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 .
Priority
The present application is a continuation of U.S. Application No. 16/030,622, filed July 9, 2018, now U.S. Patent No. 10,799,331, which is a continuation of U.S. Application No. 15/834,869, filed December 7, 2017, now U.S. Patent No. 10,016,266, which is a continuation of U.S. Application No. 14/623,425, filed February 16, 2015, now U.S. Patent No. 9,848,975, which is a continuation of U.S. Application No. 13/597,118, filed August 28, 2012, now U.S. Patent No. 8,956,386, which is a continuation of U.S. Application No. 12/749,233, filed March 29, 2010, now U.S. Patent No. 8,252,020, which is a continuation of U.S. Application No. 10/594,198, filed September 25, 2006, now U.S. Patent No. 7,686,825, which is a National Phase Application of International Application No. PCT/US2005/010160, filed March 25, 2005, which claims the benefit of priority of U.S. Provisional Application No. 60/556,152, filed March 25, 2004.
Claim Objections
Claim 11 is objected to because of the following informalities: lines 13-14 recite “the self-expanding filter body.” It is understood that applicant intended to recite “the self-expanding body,” which is referred back to “a self-expanding body” in line 6. Appropriate correction is required.
Information Disclosure Statement
Information Disclosure Statements filed on November 11, 2024 and July 19, 2025 have been considered. Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson (US 2003/0216774, which is cited in the IDS filed November 11, 2024, hereinafter “Larson”) in view of Andrews (US 5,154,724, which is cited in the IDS filed November 11, 2024, hereinafter “Andrews”).
Referring to claim 15, Larson discloses a method for removal of a thrombus from a blood vessel in a patient (paras. [0002] and [0016]-[0017]), the method comprising:
identifying a blood vessel having an occlusive thrombus (Fig. 1, in paragraph [0017] Larson discloses the catheter system is used to treat a blockage in renal artery 20);
selecting a mechanical thrombectomy device 10 (Fig. 1) sized for percutaneous advancement through the blood vessel (Larson inherently discloses this step to ensure that size of the catheter system and other instruments are meeting an objective of the operation), the thrombectomy device comprising a sheath 28 or 14 (catheter 28 as shown in Figs. 1 and 5-6; paras. [0017] and [0021]. In alternative, catheter 14 is interpreted as “a sheath” because claim 15 does not require that the self-expanding body is attached to any structure as cited in the claim), a self-expanding body 16 (filter 16 as shown in Fig. 1; para. [0017]), and an elongate inner catheter 18 (device 18 as shown in Fig. 1; para. [0017])[Larson is silent about “having an agitation element disposed along a distal end portion thereof”];
inserting the sheath 28 or 14 through a peripheral access site and into the blood vessel (para. [0016] discloses the catheter is advanced to the renal artery via the femoral artery); advancing the sheath through the blood vessel toward the thrombus (para. [0016] discloses the catheter is advanced to the renal artery via the femoral artery);
deploying the self-expanding body 16 (para. [0020]: “Filter 16 may include a frame that is comprised of a self-expanding metal alloy (e.g., nickel-titanium alloy).”) within the blood vessel, the self-expanding body having a tapered proximal end portion and an open distal mouth (Figs. 5-6 shows filter 16 is expanded when the sheath 28 is retracted or the filter is moved past the distal end of sheath 28), the self-expanding body made from a nickel-titanium alloy, the self-expanding body having an exterior surface shaped to conform to an inner wall of the blood vessel (Fig. 1 appears to show the exterior surface of the filter 16 contacts an inner wall of the blood vessel; examiner notes that it is well known in the art that the rim of the filter must conform to an inner wall of the blood vessel to prevent debris escape between the rim of the filter and the inner wall of the blood vessel);
advancing the inner catheter 18 through a lumen of the sheath 28 or 14 and through a central opening in the self-expanding body 16 (Fig. 1; para. [0032]);
moving the agitation member while maintaining the sheath and self-expanding body in a substantially fixed location within the blood vessel (Fig. 1; para. [0032]: “In use, embolic protection device 10 can be advanced to a landing area within the aorta as shown in FIG. 1. Filter 16 may be expanded by advancing shaft 14 or retracting sheath 28. Medical device 18 can then be advanced to renal artery 20.” Examiner contends that based on the disclosure above one of ordinary skill in the art will understand that Larson discloses the sheath 28 and catheter 14, which includes filter 16, must maintain at a fixed location while the medical device 18 is advanced to the renal artery to perform an operation);
capturing resulting thrombus particles with the self-expanding body 16 (paras. [0030]-[0032]); and
removing the thrombectomy device from the blood vessel and restoring blood flow through the blood vessel (paras. [0030]-[0032]).
Larson discloses the invention substantially as claimed except for disclosing the medical device 18 is an atherectomy device that perform the step of contacting the thrombus with the agitation element, wherein the thrombus is contacted at a location distal to the open distal mouth of the self-expanding body; moving the agitation member while maintaining the sheath and self-expanding body in a substantially fixed location within the blood vessel, wherein movement of the agitation member cuts through the thrombus and removes the thrombus from the inner wall of the blood vessel.
In the field of endeavor, which is a method for removal of a thrombus from a blood vessel in a patient, Andrews discloses a thrombus engagement catheter 52 (Figs. 3-4) includes thrombus separator or cutter 62, which is being expandable from a contracted profile configured to fit through a guiding catheter 40 to an expanded profile having an expanded diameter sized for contacting the thrombus when deployed in the blood vessel (Figs. 3-4). Andrews discloses the advantage of the incrementally expandable cutter 62 is to overcome the problems of time consuming because of using a series of cutting device of varying size and high risk to patient due to repeating inserting and removing of the cutting devices from the patient (Fig. 4 and col. 1, ln 40-54), thereby, reducing the risk and the length of the operation.
In paragraphs [0005] and [0016] Larson discloses that it is old and well known in the art that occluded, stenotic, or narrowed blood vessels can be treated with an atherectomy procedure and during an atherectomy procedure, the stenotic lesion may be mechanically cut away from the blood vessel wall using an atherectomy catheter. Based on the disclosure in paragraph [0005] and [0016], one of ordinary skill will appreciate that the medical device 18 as disclosed by Larson is an atherectomy device. Therefore, it would have been obvious to one of ordinary skill in the art to have utilized the thrombus engagement catheter 52 and thrombus engagement member 62 of Andrews as the atherectomy device 18 of Larson so that it too would have the same advantage.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larson in view of Andrews as applied to claim 15 above and further in view of Miller et al. (US 5,549,626, which is cited in the IDS filed November 11, 2024, hereinafter “Miller”).
Referring to claim 16, Larson as modified by Andrews discloses the method of claim 15 but fails to disclose wherein negative pressure is applied along a proximal end portion of the sheath 14 for aspirating remaining fragments through a central lumen of the sheath after removing the thrombus from the blood vessel.
Referring again to claim 16, however, in the same field of endeavor, which is a method for removal of a thrombus from a blood vessel in a patient, Miller disclose filter 13 is attached to a distal end of inner catheter 17 and a negative pressure is applied along a proximal end portion of the inner catheter 17 for aspirating fragments through a central lumen 21 of the inner catheter 17 and filter 13 (FIGS. 1 and 4, FIG. 4 is reproduced below; col. 3, ln 20-28: “After deployment, the material 11 to be filtered is aspirated through the lumen 21 of the inner catheter 17 by means of the syringe 22, which is connected to a port 24 at the proximal end 19 of the inner catheter 17.”). Therefore, it would have been obvious to one of ordinary skill in the art to have provided aspiration to the proximal end of inner catheter 14 of Larson to allow the surgeon to evacuate debris to prevent the debris from accumulating in the space of the filter, thereby, providing a continuous oxygenated blood flow through the filter.
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Referring to claim 17, Larson as modified by Andrews and Miller disclose the method of claim 16, wherein the self-expanding body 16 is covered by a flexible membrane (Larson: Fig. 5 and paragraph [0029]-[0030] Larson discloses the filter include a non-filtering region 238, which is a nonporous. Therefore, it would have been obvious to one of ordinary skill in the art to have provided a nonpermeable membrane as a non-filtering region since filter with a nonpermeable membrane is old and well known in the art).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 11 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 10-11 of U.S. Patent No. 10,695,159 (hereinafter “the patent”).
The claims match-up with respect to one another as listed below:
Patent Application No. 18/665,301
U.S. Patent No. 10,695,159
Claim 1. A method for removal of a thrombus from a blood vessel in a patient, the method comprising:
identifying an occlusive thrombus in a vein in a patient's leg;
entering the vein through a peripheral access site; advancing a tubular delivery sheath through the vein;
positioning a distal end of the tubular delivery sheath proximal to the thrombus;
deploying a self-expanding filter body at a location distal to the tubular delivery sheath and proximal to the thrombus, the filter body having a tapered proximal end portion and an open distal end, the filter body made from a nickel-titanium alloy, the filter body having an expanded shape sized to engage an inner wall of the vein, the filter body formed with a permeable mesh structure for allowing blood to pass therethrough;
advancing an elongate inner catheter through the tubular delivery sheath and through the filter body while maintaining the tubular delivery sheath and filter body at a fixed location within the vein;
contacting the thrombus with the inner catheter at a location distal to the filter body;
manipulating the inner catheter to remove the thrombus while minimizing damage to the inner wall of the vein, wherein an expandable agitation element is disposed along a distal end portion of the inner catheter, the expandable agitation member adapted for cutting and removing the thrombus from the vein;
capturing thrombus particles with the filter body; and applying negative pressure at a proximal end portion of the tubular delivery sheath for aspirating remaining thrombus particles.
Claim 2. The method of claim 1, wherein the filter body is shaped to funnel the thrombus particles toward a central region of the filter body.
Claim 3. The method of claim 2, wherein the mesh structure of the filter body is provided with openings sized to allow blood to pass freely therethrough while capturing the thrombus particles.
Claim 1 and 7.
Claim 1. A method of capturing and removing a thrombus from a large vein in a patient, comprising:
identifying a large vein having an occlusive thrombus;
selecting a thrombectomy device adapted for percutaneous advancement through the vein, the thrombectomy device comprising a delivery sheath, a self-expanding filter body (examiner notes that “a filter body” means that the body is designed to filter out debris and let blood to flow through the filter body), and an inner catheter, wherein an agitation member is disposed along a distal end portion of the inner catheter;
inserting the sheath through a peripheral access site and into the vein;
advancing the sheath until a distal end of the sheath is positioned proximal to the thrombus;
deploying the filter body at a location distal to the sheath and proximal to the thrombus, the filter body having a tapered proximal end portion and an open distal end, the filter body having an interior volume shaped to funnel particles toward a center of the filter body (read on claim 2 of the patent application), the filter body made from a nickel-titanium alloy and having an exterior surface shaped to conform to an inner wall of the vein;
longitudinally advancing the inner catheter through the sheath and through the filter body such that the agitation member is positioned distal to the filter body;
contacting the thrombus with the agitation member; moving the agitation member to agitate and disrupt the thrombus;
capturing resulting thrombus particles with the filter body;
applying negative pressure through a central lumen of the sheath for aspirating remaining particles; and withdrawing the thrombectomy device from the patient and restoring blood flow through the vein.
Claim 7. The method of claim 1, wherein a diameter of the agitation member is controllable.
Claim 11. A method for extracting a clot from a vein without requiring thrombolytic drugs, the method comprising:
inserting an elongate tubular sheath through an access site and into a vein;
advancing the sheath through the vein until a distal end of the sheath is positioned proximal to a clot;
deploying a self-expanding body from a distal end of the sheath, the self-expanding body having an open distal end and a tapered profile for funneling particles toward a center of the self-expanding body, wherein the distal end of the self-expanding body has an expanded diameter sized for contacting an inner wall of the vein;
advancing an elongate inner catheter through a lumen of the sheath and through the self-expanding body, wherein an agitation element is disposed along a distal end portion of the inner catheter;
contacting the clot with the agitation element at a location distal to the self-expanding filter body;
moving the agitation member to dislodge the clot from the vein while maintaining the sheath and self-expanding body at a fixed position within the vein; and
applying negative pressure along a proximal end of the sheath for aspirating remaining particles after the clot has been removed.
Claims 10-11:
Claim 10. A method of capturing and removing a thrombus for treating deep vein thrombosis, comprising:
selecting a thrombectomy device sized for percutaneous advancement through a large vein, the thrombectomy device comprising an elongate tubular delivery sheath, a self-expanding filter body formed with a permeable mesh structure, and an inner catheter having an agitation member disposed along a distal end portion thereof;
inserting the sheath through a peripheral access site and into the vein;
advancing the sheath until a distal end of the sheath is positioned proximal to a thrombus;
deploying the self-expanding filter body at a location between the sheath and the thrombus, the filter body having a tapered proximal end portion and an open distal end when in an expanded configuration, the filter body forming an interior volume shaped to funnel particles toward a center of the filter body, the filter body having an exterior surface shaped to contact an inner wall of the vein;
longitudinally advancing the inner catheter and agitation member through the sheath and through the filter body; contacting the thrombus with the agitation member;
moving the agitation member to agitate and disrupt the thrombus; capturing thrombus particles with the filter body;
applying negative pressure through a central lumen of the sheath; and removing the thrombectomy device and restoring blood flow through the vein.
Claim 11. The method of claim 10, wherein the thrombus is mechanically captured and removed without using thrombolytic drugs.
Claim 15. A method for removal of a thrombus from a blood vessel in a patient, the method comprising:
identifying a blood vessel having an occlusive thrombus;
selecting a mechanical thrombectomy device sized for percutaneous advancement through the blood vessel, the thrombectomy device comprising a sheath, a self-expanding body, and an elongate inner catheter having an agitation element disposed along a distal end portion thereof;
inserting the sheath through a peripheral access site and into the blood vessel;
advancing the sheath through the blood vessel toward the thrombus;
deploying the self-expanding body within the blood vessel, the self-expanding body having a tapered proximal end portion and an open distal mouth, the self-expanding body made from a nickel-titanium alloy, the self-expanding body having an exterior surface shaped to conform to an inner wall of the blood vessel;
advancing the inner catheter through a lumen of the sheath and through a central opening in the self-expanding body;
contacting the thrombus with the agitation element, wherein the thrombus is contacted at a location distal to the open distal mouth of the self-expanding body; moving the agitation member while maintaining the sheath and self-expanding body in a substantially fixed location within the blood vessel, wherein movement of the agitation member cuts through the thrombus and removes the thrombus from the inner wall of the blood vessel;
capturing resulting thrombus particles with the self-expanding body; and removing the thrombectomy device from the blood vessel and restoring blood flow through the blood vessel.
Claim 16. The method of claim 15, wherein negative pressure is applied along a proximal end portion of the sheath for aspirating remaining fragments through a central lumen of the sheath after removing the thrombus from the blood vessel.
Claim 1 and 7.
Claim 1. A method of capturing and removing a thrombus from a large vein in a patient, comprising:
identifying a large vein having an occlusive thrombus;
selecting a thrombectomy device adapted for percutaneous advancement through the vein, the thrombectomy device comprising a delivery sheath, a self-expanding filter body, and an inner catheter, wherein an agitation member is disposed along a distal end portion of the inner catheter;
inserting the sheath through a peripheral access site and into the vein;
advancing the sheath until a distal end of the sheath is positioned proximal to the thrombus;
deploying the filter body at a location distal to the sheath and proximal to the thrombus, the filter body having a tapered proximal end portion and an open distal end, the filter body having an interior volume shaped to funnel particles toward a center of the filter body, the filter body made from a nickel-titanium alloy and having an exterior surface shaped to conform to an inner wall of the vein;
longitudinally advancing the inner catheter through the sheath and through the filter body such that the agitation member is positioned distal to the filter body;
contacting the thrombus with the agitation member; moving the agitation member to agitate and disrupt the thrombus;
capturing resulting thrombus particles with the filter body;
applying negative pressure through a central lumen of the sheath for aspirating remaining particles; and withdrawing the thrombectomy device from the patient and restoring blood flow through the vein.
Claim 7. The method of claim 1, wherein a diameter of the agitation member is controllable.
Referring again to claims 1, 11 and 15, claims 1 and 10 of the patent discloses substantially all limitation in claim 1, 11, and 15 except for disclosing advancing the elongate inner catheter while maintaining the tubular delivery sheath and filter body at a fixed location within the vein. Examiner notes that this step is obvious to one of ordinary skill in the art because the filter body is always deployed to the target location before advancing the cutter or agitator to work on the target location to ensure that the debris is capture by the filter. Since the rim of the filter is contacted with the inner surface of the blood vessel, therefore, keeping the sheath and the filter at a fixed location while the cutter or agitator would prevent injury the delicate tissue of inner surface of the blood vessel and ensure that the agitator or cutter is positioned at the desired location before activating the agitator or cutter to remove the clot or lesion.
Claims 1-3, 11 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 10-11 of U.S. Patent No. 10,695,159 (hereinafter “the patent”).
Allowable Subject Matter
Claims 1-14 are allowed if a terminal disclaimer is filed to overcome the nonstatutory double patenting rejection set forth above.
Claims 18-20 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 and a terminal disclaimer is filed to overcome the nonstatutory double patenting rejection set forth above.
Larson (US 2003/0216774), which is the best prior art of record, discloses a method for removal of a thrombus from a blood vessel in a patient (paras. [0002] and [0016]-[0017]), the method comprising:
identifying an occlusive thrombus in a vein in a patient's leg (Fig. 1, in [0005] and [0016] Larson discloses that it is old and well known in the art that any blood vessel can have an occluded region or stenotic and the blood vessels can be treated with an atherectomy procedure. In paragraph [0017] Larson discloses the catheter system is used to treat a blockage in renal artery 20 and other vessel, thus, it would have been obvious to perform an atherectomy procedure in a vein);
entering the vein through a peripheral access site; advancing a tubular delivery sheath 28 or 14 (catheter 28 as shown in Figs. 1 and 5-6; paras. [0017] and [0021]) through the vein (in paragraph [0016] Larson discloses the catheter is advanced to the operation site via the femoral artery. Thus, for performing a procedure in a vein the catheter of Larson would entering the vein through a peripheral access site then the catheter is advanced toward the operation site);
positioning a distal end of the tubular delivery sheath 14 proximal to the thrombus;
deploying a self-expanding filter body 16 at a location distal to the tubular delivery sheath and proximal to the thrombus, the filter body having a tapered proximal end portion and an open distal end, the filter body made from a nickel-titanium alloy (para. [0020]: “Filter 16 may include a frame that is comprised of a self-expanding metal alloy (e.g., nickel-titanium alloy).”), the filter body having an expanded shape sized to engage an inner wall of the vein, the filter body formed with a permeable mesh structure for allowing blood to pass therethrough; advancing an elongate inner catheter 18 through the tubular delivery sheath 28 and through the filter body 16 while maintaining the tubular delivery sheath and filter body at a fixed location within the vein;
contacting the thrombus with the inner catheter at a location distal to the filter body (Fig. 1);
manipulating the inner catheter to remove the thrombus while minimizing damage to the inner wall of the vein, wherein an expandable agitation element is disposed along a distal end portion of the inner catheter, the expandable agitation member adapted for cutting and removing the thrombus from the vein; capturing thrombus particles with the filter body 16.
Prior art of record alone or in combination did not teach a method for removal of a thrombus from a blood vessel in a patient that includes the combination of recited limitation in claims 1 and 11. Prior art of record alone or in combination did not teach the limitation of applying negative pressure at a proximal end portion of the tubular delivery sheath for aspirating remaining thrombus particles.
Conclusion
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771