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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/13/2025 has been entered.
Response to Amendment
Applicant’s amendment filed on 08/13/2025 have been fully considered. Claims 1-8 are pending in this application. Claims 1 and 5 are amended.
Response to Arguments
Applicant's arguments filed 08/13/2025, regarding the prior arts of Janardhan and Galdonik, have been fully considered but they are not persuasive.
The applicant argues that Janardhan does not teach the catheter structure of the claimed invention. However, the teachings of Janardhan is incorporated to the primary references to teach the braiding material characteristics, since both Janardhan, Hart, and the claimed invention are analogous to each other in the field of vascular catheters. Thus, the teachings of the shapes/braiding angles of Janardhan is applied to the tubular body of Hart and would not disrupt the functionality of the device of Hart.
The teachings of Galdonik, with the elasticity of the expansion portion compared to the shaft portion, was applied to the tubular body of Hart in view of Janardhan, since the prior art references are analogous to the claimed invention. Thus, the prior arts of Janardhan and Hart are applicable to the claim limitations of the claimed invention.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Though overall the same prior art references are used herein, at least applicant’s amended independent claim 1 and the request for continued examination required a change in the grounds of rejection as detailed below in the prior art rejection.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hart et al. (Patent No. US 5,868,708 A) in view of Janardhan et al. (Publication No. US 2018/0368965 A1) and Galdonik (Patent No. US 6,464,684 B1).
Regarding claim 1, Hart teaches a percutaneous catheter that extends in an axial direction and through which blood is passed (device 10 that extends in an axial direction where blood is passed in the vascular conduit 2; Figure 2; Column 5, line 65 to Column 6, lines 24), wherein the percutaneous catheter is configured to be axially stretched over a stylet in the axial direction (device 10 is configured to axially stretch over an inner member 18 in the axial direction; Figure 2 and 3; Column 7, lines 1-8), the percutaneous catheter comprising:
an expansion portion extending in the axial direction to be expandable and having a respective inner diameter and a respective outer diameter (expansion portion that is expandable and has an inner and outer diameter; annotated Figure 2 below; Column 7, lines 1-8), wherein the respective inner diameter and outer diameter of the expansion portion are reduced when the percutaneous catheter is stretched over the stylet (expansion portion has inner and outer diameter that decreases when stretched/when inner member 18 is pushed forward; Figure 2 and 3; Column 7, lines 1-8);
a shaft portion extending in the axial direction and provided on a proximal end side in an insertion direction of the expansion portion and having a respective inner diameter and a respective outer diameter (shaft portion extends in the axial direction and is on the proximal end side of the expansion portion and has an inner and outer diameter; annotated Figure 2 below); and
an intermediate portion provided between the expansion portion and the shaft portion (intermediated portion is between expansion and shaft portion; annotated Figure 2 below), wherein:
the respective inner diameter and outer diameter of the expansion portion are respectively larger than the inner diameter and outer diameter of the shaft portion when the percutaneous catheter is not being stretched over the stylet (expansion portion has an inner and outer diameter that is larger than the shaft portion when the catheter is not stretched; annotated Figure 2 below; Figure 3; Column 7, lines 1-8), wherein the respective inner diameter and outer diameter of the expansion portion are reduced when the percutaneous catheter is stretched over the stylet (expansion portion’s inner and outer diameter reduces when catheter is stretched; Figure 2 and 3; Column 7, lines 1-8), and
the intermediate portion is configured to have a respective inner diameter and a respective outer diameter gradually decreasing from the expansion portion to the shaft portion when the percutaneous catheter is not being stretched over the stylet (intermediate has an inner and outer diameter that is gradually decreasing from the expansion portion to the shaft portion when catheter is not stretched; annotated Figure 2 below);
the outer diameter of the expansion portion and the outer diameter of the intermediate portion are approximately the same as the outer diameter of the shaft portion when the percutaneous catheter is stretched over the stylet (outer diameter of the expansion portion and the intermediate portion is equal to the shaft portion when catheter is stretched; Figure 3; Column 7, lines 1-8).
Hart does not teach the expansion portion comprises a first reinforcing body including first braided wires which intersect with each other in the first reinforcing body at a first braiding angle;
the shaft portion comprises a second reinforcing body including second braided wires which intersect with each other at a second braiding angle;
the intermediate portion includes a third reinforcing body including third braided wires which intersect with each other at a third braiding angle.
However, Janardhan teaches the expansion portion comprises a first reinforcing body including first braided wires which intersect with each other in the first reinforcing body at a first braiding angle (expansion portion 9902 has braiding wires that create a first braiding angle; Figure 6J; Paragraph 0688);
the shaft portion comprises a second reinforcing body including second braided wires which intersect with each other at a second braiding angle (shaft portion 9906 has braiding wires that create a second braiding angle; Figure 6J; Paragraph 0688);
the intermediate portion includes a third reinforcing body including third braided wires which intersect with each other at a third braiding angle (intermediate portion 9904 that has braiding wires that create third braiding angle; Figure 6J; Paragraph 0688).
Hart and Janardhan are considered to be analogous to the claimed invention between they are in the same field of vascular devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Janardhan to incorporate the teachings of Hart to have the braiding structure of the intermediate and shaft portion with the braiding angle and diameters of Janardhan connected to the expansion portion of Hart and incorporating the braiding angle and diameter of the expansion portion of Janardhan to the expansion portion of Hart. This would allow for the varying in shape of the bulbs and braiding angles of the braiding structure to vary the blood flow at specific regions of the target site, such as aiding thrombosis or providing blood to travel through damaged vascular regions (Janardhan; Paragraph 0687-0689).
The combination of Hart in view of Janardhan does not teach a major portion of the third reinforcing body is configured such that the third braiding angle is smaller than the first braiding angle and the second braiding angle.
However, another embodiment, Figure 6D, of Janardhan teaches a major portion of the third reinforcing body is configured such that the third braiding angle is smaller than the first braiding angle and the second braiding angle (Paragraph 0677 – various porosities can be combined with bulbs and necks as described, embodiment of Figure 6D shows that the intermediate portion 9320 has a smaller braiding angle than the expansion portion 9304 and shaft portion 9306; Figure 6D; Paragraph 0675-0677).
Janardhan is considered to be analogous to the claimed invention between they are in the same field of vascular devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified device of Hart in view of Janardhan to incorporate the embodiment of Figure 6D of Janardhan to have the braid angle of Figure 6D on the first, second, and third reinforcing bodies of Figure 6J of the device of Hart in view of Janardhan. This would allow for specific regions of the device to have different porosities which would be compatible for controlling blood flow at the target vascular location, such as the region with a lower braid angle is more porous to provide higher blood flow (Janardhan; Paragraph 0675-0677).
The modified device of Hart in view of Janardan does not teach wherein the expansion portion is configured to have higher elasticity than that of the shaft portion.
However, Galdonik teaches wherein portions 20, 22, and 24 have different braid densities to vary the flexibility and rigidity of discrete regions (Column 5, line 62 to Column 6, line 6; Figure 1).
Galdonik and Hart in view of Janardhan are considered to be analogous to the claimed invention between they are in the same field of vascular devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hart in view of Janardhan to incorporate the teachings of Galdonik to have the varying braid densities at different portions, where the braid density at the expansion portion is more elastic than the shaft portion of the device of Hart in view of Janardhan. This would allow for specific regions of the device to have optimized stiffness and flexibility to help reduce catheter back-out and maximize catheter performance (Galdonik; Column 2, lines 47-58 and Column 5, line 62 to Column 6, line 6).
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Annotated Figure 2
Regarding claim 2, Hart in view of Janardhan and Galdonik teaches the catheter of claim 1. The combination of Hart in view of Janardhan and Galdonik further teaches wherein the third reinforcing body has a first region in which the third braiding angle is configured to gradually decrease from the first braiding angle of the first reinforcing body, and a second region in which the third braiding angle is configured to gradually increase continuously from the braiding angle of the first region toward the second braiding angle of the second reinforcing body (Janardhan; Figure 6J – intermediate portion 9904 has differing braid angle than expansion portion 9902 and shaft portion 9906 and is tapered at both ends; Figure 6D – obvious that tapered ends of the intermediate section 9320 would have decreasing braid angle between the expansion section 9304 and the intermediate section 9320 and an increasing braid angle between the intermediate section 9320 and the shaft portion 9306; Paragraph 0675-0677 and 0688; see rejection of claim 1 above).
Regarding claim 3, Hart in view of Janardhan and Galdonik teaches the catheter of claim 1. The combination of Hart in view of Janardhan and Galdonik further teaches wherein the third reinforcing body includes a constant region where the third braiding angle is constant (obvious that the non-tapered portion of the intermediate portion of the device of Hart in view of Janardhan and Galdonik, such as the planar end of the intermediate portion adjacent to the shaft portion, would have a constant third braiding angle; Janardhan; Paragraph 0675-677; Figures 6D and 6J; see rejection of claim 1 above).
Regarding claim 4, Hart in view of Janardhan and Galdonik teaches the catheter of claim 1. The combination of Hart in view of Janardhan and Galdonik further teaches the first braiding angle of the first reinforcing body is in a range of 100 degrees to 120 degrees (Janardhan; first braiding angle at expansion portion 9304 is about 91 to 180 degrees; Paragraph 0675; see rejection of claim 1 above); the second braiding angle of the second reinforcing body is in a range of 130 degrees to 150 degrees (Janardhan; second braiding angle at shaft portion 9306 is about 91 to 180 degrees; Paragraph 0675; see rejection of claim 1 above); and the third braiding angle of the third reinforcing body is equal to or larger than 60 degrees (Janardhan; third braiding angle is about 0 to 90 degrees at intermediate portion 9320 and is smaller than first and second braiding angles; Paragraph 0675; see rejection of claim 1 above).
In addition, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first braiding angle in a range of 100 degrees to 120 degrees; the second braiding angle in a range of 130 degrees to 150 degrees; and the third braiding angle to be equal to or larger than 60 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the braiding angles of Hart in view of Janardhan and Galdonik would not operate differently with the claimed first, second, and third braiding angles since it has the same function of allowing blood flow through the catheter. Further, applicant places no criticality on the range claimed, indicating simply that the first, second, and third angles are “not particularly limited to” the ranges of degrees (specification; Paragraph 0069 and 0071).
Regarding claim 5, Hart teaches a percutaneous catheter system for insertion into a blood vessel in an axial direction and through which blood flows (device 10 that extends in an axial direction where blood is passed in the vascular conduit 2; Figure 2; Column 5, line 65 to Column 6, lines 24), the percutaneous catheter system comprising:
a tubular body with a lumen for carrying the blood (outer mesh sleeve 36 has a lumen 32 internally that allows for fluid to travel through; Figure 3), wherein the percutaneous catheter is configured to be axially stretched (device 10 is configured to axially stretch over an inner member 18 in the axial direction; Figure 2 and 3; Column 7, lines 1-8);
a tip at a distal end of the tubular body with a through hole (tip of the distal end of the sleeve 36 is the opening to the passageway 32; Figure 3); and
a stylet insertable through the tubular body to press against the tip to axially expand the tubular body so that the tubular body is axially stretched over the stylet (inner member 18 is inserted within the outer mesh sleeve 36 to press against the tip of the device to stretch the device in the axial direction; Figure 2 and 3; Column 6, lines Column 7, lines 1-8 and Column 8, lines 10-23);
wherein the tubular body comprises an expansion portion, a shaft portion, and an intermediate portion (sleeve 36 has expansion portion, shaft portion, and intermediate portion; see annotated Figure 2 above);
wherein the expansion portion extends in the axial direction to be expandable and has a respective inner diameter and a respective outer diameter (expansion portion that is expandable and has an inner and outer diameter; annotated Figure 2 above; Column 7, lines 1-8), wherein the respective inner diameter and outer diameter of the expansion portion are reduced when the percutaneous catheter is stretched over the stylet (expansion portion has inner and outer diameter that decreases when stretched/when inner member 18 is pushed forward; Figure 2 and 3; Column 7, lines 1-8);
wherein the shaft portion extends in the axial direction and is provided on a proximal end side in an insertion direction of the expansion portion and has a respective inner diameter and a respective outer diameter (shaft portion extends in the axial direction and is on the proximal end side of the expansion portion and has an inner and outer diameter; annotated Figure 2 above);
wherein the intermediate portion is provided between the expansion portion and the shaft portion (intermediated portion is between expansion and shaft portion; annotated Figure 2 above);
wherein the respective inner diameter and outer diameter of the expansion portion are respectively larger than the inner diameter and outer diameter of the shaft portion when the percutaneous catheter is not being stretched over the stylet (expansion portion has an inner and outer diameter that is larger than the shaft portion when the catheter is not stretched; annotated Figure 2 above; Figure 3; Column 7, lines 1-8), and the outer diameter of the expansion portion is approximately equal to the outer diameter of the shaft portion when the percutaneous catheter is stretched over the stylet (outer diameter of expansion portion is equal to outer diameter of shaft portion when stretched; Figure 3);
wherein the intermediate portion is configured to have a respective inner diameter and a respective outer diameter gradually decreasing from the expansion portion to the shaft portion when the percutaneous catheter is not being stretched over the stylet (intermediate has an inner and outer diameter that is gradually decreasing from the expansion portion to the shaft portion when catheter is not stretched; annotated Figure 2 above), wherein the respective inner diameter and outer diameter of the intermediate portion are reduced when the percutaneous catheter is stretched over the stylet (intermediate portion’s inner and outer diameter reduces when catheter is stretched; Figure 2 and 3; Column 7, lines 1-8), and the outer diameter of the intermediate portion is approximately equal to the outer diameter of the shaft portion when the percutaneous catheter is stretched over the stylet (outer diameter of intermediate portion is equal to outer diameter of shaft portion when stretched; Figure 3). Hart does not teach wherein the expansion portion comprises a first reinforcing body including first braided wires which intersect with each other in the first reinforcing body at a first braiding angle;
wherein the shaft portion comprises a second reinforcing body including second braided wires which intersect with each other at a second braiding angle;
wherein the intermediate portion includes a third reinforcing body including third braided wires which intersect with each other at a third braiding angle.
However, Janardhan teaches wherein the expansion portion comprises a first reinforcing body including first braided wires which intersect with each other in the first reinforcing body at a first braiding angle (expansion portion 9902 has braiding wires that create a first braiding angle; Figure 6J; Paragraph 0688);
wherein the shaft portion comprises a second reinforcing body including second braided wires which intersect with each other at a second braiding angle (shaft portion 9906 has braiding wires that create a second braiding angle; Figure 6J; Paragraph 0688);
wherein the intermediate portion includes a third reinforcing body including third braided wires which intersect with each other at a third braiding angle (intermediate portion 9904 that has braiding wires that create third braiding angle; Figure 6J; Paragraph 0688).
Hart and Janardhan are considered to be analogous to the claimed invention between they are in the same field of vascular devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Janardhan to incorporate the teachings of Hart to have the braiding structure of the intermediate and shaft portion with the braiding angle and diameters of Janardhan connected to the expansion portion of Hart and incorporating the braiding angle and diameter of the expansion portion of Janardhan to the expansion portion of Hart. This would allow for the varying in shape of the bulbs and braiding angles of the braiding structure to vary the blood flow at specific regions of the target site, such as aiding thrombosis or providing blood to travel through damaged vascular regions (Janardhan; Paragraph 0687-0689).
The combination of Hart in view of Janardhan does not teach wherein at least a major portion of the third reinforcing body is configured such that the third braiding angle is smaller than the first braiding angle and the second braiding angle.
However, another embodiment, Figure 6D, of Janardhan teaches wherein at least a major portion of the third reinforcing body is configured such that the third braiding angle is smaller than the first braiding angle and the second braiding angle (Paragraph 0677 – various porosities can be combined with bulbs and necks as described, embodiment of Figure 6D shows that the intermediate portion 9320 has a smaller braiding angle than the expansion portion 9304 and shaft portion 9306; Figure 6D; Paragraph 0675-0677).
Janardhan is considered to be analogous to the claimed invention between they are in the same field of vascular devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified device of Hart in view of Janardhan to incorporate the embodiment of Figure 6D of Janardhan to have the braid angle of Figure 6D on the first, second, and third reinforcing bodies of Figure 6J of the device of Hart in view of Janardhan. This would allow for specific regions of the device to have different porosities which would be compatible for controlling blood flow at the target vascular location, such as the region with a lower braid angle is more porous to provide higher blood flow (Janardhan; Paragraph 0675-0677).
The modified device of Hart in view of Janardan does not teach wherein the expansion portion is configured to have higher elasticity than an elasticity of the shaft portion.
However, Galdonik teaches wherein portions 20, 22, and 24 have different braid densities to vary the flexibility and rigidity of discrete regions (Column 5, line 62 to Column 6, line 6; Figure 1).
Galdonik and Hart in view of Janardhan are considered to be analogous to the claimed invention between they are in the same field of vascular devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hart in view of Janardhan to incorporate the teachings of Galdonik to have the varying braid densities at different portions, where the braid density at the expansion portion is more elastic than the shaft portion of the device of Hart in view of Janardhan. This would allow for specific regions of the device to have optimized stiffness and flexibility to help reduce catheter back-out and maximize catheter performance (Galdonik; Column 2, lines 47-58 and Column 5, line 62 to Column 6, line 6).
Regarding claim 6, Hart in view of Janardhan and Galdonik teaches the catheter system of claim 5. The combination of Hart in view of Janardhan and Galdonik further teaches wherein the third reinforcing body has a first region in which the third braiding angle is configured to gradually decrease from the first braiding angle of the first reinforcing body, and a second region in which the third braiding angle is configured to gradually increase continuously from the braiding angle of the first region toward the second braiding angle of the second reinforcing body (Janardhan; Figure 6J – intermediate portion 9904 has differing braid angle than expansion portion 9902 and shaft portion 9906 and is tapered at both ends; Figure 6D – obvious that tapered ends of the intermediate section 9320 would have decreasing braid angle between the expansion section 9304 and the intermediate section 9320 and an increasing braid angle between the intermediate section 9320 and the shaft portion 9306; Paragraph 0675-0677 and 0688; see rejection of claim 5 above).
Regarding claim 7, Hart in view of Janardhan and Galdonik teaches the catheter system of claim 5. The combination of Hart in view of Janardhan and Galdonik further teaches wherein the third reinforcing body includes a constant region where the third braiding angle is constant (obvious that the non-tapered portion of the intermediate portion of the device of Hart in view of Janardhan and Galdonik, such as the planar end of the intermediate portion adjacent to the shaft portion, would have a constant third braiding angle; Janardhan; Paragraph 0675-677; Figures 6D and 6J; see rejection of claim 5 above).
Regarding claim 8, Hart in view of Janardhan and Galdonik teaches the catheter system of claim 5. The combination of Hart in view of Janardhan and Galdonik further teaches wherein: the first braiding angle of the first reinforcing body is in a range of 100 degrees to 120 degrees (Janardhan; first braiding angle at expansion portion 9304 is about 91 to 180 degrees; Paragraph 0675; see rejection of claim 5 above); the second braiding angle of the second reinforcing body is in a range of 130 degrees to 150 degrees (Janardhan; second braiding angle at shaft portion 9306 is about 91 to 180 degrees; Paragraph 0675; see rejection of claim 5 above); and the third braiding angle of the third reinforcing body is equal to or larger than 60 degrees (Janardhan; third braiding angle is about 0 to 90 degrees at intermediate portion 9320 and is smaller than first and second braiding angles; Paragraph 0675; see rejection of claim 5 above).
In addition, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the first braiding angle in a range of 100 degrees to 120 degrees; the second braiding angle in a range of 130 degrees to 150 degrees; and the third braiding angle to be equal to or larger than 60 degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the braiding angles of Hart in view of Janardhan and Galdonik would not operate differently with the claimed first, second, and third braiding angles since it has the same function of allowing blood flow through the catheter. Further, applicant places no criticality on the range claimed, indicating simply that the first, second, and third angles are “not particularly limited to” the ranges of degrees (specification; Paragraph 0069 and 0071).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781