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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the lateral edge of the second cross-section of the second stent segment transitions smoothly with “a radius” into a first connecting end of the first stent segment of claim 13 and paragraph 0036 of the specification of the instant application must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The spacing of the lines of the specification is such as to make reading difficult. New application papers with lines 1 1/2 or double spaced (see 37 CFR 1.52(b)(2)) on good quality paper are required.
Claim Objections
Claims 11-16 and 18-24 are objected to because of the following informalities:
Claim 11, line 8: “…is cured un a second direction” should read “…is curved in a second direction”.
Claim 15, line 6: “…the second angle is 30°, 45°, 60°.” should read “…the second angle is 30°, 45°, or 60°.”.
Claims 12-16 and 18-24: “… characterized in that…” should read “…further characterized in that…”. Appropriate correction is required.
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 15 and 24 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 15 recites the limitation "the first connecting end" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the first connecting end” is interpreted to be the first stent segment’s side of the intersection between the first stent segment and the second stent segment.
Claim 24 recites the limitation "the first connecting end" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the first connecting end” is interpreted to be the first stent segment’s side of the intersection between the first stent segment and the second stent segment.
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) 11-12, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rickner et al. (Publication No. US 2012/0053700 A1).
Regarding claim 11, Rickner discloses a stent (ureteral stent 10; Paragraphs 0023-0024; Figure 1), comprising a stent body (stent 10 has a body; Paragraphs 0023-0024; Figure 1), characterized in that the stent body includes: a first stent segment (first stent segment; see annotated Figure 1 of Rickner below), having a lumen therein and forming a continuous hollow tube, with an end curved in a first direction to form a deformable first loop (upper tubular body 12 with a coiled, renal segment 16 that is a continuous hollow tube having a lumen with an end curved in a first direction and have a deformable first loop at segment 16 is the first stent segment; Paragraphs 0023 and 0026; Figure 6; annotated Figure 1 below); and a second stent segment (second stent segment; see annotated Figure 1 of Rickner below), provided with at least one recess communicating with and adapted to the lumen (lower, intramural segment 14 with coiled, bladder end region 18 having a first flap 22 and a second flap 24 forming a recess with the semi-circular cross-section, is the second stent segment, that can is in fluid communication with the upper tubular body 12 with a coiled, renal segment 16; Figures 9-10, annotated Figure 1 of Rickner below; Paragraphs 0028-0029); , the recess rendering the second cross-section of the second stent segment a non-circular incomplete cross-section (Paragraph 0029 – “In this preferred embodiment, when the flaps 22, 24 enter the bladder 112 the flaps 22, 24 would become semicircular with the first flap 22 of the coiled, bladder end segment 18 being convex so that a smooth surface and minimal surface area will be in contact with the bladder wall.”; Figures 1 and 9-10), wherein an end of the second stent segment is curved in a second direction to form a deformable second loop (end of segment 18 of second stent segment is curved in a second direction to form a loop; Paragraphs 0028-0029; Figures 8-9 and annotated Figure 1 of Rickner below); wherein at a connecting portion between the first stent segment and the second stent segment, the second cross-section of the second stent segment transitions smoothy to a first cross-section of the first stent segment, such that the connecting portion is free from sharp edges (point where flaps 22/24 end at segment 14 ends and transitions to tubular body 12 with the end 16 of the first stent segment, wherein the connecting portion has a transition between a second semi-circular cross-section of segment 14 with region 18 of the second stent segment to a first cross-section of segment 12 with end 16 of the first stent segment that is circular with no sharp edges; Paragraph 0029; Figures 9-10; annotated Figure 1 of Rickner below).
PNG
media_image1.png
525
451
media_image1.png
Greyscale
Annotated Figure 1 of Rickner
Regarding claim 12, Rickner discloses the stent of claim 11. Rickner further discloses characterized in that the recess in the second stent segment is configured such that the second cross-section of the second stent segment presents a crescent or planar shape (Paragraph 0029 – “In this preferred embodiment, when the flaps 22, 24 enter the bladder 112 the flaps 22, 24 would become semicircular with the first flap 22 of the coiled, bladder end segment 18 being convex so that a smooth surface and minimal surface area will be in contact with the bladder wall.”, meaning that the second cross-section of the second stent segment is a crescent; Figures 9-10 and Annotated Figure 1 of Rickner above), with the ratio of the crescent or planar cross- sectional area being not less than 50% of the overall second cross-section (obvious that the ratio of the semicircular cross-section will be more than 50% of the overall second cross-section, where the flaps 22, 24 extend the entirety of the second stent segment; Paragraph 0029; Figures 1 and 9-10).
Regarding claim 14, Rickner discloses the stent of claim 11. Rickner further discloses characterized in that a first angle between a first radial surface of the first loop and a second radial surface of the second loop is within the range of 0° to 180° (first angle between first radial surface of the first loop and second radial surface of second loop is 90 degrees; Figures 2-7; Claim 4; Paragraph 0026).
Regarding claim 16, Rickner discloses the stent of claim 14. Rickner further disclosed characterized in that an opening communicating with the lumen is provided at the end of the first loop of the first stent segment, or the end of the first loop is formed as a closed end (opening at end of first stent segment 16 is in communication with the lumen of the end 16 with the body 12; Figure 6; Paragraph 0023).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Rickner et al. (Publication No. US 2012/0053700 A1) in view of McWeeney et al. (Publication No. US 2004/0059279 A1).
Regarding claim 13, Rickner discloses the stent of claim 12. Rickner does not teach characterized in that the lateral edge of the second cross-section of the second stent segment transitions smoothly with a radius (R) into a first connecting end of the first stent segment, wherein the first connecting end connects with the second stent segment.
However, McWeeney teaches characterized in that the lateral edge of the second cross-section of the second stent segment transitions smoothly with a radius (R) into a first connecting end of the first stent segment, wherein the first connecting end connects with the second stent segment (tail 110/second stent segment has a lateral edge that transitions smoothly with a radius/curvature with a taper to the elongated tubular body 130/first stent segment at the bladder end region 120; Paragraph 0053; Figure 3).
Rickner and McWeeney are considered to be analogous to the claimed invention because they are in the same field of ureter catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rickner to incorporate the teachings of McWeeney and have the rounded taper with a radius of McWeeney applied to the lateral edge of the second cross-section of the second stent segment of Rickner. This allows for the device to fit within the diameter of the anatomy of the user (McWeeney; Paragraph 0051 and 0053).
Regarding claim 15, Rickner discloses the stent of claim 14. Rickner does not teach characterized in that the first connecting end of the first stent segment is formed as an oblique end that defines a tangent plane intersecting an axis of the first stent segment to form a second angle, wherein a second connecting end of the second stent segment transitions smoothly with the first connecting end; and the second angle is 30°, 45°, 60°.
However, McWeeney teaches characterized in that the first connecting end of the first stent segment is formed as an oblique end that defines a tangent plane intersecting an axis of the first stent segment to form a second angle (first connecting end is the end of first stent segment that is connected to the second stent segment and forms an oblique end that defines a tangent plant intersecting an axis of the first stent segment to have a second angle; see annotated Figure 1 of McWeeney below), wherein a second connecting end of the second stent segment transitions smoothly with the first connecting end (second connecting end is the end that is connected to first connecting end and transitions smoothly with first connecting end; annotated Figure 1 of McWeeney below; Paragraph 0053).
Rickner and McWeeney are considered to be analogous to the claimed invention because they are in the same field of ureter catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rickner to incorporate the teachings of McWeeney and have the rounded taper with an oblique end of McWeeney applied to the first connecting end of the first segment of Rickner. This allows for the device to fit within the diameter of the anatomy of the user (McWeeney; Paragraph 0051 and 0053).
The combination of Rickner in view of McWeeney does not teach the second angle is 30°, 45°, 60°.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second angle be 30°, 45°, or 60° 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) (MPEP 2144.04(IV)(A)). In the instant case, the catheter of Rickner in view of McWeeney would not operate differently with the claimed second angle since the ureter catheter is constructed with similar components and structure (see disclosed above) and is intended to be inserted into the bladder of the user for draining of urine. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the immersion speed is “may be” the claimed ranges (specification; paragraphs 0042).
PNG
media_image2.png
255
676
media_image2.png
Greyscale
Annotated Figure 1 of McWeeney
Claim(s) 17, 19, 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Rickner et al. (Publication No. US 2012/0053700 A1) in view of Gregory (Patent No. US 4,913,683 A).
Regarding claim 17, Rickner teaches a stent body (stent 10 has a body; Paragraphs 0023-0024; Figure 1), characterized in that the stent body includes: a first stent segment (first stent segment; see annotated Figure 1 of Rickner above), having a lumen therein a forming a continuous hollow tube, with an end curved in a first direction to form a deformable first loop (upper tubular body 12 with a coiled, renal segment 16 that is a continuous hollow tube having a lumen with an end curved in a first direction and have a deformable first loop at segment 16 is the first stent segment; Paragraphs 0023 and 0026; Figure 6; annotated Figure 1 above); and a second stent segment (second stent segment; see annotated Figure 1 of Rickner above), provided with at least one recess communicating with and adapted to the lumen (lower, intramural segment 14 with coiled, bladder end region 18 having a first flap 22 and a second flap 24 forming a recess with the semi-circular cross-section, is the second stent segment, that can is in fluid communication with the upper tubular body 12 with a coiled, renal segment 16; Figures 9-10, annotated Figure 1 of Rickner above; Paragraphs 0028-0029), the recess rendering the second cross-section of the second stent segment a non-circular incomplete cross-section (Paragraph 0029 – “In this preferred embodiment, when the flaps 22, 24 enter the bladder 112 the flaps 22, 24 would become semicircular with the first flap 22 of the coiled, bladder end segment 18 being convex so that a smooth surface and minimal surface area will be in contact with the bladder wall.”; Figures 1 and 9-10), wherein an end of the second stent segment is curved in a second direction to form a deformable second loop (end of segment 18 of second stent segment is curved in a second direction to form a loop; Paragraphs 0028-0029; Figures 8-9 and annotated Figure 1 of Rickner above); wherein at a connecting portion between the first stent segment and the second stent segment, the second cross-section of the second stent segment transitions smoothly to a first cross-section of the first stent segment, such that the connecting portion is free from sharp edges (point where flaps 22/24 end at segment 14 ends and transitions to tubular body 12 with the end 16 of the first stent segment, wherein the connecting portion has a transition between a second semi-circular cross-section of segment 14 with region 18 of the second stent segment to a first cross-section of segment 12 with end 16 of the first stent segment that is circular with no sharp edges; Paragraph 0029; Figures 9-10; annotated Figure 1 of Rickner above). Rickner does not teach an inserting apparatus with stent, the inserting apparatus comprising an inner tube, an outer tube, and a tapered end of the inner tube, distant from the handle, is inserted into the lumen of the first stent segment to integrate with the stent body, and an inner tube body of the outer tube is inserted into an outer tube body of the inner tube along with a guidewire for positioning the stent body at a designated location within the patient's body.
However, Gregory teaches an inserting apparatus with stent (ureteral stent system 10; Figure 1-2; Column 4, lines 28-32), the inserting apparatus comprising an inner tube (guide tube member 36; Figure 1-2 and 7-8; Column 4, lines 43-51), an outer tube (push-catheter member 64; Figures 7-8 and 10-11; Column 5, lines 11-19), and a tapered end of the inner tube, distant from the handle, is inserted into the lumen of the first stent segment to integrate with the stent body (tapered end of member 36 that is distant from luer hub 68 is inserted into the lumen of first stent segment of stent member 12; Figures 7-8), and an inner tube body of the outer tube is inserted into an outer tube body of the inner tube along with a guidewire for positioning the stent body at a designated location within the patient's body (guide tube member 36 and guidewire 34 is within push-catheter member 64 to position stent at given location in patient; Figures 7-8 and 10-11).
Rickner and Gregory are considered to be analogous to the claimed invention because they are in the same field of ureter catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rickner to incorporate the teachings of Gregory and have the inserting apparatus of Gregory connected to the stent of Rickner. This allows for the position of the stent in the proper position within the patient (Gregory; Abstract).
Regarding claim 19, Rickner in view of Gregory teaches the inserting apparatus of claim 17. The combination of Rickner in view of Gregory further teaches characterized in that the recess in the second stent segment is configured such that the second cross-section of the second stent segment presents a crescent or planar shape (Rickner; Paragraph 0029 – “In this preferred embodiment, when the flaps 22, 24 enter the bladder 112 the flaps 22, 24 would become semicircular with the first flap 22 of the coiled, bladder end segment 18 being convex so that a smooth surface and minimal surface area will be in contact with the bladder wall.”, meaning that the second cross-section of the second stent segment is a crescent; Figures 9-10; annotated Figure 1 of Rickner above), with the ratio of the crescent or planar cross-sectional area being not less than 50% of the overall second cross-section obvious that the ratio of the semicircular cross-section will be more than 50% of the overall second cross-section, where the flaps 22,24 extend the entirety of the second stent segment; Paragraph 0029; Figures 9-10; annotated Figure 1 of Rickner above).
Regarding claim 23, Rickner in view of Gregory teaches the inserting apparatus of claim 17. The combination of Rickner in view of Gregory further teaches characterized in that a first angle between a first radial surface of the first loop and a the second radial surface of the second loop is within range of 00 to 1800 (Rickner; first angle between first radial surface of the first loop and second radial surface of second loop is 90 degrees; Figures 2-7; Claim 4; Paragraph 0026).
Regarding claim 25, Rickner teaches a stent comprising a stent tube body (stent 10 has a body; Paragraphs 0023-0024; Figure 1), characterized in that the stent tube body includes: a first stent segment (first stent segment; see annotated Figure 1 of Rickner above), having a lumen therein a forming a continuous hollow tube, with an end curved in a first direction to form a deformable first loop (upper tubular body 12 with a coiled, renal segment 16 that is a continuous hollow tube having a lumen with an end curved in a first direction and have a deformable first loop at segment 16 is the first stent segment; Paragraphs 0023 and 0026; Figure 6; annotated Figure 1 above); and a second stent segment (second stent segment; see annotated Figure 1 of Rickner above), provided with at least one recess communicating with and adapted to the lumen (lower, intramural segment 14 with coiled, bladder end region 18 having a first flap 22 and a second flap 24 forming a recess with the semi-circular cross-section, is the second stent segment, that can is in fluid communication with the upper tubular body 12 with a coiled, renal segment 16; Figures 9-10, annotated Figure 1 of Rickner above; Paragraphs 0028-0029), the recess rendering the second cross-section of the second stent segment a non-circular incomplete cross-section (Paragraph 0029 – “In this preferred embodiment, when the flaps 22, 24 enter the bladder 112 the flaps 22, 24 would become semicircular with the first flap 22 of the coiled, bladder end segment 18 being convex so that a smooth surface and minimal surface area will be in contact with the bladder wall.”; Figures 1 and 9-10), wherein an end of the second stent segment is curved in a second direction to form a deformable second loop (end of segment 18 of second stent segment is curved in a second direction to form a loop; Paragraphs 0028-0029; Figures 8-9 and annotated Figure 1 of Rickner above). Rickner does not teach wherein a tapered end of an inner tube, distant from a handle, is inserted into the lumen of the first stent segment to integrate with the stent body, and an inner tube body of an outer tube is inserted into an outer tube body of the inner tube along with a guidewire, for positioning the stent body at a designated location within the patient's body when the inner tube and the outer tube are assembled.
However, Gregory teaches wherein a tapered end of an inner tube, distant from a handle, is inserted into the lumen of the first stent segment to integrate with the stent body (tapered end of member 36 that is distant from luer hub 68/handle is inserted into the lumen of first stent segment of stent member 12; Figures 7-8; Column 4, lines 15-21), and an inner tube body of an outer tube is inserted into an outer tube body of the inner tube along with a guidewire, for positioning the stent body at a designated location within the patient's body when the inner tube and the outer tube are assembled (guide tube member 36 and guidewire 34 is within push-catheter member 64 to position stent at given location in patient; Figures 7-8 and 10-11; Column 4, lines 33-42 and Column 6, lines 22-27).
Rickner and Gregory are considered to be analogous to the claimed invention because they are in the same field of ureter catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rickner to incorporate the teachings of Gregory and have the inserting apparatus of Gregory connected to the stent of Rickner. This allows for the position of the stent in the proper position within the patient (Gregory; Abstract).
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Rickner et al. (Publication No. US 2012/0053700 A1) in view of Gregory (Patent No. US 4,913,683 A), as applied to claim 17 above, and further in view of Carter et al. (Publication No. US 2008/0208129 A1).
Regarding claim 18, Rickner in view of Gregory teaches the inserting apparatus of claim 17. The combination of Rickner in view of Gregory does not teach characterized in that the outer tube comprises a first radiopaque marker and a second radiopaque marker, wherein the first radiopaque marker and the second radiopaque marker are embedded at different positions on the inner tube body, allowing accurate radiographic localization of the outer tube.
However, Carter teaches characterized in that the outer tube comprises a first radiopaque marker and a second radiopaque marker (first radiopaque marker 17 and second radiopaque marker 18 are positioned away from each other; Figures 4-5; Paragraph 0095) .
Rickner in view of Gregory and Carter are considered to be analogous to the claimed invention because they are in the same field of fluid catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rickner in view of Gregory to incorporate the teachings of Carter and have the first and second radiopaque markers of Carter to be embedded in different positions on the inner tube of Rickner in view of Gregory. This allows for the physician to see the position of the catheter within the patient under x-ray (Carter; Paragraph 0095).
The combination of Rickner in view of Gregory and Carter further teaches wherein the first radiopaque marker and the second radiopaque marker are embedded at different positions on the inner tube body, allowing accurate radiographic localization of the outer tube (radiopaque markers of Rickner are on the inner tube of Rickner in view of Gregory to identify the positioning of the outer tube; see combination above).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Rickner et al. (Publication No. US 2012/0053700 A1) in view of Gregory (Patent No. US 4,913,683 A), as applied to claim 17 above, and further in view of Al-Jazaeri et al. (Patent No. US 10,765,847 B1).
Regarding claim 20, Rickner in view of Gregory teaches the inserting apparatus of claim 17. The combination of Rickner in view of Gregory does not teach characterized in that distance markers are provided on an outer surface of the outer tube.
However, Al-Jazaeri teaches characterized in that distance markers are provided on an outer surface of the outer tube (stylet 100 has a first level marker and a second level marker 112 on outer surface; Figures 15A-15B; Column 29, lines 3-16).
Rickner in view of Gregory and Al-Jazaeri are considered to be analogous to the claimed invention because they are in the same field of fluid catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rickner in view of Gregory to incorporate the teachings of Al-Jazaeri and have the first and second level markers of Al-Jazaeri to be on the outer surface of the outer tube of Rickner in view of Gregory. This allows for a visual indication on the distance of the device within the user (Al-Jazaeri; Column 29, lines 3-16).
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Rickner et al. (Publication No. US 2012/0053700 A1) in view of Gregory (Patent No. US 4,913,683 A), as applied to claim 17 above, and further in view of Toyokawa (Publication No. JP 2015073547 A – translated copy attached in PTO-892).
Regarding claim 21, Rickner in view of Gregory teaches the inserting apparatus of claim 17. The combination of Rickner in view of Gregory does not teach characterized in that a fastener is provided on the inner tube to pass through and secure the stent's end connected to the inner tube, preventing displacement of the stent's end.
However, Toyokawa teaches characterized in that a fastener is provided on the inner tube to pass through and secure the stent's end connected to the inner tube, preventing displacement of the stent's end (tongue piece 35 with protrusion 36 as a fastener to hold connecting member 25 of stent 20; Figure 11; Page 6; line 24-46).
Rickner in view of Gregory and Toyokawa are considered to be analogous to the claimed invention because they are in the same field of stent delivery catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rickner in view of Gregory to incorporate the teachings of Toyokawa and have the connecting member of Toyokawa on the stent of Rickner in view of Gregory and the tongue piece with the protrusion of Toyokawa on the inner tube of Rickner in view of Gregory. This allows for the stent to be accurately placed in the patient (Toyokawa; Abstract) by allowing for the stent to be pushed or pulled back into the desired position (Toyokawa; Background; Page 1).
Claim(s) 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Rickner et al. (Publication No. US 2012/0053700 A1) in view of Gregory (Patent No. US 4,913,683 A), as applied to claim 17 above, and further in view of McWeeney et al. (Publication No. US 2004/0059279 A1).
Regarding claim 22, Rickner in view of Gregory teaches the inserting apparatus of claim 17. The combination of Rickner in view of Gregory does not teach characterized in that the lateral edge of the second cross-section of the second stent segment transitions smoothly with a radius (R) into a first connecting end of the first stent segment, wherein the first connecting end connects with the second stent segment.
However, McWeeney teaches characterized in that the lateral edge of the second cross-section of the second stent segment transitions smoothly with a radius (R) into a first connecting end of the first stent segment, wherein the first connecting end connects with the second stent segment (tail 110/second stent segment has a lateral edge that transitions smoothly with a radius/curvature with a taper to the elongated tubular body 130/first stent segment at the bladder end region 120; Paragraph 0053; Figure 3).
Rickner and McWeeney are considered to be analogous to the claimed invention because they are in the same field of ureter catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rickner to incorporate the teachings of McWeeney and have the rounded taper with a radius of McWeeney applied to the lateral edge of the second cross-section of the second stent segment of Rickner. This allows for the device to fit within the diameter of the anatomy of the user (McWeeney; Paragraph 0051 and 0053).
Regarding claim 24, Rickner in view of Gregory teaches the inserting apparatus of claim 17. The combination of Rickner in view of Gregory does not teach characterized in that the first connecting end of the first stent segment is formed as an oblique end that defines a tangent plane intersecting an axis of the first stent segment to form a second angle, wherein a second connecting end of the second stent segment transitions smoothly with the first connecting end; and the second angle is 30°, 45°, 60°.
However, McWeeney teaches characterized in that the first connecting end of the first stent segment is formed as an oblique end that defines a tangent plane intersecting an axis of the first stent segment to form a second angle (first connecting end is the end of first stent segment that is connected to the second stent segment and forms an oblique end that defines a tangent plant intersecting an axis of the first stent segment to have a second angle; see annotated Figure 1 of McWeeney above), wherein a second connecting end of the second stent segment transitions smoothly with the first connecting end (second connecting end is the end that is connected to first connecting end and transitions smoothly with first connecting end; annotated Figure 1 of McWeeney above; Paragraph 0053).
Rickner and McWeeney are considered to be analogous to the claimed invention because they are in the same field of ureter catheters. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rickner to incorporate the teachings of McWeeney and have the rounded taper with an oblique end of McWeeney applied to the first connecting end of the first segment of Rickner. This allows for the device to fit within the diameter of the anatomy of the user (McWeeney; Paragraph 0051 and 0053).
The combination of Rickner in view of McWeeney does not teach the second angle is 30°, 45°, 60°.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second angle be 30°, 45°, or 60° 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) (MPEP 2144.04(IV)(A)). In the instant case, the catheter of Rickner in view of McWeeney would not operate differently with the claimed second angle since the ureter catheter is constructed with similar components and structure (see disclosed above) and is intended to be inserted into the bladder of the user for draining of urine. Further, it appears that the applicant places no criticality on the range claimed, indicating simply that the immersion speed is “may be” the claimed ranges (specification; paragraphs 0042).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Densow (Patent No. US 4,610,657 A) – ureteral stent with delivery apparatus;
Kolb (Publication No. US 2005/0125072 A1) – ureteral stent with a first stent segment and a second stent segment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
Prosecution Insights