prosthetic valve 108 is deployed in tandem with stent portion 236); an elongated member (Fig. 1, prosthetic valve delivery system 100) having a proximal end portion (Fig. 1, hub 114) configured to be positioned at an extracorporeal location during implantation of the expandable structure (Fig. 1, hub 114 is positioned outside the patient [0025]) and a distal end portion configured to be delivered through the sheath to the treatment site (Fig. 1, distal tip 116). Dolan discloses that this stent and method of its delivery support a heart valve replacement procedure that involves minimal blood flow stoppage or interruption [0038]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the expandable structure taught by Ruiz with the self-expanding features taught by Vad, and the martensitic/austenite transition temperature features of the SMA ligament taught by White, with the placement taught by Dolan in order to minimize the stoppage of blood flow during the procedure.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz (US Pat. No. 6120534), “Ruiz” in view of Vad (US 2013/0166010 A1), “Vad”, and White (US 2009/0131981 A1), “White”, and Dolan (US 2010/0234940 A1), “Dolan”, and further in view of Mirzaee (US 2007/0293942 A1), “Mirzaee”.
Regarding claim 19, Ruiz teaches wherein the heating element (Fig. 8B, heated fluid 81) is a plurality of openings in the distal end portion of the elongated member (Fig. 8B, end of catheter 80 injects heated fluid 81 into the stent), but Ruiz in view of Vad, White, and Dolan fails to teach wherein the system further comprises a fluid source coupled to the proximal end portion of the elongated member and configured to deliver heated fluid through a lumen extending through the elongated member and through the openings to a vicinity of the second portion.
Mirzaee teaches a prosthetic valve deployment method wherein the system further comprises a fluid source coupled to the proximal end portion of the elongated member and configured to deliver heated fluid through a lumen extending through the elongated member and through the openings to a vicinity of the second portion (Fig. 4, fluid source (not shown) may be connected to infusion and ventilation points 216, 218 and used to inflate balloon 204 [0041]). Mirzaee discloses that the fluid source may also be used to circulate the fluid heated to the transition temperature during repositioning [0041]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the heating element taught by Ruiz with the fluid source taught by Mirzaee in order to simplify the heating method used for stent expansion and deployment.
Regarding claim 20, Ruiz in view of Vad, White, and Dolan fails to teach the limitations of claim 20. Mirzaee teaches a prosthetic valve deployment method wherein the heating element is a balloon (Fig. 5, balloon 204) carried by the distal end portion of the elongated member, and wherein the system further comprises a fluid source coupled to the proximal end portion of the elongated member and configured to deliver heated fluid to the balloon through a lumen extending through the elongated member (Fig. 4, fluid source (not shown) may be connected to infusion and ventilation points 216, 218 and used to inflate balloon 204 [0041]).
Mirzaee discloses that the fluid source may also be used to circulate the fluid heated to the transition temperature during repositioning [0041]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the heating element taught by Ruiz with the fluid source taught by Mirzaee in order to simplify the heating method used for stent expansion and deployment.
Conclusion
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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