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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 2,3,8-9 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 claim 2, the recitation of "no less than 1 mm" raises an issue of indefiniteness because it is not evident of how long the protrusion length can be or what the upper limit is. Since the limitation of "no less than 1mm" encompasses values of size beyond 1 mm, one does not know the maximum value in a protrusion length. It is an open ended limitation which MPEP 2173.05 (c) states can be indefinite by lacking clear boundaries.
In addition claim 3 recites "no more than 5mm" raises an issue of indefiniteness because one does not know the lower limit or length of the hooking portion as it could even encompass 0 according to the scope no more than 5 mm since it is an open-ended limitation.
Claims 8,9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the location of movable ridge portions and fixed ridge portions so as to permit the movable ridge portion to move upon expansion. The scope of the claim encompasses movable ridge portions next to one another but also fixed ridge portions next to one another, thus would that allow the claimed function to occur? The Examiner believes not, thus the specific arrangement for the various species should be detailed in how the fixed ridge portion(s) and movable ridge portion(s) are arranged relative to one another with any other components coupled thereto to permit the function. Claim 9 depends on claim 8 and inherits the indefinite issue.
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) 1,4-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshimori et al. (WO 2021/177303) or, in the alternative, under 35 U.S.C. 103 as obvious over Lostetter et al. (2017/0281382). Fig. 1 shows a stent graft 1 comprising: a graft 30 having a cylindrical shape, see Fig. 3; and an end stent 23 connected to at least an axial end of the graft (paragraph 18 translation). Please note the recitation of “the end stent includes a hooking portion hooked on a stent constraining mechanism of a delivery device” so as to constrain expansion of the end stent is an intended use limitation as the preamble recites a product of a stent graft not a combination with any instrument. Fig. 4A shows the hooking portion is configured to shorten a protrusion length 23a of a part protruding from the axial end to an outer side in an axial direction by expansion of the axial end together with the end stent as compared with contracted state in Fig. 4B. However, in the alternative Yoshimori et al. did not explicitly disclose a delivery device with the constraining mechanism. Lostetter et al. show (Figs. 4,5) how a delivery device including a stent constraining mechanism 84 is used with a stent graft 70 having an end stent connected to an axial end of the graft. It would have been obvious to one of ordinary skill in the art to use stent constraining mechanism of a delivery device as taught by Lostetter et al. with the stent graft of Yoshimori et al. such that it provides the ability to capture and controlled for expansion from the sheath of the delivery device. Regarding claim 4, please note the recitation of “when a state in which an outer diameter of the axial end is contracted to 50% of the outer diameter thereof in a case where the graft is in a maximum expansion state is called a reference contraction state, and a maximum protrusion length of the hooking portion when the graft is in the reference contraction state is called L1, and a maximum protrusion length of the hooking portion when the graft is in the maximum expansion state is called L0, a shortening ratio expressed by equation (1) below is no less than 50%: shortening ratio (%) = {(L1 - L0)/L1} × 100 --- (1)” is conditional and a range with no specific boundaries. Please note that "determining where in a disclosed set of percentage ranges the optimum combination of percentages lies is prima facie obvious." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003); see also In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1365 (Fed. Cir. 1997) ("It is not inventive to discover the optimum or workable ranges by routine experimentation." (quoting In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995)). Thus one of ordinary skill in the art is an obvious expedient to find the optimal values to provide a ratio resulting from conditions of a maximum protrusion length of the hooking portion when the graft is in the maximum expansion state is called L0, a shortening ratio expressed by equation (1) below is no less than 50%: shortening ratio (%) = {(L1 - L0)/L1} × 100 --- (1) with the stent graft of Yoshimori as it is obvious to find optimal conditions to meet the needs of the patient. See evidence Luo et al. (CN 1736349) stating (page 4 of translation) length can be optimized for need with stents. Regarding claim 5, it can be seen (Fig. 4a) that the stent end ring 23 has flexibility shortening its length when expanded from a contracted state, Fig. 4B. Thus, it would have been obvious to one of ordinary skill in the art to provide the flexibility in the stent end ring with a variable range that due to a large diameter expansion the protrusion length can range down to zero in stretching out the ring about the circumference of the graft. Regarding claim 6, see paragraphs 18,29,31,37,38 of translation along with Figs. 1,4a, 4b. It clearly can be understood that the end stent of Yoshimori has a movable ridge portion 23a protruding to the outer side in the axial direction of the graft 30; and a plurality of fixed portions (valleys defined by 23b) provided continuously at the movable ridge portion on both sides in a circumferential direction relative to the movable ridge portion, the plurality of fixed portions being fixed to the graft via sutures 40, and the movable ridge portion is movable relative to the graft at least at an apex portion in the axial direction, and constitutes the hooking portion. With respect to claim 7, it is noted that Yoshimori discloses (paragraph 37 of translation) the end stent 23 is connected to the graft membrane 30 by sewing the intermediate line portion defined by section 23c to the graft membrane 30, as seen in Figs. 4A, 4B of which illustrates X-shaped stitching. Due to this arrangement of suturing it can be construed that the end stent has the ability to move more or less about the sutured portion. Since the suturing feature can be considered a “connecting member” these stitches are clearly configured to connect the intermediate line portion to the graft so as to be movable in a length direction of the intermediate line portion in relation to the graft.
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) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshimori et al. (WO 2021/177303) in view of Jensen et al. (2011/0125249). Yoshimori et al. is explained supra. However, Yoshimori et al. did not explicitly disclose when a state in which an outer diameter of the axial end is contracted to 50% of the outer diameter thereof in a case where the graft is in a maximum expansion state is called a reference contraction state, a maximum protrusion length L1 of the hooking portion when the graft is in the reference contraction state is no less than 1 mm. Please note claims are given their broadest reasonable interpretation and as best understood of the scope of the recited range (no upper limit). Jensen et al. teach (Figs. 4,5) an end (bare) stent 44 of a stent graft be provided a maximum protrusion length L1 of the hooking portion when the graft is in the reference contraction state is no less than 1 mm and when contracted the outer diameter is 50% of the maximum expansion state, see paragraph 12. It would have been obvious to one of ordinary skill in the art to provide when a state in which an outer diameter of the axial end is contracted to 50% of the outer diameter thereof in a case where the graft is in a maximum expansion state is called a reference contraction state, a maximum protrusion length L1 of the hooking portion when the graft is in the reference contraction state is no less than 1 mm as taught by Jensen et al. with the stent graft of Yoshimori et al. such that the appropriate support is provided against the tissue.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshimori et al. (WO 2021/177303) in view of Xiao et al. (WO 2018/072432). Yoshimori et al. is explained supra. However, Yoshimori et al. did not explicitly disclose a maximum protrusion length L0 of the hooking portion when the graft is in a maximum expansion state is no more than 5 mm. Please note claims are given their broadest reasonable interpretation and as best understood of the clause “portion” with no lower limit. Xiao et al. teach (page 4 of translation) an end (bare) stent of a stent graft be provided with a length no more than 5mm when expansion occurs. It would have been obvious to one of ordinary skill in the art to provide a segment exposed after expansion to be no more than 5mm as taught by Xiao et al. with the stent graft of Yoshimori et al. such that the appropriate support is provided against the tissue.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshimori et al. (WO 2021/177303) in view of Arbefeuille (2007/0055347). Yoshimori et al. is explained supra. However, Yoshimori et al. did not explicitly disclose the plurality of ridge portions are formed by at least a plurality of wave portions each extending in the circumferential direction and forming a wave shape, the plurality of wave portions include: a first wave portion forming a wave shape of a first wavelength; and a second wave portion forming a wave shape of a second wavelength longer than that of the first wavelength, and the movable ridge portion is composed of a ridge portion of the second wave portion. Arbefeuille teaches (Fig. 1) a stent ring defined with a plurality of ridge portions formed by at least a plurality of wave portions each extending in the circumferential direction and forming a wave shape, the plurality of wave portions include: a first wave portion forming a wave shape of a first wavelength; and a second wave portion forming a wave shape of a second wavelength longer than that of the first wavelength. It would have been obvious to one of ordinary skill in the art to provide a stent end ring with ridge portions formed by at least a plurality of wave portions each extending in the circumferential direction and forming a wave shape such that there is a first wave portion forming a wave shape of a first wavelength and a second wave portion forming a wave shape of a second wavelength longer than that of the first wavelength as taught by Arbefeuille with the stent graft of Yoshimori et al. such that the appropriate support is provided against the tissue wall, see Arbefeuille paragraph 18.
Allowable Subject Matter
Claim 10 is 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.
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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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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