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 as failing to comply with 37 CFR 1.84(p)(4) because reference character “3” has been used to designate both a proximal end [Figs. 1-1A] and an axis [Fig. 2].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “4” in Fig. 3; “4B” in Fig. 3B; “6” in Fig. 5; “9” in Fig. 8.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Claim Objections
Claim(s) 1, 9, 11, 15, and 23 is/are objected to because of the following informalities:
Claim 1 should read “a diameter of the at least one wire” [line 14]. A similar objection is made to claim 15 mutatis mutandis.
Claim 9 should read “[[the]] a circumference of the tube” [line 2].
Claim 11 should read “enhances [[the]] flexibility of the tube in the portion” [line 4]. A similar objection is made to claim 23 mutatis mutandis.
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Claim(s) 10, 18, and those dependent therefrom is/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 10 recites the limitation “a second extent of the second slot” [lines 3-4], which is considered indefinite, as there is no previously defined “first extent of the second slot”, such that it is unclear how the second slot may comprise a second extent. For examination purposes, the Examiner has interpreted claim 10 to read “an [[first]] extent of the first slot is greater than an [lines 3-4]. The Examiner notes that claim 18 recites similarly indefinite subject matter that is rejected and interpreted similar to the § 112(b) rejection of claim 10 as noted above mutatis mutandis.
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) 1-6 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz (US-8206343-B2) in view of Truckai (US-5397304-A).
Regarding claim 1, Racz teaches
An endovascular device, comprising:
a tube comprising a selectively bendable portion, wherein at least a portion of the tube is configured to be inserted into a blood vessel [A flexible tube 140 (Racz Fig. 10); While the various teachings of the invention disclosed herein find full utility in catheters utilizable in epidural procedures, those teachings also have applicability in whole or in part in all types of medical catheters, including cardiovascular access catheters, coronary catheters, endoscopic catheters, and surgical catheters (Racz Col 3:10-15)];
a plug disposed at a distal end of the tube, wherein the plug has a rounded tip configured to be inserted into the blood vessel [A rigid end piece 156 is secured to distal end 158 of flexible tube 140. In various embodiments, end piece 156 is welded, such as in a welded ball, to distal end 158 and/or to coil spring 136 and/or to filament 146. End piece 156, functions as a closed distal terminus for the working lumen within catheter 130 and has a semispherical exterior profile (Racz Col 8:65-9:3, Fig. 10); see Racz Col 3:10-15 regarding configuration to be inserted into a blood vessel];
a control element extending through at least a portion of the tube, wherein movement of the control element relative to the tube is configured to cause the selectively bendable portion of the tube to bend [Filament 146 also includes a free portion 152 having a distal end 154 that is joined to distal end 150 of bound portion 148… The withdrawal of free portion 152 of filament 146 proximally through the working lumen in catheter 130 as indicated by an arrow W.sub.3 causes distal tip 132 of catheter 130 to be deflected to the right in a direction indicated by an arrow an D.sub.3 (Racz Col 8:47-57, Fig. 10)]; and
a spacer disposed within the tube and placed between the tube and the control element, the spacer comprising at least one wire formed in a coil [Catheter 130 includes an elongated, helical coil spring 136 that encloses a longitudinally extending passageway. In a terminal portion 138 of coil spring 136 adjoining the distal end thereof, successive loops of coil spring 136 are longitudinally separated (Racz Col 8:17-31)] and configured to reduce sliding friction between the tube and the control element [wherein as depicted in Racz Fig. 10, the coil spring 136 physically separating/spacing away the free portion 152 of filament 146 (control element) from the flexible tube 140 (tube) is considered to read on being configured to reduce sliding friction between the tube and the control element].
However, Racz fails to explicitly disclose wherein a distal end of the control element connected to a washer disposed between the plug and the tube, the washer fixed with respect to the tube.
Truckai discloses systems for a steerable catheter, wherein Truckai discloses a bendable tube [tubing 50 (Truckai Fig. 5); tip section 16 comprises tubing 50 of a low durometer flexible plastic, such as Pebax.TM., silicone rubber, or other resilient material (Truckai Col 5:67-6:2)], a plug disposed at a distal end of the tube [tip electrode 20 (Truckai Fig. 5)], a washer disposed between the plug and the tube, the washer fixed with respect to the tube [An electrically and thermally insulating anchor plate 72 is bonded to distal end 74 of tubing 50, tip electrode 20 being bonded to the distal side of anchor plate 72. Anchor plate 72, as shown in FIG. 8, has a central passage 78 corresponding to central lumen 54 of tip section 16, and four radially offset apertures 76 through which pull wires 44 pass… Anchor plate 72 serves several functions… Secondly, it provides a strong component to which the pull wires 44 can be attached, without reliance on adhesive (Truckai Col 6:45-51, 57-62, Fig. 5); wherein the anchor plate 72 of Truckai is considered to read on the broadest reasonable interpretation of a washer, based on the plain definition of a washer referring to a flat thin ring or a perforated plate used in joints or assemblies to ensure tightness, prevent leakage, or relieve friction (https://www.merriam-webster.com/dictionary/washer)]; wherein a distal end of a control element is connected to the washer, wherein movement of the control element relative to the tube is configured to cause the selectively bendable portion of the tube to bend [Anchor plate 72, as shown in FIG. 8, has a central passage 78 corresponding to central lumen 54 of tip section 16, and four radially offset apertures 76 through which pull wires 44 pass. Referring again to FIG. 5, pull wires 44 terminate in anchors 80, which usually comprise steel balls formed on or welded to ends of pull wires 44. The anchors 80 are of larger diameter than apertures 76, providing a strong, pivotal connection between pull wires 44 and the distal end of tip section 16 (Truckai Col 6:48-57); Accordingly, at the distal end of the catheter, pull wires 44 brought into tension pull the distal end via anchor plate 72, with the opposing relaxed pull wires allowing the tube to deflect (Truckai Col 10:27-30)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz to employ wherein a distal end of the control element is bound to a washer disposed between the plug and the tube, the washer fixed with respect to the tube, as this modification would amount to mere simple substitution of one known element [control element of Racz coupled to the plug] for another [control element coupled to washer disposed between plug and tube] with similar expected results [allowing for movement of the control element to selectively bend the tube] [MPEP § 2143(I)(B)].
However, while Racz discloses and depicts the coil as having a non-zero pitch [In a terminal portion 138 of coil spring 136 adjoining the distal end thereof, successive loops of coil spring 136 are longitudinally separated. Proximal of terminal portion 138 successive loops of coil spring 136 are bottomed out (Racz Col 8:19-23, Fig. 10), wherein a non-zero pitch is considered to define a pitch that is an undisclosed variable times the diameter of the coil] and further notes that the spacing between successive loops of the coil [pitch] is considered to be a result effective variable in that changing the pitch of the coil affects the flexibility and ease of steering the device [As shown in FIG. 3, the longitudinal separation between successive loops of coil spring 36 within the embrace of flexible tube 40 is repeated through a terminal portion 64 of coil spring 36 adjoining distal end 34 thereof. This arrangement increases the lateral flexibility in catheter 10 at terminal portion 64 of coil spring 36, and that in turn facilitates steering movements of the type illustrated in FIG. 5B… The portion of catheter 10 that encircles terminal portion 64 of coil spring 36 is readily deflectable laterally. This reduces the likelihood of injury by that portion of catheter 10 to internal physiological structures in the body of a patient (Racz Col 5:35-41, 48-52, Fig. 3)], Racz in view of Truckai fails to explicitly disclose wherein the coil has a pitch at least 1.2 times a diameter of the wire. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Racz as modified by Truckai to have a pitch in the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz in view of Truckai to employ wherein the coil has a pitch at least 1.2 times a diameter of the wire 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 2, Racz in view of Truckai teaches
The endovascular device of claim 1, wherein the washer is fixed rotationally with respect to an axis of the tube such that application of torque to the control element causes the selectively bendable portion of the tube to bend [see § 103 modification of claim 1 above; Then the retraction of free portion 152 of filament 146 through the working lumen in catheter 130 in the direction of arrow W.sub.3 will cause distal tip 132 to be deflected to the left in FIG. 10 (Racz Col 8:61-64), wherein as Truckai Col 6:48-57 discloses that the anchor plate 72 (washer) is bonded to the tube and the plug, such that as modified, the washer is considered to be rotationally fixed and capable of transmitting torque as claimed; wherein the tube as modified is considered to bend based on the plain definition of bend referring to “force from a proper shape” (https://www.merriam-webster.com/dictionary/bend)].
Regarding claim 3, Racz in view of Truckai teaches
The endovascular device of claim 1, wherein a distal end of the spacer is connected to the washer [see § 103 modification of claim 1 above; A rigid end piece 156 is secured to distal end 158 of flexible tube 140. In various embodiments, end piece 156 is welded, such as in a welded ball, to distal end 158 and/or to coil spring 136 and/or to filament 146 (Racz Col 8:65-9:1, Fig. 10), wherein as Racz discloses that the filament 146 (control element) is coupled to each of the end piece 156 (plug), tube 140 (tube), and coil spring 136 (spacer), based on the modification of claim 1 to employ a washer, the washer as modified is considered to be connected a distal end of the spacer to allow for the control element to selectively bend the tube/spacer].
Regarding claim 4, Racz in view of Truckai teaches
The endovascular device of claim 1, wherein the control element is configured to slide with respect to at least a portion of the tube [Racz Col 8:47-57, Fig. 10].
Regarding claim 5, Racz in view of Truckai teaches
The endovascular device of claim 1, wherein the control element extends through the tube from the washer at the distal end of the tube to a proximal end of the tube [see § 103 modification of claim 1 above; Racz Fig. 10].
Regarding claim 6, Racz in view of Truckai teaches
The endovascular device of claim 5, wherein the proximal end of the control element is connected to an actuator control [This deflection is accomplished by the selective displacement of structures interior of catheter 10 that are actuated by mechanisms of a user handle 18 to which proximal end 14 of catheter 10 is attached (Racz Col 2:22-25)].
Regarding claim 9, Racz in view of Truckai teaches
The endovascular device of claim 1, wherein the tube comprises a plurality of slots, each of the slots disposed partially around the circumference of the tube [In various embodiments, eye-holes or eyelets 139 are cut or formed in flexible tube 140 for infusion along terminal portion 138 (Racz Col 8:34-36, Fig. 10)].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz in view of Truckai, as applied to claim 5, in further view of Hampton (US-4940062-A).
Regarding claim 7, Racz in view of Truckai teaches
The endovascular device of claim 5.
However, Racz in view of Truckai fails to explicitly disclose wherein a diameter of the control element tapers from the proximal end of the tube to the distal end of the tube.
Hampton discloses a steerable catheter comprising a coil and a control element for selectively bending the coil [The relative axial movement between the core 11 and the outer tubular element 12 compresses the expanded coil section 16 causing the reference member 18 to be thrust toward the tip 17. However, because the distal end of reference member 18 is secured to the plug 22, the reference member 18 bends toward the side of the coil 13 secured to the core element 11 causing tip deflection in that direction, as shown by the arrow 40 (Hampton Col 4:24-31, Fig. 1)], wherein a diameter of the control element tapers from the proximal end of the tube to the distal end of the tube [As shown in FIG. 1, the tapered portion of core element 11 is preferably flattened in one or more stages 24 to provide improved flexibility and stiffness transition in the tip thereof (Hampton Fig. 1)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Racz in view of Truckai to employ wherein a diameter of the control element tapers from the proximal end of the tube to the distal end of the tube, so as to improve flexibility and stiffness transition from the control element to the plug.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz in view of Truckai, as applied to claim 1, in further view of Friedman (US-20200060683-A1).
Regarding claim 8, Racz in view of Truckai teaches
The endovascular device of claim 1.
However, Racz in view of Truckai fails to explicitly disclose wherein a portion of the control element closer to the distal end of the tube has a rectangular cross-section, and a portion of the control element closer to a proximal end of the tube has a circular cross-section.
Friedman discloses a steerable endovascular device comprising an elongated shaft [elongated shaft 204 (Friedman Fig. 2)], a plug [distal end 210 (Friedman Fig. 2)], and a control element, wherein movement of the control element relative to the elongated shaft is configured to cause the elongated shaft to selectively bend [control wire 101 (Friedman Figs. 1-2); At a proximal end of the elongated shaft 204, the control wire 101 may be connected to a slider 211 of a handle 209, with the elongated shaft 204 connected to the handle 209 to facilitate the relative movement. (In FIG. 2, handle 209 is not depicted to the same scale as that of elongated shaft 204.) (Friedman ¶0049)], wherein Friedman further discloses wherein a portion of the control element closer to the distal end of the elongated shaft has a rectangular cross-section, and a portion of the control element closer to a proximal end of the elongated shaft has a circular cross-section [Alternatively, other non-symmetrical shapes (e.g., cross-sections) may be employed, consistent with the present disclosure to resist rotation and to permit torqueing (Friedman ¶0038); At least some embodiments of an exemplary endovascular device of the disclosure may encompass a fixture enabling transmission of a radial force of the elongated shaft 204 to the control wire 101 with 1:1 ratio. This may be achieved, for example, by preventing axial rotation between the control wire 101 and the elongated shaft 204 without preventing the axial movement between the control wire 101 and the elongated shaft 204. And such axial rotation prevention (without axial movement prevention) may be achieved, for example, by deforming at least a portion of the control wire 101 and making at least a portion of the inner cross-section of the round elongated shaft 204 non-round respectively. For example, there may be an overlap between the two rectangular (or flattened) portions 101-3 even during axial movement of the control wire 101 compared to the elongated shaft 204 (Friedman ¶0039); A control wire 101 with at least some flat or rectangular section or sections (Friedman ¶0040); In some embodiments, core wire 1330 may have a similar configuration as control wire 101 as depicted in FIG. 1. For example, core wire zones 1333 and 1335 may have cross-sections that are non-circular (e.g., elliptical, oval-shaped, rectangular, etc.) and may have smaller cross-sectional areas than core wire zones 1332, 1334, and 1336 (Friedman ¶0078, Fig. 13A)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz in view of Truckai to employ wherein a portion of the control element closer to the distal end of the tube has a rectangular cross-section, and a portion of the control element closer to a proximal end of the tube has a circular cross-section, so as to allow for torque and axial movement to be transmitted to the tube and plug via the control element.
Claim(s) 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz in view of Truckai, as applied to claim 9 above, in further view of Dewaele (US-20170172678-A1, cited by Applicant).
Regarding claim 10, Racz in view of Truckai teaches
The endovascular device of claim 9.
However, Racz in view of Truckai fails to explicitly disclose wherein a first slot of the plurality of slots faces in the first direction, and a second slot of the plurality of slots faces in a second direction different from the first direction, such that a first extent of the first slot is greater than a second extent of the second slot.
Dewaele discloses a steerable instrument comprising a tube with a plurality of slots formed in the tube, each of the slots disposed partially around the circumference of the tube [The wall of the hollow tube 21 in the proximal flexible region 24 and the distal flexible region may comprise a structure that is a plurality of linkages 28 separated by strain-relief apertures 29, which linkages 28 and apertures 29 allow the second tubular member to flex. Two or more separate series of such apertures 29 may be formed adjacent one another on opposite or different sides as shown in FIG.7 of the tubular body to permit deflection or bending of the tubular body in multiple directions about its longitudinal axis (F-F′). Other known techniques that make rigid tubes more flexible are the use of spiral cuts, hinges cuts, dove-tail cuts, and heart-like cuts. The apertures and patterns can be cut using the methods mentioned herein, in particular laser cutting technology. To better control the bending radius, for instance less bending in the distal portion of the proximal bending zone, the apertures (or linkages) may have different sizes (Dewaele ¶0170, Fig. 7)]; wherein a first slot of the plurality of slots faces in the first direction, and a second slot of the plurality of slots faces in a second direction different from the first direction, such that a first extent of the first slot is greater than a second extent of the second slot [wherein as depicted in Dewaele Fig. 7, each aperture 29 (slot) may face a different direction, and Dewaele ¶0170 discloses that each slot may be of a different size].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz in view of Truckai to employ wherein a first slot of the plurality of slots faces in the first direction, and a second slot of the plurality of slots faces in a second direction different from the first direction, such that a first extent of the first slot is greater than a second extent of the second slot, so as to allow for increased control over the flexibility of the tube.
Regarding claim 11, Racz in view of Truckai teaches
The endovascular device of claim 9, further comprising a second plurality of slots formed on a portion of the tube separate from the selectively bendable portion [Racz Fig. 10, wherein the “selectively bendable portion” is sufficiently broad to interpret any specific location of the modified tube of Racz in view of Truckai as the “selectively bendable portion” and any other portion of the tube that comprises slots along the length of the tube as the claimed portion that comprises the second plurality of slots].
However, Racz in view of Truckai fails to explicitly disclose wherein the second plurality of slots are distributed symmetrically about the tube, and wherein the second plurality of slots enhances the flexibility of the tube in the portion.
Dewaele discloses a steerable instrument comprising a tube with a plurality of slots formed in the tube, each of the slots disposed partially around the circumference of the tube [Dewaele ¶0170, Fig. 7]; wherein a second plurality of slots are distributed symmetrically about the tube, and wherein the second plurality of slots enhances the flexibility of the tube in the portion [Dewaele ¶0170, Fig. 7, wherein any first number of the apertures 29 may be interpreted to comprise a first plurality and any other number of the apertures 29 may be interpreted to comprise the second plurality].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz in view of Truckai to employ wherein the second plurality of slots are distributed symmetrically about the tube, and wherein the second plurality of slots enhances the flexibility of the tube in the portion, so as to allow for increased control over the flexibility of the tube.
Regarding claim 12, Racz in view of Truckai teaches
The endovascular device of claim 9.
However, Racz in view of Truckai fails to explicitly disclose wherein a first slot of the plurality of slots is rotationally offset with respect to an adjacent second slot of the plurality of slots such that ends of the first slot are not aligned with ends of the second slot.
Dewaele discloses a steerable instrument comprising a tube with a plurality of slots formed in the tube, each of the slots disposed partially around the circumference of the tube [Dewaele ¶0170, Fig. 7]; wherein a first slot of the plurality of slots is rotationally offset with respect to an adjacent second slot of the plurality of slots such that ends of the first slot are not aligned with ends of the second slot [Dewaele Fig. 7].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz in view of Truckai to employ wherein a first slot of the plurality of slots is rotationally offset with respect to an adjacent second slot of the plurality of slots such that ends of the first slot are not aligned with ends of the second slot, so as to allow for increased control over the flexibility of the tube.
Regarding claim 13, Racz in view of Truckai teaches
The endovascular device of claim 9.
However, Racz in view of Truckai fails to explicitly disclose wherein each slot of the plurality of slots are formed with an elongated side, and wherein the elongated side is aligned perpendicular to an axis of the tube.
Dewaele discloses a steerable instrument comprising a tube with a plurality of slots formed in the tube, each of the slots disposed partially around the circumference of the tube [Dewaele ¶0170, Fig. 7]; wherein each slot of the plurality of slots are formed with an elongated side, and wherein the elongated side is aligned perpendicular to an axis of the tube [Dewaele Fig. 7].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz in view of Truckai to employ wherein each slot of the plurality of slots are formed with an elongated side, and wherein the elongated side is aligned perpendicular to an axis of the tube, so as to allow for increased control over the flexibility of the tube.
Regarding claim 14, Racz in view of Truckai teaches
The endovascular device of claim 9.
However, Racz in view of Truckai fails to explicitly disclose wherein each slot of the plurality of slots are formed with an elongated side, and wherein the elongated side is aligned at a non-perpendicular angle to an axis of the tube.
Dewaele discloses a steerable instrument comprising a tube with a plurality of slots formed in the tube, each of the slots disposed partially around the circumference of the tube [Dewaele ¶0170, Fig. 7]; wherein each slot of the plurality of slots are formed with an elongated side, and wherein the elongated side is aligned at a non-perpendicular angle to an axis of the tube [Dewaele ¶0170, Fig. 7, wherein at least a dovetail cut and a hinge cut is/are considered to be aligned at a non-perpendicular angle to an axis of the tube].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz in view of Truckai to employ wherein each slot of the plurality of slots are formed with an elongated side, and wherein the elongated side is aligned at a non-perpendicular angle to an axis of the tube, so as to allow for increased control over the flexibility of the tube.
Claim(s) 15-16 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz (US-8206343-B2).
Regarding claim 15, Racz teaches
An endovascular device, comprising:
a tube comprising a selectively bendable portion, wherein at least a portion of the tube is configured to be inserted into a blood vessel [A flexible tube 140 (Racz Fig. 10); While the various teachings of the invention disclosed herein find full utility in catheters utilizable in epidural procedures, those teachings also have applicability in whole or in part in all types of medical catheters, including cardiovascular access catheters, coronary catheters, endoscopic catheters, and surgical catheters (Racz Col 3:10-15)];
a plurality of slots formed in the tube, each of the slots disposed partially around the circumference of the tube [In various embodiments, eye-holes or eyelets 139 are cut or formed in flexible tube 140 for infusion along terminal portion 138 (Racz Col 8:34-36, Fig. 10)];
a control element extending through at least a portion of the tube, the control element connected to a distal portion of the selectively bendable portion, wherein movement of the control element relative to the tube is configured to cause the selectively bendable portion of the tube to bend [Filament 146 also includes a free portion 152 having a distal end 154 that is joined to distal end 150 of bound portion 148… The withdrawal of free portion 152 of filament 146 proximally through the working lumen in catheter 130 as indicated by an arrow W.sub.3 causes distal tip 132 of catheter 130 to be deflected to the right in a direction indicated by an arrow an D.sub.3 (Racz Col 8:47-57, Fig. 10)]; and
a spacer disposed within the tube and placed between the tube and the control element, the spacer comprising at least one wire formed in a coil and configured to reduce sliding friction between the tube and the control element [Catheter 130 includes an elongated, helical coil spring 136 that encloses a longitudinally extending passageway. In a terminal portion 138 of coil spring 136 adjoining the distal end thereof, successive loops of coil spring 136 are longitudinally separated (Racz Col 8:17-31)] and configured to reduce sliding friction between the tube and the control element [wherein as depicted in Racz Fig. 10, the coil spring 136 physically separating/spacing away the free portion 152 of filament 146 (control element) from the flexible tube 140 (tube) is considered to read on being configured to reduce sliding friction between the tube and the control element].
However, while Racz discloses and depicts the coil as having a non-zero pitch [In a terminal portion 138 of coil spring 136 adjoining the distal end thereof, successive loops of coil spring 136 are longitudinally separated. Proximal of terminal portion 138 successive loops of coil spring 136 are bottomed out (Racz Col 8:19-23, Fig. 10), wherein a non-zero pitch is considered to define a pitch that is an undisclosed variable times the diameter of the coil] and further notes that the spacing between successive loops of the coil [pitch] is considered to be a result effective variable in that changing the pitch of the coil affects the flexibility and ease of steering the device [As shown in FIG. 3, the longitudinal separation between successive loops of coil spring 36 within the embrace of flexible tube 40 is repeated through a terminal portion 64 of coil spring 36 adjoining distal end 34 thereof. This arrangement increases the lateral flexibility in catheter 10 at terminal portion 64 of coil spring 36, and that in turn facilitates steering movements of the type illustrated in FIG. 5B… The portion of catheter 10 that encircles terminal portion 64 of coil spring 36 is readily deflectable laterally. This reduces the likelihood of injury by that portion of catheter 10 to internal physiological structures in the body of a patient (Racz Col 5:35-41, 48-52, Fig. 3)], Racz fails to explicitly disclose wherein the coil has a pitch at least 1.2 times a diameter of the wire. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Racz to have a pitch in the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz to employ wherein the coil has a pitch at least 1.2 times a diameter of the wire 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 16, Racz teaches
The endovascular device of claim 15, wherein the spacer surrounds at least part of the control element circumferentially [Racz Fig. 10].
Regarding claim 29, Racz teaches
The endovascular device of claim 15, further comprising a plug disposed at a distal end of the tube, wherein the plug has a rounded tip configured to be inserted into a blood vessel [Racz Col 8:65-9:3, Fig. 10; see Racz Col 3:10-15 regarding configuration to be inserted into a blood vessel].
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz, as applied to claim 15 above, in further view of Hampton (US-4940062-A).
Regarding claim 17, Racz teaches
The endovascular device of claim 15.
However, while Racz discloses that certain elements of the device may be formed from a radiopaque material [In various embodiments, steering cable 112, reinforcement cable 108, and/or filament 146 increase radiopacity of the embodiment, thereby allowing for better visibility when using fluoroscopic guidance or the like (Racz Col 7:40-43)], Racz fails to explicitly disclose wherein the spacer is at least partially formed from a radiopaque material.
Hampton discloses a steerable catheter comprising a coil and a control element for selectively bending the coil [The relative axial movement between the core 11 and the outer tubular element 12 compresses the expanded coil section 16 causing the reference member 18 to be thrust toward the tip 17. However, because the distal end of reference member 18 is secured to the plug 22, the reference member 18 bends toward the side of the coil 13 secured to the core element 11 causing tip deflection in that direction, as shown by the arrow 40 (Hampton Col 4:24-31, Fig. 1)], wherein the coil is at least partially formed from a radiopaque material [At least the portion 26 of the coil 13 distally of the expanded section 16 should be formed of suitable radiopaque material, such as platinum, tungsten, and alloys thereof, to facilitate the fluoroscopic observation thereof during angioplasty procedures (Hampton Col 3:45-50, Fig. 1)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz to employ wherein the spacer is at least partially formed from a radiopaque material, so as to facilitate fluoroscopic observation of the device.
Claim(s) 18-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz, as applied to claim 15 above, in further view of Dewaele (US-20170172678-A1, cited by Applicant).
Regarding claim 18, Racz teaches
The endovascular device of claim 15.
However, Racz fails to explicitly disclose wherein a first slot of the plurality of slots faces in the first direction, and a second slot of the plurality of slots faces in a second direction different from the first direction, such that a first extent of the first slot is greater than a second extent of the second slot.
Dewaele discloses a steerable instrument comprising a tube with a plurality of slots formed in the tube, each of the slots disposed partially around the circumference of the tube [The wall of the hollow tube 21 in the proximal flexible region 24 and the distal flexible region may comprise a structure that is a plurality of linkages 28 separated by strain-relief apertures 29, which linkages 28 and apertures 29 allow the second tubular member to flex. Two or more separate series of such apertures 29 may be formed adjacent one another on opposite or different sides as shown in FIG.7 of the tubular body to permit deflection or bending of the tubular body in multiple directions about its longitudinal axis (F-F′). Other known techniques that make rigid tubes more flexible are the use of spiral cuts, hinges cuts, dove-tail cuts, and heart-like cuts. The apertures and patterns can be cut using the methods mentioned herein, in particular laser cutting technology. To better control the bending radius, for instance less bending in the distal portion of the proximal bending zone, the apertures (or linkages) may have different sizes (Dewaele ¶0170, Fig. 7)]; wherein a first slot of the plurality of slots faces in the first direction, and a second slot of the plurality of slots faces in a second direction different from the first direction, such that a first extent of the first slot is greater than a second extent of the second slot [wherein as depicted in Dewaele Fig. 7, each aperture 29 (slot) may face a different direction, and Dewaele ¶0170 discloses that each slot may be of a different size].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz to employ wherein a first slot of the plurality of slots faces in the first direction, and a second slot of the plurality of slots faces in a second direction different from the first direction, such that a first extent of the first slot is greater than a second extent of the second slot, so as to allow for increased control over the flexibility of the tube.
Regarding claim 19, Racz in view of Dewaele teaches
The endovascular device of claim 18, wherein the extent difference between the first slot and the second slot biases the selectively bendable portion to bend in the first direction when the wire is moved [Dewaele ¶0170, Fig. 7].
Regarding claim 20, Racz in view of Dewaele teaches
The endovascular device of claim 18, wherein the first slot of the plurality of slots has a larger area than the second slot of the plurality of slots [Dewaele ¶0170, Fig. 7].
Regarding claim 21, Racz in view of Dewaele teaches
The endovascular device of claim 18, wherein the first slot of the plurality of slots has a different shape than the second slot of the plurality of slots [Dewaele ¶0170, Fig. 7].
Regarding claim 22, Racz in view of Dewaele teaches
The endovascular device of claim 18, wherein the second direction is oriented to face an opposite radial direction than the first direction [Dewaele ¶0170, Fig. 7].
Regarding claim 23, Racz teaches
The endovascular device of claim 15, further comprising a second plurality of slots formed on a portion of the tube separate from the selectively bendable portion [wherein the “selectively bendable portion” is sufficiently broad to interpret any specific location of the modified tube of Racz in view of Dewaele as the “selectively bendable portion” and any other portion of the tube that comprises slots along the length of the tube as the claimed portion that comprises the second plurality of slots].
However, Racz fails to explicitly disclose wherein the second plurality of slots are distributed symmetrically about the tube, and wherein the second plurality of slots enhances the flexibility of the tube in the portion.
Dewaele discloses a steerable instrument comprising a tube with a plurality of slots formed in the tube, each of the slots disposed partially around the circumference of the tube [Dewaele ¶0170, Fig. 7]; wherein a second plurality of slots are distributed symmetrically about the tube, and wherein the second plurality of slots enhances the flexibility of the tube in the portion [Dewaele ¶0170, Fig. 7, wherein any first number of the apertures 29 may be interpreted to comprise a first plurality and any other number of the apertures 29 may be interpreted to comprise the second plurality].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz to employ wherein the second plurality of slots are distributed symmetrically about the tube, and wherein the second plurality of slots enhances the flexibility of the tube in the portion, so as to allow for increased control over the flexibility of the tube.
Regarding claim 24, Racz teaches
The endovascular device of claim 15.
However, Racz fails to explicitly disclose wherein a first slot of the plurality of slots is rotationally offset with respect to an adjacent second slot of the plurality of slots such that ends of the first slot are not aligned with ends of the second slot.
Dewaele discloses a steerable instrument comprising a tube with a plurality of slots formed in the tube, each of the slots disposed partially around the circumference of the tube [Dewaele ¶0170, Fig. 7]; wherein a first slot of the plurality of slots is rotationally offset with respect to an adjacent second slot of the plurality of slots such that ends of the first slot are not aligned with ends of the second slot [Dewaele ¶0170, Fig. 7].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz to employ wherein a first slot of the plurality of slots is rotationally offset with respect to an adjacent second slot of the plurality of slots such that ends of the first slot are not aligned with ends of the second slot, so as to allow for increased control over the flexibility of the tube.
Regarding claim 25, Racz in view of Dewaele teaches
The endovascular device of claim 24, wherein the plurality of slots comprises at least two slots dispersed along the tube, and wherein each of the slots is rotationally interleaved with an adjacent slot [Dewaele ¶0170, Fig. 7].
Regarding claim 26, Racz teaches
The endovascular device of claim 15.
However, Racz fails to explicitly disclose wherein each slot of the plurality of slots is rotationally offset from an adjacent slot of the plurality of slots by a predetermined angle.
Dewaele discloses a steerable instrument comprising a tube with a plurality of slots formed in the tube, each of the slots disposed partially around the circumference of the tube [Dewaele ¶0170, Fig. 7]; wherein each slot of the plurality of slots is rotationally offset from an adjacent slot of the plurality of slots by a predetermined angle [Dewaele ¶0170, Fig. 7].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz to employ wherein each slot of the plurality of slots is rotationally offset from an adjacent slot of the plurality of slots by a predetermined angle, so as to allow for increased control over the flexibility of the tube.
Regarding claim 27, Racz teaches
The endovascular device of claim 15.
However, Racz fails to explicitly disclose wherein each slot of the plurality of slots are formed with an elongated side, and wherein the elongated side is aligned perpendicular to an axis of the tube.
Dewaele discloses a steerable instrument comprising a tube with a plurality of slots formed in the tube, each of the slots disposed partially around the circumference of the tube [Dewaele ¶0170, Fig. 7]; wherein each slot of the plurality of slots are formed with an elongated side, and wherein the elongated side is aligned perpendicular to an axis of the tube [Dewaele ¶0170, Fig. 7].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz to employ wherein each slot of the plurality of slots are formed with an elongated side, and wherein the elongated side is aligned perpendicular to an axis of the tube, so as to allow for increased control over the flexibility of the tube.
Regarding claim 28, Racz teaches
The endovascular device of claim 15.
However, Racz fails to explicitly disclose wherein each slot of the plurality of slots are formed with an elongated side, and wherein the elongated side is aligned at a non-perpendicular angle to an axis of the tube.
Dewaele discloses a steerable instrument comprising a tube with a plurality of slots formed in the tube, each of the slots disposed partially around the circumference of the tube [Dewaele ¶0170, Fig. 7]; wherein each slot of the plurality of slots are formed with an elongated side, and wherein the elongated side is aligned at a non-perpendicular angle to an axis of the tube [Dewaele ¶0170, Fig. 7, wherein at least a dovetail cut and a hinge cut is/are considered to be aligned at a non-perpendicular angle to an axis of the tube].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz to employ wherein each slot of the plurality of slots are formed with an elongated side, and wherein the elongated side is aligned at a non-perpendicular angle to an axis of the tube, so as to allow for increased control over the flexibility of the tube.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz, as applied to claim 15 above, in further view of Truckai.
Regarding claim 30, Racz in view of Truckai teaches
The endovascular device of claim 15.
However, Racz fails to explicitly disclose further comprising a washer disposed in the tube, the washer fixed with respect to the tube, wherein at least one of the control element and the spacer are connected to the washer.
Truckai discloses systems for a steerable catheter, wherein Truckai discloses a bendable tube [tubing 50 (Truckai Col 5:67-6:2, Fig. 5)], a plug disposed at a distal end of the tube [tip electrode 20 (Truckai Fig. 5)], a washer disposed between the plug and the tube, the washer fixed with respect to the tube [anchor plate 72 (Truckai Col 6:45-51, 57-62, Fig. 5); wherein the anchor plate 72 of Truckai is considered to read on the broadest reasonable interpretation of a washer, based on the plain definition of a washer referring to a flat thin ring or a perforated plate used in joints or assemblies to ensure tightness, prevent leakage, or relieve friction (https://www.merriam-webster.com/dictionary/washer)]; wherein a distal end of a control element is connected to the washer, wherein movement of the control element relative to the tube is configured to cause the selectively bendable portion of the tube to bend [Truckai Col 6:48-57, 10:27-30].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Racz to employ a washer disposed in the tube, the washer fixed with respect to the tube, wherein at least one of the control element and the spacer are connected to the washer, as this modification would amount to mere simple substitution of one known element [control element of Racz coupled to the plug] for another [control element coupled to washer disposed between plug and tube] with similar expected results [allowing for movement of the control element to selectively bend the tube] [MPEP § 2143(I)(B)].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791