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 .
Status of Claims
Claims 1-10 are pending and examined below.
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 1-10 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.
Regarding claims 1-10, claim 1 recites “axial size ratio”. This renders the claim indefinite because it is unclear exactly what is being measured for this ratio. This also renders claims 2-10 indefinite due to their dependency. Is this a ratio between measurements of length or diameter? From what direction are these measurements taken? To which axis is the ratio referring?
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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 114271992 (Chen) in view of US 2007/0142906 (Figulla)
Regarding claim 1, Chen discloses a recoverable and self-expanding short-frame valve suitable for aortic valve regurgitation (Fig. 1), comprising:
a tubular frame (Fig. 1, see also ¶0012 of the attached translation) and valve leaflets (¶0031, “three leaflets”) sutured to an inner periphery of the tubular frame (¶0031, “sewing three leaflets of the inner circumference of the tubular frame”), the tubular frame having a plurality of hollow grids (¶0031, “the tubular frame is provided with a plurality of follow grids) thereon to cause the tubular frame to contract to a delivery configuration or expand to a use configuration in a radial direction (¶0031, “shrink to the conveying shape or expand to the use shape in the radial direction”), the tubular frame comprising a first portion (Fig. 1, 1) and a second portion (Fig. 1, 2) integrally formed and coaxially arranged (¶0032), a waist portion (Fig. 1, 3) being formed at the junction of the first portion and the second portion when the tubular frame is in the use configuration (see Fig. 1, wherein 3 is at junction of 2 and 1), and the second portion being divergently arranged in a direction away from the waist portion, wherein (see Fig. 1, wherein 2 is divergently arranged in a direction away from 3):
the first portion in the direction away from the waist portion comprises a divergent portion and an adduction portion (see annotated Fig. 1 provided below)
an end of the adduction portion away from the waist portion is formed with a plurality of endpoints (see Fig. 1),
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Chen discloses a divergent portion and an addiction portion (see annotated Fig. 1 below) but doesn't explicitly teach or disclose an axial size ratio of the divergent portion to the adduction portion of 2: 1, an axial size ratio of the second portion to the first portion is 1: 3; and connection sections being arranged on at least five of the endpoints and configured to be detachably connected to steel wires of a valve delivery system
Figulla discloses a stent (Fig. 1) comprising a divergent portion and an adduction portion (see annotated Fig. 1 below), with an axial size ratio of the divergent portion to the adduction portion of 2::1 (see annotated Fig. 1 below); an axial size ratio of the second portion to the first portion is 1: 3 (see annotated Fig. 1 below) and connection sections being arranged on at least five of the endpoints (see Fig. 1 below, wherein 4 is arranged on a least 5 endpoints) and configured to be detachably connected to steel wires of a valve delivery system (¶0052, wherein “engagement with a catheter system” corresponds to configured to be detachably connected to steel wires of a valve delivery system)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the axial size ratios of the divergent portion to the adduction portion and the second portion to the first portion to be 2:1 and 1:3 respectively as well as connection sections on five endpoints configured to be detachably connected to steel wires of a valve delivery system , as taught by Figulla, in order to anchor the stent in the patient’s heart as precisely as possible (Figulla, abstract) while still allowing for recover and/or replacement.
Regarding claim 2, Chen further discloses a stud integrally formed on the endpoints (Fig. 1, 121, see also ¶0033 of translation wherein 121 corresponds to a stud because it prevents aortic perforation)
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Regarding claim 3, Chen discloses a plurality of endpoints (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the number of the endpoints is 5-10.
Figulla discloses wherein the number of the endpoints is 5-10 (see annotated Fig. 1 below, wherein five to ten endpoints are shown)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the frame of Chen with five to ten endpoints, as taught by Figulla, in order to sufficient attachment points for repositioning and/or reconfiguration of the frame.
Regarding claim 4, Chen further discloses a cross section where the junction of the adduction portion and the divergent portion is located is a first cross section (see annotated Fig. 1, “first cross section”), and a cross section where an end of the second portion away from the waist portion is located is a second cross section (annotated Fig. 1, “second cross section”); and diameter of the first cross section is greater than that of the section cross section when the tubular frame is in the use configuration (See annotated Fig. 1 below, wherein the diameter of the annotated first cross section is larger than the diameter of the annotated second cross section)
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Regarding claim 5, Chen further discloses an outer tectorial membrane (Fig. 1, 4) covered on the peripheries of the second portion and a portion of the divergent portion near the waist portion
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Regarding claim 6, Chen further discloses a divergence angle of the second portion in the direction away from the waist portion is 5°-10° (¶0014, see also claim 2)
Regarding claim 7, Chen further discloses that the tubular frame is made of a nickel-titanium alloy (¶0035, “the tubular frame of the embodiment is made of nickel-titanium alloy material”)
Regarding claim 8, Chen further discloses a plurality of positioning mark points are uniformly distributed in a circumferential direction of the waist portion (¶0016, “waist circumference is uniformly distributed with a plurality of locating mark points”)
Regarding claim 9, Chen further discloses a positioning mark point is made of gold (¶0017, “Preferably, the locating mark point is made of gold material”)
Regarding claim 10, Chen further discloses an outer tectorial membrane is made of PET (¶0018, “Preferably, the material of the outer coating is PET material”)
Conclusion
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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