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 1/20/2026 have been fully considered but they are not persuasive. The amendments have raised new issues of indefiniteness under 112(b) as set forth below, and therefore were not found to be allowable. New rejections are set forth below accordingly.
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 1-20 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 “moving an annular member … proximally with respect to the central ring…” The claim does not previously define a proximal direction with respect to a component of the implantable device, the patient or the operator. Therefore, any direction in which the annular member is moved meets the claim requirement.
Claim 10 now recites that an “annular member is coupled to each of the three or more tissue-engaging members with a linkage.” The use of the term “annular member” renders the claim indefinite, as Applicant has used this term to describe the ring-shaped engaging member 510 of Figure 5B. This ring-shaped annular 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 10-15 are rendered indefinite, as it is unclear what structure is being claimed with the term “annular member.”
Regarding claim 11, the limitation “engaging the annular member with the implantable device” appears to contradict the limitation in claim 10 that the annular member is coupled to the device. Further the specification does not disclose the slider (140) functions to maintain the reshaped configuration. The ring-shaped engaging member 510 of Figure 5B is disclosed as maintaining the reshaped configuration and is not coupled to the leg members with linkages. Therefore, the combination of claim elements is unclear.
Claim 16 now recites “axially advancing a member of the implantable device…to maintain the reshaped configuration of the cardiac tissue, the member being coupled to the tissue engaging element with a linkage.” The new combination of limitations renders the claim indefinite. The only element disclosed in the specification for performing the function of maintaining the arms (120) in the reshaped configuration of the cardiac tissue is the ring-shaped engaging member 510 of Figure 5B. This ring (510) is not connected to the arms 120 with linkages (140). Rather, the slider (140) is connected to the arms (120) with linkages (140). Claims 16 is indefinite, as it is unclear what structure is being claimed.
Further in regards to Claim 16, the limitation “axially advancing a member of the implantable device…proximally with respect to the central ring…” renders the claim indefinite. The claim does not previously define a proximal direction with respect to a component of the implantable device, the patient or the operator. Therefore, any direction in which the annular member is moved meets the claim requirement.
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 1-9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over USPAP 2007/0093869 (Bloom et al.) in view of US Patent No. 9,398,902 (Paul, Jr. et al.).
Regarding claim 1: Bloom discloses a method of reshaping a valve that involves the deployment of an implantable device (110) having three arms (112) coupled to a central ring (111), wherein each arm 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]). The device is axially controlled by moving it relatively to the delivery catheter (120) [0043]. The device is rotationally controlled by moving portions of the arms (112) radially outwardly/inwardly between three configurations: first contracted configuration (Fig. 7), and expanded configuration (Fig. 1, 8 and 10), and a second 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]). Since the tissue-engaging features grasp the tissue while moving it radially inwardly, this is considered to meet the requirement of “gathering or pushing” the annular cardiac tissue inwardly.
Bloom fails to disclose the step of engaging an annular member with the implantable device to maintain the reduced circumference of the annular cardiac tissue.
Paul discloses another implantable device (22; see Figures 16A-19) having a plurality of legs (210) with tissue-engaging members (213) at the ends (col 7, lines 36-53), wherein the legs are pivotably coupled to a central ring (204) (see description of tubular member having a circular cross-section and a central opening for receiving a guidewire 15; column 11, lines 40-52; Figure 20A-B). The legs (210) are biased to a radially outward expanded position of Figure 16B (col 11, lines 60-67). Similar to the method of Bloom, Paul discloses a method of reducing a circumference of tissue by grasping tissue (see edges of tissue V1 around tissue opening A) with the tissue engaging members (teeth 213) and moving the legs radially inwardly to reduce a circumference of the penetrated tissue (Figures 17-19; column 13, line 35 – column 14). Paul teaches that an annular member (closing member 220) is moved axially over the legs (210) in a proximally direction to radially contract the legs inwardly (and thus the attached tissue) and to maintain reduced circumference of the tissue (col 11, line 65 to col 12; col 13, line 62 – col 13). The direction of axial movement can be considered proximally, as it may be towards a center of the patient’s anatomy. The annular member (220) is engaged with protrusions (215) along the surface of the legs (210) so that the arms can be locked in the closed position of Figure 16B (col 12, lines 6-20). Since both Bloom and Paul are directed towards the concept of moving tissue radially inwardly, one of ordinary skill in the art at the time the invention was made would have found it obvious to combine structures of Paul with the Bloom method. One of ordinary skill in the art would have found it obvious to substitute the slidable annular member (220) taught by Paul for the snap memory shape disclosed by Bloom, wherein the substitution obtains the predictable result of moving the legs radially inwardly. The modification additionally provides the benefit of locking the legs the radial inward position.
Regarding claims 2: Bloom and Paul disclose three tissue engaging members and that the tissue-engaging features grasp the tissue while moving it radially inwardly (see Bloom at [0045]; see teeth 213 of Paul at col 13, lines 20-35), therefore reducing the circumference of the annular cardiac tissue (see description of reducing the “compass” of the tissue in Bloom at the abstract; [0006; 0031]; and closing the opening “A” in tissue at column 13, line 35 – column 14 of Paul; Figure 17-19).
Regarding claims 3, Paul teaches the annular member (220) is moved axially from the position of Figure 16A towards the tissue engaging members (213) to a position of Figure 16B (col 11, line 65 to column 12, line 5).
Regarding claim 4, Bloom discloses the distal ends (117) of the tissue-engaging members (112) are pivotably coupled to the central ring (111) via the length of the members (112). The members pivot radially away from the central ring (111) to engage the cardiac tissue when the device is deployed from the delivery configuration (Figure 7) to an expanded configuration (Figure 8).
Regarding claim 5, the legs (112) of the modified Bloom device are moved radially inwardly (not axially) relatively to the cardiac tissue in order to reshape it. The annular member (220) taught by Paul maintains a reduced circumference by moving it relative to tissue-engaging members.
Regarding claim 6, Bloom discloses the device is moved by a delivery catheter (120) [0043], which is understood to have a control handle for controlling relative movement of the push tube (126) and holding tube (1240). Paul discloses a delivery device (see 232 and 240 in Figures 17-19) comprising relatively moveable components, wherein it is understood in the art to comprise a control handle.
Regarding claims 7-8, Paul teaches that the annular member (220) is moved axially towards the tissue being grasped by the tissue-engaging members (213) (see Figures 16A-B).
In regards to claim 9, the tissue-engaging members (112) extend around and are operably coupled to the central ring member (111/204) of modified Bloom. The step of reducing the circumference of tissue can be performed by moving only the annular member taught by Paul, as it acts to reduce the circumference of tissue by radially moving the legs without axially moving the implantable device.
Claims 10-12 and 14-16 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 10 and 16: Bloom discloses a method of reshaping a valve that involves the deployment of an implantable device (110) having three arms (112) coupled to a central ring (111), wherein each arm 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]). The device is axially controlled by moving it relatively to the delivery catheter (120) [0043]. The device is rotationally controlled by moving portions of the arms (112) radially outwardly/inwardly between three configurations: first contracted configuration (Fig. 7), and expanded configuration (Fig. 1, 8 and 10), and a second 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]). Since the tissue-engaging features grasp the tissue while moving it radially inwardly, this is considered to meet the requirement of “gathering or pushing” the annular cardiac tissue inwardly.
Bloom fails to disclose the implantable device comprises an annular member that is coupled to each of the three or more tissue-engaging members with a linkage, and that the annular member is relative to the central ring to reshape tissue.
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.
In regards to claim 11, the annular member of modified Bloom is engaged with the device in the reshaped configuration.
Regarding claim 12: Bloom discloses 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]).
In regards to claim 14, Paul teaches that the tissue-engaging members (210) move radially inwardly without needing to move the central ring (204) axially, as the tissue-engaging members (210) can be contracted by only moving the annular member (220) axially (See Figures 16A-B; col 11, line 60 to col 12).
Regarding claim 15, Bloom teaches the tissue-engaging features are engaged with circumferentially with respect to cardiac tissue and then the implant is moved to reshape the cardiac tissue.
Regarding claim 17, Bloom discloses tissue-engaging features (117) pierce tissue [0027] and move the tissue when the device is reshaped in Figure 13 [0045].
Regarding claim 18, the annular member (220) of modified Bloom is advanced towards the tissue engaging features (117) at the free ends of the legs (see member 220 moved towards tissue engaging features 213 in Paul), which can be considered the proximal direction as required by claim 16.
Regarding claim 19, although not explicitly stated, reducing the circumference of the annular cardiac tissue would reduce blood flow therethrough (see description of reducing the “compass” of the tissue in Bloom at the abstract; [0006; 0031]).
Regarding claim 20, the legs (112) of the device are moved radially inwardly relative to the cardiac tissue in order to reshape it.
Claims 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bloom et al. in view of Fitz, and further in view of US Patent No. 9,662,205 (Eidenschink).
Bloom and Fitz fail to disclose the step of engaging an annular member with the implantable device to maintain the reduced circumference of the annular cardiac tissue. Eidenschink discloses another device for gathering and securing heart valve tissue (2) that has radially inwardly moving legs (see Figure 5D and 5E). Eidenschink teaches the concept of retaining the legs in the radially inward configuration with a securing ring (130) that is engaged over the legs (see Figures 5F-G) (column 10, lines 35-45). Since both Bloom and Eidenschink are directed towards the concept of gathering tissue radially inwardly, one of ordinary skill in the art at the time the invention was made would have found it obvious to combine the securing ring (130) taught by Eidenschink with the Bloom method, in order to retain the legs and corresponding grasped tissue in a desired radially inward position.
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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