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 .
Allowable Subject Matter
Claim 3 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art is De Bonis et al. (Pub. No.: US 2020/0163757; note the same application is published on 11/22/2018 as PCT/IB2018/053074) in view of Goldfarb et al. (Pub. No.: US 2010/0022823) and Metchik et al. (Pub. No.: US 2019/0209293), as applied below, however, the combination of references fails to fairly teach or suggest the wire winding as detailed in claim three, specifically wherein said enters in said proximal annular portion, crosses axially said central annular portion in said first direction, runs radially outwards and it is fixed to said slider, turns around an outer pin that hinges an end of an arm of said second plurality of arms to an arm of said fourth plurality of arms, runs radially inwards, crosses axially said central annular portion in said second direction and then exits from said proximal annular portion. The control wires of Goldfarb and Metchik do not turn around an outer pin that hinges an end of the an arm of the second plurality of arms to an arm of the fourth plurality of arms. Instead, the control wires have a direct path between the gripper and the central shaft of the leaflet clip devices, without extending radially outwards.
Drawings
Figures 1-6B should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-7 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 states, in relevant part, “said central annular portion defining a through hole for letting said proximal annular portion pass through.” However, only the screw passes through the central annular portion through hole. Because the “proximal annular portion” includes both the collar and the screw, this limitation is indefinite. Examiner suggests amending the claim to recite ---for letting said screw pass through--- or some equivalent to overcome this rejection.
Likewise, the limitation “to an expanded configuration, in which said proximal annular portion is threaded throughout said central annular portion and is engaged with said distal annular portion” is indefinite as the proximal annular portion includes both the collar and the screw, whereas only the screw is threaded to the central and distal annular portions.
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.
Claims 1, 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over De Bonis et al. (Pub. No.: US 2020/0163757; note the same application is published on 11/22/2018 as PCT/IB2018/053074) in view of Goldfarb et al. (Pub. No.: US 2010/0022823).
De Bonis et al. (hereinafter, De Bonis) discloses an articulated prosthesis for a tricuspid or a mitral valve (abstract), comprising:
a distal annular portion 6, a central annular portion 7 and a proximal annular portion 8;
a first plurality of arms 10 hinged to an outer side surface of said distal annular portion 6;
a second plurality of arms 11 hinged to an outer side surface of said proximal annular portion 8;
a third plurality of arms 12 each of which is hinged to an outer side surface of said central annular portion, from one end, and to a corresponding end of an arm of said first plurality, from an opposite end (e.g., fig. 5, 6A);
a fourth plurality of arms 13 each of which is hinged to an outer side surface of said central annular portion, from one end, and to a corresponding end of an arm of said second plurality, from an opposite end (e.g., fig. 5, 6A);
said distal annular portion 6 having an internal screw thread 14, said proximal annular portion 8 having:
- a cylindrical collar on a side surface of which said second plurality of arms is hinged (e.g., fig. 5, 6A), and
- a screw 9 engaged into said collar and supported thereby so as to be free to rotate along a longitudinal axis of the screw, the screw being configured to engage with said internal screw
said central annular portion defining a through hole for letting said proximal annular portion pass through (as best understood by examiner, e.g., fig. 7A);
the articulated prosthesis being movable from a distended configuration, in which all said arms hinged in correspondence of their ends are distended (e.g., fig. 4, 5), to an expanded configuration, in which said proximal annular portion is threaded throughout said central annular portion (e.g., fig. 7A) and is engaged with said distal annular portion (e.g., fig. 7A), the arms of said third plurality and fourth plurality being configured to hold therebetween leaflets of a tricuspid or mitral valve (e.g., abstract),
wherein
said arms of said third plurality and/or of said fourth plurality are equipped with sliders, each slider of said sliders being configured to be suspended between a respective pair of said arms of said third plurality and/or of said fourth plurality and to slide back and forth along said respective pair of arms in a radial direction of said articulated prosthesis when the prosthesis is in said expanded configuration;
each slider of said sliders has a catching surface configured to grasp by friction leaflets of a tricuspid or mitral valve, and has a respective wire fixed thereto and configured to pull said slider radially outwards, when the wire is pulled in a first direction, and to pull said slider radially inwards, when the wire is pulled in a second direction opposite to said first direction; and
said proximal annular portion being equipped with a holding mechanism configured to hold pulled said wire (not disclosed).
Goldfarb teaches a leaflet tissue grasping implant with arms 16, 18 that grip leaflet tissue. Goldfarb teaches arms 16 and 18 are equipped with sliders 154, each slider of said sliders being configured to be suspended between a respective pair of said arms (e.g., fig. 16) and to slide back and forth along said respective pair of arms in a radial direction of said articulated prosthesis when the prosthesis is in said expanded configuration (e.g., fig. 16, para. 101);
each slider of said sliders has a catching surface 154 configured to grasp by friction leaflets of a tricuspid or mitral valve (e.g., para. 101), and has a respective wire 152 fixed thereto and configured to pull said slider radially outwards, when the wire is pulled in a first direction, and to pull said slider radially inwards, when the wire is pulled in a second direction opposite to said first direction (para. 101, the wire is advanced and retracted); and a holding mechanism 150 configured to hold pulled said wire (e.g., para. 101, Examiner notes that while not expressly described, Goldfarb includes some means of holding the wire in order to functionally advance and retract the slider).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have included sliders as taught by Goldfarb in between the third and fourth arms of De Bonis for the purpose of providing secondary grasping and movement of the leaflet to better address cardiac valve regurgitation. This modification would have occurred using known methods and would have yielded predictable results.
For claim 4, De Bonis and Goldfarb teach the articulated prosthesis of claim 1, wherein each slider of said sliders has a surface with teeth configured to grasp a leaflet of a tricuspid or mitral valve (Goldfarb, e.g., jaws, para. 101).
For claim 5, Goldfarb teaches the articulated prosthesis of claim 1, wherein said sliders are in the form of a plate having a surface with a knurling (not taught) configured to grasp by friction a leaflet of a tricuspid or mitral valve (Goldfarb, e.g., clamps, para. 101), however, does not specify the plate has a knurled surface. De Bonis teaches knurling 15 as a leaflet gripping mechanism (e.g., para. 38). It would have been obvious to have provided knurling as the griping on the sliders as an obvious expedient to grasp the leaflets with suitable grip. This modification would have occurred using known methods and would have yielded predictable results.
For claim 6, De Bonis discloses the articulated prosthesis of claim 1, wherein the number of said arms of said second plurality and third plurality is twice the number of arms of said first plurality and fourth plurality, each arm of said fourth plurality is hinged together with two arms of said second plurality at said opposite end, each arm of said third plurality is hinged together with two arms of said first plurality at said opposite end (e.g., fig. 7A).
For claim 7, De Bonis discloses the articulated prosthesis of claim 1 for a tricuspid valve, wherein each of said pluralities of arms comprises three arms or an integer multiple of three arms (e.g., fig. 7A).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over De Bonis et al. (Pub. No.: US 2020/0163757; note the same application is published on 11/22/2018 as PCT/IB2018/053074) in view of Goldfarb et al. (Pub. No.: US 2010/0022823), as applied above, further in view of Metchik et al. (Pub. No.: US 2019/0209293).
De Bonis in view of Goldfarb is explained supra, however, the combination lacks specific disclosure that the holding mechanism comprises: an element with a slit fixed to said cylindrical collar, said element with the slit being placed to intercept a path along which said wire is disposed, wherein said wire is held pulled when both its terminations are forcibly inserted in said slit. Metchik teaches gripper control wire 2302 on a heart valve clip, where the gripper control wire 2302 is held pulled via an element 615 with a slit 2417 located on a cylindrical collar (e.g., fig. 23, 24, para. 139, 140). The Metchik gripper is fully capable of holding both terminations of a wire loop. It would have been obvious to one of ordinary skill in the art to have modified De Bonis and Goldfarb to include a holding mechanism as taught by Metchik as an obvious expedient to control the advancing and retracting of wire 152. This modification would have occurred using known methods and would have yielded predictable results.
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774