DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
The amendments filed February 23, 2026 are entered.
Claims 2-8, 11-21, 23 are pending.
Examiner Notes Regarding Conditional Language
Regarding claims 12 and 16, Examiner notes that the language “after determining that the aspiration lumen is occluded” makes the claim conditional on the previous limitation “determining that the aspiration lumen is occluded…” Specifically, Examiner notes that if the aspiration lumen is NOT occluded, the remaining method steps are moot and will not be considered.
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.
Claims 4-7, 16-21 are 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.
Claim 4 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Specifically, claim 4 recites “the catheter defines a wall, wherein the wall encloses the aspiration lumen, and wherein the injection lumen extends through the wall along the longitudinal axis.” In light of claim 1, which discloses that the lumens are fluidly separate, it is unclear how the aspiration lumen can be fluidly separate from the injection lumen if the injection lumen extends into the aspiration lumen. Further, there is no specification support that discloses how the lumens can be fluidly separate while also extending into each other. As such, claims 4-7 are unable to be examined. Claims 5-7 are rejected based on their dependency from claim 4.
Regarding claim 16, it is unclear what the Applicant is intending to claim. Specifically, claim 16 recites in part “determining that the aspiration lumen is occluded based on an amount of blood and/or clot material…” “injecting, after determining…that the aspiration lumen is occluded by a wall of the blood vessel.” Examiner is unsure how both could be true. Examiner notes that there are three possibilities with the claim set. First, if the aspiration lumen is occluded by blood or clot material, then the next two steps of injecting would be irrelevant as they are specifically related to occlusion based on a blood vessel wall. However, if the aspiration lumen is occluded by a blood vessel wall, then the determining step is irrelevant and shouldn’t be included. Finally, if Applicant intends to determine what the occlusion material is, then the determining and injecting steps need to correspond to determining specifically what the occlusion material is. As there are three possible claim scopes, Examiner is unable to properly search and examine claims 16-21.
Claims 17-21 are rejected based on their dependency from claim 16.
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 12-14, 2 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Look et al. (US 2020/0022711 A1)
Regarding claim 12, Look discloses a method (i.e., method of para. [0019]-[0035]) of treating clot material within a blood vessel of a patient (paras. [0019], [0032]-[0033]), the method comprising: intravascularly positioning a distal tip of a catheter 2450 proximate to the clot material within the blood vessel (para. [0019]); generating, via an aspiration source, negative pressure within an aspiration lumen 1930 of the catheter (para. [0022]); determining that the aspiration lumen is occluded (para. [0029], [0031]); injecting a first fluid through an injection lumen 2456 of the catheter fluidly separate from the aspiration lumen to visualize that the aspiration lumen is occluded by either a wall of the blood vessel or the clot material (para. [0032] discloses a separate contrast and aspiration lumen such that contrast may have a controlled delivery either during aspiration (to reduce the amount of injected contrast thereby protecting the kidneys) or while aspiration is paused (i.e., because it is occluded as disclosed in para. [0031))); 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. [0033]).
Regarding claim 2, Look discloses the method of claim 12. Look also discloses wherein the first fluid is a contrast agent visible under fluoroscopic imaging (para. [0029]).
Regarding claim 3, Look discloses the method of claim 12. 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 13, Look 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, Look discloses the method of claim 13. Look also discloses also discloses wherein the first fluid comprise a contrast fluid visible under fluoroscopic imaging (see claim 2 above). 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).
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 11 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Look in view of Keating et al. (US 20210069468 A1—previously cited).
Regarding claim 11, Look discloses the method of claim 12. Look also discloses wherein the aspiration lumen has a first cross-sectional area (Fig. 1), and wherein the injection lumen has a second cross-sectional area (Fig. 1)
Look doesn’t directly disclose that the cross-sectional area of the injection lumen is less than the first cross-sectional area.
In the same field of endeavor, namely expandable mouth catheters, Keating discloses that the cross-sectional area of the injection lumen is less than the first cross-sectional area (i.e., at least because para. [0177] discloses the injection lumen can extend through the aspiration lumen such that contrast is injected through the system).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reverse the injection and aspiration lumen such that the resulting device would have the injection lumen extend through the aspiration lumen instead of the reverse because reversing the location of one shaft inside another shaft is well within the skill of those in the art. Furthermore, it has been held that “mere reversal of parts is a nonobvious modification of the prior art,” see In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955) and MPEP 2144.04(VI)(A).
Regarding claim 23, Look discloses the method of claim 12. Look doesn’t directly 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 proximally retracting the catheter and the clot material comprises proximally retracting the 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 Look to have a funnel as disclosed by Keating for purposes of increasing the speed and efficiency of the clot retrieval procedure (para. [0126]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Look in view of Kamalova (US 20220047281 A1—previously cited).
Regarding claim 15, Look discloses the method of claim 12. Look doesn’t directly disclose wherein the aspiration lumen terminates distally at the distal tip of the catheter, and wherein the injection lumen terminates distally 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 an injection lumen 21 (Fig. 4) that extends through the all along a longitudinal axis (i.e., out 15).
Kamalova also discloses wherein the injection lumen terminates distally at the distal tip of the catheter (Fig. 5), and wherein the injection lumen terminates distally proximal of the distal tip of the catheter (Fig. 5).
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 Look 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]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Look in view of Sigmon Jr. et al. (US 2018/0353195 A1—previously cited).
Regarding claim 8, Look discloses the method of claim 12. Look doesn’t directly disclose wherein the injection lumen comprises multiple parallel lumens.
In the same field of endeavor, namely medical devices, kits, and methods for stone extractions, Sigmon discloses a catheter 12 that can be inserted through a working lumen of an endoscope 30 to help remove fragments (Abstract). The device also includes an injection lumen for injecting contrast. Sigmon also discloses the injection lumen comprises multiple parallel lumens 16, 20 (Fig. 2; paras. [0033], [0035]).
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 Keating to have the injection lumen comprise multiple parallel lumens as disclosed by Sigmon for purposes of delivery contrast at various positions (para. [0035]).
Response to Arguments
Applicant’s arguments with respect to claim 12 and its dependents 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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