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 .
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.
Response to Amendment
The amendment filed 07/29/2026 has been entered. Claims 1, 4-9, 10, 13-17, and 19-20 are pending in the application. Claims 8 and 18 have been cancelled. Claims 10 and 13-20 remain withdrawn from the application. Claims 22-24 have been added.
Response to Arguments
Applicant's arguments regarding claim 1 filed 07/29/2026 have been fully considered but they are not persuasive. Applicant’s arguments regarding claim 21 have been deemed persuasive, and claim 21 is deemed allowable.
Upon further examination of the prior art, the Examiner disagrees that the amendment to claim 1 overcomes the previous prior art. Regarding Applicant’s arguments that the addition of “configured for transseptal delivery” overcomes the previous rejection, the Examiner respectfully disagrees. This claim is an apparatus claim, so functional language is not given full patentable weight. The device is only required to be capable of said functional language. Since the device is sized to be delivered to the heart using a transapical approach (see paragraph [0040]), the device of the prior art would be capable of being delivered transeptally. The Examiner recommends distinguishing over prior art by reciting a structural feature.
Lastly, regarding Applicant’s arguments that the addition of “a second grasping component disposed distal to the first grasping component” overcomes the previous rejection, the Examiner respectfully disagrees. The second grasping component, being component 122, allows range of relative movement between the grasping component and the valve component (see paragraph [0111]). It is additionally disclosed that the coupling component can be coupled to the lower portion 152 of the grasping component (see paragraph [0111]). Since the connection allows free movement of the two components, the device is capable, upon movement into a certain position, that a portion of the second grasping component being a long flexible coupler component, could be “disposed distal to” the first grasping component.
Claim Objections
Claims 1 and 21 are objected to because of the following informalities: the preamble of both claims 1 and 21 first recite “a grasping device” in line 1 and subsequently recite “the device” in line 4. The Examiner recommends amending “the device” to “the grasping device” for consistency. 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.
Claims 1, 4-6, 9, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170128203 A1 (hereafter --Zhang--).
Regarding Claim 1, Zhang discloses a grasping device (120) configured for transseptal delivery (the device is capable of being delivered transeptally in at least some patient) for securing a leaflet component of a native mitral valve, wherein the leaflet component comprises a leaflet and chordae tendineae associated with the leaflet (see paragraph [0091]), the device comprising: a) a first grasping component (see annotated first grasping component in Figure 5 below) configured to grab chordae tendineae of said leaflet component of a native mitral valve (see paragraph [0091]); b) an actuator (395c) operatively coupled to the first grasping component (see delivery system 300 and actuator 392c in Figure 11B and 11C below, see also paragraph [0133] denoting distal end of each of the anchor control sleeves 395a, 395b, and 395c can enclose or be coupled to a hook of the anchoring element 304, see also paragraph [0130] denoting that the delivery system 300 could deliver a prosthetic valve 302 that is the same as prosthetic valve 100), wherein the actuator is configured to actuate movement of the first grasping component to grab the chordae tendineae (see paragraph [0138] denoting that the hooks of the anchoring element 304 can be releasably or reversibly connected to an anchor control sleeve 395a, 395b, and c (e.g., a hook is enclosed by an anchor control sleeve 395a, 395b, and 395c) and the physician can move the anchoring element 304 along either the rotational or longitudinal axis in order to properly position the anchoring element 304 within the native valve annulus prior to positioning and releasing the valve component) c) a second grasping component disposed distal to the first grasping component (See paragraph [0111] denoting that component 122 allows range of relative movement between the grasping component and the valve component, and that the coupling component can be coupled to the lower portion 152 of the grasping component. Since the connection allows free movement of the two components, the device is capable, upon movement into a certain position, that a portion of the second grasping component being a long flexible coupler component, could be “disposed distal to” the first grasping component) configured to anchor the leaflet component to a prosthetic component (see paragraph [0113], see also annotated second grasping component in Figure 5 below), wherein the prosthetic component is independent of the grasping device (see annotated stent in Figure 5 below, see also paragraphs [0111] and [0113]) and is configured to be delivered separately from the grasping device (see paragraph [0011] denoting the valve and the anchoring element 120 can be completely separate from one another, see paragraph [0124] saying that the anchoring element and the valve can be delivered in two separate operations).
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Regarding Claim 4, Zhang discloses the device of claim 1, wherein the second grasping component comprises a hook to grasp the prosthesis (see paragraph [0113]). The term “hook” is being given its broadest reasonable interpretation, and is being interpreted under the definition “a curved or bent device for catching, holding, or pulling” (see Merriam Webster online, definition 1a). The sutures of the connecting portion 122 are “curved or bent” for holding, catching, and pulling as they connect the two components together.
Regarding Claim 5, Zhang discloses the device of claim 4, wherein the hook to grasp the prosthesis further comprises a prosthesis hook actuator and a second detachment region (see annotated prosthesis hook actuator and first detachment region in Figure 11B and 11C above, see also paragraph [0130] denoting that the delivery system 300 could deliver a prosthetic valve 302 that is the same as prosthetic valve 100), wherein the hook is actuated by the prosthesis hook actuator, wherein the hook to grasp the prosthesis, upon anchoring to the prosthetic component, detaches from the prosthesis hook actuator at the second detachment region (see Figures 11B and 11C above, denoting that the hooks that attach the grasping device and the stent are “actuated once the stent is released from the cone 330, as the stent goes into the grasping device upon release).
Regarding Claim 6, Zhang discloses the device of claim 1, wherein the first grasping component comprises a grasping arm (see annotated grasping arm in Figure 5 below) comprising a memory wire disposed lengthwise and attached to a surface of the arm (see annotated memory wire in Figure 5 below, see also paragraph [0091] denoting the entire hook 200 is made of shape memory material, the arm therefore comprising “a memory wire” as that is what the entire hook is made out of, the wire being the annotated piece of wire that connects the two pieces of the hook at the tip), wherein the arm is configured to transition from a non-extended state to an extended state to a grasping state (see paragraph [0091] denoting “the hook 200 can expand toward the chordae tendineae during valve prosthesis delivery, their design with shape memory metal allows them to expand and hook between and/or around the chordae tendineae. Optionally, the hooks of the lower support 152 can be pulled toward the chordae tendineae during valve prosthesis delivery, their design with shape memory metal allows them to expand and hook between and/or around the chordae tendinea”, illustrating that the hooks are able to transition from different shapes and angles due to the shape memory material they are made out of).
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The limitation “wherein transitioning from the extended state to the grasping state comprises pulling the memory wire to curl the grasping arm such that a first end meets or overlaps a second end of the grasping arm” is given limited patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. Since it is explicitly discloses that the hook 200 (comprising of the grasping arm and memory wire) can be pulled toward the chordae tendineae during valve prosthesis delivery, as its design with shape memory metal allows it to expand and hook between and/or around the chordae tendinea (see paragraph [0091]), the grasping arm is able to be pulled on by the memory wire to curl the arm such that the first end meets or overlaps the second end of the arm.
Regarding Claim 9, Zhang discloses the device of claim 8, further comprising a second slide lock adapted to slide between a locked position and an unlocked position along the device (see annotated second slide lock 140 (skirt) in Figures 5 and 6 above, see also paragraph [0094] denoting that 140 is a “skirt”, see paragraph [0104] denoting that the skirt acts as a lock between the two “subassemblies”, meaning the stent and the grasping device), wherein the locked position closes the hook to grasp the prosthesis (see paragraph [0104] denoting that the skirt 140 acts as a lock that locks the anchor (grasping device) to the valve), and wherein the unlocked position allows the hook to grasp the prosthesis to anchor the native mitral leaflet component to the prosthetic component (see paragraph [0104] denoting that elasticity from both the fabric and the native tissue lets the hooks slip into their intended anchor points and then rebound to lock in place).
Regarding Claim 24, Zhang discloses the device of claim 1, wherein the prosthetic component is a stent that is independent of the grasping device (see annotated stent in Figure 5 below, see also paragraphs [0111] and [0113], see also paragraph [0011] denoting the valve and the anchoring element 120 can be completely separate from one another, see paragraph [0124] saying that the anchoring element and the valve can be delivered in two separate operations).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over US 20170128203 A1 (hereafter --Zhang--), as applied to claim 6 above, and further in view of US 20200078002 A1 (hereafter -- Hacohen-).
Regarding Claim 7, Zhang discloses the device of claim 6.
Zhang fails to disclose a first slide lock adapted to slide between a locked position and an unlocked position along the device, wherein the unlocked position of the first slide lock permits the arm to transition from the non-extended state to the extended state, wherein the locked position of the first slide lock keeps the arm in the non-extended state or the grasping state.
Hacohen discloses a grasping device (see grasping device 80 in Figure 11D below) for securing a leaflet component of a native mitral valve (see paragraph [0480]), wherein the leaflet component comprises a leaflet and chordae tendineae associated with the leaflet (see annotated leaflet and chordae in Figure 11D below), the device comprising: a) a first grasping component configured to grab chordae tendineae of said leaflet component of a native mitral valve; and b) a second grasping component configured to anchor the leaflet component to a prosthetic component (see annotated second grasping component in Figure 11D below, see also paragraph [0534] denoting that barbs or hooks can protrude from the grasping device and into the prosthesis 40 to facilitate coupling). Hacohen teaches further comprising a first slide lock adapted to slide between a locked position and an unlocked position along the device (see locked and unlocked positions and first slide lock in Figures 5B and 5D below). The word “slide” is being given its broadest interpretation by interpreting the term to mean “to change position.”
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the device further comprise a first slide lock adapted to slide between a locked position and an unlocked position along the device, as taught by Hacohen, as by doing so would further anchor and/or provide sealing for the prosthetic valve (see paragraph [0496]) to the native valve, as well as would seal the arm of the grasping component if applied onto it, as it is taught by Hacohen that the slide locks are closed such that what is within the locks are grasped and sealed by the slide locks (106a, 106b) (see paragraph [0494]).
The limitation “wherein the unlocked position of the first slide lock permits the arm to transition from the non-extended state to the extended state, wherein the locked position of the first slide lock keeps the arm in the non-extended state or the grasping state” is treated as functional language, that is given limited patentable weight. The prior art is not required to disclose this function, but merely have the capability of performing the recited function. As modified, the device of Zhang discloses a grasping arm and a memory wire attached. The first slide lock can be placed on top of the grasping arm so that when the lock is unlocked (see Figure 5B above), the two arms (and therefore the two ends of the grasping arm) of the lock are able to be opened, making the ends of the grasping arm to be extended away from each other, which can be considered “permitting” movement of the arm from an “non-extended state” to an “extended state.” When the lock is in the locked configuration (see Figure 5D above), the arms of the lock (and therefore the ends of the grasping arms) are pressed together, keeping the arm in the grasping state or non-extended state (depending on if the arms of “grasping” something or not). Therefore, since the grasping arm and slide lock have all the structural features, and since the grasping arm is able to be within the slide lock in Zhang as modified, the position of the lock is able to directly permit the transition and position of the grasping arm as claimed.
Allowable Subject Matter
Claims 21-23 are allowed.
REASONS FOR ALLOWANCE
Regarding Claim 21, the prior art fails to disclose or suggest, in combination with other limitations recited in the claims, wherein the grasping device is configured for transseptal delivery for immobilizing a leaflet component of a native mitral wherein transition from the extended state to the grasping state causes the first grasping arm to curl such that a first end of the grasping arm meets or overlaps a second end of the grasping arm; and c) a second grasping component disposed distal to the first grasping component and configured to anchor the leaflet component to a prosthetic component, after the first grasping component immobilizes the chordae tendineae.
Regarding Claim 21, Zhang discloses a grasping device (120) for securing a leaflet component of a native mitral valve, wherein the leaflet component comprises a leaflet and chordae tendineae associated with the leaflet (see paragraph [0091]), the device comprising: a) a first grasping component (see annotated first grasping component in Figure 5 below) configured to grab chordae tendineae of said leaflet component of a native mitral valve (see paragraph [0091]); b) an actuator (395c) operatively coupled to the first grasping component (see delivery system 300 and actuator 392c in Figure 11B and 11C below, see also paragraph [0133] denoting distal end of each of the anchor control sleeves 395a, 395b, and 395c can enclose or be coupled to a hook of the anchoring element 304, see also paragraph [0130] denoting that the delivery system 300 could deliver a prosthetic valve 302 that is the same as prosthetic valve 100) to grab the chordae tendineae (see paragraph [0138] denoting that the hooks of the anchoring element 304 can be releasably or reversibly connected to an anchor control sleeve 395a, 395b, and c (e.g., a hook is enclosed by an anchor control sleeve 395a, 395b, and 395c) and the physician can move the anchoring element 304 along either the rotational or longitudinal axis in order to properly position the anchoring element 304 within the native valve annulus prior to positioning and releasing the valve component); and c) a second grasping component configured to anchor the leaflet component to a prosthetic component (see paragraph [0113], see also annotated second grasping component in Figure 5 below), wherein the prosthetic component is a stent that is independent of the grasping device (see annotated stent in Figure 5 below, see also paragraphs [0111] and [0113]).
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Zhang fails to disclose wherein the grasping device is configured for transseptal delivery for immobilizing a leaflet component of a native mitral wherein transition from the extended state to the grasping state causes the first grasping arm to curl such that a first end of the grasping arm meets or overlaps a second end of the grasping arm; and c) a second grasping component disposed distal to the first grasping component and configured to anchor the leaflet component to a prosthetic component, after the first grasping component immobilizes the chordae tendineae.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
