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
The Amendment filed 10/15/25 has been entered. Claims 1, 5, 7, 15 and 20 are amended. Claims 3- 4 and 6 are canceled. Claims 1- 2, 5 and 7- 20 are being addressed by this Action.
Response to Arguments
The Amendment has obviated the rejection made under 35 U.S.C. 112(a) made in the Non-Final Office Action, mailed 7/15/25. As such, the rejection made under 35 U.S.C. 112(a) made in the Non-Final Office Action, mailed 7/15/25 has been withdrawn.
Applicant’s arguments, see Remarks, filed 10/15/25, with respect to the rejection(s) of claim(s) 1- 2, 8- 9, 11- 14 and 20 under 35 U.S.C. 103 over Greenhalgh ‘947 have been fully considered and are persuasive because Greenhalgh ‘947 does not teach the newly added limitation regarding N is 24- 32 loops. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Greenhalgh et al. (US Pub. No. 2017/0086864 A1) (hereinafter “Greenhalgh ‘864”). It is noted that Greenhalgh ‘864 is relied upon for the teaching of the N is 24- 32 loops feature.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1- 2, 5 and 7- 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Greenhalgh et al. (US Pub. No. 2017/0303947 A1) (hereinafter “Greenhalgh ‘947) in view of Greenhalgh et al. (US Pub. No. 2017/0086864 A1) (hereinafter “Greenhalgh ‘864”). Greenhalgh ‘947 is cited in the IDS filed 3/04/22. Greenhalgh ‘864 is cited in the IDS filed 3/04/24.
Regarding claim 1 and claim 7, Greenhalgh ‘947 discloses an apparatus for removing a material from a body lumen, the apparatus comprising:
an elongate inversion support comprising a catheter (207) (Figs. 2A- 3G) having a circumference, a distal end, and a distal end opening;
a knitted tube (203) (Figs. 2A- 2G) that extends distally in an un-inverted configuration along an outer surface of the catheter (207), inverts into the distal end opening of the catheter (207), and extends proximally within the catheter (207) in an inverted configuration (Ps. [0046], [0072] - - the tractor may be knitted, braided, woven, etc.; In FIG. 2A, the rolling thrombectomy apparatus includes a tractor 203 that is configured to roll over the distal end opening of a catheter 207… In FIG. 2B, the puller 209, coupled to the first end of the tractor within the catheter, is pulled to deploy the tractor), wherein the knitted tube (203) is configured to invert by rolling into the distal end opening of the catheter (207) when a first end of the knitted tube (203) is pulled proximally within the catheter (P. [0073] - - As shown in FIG. 2B, the tractor may be rolled and inverted 282 into the catheter by pulling the first end of the tractor from within the catheter (e.g., by pulling 219 the puller proximally)), and
wherein the knitted tube (203) is configured to stretch less than 3 percent when pulled in tension with a force of 2 Newtons so that the knitted tube (203) does not lock onto the outer surface of the catheter (207) (See Figs. 2A, 2B) (Ps. [0022], [0068], [0072] - - Any of these apparatuses may be configured to controllably deploy the tractor, which may be held compressed and/or against the catheter of the elongate inversion support until being deployed. For example, any of these apparatus may include a releasable attachment between the tractor and an outer surface of the catheter (e.g., a tractor hold), wherein the releasable attachment is configured to release when the tractor is pulled (e.g., proximally by the puller) with a force that is greater than a predetermined force threshold; The range of force appropriate to the threshold force may be important in proper functioning of the apparatus, particularly when the force is applied by pulling proximally on the puller and/or tractor; too little force for the threshold and the tractor will prematurely deploy; too much force and the apparatus will jam (e.g., by kinking the elongate inversion support); In FIG. 2A, the tractor is held in tension by holding in a fixed position relative to the catheter at a second (outer) end of the tractor; a tractor hold (not shown in FIG. 2A) may be used to releasably hold an end of the tractor fixed relative to the catheter. When a force sufficient to overcome the deployment force (e.g., 100 g of force or greater, 200 g of force or greater, etc.) is applied by pulling 219 the first end of the tractor, as shown in FIG. 2B. In FIG. 2B, the puller 209, coupled to the first end of the tractor within the catheter, is pulled to deploy the tractor. When deployed the tractor may expand away from the catheter and towards the wall(s) of the vessel 260).
It is noted that according to the applicant, “to stretch” is an equivalent of “to constrict” (See p. [0081] of applicant’s Specification - - “the tractor may be configured so that it does not stretch (and therefore constrict) more than a predefined percentage when pulled in tension”). Greenhalgh ‘947 teaches that when the knitted tube is pulled with 200 g of force, the knitted tube is deployed/ released and does not lock onto the outer surface of the catheter. Greenhalgh ‘947 does not specifically disclose that upon application of a deployment force, the knitted tube is stretching or constricting less than 3%, however, it would have been obvious to a person having ordinary skill in the art that at least at the moment of reaching the threshold force, the knitted tube is no longer stretched or constricted upon the outer surface of the catheter and, since 0 % is less than 3%, the knitted tube disclosed by Greenhalgh ‘947 is capable of stretching less than 3 percent when pulled in tension with a force of 2 Newtons so that the knitted tube does not lock onto the outer surface of the catheter.
It is further noted that the language “wherein the knitted tube is configured to stretch less than 3 percent when pulled in tension with a force of 2 Newtons so that the knitted tube does not lock onto the outer surface of the catheter,” merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. “Wherein the knitted tube is configured to stretch less than 3 percent when pulled in tension with a force of 2 Newtons so that the knitted tube does not lock onto the outer surface of the catheter,” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The Office submits that the device of Greenhalgh ‘947 meets the structural limitations of the claim, including being pulled in tension with a force of 2 Newtons so that the knitted tube does not lock onto the outer surface of the catheter and, as such
is capable of being stretched less than 3 percent.
Greenhalgh ‘947 does not explicitly disclose
(claim 1 and claim 7) loops per turn as claimed.
However, Greenhalgh ‘864 teaches an apparatus for removing a material from a body lumen in the same field of endeavor (Abstract)
(claim 1) wherein the knitted tube has a length of 20 cm or greater and comprises a filament knitted into N loops per turn where N is 24-32 loops per turn, the filament having a filament diameter Dfiament, and wherein the knitted tube has a choke ratio, (N2 x Dfllament)/Ccath, greater than 2.9, where Ccath is the catheter circumference wherein the diameter of the filament is between 0.030 mm and 0.06 mm (Ps. [0049], [0058], [0063], [0165])
(P. [0049] - - In general, as used herein a woven material includes any material formed by weaving multiple strands of material in an interlacing pattern (e.g., interlacing strands, filaments, lengths of material, etc.). A mesh is one type of woven material … A knitted material may be more flexible and generally refers to a single path or course that is meandering, forming loops that may be symmetrically arranged and interlocking);
(P. [0058] - - the flexible tube comprises a soft outer mesh that is pushable. For example the distal tractor region (and particularly the expandable first end region) may be formed from 24 to 144 stands, having a thickness of 0.0020 inches or less in diameter);
(P. [0063] - - In general, the flexible tube may be any appropriate length. For example, the flexible tube may be between 3 to 200 cm (e.g., between 3 to 150 cm, 3 to 100 cm, 3 to 50 cm, etc.);
(P. [0165] - - Other examples of designs for apparatuses including distal tractor region of different shapes may be a function of catheter ID. For example, in some variations the apparatus may select the catheter ID, number of filaments, diameter/length of filaments, stiffness of bending/rolling stiffness, Poisson's ratio, friction (and/or texture) of the inner surface of the grabber, etc. … For example, in some variations in which the distal tractor region is braided, the apparatus may include a 0.072″ ID catheter having a distal tractor region with 24 to 72 ends of 0.0008″ to 0.002 Niti wire).
It is noted that a) 3 to 200 cm falls within the claimed range of 20 cm or greater; b) since a single loop consists of two strands, 12 to 72 loops (specifically 32 loops) falls within the claimed range of 24- 32 loops; c) 0.0020 inches falls within the claimed range of 0.030- 0.06 mm; d) catheter circumference is derived from catheter diameter and e) choke ratio using 32 loops, 0.002 inch diameter filament and 0.072 inch diameter catheter is greater than 2.9.
(claim 7) It is noted that a) 3 to 200 cm falls within the claimed range of 20 cm or greater; b) since a single loop consists of two strands, 12 to 72 loops (specifically 32 loops) falls within the claimed range of 24- 32 loops; c) 0.0020 inches falls within the claimed range of 0.030- 0.06 mm; d) catheter circumference is derived from catheter diameter and e) choke ratio using 32 loops, 0.002 inch diameter filament and 0.072 inch diameter catheter is greater than 3.0;
It would have been obvious to a person having ordinary skill in the art to modify the dimensions of the flexible tube elements associated with Greenhalgh ‘947 such that the choke ratio is greater than 2.9 and greater than 3.0 according to the teachings of Greenhalgh ‘864 because the configuration of the flexible tube would allow pushing out of the catheter without binding up or becoming caught on the inner walls of the catheter, preventing deployment (Greenhalgh ‘864 - - P. [0021]).
Regarding claim 2, Greenhalgh ‘947 in view of Greenhalgh ‘864 discloses the apparatus of claim 1, Greenhalgh ‘947 further disclosing wherein the knitted tube (203) is configured to stretch less than 2 percent when pulled in tension with a force of 2 Newtons (See Figs. 2A, 2B) (Ps. [0022], [0068], [0072]).
It is noted that according to the applicant, “to stretch” is an equivalent of “to constrict” (See p. [0081] of applicant’s Specification - - “the tractor may be configured so that it does not stretch (and therefore constrict) more than a predefined percentage when pulled in tension”). Greenhalgh ‘947 teaches that when the knitted tube is pulled with 200 g of force, the knitted tube is deployed/ released and does not lock onto the outer surface of the catheter. Greenhalgh ‘947 does not specifically disclose that upon application of a deployment force, the knitted tube is stretching or constricting less than 2%, however, it would have been obvious to a person having ordinary skill in the art that at least at the moment of reaching the threshold force, the knitted tube is no longer stretched or constricted upon the outer surface of the catheter and, since 0 % is less than 2%, the knitted tube disclosed by Greenhalgh ‘947 is capable of stretching less than 2 percent when pulled in tension with a force of 2 Newtons so that the knitted tube does not lock onto the outer surface of the catheter.
It is further noted that the language “wherein the knitted tube is configured to stretch less than 2 percent when pulled in tension with a force of 2 Newtons,” merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. “Wherein the knitted tube is configured to stretch less than 2 percent when pulled in tension with a force of 2 Newtons,” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The Office submits that the device of Greenhalgh ‘947 meets the structural limitations of the claim, including being pulled in tension with a force of 2 Newtons so that the knitted tube does not lock onto the outer surface of the catheter and, as such is capable of being stretched less than 2 percent.
Regarding claim 5, Greenhalgh ‘947 in view of Greenhalgh ‘864 discloses the apparatus of claim 1, Greenhalgh ‘947 further disclosing wherein the filament comprises one or more of: steel, polyester, nylon, expanded Polytetrafluoroethylene (ePTFE), or Nitinol (P. [0019]).
Regarding claim 8, Greenhalgh ‘947 in view of Greenhalgh ‘864 discloses the apparatus of claim 1, Greenhalgh ‘947 further disclosing wherein the knitted tube (203) is configured to ride over the outer surface of the catheter (207) in the un-inverted configuration for up to about 0.5 mm (P. [0091] - - any of the apparatuses and methods described herein may be used with aspiration (e.g., vacuum). For example, any of these methods described herein may be may use a combination of aspiration and a tractor pull mechanism. For example, to initiate the grabbing of the clot by the tractor, the tractor may be rolled around a catheter wall and may make physical (e.g., direct) contact with the clot …The application of vacuum prior to pulling the braid will ensure the proximal most end of the clot is in contact with the catheter tip and some amount of the clot (>0.5 mm) is extruded into the lumen of the catheter tip. Next when the dozer is pulled there will be clot at the tip of the catheter for the braid/dozer to grab and pull in …Once the tractor engages a grabs a few mm of clot the vacuum may be kept on or turned off).
Regarding claim 9, Greenhalgh ‘947 in view of Greenhalgh ‘864 discloses the apparatus of claim 1, Greenhalgh ‘947 further disclosing wherein the knitted tube (203) has a length of at least 65 cm (P. [0021] - - The tractor may be any appropriate length (e.g., between about is 3 cm to 100 cm long, between about 10 cm to 200 cm long, … between about 200 cm to 500 cm long, etc.).
Regarding claim 10, Greenhalgh ‘947 in view of Greenhalgh ‘864 discloses the apparatus of claim 1, Greenhalgh ‘947 further disclosing that the catheter of the elongate inversion support may be any appropriate type of catheter or portion of a catheter, including microcatheters appropriate for neurovascular use (P. [0059]), but Greenhalgh ‘947 does not explicitly disclose
(claim 10) wherein the catheter circumference is between 3 mm and 13 mm.
However, Greenhalgh ‘864 teaches an apparatus for removing a material from a body lumen in the same field of endeavor (Abstract)
(claim 10) wherein the catheter circumference is between 3 mm and 13 mm (P. [0012] - - The apparatuses described herein typically include an elongate catheter having a lumen and a distal end and with a distal end opening into the lumen. The catheter may be low-profile neurovascular catheters (e.g., microcatheters, insertion catheters, etc.) having any appropriate diameter (e.g., <1 Fr, 1 Fr-6 Fr, 1 Fr-9 Fr, etc.). A flexible tractor assembly or portion (e.g., which may be referred to herein as a flexible tractor tube or simply a flexible tube) is typically positioned and longitudinally slideable within the catheter, and arranged so that the distal end region (“distal tractor region”) doubles back over the distal end of the catheter…The combined catheter and flexible tractor assembly also forms a guidewire lumen through the catheter and the flexible tube that is configured to pass a guidewire; it is noted that the catheter diameter range of 1Fr- 9 Fr falls within the claimed range of the catheter circumference is between 3 mm and 13 mm).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the catheter circumference of the catheter associated with Greenhalgh ‘947 such that the catheter circumference is between 3 mm and 13 mm as taught by Greenhalgh ‘864 because it would provide an appropriate and predictable dimension for low-profile neurovascular catheters (e.g., microcatheters, insertion catheters, etc.) contemplated by Greenhalgh ‘947 and allowing for a flexible tractor assembly and a guidewire lumen extending therethrough (Greenhalgh ‘864 - - P. [0012]).
Regarding claim 11, Greenhalgh ‘947 in view of Greenhalgh ‘864 discloses the apparatus of claim 1, Greenhalgh ‘947 further disclosing further comprising an elongate puller (209) (Figs. 2A- 2G) within the catheter (207), wherein the first end of the knitted tube (203) is coupled to the puller (209) so that pulling the puller (209) proximally pulls the knitted tube (203) proximally within the catheter (207) and rolls and inverts the knitted tube (203) into the catheter (207) (P. [0072] - - In FIG. 2B, the puller 209, coupled to the first end of the tractor within the catheter, is pulled to deploy the tractor).
Regarding claim 12, Greenhalgh ‘947 in view of Greenhalgh ‘864 discloses the apparatus of claim 11, Greenhalgh ‘947 further disclosing wherein the puller (209) comprises a hypotube having an inner lumen that is continuous with an inner lumen of the knitted tube, the inner lumen of the hypotube and inner tube lumen together forming a guidewire lumen (Ps. [0018], [0054], [0072] - - The elongate manipulator may be a wire, tube (e.g., hypotube), rod, etc.; The apparatus may include a guidewire lumen extending through the … tractor puller; In FIG. 2A, the rolling mechanical thrombectomy apparatus 200 is brought near to the clot 220. In this example, a guidewire 205 may be used to help position the apparatus adjacent to the clot … In FIG. 2B, the puller 209, coupled to the first end of the tractor within the catheter, is pulled to deploy the tractor).
Regarding claim 13, Greenhalgh ‘947 in view of Greenhalgh ‘864 discloses the apparatus of claim 1, Greenhalgh ‘947 further disclosing wherein, in the inverted configuration, the knitted tube (203) is biased to expand into a configuration having a diameter greater than an inner diameter of the catheter (207) (P. [0017] - - Further, in any of these apparatuses, the tractor may be biased to expand to greater than the outer diameter of the catheter in the inverted configuration and is biased to expand to greater than the inner diameter of the catheter in the un-inverted configuration).
Regarding claim 14, Greenhalgh ‘947 in view of Greenhalgh ‘864 discloses the apparatus of claim 1, Greenhalgh ‘947 further disclosing wherein the knitted tube (203) comprises one or more of a lubricious coating, a metal coating, a heparin coating, an adhesive coating, and a drug coating (P. [0021] - - The tractor may be lubricious and/or may comprise one or more coatings from the group of: a lubricious coating, a metal coating, a heparin coating, an adhesive coating, and a drug coating).
Regarding claims 15- 17, Greenhalgh ‘947 discloses an apparatus for removing a material from a body lumen, the apparatus comprising:
an elongate inversion support comprising a catheter (207) (Figs. 2A- 3G) having a circumference, a distal end, and a distal end opening;
a knitted tube (203) (Figs. 2A- 2G) that extends distally in an un-inverted configuration along an outer surface of the catheter (207), inverts into the distal end opening of the catheter (207), and extends proximally within the catheter (207) in an inverted configuration (Ps. [0046], [0072] - - the tractor may be knitted, braided, woven, etc.; In FIG. 2A, the rolling thrombectomy apparatus includes a tractor 203 that is configured to roll over the distal end opening of a catheter 207… In FIG. 2B, the puller 209, coupled to the first end of the tractor within the catheter, is pulled to deploy the tractor), wherein the knitted tube (203) is configured to invert by rolling into the distal end opening of the catheter (207) when a first end of the knitted tube (203) is pulled proximally within the catheter (P. [0073] - - As shown in FIG. 2B, the tractor may be rolled and inverted 282 into the catheter by pulling the first end of the tractor from within the catheter (e.g., by pulling 219 the puller proximally)), and
(claim 16) wherein the knitted tube (203) is configured to ride over the outer surface of the catheter (207) in the un-inverted configuration for up to about 0.5 mm (P. [0091] - - any of the apparatuses and methods described herein may be used with aspiration (e.g., vacuum). For example, any of these methods described herein may be may use a combination of aspiration and a tractor pull mechanism. For example, to initiate the grabbing of the clot by the tractor, the tractor may be rolled around a catheter wall and may make physical (e.g., direct) contact with the clot …The application of vacuum prior to pulling the braid will ensure the proximal most end of the clot is in contact with the catheter tip and some amount of the clot (>0.5 mm) is extruded into the lumen of the catheter tip. Next when the dozer is pulled there will be clot at the tip of the catheter for the braid/dozer to grab and pull in …Once the tractor engages a grabs a few mm of clot the vacuum may be kept on or turned off).
Greenhalgh ‘947 does not explicitly disclose
(claims 15- 17) loops per turn as claimed.
However, Greenhalgh ‘864 teaches an apparatus for removing a material from a body lumen in the same field of endeavor (Abstract)
(claim 15) wherein the knitted tube has a length of 20 cm or greater and comprises a filament knitted into N loops per turn where N is 24-32 loops per turn, the filament having a filament diameter Dfiament, and wherein the knitted tube has a choke ratio, (N2 x Dfllament)/Ccath, greater than 2.9, where Ccath is the catheter circumference wherein the diameter of the filament is between 0.030 mm and 0.06 mm (Ps. [0049], [0058], [0063], [0165])
(P. [0049] - - In general, as used herein a woven material includes any material formed by weaving multiple strands of material in an interlacing pattern (e.g., interlacing strands, filaments, lengths of material, etc.). A mesh is one type of woven material … A knitted material may be more flexible and generally refers to a single path or course that is meandering, forming loops that may be symmetrically arranged and interlocking);
(P. [0058] - - the flexible tube comprises a soft outer mesh that is pushable. For example the distal tractor region (and particularly the expandable first end region) may be formed from 24 to 144 stands, having a thickness of 0.0020 inches or less in diameter);
(P. [0063] - - In general, the flexible tube may be any appropriate length. For example, the flexible tube may be between 3 to 200 cm (e.g., between 3 to 150 cm, 3 to 100 cm, 3 to 50 cm, etc.);
(P. [0165] - - Other examples of designs for apparatuses including distal tractor region of different shapes may be a function of catheter ID. For example, in some variations the apparatus may select the catheter ID, number of filaments, diameter/length of filaments, stiffness of bending/rolling stiffness, Poisson's ratio, friction (and/or texture) of the inner surface of the grabber, etc. … For example, in some variations in which the distal tractor region is braided, the apparatus may include a 0.072″ ID catheter having a distal tractor region with 24 to 72 ends of 0.0008″ to 0.002 Niti wire).
It is noted that a) 3 to 200 cm falls within the claimed range of 20 cm or greater; b) since a single loop consists of two strands, 12 to 72 loops (specifically 32 loops) falls within the claimed range of 24- 32 loops; c) 0.0020 inches falls within the claimed range of 0.030- 0.06 mm; d) catheter circumference is derived from catheter diameter and e) choke ratio using 32 loops, 0.002 inch diameter filament and 0.072 inch diameter catheter is greater than 2.9.
(claim 16) wherein the length of the knitted tube is 65 cm or greater, the filament diameter is between 0.030 mm and 0.06 mm, and the catheter circumference is between 3 mm and 13 mm (P. [0165] - - Other examples of designs for apparatuses including distal tractor region of different shapes may be a function of catheter ID. For example, in some variations the apparatus may select the catheter ID, number of filaments, diameter/length of filaments, stiffness of bending/rolling stiffness, Poisson's ratio, friction (and/or texture) of the inner surface of the grabber, etc. … For example, in some variations in which the distal tractor region is braided, the apparatus may include a 0.072″ ID catheter having a distal tractor region with 24 to 72 ends of 0.0008″ to 0.002 Niti wire; it is noted that 0.0020 inches falls within the claimed range of 0.030- 0.06 mm).
Modified Greenhalgh ‘947 does not explicitly disclose
(claim 16) wherein the catheter circumference is between 3 mm and 13 mm.
However, Greenhalgh ‘864 teaches an apparatus for removing a material from a body lumen in the same field of endeavor (Abstract)
(claim 16) wherein the catheter circumference is between 3 mm and 13 mm (P. [0012] - - The apparatuses described herein typically include an elongate catheter having a lumen and a distal end and with a distal end opening into the lumen. The catheter may be low-profile neurovascular catheters (e.g., microcatheters, insertion catheters, etc.) having any appropriate diameter (e.g., <1 Fr, 1 Fr-6 Fr, 1 Fr-9 Fr, etc.). A flexible tractor assembly or portion (e.g., which may be referred to herein as a flexible tractor tube or simply a flexible tube) is typically positioned and longitudinally slideable within the catheter, and arranged so that the distal end region (“distal tractor region”) doubles back over the distal end of the catheter…The combined catheter and flexible tractor assembly also forms a guidewire lumen through the catheter and the flexible tube that is configured to pass a guidewire; it is noted that the catheter diameter range of 1Fr- 9 Fr falls within the claimed range of the catheter circumference is between 3 mm and 13 mm).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the applicant’s claimed invention to modify the catheter circumference of the catheter associated with Greenhalgh ‘947 such that the catheter circumference is between 3 mm and 13 mm as taught by Greenhalgh ‘864 because it would provide an appropriate and predictable dimension for low-profile neurovascular catheters (e.g., microcatheters, insertion catheters, etc.) contemplated by Greenhalgh ‘947 and allowing for a flexible tractor assembly and a guidewire lumen extending therethrough (Greenhalgh ‘864 - - P. [0012]).
(claim 17) It is noted that a) 3 to 200 cm falls within the claimed range of 20 cm or greater; b) since a single loop consists of two strands, 12 to 72 loops (specifically 32 loops) falls within the claimed range of 24- 32 loops; c) 0.0020 inches falls within the claimed range of 0.030- 0.06 mm; d) catheter circumference is derived from catheter diameter and e) choke ratio using 32 loops, 0.002 inch diameter filament and 0.072 inch diameter catheter is greater than 3.0;
It would have been obvious to a person having ordinary skill in the art to modify the dimensions of the flexible tube elements associated with Greenhalgh ‘947 such that the choke ratio is greater than 2.9 and greater than 3.0 according to the teachings of Greenhalgh ‘864 because the configuration of the flexible tube would allow pushing out of the catheter without binding up or becoming caught on the inner walls of the catheter, preventing deployment (Greenhalgh ‘864 - - P. [0021]).
Regarding claim 18, Greenhalgh ‘947 in view of Greenhalgh ‘864 discloses the apparatus of claim 15, Greenhalgh ‘947 further disclosing further comprising an elongate puller (209) (Figs. 2A- 2G) within the catheter (207), wherein the first end of the knitted tube (203) is coupled to the puller (209) so that pulling the puller (209) proximally pulls the knitted tube (203) proximally within the catheter (207) and rolls and inverts the knitted tube (203) into the catheter (207) (P. [0072] - - In FIG. 2B, the puller 209, coupled to the first end of the tractor within the catheter, is pulled to deploy the tractor).
Regarding claim 19, Greenhalgh ‘947 in view of Greenhalgh ‘864 discloses the apparatus of claim 15, Greenhalgh ‘947 further disclosing wherein, in the inverted configuration, the knitted tube (203) is biased to expand into a configuration having a diameter greater than an inner diameter of the catheter (207) (P. [0017] - - Further, in any of these apparatuses, the tractor may be biased to expand to greater than the outer diameter of the catheter in the inverted configuration and is biased to expand to greater than the inner diameter of the catheter in the un-inverted configuration).
Regarding claim 20, Greenhalgh ‘947 discloses a method of removing material from within a body lumen, the method comprising:
positioning a distal end of a catheter (207) (Figs. 2A- 2G) adjacent to the material (220) (Figs. 2A- 2G) (P. [0072] - - In FIG. 2A, the rolling mechanical thrombectomy apparatus 200 is brought near to the clot 220);
pulling a first end of a knitted tube (203) (Figs. 2A- 2G) so that the knitted tube (203) is drawn proximally into the catheter (207) by rolling over a distal end opening of catheter (207) and inverting from an un-inverted configuration (Fig. 2A) along an outer surface of the catheter (207) into an inverted configuration (Fig. 2B) within the catheter (207) (P. [0073] - - As shown in FIG. 2B, the tractor may be rolled and inverted 282 into the catheter by pulling the first end of the tractor from within the catheter (e.g., by pulling 219 the puller proximally)); and
capturing the material (220) with the knitted tube (203) and drawing the material (220) into the catheter (207) (Ps. [0076], [0077] - - As shown in FIG. 2D, when the puller is pulled proximally either with the catheter or with the catheter withdrawn proximally (as shown) so that the tractor cannot roll over the distal end opening of the tractor, the interference between the wall of the vessel 260 and the expanded tractor 251 may hold the tractor in place as the clot, which is still secured to the tractor either by the force of interaction between the tractor and the clot, and/or by suction (e.g., through the puller or other lumen connected to the tractor), is pulled proximally with the tractor. Thus, as shown in FIGS. 2D and 2E, the clot may be engulfed by the tractor and pulled proximally into the expanded tractor; as shown in FIGS. 2F and 2G, the clot may be pulled with the tractor into the catheter once it has been fully engulfed by the tractor).
Regarding the limitation “wherein the knitted tube is configured to stretch less than 3 percent when pulled in tension with a force of 2 Newtons so that the knitted tube does not lock onto the outer surface of the catheter,” Greenhalgh ‘947 further discloses:
wherein the knitted tube (203) is configured to stretch less than 3 percent when pulled in tension with a force of 2 Newtons so that the knitted tube (203) does not lock onto the outer surface of the catheter (207) (See Figs. 2A, 2B) (Ps. [0022], [0068], [0072] - - Any of these apparatuses may be configured to controllably deploy the tractor, which may be held compressed and/or against the catheter of the elongate inversion support until being deployed. For example, any of these apparatus may include a releasable attachment between the tractor and an outer surface of the catheter (e.g., a tractor hold), wherein the releasable attachment is configured to release when the tractor is pulled (e.g., proximally by the puller) with a force that is greater than a predetermined force threshold; The range of force appropriate to the threshold force may be important in proper functioning of the apparatus, particularly when the force is applied by pulling proximally on the puller and/or tractor; too little force for the threshold and the tractor will prematurely deploy; too much force and the apparatus will jam (e.g., by kinking the elongate inversion support); In FIG. 2A, the tractor is held in tension by holding in a fixed position relative to the catheter at a second (outer) end of the tractor; a tractor hold (not shown in FIG. 2A) may be used to releasably hold an end of the tractor fixed relative to the catheter. When a force sufficient to overcome the deployment force (e.g., 100 g of force or greater, 200 g of force or greater, etc.) is applied by pulling 219 the first end of the tractor, as shown in FIG. 2B. In FIG. 2B, the puller 209, coupled to the first end of the tractor within the catheter, is pulled to deploy the tractor. When deployed the tractor may expand away from the catheter and towards the wall(s) of the vessel 260).
It is noted that according to the applicant, “to stretch” is an equivalent of “to constrict” (See p. [0081] of applicant’s Specification - - “the tractor may be configured so that it does not stretch (and therefore constrict) more than a predefined percentage when pulled in tension”). Greenhalgh ‘947 teaches that when the knitted tube is pulled with 200 g of force, the knitted tube is deployed/ released and does not lock onto the outer surface of the catheter. Greenhalgh ‘947 does not specifically disclose that upon application of a deployment force, the knitted tube is stretching or constricting less than 3%, however, it would have been obvious to a person having ordinary skill in the art that at least at the moment of reaching the threshold force, the knitted tube is no longer stretched or constricted upon the outer surface of the catheter and, since 0 % is less than 3%, the knitted tube disclosed by Greenhalgh ‘947 is capable of stretching less than 3 percent when pulled in tension with a force of 2 Newtons so that the knitted tube does not lock onto the outer surface of the catheter.
It is further noted that the language “wherein the knitted tube is configured to stretch less than 3 percent when pulled in tension with a force of 2 Newtons so that the knitted tube does not lock onto the outer surface of the catheter,” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The Office submits that the device of Greenhalgh ‘947 meets the structural limitations of the claim, including being pulled in tension with a force of 2 Newtons so that the knitted tube does not lock onto the outer surface of the catheter and, as such is capable of being stretched less than 3 percent.
Greenhalgh ‘947 does not disclose
(claim 20) loops per turn as claimed.
However, Greenhalgh ‘864 teaches an apparatus for removing a material from a body lumen in the same field of endeavor (Abstract)
(claim 20) wherein the knitted tube has a length of 20 cm or greater and comprises a filament knitted into N loops per turn where N is 24-32 loops per turn, the filament having a filament diameter Dfiament, and wherein the knitted tube has a choke ratio, (N2 x Dfllament)/Ccath, greater than 2.9, where Ccath is the catheter circumference wherein the diameter of the filament is between 0.030 mm and 0.06 mm (Ps. [0049], [0058], [0063], [0165])
(P. [0049] - - In general, as used herein a woven material includes any material formed by weaving multiple strands of material in an interlacing pattern (e.g., interlacing strands, filaments, lengths of material, etc.). A mesh is one type of woven material … A knitted material may be more flexible and generally refers to a single path or course that is meandering, forming loops that may be symmetrically arranged and interlocking);
(P. [0058] - - the flexible tube comprises a soft outer mesh that is pushable. For example the distal tractor region (and particularly the expandable first end region) may be formed from 24 to 144 stands, having a thickness of 0.0020 inches or less in diameter);
(P. [0063] - - In general, the flexible tube may be any appropriate length. For example, the flexible tube may be between 3 to 200 cm (e.g., between 3 to 150 cm, 3 to 100 cm, 3 to 50 cm, etc.);
(P. [0165] - - Other examples of designs for apparatuses including distal tractor region of different shapes may be a function of catheter ID. For example, in some variations the apparatus may select the catheter ID, number of filaments, diameter/length of filaments, stiffness of bending/rolling stiffness, Poisson's ratio, friction (and/or texture) of the inner surface of the grabber, etc. … For example, in some variations in which the distal tractor region is braided, the apparatus may include a 0.072″ ID catheter having a distal tractor region with 24 to 72 ends of 0.0008″ to 0.002 Niti wire).
It is noted that a) 3 to 200 cm falls within the claimed range of 20 cm or greater; b) since a single loop consists of two strands, 12 to 72 loops (specifically 32 loops) falls within the claimed range of 24- 32 loops; c) 0.0020 inches falls within the claimed range of 0.030- 0.06 mm; d) catheter circumference is derived from catheter diameter and e) choke ratio using 32 loops, 0.002 inch diameter filament and 0.072 inch diameter catheter is greater than 2.9.
It would have been obvious to a person having ordinary skill in the art to modify the dimensions of the flexible tube elements associated with Greenhalgh ‘947 such that the choke ratio is greater than 2.9 and greater than 3.0 according to the teachings of Greenhalgh ‘864 because the configuration of the flexible tube would allow pushing out of the catheter without binding up or becoming caught on the inner walls of the catheter, preventing deployment (Greenhalgh ‘864 - - P. [0021]).
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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/KANKINDI RWEGO/Primary Examiner, Art Unit 3771