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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 10th, 2025 has been entered.
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 claim 1-4, 13, 16, 18, and 24- 25 under 35 U.S.C. 103 over Fischell (US 5423846) in view of Cragg et al. (US 20020091372), Torrance et al. (AU 2013205920), and Shiu (EP 0373927), as evidenced by the Merriam-Webster Dictionary has been withdrawn in light of applicant’s arguments, specifically the teachings of Cragg et al. appears to not be analogous art.
The rejection of claim 19 under 35 U.S.C. 103 over Fischell (US 5423846) in view of Cragg et al. (US 20020091372), 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 (US 20170035444) has been withdrawn in light of applicant’s arguments, specifically the teachings of Cragg et al. appears to not be analogous art.
The rejection of claims 21- 23 under 35 U.S.C. 103 over Fischell (US 5423846) in view of Cragg et al. (US 20020091372), 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 (US 20170239447) has been withdrawn in light of applicant’s arguments, specifically the teachings of Cragg et al. appears to not be analogous art.
Claim(s) 1-4, 13, 16, 18, and 24- 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell (US 5423846) in view of Torrance et al. (AU 2013205920), and Shiu (EP 0373927), as evidenced by the Merriam-Webster Dictionary.
Regarding claim 1, 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).
PNG
media_image1.png
444
1103
media_image1.png
Greyscale
PNG
media_image2.png
396
1029
media_image2.png
Greyscale
Fischell does not teach the catheter as being flexible, wherein the thread comprises a blunt outer edge, and 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 manually 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.
Torrance (Torrance et al.) teaches a similar system (10)(Fig. 1- 2B) for use at an intravascular site (Page 1, Lines 13- 17) comprising: an aspiration catheter (32) that is flexible (Page 2, Lines 7- 12 and page 10 lines 7-8) with a lumen (Page 14, Line 27), wherein the lumen is configured to be in fluid communication with a vacuum source (aspiration pump 16) and aspiration is provided to the lumen from the vacuum source during a procedure (Page 14, Lines 26- 29), and an engaging tip (operating head 40)(Page 18, Lines 19- 26).
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 Fischell to be a flexible aspiration catheter with a lumen configured to be in fluid communication with a vacuum source as taught by Torrance, since Torrance teaches that removing debris is “critical to prevent distal embolization of the debris” (Page 4, Lines 9- 10) and that the flexibility of a catheter is important and a catheter must be “flexible enough to navigate through sometimes tortuous internal structures and passageways, such as blood vessels” (Page 2, Lines 7- 12).
Regarding wherein the rotatable core wire is configured to be manually 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, as Fischell teaches that the rotatable core wire is configured to be manually rotated by the handle during an operation (Fischell, Column 3, Lines 10- 20), Torrance teaches that aspiration occurs during an operation (Torrance, Page 14, Lines 26- 29), and since the catheter of the combination, in which the rotatable core wire is within, is the aspiration catheter, the rotatable core wire within the combination would be able to be manually rotated while it extends through the aspiration catheter.
The combination does not teach wherein the thread comprises a blunt outer edge.
Shiu teaches a similar system (Column 3, Line 58- Column 4, Line 5)(Fig. 1) for removing embolic material from an intravascular site (abstract) comprising: a catheter (cylindrical housing 10), a rotatable core wire (flexible drive cable 42)(Column 5, Lines 15- 18), and an engaging tip (cutter member 30) on the distal end of the core wire (see Fig. 1)(Column 4, Lines 54- 56), wherein the engaging tip comprises a thread (screw threading 38) and the thread comprises a blunt outer edge (In Column 4, Lines 44- 48, Shiu teaches that the forward end of the screw threading is blunt and has no sharp edges, therefore, the outer edge of the screw threading is blunt, since the forward end is an outer edge (see annotated Fig. 1 below).).
PNG
media_image3.png
394
821
media_image3.png
Greyscale
It would have been obvious to modify the outer edge of the thread of the engaging tip of the combination to be blunt as taught by Shiu, since Shiu teaches that having a blunt outer edge minimizes “the risk of inadvertent penetration of the arterial wall during use” (Column 4, Lines 46- 48).
Regarding claims 2-4, Fischell, Torrance, and Shiu make obvious the system, including the axial restraint and the limit, as discussed above for claim 1. Fischell further teaches wherein the engaging tip comprises a helical thread (Column 3, Lines 33- 39).
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 Fischell and Torrance teach devices that are used intravascularly (Fischell, abstract; Torrance, Page 1, Lines 13- 18) like applicant’s device (Applicant’s specification, Paragraph 0011), and both Fischell and the device deal with material within a blood vessel (Fischell, Column 1, Lines 29- 34; 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 13, Fischell, Torrance, and Shiu make obvious the system, including the axial restraint and the limit, as discussed above for claim 3.
Fischell further teaches wherein the helical thread has a greatest major diameter that is no more than about 90% of an inside diameter of the lumen (see Fig. 1A, wherein the helical thread of the tip 30 leaves a narrow gap between the maximum diameter of the helical thread of the tip 30 and the inner wall of the lumen 43, such that the maximum diameter of helical thread of tip 30 is approximately 90% of inside diameter of the lumen 43 based on annotated Fig. 1A below.).
Alternatively, Fischell further wherein the greatest major diameter of the helical thread is smaller than an inside diameter of the lumen (see annotated Fig. 1A below).
Regarding leaving an annular flow path between the engaging tip and an inner surface of the side wall, since a gap is between the helical thread and the inside diameter of the lumen (see annotated Fig. 1A below), it would be obvious that an annular flow path is created.
PNG
media_image4.png
444
1103
media_image4.png
Greyscale
PNG
media_image5.png
444
1103
media_image5.png
Greyscale
Fischell is not specific to wherein the helical thread has a greatest major diameter that is no more than about 90% of an inside diameter of the lumen. However, it would have been obvious to one of ordinary skill in the art to modify the greatest major diameter to be no more than about 90% of an inside diameter of the lumen, 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. MPEP 2144.04(IV)(A). It is additionally noted that the term “about” means near or close to, and does not limit the claim to 90%, but rather encompasses more broad ranges, such as 99%, and that some gap must be present between the greatest major diameter of the thread and the inside diameter of the lumen in order for the thread to travel through the lumen. Therefore, the claimed range is considered further obvious to one of ordinary skill in the art.
Regarding claim 16, Fischell, Torrance, and Shiu make obvious the system, including the axial restraint and the limit, as discussed above for claim 1.
Fischell further teaches wherein the core wire is removably positionable within the tubular body (Column 3, Lines 58- 63).
Regarding claim 18, Fischell, Torrance, and Shiu make obvious the system, including the axial restraint and the limit, as discussed above for claim 3.
Fischell further teaches wherein the helical thread extends through no more than about eight full revolutions (As Fischell teaches that the helical thread has about six full revolutions (see annotated Fig. 1A below), the helical thread would extend through no more than six revolutions.).
PNG
media_image6.png
444
1103
media_image6.png
Greyscale
Regarding claim 24, Fischell, Torrance, and Shiu make obvious the system, including the axial restraint and the limit, as discussed above for claim 1.
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, Fischell, Torrance, and Shiu make obvious the system, including the blunt outer edge, the axial restraint and the limit, as discussed above for claim 1.
The combination is silent to wherein the blunt outer edge comprises a smooth surface over an entirety of the thread.
However, Shiu teaches a cutting helix that has flat and smooth outer surfaces is well known in the art (Column 1, Lines 30- 34).
It would have been obvious to try to one of ordinary skill in the art before the effective filing date to modify the blunt outer edge of the combination to comprise a smooth surface over an entirety of the thread as taught by Shiu. Shiu discloses that a flat and smooth outer surface on a cutting helix is an option that is known in the art (Column 1, Lines 30- 34). Furthermore, 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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell (US 5423846) in view of Torrance et al. (AU 2013205920), and Shiu (EP 0373927), as applied to claim 3 above, in further view of Carrison et al. (US 20170035444).
Regarding claim 19, Fischell, Torrance, and Shiu make obvious the system, including the axial restraint and the limit, as discussed above for claim 3.
Fischell teaches 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 (see annotated Fig. 1A below).
PNG
media_image7.png
444
1103
media_image7.png
Greyscale
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).
PNG
media_image8.png
389
916
media_image8.png
Greyscale
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 (Fischell, Column 3, Lines 21- 39; 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).
Claim(s) 21- 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell (US 5423846) in view of Torrance et al. (AU 2013205920), and Shiu (EP 0373927), as applied to claim 1 above, in further view of Yang et al. (US 2017/0239447).
Regarding claims 21 and 22, Fischell, Torrance, and Shiu make obvious the system, including the axial restraint and the limit, as discussed above for claim 1.
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 of Fischell, Torrance, Shiu, and Yang 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, Fischell, Torrance, and Shiu make obvious the system, including the axial restraint and the limit, as discussed above for claim 1.
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
Applicant's arguments filed October 10th, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments, see Pages 5- 6, regarding the combination of Fischell (US 5423846) in view of Cragg et al. (US 20020091372), Torrance et al. (AU 2013205920), and Shiu (EP 0373927), as evidenced by the Merriam-Webster Dictionary and the argument that Fischell and Torrance address fundamentally different clinical problems and that modifying Fischell to include aspiration as taught by Torrance would change the principle of operation of Fischell’s invention has been fully considered but is not persuasive. Applicant’s argument that Fischell’s system is not designed for aspiration or for the removal of embolic material during the mechanical opening of a vessel is not convincing, Torrance teaches that the removal of debris during an operation of reducing an obstruction is “critical to prevent distal embolization of the debris” (Torrance, Page 4, Lines 9- 10) thereby giving reasoning as to why a modification of Fischell to provide an aspiration catheter is needed. Furthermore, Fischell teaches that the screw is rotated into a blockage to create a passage (Fischell, abstract, Column 3, Lines 23- 27), which would create debris as the screw removes material from the blockage in order to do this, therefore there is a need to aspirate the debris, as Torrance teaches, to prevent embolization after the procedure. So, it would have been obvious to one of ordinary skill in the art to modify the catheter as taught by the combination of Fischell in view of Craig to be a flexible aspiration catheter with a lumen configured to be in fluid communication with a vacuum source as taught by Torrance. Additionally, Fischell teaches that an atherectomy device can be used during the procedure (abstract), which is known in the art to produce debris during an operation, so modifying the device to include an aspiration catheter as taught by Torrance would not change the principle of operation of Fischell, that of reducing an obstruction within a vessel (abstract and Column 1, Lines 9- 13), since the aspiration catheter would be able to remain within the vessel after the removal of the screw in order to further aspirate other debris generated in the next step of the procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771