DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 01/20/2026 have been fully considered but they are not persuasive. The amendments have raised new issues under 112(b) and new prior art rejections are made to address the new limitation of linkages.
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 1-18 are 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.
Claim 1 now recites “an engaging member” moveable with respect to said central ring and coupled to each of the three or more tissue-engaging features with a linkage.” The use of the term “engaging member” in combination with linkages connecting it to the tissue-engaging features renders the claim indefinite, as Applicant has used the term “engaging member” to describe the ring-shaped member 510 of Figure 5B [0034]. This ring-shaped member 510 is not disclosed as being coupled to the members with linkages. Rather, the “slider” (140) is coupled to each of the three or more tissue-engaging members with a linkage (140) [0020]. Therefore, claims 1-10 are rendered indefinite, as it is unclear what structure is being claimed with the term “engaging member.”
Claim 11 now recites “a securing member coupled to the tissue-engaging features with a linkage and axially moveable with respect to said central ring to retain a configuration of the cardiac tissue…” The use of the term “securing member” in combination with linkages connecting it to the tissue-engaging features and the function of retaining a configuration renders the claim indefinite, as Applicant has used the term “securing member” to describe the ring-shaped member 510 of Figure 5B [0034]. This ring-shaped member 510 is not disclosed as being coupled to the members with linkages. Rather, the “slider” (140) is coupled to each of the three or more tissue-engaging members with a linkage (140) [0020]. Therefore, claims 11-18 are rendered indefinite, as it is unclear what structure is being claimed with the term “securing member.”
Regarding claim 17, the phrase “securing member is coupled with said implantable member” appears to be redundant.
Regarding claim 18, the recited function of retaining a contracted tissue configuration renders the claim indefinite, as the specification does not disclose that the slider (140) connected to linkages (150) performs this function. Rather, Applicant described the ring-shaped member 510 of Figure 5B as performing this function [0034].
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 an engaging/securing 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 toe ach 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 an expansion control mechanism for moving the arms from a compressed configuration of Figure 1 to an expanded configuration of Figure 2, wherein the mechanism a slider (24) slidable along the central axis of a central support (12) and a plurality of linkages (26) coupled to both the slider and arms (16). Fitz indicates this type of control mechanism is similar to a well-known umbrella design (page 6, lines 5-20). 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.
Regarding claims 2-5 and 13, Fitz teaches the engaging/securing 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. 1-2).
Regarding claim 6, both Bloom and Fitz disclose one end of the struts are coupled together circumferentially via the central ring (111) (see 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 regards 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).
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 fond 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
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.
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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