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 .
Specification
The disclosure is objected to because of the following informalities:
In paragraph 0007, “0.4mm~1mm” should read “0.4mm-1mm”.
In paragraph 0010, line 3, “1/4~1” should read “1/4-1”.
In paragraph 0011, line 2, "2 mm~20 mm" should read "2 mm-20 mm".
In paragraph 0012, line 2, ”0.5 mm~31.4 mm” should read ”0.5 mm-31.4 mm”.
In paragraph 0015, line 2, “0.5mm~1mm” should read “0.5mm-1mm”.
In paragraph 0016, line 2, ”0.5~1” should read ”0.5-1”.
Appropriate correction is required.
Claim Objections
Claims 1-15 are objected to because of the following informalities:
The preamble of the claim 1 should recite: A stent having an assistant extension portion. The dependent claims should recite: The stent having the assistant extension portion of claim #.
In claim 2, line 2, “0.4mm~1mm” should read “0.4mm-1mm”.
In claim 5, line 2, “1/4~1” should read “1/4-1”.
In Claim 6, line 2, "2 mm~20 mm" should read "2 mm-20 mm".
In Claim 7, line 2, ”0.5 mm~31.4 mm” should read ”0.5 mm-31.4 mm”.
In claim 10, line 2, “0.5mm~1mm” should read “0.5mm-1mm”.
In Claim 11, line 2, ”0.5~1” should read ”0.5-1”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-3, 6, 8, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bales, JR. et al. (2013/0238084) "Bales".
Regarding Claim 1, Bales discloses a stent (See Annotated Fig. 14, below) having an assistant extension portion (See Annotated Fig. 14, below, markers 13; Abstract) comprising:
a plurality of ring layers (See Annotated Fig. 14, below), each of the ring layers having a plurality of first crowns (See Annotated Fig. 14, below) connected to each other;
and a connecting layer (See Annotated Fig. 14, below) having the plurality of first crowns and a second crown (See Annotated Fig. 14, below) connected to each other, wherein the connecting layer and the plurality of ring layers are connected to each other to form a stent body (See Annotated Fig. 14, below), the connecting layer is located at one end of the stent body (See Annotated Fig. 14, below);
an assistant extension portion (See Annotated Fig. 14, below) having a fixed end and a free end, the fixed end of the assistant extension portion being connected to the second crown (See Annotated Fig. 14, below), and the free end of the assistant extension portion (See Annotated Fig. 14, below) having at least one hole (par. 0027, the ultrasound markers that serve as part of the assistant extension portion can be holes).
Regarding Claim 2, Bales discloses a diameter of the hole is 0.4mm-1mm (par. 0027).
Regarding Claim 3, Bales discloses the width of the second crown is greater than or equal to a width of the first crown (See Annotated Fig. 14, below).
Regarding Claim 6, Bales discloses the section of the stent body forms a reference circle, and a diameter of the reference circle is 2 mm-20 mm (par. 0037).
Regarding Claim 8, Bales discloses the assistant extension portion comprises an extension body (See Annotated Fig. 14, below) and a connecting portion (See Annotated Fig. 14, below) connected to each other, the extension body is connected to the second crown through the connecting portion (See Annotated Fig. 14, below), and a width of the connecting portion is smaller than a width of the extension body (See Annotated Fig. 14, below, Abstract) to form two grooves in two sides of the assistant extension portion (See Annotated Fig. 14, below).
Regarding Claim 12, Bales discloses one of the first crowns of each of the ring layers is connected to one of the first crowns of the ring layer adjacent thereto through a bridging portion (See Annotated Fig. 14, below).
Regarding Claim 14, Bales discloses one of the first crowns of the connecting layer is connected to one of the first crowns of the ring layers adjacent thereto through a bridging portion (See Annotated Fig. 14, below, connecting bridge 8, Abstract).
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Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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) 4,9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bales, JR. et al. (2013/0238084) "Bales".
Regarding Claim 4, the first embodiment of Bales (shown in Annotated Fig. 14, above) is silent regarding the two corners of the free end of the assistant extension portion (See Annotated Fig. 14, above, markers 13) are rounded. However, Bales teaches a second embodiment (shown in Annotated Fig. 5, below) discloses the assistant extension portion (See Annotated Fig. 5, below, paddle-shaped marker 12) can be rounded (par. 0072), which is a useful feature for helping to anchor the stent (See Annotated Fig. 5, below, stent 1) during and after deployment (par. 0073). Therefore, 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 assistant extension portion disclosed in the first embodiment of Bales to include two corners of the free end of the assistant extension portion that are rounded, as taught and suggested in the second embodiment of Bales, in order to help anchor the stent during and after deployment.
Regarding Claim 9, the first embodiment of Bales (shown in Annotated Fig. 14, above) is silent regarding the width of the groove gradually increasing from a bottom of the groove to a top of the groove. However, Bales’ second embodiment (shown in Annotated Fig. 5, below) further discloses that the width of the groove (see Annotated Fig. 5, below, where the narrow connectors correspond to the recited groove) gradually increases from a bottom of the groove to a top of the groove (see Annotated Fig. 5, below). Therefore, 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 assistant extension portion disclosed in the first embodiment of Bales to include a gradually increasing width of the groove from the bottom to the top, as disclosed in the second embodiment of Bales, in order to create a narrow connecting portion so that the markers can be spaced from the helical end of the stent for easier visualization (See Annotated Fig. 5, below, par. 0069).
Regarding Claim 11, the first embodiment of Bales (shown in Annotated Fig. 14, above) is silent regarding a ratio of a width of the connection portion to a width of the extension portion body of 0.5-1. However, Bales’ second embodiment (shown in Annotated Fig. 5, below) comprising a ratio of a width of the connection portion (See Annotated Fig. 5, paddle-shaped marker 12) to a width of the extension portion (See Annotated Fig. 5, below) body of 1 (par. 0071, where Bales defines the full-width connectors as having a uniform width from their ends to where they join the stent body). 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 assistant extension portion disclosed in the first embodiment of Bales to include a ratio of a width of the connection portion to a width of the extension portion body of 0.5-1 as disclosed in the second embodiment of Bales, in order to create a narrow enough connecting portion so that the markers can be spaced from the helical end of the stent for easier visualization (See Annotated Fig. 5, below, par. 0069).
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Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bales, JR. et al. (2013/0238084) "Bales" in view of Chanduszko (2018/0221151) "Chanduszko". Regarding Claim 5, Bales does not disclose that a section of the structure forms a reference circle, however, Chanduszko discloses a stent scaffold structure (Fig. 8A, Abstract, stent 86) supporting a patch along a portion of an interior surface (Fig. 8A, Abstract, stent 86), in which a section of the structure forms a reference circle (Fig 8A, circumference of stent 86), a section of the assistant extension portion forms an arc (Fig. 8A, arc length L1, par. 0027) and a ratio of an arc length of the arc to a circumference of the reference circle is ¼-1 (Fig. 8A, arc length L1, par. 0027). 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 structure disclosed by Bales to include an arc and a ratio of an arc length of the arc to a circumference of the reference circle is ¼-1 as disclosed by Chanduszko in order to provide a reference for a terminal end of the stent (Chanduszko, Fig. 8A, par. 0027).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bales, JR. et al. (2013/0238084) "Bales" in view of Bonsignore et al (2005/0085896) "Bonsignore". Regarding Claim 7, Bales does not disclose a section of the assistant extension portion forming an arc and an arc length of the arc is 0.5 mm-31.4 mm, however, Bonsignore discloses a stent (Fig. 7, stent 100) with a modified bridge design (par. 0002) wherein a section of the assistant extension portion (See Annotated Fig. 9, below) forms an arc (Fig. 8, par. 0081), and an arc length of the arc is 0.5 mm-31.4 mm (Fig. 8, par. 0079). 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 assistant extension portion disclosed by Bales to include an arc and an arc length of the arc between 0.5 mm-31.4 mm as disclosed by Bonsignore in order to minimally impact the overall profile of the stent and ensure minimal interference with the deployment and operation of the device (Bonsignore, par. 0024).
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Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bales, JR. et al (2013/0238084) "Bales" in view of Higashi et al (10292845) "Higashi". Regarding Claim 10, Bales does not disclose a shortest distance from a central point of the hole to an edge of the extension body of 0.5 mm-1 mm, however, Higashi discloses a stent (Fig. 1a, stent 11) with an assistant extension portion (Fig. 1a, markers 12, par. 17) wherein a shortest distance from a central point of the hole (Fig. 9, opening 26, central point of marker insert 13a) to an edge of the extension body (Fig. 9, marker housing 14) is 0.5 mm-1 mm (Fig. 9, pars. 46 and 50, marker insert (13a) has outside diameter of 1.00 mm and marker housing (14) has inside diameter 0.10 mm larger than the outside diameter of marker insert (13a), which calculates to a distance of at least 0.55 mm between the central point of the marker hole to the edge of the extension body). 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 assistant extension portion disclosed by Bales so that the shortest distance from a central point of the hole to an edge of the extension body is 0.5 mm-1 mm, as disclosed by Higashi in order to ensure proper fitting when the indenter (Fig. 2, indenter 21) is used to fix the marker insert into the opening, which will therefore allow the marker to indicate the stent position (Higashi, pars. 3 and 11).
Claim(s) 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bales, JR. et al (2013/0238084) "Bales" in view of Cottone (2013/0345790) "Cottone".
Regarding Claims 13 and 15, Bales does not disclose a bridging portion with a marker hole and a marker disposed in the marker hole., however, Cottone discloses a stent (Fig. 12) wherein the bridging portion (Fig. 13A, end zones 2 and 3 and bridging elements 31, 32, 132 (or 33, 34, 134 for end zone 3)) has a marker hole (Fig. 13A, par. 0080, radiopaque markers 37 and 38 contain a centrally placed marker hole) and a marker (Fig. 13A, radiopaque markers 37 and 38) is disposed in the marker hole (Fig. 13A, par. 0080). Therefore, it would have been obvious before the effective filing date of the claimed invention to modify the assistant extension portion disclosed by Bales to include a bridging portion that has a marker hole and a marker disposed in the marker hole as disclosed by Cottone in order to allow for different marker shapes and materials to be contained about the stent and indicate the stent’s position (Cottone, pars. 0072 and 0073).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATALIE N THOMAS/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774