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 .
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 13-20 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 13 recites the limitation "the helical main body" in line 3-4. There is insufficient antecedent basis for this limitation in the claim.
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)(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 1, 2, 5, 7, 13-15, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evans et al. (US 5,226,909).
Regarding claim 1 Evans discloses (fig. 1, 2A, and 2D) an intravascular therapy device, comprising:
an intravascular catheter 160; a helical coil 162 disposed at a distal end of the intravascular catheter 160 (see fig. 2A and col. 6 ln. 1-9);
at least one cutter 190 mounted on the helical coil (see fig. 2D and col. 6 ln. 17-20); and
a rotary control 26 disposed at a proximal end of the intravascular catheter and operatively connected to rotate the helical coil (see fig. 1 and col. 3 ln. 50 – col. 4 ln. 5).
Regarding claim 2 Evans further discloses (fig. 1, 2A, and 2D) the at least one cutter 190 includes at least one tangential cutter 190 connecting across adjacent turns of the helical coil 162 (see fig. 2D).
Regarding claim 5 Evans further discloses (fig. 1, 2A, and 2D) the helical coil has stiffness (every material has a 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. 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 Evans 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 7 Evans further discloses (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).
Regarding claims 1 and 3 Evans discloses (fig. 1, 2A, and 2B) an intravascular therapy device, comprising:
an intravascular catheter 160; a helical coil 162 disposed at a distal end of the intravascular catheter 160 (see fig. 2A and col. 6 ln. 1-9);
at least one cutter 170 mounted on the helical coil (see fig. 2B and col. 6 ln. 10-15); and
a rotary control 26 disposed at a proximal end of the intravascular catheter and operatively connected to rotate the helical coil (see fig. 1 and col. 3 ln. 50 – col. 4 ln. 5);
the at least one cutter 170 includes at least one spanning cutter 170 connecting across a single turn of the helical coil 162 (see fig. 2B and col. 6 ln. 10-15).
Regarding claim 13 Evans discloses (fig. 1, 2A, and 2B) an intravascular therapy device comprising a helical coil 162 (see fig. 2A and col. 6 ln. 1-9) having 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 170 mounted on the helical main body and configured to cut into the vascular occlusion (see fig. 2B and col. 6 ln. 10-15).
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 Evans 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 Evans further discloses (fig. 1, 2A, and 2B) the helical coil 162 comprises a plurality of turns (see fig. 2B); wherein the at least one cutter 170 is disposed on one or more of the turns (see fig. 2B and col. 6 ln. 10-15).
Regarding claim 15 Evans further discloses (fig. 1, 2A, and 2B) the at least one cutter 170 comprises a cutter 170 disclosed across a diameter of a single turn of the helical coil (see fig. 2B and col. 6 ln. 10-15).
Regarding claim 17 Evans further discloses (fig. 1, 2A, and 2B) a rotary control 26 operatively connected to rotate the helical coil (see fig. 1 and col. 3 ln. 50 – col. 4 ln. 5); wherein the helical coil is disposed at a distal end of the intravascular catheter and the rotary control is disposed at a proximal end of the intravascular catheter (see fig. 1 and col. 3 ln. 50 – col. 4 ln. 5).
Regarding claim 18 Evans further discloses (fig. 1, 2A, and 2B) 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).
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Costello et al. (US 20150141869 A1).
Regarding claim 4, Evans discloses the claimed invention substantially as claimed, as set forth above for claim 1. Evans further discloses (fig. 1, 2A, and 2D) the at least one cutter 190 includes: at least one tangential cutter 190 connecting across adjacent turns of the helical coil (see fig. 2D and col. 6 ln. 17-19).
Evans is silent regarding and at least one spanning cutter connecting across a single turn of the helical coil; wherein the at least one tangential cutter is located closer to a tip of the helical coil than the at least one spanning cutter.
However Costello, in the same filed of endeavor, teaches (fig. 10A) a helical member including at least one tangential element 1146 and at least one spanning cutter 1144b connecting across a single turn of the helical coil (see fig. 10A and [0069]); wherein the at least one tangential element 1146 is located closer to a tip of the helical coil than the at least one spanning cutter 1144b (see fig. 10A).
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 Evans to also have at least one spanning cutter connecting across a single turn of the helical coil; wherein the at least one tangential cutter is located closer to a tip of the helical coil than the at least one spanning cutter as taught by Costello, for the purpose of facilitating capture of tissue to facilitate the procedure (see Costello [0050]).
Claims 6 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Gifford et al. (US 20210307767 A1).
Regarding claims 6 and 20, Evans discloses the claimed invention substantially as claimed, as set forth above for claims 1 and 13. Evans is silent regarding the helical coil comprises nitinol.
However Casiraro, 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 Casiraro) for another (as taught in Evans) would have been obvious to one of ordinary skill in the art at the time of the invention since Casiraro teaches that nitinol is a suitable material to form a helical member out of and the substitution of the nitinol as taught in Casiraro would have yielded predictable results, namely, a coil of Evans that would expcut tissue. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Evans in view of Begg (US 20210322047 A1).
Regarding claims 8 and 19, Evans discloses the claimed invention substantially as claimed, as set forth above for claims 7 and 18. Evans 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 Evans 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 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Costello in view of Olson et al. (US 20100125253 A1).
Regarding claim 9 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]) to cause the helical coil to screw into the tissue and to cause the tissue to be cut by at least one cutter 144a/144b mounted on the helical coil 142 (see [0050]).
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.
Regarding claim 12, Costello as modified discloses the claimed invention substantially as claimed, as set forth above for claims 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]).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Costello in view of Olson as applied to claim 9 above, and further in view of Evans.
Regarding claims 10 and 11, Costello as modified discloses the claimed invention substantially as claimed, as set forth above for claims 9. Costello further discloses (fig. 1-5D) the rotating causes a clot core to be cut out of the clot by a tangential cutter 144b (see [0050] and [0057]); the rotating further causes the clot core to be debulked by a spanning cutter 144a connecting across a single turn of the helical coil (see fig. 5B, 144a debulks the clot as it is rotating by separating it from the whole).
Costello as modified is silent regarding the tangential cutter connecting across adjacent turns of the helical coil.
However Evans, in the same filed of endeavor, teaches (fig. 1, 2A, and 2D) a tangential cutter 190 connecting across adjacent turns of a helical coil 162 (see fig. 2D and col. 6 ln. 17-19).
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 have the tangential cutter connecting across adjacent turns of the helical coil as taught by Evans, for the purpose of further facilitating coring of the tissue by precenting tissue from escaping from the gap between the cutter and the adjacent coil (see Costello [0050]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Evans.
Regarding claim 16, Evans discloses the claimed invention substantially as claimed, as set forth above for claim 15. Evans (fig. 2B) is silent regarding a second cutter disposed across neighboring turns of the helical coil.
However Evans (fig. 2D) teaches of cutter 190 disposed across neighboring turns of the helical coil (see fig. 2D and col. 6 ln. 17-19).
To provide the device of Evans (fig. 2B) with a second cutter as shown in Evans (fig. 2D) would have been obvious to one of ordinary skill in the art, in view of the teachings of Evans, since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention, i.e., one skilled in the art would have recognized that adding a second cutter would improve the removal of tissue during the procedure. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 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 SCHWIKER/Primary Examiner, Art Unit 3771
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