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 Amendment
The amendment filed April 23, 2026 has been acknowledged. Claims 1-20 remain pending in the application and are under examination.
Response to Arguments
Applicant’s arguments with respect to claims 1-14 have been considered but are not persuasive or are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Interpretation
In re claim 6, the limitations “inner shaft” and “outer shaft” are being interpreted as perspective-based descriptions. In this instance, the inner and outer shaft correspond to a catheter having an outer sheath with components located inside the sheath such as an inner shaft.
In re claim 7, the limitations “proximal shaft” and “distal shaft” are being interpreted as perspective-based descriptions. In this instance, the terms proximal and distal correspond to their anatomical terms of location in relation to the orientation of the catheter and the user’s heart. The proximal and distal shafts in this instance are being interpreted to correspond to which part of the catheter must advance to deploy the valve.
In re claim 8, the limitations “proximal shaft”, “distal shaft”, and “outer shaft” are being as perspective-based descriptions. In this instance, the terms proximal and distal correspond to their anatomical terms of location in relation to the orientation of the catheter and the user’s heart. The proximal and distal shafts in this instance are being interpreted to correspond to which part of the catheter must advance to deploy the valve. The outer shaft is being interpreted as being an outer cover or sheath of the delivery device that houses the other components within it.
Applicant is asked to confirm or correct these interpretations.
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 6-8 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In re claim 6:
The limitation “the supplemental valve apparatus includes a delivery system… comprising… a supplemental valve apparatus” is unclear. It is unclear whether “a supplemental valve apparatus” is referring to the same supplemental valve apparatus as “the supplemental valve apparatus” or to a different one. For examination purposes, as best understood, the limitation “a supplemental valve apparatus” will be interpreted to mean the same supplemental valve apparatus.
The limitation “the supplemental valve apparatus includes a delivery system for deploying a supplemental valve into the right atrium” is unclear. Specifically, it is unclear how the supplemental valve apparatus can include a delivery system as the supplemental valve apparatus is the apparatus that is positioned in the heart and cannot include a delivery system. For examination purposes, as best understood, the limitation “a supplemental valve apparatus includes a delivery system” will be interpreted to mean that a delivery system is used to deploy the supplemental valve apparatus.
In re claim 7: see above (In re claim 6).
In re claim 8: see above (In re claim 6).
In re claim 8, the limitation "distal shaft inner member" lacks antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 9-10, 14, 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wei (US 2017/0239043).
In re claim 1, Wei discloses a supplemental valve apparatus (fig 8: 220, 246) for implantation into the right atrium of a patient's heart (238), comprising:
a supplemental valve configured to be positioned in or adjacent the right atrium (246);
a supplemental valve leg supporting the supplemental valve and configured to extend toward the tricuspid valve when the apparatus is implanted in the patient's heart so as to position the supplement valve adjacent or within the tricuspid valve (224; [0029]); and
the supplemental valve coupled to at least one supplemental valve structure (fig 6: 222), the supplemental valve structure including the supplemental valve leg (fig 8: 224) and one or more additional legs configured to extend into at least one of the inferior vena cava (232) or superior vena cava (226); and
In re claim 2, Wei discloses and wherein: the supplemental valve is a biologic valve ([0032]: bioprosthetic valve).
In re claim 3, Wei discloses and wherein: the supplemental valve apparatus is positioned within the right atrium (fig 8: 220, 238), and anchored in position by the one or more additional legs [0029] extending into the inferior vena cava (232) and into the superior vena cava (226).
In re claim 4, Wei discloses and wherein: the supplemental valve apparatus includes one or more of a jacket and/or seal(s) [0033] to direct blood flow from the inferior vena cava and superior vena cava through the supplemental valve ([0028]: “regulate flow through the tricuspid valve”).
In re claim 5, Wei discloses and wherein: the supplemental valve apparatus is configured to enable percutaneous delivery via a delivery system [0034].
In re claim 9, Wei discloses a method for treating a compromised tricuspid valve of a patient's heart [0028], comprising:
a supplemental valve apparatus (fig 8: 220) including a supplemental valve (246) supported by a supplemental valve leg configured to extend toward the tricuspid valve when implanted in the patient's heart (224; [0029]);
leaving the existing tricuspid valve in position [0029]: “extending… through the tricuspid valve 240”);
placing a supplemental valve in or adjacent the right atrium (246);
maintaining the position of the supplemental valve with one or more additional legs of the apparatus located at least in part within the superior vena cava and/or the inferior vena cava of the patient's heart (226, 232); and
directing blood flow from the superior vena cava and inferior vena cava through the supplemental valve [0028].
In re claim 10, Wei discloses wherein the supplemental valve apparatus is delivered to the desired location percutaneously [0034], and further comprising:
sealing against the atrium wall with a skirt or seal of the supplement valve leg surrounding the supplemental valve [0033].
In re claim 14, Wei discloses and wherein: the supplemental valve is deployed in or adjacent the right atrium (246), and then the supplemental valve apparatus is anchored in position [0033].
In re claim 19, Wei discloses wherein the one or more additional legs include both an inferior vena cava leg for anchoring in the inferior vena cava (fig 8: 232), and a superior vena cava leg for anchoring in the superior vena cava (226).
In re claim 20, Wei discloses wherein the supplemental valve leg includes a skirt or seal that is configured to seal against the right atrium wall along or near the tricuspid when deployed [0033], so as to direct blood flow through the native tricuspid valve [0028].
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.
Claims 6-8, 11-13, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Wei (US 2017/0239043) in view of Li et al. (US 2016/0262880).
In re claim 6, Wei discloses and wherein:
the supplemental valve apparatus includes a delivery system for deploying a supplemental valve into the right atrium [0034], comprising:
a balloon expandable stent;
a supplemental valve apparatus positioned on a bifurcated balloon delivery catheter;
the supplemental valve apparatus having
a supplemental valve (fig 8: 246),
an inferior vena cava leg for anchoring at least a portion of the supplemental valve apparatus in the inferior vena cava (232), and
a superior vena cava leg, for anchoring at least a portion of the supplemental valve apparatus in the superior vena cava (226).
Wei lacks:
an inner shaft;
an outer shaft; and
a supplemental valve apparatus positioned between the inner shaft and the outer shaft, the outer shaft configured to be retracted with respect to the inner shaft to deploy the supplemental valve apparatus;
Li teaches a therapeutic device that has a prosthetic heart valve coupled to a multi-branch graft [0063] with a collapsible and expandable stent [0006] that can be used to replace a native heart valve [0032]. The therapy device is loaded into a delivery device [0049] that has an inner shaft (fig 4A: 484) and outer sheath (482) with the graft (350) between them. The outer sheath can be retracted to expose the graft [0056].
It would be obvious to one of ordinary skill in the art at the time the instant invention was followed to modify the system of Wei by using a delivery device that deploys the supplemental valve apparatus by retracting an outer shaft with respect to an inner shaft as taught by Li, as this would allow for a more controlled deployment of the apparatus by ensuring the apparatus is in the proper position before retracting the shaft and by controlling how quickly the apparatus is deployed to the desired position.
In re claim 7, see above (In re claim 6) and the following limitations:
Wei lacks:
a distal shaft;
a proximal shaft; and
a supplemental valve apparatus positioned between the distal shaft and the proximal shaft, the distal shaft configured to be advanced with respect to the proximal shaft to deploy the supplemental valve apparatus;
Li teaches a prosthetic heart valve device that has a delivery device that can include a core (fig 5A: 486) extending from an end with an inner shaft (484) to an atraumatic tip (487). The inner shaft is at the proximal end of the delivery device, and can be considered a proximal shaft. The core extends from the proximal and distal end and the graft is positioned between the two. The core can be considered the distal shaft (486 near the atraumatic tip, 487). As the core is advanced towards the atraumatic tip, the device is deployed [0055].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Wei by having a proximal and distal shaft that deploys the valve apparatus as the distal shaft is advanced as taught by Li, as this would allow for the device to be constrained within in the catheter and deployed into the proper position in a controlled manner.
In re claim 8, see above (In re claim 6) and the following limitations:
Wei lacks:
a distal shaft;
a proximal shaft;
an outer shaft; and
a supplemental valve apparatus positioned between at least a portion of the distal shaft inner member and the outer shaft and the proximal shaft,
the outer shaft configured to be retracted with respect to the distal shaft inner member to deploy at least a portion of the supplemental valve apparatus;
the distal shaft configured to be advanced with respect to the distal shaft inner member to deploy at least a portion of the supplemental valve apparatus;
wherein the supplemental valve apparatus is positioned such that relative movement of the distal shaft and the outer shaft deploys the supplemental valve leg first before the inferior vena cava leg or superior vena cava leg.
Li teaches a prosthetic heart valve device that has a delivery device that can include a core, or distal shaft, (fig 5A: 486) extending from an end with an inner shaft, or proximal shaft, (484) to an atraumatic tip (487), that has an outer sheath (482). The prosthetic heart valve device (300) is positioned between the outer sheath, proximal shaft, and distal shaft. As the distal shaft is advanced, the outer sheath is retracted to deploy the prosthetic heart valve device [0055]. The prosthetic heart valve device can be positioned in a way that allows for the leg with the valve to be deployed before the superior and inferior vena cava legs are deployed [0063].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Wei by having a distal, proximal, and outer shaft where the distal shaft advances while the outer shaft retracts as taught by Li, as this would allow for a controlled release of the valve while ensuring that the graft is not shortened during deployment and would allow for re-sheathing and repositioning the device if the original location was not proper.
In re claim 11, Wei lacks
and wherein: the supplemental valve apparatus is deployed at least in part by retracting an outer shaft to deploy the supplemental valve leg first before deploying the one or more additional legs of the apparatus located within the superior vena cava and/or the inferior vena cava.
Li teaches a therapeutic device that has a prosthetic heart valve coupled to a multi-branch graft [0063] that can be deployed by retracting an outer sheath [0056]. The delivery device can deliver the prosthetic heart valve first, followed by the other branches of the device [0063].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Wei by deploying the supplemental valve leg first as taught by Li, as this would allow for the supplemental valve to be properly positioned in the desired place before deploying the other legs to help secure the graft.
In re claim 12, see above (In re claim 7).
In re claim 13, see above (In re claim 8).
In re claim 15, Wei lacks
further comprising: positioning the supplemental valve in a desired position within or adjacent the tricuspid valve before deploying the one or more additional legs of the apparatus within the inferior vena cava and the superior vena cava.
Li teaches a therapeutic device that has a prosthetic heart valve coupled to a multi-branch graft [0063] that can deliver the prosthetic heart valve first, followed by the other branches of the device [0063].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Wei by deploying the supplemental valve leg before the other legs of the device as taught by Li, as this would allow for the supplemental valve to be properly positioned in the desired place before deploying the other legs to help secure the graft.
In re claim 16, Wei discloses wherein the one or more additional legs include both an inferior vena cava leg for anchoring in the inferior vena cava (232), and a superior vena cava leg for anchoring in the superior vena cava (226),
Wei lacks
such that the inferior vena cava leg and the superior vena cava leg are deployed after deployment of the supplemental valve in the desired position.
Li teaches a therapeutic device that has a prosthetic heart valve coupled to a multi-branch graft [0063] that can deliver the leg of the graft with the prosthetic heart valve first, followed by the other branches of the device [0063].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Wei by deploying the additional legs after the leg with the valve as taught by Li, as this would allow for the leg with the valve to be secured in the proper position before fully deploying the rest of the device.
In re claim 17, Wei lacks
further comprising: testing functionality and/or sealing of the supplemental valve after deployment of the supplement valve leg but before deployment of the inferior vena cava leg and the superior vena cava leg.
Li teaches a therapeutic device that can partially deploy a prosthetic heart valve and re-sheath, reposition, and redeploy until satisfactory functioning of the heart valve is confirmed [0071]. After deploying, a coil pushes the lining out to prevent blood from flowing around the graft. Then, more of the graft will be deployed until eventually the entire graft is deployed [0071].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Wei by testing the position of the supplemental valve leg to ensure the valve is functioning properly before fully deploying the rest of the device as taught by Li, as this would ensure the device is in the proper position and functioning as needed before fully deploying it and sealing it to the structure of the heart.
In re claim 18, Wei lacks
further comprising: repositioning the supplemental valve after testing before deployment of the inferior vena cava leg and the superior vena cava leg.
Li teaches a therapeutic device that can partially deploy a prosthetic heart valve by deploying the leg with the valve first [0063] and can re-sheath, reposition, and redeploy until satisfactory functioning of the heart valve is confirmed [0071] before deploying the rest of the valve [0063, 0071].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Wei by repositioning the supplemental valve leg to ensure the valve is functioning properly before fully deploying the rest of the device as taught by Li, as this would ensure the valve is in the proper position before deploying the rest of the device to redirect blood flow through the valve.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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