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.
Claim(s) 4, 5-6, 10, 13, 18, 20 is/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.
Within claim 4, line 1: Applicant claims, “the first leg”; it is unclear, and therefore indefinite, which of the plurality of first legs is being referred to.
Within claim 4, lines 1-2: Applicant claims, “the second leg”; it is unclear, and therefore indefinite, which of the plurality of second legs is being referred to.
Within claim 5, line 2: Applicant claims, “a woven or braided pattern of the tubular body”; it is unclear, and therefore indefinite, how the tubular body which is made of interwoven wires (as required by claim 1, line 2) can have a braid pattern instead of a woven pattern. Claim(s) 6, which depend from claim 5, inherit all the problems associated with claim 5.
Within claim 10, lines 1-2: Applicant claims, “at least one of the first and second open ends includes a flared region” (i.e. ONLY ONE OF the open ends could have a flared region); additionally, within claim 10, lines 2-3: Applicant claims, “the flared regions” (i.e. BOTH ends must have flared regions for there to be plural flared regions); as such, it is unclear, and therefore indefinite, how many flared regions are required of the claim.
Within claim 13, line 1: Applicant claims, “the first leg”; it is unclear, and therefore indefinite, which of the plurality of first legs is being referred to.
Within claim 13, lines 1-2: Applicant claims, “the second leg”; it is unclear, and therefore indefinite, which of the plurality of second legs is being referred to.
Within claim 13, line 3: Applicant claims, “a woven or braided pattern of the tubular body”; it is unclear, and therefore indefinite, how the tubular body which is made of interwoven wires (as required by claim 11, line 2) can have a braid pattern instead of a woven pattern.
Within claim 18, lines 1-2: Applicant claims, “at least one of the first and second open ends includes a flared region” (i.e. ONLY ONE OF the open ends could have a flared region); additionally, within claim 18, line 3: Applicant claims, “the flared regions” (i.e. BOTH ends must have flared regions for there to be plural flared regions); as such, it is unclear, and therefore indefinite, how many flared regions are required of the claim.
Within claim 20, line 2: Applicant claims, “a woven or braided pattern of the tubular body”; it is unclear, and therefore indefinite, how the tubular body which is made of interwoven wires (as required by claim 19, line 2) can have a braid pattern instead of a woven pattern.
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) 11-15, 17-20 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Vong et al. (US 2013/0245745 A1- as cited by Applicant).
With respect to claim 11:
Vong et al. discloses a stent (stent 200, 810) (paragraph [0088]), as can be seen in figs. 12-14 or 62-66, comprising:
a tubular body (flow diverting layer 202) formed of a plurality of interwoven wires (wires 204) (paragraph [0090]), the tubular body (flow diverting layer 202) having a first open end and an opposing second open end, as can be seen in fig. 12; and
a plurality of repositioning and/or retrieval levers (loops 104 of stent 100) (paragraph [0052]), as can be seen in figs. 1-6, 9, 11-14, 62-66, attached to (via attachment members 206) the tubular body (flow diverting layer 202) at one or both of the first and second open ends (as can be seen in fig. 13), each of the plurality of repositioning and/or retrieval levers (lever 104) made of a material (material of wire 102 which is nitinol wire with a diameter of 0.001-0.01 inches) having a greater stiffness (due to the differences in diameter) than a material (material of wire 204 which is nitinol wire with a diameter of 0.0005-0.002 inches) forming the plurality of interwoven wires (wires 204) forming the tubular body (flow diverting layer 202) (paragraphs [0076, 0090, 0096]), each of the plurality of repositioning and/or retrieval levers (lever 104) having a loop portion (center area of loops 104 near coil members 106) and first and second legs (sections of loops 104 below coil members 106) extending from the loop portion (center area of loops 104 near coil members 106) (paragraphs [0052, 0056]), wherein each of the first and second legs (sections of loops 104 below coil members 106) extends along (in a generally parallel relationship to) a different wire portion of the plurality of interwoven wires (wires 204) of the tubular body (flow diverting layer 202) (paragraph [0152]).
With respect to claim 12:
Wherein the first and second legs (sections of loops 104 below coil members 106) extend helically along the plurality of interwoven wires (wires 204) of the tubular body (flow diverting layer 202) (paragraph [0152]), as can be seen in figs. 12-14 or 62-66.
With respect to claim 13:
Wherein the first leg (one section of loops 104 below coil members 106) extends in a first helical direction and the second leg (the other section of loops 104 below coil members 106) extends in a second helical direction opposite the first helical direction, each of the first and second legs (sections of loops 104 below coil members 106) following a woven pattern of the tubular body (flow diverting layer 202) (paragraph [0152]), as can be seen in figs. 12-14 or 62-66.
With respect to claim 14:
Wherein the first and second legs (sections of loops 104 below coil members 106) extend along 25% or more (100% - the entire length) of a length of the tubular body (flow diverting layer 202) between the first and second open ends, as can be seen in figs. 12-14 or 62-66.
With respect to claim 15:
Wherein the loop portion (center area of loops 104 near coil members 106) of each of the plurality of repositioning and/or retrieval levers (loops 104 of stent 100) extends radially outward from a longitudinal axis of the tubular body (flow diverting layer 202) at an angle of between 20 and 90 degrees, as can be seen in fig. 13 (Please note: Although Vong et al. does not disclose the figures as being drawn to scale the drawing must accurately represent the invention disclosed, as such features in the drawing must be approximately proportionally shown; as can be seen in fig. 13, the flare angle of the loop portion (center area of loops 104 near coil members 106) with respect to the longitudinal axis of the tubular body (flow diverting layer 202) appears to be about 45˚, which is within the 20-90˚ as currently claimed.)
With respect to claim 17:
Further comprising a covering (made up of support wires 814) extending over the tubular body (flow diverting layer 202), wherein the plurality of repositioning and/or retrieval levers (loops 104 of stent 100) are uncovered, as can be seen in figs. 62-67 (paragraphs [0155-0156]) (Please note: Applicant has not claimed any structure defining the covering, as such, Examiner is considering the layer created by the multiple wires (814) to make up the covering as currently claimed).
With respect to claim 18:
Wherein at least one of the first and second open ends (one end of flow diverting layer 202 with the larger diameter when the entire structure is tapered) includes a flared region (due to the overall structure being tapered) (paragraphs [0158-0159]), wherein the plurality of repositioning and/or retrieval levers (loops 104 of stent 100) are attached to the flared region due to the overall structure being tapered).
With respect to claim 19:
Vong et al. discloses a stent (stent 200, 810) (paragraph [0088]), as can be seen in figs. 12-14 or 62-66, comprising:
a tubular body (flow diverting layer 202) formed of a plurality of interwoven wires (wires 204) (paragraph [0090]), the tubular body (flow diverting layer 202) having a first open end and an opposing second open end, as can be seen in fig. 12; and
a plurality of repositioning and/or retrieval levers (loops 104 at only one end of stent 100) (paragraph [0052]), as can be seen in figs. 1-6, 9, 11-14, 62-66, attached to (via attachment members 206) the tubular body (flow diverting layer 202) at the first open end (one end of stent 100 as can be seen in fig. 13), each of the plurality of repositioning and/or retrieval levers (lever 104) made of a material (material of wire 102 which is nitinol wire with a diameter of 0.001-0.01 inches) having a greater stiffness (due to the differences in diameter) than a material (material of wire 204 which is nitinol wire with a diameter of 0.0005-0.002 inches) forming the plurality of interwoven wires (wires 204) forming the tubular body (flow diverting layer 202) (paragraphs [0076, 0090, 0096]), wherein each of the plurality of repositioning and/or retrieval levers (loops 104 at only one end of stent 100) has a loop portion (center area of loops 104 near coil members 106) extending axially away from the first open end (one end of stent 100 as can be seen in fig. 13) and first and second legs (sections of loops 104 below coil members 106) extending from the loop portion (center area of loops 104 near coil members 106) towards the second open end, as can be seen in figs. 12-14 and 62-66, the first leg (one section of loops 104 below coil members 106) extending in a first helical direction and the second leg (the other section of loops 104 below coil members 106) extending in a second helical direction opposite the first helical direction, as can be seen in figs. 12-14 and 62-66.
With respect to claim 20:
Wherein the first and second legs (sections of loops 104 below coil members 106) of the plurality of repositioning and/or retrieval levers (loops 104 at only one end of stent 100) follow a woven pattern of the tubular body (flow diverting layer 202) along 25% or more (100% - the entire length) of a length of the tubular body (flow diverting layer 202) between the first and second open ends, as can be seen in figs. 12-14 or 62-66.
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) 1-10, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vong et al. (US 2013/0245745 A1 – as cited by Applicant) in view of Norton et al. (US 7462192 B2 – as cited by Applicant).
With respect to claim 1:
Vong et al. discloses the invention substantially as claimed. Specifically, Vong et al. discloses a stent (stent 200, 810) (paragraph [0088]), as can be seen in figs. 12-14 or 62-66, comprising:
a tubular body (flow diverting layer 202) formed of a plurality of interwoven wires (wires 204) (paragraph [0090]), the tubular body (flow diverting layer 202) having a first open end and an opposing second open end (the two ends of stent 100 as can be seen in fig. 13), as can be seen in fig. 12, the tubular body (flow diverting layer 202) defining an outer surface (outermost surface of the flow diverting layer 202) extending between the first and second open ends (the two ends of stent 100 as can be seen in fig. 13); and
a plurality of repositioning and/or retrieval levers (loops 104 of stent 100) (paragraph [0052]), as can be seen in figs. 1-6, 9, 11-14, 62-66, attached to (via attachment members 206) the tubular body (flow diverting layer 202) at one or both of the first and second open ends (the two ends of stent 100 as can be seen in fig. 13), each of the plurality of repositioning and/or retrieval levers (lever 104) made of a material (material of wire 102 which is nitinol wire with a diameter of 0.001-0.01 inches) having a greater stiffness (due to the differences in diameter) than a material (material of wire 204 which is nitinol wire with a diameter of 0.0005-0.002 inches) forming the plurality of interwoven wires (wires 204) forming the tubular body (flow diverting layer 202) (paragraphs [0076, 0090, 0096]), each of the plurality of repositioning and/or retrieval levers (lever 104) having a loop portion (center area of loops 104 near coil members 106) extending radially outward of the outer surface (outermost surface of the flow diverting layer 202) of the tubular body (flow diverting layer 202) and extending axially away from the first and/or second open ends (the two ends of stent 100), as can be seen in fig. 13, of the tubular body (flow diverting layer 202).
However, Vong et al. does not disclose the each of the first and second open ends (the two ends of stent 100 as can be seen in fig. 13) being defined by a series of closes loops (as required by claim 1); nor the plurality of interwoven wires (wire 204) forming the tubular body (flow diverting layer 202) have weld joints joining wire ends at only the first open end (one end) of the tubular body (flow diverting layer 202) (as required by claim(s) 8 and 16).
Norton et al. teaches a stent (stent 10), as can be seen in figs. 1-12, comprising: a tubular body (hollow tubular structure) formed of a plurality of interwoven wires (wire 18 which are braided/ interwoven in an over under pattern) (column 4, line 48-column 5, line 3), the tubular body (hollow tubular structure) having a first open end (open end 12 or 14) and an opposing second open end (the other of open end 12 or 14), each of the first and second open ends (open ends 12, 14) defined by a series of closed loops (closed loop end 15 or cathedral type of arch/ loop) (column 8, line 9-column 9, line 14). The plurality of interwoven wires (wire 18 which are braided/ interwoven in an over under pattern) are braided/ interwoven such that the tubular body (hollow tubular structure) has weld joints (welds 76) joining wire ends at only the first open end (one end) of the tubular body (hollow tubular structure) (column 5, lines 4-50 and column 8, lines 55-65). The closed loops (closed loop end 15 or cathedral type of arch/ loop) create atraumatic ends to the tubular body (hollow tubular structure) eliminating sharp pointed ends which may damage the vascular tissue (column 5, lines 30-50).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use the weave pattern/ methodology of making the tubular body (hollow tubular structure), as taught by Norton et al., to make the weave pattern/ methodology of making tubular body (flow diverting layer 202), as both weave patterns/ methodology of making a tubular body create similar final products (woven tubular vascular implants made from nitinol wire) however the weave patterns/ methodology of making a tubular body, as taught by Norton et al., has the distinct advantage of creating a tubular body with atraumatic ends thereby eliminating sharp pointed ends which may damage the vascular tissue. (In making the aforementioned combination the wires (204) making up the woven flow diverting layer (202), as disclosed by Vong et al., will be woven using the methodology (such that there are weld joints at only one end), as taught by Norton et al., thus resulting in the wires (204) of the flow diverting layer (202), as disclosed by Vong et al., having the series of closed loops (closed loop end 15 or cathedral type of arch/ loop), as taught by Norton et al.)
With respect to claim 2:
Wherein each of the plurality of repositioning and/or retrieval levers (loops 104 of stent 100), as disclosed by Vong et al., has first and second legs (sections of loops 104 below coil members 106) extending from the loop portion (center area of loops 104 near coil members 106), as can be seen in figs. 1-6, 9, 11-14, 62-66, wherein each of the first and second legs (sections of loops 104 below coil members 106) extends along a different wire portion (wire 204) of the plurality of interwoven wires (wire 204) of the tubular body (flow diverting layer 202), as disclosed by Von et al. and modified by Norton et al. (as discussed above).
With respect to claim 3:
Wherein the first and second legs (sections of loops 104 below coil members 106) extend helically along the plurality of interwoven wires (wire 204) of the tubular body (flow diverting layer 202), as disclosed by Von et al. and modified by Norton et al. (as discussed above).
With respect to claim 4:
Wherein the first leg (one section of loops 104 below coil members 106), as disclosed by Vong et al., extends in a first helical direction and the second leg (the other section of loops 104 below coil members 106) extends in a second helical direction opposite the first helical direction, as can be seen in figs. 12-14 or 62-66.
With respect to claim 5:
Wherein the first and second legs (sections of loops 104 below coil members 106) of the plurality of repositioning and/or retrieval levers (loops 104 of stent 100), as disclosed by Vong et al., follow a woven or braided pattern of the tubular body (flow diverting layer 202) (paragraph [0152 as disclosed by Von et al. and modified by Norton et al. (as discussed above).
With respect to claim 6:
Wherein the first and second legs (sections of loops 104 below coil members 106), as disclosed by Vong et al., extend along 25% or more (100% - the entire length) of a length of the tubular body (flow diverting layer 202) between the first and second open ends, as can be seen in figs. 12-14 or 62-66.
With respect to claim 7:
Wherein the loop portion (center area of loops 104 near coil members 106) of each of the plurality of repositioning and/or retrieval levers (loops 104 of stent 100), as disclosed by Vong et al., extends radially outward from a longitudinal axis of the tubular body (flow diverting layer 202) at an angle of between 20 and 90 degrees, as can be seen in fig. 13 (Please note: Although Vong et al. does not disclose the figures as being drawn to scale the drawing must accurately represent the invention disclosed, as such features in the drawing must be approximately proportionally shown; as can be seen in fig. 13, the flare angle of the loop portion (center area of loops 104 near coil members 106) with respect to the longitudinal axis of the tubular body (flow diverting layer 202) appears to be about 45˚, which is within the 20-90˚ as currently claimed.)
With respect to claim(s) 8 and 16:
Wherein the plurality of interwoven wires (wires 204) forming the tubular body (flow diverting layer 202), as disclosed by Von et al. and modified by Norton et al., have weld joints (welds 76) joining wire ends at only the first open end of the tubular body (flow diverting layer 202) (Norton et al. column 5, lines 4-50 and column 8, lines 55-65), wherein the plurality of repositioning and/or retrieval levers (loops 104 of stent 100), as disclosed by Vong et al., are attached at the second open end (both ends) of the tubular body (flow diverting layer 202).
With respect to claim 9:
Further comprising a covering (made up of support wires 814), as disclosed by Vong et al., extending over the tubular body (flow diverting layer 202), wherein the plurality of repositioning and/or retrieval levers (loops 104 of stent 100) are uncovered, as can be seen in figs. 62-67 (paragraphs [0155-0156]) (Please note: Applicant has not claimed any structure defining the covering, as such, Examiner is considering the layer created by the multiple wires (814) to make up the covering as currently claimed).
With respect to claim 10:
Wherein at least one of the first and second open ends (one end of flow diverting layer 202 with the larger diameter when the entire structure is tapered), as disclosed by Vong et al., includes a flared region (due to the overall structure being tapered) (paragraphs [0158-0159]), wherein the plurality of repositioning and/or retrieval levers (loops 104 of stent 100) are attached to the flared region due to the overall structure being tapered).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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/REBECCA S PRESTON/ Examiner, Art Unit 3774