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 .
Response to Amendment
The preliminary amendment filed August 5, 2024 has been entered. Claims 56-73 are currently pending.
Claim Objections
Claim 56 is objected to because of the following informalities: Line 10 of the claim should recite “…advancing [[an]] the endovascular device…” to maintain proper antecedent basis and clearly refer to the endovascular device defined in lines 2-7. Appropriate correction is required.
Claim 69 is objected to because of the following informalities: Line 9 of the claim should recite “…advancing a microcatheter through [[a]] the side hole…” to maintain proper antecedent basis and clearly refer to the side hole defined in line 3. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 68 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitations of claim 68 are recited in line 19 of claim 61. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 56-58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 2014/0214071, hereinafter “Thomas”) in view of Don Michael et al. (US 7,524,303, hereinafter “Don Michael”) and Garrison et al. (US 2013/0035628, hereinafter “Garrison”).
Regarding claim 56, Thomas discloses the invention substantially as claimed including a method of treating an intracranial aneurysm in a patient (para [0012]), wherein the method comprises:
providing an endovascular device (14), wherein the endovascular device includes: a proximal segment (20); a distal segment (22); and at least one side-hole (30) located between the proximal segment and the distal segment (Fig 1; para [0014]);
advancing the endovascular device (14) such that endovascular device spans the intracranial aneurysm (Fig 1; para [0019]);
positioning the at least one side-hole (30) adjacent to a neck (44) of the intracranial aneurysm (36) (Fig 1; para [0019]);
confirming that the at least one side-hole is centered on the intracranial aneurysm via imaging (para [0019]);
positioning the distal segment in apposition with the precerebral artery to thereby anchor the endovascular device and reduce kickback and/or prolapse (Fig 1; para [0019-0020, 0022]);
advancing a microcatheter (46) into the intracranial aneurysm through the proximal segment and the at least one side-hole (30); advancing an aneurysm treatment device (16) through the microcatheter (46) and into the intracranial aneurysm; deploying the aneurysm treatment device (Figs 1, 6; para [0018]);
removing the microcatheter; removing the endovascular device; and removing the guide catheter (para [0024]).
Thomas teaches “it should be appreciated that catheters of any suitable dimensions may be used” (para [0015]). However, Thomas fails to disclose the distal segment includes a tapered outer diameter and a constant inner diameter. Don Michael discloses a catheter for insertion into a blood vessel and teaches the distal tip of the catheter may be tapered (Fig 1) with a gradually decreasing external wall thickness to give the catheter “greater flexibility, and thus an improved ability to negotiate bends and traverse severe obstructions in the blood vessel during insertion” (col 3, ln 11-17). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Thomas such that the distal segment included a tapered outer diameter and a constant inner diameter, as taught by Don Michael, for the purpose of increasing flexibility of the distal end of the catheter and improving the ability of the device to traverse bends and obstructions during insertion.
Furthermore, Thomas fails to teach introducing a guide catheter into the precerebral artery and advancing the endovascular device (14) through the guide catheter. Garrison discloses a similar endovascular device for insertion into a blood vessel (Fig 1) comprising an endovascular device (2030) for delivery of therapeutic devices (4100) at a distal target location (para [0048, 0050]). Additionally, Garrison teaches a guide catheter or access device/sheath (2010), wherein the endovascular device (2030) is inserted therethrough (para [0046-0048]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Thomas and Don Michael such that a guide catheter or access device/sheath was used to deliver the endovascular device, as taught by Garrison, for the purpose of allowing a user access to the target location through a central access sheath placed through a puncture in the patient's skin to minimize trauma to the patient.
Regarding claim 57, further comprising: inflating at least one balloon (32a) on the endovascular device (14) to further anchor the endovascular device within the precerebral artery (para [0019-0020]).
Regarding claim 58, wherein inflating the at least one balloon includes inflating the at least one balloon via a lumen substantially within a wall of the endovascular device utilized solely for inflation and deflation of the at least one balloon (para [0016]).
Claim(s) 59-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 2014/0214071), Don Michael (US 7,524,303), and Garrison (US 2013/0035628), as applied to claim 56 above, further in view of Ruiz (US 6,261,273, hereinafter “Ruiz”). Regarding claim 59, Thomas, Don Michael, and Garrison disclose the invention substantially as claimed, as shown above. However, the combination fails to teach the claimed angled extension. Ruiz discloses a similar endovascular device (Figs 1-3 and 4A-D) comprising a tube (11) having at least one side hole (14) (Fig 2) and teaches further providing an actively adjustable angled extension (25) (Fig 3) extending from the side hole (Fig 1) to facilitate steering of one or more additional devices into the blood vessel ("Branch segment 25 extends through lateral opening 14 of main tubular branch 11 and into a branch of the patient's vasculature. Therapeutic devices, such as dilatation balloons or stent delivery systems, thus may be disposed in the patient's vasculature through either the main tubular member or a branch segment." - col 3, In 35-40). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination to include an actively adjustable angled extension extending from said side-hole serving to facilitate steering of microcatheter into the target area to more easily guide the microcatheter and endovascular device to the aneurysm.
Regarding claim 60, Ruiz teaches the angled extension is formed of a polymer (col 4, ln 11-14) and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination to have the angled extension be formed of a shape memory polymer for the purpose of maintaining the desired shape or curvature of the angled extension upon delivery and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 61-68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 2014/0214071, hereinafter “Thomas”) in view of Garrison (US 2013/0035628).
Regarding claim 61, Thomas discloses the invention substantially as claimed including a method of treating an intracranial aneurysm in a patient (para [0012]), wherein the method comprises:
introducing a delivery device (guidewire 12) into the precerebral artery;
advancing an endovascular device (14) over the delivery device (guidewire 12) such that a side-hole (30) of the endovascular device is positioned substantially adjacent to the intracranial aneurysm (36) and such that an end-hole (26) of the endovascular device is positioned distally of the intracranial aneurysm (Fig 1; para [0019, 0022]);
rotating the endovascular device (14) such that the side-hole (30) of the endovascular device is oriented towards the intracranial aneurysm (36) (Fig 1; para [0019]); removing the delivery device (para [0024]);
advancing a microcatheter (46) through a first segment (20) of the endovascular device and into the intracranial aneurysm (36) through the side-hole (30) (Fig 6), wherein the first segment extends proximally of the side-hole (Figs 1, 6; para [0014]);
anchoring the endovascular device (14) to inhibit kickback and/or prolapse (Fig 1; para [0019-0020, 0022]);
advancing an aneurysm treatment device (16) through the microcatheter (46) and into the intracranial aneurysm (36), wherein the aneurysm treatment device is attached to a delivery system (40); deploying the aneurysm treatment device; performing radiographic confirmation of positioning of the aneurysm treatment device (para [0019]); detaching the aneurysm treatment device from the delivery system (Figs 1, 6; para [0018, 0023]);
removing the microcatheter; removing the endovascular device; removing the guide catheter; and establishing hemostasis at the vascular access site (para [0024]).
However, Thomas fails to teach introducing a guide catheter into the precerebral artery via a vascular access site and advancing the endovascular device (14) through the guide catheter. Garrison discloses a similar endovascular device for insertion into a blood vessel (Fig 1) comprising an endovascular device (2030) for delivery of therapeutic devices (4100) at a distal target location (para [0048, 0050]). Additionally, Garrison teaches a guide catheter or access device/sheath (2010), wherein the endovascular device (2030) is inserted therethrough (para [0046-0048]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Thomas and Don Michael such that a guide catheter or access device/sheath was used to deliver the endovascular device, as taught by Garrison, for the purpose of allowing a user access to the target location through a central access sheath placed through a puncture in the patient's skin to minimize trauma to the patient.
Regarding claims 62-63, Thomas fails to disclose the method comprises advancing the guide catheter into a vertebral artery or an internal carotid artery. Garrison teaches “Most neurointerventional procedures use a transfemoral access to the carotid or vertebral artery and thence to the target cerebral artery” (para [0008]). Alternatively, access to the target vasculature can be achieved directly via percutaneous puncture of the vertebral artery or through an opening directly below the carotid artery (para [0047]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to further modify the combination such that the method comprised advancing the guide catheter into a vertebral artery or an internal carotid artery, as taught by Garrison, to use known arterial access points.
Regarding claim 64, wherein introducing the delivery device into the precerebral artery includes introducing a delivery wire (guidewire 12) into the precerebral artery (para [0012-0013, 0019]).
Regarding claim 65, Thomas fails to teach wherein introducing the delivery device (guidewire 12) into the precerebral artery includes introducing a delivery catheter into the precerebral artery. Garrison teaches a guidewire (2615) with an expandable tip (2620) that is placed using a microcatheter or is attached to a distal end of a hollow hypotube (para [0072]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination such that introducing the delivery device includes introducing a delivery catheter, as taught by Garrison, to allow for insertion of a guidewire with an expandable tip and further control and delivery of the guidewire and endovascular device.
Regarding claim 66, wherein advancing the microcatheter through the first segment of the endovascular device includes advancing the microcatheter (46) over a wire (40) (Fig 6; para [0018, 0023]).
Regarding claim 67, wherein anchoring the endovascular device includes positioning a second segment (22) thereof in apposition with the precerebral artery, wherein the second segment extends distally from the side-hole (30) (Figs 1, 6; para [0019, 0022]).
Regarding claim 68, further comprising: performing radiographic confirmation of positioning of the aneurysm treatment device (para [0019]).
Claim(s) 69, 71, and 72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 2014/0214071) in view of Islak et al. (US 2015/0327868, hereinafter “Islak”).
Regarding claim 69, Thomas discloses a method of treating a patient substantially as claimed, wherein the method comprises:
advancing an endovascular device (14) into an artery such that a side-hole (30) of the endovascular device is positioned substantially adjacent to a treatment area (36) of the vessel (Fig 1), wherein the endovascular device includes: a first segment (20) extending proximally from the side-hole; and a second segment (22) extending distally from the side-hole (Fig 1; para [0014]);
positioning the endovascular device (14) such that the side-hole (30) is oriented towards the treatment area (36) (Fig 1; para [0019]);
advancing a microcatheter (46) through the side-hole (30) of the endovascular device (14) and into the treatment area (36); anchoring the endovascular device (14) within the artery to inhibit kickback and/or prolapse (Figs 1, 6; para [0019-0020, 0022]); advancing a treatment device (16) through the microcatheter (46) and into the treatment area; deploying the treatment device (Figs 1, 6; para [0018]); removing the microcatheter; and removing the endovascular device (para [0024]).
However, Thomas teaches the method comprises treating an intracranial aneurysm and fails to teach treating an arteriovenous malformation (AVM) as claimed. Islak teaches methods of treating both intracranial aneurysms (para [0046]) and AVMs (para [0047]) with a treatment device comprising an embolic coil (para [0051-0053]), similar to Thomas. Islak teaches “Embolization of brain aneurysms and arteriovenous malformations (AVM)/fistulas is a minimally invasive treatment for aneurysms and other blood vessel malformations that occur in the brain” (para [0052]). Therefore, it would have been obvious to modify the method of Thomas to treat an arteriovenous malformation and modify the steps such that the treatment area included the AVM, particularly comprising the steps of positioning the side-hole (30) of the endovascular device substantially adjacent to a vessel attached to the AVM and advancing the microcatheter into the vessel attached to the AVM and deploying the treatment device into the AVM, as claimed, for the benefit of using a known method to treat additional areas known to be successfully treated with similar treatment devices.
Regarding claim 71, Thomas teaches positioning the endovascular device (14) includes rotating the endovascular device such that the side-hole (30) is oriented towards the opening of the treatment area (neck of aneurysm) (para [0024]), and wherein advancing the microcatheter through the side-hole (30) includes advancing the microcatheter (46) into the opening of the treatment area (neck of aneurysm) (Figs 1, 6; para [0018]). Therefore, 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 combination of Thomas and Islak such that the method comprised rotating the endovascular device such that the side-hole is oriented towards a branch feeder of the AVM and wherein advancing the microcatheter through the side-hole includes advancing the microcatheter into the branch feeder of the AVM to treat an arteriovenous malformation.
Regarding claim 72, Thomas teaches wherein anchoring the endovascular device includes positioning the second segment (22) in apposition with the artery to thereby reduce kickback and/or prolapse (Figs 1, 6; para [0019, 0022]).
Claim(s) 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 2014/0214071) and Islak (US 2015/0327868), as applied to claim 69 above, further in view of Losordo et al. (US 2016/0030709, hereinafter “Losordo”). Thomas and Islak disclose the invention substantially as claimed, as shown above. However, they fail to disclose advancing the endovascular device into a left middle cerebral artery. Losordo discloses a similar endovascular device for delivering a treatment device to a target area within the cerebral vasculature. Losordo teaches the target location (i.e. aneurysm) can be located at various locations in the human body and discloses one example where the target location is in the middle cerebral artery (Fig 2; para [0047]). Therefore, it would have been obvious to one of ordinary skill in the art to modify the combination such that the method comprised step of advancing the endovascular device into a left middle cerebral artery to be able to treat a target location within the middle cerebral artery, as taught by Losordo.
Claim(s) 73 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (US 2014/0214071) and Islak (US 2015/0327868), as applied to claim 72 above, further in view of Don Michael (US 7,524,303). Thomas and Islak disclose the invention substantially as claimed, including wherein advancing the endovascular device into the artery includes positioning the second segment (22) distally of the treatment area (36) (Fig 1; para [0019, 0022]). Therefore, it would be obvious in the combination of Thomas and Islak, the second segment would be positioned distally of the AVM when the treatment area is modified to be the AVM.
Furthermore, Thomas teaches “it should be appreciated that catheters of any suitable dimensions may be used” (para [0015]). However, Thomas fails to disclose the distal second segment (22) includes a tapered outer diameter and a constant inner diameter. Don Michael discloses a catheter for insertion into a blood vessel and teaches the distal tip of the catheter may be tapered (Fig 1) with a gradually decreasing external wall thickness to give the catheter “greater flexibility, and thus an improved ability to negotiate bends and traverse severe obstructions in the blood vessel during insertion” (col 3, ln 11-17). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Thomas and Islak such that the distal segment included a tapered outer diameter and a constant inner diameter, as taught by Don Michael, for the purpose of increasing flexibility of the distal end of the catheter and improving the ability of the device to traverse bends and obstructions during insertion.
Conclusion
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771