DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/22/2026 and 8/21/2026 has been entered.
Response to Arguments
Applicant’s arguments, see page 6, filed 7/22/26, with respect to the 112 rejections, have been fully considered and are persuasive. The 112 rejections have been overcome by the amendments to the claims.
Applicant's arguments filed 7/22/2026 have been fully considered but they are not persuasive. Applicant argues that the cited art fails to teach reshaping cardiac tissue by moving the cylindrical member away from the central ring. The amendments fail to distinguish over the previous combination of Bloom and Fitz, so the rejections have been maintained. Bloom is relied upon for teaching a method of reshaping annular cardiac tissue by moving three tissue engaging features radially inwardly. Fitz is relied upon for teaching an umbrella-like mechanism having a cylindrical member and linkages coupled to tissue engaging features of an implant, wherein moving the cylindrical member (24) moved away from a central ring (20) from which the legs extend results in radially inward movement of the tissue engaging members (16).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over USPAP 2007/0093869 (Bloom et al.) in view of WO 00/07521 (Fitz).
Regarding claims 1, 11 and 19: Bloom discloses an implantable device (110) having three struts (112) arranged circumferentially about a central ring (111), wherein each strut (112) has a tissue-engaging feature (117) at a second end (see Figure 1 and [0022]) arranged and configured for engagement with annular cardiac tissue (see heart valve 205 in Figures 9-13 [0038]). Portions of the struts (112) move radially inwardly from an expanded configuration (Fig. 1, 8 and 10) to a contracted configuration of Figures 2 and 13 [0045]. The tissue-engaging features (117) are engaged with the cardiac tissue in Figure 12 and subsequently moved radially inwardly in Figure 13 [0045] to thereby reduce the circumference of the annular cardiac tissue (abstract; [0031]).
Bloom fails to disclose a cylindrical member that is axially moveable relative to the central ring and that holds the cardiac tissue in the reshaped configuration, and wherein the engaging/securing member is coupled to each of the tissue-engaging features (112/117) by a linkage.
Fitz discloses another device in Figures 1 and 2 adapted to be deployed in the cardiovascular system (page 7) that comprises a plurality of expandable arms (16) pivotally extending from a central ring (20). Fitz teaches that movement of the tissue engaging members (14) can be controlled by a well-known umbrella design (page 6, lines 5-20), which comprises a cylindrical member (24) slidable along the central axis of a central support (12) and a plurality of linkages (26) coupled to both the cylindrical member (24) and arms (16). Moving the cylindrical member (24) along the central axis of a central support (12) in a direction away from the central ring (20) moves the tissue engaging members (14) radially inwardly from expanded configuration of Figure 2 to a compressed configuration of Figure 1. Fitz teaches that this control mechanism provides the operator the ability to manually control the expansion of the arms in order to achieve a desired expanded diameter. Bloom also comprises a relatively movable central wire (128) received in the central passage (111) of the device (110) that is configured to aid in controlling deployment of the device [0037]. One of ordinary skill in the art at the time the invention was made would therefore have found it obvious to incorporate the slider and linkages taught by Fitz with the Bloom device to provide an operator manual control over the precise diameter of radial expansion and contraction of the arms, which allows the implantable device to be adapted for a variety of differences in patient anatomy. The modification involves a combination of known vascular devices according to known methods that obtains a predictable result of a device having a plurality of radially extendable and contractible arms. Additionally, the engaging member taught by Fitz is capable of performing the function of holding the cardiac tissue in the reshaped configurations.
Further in regard to claim 11 and 19, the central ring (111) of Bloom is located at the distal end of the implant and the tissue engaging features (117) are at the distal end. The cylindrical member (24) taught by Fitz is disposed “adjacent to” the distal end in the expanded position of Figure 2 and moves in a proximal direction away from the ring (20) to bring the struts together to the position of Figure 1.
Regarding claims 2-5 and 13, Fitz teaches the cylindrical member (24) is slidable towards the tissue engaging members (free ends of legs 16) to contract the legs radially inwardly and hold the device and corresponding tissue in a reshaped/ contracted configuration (Fig. 1).
Regarding claim 6, both Bloom and Fitz disclose one end of the struts are coupled together circumferentially via the central ring (111; ring 20 of Fitz).
Regarding claim 5 and 16, the struts (112) of the modified Bloom device move radially inwardly along different radial directions relative to the longitudinal axis which are orthogonal to each other (see also struts 16 of Fitz).
In regard to claim 7, Bloom discloses that the legs are coupled to the central ring (111) in a spaced manner (see especially Fig. 1; [0022]).
Regarding claim 8, Bloom discloses a contracted delivery state in a catheter wherein the arms are parallel to one another (see Figure 7; [0036]).
Regarding claims 9-10 and 15, Bloom discloses the tissue-engaging features (117) comprise barbs/hooks positioned on struts (112).
Regarding claim 17, the securing member (slider 24 taught by Fitz) is coupled with the implantable member.
Claim 18 merely recites an intended use of the device that is not given full patentable weight. The Bloom teaches a contracted configuration of tissue and Fitz teaches that the contracted position may be achieved by the securing member (slider 24).
Further regarding claim 19, Bloom discloses a delivery catheter in combination with the features of the implantable device above.
Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bloom et al. in view of Fitz, as applied to claim 19 above, and further in view of USPAP 2004/0220593 (Greenhalgh).
Bloom fails to disclose the delivery shaft is threadably coupled with the implantable device. Greenhalgh is in the same field of endeavor, disclosing an implantable device with contracting legs (12/14) that draws cardiac tissue radially inwardly. Greenhalgh teaches the concept of coupling the implantable device with a shaft (32) of the delivery catheter via threads (28/30), such that the shaft is selectively disengaged from the implantable device after the desired implantation configuration is achieved [0038]. One of ordinary skill in the art before the invention was made would have found it obvious to threadably couple the modified Bloom implant to a shaft of the delivery device, as taught by Greenhalgh, as the modification merely involves a combination of known delivery devices that obtains a predictable result of a selectively detachable coupling between an implant and delivery device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. USPAP 2012/0083804 and USPAP 2006/0195123 disclose devices having a plurality legs that are brought together by a cylindrical member that slides away from a central member to which the legs are connected.
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 SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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