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 07/13/2026. As directed by the amendment: claims 1, 4, 9, 11, 13, 15, 16 have been amended and claim 3 has been cancelled. Thus, claims 1, 2, and 4-20 are presently pending in this application.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Casiraro et al. (US 20250261963 A1).
Regarding claim 13 Casiraro discloses (fig. 1, 2D, and 3A) an intravascular therapy device, comprising: a helical coil 110 having a main helical body 110 (see [0034]) and a stiffness effective for rotation into engagement with a vascular occlusion and a flexibility effective to provide bending of the helical main body to conform with a path of a blood vessel in which the vascular occlusion is disposed (see note below); and at least one cutter 116 mounted on the helical main body 110 and configured to cut into the vascular occlusion (see [0035]), wherein the at least one cutter 116 includes at least one spanning cutter connecting across a single turn of the helical coil (“the longitudinally-oriented blade 116 may be attached to one or more loops 111 of the rotational helix” [0039]) and configured to spirally cut the vascular occlusion (see [0034]).
Note: The language “a stiffness effective for rotation into engagement with a vascular occlusion and a flexibility effective to provide bending of the helical main body to conform with a path of a blood vessel in which the vascular occlusion is disposed” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Casiraro meets the structural limitations of the claim, and the stiffness is capable of rotation into engagement with a vascular occlusion (the coil has a stiffness effective to cut through plaque, thus is capable of rotation into engagement with a vascular occlusion) and the flexibility is capable of bending of the helical main body to conform with a path of a blood vessel in which the vascular occlusion is disposed (the coil has a structure with spaces that permit flexibility therein that is capable of ending of the helical main body to conform with a path of a blood vessel in which the vascular occlusion is disposed).
Regarding claim 14, Casiraro further discloses (fig. 1, 2D, and 3A) the helical coil 110 comprises a plurality of turns (see fig. 3A); wherein the at least one cutter 116 is disposed on one or more of the turns (see fig. 3A and [0039]).
Regarding claim 15, Casiraro further discloses (fig. 1, 2D, and 3A) the at least one spanning cutter comprises: a cutter 121 disposed across a diameter of a single turn of the helical coil 110 (see fig. 2D and [0038]).
Regarding claim 16, Casiraro further discloses (fig. 1, 2D, and 3A) at least one cutter further comprises: a second cutter 116 disposed across neighboring turns of the helical coil 110 (see fig. 2D and 3A).
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 1, 2, 4-7, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Casiraro in view of Evans et al. (US 5,226,909).
Regarding claim 1 Casiraro discloses (fig. 1, 2D, and 3A) an intravascular therapy device, comprising:
an intravascular catheter 100; a helical coil 110 disposed at a distal end of the intravascular catheter 100 (see fig. 1 and [0034]);
at least one cutter 116 mounted on the helical coil (see fig. 1, 3A and [0035]); and
a rotary control (motor; see [0034]) operatively connected to rotate the helical coil (see [0034]);
wherein the at least one cutter 116 includes at least one spanning cutter 116 connecting across a single turn of the helical coil 110 (“the longitudinally-oriented blade 116 may be attached to one or more loops 111 of the rotational helix” [0039]) and spanning through an internal region of the helical coil 110 (the cutter 116 is located inside of 2 arches of the coil thus is it spanning an internal region of the coil, see fig. 3A and [0039]).
Casiraro is silent regarding the rotary control disposed at a proximal end of the intravascular catheter.
However Evans, in the same filed of endeavor, teaches (fig. 1, 2A, and 2D) a catheter 160, a helical coil 162 disposed at the distal end of the catheter 160 (see fig. 2A and col. 6 ln. 1-9), a rotary control 26 disposed at a proximal end of the intravascular catheter 160 and operatively connected to rotate the helical coil (see fig. 1 and col. 3 ln. 50 – col. 4 ln. 5).
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 Casiraro to have the rotary control disposed at a proximal end of the intravascular catheter as taught by Evans, for the purpose of having the motor proximal a handle to make it easier to service the motor.
Regarding claim 2, Casiraro as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Casiraro further discloses (fig. 1, 2D, and 3A) the at least one cutter includes at least one tangential cutter 121 connecting across adjacent turns of the helical coil 110 (see fig. 2D and [0038]).
Regarding claim 4, Casiraro as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Casiraro further discloses (fig. 1, 2D, and 3A) the at least one cutter includes: at least one tangential cutter 121 connecting across adjacent turns of the helical coil (see fig. 2D and [0038]); wherein the at least one tangential cutter 121 is located closer to a tip of the helical coil 110 than the at least one spanning cutter 116 (see fig. 2D).
Regarding claim 5, Casiraro as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Casiraro further discloses (fig. 1, 2D, and 3A) the helical coil has stiffness effective for the helical coil to be screwed into a clot by rotation of the helical coil by the rotary control of the intravascular therapy device. The language “stiffness effective for the helical coil tube screwed into a clot by rotation of the helical coil by the rotary control of the intravascular therapy device” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Casiraro meets the structural limitations of the claim, and the stiffness is capable of having the helical coil tube screwed into a clot by rotation of the helical coil by the rotary control of the intravascular therapy device. Clots come in different shapes, sizes and hardness levels. The coil has a stiffness effective to cut through plaque, thus is capable of having the helical coil tube screwed into a clot by rotation of the helical coil by the rotary control of the intravascular therapy device.
Regarding claim 6, Casiraro as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Casiraro further discloses (fig. 1, 2D, and 3A) the helical coil 110 comprises stainless steel (see [0034]).
Regarding claim 7, Casiraro as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Casiraro is further silent regarding the intravascular catheter includes: a control wire or cable; and a sheath coaxially surrounding the control wire or cable; wherein the rotary control is operatively connected to rotate the helical coil by the control wire or cable.
However Evans further teaches (fig. 1, 2A, and 2D) the intravascular catheter includes: a control wire or cable 168; and a sheath (outer tube surrounding 168) coaxially surrounding the control wire or cable 168 (see fig. 2A); wherein the rotary control is operatively connected to rotate the helical coil by the control wire or cable (see col. 6 ln. 1-9 and col. 3 ln. 50 – col. 4 ln. 5).
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 Casiraro to have the intravascular catheter includes: a control wire or cable; and a sheath coaxially surrounding the control wire or cable; wherein the rotary control is operatively connected to rotate the helical coil by the control wire or cable as taught by Evans, for the purpose of having a mechanism to transfer the motor rotation to the helical coil (see Evans col. 3 ln. 50 – col. 4 ln. 5 and col. 6 ln. 1-9).
Regarding claims 17 and 18, Casiraro as modified discloses the claimed invention substantially as claimed, as set forth above for claim 13. Casiraro further discloses (fig. 1, 2D, and 3A) an intravascular catheter 100; a rotary control (motor) operatively connected to rotate the helical coil (see [0034]); wherein the helical coil 110 is disposed at a distal end of the intravascular catheter 130 (see fig. 1).
Casiraro is silent regarding the rotary control disposed at a proximal end of the intravascular catheter; the intravascular catheter includes: a control wire or cable; and a sheath coaxially surrounding the control wire or cable; wherein the rotary control is operatively connected to rotate the helical coil by the control wire or cable.
However Evans, in the same filed of endeavor, teaches (fig. 1, 2A, and 2D) a catheter 160, a helical coil 162 disposed at the distal end of the catheter 160 (see fig. 2A and col. 6 ln. 1-9), a rotary control 26 disposed at a proximal end of the intravascular catheter 160 and operatively connected to rotate the helical coil (see fig. 1 and col. 3 ln. 50 – col. 4 ln. 5); the intravascular catheter includes: a control wire or cable 168; and a sheath (outer tube surrounding 168) coaxially surrounding the control wire or cable 168 (see fig. 2A); wherein the rotary control is operatively connected to rotate the helical coil by the control wire or cable (see col. 6 ln. 1-9 and col. 3 ln. 50 – col. 4 ln. 5).
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 Casiraro to have the rotary control disposed at a proximal end of the intravascular catheter and the intravascular catheter includes: a control wire or cable; and a sheath coaxially surrounding the control wire or cable; wherein the rotary control is operatively connected to rotate the helical coil by the control wire or cable as taught by Evans, for the purpose of having the motor proximal a handle to make it easier to service the motor and having a mechanism to transfer the motor rotation to the helical coil (see Evans col. 3 ln. 50 – col. 4 ln. 5 and col. 6 ln. 1-9).
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Casiraro in view of Evans, as applied to claims 7 and 18 above, and further in view of Begg (US 20210322047 A1).
Regarding claims 8 and 19, Casiraro as modified discloses the claimed invention substantially as claimed, as set forth above for claims 7 and 18. Casiraro as modified is silent regarding the control wire or cable is longitudinally movable within the sheath to selectably (i) withdraw the helical coil into the sheath and (ii) deploy the helical coil out of the sheath.
However Begg, in the same filed of endeavor, teaches (fig. 1-4) a helical coil 152 (see fig. 2 and [0031]), a control wire or cable 130 (see fig. 1-2 and [0030]); and a sheath 120 coaxially surrounding the control wire or cable (see fig. 1 and [0018]); the control wire or cable is longitudinally movable within the sheath to selectably (i) withdraw the helical coil into the sheath and (ii) deploy the helical coil out of the sheath (see [0018] and [0033]).
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 Casiraro as modified to have the control wire or cable is longitudinally movable within the sheath to selectably (i) withdraw the helical coil into the sheath and (ii) deploy the helical coil out of the sheath as taught by Begg, for the purpose of being able to withdraw tissue into the sheath for removal from the body after treatment (see Begg [0033]).
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Costello et al. (US 20150141869 A1) in view of Olson et al. (US 20100125253 A1) and Casiraro.
Regarding claims 9-11 Costello discloses (fig. 1-5D) a vascular therapy method, comprising: inserting an intravascular catheter to position a helical coil 142 at a distal end of the intravascular catheter proximate to tissue (see fig. 5A and [0055]-[0056]); and rotating the helical coil 142 (see [0056])) using a rotary control 124 at a proximal end of the intravascular catheter 150 (see fig. 4A and [0048]).
Costello is silent regarding inserting the intravascular catheter into a blood vessel proximate to a clot.
However Olson, in the same filed of endeavor, teaches (fig. 1 and 5) a vascular therapy method, comprising: inserting an intravascular catheter 102 to position a helical coil 110 at a distal end of the intravascular catheter into a blood vessel proximate to a clot (see fig. 5 and [0048]); screwing into the clot (see fig. 8 and [0050]).
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 Costello to insert the intravascular catheter into a blood vessel proximate to a clot as taught by Olson, for the purpose of being able to use the device to treat a chronic total occlusion (see Olson [0048]) and collect said material therefrom for testing.
Costello fails to expressly disclose at least one cutter mounted on the helical coil that includes at least one spanning cutter connecting across a single turn of the helical coil and spanning through an internal region of the helical coil; the rotating causes a clot core to be cut out of the clot by a tangential cutter connecting across adjacent turns of the helical coil; the rotating further causes the clot core to be debulked by a-the spanning cutter.
However Casiraro, in the same field of endeavor, teaches (fig. 1, 2D, and 3A) at least one cutter 116 mounted to the helical coil 110 (see [0035]), wherein the at least one cutter 116 includes at least one spanning cutter connecting across a single turn of the helical coil (“the longitudinally-oriented blade 116 may be attached to one or more loops 111 of the rotational helix” [0039]) and configured to spirally cut the vascular occlusion (see [0034]); the rotating causes a clot core to be cut out of the clot by a tangential cutter 121 connecting across adjacent turns of the helical coil (see fig. 2D and [0038]); the rotating further causes the clot core to be debulked by a-the spanning cutter (see [0035]).
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 Costello as modified to have at least one cutter mounted on the helical coil that includes at least one spanning cutter connecting across a single turn of the helical coil and spanning through an internal region of the helical coil; the rotating causes a clot core to be cut out of the clot by a tangential cutter connecting across adjacent turns of the helical coil; the rotating further causes the clot core to be debulked by a-the spanning cutter as taught by Casiraro, for the purpose the blades being able to fragment clots to make it easier to remove them from the vessel (see Casiraro [0035] and [0038]).
Regarding claim 12, Costello as modified discloses the claimed invention substantially as claimed, as set forth above for claim 9. Costello further discloses (fig. 1-5D) the catheter 150 includes a control wire or cable 130 surrounded by a sheath 160 (see fig. 5A and [0052]), the rotary control 124 is operatively connected via the control wire or cable 130 to rotate the helical coil 142 (see [0047] and fig. 4A), the helical coil is withdrawn into the sheath during the inserting (see fig. 5A and [0056]), and the method further comprises: after the inserting and before the rotating, deploying the helical coil from the sheath by longitudinal movement of the control wire or cable 160 within the sheath 160 (see [0056] and fig. 5A-5B); and after the rotating, withdrawing the helical coil back into the sheath 160 by longitudinal movement of the control wire or cable within the sheath (see [0058]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Casiraro in view of Gifford et al. (US 20210307767 A1).
Regarding claim 20, Casiraro discloses the claimed invention substantially as claimed, as set forth above for claim 13. Casiraro is silent regarding the helical coil comprises nitinol.
However Gifford, in the same filed of endeavor, teaches a helical coil comprises nitinol (see fig. 1 and [0095]).
Therefore, the substitution of one known material (nitinol as taught in Gifford) for another (metal as taught in Casiraro) would have been obvious to one of ordinary skill in the art at the time of the invention since Gifford teaches that nitinol is a suitable material to form a helical member out of and the substitution of the nitinol as taught in Gifford would have yielded predictable results, namely, a coil of Casiraro that would cut tissue. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Response to Arguments
Applicant’s arguments, see pg. 6, filed 07/13/2026, with respect to the rejection of claims 13-20 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 13-20 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments with respect to claim(s) 1, 2, and 4-20 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 KATHERINE H MENDEZ whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 8 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H MENDEZ/Primary Examiner, Art Unit 3771
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