,20DETAILED 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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, and any dependents rejected 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the recitation of “connection portions connecting junctions between the terminal ends of the axial linear portions and the starting ends of the bent portion” was not found in the written disclosure.
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 1-7,10-17,19,20 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.
In claims 1, 17,20 the recitation of “connection portions connecting junctions between the terminal ends of the axial linear portions and the starting ends of the bent portion” is ambiguous because it implies a plurality of locations which makes no sense if one connector is meant to be defined between two points of joining features together. What is very confusing is how one end of a connection portion joined to multiple locations (starting ends of the bent portion) implied by this clause is feasible because if joined to a bent portion, it would be understood to possibly be at a vertice single point of connection, but the use of starting ends suggests two connections and not even at the vertice. Thus, the clause is indefinite especially because it uses two and clauses to make it unclear where in the structure a connection actually takes place. Additionally it should be noted that a “junction” is just some central region where items converge, however the further clause of “between terminal ends” could imply any location disposed between two ends since it is not specific. Dependent claims do not clarify the independent claims and thus are indefinite for depending therefrom.
In claim 10, it is noted the claim uses negative limitations which are permissible but should be clear. In this instance the recitation of “stent does not have a one end side bent portion that is a free end except for the annular body located at one end, the free end being the one end side in the axial direction of the stent without any connection portions” is ambiguous since “ends” of a bent portion actually define points of the linear portions. Thus, the terminology is ambiguous. Claim 12 is ambiguous as it recites annular bodies are connected to vertices, whereas claim 1 had recited connection portions join to a junction and starting ends of a bent portion, thus what is the exact location for joined annular bodies?
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,3,10,11,14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wolinsky et al. (2003/0149469). Fig. 5 shows an in-vivo indwelling stent comprising: a tubular body having one end side and an other end side, the tubular body including a plurality of annular bodies, each of the plurality of annular bodies formed in a circular shape and arranged in an axial direction, and adjacent annular bodies of the plurality of annular bodies being connected by connection portions; each of the plurality of annular bodies includes a plurality of one end side bent portions located on the one end side in the axial direction of the stent, a plurality of other end side bent portions located on the other end side in the axial direction of the stent, and a plurality of connection linear portions that connect the one end side bent portions and the other end side bent portions; in an expanded state of the stent, one of the plurality of connection linear portions of the plurality of annular bodies located in a central portion of the stent extending so as to be parallel to the axial direction of the stent as compared with the bent portions.
[AltContent: textbox (one end side vertices of the one end side bent portions as starting ends)]
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[AltContent: textbox (Starting end of a bent portion where the connecting portion is joined)][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (bent portions having starting ends at terminal ends of the axial linear portions, extending in a circumferential direction of the stent and in a direction away from the one end side vertices )][AltContent: arrow][AltContent: arrow][AltContent: textbox (axial linear portions)]
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[AltContent: textbox ( greater axial length connection linear portions of the plurality of annular bodies than an axial length other portion of the connection linear portions )]
[AltContent: textbox (having terminal ends connected to a remaining portion of the one of the connection linear portions)]
Thus, as shown above the connection portions connecting junctions between the terminal ends of the axial linear portions and the starting ends of the bent portion. As best understood it can be construed a connection portion is established at a “one end side vertice” since a vertice is just where an element ended thus one is established at an end of an axial linear portions on the other end side in the axial direction of the stent where the other terminal end of the connection portion joined with a second axial linear portion of the annular body since as best understood according to applicant’s specification applicant is splitting a strut of an annular body in half at an arbitrary so called “junction” and calling these axial linear portions. Regarding claim 3, it can be seen above axial linear portions are straight-line portions elongated along the axial direction of the stent. Regarding claim 6, as best understood it can be seen above that annular body has on both sides of a bent portion one connection linear portion longer than its adjacent connection linear portion as it is essentially split to define a connection linear portion and the axial linear portion. With respect to claim 10, as best understood Fig. 5 shows end rings with outside bent portions if that is the intent to be the one end side in the axial direction without any connection portions. Regarding claim 11, as shown above terminal ends of all the axial linear portions of the plurality of annular bodies having the axial linear portions are connected to the connection portions. With respect to claim 14, Wolinsky et al. disclose (paragraph 9) the stent is formed in a substantially cylindrical shape, is configured to be compressed in a central axis direction at the time of in-vivo insertion, and configured to expand outward to restore a shape before compression at the time of in-vivo indwelling.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wolinsky et al. (2003/0149469) in view of Nissl (DE 102013104062). Wolinsky et al. is explained supra. However, Wolinsky et al. did not explicitly state the stent does not include convex portions that are located between adjacent annular bodies and protrude to the outside of the stent in an expanded state of the stent. Nissl teaches (Figs. 3,5) a stent 1 in which there is convex portions 4 that are located between adjacent annular bodies 3 and protrude to the outside of the stent in an expanded state of the stent. It would have been obvious to one of ordinary skill in the art to utilize convex portions that are located between adjacent annular bodies and protrude to the outside of the stent in an expanded state of the stent as taught by Nissl in the stent of Wolinsky et al. such that one can provide an anchoring means to assist in engagement with the vessel wall.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wolinsky et al. (2003/0149469) in view of Andreas et al. (2007/0276461). Wolinsky et al. is explained supra and a catheter system is used to deploy a stent (abstract). However, Wolinsky et al. did not explicitly state the specifics of the stent delivery system having a sheath, such that the stent is configured to be stored in a distal end portion of the sheath and a shaft configured to be inserted into the sheath and to release the stent from a distal end of the sheath. Andreas et al. teach (Fig. 5B) a stent delivery system 20 with a sheath 25, such that the stent 24 is configured to be stored in a distal end portion of the sheath and a shaft 86 configured to be inserted into the sheath and to release the stent from a distal end of the sheath. It would have been obvious to one of ordinary skill in the art to utilize stent delivery system with a sheath, such that the stent is configured to be stored in a distal end portion of the sheath and a shaft configured to be inserted into the sheath and to release the stent from a distal end of the sheath.as taught by Andreas et al. with the stent of Wolinsky such that one can provide controlled delivery of the stent to the desired site for expansion.
Claim(s) 15,16 are rejected under 35 U.S.C. 103 as being unpatentable over
Wolinsky et al. (2003/0149469) in view of Letendre et al. (6214036). Wolinsky et al. is explained supra and a catheter system is used to deploy a stent (abstract). However, Wolinsky et al. did not explicitly state the specifics of the stent delivery system with a sheath, such that the stent is configured to be stored in a distal end portion of the sheath and a shaft configured to be inserted into the sheath and to release the stent from a distal end of the sheath. Letendre et al. teach (Fig. 3) a stent delivery system 40 with a sheath 50, such that the stent 12 is configured to be stored in a distal end portion of the sheath and a shaft 60 configured to be inserted into the sheath and to release the stent from a distal end of the sheath. It would have been obvious to one of ordinary skill in the art to utilize stent delivery system with a sheath, such that the stent is configured to be stored in a distal end portion of the sheath and a shaft configured to be inserted into the sheath and to release the stent from a distal end of the sheath as taught by Letendre et al. with the stent of Wolinsky such that one can provide controlled delivery of the stent to the desired site for expansion. Regarding claim 16, Letendre et al. further teach (col. 7, lines 57-63) that the stent is released from the distal end of the sheath by movement of the sheath to a proximal end side, and the stent partially exposed from the sheath can be restored in the sheath by moving the sheath to a distal end side with respect to the stent.
Allowable Subject Matter
Claims 2,4,5,7,19 would be allowable if rewritten 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 and to include all of the limitations of the base claim and any intervening claims.
Claims 17,20 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Abunassar et al. (2013/0123905) discloses a stent with connecting portions that join at junction between axial linear portions of one annular band and then to a vertice of an adjacent annular band.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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