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
Claims filed on October 29th, 2025 have been entered. Claims 1-5, 7-10, and 12- 20 are pending in the application. Claim 14 remains withdrawn for being drawn to an unelected invention. The amendment to claim 15 overcomes the previous claim objection and the amendments to claims 8 and 15 overcome the previous 112(a) and 112(b) rejections.
Claim Objections
Claims 1-5, 7-10, 12- 13, and 15- 20 are objected to because of the following informalities:
Claim 1, Line 13 states “the front open end”, it is suggested to change this to “the front open end of the catheter”.
Claims 2-5, and 7 are objected to for being dependent on or from objected claim 1.
Claim 8, Line 14 states “the front open end”, it is suggested to change this to “the front open end of the catheter”.
Claims 9-10 and 12- 13 are objected to for being dependent on or from objected claim 8.
Claim 15, Line 13 states “the front open end”, it is suggested to change this to “the front open end of the catheter”.
Claims 16- 20 are objected to for being dependent on or from objected claim 15.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1- 5, 7- 10, and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel et al. (US 2006/0100662) in view of Yadav (US 6,755,846).
Regarding claim 1, Daniel (Daniel et al.) teaches an embolic filter device (250)(Figs. 18A- 18D)(abstract, Paragraphs 0003 and 0071- 0076) comprising:
A catheter portion (254) having a front open end, a rear open end (As Daniel teaches in Paragraph 0071 that the catheter portion has a lumen in which the inner wire extends through, the catheter would necessarily have a rear open end.), and an exterior surface (see annotated Fig. 18A below);
A wire (252), the wire for insertion into the rear open end through the catheter portion (As the wire element is taught by Daniel to extend through the catheter (see annotated Fig. 18A below)(Paragraph 0071), one of ordinary skill in the art would recognize that the wire element would be inserted through the rear open end of the catheter in order to extend through the lumen and out the front open end.) and out the front open end (see annotated Fig. 18A below); and
A canopy (expandable mesh or braid portion 262) having a proximal end and extending along the exterior surface of the catheter portion (see annotated Fig. 18A below)(Paragraph 0072), with the canopy being in an expanded state when the wire is moved toward the front open end (In Paragraph 0074, Daniel teaches that the mesh canopy expands when the catheter portion and the wire move towards each other. When the catheter portion is held and the wire is moved relative to the catheter portion, then the canopy would expand in the same manner as set forth in Paragraph 0074 of the catheter portion being moved relative to the wire.).
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Daniel does not teach wherein the wire has a cap portion, the cap portion extending out of and away from the front open end when the embolic filter device is in a collapsed state or a pair of expanding arms with each arm having a first end and a second end, each first end being connected to the cap portion, the pair of expanding arms extending from the cap portion to the front open end of the catheter portion, wherein the proximal end of the canopy is connected to each of the second ends of the pair of expanding arms at the front open end of the catheter.
Yadav teaches a similar embolic filter device (abstract)(Figs. 1- 3; Column 3, Lines 4- 12) comprising: a wire (guidewire 10)(Column 3, Lines 67) having a cap portion (soft tip 15)(Column 4, Line 2), a pair of expanding arms (deploying wires or fibers 30)(Column 4, Lines 15- 17) with each arm having a first end and a second end (see annotated Fig. 2 below), each first end being connected to the cap portion (Yadav teaches that the pair of expanding arms are connected to the wire (Column 4, Lines 15- 19), which is connected to the cap portion (Column 4, Lines 1- 4), therefore each a first end is connected to the cap portion.), the pair of expanding arms extending from the cap portion to the end of the catheter portion (see annotated Fig. 1 below), and a canopy (filter membrane 20) having a proximal end connected to each of the second ends of the pair of expanding arms (Column 4, Lines 15- 19)(see annotated Fig. 2 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the filter device canopy and the wire element as taught by Daniel that captures embolic debris and allows blood flow (Paragraph 0076), for the filter device including the canopy and wire with a cap portion as taught by Yadav since these mechanisms perform the same function of capturing and retaining embolic debris and allowing blood flow (Daniel, Paragraph 0076; Yadav, abstract and Column 5, Lines 17- 21). Simply substituting one filter device and wire for another would yield the predicable result of capturing embolic debris in an operation. See MPEP 2143.
Regarding the cap portion extending out of and away from the front open end, as the wire is taught by Daniel to extend out of and away from the front open end (see annotated Fig. 18A of Daniel above), and the combination replaces the filter device and the wire element but not the positioning of them relative to the catheter, the cap portion would extend out of and away from the front open end.
Regarding the canopy being in an expanded state when the wire and the cap portion are moved toward the front open end, as the combination retains the basic functions of the device and the filter as taught by Daniel, it would also have the same function of expanding when the wire and the cap portion are moved toward the front open end, as discussed above.
Regarding claim 2, as discussed above, it would have been obvious to have substituted the filter device including the canopy and the element as taught by Daniel for the filter device and wire with a cap portion as taught by Yadav.
As the combination has the filter device and wire of Yadav, which teaches that the canopy (filter membrane 20) can be made of a polymer or a metal (Column 5, Lines 33- 36), the pair of expandable arms (deploying wires or fibers 30) can be made of a metal or a polymer, and the wire (10) can be made of similar materials as well (Column 4, Lines 35- 43), part of the device is constructed as a polymer.
However, the combination is silent to wherein the catheter is made of a polymeric material.
Daniel teaches in a different embodiment wherein a catheter (proximal shaft 390) is made of a polymeric material (Paragraph 0113).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter of the combination to be made of a polymeric material, since Daniel teaches that the polymer material is preferable (Paragraph 0113).
Therefore, now that each part of the device is taught to be made of a polymeric material, the combination makes obvious the device being made of a polymeric material.
Regarding claims 3 and 4, as discussed above, it would have been obvious to have substituted the filter device including the canopy and the element as taught by Daniel for the filter device and wire with a cap portion as taught by Yadav.
The combination further teaches wherein the canopy (Yadav, filter membrane 20) is constructed of a mesh (Yadav, Column 5, Line 16) which is capable of capturing and retaining debris (Yadav, Column 5, Lines 17- 21)
Regarding claims 5 and 7, as discussed above, it would have been obvious to have substituted the filter device including the canopy and the element as taught by Daniel for the filter device and wire with a cap portion as taught by Yadav.
The combination further teaches wherein the device is constructed of metal (claim 5), or of a combination of polymer and metal (claim 7).
As the combination has the filter device and wire of Yadav, which teaches that the canopy (filter membrane 20) can be made of a polymer or a metal (Column 5, Lines 33- 36), the pair of expandable arms (deploying wires or fibers 30) can be made of a metal or a polymer, and the wire (10) can be made of similar materials as well (Column 4, Lines 35- 43), part of the device is constructed as a polymer.
However, the combination is silent to wherein the catheter is made of a polymeric material or a metal.
Daniel teaches in a different embodiment wherein a catheter (proximal shaft 390) can be made of a polymeric material or nitinol, a metal (Paragraph 0113).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter of the combination to be made of a polymeric material, since Daniel teaches that the polymer material is preferable (Paragraph 0113).
Therefore the combination makes obvious a device constructed of a metal, as set forth in claim 5, or a device made of a combination of polymer and metal, as set forth in claim 7.
Regarding claim 8, Daniel (Daniel et al.) teaches an embolic filter device (250)(Figs. 18A- 18D)(abstract, Paragraphs 0003 and 0071- 0076) comprising:
A catheter portion (254) having a front open end, a rear open end (As Daniel teaches in Paragraph 0071 that the catheter portion has a lumen in which the inner wire extends through, the catheter would necessarily have a rear open end. ), and an exterior surface (see annotated Fig. 18A below);
A wire (252), the wire for insertion into the rear open end through the catheter portion (As the wire element is taught by Daniel to extend through the catheter (see annotated Fig. 18A below)(Paragraph 0071), one of ordinary skill in the art would recognize that the wire element would be inserted through the rear open end of the catheter in order to extend through the lumen and out the front open end.) and out the front open end, the wire extending out of and away from the front open end when the embolic filter device is in a collapsed state (see annotated Fig. 18A below); and
A mesh canopy (expandable mesh or braided portion 262) having a proximal end with the canopy connected to the element and extending along the exterior surface of the catheter portion (see annotated Fig. 18A below)(Paragraph 0072) and capable of being in an opened position when the wire is pulled toward the front open end (Paragraphs 0074- 0076).
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Daniel does not teach wherein the wire has a cap portion, the cap portion extending out of and away from the front open end or a pair of expanding arms with each arm having a first end and a second end, each first end being connected to the cap portion, the pair of expanding arms extending from the cap portion to the front open end of the catheter portion or the proximal end of the mesh canopy connected to each of the second ends of the pair of expanding arms.
Yadav teaches a similar embolic filter device (abstract)(Figs. 1- 3; Column 3, Lines 4- 12) comprising: a wire (guidewire 10)(Column 3, Lines 67) having a cap portion (soft tip 15)(Column 4, Line 2), a pair of expanding arms (deploying wires or fibers 30)(Column 4, Lines 15- 17) with each arm having a first end and a second end with each first end being connected within the cap portion (Yadav teaches that the pair of expanding arms are connected to the wire (Column 4, Lines 15- 19), which is connected to the cap portion (Column 4, Lines 1- 4), therefore the first end of each arm is connected to the cap portion.) the pair of expanding arms extending from the cap portion to the front of the catheter portion (see annotated Fig. 1 below), and a canopy (filter membrane 20)(Column 3, Line 67- Column 4, Line 1) having a proximal end connected to each of the second ends of the pair of expanding arms (see annotated Fig. 2 below)(Column 4, Lines 15- 19) wherein the canopy is capable of being in a closed position (see annotated Fig. 1 below) and the canopy capable of being in an opened position when the cap portion is pulled by use of the wire (Column 4, Lines 27- 34).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the filter device canopy and the wire element as taught by Daniel that captures embolic debris and allows blood flow (Paragraph 0076), for the filter device including the canopy and wire with a cap portion as taught by Yadav since these mechanisms perform the same function of capturing and retaining embolic debris and allowing blood flow (Daniel, Paragraph 0076; Yadav, abstract and Column 5, Lines 17- 21). Simply substituting one filter device and wire for another would yield the predicable result of capturing embolic debris in an operation. See MPEP 2143.
Regarding the cap portion extending out of and away from the front open end, as the wire is taught by Daniel to extend out of and away from the front open end (see annotated Fig. 18A of Daniel above), and the combination replaces the filter device and the wire element but not the positioning of them relative to the catheter, the cap portion would extend out of the front open end.
Regarding claim 9, as discussed above, it would have been obvious to have substituted the filter device including the canopy and the element as taught by Daniel for the filter device and wire with a cap portion as taught by Yadav.
The combination teaches wherein the device is constructed of a combination of polymer and metal.
As the combination has the filter device and wire of Yadav, which teaches that the canopy (filter membrane 20) can be made of a polymer or a metal (Column 5, Lines 33- 36), the pair of expandable arms (deploying wires or fibers 30) can be made of a metal or a polymer, and the wire (10) can be made of similar materials as well (Column 4, Lines 35- 43), part of the device is constructed as a polymer.
However, the combination is silent to wherein the catheter is made of a polymeric material or a metal.
Daniel teaches in a different embodiment wherein a catheter (proximal shaft 390) can be made of a polymeric material or nitinol, a metal (Paragraph 0113).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter of the combination to be made of a polymeric material, since Daniel teaches that the polymer material is preferable (Paragraph 0113).
Therefore the combination makes obvious a device made of a combination of polymer and metal, as set forth in claim 9.
Regarding claims 10, 12, and 13, as discussed above, it would have been obvious to have substituted the filter device including the canopy and the element as taught by Daniel for the filter device and wire with a cap portion as taught by Yadav.
The combination further teaches wherein the canopy (Yadav, filter membrane 20) is capable of capturing and retaining debris and allowing blood to flow through (Column 5, Lines 17- 21).
Claim(s) 15- 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daniel et al. (US 2006/0100662) in view of Yadav (US 6,755,846) and in view of Stalker (US 2010/0004674).
Regarding claim 15, Daniel (Daniel et al.) teaches an embolic filter device (250)(Figs. 18A- 18D)(abstract, Paragraphs 0003 and 0071- 0076) comprising:
A catheter portion (254) having a front open end, a rear open end (As Daniel teaches in Paragraph 0071 that the catheter portion has a lumen in which the inner wire extends through, the catheter would necessarily have a rear open end. ), and an exterior surface (see annotated Fig. 18A below);
A wire (252), the wire for insertion into the rear open end through the catheter portion (As the wire element is taught by Daniel to extend through the catheter (see annotated Fig. 18A below)(Paragraph 0071), one of ordinary skill in the art would recognize that would be inserted through the rear open end of the catheter in order to extend through the lumen and out the front open end.) and out the front open end, wherein the wire extends out of and away from the front open end when the embolic filter is in a collapsed state (see annotated Fig. 18A below); and
A canopy (expandable mesh or braid portion 262) having a proximal end and extending along the exterior surface of the catheter portion, with the canopy being in an expanded state when the wire is moved toward the front open end (see annotated Fig. 18A below)(Paragraphs 0074- 0076).
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Daniel does not teach the wire having a cap portion, the cap portion extending out of and away from the front open end when the embolic filter device is in a collapsed state, a pair of expanding arms with each arm having a first end and a second end, each first end being connected to the cap portion, the pair of expanding arms extending from the cap portion to the front open end of the catheter, the canopy having a proximal end connected to each of the second ends of the pair of expanding arms at the front open end of the catheter and extending along the exterior surface of the catheter portion, or a stent having an interior, the catheter portion capable of insertion into the interior of the stent.
Yadav teaches a similar embolic filter device (abstract)(Figs. 1- 3; Column 3, Lines 4- 12) comprising: a wire (guidewire 10)(Column 3, Lines 67) having a cap portion (soft tip 15)(Column 4, Line 2), a pair of expanding arms (deploying wires or fibers 30)(Column 4, Lines 15- 17) with each arm having a first end and a second end, each first end being connected to the cap portion (Yadav teaches that the pair of expanding arms are connected to the wire (Column 4, Lines 15- 19), which is connected to the cap portion (Column 4, Lines 1- 4), therefore the first end of each arm is connected to the cap portion.), the pair of expanding arms extending from the cap portion to the front open end of the catheter (see annotated Fig. 1 below), and a canopy (filter membrane 20)(Column 3, Line 67- Column 4, Line 1) having a proximal end connected to each of the second ends of the pair of expanding arms at the front open end of the catheter (see annotated Fig. 2 below)(Column 4, Lines 15- 19).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the filter device canopy and the wire element as taught by Daniel that captures embolic debris and allows blood flow (Paragraph 0076), for the filter device including the canopy and wire with a cap portion as taught by Yadav since these mechanisms perform the same function of capturing and retaining embolic debris and allowing blood flow (Daniel, Paragraph 0076; Yadav, abstract and Column 5, Lines 17- 21). Simply substituting one filter device and wire for another would yield the predicable result of capturing embolic debris in an operation. See MPEP 2143.
The combination of Daniel and Yadav does not teach a stent having an interior, the catheter portion capable of insertion into the interior of the stent.
Stalker teaches an embolic filter device (10, Paragraph 0016)(abstract)(Figs. 1- 5, Paragraphs 0011- 0015) comprising: a catheter portion (16, Paragraph 0016) having a front open end (see annotated Fig. 2 below), a rear open end (Stalker teaches in Paragraph 0020 that the device comprises a set of retraining wires 56 that extend through the lumen of the catheter portion (see Fig. 1) to the outside of a patient. Therefore, in order for an operator to use these retaining portions, the catheter portion would have an rear open end.); an element (shaft 40, Paragraph 0018) for holding an expanding directional member (42)(Paragraph 0018) that extends out of the front open end and through the catheter (see annotated Fig. 2 below) and a canopy (filtering member 36) with the canopy connected to the expanding directional member (42)(Paragraph 0018); and a stent (24, Paragraph 0017) having an interior (see annotated Fig. 3 below), the catheter portion capable of insertion into the interior of the stent (Paragraph 0017).
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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 device of the combination to have a stent having an interior, the catheter portion capable of insertion inside of the interior as taught by Stalker, since Stalker teaches that the stent “can be utilized to treat the lesion 20 and open up the artery 12 to increase blood flow therethrough” (Paragraph 0017).
Regarding the cap portion extending out of the front open end, as the wire is taught by Daniel to extend out of the front open end (see annotated Fig. 18A of Daniel above), and the combination replaces the filter device and the wire element but not the positioning of them relative to the catheter, the cap portion would extend out of the front open end.
Regarding claim 16, as discussed above, to have substituted the filter device and the element as taught by Daniel for the filter device including the canopy and wire with a cap portion as taught by Yadav.
As the combination has the filter device and wire of Yadav, which teaches that the canopy (filter membrane 20) can be made of a polymer or a metal (Column 5, Lines 33- 36), the pair of expandable arms (deploying wires or fibers 30) can be made of a metal or a polymer, and the wire (10) can be made of similar materials as well (Column 4, Lines 35- 43), part of the device is constructed as a polymer.
However, the combination is silent to wherein the catheter is made of a polymeric material.
Daniel teaches in a different embodiment wherein a catheter (proximal shaft 390) is made of a polymeric material (Paragraph 0113).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter of the combination to be made of a polymeric material, since Daniel teaches that the polymer material is preferable (Paragraph 0113).
Therefore, now that each part of the device is taught to be made of a polymeric material, the combination makes obvious the device being made of a polymeric material.
Regarding claims 17 and 18, as discussed above, to have substituted the filter device and the element as taught by Daniel for the filter device including the canopy and wire with a cap portion as taught by Yadav.
The combination further teaches wherein the canopy (Yadav, filter membrane 20) is constructed of a mesh (Column 5, Line 16) which is capable of capturing and retaining debris (Column 5, Lines 17- 21).
Regarding claim 19, as discussed above, to have substituted the filter device and the element as taught by Daniel for the filter device including the canopy and wire with a cap portion as taught by Yadav..
The combination further teaches wherein the canopy (Yadav, filter membrane 20) allows blood to flow through (Column 5, Lines 17- 21).
Regarding claim 20, as discussed above, to have substituted the filter device and the element as taught by Daniel for the filter device including the canopy and wire with a cap portion as taught by Yadav.
The combination further teaches wherein the device is constructed of metal.
As the combination has the filter device and wire of Yadav, which teaches that the canopy (filter membrane 20) can be made of a polymer or a metal (Column 5, Lines 33- 36), the pair of expandable arms (deploying wires or fibers 30) can be made of a metal or a polymer, and the wire (10) can be made of similar materials as well (Column 4, Lines 35- 43), part of the device is constructed as a polymer.
However, the combination is silent to wherein the catheter is made of a metal.
Daniel teaches in a different embodiment wherein a catheter (proximal shaft 390) can be made of nitinol, a metal (Paragraph 0113).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter of the combination to be made of nitinol, a metal, since Daniel teaches that nitinol is preferable (Paragraph 0113).
Therefore, now that each part of the device is taught to be made of a metal, the combination makes obvious a device constructed of a metal.
Response to Arguments
Applicant's arguments filed October 29th, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments, see Pages 8- 10, regarding that the prior art fails to teach the newly added claim limitations, specifically that the proximal end of the canopy is connected to each of the seconds ends of the pair of expanding arms, has been fully considered but is not persuasive. As discussed above, Yadav teaches a similar embolic filter device (abstract)(Figs. 1- 3; Column 3, Lines 4- 12) comprising: a wire (guidewire 10)(Column 3, Lines 67) having a cap portion (soft tip 15)(Column 4, Line 2), a pair of expanding arms (deploying wires or fibers 30)(Column 4, Lines 15- 17) with each arm having a first end and a second end, each first end being connected to the cap portion (Yadav teaches that the pair of expanding arms are connected to the wire (Column 4, Lines 15- 19), which is connected to the cap portion (Column 4, Lines 1- 4), therefore the first end of each arm is connected to the cap portion.), the pair of expanding arms extending from the cap portion to the front open end of the catheter (see annotated Fig. 1 below), and a canopy (filter membrane 20)(Column 3, Line 67- Column 4, Line 1) having a proximal end connected to each of the second ends of the pair of expanding arms at the front open end of the catheter (see annotated Fig. 2 below)(Column 4, Lines 15- 19).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the filter device canopy and the wire element as taught by Daniel that captures embolic debris and allows blood flow (Paragraph 0076), for the filter device including the canopy and wire with a cap portion as taught by Yadav since these mechanisms perform the same function of capturing and retaining embolic debris and allowing blood flow (Daniel, Paragraph 0076; Yadav, abstract and Column 5, Lines 17- 21). Simply substituting one filter device and wire for another would yield the predicable result of capturing embolic debris in an operation. See MPEP 2143.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771