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 .
Claim Objections
Claim 6 is objected to because it includes a reference character (“h”) which is not enclosed within parentheses.
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
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 10 and 11 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.
Claims 10 and 11 are generally unclear. Claim 10 is unclear because no actual method steps are required by the claims. Claim 10 recites “Use of an anchoring device and/or an cardiac valve replacement apparatus in manufacture of a cardiac valve replacement product” and then simply defines what the anchoring device and cardiac valve replacement apparatus comprise. How are the anchoring device and cardiac valve replacement apparatus used to “manufacture” a cardiac valve replacement product? What is the cardiac valve replacement product? Is the cardiac valve replacement product just the anchoring device or the combination of the anchoring device and a prosthetic valve or some other device/product? Additionally, claim 10, line 7 recites “the cardiac valve replacement apparatus comprising the anchoring device and a prosthetic valve”. This makes line 2 unclear since “and” implies using the anchoring device and the anchoring device and heart valve.
Claim 11, lines 1-2 recite “the anchoring device and the prosthetic valve in the cardiac valve replacement product” but such a combination lacks antecedent basis. In other words, claim 10 does not define that the cardiac valve replacement product comprises the anchoring device and the prosthetic valve or that the anchoring device and prosthetic valve are “in” the cardiac valve replacement product.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 5, 7-10, 12, and 13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yang et al. US 2023/0263632 (hereafter referred to as Yang).
Regarding claim 1, Yang discloses an anchoring device 15 for a cardiac valve, the anchoring device comprising a ventricular section (this is directed to where the anchoring device is intended to be placed; fig.2H shows the anchoring device located in the ventricle), the ventricular section comprising an anchoring segment (considered at least the segment anchoring to the chordae and/or native valve leaflets as shown in fig.2H), the anchoring segment in the form of a helical coil (fig.1A), wherein a radius of curvature of the helical coil is constant and a distance between turns of the helical coil is the same (fig.1A), and the anchoring device does not comprise an atrial section (while this is directed to an intended use of the device, Yang does show the anchoring device only located in the ventricle and without an atrial section in at least fig.2H).
Regarding claim 2, see par.30 for shape memory material which is elastic.
Regarding claims 4, 5, and 7, see fig.1B for capture segment 22 having .5 turns and a radius of curvature greater than that of the anchoring segment.
Regarding claims 8 and 9, see figs. 1A and 2H for prosthetic valve 12, 14 having an outflow section, an annulus section, and an inflow section joined sequentially and capable of being received in the internal space defined by the anchoring device 15.
Regarding claim 10, see figs. 1A and 2H which show use of the anchoring device and prosthetic valve to replace a cardiac valve.
Regarding claims 12 and 13, see figs. 2B-2G for a delivery system comprises a delivery sheath 50, a delivery catheter 153, and a connecting member 78 (fig.2G), the delivery catheter nesting in the delivery sheath (fig.2C), the connecting member connected to the delivery catheter (fig.2F; at least before removal of the delivery catheter).
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 3, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Yang as applied to claims 1 and 13 above, and further in view of Patel et al. US 2018/0177594 (hereafter referred to as Patel).
Regarding claim 3, Yang discloses the anchoring device of claim 2 as discussed above, but the embodiment of figs. 1A-2H does not disclose that a surface of the elastic material is provided with a cover layer.
Patel teaches an anchoring device, in the same field of endeavor, wherein a coil anchor device has a cover layer for the purpose of providing high friction between the anchoring device and the valve (par.142).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a cover layer as taught by Patel to the anchoring device of Yang in order to provide greater friction between the anchoring device and prosthetic valve to improve fixation.
Regarding claims 14 and 15, Yang teaches a connecting member/tether 78 attached to the anchoring member but Yang does not disclose the connecting member is a connecting wire, wherein a free end of the anchoring segment is correspondingly provided with a through slot, or wherein the connecting member is a connector, one end of the connector is a threaded end and the other end of the connector is a smooth end, correspondingly, one end of the delivery catheter is provided with a thread matching the threaded end, and wherein the smooth end is adapted to be connected to a free end of the anchoring segment.
Patel teaches an anchoring device, in the same field of endeavor, wherein a connecting member is a connecting wire 1163, and wherein a free end of an anchoring device is correspondingly provided with a through slot 1162 (fig.22A) for the purpose of attaching the anchoring device to a delivery catheter for delivery (par.166; fig.27C). Patel also teaches an embodiment wherein an anchor that can screw into a delivery device is used as a connector to connect the delivery device to a free end of the anchoring device (par.116).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yang and use either the connecting wire and slot or the screw anchor as taught by Patel in order to secure the anchoring device to the delivery catheter of Yang.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Yang as applied to claim 1 above, and further in view of Argento et al. US 2020/0261220 (hereafter referred to as Argento). Yang discloses the anchoring device of claim 1 as discussed above but Yang does not disclose that the anchoring device has a height of 3-20 mm.
Argento teaches an anchoring device, in the same field of endeavor, wherein the height of the anchoring device is 3-6 mm (par.144; figs.31-32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a height of 3-6 mm as taught by Argento for the height of the anchoring device of Yang since Argento teaches this is a suitable height for an anchoring device used for the same purpose and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yang as applied to claim 10 above, and further in view of Weber US 2013/0116779 (hereafter referred to as Weber). Yang discloses the anchoring device of claim 10 as discussed above but Yang does not disclose that the anchoring device and prosthetic valve are implanted through different paths.
Weber teaches an anchoring device and prosthetic valve, in the same field of endeavor, wherein the anchoring device is implanted through the aorta and aortic valve to the ventricle while the prosthetic valve is implanted through the atrial septum into the left atrial chamber (pars.72, 92-94 and figs.1-2E).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to deliver the anchoring device and prosthetic valve of Yang through different paths as taught by Weber since Weber teaches the different paths are suitable for delivering the devices to the native valve (Weber par.72) and selection of the known paths as specifically taught by Weber would yield predictable results with a reasonable expectation of success.
Conclusion
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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