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 .
Detailed Action
This is in response to the amendment filed 01/30/2026.
Allowable Subject Matter
Claims 7-9, 14-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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: claim 7 recites wherein each first cell includes, in an annular direction inclined with respect to the circumferential direction, a pair of first struts and one first strut arranged with a clearance from the pair of first struts, and each second cell includes, in an annular direction inclined with respect to the circumferential direction, a pair of second struts and one second strut arranged with a clearance from the pair of second struts.
Claim 14 recites wherein each first cell includes, in an annular direction inclined with respect to the circumferential direction, a pair of first struts and one first strut arranged with a clearance from the pair of first struts, and each second cell includes, in an annular direction inclined with respect to the circumferential direction, a pair of second struts and one second strut arranged with a clearance from the pair of second struts.
The Office agrees the art of record fails to teach or suggest these features.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over U.S. Patent Publication Number 2013/0325051 (Martin et al.)
Regarding claims 1, 4, Martin et al. discloses as shown in Figures 3A-3C, a stent that is capable of being inserted into a catheter and pushed out of the catheter in a blood vessel to expand the blood vessel, comprising: a first stent body (cover 300, see paragraph [0064]) configured such that a plurality of first cells (cells in braid, see paragraph [0071] and shown in Figures 3A-3C) including struts (strands of braid, see paragraph [0071] and shown in Figures 3A-3C) arranged in a frame shape spreads in a circumferential direction and is continuously arranged in a center axis direction; and a second stent body (obstruction removal device 200, see paragraph [0060]) configured such that a plurality of second cells (cells of stent, see paragraph [0062]) including struts (struts of stent, see paragraph [0062]) arranged in a frame shape spreads in a circumferential direction and is continuously arranged in a center axis direction and inserted into the first stent body, wherein in a state in which the second stent body is inserted into the first stent body, an intersection between the second cells is arranged in a hole of each first cell, wherein in a diameter-expanded state, the first stent body and the second stent body closely contact each other (area generally indicated as A, shown in Figure 3A) and are not coupled to each other in a radial direction and, wherein a proximal side end portion of the first stent body and a proximal side end portion of the second stent body are connected to a push wire (wire 202, see paragraph [0063]) undetachably, wherein in the state in which the second stent body is inserted into the first stent body, the second stent body is capable of pressing the first stent body outward in the radial direction (if manipulated by hand).
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Alternatively, 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 stent disclosed by Martin et al. by rearranging the location of the cells such that wherein in a state in which the second stent body is inserted into the first stent body, an intersection between the second cells is arranged in a hole of each first cell because it would only require a rearrangement of parts without changing how the device operates. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 5, Martin et al. fails to disclose wherein in a configuration in which the intersection between the second cells is arranged in the hole of each first cell, one intersection between the second cells is arranged in one hole of each first cell
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 stent disclosed by Martin et al. by rearranging the location of the cells such that wherein in a configuration in which the intersection between the second cells is arranged in the hole of each first cell, one intersection between the second cells is arranged in one hole of each first cell because it would only require a rearrangement of parts without changing how the device operates. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 6, Martin et al. fails to disclose wherein in the state in which the second stent body is inserted into the first stent body, a percentage of a non-hole portion per unit surface area in a portion where the first stent body and the second stent body overlap with each other is 5 to 50.
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 stent disclosed by Martin et al. by rearranging the location of the cells such that wherein in the state in which the second stent body is inserted into the first stent body, a percentage of a non-hole portion per unit surface area in a portion where the first stent body and the second stent body overlap with each other is 5 to 50%, because it would only require a rearrangement of parts without changing how the device operates. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)
Regarding claim 2, Martin et al. discloses as shown in Figures 3A-3C a stent that is inserted into a catheter and pushed out of the catheter in a blood vessel to expand the blood vessel, comprising: a first stent body (cover 300, see paragraph [0064]) configured such that a plurality of first cells (cells in braid, see paragraph [0071] and shown in Figures 3A-3C) including struts (strands of braid, see paragraph [0071] and shown in Figures 3A-3C) arranged in a frame shape spreads in a circumferential direction and is continuously arranged in a center axis direction; and a second stent body (obstruction removal device 200, see paragraph [0060]) configured such that a plurality of second cells (cells in stent, see paragraph [0062] and shown in Figures 3A-3C) including struts (struts of stent, see paragraph [0062] and shown in Figures 3A-3C) arranged in a frame shape spreads in a circumferential direction and is continuously arranged in a center axis direction and inserted into the first stent body, wherein in a state in which the second stent body is inserted into the first stent body, an intersection between the second cells is arranged in a hole of each first cell, and wherein in a diameter-expanded state, the first stent body and the second stent body closely contact each other (area generally indicated as A, shown in Figure 3A) and are not coupled to each other in a radial direction and, wherein a proximal side end portion of the first stent body and a proximal side end portion of the second stent body are connected at different positions in an axial direction of a push wire (wire 202, see paragraph [0063]). See paragraph [0063] and annotated figure 3a provided below.
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Alternatively, 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 stent disclosed by Martin et al. by rearranging the location of the cells such that wherein in a state in which the second stent body is inserted into the first stent body, an intersection between the second cells is arranged in a hole of each first cell because it would only require a rearrangement of parts without changing how the device operates. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Alternatively, 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 stent disclosed by Martin et al. by rearranging the a proximal side end portion of the first stent body and a proximal side end portion of the second stent body are connected to the push wire such that they are connected at different positions in an axial direction of a push wire because it would only require a rearrangement of parts without changing how the device operates. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 3, Martin et al. discloses as shown in Figures 3A-3C a recovery stent that is capable of being inserted into a catheter and pushed out of the catheter in a narrowed or occluded blood vessel to expand the blood vessel, the recovery stent including a proximal side end portion to which a push wire (wire 202, see paragraph [0063]) is connected, an operation is capable of moving the push wire back and forth allowing for temporary implantation and recovery of the recovery stent in the blood vessel, the recovery stent comprising: a first stent body (cover 300, see paragraph [0064]) configured such that a plurality of first cells (openings in braid, see paragraph [0071] and shown in Figures 3A-3C) including struts (strands of braid, see paragraph [0071] and shown in Figures 3A-3C) arranged in a frame shape spreads in a circumferential direction and is continuously arranged in a center axis direction; a second stent body (obstruction removal device 200, see paragraph [0060]) configured such that a plurality of second cells (cells of stent, see paragraph [0062]) including struts (struts of stent, see paragraph [0062]) arranged in a frame shape spreads in a circumferential direction and is continuously arranged in a center axis direction and inserted into the first stent body, wherein in a state in which the second stent body is inserted into the first stent body, an intersection between the second cells is arranged in a hole of each first cell, wherein the first stent body and the second stent body are not coupled to each other in a radial direction, and wherein a proximal side end portion of the first stent body and a proximal side end portion of the second stent body are connected to the push wire (wire 202, see paragraph [0063]).
Alternatively, 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 stent disclosed by Martin et al. by rearranging the location of the cells such that wherein in a state in which the second stent body is inserted into the first stent body, an intersection between the second cells is arranged in a hole of each first cell because it would only require a rearrangement of parts without changing how the device operates. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication Number 2001/0016726 (Dubrul et al.) in view of U.S. Patent Publication Number 2013/0325051 (Martin et al.) and U.S. Patent Publication Number 2003/0216807 (Jones et al.)
Regarding claims 10-12 Dubrul et al. discloses as shown in Figures 3A, 3B, 4A, 4B, a method of expanding a narrowed or occluded blood vessel with a stent (stent 10 or dilation mechanism 9, see paragraph [0054]), the stent including a proximal side end portion to which a push wire is connected (inner wire 20, see paragraph [0063]), the method comprising: pushing the stent at a location where restenosis or reocclusion in a blood vessel occurs; temporarily implanting the stent at the location; and recover the stent from the blood vessel. See paragraphs [0054], [0094].
Dubrul et al. fails to disclose the stent including a first stent body including a plurality of first cells, and a second stent body including a plurality of second cells and inserted into the first stent body, a proximal side end portion of the first stent body and a proximal side end portion of the second stent body being connected to a push wire undetachably, pushing the stent out of a catheter, resheathing the stent in the catheter.
Martin et al., from the same field of endeavor teaches a similar method as shown in Figures 3A-3C 10E where a stent (cover 300, see paragraph [0117]) a first stent body including a plurality of first cells, and a second stent body including a plurality of second cells and inserted into the first stent body, a proximal side end portion of the first stent body and a proximal side end portion of the second stent body being connected to a push wire undetachably, wherein in the state in which the second stent body is inserted into the first stent body, the second stent body presses the first stent body outward in the radial direction, wherein in a state in which the second stent body is inserted into the first stent body, an intersection between the second cells is arranged in a hole of each first cell.
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 method disclosed by Dubrul et al. by substituting the stent disclosed by Dubrul et al. for the one taught by Martin because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Jones et al., from the same field of endeavor teaches a similar method as shown in Figure 1, where pushing the stent out of a catheter, resheathing the stent in the catheter, for the purpose of facilitating guiding the stent through the body and allowing it to be repositioned. See paragraph [0031].
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 method disclosed by Dubrul in view of Martin to include the steps of pushing the stent out of a catheter, resheathing the stent in the catheter taught by Jones in order to facilitating guiding the stent through the body and allow it to be repositioned, a predictable use of known components to obtain expected ergonomic benefits. See KSR, 550 U.S. at 417; MPEP § 2143.
Alternatively, 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 stent disclosed by Martin et al. by rearranging the location of the cells such that wherein in a state in which the second stent body is inserted into the first stent body, an intersection between the second cells is arranged in a hole of each first cell because it would only require a rearrangement of parts without changing how the device operates. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Regarding claim 13 Martin et al. fails to disclose wherein in the state in which the second stent body is inserted into the first stent body, a percentage of a non-hole portion per unit surface area in a portion where the first stent body and the second stent body overlap with each other is 5 to 50.
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 stent disclosed by Martin et al. by rearranging the location of the cells such that wherein in the state in which the second stent body is inserted into the first stent body, a percentage of a non-hole portion per unit surface area in a portion where the first stent body and the second stent body overlap with each other is 5 to 50%, because it would only require a rearrangement of parts without changing how the device operates. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Response to Arguments
Applicant’s arguments with respect to the rejection of claim(s) 1-16, filed 01/30/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771
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