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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/JP2021/048280, filed on 12/24/2021.
Election/Restrictions
Applicant’s election of Specie A, to stents shown in Fig. 4 in the reply filed on 2/16/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 8, 9, 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie of stent, there being no allowable generic or linking claim.
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.
The term “endless” in claim 1 is a relative term which renders the claim indefinite. The term “endless” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The recited element defined by the clause “endless linear component” implies an unending, limitless structure which would be impossible. Thus the claim (1) is indefinite and its dependents.
Additionally the term “closest” in claims 2,17,20 is a relative term which renders the claims indefinite. The term “closest” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The recited location defined by the term “closest” implies in close proximity but is impossible to know exactly which direction is intended since there are a plurality of vertices near, but no boundaries are implied by the term to limit it to a specific location.
Further the clause “slightly closer” in claim 5 is a relative phrase which renders the claim indefinite. The clause “slightly closer” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The recited location defined by the clause “slightly closer” implies in close proximity but is impossible to know exactly which direction is intended since there are a plurality of vertices near, but no boundaries are implied by the phrase to limit it to a specific location.
In claim 10, the recitation of “one end side bent portion that is a free end except for the annular body located at one end” is ambiguous because the claim (1) from which claim 10 depends recites a “plurality” of annular bodies, so it is not evident which one is meant for this feature.
In claim 12, the claim recites features already recited in claim 1 from which it depends, but uses broadening terms such “portions” and “ends” such that it impossible to discern what further elements are being defined or where features are specifically located with any degree of certainty.
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) 1-3,5,6,11,14,17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jang (WO 99/38457). Jang shows (Fig. 3) shows an in-vivo indwelling stent 10 comprising: a plurality of annular bodies 32, each of the plurality of annular bodies formed in a circular shape with one endless linear component arranged in an axial direction, and adjacent annular bodies of the plurality of annular bodies being connected by connection portions 44; each of the plurality of annular bodies includes a plurality of one end side bent portions 48 located on one end side in the axial direction of the stent, a plurality of other end side bent portions 48 located on the other end side in the axial direction of the stent, and a plurality of connection linear portions 42 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 includes: axial linear portions (shown with axis 60”’ in Fig. 4) having one end side vertices of the one end side bent portions as starting ends, extending so as to be parallel to the axial direction of the stent as compared with the other portion of the connection linear portions, and having a shorter axial length than an axial length of the plurality of annular bodies (see also 42’’’ in Fig. 4); and bent portions 92 “ defined in Fig. 4 having starting ends at terminal ends of the axial linear portions, extending in angled circumferential direction of the stent and in a direction away from the one end side vertices, and having terminal ends connected to a remaining portion of the one of the connection linear portions 42’’’ defined in Fig. 4. Additionally Figs. 3,4 show the connection portions 44,44’’ respectively connecting the terminal ends of the axial linear portions and the one end side vertices of the annular body adjacent to the annular body having the axial linear portions on the other end side in the axial direction of the stent. Regarding claims 2,17, the connection portions include (see Fig. 4 for reference): connection portion parallel portions (defined by portion 72’’) having one ends at the terminal ends of the axial linear portions and extending substantially parallel to the axial direction of the stent; and connection portion inclined portions 74” extending obliquely in the circumferential direction and the axial direction of the stent from the other ends of the connection portion parallel portions, and terminal ends of the connection portion inclined portions are connected via portion 68” to one end side vertices other than the closest one end side vertices of the adjacent annular body. Regarding claim 3, as seen in Fig. 4, reference axis 60’’’ shows the axial linear portions are straight-line portions elongated along the axial direction of the stent. With respect to claim 5, see Fig. 4 which can be construed to illustrate as best understood terminal ends of the connection portion parallel portions of the connection portions are located on the same side as the other end side vertices of the annular body including the axial linear portions to which one ends of the connection portions are connected or slightly closer to the other end side of the stent than the other end side vertices in the axial direction of the stent in an expanded state of the stent, and are located on the same side as the other end side vertices of the annular body including the axial linear portions to which the one ends of the connection portions are connected or slightly closer to the one end side of the stent than the other end side vertices in the axial direction of the stent in a contracted state of the stent. Regarding claim 6, it can be construed that the strut portion opposite the axial linear portions is shorter and thus it is reasonable to interpret the clause the connection linear portions that connect the terminal ends of the axial linear portions and the other end side vertices of the other end side bent portions are shorter than the connection linear portions that connect the one end side vertices of the one end side bent portions and the other end side vertices of the other end side bent portions since the annular bodies essentially alternate orientations. With respect to claim 11, it can be construed that 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 44, see Fig. 3. Please note it must be understood that all elements defined as part of the struts considered axial portions, inherently have two terminal ends and the end near the vertices clearly join with the connectors of adjacent annular bodies. Regarding claim 14, Fig. 1 shows the stent is formed in a substantially cylindrical shape. Jang also discloses (page 16, lines 11-13) that the stent 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 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) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jang (WO 99/38457) in view of Dreher (8323331). Jang is explained supra. However, Jang did not explicitly state the stent does not have a one end side bent portion that is a free end except for the annular body located at one end. Dreher teaches (Fig. 6) a stent in which there is a free end 43 on one of the annular bodies. It would have been obvious to one of ordinary skill in the art to utilize a free end on an annular body as taught by Dreher in the stent of Jang such that one can provide a flexible annular body.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Jang (WO 99/38457) in view of Nissl (DE 102013104062). Jang is explained supra. However, Jang 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 Jang 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 Jang (WO 99/38457) in view of Andreas et al. (2007/0276461). Jang is explained supra. However, Jang did not explicitly state a 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. 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 Jang 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 Jang (WO 99/38457) in view of Letendre et al. (6214036). Jang is explained supra. However, Jang did not explicitly state a 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. Andreas 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 Jang 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.
Claim(s) 4,19,20 are rejected under 35 U.S.C. 103 as being unpatentable over Jang (WO 99/38457) in view of Wolinsky et al. (6730116). Jang is explained supra. However, Jang did not explicitly state the axial linear portions and the connection portion parallel portions of the connection portions have a continuous linear shape. It is noted that Jang shows axial linear portions defined by axis 60”’and connection portion parallel portions 68” or 72”of the connection portions, just not a continuous linear shape. Wolinsky et al. teach (Fig. 5) that there can be an axial linear portion of an annular body that is a [AltContent: textbox (Continuous linear shape)]continuous linear shape with a connection portion parallel portion to alleviate stress at [AltContent: connector]connections.
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Axial linear portion)][AltContent: textbox (Connection portion parallel portion)]
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It would have been obvious to one of ordinary skill in the art to provide an axial linear portion with one connection portion parallel portion of the connection portions as taught by Wolinsky et al. in the stent of Jang in order to aligning these two sections and reducing stress, see Wolinsky, col. 4, lines 38-40,44-51. Regarding claim 19, the same explanation is used as presented herein for rejecting claim 4 since it is the same scope or limitation. Regarding claim 20, please note the explanation is the same with Jang detailed above for claims 1,2, and the feature of claim 4 included in claim 20 which thus is taught and detailed here by Wolinsky since the claim (20) recites features or limitations of these other claims.
Allowable Subject Matter
Claim 7 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.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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