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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 12, 2026 has been entered.
Claim Rejections - 35 USC § 112
The rejections under 35 U.S.C. 112 are withdrawn in light of the amendments and arguments.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 2, 3, 5, 8, 11, 12, 13, 14, 16-20, 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gurm et al. (US 20020169436 A1).
Regarding claim 12, Gurm discloses a method of treating clot material within a blood vessel of a patient (para. [0032]), the method comprising: intravascularly positioning a distal tip of a catheter proximate to the clot material within the blood vessel (para. [0038]; See also claim 1); wherein the outer catheter extends along a longitudinal axis (i.e., by way of being a catheter), wherein the catheter defines a wall (i.e., the exterior wall of the catheter), wherein the wall encloses an aspiration lumen terminating at a distal aspiration opening (paras. [0037]-[0038]), wherein an injection lumen extends in the wall along the longitudinal axis generally parallel to the aspiration lumen and terminates at a distal injection opening (para. [0035]), wherein the injection lumen is fluidly separate from the aspiration lumen (i.e., by way of being a different lumen as disclosed in para. [0035]), and wherein the distal injection opening opens to outside the aspiration lumen (i.e., at least since both lumens extend to the distal end of the catheter to deliver contrast and suction debris) generating, via an aspiration source, negative pressure within the aspiration lumen (para. [0038]); determining that the aspiration lumen is occluded (paras. [0037]-[0038]); injecting, after determining that the aspiration lumen is occluded, a first fluid through the injection lumen of the catheter (para. [0038]) to visualize that the aspiration lumen is occluded by either a wall of the blood vessel or the clot material while aspiration is paused (para. [0047] discloses occlusion is confirmed using dye in a separate port to ensure adequate isolation of the arterial segments proximal and distal to the occluding member); and if the aspiration lumen is occluded by the clot material, proximally retracting the catheter and the clot material from within the blood vessel and out of the patient (para. [0038]).
Regarding claim 2, Gurm discloses the method of claim 12. Gurm also discloses wherein the first fluid is a contrast agent visible under fluoroscopic imaging (para. [0038], [0047]).
Regarding claim 3, Gurm discloses the method of claim 12. Gurm also discloses wherein the second fluid is filtered blood (para. [0032]). Also, the broadest reasonable interpretation of the claim does not require that the prior art teach that the second fluid is filtered blood because claim 3 is a contingent limitation which is dependent on a condition precedent (i.e., if the aspiration lumen is occluded by the wall of the blood vessel, injecting a second fluid through the injection lumen into the blood vessel and/or proximally retracting the catheter until the aspiration lumen is no longer occluded) that has not occurred. See MPEP 2111.04(II).
Regarding claim 5, Gurm discloses the method of claim 12. Gurm also discloses wherein the injection lumen has a circular cross-sectional shape (Fig. 1).
Regarding claim 8, Gurm discloses the method of claim 12. Gurm also discloses wherein the injection lumen comprises multiple parallel lumens (para. [0035]).
Regarding claim 11, Gurm discloses the method of claim 12. Gurm also discloses wherein the aspiration lumen has a first cross-sectional area, and wherein the injection lumen has a second cross-sectional area less than the first cross-sectional area (Figs. 1-2).
Regarding claim 13, Gurm discloses the method of claim 12. The broadest reasonable interpretation of the claim does not require that the prior art teach that the wherein the first fluid is the same as the second fluid because claim 13 is a contingent limitation which is dependent on a condition precedent (i.e., if the aspiration lumen is occluded by the wall of the blood vessel, injecting a second fluid through the injection lumen into the blood vessel and/or proximally retracting the catheter until the aspiration lumen is no longer occluded) that has not occurred. See MPEP 2111.04(II).
Regarding claim 14, Gurm discloses the method of claim 13. Gurm also discloses wherein the first fluid comprise a contrast fluid visible under fluoroscopic imaging (para. [0035]).
The broadest reasonable interpretation of the claim does not require that the prior art teach that the second fluid comprise a contrast fluid visible under fluoroscopic imaging because claim 14 is a contingent limitation which is dependent on a condition precedent (i.e., if the aspiration lumen is occluded by the wall of the blood vessel, injecting a second fluid through the injection lumen into the blood vessel and/or proximally retracting the catheter until the aspiration lumen is no longer occluded) that has not occurred. See MPEP 2111.04(II).
Regarding claim 16, Gurm discloses a method of treating clot material within a blood vessel of a patient (para. [0032]), the method comprising: intravascularly positioning a distal tip of a catheter proximate to the clot material within the blood vessel para. [0038]; See also claim 1); generating, via an aspiration source, negative pressure within an aspiration lumen of the catheter (para. [0038]); determining that the aspiration lumen is occluded based on an amount of blood and/or clot material aspirated through the aspiration lumen from the negative pressure (para. [0038]); injecting, after determining that the aspiration lumen is occluded, a first fluid through an injection lumen of the catheter fluidly separate from the aspiration lumen to determine that the aspiration lumen is occluded by a wall of the blood vessel (paras. [0035], [0037]-[0038]); and proximally retracting the catheter until the aspiration lumen is no longer occluded by the wall of the blood vessel (para. [0038]).
Regarding claim 17, Gurm discloses the method of claim 16. Gurm also discloses wherein the first fluid comprise a contrast fluid visible under fluoroscopic imaging (para. [0038], [0047]).
The broadest reasonable interpretation of the claim does not require that the prior art teach that the second fluid comprise a contrast fluid visible under fluoroscopic imaging because claim 17 is a contingent limitation which is dependent on a condition precedent (i.e., if the aspiration lumen is occluded by the wall of the blood vessel, injecting a second fluid through the injection lumen into the blood vessel and/or proximally retracting the catheter until the aspiration lumen is no longer occluded) that has not occurred. See MPEP 2111.04(II).
Regarding claim 18, Gurm discloses the method of claim 16. Gurm also discloses wherein the method comprises injecting the second fluid through the injection lumen into the blood vessel until the aspiration lumen is no longer occluded by the wall of the blood vessel. The broadest reasonable interpretation of the claim does not require that the prior art teach wherein the method comprises injecting the second fluid through the injection lumen into the blood vessel until the aspiration lumen is no longer occluded by the wall of the blood vessel because claim 18 is a contingent limitation which is dependent on a condition precedent (i.e., if the aspiration lumen is occluded by the wall of the blood vessel, injecting a second fluid through the injection lumen into the blood vessel and/or proximally retracting the catheter until the aspiration lumen is no longer occluded) that has not occurred. See MPEP 2111.04(II).
Regarding claim 19, Gurm discloses the method of claim 16. Gurm also discloses wherein the method comprises proximally retracting the catheter until the aspiration lumen is no longer occluded by the wall of the blood vessel (para. [0038]).
Regarding claim 20, Gurm discloses the method of claim 16. Gurm also discloses wherein the method further comprises again generating, via the aspiration source, negative pressure within the aspiration lumen of the catheter after the aspiration lumen is no longer occluded by the wall of the blood vessel (para. [0037]-[0038]).
Regarding claim 25, Gurm discloses the method of claim 16. Gurm also discloses wherein the catheter extends along a longitudinal axis (Fig. 1), wherein the catheter defines a wall (i.e., exterior wall of catheter), wherein the wall encloses the aspiration lumen (Fig. 1), wherein the aspiration lumen terminates at a distal aspiration opening (Fig. 1), wherein the injection lumen extends in the wall along the longitudinal axis generally parallel to the aspiration lumen and terminates at a distal aspiration opening (para. [0035], [0037]-[0038]), and wherein the distal injection opening opens to outside the aspiration lumen (i.e., at least by way of opening outside the catheter).
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.
Claims 6-7, 15, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gurm in view of Kamalova (US 2022/0047281 A1).
Regarding claim 6, 7, and 15, Gurm discloses the method of claim 12. Gurm doesn’t directly disclose wherein the injection lumen has a generally U-like shape extending about the longitudinal axis; wherein the distal aspiration opening is positioned at the distal tip of the catheter, and wherein the distal injection opening is positioned proximal of the distal tip of the catheter.
In the same field of endeavor, namely catheter apparatus, Kamalova discloses a suction catheter for removing obstructive material and thrombus from the body including a pressure lumen 25 and discharge lumen 22. Kamalova also discloses the distal injection opening 21 (Fig. 4) that extends through the all along a longitudinal axis (i.e., out 15) wherein the injection lumen (para. [0019]) that has a generally U-like shape extending about the longitudinal axis (para. [0019]). Kamalova also discloses wherein the injection lumen terminates distally proximal of the distal tip of the catheter (Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gurm to have wherein the injection lumen extends through the wall along the longitudinal axis, wherein the injection lumen has a generally U-like shape extending about the longitudinal axis, wherein the injection lumen terminates distally proximal of the distal tip of the catheter as disclosed by Kamalova for purposes of directing fluid in a carefully controlled manner, so that an ejector action is obtained in a reliable and efficient way (para. [0019]).
Regarding claim 7, Gurm discloses the method of claim 6. Gurm doesn’t directly disclose wherein the injection lumen extends between about 110-140 degrees about the longitudinal axis.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Keating to have the injection lumen extends between about 110-140 degrees about the longitudinal axis 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 Deville would not operate differently with the injection lumen extending between about 110-140 degrees and the device would function appropriately having the claimed range. Further, it appears that applicant places no criticality on the range claimed, indicating simply that the angle can be “anywhere between about 110-140 degrees or between about 110-360 degrees.” (specification pp. [0041]).
Regarding claim 21, Gurm discloses the method of claim 16. Gurm also discloses wherein the aspiration lumen terminates distally at the distal tip of the catheter (Fig. 1).
Kamalova also discloses wherein the injection lumen terminates distally proximal of the distal tip of the catheter (Fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gurm to have wherein the injection lumen extends through the wall along the longitudinal axis, wherein the injection lumen has a generally U-like shape extending about the longitudinal axis, wherein the injection lumen terminates distally proximal of the distal tip of the catheter as disclosed by Kamalova for purposes of directing fluid in a carefully controlled manner, so that an ejector action is obtained in a reliable and efficient way (para. [0019]).
Claims 23 is rejected under 35 U.S.C. 103 as being unpatentable over Gurm in view of Keating (US 2021/0069468 A1).
Regarding claim 23, Gurm discloses the method of claim 12. Gurm doesn’t directly disclose wherein proximally retracting the catheter and the clot material comprises proximally retracting the catheter and the clot material into the lumen of a funnel catheter and out of the patient.
Keating discloses wherein proximally retracting the catheter (i.e., herein, the catheter is disclosed to be 70) and the clot material comprises proximally retracting the catheter and the clot material into the lumen of a funnel catheter 100 (i.e., created such that 52 becomes a funnel as shown in Figs. 1A-1C) and out of the patient (para. [0126]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gurm to have a funnel catheter for purposes of easy withdrawal from the patient (para. [0126]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 12 and 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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