DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 26 May 2026. The Examiner acknowledges the amendments to claims 1, 9, 11-15, 18, 20-21, and 23-28, and the cancelation of claim 10. Claims 1-9, 11-30 are pending.
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 because the Examiner objects to the use of “FIG. 2” and “FIG. 3” to designate the same illustration on Replacement Sheet p. 1 dated 26 May 2026 [the Examiner notes that “FIG. 3” and “FIG. 4” are similarly used to designate the same illustration on Replacement Sheet p. 2; “FIG. 3B” and “FIG. 4B” are similarly used to designate the same illustration on Replacement Sheet p. 3; “FIG. 5” and “FIG. 6” are similarly used to designate the same illustration on Replacement Sheet p. 4; “FIG. 8” and “FIG. 9” are similarly used to designate the same illustration on Replacement Sheet p. 5]. The Examiner suggests using reference characters such as “A” [or any other reference number or character not already in use] in place of each instance of “FIG. 3” on Replacement Sheet p. 1, and referring to corresponding section view “A-A” in ¶0016 of the Applicant’s Specification [such that ¶0016 of the Applicant’s Specification would read “Fig. 3 is a partial section view A-A of the endovascular device of FIG. 2” based on the suggested amendment to the illustration on Replacement Sheet p. 1]. Similar amendments are suggested for each instance identified above regarding the designation of illustrations with different figure numbers and corresponding reference in the Applicant’s Specification [use of “B-B” in Fig. 3 to refer to the cross section depicted in Fig. 4 (¶0020); use of “C-C” in Fig. 3B to refer to the cross section in Fig. 4B (¶0022); use of “D-D” in Fig. 5 to refer to the cross section in Fig. 6 (¶0025); use of “E-E” in Fig. 8 to refer to the cross section depicted in Fig. 9 (¶0029)].
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.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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, 9, and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz (US-8206343-B2, previously presented) in view of Northrop (US-8821477-B2) and Truckai (US-5397304-A, previously presented).
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, while Racz acknowledges that catheters that employ apertures or valving in the side walls of the catheter are known in the art and such teaching are applicable to the catheter of Racz [the teachings of the invention have utility in a catheter having a working lumen with a closed distal end or a working lumen that communicates with the exterior of that catheter through the sidewalls thereof (Racz Col 2:55-58); In addition, catheters are known in which the working lumen thereof is closed at the distal end thereof; so that fluid flow therethrough is precluded, or if effected at all, is effected through apertures or valving provided in the side walls or the tip of the catheter (Racz Col 4:14-18)], Racz fails to explicitly disclose a first plurality of slots disposed in the selectively bendable portion and facing a first direction and a second plurality of slots disposed in the selectively bendable portion and facing a second direction different from the first direction, wherein each slot of the first plurality of slots comprises a first width and each slot of the second plurality of slots comprises a second width less than the first width to bias the tube in the first direction.
Northrop discloses an endovascular device comprising: a tube comprising a selectively bendable portion; and a first plurality of slots disposed in the selectively bendable portion and facing a first direction and a second plurality of slots disposed in the selectively bendable portion and facing a second direction different from the first direction, wherein each slot of the first plurality of slots comprises a first width and each slot of the second plurality of slots comprises a second width less than the first width to bias the tube in the first direction [As shown in FIG. 7, two narrow slots 330b/330c are disposed directly opposite wide slot 330a. As such, wide slots 330a may be about twice or more as wide as slots 330b/330c. The exact widths of slots 330a/330b/330c, however, can vary any include any suitable width. In other embodiments, the arrangement of slots 330a/330b/330c may be altered so that more than two narrow slots are disposed opposite wide slot 330a. In these embodiments, the width of wide slots 330a and/or the width of narrow slots 330b/330c can vary to be "wider" or "narrower", as desired. In addition, tubular member 328 may include some wide slots 330a with one, two, three, or more narrow slots opposite it and other wide slots 330a with the same or a different number of slots opposite it (including wide and/or narrow slots). In some embodiments, all the wide slots 330a are disposed along the same side of tubular member 328 and all the narrow slots 330b/330c are disposed on the opposite side. In other embodiments, however, wide slots 330a and/or narrow slots 330b/330c can be distributed on either side of tubular member 328 in any suitable pattern or arrangement. It can be appreciated that a preferential bending direction may be defined along the side of tubular member 328 where wide slots 330a are positioned. Along the opposite side (e.g., wherein slots 330b/330c are positioned), tubular member 328 may or may not have a more difficult or "least preferential bending direction". The most/least preferential bending directions may be desirable for the same reasons described above as well as for a number of additional reasons (Northrop Col 5:15-42, 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 a first plurality of slots disposed in the selectively bendable portion and facing a first direction and a second plurality of slots disposed in the selectively bendable portion and facing a second direction different from the first direction, wherein each slot of the first plurality of slots comprises a first width and each slot of the second plurality of slots comprises a second width less than the first width to bias the tube in the first direction, so as to allow for increased control over the flexibility of the tube and to achieve a preferential bending direction, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [enhance flexibility of the tube in a particular direction] [MPEP § 2143(I)(D)].
However, Racz in view of Northrop 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 in view of Northrop 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 Northrop and Truckai fails to explicitly disclose wherein the coil has a pitch at least 1.2 times a diameter of the at least one 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 in view of Northrop 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 Northrop and Truckai to employ wherein the coil has a pitch at least 1.2 times a diameter of the at least one 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 Northrop and 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 Northrop and 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 Northrop and 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 Northrop and 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 Northrop and 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 Northrop and Truckai teaches
The endovascular device of claim 1, wherein each of the slots of the first and second plurality of slots are disposed partially around a circumference of the tube [See § 103 modification of claim 1 above; Northrop Col 5:15-42, Fig. 7].
Regarding claim 11, Racz in view of Northrop and Truckai teaches
The endovascular device of claim 1.
However, Racz in view of Northrop and Truckai as presently modified fails to explicitly disclose further comprising a third plurality of slots formed on a portion of the tube separate from the selectively bendable portion, wherein the third plurality of slots are distributed symmetrically about the tube, and wherein the third plurality of slots enhances flexibility of the tube in the portion.
Northrop does disclose employing different sections along a length of the tube comprising separate pluralities of slots formed on each respective section of the tube, wherein each plurality of slots is distributed symmetrically about the tube, and wherein each plurality of slots enhances flexibility of the tube in the respective section [Additionally, slots 30 can be arranged along the length of, or about the circumference of, tubular member 28 to achieve desired properties. For example, adjacent slots 30, or groups of slots 30, can be arranged in a symmetrical pattern, such as being disposed essentially equally on opposite sides about the circumference of tubular member 28, or can be rotated by an angle relative to each other about the axis of tubular member 28. Additionally, adjacent slots 30, or groups of slots 30, may be equally spaced along the length of tubular member 28, or can be arranged in an increasing or decreasing density pattern, or can be arranged in a non-symmetric or irregular pattern. Other characteristics, such as slot size, slot shape and/or slot angle with respect to the longitudinal axis of tubular member 28, can also be varied along the length of tubular member 28 in order to vary the flexibility or other properties (Northrop Col 10:35-50)].
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 Northrop and Truckai to employ further comprising a third plurality of slots formed on a portion of the tube separate from the selectively bendable portion, wherein the third plurality of slots are distributed symmetrically about the tube, and wherein the third plurality of slots enhances flexibility of the tube in the portion, so as to allow for increased control over the flexibility of particular portions of the tube and to achieve a particular bend angle of articulation of particular portions of the tube, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [enhance flexibility of particular portions of the tube] [MPEP § 2143(I)(D)].
Regarding claim 12, Racz in view of Northrop and Truckai teaches
The endovascular device of claim 1, wherein a first slot of the first plurality of slots is rotationally offset with respect to an adjacent second slot of the first plurality of slots such that ends of the first slot are not aligned with ends of the second slot [See § 103 modification of claim 1 above; Northrop Col 5:15-42, Fig. 7].
Regarding claim 13, Racz in view of Northrop and Truckai teaches
The endovascular device of claim 1, wherein each slot of the first and second plurality of slots are formed with an elongated side, and wherein the elongated side is aligned perpendicular to an axis of the tube [See § 103 modification of claim 1 above; Northrop Col 5:15-42, Fig. 7].
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz in view of Northrop and Truckai, as applied to claim 5, in further view of Hampton (US-4940062-A, previously presented).
Regarding claim 7, Racz in view of Northrop and Truckai teaches
The endovascular device of claim 5.
However, Racz in view of Northrop and 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 Northrop and 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 Northrop and Truckai, as applied to claim 1, in further view of Friedman (US-20200060683-A1, previously presented).
Regarding claim 8, Racz in view of Northrop and Truckai teaches
The endovascular device of claim 1.
However, Racz in view of Northrop and 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 Northrop and 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) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz in view of Northrop and Truckai, as applied to claim 14 above, in further view of Dewaele (US-20170172678-A1, cited by Applicant, previously presented).
Regarding claim 14, Racz in view of Northrop and Truckai teaches
The endovascular device of claim 1, wherein each slot of the first and second plurality of slots are formed with a first elongated side and a second elongated side opposite the first elongated side [See § 103 modification of claim 1 above; Northrop Col 5:15-42, Fig. 7].
However, Racz in view of Northrop and Truckai fails to explicitly disclose wherein the first and second elongated sides are 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 [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 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 Northrop Truckai to employ wherein the first and second elongated sides are aligned at a non-perpendicular angle to an axis of the tube, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [employ a known type of slot pattern along a tube to allow for flexibility of the tube] [MPEP § 2143(I)(D)].
Claim(s) 15-16, 18-27, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz (US-8206343-B2, previously presented) in view of Northrop (US-8821477-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 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 acknowledges that catheters that employ apertures or valving in the side walls of the catheter are known in the art and such teaching are applicable to the catheter of Racz [the teachings of the invention have utility in a catheter having a working lumen with a closed distal end or a working lumen that communicates with the exterior of that catheter through the sidewalls thereof (Racz Col 2:55-58); In addition, catheters are known in which the working lumen thereof is closed at the distal end thereof; so that fluid flow therethrough is precluded, or if effected at all, is effected through apertures or valving provided in the side walls or the tip of the catheter (Racz Col 4:14-18)], Racz fails to explicitly disclose a first plurality of slots formed in the selectively bendable portion and facing a first direction and a second plurality of slots formed in the selectively bendable portion and facing a second direction different from the first direction, wherein each slot of the first plurality of slots comprises a first width and each slot of the second plurality of slots comprises a second width less than the first width, each of the slots disposed partially around a circumference of the tube.
Northrop discloses an endovascular device comprising: a tube comprising a selectively bendable portion; and a first plurality of slots formed in the selectively bendable portion and facing a first direction and a second plurality of slots formed in the selectively bendable portion and facing a second direction different from the first direction, wherein each slot of the first plurality of slots comprises a first width and each slot of the second plurality of slots comprises a second width less than the first width, each of the slots disposed partially around a circumference of the tube [As shown in FIG. 7, two narrow slots 330b/330c are disposed directly opposite wide slot 330a. As such, wide slots 330a may be about twice or more as wide as slots 330b/330c. The exact widths of slots 330a/330b/330c, however, can vary any include any suitable width. In other embodiments, the arrangement of slots 330a/330b/330c may be altered so that more than two narrow slots are disposed opposite wide slot 330a. In these embodiments, the width of wide slots 330a and/or the width of narrow slots 330b/330c can vary to be "wider" or "narrower", as desired. In addition, tubular member 328 may include some wide slots 330a with one, two, three, or more narrow slots opposite it and other wide slots 330a with the same or a different number of slots opposite it (including wide and/or narrow slots). In some embodiments, all the wide slots 330a are disposed along the same side of tubular member 328 and all the narrow slots 330b/330c are disposed on the opposite side. In other embodiments, however, wide slots 330a and/or narrow slots 330b/330c can be distributed on either side of tubular member 328 in any suitable pattern or arrangement. It can be appreciated that a preferential bending direction may be defined along the side of tubular member 328 where wide slots 330a are positioned. Along the opposite side (e.g., wherein slots 330b/330c are positioned), tubular member 328 may or may not have a more difficult or "least preferential bending direction". The most/least preferential bending directions may be desirable for the same reasons described above as well as for a number of additional reasons (Northrop Col 5:15-42, 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 a first plurality of slots formed in the selectively bendable portion and facing a first direction and a second plurality of slots formed in the selectively bendable portion and facing a second direction different from the first direction, wherein each slot of the first plurality of slots comprises a first width and each slot of the second plurality of slots comprises a second width less than the first width, each of the slots disposed partially around a circumference of the tube, so as to allow for increased control over the flexibility of the tube and to achieve a preferential bending direction, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [enhance flexibility of the tube in a particular direction] [MPEP § 2143(I)(D)].
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 Northrop fails to explicitly disclose wherein the coil has a pitch at least 1.2 times a diameter of the at least one 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 in view of Northrop to employ wherein the coil has a pitch at least 1.2 times a diameter of the at least one 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 in view of Northrop teaches
The endovascular device of claim 15, wherein the spacer surrounds at least part of the control element circumferentially [Racz Fig. 10].
Regarding claim 18, Racz in view of Northrop teaches
The endovascular device of claim 15, wherein a first extent of a first slot of the first plurality of slots is greater than a second extent of a second slot of the second plurality of slots [See § 103 modification of claim 15 above; Northrop Col 5:15-42, Fig. 7, wherein the area of the coarse cuts is considered to read on a “first extent” and the area of the fine cuts are considered to read on a “second extent” based on the broadest reasonable interpretation of “extent” referring to open area (Applicant’s Specification ¶0062)].
Regarding claim 19, Racz in view of Northrop 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 [See § 103 modification of claim 15 above; Northrop Col 5:15-42, Fig. 7].
Regarding claim 20, Racz in view of Northrop teaches
The endovascular device of claim 18, wherein the first slot of the first plurality of slots has a larger area than the second slot of the second plurality of slots [See § 103 modification of claim 15 above; Northrop Col 5:15-42, Fig. 7].
Regarding claim 21, Racz in view of Northrop teaches
The endovascular device of claim 18, wherein the first slot of the first plurality of slots has a different shape than the second slot of the second plurality of slots [See § 103 modification of claim 15 above; Northrop Col 5:15-42, Fig. 7].
Regarding claim 22, Racz in view of Northrop teaches
The endovascular device of claim 18, wherein the second direction is oriented to face an opposite radial direction than the first direction [See § 103 modification of claim 15 above; Northrop Col 5:15-42, Fig. 7].
Regarding claim 23, Racz in view of Northrop teaches
The endovascular device of claim 15.
However, Racz in view of Northrop as presently modified fails to explicitly disclose further comprising a third plurality of slots formed on a portion of the tube separate from the selectively bendable portion, wherein the third plurality of slots are distributed symmetrically about the tube, and wherein the third plurality of slots enhances flexibility of the tube in the portion.
Northrop does disclose employing different sections along a length of the tube comprising separate pluralities of slots formed on each respective section of the tube, wherein each plurality of slots is distributed symmetrically about the tube, and wherein each plurality of slots enhances flexibility of the tube in the respective section [Northrop Col 10:35-50].
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 Northrop to employ further comprising a third plurality of slots formed on a portion of the tube separate from the selectively bendable portion, wherein the third plurality of slots are distributed symmetrically about the tube, and wherein the third plurality of slots enhances flexibility of the tube in the portion, so as to allow for increased control over the flexibility of particular portions of the tube and to achieve a particular bend angle of articulation of particular portions of the tube, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [enhance flexibility of particular portions of the tube] [MPEP § 2143(I)(D)].
Regarding claim 24, Racz in view of Northrop teaches
The endovascular device of claim 15, wherein a first slot of the first plurality of slots is rotationally offset with respect to an adjacent second slot of the second plurality of slots such that ends of the first slot are not aligned with ends of the second slot [See § 103 modification of claim 1 above; Northrop Col 5:15-42, Fig. 7].
Regarding claim 25, Racz in view of Northrop teaches
The endovascular device of claim 24, wherein the first 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 [See § 103 modification of claim 1 above; Northrop Col 5:15-42, Fig. 7].
Regarding claim 26, Racz in view of Northrop teaches
The endovascular device of claim 15, wherein each slot of the first plurality of slots is rotationally offset from an adjacent slot of the second plurality of slots by a predetermined angle [See § 103 modification of claim 1 above; Northrop Col 5:15-42, Fig. 7].
Regarding claim 27, Racz in view of Northrop teaches
The endovascular device of claim 15, wherein each slot of the first plurality of slots are formed with an elongated side, and wherein the elongated side is aligned perpendicular to an axis of the tube [See § 103 modification of claim 1 above; Northrop Col 5:15-42, Fig. 7].
Regarding claim 29, Racz in view of Northrop 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 in view of Northrop, as applied to claim 15 above, in further view of Hampton (US-4940062-A, previously presented).
Regarding claim 17, Racz in view of Northrop 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 in view of Northrop 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 in view of Northrop 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) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz in view of Northrop, as applied to claim 15 above, in further view of Dewaele (US-20170172678-A1, cited by Applicant, previously presented).
Regarding claim 28, Racz in view of Northrop teaches
The endovascular device of claim 15, wherein each slot of the first plurality of slots are formed with a first elongated side and a second elongated side opposite the first elongated side [See § 103 modification of claim 1 above; Northrop Col 5:15-42, Fig. 7].
However, Racz in view of Northrop fails to explicitly disclose wherein the first and second elongated sides are 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 Northrop to employ wherein the first and second elongated sides are aligned at a non-perpendicular angle to an axis of the tube, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [employ a known type of slot pattern along a tube to allow for flexibility of the tube] [MPEP § 2143(I)(D)].
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Racz in view of Northrop, as applied to claim 15 above, in further view of Truckai.
Regarding claim 30, Racz in view of Northrop teaches
The endovascular device of claim 15.
However, Racz in view of Northrop 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 in view of Northrop 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)].
Response to Arguments
Applicant's arguments, see Applicant’s Remarks p. 9, filed 26 May 2026, with respect to the previously presented Drawing Objections have been fully considered but they are not persuasive.
See above Drawing Objections for proposed amendments to the drawings.
Applicant’s arguments, see Applicant’s Remarks p. 9, with respect to the previously presented Claim Objections have been fully considered and are persuasive. The objections to claims 1, 9, 11, 15, and 23 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 9-10, with respect to the previously applied Rejections under § 112(b) have been fully considered and are persuasive. The rejections of claims 10, 18, and those dependent therefrom have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 10-12, with respect to the rejection(s) of claim(s) 1, 15, and those dependent therefrom under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Racz (US-8206343-B2, previously presented) in view of Northrop (US-8821477-B2) and Truckai (US-5397304-A, previously presented) with respect to claim 1, as well as Racz (US-8206343-B2) in view of Northrop (US-8821477-B2) with respect to claim 15.
The Applicant asserts that Racz, Truckai, and Dewaele, alone or in combination, do not disclose or suggest the amended slot arrangement of “a first plurality of slots disposed in the selectively bendable portion and facing a first direction and a second plurality of slots disposed in the selectively bendable portion and facing a second direction different from the first direction, where each slot of the first plurality of slots comprises a first width and each slot of the second plurality of slots comprises a second width less than the first width” of claims 1 and 15; wherein the Applicant acknowledges that while Dewaele is relied upon to teach dependent claim 10 [first slots facing a first direction and second slots facing a second direction different from the first direction], the Applicant notes that Dewaele does not disclose different widths of first and second plurality of slots to bias a tube as claimed [Applicant cites Dewaele ¶0170 and Figs. 2A, 7, 10A, 11A-B as depicting slots having the same width]. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 and 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Racz is modified in view of Northrop (US-8821477-B2) [with respect to claim 15; and in further view of Truckai with respect to claim 1], wherein Northrop is considered to disclose an endovascular device comprising: a tube comprising a selectively bendable portion; and a first plurality of slots disposed in the selectively bendable portion and facing a first direction and a second plurality of slots disposed in the selectively bendable portion and facing a second direction different from the first direction, wherein each slot of the first plurality of slots comprises a first width and each slot of the second plurality of slots comprises a second width less than the first width to bias the tube in the first direction [Northrop Col 5:15-42, Fig. 7].
Furthermore, the Applicant asserts that a person having ordinary skill in the art would not be motivated to modify Racz’s catheter 10 with apertures 29 of Dewaele, as the Applicant notes that the eye-holes/eyelets of Racz for infusion of medicine along a terminal portion 138 at the distal tip [Racz Col 8:34-36] would have to be carefully sized to allow controlled delivery and withdrawal of fluids at the target site, such that a person having ordinary skill in the art would not scattering catheter 10 of Racz with apertures 29 of Dewaele, as the slots of Dewaele are not designed for, nor sized appropriately to support controlled medical infusion and instead serve a different function. As such, the Applicant notes that incorporating the apertures of Dewaele into the catheter of Racz would compromise the catheter’s ability to perform its intended therapeutic purpose. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 and 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument [See Examiner’s response above]. Furthermore, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that the use of eye-holes/eyelets in the catheter of Racz for for infusion of medicine is considered to be an exemplary embodiment of the catheter of Racz, wherein Racz further discloses additional and alternative uses of the catheter beyond infusion/withdrawal of fluids [Depending upon the uses to which catheter 10 is intended to be applied, such therapeutic activity might include the infusion of medication or the aspiration of body fluids, the visualization of regions interior the body of the patient, the measurement of internal body conditions, or the subjugation of regions of the interior of the body of a patient to cauterization or radio frequency ("RF") heating, pulsed RF, and electrical nerve stimulation (Racz Col 2:29-36)]. Moreover, Racz acknowledges that catheters that employ apertures or valving in the side walls of the catheter are known in the art and such teaching are applicable to the catheter of Racz [the teachings of the invention have utility in a catheter having a working lumen with a closed distal end or a working lumen that communicates with the exterior of that catheter through the sidewalls thereof (Racz Col 2:55-58); In addition, catheters are known in which the working lumen thereof is closed at the distal end thereof; so that fluid flow therethrough is precluded, or if effected at all, is effected through apertures or valving provided in the side walls or the tip of the catheter (Racz Col 4:14-18)], such that the present modification by Northrop is not considered to render Racz unable to perform its possible intended therapeutic purposes.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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