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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/16/25 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/16/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 10/16/25. As directed by the amendment: Claims 12 and 34 have been amended. Claims 7-11 have been previously withdrawn and claims 2 and 16-33 have been previously cancelled.
Thus, claims 1, 3-6, 12-15 and 34 are still pending in this application.
Response to Arguments
Applicant's arguments filed 10/16/25 regarding claim 1 have been fully considered but they are not persuasive.
With regards to the arguments that “Applicant respectfully submits that (1) there would be no motivation to combine Jeffrey and Williams, and (2) Williams teaches away from claim 1 reciting "wherein the proximal segment of the catheter body is coplanar with the pre-shaped segment of the distal segment"”, examiner respectfully disagrees. Jeffrey teaches the proximal segment of the catheter body is coplanar with the pre-shaped segment of the distal segment (see fig 1A, proximal section 24 is coplanar with pre-shaped segment 53).
Examiner acknowledges that Williams et al fail to disclose the proximal segment of the catheter body is NOT coplanar with the pre-shaped segment of the distal segment but applicant is reminded that Jeffrey teaches the proximal segment of the catheter body is coplanar with the pre-shaped segment of the distal segment. Thus there is no need to combine Jeffery and Williams et al to meet that limitations.
With regards to the arguments that “the if Williams' device were flattened to be co-planar, then the dimensions that it would no longer have the same dimensions (arc of 180 degrees and a radius of 0.3-0.6 inches)”, examiner respectfully disagrees. Williams et al disclose a delivery catheter (see fig 5, catheter 20) wherein during rest state, the shaped segment includes an arc of 180 degrees (para 0023) having a radius of 0.3-0.6 inches (which is at least 2 mm).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, the claims only require that the pre-shaped segment to include an arc of 180 degrees having a radius of at least 2 mm during the first geometric configuration (rest state), and does not require the proximal segment of the catheter body to be coplanar with the pre-shaped segment of the distal segment in order for the arc to have 180 degrees having a radius of at least 2 mm.
Furthermore, 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 radius of Jeffrey from between 0.145cm in radius to between least 2 mm as applicant appears to have placed no criticality on the claimed radius (see pp. [0005], an arc of 180 degrees having a radius of at least 2 mm) and as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim Rejections - 35 USC § 103
Claims 1, 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey (US 20120016341 A1) in view of Cottone (US 20180093070 A1).
Regarding claim 1, Jeffrey discloses a medical device (catheter 20, fig 1), comprising: a catheter body (see fig 1:body of catheter 20) defining a proximal segment (proximal section 24), a distal segment (distal section 53), and a lumen therethrough (see fig 1A, lumen 32), wherein the distal segment includes a pre-shaped segment (see fig 1A, pre-formed distal tip 63 and abs) having a first geometric configuration in an unloaded state (see fig 1A), and a second geometric configuration in a loaded state (see figs 3B-D, para 0014 and 0037) and; wherein in the first geometric configuration, the pre-shaped segment (section 53) includes an arc of 180 degrees (para 0032), and wherein a center of the arc is laterally offset from a longitudinal axis of the proximal segment of the catheter body (fig 1A),
and wherein the proximal segment of the catheter body is coplanar with the pre-shaped segment of the distal segment (see fig 1A, proximal section 24 is coplanar with pre-shaped segment).
Jeffrey fails to teach in the first geometric configuration, the pre-shaped segment includes an arc of 180 degrees having a radius of at least 2 mm.
However, Jefrey discloses in the first geometric configuration, the pre-shaped segment includes an arc of 180 degrees (para 0032) having a radius of 0.145 cm (see fig 1A, the outer diameter of the preformed curve is 0.290 cm or 0.145cm which is 1.45mm in radius).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the medical device of Jeffery by making the arc of 180 degrees having a radius of at least 2 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Jeffrey fails to teach said distal segment includes a tube with a cut pattern therein, the cut pattern being an interrupted spiral cut pattern and the cut pattern defining: a plurality of cuts, with each cut having a width between 0.03 mm and 0.05 mm, a longitudinal uncut width between 0.02 mm and 0.03 mm between each of the plurality of cuts, a strut height between 0.08 mm and 0.12 mm, and a pitch between 0.05 mm and 0.08 mm.
However, Cottone discloses a vascular catheter (see fig 1, catheter 100) comprising proximal segment (proximal tubular module 110), a distal segment (distal tubular module 120) includes a tube with a cut pattern (see fig 3) therein, the cut pattern being an interrupted spiral cut pattern (see para 0161) and the cut pattern defining: a plurality of cuts (cut 340), with each cut having a width (width 330), a longitudinal uncut width (uncut potion 310, 320) between each of the plurality of cuts, a strut height (uncut portion 350) and a pitch (para 0156).
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 distal segment of Jeffrey and incorporated the teachings of Cottone to have said distal segment includes a tube with a cut pattern therein, the cut pattern being an interrupted spiral cut pattern and the cut pattern defining: a plurality of cuts, with each cut having a width, a longitudinal uncut width between each of the plurality of cuts, a strut height, and a pitch. The modification would provide the benefit of increasing flexibility and adjusting pushability, kink resistance, torque, and compression resistance in said distal segment to improve access to tortuous vascular pathways having extreme turning or bending dimensions (see para 0154).
Cottone fails to explicitly disclose said cut having a width between 0.03 mm and 0.05 mm but teaches the width of the spiral cuts can vary from about 1 micron to about 100 microns (para 0157).
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 angle of Cottone from between 1 micron to about 100 microns to between 0.03 mm and 0.05 mm as applicant appears to have placed no criticality on the claimed range (see pp. [0049 and 0050] indicating the angle “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Cottone fails to explicitly disclose a longitudinal uncut width between 0.02 mm and 0.03 mm but disclose those skilled in the art will recognize that there are suitable alternatives to the depicted examples of configurations, constructions, and dimensions, and materials (see para 0254).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify said longitudinal uncut width between 0.02 mm and 0.03 mm 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 medical device of Jeffrey in view of Cottone would not operate differently with the claimed width and since longitudinal uncut width is the width between the plurality of cuts in the longitudinal direction, the device would function appropriately having the claimed width. Further, applicant places no criticality on the range claimed, indicating simply that the width “may” be within the claimed ranges (specification pp. [0049]).
Cottone fails to explicitly disclose said strut height between 0.08 mm and 0.12 mm but disclose those skilled in the art will recognize that there are suitable alternatives to the depicted examples of configurations, constructions, and dimensions, and materials (see para 0254).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify strut height between 0.08 mm and 0.12 mm 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 medical device of Jeffrey in view of Cottone would not operate differently with the claimed width and since strut height are between the cuts to form an interrupted spiral configuration, the device would function appropriately having the claimed width. Further, applicant places no criticality on the range claimed, indicating simply that the width “may” be within the claimed ranges (specification pp. [0049]).
Cottone fails to explicitly disclose said pitch between 0.05 mm and 0.08 mm but teaches pitch can vary from about 0.05 mm to about 10 mm (para 0156).
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 pitch of Cottone from between 0.05 mm to about 10 mm to between 0.05 mm and 0.08 mm as applicant appears to have placed no criticality on the claimed range (see pp. [0049] indicating the pitch “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 3, Jeffrey in view of Cottone disclose the limitations in claim 1 but did not explicitly teach that the medical device, wherein the pre-shaped segment transitions from the first geometric configuration to the second geometric configuration under a load between 6 gF and 14 gF.
Jeffery discloses the medical device of claim 1, wherein the pre-shaped segment transitions from the first geometric configuration to the second geometric configuration (see fig 3B-D and para 0037-39) and further discloses many other variations modifications, and applications of the disclosure may be made without departing from the spirit and scope of the present disclosure (see para 0047 and 0048).
Cottone discloses a greater force is required to straighten or diminish and maintain via a resistive load force along the cut and shape treated portion of the distal tubular segment (see para 0128).
However, Jeffrey or Cottone did not expressly disclose said pre-shaped segment transitions from the first geometric configuration to the second geometric configuration under a load between 6 gF and 14 gF.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the pre-shaped segment of Jeffrey to transition from the first geometric configuration to the second geometric configuration under a load between 6 gF and 14 gF 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 Jeffrey view of will
Cottone would not operate differently with the claimed load and since the guidewire exert force on the preformed curved subsection making it change from first geometric configuration to the second geometric configuration. The device would function appropriately having the claimed load. Further, applicant places no criticality on the range claimed, indicating simply that the diameter “may” be within the claimed ranges (specification pp. [0006 and 0007]).
Regarding claim 4, Jeffrey in view of Cottone discloses the limitations in claim 1 but did not explicitly teach that the medical device, wherein the pre-shaped segment transitions from the first geometric configuration to the second geometric configuration under a load between 9 gF and 11 gF.
Jeffery disclosed the medical device of claim 1, wherein the pre-shaped segment transitions from the first geometric configuration to the second geometric configuration (see fig 3B-D and para 0037-39) and further disclosed many other variations modifications, and applications of the disclosure may be made without departing from the spirit and scope of the present disclosure (see para 0047 and 0048).
Cottone discloses a greater force is required to straighten or diminish and maintain via a resistive load force along the cut and shape treated portion of the distal tubular segment (see para 0128).
However, Jeffrey did not expressly disclose the pre-shaped segment transitions from the first geometric configuration to the second geometric configuration under a load between 9 gF and 11 gF.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the pre-shaped segment of Jeffrey to transition from the first geometric configuration to the second geometric configuration under a load between 9 gF and 11 gF 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 Jeffrey Cottone would not operate differently with the claimed load and since the guidewire exert force on the preformed curved subsection making it change from first geometric configuration to the second geometric configuration. The device would function appropriately having the claimed load. Further, applicant places no criticality on the range claimed, indicating simply that the diameter “may” be within the claimed ranges (specification pp. [0006]).
Regarding claim 5, Jeffrey in view of Cottone discloses the medical device of claim 1, wherein at least a portion of the distal segment is radiopaque (covering 36 and para 0012 and 0027).
Regarding claim 6, in the modified device of Jeffrey, Cottone discloses the medical device of claim 1, wherein the distal segment includes an atraumatic distal tip (see fig 25 and para 0224).
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey (US 20120016341 A1) in view of Williams et al (US 20180078772 A1) and further in view of Chan et al (US 20130304062 A1).
Regarding claim 12, Jeffrey discloses a medical device (catheter 20, fig 1), comprising: a catheter body (see fig 1: body of catheter 20) defining a proximal segment (proximal section 23), a distal segment (section 53), and a lumen therethrough (see fig 1A, lumen 32), wherein the distal segment includes a pre-shaped segment (see fig 1 and abs) having a first geometric configuration in an unloaded state (see fig 1A), and a second geometric configuration in a loaded state (see fig 3B-D, para 0014 and para 0037) and; wherein in the first geometric configuration, the pre-shaped segment includes an arc of 180 degrees (para 0032), and wherein a center of the arc is laterally offset from a longitudinal axis of the proximal segment of the catheter body (fig 1A), wherein the catheter body includes an intermediate segment (see fig 1: intermediate section 23) extending proximally of the distal segment (para 0029).
Jeffrey fails to teach in the first geometric configuration, the pre-shaped segment includes an arc of 180 degrees having a radius of at least 2 mm.
However, Jefrey discloses in the first geometric configuration, the pre-shaped segment includes an arc of 180 degrees (para 0032) having a radius of 0.145 cm (see fig 1A, the outer diameter of the preformed curve is 0.290 cm or 0.145cm which is 1.45mm in radius).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the medical device of Jeffery by making the arc of 180 degrees having a radius of at least 2 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Jeffrey also fails to disclose the intermediate segment defines a radius of curvature between 20 mm and 30 mm.
Williams et al disclose a delivery catheter (see fig 5, catheter 20) wherein an intermediate segment defines a radius of curvature (para 0022, region 25 and figs 5 and 8).
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 Jeffrey to have an intermediate segment defines a radius of curvature. This would provide the benefit of having the device ensuring proper orientation and positioning of the distal segment at the target vascular site of other regions of the body (see para 0021).
Williams et al in view of Jeffrey fail to disclose the intermediate segment defines a radius of curvature between 20 mm and 30 mm but disclose in para 0032 “since such modifications are possible, the invention is not to be limited to the exact construction and operation illustrated and described”.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the modified intermediate segment of Jeffrey to have a radius of curvature between 20 mm and 30 mm 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). Further, applicant places no criticality on the range claimed, indicating simply that radius of curvature “may” be within the claimed ranges (specification pp. [0007]).
Jeffrey and Williams et al both fail to teach said device further comprises a tip that is colinear with the longitudinal axis of the proximal segment of the catheter body and wherein the tip is coplanar with the proximal segment of the catheter body.
However, Chan et al disclose a medical device comprising a catheter (see fig 1, catheter 10) with a tip (see fig 3, tip of helical form 22) that is colinear with the longitudinal axis of a segment of the catheter body in the unloaded state and wherein the tip is coplanar with the segment of the catheter body in the unloaded state (see fig 3, tip is colinear and coplanar with segment 14 of catheter 10, see annotated figure below).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Jeffrey in view of Williams et al and incorporate the teachings of Chan et al to have said device further comprises a tip that is colinear with the longitudinal axis of the proximal segment of the catheter body and wherein the tip is coplanar with the proximal segment of the catheter body. This modification would provide the benefit of conforming or adapting its use in different anatomical structures (see para 0072 and 0104).
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Regarding claim 13, Jeffrey in view of Williams et al and Chan et al fail to explicitly disclose the intermediate segment has a length between 10 mm and 20 mm.
However, Jeffrey states many other variations, modifications, and applications of the disclosure may be made (see para 0047 and 0048) and further disclosed the intermediate section is 25cm in length (see para 0025 and fig 1).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the intermediate segment by making the length between 10 mm and 20 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 14, Jeffrey in view of Williams et al and Chan et al fail to explicitly disclose the medical device, wherein the intermediate segment has an arc length between 45 degrees and 90 degrees.
Williams et al in view Jeffrey a delivery catheter (see fig 5, catheter 20) wherein an intermediate segment defines a radius of curvature (para 0022, region 25 and figs 5 and 8).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the intermediate segment has an arc length between 45 degrees and 90 degrees 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 Jeffrey and Williams et al and Chan et al would not operate differently with the claimed intermediate segment having an arc length between 45 degrees and 90 degrees. Further, applicant places no criticality on the range claimed, indicating simply that the arc length “may” be within the claimed ranges (specification pp. [0007]).
Regarding claim 15, Jeffrey in view of Williams et al and Chan et al discloses the limitations in claim 12 but did not explicitly teach that the medical device, wherein the pre-shaped segment transitions from the first geometric configuration to the second geometric configuration under a load between 6 gF and 14 gF.
Jeffery disclosed the medical device of claim 1, wherein the pre-shaped segment transitions from the first geometric configuration to the second geometric configuration (see fig 3B-D and para 0037-39) and further disclosed many other variations modifications, and applications of the disclosure may be made without departing from the spirit and scope of the present disclosure (see para 0047 and 0048).
However, Jeffrey did not expressly disclose said pre-shaped segment transitions from the first geometric configuration to the second geometric configuration under a load between 6 gF and 14 gF.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the pre-shaped segment of Jeffrey to transition from the first geometric configuration to the second geometric configuration under a load between 6 gF and 14 gF 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 Jeffrey view of Williams et al and Chan et al would not operate differently with the claimed load and since the guidewire exert force on the preformed curved subsection making it change from first geometric configuration to the second geometric configuration. The device would function appropriately having the claimed load. Further, applicant places no criticality on the range claimed, indicating simply that the load “may” be within the claimed ranges (specification pp. [0047 and 0048]).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey (US 20120016341 A1) in view of Cottone (US 20180093070 A1).
Regarding claim 34, Jeffrey discloses a medical device (catheter 20, fig 1), comprising: a catheter body (see fig 1: body of catheter 20) defining a proximal segment (proximal section 24), a distal segment (section 53), a first tube segment (section 22) proximal of the distal segment (see fig 1A) and a lumen therethrough (see fig 1A, lumen 32), wherein the distal segment includes a pre-shaped segment (see fig 1A, pre-formed distal tip 63 and abs) having a first geometric configuration in an unloaded state (see fig 1A), and a second geometric configuration in a loaded state (see figs 3B-D, para 0014 and 0037) and; wherein in the first geometric configuration, the pre-shaped segment includes an arc of 180 degrees (para 0032) having a radius of at least 1 mm (see fig 1A, the outer diameter of the preformed curve is 0.290 cm or 0.145cm in radius), and wherein a center of the arc is laterally offset from a longitudinal axis of the proximal segment of the catheter body (fig 1A), and wherein the proximal segment of the catheter body is coplanar with the pre-shaped segment of the distal segment (see fig 1A, proximal section 24 is coplanar with pre-shaped segment).
Jeffrey fails to teach said distal segment includes a tube with a cut pattern therein, the cut pattern being an interrupted spiral cut pattern and the cut pattern defining: a plurality of cuts, with each cut having a width between 0.03 mm and 0.05 mm, a longitudinal uncut width between 0.02 mm and 0.03 mm between each of the plurality of cuts, a strut height between 0.08 mm and 0.12 mm, and a pitch between 0.05 mm and 0.08 mm.
However, Cottone discloses a vascular catheter (see fig 1, catheter 100) comprising a distal segment (distal tubular module 120) includes a tube with a cut pattern (see figs 2b-d and 3) therein, the cut pattern being an interrupted spiral cut pattern (see para 0161) and the cut pattern defining: a plurality of cuts (cut 340), with each cut having a width (width 330), a longitudinal uncut width (uncut potion 310, 320) between each of the plurality of cuts, a strut height (uncut portion 350) and a pitch (para 0156).
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 distal segment of Jeffrey and incorporated the teachings of Cottone to have said distal segment includes a tube with a cut pattern therein, the cut pattern being an interrupted spiral cut pattern and the cut pattern defining: a plurality of cuts, with each cut having a width, a longitudinal uncut width between each of the plurality of cuts, a strut height, and a pitch. The modification would provide the benefit of increasing flexibility and adjusting pushability, kink resistance, torque, and compression resistance in said distal segment to improve access to tortuous vascular pathways having extreme turning or bending dimensions (see para 0154).
Cottone fails to explicitly disclose said cut having a width between 0.03 mm and 0.05 mm but teaches the width of the spiral cuts can vary from about 1 micron to about 100 microns (para 0157).
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 angle of Cottone from between 1 micron to about 100 microns to between 0.03 mm and 0.05 mm as applicant appears to have placed no criticality on the claimed range (see pp. [0049 and 0050] indicating the angle “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Cottone fails to explicitly disclose a longitudinal uncut width between 0.01 mm and 0.03 mm but disclose those skilled in the art will recognize that there are suitable alternatives to the depicted examples of configurations, constructions, and dimensions, and materials (see para 0254).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify said longitudinal uncut width between 0.01 mm and 0.03 mm 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 Jeffrey in view of Cottone would not operate differently with the claimed width and since longitudinal uncut width is the width between the plurality of cuts in the longitudinal direction, the device would function appropriately having the claimed width. Further, applicant places no criticality on the range claimed, indicating simply that the longitudinal uncut width “may” be within the claimed ranges (specification pp. [0009]).
Cottone fails to explicitly disclose said strut height between 0.06 mm and 0.15 mm but disclose those skilled in the art will recognize that there are suitable alternatives to the depicted examples of configurations, constructions, and dimensions, and materials (see para 0254).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify strut height between 0.06 mm and 0.15 mm 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 Jeffrey in view of Cottone would not operate differently with the claimed width and since strut height are between the cuts to form an interrupted spiral configuration, the device would function appropriately having the claimed width. Further, applicant places no criticality on the range claimed, indicating simply that the strut height “may” be within the claimed ranges (specification pp. [0009]).
Cottone fails to explicitly disclose said pitch between 0.05 mm and 0.07 mm but teaches pitch can vary from about 0.05 mm to about 10 mm (para 0156).
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 pitch of Cottone from between 0.05 mm to about 10 mm to between 0.05 mm and 0.08 mm as applicant appears to have placed no criticality on the claimed range (see pp. [0009] indicating the pitch “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Jeffrey fails to teach said first tube segment proximal of the distal segment includes a tube with a cut pattern therein, the cut pattern being an interrupted spiral cut pattern and the cut pattern defining: a plurality of cuts, with each cut having a width between 0.03 mm and 0.05 mm, a longitudinal uncut width between 0.03 mm and 0.04 mm between each of the plurality of cuts, a strut height between 0.08 mm and 0.12 mm, and a pitch between 0.06 mm and 0.09 mm.
However, Cottone discloses a vascular catheter (see fig 1, catheter 100) comprising a first tube segment proximal of the distal segment (module 110) includes a tube with a cut pattern (see figs 2f-i) therein, the cut pattern being an interrupted spiral cut pattern (see para 0160-61) and the cut pattern defining: a plurality of cuts (cut 340), with each cut having a width (width 330), a longitudinal uncut width (uncut potion 310, 320) between each of the plurality of cuts, a strut height (uncut portion 350) and a pitch (para 0156).
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 distal segment of Jeffrey and incorporated the teachings of Cottone to have said distal segment includes a tube with a cut pattern therein, the cut pattern being an interrupted spiral cut pattern and the cut pattern defining: a plurality of cuts, with each cut having a width, a longitudinal uncut width between each of the plurality of cuts, a strut height, and a pitch. The modification would provide the benefit of increasing flexibility and adjusting pushability, kink resistance, torque, and compression resistance in said distal segment to improve access to tortuous vascular pathways having extreme turning or bending dimensions (see para 0154).
Cottone fails to explicitly disclose said cut having a width between 0.03 mm and 0.05 mm but teaches the width of the spiral cuts can vary from about 1 micron to about 100 microns (para 0157).
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 angle of Cottone from between 1 micron to about 100 microns to between 0.03 mm and 0.05 mm as applicant appears to have placed no criticality on the claimed range (see pp. [0049 and 0050] indicating the angle “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Cottone fails to explicitly disclose a longitudinal uncut width between 0.03 mm and 0.05 mm but disclose those skilled in the art will recognize that there are suitable alternatives to the depicted examples of configurations, constructions, and dimensions, and materials (see para 0254).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify said longitudinal uncut width between 0.03 mm and 0.05 mm 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 Jeffrey in view of Cottone would not operate differently with the claimed width and since longitudinal uncut width is the width between the plurality of cuts in the longitudinal direction, the device would function appropriately having the claimed width. Further, applicant places no criticality on the range claimed, indicating simply that the longitudinal uncut width “may” be within the claimed ranges (specification pp. [0049]).
Cottone fails to explicitly disclose said strut height between 0.08 mm and 0.12 mm but disclose those skilled in the art will recognize that there are suitable alternatives to the depicted examples of configurations, constructions, and dimensions, and materials (see para 0254).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify strut height between 0.08 mm and 0.12 mm 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 Jeffrey in view of Cottone would not operate differently with the claimed width and since strut height are between the cuts to form an interrupted spiral configuration, the device would function appropriately having the claimed width. Further, applicant places no criticality on the range claimed, indicating simply that the strut height “may” be within the claimed ranges (specification pp. [0049]).
Cottone fails to explicitly disclose said pitch between 0.06 mm and 0.09 mm but teaches pitch can vary from about 0.05 mm to about 10 mm (para 0156).
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 pitch of Cottone from between 0.05 mm to about 10 mm to between 0.06 mm and 0.09 mm as applicant appears to have placed no criticality on the claimed range (see pp. [0050] indicating the pitch “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /DUNG T ULSH/Examiner, Art Unit 3783