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 May 28th, 2026 have been entered. Claims 1-2, 4, 16, and 18-25 are pending in the application.
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.
The rejection of claims 1-4, 13, 16, 18, and 24- 25 under 35 U.S.C. 103 over Fischell (US 5423846) in view of Torrance et al. (AU 2013205920) and Shiu (EP 0373927) has been withdrawn in light of applicant’s amendments; specifically Fischell does not teach wherein the helical thread comprises a blunt outer edge and has a greatest major diameter that is no more than about 90% of an inside diameter of the at least one lumen, leaving an annular flow path between the engaging tip and an inner surface of the tubular side wall, wherein rotation of the helical thread is configured to pull embolic material into at least one lumen of the aspiration catheter.
The rejection of claim 19 under 35 U.S.C. 103 over Fischell (US 5423846) in view of Torrance et al. (AU 2013205920) and Shiu (EP 0373927) in further view of Carrison et al. (US 20170035444) has been withdrawn in light of applicant’s amendments; specifically Fischell does not teach wherein the helical thread comprises a blunt outer edge and has a greatest major diameter that is no more than about 90% of an inside diameter of the at least one lumen, leaving an annular flow path between the engaging tip and an inner surface of the tubular side wall, wherein rotation of the helical thread is configured to pull embolic material into at least one lumen of the aspiration catheter.
The rejection of claims 21- 23 under 35 U.S.C. 103 over Fischell (US 5423846) in view of Torrance et al. (AU 2013205920) and Shiu (EP 0373927) in further view of Yang et al. (US 20170239447) has been withdrawn in light of applicant’s amendments; specifically Fischell does not teach wherein the helical thread comprises a blunt outer edge and has a greatest major diameter that is no more than about 90% of an inside diameter of the at least one lumen, leaving an annular flow path between the engaging tip and an inner surface of the tubular side wall, wherein rotation of the helical thread is configured to pull embolic material into at least one lumen of the aspiration catheter.
Claim(s) 1-2, 4, 18, and 24- 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt et al. (WO 00/51503) in view of Fischell (US 5423846) as evidenced by the Merriam- Webster Dictionary.
Regarding claim 1, Honeycutt (Honeycutt et al.) teaches a system (10, control 18)(Figs. 1- 9) for removing embolic material from an intravascular site (abstract and Page 2, Lines 24- 30), comprising:
an aspiration catheter (surgical instrument 10) comprising an elongate, flexible tubular body (12) having a proximal end (14), a distal end (16), and a tubular side wall (see annotated Fig. 2 below) defining at least one lumen (20) extending axially there through (Page 4, Lines 28- 29);
a proximal hub configured to be positioned on a proximal end of the aspiration catheter (see annotated Fig. 1 below);
a rotatable core wire (elongate flexible drive shaft 24)(According to the Merriam- Webster Dictionary, a wire is defined as “metal in the form of a usually very flexible thread or slender rod”, as Honeycutt teaches that the drive shaft is elongate and flexible (Page 4, Lines 22- 25), Honeycutt therefore teaches a wire.) extendable through the at least one lumen (Page 4, Lines 30- 33), the core wire having a proximal end and a distal end (see annotated Fig. 1 below);
a handle (control 18); and
an engaging tip (cutter 22) on the distal end of the rotatable core wire (Page 4, Liens 30- 31), wherein the engaging tip comprises a helical thread (46)(Page 8, Lines 12- 13);
wherein the helical thread comprises a blunt outer edge (Page 9, Lines 14- 17) and has a diameter that leaves an annular flow path between the engaging tip and an inner surface of the tubular side wall (Page 9, Lines 26- 35);
wherein the at least one lumen is configured to be in fluid communication with a vacuum source and the rotatable core wire is configured to be rotated by the handle while the rotatable core wire extends through the at least one lumen of the aspiration catheter and aspiration is provided to the at least one lumen from the vacuum source (Page 9, Lines 29- 31);
wherein rotation of the helical thread is configured to pull embolic material into the at least one lumen of the aspiration catheter (Page 9, Lines 19- 21); and
wherein the annular flow path between the helical thread and the inner surface of the tubular side wall is configured to cooperate with the vacuum and rotation of the helical thread to grab and pull embolic material into the at least one lumen of the aspiration catheter, while enabling aspiration through a helical channel formed between adjacent helical threads and through the outside of the engaging tip (Page 9, Lines 26- 35).
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Regarding wherein the helical thread has a greatest major diameter that is no more than 90% of an inside diameter of the at least one lumen, as Honeycutt teaches that the inner diameter of the cutter housing, which correlates to the inside diameter of the lumen, can be about 0.0685 inch (Page 8, Lines 9- 10), and that the major diameter of the thread can range from 0.050 inch to 0.130 inch (Page 8, Lines 10- 12), the major diameter of the thread ranges from around 70% to 189% of the inside diameter of the at least one lumen. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range as taught by Honeycutt to be no more than 90%, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)). Furthermore, Honeycutt teaches that it would have been obvious to optimize the greatest major diameter according to what is needed during a procedure (Page 9, Line 34- Page 10, Line 4).
Honeycutt does not teach wherein the proximal hub comprises an axial restraint, the axial restraint comprising a proximally facing bearing surface, the handle carried by the proximal end of the rotatable core wire, the handle comprising a limit, the limit having a distally facing bearing surface configured to abut the proximally facing bearing surface of the axial restraint, wherein the limit and the axial restraint are configured to permit rotation of the rotatable core wire, and wherein the limit and the axial restraint are configured such that the distal facing bearing surface of the limit and the proximally facing bearing surface of the axial restraint are separated by an axial gap when the distal end of the rotatable core wire is approximately aligned with the distal end of the tubular body.
Fischell teaches a system (10)(Figs. 1- 3) for removing embolic material from an intravascular site (abstract), comprising: a catheter (centering catheter 40) comprising an elongate tubular body (Column 3, Lines 58-63) having a proximal end, a distal end, and a tubular side wall defining at least one lumen (central lumen 43, second lumen 44) extending axially there through (see annotated Fig. 1A and Fig. 3 below); a proximal hub comprising an axial restraint and configured to be positioned on a proximal end of the aspiration catheter, the axial restrain comprising a proximally facing bearing surface (see annotated Fig. 3 below); a rotatable core wire (dottering auger catheter 20)(According to the Merriam- Webster Dictionary, a wire is defined as “metal in the form of a usually very flexible thread or slender rod”, as Fischell teaches that the catheter is made of metal (Column 3, Lines 6- 15)) and is slender (see Fig. 1A) and flexible (Column 3, Line 9), Fischell therefore teaches a wire.)(Column 3, Lines 8- 20) extendable through the at least one lumen (Column 3, Lines 58- 61), the core wire having a proximal end and a distal end (see annotated Fig. 1A and Fig. 3 below); a handle (23) (Column 4, Lines 45) configured for manual rotation of the rotatable core wire and comprising a limit with a distally facing bearing surface configured to abut the proximally facing bearing surface of the axial restraint (see annotated Fig. 3 below)(Column 4, Lines 51- 65), wherein the handle is carried by the proximal end of the rotatable core wire and the rotatable core wire is configured to be manually rotated by the handle during a procedure (Column 3, Lines 10- 20); an engaging tip (self-tapping screw 30)(Column 3, Lines 21- 30) on the distal end of the rotatable core wire (see annotated Fig. 1A below) wherein the engaging tip comprises a thread (Column 3, Line 37 teaches that the screw has threads.); wherein the limit and the axial restraint are configured to permit rotation of the rotatable core wire (Column 3, Lines 5- 20 and Column 4, Lines 51- 65); and wherein the limit and the restraint are configured such that the distal facing bearing surface of the limit and the proximally facing bearing surface of the restraint are separated by an axial gap when the distal end of the rotatable core wire is approximately aligned with the distal end of the tubular body (Column 4, Lines 51- 65).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the proximal hub and the handle to have the limit and the axial restraint, as Honeycutt teaches providing a limit to axial movement within the system (Page 11, Line 33- Page 12, Line 3) and Fischell teaches the limit and axial restraint (see annotated Fig. 3 above).
Regarding the device being handled manually, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system as taught by Honeycutt to have the manual handle and the handle carried on the proximal end of the rotatable core wire as taught by Fischell, since it would allow the operator to use the device when there is no electricity.
Regarding claims 2 and 4, Honeycutt and Fischell make obvious the system, including the axial restraint and the limit, as discussed above.
The combination does not teach wherein the limit and the restraint are configured to limit distal advancement of the engaging tip to no more than about 6 mm beyond the distal end of the tubular body as recited in claim 2, or the limit and the axial restraint are configured to limit distal advancement of the engaging tip to expose between about one and three full revolutions of the thread beyond the distal end of the tubular body as recited in claim 4.
As Honeycutt and Fischell teach devices that are used intravascularly (Honeycutt, abstract; Fischell, abstract) like applicant’s device (Applicant’s specification, Paragraph 0011), and both Honeycutt and the device deal with material within a blood vessel (Honeycutt, Page 2, Lines 31- 35; Applicant’s specification, Paragraph 0011), the claimed limit is considered particularly obvious. Additionally, it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the device and a device having the claimed relative dimensions would not perform materially different than the prior art, the claimed device is not patentably distinct from the prior art device. MPEP 2144.04(IV)(A).
Regarding claim 16, Honeycutt and Fischell make obvious the system, including the axial restraint and the limit, as discussed above.
Honeycutt further teaches wherein the core wire is removably positionable within the tubular body (Page 12, Line 32- Page 13, Line 3).
Regarding claim 18, Honeycutt and Fischell make obvious the system, including the axial restraint and the limit, as discussed above.
Honeycutt further teaches wherein the helical thread extends through no more than about eight full revolutions (Page 8, Lines 18- 26).
Regarding claim 24, Honeycutt and Fischell make obvious the system, including the axial restraint and the limit, as discussed above.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the proximal hub and the handle to have the limit and the axial restraint, as Honeycutt teaches providing a limit to axial movement within the system (Page 11, Line 33- Page 12, Line 3) and Fischell teaches the limit and axial restraint (see annotated Fig. 3 of Fischell above).
Regarding wherein an entirety of the engaging tip is positioned outside the aspiration catheter when the distally facing bearing surface abuts the proximally facing bearing surface, as Fischell teaches in Column 4, Lines 51- 65 that the total lengths of the catheter and the core wire can be predetermined so that the distance between the limit on the handle and the axial restraint is predetermined and doing so allows for the point 36 to extend beyond the distal end of the centering catheter by a specific distance, then when the length between the catheter and the core wire is modified to reflect the length of the entirety of the engaging tip, it would be positioned outside of the aspiration catheter when the distally facing bearing surface abuts the proximally facing bearing surface.
Regarding claim 25, Honeycutt and Fischell make obvious the system, including the axial restraint and the limit, as discussed above.
Honeycutt further teaches wherein the blunt outer edge comprises a smooth surface over an entirety of the helical thread (Page 9, Lines 10- 17).
Alternatively, a person of ordinary skill in the art would recognize that there are two options to a surface, a surface that is smooth and a surface that is not. Thus, a smooth surface over an entirety of the thread would have been obvious because “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp”. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. See MPEP 2143.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt et al. (WO 00/51503) in view of Fischell (US 5423846) as evidenced by the Merriam- Webster Dictionary, as applied to claim 3 above, in further view of Carrison et al. (US 20170035444).
Regarding claim 19, Honeycutt and Fischell make obvious the system, including the axial restraint and the limit, as discussed above.
The combination does not teach wherein the helical thread has a major diameter that increases in a proximal direction from a first diameter near a distal tip to a second, greatest major diameter, and then decreases proximally of the greatest major diameter to a third diameter.
Carrison (Carrison et al.) discloses a similar device (510)(Figs. 23- 24) for cutting tissue (Paragraph 0106) with a helical thread (tissue removal element 534)(Paragraph 0108) that has a blunt outer edge (blunt tip 536) and wherein the helical thread diameter decreases proximally from the second, greatest major diameter to a third diameter (see annotated Fig 24 below).
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It would have been obvious to one of ordinary skill in the art to modify the helical thread as taught by the combination to have the shape of the helical thread as taught by Carrison for the purpose of cutting tissue. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute the shape of one helical thread for the other because both are disclosed as equivalent structures for cutting tissue (Honeycutt, abstract and Page 8, Lines 4- 8; Carrison, Paragraph 0108) and substitution of one for the other would have resulted in the predictable result of cutting tissue. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 20, Honeycutt, Fischell, and Carrison make obvious the system, including the axial restraint and the limit, as discussed above.
The combination does not teach wherein an inside diameter of the tubular body adjacent the engaging tip is at least about 0.015” greater than a maximum outside diameter of the engaging tip.
However, since Honeycutt teaches that the system is inserted into the vasculature, that the inside diameter and the maximum outside diameter can be optimized according to what procedure is needed (Page 9, Line 34- Page 10, Line 4), and that the threads both can cut and move embolic material through the annular flow path (Page 9, Lines 19- 31), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the inside diameter of the tubular body to be at least about 0.015” greater than a maximum outside diameter of the engaging tip, as 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 dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Claim(s) 21- 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Honeycutt et al. (WO 00/51503) in view of Fischell (US 5423846) as evidenced by the Merriam- Webster Dictionary, as applied to claim 1 above, in further view of Yang et al. (US 20170239447).
Regarding claims 21 and 22, Honeycutt and Fischell make obvious the system, including the axial restraint and the limit, as discussed above.
The combination does not teach the system further comprising a tubular radiopaque marker embedded in the flexible tubular body or wherein a distal end of the tubular radiopaque marker comprises a distal face residing on a plane which crosses a longitudinal axis of the aspiration catheter at an angle within a range of about 45 degrees to about 80 degrees.
Yang (Yang et al.) teaches a similar system (abstract)(Fig. 30) comprising a catheter (3000) with a tubular body (see Fig. 30) and a tubular radiopaque marker (3040) embedded in the tubular body and wherein the tubular radiopaque marker is at an angle in reference to a longitudinal axis of the aspiration catheter at an angle (Paragraph 0182).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter as taught by the combination to have a tubular radiopaque marker as taught by Yang in order to provide a way to visualize the device while in the body.
The combination does not teach wherein a distal end of the tubular radiopaque marker comprises a distal face residing on a plane which crosses a longitudinal axis of the aspiration catheter at an angle within a range of about 45 degrees to about 80 degrees.
However, it would have been obvious to one of ordinary skill in the art to modify the angle of the marker and therefore the distal face of the marker to be at an angle within a range of about 45 degrees to about 80 degrees, as it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the device and a device having the claimed relative dimensions would not perform materially different than the prior art, the claimed device is not patentably distinct from the prior art device, and Yang teaches that the marker can be at an angle (Paragraph 0182). MPEP 2144.04(IV)(A).
Regarding claim 23, Honeycutt and Fischell make obvious the system, including the axial restraint and the limit, as discussed above.
The combination does not teach wherein the distal end of the aspiration catheter comprises a beveled surface.
Yang (Yang et al.) teaches a similar system (abstract)(Fig. 30) comprising a catheter (3000) with a tubular body (see Fig. 30) wherein the distal end of the catheter comprises a beveled surface (3006)(Paragraph 0182).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the distal end of the catheter of the combination to be beveled as taught by Yang for the purpose of navigating the vasculature of the body. Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one catheter for the other because both catheters are disclosed as equivalent structures for navigating vasculature within the body (Fischell, abstract; Yang, Paragraph 0064) and substitution of one for the other would have resulted in the predictable result of providing a catheter that navigates the vasculature of the body. KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Response to Arguments
Regarding applicant’s arguments filed May 28th, 2026 with respect to the 103 rejections of claims 1-4, 13, 16, 18, and 24- 25 over Fischell (US 5423846) in view of Torrance et al. (AU 2013205920) and Shiu (EP 0373927), of claim 19 over Fischell (US 5423846) in view of Torrance et al. (AU 2013205920) and Shiu (EP 0373927) in further view of Carrison et al. (US 20170035444), and of claims 21- 23 in view of Fischell (US 5423846) in view of Torrance et al. (AU 2013205920) and Shiu (EP 0373927) in further view of Yang et al. (US 20170239447) have been considered but are moot since, as discussed above, the previous prior art rejections were withdrawn in view of applicant’s amendments. However, it is noted that Fischell, Carrison, and Yang are still relied upon for limitations not argued.
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
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