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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1 and 4-20 is/are pending. Claim(s) 13 and 15-20 is/are withdrawn. Claim(s) 2-3 is/are canceled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/18/2026 has been entered.
Response to Arguments
Applicant's arguments filed 5/18/2026 have been fully considered but they are not persuasive.
With respect to claim 1, Applicant repeats the arguments presented 4/2/2026 and responded to by the Examiner on 4/9/2026. Applicant argues the prior art fails to teach "the treatment device includes … a plurality of piercing elements, connected to the anchoring structure and having sharp tips pointing toward the clamping structure, the sharp tips being configured to pierce into the annulus of the native valve in the deployed state" (Response on 5/18/2026, herein "Response", pages 2-4).
In response to the 4/9/2026 Advisory Action (herein "Advisory Action"), Applicant argues the modification of Li as proposed in the Office action would prevent Li from functioning properly (Response, page 4). Applicant argues the piercing elements of Oba would have to be added to the underside of Li's portion #1 (Response, page 4) and that this position would necessarily cause damage beyond piercing (Response, pages 5-6).
Annotated Figures 6 and 13 noted in the following are found below in the prior art rejection section.
Oba's cited Figures 12-13 shows locations of the piercing elements. When added to Li, they will be located on anchoring element #1 of Li (e.g. annotated Figure 6 below). Further, each piercing element has two sharp tips (e.g. Oba, annotated Figure 13 below, arrows point to sharp tips), one of which is "toward the clamping structure" as required by the claim when combined (e.g. Li, annotated Figure 6 below). When the piercing element is placed as shown in annotated Figure 6 below of Li, the piercing element enters the tissue and is pushed in place, but would not further scrape or tear the tissue. Thus, there is a location on Li's anchor that allows for anchoring without unnecessary tissue trauma and the piercing element has a sharp tip pointing toward the clamping structure. Therefore, Applicant’s arguments are not persuasive.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li, et al (Li) (US 2020/030083 A1) in view of Oba, et al (Oba) (US 2016/0310268 A1).
Regarding Claim 1, Li teaches a native leaflet treatment system (e.g. abstract) for treating native leaflets of a native valve of a heart (e.g. abstract), comprising:
a delivery apparatus (e.g. abstract, #9), including a sheath (e.g. [0028], tube), configured to be inserted into the heart (e.g. Figures 4-6); and
a native leaflet treatment device (e.g. Figure 6, abstract, #10), having a compressed state for delivery (e.g. [0028]) and a deployed state (e.g. Figure 6, [0029]), wherein in the compressed state, the treatment device is compressed and stored inside the delivery apparatus (e.g. [0028]), and in the deployed state, the treatment device is expanded (e.g. Figure 6, [0029]),
wherein the treatment device includes:
a clamping structure (e.g. Figures 1 and 4-6; annotated Figure 4 below, between two dashed lines), and wherein in the deployed state, the clamping structure is configured to capture and retain at least a portion of the native leaflets (e.g. Figure 6);
an anchoring structure (e.g. Li, Figures 1 and 4-6, #1); and
a plurality of connecting bridges (e.g. Li, #s 2) connecting the clamping structure and the anchoring structure (e.g. Li, Figures 4-6),
wherein the anchoring structure is connected at first ends of the connecting bridges (e.g. Li, Figures 4-6), and wherein in the deployed state, the anchoring structure is configured to abut an annulus of the native valve (e.g. Li, Figures 4-6).
Li discloses the invention substantially as claimed but fails to teach the delivery apparatus having a tip separate from the sheath and a plurality of piercing elements, connected to the anchoring structure and having sharp tips pointing toward the clamping structure, the sharp tips being configured to pierce into the annulus of the native valve in the deployed state.
Oba teaches a delivery system for a heart valve treatment device (e.g. Figure 4), having a sheath (#205), a tip (#210), and a guidewire (e.g. [0087]).
Oba further teaches a treatment device further includes a plurality of piercing elements (e.g. Figures 12-13, [0103]), connected to the anchoring structure (e.g. Figures 12-13) and having sharp tips (e.g. Figures 12-13, [0103]) pointing toward the clamping structure (e.g. Figure 13), the sharp tips being configured to pierce into the annulus of the native valve in the deployed state (e.g. [0103]).
Oba and Li are concerned with the same field of endeavor as the claimed invention, namely heart valve repair devices delivered in compressed configurations by a delivery system.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Li such that there are piercing elements as taught by Oba in order to position and secure the prosthesis in the native heart valve region (e.g. Oba, [0013], [0103]) and such that the delivery system includes the tip and guidewire as taught by Oba as it is combining prior art elements according to known methods to yield predictable results (MPEP 2143(I)). Here, the results are predictable because each claimed element performs in the same manner in the combination as it does separately. Specifically, the guidewire provides a small diameter means to guide the delivery device having the treatment device therein to the treatment site and the nose cone provides a tapered and rounded shape at the leading end of the delivery/treatment system to provide an atraumatic surface in the event of pushing into tissue along the way to the treatment site.
For the combination and the piercing elements, Oba's cited Figures 12-13 show locations of the piercing elements. When added to Li, they will be located on anchoring element #1 of Li (e.g. annotated Figure 6). Further, each piercing element has two sharp tips (e.g. Oba, annotated Figure 13 below, arrows point to sharp tips), one of which is "toward the clamping structure" as required by the claim when combined (e.g. Li, annotated Figure 6 below). When the piercing element is placed as shown in annotated Figure 6 below of Li, the piercing element enters the tissue and is pushed in place, but would not further scrape or tear the tissue. Thus, there is a location on Li's anchor that allows for anchoring without unnecessary tissue trauma and the piercing element has a sharp tip pointing toward the clamping structure.
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Annotated Figure 4, Li
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Annotated Figure 13, Oba
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Annotated Figure 6, Li
Regarding Claim 4, the clamping structure, the anchoring structure and the connecting bridges are formed of a shape memory material (e.g. Li, Figures 4-6, [0027], #10 is made of a shape memory material).
Regarding Claim 5, the treatment device further includes a plurality of proximal locking members joined to the anchoring structure (e.g. Li, Figure 1, #s 7, [0026]) and configured to be detachably coupled to the sheath of the delivery apparatus when the treatment device is stored in the delivery apparatus (e.g. Li, [0026]).
Regarding Claim 6, the treatment device further includes a plurality of distal locking members joined to the clamping structure (e.g. Li, Figure 1, #s 8, [0026]) and configured to be detachably coupled to the tip of the delivery apparatus when the treatment device is stored in the delivery apparatus (e.g. Li, [0026]).
Regarding Claim 7, the plurality of proximal locking members are respectively joined to upper points of the anchoring structure (e.g. Li, Figure 1), and the plurality of distal locking members are respectively joined to lower points of the clamping structure (e.g. Li, Figure 1).
Regarding Claim 8, the plurality of proximal locking members are respectively joined to upper points of the anchoring structure (e.g. Li, Figure 1), wherein the treatment device further includes a plurality of legs (e.g. Li, annotated Figure 4 above, between the dotted line and the adjacent dashed line as labeled), wherein each leg is joined at its upper end to an upper point of the clamping structure (e.g. Li, annotated Figure 4 above) and bends downwardly in the deployed state (e.g. Li, annotated Figure 4 above), and wherein the plurality of distal locking members are respectively joined to lower ends of the plurality of legs (e.g. Li, annotated Figure 4 above; Figure 1).
Regarding Claim 9, each of the clamping structure and the anchoring structure is formed of connected struts (e.g. Li, Figure 1), and wherein in the deployed state, each of the clamping structure and the anchoring structure forms an undulating structure (e.g. Li, Figure 1), each connecting bridge is connected to a lower point of the undulating structure of the anchoring structure (e.g. Li, Figures 1-2, as broadly claimed the connection is made via intervening struts) and a lower point of the undulating structure of the clamping structure (e.g. Li, Figures 1-2, as broadly claimed the connection is made via intervening struts), and both the clamping structure and the anchoring structure extend upwardly and outwardly from the respective lower points where they are joined to the connecting bridges (e.g. Li, Figure 6).
Regarding Claim 10, in the deployed state, the anchoring structure forms an angle between 0 and 75 degrees with respect to a horizontal plane of the treatment device (e.g. Li, Figure 6, the portion of #1 directly connected to #2 is flat and thus at 0 degrees relative to a horizontal plane of the treatment device, where the horizontal plane of the treatment device is considered that perpendicular to the longitudinal axis of the treatment device; the longitudinal axis of the Li device being top-bottom on the page for Figure 6).
Regarding Claim 11, the treatment device is formed of a plurality of repeating units connected to each other and arranged in an angular direction around an longitudinal axis of the treatment device (e.g. Li, Figure 1).
Regarding Claim 12, in a top view in the deployed state, the treatment device has an open shape forming an incomplete ring around the longitudinal axis (e.g. Li, Figure 3).
Regarding Claim 14, the delivery apparatus further includes a wire which passes through the sheath (guidewire from Oba in the combined device as discussed supra for claim 1) and is connected at its distal end to the tip of the delivery apparatus (e.g. Oba, [0087], distal is toward the nosecone, Figure 4 shows the distal end of the guidewire is located at the nosecone as described in [0087]).
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JERRAH EDWARDS can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 7/24/2026
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