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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/12/2026 has been entered.
Claim Objections
Claim 48 is objected to because of the following informalities: In line 3 of claim 48, “poisoned apart from” should be changed to “positioned apart from”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 48 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “not near” in claim 48 is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what position would be considered “apart from and not near”. For example, a location where the two object are not in contact with one another could be considered positioned apart but is it unclear what distance apart would be required for the object to be “not near” one another. For the purpose of examination, any distance which allows for a spacing an no direct contact between the clot material and the rigidizing aspiration sheath catheter will be interpreted as meeting the limitation of “not near”.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 01/12/2026, with respect to the rejection(s) of claim(s) 33 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of an alternative embodiment and interpretation of the teachings of Gomes.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 33, 35, 36, 38-44, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Gomes et al. (WO 2022/051682) in view of Tilson et al. (US 2021/0138187), further in view of Deville et al. (US 2020/0022712).
Regarding claim 33, Gomes et al. discloses a method for removing clot material from a patient (FIGs 11A-11E, [0135 and 0152-0188]), the method comprising: advancing a rigidizing aspiration sheath catheter (970y, FIG 11C) in a vessel (1160z) while the rigidizing aspiration sheath catheter is in a flexible state ([0135] “At FIG. 11C, a large bore catheter 970y can be slid over the rigidizing guiderail 900 while the rigidizing guiderail 900 is in the rigid configuration. If the large bore catheter 970y is rigidizing (i.e., includes layers that are rigidized via pressure or vacuum as described elsewhere herein), then the large bore catheter 970y can be rigidized (e.g., increasing its stiffness at least 1.1 times its initial stiffness) after placement over the rigidizing guiderail 900.” Therefore it is understood that 970y is in a flexible configuration while being placed such that it can track over the curved rigid guiderail 900) so that a distal end of the rigidizing aspiration sheath catheter is within the vessel (FIG 11C); transitioning the rigidizing aspiration sheath catheter from the flexible state to a more rigid state ([0135] “large bore catheter 970y can be rigidized (e.g., increasing its stiffness at least 1.1 times its initial stiffness) after placement over the rigidizing guiderail 900”); advancing a rigidizing catheter (910) through and distally out of the rigidizing aspiration sheath catheter while the rigidizing aspiration sheath catheter is in the more rigid state until the aspiration catheter is proximate to the clot material ([0135] discloses “an additional catheter 910 can be passed through the large bore catheter 970y. The additional catheter 910 (either rigidizing or non-rigidizing) can, for example, pass beyond the distal end of the large bore catheter 970y and be directed towards a bifurcated path”. As shown in FGI 11, the bifurcated path is where clot material 1169y is located); transitioning the catheter from a flexible state to a more rigid state ([0135] discloses that 910 can be rigidized).
Gomes further discloses in the method that “An aspiration catheter can be inserted through the rigidizing large bore catheter 970y, the aspiration catheter can be precisely navigated through the rigidizing large bore catheter 970y, both axially and rotationally, up to the clot... The clot can be aspirated into and through aspiration catheter into proximal collection source” ([0141]) but fails to explicitly state that the aspiration catheter is the “additional catheter 910” described in [0135]).
However, it would have been obvious to one of ordinary skill in the art at the time of filing to select the additional rigidizing catheter to be an aspiration catheter, for the purpose of performing aspiration of the clot material as described in [0135], with the additional benefit that use of an additional catheter 910 can advantageously enable further penetration of smaller branches with the benefit of a stable base e.g., the rigidized large bore catheter 970y. Thus, aspiration of clot material in smaller branches can be achieved due to the stabilized support of the rigidizing aspiration sheath catheter. It is understood that aspiration is performed after the aspirating catheter has been appropriately placed and rigidized.
Gomes et al. is silent regarding the proximal end of the rigidizing aspiration sheath catheter comprising a hemostasis valve portion.
However, Tilson et al. teaches a rigidizing aspiration sheath catheter (300, FIG 1, 0155]) for placement within a blood vessel ([0153, 0348]) comprising a hemostasis valve portion (0343]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the rigidizing aspiration sheath catheter of Gomes et la. to comprise a hemostasis valve portion at its proximal end, as taught by Tilson et al., for the purpose of minimizing blood loss from the sheath catheter and therefore obviating the need for a separate access sheath ([0343]).
Gomes et al. further discloses clots can be aspirated into clot capture chamber ([0175] proximal collection source) but is silent regarding passing blood through screen or mesh of a clot capture chamber connected in line with the rigidizing aspiration sheath catheter and observing captured clot material within a window of the clot capture chamber while aspirating blood.
However, Deville et al. teaches an aspiration thrombectomy system and method for removal with aspiration catheter (abstract, [0148]) where a proximal end of the aspiration tube (Vacuum tube 2, FIG 14, [0149]) is connected in line with a clot capture chamber (200, FIG 18, [0186-0190]) and blood is passed through a screen or mesh of the clot capture chamber (filter 222, FIGs 18-29, [0187, 0189]) such that a clot material (4) which has been aspirated into the chamber can be observed through a window ([0189] discloses thrombus trap 200 is transparent “for viewing inside by a user”) while aspirating blood ([0189] discloses “airflow displaces fluids from the volume of the thrombus trap 200, leaving the volume mostly full of transparent air, instead of opaque blood. This temporary transparency allows for easier inspection of the material caught by the filter 222. The surgeon then can view the thrombus 4 unobstructed within the trap chamber 224. During this examination, the control of the bleed valve 214 can cause the vacuum pump 80 to reduce vacuum”. Reduced vacuum means there is some degree of aspiration still in effect).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method to include passing blood through a screen or mesh of a clot capture chamber and observing the aspirated clot material within a window of the clot capture chamber connected in-line with a rigidizing aspiration sheath catheter while aspirating blood, as taught by Deville et al., for the purpose of determining if a sufficient amount of clot material has been retrieved from the treatment site and therefore determine if the procedure is complete and the devices can be withdrawn (Gomes [0182-0188] and Deville [0185, 0189]).
Regarding claim 35, Gomes et al./Tilson et al./Deville discloses the invention substantially as claimed, as set forth above for claim 33. Gomes et al. further discloses transitioning the rigidizing aspiration sheath catheter from the flexible state to a more rigid state comprises applying pressure to one or more layers of the rigidizing aspiration sheath catheter ([0135] discloses 970y is rigidized “via pressure or vacuum as described elsewhere herein”. [0049] discloses the general process by which the application of pressure to the layers of the rigidizing device can transition to a condition in which they exhibit substantially enhanced ability to resist shear, movement, bending, and buckling, thereby providing system rigidization).
Regarding claim 36, Gomes et al./Tilson et al./Deville discloses the invention substantially as claimed, as set forth above for claim 33. Gomes et al. further discloses applying aspiration through the rigidizing aspiration sheath catheter ([0135 and 0143] discloses aspirating through 970y) and applying aspiration through the aspiration catheter ([0141-0143]).
However, Gomes et al. is silent regarding applying aspiration through both the rigidizing aspiration sheath catheter and the aspiration catheter at the same time.
However, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method such that aspiration is applied through the rigidizing sheath while aspirating through the aspiration catheter, for the purpose of increasing the clot removal efficacy while allowing for different sized particles to be aspirated.
Regarding claim 38, Gomes et al./Tilson et al./Deville discloses the invention substantially as claimed, as set forth above for claim 33. Gomes et al. further discloses coupling a vacuum line (344) to the proximal end of the aspiration catheter (FIG 1, [0050]).
Regarding claim 39, Gomes et al./Tilson et al./Deville discloses the invention substantially as claimed, as set forth above for claim 33.
Gomes et al. is silent regarding aspirating through the aspiration catheter comprising activating a hand-triggered activation valve that is in-line with a vacuum line coupled to the aspiration catheter.
However, Deville et al. teaches an aspiration thrombectomy system and method for removal with aspiration catheter (abstract, [0148]) where a proximal end of an aspiration catheter (Vacuum tube 2, FIG 14, [0149]) is connected to a hand-triggered activation valve (10, FIGs 1, 2, 4, 5, 7-10, [0148]; 40 is compressible by hand relative to 20. Compression roller 60 connected to arm 54 acts as a valve because it selectively opens and closes the aspiration pathway along channel 3, [0154-0157]) that is in-line with a vacuum line coupled to the aspiration catheter (FIG 14-15 shows the elements are in line and the hand trigger activation valve controls the aspiration pathway between the suction source and the distal end of the aspiration catheter adjacent to the thrombus).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of Gomes to include activating a hand-triggered activation valve that is in-line with a vacuum line coupled to the aspiration catheter, as taught by Deville, for the purpose of manually controlling the amount and timing of aspiration force being applied to a thrombus to ensure proper collection within the aspiration catheter and eliminate clogging ([0160]).
Regarding claim 40, Gomes et al./Tilson et al./Deville discloses the invention substantially as claimed, as set forth above for claim 33. Gomes et al. further discloses extending the aspiration catheter distally out of the rigidizing aspiration sheath catheter comprises advancing the aspiration catheter distally without the use of a guidewire ([0174] discloses advancing the aspiration catheter with or without the guidewire in place).
Regarding claim 41, Gomes et al./Tilson et al./Deville discloses the invention substantially as claimed, as set forth above for claim 33. Gomes et al. further discloses extending the aspiration catheter distally out of the rigidizing aspiration sheath catheter comprises steering a distal end of the aspiration catheter while the rigidizing aspiration sheath catheter is in the more rigid state ([0174] discloses the aspiration catheter can be precisely navigated through the rigidizing large bore catheter 970y, both axially and rotationally, up to the clot. [0169] discless that before this step, the rigidizing aspiration sheath catheter 970y is advanced into the vasculature and transitioned to the more rigid state).
Regarding claim 42, Gomes et al./Tilson et al./Deville discloses the invention substantially as claimed, as set forth above for claim 33. Gomes et al. further discloses repositioning the rigidizing aspiration sheath catheter within the vessel by converting the rigidizing aspiration sheath catheter into the flexible state, moving the rigidizing aspiration sheath catheter within the vessel, and rigidizing the rigidizing aspiration sheath catheter ([0178-0181] discloses the rigidizing aspiration sheath catheter can be made flexible, moved to a new location, and be rigidized again).
Regarding claim 43, Gomes et al./Tilson et al./Deville discloses the invention substantially as claimed, as set forth above for claim 42. Gomes et al. further discloses moving the rigidizing aspiration sheath catheter comprises moving the rigidizing aspiration sheath catheter within the vessel with an obturator within a lumen of the rigidizing aspiration sheath catheter ([0177] discloses an obturator can be used in conjunction with aspiration catheter advancement. Since the aspiration catheter is within the lumen of the rigidizing aspiration sheath catheter, the obturator would be as well).
Regarding claim 44, Gomes et al./Tilson et al./Deville discloses the invention substantially as claimed, as set forth above for claim 33. Gomes et al. further discloses advancing the rigidizing aspiration sheath catheter comprises advancing a distal end of the rigidizing catheter to a pulmonary artery of the patient ([0034] discloses the location of FIGs 11A-11E is the pulmonary vasculature. [0135 and 0152-0188]).
Regarding claim 48, Gomes et al./Tilson et al./Deville discloses the invention substantially as claimed, as set forth above for claim 33. Gomes et al. further discloses advancing the rigidizing aspiration sheath catheter in the vessel comprises positioning the rigidizing aspiration sheath catheter so that the distal end of the rigidizing aspiration sheath catheter is poisoned apart from and not near clot material where the rigidizing aspiration sheath catheter is transitioned to the more rigid state (FIG 11C shows the distal end of 970y is placed away from the clot material and locked into rigid positioning. It is the guidewire 985, not 970y, which becomes positioned next to the clot material).
Claim(s) 45 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Gomes et al. (WO 2022/051682) in view of Deville et al. (US 2020/0022712), further in view of Schaller et al. (US 2023/0346399).
Regarding claim 45, Gomes et al. discloses a method for removing clot material from a patient (FIGs 11A-11E, [0135 and 0152-0188]), the method comprising: advancing a guidewire (985) through a vessel (FIG 11A, [0154]); advancing a rigidizing aspiration sheath catheter (970y) over the guidewire ([0167]); transitioning the rigidizing aspiration sheath catheter from a flexible state to a more rigid state ([0169]) by applying or removing pressure within a wall of the rigidizing aspiration sheath catheter ([0135] discloses 970y is rigidized “via pressure or vacuum as described elsewhere herein”. [0049] discloses the general process by which the application of pressure to the layers of the rigidizing device can transition to a condition in which they exhibit substantially enhanced ability to resist shear, movement, bending, and buckling, thereby providing system rigidization); and advancing a rigidizing catheter (910) through and distally out of the rigidizing aspiration sheath catheter while the rigidizing aspiration sheath catheter is in the more rigid state until the aspiration catheter is proximate to the clot material ([0135] discloses “an additional catheter 910 can be passed through the large bore catheter 970y. The additional catheter 910 (either rigidizing or non-rigidizing) can, for example, pass beyond the distal end of the large bore catheter 970y and be directed towards a bifurcated path”. As shown in FGI 11, the bifurcated path is where clot material 1169y is located); transitioning the catheter from a flexible state to a more rigid state ([0135] discloses that 910 can be rigidized).
Gomes further discloses in the method that “An aspiration catheter can be inserted through the rigidizing large bore catheter 970y, the aspiration catheter can be precisely navigated through the rigidizing large bore catheter 970y, both axially and rotationally, up to the clot... The clot can be aspirated into and through aspiration catheter into proximal collection source” ([0141]) but fails to explicitly state that the aspiration catheter is the “additional catheter 910” described in [0135]).
However, it would have been obvious to one of ordinary skill in the art at the time of filing to select the additional rigidizing catheter to be an aspiration catheter, for the purpose of performing aspiration of the clot material as described in [0135], with the additional benefit that use of an additional catheter 910 can advantageously enable further penetration of smaller branches with the benefit of a stable base e.g., the rigidized large bore catheter 970y. Thus, aspiration of clot material in smaller branches can be achieved due to the stabilized support of the rigidizing aspiration sheath catheter. It is understood that aspiration is performed after the aspirating catheter has been appropriately placed and rigidized.
Gomes et al. further discloses clots can be aspirated into clot capture chamber ([0175] proximal collection source) but is silent regarding passing blood through screen or mesh of a clot capture chamber connected in line with the rigidizing aspiration sheath catheter and observing captured clot material within a window of the clot capture chamber while aspirating blood.
However, Deville et al. teaches an aspiration thrombectomy system and method for removal with aspiration catheter (abstract, [0148]) where a proximal end of the aspiration tube (Vacuum tube 2, FIG 14, [0149]) is connected in line with a clot capture chamber (200, FIG 18, [0186-0190]) and blood is passed through a screen or mesh of the clot capture chamber (filter 222, FIGs 18-29, [0187, 0189]) such that a clot material (4) which has been aspirated into the chamber can be observed through a window ([0189] discloses thrombus trap 200 is transparent “for viewing inside by a user”) while aspirating blood ([0189] discloses “airflow displaces fluids from the volume of the thrombus trap 200, leaving the volume mostly full of transparent air, instead of opaque blood. This temporary transparency allows for easier inspection of the material caught by the filter 222. The surgeon then can view the thrombus 4 unobstructed within the trap chamber 224. During this examination, the control of the bleed valve 214 can cause the vacuum pump 80 to reduce vacuum”. Reduced vacuum means there is some degree of aspiration still in effect).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the method to include passing blood through a screen or mesh of a clot capture chamber and observing the aspirated clot material within a window of the clot capture chamber connected in-line with a rigidizing aspiration sheath catheter while aspirating blood, as taught by Deville et al., for the purpose of determining if a sufficient amount of clot material has been retrieved from the treatment site and therefore determine if the procedure is complete and the devices can be withdrawn (Gomes [0182-0188] and Deville [0185, 0189]).
The method as modified is further silent regarding returning the blood to the patient using a blood return circuit including the rigidizing aspiration sheath catheter.
However, Schaller et al. teaches a system of aspirating blood and thrombus material through an aspiration line (132, FIG 7) into a clot capture chamber (112, [0131]) having a mesh filter (714) to separate a clot (602) from the blood ([0131]) and further comprising returning the blood to the patient using a blood return circuit (716) including the original aspiration catheter (710, [0131]).
Therefore, it would have been obvious to modify the method such that it comprises returning the blood to the patient using a blood return circuit including a return line and the rigidizing aspiration sheath catheter, as taught by Schaller, for the purpose of preventing excessive blood loss from the patient while permitting the removal of clots or other similar material (Schaller: [0131]).
Regarding claim 46, Gomes et al. discloses a method for removing clot material (FIGs 11A-11E, [0135 and 0152-0188]), the method comprising: advancing a guidewire (985) through a vessel (FIG 11A, [0154]); advancing a rigidizing aspiration sheath catheter (970y) over the guidewire ([0167]) s; transitioning the rigidizing aspiration sheath catheter from a flexible state to a more rigid state ([0169]) by applying or removing pressure within a wall of the rigidizing aspiration sheath catheter ([0135] discloses 970y is rigidized “via pressure or vacuum as described elsewhere herein”. [0049] discloses the general process by which the application of pressure to the layers of the rigidizing device can transition to a condition in which they exhibit substantially enhanced ability to resist shear, movement, bending, and buckling, thereby providing system rigidization); advancing a rigidizing catheter (910) through and distally out of the rigidizing aspiration sheath catheter while the rigidizing aspiration sheath catheter is in the more rigid state until the aspiration catheter is proximate to the clot material ([0135] discloses “an additional catheter 910 can be passed through the large bore catheter 970y. The additional catheter 910 (either rigidizing or non-rigidizing) can, for example, pass beyond the distal end of the large bore catheter 970y and be directed towards a bifurcated path”. As shown in FGI 11, the bifurcated path is where clot material 1169y is located); transitioning the catheter from a flexible state to a more rigid state ([0135] discloses that 910 can be rigidized).
Gomes further discloses in the method that “An aspiration catheter can be inserted through the rigidizing large bore catheter 970y, the aspiration catheter can be precisely navigated through the rigidizing large bore catheter 970y, both axially and rotationally, up to the clot... The clot can be aspirated into and through aspiration catheter into proximal collection source” ([0141]) but fails to explicitly state that the aspiration catheter is the “additional catheter 910” described in [0135]).
However, it would have been obvious to one of ordinary skill in the art at the time of filing to select the additional rigidizing catheter to be an aspiration catheter, for the purpose of performing aspiration of the clot material as described in [0135], with the additional benefit that use of an additional catheter 910 can advantageously enable further penetration of smaller branches with the benefit of a stable base e.g., the rigidized large bore catheter 970y. Thus, aspiration of clot material in smaller branches can be achieved due to the stabilized support of the rigidizing aspiration sheath catheter.
The method as modified is further silent regarding returning the blood to the patient using a blood return circuit including the rigidizing aspiration sheath catheter.
However, Schaller et al. teaches a system of aspirating blood and thrombus material through an aspiration line (132, FIG 7) into a clot capture chamber (112, [0131]) having a mesh filter (714) to separate a clot (602) from the blood ([0131]) and further comprising returning the blood to the patient using a blood return circuit (716) including the original aspiration catheter (710, [0131]).
Therefore, it would have been obvious to modify the method such that it comprises returning the blood to the patient using a blood return circuit including a return line and the rigidizing aspiration sheath catheter, as taught by Schaller, for the purpose of preventing excessive blood loss from the patient while permitting the removal of clots or other similar material (Schaller: [0131]).
Claim(s) 47 is rejected under 35 U.S.C. 103 as being unpatentable over Gomes et al. (WO 2022/051682) in view of Tilson et al. (US 2021/0138187), further in view of Deville et al. (US 2020/0022712), further in view of Schaller et al. (US 2023/0346399).
Regarding claim 47, Gomes et al./Tilson et al./Deville discloses the invention substantially as claimed, as set forth above for claim 33.
The method as modified is further silent regarding returning the blood to the patient using a blood return circuit including the rigidizing aspiration sheath catheter.
However, Schaller et al. teaches a system of aspirating blood and thrombus material through an aspiration line (132, FIG 7) into a clot capture chamber (112, [0131]) having a mesh filter (714) to separate a clot (602) from the blood ([0131]) and further comprising returning the blood to the patient using a blood return circuit (716) including the original aspiration catheter (710, [0131]).
Therefore, it would have been obvious to modify the method such that it comprises returning the blood to the patient using a blood return circuit including a return line and the rigidizing aspiration sheath catheter, as taught by Schaller, for the purpose of preventing excessive blood loss from the patient while permitting the removal of clots or other similar material (Schaller: [0131]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771