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 .
Priority
This application is a continuation application of U.S. Patent Application No. 18/104,541, now U.S. Patent No. 12,185,969, filed February 1, 2023, which is a continuation application of U.S. Application No. 16/541,435, filed August 15, 2019, now U.S. Patent No. 11,596,437, which is a continuation application of U.S. Application No. 14/955,429, filed December 1, 2015, now U.S. Patent No. 10,405,879, which claims priority under 35 U.S.C. §119 to U.S. Provisional Application Serial No. 62/087,531, filed December 4, 2014.
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.
Claim(s) 1, 4-5, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barry et al. (US 6,126,667, hereinafter “Barry”).
Referring to claim 1, Barry discloses a rotational atherectomy device (Fig. 4, which is reproduced below, col. 4, ln. 18-34 and col. 5, ln. 66 – col. 7, ln. 2), comprising:
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an outer tubular member having a lumen extending therethrough (“A guide catheter may be used to assist in the positioning of both guide wire 13 and ablation device 10, as is known in the art.”(col. 4, ln. 28-32));
a cutting member 37 (Fig. 4; col. 5, ln. 65-68) positioned adjacent to a distal end of the outer tubular member;
a cylindrical bore extending from a proximal end to a distal end of the cutting member (“A passageway 40 extends through burr 37, along a longitudinal axis 44.” (col. 6, lns. 30-31));
a coiled drive shaft (shaft 11 and collet 41 as shown in Fig. 4 has been interpreted as “a coiled drive shaft”. Fig. 4 shows the portion at lead line 11 of the drive shaft has a coiled formation) extending through the lumen of the outer tubular member and into a proximal region of the cylindrical bore (“A guide catheter may be used to assist in the positioning of both guide wire 13 and ablation device 10, as is known in the art.”(col. 4, ln. 28-32)), the coiled drive shaft configured to rotate the cutting member, wherein the cutting member is mounted on the coiled drive shaft (“The proximal end of driveshaft 11 remains outside the patient's body and is attached to an electric motor or turbine (not shown). The motor rotates ablation device 10 while it is advanced distally through the occlusion site to ablate occluding material.” (col. 4, lns. 29-34)); and
an insert 42 (bearing 42 as shown in Fig. 4, col. 6, lns. 30-33) positioned within a distal region of the cylindrical bore distal of a distal end of the coiled drive shaft, the insert having an opening extending therethrough.
Referring to claim 4, Barry discloses the rotational atherectomy device of claim 1, further comprising a guidewire 13 (Fig. 4) slidably disposed within a guidewire lumen of the coiled drive shaft 11 and extending through an opening of the insert 42 (Fig. 4).
Referring to claim 5, Barry discloses the rotational atherectomy device of claim 4, wherein a tolerance between the guidewire 13 and the inner surface of the opening of the insert 42 is closer than a tolerance between the guidewire 13 and one or more inner surfaces of the coiled drive shaft 11 (Fig. 4).
Referring to claim 9, Barry discloses the rotational atherectomy device of claim 1, wherein the opening of the insert 42 has a diameter less than a diameter of a guidewire lumen of the coiled drive shaft. (attention is directed to Fig. 4. The figure shows element 41 is attached to the lumen of shat 11. Thus, the diameter of the lumen of elements 41 and 42 is smaller than the diameter of the lumen of shaft 11).
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wulfman et al. (US 2002/0007190, hereinafter “Wulfman”).
Referring to claim 1, Wulfman discloses a rotational atherectomy device (Figs. 5 and 11A-11B. Fig. 11B is reproduced below), comprising:
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an outer tubular member having a lumen extending therethrough (catheter 40 as shown in Fig. 5, para. [0093]);
a cutting member (cutter 150 and tubular cutter shaft 154 as shown in Fig. 11A-11B have been interpreted as a cutting member, para [0107]) positioned adjacent to a distal end of the outer tubular member;
a cylindrical bore extending from a proximal end to a distal end of the cutting member (Fig. 11B);
a coiled drive shaft 25 (Figs. 5 and 11B, paras [0075]-[0076] and [0108]) extending through the lumen of the outer tubular member and into a proximal region of the cylindrical bore, the coiled drive shaft configured to rotate the cutting member (Fig. 5 shows shaft 25 connected to motor of drive system 24 (para. [0073]), wherein the cutting member is mounted on the coiled drive shaft 25; and
an insert 153 (“a guide tip 153 having a central bore in slidable relationship to the guidewire and that is mounted on a distal end of cutter 150.” (para. [0106])) positioned within a distal region of the cylindrical bore distal of a distal end of the coiled drive shaft, the insert having an opening extending therethrough.
Referring to claim 4, Wulfman discloses the rotational atherectomy device of claim 1, further comprising a guidewire 11 (Figs. 5 and 6A) slidably disposed within a guidewire lumen of the coiled drive shaft and extending through an opening of the insert 153 (Fig. 11).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-3 and 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry in view of in view of Shturman (US 5,314,438, hereinafter “Shturman”) and further in view of Huang et al. (US 2003/0089660, hereinafter “Huang”).
Referring to claims 2-3, Barry discloses the rotational atherectomy device of claim 1, but fails to disclose wherein the inner surface of the opening of the insert has an average surface roughness Ra of about 0.4 micrometers or less (claim 2) and about 0.2 micrometers or less (claim 3).
Referring again to claims 2-3, however, in the same field of endeavor, which is an atherectomy device, Shturman discloses bushing 81 or insert 81 is coated with Teflon to reduce friction between the bushing and the guide wire 90 (Fig. 4; col. 9, lns. 22-35: “Also, desirably at least the surface of the bushing lumen 82 is made of (or coated with) a low friction material (e.g., TEFLON.RTM.) to reduce friction between the bushing 81 and the guide wire 90, a particularly important feature when external radial forces on the intermediate segment are not symmetrical as the device is being used to remove stenotic tissue (particularly eccentric stenotic lesions in tortuous arteries).” Examiner notes that Teflon is a trademark of polytetrafluoroethylene (PTFE)). Furthermore, Huang discloses PTFE can have a surface roughness of 20 nm to 165 nm (para. [0054])(20 nm = 0.02 micrometers and 165 nm = 0.165 micrometers).
Referring still to claims 2-3, in view of Shturman and Huang disclosures, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided a coating of PTFE with a surface roughness in the range of 0.02 micrometers to 0.165 micrometers to the elements 41 and 42 to reduce friction between the elements and guide wire 13.
Referring to claims 10-11, Barry discloses a rotational atherectomy device (Fig. 4, which is reproduced above, col. 4, ln. 18-34 and col. 5, ln. 66 – col. 7, ln. 2), comprising:
an outer tubular member having a lumen extending therethrough (“A guide catheter may be used to assist in the positioning of both guide wire 13 and ablation device 10, as is known in the art.”(col. 4, ln. 28-32));
a cutting member 37 (Fig. 4; col. 5, ln. 65-68) rotationally positioned adjacent to a distal end of the outer tubular member;
a cylindrical bore extending from a proximal end to a distal end of the cutting member (“A passageway 40 extends through burr 37, along a longitudinal axis 44.” (col. 6, lns. 30-31));
a coiled drive shaft extending through the lumen of the outer tubular member and into a proximal region of the cylindrical bore (shaft 11 and collet 41 as shown in Fig. 4 has been interpreted as “a coiled drive shaft”. Fig. 4 shows the portion at lead line 11 of the drive shaft has a coiled formation), the coiled drive shaft configured to rotate the cutting member, wherein the cutting member is mounted on the coiled drive shaft (“The proximal end of driveshaft 11 remains outside the patient's body and is attached to an electric motor or turbine (not shown). The motor rotates ablation device 10 while it is advanced distally through the occlusion site to ablate occluding material.” (col. 4, lns. 29-34)); and
an insert disposed within the cylindrical bore of the cutting member distal of a distal end of the coiled drive shaft, the insert having an opening extending therethrough (bearing 42 as shown in Fig. 4, col. 6, lns. 30-33);
Barry discloses the invention substantially as claimed except for disclosing wherein a surface of the opening of the insert has an average surface roughness Ra of about 0.4 micrometers or less (claim 10) and an average surface roughness Ra of about 0.2 micrometers or less (claim 11).
However, in the same field of endeavor, which is an atherectomy device, Shturman discloses bushing 81 or insert 81 is coated with Teflon to reduce friction between the bushing and the guide wire 90 (Fig. 4; col. 9, lns. 22-35: “Also, desirably at least the surface of the bushing lumen 82 is made of (or coated with) a low friction material (e.g., TEFLON.RTM.) to reduce friction between the bushing 81 and the guide wire 90, a particularly important feature when external radial forces on the intermediate segment are not symmetrical as the device is being used to remove stenotic tissue (particularly eccentric stenotic lesions in tortuous arteries).” Examiner notes that Teflon is a trademark name of polytetrafluoroethylene (PTFE)). Furthermore, Huang discloses PTFE can have a surface roughness of 20 nm to 165 nm (para. [0054])(20 nm = 0.02 micrometers and 165 nm = 0.165 micrometers).
In view of Shturman and Huang disclosures, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided a coating of PTFE with a surface roughness in the range of 0.02 micrometers to 0.165 micrometers to elements 41 and 42 to reduce friction between the elements and guide wire 13.
Referring to claim 12, the modified device of Barry discloses the rotational atherectomy device of claim 10, wherein the coiled drive shaft 11 defines a guidewire lumen extending therethrough (Fig. 4).
Referring to claim 13, the modified device of Barry discloses the rotational atherectomy device of claim 12, wherein the opening of the insert 42 includes has a diameter less than a diameter of the guidewire lumen of the coiled drive shaft (attention is directed to Fig. 4. The figure shows element 41 is attached to the lumen of shat 11. Thus, the diameter of the lumen of elements 41 and 42 is smaller than the diameter of the lumen of shaft 11).
Referring to claim 14, the modified device of Barry discloses the rotational atherectomy device of claim 12, further comprising a guidewire 13 (Fig. 4) slidably disposed within the guidewire lumen and extending through the opening of the insert 42.
Referring to claim 15, the modified device of Barry discloses the rotational atherectomy device of claim 10, wherein the coiled drive shaft is both rotationally and longitudinally movable relative to the outer tubular member (Barry discloses “A guide catheter may be used to assist in the positioning of both guide wire 13 and ablation device 10, as is known in the art.”(col. 4, lns. 28-32) and “The proximal end of driveshaft 11 remains outside the patient's body and is attached to an electric motor or turbine (not shown). The motor rotates ablation device 10 while it is advanced distally through the occlusion site to ablate occluding material.” (col. 4, lns. 29-34). Based on these disclosures one of ordinary skill in the art will understand that Barry discloses coiled drive shaft is both rotationally and longitudinally movable relative to the outer tubular member).
Claim(s) 6 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry in view of in view of Shturman (US 5,314,438, hereinafter “Shturman”) and https://www.teflon.com/en/products/coatings (accessed on May 14, 2026) as evidentiary reference.
Referring to claim 6, Barry discloses the rotational atherectomy device of claim 4, but fails to disclose wherein an inner surface of the opening of the insert has a coefficient of static friction us between the inner surface and the guidewire of less than 0.25 and is configured to provide a low friction interface with the guidewire.
Referring again to claim 6, however, in the same field of endeavor, which is an atherectomy device, Shturman discloses bushing 81 or insert 81 is coated with Teflon to reduce friction between the bushing and the guide wire 90 (Fig. 4; col. 9, lns. 22-35: “Also, desirably at least the surface of the bushing lumen 82 is made of (or coated with) a low friction material (e.g., TEFLON.RTM.) to reduce friction between the bushing 81 and the guide wire 90, a particularly important feature when external radial forces on the intermediate segment are not symmetrical as the device is being used to remove stenotic tissue (particularly eccentric stenotic lesions in tortuous arteries).”). Attention is directed to the Properties of Teflon Industrial Coating section from Teflon.com/en/products/coatings website. The attachment below shows PTFE, FEP and PFA has a static coefficient of friction less than .25.
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Referring still to claim 6, in view of Shturman’s teaching it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided a coating of PTFE to element 41 and element 42 to reduce friction between the elements and guide wire 13.
Referring to claim 18, Barry discloses a rotational atherectomy device (Fig. 4, which is reproduced above, col. 4, ln. 18-34 and col. 5, ln. 66 – col. 7, ln. 2), comprising:
an outer tubular member having a lumen extending therethrough (“A guide catheter may be used to assist in the positioning of both guide wire 13 and ablation device 10, as is known in the art.”(col. 4, ln. 28-32));
a cutting member 37 (Fig. 4; col. 5, ln. 65-68) rotationally positioned adjacent to a distal end of the outer tubular member;
a cylindrical bore extending from a proximal end to a distal end of the cutting member (“A passageway 40 extends through burr 37, along a longitudinal axis 44.” (col. 6, lns. 30-31));
a coiled drive shaft (shaft 11 and collet 41 as shown in Fig. 4 has been interpreted as “a coiled drive shaft”. Fig. 4 shows the portion at lead line 11 of the drive shaft has a coiled formation), extending through the lumen of the outer tubular member and into a proximal region of the cylindrical bore, the coiled drive shaft having a guidewire lumen (Fig. 4 shows guidewire 13 extends through shaft 11 and cutter 37) extending therethrough, the coiled drive shaft configured to rotate the cutting member, wherein the cutting member is mounted on the coiled drive shaft (“The proximal end of driveshaft 11 remains outside the patient's body and is attached to an electric motor or turbine (not shown). The motor rotates ablation device 10 while it is advanced distally through the occlusion site to ablate occluding material.” (col. 4, lns. 29-34));
an insert (bearing 42 as shown in Fig. 4, col. 6, lns. 30-33) positioned within a distal region of the cylindrical bore distal of a distal end of the coiled drive shaft, the insert having a lumen extending therethrough, the lumen of the insert having a diameter less than a diameter of the guidewire lumen of the coiled drive shaft; and
a guidewire 13 (Fig. 4, col. 4, lns. 28-29) slidably disposed within the guidewire lumen of the coiled drive shaft and extending through the lumen of the insert 42.
Barry discloses the invention substantially as claimed except for disclosing wherein an inner surface of the lumen of the insert has a coefficient of static friction us between the inner surface and the guidewire of less than 0.25 and is configured to provide a low friction interface with the guidewire.
However, in the same field of endeavor, which is an atherectomy device, Shturman discloses bushing 81 or insert 81 is coated with Teflon to reduce friction between the bushing and the guide wire 90 (Fig. 4; col. 9, lns. 22-35: “Also, desirably at least the surface of the bushing lumen 82 is made of (or coated with) a low friction material (e.g., TEFLON.RTM.) to reduce friction between the bushing 81 and the guide wire 90, a particularly important feature when external radial forces on the intermediate segment are not symmetrical as the device is being used to remove stenotic tissue (particularly eccentric stenotic lesions in tortuous arteries).”). Attention is directed to the Properties of Teflon Industrial Coating section from Teflon.com/en/products/coatings website. The attachment below shows PTFE, FEP and PFA has a static coefficient of friction less than 0.25.
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in view of Shturman’s teaching it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have provided a coating of PTFE to element 41 and element 42 to reduce friction between the elements and guide wire 13.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barry in view of in view of Shturman (US 5,314,438, hereinafter “Shturman”) and further in view of Huang et al. (US 2003/0089660, hereinafter “Huang”).
Referring to claim 19, the modified device of Barry discloses the rotational atherectomy device of claim 18, but fails to disclose wherein the surface of the lumen of the insert has an average surface roughness Ra of about 0.2 micrometers or less.
Referring again to claim 19, however, Huang discloses PTFE can have a surface roughness of 20 nm to 165 nm (para. [0054])(20 nm = 0.02 micrometers and 165 nm = 0.165 micrometers). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided a coating of PTFE to elements 41 and 42 of Barry with a surface roughness in the range of 20 nm to 165 nm because it is well known that less surface roughness means less friction.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wulfman.
Referring to claim 7, Wulfman discloses the rotational atherectomy device of claim 1, but fails to disclose wherein the distal end of the coiled drive shaft abuts a proximal end of the insert within the cylindrical bore of the cutting member.
Referring again to claim 7, attention is directed to Fig. 11B, which is reproduced above, the figure shows a gap between the terminal distal end of drive shaft 25 and proximal face of insert 153. Examiner contends that one of ordinary skill in the art will recognize that pushing the distal terminal end of drive shaft 25 to abut the proximal face of insert 153 would improve the security between the drive shaft and tubular cutter 154. Furthermore, pushing the distal terminal end of the drive shaft to abut the proximal face of insert 153 during assembly process would give the assembler a force feedback that would ensure that the drive shaft is fully secured in the tubular cutter 154. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have made the distal end of the drive shaft 25 abuts a proximal end of the insert 153 to improve the security between the drive shaft and the cutter member.
Claim(s) 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wulfman et al. (US 20020007190, hereinafter “Wulfman”) in view of Shturman (US 5,314,438, hereinafter “Shturman”) and further in view of Huang et al. (US 2003/0089660, hereinafter “Huang”).
Referring to claims 10-11, Wulfman discloses a rotational atherectomy device (Figs. 5 and 11A-11B. Fig. 11B is reproduced below), comprising:
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an outer tubular member having a lumen extending therethrough (catheter 40 as shown in Fig. 5, para. [0093]);
a cutting member (cutter 150 and tubular cutter shaft 154 as shown in Fig. 11A-11B have been interpreted as a cutting member, para [0107]) rotationally positioned adjacent to a distal end of the outer tubular member;
a cylindrical bore extending from a proximal end to a distal end of the cutting member (Fig. 11B);
a coiled drive shaft 25 (Fig. 11B) extending through the lumen of the outer tubular member and into a proximal region of the cylindrical bore, the coiled drive shaft configured to rotate the cutting member, wherein the cutting member is mounted on the coiled drive shaft (Fig. 5 shows shaft 25 connected to motor of drive system 24 (para. [0073]); and
an insert 153 (“a guide tip 153 having a central bore in slidable relationship to the guidewire and that is mounted on a distal end of cutter 150.” (para. [0106])) disposed within the cylindrical bore of the cutting member distal of a distal end of the coiled drive shaft, the insert having an opening extending therethrough (Fig. 11B);
Wulfman discloses the invention substantially as claimed except for disclosing wherein a surface of the opening of the insert has an average surface roughness Ra of about 0.4 micrometers or less (claim 10) and an average surface roughness Ra of about 0.2 micrometers or less (claim 11).
However, in the same field of endeavor, which is an atherectomy device, Shturman discloses bushing 81 or insert 81 is coated with Teflon to reduce friction between the bushing and the guide wire 90 (Fig. 4; col. 9, lns. 22-35: “Also, desirably at least the surface of the bushing lumen 82 is made of (or coated with) a low friction material (e.g., TEFLON.RTM.) to reduce friction between the bushing 81 and the guide wire 90, a particularly important feature when external radial forces on the intermediate segment are not symmetrical as the device is being used to remove stenotic tissue (particularly eccentric stenotic lesions in tortuous arteries).” Examiner notes that Teflon is a trademark name of polytetrafluoroethylene (PTFE)). Furthermore, Huang discloses PTFE can have a surface roughness of 20 nm to 165 nm (para. [0054])(20 nm = 0.02 micrometers and 165 nm = 0.165 micrometers).
In view of Shturman and Huang disclosures, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided a coating of PTFE with a surface roughness in the range of 0.02 micrometers to 0.165 micrometers to the insert 153 to reduce friction between the insert and guide wire 11.
Referring to claim 12, the modified device of Wulfman discloses the rotational atherectomy device of claim 10, wherein the coiled drive shaft 25 defines a guidewire lumen extending therethrough (Fig. 11B).
Referring to claim 13, the modified device of Wulfman discloses the rotational atherectomy device of claim 12, wherein the opening of the insert 153 includes has a diameter less than a diameter of the guidewire lumen of the coiled drive shaft (Fig. 11B).
Referring to claim 14, the modified device of Wulfman discloses the rotational atherectomy device of claim 12, further comprising a guidewire 11 (Figs. 5 and 11B) slidably disposed within the guidewire lumen and extending through the opening of the insert 153.
Referring to claim 15, the modified device of Wulfman discloses the rotational atherectomy device of claim 10, wherein the coiled drive shaft 25 is both rotationally and longitudinally movable relative to the outer tubular member (Fig. 5, “Drive system 24 is also preferably capable of rotating drive shaft 25 at variable speeds ranging from 500 rpm to 200,000 rpm, more preferably from 500 to 150,000 rpm.” (para. [0075]) and “FIG. 2 illustrates a preferred embodiment of an advancer 14 for axially translating drive shaft 25 and associated components.” (para. [0077])).
Referring to claim 16, the modified device of Wulfman discloses the rotational atherectomy device of claim 10, but fails to disclose wherein the distal end of the coiled drive shaft abuts a proximal end of the insert within the cylindrical bore of the cutting member.
Referring again to claim 16, attention is directed to Fig. 11B, which is reproduced above, the figure shows a gap between the terminal distal end of drive shaft 25 and proximal face of insert 153. Examiner contends that one of ordinary skill in the art will recognize that pushing the distal terminal end of drive shaft 25 to abut the proximal face of insert 153 would improve the security between the drive shaft and tubular cutter 154. Furthermore, pushing the distal terminal end of the drive shaft to abut the proximal face of insert 153 during assembly process would give the assembler a force feedback that would ensure that the drive shaft is fully secured in the tubular cutter 154. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have made the distal end of the drive shaft 25 abuts a proximal end of the insert 153 to improve the security between the drive shaft and the cutter member.
Claim(s) 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wulfman et al. (US 20020007190, hereinafter “Wulfman”) in view of Shturman (US 5,314,438, hereinafter “Shturman”) and further in view of https://www.teflon.com/en/products/coatings (accessed on May 14, 2026) as evidentiary reference.
Referring to claim 18, Barry discloses a rotational atherectomy device (Figs. 5 and 11A-11B. Fig. 11B is reproduced below), comprising:
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an outer tubular member having a lumen extending therethrough (catheter 40 as shown in Fig. 5, para. [0093]);
a cutting member (cutter 150 and tubular cutter shaft 154 as shown in Fig. 11A-11B have been interpreted as a cutting member, para [0107]) rotationally positioned adjacent to a distal end of the outer tubular member;
a cylindrical bore extending from a proximal end to a distal end of the cutting member (Fig. 11B);
a coiled drive shaft 25 (Figs. 5 and 11B), extending through the lumen of the outer tubular member and into a proximal region of the cylindrical bore, the coiled drive shaft having a guidewire lumen (Figs. 5 shows guidewire 11 extends through shaft 25 and cutter) extending therethrough, the coiled drive shaft configured to rotate the cutting member, wherein the cutting member is mounted on the coiled drive shaft (Fig. 5 shows shaft 25 connected to motor of drive system 24 (para. [0073]);
an insert 153 (“a guide tip 153 having a central bore in slidable relationship to the guidewire and that is mounted on a distal end of cutter 150.” (para. [0106])) positioned within a distal region of the cylindrical bore distal of a distal end of the coiled drive shaft, the insert having a lumen extending therethrough, the lumen of the insert having a diameter less than a diameter of the guidewire lumen of the coiled drive shaft; and
a guidewire 11 (Fig. 5) slidably disposed within the guidewire lumen of the coiled drive shaft and extending through the lumen of the insert 153.
Wulfman discloses the invention substantially as claimed except for disclosing wherein an inner surface of the lumen of the insert has a coefficient of static friction us between the inner surface and the guidewire of less than 0.25 and is configured to provide a low friction interface with the guidewire.
However, in the same field of endeavor, which is an atherectomy device, Shturman discloses bushing 81 or insert 81 is coated with Teflon to reduce friction between the bushing and the guide wire 90 (Fig. 4; col. 9, lns. 22-35: “Also, desirably at least the surface of the bushing lumen 82 is made of (or coated with) a low friction material (e.g., TEFLON.RTM.) to reduce friction between the bushing 81 and the guide wire 90, a particularly important feature when external radial forces on the intermediate segment are not symmetrical as the device is being used to remove stenotic tissue (particularly eccentric stenotic lesions in tortuous arteries).”). Attention is directed to the Properties of Teflon Industrial Coating section from Teflon.com/en/products/coatings website. The attachment below shows PTFE, FEP and PFA has a static coefficient of friction less than 0.25.
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in view of Shturman’s teaching it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have provided a coating of PTFE to the insert 153 to reduce friction between the insert and guide wire 11.
Referring to claim 20, the modified device of Wulfman discloses the rotational atherectomy device of claim 18, but fails to disclose wherein the distal end of the coiled drive shaft abuts a proximal end of the insert within the cylindrical bore of the cutting member.
Referring again to claim 20, attention is directed to Fig. 11B, which is reproduced above, the figure shows a gap between the terminal distal end of drive shaft 25 and proximal face of insert 153. Examiner contends that one of ordinary skill in the art will recognize that pushing the distal terminal end of drive shaft 25 to abut the proximal face of insert 153 would improve the security between the drive shaft and tubular cutter 154. Furthermore, pushing the distal terminal end of the drive shaft to abut the proximal face of insert 153 during assembly process would give the assembler a force feedback that would ensure that the drive shaft is fully secured in the tubular cutter 154. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have made the distal end of the drive shaft 25 abuts a proximal end of the insert 153 to improve the security between the drive shaft and the cutter member.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12, and 17-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-10 and 13 of U.S. Patent No. 12,185,969 (hereinafter “the patent”) in view of Wulfman et al. (US 2002/0007190, hereinafter “Wulfman”).
The claims match-up with respect to one another as listed below:
U.S. Application No. 18/968,417
U.S. Patent No. 12,185,969
Claim 1. A rotational atherectomy device, comprising: an outer tubular member having a lumen extending therethrough; a cutting member rotationally positioned adjacent to a distal end of the outer tubular member; a cylindrical bore extending from a proximal end to a distal end of the cutting member; a coiled drive shaft extending through the lumen of the outer tubular member and into a proximal region of the cylindrical bore, the coiled drive shaft configured to rotate the cutting member, wherein the cutting member is mounted on the coiled drive shaft; and an insert positioned within a distal region of the cylindrical bore distal of a distal end of the coiled drive shaft, the insert having an opening extending therethrough.
Claim 4. The rotational atherectomy device of claim 1, further comprising a guidewire slidably disposed within a guidewire lumen of the coiled drive shaft and extending through an opening of the insert.
Claim 6. The rotational atherectomy device of claim 4, wherein an inner surface of the opening of the insert has a coefficient of static friction µs between the inner surface and the guidewire of less than 0.25 and is configured to provide a low friction interface with the guidewire.
Claim 8. The rotational atherectomy device of claim 1, wherein the inner surface of the opening of the insert tapers radially outward from a central longitudinal axis in a distal direction.
Claim 1. A rotational atherectomy device, comprising: an outer tubular member having a lumen extending therethrough; a cutting member rotationally positioned adjacent to a distal end of the outer tubular member; a bore extending from a proximal end to a distal end of the cutting member; a drive shaft extending through the lumen of the outer tubular member and configured to rotate the cutting member, wherein the cutting member is mounted on the drive shaft;
an insert disposed within the bore of the cutting member, the insert having an opening extending therethrough; and
a guidewire slidably disposed within a guidewire lumen of the drive shaft and extending through the opening of the insert;
wherein an inner surface of the opening of the insert has a coefficient of static friction us between the inner surface and the guidewire of less than 0.25 and is configured to provide a low friction interface with the guidewire;
wherein the cutting member includes a distal opening with a diameter greater than a diameter of the opening of the insert; wherein at least a portion of the inner surface is non-parallel to a central longitudinal axis of the drive shaft.
Claim 1 of the patent fails to disclose the drive shaft is a coiled drive shaft, the bore through the cutter is a cylindrical bore, and . However, in the same field of endeavor, which is an atherectomy device, Wulfman discloses drive shaft 25 (Fig. 5) is made from a multi-filar stainless steel coil to provide flexibility and torqueability (para. [0076]) and the bore in the cutter is a cylindrical bore. Therefore, it would have been obvious to one of ordinary skill in the art to make the drive shaft of the patent from a multi-filar stainless steel coil as suggested by Wulfman so that it too would have the same advantage. Furthermore, it would have been obvious to made the bore of the cutter as a cylindrical bore because cylindrical bore will provide a uniform support to the guidewire.
As to claim 8 of the application, claim 1 of the patent discloses “wherein the cutting member includes a distal opening with a diameter greater than a diameter of the opening of the insert; wherein at least a portion of the inner surface is non-parallel to a central longitudinal axis of the drive shaft.” Thus, it would have been obvious to make the inner surface flared outward to match the diameter of the opening of the insert with the diameter of the opening at the distal end of the cutting member.
Claim 2. The rotational atherectomy device of claim 1, wherein the inner surface of the opening of the insert has an average surface roughness Ra of about 0.4 micrometers or less.
Claim 2. The rotational atherectomy device of claim 1, wherein the inner surface of the opening of the insert has an average surface roughness R.sub.a of about 0.4 micrometers or less.
Claim 3. The rotational atherectomy device of claim 1, wherein the inner surface of the opening of the insert has an average surface roughness Ra of about 0.2 micrometers or less.
Claim 3. The rotational atherectomy device of claim 1, wherein the inner surface of the opening of the insert has an average surface roughness R.sub.a of about 0.2 micrometers or less.
Claim 5. The rotational atherectomy device of claim 4, wherein a tolerance between the guidewire and the inner surface of the opening of the insert is closer than a tolerance between the guidewire and one or more inner surfaces of the coiled drive shaft.
Claim 4. The rotational atherectomy device of claim 1, wherein a tolerance between the guidewire and the inner surface of the opening of the insert is closer than a tolerance between the guidewire and an inner surface of the drive shaft.
Claim 7. The rotational atherectomy device of claim 1, wherein the distal end of the coiled drive shaft abuts a proximal end of the insert within the cylindrical bore of the cutting member.
Claim 5. The rotational atherectomy device of claim 1, wherein a distal end of the drive shaft abuts a proximal end of the insert within the bore of the cutting member.
Claim 10. A rotational atherectomy device, comprising: an outer tubular member having a lumen extending therethrough; a cutting member rotationally positioned adjacent to a distal end of the outer tubular member; a cylindrical bore extending from a proximal end to a distal end of the cutting member;
a coiled drive shaft extending through the lumen of the outer tubular member and into a proximal region of the cylindrical bore, the coiled drive shaft configured to rotate the cutting member, wherein the cutting member is mounted on the coiled drive shaft; and
an insert disposed within the cylindrical bore of the cutting member distal of a distal end of the coiled drive shaft, the insert having an opening extending therethrough; wherein a surface of the opening of the insert has an average surface roughness Ra of about 0.4 micrometers or less.
Claim 17. The rotational atherectomy device of claim 10, wherein the inner surface of the opening of the insert tapers radially outward from a central longitudinal axis in a distal direction.
Claim 9. A rotational atherectomy device, comprising: an outer tubular member having a lumen extending therethrough; a cutting member rotationally positioned adjacent to a distal end of the outer tubular member; a bore (see rejection of claim 1 above (claim 1 of the patent as modified by Wulfman provides a cylindrical bore)) extending from a proximal end to a distal end of the cutting member; a drive shaft (see rejection of claim 1 above (claim 1 of the patent as modified by Wulfman provides a coil drive shaft )) extending through the lumen of the outer tubular member and configured to rotate the cutting member, wherein the cutting member is mounted on the drive shaft; and an insert disposed within the bore of the cutting member, the insert having an opening extending therethrough;
wherein a surface of the opening of the insert has an average surface roughness R.sub.a of about 0.4 micrometers or less;
wherein the cutting member includes a distal opening with a diameter greater than a diameter of the opening of the insert; wherein at least a portion of the inner surface is non-parallel to a central longitudinal axis of the drive shaft. (see rejection of claim 8 above)
Claim 11. The rotational atherectomy device of claim 10, wherein the surface of the opening of the insert has an average surface roughness Ra of about 0.2 micrometers or less.
Claim 10. The rotational atherectomy device of claim 9, wherein the surface of the opening of the insert has an average surface roughness R.sub.a of about 0.2 micrometers or less.
Claim 12. The rotational atherectomy device of claim 10, wherein the coiled drive shaft defines a guidewire lumen extending therethrough.
Claim 13. The rotational atherectomy device of claim 9, wherein the drive shaft defines a guidewire lumen extending therethrough.
Claim 18. A rotational atherectomy device, comprising: an outer tubular member having a lumen extending therethrough; a cutting member rotationally positioned adjacent to a distal end of the outer tubular member; a cylindrical bore extending from a proximal end to a distal end of the cutting member;
a coiled drive shaft extending through the lumen of the outer tubular member and into a proximal region of the cylindrical bore, the coiled drive shaft having a guidewire lumen extending therethrough, the coiled drive shaft configured to rotate the cutting member, wherein the cutting member is mounted on the coiled drive shaft; an insert positioned within a distal region of the cylindrical bore distal of a distal end of the coiled drive shaft, the insert having a lumen extending therethrough, the lumen of the insert having a diameter less than a diameter of the guidewire lumen of the coiled drive shaft; and
a guidewire slidably disposed within the guidewire lumen of the coiled drive shaft and extending through the lumen of the insert;
wherein an inner surface of the lumen of the insert has a coefficient of static friction µs between the inner surface and the guidewire of less than 0.25 and is configured to provide a low friction interface with the guidewire.
Claim 20. The rotational atherectomy device of claim 18, wherein the distal end of the coiled drive shaft abuts a proximal end of the insert within the cylindrical bore of the cutting member.
Claim 9. The rotational atherectomy device of claim 1, wherein the opening of the insert has a diameter less than a diameter of a guidewire lumen of the coiled drive shaft.
Claim 1. A rotational atherectomy device, comprising: an outer tubular member having a lumen extending therethrough; a cutting member rotationally positioned adjacent to a distal end of the outer tubular member;
a bore (see rejection of claim 1 above (claim 1 of the patent as modified by Wulfman provides a cylindrical bore)) extending from a proximal end to a distal end of the cutting member;
a drive shaft (see rejection of claim 1 above (claim 1 of the patent as modified by Wulfman provides a coil drive shaft )) extending through the lumen of the outer tubular member and configured to rotate the cutting member, wherein the cutting member is mounted on the drive shaft;
an insert disposed within the bore of the cutting member, the insert having an opening extending therethrough; and
a guidewire slidably disposed within a guidewire lumen of the drive shaft and extending through the opening of the insert;
wherein an inner surface of the opening of the insert has a coefficient of static friction us between the inner surface and the guidewire of less than 0.25 and is configured to provide a low friction interface with the guidewire;
wherein the cutting member includes a distal opening with a diameter greater than a diameter of the opening of the insert; wherein at least a portion of the inner surface is non-parallel to a central longitudinal axis of the drive shaft.
As to the limitation of “the insert having a lumen extending therethrough, the lumen of the insert having a diameter less than a diameter of the guidewire lumen of the coiled drive shaft” in claim 18 and claim 9, claim 1 of the patent discloses “a guidewire slidably disposed within a guidewire lumen of the drive shaft and extending through the opening of the insert” However, Wuflman discloses “In general, central bore 71 is not substantially larger than the outer diameter of guidewire 11.” (para. [0091]) and Fig. 6B shows the guidewire lumen of the drive shaft is larger than the lumen 71 for aspiration and/or infusion of fluids (para. [0093]). In view of Wulfman’s teaching, it would have been obvious to make the lumen of the insert smaller than the lumen of the drive shaft to allow the lumen of the insert to support the guidewire and allow the surgeon to use the lumen of the drive shaft for aspiration and/or infusion of fluids.
As to claim 20 of the application, claim 1 of the patent discloses “wherein the cutting member includes a distal opening with a diameter greater than a diameter of the opening of the insert; wherein at least a portion of the inner surface is non-parallel to a central longitudinal axis of the drive shaft.” Thus, it would have been obvious to make the inner surface flared outward to match the diameter of the opening of the insert with the diameter of the opening at the distal end of the cutting member.
Claim 19. The rotational atherectomy device of claim 18, wherein the surface of the lumen of the insert has an average surface roughness Ra of about 0.2 micrometers or less.
Claim 3. The rotational atherectomy device of claim 1, wherein the inner surface of the opening of the insert has an average surface roughness R.sub.a of about 0.2 micrometers or less.
Allowable Subject Matter
Claims 8 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and a terminal disclaimer is filed to overcome the nonstatutory double patenting rejection set forth in this Office action.
Conclusion
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771
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