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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/13/2025 has been entered.
Status of Claims
Claims 1-7, 11-17, 19-21, and 25-37 are currently pending. Claims 8-10, 18, and 22-24 are cancelled. Claims 20 and 25 are currently amended. Claims 36-37 are newly added. No new subject matter added.
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.
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.
Claims 1, 4, 6, 11-12, 14-16, 19, 21, 26-27, 29, 31, 33-34, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Brady (WO 2018019829 A1) in view of Garrison et al. (US 20160220741 A1), hereinafter referred to as “Garrison”.
Regarding claim 1, Brady teaches a method of treating a pulmonary embolism within a vasculature of a patient (removing clot from pulmonary arteries in patients suffering from pulmonary embolism, see Col. 1 ln 5-17), the method comprising:
positioning an aspiration catheter (503) through the vasculature of the
patient such that a distal end portion of the aspiration catheter is positioned proximate to the pulmonary embolism (catheter 503 is introduced through the vasculature to the target location in a vessel 507 of the clot 508, see Figure 19), wherein a lumen of the aspiration catheter is fluidly coupled along a fluid path to an aspiration container (lumen of catheter 503 is fluidly coupled to container 502, see Figure 19);
generating vacuum pressure in the aspiration container (container 502 being a vacuum
pump, see Col. 20 ln 20) applying the vacuum pressure to the lumen of the aspiration catheter such that at least a portion of the pulmonary embolism is aspirated toward the distal end portion of the aspiration catheter (producing a pressure differential waveform at the tip of the catheter 503, see Col. 20 ln 20-21).
However, Brady does not explicitly disclose positioning an aspiration catheter at least partially through a lumen of an outer sheath; and determining that a clogging portion of the pulmonary embolism is at least partially clogging the lumen of the aspiration catheter; and aspirating through the lumen of the outer sheath to at least partially aspirate the clogging portion of the pulmonary embolism through the lumen of the outer sheath.
Garrison teaches an intravascular access system (100) for facilitation of intraluminal medical procedures within the neuro vasculature through an access sheath (see Abstract) comprising positioning an aspiration catheter (catheter system 300 connected to aspiration line 230) at least partially through a lumen of an outer sheath (the access sheath 220 can have a sheath body 222 and an inner lumen 223, see Figure 1; the catheter system 300 having a catheter 320 positioning through the access sheath 220, see Figure 9); and determining that a clogging portion of the pulmonary embolism is at least partially clogging the lumen of the aspiration catheter (a flow sensor 275 that senses flow in the aspiration line 230; the force is greatest when the catheter is clogged or partially clogged, see Paragraph [0113]); and aspirating through the lumen of the outer sheath to at least partially aspirate the clogging portion of the pulmonary embolism through the lumen of the outer sheath (providing the ability to maintain aspiration continuously from either the catheter tip or the sheath tip or the sheath distal region, and providing the means to change aspiration levels, see Paragraph [0128]).
Brady and Garrison are analogous art because both teach an aspiration catheter for clot material.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the aspiration catheter of Brady and further include wherein the catheter is position within an outer sheath capable of detecting a clogged portion of the catheter, and aspirating clot material through the outer sheath, as taught by Garrison. Garrison teaches the procedure optimizes the ability to aspiration clot while minimizing distal emboli and minimizing blood loss from aspiration (see Paragraph [0128]).
Regarding claim 4, Brady teaches all of the limitations of claim 1 and Brady further teaches wherein positioning the aspiration catheter includes advancing the aspiration catheter such that the distal end portion of the aspiration catheter is positioned proximate to the pulmonary embolism within a pulmonary artery of the patient (catheter 503 is introduced through the vasculature to the target location in a vessel 507 of the clot 508, see Figure 19; device is configured for removing clot from pulmonary arteries in patients suffering from pulmonary embolism, see Col. 1 ln 5-17).
Regarding claim 6, Brady and Garrison teaches all of limitations as discussed above in claim 1 and Brady further teaches wherein the method further comprises:
generating vacuum pressure in the aspiration container while a valve (pulse generator 501/550) positioned along the fluid path between the aspiration catheter and the aspiration container (see Figure 19) is in a first position that inhibits fluid flow along the fluid path from the lumen of the aspiration catheter to the aspiration container (pulse generator 501/550 can be in first position where plunger 551 can compress the tubing 552 to create a pressure wave, see Figure 20B; see Col. 20 ln 19-23);
and applying the vacuum pressure to the lumen of the aspiration catheter comprises moving the valve from the first position with the vacuum pressure generated in the aspiration container to a second position (moving pulse generator in a second position where plunger 551 is moved up not depressing the tubing 552, see Figure 20A; Col. 20 ln 31-34), thereby applying the vacuum pressure to the lumen of the aspiration catheter such that the portion of the pulmonary embolism is aspirated toward the distal end portion of the aspiration catheter (producing a pressure differential waveform at the tip of the catheter 503, see Col. 20 lin 20-21), wherein in the second position the valve permits fluid flow along the fluid path from the lumen of the aspiration catheter to the aspiration container (opening the tubing 522, see Figure 20A; see Col. 20 ln 19-34).
Regarding claim 11, Brady and Garrison teaches all of the limitations of claim 6 and Brady further teaches wherein generating the vacuum pressure in the aspiration container comprises generating the vacuum pressure with an aspiration source fluidly (pump 905 can generate vacuum pressure) coupled to the aspiration container while the valve is in the first position (pulse generator 501/550 can be in first position where plunger 551 can compress the tubing 552 to create a pressure wave, see Figure 20B; see Col. 20 ln 19-23), and wherein the aspiration source is separate from and proximal to the aspiration container (pump 905 can be separate from an aspiration container 904, see Figure 25; the invention includes embodiments having different combinations of features, see Col. 25 ln 12-13).
Regarding claim 12, Brady and Garrison teach all of the limitations, as discussed in claim 11. However, Brady does not explicitly disclose wherein the aspiration source has a volume of 60 cubic centimeters or greater.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of modified Brady to have an aspiration volume of 60 cubic centimeters or greater 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 device of Brady would not operate differently with the aspiration volume and since the aspiration volume is intended to generate a vacuum pressure would function appropriately having the claimed volume. Further, applicant places no criticality on the range claimed, indicating simply that the aspiration volume (syringe volume) “of about” 60cc (specification pp. [0057]).
Regarding claim 14, Brady and Garrison teaches all of the limitations of claim 11 and Brady further teaches wherein the aspiration source comprises a syringe (the source of aspiration can be a syringe attached to proximal end of the catheter, see Col. 3 lines 11-12).
Regarding claim 15, Brady and Garrison teaches all of the limitations of claim 1 and Brady further teaches wherein the aspiration container comprises a syringe (the source of aspiration can be a syringe attached to proximal end of the catheter, see Col. 3 lines 11-12).
Regarding claim 16, Brady teaches a method of treating a deep vein thrombosis within a vasculature of a patient (removing clot from other peripheral arterial and venous vessels in which clot is causing an occlusion, see Col. 1 ln 13-17), the method comprising:
positioning an aspiration catheter (503) at least partially through the vasculature of the
patient such that a distal end portion of the aspiration catheter is positioned proximate to the deep vein thrombosis (catheter 503 is introduced through the vasculature to the target location in a vessel 507 of the clot 508, see Figure 19), wherein a lumen of the aspiration catheter is fluidly coupled along a fluid path to an aspiration container (lumen of catheter 503 is fluidly coupled to container 502, see Figure 19);
generating vacuum pressure in the aspiration container (container 502 being a vacuum
pump , see Col. 20 ln 20);
applying the vacuum pressure to the lumen of the aspiration catheter such that at least a portion of the deep vein thrombosis is aspirated toward the distal end portion of the aspiration catheter (producing a pressure differential waveform at the tip of the catheter 503, see Col. 20 ln 20-21).
However, Brady does not explicitly disclose positioning an aspiration catheter at least partially through a lumen of an outer sheath; and determining that a clogging portion of the pulmonary embolism is at least partially clogging the lumen of the aspiration catheter; and aspirating through the lumen of the outer sheath to at least partially aspirate the clogging portion of the pulmonary embolism through the lumen of the outer sheath.
Garrison teaches an intravascular access system (100) for facilitation of intraluminal medical procedures within the neuro vasculature through an access sheath (see Abstract) comprising positioning an aspiration catheter (catheter system 300 connected to aspiration line 230) at least partially through a lumen of an outer sheath (the access sheath 220 can have a sheath body 222 and an inner lumen 223, see Figure 1; the catheter system 300 having a catheter 320 positioning through the access sheath 220, see Figure 9); and determining that a clogging portion of the pulmonary embolism is at least partially clogging the lumen of the aspiration catheter (a flow sensor 275 that senses flow in the aspiration line 230; the force is greatest when the catheter is clogged or partially clogged, see Paragraph [0113]); and aspirating through the lumen of the outer sheath to at least partially aspirate the clogging portion of the pulmonary embolism through the lumen of the outer sheath (providing the ability to maintain aspiration continuously from either the catheter tip or the sheath tip or the sheath distal region, and providing the means to change aspiration levels, see Paragraph [0128]).
Brady and Garrison are analogous art because both teach an aspiration catheter for clot material.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the aspiration catheter of Brady and further include wherein the catheter is position within an outer sheath capable of detecting a clogged portion of the catheter, and aspirating clot material through the outer sheath, as taught by Garrison. Garrison teaches the procedure optimizes the ability to aspiration clot while minimizing distal emboli and minimizing blood loss from aspiration (see Paragraph [0128]).
Regarding claim 19, Brady further teaches wherein positioning the aspiration catheter includes advancing the aspiration catheter such that the distal end portion of the aspiration catheter is positioned proximate to the deep vein thrombosis within a peripheral portion of the vasculature of the patient (catheter 503 is introduced through the vasculature to the target location in a vessel 507 of the clot 508, see Figure 19; device is configured for removing clot other peripheral arterial and venous vessels in which clot is causing an occlusion, see Col. 1 ln 5-17) ).
Regarding claim 21, Brady and Garrison teaches all of limitations as discussed above in claim 16 and Garrison further teaches wherein
generating vacuum pressure in the aspiration container while a valve (pulse generator 501/550) positioned along the fluid path between the aspiration catheter and the aspiration container (see Figure 19) is in a first position that inhibits fluid flow along the fluid path from the lumen of the aspiration catheter to the aspiration container (pulse generator 501/550 can be in first position where plunger 551 can compress the tubing 552 to create a pressure wave, see Figure 20B; see Col. 20 ln 19-23);
and applying the vacuum pressure to the lumen of the aspiration catheter comprises moving the valve from the first position with the vacuum pressure generated in the aspiration container to a second position (moving pulse generator in a second position where plunger 551 is moved up not depressing the tubing 552, see Figure 20A; Col. 20 ln 31-34), thereby applying the vacuum pressure to the lumen of the aspiration catheter such that the portion of the deep vein thrombosis is aspirated toward the distal end portion of the aspiration catheter (producing a pressure differential waveform at the tip of the catheter 503, see Col. 20 line 20-21), wherein in the second position the valve permits fluid flow along the fluid path from the lumen of the aspiration catheter to the aspiration container (opening the tubing 522, see Figure 20A; see Col. 20 ln 19-34).
Regarding claim 26, Brady and Garrison teach all of the limitations as discussed above in claim 21 and Brady further teaches wherein generating the vacuum pressure in the aspiration container comprises generating the vacuum pressure with an aspiration source fluidly (pump 905 can generate vacuum pressure) coupled to the aspiration container while the valve is in the first position (pulse generator 501/550 can be in first position where plunger 551 can compress the tubing 552 to create a pressure wave, see Figure 20B; see Col. 20 ln 19-23), and wherein the aspiration source is separate from and proximal to the aspiration container (pump 905 can be separate from an aspiration container 904, see Figure 25; the invention includes embodiments having different combinations of features, see Col. 25 ln 12-13).
Regarding claim 27, Brady and Garrison teaches all of the limitations, as discussed in claim 26. However, Brady does not explicitly disclose wherein the aspiration source has a volume of 60 cubic centimeters or greater.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of modified Laub to have an aspiration volume of 60 cubic centimeters or greater 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 device of Brady would not operate differently with the aspiration volume and since the aspiration volume is intended to generate a vacuum pressure would function appropriately having the claimed volume. Further, applicant places no criticality on the range claimed, indicating simply that the aspiration volume (syringe volume) “of about” 60cc (specification pp. [0057]).
Regarding claim 29, Brady teaches wherein the aspiration source comprises a syringe (the source of aspiration can be a syringe attached to proximal end of the catheter, see Col. 3 lines 11-12).
Regarding Claim 31, Brady teaches a method of treating clot material within a vasculature of a patient (removing clot from pulmonary arteries in patients suffering from pulmonary embolism, see Col. 1 ln 5-17), the method comprising:
positioning an aspiration catheter (503) at least partially through the vasculature of the patient such that a distal end portion of the aspiration catheter is positioned proximate to the clot material (catheter 503 is introduced through the vasculature to the target location in a vessel 507 of the clot 508, see Figure 19), wherein a lumen of the aspiration catheter is fluidly coupled along a fluid path to an aspiration container (lumen of catheter 503 is fluidly coupled to container 502, see Figure 19);
generating vacuum pressure in the aspiration container (container 502 being a vacuum
pump , see Col. 20 ln 20); and
applying the vacuum pressure to the lumen of the aspiration catheter such that at least a portion of the clot material is aspirated toward the distal end portion of the aspiration catheter (producing a pressure differential waveform at the tip of the catheter 503, see Col. 20 ln 20-21).
However, Brady does not explicitly disclose positioning an aspiration catheter at least partially through a lumen of an outer sheath; and determining that a clogging portion of the pulmonary embolism is at least partially clogging the lumen of the aspiration catheter; and aspirating through the lumen of the outer sheath to at least partially aspirate the clogging portion of the pulmonary embolism through the lumen of the outer sheath.
Garrison teaches an intravascular access system (100) for facilitation of intraluminal medical procedures within the neuro vasculature through an access sheath (see Abstract) comprising positioning an aspiration catheter (catheter system 300 connected to aspiration line 230) at least partially through a lumen of an outer sheath (the access sheath 220 can have a sheath body 222 and an inner lumen 223, see Figure 1; the catheter system 300 having a catheter 320 positioning through the access sheath 220, see Figure 9); and determining that a clogging portion of the pulmonary embolism is at least partially clogging the lumen of the aspiration catheter (a flow sensor 275 that senses flow in the aspiration line 230; the force is greatest when the catheter is clogged or partially clogged, see Paragraph [0113]); and aspirating through the lumen of the outer sheath to at least partially aspirate the clogging portion of the pulmonary embolism through the lumen of the outer sheath (providing the ability to maintain aspiration continuously from either the catheter tip or the sheath tip or the sheath distal region, and providing the means to change aspiration levels, see Paragraph [0128]).
Brady and Garrison are analogous art because both teach an aspiration catheter for clot material.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the aspiration catheter of Brady and further include wherein the catheter is position within an outer sheath capable of detecting a clogged portion of the catheter, and aspirating clot material through the outer sheath, as taught by Garrison. Garrison teaches the procedure optimizes the ability to aspiration clot while minimizing distal emboli and minimizing blood loss from aspiration (see Paragraph [0128]).
Regarding Claim 33, Brady and Garrison teaches all the limitations as discussed above in claim 31 and Brady further teaches wherein the clot material comprises a pulmonary embolism (removing clot from pulmonary arteries in patients suffering from pulmonary embolism, see Col. 1 ln 5-17), and wherein positioning the aspiration catheter comprises positioning the aspiration catheter such that the distal end portion of the aspiration catheter is positioned in a pulmonary artery proximate to the pulmonary embolism (catheter 503 is introduced through the vasculature to the target location in a vessel 507 of the clot 508, see Figure 19; the target location being an obstruction within the pulmonary arteries is a condition known as pulmonary embolism, see Paragraph [0005]).
Regarding Claim 34, Brady and Garrison teaches all the limitations as discussed above in claim 31 and Garrison further teaches wherein aspirating through the lumen of the outer sheath (aspirating through outer sheath 220) comprises aspirating through the lumen of the outer sheath with a syringe fluidly coupled to the lumen of the outer sheath (the aspiration source 600 can be attached to the aspiration line 230 on the access sheath 220, see Paragraph [0111]).
Regarding Claim 36, Brady teaches wherein the aspiration catheter (503) has a proximal end portion (proximal portion 504 coupled to the vacuum pump 502, see Figure 19), wherein positioning the aspiration catheter comprises positioning the proximal end portion of the aspiration catheter outside the patient (see Figure 19), and wherein the lumen of the aspiration catheter extends continuously from the distal end portion to the proximal end portion (connector tubing 504 and catheter 503 are continuously connected to provide aspiration at the distal tip of catheter 503, see Figure 19).
Claims 2-3, 5, 17, 20, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Brady and Garrison, as applied in claim 1, and in further view of Laub (US 20170043066 A1).
Regarding claim 2, Brady and Garrison teaches all of limitations as discussed above in claim 1. However, Brady and Garrison do not explicitly disclose wherein positioning the aspiration catheter comprises inserting a catheter having a size of 16 French or greater through the vasculature.
Laub teaches a system and method for treating clot material in the vasculature of the patient (a system for removing material from the body of a patient, see Abstract; Paragraph [0005]), wherein positioning the aspiration catheter comprises inserting a catheter having a size of 16 French or greater through the vasculature (aspiration catheter 200 has a French size of at least 20 Fr, see Paragraph [0028]).
Brady, Garrison, and Laub are analogous art because all deal with a system for removing occlusive clot from a blood vessel.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter of modified Brady and further include a catheter with a size of 16 French or greater, as taught by Laub. Laub teaches the size of the catheter allows for aspiration of large thrombi and/or other solid materials from the patient (see last line of Paragraph [0028]).
Regarding claim 3, Brady and Garrison teaches all of limitations as discussed above in claim 1. However, Brady and Garrison do not explicitly disclose wherein positioning the aspiration catheter comprises inserting a catheter having a size of 20 French or greater through the vasculature.
Laub teaches a system and method for treating clot material in the vasculature of the patient (a system for removing material from the body of a patient, see Abstract; Paragraph [0005]), wherein positioning the aspiration catheter comprises inserting a catheter having a size of 20 French or greater through the vasculature (aspiration catheter 200 has a French size of at least 20 Fr, see Paragraph [0028]).
Brady, Garrison, and Laub are analogous art because all deal with a system for removing occlusive clot from a blood vessel.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter of Modified Brady and further include a catheter with a size of 20 French or greater, as taught by Laub. Laub teaches the size of the catheter allows for aspiration of large thrombi and/or other solid materials from the patient (see last line of Paragraph [0028]).
Regarding claim 5, Brady and Garrison teach all of limitations as discussed above in claim 1 and Garrison further teaches aspirating through the lumen of the outer sheath (providing the ability to maintain aspiration continuously from either the catheter tip or the sheath tip or the sheath distal region, and providing the means to change aspiration levels, see Paragraph [0128]).
However, Brady and Garrison do not explicitly disclose wherein the method further comprises: an aspirated portion of the pulmonary embolism from blood via a filter; and reintroducing the filtered blood into the vasculature of the patient.
Laub teaches a system and method for treating clot material in the vasculature of the patient (a system for removing material from the body of a patient, see Abstract; Paragraph [0005]), wherein the method further comprises:
filtering the at least portion of the pulmonary embolism from blood via a filter (300; a filter may be integrated into aspiration catheter 200 and/or pump 400, see last line of Paragraph [0024]);
and reintroducing the filtered blood into the vasculature of the patient (reintroducing blood through return catheter 500, see Figure 1A; see Paragraph [0024]).
Brady, Garrison, and Laub are analogous art because both deal with a system for removing occlusive clot from a blood vessel.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter of Modified Brady and further include a filter positioned in the aspiration catheter and reintroducing filtered blood back in the patient, as taught by Laub. Laub teaches by returning the aspirated blood back to the patient, embodiments of the present system (100) allows for aspiration while minimizing the blood loss of the patient. In certain embodiments, reinfusing the patient's blood continuously during aspiration allows for greater suction pressure and/or flow rates (e.g., 2-4 L/min) which can assist in dislodging and removing larger clots and/or tumors than would otherwise be possible (see Paragraph [0045]).
Regarding claim 17, Brady and Garrison teaches all of limitations as discussed above in claim 16. However, Brady and Garrison do not explicitly disclose wherein positioning the aspiration catheter comprises inserting a catheter having a size of 16 French or greater through the vasculature.
Laub teaches a system and method for treating clot material in the vasculature of the patient (a system for removing material from the body of a patient, see Abstract; Paragraph [0005]), wherein positioning the aspiration catheter comprises inserting a catheter having a size of 16 French or greater through the vasculature (aspiration catheter 200 has a French size of at least 20 Fr, see Paragraph [0028]).
Brady, Garrison, and Laub are analogous art because all deal with a system for removing occlusive clot from a blood vessel.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter of modified Brady and further include a catheter with a size of 16 French or greater, as taught by Laub. Laub teaches the size of the catheter allows for aspiration of large thrombi and/or other solid materials from the patient (see last line of Paragraph [0028]).
Regarding claim 20, Brady and Garrison teach all of limitations as discussed above in claim 16 and Garrison further teaches aspirating through the lumen of the outer sheath (providing the ability to maintain aspiration continuously from either the catheter tip or the sheath tip or the sheath distal region, and providing the means to change aspiration levels, see Paragraph [0128]).
However, Brady and Garrison does not explicitly disclose wherein the method further comprises: filtering an aspirated portion of the deep vein thrombosis from blood and reintroducing the filtered blood into the vasculature of the patient.
Laub teaches a system and method for treating clot material in the vasculature of the patient (a system for removing material from the body of a patient, see Abstract; Paragraph [0005]), wherein the method further comprises:
filtering the at least portion of the deep vein thrombosis from blood via a filter (300; a filter may be integrated into aspiration catheter 200 and/or pump 400, see last line of Paragraph [0024]);
and reintroducing the filtered blood into the vasculature of the patient (reintroducing blood through return catheter 500, see Figure 1A; see Paragraph [0024]).
Brady, Garrison, and Laub are analogous art because both deal with a system for removing occlusive clot from a blood vessel.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter of Modified Brady and further include a filter positioned in the aspiration catheter and reintroducing filtered blood back in the patient, as taught by Laub. Laub teaches by returning the aspirated blood back to the patient, embodiments of the present system (100) allows for aspiration while minimizing the blood loss of the patient. In certain embodiments, reinfusing the patient's blood continuously during aspiration allows for greater suction pressure and/or flow rates (e.g., 2-4 L/min) which can assist in dislodging and removing larger clots and/or tumors than would otherwise be possible (see Paragraph [0045]).
Regarding Claim 35, Brady and Garrison teaches all the limitations as discussed above in claim 31. However, Brady and Garrison do not explicitly disclose wherein the aspiration catheter has a size of 16 French or greater.
Laub teaches a system and method for treating clot material in the vasculature of the patient (a system for removing material from the body of a patient, see Abstract; Paragraph [0005]), wherein positioning the aspiration catheter comprises inserting a catheter having a size of 16 French or greater through the vasculature (aspiration catheter 200 has a French size of at least 20 Fr, see Paragraph [0028]).
Brady, Garrison, and Laub are analogous art because all deal with a system for removing occlusive clot from a blood vessel.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the catheter of modified Brady and further include a catheter with a size of 16 French or greater, as taught by Laub. Laub teaches the size of the catheter allows for aspiration of large thrombi and/or other solid materials from the patient (see last line of Paragraph [0028]).
Brady, Garrison, and Laub teach all of limitations as discussed above and Laub further teaches catheter (200) may be inserted through a tubular sheath (800). However, Brady, Garrison, and Laub do not explicitly disclose wherein the outer sheath has a size of 20 French or greater.
Laub discloses (Paragraph [0046]) the size of the outer sheath needs to be optimized to allow “catheter to be inserted through a tubular sheath” As seen in Fig. 6, the outer sheath comprises a size of the outer sheath and as such the size of the outer sheath is disclosed to be a result effective variable in that changing the size of the outer sheath changes diameter of the lumen which affects the catheter being able to be inserted. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Laub device to select among a plurality sizes of the outer sheath of a fluid passage within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Laub by selecting the size of the outer sheath among a plurality of size of the outer sheath as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 7, 22, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Brady and Garrison, as applied in claim 1, and in further view of Hartley (US 20030116731 A1).
Regarding claim 7, Brady and Garrison teach all of the limitations, as discussed above in claim 1 and Brady further teaches selectively providing fluid access to the lumen of the aspiration catheter via (valve/seal 506). However, Brady and Garrison do not explicitly disclose wherein the method further comprises selectively providing fluid access to the lumen of the aspiration catheter via a hemostasis valve .
Hartley discloses a hemostasis valve (rotating hemostasis valve 2, see Figure 1) for selectively providing fluid access to the lumen of the aspiration catheter (see Abstract).
Brady, Garrison, and Hartley are analogous art because both deal with a valve mechanism within a medical suction device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the valve of modified Brady and replace it with the hemostasis valve, as taught by Hartley. Hartley teaches the hemostasis valve allow fluid flow prevention and access valves in medical applications for instance where it is desired to seal around a catheter or other instrument in a manner which permits the catheter or other instrument to be passed through the access valve and the valve to form a seal against the walls of the catheter or other instrument to prevent loss of blood or other fluid (see Paragraph [0003]).
Regarding claim 25, Modified Brady teaches all of the limitations as discussed above in claim 21 and Brady further teaches selectively providing fluid access to the lumen of the aspiration catheter via (valve/seal 506), wherein the valve is coupled to a proximal end portion of the aspiration catheter (valve seal of Bradly is coupled to a proximal end portion of catheter 503, see Figure 19) and the aspiration container (502) is fluidly coupled to the lumen of the aspiration catheter (503) via a tube branching (505) from the valve (valve 506, see Figure 19). Hartley further teaches wherein the valve is a hemostasis valve (rotating hemostasis valve 2, see Figure 1).
However, Brady and Garrison do not explicitly disclose wherein the method further comprises selectively providing fluid access to the lumen of the aspiration catheter via a hemostasis valve .
Hartley discloses a hemostasis valve (rotating hemostasis valve 2, see Figure 1) for selectively providing fluid access to the lumen of the aspiration catheter (see Abstract).
Brady, Garrison, and Hartley are analogous art because both deal with a valve mechanism within a medical suction device.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the valve of modified Brady and replace it with the hemostasis valve, as taught by Hartley. Hartley teaches the hemostasis valve allow fluid flow prevention and access valves in medical applications for instance where it is desired to seal around a catheter or other instrument in a manner which permits the catheter or other instrument to be passed through the access valve and the valve to form a seal against the walls of the catheter or other instrument to prevent loss of blood or other fluid (see Paragraph [0003]).
Claims 13, 28, 30, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Brady and Garrison as applied in claim 11, and in further view of Garrison et al. (US 20180064453 A1), hereinafter referred to as “Garrison 453’”.
Regarding claim 13, Brady and Garrison teaches all of the limitations as discussed above in claim 11 and Brady further teaches the vacuum pump may comprise a diaphragm or vane or piston pump, or a peristaltic pump, or other means of generating a negative pressure differential (see Col. 21 ln 18-19). However, Brady and Garrison does not explicitly disclose wherein the aspiration source comprises an electric pump.
Garrison 543’ teaches a clot treatment system (100), comprising: a source of aspiration (600), wherein the aspiration source is an electric pump (aspiration source (600) may be an electromechanical pump, see Paragraph [0111]).
Brady, Garrison, and Garrison 543’ analogous art because all teach an aspiration system for clot retrieval.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the aspiration source of modified Brady and further include wherein the aspiration source is an electromechanical pump, as taught by Garrison 543’. Garrison 543’ teaches a positive displacement such as a electromechanical pump to vary the aspiration rate by modifying the power to the motor is beneficial in order be used in different steps of the clot removal procedure (see Paragraph [0112]).
Regarding claim 28, Brady and Garrison teach all of the limitations as discussed above in claim 26 and Brady further teaches the vacuum pump may comprise a diaphragm or vane or piston pump, or a peristaltic pump, or other means of generating a negative pressure differential (see Col. 21 ln 18-19). However, Brady and Garrison do not explicitly disclose wherein the aspiration source comprises an electric pump.
Garrison 543’ teaches a clot treatment system (100), comprising: a source of aspiration (600), wherein the aspiration source is an electric pump (aspiration source (600) may be an electromechanical pump, see Paragraph [0111]).
Brady, Garrison, and Garrison 543’ are analogous art because all teach an aspiration system for clot retrieval.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the aspiration source of modified Brady and further include wherein the aspiration source is an electromechanical pump, as taught by Garrison 543’. Garrison 543’ teaches a positive displacement such as a electromechanical pump to vary the aspiration rate by modifying the power to the motor is beneficial in order be used in different steps of the clot removal procedure (see Paragraph [0112]).
Regarding Claim 30, Brady and Garrison teach all of the limitations as discussed above in claim 16 and Brady further teaches the vacuum pump may comprise a diaphragm or vane or piston pump, or a peristaltic pump, or other means of generating a negative pressure differential (see Col. 21 ln 18-19). However, Brady and Garrison do not explicitly disclose wherein the aspiration container comprises an electric pump.
Garrison 543’ teaches a clot treatment system (100), comprising: a source of aspiration (600), wherein the aspiration source is an electric pump (aspiration source (600) may be an electromechanical pump, see Paragraph [0111]).
Brady, Garrison, and Garrison 543’ are analogous art because all teach an aspiration system for clot retrieval.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the aspiration container of modified Brady and further include wherein the aspiration container is an electromechanical pump, as taught by Garrison 543’. Garrison 543’ teaches a positive displacement such as a electromechanical pump to vary the aspiration rate by modifying the power to the motor is beneficial in order be used in different steps of the clot removal procedure (see Paragraph [0112]).
Regarding Claim 32, Brady and Garrison teach all of the limitations as discussed above in claim 31 and Brady further teaches the vacuum pump may comprise a diaphragm or vane or piston pump, or a peristaltic pump, or other means of generating a negative pressure differential (see Col. 21 ln 18-19). However, Brady and Garrison do not explicitly disclose wherein generating the vacuum pressure in the aspiration container comprises generating the vacuum pressure with an electric pump.
Garrison 543’ teaches a clot treatment system (100), comprising: a source of aspiration (600), wherein the aspiration source is an electric pump (aspiration source (600) may be an electromechanical pump, see Paragraph [0111]).
Brady, Garrison, and Garrison 543’ are analogous art because all teach an aspiration system for clot retrieval.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the aspiration container of modified Brady and further include wherein the aspiration container is an electromechanical pump, as taught by Garrison 543’. Garrison 543’ teaches a positive displacement such as a electromechanical pump to vary the aspiration rate by modifying the power to the motor is beneficial in order be used in different steps of the clot removal procedure (see Paragraph [0112]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Brady and Garrison as applied in claim 31, and in further view of Garrison et al. (US 20150173782 A1), hereinafter referred to as “Garrison 782’.
Regarding Claim 37, Brady and Garrison teaches all of the limitation as discussed above in claim 31 and Brady further teaches wherein generating the vacuum pressure in the aspiration container comprises generating the vacuum pressure with a first aspiration source (vacuum pump 502 generating a vacuum pressure, see Col. 20 ln 20; Figure 19).
However, Brady and Garrison do not explicitly disclose wherein aspirating through the lumen of the outer sheath comprises aspirating through the lumen of the outer sheath with a second aspiration source different than the first aspiration source.
Garrison 782’ teaches a system of devices for treating an artery includes an arterial access sheath adapted to introduce an interventional catheter into an artery and an elongated dilator positionable within the internal lumen of the sheath body (see Abstract) comprising a controller (3400) connected a first aspiration source (an active source of aspiration 3420 can be a vacuum pump, see Paragraph [0133]) and a second aspiration source (a passive source of aspiration 3410), and wherein aspirating through the lumen of the outer sheath comprises aspirating through the lumen of the outer sheath with a second aspiration source different than the first aspiration source (the passive source of aspiration may be a site with lower pressure, for example a sheath inserted into a central vein (for venous return) or an IV bag placed at a vertical level that would vary depending on what amount of negative pressure is desired, see Paragraph [0140]).
Brady, Garrison, and Garrison 782’ are analogous art because all teach an aspiration catheter.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the outer sheath of Modified Brady and further include wherein aspirating through the lumen of the outer sheath comprises aspirating through the lumen of the outer sheath with a second aspiration source different than the first aspiration source, as taught by Garrison 782’. Garrison 782’ teaches it is beneficial for a user to regulate which device is being aspirated, for example the arterial access device, the catheter, both, or neither. The controller may include a control that permits a pulsatile aspiration mode which may facilitate the breaking up and aspiration of the cerebral occlusion. The flow controller may have an interface for switching between continuous and pulsatile aspiration modes (see Paragraph [0133]).
Response to Arguments
Applicant’s arguments, see pg. 1, filed 10/13/2025, with respect to claim 20 have been fully considered and are persuasive. The claim objection of claim 20 has been withdrawn.
Applicant's arguments filed 10/13/2025 have been fully considered but they are not persuasive.
Specifically, Applicant argues in claim 1 that a person of ordinary skilled in art would not have modified Brady to further include “wherein the catheter is positioned within an outer sheath capable of detecting a clogged portion of the catheter and aspiration clot material through the outer sheath, as taught by Garrison” because Brady discloses that its system can aspirate any clogging clot material simply utilizing the pulse generator (501). Applicant further argues that further modifying Brady to include an outer sheath and aspirating the outer sheath would increase the cost and complexity of Brady’s system with no discernible benefit.
The examiner respectfully disagrees with the applicant that there would be no motivation/discernible benefit to combine Brady and Garrison. The examiner agrees that Brady disclose a pulse generator (501) to create changes in aspiration levels to assist with deforming the clot and overcome the resistance or extrusion energy required to get the clot into the catheter more quickly and effectively than applying a continuous or steady aspiration force. However, Garrison’s provides a specific procedure of retracting a distal catheter that has a high level of aspiration into an outer sheath with a lower level of aspiration that provides benefits that Brady does not disclose. Therefore, Garrison’s device of using an outer sheath to provide aspiration at the distal tip provides an additional benefit of “optimizing the ability to aspiration clot while minimizing distal emboli and minimizing blood loss from aspiration”. Therefore, Claim 1 would remain rejected by Brady in view of Garrison.
Conclusion
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/ERIC RASSAVONG/ (3/2/2026)Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781