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 .
Election/Restrictions
The applicant’s election of group I directed towards a medical delivery device system without traverse is acknowledged.
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) 1-2, 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stephens (WO2015/105530A1).
In regard to claim 1, Stephens discloses a medical device delivery system 100 comprising:
an elongate member 172 having a main lumen 104 configured to contain a main guidewire 102
and at least one secondary lumen 200 configured to releasably contain a secondary guidewire 202
the secondary lumen 200 configured to release a first portion of the secondary guidewire 202 when an implantable medical device (124, 106) is advanced along the main guidewire 102 to a first longitudinal position proximate the first portion of the guidewire and configured to release a second portion of the guidewire when the implantable medical device is advanced along the main guidewire to a second longitudinal position proximate the second portion of the guidewire. [0088; 0092; Figure 4; the guidewire moves relative to the implant which is interpreted as releasing]
In regard to claim 2, Stephens discloses the medical device delivery system of claim 1, and further discloses the elongate member 172 comprises a radially stiff material. [0059: high density polyethylene; 0023: placed in lumen to help retain its shape: nitinol wire helix laminated in; braided metal tubing ]
In regard to claim 8, Stephens meets the claim limitations as discussed in the rejection of claim 1, and further discloses the secondary lumen 200 is operable to restrict the secondary guidewire 202 from interweaving with the main guidewire 102 along a length of the secondary wire contained by the secondary lumen. By using separate lumens, interweaving is prevented to some extent because the wires are kept separate.
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) 4-5, 6-7, 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stephens (WO2015/105530A1) in view of Hamer (2007/0083215A1).
In regard to claim 4, Stephens meets the claim limitations as discussed in the rejection of claim 1, but does not teach an opening into the secondary lumen is defined in the elongate member between the secondary lumen and main lumen.
Hamer teaches an opening into the secondary lumen 112 is defined in the elongate member between the secondary lumen and the main lumen 130 along a longitudinal length of the elongate member. (see opening toward the center of 130 within 112 and 116 in figure 21).
It would have been obvious to one of ordinary skill in the art of catheters and branched stents at the time the invention was filed to use the secondary lumen configuration of Hamer in place of the secondary lumen of Stephens because the configuration prevents entanglement of the guidewires [0081] while still allowing multiple guidewires to pass [0006].
In regard to claims 6-7, Stephens meets the claim limitations as discussed in the rejection of claim 1, but does not teach a partition in the main lumen of the elongate member.
Hamer teaches a partition positioned in the main lumen of the elongate member, the partition defining the secondary lumen. [0051: flexible disruptable partitions forming several lumens] wherein the partition comprises a single sheet of material. In figures 19A, 19B the three lumens are continuous and therefore comprise a single sheet. Further, as currently written, the claim requires at least a single sheet, not only a single sheet.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the partition of Hamer in the lumen of Stephens because the partitions provide a means to prevent entanglement of the guidewires [0051].
In regard to claim 9, Stephens teaches a medical device delivery system comprising:
an elongate member 172 having a main lumen 104 configured to contain a main guidewire 102
and a secondary lumen 200 within the main lumen 104 configured to contain a secondary guidewire 202 along at least a portion of a longitudinal length of the elongate member 172.
However, Stephens does not teach a removable partition.
Hamer teaches a partition removably positioned within the elongate member, the partition forming at least one secondary lumen within the main lumen,
the partition configured to sequentially disrupt (capable of sequential disruption depending on the guidewires/catheter the partition is used with since individual portions are capable of separate disruption due to their structure) along the longitudinal length of the elongate member to free the secondary guidewire from the secondary lumen when the elongate member is removed from surrounding the partition and as an implantable medical device is advanced along the main guidewire, the partition including a disruptable seam. [0051: flexible disruptable partitions forming several lumens]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the partition of Hamer in the lumen of Stephens because the partitions provide a means to prevent entanglement of the guidewires [0051].
In regard to claim 10, Stephens meets the claim limitations as discussed in the rejection of claim 9, but does not teach the partition as claimed.
Hamer further teaches a portion of the partition is configured to release a portion of the secondary guidewire into a lumen of the medical device when the portion of the partition is disrupted. [0006: as the multi-lumen device is advanced through the introducer sheath, the disruptable barrier tears to form fewer lumens]
In regard to claim 11, Stephens meets the claim limitations as discussed in the rejection of claim 9, but does not teach the partition as claimed.
Hamer further teaches the partition subdivides the main lumen to include at least two secondary lumens. [0006: at least two separate lumens, separated by disruptable barriers; see barriers 46, 48 in figure 2A; figures 19A-B; 122 in figure 20]
In regard to claim 12, Stephens meets the claim limitations as discussed in the rejection of claim 9, but does not teach the partition as claimed.
Hamer further teaches the partition comprises a sheet of material. In figures 19A-B the lumens are made of a sheet. Further see partitions 46 and 48 in figure 2A.
In regard to claim 13, Stephens meets the claim limitations as discussed in the rejection of claim 9, but does not teach the partition as claimed.
Hamer further teaches the partition is folded to form the secondary lumen. Folded ius a product-by-process limitation, patentable only based on the resulting structure. See the lumens in figures 19a-b, 17A-B which have creases/folds between lumens.
In regard to claim 14, Stephens meets the claim limitations as discussed in the rejection of claim 9, but does not teach the partition.
Hamer further teaches the partition includes an adhesive [0072: assembly can be wrapped with adhesive coated film] for releasably coupling a first edge of the partition to a second edge of the partition. [0072]
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stephens (WO2015/105530A1) in view of Weber (8562566B2).
In regard to claim 5, Stephens meets the claim limitations as discussed in the rejection of claim 1, but does not teach an opening into the secondary lumen is defined through an outer radial surface of the elongate member.
Weber teaches an opening into the secondary lumen (32) is defined through an outer radial surface (via 34) of the elongate member along a longitudinal length of the elongate member (fig 2, 3A).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the secondary lumen configuration of Weber in place of the secondary lumen of Stephens because this reduces wire crossing during advancement of the catheter (Col 2, lines 1-2).
Claim(s) 3, 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stephens (WO2015/105530A1) in view of Golden (8876704B2).
In regard to claim 3, Stephens meets the claim limitations as discussed in the rejection of claim 1, but does not teach the secondary lumen is formed in a wall of the elongate member.
Golden teaches the elongate member 36 having at least one secondary lumen 60 formed in a wall of the elongate member 36 (see figure 3, at least partially within wall 82, via channel 78).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the secondary lumen configuration of Golden to contain the secondary lumen of Stephens within the main lumen because this configuration through the exterior wall allows for rapid exchange capabilities. (Col 8, lines 43-55).
In regard to claim 15, Stephens teaches a medical device delivery system 100 comprising:
an elongate member 172 having a wall and a main lumen 104,
the main lumen 104 configured to contain a main guidewire 102 the wall having an inner surface and an outer surface,
the elongate member 172 having at least one secondary lumen 200 the at least one secondary lumen configured to releasably contain a secondary guidewire 202.
However, Stephens does not teach the at least one secondary lumen is defined at least partially between the inner surface and outer surface of the wall (of the elongate member).
Golden teaches the elongate member 36 having at least one secondary lumen 60 defined at least partially between the inner surface and outer surface of the wall (see figure 3, at least partially within wall 82, via channel 78).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the secondary lumen configuration of Golden to contain the secondary lumen of Stephens within the main lumen because this configuration through the exterior wall allows for rapid exchange capabilities. (Col 8, lines 43-55).
Please note, the claim does not require for the secondary lumen to be completely located between the interior and exterior wall.
In regard to claim 16, Stephens meets the claim limitations as discussed in the rejection of claim 15, and further teaches the at least one secondary lumen 200 is configured to sequentially release (sequential release is interpreted in the instant disclosure as inch by inch or stepwise; as moving relative to the implant) the secondary guidewire 202 (see figure 4; [0088]).
In regard to claim 17, Stephens meets the claim limitations as discussed in the rejection of claim 15, and further teaches the at least one secondary lumen 200 is configured to release a first portion of the secondary guidewire 202 when an implantable medical device is advanced along the main guidewire to a first longitudinal position proximate the first portion of the guidewire and configured to release a second portion of the guidewire when the implantable medical device is advanced along the main guidewire to a second longitudinal position proximate the second portion of the guidewire. [0088; figure 4; release is interpreted as moving relative to the implant]
In regard to claim 18, Stephens meets the claim limitations as discussed in the rejection of claim 15 but does not teach wherein an opening into the at least one secondary lumen is defined through the inner surface of the wall along a longitudinal length of the elongate member.
Golden teaches an opening 78 into the at least one secondary lumen 60 is defined through the inner surface (extends completely through the wall which includes the interior and exterior surface) of the wall 82 along a longitudinal length of the elongate member. (fig 3)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the secondary lumen configuration of Golden to contain the secondary lumen of Stephens within the main lumen because this configuration through the exterior wall allows for rapid exchange capabilities. (Col 8, lines 43-55).
It is recommended to further clarify the structure of the secondary lumen in this claim.
In regard to claim 19, Stephens meets the claim limitations as discussed in the rejection of claim 15, but does not teach an opening into the at least one secondary lumen is defined through the outer surface of the wall along a length of the elongate member.
Golden further teaches an opening into the at least one secondary lumen 60 is defined through the outer surface of the wall 78 along a longitudinal length of the elongate member. (fig 3, the opening 78 into 60 extends completely through the wall which includes the interior and exterior portions of the wall.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the secondary lumen configuration of Golden to contain the secondary lumen of Stephens within the main lumen because this configuration through the exterior wall allows for rapid exchange capabilities. (Col 8, lines 43-55).
It is recommended to further clarify the structure of the secondary lumen in this claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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