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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/17/2024 is being considered by the examiner.
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.
Claims 7–8, 11, and 25 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 the inventor or a joint inventor regards as the invention.
Claim 7 recites, in relevant part, “the attachment element operable by the delivery tool to attach to a lip of the first leaflet.” Claim 8 further recites that the attachment element comprises a clip “configured to attach to the lip of the first leaflet by … transitioning between an open conformation and a closed conformation.” The metes and bounds of claims 7–8 are unclear because it is not reasonably clear how the recited attachment element is “operable by the delivery tool” and, in claim 8, how the clip is caused to transition between the recited conformations. The claims do not clearly set forth what structure of the delivery tool operates the attachment element, whether the operation is direct or indirect, or what structural relationship exists between the delivery tool and the attachment element to accomplish the recited attachment. As a result, one of ordinary skill in the art would not be reasonably apprised of the scope of the claims. Additionally, the phrase “attach to a lip of the first leaflet” is unclear in scope because the claim does not sufficiently define the manner of attachment, the structure by which the attachment is achieved, or the positional boundaries of the claimed “lip” as recited in connection with the first leaflet. Accordingly, claims 7–8 are indefinite.
Claim 11 recites “the delivery tool further comprises a driver-lance configured to stabilize the delivery tool at the tissue.” Claim 11 is indefinite because the term “driver-lance” renders the scope of the claim unclear. The term does not have a reasonably well-established meaning in the art on this record, and the claim does not provide sufficient structural context to inform one of ordinary skill in the art of the bounds of the claimed subject matter. It is unclear whether the recited driver-lance is a driver, a lance, a combined driver/lance structure, or another component altogether, and it is further unclear how such structure differs from other recited drivers or lances in the application. Further, the phrase “configured to stabilize the delivery tool at the tissue” lacks sufficient clarity because the claim does not specify the relevant tissue, the manner of stabilization, or the structural cooperation by which the recited stabilization occurs. Therefore, claim 11 fails to particularly point out and distinctly claim the invention.
Claim 25 recites “the delivery tool further comprises an adjustment actuator configured to adjust a length of the adjustment element.” Claim 25 is indefinite because the term “adjustment actuator” is functional and lacks sufficient structural meaning in the context of the claim. The claim does not make reasonably clear what the adjustment actuator is, how it is coupled to the adjustment element, or by what mechanism it adjusts the length of the adjustment element. It is therefore unclear what structures are encompassed by the claim. Additionally, the phrase “adjust a length of the adjustment element” is unclear because the claim does not specify whether the adjustment element itself changes length, whether a portion of the adjustment element is taken up or released, or whether the phrase refers instead to changing a spacing established by the adjustment element. As such, the scope of claim 25 is uncertain. Accordingly, claim 25 is indefinite under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 102
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 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)(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, 3–5, 9–10, 15–18, and 20-27 are rejected under 35 U.S.C. 102 as being anticipated by Khairkhahan et al., US 11,464,634 B2.
Claim 1, Khairkhahan discloses:
A system for use with a valve of a heart, the valve having a first leaflet and an opposing leaflet, the heart having a chamber upstream of the valve, mitral valve with anterior and posterior leaflets, and left atrium upstream of the valve (paras. 77–81, 93–99, 163), the system comprising:
an implant comprising
a wing coaptation assistance element (400/500/600/700) functioning as the claimed wing/body (paras. 93–99, 154–163, 290–291), defining a contact face, and an opposing face opposite to the contact face first surface (405/505/705) and opposed second surface (415/515/715), with coaptation surface (460/560/760, paras. 93, 155, 290–301) and comprising a flexible frame, frame 465/565 and flexible struts 430/530/630/730, resiliently deformable for catheter delivery (paras. 105, 119, 123–142, 316).
a first anchor receiver and a second anchor receiver, each … coupled to the wing laterally spaced annular anchor receiving regions / anchor zones / passage locations in the annular section, including two sections spaced apart and extending laterally from the hub for accepting secondary anchors (paras. 305–307, 314, 322–333, 373–381) configured to be anchored to an annulus of the valve in a manner in which the wing extends away from the first and second anchor receivers and over the first leaflet toward the opposing leaflet, with the contact face facing the first leaflet implant attached at annular/atrial/commissural locations and extending over the posterior/first leaflet toward the opposing leaflet, with the leaflet-facing surface facing the leaflet (paras. 94–99, 104, 163, 279, 290–301)
a first anchor and a second anchor configured for being coupled to the wing via the first and second anchor receivers, secondary anchors (1770 and 1780, or 2220 etc.), coupled to corresponding annular anchor locations/receiving regions (paras. 202–214, 305–307, 328, 369, 387), the first and second anchors being implantable at sites upstream to the valve and configured to support the implant, attachment sites only in the atrium or near the annulus/commissures; no ventricular attachment required in certain embodiments (paras. 94–95)
a delivery tool, comprising
a catheter, transluminally advanceable to the chamber delivery catheter (1000 / 1402), transseptal sheath system (paras. 164–171, 185, 335, 356, 364)
a first shaft and a second shaft disposed alongside each other within the catheter secondary anchor drivers (2330, 2332, 2334, 2336); paragraph (370) expressly states the secondary anchor driver can be a torque shaft; multiple such shafts are present in the same catheter system (paras. 195, 322–333, 370–373) each of the first and second shafts engaged with a corresponding one of the first and second anchor receivers, each secondary anchor delivery path corresponds to a respective annular anchor zone / receiving location via the corresponding tether and guide rail (paras. 332–333, 373–381, 384–390) and housing a corresponding one of the first and second anchors, each torque shaft/secondary anchor driver corresponds to and carries/delivers a respective secondary anchor through the delivery path (paras. 370–373, 384–390, 407–416)
a first anchor driver and a second anchor driver, each … extending distally within a corresponding one of the first and second shafts secondary anchor drivers 2330/2332 as torque shafts extending distally through the delivery system (paras. 370–372) and within the corresponding one of the first and second shafts, engaged with the corresponding one of the first and second anchors proximally of the corresponding one of the first and second anchor receivers
the secondary anchor driver engages the shoulder/windows/grooves of the corresponding anchor proximally of the annular receiving zone/anchor location (paras. 392–419)
Claim 3, Khairkhahan discloses that the delivery tool delivers the implant such that the implant extends, within the catheter/sheath, distally from the delivery structures. See paras. 183–186, 195–201, 364–365.
Claim 4, Khairkhahan discloses that the wing/body extends, within the catheter, distally from the annular hub / anchor-receiver region during delivery. See paras. 183–188, 195–201.
Claim 5, Khairkhahan discloses that the delivery members deploy the implant out of the catheter and position it so that: the implant extends away from annular anchor regions, the wing extends over the first leaflet toward the opposing leaflet, and the contact face faces the first leaflet. See paras. 94–99, 163, 183–188, 199–201, 356–357.
Claim 9, Khairkhahan discloses first and second drivers engaged with corresponding anchors and configured to secure the implant by anchoring at corresponding annular sites. See paras. 211–214, 328–330, 357–361, 370–372.
Claim 10, Khairkhahan discloses concurrent positioning of multiple drivers within the chamber via multilumen / multicomponent transcatheter delivery structures. See paras. 322–333, 369–373.
Claim 15, Khairkhahan is directed to implantable intracardiac devices and delivery systems. Sterility of at least one of the implant, delivery tool, and anchors is inherent in such systems.
Claim 16, Khairkhahan discloses an adjustment arrangement in the frame/implant including a tether or purse-string suture extending from one region to another such that increased tension changes spacing and implant configuration. See paras. 108–115, 113–114.
Claim 17, Khairkhahan discloses a plurality of barbs extending from the contact face / first surface, namely leaflet anchor sites 545 extending from first surface 505. See paras. 134–138.
Claim 18, Khairkhahan discloses barbs configured to progressively engage/penetrate leaflet tissue, including passive leaflet anchor sites exposed through the covering and engaging leaflet tissue during use. See paras. 136–138.
Claim 20, Khairkhahan discloses barbs dimensioned/configured to penetrate through tissue/covering and engage the leaflet. See paras. 136–138.
Claim 21, Khairkhahan discloses flexibility of the frame enabling intracardiac change in spacing and geometry between anchor regions, including collapse, expansion, and adjustment. See paras. 105, 108–115, 279–287, 305–307.
Claim 22, Khairkhahan discloses that the distance between anchor locations can be changed intracardially by positioning corresponding anchor regions with corresponding delivery members. See paras. 199, 211–214, 357–361.
Claim 23, Khairkhahan discloses that the distance is fixable by anchoring one anchor relative to another at corresponding heart sites. See paras. 211–214, 357–361.
Claim 24, Khairkhahan discloses an adjustment element extending between anchor-receiving regions, including secondary anchor tether arrangements and tether/guide structures between spaced annular regions. See paras. 108–115, 332–333, 354, 373–381.
Claim 25, Khairkhahan discloses an adjustment actuator in the delivery tool, such as implant control knob 1003, configured to adjust tether tension/implant geometry. See paras. 165–166.
Claim 26, Khairkhahan discloses the adjustment element as a compressive/tension member, such as a tether/purse-string/release-wire arrangement that draws portions together. See paras. 108–115, 403–404.
Claim 27, Khairkhahan expressly discloses tether-based adjustment structures. See paras. 108–115, 245–246, 332, 354.
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 2, 6–8, 11–14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Khairkhahan et al., US 11,464,634 B2.
Khairkhahan discloses the coaptation implant, frame, annular anchor zones, multiple annular anchors, multiple torque-shaft drivers, leaflet anchor sites, and tether-based adjustment. However, the more specific limitations of claims 2, 6–8, 11–14, and 19 are not as clearly disclosed in the exact claimed form. Those limitations would nevertheless have been obvious variations of the structures expressly taught by Khairkhahan.
Claim 2 recites a rod engaged with the implant and operable by the delivery tool to change conformation of the implant. Khairkhahan teaches elongate implant-manipulation members such as: tether rails, guide tethers, purse-string sutures, and frame/strut-based control members operable by the delivery system to collapse, expand, and change implant conformation. See paras. 108–115, 165–166, 207, 240, 249, 258, 364, 368.
It would have been obvious to use a rod-shaped elongate member instead of or in addition to one of the disclosed elongate control members as a predictable equivalent for changing implant conformation.
Claim 6 recites a leg extending from the tip portion of the wing and contacting downstream tissue. Khairkhahan teaches inferior/ventricular struts extending from the hub toward downstream tissue and contacting downstream/subvalvular structures. See paras. 125, 287.
It would have been obvious to configure or characterize one such inferior extension as a leg extending from the wing tip and contacting downstream tissue, since this is a predictable variation of the disclosed distal support structure.
Claims 7–8 recite an attachment element at the tip portion, including a clip that attaches to a lip of the first leaflet. Khairkhahan teaches: leaflet anchor sites 545, passive and retractable leaflet-engaging barbs, and alternative attachment means including clips. See paras. 90, 134–138.
Although Khairkhahan does not expressly show in one embodiment a clip at the wing tip transitioning between open and closed conformations on a leaflet lip, it would have been obvious to substitute a clip-type leaflet attachment for the disclosed leaflet anchor/barb arrangements as a known alternative leaflet attachment structure for predictable securement of the distal portion of the implant to the leaflet.
Claim 11 recites a driver-lance configured to stabilize the delivery tool at tissue. Khairkhahan teaches multiple stabilizing and tissue-positioning structures associated with the anchor-delivery path, including: primary anchor housings, release wires, guide rails, and tissue-oriented elongate support members used during deployment. See paras. 322–338, 347, 354–360, 382–390.
It would have been obvious to include a lance-like stabilizing projection on the driver path as a predictable variation for temporarily stabilizing the tool at tissue during anchor deployment.
Claims 12–14 recite an implant lance attached to the first anchor receiver, maintained in a deformed position by shaft engagement and moving toward a resting position upon disengagement. Khairkhahan teaches: passive tissue-engaging members and barbs associated with annular anchor regions, resilient frame/strut structures, and delivery-dependent constrained/released configurations. See paras. 101–102, 131–138, 157, 159, 228, 316.
It would have been obvious to implement a resilient lance-like stabilizer attached to an anchor-receiver region, temporarily constrained by the shaft during delivery and released to a resting position after disengagement, because this is a predictable use of a biased resilient tissue-engaging structure in a catheter-delivered implant.
Claim 19 recites barbs dimensioned to penetrate only partway through the first leaflet. Khairkhahan discloses leaflet-engaging barbs/leaflet anchor sites in different numbers, locations, and configurations for engaging leaflet tissue. See paras. 134–138.
It would have been obvious to dimension some of the disclosed barbs for partial-thickness penetration to reduce trauma while retaining leaflet engagement, because barb length and penetration depth are routine design parameters in tissue-engaging implant structures.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kahirkhanhan et al. US 11413145 B2, US 11, 759, 321 B2, US 11,622,759 B2, US11,534,302 B2, US 11,497,606 B2, US 11,419,722 B2, US 11,298,229 B2 disclose mitral valve implants with wings and anchors
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAN-UYEN THI HO whose telephone number is (571)272-4696. The examiner can normally be reached Normal Schedule M-F Between 7:00 am and 4:00 pm.
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, TAN-UYEN T HO can be reached at 7034745263. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
Prosecution Insights