DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 6/8/2026 have been fully considered but they are not persuasive. Applicant argues that Griffin does not disclose that a pull wire performs the functions of both changing the arc of a tensioned portion and elevating a tensioned portion.
While the Examiner agrees with the Applicant’s characterization of Griffin, the Examiner asserts that the new language does not distinguish over the previously cited art. In looking to Applicant’s specification, the only mention of changing an arc is with reference to Figure 15-16, which states that a pulling force applied to the pull ring changes an arc of the catheter 1022 with a right atrium, as shown by comparing the phantom image of catheter 922 in Fig. 13B to Figures 15-16. While the arc of the tensioned portion changes when the pull-wire/pull-ring elevates the tensioned portion, this is due to a portion of the catheter extending through the septum. Changing the arc of the tensioned portion is not due only to the pulling force to the pull-wire/pull-ring, but due to the distal portion of catheter being held in position by the septum.
The modified Griffin device comprises all the claimed structural features and functions to elevate the tensioned portion when a pulling force is applied to the pull-ring (129). The modified Griffin device is further capable of being positioned in a patient such that the tensioned portion (142) is positioned against a lumen wall, such that a pulling force will elevate the tensioned portion and change the arc of the tensioned portion (142).
In regards to method claim 152, the Sheps reference is relied upon for teaching advancing the catheter through a septum, while the catheter (12) is bent within the right atrium (220) and steered towards the left atrium (224) (see Fig. 10A-G; [560-566]). It would have been further obvious to one of ordinary skill in the art to perform the step of applying a pulling force to the pull-ring to elevate the tensioned portion of modified Griffin, while a portion of the catheter distal to the pull ring is positioned through the septum (as taught by Sheps). Since a distal portion of the catheter extends through the septum, elevating the tensioned portion of modified Griffin would result in an arc, or radius of curvature, of the tensioned portion being changed at least to some degree. The modification merely involves known methods of steering a catheter to access a treatment site, according to many variables of patient anatomy, including but not limited to patient age, height, health, birth defects, etc.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 146-151 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2017/0258614 (Griffin) in view of USPAP 2010/0022948 (Wilson et al.).
Griffin discloses a delivery tool comprising a catheter defining a primary lumen (108) and a secondary pull-wire lumen (112) (see cross-section of Figure 1A-B; [0025]), the catheter comprising:
a pull-ring (129) fixed to a wall of the catheter [0029];
a steerable distal portion (at distal end 139 in Fig. 3);
and a tensioned portion (142 in Fig. 3) of the catheter that is distal of the pull-ring (129) and proximal of the steerable portion (139);
and a pull-wire (122) that is fastened to the pull-ring (129) and passes through the secondary pull-wire lumen (112) [0028], the pull-wire (122) extending proximally from the pull-ring (129) to a proximal portion of the delivery tool (handle 150; [0024-0025; 0028]), such that a pulling force, when applied to a proximal portion of the pull-wire, is transferred, via the pull-ring, to the tensioned portion of the catheter in order to elevate the tensioned portion (142) (see Fig.4; [0028-0029]).
Griffin discloses the pull wire (122), which is inside the wall of the catheter (Fig. 1-A-B), is directly attached to the pull ring (129) [0029]. Griffin discloses that elements may be embedded within the catheter wall [0030]). Griffin fails to explicitly disclose the pull ring (129) is embedded within the catheter wall. Wilson discloses another steerable catheter having pull wires (220) attached to pull rings (210 and 212) [0078-0079]. Wilson teaches that the pull rings are embedded within the wall of the catheter (see Figures 20A-D), with an inner layer (230) that provides a seamless lumen and aids in reducing friction [0081]. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to embed the pull rings of Griffin within the catheter wall, as taught by Wilson, as the modification merely involves a combination of known catheter steering mechanisms according to known methods that obtains a predictable result of a seamless lumen and friction reduction.
The phrases “for transfemorally implanting a prosthetic valve at a native valve of a heart…”, “…configured to be disposed adjacent to a fossa ovalis of the heart…”, and “the tensioned portion (142) being configured to abut the fossa ovalis…” are functional recitations that are not given full patentable weight. The prior art is not required to disclose this particular manner of use, but merely have the capability of being positioned in the body in the recited manner. In this case, Griffin discloses that the catheter is used to access the heart [0002] and used to deliver a prosthetic heart valve (172) (Fig. 7; [0039]).
Claims 146 now requires that the a pulling force applied to the pull-wire is transferred via the pull ring to the tensioned portion of the catheter in order to change an arc of the tensioned portion and to elevate the tensioned portion. This is another functional recitation met by a capability of the prior art to perform the function. The only mention of changing an arc is with reference to Figure 15-16, which states that a pulling force changes an arc of the catheter 1022 with a right atrium, as shown by comparing the phantom image of catheter 922 in Fig. 13B to Figures-16 15. While the arc of the tensioned portion changes when the pull-wire elevates the tensioned portion, this is due to a portion of the catheter extending through the patient’s anatomy. The modified Griffin device comprises all the claimed structural features and functions to elevate the tensioned portion when a pulling force is applied to the pull-ring (129). The modified Griffin device is further capable of being positioned in a patient such that the tensioned portion (142) is positioned against a lumen wall, such that a pulling force will elevate the tensioned portion and change the arc of the tensioned portion (142).
Regarding claim 147, Griffin discloses the delivery tool further comprises a shaft (170) passing through the primary lumen (see Fig. 7), the shaft defining a shaft-lumen for facilitating passage therethrough of a guidewire (180) ([0028] of USPAP 2011/0245917 inc. by reference at [0039]).
Regarding claim 148, although Griffin fails to disclose the tensioned portion (142) is more flexible than portions of the catheter that are proximal of the pull-ring, Wilson teaches the concept of forming a catheter to increase in flexibility towards the distal end. The catheter has a proximal section (236 or 238) extending from the handle to the pull ring (210) that is reinforced and kink resistant [0083-0084], and a middle section between the two pull rings (210 and 212) that has increased flexibility [0082]. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the Griffin catheter such that the tensioned portion (142) distal of the pull ring (129) is more flexible than a portion proximal to the pull ring (129), as taught by Wilson, as the modification merely involves a combination of known catheter components according to known methods that obtains a predictable result of tailoring the stiffness and flexibility of catheter portions to obtain desired mechanical properties and performance.
In regards to claim 149, Wilson teaches the concept of varying the thickness of a catheter shaft to vary the stiffness/ flexibility to achieve different degrees of bending [0056; 0073]. Since the tensioned portion of Griffin is adapted to bend, one of ordinary skill in the art would have found it obvious to form the tensioned portion to be thinner than portions of the catheter that are proximal of the pull-ring, as Wilson teaches that this is another way to achieve desired flexibility characteristics of a catheter section.
In regards to claim 150, the language “…configured to maintain the prosthetic valve in contact with the native valve, during the pulling of the proximal portion of the pull-wire…” is a functional recitation that is not given full patentable weight. The prior art is not required to disclose this particular manner of use, but merely have the capability of being positioned in the body in the recited manner. In this case, the Griffin discloses aiding delivery of a prosthetic valve (Fig. 7; [0039]) and is capable of being manipulated to maintain a desired position of the prosthetic valve while the pull wire is pulled.
Regarding claim 151, Griffin discloses pulling of the proximal portion of pull-wire (122) changes an arc of the catheter (see Figure 4; [0029]). Although Griffin does not explicitly disclose that the catheter is bent within the right atrium of the heart, the capability of the device to be manipulated in this manner meets the functional requirement.
Claim(s) 152-159 are rejected under 35 U.S.C. 103 as being unpatentable over Griffin in view of Wilson et al., as applied above, and further in view of USPAP 2015/0272734 (Sheps).
Regarding claims 152 and 157: Griffin in view of Wilson includes all the structural limitations of the catheter. Griffin discloses that the catheter is used to access the heart [0002] and used to deliver a prosthetic heart valve (172) (Fig. 7; [0023]; [0039]). Griffin fails to disclose the particular path for advancing the catheter to the heart.
Sheps discloses another method of delivering a prosthesis to a heart valve with a steerable catheter (12). Sheps teaches that it is well known in the art to advance a catheter to the mitral valve by a transfemoral approach in order to access the left atrium to implant a prosthesis (annuloplasty ring [0243]) at a mitral valve (see Figure 10A-F; [0463];[0561]; [0727]). Similar to Griffin, the Sheps catheter is steerable with pull rings (11 and 13) and pull wires (29) [0467], wherein the catheter (12) is bent within the right atrium (220) to steer towards the fossa ovalis and left atrium (224) (see Fig. 10A-G; [560-566]). Sheps additionally discloses the curved, or tensioned, portion of the catheter is configured to abut the fossa ovalis. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to advance the modified Griffin catheter to the heart by a transfemoral approach that crosses through the fossa ovalis [560], as Sheps teaches that this is one well-known path for guiding a catheter to a treatment site at a native heart valve.
It would have been further obvious to pull on the pull-wire in order to “elevate”, or bend, the tensioned portion of the catheter in order to achieve steering the distal end of the catheters towards the fossa ovalis and left atrium (see Figure 4 of Griffin and Figures 10A-F of Sheps). Since the claim does not specify a direction in which “elevation” occurs, the relative motion of the tensioned portion (142) of the modified Griffin catheter to the portion proximal of the pull ring can be considered “elevation” in at least one direction in 3-D space.
Claims 152 now requires that the a pulling force applied to the pull-wire is transferred via the pull ring to the tensioned portion of the catheter in order to change an arc of the tensioned portion and to elevate the tensioned portion. Sheps discloses the catheter is advanced through a septum, wherein a portion of the catheter is positioned within the septum, while the catheter (12) is bent within the right atrium (220) and steered towards the left atrium (224) (see Fig. 10A-G; [560-566]). It would have been further obvious to apply a pulling force to the pull-ring to elevate the tensioned portion of modified Griffin, while a portion of the catheter distal to the pull ring is positioned through the septum, such that the pulling force will elevate the tensioned portion and change the arc of the tensioned portion (142) of the catheter. The modification merely involves a combination of known methods of operating a steerable catheter to access a treatment site, which allows the catheter to be steered according to many variables of patient anatomy, including but not limited to patient age, height, health, birth defects, etc.
Regarding claim 153, although Griffin fails to disclose the tensioned portion (142) is more flexible than portions of the catheter that are proximal of the pull-ring, Wilson teaches the concept of forming a catheter to increase in flexibility towards the distal end. The catheter has a proximal section (236 or 238) extending from the handle to the pull ring (210) that is reinforced and kink resistant [0083-0084], and a middle section between the two pull rings (210 and 212) that has increased flexibility [0082]. Sheps additionally teaches forming a tensioned portion (see bending section 1203 in Figure 3E and Figure 4) to be more flexible than portions of the catheter that are proximal of the pull-ring (11) (see description of softness of portion 1203 to facilitate bending at [0521] and immediately proximal portion 1208 having a higher durometer [0524]).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the Griffin catheter such that the tensioned portion (142) distal of the pull ring (129) is more flexible than a portion proximal to the pull ring (129), as taught by Wilson and Sheps, as the modification merely involves a combination of known catheter components according to known methods that obtains a predictable result of tailoring the stiffness and flexibility of catheter portions to obtain desired mechanical properties and performance.
In regards to claim 154, Wilson teaches the concept of varying the thickness of a catheter shaft to vary the stiffness/ flexibility to achieve different degrees of bending [0056; 0073]. Since the tensioned portion of Griffin is adapted to bend, one of ordinary skill in the art would have found it obvious to form the tensioned portion to be thinner than portions of the catheter that are proximal of the pull-ring, as Wilson teaches that this is another way to achieve desired flexibility characteristics of a catheter section.
In regards to claims 155 and 158, Griffin discloses delivery of a heart valve and Sheps discloses that the catheter remains curved while the prosthesis is being delivered to the heart valve (Fig. 10G-H), it would have been further obvious to perform the step of maintaining the prosthetic valve in contact with the native valve by a distal portion of the catheter during the pulling of the proximal portion of the pull-wire.
Regarding claims 156 and 159, Sheps teaches that the catheter is steered towards the right atrium (see Fig. 10A-G; [0559-0560]; [0727]) and steered within the atrium to face the mitral valve annulus (Fig. 12c; Fig. 26c; [0729]), such that pulling of the proximal portion of pull- wire comprises changing an arc of the catheter within a right atrium of the heart.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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