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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1- 28 in the reply filed on 12/17/25 is acknowledged. Claims 29- 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant's election with traverse of Species A, Figs. 1 and 5A- 5D in the reply filed on 12/17/25 is acknowledged. The traversal is on the ground(s) that Species A should also include Figs. 2A, 2B, and 6A- 6F. This is found persuasive because Figs. 1 and 5A- 5D and Figs. 2A, 2B, and 6A- 6F are not mutually exclusive (See p. 9- 10 of applicant’s Remarks, filed 12/17/25).
It is noted that applicant states that at least claims 1- 9, 11- 22 and 26- 28 encompass the elected Species A, Figs. 1, 2A, 2B, 5A- 5D and 6A- 6F. However, since claim 28 is a duplicate of withdrawn claim 10, claim 28 is withdrawn by the examiner.
Claims 1- 9, 11- 22 and 26- 27 are being addressed by this Office Action.
Claim Objections
Claim 14 is objected to because of the following informalities: line 7- “a exchange sheath” should be amended to - - [[a]] an exchange sheath - - to correct an apparent typographical error. Appropriate correction is required.
Claims 14- 22 and 26- 27 are objected to because they depend off claim 14.
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 3- 4, 16- 17 and 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 3 recites the limitation "the dilator" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off claim 3.
Claim 4 recites the limitation "the guide sheath" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the guide sheath” is interpreted as - - the exchange sheath - -.
Claim 16 recites the limitation "the dilator" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off claim 16.
Claim 17 recites the limitation "the guide sheath" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the guide sheath” is interpreted as - - the exchange sheath - -.
Claim 20 recites the limitation "the guide sheath" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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- 6 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sachar et al. (US Pub. No. 2018/0161143 A1 hereinafter “Sachar ‘143”).
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Regarding claim 1, Sacher ‘143 discloses a thrombectomy guidewire system for delivering an intravascular thrombectomy device, comprising:
a thrombectomy guidewire including:
a wire shaft (220) (Figs. 1- 3, 5, 8, 9A- 10A, 11) having a proximal end (220a) (Figs. 1, 2, 8, 9A) and a distal end (220b) (Figs. 3, 8, 11) the wire shaft (220) is sized for receiving and delivering a guidewire deliverable intravascular thrombectomy device (Ps. [0037], [0063] - - FIG. 3 illustrates a cross sectional view of the distal portion 220b of the catheter 220 as taken through line C-C as shown in FIG. 1 … And, as shown in FIG. 3, the distal portion 220b defines … a guidewire lumen 227; A proximal portion of the guidewire 250 extends out of the distal portion 220b of catheter 220 proximally of the sheath 284 via the guidewire port 302. The guidewire 250 according to some implementations has a diameter of between 0.010 inches and 0.038 inches (e.g., 0.014 inches); it is noted that a guidewire deliverable intravascular thrombectomy device is not positively recited by applicant and the guidewire lumen 227 is broadly interpreted as being capable of receiving and delivering a guidewire deliverable intravascular thrombectomy device); and
a self-expanding basket (240) (Figs. 4- 5, 10A- 12) positioned at the distal end of the wire shaft (220b) (See Fig. 11) and configured to self- expand from a collapsed configuration (Fig. 1) to an expanded configuration (Fig. 5) to press radially outward against vessel walls (P. [0043] - - In the expanded position, an outer diameter of the filter frame 240b around the central portion 240g and an outer diameter of the proximal portion 240f of the filter membrane 240a correspond to an inner diameter of an artery or vessel to ensure that any embolic material is captured by the filter assembly 240);
an exchange sheath (284) (Figs. 1, 3- 6, 10A, 10B) defining a first lumen (L1) (Annotated Fig. 3 - - showing central lumen of exchange sheath (284)) configured to slidably receive the wire shaft (220) and a second lumen (227) (Figs. 3, 8) laterally offset from the first lumen (L1) (See Annotated Fig. 3 - - showing second lumen (227) having a center laterally offset from the center of the first lumen (L1); it is noted that since the lumens do NOT have a common/ coincident center, they are considered laterally offset); and
wherein the exchange sheath (284) is slidable in a distal direction over the wire shaft (220) from the proximal end (220a) of the wire shaft (220) at least until the self-expanding basket (240) is sheathed within the first lumen and collapsed into the collapsed configuration (Fig. 1) (P. [0035] - - FIG. 1 is a side view of the percutaneous transluminal angioplasty device 200 with the sheath 284 covering the filter assembly 240).
Regarding claim 2, Sacher ‘143 further discloses wherein the wire shaft (220) has an outer diameter of at least one of about 0.014, about 0.018, and about 0.035 inches (P. [0063] - - A proximal portion of the guidewire 250 extends out of the distal portion 220b of catheter 220 proximally of the sheath 284 via the guidewire port 302. The guidewire 250 according to some implementations has a diameter of between 0.010 inches and 0.038 inches (e.g., 0.014 inches); it is noted that since guidewire 250 according to some implementations has a diameter of between 0.010 inches and 0.038 inches (e.g., 0.014 inches), the outer diameter of the wire shaft (220) is necessarily larger than at least one of about 0.014, about 0.018, and about 0.035 inches).
Regarding claim 3 in view of the rejection under 35 U.S.C. 112(b) above, Sacher ‘143 further discloses wherein the wire shaft (220) further comprises:
a tapered wire tip (235) (Fig. 4) positioned on the distal end (220b) of the wire shaft (220);
wherein the wire tip (235) tapers radially from a larger diameter proximal end of the dilator to a smaller diameter distal end of the dilator (P. [0039] - - the distal tip 235 is conical or frusto-conically shaped to facilitate penetration through the body; it is noted that since tip 235 is conical or frusto-conically shaped to facilitate penetration through the body, the device is interpreted as including a dilator).
Regarding claim 4 in view of the rejection under 35 U.S.C. 112(b) above, Sacher ‘143 further discloses wherein an outer diameter of the proximal end of the wire tip (235) approximates an outer diameter of the exchange sheath (284);
wherein the exchange sheath (284) is slidable over the wire shaft (220) in the distal direction to abut the distal end of the guide sheath (284) against the proximal end of the wire tip (235) (See Fig. 1) (Ps. [0035], [0036], [0039] - - FIG. 1 is a side view of the percutaneous transluminal angioplasty device 200 with the sheath 284 covering the filter assembly 240 and balloon 260; In the implementation shown in FIG. 1, the device 200 includes a catheter 220 having a proximal end 225 and a distal end 223; As illustrated in FIGS. 4-5, the device 200 further includes a distal tip 235 coupled to the distal end 223).
Regarding claim 5, Sacher ‘143 further discloses wherein the exchange sheath (284) has a proximal end and a distal end;
wherein the first lumen (L1) extends from the proximal end to the distal end of the exchange sheath (284) (See Fig. 1, Annotated Fig. 3) (Ps. [0037], [0061] - - FIG. 3 illustrates a cross sectional view of the distal portion 220b of the catheter 220 as taken through line C-C as shown in FIG. 1; the sheath 284 does not extend over the entire length of the catheter. By disposing the sheath wire 286 within the proximal portion 220a of the catheter 220; it is noted that the first lumen (L1) for receiving wire shaft (220) extends from the proximal end (220a) of wire shaft (220) to the distal end (220b) of wire shaft (220)).
Regarding claim 6, Sacher ‘143 discloses wherein the second lumen (227) extends from the proximal end to the distal end of the exchange sheath (284) (See Fig. 1, 3) (Ps. [0037], [0063] - - FIG. 3 illustrates a cross sectional view of the distal portion 220b of the catheter 220 as taken through line C-C as shown in FIG. 1; The opening of the guidewire port 302 defined by the external surface of the catheter 220 is proximal to guidewire lumen 227 to facilitate rapid exchange of the guidewire 250. In the implementation shown, the guidewire port 302 is defined by the opening of the guidewire lumen 227 at the proximal end of the distal portion 220b. A proximal portion of the guidewire 250 extends out of the distal portion 220b of catheter 220 proximally of the sheath 284 via the guidewire port 302; it is noted that since second lumen (227) and guidewire 250 extends from a distal end of wire shaft (220) and exchange sheath (284) as shown in Fig. 3 to proximally past the proximal end of the exchange sheath (284) as shown in Fig. 1, the second lumen (227) extends from the proximal end to the distal end of the exchange sheath (284)).
Regarding claim 11, Sacher ‘143 further discloses wherein the self-expanding basket (240) further comprises:
a fenestrated structure (240a, 240b) (Fig. 5) extending between a proximal collar (240d) (Fig. 5) and a distal collar (240e) (Fig. 5), the fenestrated structure (240a, 240b) defining a plurality of openings permitting fluid flow through the self- expanding basket (240) while capturing solid material within the self-expanding basket (240) (P. [0040] - - In the expanded configuration, illustrated in FIG. 5, the filter assembly 240 is sized and configured to capture emboli within the bloodstream. For example, at least a portion of the filter assembly 240 in the expanded configuration extends across a diameter of the vessel to catch emboli that may be flowing through the bloodstream);
wherein the proximal collar (240d) is fixedly attached to the wire shaft (220) and the distal collar (240e) is slidably attached to the wire shaft (220), wherein the distal collar (240e) slides distally along the wire shaft when the self-expanding basket (240) is radially constrained (Fig. 4) to collapse the self-expanding basket (240) and slides proximally along the wire shaft (220) to expand the self-expanding basket (Fig. 5) (Ps. [0041] - - a distal end 240e of the filter frame 240b is disposed proximally of the conical tip 240c of the membrane 240a and is slidably coupled around the distal portion 220b … a proximal portion 240d of the filter frame 240b is fixedly coupled around the distal portion 220b; it is noted that since distal collar (240e) is slidably attached to the wire shaft (220) and the proximal collar (240d) is fixedly attached to the wire shaft (220), the distal collar (240e) necessarily slides distally along the wire shaft when the self-expanding basket (240) is radially constrained (Fig. 4) to collapse the self-expanding basket (240) and necessarily slides proximally along the wire shaft (220) to expand the self-expanding basket (Fig. 5)).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 8- 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar et al. (US Pub. No. 2018/0161143 A1 hereinafter “Sachar ‘143”) in view of Deaton et al. (US Pub. No. 2022/0257279 A1).
Regarding claim 8, Sachar ‘143 discloses the system of claim 1, but Sachar ‘142 does not disclose
(claim 8) wherein the self-expanding basket has an outer diameter that is at least 30 mm when the self-expanding basket is in the expanded configuration.
However, Deaton teaches systems for removing material (e.g., clot) from within a body in the same field of endeavor (Abstract, P. [0030]).
(claim 8) wherein the self-expanding basket (2007) (Figs. 20A- 20C) has an outer diameter that is at least 30 mm when the self-expanding basket is in the expanded configuration (Ps. [0030], [0060], [0134] - - As mentioned, the diameter of the wires forming the basket may be 0.15 mm or more (e.g., 0.2 mm or more), particularly when braided into a pore area of between 1.2 and 7.5 mm.sup.2 when expanded to between 5 and 15 mm in diameter (for baskets having a maximum expanded diameter of between 20-40 mm); In some examples the method may include adjusting (e.g., manually, automatically or semi-automatically) the diameter of the basket as it is pulled to maintain force within a range. For example, a method of removing clot may include: positioning an expandable scraper device within a lumen of a vessel in an unexpanded configuration so that an expandable braided basket of the expandable scraper device is positioned distal to or within the clot; expanding the expandable braided basket to an expanded configuration against a wall of the vessel lumen where the expandable braided basket is configured to apply a maximum scraping force against the wall of the vessel lumen … to expand or contract the expandable braided basket to maintain the pull force between about 0.2 and 1.5 pounds of force to scrape clot material from the wall of the vessel lumen without damaging the wall of the vessel lumen;
FIGS. 20A and 20B illustrate one example a distal end of a device similar to that shown in FIG. 19A-19D, including the basket 2007, an inner elongate member 2027 and an outer elongate member 2025. The basket in this example is formed of a plurality of wires that are braided loosely together. FIG. 20A shows the basket in the collapsed, fully un-expanded configuration. FIG. 20B shows the basket 2007 in a fully deployed, expanded configuration. In this example, the braided wires are Nitinol wires that are configured to expand outwards to a maximum expansion diameter of, e.g., between 10 mm and 40 mm (e.g., 20 mm, 30 mm, etc.). The basket region may have an unexpanded length of between 3 and 14 cm, such as, e.g., 5 cm (+/−0.2 cm), 7 cm (+/−0.2 cm), etc.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the outer diameter of the self-expanding basket associated with Sachar ‘143 such that it has an outer diameter that is at least 30 mm when the self-expanding basket is in the expanded configuration according to the teachings of Deaton in order to apply a maximum force needed scrape clot material from the wall of the vessel lumen without damaging the wall of the vessel lumen (Deaton - - Ps. [0030], [0060], [0134]).
Regarding claim 9, Sachar ‘143 discloses the system of claim 1, but Sachar ‘143 does not disclose
(claim 9) wherein the self-expanding basket has an outer diameter between about 32 mm to about 36 mm when the self-expanding basket is in the expanded configuration. However, Deaton teaches systems for removing material (e.g., clot) from within a body in the same field of endeavor (Abstract, P. [0030]).
(claim 9) wherein the self-expanding basket (2007) has an outer diameter between about 32 mm to about 36 mm when the self-expanding basket is in the expanded configuration (P. [0030] - - As mentioned, the diameter of the wires forming the basket may be 0.15 mm or more (e.g., 0.2 mm or more), particularly when braided into a pore area of between 1.2 and 7.5 mm.sup.2 when expanded to between 5 and 15 mm in diameter (for baskets having a maximum expanded diameter of between 20-40 mm)). It is noted that the claimed diameter range falls within the disclosed range of between 20- 40 mm.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the outer diameter of the self-expanding basket associated with Sachar ‘143 such that it has an outer diameter between about 32 mm to about 36 mm when the self-expanding basket is in the expanded configuration according to the teachings of Deaton in order to apply a maximum force needed scrape clot material from the wall of the vessel lumen without damaging the wall of the vessel lumen (Deaton - - Ps. [0030], [0060], [0134]).
Claim(s) 12- 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar et al. (US Pub. No. 2018/0161143 A1 hereinafter “Sachar ‘143”) in view of Ladd (US Pat. No. 6,761,727 B1) in view of Deaton et al. (US Pub. No. 2022/0257279 A1). Ladd is cited in the IDS filed 8/13/24.
Regarding claims 12- 13, Sachar ‘143 discloses the system of claim 11, but Sachar ‘143 does not disclose
(claim 12) wherein the wire shaft comprises:
a wire stop limiting axial movement of the distal collar in the proximal direction to prevent radial expanding of the self-expanding basket beyond a first outer diameter.
(claim 13) wherein the first outer diameter is about 36 mm.
However, Ladd teaches a system for removing emboli from a patient’s blood in the same field of endeavor (Abstract, Col. 3, l. 5- 20)
(claim 12) wherein the wire shaft (28) (Figs. 1- 4) comprises:
a wire stop (56) (Figs. 1- 4) limiting axial movement of the distal collar (44) (Figs. 1- 4) in the proximal direction to prevent radial expanding of the self-expanding basket (40) beyond a first outer diameter (Col. 6, l. 4- 26 - - Catheter assembly 10 also includes a number of safety features to ensure that, even if the device is damaged during use, parts thereof will not break off and enter the bloodstream. First, wires 46 are all made from titanium, which does not react with water or the chemicals present in the blood stream. In addition, titanium has great strength for per unit weight which reduces the chance that the wires will break during normal use. Wires 46 are each fastened to both rings by welds and therefore both ends of the wires will remain attached to a structure even if a wire breaks. In the unlikely event that all of the wires 46 break, or that they all become detached from distal ring 44, stop 38 will prevent ring 44 from sliding off of rod 28 and into the bloodstream. Finally, a safety wire 56 is connected between proximal ring 42 and distal ring 44 and also welded to rod 28 at a central point therebetween. Wire 56 limits the range of movement of distal ring 44 and is fully extended along rod 28 when wires 46 are pressed against rod 28. This wire provides added protection to retain distal ring 44 on rod 28. Wire 56 also provides a biasing force to help prevent distal ring 44 form coming too close to proximal ring 42. These safety features help to ensure that the subject device functions properly during use).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the wire shaft associated with Sachar ‘143 to include a wire stop as taught by Ladd because it would prevent the distal collar from sliding off the wire shaft into the bloodstream (Ladd - - Col. 6, l. 4- 26).
Modified Sachar ‘143 does not disclose
(claim 13) wherein the first outer diameter is about 36 mm.
However, Deaton teaches systems for removing material (e.g., clot) from within a body in the same field of endeavor (Abstract, P. [0030]).
(claim 13) wherein the first outer diameter is about 36 mm.
(Ps. [0030], [0060], [0134] - - As mentioned, the diameter of the wires forming the basket may be 0.15 mm or more (e.g., 0.2 mm or more), particularly when braided into a pore area of between 1.2 and 7.5 mm.sup.2 when expanded to between 5 and 15 mm in diameter (for baskets having a maximum expanded diameter of between 20-40 mm); In some examples the method may include adjusting (e.g., manually, automatically or semi-automatically) the diameter of the basket as it is pulled to maintain force within a range. For example, a method of removing clot may include: positioning an expandable scraper device within a lumen of a vessel in an unexpanded configuration so that an expandable braided basket of the expandable scraper device is positioned distal to or within the clot; expanding the expandable braided basket to an expanded configuration against a wall of the vessel lumen where the expandable braided basket is configured to apply a maximum scraping force against the wall of the vessel lumen … to expand or contract the expandable braided basket to maintain the pull force between about 0.2 and 1.5 pounds of force to scrape clot material from the wall of the vessel lumen without damaging the wall of the vessel lumen;
FIGS. 20A and 20B illustrate one example a distal end of a device similar to that shown in FIG. 19A-19D, including the basket 2007, an inner elongate member 2027 and an outer elongate member 2025. The basket in this example is formed of a plurality of wires that are braided loosely together. FIG. 20A shows the basket in the collapsed, fully un-expanded configuration. FIG. 20B shows the basket 2007 in a fully deployed, expanded configuration. In this example, the braided wires are Nitinol wires that are configured to expand outwards to a maximum expansion diameter of, e.g., between 10 mm and 40 mm (e.g., 20 mm, 30 mm, etc.). The basket region may have an unexpanded length of between 3 and 14 cm, such as, e.g., 5 cm (+/−0.2 cm), 7 cm (+/−0.2 cm), etc.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the first outer diameter of the self-expanding basket associated with Sachar ‘143 in view of Ladd such that it has an outer diameter that is about 36 mm according to the teachings of Deaton in order to apply a maximum force needed scrape clot material from the wall of the vessel lumen without damaging the wall of the vessel lumen (Deaton - - Ps. [0030], [0060], [0134]).
Claim(s) 14- 19 and 26- 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar et al. (US Pub. No. 2018/0161143 A1 hereinafter “Sachar ‘143”) in view of Sachar et al. (US Pub. No. 2005/0228438 A1 hereinafter “Sachar ‘438”).
Regarding claim 14, Sachar ‘143 discloses a thrombectomy system for removing a clot from a vessel, comprising:
a thrombectomy guidewire including:
a wire shaft (220) (Figs. 1- 3, 5, 8, 9A- 10A, 11) having a proximal end (220a) (Figs. 1, 2, 8, 9A) and a distal end (220b) (Figs. 3, 8, 11); and
a self-expanding basket (240) (Figs. 4- 5, 10A- 12) positioned at the distal end of the wire shaft (220d) (See Fig. 11) and configured to self- expand from a collapsed configuration (Fig. 1) to an expanded configuration (Fig. 5) when unconstrained to provide embolic protection (P. [0040] - - In the expanded configuration, illustrated in FIG. 5, the filter assembly 240 is sized and configured to capture emboli within the bloodstream. For example, at least a portion of the filter assembly 240 in the expanded configuration extends across a diameter of the vessel to catch emboli that may be flowing through the bloodstream);
an exchange sheath (284) (Figs. 1, 3- 6, 10A, 10B) defining a central lumen (L1) (Annotated Fig. 3 - - showing central lumen of exchange sheath (284)) sized to slidably receive the wire shaft (220) and a secondary lumen (227) (Figs. 3, 8) oriented parallel to the central lumen (L1) (See Annotated Fig. 3 - - showing secondary lumen (227) having a center laterally offset from the center of the first lumen (L1); it is noted that since the lumens do NOT have a common/ coincident center, they are considered to be oriented parallel to each other), wherein the exchange sheath (284) is slidable in a distal direction over the wire shaft (220) from the proximal end (220a) of the wire shaft (220) at least until the self-expanding basket (240) is sheathed within the central (L1) lumen and collapsed into the collapsed configuration (Fig. 1) (P. [0035] - - FIG. 1 is a side view of the percutaneous transluminal angioplasty device 200 with the sheath 284 covering the filter assembly 240).
Sachar ‘143 does not disclose
(claim 14) an intravascular thrombectomy device that is slidable over the wire shaft as claimed.
However, Sachar ‘438 teaches a thrombectomy device comprising a wire shaft (1295) (Figs. 33, 34) and a self-expanding basket (1220) (Figs. 33, 34) positioned at the distal end of the wire shaft (1295) in the same field of endeavor (Abstract)
(claim 14) an intravascular thrombectomy device (1210) (Figs. 33, 34) having a device lumen configured to slidably receive the wire shaft (295), the intravascular thrombectomy device (1210) is slidable over the wire shaft (1295) (Ps. [0070], [0075]- - While the embodiment 1000 of FIGS. 26 and 27 employs the same method and device for erecting the embolic filter as the embodiment 10 of FIGS. 1-3, it will be understood that the methods and devices for erecting the embolic filter of other embodiments disclosed above are equally applicable to a configuration like the device of embodiment 1000 where the angioplasty balloon is positioned between the embolic filter and the tip of the device; FIGS. 33 and 34 illustrate a further embodiment of a percutaneous angioplasty device 1210, in which the embolic filter 1220 is located on a different carrier than the angioplasty balloon 1218. Specifically, the angioplasty balloon 1218 is located on an outer catheter 1294, and the embolic filter 1220 is located at the forward end of an inner catheter 1295. (The embolic filter 1220 is shown without filter mesh in FIGS. 33 and 34 for clarity of illustration.) The outer catheter preferably has three lumens, one for inflating the angioplasty balloon 1218, one for accommodating a guide wire (not shown), and one for receiving the inner catheter 1295 and embolic filter 1220. The inner catheter 1295 is slidably telescopically disposed within the outer catheter 1294).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention that a configuration in which the embolic filter is located on a different carrier than the angioplasty balloon (Figs. 33, 34) is an equivalent structure to a configuration in which the embolic filter is located on the same carrier as the angioplasty balloon (Figs. 1- 3) since the configurations are described as equally applicable to the other device and methods disclosed by the reference (Sachar ‘438 - - Ps. [0070], [0075]).
It is noted that the angioplasty balloon disclosed by Modified Sachar ‘143 is broadly interpreted as a thrombectomy device. If applicant does not agree with this interpretation, alternatively, the Office points to Sachar ‘438:
(claim 14) an intravascular thrombectomy device (described, not shown) (P. [0080] - - In each of the foregoing examples, it will be appreciated that an angioplasty balloon is but one means for relieving a stenosis in a vessel. Stents, mechanical thrombectomy devices, or other suitable apparatus may be substituted for the angioplasty balloon and positioned on the catheter at a location proximal to the embolic filter. Thus any emboli loosened by the stent or mechanical thrombectomy device will be captured by the embolic filter in the same manner as described above with respect to the angioplasty balloon).
The mechanical thrombectomy device (described, not shown) (Sachar ‘438 - - P. [0080]) taught by Sachar ‘438 performs the same function of relieving a stenosis in a vessel as the angioplasty balloon (260) (Figs. 10A, 10B, 12) disclosed by Sachar ‘143 (Sachar ‘143 - - P. [0069] - - The embolic material may include material from the vessel and fragments of the drug coating that separated from the balloon 260 during expansion. The blocked vessel is opened and blood flow is restored). Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (mechanical thrombectomy device (described, not shown) (Sachar ‘438 - - P. [0080])) for another (angioplasty balloon (260) (P. [0069])) since the substitution would have yielded predictable results, namely, relieving a stenosis in a vessel. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Regarding claim 15, Sacher ‘143 in view of Sachar ‘438 discloses the system of claim 14, Sachar ‘143 further disclosing wherein the wire shaft (220) has an outer diameter of at least one of about 0.014, about 0.018, and about 0.035 inches (P. [0063] - - A proximal portion of the guidewire 250 extends out of the distal portion 220b of catheter 220 proximally of the sheath 284 via the guidewire port 302. The guidewire 250 according to some implementations has a diameter of between 0.010 inches and 0.038 inches (e.g., 0.014 inches); it is noted that since guidewire 250 according to some implementations has a diameter of between 0.010 inches and 0.038 inches (e.g., 0.014 inches), the outer diameter of the wire shaft (220) is necessarily larger than at least one of about 0.014, about 0.018, and about 0.035 inches).
Regarding claim 16 in view of the rejection under 35 U.S.C. 112(b) above, Sacher ‘143 in view of Sachar ‘438 discloses the system of claim 14, Sachar ‘143 further disclosing wherein the wire shaft (220) further comprises:
a tapered wire tip (235) positioned on the distal end of the wire shaft (220);
wherein the wire tip (235) tapers radially from a larger diameter proximal end of the dilator to a smaller diameter distal end of the dilator (P. [0039] - - the distal tip 235 is conical or frusto-conically shaped to facilitate penetration through the body; it is noted that since tip 235 is conical or frusto-conically shaped to facilitate penetration through the body, the device is interpreted as including a dilator).
Regarding claim 17 in view of the rejection under 35 U.S.C. 112(b) above, Sacher ‘143 in view of Sachar ‘438 discloses the system of claim 16, Sachar ‘143 further disclosing wherein an outer diameter of the proximal end of the wire tip (235) approximates an outer diameter of the exchange sheath (284);
wherein the exchange sheath (284) is slidable over the wire shaft (220) in the distal direction to abut the distal end of the guide sheath (284) against the proximal end of the wire tip (235) (See Fig. 1) (Ps. [0035], [0036], [0039] - - FIG. 1 is a side view of the percutaneous transluminal angioplasty device 200 with the sheath 284 covering the filter assembly 240 and balloon 260; In the implementation shown in FIG. 1, the device 200 includes a catheter 220 having a proximal end 225 and a distal end 223; As illustrated in FIGS. 4-5, the device 200 further includes a distal tip 235 coupled to the distal end 223).
Regarding claim 18, Sacher ‘143 in view of Sachar ‘438 discloses the system of claim 14, Sachar ‘143 further disclosing wherein the exchange sheath (284) has a proximal end and a distal end;
wherein the central lumen (L1) extends from the proximal end to the distal end of the exchange sheath (284) (See Fig. 1, Annotated Fig. 3) (Ps. [0037], [0061] - - FIG. 3 illustrates a cross sectional view of the distal portion 220b of the catheter 220 as taken through line C-C as shown in FIG. 1; the sheath 284 does not extend over the entire length of the catheter. By disposing the sheath wire 286 within the proximal portion 220a of the catheter 220; it is noted that the central lumen (L1) for receiving wire shaft (220) extends from the proximal end (220a) of wire shaft (220) to the distal end (220b) of wire shaft (220)).
Regarding claim 19, Sacher ‘143 in view of Sachar ‘438 discloses the system of claim 18, Sachar ‘143 further disclosing wherein the secondary lumen (227) extends from the proximal end to the distal end of the exchange sheath (284) (See Fig. 1, 3) (Ps. [0037], [0063] - - FIG. 3 illustrates a cross sectional view of the distal portion 220b of the catheter 220 as taken through line C-C as shown in FIG. 1; The opening of the guidewire port 302 defined by the external surface of the catheter 220 is proximal to guidewire lumen 227 to facilitate rapid exchange of the guidewire 250. In the implementation shown, the guidewire port 302 is defined by the opening of the guidewire lumen 227 at the proximal end of the distal portion 220b. A proximal portion of the guidewire 250 extends out of the distal portion 220b of catheter 220 proximally of the sheath 284 via the guidewire port 302; it is noted that since secondary lumen (227) and guidewire 250 extends from a distal end of wire shaft (220) and exchange sheath (284) as shown in Fig. 3 to proximally past the proximal end of the exchange sheath (284) as shown in Fig. 1, the secondary lumen (227) extends from the proximal end to the distal end of the exchange sheath (284)).
Regarding claim 26, Sacher ‘143 in view of Sachar ‘438 discloses the system of claim 14, Sachar ‘143 further disclosing further comprising:
a procedural guidewire (250) (Figs. 1, 3, 8- 9B);
wherein the secondary lumen (227) of the exchange sheath (284) is sized to slidably receive the procedural guidewire (250) such that the exchange sheath (284) is navigable over the procedural guidewire (250) (P. [0039] - - The tip 235 defines a guidewire port through which a guidewire 250 extends during placement of the device 200 within the body).
Regarding claim 27, Sacher ‘143 in view of Sachar ‘438 discloses the system of claim 14, Sachar ‘143 further disclosing the substance of claim 26 above.
Sachar ‘143 does not disclose
(claim 27) further comprising:
a procedural sheath defining a procedural lumen sized to deliver at least the intravascular device through the vessel.
It is noted that the angioplasty balloon disclosed by Modified Sachar ‘143 is broadly interpreted as a thrombectomy device. If applicant does not agree with this interpretation, alternatively, the Office points to Sachar ‘438:
(claim 27) an intravascular thrombectomy device (described, not shown) (P. [0080] - - In each of the foregoing examples, it will be appreciated that an angioplasty balloon is but one means for relieving a stenosis in a vessel. Stents, mechanical thrombectomy devices, or other suitable apparatus may be substituted for the angioplasty balloon and positioned on the catheter at a location proximal to the embolic filter. Thus any emboli loosened by the stent or mechanical thrombectomy device will be captured by the embolic filter in the same manner as described above with respect to the angioplasty balloon).
The mechanical thrombectomy device (described, not shown) (Sachar ‘438 - - P. [0080]) taught by Sachar ‘438 performs the same function of relieving a stenosis in a vessel as the angioplasty balloon (260) (Figs. 10A, 10B, 12) disclosed by Sachar ‘143 (Sachar ‘143 - - P. [0069] - - The embolic material may include material from the vessel and fragments of the drug coating that separated from the balloon 260 during expansion. The blocked vessel is opened and blood flow is restored). Thus it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute one known element (mechanical thrombectomy device (described, not shown) (Sachar ‘438 - - P. [0080])) for another (angioplasty balloon (260) (P. [0069])) since the substitution would have yielded predictable results, namely, relieving a stenosis in a vessel. KSR, 550 U.S. at, 82 USPQ2d at 1396.
Claim(s) 21- 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar et al. (US Pub. No. 2018/0161143 A1 hereinafter “Sachar ‘143”) in view of Sachar et al. (US Pub. No. 2005/0228438 A1 hereinafter “Sachar ‘438”) as applied to claim 14 above, and further in view of Deaton et al. (US Pub. No. 2022/0257279 A1).
Regarding claim 21, Sachar ‘143 in view of Sachar ‘438 discloses the system of claim 14, but Sachar ‘143 in view of Sachar ‘438 does not disclose
(claim 21) wherein the self-expanding basket has an outer diameter that is at least 30 mm when the self-expanding basket is in the expanded configuration.
However, Deaton teaches systems for removing material (e.g., clot) from within a body in the same field of endeavor (Abstract, P. [0030]).
(claim 21) wherein the self-expanding basket (2007) (Figs. 20A- 20C) has an outer diameter that is at least 30 mm when the self-expanding basket is in the expanded configuration (Ps. [0030], [0060], [0134] - - As mentioned, the diameter of the wires forming the basket may be 0.15 mm or more (e.g., 0.2 mm or more), particularly when braided into a pore area of between 1.2 and 7.5 mm.sup.2 when expanded to between 5 and 15 mm in diameter (for baskets having a maximum expanded diameter of between 20-40 mm); In some examples the method may include adjusting (e.g., manually, automatically or semi-automatically) the diameter of the basket as it is pulled to maintain force within a range. For example, a method of removing clot may include: positioning an expandable scraper device within a lumen of a vessel in an unexpanded configuration so that an expandable braided basket of the expandable scraper device is positioned distal to or within the clot; expanding the expandable braided basket to an expanded configuration against a wall of the vessel lumen where the expandable braided basket is configured to apply a maximum scraping force against the wall of the vessel lumen … to expand or contract the expandable braided basket to maintain the pull force between about 0.2 and 1.5 pounds of force to scrape clot material from the wall of the vessel lumen without damaging the wall of the vessel lumen;
FIGS. 20A and 20B illustrate one example a distal end of a device similar to that shown in FIG. 19A-19D, including the basket 2007, an inner elongate member 2027 and an outer elongate member 2025. The basket in this example is formed of a plurality of wires that are braided loosely together. FIG. 20A shows the basket in the collapsed, fully un-expanded configuration. FIG. 20B shows the basket 2007 in a fully deployed, expanded configuration. In this example, the braided wires are Nitinol wires that are configured to expand outwards to a maximum expansion diameter of, e.g., between 10 mm and 40 mm (e.g., 20 mm, 30 mm, etc.). The basket region may have an unexpanded length of between 3 and 14 cm, such as, e.g., 5 cm (+/−0.2 cm), 7 cm (+/−0.2 cm), etc.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the outer diameter of the self-expanding basket associated with Sachar ‘143 such that it has an outer diameter that is at least 30 mm when the self-expanding basket is in the expanded configuration according to the teachings of Deaton in order to apply a maximum force needed scrape clot material from the wall of the vessel lumen without damaging the wall of the vessel lumen (Deaton - - Ps. [0030], [0060], [0134]).
Regarding claim 22, Sachar ‘143 in view of Sachar ‘438 discloses the system of claim 14, but Sachar ‘143 in view of Sachar ‘438 does not disclose
(claim 22) wherein the self-expanding basket has an outer diameter between about 32 mm to about 36 mm when the self-expanding basket is in the expanded configuration. However, Deaton teaches systems for removing material (e.g., clot) from within a body in the same field of endeavor (Abstract, P. [0030]).
(claim 22) wherein the self-expanding basket (2007) has an outer diameter between about 32 mm to about 36 mm when the self-expanding basket is in the expanded configuration (P. [0030] - - As mentioned, the diameter of the wires forming the basket may be 0.15 mm or more (e.g., 0.2 mm or more), particularly when braided into a pore area of between 1.2 and 7.5 mm.sup.2 when expanded to between 5 and 15 mm in diameter (for baskets having a maximum expanded diameter of between 20-40 mm)). It is noted that the claimed diameter range falls within the disclosed range of between 20- 40 mm.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the outer diameter of the self-expanding basket associated with Sachar ‘143 such that it has an outer diameter between about 32 mm to about 36 mm when the self-expanding basket is in the expanded configuration according to the teachings of Deaton in order to apply a maximum force needed scrape clot material from the wall of the vessel lumen without damaging the wall of the vessel lumen (Deaton - - Ps. [0030], [0060], [0134]).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sachar et al. (US Pub. No. 2018/0161143 A1 hereinafter “Sachar ‘143”) in view of Sachar et al. (US Pub. No. 2005/0228438 A1 hereinafter “Sachar ‘438”) as applied to claim 26 above, and further in view of Sepetka et al. (US Pub. No. 2002/0072764 A1).
Regarding claim 27, Sacher ‘143 in view of Sachar ‘438 discloses the system of claim 26, but Sachar ‘143 in view of Sachar ‘438 does not disclose
(claim 27) further comprising:
a procedural sheath defining a procedural lumen sized to deliver at least the intravascular device through the vessel.
However, Sepetka teaches a system for retrieving and removing clots and other biological obstructions in the same field of endeavor (P. [0002])
(claim 27) further comprising:
a procedural sheath (4, 10) (Figs. 1- 2) defining a procedural lumen sized to deliver at least the intravascular device (8) (Figs. 1- 8) through the vessel.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the applicant’s invention to modify the system associated with Sachar ‘143 in view of Sachar ‘438 in order to include procedural sheath defining a procedural lumen sized to deliver at least the intravascular device through the vessel as taught by Sepetka because it would allow the system associated with Sachar ‘143 in view of Sachar ‘438 to be introduced further into the vasculature (Sepetka - - Ps. [0017], [0087]). The motivation for the modification would have been to allow additional catheters and/or instruments disposed within the procedural sheath to be advanced further into the vasculature to a position proximal to, within or distal to the obstruction to be retrieved (Sepetka - - P. [0087]).
Allowable Subject Matter
Claim 7 is 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.
Claim 20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 7, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein the second lumen extends from a proximal opening in a sidewall of the exchange sheath to a distal opening in the sidewall of the exchange sheath, wherein the proximal opening and the distal opening are positioned between the proximal end and the distal end of the exchange sheath.
Regarding claim 20, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein the secondary lumen extends from a proximal opening in a sidewall of the guide sheath to a distal opening in the sidewall of the exchange sheath, wherein the proximal opening and the distal opening are positioned between the proximal end and the distal end of the exchange sheath.
The closest cited prior art reference Sachar et al. (US Pub. No. 2018/0161143 A1 hereinafter “Sachar ‘143”) teaches a wire shaft (220) sized for receiving and delivering a guidewire deliverable intravascular thrombectomy device, a second lumen (227) and an exchange sheath (284) defining a first lumen (L1). The second lumen (227) is disposed within wire shaft (220), which is disposed within the exchange sheath (284). Even though second lumen (227) is laterally offset from the first lumen (L1) of the exchange sheath (284), the second lumen (227) does not extend from a proximal opening in a sidewall of the exchange sheath (284) to a distal opening in the sidewall of the exchange sheath (284), wherein the proximal opening and the distal opening are positioned between the proximal end and the distal end of the exchange sheath (284). Since wire shaft (220) defines a guidewire port 302 that extends between the second lumen (227) and an external surface of the wire shaft (220) and since the opening of the guidewire port 302 defined by the external surface of the wire shaft (220) is proximal to second lumen (227) to facilitate rapid exchange of the guidewire 250 (P. [0063]), there is no motivation for modifying the device of Sachar ‘143 such that the second lumen extends from a proximal opening in a sidewall of the exchange sheath to a distal opening in the sidewall of the exchange sheath without improper hindsight reasoning.
Conclusion
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771