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 1-15 is 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 1-15: The phrase “in particular” recited throughout the claims renders any limitation occurring thereafter indefinite, as it is unclear whether this is an optional limitation or necessarily required.
Claim 1 repeats “an upstream sleeve unit end” in lines 16-17. Therefore, it is unclear whether Applicant intended to claim a different structure or two upstream sleeve unit ends.
Claims 2 and 3: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). I
Claim 2 recites the broad recitation at least 10%, and the claim also recites preferably at least 20%, more preferably 25% to 100%, in particular 40% to 80%, which are the narrower statement of the range/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 2 also recites the broad recitation 10 mm to 100 mm, and the claim also recites preferably 20 mm to 80 mm and more preferably 40 – 60 mm, which are the narrower statement of the range/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 3 recites the broad recitation at least 10%, and the claim also recites preferably at least 15%, more preferably 20% to 60%, in particular 30% to 50%, which are the narrower statement of the range/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 3 also recites the broad recitation 10 mm to 60 mm, and the claim also recites preferably 15 mm to 50 mm and more preferably 20 – 40 mm, which are the narrower statement of the range/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 5 recites “wherein at least one of the following applies” and then lists 3 parameters having various ranges. It is unclear what structure is required and what structure is optional.
Claim 5 recites the broad recitation at least 101%, and the claim also recites preferably at least 105%, more preferably 110% to 130%, in particular 115% to 125%, which are the narrower statement of the range/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 5 also recites the broad recitation 55 mm to 75 mm, and the claim also recites preferably 60 mm to 70 mm and more preferably 62 – 65 mm, which are the narrower statement of the range/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 5 also recites the broad recitation 50mm to 70 mm, and the claim also recites preferably 55 mm to 65 mm and more preferably 58-62 mm, which are the narrower statement of the range/limitations. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 6, 7, and 9 recite various ranges and are indefinite for the same reasons.
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, and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 7,708,771 (Chuter et al.).
Regarding claim 1: Chuter discloses an endograft device for treatment of ruptures in one or more inner layers of a blood vessel comprising an anchoring unit and a sleeve unit; the endograft device defines an upstream endograft end (131) and a downstream, a collapsible anchoring unit (40) located at said upstream endograft end (Figure 3B) that is configured to anchor, in said implanted state, said endograft device within said blood vessel by engaging an inner surface of said blood vessel with an expanded anchoring section (150);
a sleeve unit (130) is located downstream of said anchoring unit (40), said sleeve unit (130) is a thin-walled foldable element (see description of graft material 30) defining a longitudinal direction, a radial direction, a circumferential direction, an upstream sleeve unit end and a downstream sleeve unit end characterized in that said sleeve unit (130) comprises an unsupported section (sections of graft between stents 150 and 151 in Figure 3B) located at said upstream sleeve unit end, said unsupported section extends along said longitudinal direction and, at least in said implanted state, is unsupported over its entire circumference, said sleeve unit (130) is configured to be expanded, in said implanted state, to rest against an inner wall of said blood vessel (see description of placement within the aorta at column 4, lines 4-36), wherein the unsupported section is capable of sealingly covering a rupture.
Regarding claim 6: the sleeve unit (130) is configured to have, in a relaxed and fully expanded state free of stress in said circumferential direction, a shape that is at least section-wise substantially cylindrical.
Regarding claim 8: said sleeve (130) is linked, in said longitudinal direction, to said anchoring (40) by linking means (connector loop) of said endograft device, comprising a plurality of linking elements (connector loops 44) mutually spaced and evenly distributed along the circumferential direction. The loops (44) are slender elements elongated along the longitudinal direction. The plurality of linking elements (44) exhibit a high flexibility in a direction
transverse to said longitudinal direction, as they are filaments.
Regarding claim 9: the sleeve unit comprises polytetrafluoroethylene (PTFE) (column 15, line 10-20).
Regarding claim 10: wherein at least one of the following applies:
said anchoring unit (40) and support units (150) are self-expanding stents made from a grid of wire elements and comprise a shape memory material such as Nitinol (col 8, line 45-50).
Claim(s) 1-6, 9 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 8,945,202 (Mayberry et al.).
Regarding claim 1: Mayberry discloses an endograft device for treatment of ruptures in one or more inner layers of a blood vessel comprising an anchoring unit (122) and a sleeve unit (graft body 112), the endograft device defines an upstream endograft end and a downstream end, a collapsible anchoring unit (122) located at said upstream endograft end (Figure 11) that is configured to anchor, in said implanted state, said endograft device within said blood vessel by engaging an inner surface of said blood vessel with an expanded anchoring section (122);
a sleeve unit (112) is located downstream of said anchoring unit (122), said sleeve unit (112) is a thin-walled foldable element (see description of graft material) defining a longitudinal direction, a radial direction, a circumferential direction, an upstream sleeve unit end and a downstream sleeve unit end characterized in that said sleeve unit (112) comprises an unsupported section (112 in Figure 11) located at said upstream sleeve unit end, said unsupported section extends along said longitudinal direction and, at least in said implanted state, is unsupported over its entire circumference, said sleeve unit (122) is configured to be expanded, in said implanted state, to rest against an inner wall of said blood vessel, wherein the unsupported section is capable of sealingly covering a rupture.
Regarding claim 2: Mayberry discloses that the unsupported length (112 and 120) of the sleeve extends over at least 10% of the sleeve unit (see description of excess material (120) being 10-30% of the graft body (col 18, lines 34-46), wherein the excess material is a portion of the unsupported portion).
Regarding claim 3, Mayberry includes a supported section (112c) that is adjacent to and upstream of the unsupported portion (112b and 120) that includes a support unit (stent 124).
Regarding claim 4, the upstream end unit (112b) of the sleeve defines a diameter larger than that of the anchoring unit (122) in the expanded configuration (see Fig. 11; col 17, line 63 to col 18, line 14), therefore having a greater circumferential length.
Regarding claim 5, the diameter of the upstream end unit (112b) can have a diameter of 34 mm while the diameter of the anchor unit 122 can be 26 mm (see Fig. 11; col 17, line 63 to col 18, line 14). Therefore, the expanded circumferential length of the upstream sleeve end is at least 10% larger than that of the anchoring unit (122).
Regarding claim 6, in a relaxed and expanded state, the sleeve has a substantially cylindrical shape along its length and also has a flared portion near the upstream end (see Fig 8, 9 and 11). Although not explicitly stated, it is clearly understood from the drawings that the flared ends define a diameter 101% of the cylindrical central portion (153) of the sleeve.
Regarding claim 9: Mayberry discloses the graft material can be ePTFE (col 20, line 29-35).
Regarding claim 10, the anchoring unit (122) and support unit (124) are self-expanding stents made of a wire grid formed of a Niti alloy (col 58, line 65 to col 59).
Claim(s) 1- 3, 6, and 8-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 8,992,595 (Parsons et al.).
Regarding claim 1: Parsons discloses an endograft device for treatment of ruptures in one or more inner layers of a blood vessel comprising an anchoring unit (160) and a sleeve unit (155); the endograft device defines an upstream endograft end (154) and a downstream end (158); a collapsible anchoring unit (160) located at said upstream endograft end that is configured to anchor, in said implanted state, said endograft device within said blood vessel by engaging an inner surface of said blood vessel with an expanded anchoring section (see Fig. 4);
a sleeve unit (152) is located downstream of said anchoring unit (160), said sleeve unit (152) is a thin-walled foldable element (see description of graft material at col 6, lines 45-55) defining a longitudinal direction, a radial direction, a circumferential direction, an upstream sleeve unit end and a downstream sleeve unit end characterized in that said sleeve unit (152) comprises an unsupported section (sections of graft between stents 160 and 170 in Figure 4) located at said upstream sleeve unit end, said unsupported section extends along said longitudinal direction and, at least in said implanted state, is unsupported over its entire circumference, said sleeve unit (152) is configured to be expanded, in said implanted state, to rest against an inner wall of said blood vessel (although shown at the site of aneurysm in Figure 4 is capable of being implanted to rest against a ruptured wall).
Regarding claim 2: Parsons teaches unsupported portion of the graft length can be 5-10 cm, or 50 – 100 mm (col 16, lines 65-67). Although not explicitly stated, it can be seen from the drawings that the unsupported length is at least 10% the total length of the graft.
Regarding claim 3: Parsons discloses the sleeve has a supported section having an expandable support unit (stent 170) located adjacent the unsupported portion (153) and at a distance from the upstream sleeve unit end (154). Although not explicitly stated, it can be seen from the drawings that the unsupported length of the sleeve between stents (160 and 170) is at least 10% the total length. Additionally or alternatively, the connector rings (164 and 174) provide circumferential support to the sleeve and is on an inner side of the sleeve (see especially Figure 1A; col 6, lines 62-67).
Regarding claim 6, in a relaxed and expanded state, the sleeve has a substantially cylindrical shape along its length and also has flared portions at either end (Figure 1). Although not explicitly stated, it is clearly understood from the drawings that the flared ends define a diameter 101% of the cylindrical central portion (153) of the sleeve.
Regarding claim 8, the sleeve unit is linked to the anchoring unit by linking means (radiopaque markers 116) that are mutually spaced and distributed around the circumference of the device.
Regarding claim 9: Parsons discloses the graft material can be ePTFE (col 6, line 50-55).
Regarding claim 10, the anchoring unit (160) and support unit (164) are self-expanding stents made of a wire grid formed of a Niti alloy (col 6, line 45 to col 7, line 42).
Regarding claim 11, Parsons discloses a catheter device (Figure 2) for percutaneous insertion into a blood vessel of a patient wherein said catheter device has a proximal end and a distal (location of endograft 150 in Figure 2) end, said catheter device is configured to receive, in a catheter insertion state, said endograft
device (150) within an endograft receptacle formed at said distal end of said catheter device, said endograft device (150) being in a collapsed state when received in said endograft receptacle (defined by inner cavity of outer sheath 102) and said catheter device is configured to release, in an endograft release state, said
endograft device from said endograft receptacle (column 8, lines 29-44).
Regarding claims 12 and 13, the catheter comprises an inner core (see Figure 2) and an outer catheter sleeve (102), wherein the anchoring unit (160) is located in a receptacle between the inner core and outer sheath (102), the anchoring unit (160) is self-expanding and expands upon retraction of the outer catheter (column 8, lines 29-67).
Claim(s) 1-3 and 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent App. Pub. 2006/0020319 (Kim et al.).
Regarding claim 1: Kim discloses an endograft device for treatment of ruptures in one or more inner layers of a blood vessel comprising an anchoring unit and a sleeve unit (56); the endograft device defines an upstream endograft end (left side of Figure 2) and a downstream end (right side of Figure 2), a collapsible anchoring unit (stent 52 left of graft 56) located at said upstream endograft end (Figure 2) that is configured to anchor, in said implanted state, said endograft
device within said blood vessel by engaging an inner surface of said blood vessel
with an expanded anchoring section;
a sleeve unit (56) is located downstream of said anchoring unit (52), said sleeve unit (56) is a thin-walled foldable element (see description of graft material) defining a longitudinal direction, a radial direction, a circumferential direction, an upstream sleeve unit end and a downstream sleeve unit end characterized in that said sleeve unit (130) comprises an unsupported section (sections of graft between stents 150 and 151 in Figure 3B) located at said upstream sleeve unit end, said unsupported section extends along said longitudinal direction and, at least in said implanted state, is unsupported over its entire circumference, said sleeve unit (130) is configured to be expanded, in said implanted state, to rest against an inner wall of said blood vessel (see description of placement within the aorta at column 4, lines 4-36), wherein the unsupported section is capable of sealingly covering a rupture.
Regarding claim 2: Kim discloses that the unsupported length of the graft is 1-2 cm [0030], or 10-20 mm, which is at least 10% the total length of the graft as shown in the drawings.
Regarding claim 3, Kim includes a supported section the graft that is adjacent to and upstream of the unsupported portion (see additional stent 52 overlapping with sleeve length).
Regarding claim 9: Kim discloses the graft material can be ePTFE [0006].
Regarding claim 10, the anchoring unit (56) and support unit (56) are self-expanding stents made of a wire grid formed of a superelastic alloy [0030].
Regarding claims 11-15, Kim includes a catheter device having an inner core (27), an outer catheter sleeve (28), the endograft received in a receptacle formed between the core (27) and outer sleeve (28), elastically expanding arms (30a and 30b) on the inner core that aid in expansion of the graft ([0029]; [0038]) as the outer sleeve is retracted.
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) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chuter.
Chuter discloses the sleeve unit (130), in said longitudinal direction, is located at a distance D from said anchoring unit (40) due to the presence of connector loops (44). Chuter additionally discloses the length of the linking strut (43) can be shorter or longer, depending on the particular purpose (col 10, lines 6-17). It would have been obvious to one having ordinary skill in the art at the time the invention was made to configure each loop (44) to have a length in the longitudinal direction that is at least 5% of the maximum anchoring unit diameter of the anchoring section (40), for the purpose of tailoring the device for a particular patient’s anatomy, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 9,101,506 discloses a catheter with expanding arms (108) on the inner core and USPAP 2009/0264988 (Mafi) discloses a device expanded within a graft having a frame (134).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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