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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-8 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1, line 4 recites “is fixed on a heart tissue” which positively recites the isolation device body in combination with heart tissue, thereby positively reciting part of the human body. To overcome the rejection, the limitation could be amended to recite an intended use or function. For example, line 4 could recite --is configured to be fixed on a heart tissue--.
Claim 3, line 3 recites “is connected to a ventricular tissue” which also positively recites a combination of the isolation device body and heart tissue. This limitation should be amended to recited an intended use instead of positively reciting a connection with ventricular tissue.
Claim 4, line 3 recites “is located at the cardiac apex” and lines 4-5 recite “the fixing structure is fixed on an inner wall of the cardiac apex” which each positively recite a combination of the fixing structure and the heart. This limitation should be amended to recited an intended use instead of positively reciting a placement in the heart.
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 1-8 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, lines 7-8 recite “the first connection part and the second connection part are connected in a ventricle during implantation of the valve”. This limitation is unclear because it appears the limitation is directed to a method step but the claim is for a device. As best understood, the claim limitation is interpreted to mean that the first connection part and the second connection part are configured to be connected in a ventricle during implantation of the valve.
Regarding claims 2, 5, and 6, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination, the limitations following “preferably” are considered optional and not positively recited by the claims.
Claim 6, lines 4-5 recite “is fit connection wit” which is generally unclear.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rafiee et al. US 2020/0383668 (hereafter referred to as Rafiee).
Regarding claim 1, Rafiee discloses a valve implantation device with the assistance of a heart isolation device (fig.13), comprising a valve (see “artificial valve” in fig.13), a heart isolation device (see the mesh anchor in fig.13), and a valve connection device (device connecting the valve and heart isolation device), wherein the heart isolation device comprises an isolation device body (the mesh body), the isolation device body is provided with a positioning part (considered the part extending through the heart and on the outer surface of the heart) the isolation device body is capable of being fixed on a heart tissue through the positioning part (fig.13), the valve connection device comprises a first connection part (considered the tethers), one side of the first connection part is connected with the valve (fig.13), the isolation device body is provided with a second connection part (considered the docking collar), and the first connection part and the second connection part are capable of being connected in a ventricle during implantation of the valve (par.61, lines 27-31 discloses a male/female threaded coupling).
Regarding claim 8, par.61 discloses a first delivery system configured to deliver the heart isolation device into the ventricle and a second delivery system which is used to deliver the valve.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhao et al. US 2023/0263633 (hereafter referred to as Zhao).
Regarding claim 1, Zhao discloses a valve implantation device with the assistance of a heart isolation device (fig.1), comprising a valve 100, a heart isolation device 200, and a valve connection device 300, wherein the heart isolation device comprises an isolation device body 201, the isolation device body is provided with a positioning part 207 (fig.8), the isolation device body is capable of being fixed on a heart tissue through the positioning part (par.66); the valve connection device comprises a first connection part 300, one side of the first connection part is connected with the valve (par.48; fig.12), the isolation device body is provided with a second connection part 205, and the first connection part and the second connection part are capable of being connected in a ventricle during implantation of the valve (pars. 48 and 57).
Regarding claim 2, see fig.8 for thorn-like structures oriented in an upward direction and capable of penetrating into the heart tissue to achieve fixation.
Regarding claim 3, see fig.8 for fixing structure 204 arranged below the isolation device body and capable of being connected to ventricular tissue to stably position the isolation device body.
Regarding claim 4, fixing structure 204 is connected to the isolation device body by tether 203 (fig.8). The fixing structure is capable of being located at the cardiac apex (fig.12). The fixing structure comprises thorn-like structures 207 capable of penetrating the inner wall of the cardiac apex (par.65). The heart isolation device body is tensioned by the tether 203 to provide reliable anchorage for the isolation device body (fig.8).
Regarding claim 5, par.57 discloses stitching or welding, which are considered mechanical connections.
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 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao as applied to claim 5 above, and further in view of Vidlund et al. US 2013/0172978 (hereafter referred to as Vidlund).
Regarding claim 6, Zhao discloses the valve implantation device of claim 5 as discussed above, but does not disclose that the second connection part of the isolation device body comprises a bulge structure, the first connection part connected to the valve has an indent structure and a buckle and/or a clamping slot, during connection, the bulge structure extends into the first connection part, and an edge of the bulge structure is connected with the buckle and/or the clamping slot, so that fixed connection is achieved, and disconnection is prevented.
Vidlund teaches a valve implantation device, in the same field of endeavor, wherein a second connection part 270 of a distal device body comprises a bulge structure 280, a first connection part 300 connected to the valve has an indent structure (interpreted as concave or hollow structure) and a buckle (fig.6), during connection, the bulge structure 280 extends into the first connection part 300, and an edge of the bulge structure is connected with the buckle, so that a fixed connection is achieved, and disconnection is prevented (fig.6; par.96) for the purpose of connecting a ventricular device portion to a valve (par.96) and to allow for adjusting or customizing tethers for a particular patient’s anatomy (par.72).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection device of Zhao such that the second connection part of the isolation device body comprises a bulge structure, the first connection part connected to the valve has an indent structure and a buckle, wherein during connection, the bulge structure extends into the first connection part, and an edge of the bulge structure is connected with the buckle as taught by Vidlund in order to allow for a customizable connection between the isolation device and valve.
Regarding claim 7, Zhao discloses the valve implantation device of claim 5 as discussed above, but does not disclose that the second connection part comprises a bulge structure, the first connection part is a rope or a suture, and during connection, the rope or the suture is knotted on the bulge structure by a knotting mechanism, so that the rope or the suture is fixedly connected to the bulge structure.
Vidlund teaches a valve implantation device, in the same field of endeavor, wherein a second connection part 270 of a distal device body comprises a bulge structure 320, a first connection part is a rope or a suture 290, and during connection, the rope or the suture is knotted on the bulge structure by a knotting mechanism, so that the rope or the suture is fixedly connected to the bulge structure (fig.11) for the purpose of connecting a ventricular device portion to a valve (par.101) and to allow for adjusting or customizing the tethers for a particular patient’s anatomy (par.72).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection device of Zhao such that the second connection part comprises a bulge structure, the first connection part is a rope or a suture, and during connection, the rope or the suture is knotted on the bulge structure by a knotting mechanism, so that the rope or the suture is fixedly connected to the bulge structure as taught by Vidlund in order to allow for a customizable connection between the isolation device and valve.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Biadillah et al. US 2020/0138570 discloses connection devices for heart implants. Solem US 2006/0241745 discloses a valve, a heart isolation device, and a valve connection device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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