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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-7 and 9-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou (US Pub No.: 2016/0296730).
Regarding claim 1, Zhou (US Pub No.: 2016/0296730) discloses an expandable sheath (the device in figures 19-20, inner expanding material in the abstract) comprising: an inner tubular layer radially movable between an expanded state and a non-expanded state (part 40 in figure 20, defined in [0084]), the inner tubular layer including a first and second reinforcing member extending along a length of the inner tubular member (the inner layer 42 may include a plurality of rods 60 in [0083], where the rods can be defined as a subset of reinforcing members), the inner tubular layer including a first segment and a second segment extending between a first and second longitudinally extending end of the first segment (being the segments of the inner wall part 42 that extend between a first and second end in the annotated figure below, where, as part 42 bends in multiple directions, multiple segments are shown), wherein, in the non-expanded state (being the state of the device in figure 20), at least a portion of the second segment extends between the first and second reinforcing members (being the second segment that extends between rods) and defines a folded region of the inner tubular layer, wherein, in the expanded state, the folded region at least partially unfolds (in [0093]-[0094, folded region 42 unfolds).
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Annotated Figure 1
Regarding claim 2, Zhou discloses the expandable sheath of claim 1, wherein, in the expanded state, the first and second longitudinally extending ends of the first segment of the inner tubular layer expand apart with the second segment extending therebetween (in [0093]-[0094], folded region 42 unfolds).
Regarding claim 3, Zhou discloses the expandable sheath of claim 1, wherein, in the expanded state, at least a portion of both the first and second reinforcing members are spaced circumferentially around the inner tubular layer with the second segment of the inner tubular layer extending therebetween (parts 60 in figures 19 and 20 are be spaced circumferentially around part 42 when part 42 expands in [0093]-[0094]), and a spacing between the first and second reinforcing members is increased(the spacing between part 60s increase as part 42 expands).
Regarding claim 4, Zhou discloses the expandable sheath of claim 1, wherein the first segment of the inner tubular layer is thicker in a radial direction than the second segment of the inner tubular layer (the inner segments of part 42 are thicker than the outermost segments of part 42 in figure 20).
Regarding claim 5, Zhou discloses the expandable sheath of claim 1, wherein at least one of the first or second reinforcing members extends along an entire length of the inner tubular layer (in [0070]).
Regarding claim 6, Zhou discloses the expandable sheath of claim 1, wherein at least one of the first or second reinforcing members are coupled to the inner tubular layer (shown in figures 9-10).
Regarding claim 7, Zhou discloses the expandable sheath of claim 1, wherein at least one of the first or second reinforcing members is embedded in the inner tubular layer (in the arrangement of figure 19 as per [0083]).
Regarding claim 9, Zhou discloses the expandable sheath of claim 1, wherein at least one of the first or second reinforcing members has a curvilinear shape in cross-section (the circular shape of part 60 in figures 19 and 20 is curvilinear)
Regarding claim 10, Zhou discloses the expandable sheath of claim 1, wherein at least one of the first or second reinforcing members has a circular shape in cross-section (the circular shape of part 60 in figures 19 and 20).
Regarding claim 11, Zhou discloses the expandable sheath of claim 1, wherein the at least a portion of the first and second reinforcing members are spaced circumferentially around the second segment of the inner tubular layer in both the non-expanded state and the expanded state (rods 60 are spaced about the inner tubular member in figure 19-20, which are the non-expanded state. [0094] states that the rods 60 extend axially and reduce unfolding resistance, which implies that rods 60 are still present when an expansion occurs).
Regarding claim 12, Zhou discloses the expandable sheath of claim 1, further comprising: an elastic outer tubular layer extending over the inner tubular layer (elastic outer tubular layer 40 in [0064], extends over inner laver 42 in [0064]-[0065]), wherein an outer tubular layer distal portion and an inner tubular layer distal portion are adhered to each other in a sealed configuration (adhering of outer and inner layers in [0012] and [0078]).
Regarding claim 13, Zhou discloses the expandable sheath of claim 1, further comprising: an elastic outer tubular layer extending over the inner tubular layer (in [0064]-[0065]), wherein the outer tubular layer is radially movable with the inner tubular layer between the expanded state and the non-expanded state (part 40 is movable with part 42 into an expanded state in [0079], a radial movement of the outer layer occurs when an inner layer expands. Part 40 compresses part 42 in [0069]),
and wherein the outer tubular layer urges the inner tubular layer towards the non-expanded state (in [0076]-[0077]).
Regarding claim 14, Zhou teaches an expandable sheath (the device in figures 19-20, inner expanding material in the abstract) comprising: an inner tubular layer radially movable between an expanded state and a non-expanded state (part 40 in figure 20, defined in [0084]), the inner tubular layer including a plurality of reinforcing members extending along a length of the inner tubular layer (the inner layer 42 may include a plurality of rods 60 in [0083], where the rods can be defined as a subset of reinforcing members), the plurality of reinforcing members including: a first, second, and third reinforcing member (being the segments of the inner wall part 60 that extends between a first and second end in the annotated figure below, where, as part 60 bends in multiple directions, multiple segments are shown. Said members can be divided and/or labeled as a first, second, and third member), where at least a portion of the first, second and third reinforcing members are spaced circumferentially around the inner tubular layer in both the expanded and non-expanded state (parts 60 in figures 19 and 20 are be spaced circumferentially around part 42 when part 42 expands in [0093]-[0094]), wherein the inner tubular layer includes a first segment and a second segment extending adjacent the second segment (being the segments of the inner wall part 42 that extends between a first and second end in the annotated figure below, where, as part 42 bends in multiple directions, multiple segments are shown), wherein, in the non-expanded state, at least a portion of the second segment extends between the first and second reinforcing members and defines a folded region of the inner tubular layer (being the folded region in figure 20 and annotated figure 1 between the first and second end. Said segments extend between different reinforcing members 60 in said figures), wherein, in the expanded state, the folded region at least partially unfolds (in [0093]-[0094, folded region 42 unfolds).
Regarding claim 15, Zhou discloses the expandable sheath of claim 14, wherein each of the plurality of reinforcing members extend along an entire length of the inner tubular layer (in [0070]).
Regarding claim 16, Zhou discloses the expandable sheath of claim 14, wherein each of the plurality of reinforcing members are coupled to the inner tubular layer (shown in figures 9-10).
Regarding claim 17, Zhou discloses the expandable sheath of claim 14, wherein at least one of the plurality of reinforcing members is embedded in the inner tubular layer (in the arrangement of figure 19 as per [0083]).
Regarding claim 18, Zhou discloses the expandable sheath of claim 14, wherein at least one of the plurality of reinforcing members has a curvilinear shape in cross-section (the circular shape of part 60 in figures 19 and 20 is curvilinear).
Regarding claim 19, Zhou discloses the expandable sheath of claim 14, further comprising: an elastic outer tubular layer extending over the inner tubular layer (elastic outer tubular layer 40 in [0064], extends over inner layer 42 in [0064]-[0065]), wherein an outer tubular layer distal portion and an inner tubular layer distal portion are adhered to each other in a sealed configuration (adhering of outer and inner layers in [0012] and [0078]).
Regarding claim 20, Zhou discloses the expandable sheath of claim 14, further comprising: an elastic outer tubular layer extending over the inner tubular layer (in [0064]-[0065]), wherein the outer tubular layer is radially movable with the inner tubular layer between the expanded state and the non-expanded state (part 40 is movable with part 42 into an expanded state in [0079], a radial movement of the outer layer occurs when an inner layer expands. Part 40 compresses part 42 in [0069]), and wherein the outer tubular layer urges the inner tubular layer towards the non-expanded state (in [0076]-[0077]).
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (US Pub No.: 2016/0296730) in view of Wrobel (US Pub No.: 2016/0235561).
Regarding claim 8, Zhou teaches that the expandable sheath of claim 1. However, Zhou does not teach wherein at least one of the first or second reinforcing members has a rectilinear shape in cross-section.
Wrobel (US Pub No.: 2016/0235561) teaches wherein at least one of the first or second reinforcing members has a rectilinear shape in cross-section (part 34 in [0066] has a rectilinear cross section in [0067]. Part 34 is part of an anti-migration ring 30 in [0066] that provide a reinforcement to a tubular structure to prevent a migration of the device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a rectilinear cross-section as presented in Wrobel for the purpose of providing a shape of an elongate portion that has elements in a head and a gear rack in [0067] that allow for a one way movement of the device, where a diameter change of the anti-migration feature is also disclosed. This allows for the device of Worbel to have an adjustable diameter in response to an applied force in [0064].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fitterer (US Pub No.: 2016/0213882) considered for an expandable sheath with a membrane in the abstract. Voss (US Pub No.: 2008/0004571) disclosed for an introducer sheath with an expanding means in [0006].
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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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