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 § 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 1-20 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 1, 10, and 19 each recite “a plurality of basic units” in lines 8, 9, and 5 respectively. The claims then proceed to recite “the basic unit including:”, rendering it unclear if the limitations following this phrase must apply to every one of the plurality of basic units or only to a singular one. Examiner suggests amending the limitation to recite “each of the basic units including:” in order to clarify.
Claims 1, 10, and 20 each recite that the wavy unit comprises at least four first linear portions, and that each first linear portion is connected to a first bent portion. Thus there exists a plurality of first bent portions necessary to connect the at least four first linear portions. However, the claims are written such that they reference “a first bent portion”, suggesting a singular. Therefore it is unclear if each recitation of “the first bent portion” in claims 4, 6, 7, 8, 13, 15, 16, and 17 is referring to each of the first bent portions or only one of them.
Claims 1, 10, and 19 each recite “a second linear portion… disposed at a position adjacent to the first linear portion”, which is unclear because it does not specify which of the at least four first linear portions the second linear portion is positioned adjacent to. Further, “the second bent portion connecting end portions… of the first linear portion and the second linear portion” is unclear regarding if this arrangement occurs at every one of the plurality of first linear portions or only once, as suggested by the singularity of the phrase “the second bent portion”.
Further, claims 1, 10, and 19 each recite that adjacent basic units are connected by a second bent portion, which would imply the second bent portion is a connecting between the second linear portion of one basic unit adjacent to the closest first linear portion of the next basic unit. However, the claims then proceed to define the second bent portion is positioned between a first linear portion and a second linear portion within the same basic unit. This contradicts the previous limitation. It is unclear if the second bent portion is positioned between two struts of a single basic unit or positioned between one strut of one basic unit and another strut of an adjacent basic unit, as the claims appear to suggest both.
A review of the specification and FIG 3 shows three “first bent portions” and three “second bent portions”, positioned at different locations and connecting different elements. As such, each bent portion should be referred to in the plurality (not singular) and given its only naming convention, particularly in the case of the second bent portion wherein one second bent portion 35b connects a first linear portion to a second linear portion and another second bent portion 35c connects the second linear portion to an adjacent basic unit.
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, 6-9, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ikeuchi et al (US 2017/0273811).
Regarding claims 1-3 and 19-20, Ikeuchi et al. discloses a stent (20, FIGs 1-3) of a cylindrical shape ([0018]) that is configured to be expandable and contractible in a radial direction ([0040, 0045-0048]), the stent comprising: a plurality of annular members (51, FIG 3-4) formed in an annular shape ([0028]) by a linear component (struts 30) folded in a wave shape (See zig zag shape formed in FIGs 3-4) and disposed along a longitudinal direction of the cylindrical shape to form the cylindrical shape (FIG 3); a link portion (See annotated FIG 3 below; the link portion is interpreted as one link 61, one link 62, and the strut portion of 52 which connects 61 and 62 as outlined in the box below) connecting the plurality of annular members adjacent to each other (The segment outlined below connects adjacent annular portions 51); wherein the plurality of annular members is formed by disposing a plurality of basic units (See annotated FIG 3 and 4 below) in a circumferential direction of the cylindrical shape and connecting the basic units adjacent to each other by a second bent portion (See annotated FIG 4 below, each adjacent basic unit is connected by a second bent portion); the basic unit including: a wavy unit (See annotated FIG 4 below) which has a plurality of first linear portions (Each linear strut in the unit) extending from a proximal end side to a distal end side in the longitudinal direction (From left to right or right to left as viewed in FIG 4) and disposed continuously in the circumferential direction (Each of the linear portions extends continuously in the circumferential direction because they are formed of the same strut 30) and a first bent portion (See annotated FIG 4 below) connecting end portions on the proximal end side or the distal end side of two of the first linear portions adjacent in the circumferential direction (See first fent portion connecting each of the first linear portions); a second linear portion extending from the proximal end side to the distal end side in the longitudinal direction and disposed at a position adjacent to the first linear portion in the circumferential direction (See annotated FIG 4 below); and the second bent portion connecting end portions on the proximal end side or the distal end side of the first linear portion and the second linear portion adjacent to each other in the circumferential direction (As shown in FIG 4); a second distance, which is a separation distance in the circumferential direction between an end point in the longitudinal direction of the second bent portion connected to an end portion on one end side of the second linear portion and an end point in the longitudinal direction of the second bent portion connected to an end portion on an other end side of the second linear portion (See FIG 4 below which shows the length considered to be the second distance), is longer than a first distance which is a separation distance in the circumferential direction between an end point in the longitudinal direction of the first bent portion connected to an end portion on one end side of any of the first linear portions and an end point in the longitudinal direction of the first bent portion or the second bent portion connected to an end portion on an other end side of the first linear portion (See FIG 4 below which shows the length considered to be the first distance. The second distance is longer than the first distance); and a number of the first linear portions disposed in the wavy unit is four or more (See annotated FIG below. The number of first linear portions in the wavy unit is four).
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Regarding claim 6, Ikeuchi et al. discloses a second radius, which is a radius of curvature on an inner curved side of the second bent portion, is larger than a first radius which is a radius of curvature on an inner curved side of the first bent portion (See annotated FIG 4 below which shows a radius of curvature in the second bent portion being larger than a radius of curvature in the first bent portion).
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Regarding claim 7, Ikeuchi et al. discloses a radius of curvature on an inner curved side of the first bent portion to which the link portion is connected is larger than a radius of curvature on an inner curved side of the first bent portion to which the link portion is not connected (See annotated FIG 4 above).
Regarding claim 8, Ikeuchi et al. discloses the first linear portion has an axis-parallel linear portion parallel to the longitudinal direction (For example the linear portion that falls of line 71 is parallel to the longitudinal direction); the annular members are disposed with aligned phases in the circumferential direction (FIG 3); the link portion (As defined above in FIG 3) connects the first bent portion connected to a distal end side of the axially parallel linear portion of the annular member disposed on the proximal end side and the first bent portion connected to a proximal end side of the axially parallel linear portion of the annular member disposed on the distal end side and adjacent to the annular member disposed on the proximal end side (See the circled portions in annotated FIG 3 above which show the distal end of one parallel linear portion being connected to the proximal end of another parallel linear portion of a more distal annular member, wherein connection is completed by the link portion); and a portion from a proximal end side of the axially parallel linear portion of the annular member on the proximal end side to a distal end side of the axially parallel linear portion of the annular member on the distal end side via the link portion is parallel to the longitudinal direction before and after expansion (FIG 5 shows the position of the struts in the expanded state, [0015, 0023]. All of the parallel linear portions remain parallel to the longitudinal axis in the expanded state).
Regarding claim 9, Ikeuchi et al. discloses a pair of the link portions is disposed in each of gaps between the adjacent annular members to face each other in a radial direction of the annular member (FIG 3 shows there are at least two link portions in between each annular member); and a phase of the link portion disposed in one gap and a phase of the link portion disposed in another gap adjacent to the one gap in the longitudinal direction are shifted by 90 degrees in the circumferential direction ([0038] discloses “the plurality of second link portions 62 preferably connect the annular bodies 40 at an axially central position (in the present embodiment, a position which is at 90° (offset at a rotational angle of 90°) to the first link portion 61 in the circumferential direction D2) between the first link portions 61 adjacent to each other in the circumferential direction D2”. This relationship creates a phase shift of 90 degrees of the annotated link portion as well).
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) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ikeuchi et al (US 2017/0273811) in view of Drasler et al. (US 8,016,873).
Regarding claims 4-5, Ikeuchi et al. discloses the invention substantially as claimed, as set forth above for claim 1.
Ikeuchi et al. is silent regarding a width of the first bent portion is smaller than a width of the first linear portion connected to the first bent portion and a width of the second bent portion is smaller than widths of the first linear portion and the second linear portion connected to the second bent portion.
However, Drasler et al. teaches in the same field of endeavor a stent (5, FIG 17A, ) having annular bands formed by linear portions (345, 350) and bent portions (340) wherein a width of the bent portion is smaller than a width of the linear portion connected to the bent portion (FIG 19-20, wherein 105 is the width of the bent portion and 150 is the width of the linear portion, col 33 line 58- col 34 line 22), and further teaches that a smaller width facilitates greater radial of curvature (“The hinge width 105 is significantly smaller than the strut width 150 for either the upper strut 345 or lower strut 350 to allow the hinge to deform the hinge width radius of curvature 380 in going from a nondeployed state to a deployed state”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the width of the first bent portion to be smaller than a width of the first linear portion connected to the first bent portion and a width of the second bent portion to be smaller than widths of the first linear portion and the second linear portion connected to the second bent portion, as taught by Drasler et al., for the purpose of being constructed in a manner that allows for the desired radius of curvature in the bent portions to allow radial expansion of the stent without fracture, and for the added benefit that when the strut width is significantly greater than the hinge width, the moment provided by the hinge to hold the blood vessel outward is transferred via the strut to the vessel wall without bending in the direction of the strut width.
Allowable Subject Matter
Claims 10-18 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance: Regarding claim 10, the prior art of record fails to teach or render obvious the balloon protrudes outward from a radial position of an inner surface of the stent only at a position between the first linear portion and the second linear portion, in combination with the remaining limitations of the claim. The closest prior art is Ikeuchi et al., which teaches the limitations of claim 10 as set forth above in claim 1 and further teaches a balloon catheter (10, FIG 1) having an inflatable and deflatable balloon (13, FIG 1-2, [0017-0022]); the stent being retained in contact with the balloon, which has been deflated, in a contracted state ([0021]). However, Ikeuchi is silent regarding the balloon protrudes outward from a radial position of an inner surface of the stent only at a position between the first linear portion and the second linear portion.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771