DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 05/11/2026. As directed by the amendment: claims 16-20 and 24 have been amended, claims 1-15 have been cancelled and claim 25 has been added. Thus, claims 16-25 are presently pending in this application.
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.
Claims 16-25 are rejected under 35 U.S.C. 103 as being unpatentable over Look et al. (US 20180207397 A1) in view of Mackool (US 5,569,188) and Ochoa (US 20180058438 A1).
Regarding claim 16 Look discloses (fig. 47-49) a method for removing thromboembolic material from a blood vessel (see [0176]), comprising:
positioning a distal end 568 of a catheter 516 at or near a thromboembolic mass in a blood vessel (see [0176]),
wherein a proximal end of the catheter is coupled to a connection tube 514 (see [0151]);
drawing fluid through the connection tube 514 (via the vacuum) and a lumen of the catheter such that fluid flows in a proximal direction through the lumen of the catheter 516 (see [0153] and [0175]);
sensing a block of the thromboembolic mass in the lumen of the catheter (see [0156]).
Look is silent regarding the sensing is a pressure drop indicating a lack of flow in the lumen of the catheter associated; causing a reverse flow in a distal direction through the catheter by rolling a mechanical member along the connection tube in a distal direction thereby creating a distal displacement of fluid through the lumen of the catheter that produces a positive amount of exit flow out from the distal end of the catheter, wherein the exit flow translates a least a portion of the thromboembolic mass distally; and re-drawing fluid through the lumen of the catheter whereby at least a portion of the thromboembolic mass is drawn proximally through the catheter.
However Mackool, in the same filed of endeavor, teaches (fig. 1) sensing a pressure drop indicating a lack of flow in a lumen of a catheter (distal portion conduit) associated with a block in the lumen of the catheter (see col. 4 ln. 34-46); causing a reverse flow in a distal direction through the catheter by rolling a mechanical member (one of the “petals” on 2) along a connection tube 1 in a distal direction (see fig. 1, the direction of rotation would be revered moving the “petal” in a distal direction along 1) thereby creating a distal displacement of fluid through the lumen of the catheter that produces a positive amount of exit flow out from the distal end of the catheter (see col. 2 ln. 47-68), wherein the exit flow translates a least a portion of the thromboembolic mass distally (see col. 2 ln. 47-68); and re-drawing fluid through the lumen of the catheter whereby at least a portion of the thromboembolic mass is drawn proximally through the catheter (see claim 10).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Look to have the sensing is a pressure drop indicating a lack of flow in the lumen of the catheter associated; causing a reverse flow in a distal direction through the catheter by rolling a mechanical member along the connection tube in a distal direction thereby creating a distal displacement of fluid through the lumen of the catheter that produces a positive amount of exit flow out from the distal end of the catheter, wherein the exit flow translates a least a portion of the thromboembolic mass distally; and re-drawing fluid through the lumen of the catheter whereby at least a portion of the thromboembolic mass is drawn proximally through the catheter as taught by Mackool, for the purpose of being able to automatically remove a stick mass without needing any intervention by the user (see Mackool col. 2 ln. 47-68).
Look as modified is silent regarding the mechanical member maintains a closure of the connection tube while causing the reverse flow.
However Ochoa, in the same filed of endeavor, teaches (fig. 5) a roller mechanical member 502 that causes fluid flow maintains a closure of the connection tube while causing flow (see fig. 5 and [0051]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Look as modified to have the mechanical member maintains a closure of the connection tube while causing the reverse flow as taught by Ochoa, for the purpose of simplifying manufacture of the pump (see Ochoa [0054]).
Regarding claim 25, Look as modified discloses the claimed invention substantially as claimed, as set forth above for claim 16. Look as modified further teaches further comprising closing the connection tube before causing the reverse flow by pressing the mechanical member against the connection tube (the roller compresses the tube before causing the reverse flow).
Regarding claim 17, Look as modified discloses the claimed invention substantially as claimed, as set forth above for claim 16. Look as modified further teaches (Mackool fig. 1 and Ochoa fig. 5) the mechanical member comprises a roller 2/502 and closing the connection tube comprises pressing the roller 2/502 against the connection tube (see Mackool fig. 1 and Ochoa fig. 5).
Regarding claim 18, Look as modified discloses the claimed invention substantially as claimed, as set forth above for claim 16. Look as modified further teaches (Mackool fig. 1 and Ochoa fig. 5) closing the connection tube comprises pressing the mechanical member (edge of 2) against the connection tube 2 in a first direction (see annotated fig. 1 below); and rolling the mechanical member against the connection tube comprises moving the mechanical member in a second direction at least substantially orthogonal to the first direction (see annotated fig. 1 below).
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Regarding claim 19, Look as modified discloses the claimed invention substantially as claimed, as set forth above for claim 16. Look as modified further teaches (Mackool fig. 1) the mechanical member comprises a roller 2 configured to rotate about a rotation axis (see fig. 1) and: closing the connection tube comprises pressing the roller against the connection tube 1 thereby compressing the connection tube until it closes (see fig. 1 and col. 2 ln. 47-68); and rolling the mechanical member along the connection tube comprises rotating the roller 2 about the rotation axis such that the roller moves in the distal direction (edge of 2 moves in distal direction, see fig. 1 and col. 2 ln. 47-68).
Regarding claim 20, Look as modified discloses the claimed invention substantially as claimed, as set forth above for claim 16. Look as modified further teaches (Mackool fig. 1) the roller moves in the distal direction by a controlled distance such that metered volume of fluid is displaced distally through the catheter lumen (see col. 2 ln. 47-68).
Regarding claim 21, Look as modified discloses the claimed invention substantially as claimed, as set forth above for claim 20. Look further discloses (fig. 47-49) the metered volume of fluid is approximately 0.001 ml to approximately 1.0 ml.
However, 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 Look as modified to have the metered volume of fluid is approximately 0.001 ml to approximately 1.0 ml 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 Look as modified would not operate differently with the claimed volume of fluid since the volume would still be expelled from the end to assist in dislodging the thrombus. Further, applicant places no criticality on the range claimed, indicating simply that the claimed volume is an “example” (specification [0215]).
Regarding claim 22, Look as modified discloses the claimed invention substantially as claimed, as set forth above for claim 20. Look further discloses (fig. 47-49) the metered volume of fluid is approximately 0.1 ml to approximately 0.5 ml.
However, 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 Look as modified to have the metered volume of fluid is approximately 0.1 ml to approximately 0.5 ml 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 Look as modified would not operate differently with the claimed volume of fluid since the volume would still be expelled from the end to assist in dislodging the thrombus. Further, applicant places no criticality on the range claimed, indicating simply that the claimed volume is an “example” (specification [0215]).
Regarding claim 23, Look as modified discloses the claimed invention substantially as claimed, as set forth above for claim 20. Look further discloses (fig. 47-49) the metered volume of fluid is approximately 0.5 mm to approximately 15 mm of fluid within the catheter lumen.
However, 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 Look as modified to have the metered volume of fluid is approximately 0.5 mm to approximately 15 mm of fluid within the catheter lumen 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 Look as modified would not operate differently with the claimed metered volume of fluid since the volume would still be expelled from the end to assist in dislodging the thrombus. Further, applicant places no criticality on the range claimed, indicating simply that the claimed volume is an “example” (specification [0215]).
Regarding claim 24, Look as modified discloses the claimed invention substantially as claimed, as set forth above for claim 20. Look as modified further teaches (Mackool fig. 1) closing the connection tube comprises pressing the mechanical member (“edge” of 2) against the connection tube 2 in a first direction (see annotated fig. 1 below); and rolling the mechanical member against the connection tube comprises moving the mechanical member in a second direction at least substantially orthogonal to the first direction (see annotated fig. 1 below); and re-drawing the fluid comprises moving the roller in a third direction (arrows in fig. 1) opposite the first direction (see col. 2 ln. 47-68 and claim 10).
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Response to Arguments
Applicant’s arguments, see pg. 6, filed 05/11/2026, with respect to the objection of claims 18 and 24 have been fully considered and are persuasive. The objection of claims 18 and 24 has been withdrawn.
Applicant’s arguments, see pg. 6, filed 05/11/2026, with respect to the rejection of claims 18, 19, and 24 under 35 U.S.C. 112 (b) have been fully considered and are persuasive. The rejection of claims 18, 19, and 24 under 35 U.S.C. 112 (b) has been withdrawn.
Applicant’s arguments, see pg. 6, filed 05/11/2026, with respect to the rejection(s) of claim(s) 16-24 under 35 U.S.C. 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 Look, Mackool, and Ochoa.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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