/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771 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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 07/26/2024, 05/30/2025, and 09/26/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements is being considered by the examiner. Examiner notes, in the IDS filed on 07/26/2024, the NPL cited referred to a date of August 22, 2024, which was not present in the attached/provided NPL, as such the IDS was annotated to refer to a date of May 09, 2023, the date of mailing of the NPL cited; and the IDS filed on 09/26/2025 provided an incorrect publication date for the foreign reference, CN 207768570, the IDS has been annotated to provide the correct publication date of August 28, 2018.
Claim Objections
Claims 17 and 18 are objected to because of the following informalities:
Claim 17 should be amended to the following, “The delivery device for the spring coil of claim 9, wherein the first interlocking member and the second interlocking member each comprise an interlocking notch and an interlocking protrusion, the interlocking protrusion of the second interlocking member is inserted into the interlocking notch of the first interlocking member, and the interlocking protrusion of the first interlocking member is inserted into the interlocking notch of the second interlocking member.”
Claim 18 should be amended to the following, “The delivery device for the spring coil of claim 8, wherein the spring coil unit comprises a spring coil, a first interlocking member is connected to a proximal end of the spring coil, and the distal end of the delivery unit is provided with a second interlocking member configured to engage with or separate from the first interlocking member; and
wherein the second interlocking member comprises a support rod, and the support rod is inserted into a distal end of the developing spring.”
Appropriate correction is required.
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 1-20 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.
Claim 1 recites in part, “an introducer sheath unit, comprising an introducer sheath, wherein the spring coil unit and the delivery unit are disposed in the introducer sheath; wherein the introducer sheath further comprises a first cone tube, wherein the first cone tube is disposed at a distal end of the introducer sheath, and a diameter of the first cone tube gradually decreases from a proximal end of the first cone tube to a distal end of the first cone tube, wherein the proximal end of the first cone tube is connected to the introducer sheath.” The claim is indefinite because it contains an internal structural inconsistency. The phrase “the introducer sheath further comprises a first cone tube” implies that the first cone tube is part of or included within the introducer sheath. However, the subsequent limitation requires that the proximal end of the first cone tube “is connected to the introducer sheath.” It is unclear to one of ordinary skill in the art whether the first cone tube is intended to be (1) an integral portion of the introducer sheath, (2) a separate component that is attached to the distal end of the introducer sheath, or (3) some other structural arrangement. This ambiguity renders the metes and bounds of the claim unclear.
For purposes of examination, the Examiner interprets claim 1 under the broadest reasonable interpretation (BRI) consistent with the specification as requiring: an introducer sheath unit comprising an introducer sheath (in which the delivery unit and spring coil unit are disposed) and a first cone tube disposed at (and connected to) the distal end of the introducer sheath, wherein the first cone tube tapers such that its diameter gradually decreases in the distal direction, with its larger proximal end connected to the introducer sheath (see specification Page 8-9 (corresponds to paragraphs [0051]-[0052] of the PGPUB of the current application) and Figure 2). The Examiner notes, however, that the claim language remains indefinite due to the inconsistency described above.
Claims 2-20 are rejected by virtue of their dependency on claim 1.
Claim 2 depends on claim 1 and recites, “wherein a diameter of the introducer sheath gradually increases from a proximal end of the introducer sheath to the distal end of the introducer sheath.” The claim is indefinite because when read in light of claim 1, it creates a further internal inconsistency regarding the geometry of the introducer sheath. Claim 1 (under its “further comprises” language) requires the introducer sheath to include or be connected to a first cone tube whose diameter gradually decreases from its proximal end to its distal end. In contrast, claim 2 requires the introducer sheath (as a whole) to have a diameter that gradually increases from its proximal end to its distal end. It is unclear how these two diametric profiles can coexist across the same introducer sheath. For example, it is not clear where any increasing taper would end and the decreasing taper of the first cone tube would begin, whether the cone tube is excluded from the “gradually increases” limitation, or whether local variations or transitions are permitted. One of ordinary skill in the art would not be able to determine with reasonable certainty the required overall shape and diametric transitions of the introducer sheath.
For purposes of examination, the Examiner interprets claim 2 under BRI (in light of the specification at page 9 (corresponds to paragraph [0052] of the PGPUB of the current application)) as attempting to claim an embodiment in which the introducer sheath (or at least a proximal-to-intermediate portion thereof) has a diameter that gradually increases moving distally, prior to or in addition to the distal first cone tube that tapers in the opposite direction. However, because of the conflicting tapering requirements between claims 1 and 2, the precise boundaries of the claimed diametric profile remain unclear, and the claim is indefinite.
Claims 3 and 11-12 are rejected by virtue of their dependency on claim 2.
Claim 3 which is dependent on claim 2 recites, “wherein the introducer sheath comprises a delivery tube, a straight tube, and a second cone tube, a diameter of the straight tube is smaller than a diameter of the delivery tube, a distal end of the delivery tube is connected to the proximal end of the first cone tube, and a proximal end of the delivery tube is connected to a distal end of the straight tube through the second cone tube.” The claim is indefinite because it further compounds the inconsistencies in the claim chain. Claim 2 requires the introducer sheath diameter to gradually increase from proximal to distal end. Claim 3 introduces a smaller-diameter straight tube that transitions via a second cone tube to a larger-diameter delivery tube, which then connects to the (decreasing) first cone tube. It is unclear whether this multi-section structure with a smaller proximal straight tube and multiple tapering transitions satisfies or contradicts the “gradually increases” limitation of claim 2 across the entire introducer sheath. The exact required diametric profile and the permissible transitions cannot be determined with reasonable certainty.
For purposes of examination, the Examiner interprets claim 3 under BRI consistent with the specification (Pages 9-10 (corresponds to paragraphs [0053]–[0055] of the PGPUB of the current application) and Figure 2) as reciting a sectional introducer sheath having: (1) a smaller-diameter straight tube (for limiting movement when not in use), (2) a second cone tube transition, (3) a larger-diameter delivery tube, and (4) the distal first cone tube attached to the delivery tube. However, the conflicting “gradually increases” requirement from claim 2 renders the overall geometry ambiguous, and the claim remains indefinite.
Claims 11-12 are rejected by virtue of their dependency on claim 3.
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, 9, 17, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pederson (US 2018/0133435 A1).
Regarding claim 1, as best understood in view of the 112(b) rejection above, Pederson discloses, a delivery device (Figures 1-2, medical device system (100); Paragraph [0047]) for a spring coil (Figures 1-2, medical device (130); Paragraph [0048]), comprising:
a delivery unit (Figures 1-2, elongate shaft (110) & securement member (140); Paragraphs [0047]-[0052]);
a spring coil unit (Figures 1-2, medical device (130) & second portion (174) of release mechanism (170); Paragraphs [0048] & [0054]), wherein a proximal end of the spring coil unit is detachably connected to a distal end of the delivery unit (Paragraph [0054]); and
an introducer sheath unit (Figures 1-2, microcatheter (190); Paragraph [0049]), comprising an introducer sheath (See annotated Figure 2 below, (Introducer sheath)), wherein the spring coil unit and the delivery unit are disposed in the introducer sheath (Paragraph [0049]);
wherein the introducer sheath unit further comprises a first cone tube (See annotated Figure 2 below, (First cone tube)), wherein the first cone tube is disposed at a distal end of the introducer sheath unit (As seen in Figures 1-2, the (First cone tube) is clearly at a distal end of microcatheter (190)), and a diameter of the first cone tube gradually decreases from a proximal end of the first cone tube to a distal end of the first cone tube (Figures 1-2 and 5-6 clearly show the (First cone tube) as tapering, where a diameter of the (First cone tube) gradually decreases from a proximal end of the (First cone tube) to a distal end of the (First cone tube)), wherein the proximal end of the first cone tube is connected to the introducer sheath (As seen in the Figures the proximal end of the (First cone tube) is indeed connected to the (Introducer sheath)).
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Regarding claim 9, Pederson further discloses, wherein the spring coil unit (medical device (130) & second portion (174) of release mechanism (170)) comprises a spring coil (Figures 1-2, medical device (130); Paragraph [0048]), a first interlocking member (Figures 2 and 5-7, second portion (174) of release mechanism (170); Paragraph [0054]) is connected to a proximal end of the spring coil (Figures 2 and 5-7; Paragraph [0054]), and the distal end of the delivery unit (elongate shaft (110) & securement member (140)) is provided with a second interlocking member (Figures 2 and 5-7, first portion (172) of release mechanism (170)) configured to engage with or separate from the first interlocking member (Figures 2 and 5-7; Paragraph [0054]).
Regarding claim 17, Pederson further discloses, wherein the first interlocking member (second portion (174) of release mechanism (170)) and the second interlocking member (first portion (172) of release mechanism (170)) each comprise an interlocking notch (See annotated Figure 7 below, (Notch)) and an interlocking protrusion (See annotated Figure 7 below, (Protrusion)), the interlocking protrusion of the second interlocking member is inserted into the interlocking notch of the first interlocking member, and the interlocking protrusion of the first interlocking member is inserted into the interlocking notch of the second interlocking member (As seen in Figures 2 and 5-7 and described in paragraph [0054], it is clear that the (Protrusion) of first portion (172) is inserted into the (Notch) of second portion (174), and the (Protrusion) of second portion (174) is inserted into the (Notch) of first portion (172)).
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Regarding claim 20, Pederson further discloses, wherein the spring coil (medical device (130)) and the first interlocking member (second portion (174) of release mechanism (170)) are made of biocompatible metal or alloy (Paragraph [0063]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-4 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pederson, in view of Buiser (US 2008/0234723 A1).
Regarding claim 2, as best understood in view of the 112(b) rejections above, Pederson teaches, the introducer sheath (Introducer sheath).
Pederson fails to teach, wherein a diameter of the introducer sheath gradually increases from a proximal end of the introducer sheath to the distal end of the introducer sheath.
Buiser discloses, introducer sheaths for use with vascular catheters to deliver embolic coils. Buiser teaches, an introducer sheath (Figure 2A, introducer sheath (20); Paragraph [0028]), wherein a diameter of the introducer sheath (Figure 2A, first outer diameter (230)) gradually increases from a proximal end of the introducer sheath to a distal end of the introducer sheath (Figure 2A, second outer diameter (242)) (Paragraph [0028]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the introducer sheath of Pederson such that a diameter of the introducer sheath gradually increases from a proximal end of the introducer sheath to the distal end of the introducer sheath as taught by Buiser, as both references and the claimed invention are directed to endovascular embolic coil devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the introducer sheath of Pederson such that a diameter of the introducer sheath gradually increases from a proximal end of the introducer sheath to the distal end of the introducer sheath as taught by Buiser, as such a modification would have been predictable, namely, larger main body provides column strength and narrower proximal section facilitates manufacturing and guide-wire attachment (Paragraphs [0005]-[0006], [0008], [0028], [0031], [0037], & [0039] of Buiser).
Regarding claim 3, Pederson teaches, as best understood in view of the 112(b) rejections above, the introducer sheath (Introducer sheath) comprises a delivery tube (The (Introducer sheath) section of microcatheter (190) is considered as the delivery tube), wherein the delivery tube is connected to the proximal end of the first cone tube (As seen in Figures 1-2 and 5-6 the proximal end of the (First cone tube) is indeed connected to the (Introducer sheath)/delivery tube).
Pederson fails to teach, wherein the introducer sheath comprises a straight tube and a second cone tube, a diameter of the straight tube is smaller than a diameter of the delivery tube, and a proximal end of the delivery tube is connected to a distal end of the straight tube through the second cone tube.
Buiser teaches, wherein the introducer sheath (introducer sheath (20)) comprises a delivery tube (Figure 2A, main body elongated section (210)), a straight tube (Figure 2A, first proximal elongated section (200)), and a second cone tube (Figure 2A, tapering region between first proximal elongated section (200) and main body elongated section (210)), a diameter of the straight tube (first outer diameter (230)) is smaller than a diameter of the delivery tube (second outer diameter (242)) (Paragraph [0028]), a distal end of the delivery tube is connected to the proximal end of the first cone tube (Figure 2A, distal section (220); Paragraph [0028]), and a proximal end of the delivery tube is connected to a distal end of the straight tube through the second cone tube (Figure 2A; Paragraph [0028]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the introducer sheath of Pederson such that the introducer sheath comprises a delivery tube, a straight tube, and a second cone tube, a diameter of the straight tube is smaller than a diameter of the delivery tube, a distal end of the delivery tube is connected to the proximal end of the first cone tube, and a proximal end of the delivery tube is connected to a distal end of the straight tube through the second cone tube as taught by Buiser, as both references and the claimed invention are directed to endovascular embolic coil devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the introducer sheath of Pederson such that the introducer sheath comprises a delivery tube, a straight tube, and a second cone tube, a diameter of the straight tube is smaller than a diameter of the delivery tube, a distal end of the delivery tube is connected to the proximal end of the first cone tube, and a proximal end of the delivery tube is connected to a distal end of the straight tube through the second cone tube as taught by Buiser, as such a modification would have been predictable, namely, the larger delivery tube/main body gives structural integrity for pushing, the first cone tube/distal taper enables smooth traversal of the vessel (atraumatic), and the straight tube with proximal narrowing from the delivery tube through the second cone tube aids in production and use (guide-wire attachment).
Regarding claim 4, Pederson teaches, the introducer sheath (Introducer sheath), the delivery unit (elongate shaft (110) & securement member (140)), and the spring coil unit (medical device (130) & second portion (174) of release mechanism (170)).
Pederson fails to teach, wherein the introducer sheath is provided with a limiting member configured to position the delivery unit within the introducer sheath.
Buiser teaches, the introducer sheath (Figure 3, sheath (23)) is provided with a limiting member (Figure 3, narrowed region (300)) configured to position a guide wire (delivery unit) within the introducer sheath (Paragraphs [0038]-[0039]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the introducer sheath of Pederson such that it is provided with a limiting member configured to position the delivery unit within the introducer sheath as taught by Buiser, as both references and the claimed invention are directed to endovascular embolic coil devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the introducer sheath of Pederson such that it is provided with a limiting member configured to position the delivery unit within the introducer sheath as taught by Buiser, as such a modification would have been predictable, namely, to facilitate heating and twisting of the sheath wall at the limiting member, thereby allowing the introducer sheath to be locked to and unlocked from a delivery unit to facilitate shipment, storage, and subsequent use by a physician (Paragraph [0039 of Buiser).
Regarding claim 11, modified Pederson teaches, wherein the straight tube, the delivery tube, the first cone tube, and the second cone tube are made of polymer materials (Paragraph [0040] of Buiser).
Regarding claim 12, modified Pederson teaches, wherein the straight tube, the delivery tube, the first cone tube, and the second cone tube are made of polyolefin materials (Paragraph [0040] of Buiser, where polypropylene (PP) is considered a polyolefin).
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pederson, in view of Wilson (US 6425898 B1).
Regarding claim 5, Pederson teaches, wherein the delivery unit (elongate shaft (110) & securement member (140)) comprises: a push rod (elongate shaft (110)).
Pederson fails to teach, wherein the delivery unit also comprises: a flexible connection assembly, wherein a proximal end of the flexible connection assembly is connected to a distal end of the push rod, and a distal end of the flexible connection assembly is detachably connected to the proximal end of the spring coil unit.
Wilson discloses, a delivery apparatus for an endovascular implant. Wilson teaches, a delivery unit (Figure 5, shaft (10)) comprises: a push rod (Figure 5, proximal portion (16)); and a flexible connection assembly (Figure 5, joint (17) & distal portion (18)) (Col. 5, line 15-44), wherein a proximal end of the flexible connection assembly is connected to a distal end of the push rod (Figure 5; Col. 5, line 35-38), and a distal end of the flexible connection assembly is detachably connected to the proximal end of an implant (Figure 4, stent (50); Col. 5, line 45-Col. 6, line 21).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to substitute the delivery unit of Pederson for the delivery unit of Wilson such that the delivery unit comprises: a push rod and a flexible connection assembly, wherein a proximal end of the flexible connection assembly is connected to a distal end of the push rod, and a distal end of the flexible connection assembly is detachably connected to the proximal end of the spring coil unit as taught by Wilson, as both references and the claimed invention are directed to endovascular implant delivery devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the delivery unit of Pederson for the delivery unit of Wilson such that the delivery unit comprises: a push rod and a flexible connection assembly, wherein a proximal end of the flexible connection assembly is connected to a distal end of the push rod, and a distal end of the flexible connection assembly is detachably connected to the proximal end of the spring coil unit as taught by Wilson, as such a modification would have been predictable, namely, the push rod provides the necessary rigidity or stiffness needed to effectively push out the implant/spring coil unit and the flexible connection assembly provides the necessary combination of flexibility, to navigate tortuous vessels, and column strength to effectively push out the implant/spring coil unit (Col. 5, line 38-44 of Wilson).
Regarding claim 7, modified Pederson teaches, wherein the flexible connection assembly (joint (17) & distal portion (18) as disclosed in Wilson) comprises: a heat shrink tube (Figure 5 of Wilson, joint (17); Col. 5, line 35-37 of Wilson discloses, “The two portions are joined together at joint 17 by… heat fusing…”), wherein a first end of the heat shrink tube is sleeved on the distal end of the push rod (As seen in Figure 5 of Wilson, the proximal end of joint (17) is indeed sleeved on the distal end of proximal portion (16)); and a conveying elastic member (Figure 5 of Wilson, distal portion (18); Col. 5, line 27-35 and line 42-44 of Wilson), wherein a proximal end of the conveying elastic member is connected to a second end of the heat shrink tube (Figure 5 and Col. 5, line 35-38 of Wilson), and the spring coil unit (medical device (130) & second portion (174) of release mechanism (170)) is detachably connected to a distal end of the conveying elastic member (Col. 5, line 45-Col. 6, line 21 of Wilson discloses that stent (50) (implant) is detachably connected to a distal end of the distal portion (18); It would have been obvious to one of ordinary skill in the art to substitute Pederson’s delivery unit with the delivery unit of Wilson for the reasons stated in the rejection of claim 5 (predictable result that the flexible connection assembly provides the necessary combination of flexibility, to navigate tortuous vessels, and column strength to effectively push out the implant/spring coil unit)).
Claim(s) 6, 8, 13-16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pederson, in view of Wilson, and further in view of Hebert (US 2018/0289375 A1).
Regarding claim 6, Pederson teaches, the push rod (elongate shaft (110)).
Pederson fails to teach, wherein a diameter of the push rod gradually decreases from a proximal end of the push rod to the distal end of the push rod.
Wilson teaches, the delivery unit comprised of the push rod and the flexible connection assembly according to claim 5 (See above rejection of claim 5).
Hebert discloses, delivery systems for vascular surgical implants. Hebert teaches, a diameter of a push rod (Figure 7, pusher wire (88)) gradually decreases from a proximal end of the push rod to the distal end of the push rod (Paragraphs [0228] and [0230]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the push rod of modified Pederson such that a diameter of the push rod gradually decreases from a proximal end of the push rod to the distal end of the push rod as taught by Hebert, as all the references and the claimed invention are directed to endovascular implant delivery devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the push rod of modified Pederson such that a diameter of the push rod gradually decreases from a proximal end of the push rod to the distal end of the push rod as taught by Hebert, as such a modification would have been predictable, namely, the taper acts as a proximal stop to prohibit proximal movement of the flexible connection assembly over the push rod (Paragraph [0216] of Hebert).
Regarding claim 8, Pederson teaches, the delivery device for the spring coil according to claim 1 (See above rejection of claim 1).
Pederson fails to teach, wherein the conveying elastic member comprises: a conveying spring, wherein a proximal end of the conveying spring is connected to the heat shrink tube; and a developing spring, wherein a proximal end of the developing spring is connected to a distal end of the conveying spring, and the developing spring is coated with developer.
Wilson teaches, the conveying elastic member (distal portion (18)) comprises: a conveying spring (Col. 5, line 32-35, discloses that distal portion (18), “These materials may be utilized as single or multi-layer structures, and may also include reinforcement wires, braid wires, coils, filaments or the like.” As such, distal portion (18) is indeed a conveying spring through coil structure), wherein a proximal end of the conveying spring is connected to the heat shrink tube (Figure 5; Col. 5, line 35-38). However, Wilson does not teach a developing spring, wherein a proximal end of the developing spring is connected to a distal end of the conveying spring, and the developing spring is coated with developer.
Hebert teaches, a conveying elastic member (Figure 20A, coil (110) & compression coil (192); Paragraphs [0229] & Paragraph [0262]-[0263]) comprises: a conveying spring (coil (110); Paragraph [0229]); and a developing spring (compression coil (192); Paragraphs [0263]-[0264]), wherein a proximal end of the developing spring is connected to a distal end of the conveying spring (Figure 20A; Paragraphs [0267] and [0269]), and the developing spring is coated with developer (Paragraph [0264]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the delivery unit of Pederson such that it comprises a conveying elastic member that comprises: a conveying spring, wherein a proximal end of the conveying spring is connected to the heat shrink tube and a developing spring, wherein a proximal end of the developing spring is connected to a distal end of the conveying spring, and the developing spring is coated with developer, as taught by Wilson and Hebert, as all the references and the claimed invention are directed to endovascular implant delivery devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery unit of Pederson such that it comprises a conveying elastic member that comprises: a conveying spring, wherein a proximal end of the conveying spring is connected to the heat shrink tube and a developing spring, wherein a proximal end of the developing spring is connected to a distal end of the conveying spring, and the developing spring is coated with developer, as taught by Wilson and Hebert, as such a modification would have been predictable, namely, the conveying elastic member provides the necessary combination of flexibility, to navigate tortuous vessels, and column strength to effectively push out the implant/spring coil unit (Col. 5, line 38-44 of Wilson). Furthermore, the conveying spring attaches and retains the detachment/interlocking member on the distal end of the delivery unit (Paragraph [0229] of Hebert) and the developing spring provides distal push force for spring coil unit release and deployment, and allow users/surgeons to monitor placement in real-time (Paragraphs [0263]-[0269] of Hebert).
Regarding claim 13, modified Pederson teaches, wherein a length of the push rod ranges from 600 mm to 2000 mm, and a diameter of the push rod ranges from 0.5 mm to 2 mm (Paragraph [0230] of Hebert discloses that pusher wire (88) (push rod), “The pusher wire 88 has a length (including arms) between about 20 cm and about 400 cm, more narrowly between about 100 cm and about 300 cm, for example about 200 cm. Suitable diameters for the pusher wire 88 can range from about 0.006 inches to about 0.040 inches, more narrowly between about 0.008 inches and about 0.035 inches. The overall diameter of the pusher wire 88 may taper from proximal to distal, for example about 0.014 inches tapering to about 0.003 inches.” Which meets the claimed ranges of a length of 600mm-2000mm and a diameter of 0.5mm-2mm).
Regarding claim 14, modified Pederson teaches, wherein the push rod is made of biocompatible metal or alloy (elongate shaft (110) of Pederson, Paragraph [0063]; proximal portion (16) of Wilson, Col. 5, line 23-27; and pusher wire (88) of Hebert, Paragraph [0228]).
Regarding claim 15, Pederson in view of Wilson and further in view of Hebert teach the claimed invention except for, “wherein an outer diameter of the conveying spring ranges from 1 mm to 2 mm, and a length of the conveying spring ranges from 8 mm to 20 mm.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the conveying spring as having an outer diameter ranging from 1 mm to 2 mm and a length ranging from 8 mm to 20 mm, 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 involve only routine skill in the art. In re Aller.
Regarding claim 16, modified Pederson teaches, wherein the conveying spring is made of biocompatible metal or alloy (distal portion (18) of Wilson, Col. 5, line 27-35; coil (110) of Hebert, Paragraph [0229]).
Regarding claim 18, Pederson teaches, wherein the spring coil unit (medical device (130) & second portion (174) of release mechanism (170)) comprises a spring coil (Figures 1-2, medical device (130); Paragraph [0048]), a first interlocking member (Figures 2 and 5-7, second portion (174) of release mechanism (170); Paragraph [0054]) is connected to a proximal end of the spring coil (Figures 2 and 5-7; Paragraph [0054]), and the distal end of the delivery unit (elongate shaft (110) & securement member (140)) is provided with a second interlocking member (Figures 2 and 5-7, first portion (172) of release mechanism (170)) configured to engage with or separate from the first interlocking member (Figures 2 and 5-7; Paragraph [0054]); and
wherein the second interlocking member (first portion (172) of release mechanism (170)) comprises a support rod (See annotated Figure 7 above, (Support rod))
Pederson fails to teach, the support rod is inserted into a distal end of the developing spring.
Wilson teaches, aspects of the conveying elastic member according to claim 8 (See above rejection of claim 8).
Hebert teaches, a distal end (Figure 20A, distal end (194); Paragraph [0263]) of the developing spring (compression coil (192)), wherein the distal end of the developing spring receives has inserted within it a support rod (Figure 20A, elongated member (196)) of a locking/engaging member (Figure 20A, ball (298)) (Paragraph [0263]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the delivery unit of modified Pederson such that the support rod is inserted into a distal end of the developing spring as taught by Hebert, as all the references and the claimed invention are directed to endovascular implant delivery devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery unit of modified Pederson such that the support rod is inserted into a distal end of the developing spring as taught by Hebert, as such a modification would have been predictable, namely, to retain the detachment/interlocking member on the distal end of the delivery unit.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pederson, in view of Buiser, and further in view of Que (US 2008/0306503 A1).
Regarding claim 10, Pederson teaches, the introducer sheath (Introducer sheath).
Pederson fails to teach, wherein the limiting member is a locking thread disposed on the introducer sheath.
Buiser teaches, the limiting member (narrowed region (300)). However, Buiser’s limiting member is not a locking thread disposed on the introducer sheath.
Que discloses, a device for delivering an occlusive element such as a vaso-occlusive coil. Que teaches, an introducer sheath (Figure 1A, elongate sheath (30); Paragraph [0030]) is provided with a limiting member (Figure 1A, locking member (90); Paragraph [0033]) configured to position a delivery unit (Figure 1A, elongate releasing member (40); Paragraph [0031]) within the introducer sheath (Paragraph [0033]); and wherein the limiting member (locking member (90)) is a locking thread (Figure 1A, threads (38)) disposed on the introducer sheath (Paragraph [0033]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to make the limiting member of modified Pederson as a locking thread disposed on the introducer sheath as taught by Que, as all the references and the claimed invention are directed to endovascular embolic coil devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the limiting member of modified Pederson as a locking thread disposed on the introducer sheath as taught by Que, as such a modification would have been predictable, namely, to fixedly secure the delivery unit relative to the introducer sheath (Paragraph [0033] of Que).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pederson, in view of Buiser2 (US 2007/0142859 A1).
Regarding claim 19, Pederson teaches, the spring coil (medical device (130)).
Pederson fails to teach, wherein a fiber bundle is disposed on the spring coil.
Buiser2 discloses, embolic coils. Buiser2 teaches, a fiber bundle (Figures 1B-1C, fiber bundles (18)) is disposed on a spring coil (Figures 1A-1D, embolic coil body (12)) (Paragraphs [0066]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the spring coil of Pederson to have fiber bundles disposed on it as taught by Buiser2, as both references and the claimed invention are directed to endovascular embolic coil devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify to have fiber bundles disposed on it as taught by Buiser2, as such a modification would have been predictable, namely, to improve deliverability and prevent sticking in the catheter (Paragraph [0024] of Buiser2).
Conclusion
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/O.N./Examiner, Art Unit 3771
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