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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/28/2024 is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group II, drawn to a method of implanting a prosthetic heart valve, in the reply filed on 3/20/2026 is acknowledged.
Claim Rejections - 35 USC § 112
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 15, 18, and 20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 15 recites “wherein inflating the distal portion of the balloon centers the prosthetic heart valve within the native aortic valve.” The term “centers” is indefinite because it is unclear what degree or type of positioning is required by this limitation. For example, it is unclear whether “centers” refers to axial centering, radial centering, circumferential centering, or some other positional relationship between the prosthetic heart valve and the native aortic valve. The claim therefore fails to provide clear notice of the metes and bounds of the claimed invention. Accordingly, one of ordinary skill in the art would not be reasonably apprised of the scope of the claim.
Claim 18 recites “the prosthetic heart valve maintains consistent axial alignment with respect to the native aortic valve.” The phrase “maintains consistent axial alignment” is indefinite because the term “consistent” is a term of degree that does not provide an objective standard for determining the scope of the claim. It is unclear how much movement, if any, is permitted while still satisfying the limitation. For example, the claim does not specify whether slight axial movement is encompassed, whether “consistent” means no axial movement, or whether some clinically acceptable tolerance is intended. Thus, the claim language fails to clearly define the required positional relationship during inflation of the second portion of the balloon, and the metes and bounds of the claim are therefore unclear.
Claim 20 recites “continuing to inflate the balloon until the prosthetic heart valve expands into contact with the native valve annulus.” The phrase “the native valve annulus” lacks proper antecedent basis because the claim previously recites “a native aortic valve,” but does not previously introduce “a native valve annulus” or otherwise clearly identify the annulus being referenced. As a result, it is unclear whether “the native valve annulus” refers to the annulus of the previously recited native aortic valve or some other anatomical structure. Accordingly, the scope of the claim is unclear.
The prior art rejections are made below based on the broadest reasonable interpretation of the claims. Under that interpretation, claim 15 is read as requiring general positioning/stabilization of the valve within the native aortic valve, claim 18 is read as requiring general maintenance of the intended longitudinal deployment position during inflation, and claim 20 is read as requiring a proximal balloon-associated folded or retaining configuration that changes during inflation to permit continued seating movement of the prosthetic heart valve.
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 8-12 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (US 2017/0056170 A1) in view of Cribier (US 7,585,321 B2), and further in view of Gale et al. (US 2021/0068956 A1)
With respect to claim 8, Zhu teaches advancing a balloon carrying a prosthetic heart valve and inflating a distal region of the balloon before the proximal region while the prosthetic heart valve remains mounted on the balloon, thereby forming a tapering shape with an enlarged distal region. See Zhu [0004]-[0006], [0030], [0033], [0042], and [0043]. Zhu further teaches, in the transfemoral aortic valve context, that the distal end of the balloon is positioned within the left ventricular outflow tract on the ventricular side of the annulus/native valve and that the distal or inflow end of the implantable heart valve anchors first. See Zhu [0035], [0045], and [0046]. Cribier teaches the procedural context of delivering and positioning a balloon-expandable prosthetic heart valve at a native aortic annulus before final expansion, including relative positioning of the delivery device and the annulus during deployment. See Cribier paragraphs (104)-(107), (127), and (132)-(135), and FIGS. 15a-15f. Gale teaches determining proper depth and alignment of a prosthetic heart valve relative to the native aortic annulus before full deployment, and teaches that the operator may confirm positioning and alignment prior to continued deployment. See Gale [0051]-[0054], [0065]-[0067], and [0081].
Thus, Zhu in view of Cribier teaches or suggests advancing a delivery device to a native aortic valve while the prosthetic heart valve remains crimped over the balloon; inflating a distal portion of the balloon while the valve remains crimped, the distal portion being positioned on the ventricular side of the native aortic valve; and the initial distal inflation occurring before full expansion of the valve into contact with the native valve. Gale further teaches confirming proper depth, alignment, and positioning before continued deployment. Therefore, it would have been obvious to confirm the location/contact of the initially anchored distal portion before continuing inflation. Zhu further teaches continuing inflation so that another portion of the balloon inflates and the prosthetic heart valve expands into secure contact. See Zhu [0005], [0043], and [0046].
With respect to claim 9, Zhu teaches that after distal-first inflation and anchoring, inflation continues and the proximal region of the balloon begins to expand while the distal region remains enlarged, thereby progressively expanding the valve from the ventricular side toward the aortic side. See Zhu [0009], [0030], [0043], and [0046]. In the native aortic valve implantation context taught by Cribier, the annulus/native valve lies between the ventricular side and the aortic side during deployment. See Cribier paragraphs (104)-(107), (127), and (132)-(135). Therefore, the combination teaches or at least suggests inflating a proximal portion of the balloon on the aortic side before full inflation of the remaining balloon portion such that the native aortic valve is disposed between the inflated distal and proximal portions.
With respect to claim 10, Zhu teaches a progressive transition from distal inflation to proximal inflation, such that during the transition both distal and proximal regions are inflated while the balloon proceeds from the tapered shape to a less tapered/straighter-sided shape. See Zhu [0005], [0030], [0043], and [0044]. Thus, the combination teaches or suggests inflating the distal and proximal portions simultaneously during the deployment sequence.
With respect to claim 11, Zhu teaches that after the initial distal-first inflation stage, continued inflation expands the balloon from the tapered shape to a shape with generally straighter sides that expands the mounted implantable heart valve. See Zhu [0004]-[0006], [0030], [0043], and claim 3. Because the mounted prosthetic heart valve is positioned over the working section of the balloon, it would have been obvious that the balloon portion that effects the subsequent valve expansion is the central portion of the balloon underlying the valve.
With respect to claim 12, Zhu teaches mounting an implantable cardiovascular device, including a prosthetic heart valve, on the balloon before inflation. See Zhu [0008], [0034], and [0039]. Zhu also teaches that the implant is positioned over the balloon working section. See Zhu [0003] and [0034]. Therefore, the combination teaches or suggests that the prosthetic heart valve is crimped over the central portion of the balloon prior to expansion into contact with the native valve.
With respect to claim 15, Zhu teaches that distal-first inflation allows the distal or inflow end of the implantable heart valve to anchor first, thereby preventing dislodgement and allowing controlled placement. See Zhu [0004], [0009]-[0010], [0033], [0045], and [0046]. Gale more specifically teaches centering and stabilizing a prosthetic heart valve within the native valve annulus before and during deployment. See Gale [0009], [0052]-[0054], [0066], and [0081]. In the annular positioning context taught by Cribier, and in view of Gale’s explicit teaching that engagement of the stabilization structure centers the prosthetic heart valve within the native valve annulus, it would have been obvious that the initial distal anchoring/deployment stage centers and stabilizes the prosthetic heart valve within the native aortic valve before full deployment.
With respect to claim 16, Zhu teaches repositioning the balloon after anchoring the enlarged distal region. See Zhu [0010] and claim 18. Cribier teaches careful annular positioning and repositioning of the prosthetic valve/delivery system relative to the native aortic valve. See Cribier paragraphs (104)-(107), (127), and (132)-(135). Gale teaches determining whether the prosthetic heart valve is properly positioned at the correct depth and, if not, partially disengaging the stabilization structure and advancing or retracting the delivery device until proper positioning is achieved. See Gale [0051]-[0053] and [0065]. Therefore, the combination teaches or suggests determining, prior to continued deployment, whether the prosthetic heart valve is not axially aligned with the native aortic valve.
With respect to claim 17, Zhu teaches repositioning the balloon after initial distal anchoring. See Zhu [0010] and claim 18. Cribier teaches manipulating the delivery system relative to the annulus/native aortic valve during deployment positioning. See Cribier paragraphs (104)-(107), (127), and (132)-(135). Gale teaches that if the prosthetic heart valve is not properly positioned, the physician may advance or retract the delivery device until the prosthetic heart valve is positioned at the proper depth and aligned within the native annulus. See Gale [0053], [0065], and [0081]. Therefore, the combination teaches or suggests advancing or retracting the delivery device until axial alignment is achieved before continued deployment.
With respect to claim 18, Zhu teaches controlled deployment after distal-first anchoring and continued inflation to the final deployed state. See Zhu [0030], [0043], [0046], and [0049]. Cribier teaches maintaining positional control of the prosthetic valve while completing deployment at the annulus. See Cribier paragraphs (104)-(107) and (132)-(135). Gale expressly teaches that the stabilization device remains engaged with surrounding tissue during deployment and keeps the prosthetic heart valve centered and aligned as the valve is deployed, thereby reducing repositioning or “jumping.” See Gale [0054], [0056]-[0060], [0067], and [0081]. Thus, the combination teaches or suggests maintaining the prosthetic heart valve in axial alignment relative to the native aortic valve during inflation of the later-expanding balloon portion.
With respect to claim 19, Zhu expressly teaches compressing the proximal region of the balloon with a covering and the mounted cardiovascular device such that the distal region inflates before the proximal region to form the tapering shape with an enlarged distal region. See Zhu [0004]-[0005], [0037]-[0043], and claim 1. This teaches or at least strongly suggests that, upon inflation of the distal portion, the proximal region remains uninflated or substantially constrained. Because the mounted valve overlies the balloon working section and continued expansion occurs only later, it would have been obvious that the remaining balloon portion under the valve remains uninflated or not yet expanded during the initial distal-first inflation stage.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (US 2017/0056170 A1) in view of Cribier (US 7,585,321 B2), further in view of Gale et al. (US 2021/0068956 A1), and further in view of Maimon et al. (US 10,314,703 B2).
Zhu et al. disclose a method of controlled balloon deployment for an implantable cardiovascular device, including a prosthetic heart valve, in which a proximal region of a balloon is compressed by a covering and the mounted cardiovascular device such that a distal region of the balloon inflates before the proximal region to form a tapering shape with an enlarged distal region. See Zhu [0004]-[0006], [0009]-[0010], [0030], [0033], [0037]-[0046], and claims 1, 17, and 18. Zhu further teaches that, in a transfemoral aortic valve implantation, the distal end of the balloon is positioned within the left ventricular outflow tract on the ventricular side of the aortic annulus/native valve and that the distal or inflow end of the implantable heart valve anchors first before the proximal end anchors upon continued inflation. See Zhu [0035], [0045], and [0046]. Zhu additionally teaches repositioning after anchoring the enlarged distal region. See Zhu [0010] and claim 18.
Cribier discloses implantation of a balloon-expandable prosthetic heart valve within a native aortic valve, including delivering the prosthetic valve to the native aortic annulus, carefully positioning the prosthetic valve relative to the native valve and surrounding anatomy, and expanding the prosthetic valve within the native aortic valve. See Cribier paragraphs (104)-(107), (127), and (132)-(135), including FIGS. 15a-15f.
Gale teaches determining proper depth, confirming positioning and alignment, and centering/stabilizing a prosthetic heart valve within the native valve annulus before continued deployment. See Gale [0009], [0051]-[0054], [0065]-[0067], and [0081]. Gale therefore teaches or suggests the confirming aspect of base claim 8.
Maimon et al. disclose that balloon regions may be configured to have different expansion characteristics by using different materials having different stiffnesses in different balloon regions. See Maimon paragraph (13), paragraph (43), and claim 12. In particular, Maimon teaches that the balloon can have wall material with a stiffness adjacent the inflow and outflow ends of the stent frame that is greater than a stiffness of the wall material at the central region, such that balloon regions expand differently from one another. See Maimon paragraph (43).
It would have been obvious to one of ordinary skill in the art at the time of the invention to apply Zhu’s controlled distal-first balloon inflation technique to Cribier’s native aortic valve implantation method in order to improve control of initial anchoring and reduce dislodgement during positioning of the prosthetic heart valve at the annulus. It further would have been obvious, in view of Gale, to confirm the position/alignment of the initially anchored distal balloon/valve portion before proceeding with continued deployment, because Gale teaches confirming proper depth, centering, and alignment before full deployment of a prosthetic heart valve at the native annulus. It also would have been obvious to further modify the balloon of Zhu in view of Maimon to employ balloon portions having different material properties in order to further control the sequence and profile of balloon expansion during prosthetic valve deployment.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (US 2017/0056170 A1) in view of Cribier (US 7,585,321 B2), further in view of Gale et al. (US 2021/0068956 A1), and further in view of Maimon et al. (US 10,314,703 B2).
As discussed above with respect to claim 13, Zhu et al. disclose a staged balloon deployment method for an implantable heart valve in which a distal balloon region inflates before a proximal region, Cribier discloses positioning and expanding a balloon-expandable prosthetic heart valve within a native aortic valve, and Gale teaches determining proper depth, confirming alignment, and centering/stabilizing the prosthetic heart valve before continued deployment. See Zhu [0004]-[0006], [0030], [0042]-[0046]; Cribier paragraphs (104)-(107), (127), and (132)-(135); Gale [0009], [0051]-[0054], [0065]-[0067], and [0081].
Maimon et al. further disclose controlling differential balloon expansion by varying wall thickness among balloon regions. See Maimon paragraphs (39) and (43). Maimon specifically teaches that the wall is thinner in the central portion of the balloon to facilitate greater expansion in that area, and that the thickness of the wall of the central portion can be reduced to allow its expansion to a larger diameter. See Maimon paragraphs (39) and (43).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the balloon used in Zhu’s controlled deployment method, in the native aortic valve implantation context of Cribier and with the confirming/alignment teachings of Gale, to include regional wall-thickness variation as taught by Maimon in order to control the relative expansion of balloon portions during deployment and thereby improve the precision and controllability of prosthetic valve implantation.
Accordingly, Zhu in view of Cribier and Gale teaches or suggests the subject matter of base claim 8, including the confirming step, and Maimon teaches the additional limitation of claim 13 that different balloon portions may comprise different materials having different stiffnesses so as to preferentially affect regional balloon expansion.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (US 2017/0056170 A1) in view of Cribier (US 7,585,321 B2), further in view of Gale et al. (US 2021/0068956 A1), and further in view of Miller et al. (US 2001/0000801 A1).
Zhu et al. disclose controlled balloon deployment for a prosthetic heart valve in which a proximal region of the balloon is constrained by a covering so that a distal region inflates before the proximal region, thereby forming a tapered deployment configuration with an enlarged distal region. See Zhu, e.g., [0004]-[0006], [0009]-[0011], [0030], [0037]-[0043], and [0045]-[0049]. Zhu further teaches that, as inflation continues, the restraint on the proximal region is overcome so that the proximal region subsequently expands and the prosthetic heart valve progresses toward its fully deployed state. See Zhu [0004]-[0006], [0043], [0046], and [0049]. Zhu also teaches that the covering may be configured to roll off the proximal end of the balloon during inflation. See Zhu [0038].
Cribier discloses the native aortic valve implantation context, including positioning a balloon-expandable prosthetic heart valve at the native aortic annulus and expanding the prosthetic valve into place. See Cribier, e.g., paragraphs (104)-(107), (127), and (132)-(135), including FIGS. 15a-15f. Cribier therefore supplies the annular positioning and deployment setting for the claimed method.
Gale et al. disclose techniques for aligning, stabilizing, and maintaining proper positioning of a prosthetic heart valve relative to the native valve annulus before and during deployment. See Gale, e.g., [0009]-[0010], [0051]-[0054], [0065]-[0067], and [0081]. Gale further teaches confirming proper depth, alignment, and seating relative to the native annulus before continued deployment, thereby reducing malposition and valve movement during implantation.
Miller et al. disclose a stent delivery system having a retaining sleeve overlying an end of a stent in the unexpanded state, wherein the sleeve retracts from the stent end as the balloon and stent expand. See Miller, e.g., paragraphs 21-28. Miller further teaches that rolling sleeve configurations may be used. See paragraph 28. Miller therefore teaches an end-retaining structure that changes configuration, retracts, and/or rolls back during balloon expansion.
It would have been obvious to one of ordinary skill in the art at the time of the invention to apply Zhu’s distal-first controlled balloon deployment technique in the native aortic valve implantation context taught by Cribier in order to improve controlled anchoring and reduce dislodgement during valve positioning. It further would have been obvious, in view of Gale, to confirm proper annular depth, alignment, and seating of the partially deployed prosthetic heart valve before continued deployment, because Gale teaches that such confirmation improves placement accuracy and reduces valve jump or malposition. It also would have been obvious, in view of Miller, to provide Zhu’s proximal restraint in the form of a sleeve-like or roll-back structure that retracts or changes configuration during inflation so as to progressively release the prosthetic heart valve during continued expansion.
Accordingly, the combined references teach or suggest inflating a balloon to expand a prosthetic heart valve while a proximal end restraint structure unfolds, retracts, or rolls back during inflation as deployment proceeds and the prosthetic heart valve advances distally relative to the native aortic valve until contact with the native valve annulus, as recited in claim
Alternatively, claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Maimon et al. (US 10,314,703 B2) in view of Miller et al. (US 2001/0000801 A1).
Maimon et al. disclose a method of implanting a prosthetic heart valve using a balloon catheter, wherein a prosthetic heart valve is mounted on a balloon, advanced to a native heart valve site, and the balloon is inflated to expand the prosthetic heart valve into place within the native heart valve. See Maimon, e.g., paragraphs (3), (21), (23), (24), (29), (30), and (49). Maimon further discloses shaped balloon configurations including proximal/inflow end contours, central belly portions, waists, and enlarged end portions that affect the seating, alignment, and final expansion profile of the prosthetic heart valve during deployment. See Maimon, e.g., paragraphs (32)-(43), (45), (49), (53), and (56)-(60). In particular, Maimon teaches a balloon shape having an inflow end flare and a waist positioned at the annulus to align and seat the prosthetic heart valve during expansion. See paragraph (58).
Maimon does not expressly disclose that the balloon includes at least one fold at a proximal end portion of the balloon, wherein the prosthetic heart valve advances distally relative to the native aortic valve while the fold unfolds during inflation.
Miller et al. disclose a stent delivery system including at least one retaining sleeve overlying an end of a stent in the unexpanded state, wherein the sleeve retracts off the end of the stent as the balloon and stent are expanded. See Miller, e.g., paragraphs (21), (22), and (27). Miller further teaches that the sleeve is engaged to a catheter portion adjacent the stent mounting region and is configured to move relative to the expanding stent during deployment. See paragraphs (21)-(27). Miller also states that rolling sleeve and other sleeve configurations known in the art may be used. See paragraph (28).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the balloon-based prosthetic heart valve delivery method of Maimon to include a foldable or sleeve-like proximal end structure as taught by Miller, which retracts, rolls back, or unfolds relative to the expanding prosthetic implant during deployment, in order to retain the prosthetic heart valve during delivery and permit controlled release during inflation. Such modification would have predictably allowed controlled relative axial movement between the deployment structure and the prosthetic heart valve during inflation, thereby facilitating seating of the prosthetic heart valve at the annulus while inflation continues.
As modified, the combination teaches or suggests inflating a balloon to expand a prosthetic heart valve in a native valve, wherein a proximal end structure unfolds/retracts during inflation and the prosthetic heart valve correspondingly advances distally relative to the native valve until contacting the native valve annulus, as recited in claim 20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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