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 listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered:
Meissner, Seminars in Interventional Radiology 2005; 22 (3): 147-156 (page 1, line 20)
Dermatol. Surg. 2004, 30 (5): 718-22; Dermatol. Surg. 2003, 29 (12): 1170-1175 (page 2, lines 29-30)
Curr. Cardiol. Rev. 2014, 10(4): 349-354 (page 3, lines 20-21) Bioelectromagnetics 2008, 29 (2): 100-107 (page 18, line 27).
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of the following:
Abstract is not limited to 150 word count.
Abstract is not limited to a single paragraph.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim(s) 1, 7 and 12 is/are objected to because of the following informalities:
In claim 1, line 1, Applicant is suggested to either correct “A steerable guide wire” to “a guide wire” to match the preamble of dependent claims 2-7, or include “steerable” before “guide wire” in claims 2-7.
In claim 7, lines 2-3 “non-axial joint, uniaxial joint, biaxial joint, multiaxial joint” should be amended to be “a non-axial joint, a uniaxial joint, a biaxial joint, and a multiaxial joint”
In claim 12, line 5, “the desired position” should be amended to be “a desired position” for grammatical correctness and clarity.
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.
(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) 1-4, 6 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cragg et al., (US 2015/0039020).
Regarding Claim 1, Cragg teaches a steerable guide wire (Fig. 2A, (210)) for use in a catheter assembly (Fig. 2A, (200)), the guidewire comprising:
a. a distal end expandable assembly (Fig. 2D, (O)), wherein said expandable assembly (O) is capable of being changed from a retracted state ([0185-0186] and as seen in Fig. 2C, where (O) is an expandable assembly and is retracted and retractable) to an expanded state ([0185] and seen in Fig. 2D, where the expandable assembly (O) is deployed in an expanded state), and returned to the retracted state ([0186] and Fig. 2E, where (O) is retracted to a retracted state again after being expanded as seen in Fig. 2D and [0185]), and wherein said expandable assembly (O) is arranged in a substantially conical configuration ([0256] and as seen in Fig. 2D, wherein the expandable assembly (O) is in a substantially conical configuration);
b. a pivotable joint ([0187] and Fig. 2F, wherein the expandable assembly (O) is seen expanding (Fig. 2F) and retracted in (Fig. 2E), about the tubular portion (T), therefore (T) is a pivot joint about which (O) pivots between expansion and retraction) connecting said expandable assembly (O) to said guide wire (210),
wherein the expandable assembly (O) comprises a membrane (seen in Figs 2G-2H, wherein expandable assembly (O) has a mesh (D, P), which can have a membrane cover (M), as detailed in [0187] and seen in Fig. 2H), wherein the membrane comprises a net-like filter structure (seen in Fig. 2D and [0058], where (D) and (P) are net-like filter structures),
wherein said expandable assembly (O) is configured to achieve a temporary adhesion to an inner wall of a vessel lumen ([0213] wherein the expandable assembly (O) achieves at least temporary adhesion to the inner wall of the vessel lumen by exerting sufficient radial outward pressure to maintain proper vessel wall apposition and resist migration of the occlusion device after deployment).
wherein the expandable assembly, in its expanded state, is bowl-shaped, mushroom- shaped, cup-shaped, helical-shaped, disc-shaped, bulbous-shaped, calyx-shaped, umbrella- shaped or any combination thereof (see D in Fig. 2D, which can be interpreted to be in cup-shape, bulbous-shape or calyx-shape), and
wherein the guide wire is configured for use in a method of treating venous diseases (In at least a straight 8 mm vessel or curved 8 mm vessel with a 20 mm radius to centerline of vessel, under retrograde venous deployment conditions, the structure of the deployed occlusion device 1200a permits the device to resist migration under at least 7 mmHg of pressure according to the Migration Protocol described below [0285]).
Regarding Claim 2, Cragg teaches the guide wire for use in the catheter assembly according to claim 1, wherein said expandable assembly (O) is retrievable and resiliently deformable in a retrievable configuration ([0161] wherein expandable assembly/occlusion device (O) can be retracted and resheathed (deformed back into a retrievable configuration) as seen between Figs 2D-2F, as there may be situations where it is necessary to resheath the occlusion device to deliver the occlusion device to the target vessel).
Regarding Claim 3, Cragg teaches the guide wire for use in the catheter assembly according to claim 1, wherein said membrane is made of a shape memory material ([0200] wherein the expandable assembly occlusion device (O) net structure can be made of nitinol or the like, which is a known shape memory material).
Regarding Claim 4, Cragg teaches the guide wire for use in the catheter assembly according to claim 1, wherein said expandable assembly (O) has an expansion ratio ranging from at least 1:5 to at least 1:10 of a diameter of the expandable assembly before and after expansion ([0202] wherein the diameter (after expansion):(before expansion) can be in the range of about 3:1 up to about 8:1. In other words, the diameter before expansion to after expansion would be in the range of about 1:3 up to about 1:8, which falls within the claimed range of at least 1:5 to at least 1:10).
Regarding Claim 6, Cragg teaches the guide wire for use in the catheter assembly according to claim 1, wherein the pivotable joint (T) of said guide wire (210) allows for deflecting the expandable assembly (O) in two or three dimensions (seen in Fig. 2D, wherein the expandable assembly (O) expands into a three-dimensional shape relative to the guide wire, therefore deflects in at least two dimensions) relative to said guide wire (210).
Regarding Claim 7, Cragg teaches the guide wire for use in the catheter assembly according to claim 6, wherein said pivotable joint (T) is a non-axial joint ([0187] and seen between Figs 2C-2D, wherein about the non-axial joint (T), the expandable assembly (O) is able to permit (O) to pivot between expansion and retraction).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Cragg et al., (US 2015/0039020) as applied to claim 1 above, and further in view of Morsi (US 2016/0051263).
Regarding Claim 5, Cragg teaches the guide wire for use in the catheter assembly according to claim 1.
Cragg doesn’t explicitly teach wherein said expandable assembly is configured to adhere to the inner wall of the vessel lumen by means of at least one adhesive component.
In related prior art, Morsi [0011] teaches wherein the expandable assembly has adherent (adhesive) focal scaffolding, thus can adhere to the inner wall of a vessel lumen.
It would be obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the expandable assembly tubular markers of the guide wire of Cragg, to have a temporary adhesive component as taught by Morsi, as Cragg [0364] already teaches various coatings can be applied over the tubular markers, and as Morsi [0011] teaches the adherent (adhesive) focal scaffolding facilitates tightly adhering to the vascular wall; this is beneficial to assist anchoring said expandable device (such as for facilitating growth of endothelium over the surface of the scaffold and across the defect for which the expandable device was placed (Morsi [0011])).
Claims 8, 10-11, 16-17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cragg et al., (US 2015/0039020).
Regarding Claim 8, Cragg teaches a catheter assembly (Fig. 2A, (200)) comprising
a. a first tube (Fig. 2C, (210)),
b. a guide wire (Fig. 1A, (220) including additional guide (224)) located within said first tube (210), the guide wire (220) comprising: a distal end expandable assembly (Fig. 2F, (O)), wherein said expandable assembly (O) is capable of being changed from a retracted state (as seen in Fig. 2C) to an expanded state (as seen in Fig. 2D) and returned to the retracted state ([0185-0186] and seen in Fig. 2E, where (O) is retracted to a retracted state again after being expanded), and wherein said expandable assembly (O) is arranged in a substantially conical configuration (seen in Fig. 2D and [0256] wherein the expandable assembly (O) is in a substantially conical configuration); and
a pivotable joint ([0187] and Fig. 2F, wherein the expandable assembly (O) is seen expanding (Fig. 2F) and retracted in (Fig. 2E) about the tubular portion (T), therefore (T) is a pivot joint about which (O) pivots between expansion and retraction) connecting said expandable assembly (O) to said guide wire (220),
wherein said first tube comprises one or more side holes ([0190] wherein the (outer catheter) first tube (210) can have a plurality of (side holes) openings (221) to prevent buildup of pressure and sufficient flow rate),
wherein the expandable assembly (O) comprises a membrane ([0187] and Figs 2G-2H, wherein expandable assembly (O) has a mesh (D, P), which can have a membrane cover (M)), wherein the membrane comprises a net-like filter structure (seen in Fig. 2D and [0058], where (D) and (P) are net-like filter structures).
wherein the expandable assembly, in its expanded state, is bowl-shaped, mushroom- shaped, cup-shaped, helical-shaped, disc-shaped, bulbous-shaped, calyx-shaped, umbrella- shaped or any combination thereof (see O in Fig. 2D, which can be interpreted to be in cup-shape, bulbous-shape or calyx-shape), and
wherein the catheter assembly is configured for use in a method of treating venous diseases (In at least a straight 8 mm vessel or curved 8 mm vessel with a 20 mm radius to centerline of vessel, under retrograde venous deployment conditions, the structure of the deployed occlusion device 1200a permits the device to resist migration under at least 7 mmHg of pressure according to the Migration Protocol described below [0285]).
While Cragg teaches the expandable assembly (O) is accommodated within (210) in said catheter assembly (200) in a retracted state, Cragg doesn’t explicitly teach said catheter assembly further comprises a sliding sleeve accommodating the expandable assembly in the retracted state within said catheter assembly.
In another embodiment of the delivery assembly of Cragg, Cragg [0391] and [0398] teaches the delivery system assembly including a guidewire and embolic device, further including a (introducer sheath) sliding sleeve (5F) which is capable of assisting insertion of the delivery system into and through said sheath (5F).
It would be obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter assembly of the Cragg Fig. 2A embodiment, to include a sliding sleeve receiving the expandable assembly in a retracted state, as taught by the embodiment taught in Cragg [0391, 0398], for the motivation of providing a sheath introducer with trackability allowing resheathing of the occlusion device (expandable assembly) with minimal force and without visible damage to the occlusion device or to the delivery system (Cragg [0398]).
Regarding Claim 10, Cragg teaches the modified catheter assembly according to claim 8, wherein said first tube has an inner diameter ranging from 0.6 to 2.2 mm ([0189] wherein first tube (210) can have an internal diameter less than or equal to about 0.10 inches, such as about 0.05 inches (which is 1.27mm, and falls within the claimed range of 0.6 to 2.2 mm)), an outer diameter ranging from 0.8 to 2.8 mm ([0201] wherein the outer diameter of the of the (first tube) outer catheter (such as 210) is 2.0 mm or less, therefore falls within the claimed range from 0.8 to 2.8 mm)) and a length of 15 to 85 cm ([0189] wherein the (first tube) outer catheter can have a length of about 120 cm, or any other suitable working length described above. Hence, as taught in [0144], depending on the area of application, the first tube length can range from about 60 cm up to about 175 cm. This falls within the claimed range of 15-85 cm).
Regarding Claim 11, Cragg teaches the modified catheter assembly according to claim 8, wherein said catheter assembly is configured to temporarily occlude tortuous and/or branched vessel segments in mammals ([0189] teaches depending on the target area, the length of the catheter assembly can vary. Therefore as [0045] teaches the catheter assembly can navigate tortuous vasculature to deploy an occlusion device at a target site in a vessel, the target site can be the tortuous and/or branched vessel segments).
Regarding Claim 16, Cragg teaches the modified catheter assembly according to claim 8, wherein said guide wire (224) is located in a second tube (Fig. 2B, (220)) positioned within said first tube (as seen in Fig. 2B, wherein (220) is positioned within (210)), wherein at least one of said first tube is made of a non-sticking material comprising polytetrafluoroethylene (PTFE) ([0189] wherein (210) may be constructed from (PTFE) or other suitable medical grade polymer material).
Regarding Claim 17, Cragg teaches catheter assembly according to claim 8, wherein the one or more side holes (221) of the first tube (210) are configured for injection of fluids ([0190] wherein contrast dye can be release from the plurality of openings, and also provide remove pressure of the contrast on the occlusion device), and wherein the guide wire (220) is configured for temporary blood vessel occlusion (via the expandable assembly (O) located on (220), as seen in Figs 2F-2G).
Regarding Claim 18, Cragg teaches the modified catheter assembly according to claim 17, wherein said first tube is made of a non-sticking material comprising polytetrafluoroethylene (PTFE) ([0189] wherein (210) may be constructed from (PTFE) or other suitable medical grade polymer material).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Cragg et al., (US 2015/0039020), as applied to Claim 8 above, and further in view of Bone Salat et al., (US 2016/0346041).
Regarding Claim 12, Cragg teaches use of the (modified) catheter assembly according to claim 8 for temporary vessel occlusion, the use comprising the steps of:
a. vein access by hollow needle puncture ([0144] wherein femoral access percutaneously occurs, hence it is understood that known methods of accessing the vasculature of the body percutaneously would be done through a hollow needle puncture);
b. insertion of a standard guide wire ([0187] wherein the delivery system (200) can include a guidewire, such as (224) seen within (220) in Fig. 2B);
c. advancing the catheter assembly to the desired position ([0184] wherein the catheter assembly is advanced to the desired target area);
d. removal of the standard guide wire ([0187] wherein the guidewire, if present, is also removed after the occlusion device is placed);
e. loading of the guide wire into said catheter (seen in Fig. 2B, where (224) is within catheter (210)), wherein the expandable assembly is temporarily locked in a retracted state within said catheter ([0193] and seen in Fig. 2C, wherein the expandable assembly (O) is temporarily in a retracted state within (210), and temporarily locked via interlocking attachment member (231).
In another embodiment of Cragg, detailed in [0391] and [0398], Cragg teaches a sheath introducer (5F) for the catheter, and thus the expandable assembly can lock, in a retracted state, within the sliding sleeve (sheath introducer) of the catheter.
It would be obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the use of the catheter assembly of the embodiment of Cragg Fig. 2A+, to include the sliding sleeve of the embodiment taught in [0391, 0398], for the motivation of providing a sheath introducer with trackability allowing resheathing of the occlusion device (expandable assembly) with minimal force and without visible damage to the occlusion device or to the delivery system (Cragg [0398]).
Cragg continues to teach, in the now-modified use of the catheter assembly:
f. advancing the expandable assembly (O) within said catheter assembly (210) by pushing the guide wire (wherein attached guidewire (220), containing (224), is advanced, as is expandable assembly (O) thereon);
g. release of the expandable assembly (O) from the sliding sleeve (5F) either when inside of the catheter assembly or when reaching its distal position within the catheter assembly ([0185] wherein (O) is deployed when advanced distally out of (210) by the urging of (231)). This is because, in the modified embodiment of Craig Figs 2A+, wherein the sliding sleeve as taught in [0391] and [0398] is included, the expandable assembly would be deployed from the sliding sleeve when reaching its distal position within the catheter.
It would be obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the use of the catheter assembly of the Cragg Fig. 2A embodiment, to include a sliding sleeve receiving the expandable assembly in a retracted state, as taught by the embodiment taught in Cragg [0391, 0398], for the motivation of providing a sheath introducer with trackability allowing resheathing of the occlusion device (expandable assembly) with minimal force and without visible damage to the occlusion device or to the delivery system (Cragg [0398]).
Cragg continues to teach, in the now-modified use of the catheter assembly:
h. positioning the catheter assembly over a location intended to occlude ([0184] wherein the occlusion device is deployed in the target vessel location);
i. withdrawing the catheter assembly while the guide wire is kept in place, until the expandable assembly is released and expanded ([0185] wherein (O) is deployed when advanced distally out of (210) by the urging of (231), on (220) and guidewire (224). Further, [0382] teaches the Fig. 2A+ embodiment of Cragg, particularly in Fig. 2S, that after delivering (O), the delivery system can be withdrawn. Thus, the catheter of the delivery system is also withdrawn);
j. retraction and positioning of the expandable assembly by pulling the guide wire to ensure the occlusion of the target vessel ([0161] wherein retraction (resheathing) and positioning of the expandable assembly (O) is done to ensure the expandable assembly is placed properly in the target vessel);
l. advancing the catheter assembly (210) to collect the expanded assembly (O) ([0187] and as seen in Figs 2D-2E, wherein (O) is collected back into (210) in a retracted state);
m. retracting the expandable assembly (O) by pulling the guide wire to a position within the catheter assembly ([0184] and seen in Figs 2D-2E, where the expanded assembly (O) is retracted by (231), and advanced through pushing (231), which is part of (220) and (224)); and
n. removal of the guide wire and the catheter assembly from a vein ([0187] wherein the catheter (220) is fully removed from (O) when the delivery system and guidewire (if present) are removed).
The modified use of the catheter assembly of Cragg fails to explicitly teach k. Performing foam sclerotherapy.
In related prior art, Bone Salat [0031] teaches a catheter assembly delivering a sclerosing agent, which can be either a sclerosant liquid or a sclerosant foam, to facilitate closure and sealing in the treated area.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the use of the delivered agent of Cragg, to perform foam sclerotherapy, as taught by Bone Salat, for the motivation of facilitating closure and sealing of the target area when using the chemical effect of the sclerosing agent in the target area in the vein (Bone Salat [0031]). The expandable assembly of Cragg is intended for occlusion (Cragg [0185]), and already teaches applying liquid embolics or adhesives, including chemical sclerosing agents (Cragg [0218]).
Allowable Subject Matter
Claims 13-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding Claim 13, Cragg teaches the modified guide wire for use in a catheter assembly according to claim 1.
However, Cragg does not disclose or render obvious, alone or in combination with the other prior art of record, wherein said pivotable joint is an electrically conducting pivotable joint, wherein said guide wire has an insulated conductive core, and wherein said guide wire further comprises: a. one or a plurality of contacts positioned on said expandable assembly, wherein each contact compromises and electrode element connected to a conductor, and b. a power supply capable of selectively generating an electrical signal transmitted to said one or said plurality of contacts via the conductive core of said guide wire. Therefore, the combination of these specific features with ALL of the claimed limitations are thus rendered non-obvious by the closest prior art to record, and the claim is therefore is objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim 1.
Claim 14 depends upon Claim 13, therefore is also objected to.
Response to Amendment
Applicant has amended the Specification which was previously objected to; Examiner accordingly withdraws these objections to the Specification.
Applicant has amended claims 1-6, 8, 13 and 14 which were previously objected to; Examiner accordingly withdraws these objections of claims 1-6, 8, 13 and 14. However claim 1 was objected to for other informalities. The objection of claim 7 and 12 is maintained since amendments were not appropriately made by Applicant.
Response to Arguments
Applicant’s argument filed on 05/15/2025 have been fully considered but they are not found persuasive.
Applicant has argued that Cragg is directed to an “expanded tubular frame” and fails to disclose an expandable assembly that, in its expanded state, is bowl-shaped, mushroom-shaped, cup-shaped, helical-shaped, disc-shaped, bulbous-shaped, calyx-shaped, umbrella-shaped or any combination thereof. Examiner respectfully disagrees. Kamen teaches an expandable assembly (see O in Fig. 2D), which can be interpreted to be in cup-shape, bulbous-shape or calyx-shape or a combination thereof in its expanded state.
Applicant further made argument that the device of Cragg is for treatment of arteries and is not configured for use in a method of treating venous disease, and the different nature of veins and arteries would render the device of Cragg inoperable for treatment of venous disease. This is not found persuasive since Cragg teaches the occlusion device can be used under retrograde venous deployment conditions. See Para. [0285], which recites: “In at least a straight 8 mm vessel or curved 8 mm vessel with a 20 mm radius to centerline of vessel, under retrograde venous deployment conditions, the structure of the deployed occlusion device 1200a permits the device to resist migration under at least 7 mmHg of pressure according to the Migration Protocol described below”.
Applicant further made argument that Morsi does not cure the deficiencies of Cragg, due to Cragg and Morsi failing to teach a device that can be folded back and withdrawn to achieve temporary occlusion of the vein. However, this is not found persuasive because Cragg in Para. [0194] recites: “Prior to the proximal end of the occlusion device being advanced distally of the distal end of the outer catheter 210, retracting the inner catheter 220 causes the interlocking attachment member 231 to engage the proximal hooks and retract the occlusion device (see FIG. 2EE)”, indicating that retracting the catheter allows the retraction of the occlusion device O. Morsi was combined with Cragg to teach the adhesive component of claim 5.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
- Cohn et al. (US 20130096580 A1) is considered relevant prior art with regards to using an occlusion stent device capable of an expanded state and a retracted state for temporary occlusion.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783